On April 29, 2010, a duly-noticed hearing was held by means of video-teleconferencing with sites in Tallahassee and in Daytona Beach, Florida, before Lisa Shearer Nelson, an Administrative Law Judge of the Division of Administrative Hearings.
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?
On June 16, 2008, the Department of Health (Petitioner or DOH) filed a two-count Administrative Complaint against Respondent, Ashraf Elsakr, M.D. (Respondent or Dr. Elsakr).
Count I of the Administrative Complaint alleged that he violated Section 458.331(1)(bb), Florida Statutes (2006), by operating on the wrong patient. Count II of the Administrative Complaint alleged that he failed to ensure that the "pause rule" in Florida Administrative Code Rule 64B8-9.007(2)(b) was implemented and by this failure, violated Section 458.331(nn), Florida Statutes (2006). On July 10, 2008, Respondent filed an Election of Rights form disputing the allegations of fact in the Administrative Complaint and requesting a hearing pursuant to Section 120.57(1), Florida Statutes. On July 9, 2009, the Department referred the matter to the Division of Administrative Hearings for assignment of an administrative law judge.
On July 21, 2009, a Notice of Hearing issued scheduling the final hearing for October 6-7, 2009. However, the matter was continued at the request of Respondent, and was subsequently rescheduled for February 18-19, 2010. The case was rescheduled a second time at the request of the Department, and was ultimately heard on April 29, 2010.
At hearing, Petitioner presented the testimony of Robin Brown and Petitioner's Exhibits A and B were admitted into evidence. Respondent testified on his own behalf and presented the testimony of Sharon Carter; Debra Walburg; Donald Stoner, M.D.; Mark Baretella, M.D.; and Vickie Griffin. Respondent's Exhibits 1-4 were admitted into evidence.
The two-volume transcript of the proceedings was filed with the Division on May 11, 2010. At the request of the parties, the time for filing proposed recommended orders was extended to Friday, June 11, 2010. Both submissions were timely filed and carefully considered in the preparation of this Recommended Order. Unless otherwise indicated, all references to Florida Statutes are to Florida Statutes (2006).
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.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action in accordance with Sections 120.569 and 120.57(1), Florida Statutes (2009).
The Department is seeking to take disciplinary action against Respondent's license as a medical doctor. Because disciplinary proceedings are considered to be penal proceedings, Petitioner has the burden to prove the allegations in the Administrative Complaint by clear and convincing evidence. Department of Banking and Finance v. Osborne Stern and Co.,
670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987). As stated by the Supreme Court of Florida,
Clear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the testimony must be precise and lacking in confusion as to the facts in issue. The evidence must be of such a weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.
In re Henson, 913 So. 2d 579, 590 (Fla. 2005), quoting Slomowitz
v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).
Moreover, disciplinary provisions such as Sections
456.072 and 458.331, Florida Statutes, must be strictly construed in favor of the licensee. Elmariah v. Department of Professional Regulation, 574 So. 2d 164 (Fla. 1st DCA 1990); Taylor v. Department of Professional Regulation, 534 So. 782, 784 (Fla. 1st DCA 1988).
Count I of the Administrative Complaint charged Respondent with violating Section 456.072(1)(bb), Florida Statutes, which makes it a disciplinary violation for:
(bb) Performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition. For the purposes of this paragraph, performing or attempting to perform health care services includes the preparation of the patient.
This subsection has been interpreted by the Fourth District Court of Appeal in Abram v. Department of Health,
13 So. 3d 85 (Fla. 2009).1/ The Fourth District made it clear that Section 456.072(1)(bb) is not a violation that presumes a deviation from accepted standards of care:
We agree with the Department that section 456.072(1)(aa)'s plain meaning does not include a presumption that a wrong-site procedure falls below the standard of care. The statute makes no mention of the standard of care, and many of the thirty-plus actions constituting section 456.072(1) violations have nothing to do with a patient's care.
Abram has not cited any authority supporting his assumption that the Legislature included a wrong-site procedure as a section 456.072 violation because it presumed a wrong-site procedure falls below the standard of care.
13 So. 3d at 88-89.
The court emphasized the discretionary nature of the Board's authority to discipline physicians should the Department present evidence that a wrong-site procedure, or in this case a wrong-patient procedure, occurred. The court stated:
In deciding this case, we would be remiss if we did not express our reservations regarding the origin from which this case has arisen, that is, the Board's interpretation that section 456.072(1)(aa) creates strict liability for performing a wrong-site procedure, and Abram's acknowledgement of that interpretation as the springboard for his due process argument. The statute's language, italicized below, plainly suggests a different interpretation. Subsection (1) states: "The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:
. ." Subsection (2) states, in pertinent part:
"When the board . . . finds any person guilty of the grounds set forth in subsection (1). .
