10-007289PL Department Of Health, Board Of Medicine vs. Robert Burns, M.D. Status: Closed Recommended Order on Wednesday, December 29, 2010.

Summary: Petitioner proved that Respondent performed wrong-site procedure but did provide record-keeping violation. Recommend letter of concern, fine, risk management education and community service.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 10 - 7289PL

)

ROBERT BURNS, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

On November 10 , 2010 , a duly - noticed hea ring was held in

Tallahassee , Florida , before Lisa Shearer Nelson , an

Administrative Law Judge assigned by the Division of

Administrative Hearings .

APPEARANCES

For Petitioner: Diane K. Kiesling, Esquire

Kristen Krueger Griswold, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Robert Burn, M.D., pro se

3052 Bidhurst Court

Tallahassee, Florida 32317

STATEMENT OF THE ISSUE

The issue to be determined is whether Respondent violated

s ections 458.331(1)(m ) and 458.331(1)(bb), Florida Statutes

(2008), 1/ as alleged in the Administrative Complaint and if so,

what penalty should be imposed?

PRELIMINARY STATEMENT

On April 23, 2010, the Department of Health (Petitioner or

the Department) filed a tw o - count Administrative Complaint

against Respondent, alleging that he violated section

458.331(1)(m ) and (bb), Florida Statutes. Respondent disputed

the allegations in the Administrative Complaint and on August 9,

2010, the case was referred to the Divisi on of Administrative

Hearings for the assignment of an administrative law judge.

On August 24, 2010, a Notice of Hearing was issued

scheduling the case for hearing on November 10, 2010, and the

hearing proceeded as scheduled. Petitioner presented the

tes timony of Linda Dix, R.N., and Petitioner's Exhibits numbered

1 through 6 were admitted into evidence. Respondent testified on

his own behalf and Respondent's Exhibit numbered 1 was also

admitted into evidence.

The Transcript of the proceedings was filed with the

Division on December 1, 2010. Petitioner's Proposed Recommended

Order was filed December 10, 2010, and Respondent's Proposed

Recommended Order was filed on December 13, 2010. Both

submissions have been carefully considered in the preparation of

this Recommended Order.

FINDINGS OF FACT

1. Petitioner is the state agency charged with the

licensing and regulation of medical doctors pursuant to section

20.42 and chapters 456 and 458, Florida Statutes.

2. At all times material to the allegations in the

Administrative Complaint, Respondent was a medical doctor

licensed in the State of Florida, having been issued license

number ME 98868. At the time of alleged incident, Respondent was

board certified in anesthesiology. He is now also board

certified in pain management.

3. On February 10, 2009, Respondent was working at the

Tallahassee Outpatient Surgical Center (TOSC). His duties

included performing interventional pain management procedures.

4. Patient C.C. was, at the time of the incident, a 50 -

y ear - old male. On February 10, 2009, he was adm itted to T O SC for

a dorsal medi al nerve branch block at the right cervical levels

5/6/ 7. Respondent was scheduled to perform the procedure.

5. Linda Dix was a nurse at TOSC who was present during

C.C.'s proc edure. She described the process for admission and

preparation for surgery at TOSC, which included each patient

receiving a plan, an order for surgery, and an informed consent

form.

6. C.C.'s plan, which Respondent signed, indicated that he

was to receiv e a right - side medial nerve branch block at cervical

levels 5/6/7.

7. A medial nerve branch block may also be called a dorsal

medial branch block. The procedure is a diagnostic block to rule

out the level and type of pain the patient is experiencing. In

this case, C.C.'s medical records indicate that C.C. had a left -

side medial nerve branch block performed one month prior to this

scheduled procedure, and had received relief from pain.

8. When a medial nerve branch block is performed, the

patient is pl ac ed in the prone position on the procedure table,

and prepp ed with a cleaning solution such as Betadine or

chorhexidene.

9. There is more than one way to perform the procedure

itself. However, a c - arm fluoroscope is used to identify the

cervical level s. Sometimes, the physician will numb the skin in

a subcutaneous needle pathway before inserting the needle that is

going to be advanced to the medial branch nerve. The decision to

do so, for Respondent, includes consideration of the size of the

patient, and how far the final needle will need to be advanced.

While the needle for numbing the skin and the needle for the

procedure itself are the same size, they may be different lengths

depending on how much tissue will be penetrated.

10. The medial branch nerve lies against the lateral, or

side, of the vertebral body, and the fluoroscope guides the

needle to the vertebral body. Once the needle makes contact with

bone, the physician will aspirate to ensure i t is not in a blood

vessel.

11. In this case, R espondent was aware of the patient plan

and the patient was already draped when he entered the procedure

room. C.C. had been prepped and the c - arm fluoroscope was

positioned consistent with the method used by another surgeon who

had worked at TOSC. Respo ndent requested that the technician

position the fluoroscope in a true lateral position rather than a

posterior oblique position.

