05-003165PL Department Of Health, Board Of Medicine vs. Steven Wayne Kinsey, M.D. Status: Closed Recommended Order on Tuesday, February 14, 2006.

Summary: The foreign body left in the patient did not meet the statutory definition for a violation.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 05 - 31 65 PL

)

STEVEN WAYNE KINSEY , M.D., )

)

Respondent. )

)

RECOMMEND ED ORDER

Notice was provided and on December 15 , 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 2401 State Avenue,

Suit e 100, Panama City, Florida. The hearing commenced at 9:00

a.m. Central Time. The hearing was conducted by Charles C.

Adams, Administrative Law Judge.

APPEARANCES

For Petitioner: William F. Miller

E phraim D. Livingston

Assistant s General Counsel

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Albert Peacock , Esquire

8554 Congressional Drive

Tallahassee, Florida 32312

STATEMENT OF THE ISSUE

Should the Board of Medicine (the Board) discipline

Respondent's license to practice medicine in Florida, based upon

alleg ations that he violated Sections 4 56.072(1)( bb ), and

458.331(1)( t ), Florida Statutes (2003) , in the care and treatment

of Patient H.J.?

PRELIMINARY STATEMENT

On March 7 , 2005, in Case No. 2004 - 05727, the Department of

Health (DOH) brought a n Administrative Complaint against

Respondent. I t wa s alleged that:

Respondent left a piece of peritoneal

dialysis (catheter) and some length of

plastic tubing in Patient H.J. during a

surgery that took place on or about July 21,

2003.

Under those circumstances Respondent was accused of violating

Section 456 .072(1)(bb), Florida Statutes ( 2003 ) . When served

with the DOH Administrative Complaint calling for discipline to

be imposed by the Board , Respondent made a written request for

formal hearing consistent with Section s 120.569 and 120.57(1),

Flo rida Statutes (2005) .

On August 31, 2005, Robert S. Cohen, Director of the

Division of Administrative Hearings (DOAH) received the

Administrative Complaint and Respondent's request for formal

hearing. The case became DOAH Case No. 05 - 31 65 PL and was

assigned to this administrative law judge.

Following responses from the parties November 1 and 2, 2005,

were selected as hearing dates. Upon Petitioner's motion those

hearing dates were cancelled and the case was re - noticed to be

heard on December 15 and 16, 2005.

Petitioner moved to relinquish jurisdiction in this case

alleging that dispute s of material fact no longer existed to be

resolved at hearing. § 120.57(1)(i), Fla. Stat. (2005). On

December 13, 2005, an order was entered de nying the motion to

relinquish jurisdiction.

Petitioner moved to amend the Administrative Complaint by

adding an allegation of a violation of Section 458.331(1)(t) ,

Florida Statutes (2003). On December 13, 2005 , an order was

entered granting the motion to amend. By virtue of the amendment

the Administrative Complaint became a two - count Administrative

Complaint.

Official recognition was made of Sections 456.072,

456.073 (5) , and 458.331, Florida Statutes (2003) , and 456.073(5),

Florida Statutes (2005), as well as Florida Administrative Code

Rule 64B8 - 8.001.

Petitioner presented the Responde nt as its witness , together

with Stanley P. Kococki, M.D. Petitioner's Exhibits numbered 1

through 5 were admitted . Respondent testified in his own behalf

and pr esented the t estimony of Ahmad Oussama Refai, M.D. ;

Patient H.J. ; and Thomas R. Gadacz, M.D. Respondent 's Exhibits

numbered 1 and 2 were admitted .

The parties responded to a prehearing order requiring among

other things that they offer a statement of facts stipulated by

the parties. Those facts a greed to are set out in the fact -

finding to this R ecommended Order .

A hearing transcript was prepared and filed on January 4,

2006. The parties filed proposed recommended orders which have

been considered i n preparing the Recommended Order.

FINDINGS OF FACT

Stipulated Facts

1. Respondent is and has been at all times material hereto

a licensed physician in the State of Florida, having been issued

license number ME: 65565.

2. Petitioner is the state ag ency charged with regulating

the practice of medicine pursuant to Section 20.4 2 , Florida

Statutes .

3. On or about July 21, 2003, the Respondent performed

peritoneal dialysis catheter removal on Patient H.J. at Bay

Medical Center (Bay Medical).

4. Per itoneal dialysis is a technique that uses the

patient's own body tissues inside of the abdominal cavity to act

as a filter.

5. On or about August 25, 2003, Patient H.J. presented with

erythema (a redness of the skin resulting from inflammation) and

in duration (localized hardening of soft tissue of the body) in

the area where the peritoneal dialysis catheter had been removed.

6. On or about December 3, 2003, the Respondent performed

exploratory surgery of Patient H.J.'s wound.

