08-004285PL Department Of Health, Board Of Medicine vs. Lucien Armand, M.D. Status: Closed Recommended Order on Wednesday, June 17, 2009.

Summary: Respondent violated the statutes and rules alleged when he performed Level II surgery in an office not registered for such surgery.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case Nos. 08-4285PL

) DOH Case No. 2006-38439

LUCIEN ARMAND, M.D., )

)

Respondent. )

_________________________________)

RECOMMENDED ORDER

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

before Larry J. Sartin, an Administrative Law Judge of the

Division of Administrative Hearings, on April 6, 2009, by video

teleconference between Lauderdale Lakes and Tallahassee,

Florida.

APPEARANCES

For Petitioner: Diane K. Kiesling

Assistant General Counsel

Robert A. Milne

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Sean Ellsworth, Esquire

Ellsworth Law Firm, P.A.

1501 Collins Avenue, Suite 208

Miami Beach, Florida 33139

STATEMENT OF THE ISSUES

The issues for determination are whether Respondent Lucien

Armand, M.D., violated Section 458.331(1)(v), Florida Statutes

(2006); Section 458.331(1)(nn), Florida Statutes (2006), by

violating Florida Administrative Code Rule 64B8-9.009(2) and

(4), and Section 458.351, Florida Statutes (2006); Section

458.331(1)(m), Florida Statutes (2006); and Section

458.331(1)(t), Florida Statutes (2006), as alleged in an Amended

Administrative Complaint filed by the Department of Health

before the Board of Medicine on June 20, 2008; and, if so, what

disciplinary action should be taken against his license to

practice medicine in the State of Florida.

PRELIMINARY STATEMENT

This case began with the filing by the Department of Health

before the Board of Medicine of a four-count Amended

Administrative Complaint, DOH Case Number 2006-38439, against

Respondent Lucien Armand, M.D., an individual licensed to

practice medicine in Florida. On or about July 20, 2008,

Respondent, through counsel, filed a Petition for Formal

Administrative Hearing and an Election of Rights form signed by

Respondent, disputing the allegations of fact contained in the

Amended Administrative Complaint and requesting a formal

administrative hearing pursuant to Sections 120.569(2)(a) and

120.57(1), Florida Statutes (2008).

On August 29, 2008, the matter was filed with the Division

of Administrative Hearings with a request that an administrative

law judge be assigned to conduct proceedings pursuant to Section

120.57(1), Florida Statutes (2008). The matter was designated

DOAH Case Number 08-4285PL and was assigned to the undersigned.

This case was consolidated with another case involving the

parties, DOAH Case No. 08-4403PL, DOH Case No. 2005-63004, by

Order of Consolidation entered September 12, 2008. The two

cases were consolidated for purposes of hearing only. A

separate Recommended Order is being entered in DOAH Case No. 08-

4403PL.

The final hearing was scheduled to be held on November 7,

2008, by video teleconference between sites in Miami and

Tallahassee, Florida, by Notice of Hearing by Video

Teleconference entered September 12, 2008. The hearing was re-

scheduled twice at the request of Respondent.

On March 20, 2009, the parties filed a Joint Pre-Hearing

Stipulation, in which they identified certain facts and issues

of law they agreed on. To the extent relevant, those agreed

upon facts and issues of law have been included in this

Recommended Order.

On March 31, 2009, an Order Granting Petitioner’s Motion

for Official Recognition was entered.

During the final hearing, Petitioner presented the

testimony of Melinda Gray, Patient W.C., Christian Birkedal,

M.D., and Angela Potter. Petitioner’s Exhibits 1 through 3, 6,

and 8 through 14 were admitted. Respondent testified on his own

behalf and had one exhibit admitted.

The two-volume Transcript of the final hearing was filed on

April 24, 2009. By Notice of Filing Transcript entered the same

day, the parties were informed that the Transcript had been

filed and that their proposed recommended orders were to be

filed on or by May 25, 2009. May 25, 2009, was a holiday, so

proposed orders were actually required to be filed on or before

May 26, 2009.

Petitioner’s Proposed Recommended Order and Dr. Armand’s

Memorandum in Support of a Recommended Order Dismissing

Administrative Complaints were filed on May 26, 2009. The post-

hearing proposals of both parties have been fully considered in

rendering this Recommended Order.

All references to Florida Statutes in this Recommended

Order are to the 2006 version unless otherwise noted.

FINDINGS OF FACT

A. The Parties .

1. Petitioner, the Department of Health (hereinafter

referred to as the "Department"), is the agency of the State of

Florida charged with the responsibility for the investigation

and prosecution of complaints involving physicians licensed to

practice medicine in Florida. § 20.43 and Chs. 456 and 458,

Fla. Stat.

2. Respondent, Lucien Armand, M.D., is, and was at the

times material to this matter, a physician licensed to practice

medicine in Florida, having been issued license number ME 33997.

