05-003156PL Department Of Health, Board Of Medicine vs. Walter Inkyun Choung, M.D. Status: Closed Recommended Order on Friday, January 20, 2006.

Summary: Respondent for a second time performed surgery on the wrong site.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 05-3156PL

)

WALTER INKYUN CHOUNG, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Notice was provided and on November 8, 2005, a formal hearing

was held in this case. Authority for conducting the hearing is

set forth in Sections 120.569 and 120.57(1), Florida Statutes

(2005). The hearing location was the Marion County Government

Complex, Room 105, 601 Southeast Twenty-fifth Avenue, Ocala,

Florida. The hearing was conducted by Charles C. Adams,

Administrative Law Judge.

APPEARANCES

For Petitioner: Ephraim D. Livingston

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Bruce D. Lamb, Esquire

Ruden, McClosky, Smith, Shuster

& Russell, P.A.

401 East Jackson Street, Suite 2700

Tampa, Florida 33602

STATEMENT OF THE ISSUE

Should discipline be imposed against Respondent's medical

license for alleged violations of Sections 456.072(1)(aa), and

458.331(1)(p), Florida Statutes (2003)?

PRELIMINARY STATEMENT

On January 31, 2005, by an Administrative Complaint in

Department of Health, Petitioner v. Walter Inkyun Choung, M.D.,

Respondent , Department of Health (DOH) Case No. 2004-11965,

Respondent was accused of violating the aforementioned statutes in

relation to care provided Patient D.M. In particular the

allegations are related to an incision made by Respondent on

Patient D.M.'s left knee, when the patient had been scheduled for

surgery on the right knee.

On August 31, 2005, Petitioner forwarded the case to Robert

S. Cohen, Director of the Division of Administrative Hearings

(DOAH), for conduct of a formal hearing pursuant to Respondent's

Petition Requesting a Formal Hearing. The case was established as

DOAH Case No. 05-3156PL and assigned to the present administrative

law judge. A written notice of the hearing date was provided and

the hearing proceeded as noticed.

Petitioner requested that official recognition be made of

Sections 456.072(1)(aa) and 458.331(1)(p), Florida Statutes

(2003), Section 456.073(5), Florida Statutes (2004), and Florida

Administrative Code Rule 64B8-8.001. No objection was made to the

motion. At the commencement of the hearing official recognition

was given to those provisions.

Respondent filed a Motion to Deem Request for Admissions

Admitted or, in the Alternative, to Compel Petitioner to Serve

Better Responses to Request for Admissions, Motion to Compel

Better Responses to Interrogatories, and Motion to Compel Better

Responses to Request for Production. At the commencement of the

hearing oral argument was entertained concerning the motions. The

motions were denied for reasons explained in the hearing

transcript that is submitted with this Recommended Order. This

denial was in recognition of opportunities available to the

parties in presenting their respective cases without prejudice to

their rights.

Consistent with a pre-hearing order the parties prepared a

stipulation of facts. That fact stipulation has been incorporated

as part of the findings of fact in the Recommended Order.

The parties essentially agree to the facts in this case. The

hearing was conducted to allow refinement of those facts, if a

party so desired, and to allow establishment of a record for

mitigation and aggravation. § 120.569(1), Fla. Stat. (2005).

Petitioner did not call witnesses. Petitioner's Exhibits

numbered one through three were admitted. Respondent testified in

his own behalf. He called Dr. Alex Villacastin, Dr. R. E. Hari

Iyer, and Joyce Brancato as his witnesses. Respondent's Exhibits

numbered one through three were admitted.

On December 5, 2005, the hearing transcript was filed. On

December 15, 2005, the parties filed proposed recommended orders

which have been considered in preparing the Recommended Order.

FINDINGS OF FACT

Stipulated Facts

1. Petitioner is the state department charged with

regulating the practice of medicine pursuant to Section 20.43,

Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458,

Florida Statutes.

2. At all times material to this (Administrative) Complaint,

Respondent was a licensed physician within the State of Florida,

having been issued license number ME66779.

3. Respondent's address of record is Nature Coast

Orthopedics, P.O. Box 640580, Beverly Hills, Florida 34464-0580.

4. Respondent is board-certified in orthopedic surgery.

5. On or about February 25, 2004, Respondent scheduled or

had Patient D.M. scheduled for an anterior cruciate ligament

(repair of a tear in a ligament), repair of the right knee at

Seven Rivers Regional Medical Center in Crystal River, Florida.

6. On or about February 25, 2004, Patient D.M. a 25-year-old

male, was prepped for surgery and taken to the operating room.

