02-000340PL Department Of Health, Board Of Medicine vs. Alexander D. J. Brickler, Iii, M.D. Status: Closed Recommended Order on Friday, November 8, 2002.

Summary: Respondent improperly identified the patient and performed a procedure without advance consent.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 02 - 0340PL

)

ALEXANDER D. J. BRICKLER, III, )

M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Notice was provided and on July 17 through 19, 2002, a

formal hearing was held in this case. Authority for conducting

the hearing is set forth in Sections 120.569 and 120.57(1),

Florida Statutes. The hearing location was the Office of the

Division of Administrative Hearings, Tallahassee, Florida. The

case was held before Charles C. Adams, Administrative Law Judge.

APPEARANCES

For Petitioner: Robert C. Byerts, Esquire

Kim M. Kluck, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: David W. Moye, Esquire

Linda Loomis Shelley, Esquire

Fowler, White, Boggs and Banker, P.A.

Post Office Box 11240

Tallahassee, Florida 32302

STATEMENT OF THE ISSUE

Should Petitioner discipline Respondent's license to

practice medicine?

PRELIMINARY STATEMENT

By an Amended Administrative Complaint in Case No. 1999 -

56830, before the State of Florida, Department of Health,

Respondent is accused of failing to practice medicine with the

level of care, skill, and treatment which is recognized by a

reasonably prudent similar physician as being acceptable under

similar conditions and circumstances in the treatment of patient

A.G. by performing a LEEP/Conization on patient A.G. in violation

of Section 458.331(1)(t), Florida Statutes. Petitioner q uestions

the performance of this procedure on A.G., rather than patient

N.C. who was scheduled for the procedure, having failed to

identify A.G. before performing the procedure intended for N.C.

The Amended Administrative Complaint was filed with the

Depa rtment of Health on December 18, 2001. Consistent with his

opportunities Respondent elected to contest the facts that

underlie the Amended Administrative Complaint through a formal

hearing. On January 25, 2002, the case was received by the

Division of Ad ministrative Hearings. The case was assigned and

heard on the dates stated.

CASE HISTORY

Various motions were made seeking official recognition of

Sections 458.331, 464.003 and 464.012, Florida Statutes, together

with Rule 64B8 - 8.001, Florida Administr ative Code. Those

requests were granted by written order and through rulings

announced at the hearing, as transcribed. Official recognition

of final orders entered by Petitioner in disciplinary cases were

ruled on through a written order or as noted in the hearing

record, subject to the opportunity for the parties in the course

of proposed recommended orders to argue the issue of the

relevance of those decisions to the present case as precedent for

imposing discipline. Official recognition was provided in a

written order concerning the case of Alexander D.J, Brickler,

M.D., Plaintiff vs. Florida Department of Health, Defendant , Case

No. 01 - CA - 2244, in the Circuit Court in and for Leon County,

Florida, in relation to an order on a motion to dismiss. Moti ons

in limine concerning conduct of the final hearing were ruled on

by written order. Petitioner's motion to offer a further

amendment to the Amended Administrative Complaint by

relinquishment of jurisdiction to the Board of Medicine for that

purpose was denied by written order. A written order was entered

ruling on the affirmative defenses raised by Respondent in

addressing the Amended Administrative Complaint. Respondent's

Motion to strike the use of Drs. Zelnick, Fojo, and Kast as

witnesses was denied by written order. Shortly before hearing,

Respondent moved to dismiss the Amended Administrative Complaint.

That motion was denied as reflected in the hearing transcript.

Petitioner's Motion to Deem Admitted the allegations set forth in

paragraphs 2 an d 3 to the Amended Administrative Complaint was

granted as reflected in the hearing transcript.

At final hearing Joint Exhibits numbered 1 through 4 were

received. Petitioner's Exhibits numbered 1 through 3 were

received. Video depositions and transc ripts of Roberto Fojo,

M.D., and Edward Zelnick, M.D., are Petitioner's Exhibits

numbered 2 and 3 respectively. Those depositions are received in

their entirety. Respondent's Exhibits numbered 1 through 3 were

received.

In addition to the testimony of Drs. Fojo and Zelnick,

Petitioner presented Rolando Gomez, patient A.G.; patient A.G.'s

husband T.Q.; Patricia Charbonneau, R.N.; Katherine Turner;

Margaret Canter, Midwife/Family Nurse Practitioner; Jamie Martin,

R.N.; Dale Dunsmore, R.N.; Jean Mauch, C.R .N.A.; Valerie Lazzell,

M.D.; Woodward Burgert, M.D.; and Michelle McCallanahan, M.D.

Respondent testified in his own behalf and presented the

testimony of Valerie Lazzell, M.D.; Diane Jordan, Surgical

Technician; Jana Bures - Forsthoefel, M.D.; Kenneth McAlpine, M.D.;

David O'Bryan, M.D.; and Roberto Morales, M.D.

The five - volume transcript was filed with the Clerk of the

Division of Administrative Hearings on September 10, 2002.

Consistent with their opportunities the parties had timely filed

proposed recommended orders by September 30, 2002. Those

proposed recommended orders have been considered in preparing the

Recommended Order.

FINDINGS OF FACT

1. At the times relevant to the inquiry Petitioner was the

state agency charged with regulati ng the practice of medicine in

Florida, pursuant to Section 20.43, Florida Statutes, and

Chapters 456 and 458, Florida Statutes.

2. Respondent is and has been at all times material hereto

a licensed physician within the state of Florida, having been

issued license No. ME0045474, effective December 28, 1984.

Respondent's last known address is 1401 Centerville Road, Suite

202, Tallahassee, Florida 32308.

3. Respondent is board - certified in obstetrics and

gynecology. The board certification is by t he American Board of

Obstetrics and Gynecology. Respondent is a fellow of the

American College of Obstetricians and Gynecologists.