3. Dr. Armand is board-certified in general surgery by the

American Board of Surgery.

4. Dr. Armand’s mailing address of record at all times

relevant to this matter was 2071 Southwest 52nd Way, Plantation,

Florida 33317. At the times relevant, Dr. Armand practiced

medicine at 4100 South Hospital Drive, Suite 108, Plantation,

Florida 33317. The office at which Dr. Armand practiced

medicine was located very close to Plantation General Hospital

(hereinafter referred to as “Plantation”).

5. Dr. Armand has been the subject of three prior

disciplinary matters arising out of five separate cases.

Penalties were imposed in those three disciplinary matters. The

Department summarized those disciplinary matters in paragraph 37

of its Proposed Recommended Order:

In DPR Case Numbers 0019222, 0019123 and

0091224, Respondent was fined, received a

reprimand, and was required to complete 30

hours of Continuing Medical Education (CME)

in general vascular surgery and risk

management within the surgical practice. In

Case Number 94-10100, Respondent was

required to submit to and comply with an

evaluation at the University of Florida, to

pay a fine, was reprimanded, was required to

complete twenty hours of CME in general

surgery in performing Laparoscopic

Cholecystectomy, and was placed on Probation

for two (2) years. In Case Number 1999-

58474, Respondent was restricted from

performing Level II or above office surgery

as defined in Rule 64B8-9.009(1)(d), Florida

Administrative Code, until the Respondent

demonstrated to the Board that he had

successfully completed the University of

Florida Comprehensive Assessment and

Remedial Education Service (UF C.A.R.E.S.)

course and complied with all

recommendations, was reprimanded, was placed

on probation for two (2) years, was required

to attend the Florida Medical Association

“Quality Medical Record Keeping for Health

Care Practitioners” course, was required to

perform 100 hours of community service, and

was required to reimburse the Department for

costs.

6. Dr. Armand, who is 70 years of age, has been practicing

medicine for 46 years. He has practiced medicine in Florida

since 1979. During the eight months prior to the final hearing

of this matter, Dr. Armand was working in South Sudan pursuant

to contract with the United States State Department.

B. October 6, 2006, Surgery on Patient W.C .

7. On September 14, 2006, Patient W.C. presented to

Dr. Armand and was diagnosed as having a slow-growing left

inguinal hernia.

8. Dr. Armand scheduled Patient W.C. for surgical repair

of the inguinal hernia. The surgery was scheduled for

October 6, 2006, at Dr. Armand’s office and, at the request of

Patient W.C., under local sedation.

9. At approximately 9:30 a.m., October 6, 2006, Patient

W.C. arrived as scheduled at Dr. Armand’s office, accompanied by

his wife and child. Patient W.C., who was not asked to execute

any paperwork concerning the operation, was taken into a room

where he was directed to lie down. There were two nurses in the

room.

10. Patient W.C. was given one shot of some form near the

site of the procedure. This shot is the only medication he

remembers receiving. He denied any recollection of having

received medication intravenously, intramuscularly, or rectally.

11. According to Dr. Armand, Patient W.C. was given “local

anesthesia, Xylocaine 1% and ½% during the procedure and I gave

some oral sedation, 10mg. of Valium, by mouth.” Page 171, Lines

19-21, Vol. II, Transcript of Final Hearing.

12. At some point during the surgery, Patient W.C.’s

intestines eviscerated, pushed themselves out through the

hernia, making the hernia impossible to repair in the office.

13. Due to the evisceration of Patient W.C.’s intestines,

Dr. Armand eventually closed the incision and decided to

transport Patient W.C. to Plantation to complete the procedure.

Dr. Armand’s testimony that he closed and took patient W.C. to

Plantation because Patient W.C. began “fidgeting” is not

credited.

14. While Patient W.C. did not have any clear recollection

of the surgery while at Dr. Armand’s office, he did recall that

“I was shaking myself and one of the nurses put something on my

head and I went to sleep.” Page 40, Lines 20-22, Vol. I,

Transcript of Final Hearing. Patient W.C. later indicated that

“[o]ne of the ladies sprayed something on my face,” at which

point Patient W.C. “went to sleep.” Page 41, Lines 23-24, and

Page 42, Line 8, Vol. I, Transcript of Final Hearing. Patient

W.C. did not remember anything else from this point in the

surgery until he awoke at approximately 2:00 p.m., October 6,

2006, in a room at Plantation.

15. Patient W.C. was transported to Plantation after he

“fell asleep” by Dr. Armand.

16. When Patient W.C. arrived at the Plantation emergency

representation to the emergency room physician, Cornell

Calinescu, M.D., was described as “somewhat sedated secondary to

Valium and Clonidine.” Patient W. C. was also described by Dr.

Calinescu and an emergency room nurse as able to speak.

