STATE Of FLORIDA

DEPARTMENT OF HEALTH

DEPART""!ENT OF HEALTH,

PETITIONER,

v, CASE NO.: 2009-1

DANIEL J ZALUZEC, M.D.,

080

! RESPONDENT. ,/

ADMINISTRATIVE COMPLAINT

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COMES NOW, Petitioner, Department of Health, by and throu

h its

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undersigned counsel, and files this Administrative Complaint befor

the.

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Board of Medicine against the Respondent, Daniel J. Zaluzec, M.D., nd in

support th reof alleges:

1. ! Petitioner iS the state department charged with regulatln the practice ofi medicine pursuant to Section 20.43, Florida Statutes; C apter

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

· 2. !At all times material to this Complaint, Respondent as a licensed p ysician within the State of Florida, having been issued Ii ense number M 86921.

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3. 1 Respondent's address of record is 101 NE Charleston Oaks

Drive, Porti St. Lucie, FL 34983.

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4. !

Respondent is board certified in Otolaryngology/Head an

Neck

Surgery.

1. i On or about June 2, 2009, Respondent perform d a consultation on Patient S.I., a five (5) year oid male, for recurrent pper respiratoryj infections, 1in cluding frequent tonsillitis and persistent dr inage

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   from the patient's right ear.

   
   

2. i Respondent noted that over three years prior, he had

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   performed ]a myringotomy (a surgical procedure in which an incis on is

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   created in the eardrum to relieve pressure caused by the excessive uild­ up of fluid)1 on Patient S.I., and placed tubes in the patient's ears to c rrect

   ear infections.

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3. 'Respondent did not maintain documentation for

   
   

   procedure. i

   
   

4. !During his evaluation of June 2, 2009, Respondent note Patient S.I. iwas found to have bilateral cerumen (earwax) impaction.

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that

that

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9, Respondernt's treatment plan was for Patient S.I. to und rgo a

tonsillectomy and adenoidectomy with removal of tube. Respond nt did

not specif)( which side/ear regarding the tube to be removed.

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1. On or about June 30, 2009, Respondent noted that S.I.'s right (tube was loose and his left tube was embedded in the dru

   
   

   atient

   
   

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2. • On or about July 7, 2009, Patient S.I. was admitted

   
   

   Surgery C nter of Fort Pierce ("SCFP") with consents signed for ton

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   adenoid removal, as well as removal of a tube in the patient's right e

   o the ii and r.

3. Rule 64B8 9.007(2)(b), Florida Administrative Code, state :

(b) Except in life-threatening emergencies requiring imm diate resuscitative measures, once the patient has been prepar d for the elective surgery/procedure and the team has been gathered and immediately prior to the initiation o any procedure, the team will pause and the physician(s) performing the procedure will verbally confirm the patient's identifi ation, the intended procedure and the correct surgical/procedur site. The operating physician shall not make any incision or p rform any surgery or procedure prior to performing this re uired confirmation. The medical record shall specifically reflect when this confirmation procedure was completed and hich personnel on the team confirmed each item. This requir ment for confirmation applies to physicians performing proce ures either in office settings or facilities licensed pursua t to Chapter 395, F.S., and shall be in addition to any other requirements that may be required by the office or facility.

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13, i In his written statement to the Department received o

29, 2010, Respondent stated that on the day of the surgery he w

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asked to cdnfirm the side (site) of the procedure.

April s not

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14, :, Respondent performed surgery and used the ope ating

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microscop in an attempt to locate a tube in Patient S.L's right ear.

1. :Respondent did not document his attempt to locate a t be in

   
   

   Patient S.I.is right ear.

   
   

2. i,When Resp:,ondent was unable to locate the tube in P tient

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   S.I.'s right iear, he turned the patient over and located/removed th tube from the patient's left ear.

3. i Respondent successfully performed the tonsillectomy and

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   adenoidectomy with disimpaction of the wax, including the removal f the

   
   

   imbedded left tube.

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4. !Upon learning that the surgery was being treated as a · rang-

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   site surgery by the Risk Manager of SCFP, Respondent asked Patient S.I.'s

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   parents to sign a new consent acknowledging that the tube was in f ct in

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   the patient'$ left ear and not his right ear.

   
   

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5. j Respondent failed to pause and identify the c rrect

   
   

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   surgery/prd>cedure site prior to performing surgery on Patient S.L about July 7, 2009.

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6. 1 Respondent performed a wrong-site procedure

   on or

   
   

   nd/or

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   unauthoriZll!d procedure by attempting to remove a tube from Patien right ear (wrong-site) and by removing a tube from Patient S.I.'s ,I

   
   

   S.I.'s

   
   

   ft ear

   (unauthori ed procedure).

   
   

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7. ! Respondent failed to keep medical records which justi the

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   course of reatment of Patient S.I. in that Respondent: failed to m intain

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   document ion of the myringotomy and placement of tubes th t ·he

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   performed jon Patient S.I. over three years prior to his consultation on or

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   about Jun1 2, 2009, and/or failed to document his attempt to remove a

   tube from Patient S.I.'s right ear on or about July 71 2009.

   
   

   COUNT I

8. i Petitioner realleges and incorporates paragraphs on (1) through tw nty-one (21) as if fully set forth herein.

