10-004714PL Department Of Health, Board Of Medicine vs. Enrique Puig, M.D. Status: Closed Recommended Order on Friday, March 25, 2011.

Summary: Physician did not violate section 458.331(1)(t), Florida Statutes, when he left a deflated blood pressure cuff on a patient during surgery.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE , )

)

Petitioner , )

)

vs. ) Case No. 10 - 4714PL

)

ENRIQUE PUIG, M.D. , )

)

Respondent . )

)

RECOMMENDED ORDE R

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

on October 27 and 28, 2010, and November 18, 2010 , in Winter

Haven, Florida, before Susan B. Harrell, a designated

Administrative Law Judge of the Division of Administrative

Hearings.

APPEARANCES

For Petitioner: Greg S. Marr, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Jon M. Pellet, Esquire

Barr, Murman & Tonellis, P.A.

201 East Kennedy Boulevard, Suite 1700

Tampa, Florida 33602

S TATEMENT OF THE ISSUES

The issues in this case are whether Respondent violated

section 458.331(1)(t), Florida Statutes (2008), 1/ and, if so, what

discipline should be imposed.

PRELIMINARY STATEMENT

On April 26, 2 010, Petitioner, Department of Health

(Department) , filed an Administrative Complaint before the Board

of Medicine (Board), alleging that Respondent, Enrique

Puig, M.D. (Dr. Puig), violated section 458.331(1)(t). The case

was forwarded to the Division of Administrative Hearings on

July 2, 2010, for assignment to an Administrative Law Judge.

The final hearing was scheduled for September 13 and 14,

2010. On August 23, 2010, a Joint Motion to Continue Hearing

was filed. The motion was granted by Order dated September 9,

2010, and the final hearing was rescheduled for October 27

and 28, 2010.

The parties filed a Joint Pre - hearing Stipulation, in which

the parties stipulated to certain facts contained in Section E

of the Joint Pre - hearing Stipulation. To the extent relevant,

those stipulated facts have been incorporated in this

Recommended Order.

On October 11, 2010, Petitioner filed a Motion to Take

Official Recognition of Florida Administrative Code Rule

64B8 - 8.001, effective January 2, 2009. Official recog nition was

taken of the rule by Order dated October 15, 2010.

At the final hearing, Joint Exhibits 1 through 13 were

admitted in evidence. The Department called the following

witnesses: T.M.; R.R.; Glenda Johnson, R.N.; James W.

Dennis, M.D.; Desiree Dow ling, R.N.; and Anibal

Sanchez - Salazar, M.D. Petitioner's Exhibits 1 and 2 were

admitted in evidence.

At the final hearing, Dr. Puig testified in his own behalf

and called the following witnesses: Brian M. Jurbala, M.D.;

Nikolaus Gravenstein, M.D.; Heidi Dilworth; Ashley Pollock;

Vincent Carifi, M.D.; and Dominick Ottaiano, M.D.. Dr. Puig

proffered the testimony of Charbel Kennan, M.D. Respondent's

Exhibits 1, 5, 6, 8 through 11 and 16 were admitted in evidence.

Respondent's Exhibits 12 through 15 were proffered.

On October 26, 2010, Respondent filed Respondent's Motion

for Official Recognition, requesting that official recognition

be taken of sections 458.331(1)(t), 456.50, 766.102, and

766.103, Florida Statutes (2009). The motion was granted at the

f inal hearing.

On November 23, 2010, Respondent filed Respondent's Motion

for Reconsideration and Admission of Proffered Respondent's

Exhibits 7 and 12 through 15. The exhibits were articles

dealing with compartment syndrome and position of patients.

Alth ough Orasan v. Ag ency for Health Care Admin istration ,

668 So. 2d 1062, 1063 (Fla. 1st DCA 1996), stands for the

proposition that excerpts from medical texts and treatises may

be used to bolster the testimony of an expert witness in an

administrative procee ding, the articles proffered by Respondent

were not identified as authoritative. The issue of whether the

excerpts were authoritative was not addressed in Orasan . In

section 90.706, Florida Statutes (2010) , authoritative

literature may be used to cross - e xamine an expert witness. It

stands to reason that if only authoritative literature can be

used to cross - examine , then only authoritative literature should

be used to bolster an expert witness's opinion. The motion for

reconsideration is denied.

At the f inal hearing, the parties did not make closing

arguments, but were given leave to file a written closing

argument. On January 14, 2011, Respondent filed Respondent's

Closing Argument Regarding Witness Credibility. On January 20,

2011, Petitioner filed Pe titioner's Motion to Strike

Respondent's Closing Argument Regarding Witness Credibility.

