12-001989PL Department Of Health, Board Of Medicine vs. Barry L. Migicovsky, M.D. Status: Closed Recommended Order on Friday, September 21, 2012.

Summary: Respondent is guilty of performing an unauthorized procedure in violation of section 456.072(1)(bb). Recommend letter of concern, continuing education, and $750 fine.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner, )

)

vs. ) Case No. 1 2 - 1989 PL

)

BARRY L. MIGICOVSKY , M.D., )

)

Respondent. )

____________________________ ____)

RECOMMENDED ORDER

Pursuant to notice, a final hearing was held in this case

on August 7, 2012, in Tallahassee Florida, before Edward T.

Bauer, an Administrative Law Judge of the Division of

Admini str ative Hearings.

APPEARANCES

For Pet itioner: J onathan R. Zachem , Esquire

Andre Ourso , Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Brian A. Newman, Esquire

Pennington, Moore, Wilk inson,

Bell & Dunbar, P.A.

215 South Monroe Street, Suite 200

Tallahassee, Florida 32301

STATEMENT OF THE ISSUE S

The issues in this case are whether Respondent committ ed

the allegations contained in the Administrat ive Complaint , and

if so, the penalty that should be imposed.

PRELIMINARY STATEMENT

On April 30, 2012 , Petitioner, Department of Hea lth , Board

of Medicine, filed a one - count Administrative Complaint

("Complaint") agai nst Respondent, Dr. Barry L. Migicovsk y .

Specifically, it is alleged that on February 4, 2011, Respondent

committed an unautho rized procedure on patient V.C. in violation

of section 456.072(1)(bb), Florida Statutes. 1 /

Respondent timely requested a formal hearing to contest the

allegations, a nd, on June 5 , 201 2 , the matter was referred to

the Division of A dministrative Hearings ("DOAH") and assigned to

Administrative Law Judge John G . Van Laningham. On August 6,

2012 , Judge Van Laningham transferred the instant matter to the

undersigned.

As noted above, the final hearing in this ma tter was held

on August 6, 2012 , during which Petitioner presented the

testimony of Respondent. Petitioner introduced nine exhib its

into evidence, numbered 1 - 9, which included the deposition

transcripts of patient V.C. and Ian Wooding, M.D. Respondent

called no witnesses during the final hearing, but introduced one

exhibit: the deposition transcript of Rene Mendoza. 2 /

The final hearing t ranscript was f iled with DOAH on

August 23 , 2012 . Both parties submit ted pr oposed recommended

orders, which the undersigned has considered in the preparation

of this Recommended Order .

FINDINGS OF FACT

A. The Parties

1 . Petitioner Department of Health has regulatory

jurisdiction over licen sed physicians such as Respondent . In

particular, Petitioner is authorized to file and prosecute an

administrative complaint, as it has done in this instance, when

a panel of the Board of Medicine has found probable cause exists

to suspect that the physician has committed one or more

discip linable offenses.

2. At all times relevant to this proceeding, Respondent

was a physician licensed in the State of Florida , having been

issued licens e number ME 47469. Respondent's address of record

is Gastroenterology Consultants, 4700 - M Sheridan Stree t,

Hollywood, Florida 33021.

3. Respondent, who has practiced medicine in the State of

Florida since 1984 and is board - certified in the specialty of

gastroenterology, has not been the subject of prior disciplinary

action by the Board of Medicine.

4. At all times pertinent to this matter, Respond ent

enjoyed surgical privileges at Memorial Hospital West in

Pembroke Pines , Florida.

B. The Allegations

5. On December 2, 2010, patient V.C. , a 59 - year - old

registered nurse, presented to Respondent's medical off ice to

seek treatment for gastrointestinal issues.

6. During the appointment , Respondent recommended that

V.C. undergo a colonoscopy (for routine screening purposes) , as

well as an esophagogastroduodenosco py ÏÏ an upper endoscopy, or

"EGD " ÏÏ to address her symptoms of indigestion. Following a

discussion of the risks and benefits of both procedures, V.C.

provided informed , oral consent for Respondent to perform both

procedures on a subsequent date.

7 . As is customary in the medical field, Respondent

de legates scheduling tasks to one or more of his employees. 3 /

Consistent with this practice, a member of Respondent's staff

scheduled V.C.'s colonoscopy and EGD for February 4, 2011, at

Memorial Hospital West.

