06-004638PL Department Of Health, Board Of Medicine vs. Michael Fox, M.D. Status: Closed Recommended Order on Friday, June 22, 2007.

Summary: Respondent violated the standard of care by performing a hysterectomy without lab results.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

) Case No. 06 - 4 638 PL

vs. )

)

MICHAEL FOX , M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

No tice was provided and on April 6 , 200 7 , a formal hearing

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

set forth in S ections 120.569 and 1 20.57(1), Florida Statutes

( 2006 ) . The hearing proceeded by video - teleconferencing between

sites in Tallahassee, Florida , and Jacksonville , Florida . The

hearing was held before by Cha rles C. Adams, Administrative Law

Judge .

APPEARANCES

For Petitioner: Jennifer L. Forshey, Esquire

Irving Levine , Esquire

Departmen t of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Mary Bland Love , Esquire

Scott Pauzar, Esquire

Gobelman, Love, Gavin & Wasilenko

815 South Main Street, Suite 300

Jacksonville , Florida 32 20 7

STATEMENT OF THE ISSUE

Should discipline be impose d against Respondent 's license

to practice medicine for violation of Section 458.331(1)( t ) ,

Florid a Statutes (2003) ?

PRELIMINARY STATEMENT

On September 2 5 , 200 6 , in Case No. 2003 - 29108 before the

Board of Medicine (the Board), the Department of Health (DOH)

brought a n Administrative Complaint against Respondent accusing

him of a violation of the statute referred to in the State ment

of the Issue. The Administrative Complaint was premised upon

the following allegations:

* * *

5. On or ab out September 26, 2003,

Patient T .D., a thirty - one year old female,

presented to Respondent with a history of

worsening pelvic pain, especially

premenstru al, and abnormal menstrual

bleeding. Respondent's clinical impression

was pelvic pain, meno - metrorrhagia and

endometriosis.

6. On or about October 6, 2003, Patient

T. D. returned to Respondent at which time

Respondent and Patient T.D. agreed that

Patient T.D. would undergo a hysterectomy.

7. On or about October 22, 2003, Patient

T.D. was seen by Respondent for a pre -

operative examination. At that time,

Respondent ordered pre - operative lab studies

including a urine pregnancy test.

8. On or about Oc tober 27, 2003, Respondent

performed a total abdominal hysterectomy on

Patient T.D. During Patient T.D.'s

hysterectomy, Respondent took a specimen

which was sent to pathology for evaluation.

9. On or about October 29, 2003, a

microscopic examination of the surgical

specimen was performed and revealed that

Patient T.D. was pregnant at the time

Respondent performed the hysterectomy on

Patient T.D.

10. Respondent did not ascertain the

results of Patient T.D.'s pre - operative

pregnancy test prior to perform ing the

October 27, 2003, hysterectomy on

Patient T.D.

As a consequence , Respondent is alleged to have violated

Section 458.331(1)(t), Florida Statutes (2003) , according to

allegations which state:

* * *

12. Respondent viola ted Section

458.331(1)(t), Florida Statutes, in one or

more of the following ways:

a) by failing to ascertain the results

of Patient T.D.'s preoperative pregnancy

test prior to performing a hysterectomy on

Patient T.D.; and/or

b) by performing a hysterectomy on

Patient T.D. when Patient T.D. was pregnant.

13. Based upon the foregoing, Respondent

violated Section 458.331(1)(t), Florida

Statutes (2003), by failing to practice

medicine with the level care, skill, and

treatment which is recognize d by a

reasonably prudent similar physician as

being acceptable under similar conditions

and circumstances when Respondent failed to

ascertain the results of Patient T.D.'s pre -

operative pregnancy test prior to performing

a hysterectomy on Patient T.D. and by

performing a hysterectomy on Patient T.D.

when Patient T.D. was pregnant.

Respondent was provided several options in addressing the

Administrative Complaint . He chose the third option. That

option was to dispute the allegations of fact contained in the

Administrative Complaint . Through that option , as evidenced in

the form provided him, Respondent asked that he be heard in

accordance with Sections 120.569 and 120.57(1), Florida

Statutes , by an administrative law judge to resolve the dispute.