Additional Facts

7. Patient H.J. suffers from end - stage kidney failure,

diabetes and heart disease. Dr. Ahmad Oussama Refai treated

Patient H.J. for his kidney failure. Dr . Refai is a board -

certified Nephrologist.

8. Dr. Refai referred Patient H.J. for placement of a

p eritoneal dialysis catheter (catheter) to address the e n d - stage

kidney failure. The catheter , as Dr. Refai describes it, was

intended to remove the poisonous material in the blood of Patient

H.J. B y using the catheter clean fluid is in troduced into the

a bdomen where it remains for a period of about four hours. The

flu id introduced contains electrolytes put in the patient's blood

stream. After the residence time for the fluid expires, the

fluid is with drawn through the catheter removing the harmful

mater ial. The patient , once instructed , is capable of performing

the procedures described. The other option in performing this

method of dialysis is to use a device that is employed at

nighttime called a cycler , used while the patie nt is asleep and

without th e ne e d for the patient to conduct the process. The

patient's use of the catheter for dialysis is referred to as

"home dialysis."

9 . Before Dr. Refai referred the patient to Respondent to

place the catheter , the patient had been treated for his end -

stage renal disease through a forearm AV graph to provide

hemodialysis . That technique allows access to the patient's

blood through a shunt , with the blood being run through a machine

and cleansed and returned back to the patient. This procedure is

done severa l times a week at out - patient centers , whereas the

peritoneal dialysis is done daily by the patient or at night.

10. On June 30, 200 0 , Respondent saw Patient H.J. and

determined tha t the patient was a good candidate for the surgery

necessary to place th e catheter to perform peritoneal dialysis.

On July 19, 2000, Respondent placed the catheter and peritoneal

dialysis treatment was commenced.

11. Following the placement the catheter was used by the

patient as overseen by the Dr. Re fai.

12. As Dr. Refai describes it , the catheter is a silestic

tube that has two cuffs. T he cuff at the lower level sits on the

fascia where it is secured and the other cuff is just under the

skin or in the subcutaneous tissue. Dr. Refai describes the

cuffs as fuzzy. The cuffs are expected to induce an inflammatory

process promoting scarring so that the body forms tissue to hold

the catheter in place. Dr. Refai calls this a bond. Dr. Refai

explains that the other parts of the catheter are "slippery." It

is t he fuzzy part that holds the catheter in place.

1 3 . Petitioner's Exhibit No. 5 is an unused catheter

similar in design to that place d in Patient H.J.

14 . On July 7, 2003, Respondent, Dr. Refai, and a Dr. Dean

discussed Patient H.J. and the plan to re move the catheter that

was no longer adequately performing the dialysis . On July 21,

2003, Respondent did surgery to remove the catheter from Patient

H.J.

15. On July 17, 2003, before Respondent did the surgery to

remove the catheter, a n explanation was made to Patient H.J. of

the risks associated with the surgery as to bleeding, infection,

MI stroke, death, and allergic reaction following removal of the

catheter.

1 6 . Following the surgery Dr. Refai as the treating

physician was aware that the wound associated with the surgery

was not healing well and Dr. Refai sent Patient H.J. b ack to

Respondent. Dr. Refai i s familiar with the course of antibiotics

prescribed for Patient H.J. to respond to the condition and the

surgical exp lo ration done by Respondent where a piece of cuff, as

Dr. Refai describes it, was removed and the wound healed.

December 3, 2003, was the date of the exploratory surgery. At

that time, Patient H.J. was on hemo - dialysis and was being seen

by Dr. Refai once a week. In Dr. Refai's opinion Patient H.J.

was doing remarkably well, making allowances for his underlying

condition (illnesses) . At present Dr. Refai is aware that the

patient is on the list to receive a kidney transplant.

17 . On August 1, 2003, Respondent saw Patient H.J. In his

notes Respondent stated :

H is wounds look good. There is no evidence

of infection. No fever or chills. He looks

well. He is not taking any pain medicine. I

am going to see him back in a month for a

final visit.

1 8 . On Aug ust 25, 2003, Respondent saw Patient H.J. again.

The Respondent's notes stated:

His p.d. catheter removal site which was

removed 4 weeks ago has some erythema and

induration around it. I ultrasounded it here

in the office and it looked like there was a

little fluid. I anesthetized the area and

opened i t. There was no gross pus. I am

going ahead and treat [sic] him with some

Keflex and have him see Dr. Beaver on Friday

as I am going to be out of town. This may

come to a head and become an abscess. I t may

just be some cellulitis. I am not real sure

why he would have cellulites as it certainly

did not look like a hernia. I am going to

have him see Dr. Beaver on Friday and make

sure it is improving .

19 . On August 29, 2003, a note was made by Dr. Beaver

concerning his visit with Patient H.J. In that note Dr. Beaver

said:

Patient of Dr. Kinsey. He was seen back for

re - check. Apparently he was having some

questionable cellulites around his p.d. cath

today. He states that he is feeling much

bett er. On examination, I see no redness at

all and per the office assistan ce it has much

improved. There is really not tender [sic] .