4. Respondent received his undergraduate degree from

Florida State University and his medical degree from Howard

Univers ity. His training at Howard University included a four -

year residency program from 1982 to 1986.

5. Respondent holds staff privileges at Tallahassee

Memorial Hospital (TMH) in Tallahassee, Florida.

Patient A.G.

6. Patient A.G. began treatmen t with Respondent in 1998 and

continues as Respondent's patient. A.G. is an Hispanic female

who is not proficient in English. When seen by Respondent in his

office she has been accompanied by an interpreter that would

allow Respondent to discuss details of her health care in English

for translation into Spanish for the patient's benefit.

Respondent's understanding of Spanish is limited to education in

high school and a year at the university. He has the ability to

describe some matters that are pertinen t to gynecologic practice

or obstetric practice and in particular as it relates to telling

patients, for example "how to push and when not to push." The

record does not reveal that Respondent has the ability to discuss

A.G.'s overall health care in Spanis h, her language.

7. A.G.'s husband, T.Q., who accompanied her at relevant

times principally spoke Spanish and not English. He is somewhat

proficient in English.

8. On June 16, 1999, A.G. had an office appointment with

Respondent. At that time A .G. had undergone gallbladder surgery

but her pelvic pain persisted. In consultation on that day it

was decided that A.G. would undergo diagnostic laparoscopy to

explore the reason for her chronic pelvic pain. Through the

discussion the patient was told that biopsies of the pelvic

anatomy might be performed during the procedure and that any

problems that could be addressed through laparoscopy would be

addressed as Respondent felt comfortable in carrying out that

correction. Otherwise, Respondent said tha t he would "take

pictures" and "get out of the case" with the decision to offer

further treatment left for another time.

9. Patient A.G. had been referred to Respondent for her

persistent pelvic pain following an examination on April 27,

1999, that had been made by Margaret Cantor, a Nurse/Mid - Wife and

Registered Nurse. She conducted a pelvic examination of the

patient that date. The examination included the use of speculum

to examine the cervix and vagina in the interest of looking for

abnormalities, lesions, growths, and discolorations. No cervical

lesions were found in this examination. A pap smear taken at the

time revealed normal results with some inflammation.

10. Diagnostic laparoscopy is a surgical procedure

involving an incision in the abd ominal wall through which a scope

is inserted to visualize the abdominal cavity. Typically the

workup for performing a diagnostic laparoscopy would include use

of ultrasound, pelvic examination, and a pap smear. Possible

complications in this procedure i nclude vascular injury, bowel

injury, bladder injury, infection, and bleeding. Preliminary to

the diagnostic laparoscopy it is the custom and practice in the

medical community to perform a vaginal examination with the use

of a speculum.

11. On July 1, 1999, patient A.G. was seen by the

Respondent in his office for her pre - operative check. On this

occasion A.G. was unaccompanied by a translator. Nonetheless,

Respondent was able to perform a brief physical and obtain a

history with the assist ance of A.G.'s husband. Respondent

listened to the patient's heart and lungs and performed a bi -

manual examination in which one or two fingers were inserted in

the vagina and with a hand on the abdomen compression was

performed on the pelvic viscera, uter us, tubes, and ovaries and

the lower section of the pelvis. Nothing significant was

observed in the patient since last seen.

12. On July 1, 1999, an employee in Respondent's office

witnessed patient A.G. sign a consent form allowing the

diagnostic laparo scopy. The consent form makes no reference to

the agreement for Respondent to perform a loop electrocautery

excision procedure, referred to by abbreviations as a "LEEP"

conization biopsy procedure or a LEEP cone. No evidence of such

consent is contained in patient A.G.'s medical records maintained

at Respondent's office.

13. The diagnostic laparoscopy was to be performed at TMH.

On July 1, 1999, Patricia Charbonneau, a clinical nurse at the

hospital, reviewed a consent form with patient A.G. concernin g

the diagnostic laparoscopy for the purposes of that facility.

Nurse Charbonneau was aware of the scheduling of the diagnostic

laparoscopy by reference to the history and physical prepared by

the Respondent. This conference involved the discussion of

po tential risks and complications of the laparoscopy. No

discussion was conducted concerning possible risks and

complications of a LEEP conization biopsy.

14. The consent form from TMH pertaining to patient A.G.

and the diagnostic laparoscopy stated "If any unforeseen

condition arises and additional surgery is deemed medically

necessary during my procedure, I request and authorize my

physician to proceed." Nurse Charbonneau was left with the

impression that the patient understood the explanation con cerning

the upcoming procedure and gave her consent. Ms. Charbonneau was

assisted in this communication by A.G.'s husband. No discussion

was held concerning the performance of a LEEP cone biopsy, in

that the permit from Respondent made no mention of that

procedure. Ms. Charbonneau took steps for an interpreter to be

available the next morning when the surgery was to be performed

given the nature of the surgery, the use of anesthesia and the

desire to have "everything" reviewed again.

15. A LEEP conization is a form of biopsy performed either

in an office or hospital setting with anesthesia. The cervix is

examined with the assistance of a speculum. Lugol solution is

placed on the cervix to identify any abnormal cells and an

excesion is mad e by shaving a small piece of the cervix for

examination. The workup for LEEP conization includes a pap smear

and a colposcopy. The performance of LEEP conization presents

potential risks and complications related to infection,

endometrious, bleeding, ce rvical stenosis, and cervical

incompetence.

16. On July 2, 1999, patient A.G. came to the TMH

outpatient surgery center for her scheduled diagnostic

laparoscopy to be performed by Respondent. She was the fourth

patient on a sche dule of surgeries to be performed by Respondent

on that date. Respondent was conversant with the sequence of

surgeries to be performed.