7. On or about February 25, 2004, Respondent entered the

operating room and initiated the surgery with an incision of

Patient D.M.'s left knee.

8. On or about February 25, 2004, the intended and/or

planned surgical site for Patient D.M., was his right knee.

9. Subsequent to performing the incision to Patient D.M.'s

left knee, Respondent realized that he was performing surgery on

Patient D.M.'s wrong knee.

10. Respondent applied a steri-strip to Patient D.M.'s left

knee subsequent to making an incision on the left knee.

11. Respondent made a skin incision on Patient D.M.'s left

knee.

Additional Facts

12. Respondent graduated from medical school in 1989. He

was in residency for five years and has been in practice for about

11 years beyond that time. Other than his disciplinary history

with the State of Florida, Board of Medicine (the Board of

Medicine) he has no disciplinary past with other boards or

jurisdictions.

13. Respondent is board-certified by the American Board of

Orthopedic Surgery.

14. Respondent has active privileges at Seven Rivers

Regional Medical Center (Seven Rivers Regional) and Health South

Citrus Service Center, an outpatient facility. Those facilities

are located in Crystal River, Florida, and Lancanto, Florida,

respectively.

15. Respondent has an office practice that employs 12 staff.

They include a receptionist, billing personnel, what is described

as back-help, a Physician's Assistant (P.A.) and medical

assistants. Respondent supervises the P.A., pursuant to

registration with the State of Florida.

16. Respondent takes emergency calls at Seven Rivers

Regional, to include pediatric orthopedic calls. Respondent also

takes hand calls which are related to injuries in that portion of

the anatomy below the shoulders.

17. After an 1998 incident involving a wrong-site surgery

for which discipline was imposed by the Board of Medicine on

Respondent, discussed in detail later in the facts, Respondent

made some changes to his practice in dealing with the problem of

wrong-site surgery. This involved the imposition of other checks

and balances. One of the changes was referred to as a time-out,

promoted by changes in hospital rules at what is now Seven Rivers

Regional and by Respondent's choice. In 1998 the hospital was

known as Seven Rivers Hospital. Persons other than Respondent

were engaged in the establishment of additional checks and

balances to avoid wrong-site surgeries. The risk manager and

director of nursing at Seven Rivers Regional were engaged in this

process.

18. The time-out related to the cessation of other

activities in treating the patient, to confirm the correct surgery

site. Before commencing the surgical procedure the limb involved

in the procedure would be marked by nursing staff. The nursing

staff would then confirm the site, followed by the time-out period

shortly after the preparation for surgery. Confirmation would

verbally be made with different staff members, documentation was

expected to be checked and any image studies checked to confirm

the proper site.

19. Generally, following the 1998 incident involving wrong-

site surgery by Respondent, Seven Rivers Hospital established

rules addressing the problem of wrong-site surgeries. Greater

emphasis was made to enforce those rules after the Respondent‘s

second incident considered in this case.

20. In the present case it was intended that reconstruction

be made of the anterior cruciate ligament of the right knee of

Patient D.M., through arthroscopic reconstruction.

21. The patient in the present case was seen in Respondent's

office prior to surgery. The expectation was that the office

staff would confer with the staff at Seven Rivers Regional

concerning the type of procedure to be performed, to be followed

later by orders from the Respondent that were faxed to the

operating room staff at Seven Rivers Regional. Those orders would

describe the limb involved in the surgery.

22. In the present case the circulating nurse, together with

the surgical technician were involved with preparing the limb for

surgery, applying antiseptic solution and draping the patient's

limb. Those persons are hospital employees. Prior to surgery,

the wrong limb was marked by the nursing staff and the draping

took place in the operating room. Patient D.M. underwent general

anesthesia prior to the surgery. Before the procedure commenced

in the present case, Respondent asked the nurse in the operating

room if the correct limb had been prepared and the response was in

the affirmative. Respondent started the procedure. The only

means of confirmation by Respondent at that point was by verbal

communication between the circulating nurse and Respondent.

Respondent realized that he was ultimately responsible to make

certain that the surgery was performed at the correct site.

23. In the present case Respondent took an 11 blade and made

a slight incision. He noticed that the video-screen which was

normally placed on the opposite side of the intended limb to be

examined, was on the same side as the limb that had been prepared

for examination. As Respondent made the incision he was

uncomfortable with that setting. He turned to the circulating

nurse and asked if he could see the patient's chart. By review of

the chart he discovered that he had made an incision on the wrong

knee, that had been draped and prepared for examination. The

incision was about a quarter-inch in size and the surgical knife

had been placed about a half-inch into the skin. In this case no

second incision was made as would be normal for this type of

surgery. Having discovered his error Respondent placed surgical

tape across the incision he had made and the draping was broken

down from the unintended site and a new draping placed on the

intended site. After these changes surgery was performed on the

proper knee.