It looks to me like it is improving. We will

plan for him to see Dr. Kinsey back next

week.

20. On September 12, 2003, Respondent saw Patient H.J. and

in the office note stated:

The area in his left lower quadrant is

completely healed. He is doing well. I am

going to see him back in one month for a

final visit.

2 1. On September 16, 2003, Respondent saw Patient H.J .

again and in the office note stated:

He had some drainage from his previous p.d.

catheter site. It does not appear to be

infected. I am going to follow this area and

see him in the office in a month.

2 2 . On September 30, 2003, Respondent saw Pati ent H.J.

again and in the office note it states:

He still has some drainage from the p.d.

catheter exit site [sic] it was done about

eight weeks ago. I told him that I would

like to leave that along [sic] for at least

three months and follow that. If it does not

improve after three to four months then we

may need to explore the woun d but it may be a

piece of suture that it [sic] trying to spit.

We will see him back in the office in about 6

to 8 weeks.

2 3 . On November 11, 2003, Respondent saw Patient H.J. and

noted:

He is still draining from his p.d. catheter

exit site. This has been 5 months. It is

time to explore the wound. We will proceed

to the operating room for exploration in the

sinus tract. I suspect that there will be a

piece of the catheter in the bottom of the

wound.

2 4 . On December 1, 2003 Respondent saw Patient H.J. for the

pre - operative visit . At that time he noted:

He is here for a pre - op for a wound

exp lo ration for his p.d. catheter removal

site. He still has so me granulation tissue

there. I am going to plan to probe the area

and evaluate where the sinus goes.

2 5 . On December 3, 2003, the surgery was conducted on

Patient H.J. and Respondent noted:

He underwent a left lower quadrant wound

exploration. Th e p.d. catheter cuff was

within the subcutaneous tissue and that is

why his wound [sic] not close. This was

removed and then the wo u ld [sic] was closed.

He tolerated the procedure well.

2 6 . The various surgeries that have been discussed which

were pe rformed by Respondent took place at Bay Medical in Panama

City, Florida. In the operative procedure report at the hospital

related to the December 3, 2003 exploratory operation Respondent

described a pre - operative diagnosis as:

Non - healing wound, left l ower quadrant of the

abdomen.

The post - operative diagnosis stated:

1. Non - healing wound , left lower quadrant of

the abdomen.

2. Foreign body ( peritoneal dialysis

catheter cuff), left lower quadrant abdominal

wound.

The procedure performed was described as:

Wound exp lo ration and foreign body removal.

The intra - operative findings related to the operation were:

He was found to have a cuff of the catheter

within the tissue. He had a small piece of

p.d. catheter attached to it. The cuff had

o bviously broken. The catheter was broken

with a cuff remaining in the sub c u tissue.

There was no intra - a bdominal portion.

2 7 . In comparison, o n July 21, 2003, in the

operative/proced ure report at Bay Medical through the description

of the procedur e to remove the catheter Respondent stated:

. . . The previous incision in the left

hypogast ric area was anesthetized with local

anesthetic and sharply incised. This was

carried into the subcutaneous tissue and

p.d. - catheter dissected and divided. The

catheter was then pulled from the

subcutaneous tissue at the exit site. The

catheter was then delivered into the wound

and abdominal wall cuff sharply incised and

the catheter removed. The fascial edges were

then reapproximated with 2 figure - of - eight0 -

vi cryl sutures.

28 . On July 2 1, 2003, when Respondent removed the catheter

from Patient H.J. no pathology was ordered. On December 3, 2003,

following the exploratory surgery and retrieval of the catheter

pathology was ordered.

29 . D aniel G. Dena was the pathologist at Bay Medical who

addressed the specimen which was described by the pathologist as :

"Tissue - p.d. catheter cuff" The anatomic diagnosis referred

stated: "p.d. catheter cuff: plastic catheter, with attached

fibro - fatty tissue at one end, showing acute and chronic

inflammation. " The macro s copic examination in the pathology

report stated: "The specimen is labeled 'pd catheter cuff' .

Received is a portion of plastic tubing measuring approximately 5

cm in length and up to 0.5 cm in diameter, with a cuff of soft

tissue at one end measuring 2.5 cm in length and 1.2 cm in

diameter. "

30. On July 26, 2004, in responding to the investigation

that led to this prosecution Respondent stated in writing in

relation to Patient H.J. :

The original peritoneal dialysis catheter

removal had gone uneventfully and I felt that

both cuffs of the catheter had been removed

in their entirety. But this was found not to

be the case. I have placed a number of these

catheters and removed a num ber as well and

have not had this type of problem before.