17. Patient A.G. was placed in a holding area in the

outpatient surgery center to prepare her for her surgery and to

await transport to the operating room. Sometime before moving

the patient to the operating room Respondent saw the patient in

the holding area. Respondent addressed patient A.G. by saying

hello and asking her how she was doing. This was not a visit

int ended to educate the patient and was not involved with any

other medical purpose. At the time the patient's husband was

with her during this brief encounter which was intended to

confirm that the patient was there for the surgery as had been

previously ar ranged. Several hours may have passed between the

time Respondent saw patient A.G. in the holding area and when he

next encountered the patient in the operating room.

18. Respondent also saw patient N.C. in an adjacent cubicle

to where patient A.G. was located while the patients were

awaiting their surgery. Patient N.C. was the third patient on

the schedule, there for the performance of a LEEP conization

biopsy.

19. Respondent followed his surgical schedule for the first

two patients in the intended sequence. Some delay was occasioned

by a problem experienced in the surgery performed on the second

patient.

20. Valerie Anne Lazzell, M.D., is an anesthesiologist

licensed to practice in Florida. She is employed by

Anesthesiology Associates of Talla hassee, Florida. It was

intended that she provide anesthesia during Respondent's

performance of the diagnostic laparoscopy for patient A.G. It

was anticipated that the patient be subjected to general

anesthesia which involves a rapid loss of consciousnes s and

blocks the sensory, mental and motor functions of the patient. A

general anesthesia can be provided by using an endotracheal tube,

with a mask or with an LMA. This is as distinguished from the

use of a neurolept employed in most instances when perf orming

LEEP conization biopsies. In that setting the patient is

generally anesic, not really aware, and has analgesia "on board."

The use of a neurolept promotes a pain - free state of immobility

and an insensitivity to pain and is usually accomplished by use

of IV medications.

21. From the record, it appears that Jean Mauch, C.R.N.A.,

with Anesthesiology Associates was scheduled to provide

anesthesia by neurolept for the third patient N.C. who was

scheduled for LEEP conization biopsy.

22. Patient A.G . at the time in question was 4'9" tall and

weighed 103 pounds. Patient N.C., an African - American woman was

5'2" tall and weighed 242 pounds. Their skin tone was similar in

color.

23. Dr. Lazzell saw patient A.G. before the patient was

taken for surge ry. In this examination the doctor filled out the

patient's airway, listened to her heart and lungs, and considered

the patient's ASA classification which was one of good health.

Dr. Lazzell considered the plan for anesthesia with an

endotracheal tube. She gained the assistance of a Dr. Becker who

was fluent in Spanish in explaining the use of anesthesia to the

patient. Dr. Lazzell sought Dr. Becker's assistance when the

hospital did not make an interpreter available. Dr. Lazzell

discussed the possible risks and complications of use of this

form of anesthesia and a consent form was signed and dated.

While this assessment was being made A.G.'s husband was in

attendance. It was Dr. Lazzell's expectation that the patient

A.G. would next be seen as schedu led when the nurse anesthetist

called Dr. Lazzell to the operating room to intubate patient A.G.

in association with the provision of anesthesia for the

diagnostic laparoscopy.

24. Jean Mauch, C.R.N.A., when performing her duties in the

operating room set ting at TMH outpatient surgery center was

expected to induce anesthesia, maintain the anesthesia, monitor

vital signs, treat untoward events during surgery and maintain

fluids in the patient while under the supervision of the

physician, in this instance, D r. Lazzell.

25. Nurse Mauch was principally responsible for providing

the anesthesia for the third procedure on patient N.C., the LEEP

conization biopsy. This included preparation in the operating

room of medications and other related tools and supplies. The

third procedure, the LEEP conization biopsy for N.C., was

referred to on a typed surgical schedule in the preoperative desk

in the outpatient surgery center. Having checked the schedule

Nurse Mauch obtained the chart for N.C. and went to the cubical ,

not of N.C. but A.G. When Nurse Mauch arrived at A.G.'s cubical,

Jamie Martin, R.N., the pre - op nurse and Dale Dunsmore, R.N., the

circulating nurse, were there. Nurse Dunsmore and Nurse Mauch

arrived at the cubicle where patient A.G. was located at ab out

the same time. When arriving at the cubicle for patient A.G.,

Nurse Mauch had in mind that the process was one in which she was

getting ready for the surgery to be performed on patient N.C.

While in the cubical Nurse Mauch introduced herself to the p erson

she believed to be the patient N.C., at which time Nurse Dunsmore

said that the patient only speaks Spanish. Nurse Mauch recalls

that a translator was not available for assisting in any

communication with patient A.G. Realizing that Nurse Dunsmore

was checking the armband for identification, the reference to the

fact that the patient only spoke Spanish did not cause Nurse

Mauch any concern. Nurse Mauch never heard Nurse Dunsmore orally

refer to patient A.G. by name. Nurse Mauch continued with her

presentation by commenting that she was the nurse anesthetist who

was going to put the patient to sleep. Patient A.G. nodded her

head in response to Nurse Mauch's physical gesture that the

patient was going to be put to sleep. Beyond that point Nurse

Mau ch and Nurse Dunsmore took patient A.G. to the operating room

ostensibly as the third patient on the schedule for provision of

a LEEP conization biopsy wherein Nurse Mauch would provide the

necessary anesthesia. The chart for N.C. was brought to the

opera ting room.

26. Before the patient was removed from the cubicle Nurse

Martin provided pre - op medication to patient A.G., phenergan

robinul.

27. The fact that Nurse Martin was giving preoperative

medication and that Nurse Dunsmore was checking the ar mband on

what turned out to be patient A.G. led Nurse Mauch to believe

that patient A.G. was patient N.C. the third scheduled patient,

according to Nurse Mauch.