17. Upon admission to Plantation, Dr. Armand performed

emergency surgery on Patient W.C. under general anesthesia,

completing the procedure he had begun in his office. The

surgery was completed without further complication.

18. As noted above, Patient W.C. has no recollection of

arriving at the Plantation emergency room, how he got to the

hospital, or anything else that took place after falling asleep

in Dr. Armand’s office, until he awoke in a hospital room later

in the afternoon.

C. Dr. Armand’s Medical Records for the October 6, 2006,

Surgery .

19. Dr. Armand’s office notes for Patient W.C. lack any

documentation as to what took place in his office on October 6,

2006. Dr. Armand did not record the date of the procedure; the

type of procedure performed; pre-operative care; any drugs that

were prescribed, dispensed, and/or administered; the type and

dosage of anesthetic sedation used; or post-operative care.

20. Dr. Armand’s medical records for Patient W.C. also

failed to include any informed consent for the procedure

performed on October 6, 2006.

21. As noted above, Dr. Armand did complete an operative

report after the emergency surgery performed on Patient W.C. at

Plantation.

D. Office Surgery; Level of Anesthesia .

22. Florida Administrative Code Rule 64B8-9.009

(hereinafter referred to as the “Office Surgery Rule”)

prescribes standards for the performance of office surgery. In

providing those standards, the Office Surgery Rule defines three

levels of sedation and the conditions under which each level may

be achieved and must be performed. Level II and Level III

office surgery require registration of the physician’s office to

perform. Dr. Armand’s office was not registered to perform

Level II or Level III office surgery at the times relevant to

this proceeding. Only the first and second levels of office

surgery are relevant to this case.

23. Florida Administrative Code Rule 64B8-9.009(3)

describes the types of procedures appropriate for “Level I”

office surgery, which Dr. Armand has argued he performed on

Patient W.C., as follows:

1. Minor 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-inducted alteration of

consciousness other than minimal pre-

operative tranquilization of the patient.

2. Liposuction involving the removal of

less than 4000cc supernatant fat is

permitted.

3. Incision and drainage of superficial

abscesses, limited endoscopies such as

proctoscopes, skin biopsies, arthrocentesis,

thoracentesis, paracentesis, dilation of

urethra, cysto-scopic procedures, and closed

reduction of simple fractures or small joint

dislocations (i.e., finger and toe joints).

. . . .

5. Chances of complication requiring

hospitalization are remote.

24. Florida Administrative Code Rule 64B8-9.009(4)

describes the types of procedures appropriate for “Level II”

office surgery, which the Department argues Dr. Armand utilized

on Patient W.C., as follows:

1. Level II Office Surgery is that in

which peri-operative medication and sedation

are used intravenously, intramuscularly, or

rectally, thus making intra and post-

operative monitoring necessary. Such

procedures shall include, but not be limited

to : hemorrhoidectomy, hernia repair ,

reduction of simple fractures, large joint

dislocations, breast biopsies, colonoscopy,

and liposuction involving the removal of up

to 4000cc supernatant fat.

2. Level II Office surgery includes any

surgery in which the patient is placed in a

state which allows the patient to tolerate

unpleasant procedures while maintaining

adequate cardiorespiratory function and the

ability to respond purposefully to verbal

command and/or tactile stimulation.

Patients whose only response is reflex

withdrawal from a painful stimulus are

sedated to a greater degree than encompassed

by this definition. [Emphasis added].

25. While the Department relies in part upon the language

of Florida Administrative Code Rule 64B8-9.009(4) that “[s]uch

procedures shall include, but not be limited to . . . hernia

repair . . .” to support its argument that the procedure

performed by Dr. Armand on Patient W.C. was in fact performed as

Level II surgery, this reliance is misplaced. Regardless of the

proper interpretation of this language of the Rule (whether it

clearly puts physicians on notice that all hernia repair surgery

must be conducted as Level II surgery or not), at best it

establishes a proscription. Such a proscription, cannot,

however, be relied upon to establish the “fact” that Level II

surgery was performed or not. The question of whether Dr.

Armand performed the procedure defined as “Level II” office

surgery is the disputed issue of fact in this case. Resolving

this factual dispute requires an ultimate factual determination,

which involves the application of a legal standard (the Rule) to

the historical facts (what Dr. Armand actually did) as found by

the trier-of-fact based upon the evidence. The Rule is not

evidence of what Dr. Armand did; rather it is the yardstick

against which Dr. Armand’s conduct must be measured and,

ultimately, judged.

26. The evidence either way concerning the level of

surgery performed by Dr. Armand consisted of his testimony

denying that Level II surgery was performed, the testimony of

Patient W.C. concerning his condition, the description of

Patient W.C.’s condition by emergency room personnel, and the

opinion of the Department’s expert witness, Christian Brikedal,

M.D., as to the level of surgery.