Visual inspection of the catheter on removal

is routinely undertaken to ensure that the

cuffs are removed and I felt that this had

been completely removed but I was obviously

mistaken. I am not su re if this was a defect

in the catheter. Evaluation of the catheter

and assurance of complete cuff removal would

have probably prevented this process. I am

certainly more cognizant of this being a

problem in subsequent catheters that I have

removed. At the original time of catheter

removal the operative site appeared

appropriate.

31 . At hearing Respondent offered additional explanation

concerning the July 21, 2003 operation to remove the catheter

from Patient H.J. and the exploratory surgery on Decem ber 3,

2003 .

3 2 . As Respondent explained, i n the July 21, 2 003 surgery

Respondent made a 3 - to - 4 cm incision about the belly button

towards the middle of the abdomen through the skin, subcutaneous

tissue, the fascial layer and muscle and peritoneal layer . The

peritoneal layer is a semi - permeable membrane that waste products

removed in t he dialysis will cross. T he catheter is placed into

the abdomen. The catheter is 12 to 14 inches in length with a

curlicue tail and holes in the end of the catheter that allows

the fluids to be introduced and withdrawn from the abdomen. As

Respondent explain ed the catheter has two cuffs, the smaller of

which is designed for placement in the rectus muscle located

along the inset part of the abdomen. The smaller cuff sits

inside that muscle. Tissue attaches to that cuff to keep fluid

from leaking out , to keep the catheter in place and to prevent

bacteria from going down the outside of the catheter. There is a

segment of the catheter between that cuff and a larger cuff wh ich

sits underneath the skin in the subcutaneous tissue. The tissue

in that area attaches to the cuff and serves to hold the catheter

in place.

3 3 . When removing the catheter on July 21, 2003, Respondent

used an incision of about 3 cm and encountered t he mid - portion of

the catheter located between the two cuffs which was dissected

down through the fascia and taken out with the portion in the

abdomen being removed first. Before making the incision to

remove the catheter, Respondent cut the portion of th e catheter

outside the body of Patient H.J. off , including the metal and

plastic valves and other paraphernalia hang ing out of the

patient. The purpose of removing the catheter outside the

patient's body was in the interest of protecting the surgical

fiel d from contamination to avoid wound infection.

34. The part removed inside the patient initially wa s the

intra - abdominal portion. The intra - abdominal portion of the

catheter , including the cuff in that area was sharply removed.

The cuff was 2 or 3 tim es the size that it would have been when

first placed and the part around the cuff wa s cut to allow the

catheter to be extracted. The area of the fascia was closed.

35. Next Respondent addressed the subcutaneous portion of

the catheter by following it ou t and sharply cutting the tissue

around the catheter and the subcutaneous cuff with scissors to

re move that portion which also had an ingrowth of scar and

fibroblastic tissue.

36. Once the portions of the catheter with the cuffs , had

been removed Responde nt looked to determine if he had both cuffs

which appeared at that tim e as a wad of scar and tissue.

37. Respondent then closed the wound. Respondent believed

that he had removed the whole catheter , to include the cuffs. In

fact the subcutaneous cuff w as not entirely removed and another

portion of the catheter remained in the patient following the

July 21, 2003 surgery.

38. Respondent's estimate of what had been left in the

patient and removed on December 3, 2003 , was about 2 cm of the

subcutaneous cuf f and then a portion of the balance of the

catheter.

39. In commenting on the differen ce between the pathology

report and his visual assessment on December 3, 2003, Respondent

remarked about "all the stuff" grown onto the cuff and catheter.

He also sa id it had a lot of specimen, taken to mean the "stuff"

attached to the cuff and catheter.

40 . Although in the operative notes from December 3, 2003,

Respondent says the catheter broke, at hearing he stated that he

did not know whether the catheter ha d been cut or broke during

the July 21, 2003 procedure to remove the catheter.

41. No independent test s were conducted to determine

whether the catheter broke during the July 21, 2003 surgery or

was cut by Respondent.

42 . Respondent does not precisely remember the appearance

of the catheter , to include the c u ffs , when examining it on

July 21, 2003 . But he believed that he had successfully removed

the entire catheter.

4 3 . In his testimony Respondent describes the office visits

s ubsequent to the July 21, 2003 surgery . W hen he saw Patient

H.J. he observed cellulitis around the area of the incision which

was treated with oral antibiotics and resolved. Respondent used

ultrasound to determine whether fluid had collected in the area

where he observed the cellulitis. No fluid collection was seen.

Drainage was noticed around the exit site where the catheter came

out of the skin, which ordinarily takes a month to six weeks to

heal.

44 . Concerning the drainage around this exit site ,

Respondent expected t he drainage to resolve with in around five

weeks unless there were a piece of suture or other kind of event

keeping the site opened an d draining.