28. As Nurse Mauch recalls, when the Respondent entered the

operating room where the third s cheduled procedure was to be

performed he checked the chart for patient N.C. Respondent went

out and washed his hands, returned and started the procedure. At

the end of the procedure Nurse Mauch recalls Respondent

commenting that the next patient speaks only Spanish, to which

Nurse Mauch said, "No, this patient," meaning the patient who had

been subjected to the procedure is the one who speaks Spanish.

Respondent replied "I must be mixed up." Nurse Mauch recalls

Dr. Lazzell arriving at the door of the o perating room with

patient A.G.'s chart. Dr. Lazzell looked surprised to find the

circumstances. Nurse Mauch told Dr. Lazzell that this is the

neurolept, the case involving the LEEP conization biopsy.

Dr. Lazzell commented that "No it isn't." Nurse Mau ch heard

Dr. Lazzell ask Respondent, "What procedure did you do?"

Respondent replied "LEEP conization." Dr. Lazzell said "No, this

was supposed to be the diagnostic laparoscopy." Nurse Mauch

observed Respondent leave the room and return. Patient A.G. w as

re - preped and the diagnostic laparoscopy scheduled to be provided

was performed with the patient being intubated by the use of an

endotracheal tube.

29. Nurse Martin in her capacity as pre - op nurse was

responsible for receiving patients and getting the patients ready

for administering medications that were prescribed and getting

IVs and things started on the patients prior to the patients

being sent to the operating room. She recalls performing pre -

operative duties on the patient A.G. Nurse Martin was familiar

with the schedule of patients, the sequence. She understood that

patient A.G. was the fourth patient in the schedule and provided

the pre - anesthetic to patient A.G. in preparation for the

operation. This involved the use of phenergan. Nurse Martin

made no mistake in identifying patient A.G. when providing care.

Nurse Martin heard Nurse Dunsmore identify patient A.G. in Nurse

Martin's presence and agreed with that identification. Nurse

Martin had seen the patient A.G. before the occasion at which

Nurse Mauch and Nurse Dunsmore were there with the patient in

Nurse Martin's presence and the patient A.G. was taken to the

operating room. Nurse Martin had reviewed patient A.G.'s chart

earlier in caring forward responsibilities for preparing the

patient for the operation.

30. Nurse Dunsmore identified her duties as circulating

nurse at TMH outpatient surgery center as being related to

setting up rooms for surgeries, transporting patients from pre - op

holding areas, identifying patients, verifyi ng surgeries,

verifying allergies, and so forth. Ordinarily Nurse Dunsmore in

performing her duties would read the chart of the patient

scheduled for a procedure to make certain that all permits were

signed. She would then go to where the patient was bei ng held,

introduce herself to the patient and ask for identification,

verifying the surgery that is scheduled for the patient, and

perform other related assignments. In performing her duties

Nurse Dunsmore would accompany the patient with the

anesthesiolo gist to the operating room. The method of

identification in effect at the time in question would be to

compare an addressograph card which accompanied the patient's

chart with the information on an identification bracelet worn by

the patient.

31. Nurse D unsmore verified that the operating room for the

third procedure was set up for a LEEP conization biopsy.

32. After the second procedure on the schedule, Nurse

Dunsmore recalls that she went to patient A.G.'s room. However

Nurse Dunsmore had handed Nurse Mauch patient N.C.'s chart.

Nurse Mauch carried the chart to patient A.G.'s cubicle. The two

nurses essentially entered the cubicle together. Nurse Martin

and patient A.G.'s husband were already there. Nurse Martin left

the cubicle shortly thereafter. Nurse Dunsmore introduced

herself to the patient and reached for the patient's

identification bracelet and read it out loud. The patient smiled

and nodded in response. In turn the patient's husband smiled and

nodded in response. Patient A.G. was then taken to the operating

room by Nurse Dunsmore and Nurse Mauch. The patient was sedated

by Nurse Mauch and positioned for provision of the LEEP

conization biopsy.

33. Nurse Dunsmore observed the Respondent enter the

operating room and look at the chart wh ich was in relation to

patient N.C., not patient A.G. Nurse Dunsmore saw Respondent

leave the operating room to scrub. Nurse Dunsmore was in

attendance when the procedure was performed. Nurse Dunsmore

recalls Dr. Lazzell entering the operating room at t he end of the

procedure with the chart belonging to patient A.G. and the

realization by those in attendance that the chart in the

operating room was for N.C., whom they understood to be

undergoing the procedure when in fact the patient undergoing the

proce dure was A.G.

34. Diane Jordan was a surgical technician assigned to

assist in the third procedure, the LEEP conization biopsy. She

recalls the patient being put to sleep by Nurse Mauch and the

patient being prepared for the procedure. The patient was

covered by draping towels across the upper portion of the thighs.

A blanket was placed over the patient's torso. The patient was

placed in the lithotomy position allowing observation of the

patient's buttocks, vulva, vagina and external pelvic organs.

The patient had a mask on her face and a surgical hat to cover

her hair. All of these arrangements had been made before

Respondent entered the operating room. Ms. Jordan recalls that

the chart in the room was for N.C., the patient anticipated to

undergo the LEEP conization biopsy. Ms. Jordan did not realize

that the patient in reality was patient A.G. Ms. Jordan recalls

that the Respondent when entering the room asked is this "such

and such" in relation to a LEEP conization biopsy and that Nurse

Dunsmor e replied in the affirmative. Ms. Jordan remembers

Respondent looking at the chart for N.C. and signing it.

Ms. Jordan was in attendance while the procedure was performed.

Ms. Jordan heard Respondent mention something about a lesion

before he started. Ms. Jordan provided medication to be injected

during the LEEP conization. Ms. Jordan identified the fact that

a specimen was obtained which was given to her and provided to

the nurse to send to pathology for evaluation.