27. Dr. Armand’s denial that he performed Level II surgery

was not convincing because it was inconsistent with the

patient’s description of his condition on October 6, 2006, and

the description of his condition by emergency room staff when

arrived at Plantation. Patient W.C. had no recollection of

going to the hospital or anything that transpired there until he

awoke at about 2:00 p.m. the afternoon of October 6, 2006.

Emergency room staff noted that Patient W.C. was able to talk

when he arrived. These facts, convincingly proved, are more

consistent with what constitutes Level II surgery: “the patient

is placed in a state which allows the patient to tolerate

unpleasant procedures while maintaining . . . the ability to

respond purposefully to verbal command and/or tactile

stimulation.” This finding is further supported by Dr. Brikedal

opinion that Patient W.C.’s condition was consistent with having

undergone Level II sedatopm.

28. Dr. Brikedal, whose testimony was convincing and

uncontroverted, was asked the following question and gave the

following answer at Page 22, Lines 7-14, Vol. I, Transcript of

Final Hearing:

Q Assuming W.C. is going to testify that

as soon as the complication occurred that he

was put to sleep and didn’t wake up until he

was in the hospital, are you able to reach

any conclusions about the level of sedation

that occurred?

A He would have to have been given a

sedative I.V. or I.M. to be that sleepy.

This opinion, as to Patient W.C.’s condition on October 6, 2006,

supports a finding that Patient W.C. was under Level II

anesthesia while surgery was being performed in Dr. Armand’s

office. Having found that Patient W.C. was under the level of

sedation described in the definition of “Level II” office

surgery, leads inescapably to the finding that Dr. Armand

administered Level II sedation to Patient W.C.

29. The foregoing finding is further supported by the

portion of the Office Surgery Rule quoted, supra , in finding of

fact 24. Dr. Brikedal explained during the hearing why it is

“appropriate and necessary to do an inguinal hernia repair” as

Level II surgery: “Sedation to the point that the patient’s

comfortable so they’re able to or they’re not pushing against

you, inhibiting you from performing this very safely.” Page 24,

Lines 20-22, Vol. I, Transcript of Final Hearing. As a board-

certified general surgeon who has previously registered and had

his office accredited as an office at which Level II surgery

could be performed, Dr. Armand must have been aware of why it is

prudent to perform hernia repairs as Level II surgery. While

Dr. Armand may have begun the surgery as Level I, when Patient

W.C.’s intestines eviscerated, Dr. Armand must have realized

that taking Patient W.C. to Level II sedation would give him a

better opportunity to correct the problem. Unfortunately for

Dr. Armand, it was too late.

E. Office Surgery Rule Procedures .

30. Florida Administrative Code Rule 64B8-9.009(2)

prescribes requirements for conducting “office surgery,” taking

into account of the level of sedation utilized during a

procedure.

31. The hernia repair performed by Dr. Armand on Patient

W.C. constituted “surgery” as defined in Florida Administrative

Code Rule 64B8-9.009(1). Performance of the surgery in Dr.

defined in Florida Administrative Code Rule 64B8-9.009(1)(d).

32. The “office surgery” performed by Dr. Armand on

Patient W.C. failed to comply, as required, with all the

requirements of Florida Administrative Code Rule 64B8-9.009(2),

applicable to conducting Level II office surgery and, in some

instances, Level I office surgery:

a. Dr. Armand failed to “maintain complete records” of the

surgical procedure as required by Florida Administrative Code

Rule 64B8-9.003, or a written informed consent from the patient

as required by Florida Administrative Code Rule 64B8-

9.009(2)(a)(applicable in part to Level I and Level II surgery);

b. No log of Level II surgery was kept as required by

Florida Administrative Code Rule 64B8-9.009(2)(c);

c. No adverse incident report was filed as required by

Florida Administrative Code Rule 64B8-9.009(2)(k). This portion

of the rule requires that “[t]he surgeon shall report to the

Department of Health any adverse incidents that occur within the

office surgical setting . . . .” (Emphasis added). This

requirement is separate from any requirement that a hospital

report adverse incidents and the burden of reporting is put

directly on the surgeon; and

d. Dr. Armand did not have an established risk management

program as required by Florida Administrative Code Rule 64B8-

9.009(2)(j).

F. The Standard of Care .

33. Dr. Birkedal provided an opinion to the Department and

testified at the final hearing as to whether Dr. Armand’s

treatment of Patient W.C. met the “level of care, skill, and

treatment which, in light of all relevant surrounding

circumstances, is recognized as acceptable and appropriate by

reasonably prudent similar health care providers . . . .”

(Hereinafter referred to as the “Standard of Care”).

34. In his original opinion dated December 22, 2007,

Dr. Birkedal indicated that he did not believe that Dr. Armand’s

care of Patient W.C. violated the Standard of Care. There were

caveats or assumptions, however, which Dr. Birkedal recognized

in his written opinion could change his opinion if not correct.