24. Respondent did not consult with any family member before

proceeding to perform surgery on the appropriate knee, having

addressed the wrong knee in the beginning. The family was

informed after the procedure was completed. The patient was

informed of the mistake after awakening from anesthesia.

25. The Respondent made entries into the medical record

concerning the incident in the present case.

26. After the surgery in the present case Respondent

followed-up the patient at his office. No complications were

experienced by the patient in either site, the wrong knee or the

proper knee. The initial visit involving Patient D.M. took place

on February 17, 2004, and the surgery was performed on

February 25, 2004. The last scheduled appointment at Respondent's

office was August 26, 2004, but Patient D.M. declined that

appointment having returned to work, after expressing his view

that to come to Respondent's office was an imposition.

27. Respondent made the risk manager and director of nursing

aware of the error in the treatment of Patient D.M. The incident

was reviewed by the hospital. No action was taken against

Respondent's privileges to practice at Seven Rivers Regional as a

result of the incident.

28. Following the present incident Respondent has varied his

approach. The changes are to involve more people in the time-out

period than before the present incident. This includes the

anesthesia staff, surgical technician, circulating nurse, and

Respondent. Resort is now made to the surgical consent record and

any imaging studies that were performed to confirm that the proper

site is addressed in the surgery.

29. Prior to the present incident Respondent did not follow

a practice of taking the patient's chart with him to the surgery.

He depended on orders that had been sent by fax and hard copies

following the transmittal of the initial fax to the hospital, to

create the basis for surgical site identification by others.

30. In the present case the doctor's orders forwarded to

Seven Rivers Regional made clear that the arthroscopy was to be

performed on the right knee. The comment section to the pre-

operative patient care flow sheet refers to the right knee as the

limb to be addressed by the arthroscopy. Likewise the special

consent to operation or other procedures refers to the right knee.

The anesthesia questionnaire involved with Patient D.M. refers to

the right knee, in relation to the procedure in the arthroscopy.

All are appropriate references to the location of the site for

surgery.

31. Joyce Brancato is the CEO of Seven Rivers Regional. She

identified that there are four orthopedic surgeons who practice at

the hospital. All four, including Respondent, attend adult cases.

Three including Respondent, treat hand calls, and a like number

respond to pediatric cases, to include Respondent.

32. If Respondent were suspended it would mean that at

certain times during the month patients would have to be diverted

or transferred from Seven Rivers Regional to another hospital.

There would be an influence on inpatient orthopedic care, in that

Respondent provides 63 percent of inpatient surgical care at the

facility. In particular, patients who present at the emergency

room needing hip repair or fracture repair would be

inconvenienced.

33. If Respondent were placed on probation, he would not be

allowed to supervise his P.A., who in turn could not see patients

that the P.A. follows. No other doctor is available in the

practice to supervise the P.A.

34. If Respondent were suspended, services would not be

provided through his clinic leaving the patients to seek care

elsewhere.

35. Additionally, Respondent is the sole orthopedic

physician, to his knowledge, who admits Medicare patients to Seven

Rivers Regional.

36. As a result of the present incident Respondent received

no pecuniary benefit or self-gain.

37. None of the allegations in the Administrative Complaint

involve controlled substance violations.

Prior Discipline

38. In relation to a prior disciplinary case against

Respondent, that incident took place at Seven Rivers Hospital, now

Seven Rivers Regional. The surgery in the prior case took place

in 1998. It also involved a wrong-site surgery.

39. As Respondent explained at the November 8, 2005 hearing,

the prior case involved a female patient scheduled for a knee

arthroscopy. The surgical site identification protocol involved

at the time was to have the nursing staff prepare the patient for

the surgery. As a consequence, when the Respondent entered the

operating room the unintended knee had been draped. Respondent

confirmed the surgery site by conferring with a nurse in

attendance and starting the procedure. Incisions were made to

examine the knee, the wrong knee, the incisions were about a

quarter of an inch in length, one for the camera to view the site

and one for the surgical instruments used to address the

underlying pathology. When the wrong knee was examined following

the incisions, Respondent did not find the pathology that he

expected given the patient's prior history and physical

examination that had been conducted. Other than the incisions

being made in the wrong knee, there were no other consequences in

the way of impacts to the patient's health.

40. In the prior case in which the wrong knee had been

prepped by staff, Respondent recognizes that he as the surgeon was

responsible to ensure that surgery commenced on the correct knee.