12. A pause procedure was performed, in which Respondent

participated and acknowledged agreement. He used a needle as a

mark er to show where to inject the numbing medication. However,

Respondent placed the needle on the left as opposed to the right

side.

13. Respondent began injecting L idocaine into C.C.'s left

side. Before he could finish the injection, Ms. Dix asked him to

explain how the medication was going to reach the right - side

nerve branches from the location of the injection. Respondent

realized at that point that he had injected the L idocaine into

the wrong site for a right - side medial nerve branch block.

14. Re spondent immediately stopped injecting the L idocaine.

At that point, .25 ml of L idocaine had been injected. Lidocaine

is a numbing agent.

15. Respondent explained the error to the patient, and then

completed the procedure on the correct side.

16. There is no dispute that the correct procedure, and the

only procedure intended to be performed, was to be performed on

the right side. There is also no dispute that a small amount of

Lidocaine was injected into the left side.

17. In the nurse's notes conta ined in C.C.'s medical

records for TOSC, under Intraoperative medication, it is noted

that .25 ml of L idocaine was injected on the left side, and 3 ml

of L idocaine was injected on the right. Also noted are other

medications used during the procedure.

18. On the page of the medical records containing the

surgical plan (Petitioner's Exhibit 2, page 32) dated

February 10, 2009, a list of medications used during the

procedure includes .25cc of Lidocaine on the left, and 3cc of

Lidocaine on the right, with the notation "local." Respondent

signed this page of C.C.'s medical records. In addition, an

incident report separate from the medical records was generated.

19. Respondent's procedure notes, which were dictated on

February 16, 2009, make no mention of the injection of L idocaine

on the left side. He testified that he did not view the numbing

of the left side as part of the procedure itself, but rather part

of the preparation of the patient. Specifically, he testified:

Q. And where in here did you docum ent the

injection of the lidocaine into the left

side?

A. It was not documented in the procedure

note. That only reflects the procedure that

was performed on the correct side.

Q. And why didn't you document that you

injected lidocaine into the incorrect side in

this procedure note that you're required to

prepare?

A. I have no particular reason for not doing

it. We were doing 20 - plus procedures a day,

and I was just dictating and keeping up with

the procedure notes, and I only dictated what

was performe d on the correct site. The chart

had documented the error, and we had done the

appropriate procedures for reporting the

medical error, and so I relied on the rest of

the chart to the complete the record as a

whole.

CONCLUSIONS OF LAW

20 . The Division o f Administrative Hearings has

jurisdiction over the subject matter and the parties to this

action in accordance with s ections 120.569 and 120.57(1), Florida

Statutes (2010) .

21. The Department is seeking to take disciplinary action

against Respondent's l icense 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).

22. Moreover, disciplinary provisions such as sections

456.0 72 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 1 988).

23. 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 patien t, 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.

24. This subsection has been interpreted by the Fourth

District Court of Appeal in Abram v. Department of Health ,

13 So. 3d 85 (Fla. 4th DCA 2009). 2/ The Fourth District held

t hat 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 sta ndard 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.

25. 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

regardi ng 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. . . ." . . . If

the Board had constr ued 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 Boa rd of Medical

Examiners to consider evidence in deciding

appellant's guilt or in nocence of

disciplinary charges ).

Id. at 89.

26. Ayala required the Board to consider the circumstances

attending a plea of nolo contendere when determining whether a

phy sician 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 - site surgery

occurred in order to rebut any presumption arising from section

456.072(1)(bb).

27. Evidence of the circumstances giving rise to a wrong -

site surgery is not go ing to negate whether the wrong - site

surgery occurred. However, in light of the Fourth District's

refe rence 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 s ection 456.072(1)(bb) has occurred . The

Respondent's explanation may also be used in consideration of

penalty should a violation be found.

28 . That being said, the ultimate determinatio n that a

physician has committed a violation of Section 456.072(1)(bb) is

that of the Board of Medicine.

29. In this case, c lear and convincing evidence exists to

support the allegation that indeed, Respondent injected Lidocaine

into the wrong site for C.C.'s procedure . Respondent contends

that no wrong - site surgery occurred because the injection of

Lidocaine to numb the area is preparatory to and not part of the

actual procedure.

30. Respondent's position is not consistent with the

language of se ction 456.072(1)(bb), which specifically indicates

that " performing or attempting to perform medial services

includes the preparation of the patient." It is also

inconsistent with the Board's definition of surgery/procedure

contained in Florida Administra tive Code Rule 64B8 - 9.007(2).

This rule provides in pertinent part:

(2) This rule is intended to prevent wrong

site, wrong side, wrong patient and wrong

surgeries/procedures by requiring the team to

pause prior to the initiation of the

surgery/procedure to confirm the side, site,

patient identity, and surgery/procedure.

