The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the state of Florida, having been issued license number ME 0033759. When Respondent was engaged in the practice of medicine, he practiced as a dermatologist, specializing in chemosurgery known as Moh's surgery. Subsequent to the events complained of herein, Respondent has not been engaged in the practice of medicine. Respondent and his ex-wife Nancy were married in 1972. They separated, with Respondent moving out of the marital home, in September of 1990. Their divorce became final in July of 1992. Over the years, Nancy Blender performed some secretarial and bookkeeping services for Respondent working part time or full time either at home or in Respondent's office, depending upon the ages and needs of their children. Respondent treated Nancy as a patient on only two occasions. In the early 1980s, Respondent removed several moles from her face. In 1989 Respondent removed a growth from her leg. Other than those two episodes of dermatological treatment, Nancy Blender was not a patient of Respondent, and Respondent did not treat her in his office for any other conditions or illnesses. Specifically, Respondent did not treat Nancy Blender for any type of muscle pain or muscle spasm. Toward the end of their marriage, Nancy Blender discovered a medical chart on her maintained by Respondent in his office. She was surprised to see that there was a chart on her. She opened the chart and saw that it contained only entries regarding the lesion removal from her leg in 1989. That chart contained no entries regarding medications prescribed for her and, specifically, did not contain any notations indicating that Respondent had prescribed for her either Darvocet or Valium. Nancy Blender removed her chart from Respondent's office. Thereafter, the location of that chart became unknown to both Nancy Blender and to Respondent. From April 4, 1987, through December 30, 1991, Respondent wrote in the name of Nancy Blender twenty-five prescriptions for Darvocet, 100 mg., each prescription being for one hundred tablets, for a total of twenty-five hundred tablets. Darvocet is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains propoxphene, a Schedule IV controlled substance listed in Chapter 893, Florida Statutes. From April 4, 1987, through December 30, 1991, Respondent issued twenty-four prescriptions in the name of Nancy Blender for Valium, 10 mg., each prescription being in the amount of one hundred tablets, for a total of twenty- four hundred tablets. Valium is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains diazepam, a Schedule IV controlled substance listed in Chapter 893, Florida Statutes. Each of those prescriptions was written by Respondent using either his own prescription forms or using blank prescription forms provided to him at the pharmacies where he filled the prescriptions. Each of the prescriptions was filled by Respondent personally, with Respondent physically going to a pharmacy and obtaining from the pharmacist the medication he had prescribed in Nancy's name. Nancy Blender did not ask Respondent to write prescriptions for Valium or for Darvocet. She did not see any of the prescriptions in question at the time they were written and did not have any of those prescriptions filled. She did, however, see bottles of Valium and Darvocet in the medicine cabinet of her home with her name on the bottles. She also saw Respondent consume Valium and Darvocet. During that time period Nancy Blender consumed one Darvocet, taking it for a headache while she and Respondent were on vacation. During that time period she also took a maximum of six to ten tablets of Valium per year with the exception of a two to three month period during 1989 when she took Valium three times a week. Respondent wrote and filled the prescriptions for Valium and Darvocet in order to obtain those medications for his own use. Further, Respondent ingested that Valium and Darvocet without medical supervision and was, therefore, self-administering. On Tuesdays Respondent performed Moh's surgery. Those patients undergoing surgery on Tuesdays would then return on either Thursday or Friday for repairs. An assistant was assigned to each room where patients would undergo surgery, the patients would be spread among those rooms, and Respondent would then move from room to room performing each stage of surgery on all patients before moving onto the next stage. Sometimes Respondent changed his surgical gloves and mask between patients, and sometimes he did not. Sometimes Respondent would don a clean surgical mask and clean surgical gloves and would wear that same mask and those same gloves as he went from room to room performing a stage of surgery. After the last patient, he would then remove his mask and gloves. When he was ready to start the next stage, he would put on a clean mask and clean gloves and wear those as he went from room to room. Sometimes when Respondent came into a room to perform a stage of surgery on the patient in that room, his gloves were visibly bloodied or otherwise soiled from the prior patient. Yet, he did not change them. When he did remove his surgical mask and gloves, Respondent would throw them and other items used into the sink in the patient room. The nurses and assistants would then dispose of the items in the sink, placing them either in the "red garbage" for bio-hazardous waste or into the regular trash receptacles. Respondent's office procedures fell below the minimum standard of care both as to his failure to replace his surgical mask and gloves after treating each patient and as to his failure to place waste in the appropriate waste receptacle.
Conclusions The Petitioner has the burden of proving its charges against the Respondent by clear and convincing evidence on every element of the charges against the Respondent. Ferris v. Turlington, 510 So.2d 292 (Fla.1987) and Slomowitz v Walker, 429 So.2d 797, 800 (Fla 4 DCA 1983) and Smith v HRS, 552 So2d 956 (1 DCA 1988). These cases, supra., stand for the propositions that clear and convincing evidence means the evidence must be of such great weight that the trier of fact has such a firm belief of guilt based on credible evidence lacking in witness confusion that there is no hesitancy in that belief of guilt and that such a standard of proof is greater than the preponderance of the evidence found in most civil cases and less than the beyond a reasonable doubt standard in criminal cases. The Petitioner's burden of proof has not been met in the matter at hand. Additionally, in the cases of Gonzalez v State, 547 So.2d 1274 (2 DCA 1989) and Green v state, 578 So2d 852 (1 DCA 1991), although criminal cases but analogous to the case at hand, these Courts held where the only proof of guilt is circumstantial, a conviction cannot be sustained if there is any reasonable hypothesis of innocence to the contrary no matter how strongly the evidence may suggest guilt. While these are criminal cases and the burden of proof is based on the exclusion of all reasonable doubt, they show the duty is on the prosecution to eliminate reasonable hypothesis of innocence. This the Petitioner herein did not do. The Administrative Hearing Officer by ignoring all the contradictory and tainted evidence of the Petitioner's witnesses obviously erred in law and in fact by not employing the proper evidentiary standard of requiring the Petitioner to prove its allegations against the Respondent by the clear and convincing weight of the evidence and testimony presented. A duly licensed physician in the State of Florida may prescribe medication of the type in issue to a family member including a spouse if the prescription is medically indicated and appropriate. It is not the duty of the Respondent to prove his innocence by establishing or proving the negative existence of the charges against him. The Courts of Florida have consistently held that when an individual is ill and can not adequately represent himself as was the Respondent he should be granted a continuance as a matter of right and due process and it was error to proceed to in the formal administrative hearing. WHEREFORE, the Hearing Officer erred in finding for the Petitioner because the Petitioner did not meet its burden of proof as to any and all of the allegations against the Respondent Dr. Steven L. Blender as it did not show by the clear and convincing weight of the evidence and testimony presented that the Respondent Steven L. Blender, M.D. did commit any of charges against him. Therefore, he should not have been found guilty on any of the alleged charges against him. Alternatively, the Respondent prays he be given rehearing or be allowed to reopen evidence and present evidence to defend himself. Additionally, the Administrative Hearing Officer erred by recommending that the Respondent's license to practice medicine in the State of Florida be revoked as it is too severe a penalty. Respectfully submitted, Respondent Steven Blender, M.D., Pro Se 250 Bradley Place, Apt. 608 Palm Beach, Florida 33480 CERTIFICATE OF SERVICE I certify that a copy of the foregoing has been furnished this 5th day of December 1994 to Agency for Health Care Administration, Board of Medicine, 1940 Monroe Street, Tallahassee, Florida 32399; Sam Power, Agency Clerk, Agency for Health Care Administration, The Atrium, Suite 301, 325 John Knox Road, Tallahassee, Florida 32303; Hearing officer Linda Rigot, Division of Administrative Hearings, The Desoto Building,1230 Appalachee Parkway, Tallahassee, Florida 32389 and to Petitioner's attorney Joseph Harrison, 2500 North Military Trail, Boca Raton, Florida 33431. Steven Blender, M.D. ================================================================= ORDER ON MOTION FOR REHEARING =================================================================
