07-001852PL Department Of Health, Board Of Medicine vs. Edward St. Mary, M.D. Status: Closed Recommended Order on Tuesday, October 2, 2007.

Summary: Respondent performed surgery on the wrong site and failed to affirmatively disclose the error in his medical records.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner , )

)

vs. ) Case No. 07 - 1852PL

)

EDWARD ST. MARY, M.D. , )

)

Respondent . )

)

RECOMMENDED O RDER

On June 28, 2007, a formal administrative hearing in this

case was held in Viera, Florida, before William F. Quattlebaum,

Administrative Law Judge, Division of Administrative Hearings.

APPEARANCES

For Petitioner: Jennifer Forshey, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Michael R. D'Lugo, Esquire

Richard J. Brooderson, Esquire

Wicker, Smith, O'Hara, McCoy,

Graham & Ford, P.A.

Post Office Box 2753

Orlando, Florida 32802 - 2753

STATEMENT OF THE ISSUE S

The issue s in this case are whether the allegations of t he

Administrative Complaint are correct, and , if so, what penalty

should be imposed.

PRELIMINARY STATEMENT

By Amended Administrative Complaint dated December 11,

2006, the Department of Health (Petitioner) alleged that Edward

St. Mary, M.D., (Respondent) violated various Florida Statutes

related to the practice of medicine. The Respondent disputed

the allegations and requested a formal administrative hearing.

By letter dated April 24, 2007, the Petitioner forwarded the

matter to the Division of Administr ative Hearings, which

scheduled and conducted the hearing.

At the hearing, the parties had Joint Exhibit A admitted

into evidence. The Petitioner presented no live testimony and

had Exhibits numbered A and C through E admitted into evidence.

The Respon dent presented the testimony of five witnesses,

testified on his own behalf , and had E xhibits numbered A

through L and N through MM admitted into evidence.

The hearing T ranscript was filed on July 27, 2007. Both

parties filed Proposed Recommended Orders that have been

considered in the preparat ion of this Recommended Order.

FINDINGS OF FACT

1. At all times material to this case, the Respondent, a

board - certified orthopedic surgeon, was a medical doctor holding

Florida license number ME53713, with an add ress of record of

300 Michigan Av enue, Melbourne, Florida 32901.

2. Sin c e the mid 1990’s, the Respondent provided medical

care and treatment to Patient D.P. for orthopedic problems,

including pain in both of the patient's great toes.

3. Towards the end of November 2001, the patient and the

Respondent decided to treat the continued toe pain through

surgical removal of spurs from the metatarsophalgeal joints in

both great toes, a procedure identified as a "dorsal

cheilectomy."

4. Rather than leave the p atient immobilized by performing

surgery on both feet at the same time, two separate surgeries

were planned separated by several weeks, with the repair being

done to one toe at a time. There was some discussion between

the Respondent and the patient as to which toe surgery should be

performed first. A decision was made to perform surgery on

December 6, 2001 , to the left toe, with the right toe surgery

occurring at some later date, most like ly before the end of the

year.

5. The consent documentation execu ted by the patient

stated that the December 6, 2001 , surgery would be to the great

left toe. Various insurance authorizations were obtained to

assure coverage for the December 6 procedure to the patient's

great left toe.

6. On the date of surgery, the pa tient arrived at

Melbourne Same Day Surgery, and for reasons that are unclear,

had her great right toe prepared and draped for surgery by a

nurse.

7. The Respondent thereafter performed surgery on the

great right toe of Patient D.P. He realized that he w as

operating on the wrong toe when the nurse advised the Respondent

that the wrong foot had been prepped. Approximately 75 percent

of the procedure was completed at the time the error was

discovered.

8. The Respondent completed the procedure, and while t he

patient remained in the operating room, the Respondent went to

the waiting room and spoke to the patient's husband, who was her

health care surrogate. The Respondent advised the husband of

the surgical error, and recommended that the patient's great

le ft toe be injected with medication (“depomedrol") to address

the pain for which the surgery had been planned. The husba nd

consented to the injection.

9. On the date of the surgery, the patient had a burn

injury on the great left toe. Had the extent of t he injury been

observed when the patient was being prepped for surgery, the

surgery on the left toe would not likely have occurred.