In particular, at the time of his original opinion,

Dr. Birkedalk had incorrectly assumed that the procedure

performed on Patient W.C. was a Level I procedure. Dr. Birkedal

recognized in his original opinion that, if his assumption were

incorrect, that his opinion would change: “[i]f he did give an

IV sedative, then he may have violated the standard of care if

his office is not licensed to give IV sedatives.”

35. At hearing, Dr. Birkedal was of the opinion that

Dr. Armand had not simply performed Level I surgery and,

therefore, opined that he had violated the Standard of Care

because his office was not a properly licensed office surgery

suite.

36. Dr. Birkedal also offered other opinions at hearing

concerning what he perceived were violations of the Standard of

Care, but those “violations” were not alleged by the Department

in the Amended Administrative Complaint.

CONCLUSIONS OF LAW

A. Jurisdiction .

37. The Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding and of

the parties thereto pursuant to Sections 120.569 and 120.57(1),

Florida Statutes (2008).

B. The Burden and Standard of Proof .

38. The Department seeks to impose penalties against

Dr. Armand’s license through the Amended Administrative

Complaint that include suspension or revocation of his license

and/or the imposition of an administrative fine. Therefore, the

Department has the burden of proving the specific allegations of

fact that support its charge that Dr. Armand committed the

statutory and rule violations alleged in the Amended

Administrative Complaint by clear and convincing evidence.

Department of Banking and Finance, Division of Securities and

Investor Protection v. Osborne Stern and Co. , 670 So. 2d 932

(Fla. 1996); Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987);

Pou v. Department of Insurance and Treasurer , 707 So. 2d 941

(Fla. 3d DCA 1998); Nair v. Department of Business and

Professional Regulation , 654 So. 2d 205 (Fla. 1st DCA 1995); and

§ 120.57(1)(j), Fla. Stat. (2008)("Findings of fact shall be

based on a preponderance of the evidence, except in penal or

licensure disciplinary proceedings or except as otherwise

provided by statute.").

39. What constitutes "clear and convincing" evidence was

described by the court in Evans Packing Co. v. Department of

Agriculture and Consumer Services , 550 So. 2d 112, 116, n. 5

(Fla. 1st DCA 1989), as follows:

. . . [C]lear 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 evidence must be precise and

explicit and the witnesses must be lacking

in confusion as to the facts in issue. The

evidence must be of such weight that it

produces in the mind of the trier of fact

the 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 DCA 1983).

See also In re Graziano , 696 So. 2d 744 (Fla. 1997); In re

Davey , 645 So. 2d 398 (Fla. 1994); and Walker v. Florida

Department of Business and Professional Regulation , 705 So. 2d

652 (Fla. 5th DCA 1998)(Sharp, J., dissenting).

C. The Charges of the Amended Administrative Complaint .

40. Section 458.331(1), Florida Statutes, authorizes the

Board of Medicine (hereinafter referred to as the "Board"), to

impose penalties ranging from the issuance of a letter of

concern to revocation of a physician's license to practice

medicine in Florida if a physician commits one or more acts

specified therein.

41. The four-count Amended Administrative Complaint

alleges that Dr. Armand violated the following provisions of

Section 458.331(1), Florida Statutes, in his treatment of

Patient W.C.:

a. Count One: Section 458.331(1)(v), Florida Statutes;

b. Count Two: Section 458.331(1)(nn), Florida Statutes

(2006), by violating Florida Administrative Code Rule 64B8-

9.009(2) and (4), and Section 458.351, Florida Statutes;

c. Count Three: Section 458.331(1)(m), Florida Statutes;

and

d. Count Four: Section 458.331(1)(t), Florida Statutes,

the Standard of Care.

42. In determining whether Dr. Armand committed the

alleged statutory violations, only those specific factual

grounds alleged by the Department in the Amended Administrative

Complaint can form the basis of a finding of violation. See

Trevisani v. Department of Health , 908 So. 2d 1108 (Fla. 1st DCA

2005); Cottrill v. Department of Insurance , 685 So. 2d 1371

(Fla. 1st DCA 1996). As the Department acknowledged in its

Proposed Recommended Order, “[d]ue process prohibits the

Department from taking disciplinary action against a licensee

based on matters not specifically alleged in the charging

instrument, unless those matters have been tried by consent.

See Shore Village Property Owners’ Association, Inc . v.

Department of Environmental Protection , 824 So. 2d 208, 210

(Fla. 4th DCA 2002); and Delk v. Department of Professional

Regulation , 595 So. 2d 966, 967 (Fla. 5th DCA 1992).”

D. Count One: Section 458.331(1)(v), Florida Statutes .

43. Section 458.331(1)(v), Florida Statutes, defines the

following disciplinable offense:

(v) Practicing or offering to practice

beyond the scope permitted by law or

accepting and performing professional

responsibilities which the licensee knows or

has reason to know that he or she is not

competent to perform. The board may

establish by rule standards of practice and

standards of care for particular practice

settings, including, but not limited to,

education and training, equipment and

supplies, medications including anesthetics,

assistance of and delegation to other

personnel, transfer agreements,

sterilization, records, performance of

complex or multiple procedures, informed

consent, and policy and procedure manuals.