8 . Several weeks before the scheduled procedu res , one of

Respondent's assistants telephoned V .C. and informed her (V.C.)

that her health insurance carrier would not pay for the EGD

because she had yet to exceed her $5,000 annual deductible. 4 /

( V.C.'s insurer was, howev er, willing to assume the cost of the

colonoscopy). In r esponse, V.C. advised Respondent's staff

member, during the same telephone conversation, that she no

longer wa nted the EGD on February 4, 2011 , and wished to delay

that particular procedure until later in the year ÏÏ at which

time, presumably , V.C.'s deductible would be satisfied .

Unfortunately, and for reasons that are not appare nt from the

record, Respondent's assistant never informed him of V.C.'s

instruction to cancel the EGD.

9 . On February 4, 2011, V.C. appeared at Memorial West

Hospital to undergo her scheduled colonoscopy. At 1:30 p.m., a

hospital nurse presented V.C. with a two - page document , which

V.C. agreed to sign, tit led "Consent to Surgery / Procedure."

The pre - printed section of the consent form provided, in

relev ant part:

I hereby authorize the physician(s) listed

below and such assistants (which may

include, without limitation, surgical

resident and medical assistants employed by

Memorial HealthCare System) as may be

selected by him/her to perform the procedure

k nown as . . . .

On the first page of the document, i mmediately below the above -

quoted language, "colonoscopy" was handwritten in pro minent ( and

legible ) block script; no other procedures were listed.

10 . At approximately 4:15 p.m., a member of the hospital

staff presented Respondent with a copy of V.C.'s consent to

surgery form. Consistent with his normal routine, Respondent

signed , but did not examine , the consent document ; as a

consequence, Respondent did not notice the conspicuous absence

of the EGD procedure from the form . 5 /

11 . Fifteen minutes later, V.C., who lay on a gurney and

had yet to be placed under anesthesia, was moved to the surgical

suite. Thereafter, at 4:48 p.m., while V.C. was still fully

conscious, Respondent conducted a "time out ." That is,

Respondent announced, to the members of his team, the identity

of the patient, her date of birth, any allergies the patient may

have had, and the procedures he intended to perform : a

colonoscopy and an EGD. No member of the team objected, and,

for reasons that are unclear, V.C. ÏÏ who , by that time, had been

fasting for more than 16 hours and has no recollection of what

occurred during the "timeout" ÏÏ remained silent.

12 . Following the "timeout," a gastroenterology assistant ,

Rene Mendoza, instructed V.C. to open her mouth so that a bite

block could be placed between her upper and lower teeth. Mr.

Mendoza also informed V.C. that the bite block was intended to

protect her teeth from the endoscope. V.C. , although

cooperative with the request , made no a ffirmative response to

Mr. Mendoza's statements .

13 . Moments later, general anesthesia was administered to

V.C., at which point Respondent performed a colonoscopy and an

EGD. Soon a fter the procedures were completed, Respondent

examined V.C.' s consent document and noticed that an EGD had not

been listed. In lieu of an investigation into the matter

(Respondent had not spoken personally with V.C. since the

initial appointment on December 2, 2010) , Respon dent 's immediate

reaction was to add "upp er endoscopy" next to "colonoscopy " on

V.C.'s consent document. Wisely, however, Respondent quickly

changed his mind and crossed through the added language.

14 . Shortly thereafter, and prompted by the content of the

consent document , Respondent learned for the first time o f

V.C.'s decision to delay the EGD . In a subsequent letter to

Memorial West , Respondent chalked the incident up to a

miscommunication between himself and one of his staff:

From what I know at this present tim e, the

insurance company . . . would not cover for

an upper endoscopy, however this is the fact

that I learned after the procedures had been

performed on 2/4/11 . . . . Following the

procedure I did look at the consent form and

asked why only colonoscopy was written and

why an endos copy was not included. There

was miscommunication between my medical

assistant and myself initially not knowing

this above information . . . .

Unfortunately, due to the multiple areas of

miscommunication despite our time - outs,

things were missed and we wi ll place better

constraints to verify this does not happen

again.

(emphasis added).

15 . On or about February 9, 2011 , Respondent made contact

with V.C. and advised that he would waive all costs asso ciated

with the EGD. With her financial concerns all eviated , V.C. is,

at present, satisfied with Respondent's services , and, in

retrospect, grateful that the EGD was performed.