35. When Respondent entered the room for what he

anticipated to be the third procedure what he asked specifically

was "Is this Ms. C our case for the LEEP?" referring to the LEEP

conization to be performed on patient N.C. That is when Nurse

Dunsmore responded in the affirmative. After inquiring about the

identification of the patient in association with the nature of

the procedure Respondent expected to perform and in receiving an

affirmative response, Respondent took no further steps to

personally confirm the identity of the patient. Respondent

opened the chart that was patient N.C.'s chart. Respondent took

a drawing from his pocket that a Dr. Thompson had made of patient

N.C.'s cervix when he had treated the patient. The drawing was

in association with a colposcopy. Respondent int ended to compare

that drawing with what was observed in the patient during the

performance of the LEEP conization biopsy in locating the

suspected pathology. In proceeding with what he considered to be

the third scheduled procedure for N.C., Respondent pl aced the

speculum, applied the tenaculum and observed what looked to be a

lesion that roughly approximated what he anticipated it would be

based upon the drawing from Dr. Thompson. Respondent applied

Lugol's solution and proceeded with the LEEP conization biopsy.

Having applied the solution there was an indication of some

pathology in roughly the position as the drawing had depicted.

Respondent obtained the sample from the cervix. The size of the

specimen was less than the diameter of a dime with a dept h or

thickness of about two dimes.

36. The performance of the LEEP conization biopsy took less

than five minutes. As Respondent finished Dr. Lazzell came to

the operating room and informed Respondent that this was not the

patient the he thought he was treating. Having been told by

Dr. Lazzell that there was a misidentification, Respondent for

the first time while engaged with the patient in the operating

room proceeded to the front of the table and looked at the

patient while the patient was being unma sked. By doing so

Respondent discovered that indeed the patient had been

misidentified and that he had actually performed surgery on

patient A.G., not patient N.C. Respondent left the operating

room and informed patient A.G.'s husband of the problem.

Re spondent returned to the operating room. The patient was

provided anesthesia by Dr. Lazzell and the diagnostic laparoscopy

that was scheduled was performed.

37. Notwithstanding that it was never intended that

Respondent perform a biopsy on patient A.G. f rom the cervix,

Respondent expresses the opinion that if the physician encounters

a visible lesion some form of biopsy is in order. Respondent

expresses the opinion that in performing procedures such as a

diagnostic laparoscopy greater latitude is afforde d in terms of

what the physician can do when he or she discovers "What's amiss

with the patient." This in Respondent's view is because the

patient is going into the procedure with the understanding that

there may be an unanticipated problem and if the une xpected

problem can be addressed, it should be taken care of. Of course

this assumes that the biopsy that was performed on patient A.G.

was in association with the scheduled diagnostic laparoscopy,

when in fact the biopsy was the product of happenstance, in that,

Respondent when addressing what he considered to be the condition

in the patient N.C., by chance observed a similar condition in

the patient A.G. Respondent concedes that prior to patient

A.G.'s arrival at the outpatient surgical center that LEEP

conization was not an indicated procedure for that patient. The

biopsy that was performed was with the misapprehension as to the

patient whose needs were being addressed, not merely an

unanticipated circumstance in a patient whose identity was

establishe d when Respondent performed the biopsy. This was not

an additional surgical procedure that came about in connection

with the scheduled diagnostic laparoscopy; it was perceived by

Respondent as the intended surgery being performed on a different

patient wh en the case began. As a consequence it is the planned -

for diagnostic laparoscopy which became the additional procedure.

Nonetheless, Respondent tries to explain his result by expressing

the opinion that other unexpected and unplanned - for procedures

may b e undertaken in the instance "Within the realm of the

comfort level of the physician and the patient ahead of time;

where they know each other, other things can be done as well."

Respondent believes that the ability to proceed with the biopsy

on patient A .G. while thinking that he was responding to the case

involving patient N.C. is implicit and is promoted by "A feeling

of trust that we had developed at the point in time." This

refers to the point in time at which the other surgery, the

diagnostic laparo scopy was being discussed with the patient A.G.

38. The type of pathology that was encountered by

Respondent with patient A.G. that led to the biopsy was

compatible with condyloma with warty atypia. That is what

Respondent observed and collected for ev aluation. The laboratory

confirmation of the specimen was performed by Dr. Woodard

Burgert, a board - certified anatomic and clinical pathologist. In

his assessment Dr. Burgert observed that the cone biopsy in

question was compatible with condyloma with wa rty atypia. There

was no significant dysplasia.

Expert Opinions

39. Dr. Edward Zelnick is a board - certified obstetrician

and gynecologist who practices in Florida. He has hospital

privileges at Hollywood Medical Center and Memorial Regional

Hospital. He is familiar with the procedures involved in patient

A.G.'s care based upon his own experience. He is sufficiently

familiar with the facts in this case to render an opinion

concerning Respondent's level of care for that patient. In the

instance where pathology is found in examining the cervix,

Dr. Zelnick believes that action should be taken in addressing

that pathology, but only in the instance where the pathology has

been discussed with the patient and the appropriate alternative

treatment has been discussed. Absent an emergency it is

necessary to provide the patient the alternative to surgery and

identify the risk of surgery. Absent life - threatening

circumstances, a biopsy such as that performed on patient A.G.

should not be performed without the patient's consent, which had

not been given. Dr. Zelnick further describes the instance in

which a biopsy in a case such as this would be in order, would be

in relation to an instance in which it appeared that the

circumstance was an immediate threat to t he health of the patient

that needed to be addressed. None of the exigent circumstances

existed in this case. Therefore, Dr. Zelnick expresses the

opinion that the performance of the biopsy by Respondent did not

meet the expected standard of care.

