The Issue The question presented is whether Respondent violated Section 456.072(1)(bb), Florida Statutes (2006), or Section 458.331(1)(nn), Florida Statutes (2006), by means of violating Florida Administrative Code Rule 64B8-9.007(2)(b), and if so, what penalty should be imposed?
Findings Of Fact Petitioner is the state agency charged with the licensing and regulation of medical doctors pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Respondent was a medical doctor licensed by the State of Florida, having been issued license number ME 70981. Respondent is also certified by the American Board of Internal Medicine with a subspecialty in interventional cardiology. No evidence was presented to indicate that Respondent has ever been disciplined by the Florida Board of Medicine. On March 12, 2007, Dr. Elsakr was caring for two patients at Halifax Medical Center (Halifax). Patient M.D. was an 84-year-old Caucasian female born on March 22, 1922. F.E. was an 82-year-old Caucasian female born on February 5, 1925. Both women were scheduled for cardiac procedures to be performed on March 12, 2007, but only F.E. was scheduled for a cardiac catheterization. M.D. and F.E. shared the same semi-private room at Halifax. During the night before the scheduled procedures, one of the patients asked to be moved away from the window, and as a result, the two patients' bed locations were reversed. Halifax had procedures in place related to the transport of patients from one area of the hospital to another. The policy required that a staff member referred to as a transporter was required to check at least two patient identifiers on the patient's arm band to confirm a patient's identity. The arm band contains four identifiers: the patient's name, date of birth, a medical record number and a visit number. While any of the four may be used, the patient's name and date of birth are preferred. Patient M.D. was supposed to be transported for a heart catheterization the morning of March 12. However, the hospital policy regarding patient identification was not followed, and the wrong patient, M.D. as opposed to F.E., was transported to the catheterization lab (cath lab). Apparently, the transporter relied on the room and bed placement of the patient as opposed to following the protocol for affirmatively checking the patient identifiers. Once a patient was transported to the cath lab for a procedure, Halifax had a separate "pause" or "time out" protocol designed to ensure that the correct patient was present and the correct procedure was performed. The procedure was designed to be consistent with standards provided by the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission for Accreditation of Hospitals, and the practices used by other hospitals. After transport and before a sterile field was created, the patient would be prepared for the procedure. As part of that preparation, a nurse was supposed to verify the patient's identity and confirm with another staff member that the patient's chart was the appropriate chart. The chart would then be provided to the person referred to as the recorder located in the adjacent control room outside the sterile field. The control room is separated from the sterile field by a plexi-glass wall, through which the recorder can observe everything taking place in the cath lab. The recorder would create a chronological log of the procedure, documenting the exact time when events took place. The physician performing the procedure would not necessarily be in the cath lab at the time the nurse verified the patient's identity. The chronological log for M.D. does not indicate that the patient's identity was confirmed or if it was confirmed, who confirmed it. Once a patient was prepped and draped, and the sterile field created, the recorder would call out the patient's name, procedure, procedure equipment, site and side of the procedure to be performed. The accuracy of the information was to be confirmed by a staff member saying "yes" or nodding his or her head. This procedure was considered by the hospital to be its "time out" procedure. The physician would be present but not actually participate in the time out, and would observe the time- out taking place. In this case, although the recorder called out F.E.'s name and the procedure she was scheduled to have, M.D. was actually present. Notwithstanding this error, an unidentified staff member either nodded or verbally confirmed that the information recited by the recorder was correct. Dr. Elsakr arrived at the cath lab after the patient was prepped but before the time out called by the recorder. He was present, but did not verbally participate, in the time out process. Before it took place, he met with the recorder in the control room to review the medical chart prior to the procedure. The medical chart reviewed was for F.E. After the time out, Dr. Elsakr