45. The wound site where the incision was made healed

without incident . The exit site continued to drain. Af ter a

time Respondent concluded that th e reason for the drainage was

either an epithelilized sinus tract, a piece of suture , a piece

of catheter, a piece of cuff, or a piece of dressing for the

wound . Respondent waited a time before doing the exploratory

surgery in view of the use of an absorbable suture in the

July 21, 2003 surgery which would have dissolved over time,

precluding the need to do the exploration.

4 6 . Respondent , given the problem with the drainage from

Patient H.J. following the July 2 1, 2003 surgery to remove the

catheter , does not believe that the failure to remove this

fragment would have killed the patient or have caused a lot of

problems , but it was bothersome enough that it was worth the

effort to try and find it and get the patie nt healed.

4 7 . Respondent in dictating his post - operative note on

December 3, 2003 , thinks that the catheter had broken and

continues to hold to that belief, although he recognizes that it

may have been cut in the prior surgery.

4 8 . Concerning his pr actice at Bay Medical, Respon dent did

not routinely have an X - ray done for patients undergoing surgery

without a more specific reason for ordering it. Nor did he order

a pathology exami nation following surgery absent the need for

specific information.

4 9 . Patient H.J. in his testimony described the level of

pain following the July 21, 2003 surgery to remove the catheter

as "a little pain."

Expert Opinion

50 . Dr. Stanley P. Kococki is a general surgeon licensed in

Florida. He is board - certified in gener al surgery. He has had

experience placing and removing peritoneal dialysis catheters.

He was qualified to offer expert opinion testimony concerning

Respondent's treatment of Patient H.J. , i n particular, th e

surgery performed July 21, 2003.

5 1 . Dr. Ko cocki expressed the opinion that the Respondent

fell below the standard of care in treating Patient H.J. , in that

Respondent failed to recognize that h e had left a portion of the

catheter in the patient, which Dr. Kococki des cribes as a

retained foreign bo dy and that this caused the patient to undergo

a second unnecessary procedure, meaning that the second procedure

would not have been necessary if the catheter had been removed

completely in the first surgery. The failure to remove could

possibly have caus ed serious problems f o r the patient, t o include

septicemia and death, according to Dr. Kococki. Dr. Kococki

refers to the Respondent's obligation in removing the catheter ,

to make certain that the whole catheter was removed and that the

wound properly hea led beyond that point so that the patient would

not experience problems.

5 2 . While recognizing that there are different techniques

for removing the catheter from Patient H.J., Dr. Kococki took

issue with the method employed by the Respondent. Dr. Kococ ki

believes that there are other methods for avoiding the problem

with infection than to cut the catheter outside the body. There

was no description of the use of a hemostat or clamps to hold the

retained part of the catheter once the outside segment had been

cut , so that the remaining portion of the catheter would not be

lost under the skin. In addition , by cutting the catheter in two

places there was a chan ce of leaving a piece of the catheter in

the patient. Dr. Kococki expressed the opinion that when you cut

the catheter in several places you have to remember where the

pieces of the catheter are left in the patient. Given other

circumstances during the surgery that occupy the surgeon's mind ,

it can lead to leaving a piece of catheter behind.

5 3 . Dr. Kococki expressed the opinion that leaving the

catheter behind was not in the best interest of the patient

because it led to subsequent surgery and had the sinus tract

closed over the foreign body would have caused a localized

infection and abscess f ormation around that area and possibly

allowed for the bacteria from the abscess to enter the patient's

bloodstream causing sepsis , an d abscess formation in other

organs, possibly the abdominal cavity , with a possible rupture

intra - abdominally causing the patient to have generalized

peritonitis. That can be life threatening and ultimately lethal.

It is more of a problem with the person that has end - stage renal

failure , in that the patient has a weakened immune system an d

lessened prospects to fight off in fection.

5 4 . Dr. Kococki relied upon the pathology report made after

the December 3, 2003 surgery to accurately describe the size of

the segment that was left in the patient .

5 5 . In order to ascertain what actually happened with the

catheter Dr. Koc ocki believes that the company or an independent

examining body would have to determine if the catheter was

defective . Even in the instance where the catheter may have

broken in the initial surgery to remove it on July 21, 2003, the

onus is still on the s urgeon removing the catheter to examine it

to make certain it wa s removed intact.

5 6 . Dr. Kococki characterizes the catheter as commonly

present and utilized in surgical procedures to place and remove

per itoneal dialysis catheter s. Dr. Kococki describe s the

catheter as a medica l device, unlike a sponge, force p s , clamp or

surgical needle. Dr. Kococki recognizes that the purpose of the

catheter is to perform dialysis but the retained portion left

after the initial surgery to remove the catheter does not have a

medical purpose , in his judgment .

5 7 . Dr. Kococki describes the cuff in the field related to

the abdominal wall a s providing a seal to avoid bacteria. The

cuff as he understands it has an antibiotic coating that will

help fight off infection. T he cuff reacts with the patient's

body tissue to act as a sealant.