The motion to strike is denied.

The nine - volume Transcript was filed on December 20, 2010.

At the final hearing, the parties agreed to file their proposed

recommende d orders within ten days of the filing of the

transcript. On December 14, 2010, the parties filed a Joint

Motion Regarding Submission of Proposed Recommended Orders,

requesting that the time for submitting proposed recommended

orders be extended to Januar y 11, 2011. On January 7, 2011,

Respondent filed a motion requesting that the time for filing

proposed recommended orders be extended to January 14, 2011.

The request was granted by Order dated January 7, 2011. The

parties timely filed their P roposed R e commended O rders.

FINDINGS OF FACT

1. The Department is the state department charged with

regulating the practice of medicine pursuant to section 20.43

and chapters 456 and 458, Florida Statutes.

2. Dr. Puig was at all times material to the allegatio ns

in the Administrative Complaint a licensed physician in the

State of Florida, having been issued license No. 82847.

Dr. Puig holds a certificate from the American Board of

Anesthesiology.

3. In the early morning of January 2, 2009, T.M. presented

to t he Central Florida Surgery Center in Lakeland, Florida, for

outpatient surgery to be performed by Shreekant Tripathi, M.D.

The specific procedures to be performed were bilateral lower

eyelid blepharoplasty, mini - face lift, and suspension of the

mid - face a rea with the Endotine Midface implant device. She was

accompanied by her husband, R.R.

4. T.M. has been licensed as a physician in Florida for

28 years and has worked as the head of the Tampa General

Hospital Adult Emergency Department and as that hospit al's chief

of staff.

5. T.M. has a prior history of a deep vein thrombosis

(DVT), which was treated medically. She experienced a DVT in

her leg sitting in an airplane for an extended period of time

while traveling from Florida to the Midwest. DVT is a m edical

condition that occurs when a thrombus (blood clot) forms in one

of the large veins, leading to either partial or complete

blockage of the vein.

6. After completing the financial paperwork and other

forms at the front desk of Central Florida Surgery Center , T.M.

was taken to the pre - operative holding area at approximately

7:00 a.m.

7. Once in the pre - operative holding area, the nurse went

over the contents of T.M.'s procedures and reviewed T.M.'s

medical history and medications taken. The nurse adm inistered

medications other than sedation and took T.M.'s vital signs,

including her blood pressure.

8. In order to take T.M.'s blood pressure, the nurse in

the pre - operative holding area placed a blood pressure cuff on

T.M.'s right upper arm. The blood pressure cuff would not have

given a reading if it w as placed too tight ly, and T.M. would

have complained of pain. At the time that the blood pressure

cuff was placed, T.M. was awake and alert and did not express

any discomfort. The nurse was able to get a reading from the

blood pressure cuff.

9. While T.M. was in the pre - operative holding area and

after the vital signs were taken , T.M.'s temperature was 97.4

degrees . T.M. met with Dripathi , who went over her surgery

with her. Dripathi marked t he areas for her facial cosmetic

procedures.

10. Dr. Puig served on the surgical team as

anesthesiologist. He conducted a pre - anesthesia evaluation

of T.M. Dr. Puig examined T.M. and reviewed the medications

that she was tak ing . He also reviewed T.M.'s medical history,

including her history of DVT. As part of his plan for

anesthesia, Dr. Puig included the use of sequential compression

devices on T.M.'s lower extremities.

11. While in the pre - operative holding area, T.M. was

given Versed as a pre - medicat ion for the surgery. T.M. was

taken to the operating room, accompanied by Dr. Puig , who

remained with T.M. until she was handed to the post - anesthesia

care unit (PACU) nurse. T.M. entered the operating room at

8:19 a.m.

12. T he blood pressure cuff that was placed by the

pre - operative nurse was left in place on the upper right arm.

The blood pressure cuff was disconnected from the monitoring

device in the pre - operative holding area and accompanied T.M.

into the operating room, where it was connected to another

monitoring device.

13. After T.M. was taken to the operating room, she moved

onto the operating table on her own with some assistance.

Monitoring equipment was then connected to T.M. The monitoring

equipment included a pulse oximeter on the lef t hand, sequential

compression devices on the lower extremities, and the blood

pressure monitoring device. Dr. Puig did not use any device to

monitor T.M.'s temperature during the surgery. An IV had been

placed in the pre - operative area on T.M.'s left wr ist and was

running in the operating room.