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered Dismissing Counts Two and Five of the Administrative Complaint filed in this cause, Finding Respondent guilty of the remaining allegations contained in the Administrative Complaint filed against him, and Revoking Respondent's medical license ME 0033759. DONE and ENTERED this 16th day of November, 1994, at Tallahassee, Florida. LINDA M. RIGOT 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 16th day of November, 1994. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 1 and 4-11 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 2, 12, and 13 have been rejected as not constituting findings of fact but rather as constituting argument of counsel or conclusions of law. Petitioner's proposed finding of fact numbered 3 has been rejected as being subordinate to the issues under consideration in this cause. COPIES FURNISHED: Joseph Harrison, Esquire Slepin, Harrison and Feuer 2500 North Military Trail Suite 275 Boca Raton, Florida 33431 Steven L Blender, M.D. 250 Bradley Place, Apt. 608 Palm Beach, Florida 33480 Dr. Marm Harris, Executive Director Agency for Health Care Administration, Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire General Counsel Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
Findings Of Fact Petitioner is a hospital licensed by the State of Florida and is located in Jacksonville, Florida. Respondent, the affected state agency, as defined in Subsection 120.52(1), Florida Statutes, is responsible for the regulation of health care facilities, to include Petitioner. The Department also considers the question of provision of additional health care in the community through its certificate of need program. Intervenor has made application to provide ambulatory surgery in Duval County, Florida, through a freestanding surgery center. Jacksonville, Florida, is in Duval County. This case is part of a consolidated hearing process and is the companion matter to Saint Vincent's Medical Center, Petitioner v. State of Florida, Department of Health and Rehabilitative Services and Ambulatory Care - Duval Development Corp., d/b/a Jacksonville Surgical Center - Ambulatory Surgical Center, Respondents, D.O.A.H. Case No. 83-337 and Riverside Hospital, Petitioner v. State of Florida, Department of Health and Rehabilitative Services and Ambulatory Care - Duval Development Corp. d/b/a Jacksonville Surgical Center - Ambulatory Surgical Center, Respondents, D.O.A.H. Case No. 83-482. The first three days of the hearing were conducted on the dates alluded to in this order. That presentation was transcribed. In addition, deposition testimony was presented and accepted as part of the record in this matter. The campanion cases concern the propriety of the grant of a certificate of need to the Intervenor in this cause to allow construction and operation of a freestanding ambulatory surgery center which would be used for performing outpatient surgeries. At all times relevant to this case, Saint Vincent's had a department in which outpatient surgical procedures were performed and are expected to be performed in the future. With the advent of the establishment of the Intervenor's facility, that health care unit will be in competition with Petitioner in the realm of providing surgical procedures. As recently as 1975, Respondent knew that ambulatory surgery centers, such as that proposed by the Intervenor, would need permission to construct such a facility. This permission relates to the need to apply and receive a certificate of need from the Department. The authority for such regulation was pursuant to applicable provisions of Chapter 381, Florida Statutes. Notwithstanding this regulatory role to be fulfilled, Respondent did not undertake a program for enacting rules to consider the question of need for ambulatory surgical centers. This lack of rulemaking was primarily due to inactivity of applicants seeking ambulatory surgical center certificates of need. This circumstance changed in late 1982. In December, 1982, Respondent received approximately thirteen applications for ambulatory surgical center certificates of need, as contrasted with approximately ten applications over the prior three years. At the same time Respondent was in the throes of having to revamp its certificate of need review process related to the overall health industry, brought about by statutory changes which abolished health system agencies and created local health councils. In 1983, at the time of the hearings, Respondent had received 27 applications for ambulatory surgery centers. This glut of applications by would-be ambulatory surgical centers and the 1982 applications were examined without formal rules defining the need question, related to expected numbers of surgical procedures that might be conducted on an outpatient or ambulatory basis. The determination of this ratio of outpatient surgical procedures to inpatient surgical procedures is a vital part of the need question. 1/ Absent promulgated rules, Department officials began their attempt to ascertain the percentage comparison between outpatient and inpatient surgeries, as that item was involved in the establishment of a methodology for considering the need question. Based upon information provided by applicants for ambulatory surgery centers and its own research, Respondent concluded that anywhere from 18 to 40 percent of total surgeries could be expected to be outpatient surgeries. Having utilized a median projection related to population expectations in the certificate of need process, the Department decided to use a median projection for the expected percentage of outpatient surgery. Thus, 29 percent was selected as the percentage of outpatient surgeries in the total number of surgical procedures and that percentage was utilized in the computation of the number of expected outpatient surgical procedures. Utilization of this 29 percent factor in the computation of the number of procedures to be expected on an outpatient basis may be seen in Petitioner's Exhibit 2 and Respondent's Exhibit 1, application reviews. Once the Department decided to employ the 29 percent factor, it has consistently, on a statewide basis, utilized that factor in evaluating the question of the grant of certificates of need for ambulatory surgical center applicants. This has been done in more than one batch or cycle and was done in the instance of Intervenor's application which is at issue. Although the 29 percent factor is not the only determining element of the certificate of need process, it is an integral part of that process and can affect the outcome of the grant of the certificate, as has been the case in two instances alluded to in the course of the hearing. This policy choice by the agency is not emerging. It is not one of a series of approaches that have been experimented with in trying to arrive at a concluding agency position, prior to the formal adoption of a rule. This percentage factor has been the only number utilized in the review of all ambulatory surgery center applications commencing late 1982 to the time of final hearing in this action. This choice has not stood the test or scrutiny of the rulemaking process set forth in Section 120.54, Florida Statutes. Notwithstanding the stated willingness of the agency to modify its position when presented with a more credible method, that contingency or eventuality has not occurred and every applicant for ambulatory surgery center certificate of need has had its application measured against the 29 percent factor commencing December 1982, to the exclusion of other techniques suggested by applicants. In the face of the facts reported above and the record considered, and recognizing that the agency should be afforded an opportunity to establish a record basis for the utilization of the 29 percent factor, even if it were found to be an invalid rule, a decision was reached at the time of hearing on the question of the utilization of the 29 percent factor and whether it was a rule not duly promulgated. It was found that the 29 percent factor is an unpromulgated rule and could not stand as law without first being subject to an assessment of the quality of the record basis for the agency's policy choice. The argument related to this case may be found at pages 798 through 829 of the transcript. The ruling is announced at pages 829 through 832. Respondent subsequently presented additional evidence in support of its policy choice and that may be found in succeeding sections within the transcript. This written order memorializes the ruling announced at hearing.
The Issue Whether Respondent, Dien Duong, violated the provisions of Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, as specifically alleged in the Administrative Complaint, and, if so, what penalty would be appropriate.