40. Based upon his familiarity with the form of consent in

this case which states, "If any unforeseen condition arises and

additional surgery is deemed medically necessary during my

procedure I request and authorize my physician to proceed,"

Dr. Zelnick belie ves that the physician's responsibility there is

to respond during the course of the surgery, if medically

necessary, to such matters as repairing of a blood vessel that

has been cut or damage to an internal organ or bowel. None of

those circumstances wer e associated with the biopsy performed on

the patient A.G..

41. While Dr. Zelnick delegates patient identification to

surgical staff or nursing staff, he believes that the ultimate

responsibility for patient identification to make certain that

the right operation is performed on the proper patient resides

with the surgeon. To do less is to practice below the standard

of care universally accepted and a matter of common sense.

According to Dr. Zelnick, Respondent did not meet that standard

when performin g the biopsy on patient A.G. who was misidentified.

Whatever rules and procedures may be in place setting standards

for identification in a hospital, Dr. Zelnick does not believe

those standards abrogate the duty of the physician to properly

identify the patient. What is expected of a physician is 100

percent certainty as to who the proper patient is and to assure

that the proper procedure is carried out on the proper patient.

The method of arriving at that determination is not significant,

in Dr. Zelnic k's view.

42. Dr. Roberto Fojo is a board - certified obstetrician and

gynecologist licensed to practice medicine in Florida. He has

hospital privileges at Jackson Memorial and North Shore Medical

Center in South Florida, and he is affiliated with the Un iversity

of Miami, Department of Obstetrics and Gynecology, Division of

Gynecology. He is familiar with the procedures involved in

patient A.G.'s care based upon his own experience. He is

sufficiently familiar with the facts in this case to render an

opi nion concerning Respondent's level of care for that patient.

He does not view a diagnostic laparoscopy as being intended to

discover and diagnose cervical lesions, where, as here, the

lesion is on the surface of the cervix and vagina. A diagnostic

laparo scopy is not intended to promote an examination of the

cervix, according to Dr. Fojo.

43. Dr. Fojo is familiar with the consent form executed by

patient A.G., the language previously described. He has seen

that language before or something similar to it and considers it

part of the standard surgical consent in connection with a

diagnostic laparoscopy that was intended in this case. The

consent is designed to allow the surgeon to address matters such

as puncture of the bowel or a problem with a major arte ry or

veins or scar tissue or adhesions. This consent would not

include addressing lesions on the cervix. A LEEP conization

procedure is not an accepted procedure to perform in the patient

undergoing diagnostic laparoscopy unless the LEEP conization had

already been discussed and there was a problem with the cervix

that the patient knew about. There, in Dr. Fojo's perception,

the patient would be undergoing what he refers to as dual

procedure. Dr. Fojo does not believe that surgery should be

performed o n a patient absent the patient's consent as being

part of the original procedure or in an emergency. The LEEP

conization biopsy by Respondent was not related to the consent

that had been provided nor pertaining to an emergency. In this

sense, Dr. Fojo e xpresses the opinion that Respondent failed to

meet the standard for medical practice when performing the LEEP

conization biopsy on Patient A.G.

44. Dr. Fojo believes that a surgeon should ascertain

without any doubt that the patient in the room is a pa tient that

he or she should be performing surgery on, the appropriate

surgical procedure. This need for identification is an

independent responsibility of the physician and may not be

delegated. It requires 100 percent accuracy, according to

Dr. Fojo. D r. Fojo holds to the opinion that the physician is

responsible for the identification regardless of his or her

efforts that may have been compromised by others in attempting to

properly identify the patient and perform the indicated

procedure. He believes this to be common medical practice.

Respondent was not within the standard of care in performing the

LEEP conization procedure on patient A.G. under Dr. Fojo's

assessment.

45. Dr. Michelle McCallanahan is a board - certified

obstetrician and gynecologi st who is licensed in Florida and

practices in Jacksonville, Florida. She is familiar with the

procedures involved in patient A.G.'s care based upon her own

experience. She is sufficiently familiar with the facts in this

case to render an opinion concer ning Respondent's level of care

for that patient. The consent form executed by patient A.G. is

not unfamiliar to Dr. McCallanahan. Her perception of this

consent language is that it relates to complications that occur

during the course of the diagnostic laparoscopy that were not

foreseen and constitute an emergency requiring an immediate

procedure to correct the condition. Examples are vascular

injuries to vessels, bowel injury, bladder injury, infection and

bleeding. By contrast, lesions on the cervix do not constitute

an example of an unforeseen circumstance. Dr. McCallanahan

expresses the opinion that an appropriate workup for LEEP

conization was not done for the patient A.G. Nonetheless, there

are some circumstances in which it would not be violati ve of the

standard of care to perform LEEP conization without conducting a

workup. That circumstance would be in the instance where the

lesion that was observed was highly suggestive of cervical

cancer, according to Dr. McCallanahan. The case that Respon dent

was presented with did not constitute such a condition.

Ordinarily, the standard of care contemplates the discussion of

possible risks or complications associated with LEEP conization

procedures before performing them. According to Dr. McCallanahan

it would be appropriate to perform a surgical procedure without

discussion of the risks and possible complications in an

emergency when the patient was unconscious and could not give

consent in advance. Those are not the facts here.

46. While Dr. McCalla nahan relies upon the assistance of

other persons within the surgical and nursing staff, she

expresses the opinion that the ultimate responsibility for

patient identification prior to the performance of surgery

resides with the physician. She believes tha t it is below the

standard of care to not correctly identify the patient before the

procedure is done and perform an improper procedure or non -

consenting procedure on that patient, as was the case here.