14. T.M. was positioned flat on her back on the operating

table with her shoulders on the operating table using a

mattress, a pillow, foam pads, and sheets. On the table, under

T.M. , was a two - to - three - inch thick mattress. On top of the

mattress, under T.M., was a bottom sheet that r an longitudinally

the length of the table. On top of the bottom sheet,

perpendicular with, or at a 90 - degree angle to the table , was a

folded sheet from 18 - to - 30 inches wide. This c rossways sheet is

called a draw sheet and was under T.M. with the top edge at the

armpit and the lower end in line with the waist or buttocks.

The draw sheet was pulled up between T.M.'s arm and torso for

later tucking.

15. A foam pad , egg - crate device was placed on the right

arm between the arm and the table and T.M. The device is not

large enough to completely cover the arm. The bottom sheet was

tucked around the arm between the egg - crate device and T.M.'s

torso. The draw sheet was then tucked aroun d the outside of the

arm and under the mattress with a portion left protruding, which

could be pulled on later to begin the process of removing the

sheets . The purpose of the sheets was to keep T.M.'s arm from

falling off the table during surgery. The sh eets were supposed

to be snug, but not so tight that one could not insert two

fingers between the sheets and T.M.'s arm.

16. In addition to the sheets that covered T.M., a Bair

Hugger was used. A Bair Hugger is a warming device that uses

forced warm air t o keep a patient warm during surgery.

17. The blood pressure cuff was under a portion of the

egg - crate device, the bottom sheet, the draw sheet, and the Bair

Hugger. The top edge of the blood pressure cuff was just under

the armpit and the bottom edge was approximately three - to - four

inches above the elbow joint. The blood pressure cuff had an

inflatable rubber bladder and normally would have an attached

inlet tube about six - to - eight inches long that would extend down

T.M.'s arm toward her wrist.

18. In or der to eliminate sources of infection, a sterile

field was created by using sterile towels and sterile drapes.

The sterile drape covered T.M. after the other sheets and

blankets were in place. The sterile towels were placed around

T.M.'s head.

19. At 8:4 1 a.m., the surgery began. Prior to the

commencement of surgery and while in the operating room,

Dr. Puig monitored T.M.'s blood pressure using the monitoring

device in the operating room and the blood pressure cuff that

was placed on T.M.'s right arm. D r. Puig had blood pressure

readings until 8:58 a.m. , when Dr. Puig was unable to get blood

pressure readings.

20. Dr. Puig asked Dripathi to step aside and allow

him to check the blood pressure cuff. Dr. Puig was on the right

side of T.M. and moved to the left side of T.M. He asked the

circulating nurse to hold the sterile drape so that he could go

under the drape to check the blood pressure cuff. Dr. Puig went

under the drape and felt the blood pressure cuff. The blood

pressure cuff was deflated. He disconnected the tube from the

blood pressure cuff and called for a new blood pressure cuff.

He placed the new blood pressure cuff on T.M.'s left arm and

connected the new blood pressure cuff to the blood pressure

monitoring device. Dr. Puig was able to get accurate blood

pressure readings from the new blood pressure cuff and the

monitoring device that had been attached to the blood pressure

cuff on T.M.'s right arm. Dr. Puig left the deflated blood

pressure cuff on T.M.'s right arm during the surgery .

21. After a blood pressure cuff was placed on T.M.'s left

arm, Dripathi continued with the surgery. The surgery ended

at 1:48 p.m. , at which time the circulating nurse began to

remove the sterile drape and sheets from T.M. When the nurse

removed th e deflated blood pressure cuff on T.M.'s right arm,

she noticed that the arm below the blood pressure cuff was

mottled, blue, red, dark blue and dark red. There were blisters

on T.M.'s right arm where the blood pressure cuff had been.

T.M.'s right arm wa s swollen. The condition of T.M.'s right arm

was brought to the attention of Dr. Puig. Dr. Puig examined and

evaluated T.M.'s condition.

22. At 2:00 p.m., T.M. was transferred to the PACU.

T.M. was alert. Her temperature was 98 degrees. Her husband,

R .R., was at bedside when T.M. was taken to PACU and stayed at

her bedside until T.M. was discharged.

23. T.M. was experiencing extreme pain in her right arm

and felt a tender hard spot on her right bicep. The post -

operative nurse noted the condition of T .M's right arm as red

and swollen from the biceps to the tips of T.M.'s fingers with

blisters on the upper part of the extremity. Dr. Puig noted

that T.M. had decreased sensation in her right finger tips and

some decrease in motor activity and that T.M's radial and ulnar

pulses were intact. He ordered that the right arm be elevated

with the use of pillows.