Findings Of Fact Based upon observation of the witnesses and their demeanor while testifying, the documentary evidence received, and the entire record compiled herein, the following material and relevant facts are found: Petitioner, Department of Health, Board of Medicine, is the state agency charged with regulating the practice of physician's assistants pursuant to Chapters 455 and 458, Florida Statutes, and Section 20.43, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician's assistant in the state of Florida, having been issued license number PA 0003211 in 1997. Respondent received a Bachelor's Degree in Biology from Hope College, Holland, Michigan, in 1989 and thereafter received her physician's assistant degree from Western Michigan University in 1991, and became certified in Family Practice and in Surgery in Michigan upon graduation. Respondent has maintained her certification in Family Practice and in Surgery by successfully passing an examination every six years since 1991, in addition to taking a minimum of 100 hours of Continuing Medical Education (CME) courses each year. In 1997 Respondent began working at South Florida Baptist Hospital Emergency Department and has maintained her employment in that department as a physician's assistant. During the course of her employment, Respondent has gained extensive experience in the practice of assessing lacerations and repairing lacerations of all types. Respondent is highly respected by her employing physician, Dr. Charles Eaves, and by her supervising physicians in the emergency department of the hospital. Respondent has never been the subject of discipline or corrective action regarding her professional job performance as a physician's assistant. A physician's assistant is a licensed health care professional who works under the supervision of a doctor. Typical protocol between the supervising doctor and the physician's assistant is for the physician's assistant to inspect and evaluate the patient, examine the injury, prepare the patient for treatment, consult with the supervising doctor, and thereafter administer treatment to the injury approved by the doctor, followed by after-care instructions to the patient. Based upon the testimony of the experts, the protocol between experienced physician's assistants and their supervising doctors is based upon the doctor's respect and confidence in the physician's assistant's abilities, competence, experience and work history. In these mutual trust and respect working relationships, protocol typically permits the physician's assistant to work relatively autonomously. Without involvement of the supervising doctor, the physician's assistant examines emergency room injuries; they often treat the injured patient, and thereafter present the patient's case treatment and the patient's medical record to the supervising doctor for approval and, when recommended, signature for prescribed medication. The protocol between Respondent and her supervising physician, Dr. Diaz, at South Florida Baptist Hospital on May 8, 1998, was that of mutual trust. Patient D.Z. was a 33 year-old male who had fallen from a ladder and, while attempting to break his fall with his right hand, suffered a blunt, T-shaped, tear-like laceration injury to his right hand. The injury was on the palmar aspect in the area of the fifth metacarpal of the hand-bone that extended to the small finger; a complex laceration, described by doctors as a "sort of bust or blunt type," as opposed to a clean knife cut type, approximately 3/4 centimeter in depth. On May 8, 1998, D.Z. presented himself to the South Florida Baptist Hospital (Hospital) emergency room for treatment of his right hand laceration that extended to the subcutaneous level with subcutaneous tissue exposure. The Hospital's triage nurse, after completing preliminary patient information, directed D.Z. to First Care, that part of the hospital's emergency department where Respondent was working. Respondent, following protocol, examined D.Z.'s injured right hand and ordered x-rays to be taken. An x-ray was taken of D.Z.'s right hand and was reviewed by Respondent's supervising physician, Dr. Diaz, prior to treatment of the injury by Respondent. Dr. Diaz concluded that D.Z.'s x-ray was negative, with no broken bones or tendon involved. The medical records noted that D.Z. had the full range of motion of his fingers without numbness or tingling at that time. Respondent's treatment of D.Z. consisted of laying D.Z. on his back with his arm out to his side and using local anesthesia to numb the injured area. After numbing the hand, she infiltrated the wound with one percent plain Lidocaine, irrigated the wound with normal saline, and cleaned the wound with Betadine. She then debrided the tissue. Using sterile techniques, Respondent proceeded to suture the T-shaped laceration of D.Z.'s right hand. Because of the shape and depth of the laceration and because of the exposure of jagged-edge tears to the subcutaneous tissues, Respondent placed four subcutaneous sutures with 4.0 vicryl, an absorbable suture, in order to bring and keep the jagged-edged tears of D.Z.'s laceration together. For the type of wound suffered by D.Z., described as "bust-type-ripping-flesh tear," it is not possible to close a three or four centimeter wound with only surface sutures. Subcutaneous sutures are required for those wounds of this type and depth. For these reasons and acting appropriately within the scope of the practice of an experienced physician's assistant, Respondent determined to use subcutaneous sutures on D.Z., who is right-hand dominate. The experts who testified, Dr. Eaves, Dr. Solomon, Dr. Maddalon and Ms. Vergara, agreed that the process of using subcutaneous sutures helps to control bleeding, reduce tension within the laceration, and minimize potential "air pockets" within the wound, thereby promoting the healing process, and preventing potential, after-surgery, complications. In accord with protocol established between Dr. Diaz and Respondent, it was at the conclusion of her treatment care of D.Z. that she advised Dr. Diaz of her subcutaneous suture treatment and follow-up care plan. Respondent presented D.Z.'s record for his review, approval and signature. Dr. Diaz approved Respondent's subcutaneous suture treatment, her follow- up care plan of keeping the wound clean, taking the prescribed medication and having the sutures removed within a few days during his follow up a doctor of his choice. Dr. Diaz signed both the Emergency Room report and Respondent's suggested prescription medications for D.Z. On May 11, 1998, four days after his treatment and without obtaining and taking his prescription medications as instructed, D.Z. presented himself to Dr. Maddalon's office for a follow-up examination and evaluation of his injury. On May 14, 1998, Dr. Maddalon, who employed D.Z.'s mother as his office manager and had employed D.Z. for six years to clean his office and who had operated and treated D.Z.'s right hand for carpal tunnel syndrome some years earlier, examined D.Z.'s right hand following an earlier examination by his physician's assistant. On May 15, 1998, during exploratory surgery, Dr. Maddalon reopened the laceration of D.Z.'s right hand and observed that a subcutaneous suture had passed through the ulnar nerve and tied the ulnar digital nerve to the adjoining soft tissue. He removed the subcutaneous suture and removed the damaged part of the ulnar nerve. He then re-attached the exposed ends of the ulnar nerve. D.Z. recovered satisfactorily from Dr. Maddalon's surgery with most but not all of the sensation returning to the little finger on his right hand. According to his deposition, and without a review of D.Z.'s medical records from South Florida Baptist Hospital emergency room prepared by Respondent, Dr. Maddalon opined that certain protocol should be followed in treating "blunt-tear" type hand injuries like that suffered by D.Z. Dr. Maddalon went on to stress, however, that in his opinion placing subcutaneous sutures in such an injury as D.Z.'s was not below the standard of care for a physician's assistant. Deborah Vergara, a physician's assistant at Town and Country Hospital, Tampa, Florida, qualified as an expert in physician's assistants' duties, responsibilities and protocol, and after reviewing D.Z.'s medical records, opined that the care provided D.Z. by Respondent during treatment on May 8, 1998, was appropriate for a patient with D.Z.'s type laceration and was not below the standard of care for a physician's assistant. Deborah Vergara further opined that a suture passing through the ulnar nerve, in and of itself, is not a breach of the standard of care, and she was not aware of any textbooks for physician's assistants that prohibited ever placing subcutaneous sutures in a laceration. Dr. Charles Eaves, D.O., an expert in emergency medicine and an expert in supervising physician's assistants and who also has been the supervising doctor of South Florida Baptist Hospital for the past three years, opined that Respondent's placing subcutaneous sutures in a palmar laceration was absolutely within the standard of care. Dr. Eaves further opined that Respondent's entries in D.Z.'s medical records were within the standard of care. Dr. Barry Solomon, Board Certified expert and employed by the Physician Health Care Alliance in Clearwater, Florida, after review of all of D.Z.'s medical records from South Florida Baptist Hospital, the Administrative Compliant filed in this case, Dr. Maddalon's deposition, and records from Brandon Regional Medical Center, gave his opinions in the following areas: Protocol of supervising physician and physician's assistants working in specific areas of medicine. According to Dr. Solomon, physician's assistants generally operate with relative autonomy, based upon the experience of the assistant and the confidence of the supervising physician. Physician's assistants see low acuity patients, leaving the physician to see high acuity patients. Physician's assistants do check with the physician on duty as they proceed through treating a patient, checking to make sure what they are going to do is appropriate and have the physician review and sign the chart as the patient is being made ready for discharge. Protocol for physician's assistants suturing palmar lacerations. Dr. Solomon opined that Respondent's conduct when presented with a patient with a palmar laceration in a subcutaneous area with an abnormal, complex laceration, and after assessment for nerve damage, tendon damage, bone injury, and after obtaining an x-ray which was reviewed by the emergency room physician at the time, and then proceeding to place a two- layer closure consisting of four subcutaneous sutures and eleven external sutures to close the wound, was within the standard of care of physician's assistant, in this case, the Respondent. Dr. Solomon further opined that there is nothing wrong with placing subcutaneous sutures in a hand laceration and there is always a risk, with a deep wound that nerves, blood vessels, arteries and veins could potentially be hit or sutured. This risk is a recognized complication when one places subcutaneous sutures in that (hand) part of the body. He concludes that Respondent practiced within the physician assistant's standard of care in her subcutaneous suture treatment of Patient D.Z.'s right hand. Petitioner has failed to provide the opinion of an expert that establishes a standard of care for an experienced physician's assistant; has failed to provide evidence of standard of care for maintaining medical records; and has failed to provide an expert opinion in support of the allegation that Respondent's treatment of D.Z.'s right hand laceration fell below a physician's assistant standard of care for treatment of hand lacerations. The testimony of Dr. Charles Eaves, Dr. Barry Solomon and Deborah Vergara is credible in establishing that Respondent, Dien Duong, actions were not violations of Subsection 548.331(1)(m) and 488.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of violating Subsections 458.331(1)(m) and (t), Florida Statutes. DONE AND ENTERED this 2nd day of May, 2002, in Tallahassee, Leon County, Florida. FRED L. BUCKINE 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 2nd day of May, 2002.