44. In particular, the Amended Administrative Complaint

alleges that Dr. Armand violated this prohibition because he

“performed Level II office surgery on Patient W.C. by attempting

to perform a hernia repair in his office” in violation of the

Office Surgery Rule.

45. The evidence proved clearly and convincingly that Dr.

Armand performed Level II surgery on Patient W.C. on October 6,

2006, when he knew or should have known that such surgery was

beyond the scope of what he was authorized to do under the

Officer Surgery Rule because he was not licensed at the time to

perform Level II surgery in his office.

E. Count Two: Section 458.331(1)(nn), Florida Statutes .

46. Section 458.331(1)(nn), Florida Statutes, defines the

following disciplinable offense:

(nn) Violating any provision of this

chapter or chapter 456, or any rules adopted

pursuant thereto.

47. In particular, Count Two of the Amended Administrative

Complaint goes on to allege that Dr. Armand violated Florida

Administrative Code Rule 64B8-9.009(2) and (4), “by performing

Level II office surgery on Patient W.C. in Respondent’s office

without complying with the requirements of Rule 64B8-9.009 as to

informed consent, staffing, equipment, crash cart, medications,

and assistance of other personnel.”

48. While the Department admits that it failed to prove

whether Dr. Armand violated the standards of the Office Surgery

Rule concerning staffing, equipment, crash cart, medications,

and assistance of other personnel on October 6, 2006, it did

prove that Dr. Armand failed to obtain an informed consent from

Patient W.C.

49. The Department’s suggestion that Dr. Armand’s failure

to file an adverse incident report as required by the Office

Surgery Rule in violation of Section 458.331(nn), Florida

Statutes, is rejected as a basis for discipline because the

Department did not specifically make this allegation in the

Amended Administrative Complaint. The only allegation in Count

Two of the Amended Administrative Complaint concerning Dr.

Armand’s failure to file an adverse incident report was based

upon Section 458.351, Florida Statutes.

50. It is alleged that Dr. Armand violated Section

458.331(nn), Florida Statutes, by having violated Section

458.351, Florida Statutes, “by failing to file an adverse

incident report regarding the incident involving Patient W.C.”

Section 458.351, Florida Statutes, provides, in pertinent part,

the following:

(1) Any adverse incident that occurs on

or after January 1, 2000, in any office

maintained by a physician for the practice

of medicine which is not licensed under

chapter 395 must be reported to the

department in accordance with the provisions

of this section.

(2) Any physician or other licensee under

this chapter practicing in this state must

notify the department if the physician or

licensee was involved in an adverse incident

that occurred on or after January 1, 2000,

in any office maintained by a physician for

the practice of medicine which is not

licensed under chapter 395.

(3) The required notification to the

department must be submitted in writing by

certified mail and postmarked within 15 days

after the occurrence of the adverse

incident.

. . . .

51. While not excusing his failure, the evidence did prove

that Dr. Armand’s failure to file an adverse incident report is

somewhat mitigated by the fact that the hospital filed one.

52. The evidence proved clearly and convincingly that Dr.

Armand failed to file an adverse incident report as required by

Section 458.351, Florida Statutes.

F. Count Three; Violation of Section 458.331(1)(m),

Florida Statutes .

53. Section 458.331(1)(m), Florida Statutes, defines the

following disciplinable offense:

Failing to keep legible, as defined by

department rule in consultation with the

board, medical records that identify the

licensed physician or the physician extender

and supervising physician by name and

professional title who is or are responsible

for rendering, ordering, supervising, or

billing for each diagnostic or treatment

procedure and 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

reports of consultations and

hospitalizations.

54. In the Amended Administrative Complaint it is alleged

that Dr. Armand failed to keep adequate medical records in

violation of Section 458.331(m), Florida Statutes, in that he

failed to document one or more of the following:

a. A record of the procedure performed;

b. The date the procedure was performed;

c. A record of the drugs prescribed,

dispensed or administered;

d. The type and dosage of anesthetic

sedation used during the procedure;

e. The pre-operative and post-operative

care provided;

f. The informed consent;

g. The adverse incident report.

The Department proved clearly and convincingly that Dr. Armand

failed to keep medical records documenting these matters as

alleged in the Amended Administrative Complaint.

55. The evidence proved clearly and convincingly that Dr.

Armand failed to keep medical records as alleged in the Amended

Administrative Complaint in violation of Section 458.331(1)(m),

Florida Statutes.

G. Count Four: Violation of Section 458.331(1)(t), Florida

Statutes .