In pa rticular , Respondent disputed paragraphs 10 through 13 in

the Administrative Complaint , by signing the election of rights

form sworn to before a notary public of the State of Florida on

October 20, 2006. In addition, on October 31, 2006, Respondent

filed an answer to the Administrative Complaint and a request

for formal hearing. He continued to deny the allegations set

forth in paragraphs 10 through 13.

On November 15, 2006, DOH forwarded the case to the

Division of Administrative Hearings (DOAH) to ass ign an

administrative law judge to conduct a hearing in accordance with

Respondent 's request for formal hearing. The assignment was

made by Robert S. Cohen, Director and Chief Judge of DOAH in

reference to DOAH Case No. 06 - 4 638 PL . The assign ment was to t he

present administrative law judge .

After two continuances, the hearing took place on April 6,

2007.

Petitioner presented Jose Cortes, M.D., as its witness,

together with Petitioner's Exhibit s identified as A through G

that were admitted as evidence . Respondent testified in his own

behalf and presented Bryan Cowen, M.D., and Wyatt McNeill, M.D.,

as his witnesses . Respondent 's Exhibit s identified as A through

J were admitted as evidence . Joint Exhibit identified as A was

admi tted as evidence . Petiti oner presented Dr. Cortes as a

rebuttal witness.

At the conclusion of Petitioner 's case in chief , Respondent

moved to dismiss the case based upon the evidence that had been

presented. The motion to dismiss was denied for reasons

explained in the hearing transcript.

Consistent with the Order of Prehearing Instructions, the

parties filed a Joint Prehearing Stipulation. In that

submission t he parties have set out facts upon which they agree.

The factual stipulations are reflected in the findings of fact

to this Recommended Order .

On April 25, 2007, the hearing transcript was filed.

Within the time allotted P etitioner and Respondent filed

proposed recommended order s , which have been considered in

preparing the Recommended Order .

FINDINGS OF FACT

Stipul ated Facts

1. Petitioner is the state department charged with the

regulation of the practice of medicine pursuant to Chapter

20.43, Florida Statutes; Chapter 456, Florida Statutes; and

Chapter 458, Florida Statutes.

2. Respondent is Michael D. Fox, M.D.

3. Respondent is board certified i n obstetrics and

gynecology.

4. Respondent is a licensed medical doctor in the State of

Florida having been issued license ME 66312.

5. Respondent's address is 3627 University Boulevard,

South, Suite 200, Jacksonville, Florida 32216 - 4211.

6. At all times material to this complaint, Respondent

provided professional services as an employee of North Florida

Gynecologic Specialists in Jacksonville, Florida.

7. On or about September 26, 2003, Patient T.D. presented

to Resp ondent with a history of worsening pelvic pain and

abnormal menstrual bleeding.

8. On or about October 6, 2003, Respondent and Patient

T.D. agreed that Patient T.D. would undergo a hysterectomy.

9. On or about October 22, 2003, during a pre - operative

exa mination, Respondent ordered pre - operative lab studies,

including a urine pregnancy test, for Patient T.D.

10. On or about October 27, 2003, Respondent performed a

total abdominal hysterectomy on Patient T.D.

11. During Patient T.D.'s hysterectomy, Re spondent took a

specimen from Patient T.D. , which was sent to pathology for

evaluation.

12. On or about October 29, 2003, a microscopic

examination of the surgical specimen was performed t h at revealed

Patient T.D. was pregnant at the time Respondent perfo rmed the

hysterectomy on Patient T.D.

13. Respondent did not ascertain the correct results of

Patient T.D.'s pre - operative pregnancy test prior to performing

the October 27, 2003, hysterectomy on Patient T.D.

Respondent's Care of Patient T.D.

14. Respo ndent attended medical school at the University

of Alabama, Birmingham, Alabama. He did a four - year residency

in obstetrics and gynecology ( ob / gyn ) in Jackson, Mississippi,

and a two - year sub - specialty fellowship in reproductive

endochrinology in Lexingto n, Kentucky . He is b oard - certified in

reproductive endochrinology and ob/gyn. At present his

specialty is reproductive endochrinology .