24. At 2:15 p.m., Dr. Puig was at T.M.'s bedside,

monitoring T.M.'s condition. Dripathi was aware of T.M.'s

condition and also appeared at her bed side to monitor her

condition. Dr. Puig consulted with Dripathi concerning

T.M.'s condition.

25. At 2:30 p.m., T.M. was still being monitored by the

PACU nurse. T.M. was moving her arm, fingers, and wrist. At

2:55 p.m. , T.M. told the nurse that s he was unable to feel her

pulse. Two nurses took T.M.'s pulse and verified that T.M. did

have a pulse.

26. Dr. Puig and Dripathi had gone back to the

operating room for a procedure on another patient. At

2:55 p.m., a nurse notified Dr. Puig of T.M. 's complaint of

feeling no pulse. At 3:08 p.m., T.M. complained of a decrease

in sensation from her elbow to her fingers.

27. T.M. suggested to the PACU nurse that measurements

should be taken of the circumference of her arms to determine

how much swell ing had occurred. At 3:10 p.m., the nurse marked

the area on the arms to be measured and took measurements of the

bicep and forearm in each arm. The right bicep measured

30 centimeters, and the right forearm measured 28 centimeters.

The left bicep measu red 29 centimeters, and the forearm measured

24 centimeters.

28. T.M. and her husband became concerned about the

condition of T.M.'s right arm. The right arm was still elevated

by pillows, and T.M. continued to exercise the arm.

29. At 3:14 p.m., T.M. sta ted that she could feel her

right radial pulse. T.M.'s right bicep remained red and

swollen. T.M. denied the need for pain medication.

30. At 3:20 p.m., T.M. continued to exercise the right

arm, hand, wrist, and fingers. T.M. complained of pain in the

r ight bicep and a knot in the right bicep.

31. At 3:40 p.m., T.M. continued to complain of pain in

the right bicep. T.M. was squeezing her right hand and moving

her right arm. T.M. was experiencing a prickly sensation to her

forearm and hand from the elbo w down. The nurse determined that

there was a right radial pulse. Dr. Puig was notified of T.M.'s

condition. The nurse gave T.M. a bolus of 25 micrograms of

Fentanyl; however, the pain medication did not give T.M. any

relief.

32. Dr. Puig had given an o rder for 25 micrograms of

Fentanyl to be administered every five - to - 15 minutes up to a

maximum of 100 micrograms. Fentanyl is a short - acting pain

medication. The opiate is more potent that morphine. The

effects of Fentanyl will wear off about 20 to 30 m inutes after

administration.

33. At 3:50 p.m., the nurse administered another bolus of

25 micrograms of Fentanyl to T.M. At 3:54 p.m., T.M was fully

flexing and extending her right arm and stated that the second

dose of Fentanyl had given her some reli ef to the pain.

34. At 4:00 p.m., the nurse measured the right arm again.

The right bicep was 30 centimeters, and the right forearm was

26.5 centimeters.

35. At 4:07 p.m., T.M. requested more pain medication, and

the nurse administered another bolus of 25 micrograms of

Fentanyl. T.M. received fair relief from the pain as a result

of the pain medication.

36. At 4:25 p.m., T.M. stated that she could feel

sensation to her right hand, but was unable to distinguish

between sharp and dull pain. She denied the need for further

pain medication.

37. At 4:41 p.m., T.M. continued to have pain in her right

bicep. She was experiencing numbness and tingling in her right

hand and forearm. From the right elbow to her hand, her arm was

red, mottled, and petechiae. The right bicep was warm and

swollen with thin blisters. The bicep was firm and painful.

T.M. requested and was given another 25 micrograms of Fentanyl.

At 4:50 p.m., the pain medication had produced only minimal

relief from the pain.

38. At 4:53 p.m., T.M. told the PACU nurse that her pain

and swelling was not getting any better and that she wanted to

be transferred to Tampa General Hospital after she saw Dr. Puig

and Dripathi, who were still in surgery. Dr. Puig and

Dr. Tripathi were notified in the o perating room. The nurse

continued to monitor T.M.

39. T.M. thought that she may have compartment syndrome.

Compartment syndrome is a condition that results from increased

pressure in the compartment (the muscle surrounded by the

fascia) , which can lead to lack of perfusion, nerve damage, and

eventually to the loss of function of the extremity. It is

characterized by pain out of proportion to the nature of the

observable injury that will not be alleviated by the

administration of narcotic pain medication , swelling, pallor,

paraesthesia, lack of pulse, and eventually lack of temperature

control.