. it may enter an order imposing one or more of the following penalties.. . ." Below and in their briefs, the parties wholly have ignored the Legislature's use of the permissive word "may" in subsection
regarding the taking of disciplinary actions, and in subsection (2) regarding the imposition of penalties. If the Board had construed the statute as permissive rather than mandatory, the outcome of this case may have been different. See Ayala v. Dep't of Prof. Regulation, 478 So. 2d 1116, 1117-18 (Fla. 1st DCA 1985)(construing statute as permissive rather than mandatory required Board of Medical Examiners to consider evidence in deciding appellant's guilt or innocence of disciplinary charges.).
Id. at 89.
Ayala required the Board to consider the circumstances attending a plea of nolo contendere in determining whether a physician was guilty of the underlying criminal charge, in order to decide whether the physician was guilty of a crime related to the practice of medicine. The Department contends that Respondent must negate the evidence that a wrong patient surgery occurred in order to rebut any presumption arising from Section 456.072(1)(bb).
Evidence of the circumstances giving rise to a wrong patient surgery is not going to negate whether the wrong patient surgery occurred. However, in light of the Fourth District's reference to Ayala, it seems reasonable that, contrary to the Department's contention, the Respondent may explain the circumstances attending the event giving rise to the charge which
may be considered, and his explanation may be used by the Board to determine whether it wishes, in its discretion, to find that a violation of Section 456.072(1)(bb) has occurred, and may also be used in consideration of penalty should a violation be found.
That being said, the ultimate determination that a physician has committed a violation of Section 456.072(1)(bb) is that of the Board of Medicine. Clear and convincing evidence exists to support the allegation that indeed, Respondent performed a heart catheterization on the wrong patient. Based on the evidence presented, the Board may, in its discretion, conclude that a violation of Section 456.072(1)(bb) has occurred, and it is so recommended.
Count II charges that Respondent violated Section 458.331(1)(nn), which makes it a disciplinary violation for a physician to violate any provision of Chapters 456 or 458, or any rules adopted pursuant thereto. The Administrative Complaint alleges that Respondent violated this subsection by failing to pause and confirm the correct patient, in violation of Florida Administrative Code Rule 64B8-9.007(2)(b). This rule, commonly referred to as the "pause rule," provided as follows:
(b) Except in life-threatening emergencies requiring immediate resuscitative measures, once the patient has been prepared for the elective surgery/procedure and the team has been gathered and immediately prior to the initiation of any procedure, the team will pause and the physician(s) performing the procedure will verbally confirm the patient’s identification, the intended procedure
and the correct surgical/procedure site.
The operating physician shall not make any incision or perform any surgery or procedure prior to performing this required confirmation. The medical record shall specifically reflect when this confirmation procedure was completed and which personnel on the team confirmed each item. This requirement for confirmation applies to physicians performing procedures either in office settings or facilities licensed pursuant to Chapter 395, F.S., and shall be in addition to any other requirements that may be required by the office or facility.[2/]
Respondent contends that he substantially complied with the pause rule, because Respondent not only adhered to Halifax's existing time-out policy, but also spoke to the patient, stating her name, the procedure, and the procedure site. First, compliance with Halifax's protocol is admirable but not dispositive. Rule 64B8-9.007(2)(b) specifically indicates that the requirement for confirmation shall be in addition to any other requirements imposed on the facility.
Moreover, it is clear that Halifax's protocol in effect at the time of the procedure did not, standing by itself, comply with the pause rule. The rule required that the physician, not merely a member of the surgical team, verbally confirm the patient's identification, the intended procedure and the correct surgical/procedure site. It also required that the notes of the procedure reflect when the confirmation procedure was completed and which personnel on the team confirmed each item. Here, Halifax's protocol only required the physician to be present and
observe the recorder call out the information. It did not require him to confirm the information himself.
The term "confirm" is not defined in the rule. Relying on the ordinary meaning of the term, "confirm" is defined as "to establish the truth, accuracy, validity, or genuineness of; corroborate; verify." Dictionary.com, Unabridged (Random House Dictionary @ Random House, Inc. 2000). It could be said that Halifax's protocol confirmed the patient that was supposed to be present, the procedure to be performed and the site for the procedure, but it did not confirm that the patient present was actually the patient that was supposed to be there.
Respondent argues that when Dr. Elsakr approached M.D., spoke to her and called her by name (of the patient that was supposed to be there), confirmed the procedure and location of the procedure, his actions coupled with the Halifax protocol satisfied the requirements of the pause rule. This argument has some appeal, especially where, as here, the patient responded to Dr. Elsakr when he spoke to her. However, calling the patient by her first name assumed, rather than confirmed, her identity. There is no evidence in the record that she actually heard him call the other patient's name. While his assumption was understandable in light of her response, his actions fall short of actually verifying her identity. Simply asking her to state her name would have satisfied the confirmation requirement of the pause rule. Inasmuch as Respondent did not verbally confirm the
patient's identity, a violation of Rule 64B8-9.007 has been established, and Count II was proven by clear and convincing evidence.