15. Respondent has experience in performing hysterectomies

and the pre - operative evaluations associated with those

surgeries. Respondent does 30 to 40 hysterectomies a year.

That number represented his experience in 2003.

16. The principal reason for performing hysterectomies in

his practice , is associated w i th sub - specialty interests,

surgery for endo metriosis a nd adenomyosis, a co - disease with

endometriosis .

17. Respondent has privileges to practice in hospitals in

the Jacksonville , Florida area. In particular, he has

privileges at St. Vincent's, St. Luke's, Baptist, Baptist

Beaches, Memorial and Shands hospi tals . He performs surgeries

in all those hospitals.

18. The hospitals where Respondent practices have computer

systems that allow access to laboratory records and other forms

of information associated with patient care. Although he has

access to the c omputer systems in the facilities, his routine is

to obtain laboratory information in the hospital settin g from

other persons involved in the patient care. He asks those

persons to find out the information for him and report the

finding (s) . Respondent wo uld have access to the pa tient

hospital record , as well as a source for obtaining laboratory

information. Respondent routinely looks at the patient hospital

record in preparing for surgery.

19. Concerning Patient T.D., the subject of this

proceeding, when seen by Respondent she was described as a young

female, of child - bearing age who presented with chronic pain.

She had pain with periods which Respondent found to be

characteristic of adenomyosis . She had pre - cycle pain

approximately a week prior to her menses, another characteristic

of adenomyosis . The patient had irregular bleeding that is an

indication of adenomyosis . The patient was found to have an

enlarged uterus, the primary source of her pain on the

examination. This visit with Respondent , that formed the basis

for his impression , took place on September 26, 2003.

20. On the initial visit Respondent also obtained a

history consistent with endochrin e disorder causing irregular

cycles. In the patient 's case , the cycles extended as much a s

60 days in relation to her periods.

21. Based upon his initial impression , Respondent did not

find evidence that Patient T.D. was pregnant. The patient told

Respondent that she had no desire for fertility. At that time ,

she did not report having a p artner , nor did she indicate that

she was sexual ly active.

22. To further evaluate the Patient T.D. 's condition and

complaints , Respondent ordered an ultrasound test. That study

w as performed on October 2, 2003 , and a gynecological ultrasound

report re ndered. Based upon the report , Respondent held to the

view that the report showed evidence of adenomyosis . There was

a mild and moderate enlargement of the uterus , which Respondent

found to be consistent with adenomyosis . The patient had had a

prio r pre gnancy and delivery and Respondent found the depiction

on the ultrasound of a mild enlargement of the uterus consistent

with the prior pregnancy and delivery.

23. On their next visit , Respondent discussed the choice

of a hysterectom y or some other form o f surgery that did not

involve a hysterectom y , to treat the e ndometriosis and relieve

her symptoms. That visit took place on October 6, 2003 .

24. On October 22, 2003 , Respondent met the patient again.

He reviewed the details of what he believed was the underlying

disease and potential treatments in discussion with the patient .

The patient indicated that she wanted to proceed with the

hysterectom y. T hat choice having been made, t he surgery was

discussed between the patient and Respondent and the necessa ry

paperwork was started to arrange for the surgery in the

hospital.

2 5 . When preparing for surgery Respondent ordered a

pregnancy test to verify whether the patient was pregnant or

not. The nature of the test was a urine pregnancy test under

Responden t 's preoperative orders given October 22, 2003 . The

specimen was collected on October 22, 2003 , and received by

Memorial Hospital (Memorial) , Jacksonville , Florida , where the

hysterectom y was to be performed. The test result was positive

for pregnancy. The point in time that the result was revealed

to Respondent will be discussed beyond this reference to the

result .

2 6 . On October 27, 2003, Respondent began his surgery

cases at Memorial at 7:30 a.m.

2 7 . On that date t here was no indication in the pa tient

record or chart maintained in his office practice that reflected

information concerning the pregnancy test result , nor was that

information found in the hospital chart related to Patient T.D.