47. Dr. Jana Bures - Forstheoefel is a board - certifi ed

obstetrician and gynecologist who is licensed in Florida. She

practices in Tallahassee, Florida, and has privileges at TMH and

performs surgeries in the outpatient surgery center. She is

familiar with the procedures involved in patient A.G.'s care

bas ed upon her own experience. She is sufficiently familiar with

the facts in this case to render an opinion concerning

Respondent's level of care for that patient. She believes that

Respondent met the standard of care for identifying patient A.G.

before pe rforming surgery on the patient. The method used by

Respondent to identify the patient was common to the practice of

other physicians who performed surgeries in that setting,

according to Dr. Forstheoefel.

48. In the event that Dr. Forstheoefel was per forming a

diagnostic laparoscopy and observed a cervical lesion she would

evaluate the condition to include the performance of a biopsy,

the most common method for cervical biopsy being a LEEP

conization. Notwithstanding the lack of specific consent by th e

patient for Respondent to perform the LEEP conization,

Dr. Forstheoefel holds to the opinion that it was correct to

biopsy, given what was observed in the patient.

49. The prospect that a physician would be 100 percent

accurate in identifying a patient undergoing surgery is not

humanly possible and is a standard that should not be imposed

upon a physician in Dr. Forstheoefel's opinion. She considers

that the matter of proper identification preoperatively is a team

effort. One person should not be solel y responsible for all

things in making certain of the patient's safety and assuring

that the right thing is done.

50. Dr. Kenneth John McAlpine is a board - certified

obstetrician and gynecologist. He is licensed in Florida. At

times relevant he pe rformed surgeries at the TMH outpatient

surgery center. He is familiar with the procedures involved in

patient A.G.'s care based upon his own experience. He is

sufficiently familiar with the facts in this case to render an

opinion concerning Respondent's level of care for that patient.

He believes that Respondent met the standard of care in

identifying the patient A.G. before performing the surgery and in

performing the LEEP conization on that patient. Although

Dr. McAlpine has not experienced a situati on in which he observed

a reason to do a LEEP conization in a diagnostic laparoscopy

case, where consent for LEEP conization had not been given ahead

of time, he does not question the decision to address the

condition observed, such as in the case at issue . From his point

of view, it was acceptable to do a LEEP conization biopsy to

address the lesion. Although no prior indication existed before

the lesion was observed during the procedure Dr. McAlpine would

not want to ignore the lesion.

51. Dr. McAlpine believes that the process that Respondent

undertook in identifying the patient A.G. before surgery was

consistent with practices in effect at the hospital, this

included reliance on staff in the operating room. Dr. McAlpine

does not believe that it is ne cessary for a physician to be 100

percent accurate in the identification as a person ultimately in

charge. No matter as to the facts, he sees the issue of the

identification being a multi - disciplinary approach among health

care providers.

52. Dr. David O'Bryan practices obstetrics and gynecology.

He is licensed in Florida. At times relevant he performed

surgeries at TMH outpatient surgery center. He is familiar with

the type procedures involved in patient A.G.'s care based upon

his own experien ce. He is sufficiently familiar with the facts

in this case to render an opinion concerning Respondent's level

of care for the patient. The method employed by Respondent in

identifying the patient was consistent with the practice used in

the immediate me dical community at the time, according to

Dr. O'Bryan.

53. Dr. O'Bryan believes that the Respondent performed the

appropriate surgery on Patient A.G. For Dr. O'Bryan, what is

more important in addressing the patient's needs is the apparent

pathology, n ot the consent that may have been provided by the

patient in advance of the procedure. It would be negligent not

to address the lesion on the cervix in his view. The pathology

present determines the response even without a consent for the

procedure. Dr. O'Bryan did not consider that the pathology

constituted an issue of life or death. The fact that the LEEP

conization biopsy was not planned was less significant than the

need to address the pathology. It does not matter if the patient

were A.G. or N.C. or some other patient, Dr. O'Bryan believes

that it was appropriate to perform the biopsy.

54. Dr. O'Bryan believes that the surgeon bears a great

deal of responsibility in patient identification, but the

ultimate responsibility for identification does not reside with

the physician or any other operating room staff member in

Dr. O'Bryan's assessment. Dr. O'Bryan does not conceive that

there can be any greater comfort in the identification than in

the instance where the "operating room crew" tells the ph ysician

who it is and the physician has a chart in his hands which

indicates that it is the same patient as the operating staff has

identified and the pathology that was found is consistent with

what had been anticipated according to the patient chart and the

staff identification.

55. Nothing in medicine involves the imposition of a 100

percent standard of care to include properly identifying the

patient preoperatively, according to Dr. O'Bryan.

56. Dr. Roberto Morales is a board - certified obstetrician

in gynecology licensed to practice in Florida. At times

relevant, he performed surgery at the TMH outpatient surgery

center. He is familiar with the type procedures involved in

Patient A.G.'s care based upon his own experience. He is

sufficiently famili ar with the facts in this case to render an

opinion concerning Respondent's level of care for the patient.

Dr. Morales believes that Respondent met the standard of care for

identifying the patient A.G. in that hospital and in other places

as well. Dr. Mo rales believes that the patient was correctly

identified by Respondent earlier in the day and that the

incorrect patient was brought back to the operating room. Under

those circumstances, Respondent did what was appropriate to

identify the patient in the performance of the LEEP conization on

patient A.G. and was within the standard of care, according to

Dr. Morales.

57. Assuming the patient was scheduled for a diagnostic

laparoscopy, if during the examination, visualization of the

cervix, a lesion was obs erved, a biopsy would be the typical next

step, according to Dr. Morales. The caveat to his opinion in the

ability to perform that biopsy would depend upon the patient that

was being taken care of and the sense that the physician had

about the patient's e xpectations of what should be done and not

done. It is assumed that Dr. Morales believed that the level of

relationship between Respondent and Patient A.G. would allow the

performance of the LEEP conization biopsy.