(a) Definition of Surgery/Procedure. As used

herein, Ðsurgery/procedureÑ means the

incision or curettage of tissue or an organ,

insertion of natural or artificial implants,

electro - convul sive therapy, endoscopic

procedure or other procedure requiring the

administration of anesthesia or an anesthetic

agent. Minor surgeries/procedures such as

excision of skin lesions, moles, warts,

cysts, lipomas and repair of lacerations or

surgery limited to the skin and subcutaneous

tissue performed under topical or local

anesthesia not involving drug - induced

alteration of consciousness other than

minimal pre - operative tranquilization of the

patient are exempt from the following

requirements.

(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 a nd the physician(s) performing the

procedure will verbally confirm the patientÓs

identification, the intended procedure and

the correct surgical/procedure site. The

operating physician shall not make any

incision or perform any surgery or procedure

prio r to performing this required

confirmation. . . .

(c) The provisions of paragraph (b) shall be

applicable to anesthesia providers prior to

administering anesthesia or anesthetic

agents, or performing regional blocks at any

time both within or outside a surgery

setting. (Emphasis supplied).

31. Respondent is an anesthesiologist. Lidocaine is a

numbing agent , used in the preparation of the patient for the

intended procedure. Based on the evidence presented, it is

recommended that the Board conclude that a violation of s ection

456.072(1)(bb) has been pr o v e n .

32. Count II charges Respondent with violating section

458.331(1)(m), Florida Statutes. Specifically, the

Administrative Complaint provides:

20. Section 458.331(1)(m), Florida Statutes

(2008), provides that failing to keep legible

medical records that justify the course of

treatment of the patient, including but not

limited to, patient histories; examination

results; test results; records of drugs

prescribed, dispensed or administered; and

repo rts of consultations and hospitalizations

constitutes grounds for disciplinary action

by the Board of Medicine.

21. Respondent failed to keep legible

medical records that accurately document his

treatment of Patient C.C., by failing to

document that Pati ent C.C. had Lidocaine

initially injected into his left side,

instead of the indeed right side.

33. The Department contends that a v iolation of section

458.331(1)(m ) exists because Respondent did not mention the

injection of Lidocaine on the left side i n his procedure note.

Respondent contends that the injection on the left side had been

documented previously in the medical records for the procedure,

including records that he had signed. Respondent's view is

consistent with his good faith but mistaken belief that injection

of the Lidocaine would not be considered as part of the procedure

undertaken.

34. Nothing in section 458.331(1)(m ) or in Florida

Administrative Code Rule 64B8 - 9.003, which describes the

standards for adequacy of medical records, req uires that all

records maintained by a physician be generated by the physician

personally. Moreover, records which Respondent signed did

indicate the administration of Lidocaine on the left side. While

it would have been preferable for Respondent to incl ude mention

of the left - side administration of Lidocaine in his procedure

note, he is correct in saying that the record as whole adequately

documented the drug administered on the left side. Therefore,

Count II has not been proven by clear and convincing evidence and

should be dismissed.

35. Florida Administrative Code Rule 64B8 - 8.001 constitutes

the Board of Medicine's Disciplinary Guidelines, adopted pursuant

to the mandate in section 456.079, Florida Statutes. The

recommended penalty for a first - time violation of section

456.072(1)(bb) ranges 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, a risk management

assessment, a one - hour lecture on wrong - site surgery, and

suspension to be followed by probation.

36. The Department asserts that the appropriate penalty in

this case con sists of a letter of concern, a $5,000 fine, 100

hours of community service, five hours of continuing medical

education in risk management, and a one - hour lecture in Florida

on performing wrong - site procedures. The Department suggested

this penalty as the penalty to be imposed assuming both Counts I

and II were proven, and based upon what it considered as an

aggravating factor that Respondent did not include the left - side

injection of Lidocaine in his procedure note.

37. In view of the conclusion that o nly one as opposed to

two violations were proven, and the fact that the undersigned

finds no aggravating factors as recommended by the Department, a

lesser penalty is recommended.

RECOMMENDATION

Upon consideration of the facts found and conclusions of law

reached, it is

RECOMMENDED:

That the Board of Medicine enter a final order finding that

Respondent violated section 456.072(1)(bb), as alleged in Count I

of the Administrative Complaint; that it find Respondent did not

violate section 458.331(1)(m ), as a lleged in Count II; and that

as a penalty for Count I Respondent receive a letter of concern,

pay a $2,500 fine, attend five hours of risk management

continuing medical education, present a one - hour lecture on

wrong - site surgery, and perform 50 hours of co mmunity service.

DONE AND ENTERED this 29 th day of December , 20 1 0, in

Tallahassee, Leon County, Florida.

S

LISA SHEARER NELSON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahasse e, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 2 9 th day of Decem ber, 20 1 0.

ENDNOTE S

1/ All references are to the 2008 Florida Statutes, unless

otherwise specified.

2/ 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).

COPIES FURNISHED:

Diane K. Kiesling, Esquire

Department of Heal th

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399

Robert Burns, M.D.

3032 Bidhurst Court

Tallahassee, Florida 32317

Kristen Krueger Griswold, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399

E. Renee Alsobrook, Acting General Counsel

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399

Larry McPherson, Jr., JD, Executive Director

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399

NOTICE OF RIG HT 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.