Absent the information , Respondent testified that he aske d the

circulating nurse at Memorial about the result of the pregnancy

test. That was Tracy Lloyd, R.N. According to Respondent , t he

nurse went away to check the result and as Respondent d es c rib es

"subsequently told me it was negative." No further effort was

made by Respondent to confirm the oral report that Respondent

says was made by the nurse. Respondent did not document the

results of Patient T.D. 's pre - operative pregnancy t est in the

medical record. It wa s not his habit to write that type of a

pre - operative note. Respondent testified that Ms. Lloyd told

him about the pregnancy test results while in the holding area

in the presence of the patient. Respondent commented that his

question to the nurse would have been "What are the results of

the pregn ancy test?" 1/ Aside from the results of the pregnancy

test, nothing in the patient 's condition , known to Respondent ,

led him to believe that the patient was pregnant.

2 8 . When the laparoscopic surgery commenced , Respondent

did not perform an exam inati on of the patient under anesthesia ,

given his recent examination of the patient in his office and

the results of the ultrasound . Moreover, Respondent does not

believe that such an examination under anesthesia would reveal

anything other than the adenomyos is and the endometriosis which

con formed to his preoperative diagnosis. On that subject, t he

later examinati on of the specimen on October 29 , 2003 , revealed

that Patient T.D. had an early pregnancy, estimated as 4 to 5

weeks. In Respondent 's opinion , in a 4 - to 5 - week pregnancy , the

uterus would not normally achieve the size of a uterus that was

reported on the ultrasound as mildly enlarged , not pregnant .

Mildly enlarged refers to a 6 to 8 weeks ' pregnancy .

2 9 . Respondent expected to see an enlarged uterus because

of the adenomyosis which could be anticipa ted to cause an

inflammatory response in the wall of the uterus , softening the

uterus and giving it an appearance that would be similar to an

early pregnancy .

30 . The rounded globular description of the findings

during surgery were consistent with the expectations in

addressing cases involving adenomyosis , according to Respondent .

31 . Returning to t he surgical specimen obtained in Patient

T.D. 's case , it was examined through surgical pathology

c onducted by Robert E. Barnes, M.D. A report was rendered. The

report explains that i n the examination of the specimen , the

endometrium , " gestational endometr ium with products of

conception " were present. This was the finding related to

Patient T.D. 's pr egnancy.

32 . Dr. Barnes, is a board - certified pathologist in

anatomic and clinical pathology . He describes his findings

pertaining to Patient T.D. , the gestational endometrium with

products of conception, as referring to an early embryo , the

endometri um showing changes associated with pregnancy . In his

opinion the pregnancy was between 10 and 16 days following

conception.

33 . When Dr. Barnes contacted Respondent on October 29,

2003 , to advise of his findings in the pathology . I t was a

brief conver sation and he does not recall the details.

34. After the revelation concerning the p athology,

R espondent 's office staff found the information concerning the

results of the urine pregnancy test in the hospital chart

retained in the computer at M emorial. This finding was made

around November 4, 2003 . In a section within the report on the

pregnancy test it refers to the "Result" and underneath that,

the word "POSITIVE" is entered referring to pregnancy .

35 . When it was discovered that the hysterectom y had been

performed while the Patient T.D. was pregnant, at her post -

surgery scheduled office visit , a discussion was held with the

patient concerning the "checks and balances" in place to avoid

the problem. That refers to the surgery at a time the patie nt

was pregnan t . Respondent talked to the patient about

counseling, or something similar , given the outcome in the case .

3 6 . As a result of the error , steps were taken within

Memorial to address this circumstance. The Respondent and the

Memorial Depart ment of OB / GYN made changes , by requiring a pre -

operative pregnancy test as protocol , that established a urine

pregnancy test within 72 hours of surgery. That test would be

performed by the nurses in the holding area. Respondent now

orders a blood pregna ncy test which is a more sensitive test to

determine pregnancy .

Expert Opinion

37 . Jose Cortes, M.D., is board - certified in ob /gyn ,

licensed to practice in Florida . He was recognized as a expert

in ob/gyn for purposes of expressing his opinion abou t the care

Respondent provided Patient T.D.