C. Summary of Evidence / Findings of Ultimate Fact

16 . Notwithstanding V.C.'s satis faction with the final

outcome, Respondent l acked V.C.'s authorization to conduct an

EGD at the time it was performed ÏÏ a fact of which Respondent

should have been aware when the procedures were carried out . As

deta iled above, V.C. decided , based upon financial

circumstances, to proceed only with th e colonoscopy; this

decision was communicated to one of Respondent's employees

several weeks in advance of Fe bruary 4, 2011 , and reflected in

the consent document that Respondent had in his possession

before the EGD was performed.

17 . It is determined , a s a matter of ultimate fact, that

Respondent performed an unauthorized procedure (an EGD), and is

therefore in violation of section 456.072(1)(bb), Flo rida

Statutes.

CONCLUSIONS OF LAW

A. Jurisdiction

18 . DOAH has jurisdiction over the parties and subj ect

matter of this cause, pursuant to section 120.57(1), Florida

Statutes .

B. The Burden and Standard of Proof

19 . This is a disciplinary proceeding in which Petitioner

seeks to discipline Respondent's licen se to practice medicine .

Accordingly, Petitio ner m ust prove the allegations contained in

Administrative Complaint by clear and convincing evidence.

Dep't of Banking & Fin., Div. of Secs. & Investor Prot. v.

Osborne Sterne, Inc. , 670 So. 2d 932, 935 (Fla. 1996); Ferris v.

Turlington , 510 So. 2d 292 , 294 (Fla. 1987). Clear and

convincing evidence:

[R]e quires 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

is sue. 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.

Slomowitz v. Walker , 429 So. 2d 797, 800 (Fla. 4th D CA 1983).

C. The Charge Against Respondent

20 . Petitioner alleges in the Administrative Complaint

that Responden t performed an EGD upon V.C. without her consent,

and is therefore in violation of section 456.072(1)(bb), which

provides that a physician is subject to discipline for:

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.

(emphasis added).

21 . Before proceeding further, the und ersigned would note

the absence of any dispute that V.C. , during her December 2010

office appointment with Respondent, provided informed consent to

undergo both a colonoscopy and an EGD. What i s contested ,

however, is : whether V.C.'s initial consent to an EGD wa s

revoked by operation of her statements to Respondent's employee

and/or by Respondent's receipt (prior to the EGD ) of a written

consent form that listed a colonoscopy as the only authorized

procedure ; and, if so, whether the EGD was authorized by virtue

of V.C.'s sil ence during the "timeout" and the subsequent

placement of a bite plate.

22 . Beginning with the first issue, it is axiomatic t hat

V.C.'s initial consent to undergo the EGD cannot be deemed

withdrawn unless Respondent was provided with adequate notice of

V .C.'s subsequent decision to delay the procedure. See

generally United States v. McMullin , 576 F.3d 810, 818 (8th Cir.

2009)(holding that once consent is given, it may be withdrawn,

but only by an unequivocal act or statement). With that in

mind, Petitio ner contends that V.C.'s instruction to

Respondent's assistant ÏÏ during a telephone call initiated by the

assistant to discuss insurance coverage issues with the EGD ÏÏ to

postpone the EGD until a later date was sufficient to revoke

V.C.'s consent. The under signed agrees, as it is well - settled

that the knowledge of an agent, Respondent's assistant in this

instance, is presumptively imputed to the agent's principal. 6 /

Davies v. Owens - Illinois, Inc. , 632 So. 2d 1065, 1066 (Fla. 3d

DCA 1994)("Whatever knowledge an agent acquires within the scope

of his authority is imputed to his or her principal"); Anderson

v. Walthal , 468 So. 2d 291, 294 (Fla. 1st DCA 1985)(same as

Davies ); Yorston v. Pennell , 153 A.2d 255 , 259 - 62 (Pa. 1959)

(holding physician was liable for p atient's injuries that

resulted from administration of penicillin, to which the patient

was allergic, where physician's agents were informed of the

allergy but neglected to record the information in the patient's

chart) .