The Issue Whether the license of Respondent should be revoked, annulled, withdrawn or suspended for violation of Section 477.02 (4), Florida Statutes, Section 477.27(1), (7) and (8), Florida Statutes, Section 477.15(8), Florida Statutes, and the rules and regulations promulgated pursuant thereto, to wit, Chapter 21F- and 21F-3.08, Florida Administrative Code, in that she operated a cosmetology salon without a certificate of registration, operated a salon without an active sterilizer and failed to maintain sanitary conditions.
Findings Of Fact The Respondent acknowledged receipt of a copy of the Administrative Complaint and Notice of Hearing by registered mail. The Respondent, Bertha Sewell, moved her place of business from 924 West Newhaven Avenue, Melbourne, Florida, to a new address without notifying the Board of her move. The inspector for the State Board of Cosmetology inspected the business shortly after the move from the licensed location to the unlicensed location. At the time of the move she found that the location was unlicensed and the shop was in disarray and in an unsanitary condition. The Respondent has now obtained a license from the Petitioner at the location to which she had moved `and her present location.
Recommendation Suspend the license of Respondent for operating a salon in a place not licensed by the State Board of Cosmetology for a period of seven (7) days. Suspend the license of Respondent for not maintaining her salon in a sanitary manner and without the proper sterilization equipment for a period of seven (7) days. DONE and ORDERED this 8th day of August, 1977, in Tallahassee, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire LaFace and Baggett, P.A. Post Office Box 1752 Tallahassee, Florida 32302 Bertha Sewell 316 West Newhaven Avenue Melbourne, Florida 32901
Findings Of Fact The Respondent Jorge Suarez-Menendez, M.D., is a licensed medical physician having been issued license number ME 0030879. His last known business address is 1300 Coral Way, Miami, Florida 33145. Gladys Maher was admitted to American Hospital via the emergency room on May 13, 1982, complaining of abdominal pain, nausea and vomiting. The admitting physician, Dr. Amorin also noted that laboratory results revealed problems with the patient's gall bladder and the Respondent was consulted when the surgeon detected abdominal wall defects which included hernias and diastasis of the rectus muscle. A repair of the diastasis of the rectus muscle is performed utilizing an abdominal lipectomy since such a procedure is a necessary by-product of the gall bladder surgery and repairs of the hernias and diastasis when a single incisional technique is used. Although a lipectomy was performed on the patient by the Respondent, it was not billed to the insurance company, Midland Mutual. However, the Respondent did not attempt to hide the fact that a lipectomy was performed since it was clearly described in the Respondent's operative report. The laboratory report also indicated that a lipectomy was performed. An addendum to the operative report was dictated in April, 1983, by the Respondent to clarify that a lipectomy was performed on the patient when it was brought to his attention that the term "lipectomy" was mistakenly not typed on the operative report. The patient, who had undergone prior abdominal surgery in Cuba, had four hernias repaired by the Respondent. All of the hernias were in the same general location as the original surgery which is represented by a scar running from the patient's navel to the pubic region. The bill submitted by the Respondent could be considered duplicative if the diastasis of the rectus muscle was in the same spot as the umbilical and incisional hernias. The testimony presented by the parties concerning the location of the diastasis of the rectus muscle and whether this repair should have been considered a separate procedure from the repair of the incisional, umbilical and ventral hernias, was conflicting and inconclusive. The Petitioner established that the Respondent's itemized charges for the surgery performed on this patient were significantly higher than the fees charged by other, more qualified and experienced plastic surgeons in the Dade County area. However, the appropriateness of the Respondent's charges and whether such fees should be paid are a matter between the Respondent and the patient's insurer since the Department clearly lacks the authority to regulate fees charged by physicians regardless of the unconscionable nature of such charges. In its Proposed Recommended Order, the Department conceded that no substantial evidence of fraud exists in the Respondent's treatment of Jose Menendez, although the fees charged by the Respondent were characterized as excessive. The Hearing Officer concurs in the Petitioner's assessment of the evidence concerning the Respondent's treatment of Jose Menendez since Respondent's charge of $2,000.00 to remove glass fragments from this patient's eye was grossly excessive. The counts of the Administrative Complaint relating to Gladys Maher arose as a result of a referral to the Department by a representative of the insurance carrier who had been hired to screen patient claims. At the hearing, counsel for the Respondent introduced a memorandum from the insurance carrier, Respondent's Exhibit 1, regarding the Respondent's claim for Mrs. Maher's surgery in which a disparaging comment was made regarding the Respondent's ethnic background. This document was introduced to demonstrate that the Respondent's claim could have bean scrutinized differently from other physician's because of his Hispanic heritage. The inference which surrounds the memorandum is disturbing and it is urged that the Department ensure that in the future complaints regarding a physician are initiated on the basis of the physician's alleged wrongful acts rather than his national origin.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Board of Medical Examiners enter a final order dismissing the Administrative Complaint filed against the Respondent Jose Suarez-Menendez. DONE and ENTERED this 16th day of August, 1984, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings The Oakland Building 2000 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 FILED with the Clerk of the Division of Administrative Hearings this 11th day of August, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Edward A. Carhart, Esquire 717 Ponce de Leon Boulevard, Suite 331 Coral Gables, Florida 33134 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue in this case is whether the challenged portions of the proposed amendments set forth in the Fourth Notice of Change for Rule 64B8-9.009, Florida Administrative Code (FAC), published in the Florida Administrative Weekly on February 18, 2000, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Background Rule 64B8-9.009, Florida Administrative Code, is the Board's Rule governing the standards of care for office surgery. The Rule was first adopted on February 1, 1994 as a Rule 61F6- 27.009, Florida Administrative Code. It was transferred to Rule 59R-0.009, Florida Administrative Code, and was amended on May 17, 1994; September 8, 1994; and November 15, 1994, and then was finally transferred to Rule 64B8-9.009, Florida Administrative Code. In February of 1998, the Board directed its Surgical Care Committee to evaluate Rule 64B8-9.009 and to make recommendations for any modifications or amendments to the Rule. The 1998 Florida Legislature also addressed the issue of office- based surgery and provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings . . . " including office-surgery environments. As discussed below, hearings were conducted by the Board and its Surgical Care Committee to consider changes to the office surgery rule. The Parties R. Gregory Smith, M.D., Charles Graper, D.D.S., M.D. and Florida Academy of Cosmetic Surgery Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Smith practices cosmetic surgery, plastic surgery, and oralmaxillofacial surgery in his office. Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery and a degree in medicine. Approximately 30 percent of FACS members use general anesthesia (Level III) in their office surgery procedures. At least one representative of FACS has attended each public rulemaking hearing relating to proposed Rule 64B8-9.009, Florida Administrative Code. FACS actively participated in the rulemaking process, expressing concerns relating to transfer agreements, hospital privileges, and the requirement for an anesthesiologist in Level III surgery. FACS' purposes include addressing adverse outcomes in the field of cosmetic surgery and implementing recommended approaches to improve patient safety. Petitioner Charles E. Graper, D.D.S., M.D., is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Graper is Board-certified by the American Board of Oral and Maxillofacial Surgery, Board- certified in general cosmetic surgery, Board-eligible in general plastic surgery, and is a Fellow of the American College of Surgeons. Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. Graper has experience in performing Level III office surgery using general anesthesia. The Board of Medicine The Board of Medicine (Board) regulates the practice of medicine in Florida, and is the agency that adopted the rule at issue. The Florida Society of Plastic Surgeons, Inc., Florida Chapter, American College of Surgeons and Florida Society of Dermatologists The FSPS, FCACS, and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. As licensed physicians (M.D.s), members of FSPS, FCACS, and FDS are subject to the regulations promulgated by the Board of Medicine. A substantial number of physician members of the FSPS, the FCACS, and the FSD perform office surgery and are affected by the proposed amendments to Rule 64B8-9.009, Florida Administrative Code. FSPS is a Florida not-for-profit corporation whose 270 members are board-certified plastic surgeons (of the approximately 375 such physicians statewide) licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSPS was created and exists for the purposes of promoting plastic surgery as a science and profession. FSPS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members, and has participated throughout the rulemaking process with respect to Florida Administrative Code Rule 64B8-9.009. FCACS is a Florida not-for-profit corporation whose 1400 members are surgeons licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FCACS was created and exists for the purposes of promoting surgery as a science and profession. FCACS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including Petitioner Graper, routinely perform office surgery. FSD is a Florida not-for-profit corporation whose 462 members are board-certified dermatologists licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSD was created and exists for the purposes of promoting surgery as a science and profession. FSD regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including David Allyn, M.D., and Diane Calderone, M.D., routinely perform office surgery. The Florida Society of Anesthesiologists, Inc., Florida Hospital Association, Inc. and Association of Community Hospitals and Health systems The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues related to anesthesiology. The FHA and the ACHHS are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members. The Florida Nurses Association (FNA) The Florida Nurses Association is a professional association of approximately 7,500 nurses licensed in the state of Florida, including approximately 1,700 advanced registered nurse practitioner (ARNP) members and a substantial number of CRNAs. Among its many purposes, the FNA represents the legal, legislative, and professional practice interests of the members. The Florida Association of Nurse Anesthetists Petitioner, Florida Association of Nurse Anesthetists (FANA), is a non-profit corporation and professional organization made up of more than 1,600 certified registered nurse anesthetists practicing throughout Florida, many of whom currently provide anesthesia for surgery performed in physicians' offices. As a part of its mission, FANA advocates its members' interests in legal, legislative, and professional practice issues. Rule Challenges by FSA and the Hospitals On July 8, 1999, the FSA filed a Petition for Administrative Determination of Invalidity of Proposed Rule challenging portions of the proposed amendments to Rule 64B- 8.9009 as set forth in the Second Notice of Change. The FSA's Rule challenge was assigned DOAH Case No. 99-2974RP. Also on July 8, 1999, the Hospitals filed a petition for Administrative Determination of the Invalidity of Proposed Rules challenging portions of the proposed amendments to Rule 64B8-9.009 as set forth in the Second Notice of Change. The Hospitals' Rule challenge was assigned DOAH Case No. 99-2975RP. The Board conducted a third public hearing on the proposed Rule amendments on August 7, 1999. The Board published a Third Notice of Change to the proposed Rule amendments in the August 20, 1999, issue of the Florida Administrative Weekly. None of the changes in the Third Notice of Change related to provisions that were in litigation. On January 12, 2000, the Board, the FSA, and the FSPS filed a Joint Stipulation on provisions of Rule 64B8-9.009, Florida Administrative Code (Joint Stipulation) in DOAH Case No. 99-2974RP. The Joint Stipulation released from FSA's Rule challenge, Case No. 99-2974RP, the majority of the proposed amendments to Rule 64B8-9.009 and reserved only the proposed amendments to Subsections (1)(e) and (6)(b)1.a. of Rule 64B8- 9.009 for challenge. On January 26, 2000, the Hospitals filed a Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(b)1. and 2. and (6)(b)1.a. and b. In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(I), (4)(b)1., (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for Adoption. The Board subsequently conducted an additional public meeting and published a fourth notice of change relating to the proposed amendments to Rule 64B8-9.009 still subject to challenge by the FSA and the Hospitals. These changes included the withdrawal of the proposed amendments to Subsection (4)(b)1. which would have changed "transfer agreement" to "transfer protocol." During this public meeting, the Board was informed that those parts of the Rule no longer being challenged had been filed with the Department of State. On January 28, 2000, the Board filed all of its proposed amendments to Rule 64B8-0.009, with the exception of the amendments to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)1. and 2., and (6)(b)1.a-b, for adoption with the Florida Secretary of State. The proposed amendments filed for adoption on January 28, 2000, became effective February 17, 2000. The Board voted to modify some of the proposed amendments to Rule 64B8-9.009 still subject to challenge at its public meeting on February 5, 2000. The FSA filed a Notice of Voluntary Dismissal of its Rule challenge in DOAH Case No. 99-2974RP on February 7, 2000. DOAH case No. 99-2974RP was closed on February 8, 2000. The Hospitals filed a Notice of Voluntary Dismissal of their Rule challenge in DOAH Case No. 99-2975RP on March 9, 2000, and the case was closed on March 10, 2000. The Fourth Notice of Change was published in the February 18, 2000, issue of the Florida Administrative Weekly noticing the changes to proposed amendments to Rule 64B8-9.009 voted on by the Board at its February 5, 2000, meeting. On February 25, 2000, the FACS, Graper, and Smith filed a Petition for an Administrative Determination of the Invalidity of a Proposed Rule challenging the Board's proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. This petition was assigned DOAH Case No. 00-0951RP. On March 8, 2000, the FACS, Graper, and Smith filed an Amended Petition for an Administrative Determination of the Invalidity of a Proposed Rule in DOAH Case No. 00-0951RP challenging the Board's proposed withdrawal of the proposed changes to Subsection (4)(b)1. of Rule 64B8-9.009 and the proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. The Board held a public hearing on April 8, 2000, in Orlando, Florida, and received testimony concerning the Fourth Notice of Change. At the conclusion of the hearing, the Board voted to adjourn without making any changes in the Fourth Notice of Change. On April 17, 2000, the FANA filed its petition challenging the Board's Fourth Notice of Change. The FANA's petition was assigned DOAH Case No. 00-1622RP. DOAH Case Nos. 00-0951RP and 00-1622RP were consolidated by Order of the Administrative Law Judge issued May 4, 2000. The Fourth Notice of Change states that "[t]he proposed changes to Subsection (4)(b)1., shall be withdrawn." With respect to Subsection (6)(b)1.a. of Rule 64B8- 9.009, the Fourth Notice of Change states: Proposed Subsection (6)(b)1.a. shall be changed to read, (b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia. Petitioners have challenged the Fourth Notice of Change on the following grounds: (1) the requirement that an anesthesiologist be present for all Level III surgeries in physicians' offices will increase the cost and limit surgical procedures and practice opportunities of Petitioners resulting in a substantial adverse financial impact on Petitioners and patients; (2) the Fourth Notice of Change exceeds the Board of Medicine's rulemaking authority by attempting to regulate nurse anesthetists; (3) the Fourth Notice of Change conflicts with existing statutes governing the practice of nurse anesthetists; (4) the rule is arbitrary and capricious and is not supported by competent evidence and is inconsistent with the law and policies of the federal government and of 49 states; (5) the Fourth Notice of Change is not supported by competent substantial evidence and would not have any measurable effect on patient safety; (6) the Rule was improperly adopted; and (7) that the Fourth Notice of Change conflicted with the existing requirement to provide a choice of anesthesia providers. Each of these arguments is addressed below. Final Order in DOAH Case No. 00-1058RX The Final Order in DOAH Case No. 00-1058RX invalidated certain existing Rule requirements related to transfer agreements and hospital staff privileges as a precondition for certain office surgeries. Specifically, that Final Order invalidated Subsection (4)(b) of Rule 64B8-9.009, which required a transfer agreement for any physician performing Level II office surgery who did not have staff privileges to perform the same procedure at a licensed hospital. In addition, the Final Order invalidated Subsection (6)(b) of Rule 64B8-9.009 which required a physician performing Level III office surgery to have hospital staff privileges for the procedure performed in an out-patient setting. As grounds for invalidating the staff privileges requirement, the Administrative Law Judge determined that the Board lacked specific statutory authority to mandate hospital privileges, thereby exceeding its grant of rulemaking authority. The Final Order further determined that the requirement for hospital privileges was arbitrary, deferred credentialing to individual hospitals, and was not supported by competent substantial evidence. During the prior hearing, the parties did not present specific argument related to, nor did the Final Order consider the proposed changes to the staff privileges requirement set forth in the Fourth Notice of Change due to the separate Rule challenge proceedings. The Proposed Rule Regarding Competency Demonstration Notwithstanding, Subsection 4 of the Fourth Notice of Change proposes to change Subsection (6)(b)1.a. of Rule 64B8- 9.009 to include alternatives to hospital staff privileges as a manner of demonstrating sufficient education, training and competency to perform Level III surgery in an office setting. The proposed change provides that a surgeon who seeks to provide Level III surgery in an office setting can demonstrate training as follows: The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other Board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training, and experience. (emphasis added) The proposed Rule at issue in this proceeding continues to provide for the same mechanism of hospital privileges, previously invalidated. The provision remains invalid for the reasons articulated in the previous Final Order. However, the proposed Rule also provides office surgeons with two alternative methods for objectively demonstrating sufficient training and competency through certification