40. Dr. Puig consulted with Dripathi throughout the

time that T.M. was in PACU concerning T.M.'s right arm.

Dr. Tripathi has had training in hand surgery , and , as a

surgeon , is familiar with compartment syndrome. Compartment

syndrome in the upper arm is a rare event. Neither Dr. Puig ,

nor Dr. Tripathi , felt that the swelling and pain in T.M.'s arm

was due to compartment syndrome. Because of her history with

DVT and the similarity of some of the conditions associated with

both compartment syndrome and DVT, it was felt that T.M. could

have DVT in her upper arm.

4 1 . At 5:00 p.m., Dr. Puig and Dripathi came to T.M.'s

bedside. T.M. was able to flex and ext end the right fingers , to

perform abduction and adduction of the right fingers , and to

extend and flex the right wrist.

4 2 . At 5:30 p.m., Dr. Puig was again at T.M.'s bedside.

Ice was applied to the elevated bicep. The circumference of the

right bicep wa s measured and recorded at 33 centimeters. T.M.

requested that the PACU nurse call Dr. Kelly O'Keefe at Tampa

General Hospital. T.M. spoke to Dr. O'Keefe and advised that

she was coming to the emergency room at Tampa General Hospital.

Dripathi and D r. Puig were aware that T.M. was going to

Tampa General Hospital. Dripathi suggested that an

ultrasound be done.

4 3 . At 6:00 p.m., T.M. requested that she been given

another dose of Fentanyl to help with the pain while she was

traveling to Tampa Gener al Hospital, which was about a n hour

away from the Central Florida Surgery Center. She was

discharged to be transported to Tampa General Hospital by her

husband via automobile. At the time of discharge, there was

continued swelling and redness of T.M.'s right arm. She was

experiencing pain in her right bicep. Her right arm from her

elbow to fingers was eccymotic.

4 4 . T.M. presented at the Tampa General Hospital Emergency

Department approximately an hour after her discharge from the

Central Florida Surge ry Center. When she arrived a t Tampa

General Hospital, her right arm was red and swollen from her

elbow to her fingertips. Her motor/sensory function was intact

with positive radial and ulnar pulse by Doppler. She was

triaged as a semi - urgent patient, A cuity 4.

4 5 . Dr. Kelly O'Keefe examined T.M. and found the

following:

Extremity/Pain - injury to the RUE, pt

underwent surgery today, possible issue with

bp cuff right arm during surgery, pt with

redness and swelling from elbow joint to

finger tips, m/s in tact, positive radial

pulse and dopplarble [sic] ulnar. Had

blepharoplasty and chin tuck done. P a in in

left arm is 10/10. Arm is swollen. Forearm

with petchia [sic] diffusely, NO SOB, no

chest pain. No fever. NO other current

complaints. Cuff on abo ut an hour. Prior

DVT, off Coumadin now, in leg. NO PE in

past. Weakness of hand/wrist associated

with pain. Primary symptom.

4 6 . Dr. O'Keefe's differential diagnosis was the

following:

1. Evaluate for DVT in upper extremity

2. ?arterial occlusion s econdary to cuff

without ongoing evidence of arterial

blockage, but with likely ischemic

neuropathy. Will consult neurology.

Doppler scans ordered.

4 7 . Dr. O'Keefe ordered, among other things, a Doppler

scan, a complete blood count, a cretatine phosphok inase blood

(CPK) study, elevation of the arm, and Fentanyl for pain. He

requested consultations with a neurologist and a vascular

surgeon.

4 8 . At 7:49 p.m., T.M. was given 100 micrograms of

Fentanyl. An ultrasound was performed. After T.M. returned

fr om having an ultrasound done, the nurse noted that T.M. was

complaining of pain in her right arm as ten , on a scale of one

to ten, with ten being the most painful. There was edema to the

right bicep area with stripes of vertical ecchymosis around the

enti re bicep. The bicep was tender to palpitation and slightly

hard to the touch. Petechiae and ecchymosis were noted from

elbow to fingertips. The area from the elbow to the fingertips

was also edematous, tender to palpitation. Radial and ulnar

pulses wer e detected using a bedside Doppler. There was

positive motor/sensory function in the right arm, but slightly

weak. T.M.'s right arm was elevated and ice packs were applied.

4 9 . At 9:36 p.m., the neurologist was at bedside with T.M.