56. Section 458.331(1)(t), Florida Statutes, defines, in

part, the following disciplinable offense:

Committing medical malpractice as defined in

s. 456.50. The board shall give great

weight to the provisions of s. 766.102 when

enforcing this paragraph. Medical

malpractice shall not be construed to

require more than one instance, event, or

act.

57. Section 456.50(1)(g), Florida Statutes, defines

medical malpractice as follows:

. . . the failure to practice medicine in

accordance with the level of care, skill,

and treatment recognized in general law

related to health care licensure. Only for

the purpose of finding repeated medical

malpractice pursuant to this section, any

similar wrongful act, neglect, or default

committed in another state or country which,

if committed in this state, would have been

considered medical malpractice as defined in

this paragraph, shall be considered medical

malpractice if the standard of care and

burden of proof applied in the other state

or country equaled or exceeded that used in

this state.

58. Section 456.50(1)(e), Florida Statutes, defines “level

of care, skill, and treatment recognized in general law related

to Section 766.102, Florida Statutes, which defines the Standard

of Care as “[t]he 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

reasonably prudent similar health care providers.”

59. In paragraph 39 of the Amended Administrative

Complaint, it is alleged that Dr. Armand violated the Standard

of Care in his treatment of Patient W.C. in one or more of the

following ways:

a. By performing inguinal hernia surgery

in his office in violation of Rule 64B8-

[9].009, FAC;

b. By violating Rule 64B8-9.009, FAC, by

performing invasive office surgery in an

office;

c. By administering sedation that

prevented the patient from signing the

necessary consent to the emergency surgery;

d. By failing to document his

preoperative, post operative, or operative

actions or anesthetic;

e. By failing to file an adverse incident

report as required by Section 458.351,

Florida Statutes (2006);

f. By failing to meet the Standards of

Practice and Care established by the Board

of Medicine in Rule 64B8-9.009, FAC.

60. The alleged Standard of Care violations of paragraphs

39a. and b. are essentially the same: Dr. Armand performed

surgery in his office in violation of the Office Surgery Rule.

The allegations of paragraphs 39c. and d. are more specific

failures on the part of Dr. Armand to follow the requirements of

the Office Surgery Rule. The allegation of paragraph 39f.

simply summarizes the allegations of paragraphs 39 a., b., c.

and d. The allegation of paragraph 39e. is the only allegation

that does not specifically turn on adherence to the Office

Surgery Rule.

61. The Department has pointed out in its Proposed

Recommended Order that the Office Surgery Rule itself

establishes the Standard of Care. The Office Surgery Rule is

titled “Standard of Care for Office Surgery” and it prescribes

what the Board considers the prevailing professional standard of

care for any health care provider performing office surgery.

The Department’s interpretation of its own rule is persuasive

and is accepted.

62. The Department next argues that Dr. Armand violated

the Standard of Care by failing to comply with the Office

Surgery Rule. Clearly and convincingly, Dr. Armand performed

Whether the surgery was performed at Level I or Level II, it was

performed in his office and he was required to comply with all

relevant portions of the Office Surgery Rule. His failure to do

so constituted a violation of the Office Surgery Rule and,

consequently, a violation of the Standard of Care.

63. Again, regardless of the level of the surgery

performed, it was proved clearly and convincingly that he

performed “inguinal hernia surgery in his office in violation of

Rule 64B8-[9].009, FAC” and that he violated “Rule 64B8-9.009,

FAC, by performing invasive office surgery in an office” as

alleged in the Amended Administrative Complaint.

64. The Department also proved, again without regard to

the level of the surgery performed, that Dr. Armand failed to

document his preoperative, post-operative, or operative actions

or anesthetic as required by the Office Surgery Rule.

65. The Department failed to prove, however, that failure

to comply with Section 458.351, Florida Statutes, while a

violation of Section 456.331(nn), Florida Statutes, constitutes

a violation of the Standard of Care. The Office Surgery Rule,

while also requiring that adverse incident reports be filed,

does not refer to Section 358.351, Florida Statutes, and the

Department did not specifically allege in support of the charged

violation of the Standard of Care that Dr. Armand’s failure to

file the report violated any provision other than Section

458.351, Florida Statutes.

66. In addition to alleging that Dr. Armand violated the

Standard of Care by failing to adhere to the requirements of the

Office Surgery Rule, the Department has argued in its Proposed

Recommended Order that Dr. Brikedal’s opinions at hearing

support a finding that the Standard of Care was violated

independent of the Office Surgery Rule. While Dr. Brikedal’s

testimony does support such a finding, the allegations of the

Amended Administrative Complaint concerning the Standard of Care

did not put Dr. Armand on notice that he was being charged with

any violation of the Standard of Care other than his failure to

comply with the Office Surgery Standard.

67. The Department has proved clearly and convincingly

that Dr. Armand violated the Standard of Care as alleged in

Count Four of the Amended Administrative Complaint as more

specifically alleged in paragraph 39.a., b., c., d., and f. of

the Amended Administrative Complaint.