23 . Assuming arguendo that V.C.'s statement to

Respondent's assistant cannot be imputed to him , Respondent 's

receipt of the written consent document ÏÏ prior to the

procedure s ÏÏ placed him on inquiry notice (i.e., implied actual

notice) of V.C.'s intent to pr oceed o nly with a colonoscopy;

th at Respondent chose not read the form until after the

procedures were completed does not insula te him from

responsibility. As the Supreme Court of Florida has explained:

The principle applied in cases of alleged

implied actual notice is that a person has

no right to shut his eyes or ears to avoid

information, and then say that he has no

notice; that it will not suffice the law to

remain willfull[y] ignorant of a thing

readily ascertainable by whatever party puts

him on inquiry, when the means of knowledge

is at hand.

Sapp v. Warner , 141 So. 124, 255 (Fla. 1932); Tarin v. Sniezek ,

942 So. 2d 458, 461 (Fla. 4th DCA 2006)( holding that appellant

had implied actual notice of his property's boundaries; "When

Tarin received the survey upon purchase of his propert y, he was

charged with notice of its true boundaries. His assertion that

he did not understand or did not read the survey does not serve

as a defense " ); Crown Gen. Stores v. Ultra Meat Mkt. Inc. , 843

So. 2d 287 , 289 - 90 (Fla. 3d DCA 2003)( holding that assi gnee had

implied actual notice of a pre - existing interest in a leasehold;

"[T]he information giving rise to inquiry notice does not have

to be as precise as appellee would have this court hold . . . .

Contrary to [appellee's] contentions, the document did not have

to specifically mention that the debt was owed to Crown nor lead

the purchaser to a recorded document evidencing the debt. The

circumstances may reasonably suggest the necessity of inquiry");

Belcher v. Ferrara , 511 So. 2d 1089, 1090 (Fla. 3d DCA 1987)

("Belcher contended that he had no knowledge of [his] attorney's

withdrawal or the trial date. Notice is imputed to him however

because he failed to open his mail") .

24 . As explained above , V.C.'s authorization to proceed

with an EGD was revoked, at the very latest, upon Respondent's

receipt of the cons ent document. 7 / Respondent suggests , h owever,

that V.C.'s silence during the subsequent timeout period ÏÏ when

Respondent announ ced to his medical team that a c olonoscopy and

EGD would be performed ÏÏ and the placement of a bite block

provided implied consent to proceed with the EGD. This

contention is unavailing, however, as Florida courts adhere to

the view that a patient's consent to a medical p rocedure ca n be

implied only in case s of emergency, a f actual scenario not

presented here :

[A]ppellee argues that Mrs. Pino's consent

for treatment was implied under the

circumstances. This is wrong. As we have

seen, a competent individual who needs

immediate, lifesaving treatment has the

right to refuse it. And the legal

definition of an " emergency " . . . which we

are bound to follow, is one in which the

situation calls for immediate medical

treatment and it is not feasible to obtain

consent from one legally permitted to

provide it . Only when this latter s ituation

exists is a patient's consent for treatment

implied .

Rodriguez v. Pino , 634 So. 2d 681, 687 (Fla. 3d DCA 1994)

(emphasis added)(internal citations omitted); see also Allore v.

Flower Hosp . , 699 N.E.2d 560, 564 (Ohio Ct. App. 1997)(observing

that a physician's "acts are lawful when the patient expressly

consents prior to medical treatment. Medical treatment will

also be lawful under the doctrine of implied consent when a

medical emergency requires immediate action to preserve the

health or life of the patien t")(internal citation omitted);

Tisdale v. Pruitt , 394 S.E.2d 857, 858 - 60 (S.C. Ct. App. 1990)

(hold ing that patient's silence did not provide physician with

implied consent to perform a dilation and curett age, a non -

emergency procedure); Schloe ndorff v. Soc'y of N.Y. Hosp. , 105

N.E. 92, 93 (N.Y. 1914 ) (Cardozo, J.) (cited with approval in

Rodriguez , 634 So. 2d at 687 ; " [A] surgeon who performs an

operation without his patient's consent, commits an assault, for

which he is liable . . . . This is t rue except in cases of

emergency where the patient is unconscious and where it is

necessary to operate before consent is obtained.").