The Board of Medicine is required to adopt Disciplinary Guidelines to establish meaningful ranges of penalties when discipline is imposed, to provide to the public notice of the likely penalties for proscribed conduct. § 456.079, Fla. Stat. The Board has adopted a rule listing its disciplinary guidelines, along with aggravating and mitigating factors to be considered should a lesser or greater penalty be warranted. Fla. Admin. Code R. 64B8-8.001. For a violation of Subsection 456.072(1)(bb), the guideline penalty for a first offense is from a $1,000 fine, a letter of concern, a minimum of five hours of risk management education, and a one-hour lecture on wrong site surgery to a $10,000 fine, a letter of concern, a minimum of five hours of risk management education, a minimum of 50 hours of community service, undergo a risk management assessment, and a one-hour lecture on wrong site surgery, and suspension to be followed by a term of probation. Rule 64B8-8.001(2)(qq).
No specific penalty is listed for violation of the pause rule. However, Rule 64B8-8.001(1)(x) provides that for violation of Section 458.331(1)(nn)(violation of Chapters 456 or 458, or any rule adopted thereto), the range of penalties for a first offense, based on the severity of the offense and the
potential for patient harm, go from a reprimand to revocation or denial and an administrative fine from $1,000 to $10,000.
The Department has suggested that an appropriate penalty would be a letter of concern, a fine of $7,500, 50 hours of community service, five hours of continuing medical education and a one-hour lecture on performing procedures on the wrong patient. The Department bases its recommendation in part on what it considers to be aggravating factors in terms of the number of counts proven and the harm to the patient.
Aggravating and mitigating circumstances listed under the rule are as follows:
Aggravating and Mitigating Circumstances. Based upon consideration
of aggravating and mitigating factors present in an individual case, the Board may deviate from the penalties recommended above. The Board shall consider as aggravating or mitigating factors the following:
Exposure of patient or public to injury or potential injury, physical or otherwise; none, slight, severe, or death;
Legal status at the time of the offense: no restraint, or legal constraints;
The number of counts or separate offenses established;
The number of times the same offense or offenses have previously been committed by the licensee or applicant;
The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;
Pecuniary benefit or self-gain inuring to the applicant or licensee;
The involvement in any violation of Section 458.331, F.S., of the provision of controlled substances for trade, barter or sale, by a licensee. In such cases, the Board will deviate from the penalties
recommended above and impose suspension or revocation of licensure;
Where a licensee has been charged with violating the standard of care pursuant to Section 458.331(1)(t), F.S., but the licensee, who is also the records owner pursuant to Section 456.057(1), F.S., fails to keep and/or produce the medical records;
Any other relevant mitigating factors.
Some of the factors listed above have no application to this case. For example, Respondent was under no legal constraints at the time of the incident (subsection (3)(b)). Further, no violation of Section 458.331(1)(t) was charged, so neither subsection (3)(g) or (h) is applicable.
With respect to subsection (3)(a), while the patient was clearly exposed to additional risk as a result of the cardiac catheterization, the Department did not present any evidence regarding the level of exposure to injury. Ironically, the procedure actually resulted in beneficial information for the patient.
Two separate counts were established as charged in the Administrative Complaint, but there is no evidence that Respondent has committed either violation in the past. (Subsections (3)(c) and (d)). Likewise, there was no evidence that Respondent has ever been disciplined in his career, either in Florida or elsewhere, and Dr. Elsakr has been licensed as a medical doctor since 1990 and in Florida since 1996. (Subsection 2(e)). He did not gain anything by the incident and instructed that the patient not be charged in any way (subsection 3(f)).
In addition, by all accounts, Dr. Elsakr is a fine surgeon with an excellent reputation in his field. He did speak with the patient, calling her by the name of the patient that he thought was present, and M.D. responded to his questions. While technically he did not confirm her identity, it is understandable that he thought he had the right patient. Further, immediately upon learning the mistake, he stopped the procedure, notified the patient, her daughter, and her primary care physician. He made sure that she was not charged for the procedure, and after investigation, the hospital took full responsibility for the incident.
On the whole, there are more mitigating than aggravating factors present in this case. Accordingly, a penalty within the guidelines, but at the lower end is appropriate.
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 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.
Filed with the Clerk of the Division of Administrative Hearings this 30th day of June, 2010.
2 The rule was amended after the events giving rise to this case to substitute the term "medical record" for the phrase "notes of the procedure" in the third sentence of the rule.
Thomas L. Dickens, Esquire
15 days from the date of this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.