38 . Dr. Cortes has done hysterectomies in his practice , as

recent as June 2006. He was called upon to render an opinion

concerning the care Respondent provided Patient T.D. involving

her hysterectomy. He had access to material concerning her care

involved with this case.

39 . Dr. Cortes ' impression of Respondent ' s medical

treatment of the patient in the beginning , was that it was

adequate and correct , with the proper evaluation performed and

an appropriate decision made for surgery.

40. Dr. Cortes expressed the opinion that in performing a

hysterectomy on a woman who is of child - bearing age, which

Patient T.D. was, a physician should order a pre - operative

pregnancy test.

4 1 . In reviewing Patient T.D. 's r ecords Dr. Cortes did not

find a record documenting that the pregnancy test was

ascertained by Respondent , referring to the test results. In

his experience the results of the preoperative tests would be

reflected in the patient's medical records as a matt er of

custom.

42 . Respondent , according to Dr. Cortes , could have

obtained the results of the pre - operative pregnancy test for

Patient T.D. by a fax to his office, a copy obtained through a

computer, laboratory printouts se nt t o Respondent 's office, and

a cop y of the pr e - operative laboratory results obtained by the

hospital placed in i t s medical record.

43 . Dr. Cortes stated the position that an experienced

ob / gyn , and Respondent fits that category, could reasonably be

expected to rely upon an oral r eport from a nurse as to the

results of the pregnancy test , b efore entering the operating

room, in the area of the pre - operative alcove as the patient is

being interviewed by the physician . Dr. Cortes goes on to

explain that if the conversation with the n urse in the presence

of the patient was in the operating room holding area, then the

pregnancy test results would have to have been documented in the

patient chart to find the oral report acceptable. Those test

results as reported would have had to be ent ered by the

physician in the patient chart to meet the standard of care upon

the oral report. 2/

44 . Later on , Dr. Cortes in his testimony seems to

subscribe to the view that an oral report by the nurse as to the

pregnancy test results would meet the st andard of care, assuming

that the Respondent in this case was provided an oral report.

45. I n the testimony at hearing , Dr. Cortes also said that

obtaining an oral report or verbal report on te s t results , in an

emergency situation , would meet the standa rd of care . By

contrast , in elective surgery , such as that being performed on

Patient T.D. , it would be such that there was ample time to

review a chart and laboratory studies before the patient was

brought into the surgical suite .

46. Generally stated , Dr. Cortes accepts that physicians

frequently rely upon oral information imparted by nurses in

performing surgeries, be they elective or emergent, but without

an oral report this concession is not important.

4 7 . Regardl e ss of the pre - conditions for R espondent to

receive and rely on an oral report of the results of the

pregnancy test, without an oral report, there being no other

basis for Respondent 's knowledge of the pregnancy test results,

it was below standards to proceed with the hysterectomy. Thi s

view is taken from Dr. Cortes ' testimony.

4 8 . Dr. Cortes expressed the opinion that it was below the

standard of care to not ascertain the results of the patient's

pre - operative pregnancy test prior to performing a non - emergent

hysterectomy, that is an elective hysterectomy. Dr. Cortes

expressed the opinion that it was below the standard of care for

Respondent to perform a hysterectomy on Patient T.D. while she

was pregnant in an elective setting.

4 9 . In addition to the results of the pregnancy te st ,

Dr. Cortes believes that Respondent had other opportunities to

detect the pregnancy , including an examination of the patient

while she was under anesthesia during the surgery , and would

have allowed a comparison of the results at the time of surgery

ag ainst previous examinations that Respondent had performed on

the patient.

50 . I n referring to the previous examination s compared to

an examination under anesthesia , this included the results of

the ultrasound performed on October 2, 2003 . Dr. Cortes does

agree that the underlying condition visualized under anesthesia

could be associated with p rior pregnancy or the pre - operative

diagnosis of adenomyosis .