by a recognized medical specialty board or through direct demonstration to the Board of Medicine. That provision of the proposed Rule, provides significant flexibility and meaningful options to physicians seeking to perform office surgery. The Board demonstrated that the options are an appropriate approach for the Board to utilize in exercising its delegated regulatory authority and responsibility to adopt education and training standards for the office setting. The Petitioners adequately challenged the provisions and the Board proved the validity of the proposed alternatives by a preponderance of the evidence. Increased Costs Petitioners contend that the anesthesiologist requirement in the Fourth Notice of Change violates Section 120.52(8)(g), Florida Statutes, by imposing regulatory costs on the regulated person which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives. Petitioners offered credible evidence indicating that the hourly rates charged by anesthesiologists range from 50 to 100 percent higher than the hourly rates charged by CRNAs for similar procedures. Respondent and Intervenor, FSA, on the other hand, demonstrated that hourly rates varied from market to market within Florida and in a few cases, rates for anesthesiologists were approximately the same as for CRNAs. The evidence is clear, however, that the charges for an anesthesiologist are significantly higher than those for CRNAs for similar procedures. Anesthesiologists possess broader expertise, education, and training. As a result, requiring an anesthesiologist for Level III office surgeries will increase the total cost of a typical in-office plastic or cosmetic surgery procedure between five and ten percent. Furthermore, the evidence demonstrated that although some surgeons periodically use anesthesiologists during Level III office surgery for a variety of reasons, including availability, complexity of procedure, current health of patient and contractual agreements, most surgeons utilize CRNAs due to the considerable cost savings. Petitioners also claimed that the Rule would create a monopoly in the provision of in-office anesthesia for anesthesiologists and would force hundreds of CRNAs out of office practice. The Fourth Notice of Change applies to Level III surgeries, so it is reasonable to conclude that the need for CRNAs to participate in the performance of Level III surgeries under the supervision of an anesthesiologist will be obviated. Their assistance is unnecessary and cost prohibitive. And although nurse anesthetists would still be permitted to provide Level II anesthesia in the office setting under the supervision of the operating surgeon, the proposed Rule imposes a significant increase in the cost of Level III surgeries and severely decreases competition. Rulemaking Authority and Conflicting Law Petitioners mistakenly contend that the proposed anesthesiologists requirement exceeds the scope of the Board of Medicine's rulemaking authority and conflicts with existing law. The authority for the Fourth Notice of Change is contained in part in Section 458.33(1)(v), Florida Statutes, which states in pertinent part: The Board may establish by rule standards of practice and standards of care for particular practice settings, including but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manual in order to establish grounds for disciplining doctors. Specifically, Petitioners allege that the Fourth Notice of Change constitutes an impermissible attempt by the Board of Medicine to regulate nurse anesthetists and conflicts with Chapter 464, Florida Statutes, which permits nurse anesthetists to practice under the supervision of any physician, osteopath, or dentist. The parties have stipulated that Florida-certified registered nurse anesthetists are licensed only by the Florida Board of Nursing and are subject to discipline only by the Florida Board of Nursing. In mandating that office surgeons use an anesthesiologist during in-office Level III surgery, the proposed Rule does not directly regulate any nurse or certified registered nurse anesthetist and does not subject the CRNA to any discipline by the Board of Medicine or by the Board of Nursing. Thus, the Rule on its face does not conflict with the delegated legislative authority to the Board of Medicine for rulemaking in Section 458.331(1)(v). Federal Law, Scientific Evidence, Arbitrary and Capricious, Competent Substantial Evidence Petitioners contend that the Fourth Notice of Change requiring an anesthesiologist be present during Level III surgery is inconsistent with the laws and policies of the federal government and 49 states, contrary to the overwhelming weight of scientific evidence, arbitrary and capricious, and not supported by competent substantial evidence. There is no evidence that the Fourth Notice of Change is inconsistent with the laws and policies of the federal government. There is no federal law or rule which prohibits any state from establishing its own rules governing the rights of various practitioners to administer or supervise the administration of anesthesia in any particular setting. Federal government regulations defer to state law on this subject unless a state establishes a lower standard of care. While it is insignificant whether any other state currently requires an anesthesiologist to be present for the administration or supervision of general anesthesia in an office setting, some states have considered such requirements, including Pennsylvania and New Jersey. With respect to the scientific evidence presented by the parties, it is clear that there is a lack of competent and substantial evidence to demonstrate an increased level of safety for general anesthesia patients who undergo surgery under the care of an anesthesiologist as opposed to a CRNA. CRNAs are advanced registered nurse practitioners. In addition to their nursing training, CRNAs must have at least one year of experience in a critical care setting (such as working in a hospital intensive care unit) prior to beginning their two- to-three year master's level anesthesia training. Nurse anesthetists typically are trained side by side with physician anesthesia residents, use the same textbooks, and are taught by the same instructors. Unlike physician anesthesiologists who receive a general medical-surgical license that may not require any level of training or expertise in the administration of anesthesia, CRNAs must pass a national certifying examination in anesthesia as a condition of state licensure. In addition, CRNAs must complete 40 hours of continuing anesthesia education every two years, and must be recertified every two years to retain their state license. The evidence suggests that the safety of office surgery is comparable to that of hospitals and ambulatory surgery centers. Moreover, under the existing Rule, the office surgeon and patient determine the most appropriate anesthesia provider and setting based on the individual patient's needs. The direct testimony and scientific evidence indicate no significant difference in patient outcomes based on whether anesthesia is administered by an anesthesiologist or CRNA. Hence, Florida law and the existing standard of care in Florida permits a surgeon to supervise a CRNA in the office setting. Nearly forty percent of the 1600 CRNA members of FANA provide anesthesia in physicians' offices. Furthermore, the evidence indicates that anesthesiologist supervision of CRNAs in hospitals is extremely inconsistent. "Supervision" as defined by various hospitals requires the anesthesiologists to be within five to thirty minutes of the hospital. Anesthesiologists are often absent for extended periods and typically "supervise" several operating rooms simultaneously. In fact, Federal Medicare regulations permit an anesthesiologist to receive payment for the "medical direction" of as many as four CRNAs at the same time. Moreover, several smaller and often rural hospitals and ambulatory surgical centers in Florida do not have anesthesiologists on staff. CRNAs provide the anesthesia services in those venues. Dr. David Mackey, an anesthesiologist, testified that he had reviewed information on 28 deaths related to office surgery which occurred between 1987 and 1999. Dr. Mackey concluded that there have been nine deaths resulting from office surgery in the past 12 years in which anesthesia was a cause of death. However, Dr. Mackey was able to confirm that a CRNA provided the anesthesia in only two of the nine cases. Office surgeons and related professional societies agree that an office-based surgeon may safely supervise a CRNA. Currently, there are three national accrediting organizations that may accredit office surgery facilities: Joint Commission on Accreditation for Ambulatory Healthcare Organizations; American Association for Accreditation of Ambulatory Surgery Facilities; and Accreditation Association for Ambulatory Health Care. Rule 64B8-9.0091, Florida Administrative Code. None of these accrediting organizations requires that CRNAs be supervised by an anesthesiologist. No other state currently requires anesthesiologist supervision of CRNAs in an office setting. In fact, Florida's Joint Committee of the Boards of Nursing and Medicine identify specific medical acts that may be performed by ARNPs, and the level of physician supervision required for such acts. Section 464.003(a)(c), Florida Statutes. The Joint Committee does not require anesthesiologist supervision of CRNAs in any setting. The U.S. Armed Forces do not require anesthesiologist supervision of CRNAs in any practice setting. And the American Society of Anesthesiologists' has published its own "Recommended Scope of Practice for Nurse Anesthetists" which provides for CRNAs to administer anesthesia under the supervision of the operating surgeon. Studies of Anesthesia Outcomes and Medical Error Michael B. Pine, M.D., a Board-certified cardiologist, former chief of cardiology at Cincinnati Medical school, and a former professor of medicine at Harvard Medical School and two other medical schools, testified as an expert in healthcare quality assessment and improvement. Dr. Pine has served as a healthcare quality assessment and improvement consultant to the JCAHO, the Health Care Financing Administration (HCFA), the American Medical Association (AMA), the American Osteopathic Association, the Hospital Research and Educational Trust of the American Hospital Association, the American Association of Oral and Maxillofacial Surgeons, the American Association of Nurse Anesthetists, Blue Cross/Blue Shield, and Anthem, among others. Dr. Pine characterized his career transition from clinician to consultant as moving from "dealing with diseased individuals to dealing with diseased organizations to help them assess their problems in delivering health care and help them improve and get better." Dr. Pine assisted in the development of clinical indicators for JCAHO, including indicators in anesthesia care. He has worked with the federal Health Care Financing Administration (HCFA) to measure hospital mortality and adjust for patient severity as an indicator of hospital quality. Dr. Pine's consulting experience includes evaluating outcome data for individual practitioners, groups of providers, and whole systems. Dr. Pine testified that the classic study in anesthesia mortality was a 1950's study by Beecher and Todd of 600,000 anesthetic administrations which were followed by about 8,000 deaths, 325 of which were ultimately determined to be anesthetic related. The study reflects an anesthesia mortality rate of about 1:2,500. In the Beecher and Todd study, nurse anesthetists performed twice as many cases as anesthesiologists, but the number of deaths involving nurse anesthetists was virtually the same as the number of deaths involving anesthesiologists. Beecher and Todd initially hypothesized that the greater mortality rate for anesthesiologists could be explained by the severity of illness of the patients seen by anesthesiologists rather than nurse anesthetists, but after correcting for the difference in severity of illness, they discovered the nurse anesthetists had actually treated patients who were slightly more sick. Beecher and Todd were unable to explain why physician anesthesiologists, who anesthetized only half as many patients as nurse anesthetists, were involved in an equal number of deaths. Dr. Pine testified that a later study, the Bechtoldt, measured outcomes associated with two million anesthetics in North Carolina between 1969 and 1976. The mortality rate was approximately 1:24,000; a mortality rate ten times better than the rate reflected in the Beecher and Todd study 20 years earlier. The Bechtoldt study compared the outcomes of anesthesiologists working alone, nurse anesthetists working alone, and CRNAs and anesthesiologists working together, the surgeon or dentist administering anesthesia him/herself, and deaths in which no provider could be identified. Bechtoldt concluded that: When we calculated the incidence of anesthetic related deaths for each group which administered the anesthetic, we found that the incidence among the three major groups - the CRNA, the anesthesiologist, and the combination of both - to be rather similar. Although the CRNA working alone accounted for about half the anesthesia- related deaths, the CRNA working alone also accounted for about half the anesthetics administered. A 1980 study by Forrest of 17 hospitals and about 10,0000 patents was one of the first studies to make a formal adjustment for the sickness severity of the patients. Using conservative statistical methods, Forrest concluded that "there were no significant differences in outcomes" between the hospitals that predominately used anesthesiologists and the hospitals that predominately used nurse anesthetists. Anesthesia safety continued to improve as indicated by a British study in the early 1980's, that used a procedure similar to that used by Beecher and Todd in the 1950's. The British study looked at 485,000 surgeries in which anesthesia was provided. There were 4000 deaths, only 3 of which were determined to be anesthetic related, reflecting an anesthesia mortality rate of 1:185,000. The Institute of Medicine report entitled "To Err is Human," published in 1999, reflects an even better anesthesia mortality rate of 1:200,000 to 1:300,000 cases. The Institute of Medicine report states: The gains in anesthesia are very impressive and were accomplished through a variety of mechanisms including improved monitoring techniques, the development and widespread adoption of practice guidelines and other systemic approaches to improving errors . . . . the success of anesthesia, was accomplished through a combination of technological changes, new monitoring equipment, standardization of existing equipment, information-based strategies including the development and adoption of guidelines and standards, application of human factors to improve performance such as the use of simulators for training, formation of the Anesthesia Patient Safety Foundation to bring together stakeholders form different disciplines, physicians, nurses, manufacturers, to create a focus for action and having a leader who would serve as a champion for the cause. Dr. Pine also addressed the recent study regarding anesthesia by Silber published in June 2000. This study examined 7,665 deaths following 217,000 hospital procedures for which medical bills were submitted to HCFA for Medicare reimbursement. The study attempted to characterize the type of anesthesia provider based on whether an anesthesiologist submitted a bill for providing anesthesia or supervising the anesthesia. The study assumed that a CRNA administered the anesthesia if either the CRNA billed for it, or if no bill was located. Moreover, instead of reviewing deaths that occurred within 48 hours after the surgery, the study counted all deaths which occurred within 30 days following surgery, and ignored any non-anesthesia related complications and deaths which were included in the 7,665 death toll. Conversely, the 7,665 deaths in 217,000 procedures produce a mortality rate of 1:28, nearly 100 times greater than the mortality rate in the 1950 Beecher and Todd study, and nearly 10,000 times what the 1999 Institute of Medicine study reflected as the anesthetic mortality rate. The greatly inflated and inconsistent death rate is highly questionable and provides little scientific support for the Board's proposed rule. With respect to Petitioners' argument relating to arbitrary and capricious mandate, the proposed Rule would not permit office-based surgeons to provide a choice of anesthesia provider for Level III office surgeries, since only one anesthesia provider is necessary or justified for Level III office surgery, and the proposed rule mandates the participation of an anesthesiologist. It is unreasonable and not economically feasible for the surgeon or the patient to pay for an anesthesiologist and a CRNA for the same procedure. Based on the current Rule's "choice of anesthesia provider" requirement in subsection (2)(b) of the existing Rule, the proposed anesthesiologist mandate for Level III surgery is inconsistent, confusing and illogical to the reasonable person.
The Issue The issue for consideration in this case is whether Respondent's license as a physician in Florida should be disciplined because of the matters alleged in the Administrative Complaint.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Medicine, through the Agency For Health Care Administration, and formerly the Department of Business and Professional Regulation, has been the state agency in Florida responsible for the regulation of the practice of medicine and the licensing of physicians in this state. Respondent has been a physician licensed in Florida under license number ME 003824. Starting on January 12, 1988 and continuing thereafter until on or about March 16, 1988, Respondent treated Patient #1 for a condition known as Dupuytren's Contracture of the left hand. This conditions results in the thickening of scar tissues and contracture of fibrous bands in the palm and fingers which pulls the fingers into the palm and constricts their ability to flex or straighten out. Patient #1 had suffered from this condition since 1982. In 1984, a surgeon in New Jersey performed Dupuytren's Contracture release surgery on the patient's right hand, but the results were not altogether satisfactory. Respondent first saw Patient #1 on January 12, 1988. At this initial visit, Respondent discussed the implications of the proposed surgical procedure and advised the patient of the possible adverse consequences thereof. He noted that because the patient had delayed seeking treatment for the left hand, there was a strong possibility of complications as a result of surgery which could involve nerve damage and infection in addition to a possibility of vascular damage and necrosis of the tissue of the hand. On February 10, 1988, Respondent performed a Dupuytren's Contracture release on the patient's left hand at the Gulf Coast Orthopedic Center, (GCOC). This surgery is a complicated, delicate and difficult procedure which in the instant case, was made even more difficult by the extent of the existing contracture of the patient's hand. After the completion of the surgery, Respondent placed Patient #1 on Keflex, an antibiotic, and also prescribed Darvocet for pain. Respondent saw Patient #1 again on February 11, 1988. At this time, the patient was complaining of pain in the hand and of the tightness of the bandage. Respondent examined the wound at this time, cleaned it, placed a plastic platform splint on the hand and re-bandaged it. The patient was also prescribed Percodan for pain and advised to continue the Keflex at a 1,500 mg/day dosage. Patient #1 returned to Respondent again on February 12, 1988, still complaining of pain and that the bandage was too tight. After again examining the hand, Respondent re-bandaged it, placing gauze between the patient's fingers and the splint. He also gave the patient another prescription for Percodan for the pain. On February 17, 1988, the patient again came to the Respondent's office for his third postoperative checkup. When Respondent removed the bandage, he noticed a small greenish area on the palm which was exuding what appeared to be white pus. Respondent thoroughly cleaned the wound by placing the hand in a whirlpool bath of water and Betadine solution for approximately 45 minutes. He did not culture the green area or the white exudation. When he released the patient that day, however, he