5 8 . To have a void ed the problem of failing to account for a

portion of the catheter during the initial surgery to remove it

from Patient H.J., Dr. Kococki believes that the easiest thing to

have done was w h il e the patient was in the operating room send

the catheter to a pathologist and have it measured for comparison

against the known size of the catheter when first placed. A

second safe - guard would be to use a portable X - ray of the

abdo minal cavity to make sure that there was no radiopaque

material in the abdomen or subcutaneous tissue. The catheter has

radiopaque material allowing this identification in Dr. Kococki's

u nderstanding.

5 9 . Dr. Kococki was not familiar with the procedure s at Bay

Medical where the catheter removal from Patient H.J. was

performed . T he bylaws o f the institution do not require that the

catheter be sent to pathology following removal.

60 . Dr. Thomas A. Gadacz testified in the interest of

Respondent. He is licensed in several states. He is not

licensed in Florida. He is an expert in the field of general

surgery. He has placed and removed peritoneal dialysis

catheters.

6 1 . Dr. Gadacz describes the catheter as a medical device.

It has nothing in common with a sponge, forcep s , clamp or

surgical needle, in his opinion.

6 2 . As a surgeon Dr. Gadacz refers to sponges, forceps,

clamps and surgical needles as items whose sole purpose is to

assist during an operation, not intended to be left in the body.

T hey are to facilitate an operation to provide exposure, to

conduct the operation but they are not a therapeutic modality.

By contrast the peritoneal dialysis catheter is used primarily

for therapy by remaining in the patient for specified periods of

time to treat the patient.

6 3 . Other aids in performing an operation are cotton balls

called kitners, metal retractors and cannulas.

6 4 . Dr. Gadacz explains that the purpose of the cuffs

related to the catheter is to react to the body so that tissue

grows a round them. The other part of the catheter made of Teflon

is designed to be non - reactive.

6 5 . Dr. Gadacz is aware that catheters of the type under

discussion have fractured or broken. Dr. Gadacz explained that

the fracture of a cuff is not common. In h is experience, in the

instance where a segment broke in a catheter, Dr. Gadacz removed

it. On the other hand the failure to remove the piece is not

necessarily below the standard of care as Dr. Gadacz explains ,

"because some times this happens, and its, you don't know that

that has happened." The possibility of knowing that the segment

broke off is difficult. As Dr. Gadacz describes, it was

impossible given the tract involved with the surgery here. The

gross inspection of the catheter once removed fro m the patient is

a process in which it is difficult to make certain that both

cuffs are there because of the encrusting fibrous tissue found

after removing the cuffs , causing the cuffs to no longer have the

same appearance as when first placed. The visual inspection made

of the catheter after removal would not necessarily reveal

whether it was removed in its entirety, according to Dr. Gadacz.

6 6 . Dr. Gadacz is unfamiliar with surgeons who would use an

X - ray after removal of the catheter to confirm th at the entire

catheter had been removed. Instead he defers to Respondent's

operative note on December 3, 2003 , where the Respondent says

that the catheter had obviously broken to explain the failure to

retrieve the catheter.

6 7 . Dr. Gadacz does not be lieve sending the catheter to

pathology after it was removed on July 21, 2003 , would

necessarily have been useful because it would take familiarity on

the part of the pathologist with that form of catheter to

recognize that a part was missing.

6 8 . Dr. Gadacz recognizes that the fragment from the

catheter left in Patient H.J. at the end of the initial surgery

to remove the catheter is medically considered a foreign body

because it was not part of the human body.

6 9 . Dr. Gadacz found nothing in the car e provided by

Respondent by to Patient H.J. after the July 21, 2003 surgery

that was questionable.

70 . Dr. Gadacz did not find the technique Respondent used

in removing the catheter on July 21, 2003 , from the Patient H.J.

to be below the standard of car e.

71 . Generally Dr. Gadacz did not express the opinion that

Respondent practice d below the standard of care.

72 . Dr. Gadacz explained that had the segment continued to

be present in the patient there would have been a major risk of

continuing infectio n and ultimately the patient could have

developed a serious abscess in the subcutaneou s tissue that could

become life - threatening or nothing may have happened , and the

segment may have been walled off by the patient's body.

73 . I n determining the compara bility of what is described

in Section 456.072(1)(bb), Florida Statutes (2003) , as "other

paraphernalia , " to those items listed within that section , "such

a s a sponge, clamp, forceps, surgical n e edle , " that are " used in

surgical examination, or other diagn ostic procedures , " reliance

is made upon testimony from Dr. Gadacz. As a surgeon , the

opinion by Dr. Kococki is rejected for reasons that will be

explained in the conclusions of law.