5 1 . Dr. Cortes believes that Respondent 's medical records ,

in the context of what could have been fou nd upon an examination

under anesthesia during the surgery, could be consistent with a

possible pregnancy . A change seen in the pelvic examination at

surgery would create an opportunity to evaluate and raise in the

Respondent 's mind any doubt concerning p regnancy . A slight

increase in the size of the uterus between September 26, 2003 ,

and October 27, 2003 , is what is being referred to, promoting

clinical judgment about possible pregnancy .

5 2. Bryan Cowen, M.D. specializes in ob /gyn and

reproductive e ndochrinology . He practices at the University of

Mississippi in Jackson, Mississippi. He is a professor a n d

chair in the Department of OB/GYN and has been for five years.

He has been affiliated with the University of Mississippi for 24

years. He did hi s undergraduate work at the University of

Colorado in Boulder, Colorado, and attended medical school in

Denver, Colorado.

53. Dr. Cowen is licensed to practice medicine in

Mississippi and is board - certified .

5 4. Dr. Cowen has performed a number of hyst erectomies

during his career.

5 5. Dr. Cowen is familiar with the standard of care

applicable for physicians such as Respondent , in the evaluation

of patients suspected of endometriosis and adenomyosis and the

considerations for treatment by hysterectomy . He is also

familiar with the standard of care in relation to pre - operative

testing and the associated duties of physicians when ordering

such tests.

5 6. I n preparing to testify in this case, Dr. Cowen

examined the Memorial medical records , Respondent ' s office

records , and the depositions of Respondent , Dr. Freeman ,

Dr. Widrich , Dr. Barnes , and Dr. Cortes . With this information

in mind , Dr. Cowen was able to provide an opinion concerning the

standard of care in relation to the treatment provided by

Res pondent to Patient T.D. That opinion was that Respondent did

n ot breach the standard of care i n that he met due diligence in

the process by the pre - operative laboratory - ordered, and pre -

operative evaluation a n d assessment.

5 7. Speaking to the September 26, 2003 , office visit,

Dr. Cowen saw nothing on the physical examination to indicate to

him that Patient T.D. was pregnant.

5 8. Concerning the ultrasound that was conducted on

October 2, 2003 , Dr. Cowen 's opinion is that Respondent 's

assessment that P atient T.D. had adenomyosis based upon

presentation , was confirmed by the ultrasound , t he overall

impression being that the Patient T.D. was not pregnant at that

time.

5 9. The further visit by the patient prior to the

hysterectomy did not reveal anything in the history or physical

examination that would suggest that Patient T.D. was pregnant ,

according to Dr. Cowen .

6 0. On October 22, 2003 , the pregnancy test was ordered by

Respondent . T he arrangement of ordering the test, sending the

patient for pre - operative evaluation and laboratory tests is a

common pr actice in Dr. Cowen 's experience.

6 1. In the instance where Respondent did not get a call

from the pre - admission testing as to an y abnormal results in the

pregnancy test, and no report reflect ing i n the patient chart

that the results were normal, Dr. Cowen commented on the need to

check the laboratory result s before taking the patient into the

operating r oom. Based on Dr. Cowen's experience, t here was no

necessity to personally lay eyes on the test results to

ascertain those results. He recognizes that his h ospital may be

different from Memorial in its expectation s but he believes that

Respondent followed Memorial 's policy in accepting the report of

a nurse as to the results of the pregnancy test. Dr. Cowen 's

opinion relies upon the factual predicate that Respondent was

told by a nurse that the pregnancy test was negative , t o the

extent that is not true , and it has not been found as a fact ,

his opinion is without foundation.

6 2. Further, Dr. Cow en believes that in the setting where

surgery is being performed in other than an emergency , it is a

sufficient practice to rely upon an oral report of a nurse

concerning laboratory results , such as the outcome in the

pregnancy test for Patient T.D. In hi s experience he has relied

upon nurses to report both in an emergent and non - emergent

settings. He goes on to describe how those reports come back to

the medical recor ds and the physician signs off, which did not

occur in this case.

6 3. Dr. Cowen was a sked to express his opinion about the

value of an examination under anesthesia as an assist to

understand ing the underlying condition of the Patient T.D.