approached the patient and stood near her head. By this time, the patient was fully draped, with blankets and surgical drapes covering all of her body except the surgical entry area (in this case her groin) and a portion of her face. Dr. Elsakr spoke to the patient, calling her by the first name of the patient F.E., and telling her, "[F.], this is Dr. Elsakr. I'm going to get started with your heart cath. Okay?" This interaction was consistent with his standard practice before he began a procedure, in order to give patients a level of comfort. M.D. did not initially respond to the name F., but said "yes" in response to Dr. Elsakr's question. He then moved down to the groin area, again called her by name (F.E.'s first name), and told her what she would feel as he started the procedure. She nodded her head and the procedure was begun. A catheterization was completed on the right side of the heart and begun on the left side. At that point, staff reported to Dr. Elsakr that the patient was the wrong patient. The procedure was immediately stopped. Dr. Elsakr immediately informed the patient, the patient's daughter, and the patient's primary care physician. He also noted the mistake on M.D.'s medical chart. Halifax Hospital undertook an investigation of the events leading to the procedure. The purpose of its investigation was to determine whether there was a breach in hospital safety protocols and to prevent any recurrence of the error. Dr. Donald Stoner, Halifax's Chief Medical Officer, testified that the fault lay with hospital staff, and not with Dr. Elsakr, and that if he had been the doctor involved, he likely would have done the same things as Dr. Elsakr. Halifax accepted full responsibility for the incident and independently compensated the patient for the incident. The hospital also determined that it would be inappropriate for Dr. Elsakr to be subject to any discipline for the incident by Halifax with respect to his privileges. Immediately after discovering that the wrong patient had the heart cath, Dr. Elsakr instructed that the patient should not be charged in any way for the procedure. While patient M.D. clearly could have been harmed by having to undergo the procedure, information about her condition was obtained that was actually a benefit to her.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That the Florida Board of Medicine enter a Final Order finding that Respondent, Ashraf Elsakr, M.D., violated Section 456.072(1)(bb), Florida Statutes, and Section 458.331(nn), Florida Statutes by means of violating Florida Administrative Code Rule 64B8-9.007(2)(b). As a penalty, it is recommended that the Board issue a letter of concern, and impose a $5,000 fine. In addition, Respondent should be required to obtain five hours in continuing medical education in the area of risk management, perform 25 hours of community service, and give a one-hour lecture on performing procedures on the wrong patient. DONE AND ENTERED this 30th day of June, 2010, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of June, 2010.
Findings Of Fact Ruth Rogers is a licensed medical physician authorized to practice medicine in this state. The Complaint allegations centered around testimony of the Respondent, Ruth Rogers, during a custody proceeding in which the Child Protective Services (a State Agency) was attempting to gain custody of one Dena (Nikki) Decker based on facts which will be set forth in detail hereinafter. Jack McGowan, a medical doctor engaged primarily in pediatrics in Fort Pierce, Florida, testified that he first treated Dena Decker during August of 1973, at which time Decker was approximately seven weeks old. Dr. McGowan made subsequent treatments of Dena Deckur on a regular basis through December of 1976. During December, Dr. McGowan noted that Decker's lymph glands were enlarged and he ordered that certain lab work be performed, the results of which were returned to him sometime during early January of 1977. Based on the lab results, Dr. McGowan tentatively diagnosed Dena Decker as being a patient suffering from acute leukemia. To confirm this diagnosis, he referred her to the Shands Teaching Medical Center in Gainesville, wherein Dr. McGowan's diagnosis was confirmed. The treating physicians of Patient Decker at Shands Teaching Hospital were Drs. Jerry L. Arbosa and David Pockmore. It was their medical opinion that Dena was in fact suffering from acute lymphoblastic leukemia and that this disease should be treated by chemotherapy at Shands Teaching Hospital in Gainesville. Drs. Barbosa and Rockmore explained to the parents of Dena Decker the benefits and side effects of chemotherapy treatment, and they suggested that this was the best method of treating a patient such as Dena Decker, who was suffering from acute lymphoblastic leukemia. They noted, however, that there were some side effects, such as loss of hair