At 9:42 p.m., Dr. O'K eefe noted that T.M.'s pain and swelling

were worsening, which suggested the development of compartment

syndrome.

50 . At 10:07 p.m., T.M. was given another 100 micrograms

of Fentanyl. At 10:45 p.m., T.M. was complaining of pain in her

right arm as a ten , on a scale of one to ten. T.M. stated that

the Fentanyl was not lasting very long. Dr. O'Keefe was

notified, and he ordered one milligram of Dilaudid.

51 . At 9:56 p.m., Dr. O'Keefe noted that the Doppler study

indicated that there was "[n]o evidence of a rterial thrombosis

or high grade stenosis," thus , ruling out DVT. The vascular

surgeon, Dr. Brad Johnson, saw T.M. at 11:23 p.m. Dr. Johnson

was concerned about compartment syndrome. He performed a right

upper arm fasciotomy. His discharge diagnosis wa s right

upper - extremity compartment syndrome.

5 2 . As part of his board certification, Dr. Puig is

required to comply with the American Society of

Anesthesiologists guidelines for anesthesia care. The American

Society of Anesthesiologists has developed St andards for Basic

Anesthetic Monitoring. The preamble provides:

These standards apply to all anesthesia

care although, in emergency circumstances,

appropriate life support measures take

precedence. These standards may be exceeded

at any time based on t he judgment of the

responsible anesthesiologist. They are

intended to encourage quality patient care,

but observing them cannot guarantee any

specific patient outcome. They are subject

to revision from time to time, as warranted

by the evolution of techn ology and practice.

They apply to all general anesthetics,

regional anesthetics and monitored

anesthesia care. This set of standards

addresses only the issue of basic anesthetic

monitoring, which is one component of

anesthesia care. In certain rare or u nusual

circumstances, 1) some of these methods of

monitoring may be clinically impractical,

and 2) appropriate use of the described

monitoring methods may fail to detect

untoward clinical developments. Brief

interruptions of continual monitoring may be

un avoidable. These standards are not

intended for application to the care of the

obstetrical patient in labor or in the

conduct of pain management.

5 3 . Standard II of the Standards for Basic Anesthetic

Monitoring provides:

During all anesthetics, the patie nt's

oxygenation, ventilation, circulation and

temperature shall be continually evaluated.

* * *

BODY TEMPERATURE

OBJECTIVE

To aid in the maintenance of appropriate

body temperature during all anesthetics.

METHODS

Every patient receiving anesthesia shall

have temperature monitored when clinically

significant changes in body temperature are

intended, anticipated or suspected.

5 4 . Loss of large amounts of blood or exposure of body

surface was not contemplated for T.M.'s cosmetic surgery. Since

T.M. was an adult, was almost completely covered by sheets, and

was under a Bair Hugger which supplied forced warm air, Dr. Puig

did not feel that T.M. would experience clinically significant

changes in body temperature. Dr. Puig controlled the amount of

fluid s used during the surgery and anticipated the blood loss

based on the incisions that would be used by Dripathi.

5 5 . Dr. Sanchez - Salazar testified as an expert for the

Department. Dr. Sanchez - Salazar is a board - certified

anesthesiologist. He has been licensed to practice medicine in

Florida since 1963. He has been working as a solo practitioner

in a stand - alone outpatient surgical facility since 1993.

Dr. Sanchez - Salazar testified at the final hearing that he

interpreted the temperature - monitori ng standards of the

American Society of Anesthesiologists to mean that the body

temperature of a patient had to be monitored at all times during

surgery. He also testified at the final hearing that he does

not monitor the patient's temperature during sur geries that last

a short period of time. During his deposition taken on

August 17, 2010, he testified that he did not monitor patients'

temperatures on procedures that lasted an hour or less. He also

opined that the monitoring standards of the American S ociety of

Anesthesiologists required that temperatures be monitored when

the surgery lasted more than an hour. It is clear that Dr.

Sanchez - Salazar did not consider that the monitoring of

temperatures should be determined based on whether a clinically

sig nificant change in temperature would be intended,

anticipated, or suspected. Dr. Sanchez - Salazar's testimony is

not credible.

5 6 . Dr. Nikolaus Gravenstein testified as an expert for

Dr. Puig. Dr. Gravenstein has been licensed to practice in

Florida sinc e 1983. He became board - certified in anesthesiology

in 1984 and has continued to voluntarily recertify. He is a

professor of anesthesiology at the University of Florida.