25 . E ven assuming that co nsent can be implied in the

context of a non - emergency , Respondent's silence cannot be

reasonab ly interpreted as consent under the circumstances

presented. First, Respondent's announcement during the

"timeout" was not directed specifically to V.C.; rather, the

comments (e.g., V.C.'s name, allergies, date of birth, and the

procedures to be conducted ) were, as req uired by rule, a

communication to the medical team as the final line of defense

against the performance of a wrong patient/sit e procedure . 8 / In

other words, the comm ents were not intended to confirm the

patient's assent to the procedures , fo r if they were, it makes

little sense that Respondent proceeded with the EGD in the face

of V.C.'s silence. Further, there is an absence of evidence

that V.C. ( who , albeit conscious, had not consumed food or water

for at least 16 hours when the "timeout" occurred) heard or

comprehen ded Respondent's announcement. Finally, it is not

reasonable, regardless of V.C.'s professional background, to

expect her to object ÏÏ while lying vulnerably on the procedure

table ÏÏ to the instructions of a member of the medical team j ust

moments before the administration of anesthesia .

26 . For the reasons detailed above, Respondent lacked

V.C.'s consent to proceed with an EGD at the time it was

performed. Accordingly, Respondent is in violation of section

456.072(1)(bb).

D . Penalty

27 . In determining the appropriate punitive action to

recommend in this case, it is necessary to consult the Board of

Medicine's disciplinary guidelines, which impose restrictions

and limitations on the exercise of the Board's disciplinary

author ity under section 458.331. See Parrot Heads, Inc. v.

Dep't of Bus. & Prof'l Reg. , 741 So. 2d 1231 , 1233 - 34 (Fla. 5th

DCA 1999).

28 . The Board's guidelines for a violation of section

458.331 are enumerated in Florida Administrative Code Rule 64B8 -

8.00 1. With respect to Respondent's v iolation of section

456.072(1)(bb) , a fir st offense, rule 64B8 - 8.001(2)(ss ) provides

the following penalty range:

From a $1,000 fine, a letter of concern, a

minimum of five hours of risk management

education, and one hour lec ture on wrong -

site surgery in the State of Florida to a

$10,000 fine, a letter of concern, a minimum

of five hours of risk management education,

50 to 100 hours of community service,

undergo a risk management assessment, a one

hour lecture on wrong - site su rgery, and

suspension to be followed by a term of

probation.

29 . Rule 64B8 - 8.001(3) provides that, in applying the

penalty guidelines, the following aggravating and mitigation

circumstances may be taken into account:

(a) Exposure of patient or public t o injury

or potential injury, physical or otherwise:

none, slight, severe, or death;

(b) Legal status at the time of the

offense: no restraints, 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 applic ant 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 susp ension 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.

30 . In its Proposed Recommended Order, Petitio ner concedes

that four mitigating factors are present: Respondent's lack of

prior discipline over his 24 years of practice; the c ommission

of only one violation of law ; the absence of any pecuniary

benefit ; and the lack of exposure of the patient ( or the public )

to ph ysical harm. In light of these mitigators, Petitioner

seeks a letter of concern, a fine of $5,000, five hours of ris k

management education, and a one - hour lecture on wrong - site

surger ies .

31 . The undersigned is in agreement with Petitioner's

recommendatio n, with one exception: a fine of $750.00, which

falls just below the bottom end of the penalty range, is more

appr opriate in light of the multiple factors tha t support

mitigation and Respondent's commendable decision to assume the

cost of the EGD . It is also evident that Respondent has learne d

from this incident and, as a consequence, is unlikely to violate

section 4 56.072(1)(bb) in the future.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that a final order be entered by th e

Board of Medicine :

1. Finding that Respondent violated s ection

456.072(1)(bb) , Florida Sta tutes, as charged in Count I of the

Complaint ;

2. Issuing Respondent a l etter of concern;

3. Imposing a fine of $ 750 .00;

4. Ordering Respondent to complete five hours of risk

management education; and

5. Ordering Respondent to attend a one - hour lecture on

wrong - site surgeries .

DONE AND ENTERED this 21st day of September, 2012 , in

Tallahassee, Leon County, Florida.

S

___________________________________

EDWARD T. BAUER

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative He arings

this 21st day of September, 2012 .

ENDNOTES

1 / Unless noted otherwise, all references to the Florida

Statutes are to the 2011 version.

2 / The deposition transcripts introduced by Pet itioner and

Respondent have been received in lieu of the witnesses' live

testimony.

3 / See Final Hearing Transcript, pp. 48 - 49.

4 / See Petitioner's Exhibit 5, pp. 11 - 12.

5 / Respondent explained during his final hearing testimony that

he pre fers to rely upon his own records, as opposed to those of

the hospital.