10. There was some question as to when the injury was

first observed, but there was no evidence that the extent of the

in jury was observed prior to surgery being performed on the

wrong toe, or that the erroneous surgery to the right toe was

the result of a conscious decision based with consideration of

the injury to the left toe.

11. There is no credible evidence that the p atient or the

surrogate consented to having the dorsal cheilectomy performed

on December 6, 2001, to the patient's great right toe.

12. After the Respondent completed the patient’s surgery

and injection, he reported the wrong site surgery to the

facility’ s risk managers. He also documented the procedure

performed in an operative note , which is part of the patient’s

medical records.

13. Although the operative note appears to adequately

identify the procedures that were actually performed on the

patient, t he operative note does not indicate that a wrong site

surgery occurred. Neither the operative note nor any other

document in the patient's medical records affirmatively indicate

that the right toe surgery was not the procedure t o which the

patient consent ed.

14. The medical records, including the executed consent

forms, document the course of treatment to include surgery on

December 6, 2001, to the patient's great left toe. The medical

records include no explanation or rationale as to why surgery

was per formed on the patient’s great right toe on December 6,

2001, rather than to the left toe.

15. The Respondent testified that the risk managers at the

facilities where he practices have instructed him not to

document wrong - site surgical procedures in pati ent records and

referred to such documentation as "editorializing." He

indicated that the practice was of long - standing.

16. The Respondent asserts that appropriate documentation

of the wrong - site surgery was made though the "Form 15" filed

with the Flor ida Agency for Health Care Administration; however,

that document is a confidential report to a state regulator and

is not part of the patient's medical records.

17. The Petitioner presented the expert testimony of

Dr. Jack S. Cooper by deposition. Dr. Cooper is a Florida -

licensed and board - certified orthopedic surgeon, who opined that

the patient's medical records should have stated not only what

happened with the patient, but should have included the reasons

the wrong site surgery occurred , and how the error was resolved

by the Res pondent during the procedure.

18. In response, the Respondent presented the testimony of

two persons employed by the facility where the surgery was

performed (the a dministrative d irector and the r isk m anager) and

the testimon y of a licensed Health Care Risk Manager, all of

whom testified that they believed the patient's med ical records

were appropriate.

19. Dr. Cooper's testimony was persuasive and has been

fully credited in this Recommended Order. The testimony of the

Respo ndent's witnesses on this point was not persuasive and has

been disregarded .

20. The patient testified at the hearing that at the time

of the surgery, she was receiving psychiatric treatment related

to injuries sustained in an automobile accident in 1999 and

viewed the erroneous surgery as "a significant psychological

setback , " but acknowledged that she trusted, and was still

receiving care from, the Respondent. The patient's husband also

testified at the hearing and stated that the emotional

difficulties resulting from the erroneous surgery were more an

issue related to the surgical fa cility than to the Respondent.

CONCLUSIONS OF LAW

21. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceedin g. §§ 120.569 and 120.57, Fla . Stat . (200 6 ).

22. The Respondent is the state agency charged with

regulating the practice of medicine. § 20.43 and Chapters 456

and 458, Fla . Stat . (200 6 ).

23. The Amended Administrative Complaint charges the

Respondent w ith a violation of S ubs ection 456.072(1)(aa),

Florida Statutes (2001), which provides in relevant part as

follows:

(1) The following acts shall constitute

grounds for which the disciplinary actions

specified in subsection (2) may be taken:

* * *

(aa) 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.

24. The Amended Administrative Complaint further charges

that the Respondent violated S ubs ection 45 8.331(1), Florida

Statutes (2001) , which provides in relevant part as follows:

(1) The following acts constitute grounds

for denial of a license or disciplinary

action, as specified in s. 456.072(2):

* * *

(m) Failing to keep legible, as defin ed 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

r eports of consultations and

hospitalizations.

* * *

(p) Performing professional services which

have not been duly authorized by the patient

or client, or his or her legal

representative, except as provided in

s. 743.064, s. 766.103, or s. 768. 13.

25. The Petitioner has the burden of proving by clear and

convincing evidence the allegations set forth in the

Administrative Complaint against the Respondent. Department of

Banking and Finance v. Osborne Stern and Company , 670 So . 2d

932, 935 (Fla . 1996) ; Ferris v. Turlington , 510 So. 2d 292 (Fla.