7 4 . W hen considering whether Respondent failed to practice

medicine w ith that level of care, skill and treatment whic h is

recognized by a reasonable prudent similar physician as being

acceptable under similar conditions and circumstances, as

envisioned by Section 458.331(1)(t), Florida Statutes (2003),

with the specificity called for in that provision, Dr. Kococki is

more compelling in his opinion that the fragment left in

Patient H.J. should have been removed in the earlier operation

whether it broke or was cut by Respondent. The notion that there

are time s when some porti on of the catheter may have been left in

the patient, as was the case here , with no c onsequences to the

practitioner , as expressed by Dr. Gadacz is not persuasive.

Disciplinary History

7 5 . The Respondent has no prior disciplinary history.

CONCLUSIONS OF LAW

7 6 . The Division of Administrative Hearings has

jurisdiction over the subject matter and the parties to t his

proceeding pursuant to Sections 120.569, 120.57(1), and

456.073 (5) , Florida Statutes (2005).

7 7 . The Amended Administrative Complaint left open the

possibility that discipline might be imposed that led to the

revocation or suspension of Respondent's license to practice

medicine. For that reason, clear and convincing evidence must be

shown to prove the allegations in the Amended Adminis trative

Complaint. § 458.331(3), Fla. Stat. (2003). See also 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).

78 . The meaning of clear and convincing 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).

79 . Respondent allegedly left a piece of the catheter in

Patie nt H.J. after the July 21, 2003 surgery to remove the

catheter, a nd is accused of two separate violations of law for

the oversight.

80 . Count 1 to the Amended Administrative Complaint refers

to Section 456.072(1)(bb) Florida Statutes (2003) , which would

allow the imposition of discipline for:

(1) . . . as specified in s. 456.072(2):

(bb) Leaving a foreign body in a patient,

such as a sponge, clamp, forceps, surgical

needle, or other paraphernalia commonly used

in surgical, examination or other diagnos tic

procedures. For the purposes of this

paragraph, it shall be legally presumed that

retention of a for eign body is not in the

best interest of the patient and is not

within the standard of care of the

profession, regardless of the intent of the

professi onal.

81 . In relation to Count 2 Respondent is said to have

violated Section 458.331(1)(t), Florida Statutes (2003) , which

would allow the imposition of discipline for:

(1) . . . as specified in s. 456.072(2):

(t) Gross or repeated malpractice or the

failure to practice medicine with that level

of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances. The board

shall give great weight to the provisio ns of

s. 766.102 when enforcing this paragraph.

As used in this paragraph, 'repeated

malpractice' includes, but is not limited to,

three or more claims for medical malpractice

within the previous 5 - year period resulting

in indemnities being paid in excess of

$50,000 each to the claimant in a judgment or

settlement and which incidents involved

negligent conduct by the physician. As u sed

in this paragraph, 'gross malpractice' or

'the failure to practice medicine with that

level of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances,' sha ll not be

construed so as to require more than one

instance, event, or act. Nothing in this

paragraph shall be construed to require that

a physician be incompetent to practice

medicine in order to be disciplined pursuant

to this paragraph. A recommended order by an

administrative law judge or a final order of

the board finding a violation under this

paragraph shall specify whether the licensee

was found to have committed 'gross

malpractice,' 'repeated malpractice,' or

'failure to practice medicine with th at level

of care, skill, and treatment which is

recognized as being acceptable under similar

conditions and circumstances,' or any

combination thereof, and any publication by

the board must so specify.

8 2 . As alluded to, i n the event that Respondent wa s shown

to have violated either statute he would be subject to discipline

in accordance with Section 456.072(2), Florida Statutes (2003),

which details the discipline as:

* * *

( b) Suspension or permanent revocation of a

license.

(c) Restriction of practice or license,

including, but not limited to, restricting

the licensee from practicing in certain

settings, restricting the licensee to work

only under designated conditions or in

certain settings, restricting the licensee

from performing or providing designated

clinical and administrative services,

restricting the licensee from practicing more

than a designated number of hours, or any

other restriction found to be necessary for

the protection of the public health, safety,

and w elfare.

(d) Imposition of an administrative fine not

to exceed $10,000 for each count or separate

offense. If the violation is for fraud or

making a false or fraudulent representation,

the board, or the department if there is no

board, must impose a fi ne of $10,000 per

count or offense.

(e) Issuance of a reprimand or letter of

concern.

(f) Placement of the licensee on probation

for a period of time and subject to such

conditions as the board, or the department

when there is no board, may specify. Those

conditions may include, but are not limited

to, requiring the licensee to undergo

treatment, attend continuing education

courses, submit to be reexamined, work under

the supervision of another licensee, or

satisfy any terms which are reasonably

tailo red to the violations found.

(g) Corrective action.

(h) Imposition of an administrative fine in

accordance with s. 381.0261 f or violations

regarding patient rights.

(i) Refund of fees billed and collected from

the patient or a third party on behalf of the

patient.