58. Dr. Morales believes that the attempt to be 100 percent

accurate in the identification of patients preoperatively is an

aspirational goal, not a requirement. For him all persons

concerned have the responsibility for taking care of the patient.

59. Having considered the opinions expressed by the

experts, the ultimate facts to be determined must be based upon

the realization that Respondent proceeded to perform the LEEP

conization biopsy on patient A.G. without advance written

consent, that Respondent believed that he was confronti ng the

case of patient N.C., and that the performance of the LEEP

conization on Patient A.G. was not in its timing and

justification part of the diagnostic laparoscopy scheduled to be

performed on Patient A.G. The earlier effort by Respondent to

identify his patient in the holding area was sufficient for that

stage of the process. Respondent acted in the customary manner

in relying upon his knowledge that Patient N.C. was to be the

third patient based upon the schedule. It was not unexpected

that Respond ent would rely upon the surgical staff in orally

confirming the patient identity and the procedure to be performed

when entering the operating room for the scheduled third

procedure. This identification was further confirmed by the

presence of the chart f or Patient N.C. Respondent's failure to

take further steps to physically identify the patient by looking

at her arm bracelet, by looking at her face, or in some other

manner recognizing the mistake that had been made by others in

readying Patient A.G., an d not Patient N.C. for surgery could be

forgiven if there were no consequences, but there were. Although

Respondent should not be the absolute guarantor in the

identification of the patient, what he did in the operating room

was not enough, when the resul t is that Respondent performed the

LEEP conization that was not consented to in advance, and

performed believing that the patient was N.C., the patient for

whom the procedure was intended, and was not in response to an

emergency regardless of patient ident ity. As a result,

Respondent failed to meet the standard of care for reasonably

prudent similar physicians under acceptable similar conditions

and circumstances in his actions. In mitigation, the outcome was

not harmful to the patient. Moreover, other h ealth care

professionals were in great measure responsible for the failure

to properly identify the patient.

CONCLUSIONS OF LAW

60. The Division of Administrative Hearings has

jurisdiction over the subject matter and the parties to this

proceeding in acc ordance with Sections 120.569 and 120.57(1),

Florida Statutes.

61. Petitioner is a state agency charged with the

regulation of the practice of medicine pursuant to Section 20.43,

Florida Statutes, and Chapters 456 and 458, Florida Statutes.

Respondent, as a licensed physician, is subject to that

regulation.

62. In the case, by an Amended Administrative Complaint, it

is alleged that Respondent violated Section 458.331(1)(t),

Florida Statutes, by failing to practice medicine with that level

of care, skil l, and treatment which is recognized by a reasonably

prudent similar physician as being acceptable under similar

conditions and circumstances in his treatment of Patient A.G. by

performing a LEEP conization on the patient.

63. Petitioner must prove the a llegation in the Amended

Administrative Complaint by clear and convincing evidence to show

a violation of Section 458.331(1)(t), Florida Statutes.

Department of Banking and Finance v. Osborne Stern and Company ,

670 So. 2d 932 (Fla. 1996) and Ferris v. Tu rlington , 510 So. 2d

292 (Fla. 1987). That burden of proof is explained in Slomowitz

v. Walker , 429 So. 2d 797 (Fla. 4th DCA 1983).

64. In deciding whether there is a violation of Section

458.331(1)(t), Florida Statutes, resort must be made to Section

76 2.102, Florida Statutes, which states:

The prevailing professional standard of care

for a given health care provider shall be

that level of care, skill and treatment

which, in light of all relevant surrounding

circumstances, is recognized as acceptable

and appropriate by a reasonably prudent

similar health care provider.

65. Proof of a deviation from the standard of care or

compliance with that standard is in association with the opinions

of experts in the medical profession. Purvis vs. Department of

P rofessional Regulation , 461 So. 2d 134 (Fla. 1st DCA 1984).

66. It is recognized that Respondent may not always be

responsible for mistakes in patient identification. However,

errors in identification of the patient A.G., leading to the

surgery on Patien t A.G. that was intended for Patient N.C., the

LEEP conization biopsy, is an instance where Respondent does bear

responsibility for his own conduct, even where others have

contributed to the confusion. In this case, Respondent did not

do enough to fulfill his role in practicing with the level of

care, skill, and treatment which is recognized by reasonably

prudent similar physicians as being acceptable under similar

conditions and circumstances in the attempt to identify the

patient in the operating room an d avoid the mistake that led to

performing a procedure that the patient had not provided consent

for and was not a matter of emergency without regard for patient

identity.

67. The recommendation for the imposition of a penalty for

the violation is made wit h an understanding of the range of

penalties referred to in Rule 64B8 - 8.001, Florida Administrative

Code, to include matters of mitigation which have been discussed.

68. Petitioner is entitled to the costs related to

investigation and prosecution. Sect ion 456.072(4), Florida

Statutes.

RECOMMENDATION

Upon consideration of the facts found and conclusions of law

reached, it is

RECOMMENDED:

That a final order be entered finding Respondent in

violation of Section 458.331(1)(t), Florida Statutes, and

impo sing a $1,000.00 administrative fine and costs of

investigation and prosecution.

DONE AND ENTERED this 8th day of November, 2002, in

Tallahassee, Leon County, Florida.

CHARLES C. ADAMS

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

w ww.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 8th day of November, 2002.

COPIES FURNISHED:

Robert C. Byerts, Esquire

Kim Kluck, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

David W. Moye, Esquire

Linda Loomis Shelley, Esquire

Fowler, White, Boggs and Banker, P.A.

Post Office Box 11240

Tallahassee, Florida 32302

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGH T 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 c ase.