5 7 . Dr. Raphael Miguel testified by deposition as an

expert for Dr. Puig. Dr. Mig uel has been licensed to practice

in Florida since 1984. He is board - certified in anesthesiology.

Both Dr. Miguel and Dr. Gravenstein opined that based on the

American Society of Anesthesiologists standards for monitoring

that Dr. Puig was not required t o monitor the temperature of

T.M. during surgery because there was a low expectation that

there would be a clinically significant change in T.M.'s

temperature. The testimony of Dr s . Miguel and Gravenstein is

credited.

5 8 . At the final hearing, Dr. Sanchez - Salazar testified

that it was a violation of the standard of care to leave a blood

pressure cuff on a patient who is having surgery when the blood

pressure cuff is not working and that Dr. Puig violated the

standard of care when he left the blood pressure cuff on T.M.'s

right arm. When questioned by counsel for Dr. Puig at his

deposition taken on August 17, 2010, Dr. Sanchez - Salazar

testified that it was not a violation of the standard of care to

leave the blood pressure cuff on T.M. However, when Dr. Sa lazar

was questioned by the Department's counsel in the same

deposition, he opined that it was a violation of the standard of

care to leave the blood pressure cuff on T.M. Dr. Sanchez -

Salazar's testimony concerning leav ing the blood pressure cuff

on T.M. lacks credibility.

5 9 . It is Dr. Gravenstein's opinion that Dr. Puig did not

violate the standard of care when he disconnected from the

monitoring device , but did not remove the blood pressure cuff

from T.M.'s right arm. It is his opinion that most people in

the same situation would not remove the blood pressure cuff ,

because it would be difficult to remove the blood pressure cuff

without violating the sterile field. A violation of the sterile

field would risk infection of the surgical site. In balancing

the need to remove a blood pressure cuff that is not inflated

against the need to keep a sterile field, the anesthesiologist

should leave the deflated blood pressure in place.

Dr. Gravenstein's testimony is credited.

CONCLUSIONS OF LAW

60 . The Division o f Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. §§ 120.569 and 120.57, Fla. Stat. (2010).

61 . The Department has the burden to establish the

allegations in the Administrative Complaint by clear and

convincing evidence. Dep't of Banking & Fin. v. Osborne Stern &

Co. , 670 So. 2d 932 (Fla. 1996). The Department has alleged

that Dr. Puig violated section 458.331(1)(t), which provides

that disciplinary action may be taken for the following:

Notwithst anding s. 456.072(2) but as

specified in s. 456.072(2):

1. Committing medical malpractice as

defined in s. 456.50. The board shall give

great weight to the provisions of s. 766.102

when enforcing this paragraph. Medical

malpractice shall not be cons trued to

require more than one instance, event, or

act.

2. Committing gross medical malpractice.

3. Committing repeated medical

malpractice as defined in s. 456.50. A

person found by the board to have committed

repeated medical malpractice based on s.

456.50 may not be licensed or continue to be

licensed by this state to provide health

care services as a medical doctor in this

state.

Nothing in this paragraph shall be

construed to require that a physician be

incompetent to practice medicine i n 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 medical m alpractice,"

"repeated medical malpractice," or "medical

malpractice," or any combination thereof,

and any publication by the board must so

specify.

6 2 . Section 456.50(1)(g) defines "medical malpractice" as

follows:

"Medical malpractice" means the fail ure to

practice medicine in accordance with the

level of care, skill, and treatment

recognized in general law related to health

care licensure. Only for the purpose of

finding repeated medical malpractice

pursuant to this section, any similar

wrongful act , neglect, or default committed

in another state or country which, if

committed in this state, would have been

considered medical malpractice as defined in

this paragraph, shall be considered medical

malpractice if the standard of care and

burden of proof applied in the other state

or country equaled or exceeded that used in

this state.

6 3 . The Department has alleged that Dr. Puig violated

section 458.331(1)(t) in the following ways:

a. Respondent failed to remove or

adequately loosen or deflate the bl ood

pressure cuff on Patient T.M.'s right arm

when he discovered it was not functioning

properly and discontinued its use;

b. Respondent failed to monitor Patient

T.M.'s body temperature during the period of

general anesthesia;

c. Respondent failed to timely recognize

the presence of T.M.'s compartment syndrome;

d. Respondent failed to adequately assess

Patient T.M.'s complaints and symptoms;

e. Respondent failed to refer Patient

T.M. for specialized consultation for

diagnosis of the conditi on evident on her

right arm;

f. Respondent failed to refer Patient

T.M. to a general surgeon for treatment of

the condition evident on her right arm;

and/or

g. Respondent failed to plan an

appropriate treatment for Patient T.M.