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9. j Section 456.072(1)(bb), Florida Statutes (2009), provide that

   
   

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   perfo.rmingj or attempti.ng to perform health care services (including the preparatio of the patient) on the wrong patient, a wrong-site proced re, a

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   wrong proqedure, or an unauthorized procedure or a procedure t

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   medically uhnecessary or otherwise unrelated to the patient's diagno

   at is is or

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   medical cqndition is grounds for disciplinary action by the Boa d of

   
   

   Medicine.

   
   

10. ]Respondent performed a wrong-site procedure a d/or

unauthoriz d procedure by attempting to remove a tube from Patient S.I.'s

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right ear (Wrong-site) and by removing a tube from Patient S.I.'s le ear

(unauthoriz d procedure) on or about July 7, 2009.

. 25. ]Based on the foregoing, Respondent has violated S ction

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456.072(1){bb), Florida Statutes (2009), by performinQ or attempti g to

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perform he lth care serrvices on the wrong patient, a wrong-site proce ure,

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a wrong prpcedure, or an unauthorized procedure or a procedure t at is

medically u necessary :or otherwise unrelated to the patient's diagno is or

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medical condition.

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COUNT TWO

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26. iPetitioner realleges and incorporates paragraphs on I (1)

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through twenty-one (21) as if fully set forth herein.

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27, Section 458.331(1)(nn), Florida Statutes (2009), states hat a

physician tiay be sui1)jected to discipline for violating any provisi n of

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chapter 458 or chapter 456, or any rules adopted pursuant thereto.

1. '1 The Respondent failed to comply with Rule 64B8-9.007( )(b),

   
   

   
   

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   Florida Administrative Code, by failing to ensure that the "Pause Rule" was

   
   

   implemented and followed prior to performing surgery on Patient

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   that Respordent failed to identify the correct surgery/procedure site.

   
   

2. i Based on the foregoing, Respondent has violated S

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   458.331(1)(nn), Florida Statutes (2009), by failing to pause and c

   ction nfirm

   the patient's identifidation an the correct lens to be used · i the procedure, i! in violatiorn of Rule 64B8-9.007(2)(b), Florida Administ ative

   Code.

   
   

   COUNT THREE

3. !Petitioner :realleges and incorporates paragraphs on (1)

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   through twf!nty-one (21) as if fully set forth herein.

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4. isection 45$.331(1)(m), Florida Statutes (2009), states t at a

   
   

   physician rtiay be subjected to discipline for failing to keep legibl , as

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   defined by epartment rule in consultation with the board, medical re ords

   
   

   that identify the licensed physician or the physician extender and

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   supervisin$ physician by name and professional title who is

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   responsibl for rendering, ordering, supervising, or billing for

   r are each

   diagnostic ipr treatment procedure and that justify the course of tre tment

   
   

   of the patjent, includihg1 but not limited to, patient histories; exami ation

   
   

   results; tl:!st results; records of drugs prescribed, dispense , or

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   administered; and reports of consultations and hospitalizations.

   
   

5. i Respondent failed to keep medical records which justi. the

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   course of t' reatment of Patient S.I. in that: Respondent failed to m intain

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   document tion of the myringotomy and placement of tubes th t he

   
   

   performed\ over three years prior to his consultation of June 2,

   
   

   and/or fail d to docurment his attempt to remove a tube from Patien

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   right ear 0111 or about July 7, 2009.

   2009; S.I.'s

   
   

6. 
   

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! Based on the foregoing, Respondent has violated S

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ction

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458.331(1 (m), Florida Statutes (2009), by failing to keep records

justify his treatment of Patient S.I.

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hich

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WHBREFORE, the Petitioner respectfully requests that the B

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Medicine enter an order imposing one or more of the following pe

ard of alties:

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permanent revocation or suspension of Respondent's license, restric ion of

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practice, 0riposition of an administrative fine, issuance of a repr mand,

placemen of the Respondent on probation, corrective action, ref nd of fees billedj or collecteal, remedial education and/or any other relief t at the

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Board deems appropriate.

S!G ED th Qay of             , 20 o.

Ana M. Viamonte Ros, M.D., M.P.H.

State Su n General

ert A. Milne

A sistant General Counsel DOH Prosecution Services Unit

4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265

Florida Bar #622338

(850) 245-4640

(850) 245-4681 FAX

CAB

PCP: Pct l,;i.9, .:J:DI D

PCP Memlhers: /.:J.. - iJx. Lu  

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NOTICE OF RIGHTS

Res ondent h11s the right to request a hearing ,t conducte in accordance with Section 120.569 and 12

be

.57,

Florida S tutes, to!be represented by counsel or other qua ified representr,ive, to present evidence and argument, to call and cross·exa ine witn•sses and to have subpoena and subp ena duces tee. m issued on his or her behalf if a hearing is reques ed.

: NOTICE GARDING ASSESSMENT OF COSTS

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.. Respondent is !Placed on notice that Petitioner has In rred

costs rf:!la ed to the!investigation and prosecution of this m tter. Pur5uant o Sectionj 456.072(4), Florida Statutes, the Board hall

ass•.•ss •. c sts relate ..-..•. to the investigation and p._.rQ.secution ofa disdiplina · matter,1Which may include attorney hours and sts,

on the Re pondent in addition any other discipline imposed.

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Docket for Case No: 11-002244PL