and the destruction of certain "good" cells as well as "bad" cells. Dema Decker's parents requested time to consider the chemotherapy treatment and Drs. Barbosa and Rockmore stressed to her parents that "time was of the essence". After a few days, the parents of Dena Decker declined the treatment and at that juncture, Drs. Barbosa and Rockmore called in the Child Protective Services of Gainesville wherein a custody proceeding was convened, with the State seeking a custody award of Dena Decker. During that proceeding, Dr. Ruth Rogers, Respondent, testified that she would treat such a patient suffering from acute lymphoblastic leukemia with natural foods, herbs and optimal psychological support. It was Drs. Barbosa and Rockmore's opinion that the method of treatment outlined by the Respondent would be futile and that the patient would die in a short period of time. There was no evidence that the Respondent, Ruth Rogers, counseled with Dena Decker's parents or that she at any time treated Dena Decker by the method to which she testified during the custody proceeding in Gainesville. Following the conclusion of the Petitioner's case, Respondent's counsel moved for a directed verdict, summary judgment, or a judgment based on a failure on the Petitioner's part to establish a prima facie case. After some consideration, the undersigned concluded that, based on the evidence adduced during the Petitioner's case in chief, insufficient evidence was offered to establish that the Respondent had violated Chapter 458.1201(m), Florida Statutes, as alleged. Section 458.1201 is the section of the Medical Practices Act which deals with the power of the Board in the denial, suspension, revocation of license, and other discipline of medical practitioners. It reads, in pertinent part: "458.1201l--Demial, suspension, revocation of license; disciplinary powers-- The board shall have authority to deny an application for a license or to discipline a physician licensed under this chapter or any antecedent law who, after hearing, has been adjudged unqualified or guilty of the follow- ing: (Here is set forth several categories of disqualification or misconduct included in which is subsection (m))." Subsection (m) sets forth as grounds for. . . discipline of a physician, the following facets of misconduct: "(m) Being guilty of immoral or unprofessional conduct, incompetence, negligence or will- ful misconduct. Unprofessional conduct shall be any departure from, or the failure to conform to, the standards of acceptable and prevailing medical practice in his area of expertise as determined by the board, in which proceeding actual injury to a patient need not be established; when the same is committed in the course of his practice whether committed within or without this state." (Emphasis supplied) The administrative charge herein claimed to be proscribed by the above- quoted section of the statutes deals only with the testimony of the Respondent as to a method of treatment that she would use for treating acute lymphoblastic leukemia. Based on my examination of this record and an analysis of the reported case law, I conclude that the giving of such testimony is not proscribed unprofessional conduct as that term is included within this particular subsection of Chapter 485.1201(m). As the Court of Appeals stated in Lester v. Department of Professional and Occupational Regulation, Fla.App., 348 So.2d 923 (1977), the Court stated: "In construing the language and import of this statute we must bear in mind that it is, in effect, a penal statute since it imposes sanctions and penalties in the nature of denial of license, suspension from practice, revocation of license to practice, private or public reprimand, or probation, upon those found guilty of violating its prescriptions. This being true the statute must be strictly construed and no conduct is to be regarded as included within it that is not reasonably pro- scribed by it. Furthermore, if there are any ambiguities included such must be construed in favor of the applicant or licensee." This being so, I conclude that the above-cited conduct claimed to be violative of Chapter 458 is not proscribed by Chapter 458.1201(m) and I shall recommend that the Board enter a final administrative order dismissing the instant action against the Respondent.
Recommendation Based on the foregoing findings and conclusions, hereby RECOMMEND: That the Administrative Complaint filed herein against the Respondent be DISMISSED. RECOMMENDED this 28th day of August, 1978, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael I. Schwartz, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 David Rogers, Esquire 3101 Maguire Boulevard Post Office Box 20065 Orlando, Florida 32814 George S. Palmer, M.D. Execuivo Director State of Florida, Board of Medical Examiners 2009 Apalachee Parkway, Suite 220 Tallahassee, Florida 32301