6 / The undersigned finds distinguishable the case of Pic N'

Save, Inc., v. Department of Business Regulation , 601 So. 2d 245

(Fla. 1st DCA 1992). In Pic N' Save , the court held that the

holder of a beverage license could not be punished for the

unlawful actions of its employees (the sale of alcoholic

beverages to minors) in the absence of evidence that the

"employees acted in a 'persistent and practiced manner' when

making the illega l sales." 601 So. 2d at 254. In the present

matter, by contrast, there is no attempt to punish Respondent

for the unlawful conduct of an employee ; indeed, the failure of

Respondent's employee to inform him of V.C.'s decision to delay

the EGD, although an error, was in no manner illicit. The legal

principle at issue in this cause, which Pic N' Save does not

address, is whether the information conveyed by V.C. to

Respondent's employee (within the scope of employment) should be

imputed to Respondent, thereb y rendering Respondent's own

conduct ÏÏ the performance of the EGD ÏÏ punishable.

The undersigned also rejects Respondent's suggestion that

Petitioner seeks to punish him for an offense not charged in the

Complaint. Although the Complaint arguably cou ld have included

additional factual detail, it was sufficiently specific to

provide Respondent "reasonable notice of the charge[] against

which [he] was ultimately expected to defend" ÏÏ i.e., the

performance of an EGD without the patient's consent. Wood v.

Dep't of Transp. , 325 So. 2d 25, 28 (Fla. 4th DCA 1976 ) .

7 / This conclusion does not run afoul of the result in

Departme nt of Health, Board of Medicine v. Sharma , Case No. 10 -

2416 (Fla. DOAH Feb. 16, 2011; DOH Apr. 11, 2011) . In Sharma ,

the p atient provided (during an office visit) oral consent to

undergo an EGD and a colonoscopy, both of which were to be

performed at a hospital on subsequent (and separate) dates. On

the day of the colonoscopy, the first procedure scheduled, the

patient signe d a "Consent for Operative and Invasive Procedures"

form that authorized the physician to perform a colonoscopy.

Approximately one hour before the procedure, however, the

patient complained of nausea, vomiting, and abdominal pain,

symptoms which led the p hysician to recommend to the patient

that they proceed on that day with the EGD instead of the

colonoscopy. After a thorough discussion, the patient agreed

with the recommendation and provided oral consent to conduct an

EGD. Although the EGD was complete d without incident, the

physician was later charged with performing a wrong procedure,

in violation of 456.072(1)(bb), based upon the fact that the

hospital consent form had not been amended to reflect the change

of plans. In finding the physician not gui lty, the ALJ

concluded that written consent was unnecessary and that the

patient's oral consent was sufficient.

While the reasoning of Sharma is sound, the facts of the

instant case are distinguishable. First, Petitioner neither

contests the validity of V.C.'s oral consent to undergo an EGD,

nor does it argue that Respondent was obligated to obtain

written consent for an EGD at any time. Further, in contrast to

Sharma , where the patient got exactly what she expected, V.C.

did not desire an EGD at the time Respondent performed it.

Finally, unlike Sharma , which involved the (unsuccessful) theory

that written consent is required, the consent document in the

present case is relevant only to the extent that it provided a

vehicle by which Respondent was pl aced on inquiry notice that

V.C.'s consent to an EGD had been revoked.

To be clear, Respondent is not being convicted of performing

an unauthorized procedure simply because the consent document

did not list an EGD; indeed, from a licensure stan dpoint, no

consent form was required at all. Instead, Respondent's guilt

is predicated upon his performance of a procedure for which

consent had been revoked, a fact of which he should have been

aware.

8 / Florida Administrative Code Rule 64B8 - 9.007( 2 )(b) describes

the "timeout" process as follows :

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

mak e any incision or perform any surgery or

procedure prior to perform ing 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

requ irement 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.

(emphas is added).

COPIES FURNISHED :

Brian A. Newman, Esquire

Pennington, Moore, Wilkinson,

Bell & Dunbar, P.A.

215 South Monroe Street, Suite 200

Tallahassee, Florida 32301

Jonathan R. Zachem, Esquire

Andre Ourso, Esquire

Department of Health

4052 Bald Cyp ress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Jennifer A. Tschetter, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

Joy Tootle, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

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 f iled with the agency that

will issu e the Final Order in this case.