increased the Keflex dosage to 2,000 mg/day but refused to give him a prescription for additional Percodan for the pain. Instead, he told him to take extra strength Tylenol. He also told the patient to keep the hand elevated but did not suggest the patient call in the event of pain. Respondent did not see Patient #1 again until February 24, 1988 even though the pain had increased during that period. The patient, however, did not call the Respondent to complain, believing the increase in pain was the result of the removal of the prescription for Percodan and the substitution of a lesser strength substance, Tylenol, therefor. The patient assumed, from the Respondent's prior comments, that the pain was normal and to be expected. When Respondent saw Patient #1's hand again on February 24, 1988, he became excited because it appeared there was infection in the left palm which had spread to the PIP joint of the middle finger at which point there was some necrosis. Respondent appeared upset because the Patient had not called him when the pain continued or increased. Patient #1's wife had asked that the patient do so, but the patient decided to wait until the next scheduled appointment on February 24, 1988. At this time, Respondent removed the sutures from the patient's hand and irrigated the wound with a mixture of saline solution and an antibiotic, Kepsol. A culture was also taken at this time. Since Respondent did not have hospital admitting privileges in the area, he arranged through Dr. Alea, an associate in his clinic who did have such privileges, to have Patient #1 admitted to Bayonet Point Hospital for treatment of the infection. The treating physician there was Dr. K. Sundaresh, an infectious disease specialist. The admission was on February 24, 1988. Dr. Sundaresh placed Patient #1 on prolonged antibiotic treatment, obtained a bone scan to document any infection, and directed debridement, incision and drainage of the wound. The bone scan report indicated that Patient #1 "most likely" had developed osteomyelitis, a bone infection, at the base of the middle finger on the left hand. X-rays taken around the same time, on March 1, 1988, revealed findings consistent with osteomyelitis. Following the hospital admission, Respondent departed for Arizona for three days to attend a previously scheduled medical seminar, returning on February 27, 1988. While he was gone, however, Respondent spoke daily with Patient #1 by telephone and consulted with the physicians who were treating him. Dr. Alea suggested that Patient #1 be examined by another orthopedic physician, Dr. Moss, but when Dr. Moss came to see Patient #1 in the hospital, he was told the patient had already seen Respondent. The consult report prepared by Dr. Moss reflects no consult was had because the patient "wants treatment as now arranged under Dr. Bonati." Records of GCOC indicate that on March 1, 1988, Respondent spoke with patient #1's daughter by telephone indicating that if the patient did not come to the clinic that day, he would be released from Respondent's care. In fact, the patient did go to see Respondent on March 1 and 2, 1988 on pass from the hospital, but claims he did not refuse treatment by Dr. Moss. When Respondent saw Patient #1 in his office on March 1, 1988, after noticing a greenish material on the patient's left palm which he thought might be pseudomonas, he elected to continue the antibiotic treatment that was initiated in the hospital. When the patient was released from the hospital on March 4, 1988, the wound was healing well. Dr. Sundaresh arranged for the patient to continue the intravenous antibiotic treatments through a home nursing services. The final diagnosis at the time of discharge was osteomeleyitis of the middle finger of the PIP joint on the left hand due to pseudomonas aeruginosa infection. Respondent saw Patient #1 in his office on March 7, 9, and 16, 1988, after the patient's discharge from the hospital. The patient was scheduled for another visit on March 22, 1988, but cancelled that appointment and also elected to discontinue the physical therapy Respondent had prescribed for him at GCOC. The hospital records show that while there, Patient #1 received daily physical therapy treatments consisting of whirlpool treatments to the hand and sterile dressings, starting on his admission on February 24, 1988, but no range of motion exercises. The physical therapy prescribed at GCOC by Respondent starting on March 8, 1988 included range of motion exercises which he continued until March 15, 1988. At the time of the last visit, on March 16, 1988, Respondent noted that the patient's wounds were healing well, but there was some limited range of motion. One of Petitioner's experts, Dr. Nadler, a board certified orthopedic surgeon with over 17 years experience, who is in practice with Dr. Angelides, to whom he refers all his hand surgery cases, opined that the standard of care for orthopedic surgery such as performed here by Respondent would be for the surgeon to have the ability to admit and follow the patient in a hospital if complications should arise. At very least, the surgeon should have the ability to make arrangements for another orthopedic surgeon to follow the patient in his absence. According to Dr. Nadler, it is not at all unusual for infection to occur in Dupuytren's Contracture release surgery. He concluded that Respondent fell below the standard of care when he performed a complicated surgical procedure on Patient #1 without having the personal ability to admit his patient to a hospital or to follow his patient's progress in the hospital in the event complications, such as an infection, should occur. He also concluded that Respondent's failure to have another orthopedic surgeon available to follow the patient while in the hospital was below standards as well. This opinion was shared by Petitioner's other expert, Dr. Visconti, a board certified orthopedic surgeon who, by his own admission, however, is not a hand surgeon specialist. Respondent's expert, Dr. Angelides, a board certified orthopedic surgeon who specializes exclusively in surgery to the hand and upper extremity, indicated that the presence of a green wound which exudes pus is consistent with infection. The standard of care for treating such an infection consists of cleaning the wound, obtaining cultures of the suspected infection, and seeing the patient again within a day or two for follow-up examination. In Angelides' opinion, Respondent's leaving the bandage on Patient #1's hand from the time of surgery on February 17 through February 24, without taking it off to check on the course of infection was not the way he would have handled the situation. However, he did not go so far as to state the Respondent's failure to do so was inappropriate, and he could find no impropriety in the way Respondent managed this case. Recognizing that the case presented here was about as severe an example of Dupuytren's Contracture as can be seen, Dr. Angiledes opined that the result achieved by Respondent was quite good considering the severity of the problem. He was not put off by the development of necrosis here, accepting that as a common complication in cases of this nature. He was satisfied by Respondent's calling in an infectious disease specialist and with the continuation of antibiotics administration after discharge through home health care. In his opinion, the surgery was appropriate and the ensuing complications common. The admission of the patient through an intermediary was not, to him, inappropriate so long as, as here, the patient continued to be seen by an infectious disease specialist. In substance, Dr. Angelides could see no problems with this case that were not properly handled and nothing that could have been done that was not done.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered in this case finding Respondent not guilty of the offenses alleged in the Administrative Complaint and ordering it dismissed. RECOMMENDED this 22nd day of August, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of August, 1994. APPENDIX TO RECOMMENDED ORDER The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: Accepted and incorporated herein. - 4. Accepted and incorporated herein. 5. - 7. Accepted and incorporated herein. 8. - 10. Accepted and incorporated herein. 11. - 13. Accepted and incorporated herein. - 19. Accepted and incorporated herein. Accepted and incorporated herein. - 23. Accepted and incorporated herein. 24. & 25. Accepted and incorporated herein. 26. & 27. Accepted and incorporated herein. 28. & 29. Accepted and incorporated herein. 30. & 31. Accepted. 32. - 35. Accepted and incorporated herein. 36. - 38. Accepted and incorporated herein. 39. & 40. Accepted and incorporated herein. 41. & 42. Accepted. 43. Accepted and incorporated herein. 44. & 45. No more than recitations of evidence. & 47. Accepted and incorporated herein. Rejected as a classification of Respondent's treatment as "inappropriate." The deposition cited as authority for that comment does not support it. However, the action described and the time frame in question are accurately noted. Accepted. Accepted as a recitation of the witness' testimony. Rejected as to the description "well supported." & 52. Accepted as restatements of testimony. Accepted. See "50" above. Rejected as not supported by clear and convincing evidence. FOR THE RESPONDENT: Accepted and incorporated herein. Accepted. & 4. Accepted and incorporated herein. - 9. Accepted and incorporated herein. Accepted and incorporated herein. Not an evidentiary Finding of Fact. - 14. Accepted as restatements of testimony. 15. - 18. Accepted as restatements of testimony. 19. & 20. Accepted as restatements of testimony. 21A. - O. Not proper Findings of Fact. These are more Proposed Conclusions of Law which are drawn by the Hearing Officer independently in that portion of the Recommended Order. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steven A. Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Tampa, Florida 33610 Paul B. Johnson, Esquire Johnson & Johnson, Post Office Box 3416 Tampa, Florida 33601 Sam Power Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Harold D. Lewis, Esquire Agency for Health care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