41. In the prior case, after realizing that he had commenced

surgery on the wrong knee, Respondent stopped the procedure, he

went to the waiting area and spoke to the patient's husband and

explained the circumstances and absent any objection indicated

that he intended to proceed with the case involving the correct

knee.

42. Before the correct knee could be addressed, there was a

delay associated with the breaking down the sterile field on the

incorrect knee and starting the process anew to address the

correct knee.

43. After conversing with the husband Respondent returned to

the operating room and performed surgery on the correct knee.

44. During the pendency of these events the patient was

anesthetized. When the patient recovered from the anesthesia

Respondent explained what had occurred.

45. The expected pathology was discovered in the proper knee

and addressed and the patient satisfactorily recovered from

surgery without complications.

46. In the prior case, Respondent made a record indicating

that he had initiated the surgery in the wrong site.

47. All requirements incumbent upon Respondent in view of

the terms of the Consent Order entered in the prior case, DOH Case

No. 98-16838 were met by Respondent.

CONCLUSIONS OF LAW

48. The Division of Administrative Hearings has jurisdiction

over the parties and the subject matter of this proceeding in

accordance with Sections 120.569, 120.57(1), and 456.073, Florida

Statutes (2005).

49. The parties by their agreement and stipulation of facts

have removed disputes over issues of material fact. §

120.569(1), Fla. Stat. (2005).

50. Through this arrangement the hearing was designed to

create a record that would form the basis for establishing

appropriate punishment for Respondent consistent with Chapters 456

and 458, Florida Statutes (2003), and Florida Administrative Code

Chapter 64B8, and under the guidance set forth in final orders by

the Board of Medicine in cases similar to the present case.

Nonetheless, clear and convincing evidence was presented to

establish violations of Section 456.072(1)(aa), Florida Statutes

(2003), which creates a ground for discipline under Count I for:

Performing or attempting to perform health

care service . . . a wrong-site procedure .

. . that is medically unnecessary . . .

This was in relation to surgery for Patient D.M.

51. Additionally, clear and convincing evidence was

established to show a violation, in Count II of Section

to discipline for:

Performing professional services which have

not been duly authorized by the patient . . .

Again this violation was in relation to surgery on the wrong knee

of Patient D.M.

52. The record established clear and convincing evidence in

accordance with the decisions in Department of Banking and Finance

Division of Securities and Investor Protection v. Osborne Stern

and Co. , 670 So. 2d 932 (Fla. 1996) and Ferris v. Turlington , 510

So. 2d 292 (Fla. 1987). The term clear and convincing evidence is

explained in the case In re: Davey , 645 So. 2d 398 (Fla. 1994),

quoting, with approval from Slomowitz v. Walker , 429 So. 2d 797

(Fla. 4th DCA 1983).

53. Respondent's argument in the conclusion of law to the

proposed recommended order that Section 456.072(1)(aa), Florida

Statutes (2003), is unconstitutional on its face is an argument

not subject to consideration in this forum. See Department of

Revenue v. Young American Builders , 330 So. 2d 864 (Fla. 1st DCA

1976) and Key Haven Associated Enterprises, Inc., v. Board of

Trustees of Internal Improvement Trust Fund, et. al , 427 So. 2d

153 (Fla. 1982).

54. Respondent's argument in relation to Section

D.M. authorized knee surgery and Respondent acted accordingly, in

that even though the surgery began on the wrong knee, that there

was still necessary authorization, is not an appropriate reading

of the disciplinary statute. Patient D.M. expected surgery to be

performed on his right knee, not his left knee. Authority was

provided for the right knee, not the left knee. When Respondent

began surgery on the left knee, he acted without authority from

Patient D.M.

55. In the proposed recommended order by Respondent,

argument is offered about the alleged non-compliance by the

Department of Health with the requirements in Section 120.53(1),

Florida Statutes (2005), for maintaining a subject matter index of

all its final orders. As explained in the hearing transcript in

relation to motions filed before the final hearing, whatever the

practical problems experienced by Respondent in obtaining access

to final orders, ultimately Respondent did not suffer prejudice in

preparing for the final hearing, having gained access to final

orders of the Board of Medicine concerning wrong patients, wrong-

sites, wrong procedures, etc. Likewise Respondent has not shown

prejudice in the preparation for and presentation at the final

hearing by any failure by the Department of Health, through its

web-site to maintain a summary of final orders it issued after

July 1, 2001, as required by Section 456.081, Florida Statutes

(2005), given Respondent's efforts and success at discovering

Board of Medicine final orders dealing with similar subject matter

to that in this case.