F. The Appropriate Penalty .

68. In determining the appropriate punitive action to

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

the Board's "disciplinary guidelines," which impose restrictions

and limitations on the exercise of the Board's disciplinary

authority under Section 458.331, Florida Statutes. See Parrot

Heads, Inc. v. Department of Business and Professional

Regulation , 741 So. 2d 1231 (Fla. 5th DCA 1999).

69. The Board's guidelines are set out in Florida

Administrative Code Rule 64B8-8.001(2), which provides for the

following range of penalties:

a. For a violation of Section 458.331(1)(v), Florida

Statutes: from two years' suspension to revocation and an

administrative fine from $1,000.00 to $10,000.00;

b. For a violation of Section 458.331(1)(nn), Florida

Statutes, second offense: from probation to revocation and an

administrative fine from $5,000.00 to $10,000.00;

c. For a violation of Section 458.331(1)(m), Florida

Statutes, second offense: from probation to suspension followed

by probation and an administrative fine of from $5,000.00 to

$10,000.00; and

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

Statutes, second offense: from two years' probation to

revocation and an administrative fine from $5,000.00 to

$10,000.00

70. Florida Administrative Code Rule 64B8-8.001(3)

provides that, in applying the penalty guidelines, the following

aggravating and mitigating circumstances are to be taken into

account:

(3) Aggravating and Mitigating

Circumstances. Based upon consideration of

aggravating and mitigating factors present

in an individual case, the Board may deviate

from the penalties recommended above. The

Board shall consider as aggravating or

mitigating factors the following:

(a) Exposure of patient or public to

injury or potential injury, physical or

otherwise: none, slight, severe, or death;

(b) Legal status at the time of the

offense: no 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 applicant or licensee;

(g) The involvement in any violation of

Section 458.331, Florida Statutes, of the

provision of controlled substances for

trade, barter or sale, by a licensee. In

such cases, the Board will deviate from the

penalties recommended above and impose

suspension or revocation of licensure;

(h) Any other relevant mitigating

factors.

71. In its Proposed Recommended Order, the Department has

suggested that there are no mitigating circumstances and the

following aggravating circumstances in this case:

Based on the previous serious disciplinary

history of the Respondent, including

multiple violations of the standard of care,

the fact that W.C. was exposed to potential

harm, the fact that this is a four count

complaint, and because Respondent has been

disciplined in three previous cases for the

violation of Section 458.331(1)(m), Florida

Statutes, and on five previous occasions (in

seven cases) for violation of Section

458.331(1)(t), Florida Statutes, the level

of aggravating factors is high. . . .

This summary of aggravating circumstances is accurate.

72. The Department overlooks, however, that, while there

was “potential” for harm to Patient W.C., in fact the surgery

ultimately was concluded without any actual physical harm to

Patient W.C. The Department also has failed to acknowledge the

fact that the violations concerning Dr. Armand’s failure to file

an adverse incident report are mitigated by the fact that the

hospital filed one. Finally, consideration should be given to

the fact that Dr. Armand has ceased performing Level II and

Level III surgery in an office setting and that he has

effectively closed his office practice.

73. The Department has requested that it be recommended

that Dr. Armand’s medical license be revoked. As an

alternative, the Board may want to consider suspending Dr.

Armand’s right to practice medicine in Florida, while allowing

him keep his Florida medical license in order for him to

continue to practice medicine outside the United States through

his relationship with the United States Department of State.

Such an arrangement should be conditioned upon full disclosure

to the United States Department of State and should be

considered only if his continued licensure is a condition of his

employment by the United States Department of State.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that the a final order be entered by the Board

of Medicine finding that Lucien Armand M.D., has violated

Section 458.331(1)(v), Florida Statutes (2006); Section

458.331(1)(nn), Florida Statutes (2006), by violating Florida

Administrative Code Rule 64B8-9.009 and Section 458.351, Florida

and Section 458.331(1)(t), Florida Statutes, to the extent found

in this Recommended Order; and indefinitely suspending his

license to practice medicine in Florida, but allowing him to

continue to practice medicine outside the United States through

his relationship with the United States Department of State

after full disclosure of the Board’s final order to the United

States Department of State. Should a medical license not be a

condition of employment by the United States Department of

State, his license should be revoked.

DONE AND ENTERED this 17th day of June, 2009, in

Tallahassee, Leon County, Florida.

___________________________________

LARRY J. SARTIN

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 17th day of June, 2009.

COPIES FURNISHED:

Diane Kiesling

Assistant General Counsel

Robert A. Milne

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

Sean Ellsworth, Esquire

Ellsworth Law Firm, P.A.

1501 Collins Avenue, Suite 208

Miami Beach, Florida 33139

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Dr. Ana M. Viamonte Ros, Secretary

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A-02

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 filed with the agency that

will issue the final order in these cases.