1987).

26. Clear and convincing evidence is that which is

credible, precise, explicit , and lacking 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 of

conviction, without hesitancy, as to the truth of the

allegations. Slomowitz v. Walker , 429 So. 2d 797, 800 (Fla. 4th

DCA 1983). In this case, the burden has been met.

27. The evidence establishes that the treatme nt plan

developed between the Respondent and the patient included

surgery first on the great left toe, followed by surgery on the

great right toe within a few weeks time. The surgery scheduled

for December 6, 2001 , was for D.P.’s great left toe.

28. Ther e is no credible evidence that the patient

consented to have the dorsal cheilectomy performed on

December 6, 2001, to her great right toe. On the date of

surgery, the Respondent erroneously performed surgery on the

great right toe of Patient D.P. and the reby violat ed S ubs ection

456.072(1)(aa ), Florida Statutes (2001).

29. The patient’s medical records include her consent to

the December 6, 2001 , surgery on the great left toe. The

operative notes indicate that the surgery was per formed on the

great right toe.

30. Although there is no evidence that the Respondent made

any attempt to conceal the erroneous surgery from the patient,

the facility or regulatory agencies, the patient's medical

records provide no explanation as to why the Respondent

performed su rgery on December 6, 2001 , to the patient's great

right toe rather than to the left. Another medical professional

reviewing the patient’s records would be have no information as

to why the December 6, 2001 , surgery was performed on the

patient’s great rig ht toe.

31. The failure to properly document the surgical error in

the patient’s medical records constitutes a violation of

S ubs ection 458.331(1)(m), Florida Statutes (2001), because the

records fail to justify the course of treatment actually

provided to the patient on the date of surgery.

32. There is no credible evidence that the patient or the

patient’s surrogate consented to permit the Respondent to

perform surgery on December 6, 2001, on the patient’s great

right toe, and , accordingly, the Respond ent also violated

S ubs ection 458.331(1)(p), Florida Statutes (2001).

33. Florida Administrative Code Rule 64B8 - 8.001 sets forth

the disciplinary guidelines applicable to the statutory

violations relevant to this proceeding.

34. Florida Administrative Code Rule 64B8 - 8.001(2)(qq)

provides that the penalty for a first violation of wrong site

surgery ranges from a $1,000.00 fine, a letter of concern, a

minimum of five hours of risk management education, and an one

hour lecture on wrong - site surgery, to a $10,000.00 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 n one hour lecture on wrong - site

surgery, and license suspension to be followed by a term of

probation.

35. Florida Administrative Code Rule 64B8 - 8.001(2)(m)

provides that the penalty for a first violation of S ubs ection

458.331(1)(m), Florida Statutes (2001), ranges from a reprimand

to license denial or two years ' suspension followed by

proba tion, and an administrative fine from $1,000.00 to

$10,000.00.

36. Florida Administrative Code Rule 64B8 - 8.001(2)(p)

provides that the penalty for a first violation of S ubs ection

458.331(1)(p), Florida Statutes (2001), ranges f rom a reprimand

or license d enial to two years ' suspension, and an

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

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

provides as follows:

Aggravating and Mitigating Circumstances.

Based upon consideration of aggravating and

mitigati ng 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 o r 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 previousl y been committed by

the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction

and the length of practice;

(f) Pecuniary benefit or self - gain inuring

to the applicant or licensee;

(g) The involvement in any violation of

Section 458.331, F.S., of the provision of

controlled substances for trade, barter or

sale, by a licensee. In such cases, the

Board will deviate from the penalties

recommended above and impose suspension or

revocation of licensure.

(h) Where a licensee has been charged with

violating the standard of care pursuant to

Section 458.331(1)(t), F.S., but the

licensee, who is also the records owner

pursuant to Section 456.057(1), F.S., fails

to keep and/or produce the medical records.

(i) Any other relevant mitigating factors.

38. The Respondent has had no prior disciplinary action

taken against hi s license.

39. Although the patient experienced an emotional setback

related to the wrong site surgery, the evidence establishes that

there was no phys ical injury to the patient by the December 6,

2001 , surgery to the right toe, because the treatment plan was

to surgically address both toes prior to the end of 2001 .