56. Section 456.079(2), Florida Statutes (2005), sets the

requirement for disciplinary guidelines of the Board of Medicine

in imposing punishment, where it states:

The disciplinary guidelines shall specify a

meaningful range of designated penalties based

upon the severity and repetition of specific

offenses . . . and that such penalties be

consistently applied by the Board.

57. The Board of Medicine does have disciplinary guidelines

set forth in Florida Administrative Code Chapter 64B8, and access

to the final orders introduced at hearing allows a comparison of

punishment in prior cases, under their facts, to the present

record to establish appropriate punishment here.

58. The parties were encouraged to cite and discuss final

orders by the Board of Medicine in their proposed recommended

orders. Respondent took advantage of that opportunity.

Petitioner did not.

59. Sections 456.072(2) and 458.331(2), Florida Statutes

(2003), establish basic guidance for imposition of punishment.

Florida Administrative Code Chapter 64B8 offers more specific

guidance in terms of the administration of punishment.

60. The range of suggested penalties under Florida

Administrative Code Rule 64B8-8.001, pertaining to Section

456.072(1)(aa), Florida Statutes (2003), is from a $5,000.00 to

$10,000.00 administrative fine, and suspension to revocation.

That rule establishes a range of punishment in relation to Section

458.331(1)(p), Florida Statutes (2003), from probation to

revocation and an administrative fine of $5,000.00-$10,000.00.

61. In considering the appropriate punishment, Florida

Administrative Code Rule 64B8-8.001(3) establishes aggravating and

mitigating circumstances. They are as follows:

(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, 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.

62. Under Florida Administrative Code Rule 64B8-8.001(3),

dealing with mitigation and aggravation, the nature of the injury

to D.M. was slight; no restraints or constraints were in place

against Respondent; there are two counts but one incident

involving lack of authorization and conduct of a wrong-site

surgery; this was a second offense of the same type; the first

disciplinary event comparable in its terms led to a $5,000.00

administrative fine, attendance at five hours of Continuing

Medical Education in risk management and a letter of concern from

the Board of Medicine; Respondent on this occasion derived no

pecuniary benefit or self gain; this case did not involve

controlled substances; this was not a standard of care violation

under Section 458.331(1)(t), Florida Statutes; and Respondent has

acted cooperatively beginning with the discovery of his mistake

and continuing through the final hearing itself. On the other

hand, there was no meaningful improvement in Respondent's approach

to patient identification at Seven Rivers Regional between 1998

and 2004. A pause, a time-out from undertaking surgical

procedures to allow discussion among the physician and staff

without resort by Respondent to documentation identifying the

proper surgical site immediately prior to or in the surgical

setting, leads to the conclusion that there was no meaningful

difference between the circumstances in the first incident and the

second incident when attempting to limit this form of error in

identifying the surgery site. It was only after the second

incident that Respondent personally established a useful approach

to identifying the surgical site.

63. Respondent also refers to Florida Administrative Code

Rule 64B8-8.007, which describes the inability of a physician on

probation to act in a supervisory capacity for a P.A. This would

be a hardship for Respondent's P.A. should probation be imposed.

But that reality is not the focus of this proceeding.

64. Section 456.072(4), Florida Statutes (2003) calls for

the assessment of costs related to the investigation and

prosecution of this case as part of the process.

65. Being mindful of the disciplinary parameters established

by statute and the guidance provided by rule, as well as the final

orders cited by Respondent in the proposed recommended order, and

based upon the findings of fact and legal conclusion that

Respondent has violated those provisions within Counts I and II to

the Administrative Complaint, it is

RECOMMENDED:

That a final order be entered finding Respondent in violation

of Sections 456.072(1)(aa) and 458.331(p), Florida Statutes

(2003), and for these violations that Respondent be placed on a

period of probation for one year with indirect supervision;

perform 100 hours of community service to be completed during the

probation; be required to undergo quality assurance consultation

and review of practice methods by a qualified risk manager, to

establish necessary changes to avoid a third wrong-site surgery;

make payment of an administrative fine in the amount of

$10,000.00; provide payment of costs of the investigation and

prosecution of this case and be required to present a one-hour

lecture to peers at a facility where he practices on the perils of

wrong-site surgery and how to avoid them.

DONE AND ENTERED this 20th day of January, 2006, in

Tallahassee, Leon County, Florida.

S

CHARLES C. ADAMS

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 20th day of January, 2006.

COPIES FURNISHED:

Ephraim D. Livingston

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

Bruce D. Lamb, Esquire

Ruden, McClosky, Smith, Shuster

& Russell, P.A.

401 East Jackson Street, Suite 2700

Tampa, Florida 33602

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

NOTICE OF 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.