(j) Requirement that the practition er

undergo remedial education. In determining

what action is appropriate, the board, or

department when there is no board, must first

consider what sanctions are necessary to

protect the public or to compensate the

patient. Only after those sanctions have

been imposed may the disciplining authority

consider and include in the o rder

requirements designed to rehabilitate the

practitioner. All costs associated with

compliance with orders issued under this

subsection are the obligation of the

practitioner.

83 . Section 456 .079 , Florida Statutes (2003) required that

the Board of M edicine adopt rules setting out disciplinary

guidelines applicable to each Count in the Amended Administrative

Complaint. Florida Administrative Code Rule 64B8 - 8 . 001 addresses

the requirement as to the range of punishment t a king into account

aggravating a nd mitigating circumstances.

84 . The allegations in the Amended Administrative Complaint

are considered based upon penal statutes, in their respective

Counts. As such, they are strictly construed, with ambiguities

construed to favor the Respondent. Se e Lester v. Department of

Professional and Occupational Regulation , 348 So. 2d 923 (Fla.

1st DCA 1977).

8 5 . Pertaining to Section 456.072 (1)(bb), Florida Statutes

(2003), the rule of ejusdem g eneris is applied. See Smith v.

Nussman , 156 So. 2d 680 (Fla . 3rd DCA 1963); Green v. State , 604

So. 2d 471 (Fla. 1992) a n d Suncoast International, Inc. v. Dept

of Business Regulation, Division of Florida Land Sales,

condominiums and Mobile Homes , 596 So. 2d 1118, (Fla. 1st DCA

1992). Under this rule of constructi on where there is an

enumeration of things with particular specific meanings, followed

by a general reference, the general words or reference would not

be constructed in the broader sense but would be construed as

applying to things in the same class as th e specific words. Here

the terms sponge, clamp, forceps, surgical needle, followed by

the reference to " other paraphernalia " in the statute at issue,

leads to the conclusion that the "other paraphernalia" must be of

a similar nature to the enumerated item s. Further, the foreign

body that is being described must have commonly been used in

surgical, examination, or other diagnostic procedures. Based

upon the testimony by Dr. Gadacz, the catheter is not a n item in

that category used in surgery, examination or diagnosis . The

catheter is part of a therapeutic modality to provide peritoneal

dialysis. Nor is a fragment of the catheter left within the

patient considered within that category. That the catheter was

fragmented does not change its characte r as bei ng outside the

items listed in the statute. The piece of the catheter is a

foreign body, but it is not of the class of foreign bodies

described in the statute. Therefore, even though it was not in

the best interest of the patient to retain it , there can be no

violation of the standard of care envisioned by this statute.

8 6 . Respondent did fail to practice " with the level of

care, skill, and treatment which is recognized by a reason by a

reasonably prudent similar physician as being acceptable under

similar conditions and circumstances . " W hen Respondent left the

fragment in place following the July 21, 2003 surgery he violated

the standard of care, this according to Dr. Kococki. As a

consequence he violated Section 458.331(1)(t), Florida Statu tes

(2003). Whether the catheter was excised and left by Respondent

or broke without regard for Respondent's intervention in the

case, he had a duty to remove the catheter and all its segments

and to make certain that he had accomplished that outcome. A

reasonably prudent similar physician under similar conditions and

circumstances would have recognized a significant portion of the

catheter was left in the patient. Respondent failed in that

respect. Nothing else in his conduct that has been described

fe ll below the standard of care, in particular the care provided

after the July 21, 2003 surgery and the performance of the

December 3, 2003 ex ploratory surgery to locate and remove the

piece left behind.

RECOMMENDATION

Based upon the findings of fact, an d conclusions of law, and

the guidance set forth in Florida Administrative Code Rule 64B8 -

8.001, it is

RECOMMENDED:

That a final order be entered finding that Respondent did

not violat e Section 456.072(1)( bb ) , Florida Statutes (2003); that

Respondent did violate Section 458.331( 1 ) (t) , Florida Statutes

(2003) ; placing Respo ndent on probation for two years ; imposing

an administrative fine in the amount of $ 2 , 5 00.00; requiring

Respondent to perform 50 hours of community service; requiring

the completion of 5 hours of continuing medical education on

"risk management" and requiring him to present a one - hour lecture

to a group of peers discussing retention of foreign bodies in

surgeries and techniques to avoid the retention.

DONE AND ENTERED this 14 th day of February , 2006, in

Tallahassee, Leon County, Florida.

S

CHARLES C. ADAMS

Administrative Law Judge

Division of Administrative Heari ngs

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 Administrative Hearings

this 1 4 th day of February , 2006.

COPIES FURNISHED:

William F. Miller

Ephraim D. Livingston

Assistant s General Counsel

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Albert P eacock, Esquire

8554 Congressional Drive

Tallahassee, Florida 32312

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 wi thin

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.