6 4 . The Department has failed to establish by clear and

convincing evidence that it was a violation of the standard of

care to leave the deflated blood pressure cuff on T.M. during

her surgery. At the time that the blood pressure cuff was

disconnected from the monitoring d evice, it was deflated. When

the circulating nurse uncovered T.M.'s arm, the blood pressure

cuff was deflated. It could not be anticipated that leaving the

deflated blood pressure cuff on during the surgery would do any

harm to the patient. Indeed, the evidence was inconclusive that

the blood pressure cuff was the cause of T.M.'s compartment

syndrome. When weighing the potential harm of breaking the

sterile field and risking infection against the unlikelihood

that a deflated blood pressure cuff could ca use complications,

the anesthesiologist should leave the blood pressure cuff in

place.

6 5 . The Department has failed to establish by clear and

convincing evidence that Dr. Puig violated the standard of care

when he did not monitor T.M.'s temperature durin g her surgery.

The standards of monitoring of the American Society of

Anesthesiologists do not require that patients' temperatures be

monitor ed during all surgeries. The standards require that the

temperature be monitored in circumstances in which clinic ally

significant changes in temperature are intended, anticipated or

suspected. In the instant case, because of the covering of T.M,

including the Bair Hugger, the few areas of the body that would

be exposed, and the small amount of fluid that was anticip ated

to be lost, it was not necessary to monitor T.M.'s temperature

during surgery.

6 6 . The Department failed to establish that Dr. Puig

failed to timely recognize the presence of T.M.'s compartment

syndrome, failed to adequately assess T.M.'s complaint s and

symptoms, and failed to plan an appropriate treatment for T.M.

Dr. Puig was present at the time T.M.'s condition was noted at

the end of the surgery. He immediately assessed T.M.'s right

arm. He evaluated it for swelling, color, sensory and motor

function, and the presence of circulation by checking the

pulses. Appropriate treatment was initiated to include

monitoring of the patient, elevation of the arm, application of

ice, and administration of pain medication. This is the same

treatment that T .M. was given when she first arrived at Tampa

General Hospital.

6 7 . Given T.M.'s history of DVT and the symptoms that T.M.

was experiencing right after surgery, monitoring the arm to see

if the swelling and pain reduced was appropriate. While T.M.

was in the PACU at Central Florida Surgery Center, the pain

medication did give her some relief, which contrasted with the

pain associated with compartment syndrome. The swelling in the

forearm did decrease and the swelling in the bicep remained

at 30 centime ters from 3:10 p.m. to 4:00 p.m. By 5:30 p.m., it

was apparent that the swelling had started to increase, and the

pain medication was giving little relief. It was determined

with consultation of Dripath i and T.M. that T.M. needed to

be transferred to another facility. The transfer was arranged,

T.M. was given Fentanyl for the trip to Tampa, and it was

recommended to the doctor at Tampa General Hospital that an

ultrasound be done.

6 8 . The Department has failed to establish that Dr. Puig

failed to re fer T.M. for specialized consultation for diagnosis

of the condition evident on her right arm and failed to refer

T.M. to a general surgeon for treatment of the condition evident

on her right arm. Dr. Puig consulted with Dripathi, who had

training in hand surgery and was familiar with compartment

syndrome. Dripathi was at T.M.'s bedside at times and had

first - hand knowledge of T.M.'s condition. When it became

evident that T.M. needed to be transferred to another facility,

the transfer was made.

6 9 . Based on the totality of the evidence, the Department

has failed to establish that Dr. Puig violated section

458.331(1)(t) by clear and convincing evidence.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMEND ED that a final order be entered finding that

Dr. Puig did not violate section 458.331(1)(t) and dismissing

the Administrative Complaint.

DONE AND ENT ERED this 25th day of March , 2011 , in

Tallahassee, Leon County, Florida.

S

SUSAN B. HARRELL

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Divisio n of Administrative Hearings

this 25th day of March , 2011 .

ENDNOTE

1/ Unless otherwise indicated, all references to the Florida

Statutes are to the 2008 version.

COPIES FURNISHED :

Larry McPherson, Jr., JD, Executive Director

Board of Medicine

Depar tment of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399

E. Renee Alsobrook, Acting General Counsel

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

Jon M. Pellett, Esquire

Barr, Murman, & Tonelli, P.A.

201 E ast Kennedy Boulevard, Suite 1700

Tampa, Florida 33602

Greg S. Marr, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written except ions 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.