09-003628PL Department Of Health, Board Of Medicine vs. Ashraf Elsakr, M.D. Status: Closed Recommended Order on Wednesday, June 30, 2010.

Summary: The Department proved by clear and convincing evidence that Respondent failed to adhere to the pause rule and operated on the wrong patient. Mitigating factors were present.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

)

DEPARTMENT OF HEALTH, ) )

BOARD OF MEDICINE,

)

Petitioner, )

) Case No. 09-3628PL

vs. )

)

ASHRAF ELSAKR, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

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.

APPEARANCES

For Petitioner: Edrene Johnson, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Chobee Ebbetts, Esquire

210 South Beach Street, Suite 200

Daytona Beach, Florida 32114

STATEMENT OF 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?

PRELIMINARY STATEMENT

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).

FINDINGS OF FACT

1. 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.

2. 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.

3. No evidence was presented to indicate that Respondent

has ever been disciplined by the Florida Board of Medicine.

4. 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.

5. Both women were scheduled for cardiac procedures to be

performed on March 12, 2007, but only F.E. was scheduled for a

cardiac catheterization.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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

23. 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).

24. 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).

25. 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).

26. 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.

27. 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.

28. 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

(1) 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.

29. 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).

30. 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.

31. 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.

32. 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 [2/]

may be required by the office or facility.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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).

38. 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.

39. 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.

40. Aggravating and mitigating circumstances listed under

the rule are as follows:

(3) 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:

(a) Exposure of patient or public to injury

or potential injury, physical or otherwise;

none, slight, severe, or death;

(b) Legal status at the time of the offense:

no restraint, or legal constraints;

(c) The number of counts or separate

offenses established;

(d) The number of times the same offense or

offenses have previously been committed by

the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction and

the length of practice;

(f) Pecuniary benefit or self-gain inuring

to the applicant or licensee;

(g) 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;

(h) 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;

(i) Any other relevant mitigating factors.

41. 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.

42. 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.

43. 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)).

44. 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.

45. 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.

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

[phone]

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 30th day of June, 2010.

ENDNOTES

1 The Abrams decision interpreted Section 456.072(1)(aa), Florida

Statutes (2004), which, while the text remains the same, has been

renumbered as subsection (1)(bb).

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.

COPIES FURNISHED:

Charles Chobee Ebbets, Esquire

Ebbets & Traster

210 South Beach Street, Suite 200

Daytona Beach, Florida 32114

Thomas L. Dickens, Esquire

Department of Health

4052 Bald Cypress Way, Bin #C-65

Tallahassee, Florida 32399

Larry McPherson, Jr., JD, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin #C-65

Tallahassee, Florida 32399

Sam Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

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.