40. There was no evidence of pecuniary gain related to the

wrong site surgery, although the decision to omit an affirmative

acknowledgment of, and specific explanation for, the wrong site

surgery from the patient's medical records based on risk

management concerns negates any consideration of this factor as

mitigation in favor of the Responde nt. The fact that the

failure to disclose was allegedly based on instructions from the

risk management staff at the facility where the wrong site

surgery occurred does not excuse the Respondent from his

obligation to comply with the requirements of law.

41. The Petitioner's Proposed Recommended Order suggests a

penalty of a $10,000 .00 administrative fine, completion of

100 hours of community service, completion of not less than five

hours of continuing medical education courses in risk

management, requ iring the Respondent to present a one hour

lecture on wrong site surgery to the medical staff at an

approved medical facility, and issuance of a repriman d from the

Board of Medicine.

42. The Respondent's Proposed Recommended Order suggests a

penalty of a $5,000 .00 administrative fine, completion of

50 hours of community service, completion of four hours of

continuing medical education courses in risk management,

requiring the Respondent to present a one hour lecture on wrong

site surgery to the medical st aff at an approved medical

facility, a letter of concern from the Board of Medicine, and

reimbursement to the Department of Health of all costs

associated with the investigation and prosecution of the case.

43. As support for the Respondent's suggested penalty, the

Respondent cited the penalties in numerous disciplinary cases

against medical practitioners where Final Orders were entered

based on Consent Agreements entered into between the parties.

44. Review of the cited Final Orders reveals that alth ough

the C onsent A greements indicate that each practitioner

acknowledged that the factual allegations "if proven" would

constitute violation of the various cited statutes, the Consent

Agreements were executed in order to terminate litigation. None

of the factual allegations set forth in any of the

Administrative Complaints were admitted in the Consent

Agreements. Each of the cited disciplinary cases was resolved

without an evidentiary hearing, and there was no final

determination as to whether the allegat ions of the

Administrative Complaints were accurate or were supported by

evidence.

45. In all but one of the cited cases, the allegations

involved wrong site surgical procedures and lack of consent. In

the one case , which included an alleged failure to k eep medical

records justifying the course of treatment ( Department of Health

v. Shanahan , Department of Health Case 2003 - 30327), a patient

was scheduled to undergo an upper endoscopy with biopsy, but the

physician erroneously performed a colonoscopy, and t hen

performed the endoscopy after realizing the error. The charge

of improper medical records was based on an allegation that the

physician's operative notes incorrectly stated that the

scheduled endoscopy was performed prior to the colonoscopy.

Because the case was resolved through a Consent Agreement, no

final determination as to the accuracy of the allegations was

made.

46. In the instant case, the allegations of the

Administrative Complaint have been established by clear and

convincing evidence. T he Respondent performed a wrong site

surgical procedure to which the patient had not consented and

then purposefully failed to enter any information that would

directly and specifically disclose that a wrong site surgery had

occurred. Accordingly, the fol lowing disposition is

recommended.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Department of Health enter a

f inal o rder finding Edward St. Mary, M.D. , in violation of

S ubs ection s 456.072(1)(aa) and 458.331(1)(m) and (p), Florida

Statutes (2001), and imposing a penalty as follows: a

$15,000 .00 administrative fine; a reprimand from the Board of

Medicine; completion of 75 hours of community service as

approved by the Petitioner; completion of not less than eight

hours of continuing medical education courses related to risk

management; requiring the Respondent to present a one hour

lecture on wrong site surgery to the medical staff at a facility

approved by the Petitioner; and requiring reimbursemen t to the

Department of Health of all costs associated with the

investigation and prosecution of the case.

DONE AND ENTERED this 2nd day of October , 2007 , in

Tallahassee, Leon County, Florida.

S

WILLIAM F. QUATTLEBAUM

Adm inistrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of A dministrative Hearings

this 2nd day of October , 2007 .

COPIES FURNISHED :

Michael R. D'Lugo, Esquire

Richard J. Brooderson, Esquire

Wicker, Smith, O'Hara, McCoy,

Graham & Ford, P.A.

Post Office Box 2753

Orlando, Florida 32802 - 2753

Jennifer Forshey, Es quire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

Josefina M. Tamayo, General Coun sel

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 this case.