Dr. Cowen does not believe that this would provide additional

information. In his experience most phy sicians have abandoned

examinations under anesthesia . I f a better insight is needed an

ultrasound is the best choice. To Dr. Cowen , an examination

under anesthesia does not relate to standard of care , it is in

relation to an individual practitioner's pro tocol. An

ultrasound used in this case, a transvaginal ultrasound , may

have shown the gestational sack at the time of the hysterectomy

but proceeding on the basis that a negative pregnancy test had

been established and other findings during the course of the

operation , as well as the preoperative record , would not

indicate the necessity for an ultrasound in this case , a t that

time, the place in time whe re the hysterectomy was being

performed.

64 . Dr. Cowen did not find anything in the intra - operative

fi ndings that would suggest to Respondent that the Patient T.D.

was pregnant.

6 5. Overall Dr. Cowen believes that Respondent met the

standard of care in addressing the case of Patient T.D. , who

probably had polycystic ovarian disease, irregular cycles, wa s

without a sexual partner by history, used condoms for

contraception, had an ultrasound that confirmed a slightly

enlarged uterus and had symptoms compatible with adenomyosis or

endometriosis . Respondent discussed the treatment options, made

an appropri ate pre - operative evaluation, learned that the lab

results for pregnancy were negative (an erroneous assumption) ,

and therefore, he met the standard of care , according to

Dr. Cowen .

66. Ultimately, Dr. Cowen believes that it is essential to

determine wh ether a patient is pregnant prior to performing a

non - emergent/elective hysterectomy , which was not done here.

67 . Wyatt McNeill, M.D., testified. He is an ob / gyn

practicing in Jacksonville , Florida , who in the past has had

privileges at Memorial . He ha s performed hysterectomies at that

facility.

68 . Dr. Mc Neill graduated from Florida State University.

He graduated from the University of Miami Medical School. He is

licensed in the state of Florida and is board - certified in

ob / gyn .

69 . Dr. Mc Neill is familiar with the standard of care in

relation to preoperative laboratory work done before a

hysterectomy.

70. Dr. Mc Neill is familiar with the standard of care

applicable to Respondent in the evaluation of Patient T.D. for

hysterectomy, knowing after the fact that the patient was found

to be pregnant.

7 1 . To familiarize himself with the fact s of this case ,

Dr. McNeill examined the hospital records of Memorial ,

Respondent 's office records, various depositions , to include

that of Dr. Cort es and the anesthesiologist and patholog ist ,

b efore providing testimony. He also examined the testimony of

the nurses involved in the care before offering his opinions.

72 . Concerning the patient history, objective and

subjective evidence available, Dr . Mc Neill did not believe that

there was anything to suggest that Patient T.D. was pregnant.

In particular, Dr. Mc Neill comments on the history and physical

done by Respondent , counseling, laboratory evaluation, and the

decision beyond that to proceed wit h the surgery.

73 . Dr. McNeill found the ultrasound results consistent

with a patient , who by history had a previous child and had the

complaints expressed in the report c oncerning the September 26,

2003 , visit with Respondent . Nothing in the ultrasoun d results

compared to the findings in the operative report indicated to

Dr. McNeill that the patient needed to be examined under

anesthesia . The use of the examination under anesthesia is a

training regimne for residents and students , in his experience .

It has no utility beyond that a p plic ati on , in Dr. McNeill 's

opinion.

74 . Dr. McNeill believes that an oral report of the

results of the pregnancy test meets the standard of care . As

with others, Dr. McNeill assumes that Respondent was told the

test res ults , which is not found . There was no further duty by

Respondent to investigate those results having been told . In

Dr. McNeill 's opinion , the test results are either positive or

neg ative, they are highly accurate . A negative test result

means that the patient is not pregnant. No further duty is

established beyond that realization, according to Dr. McNeill .

75 . In summary, t here is no disagreement among the experts

that Respondent is expected to ascertain the results of the

preoperative pregnancy tes t before performing the hysterectomy

and it would be inappropriate to perform the hysterectomy

without those results. Respondent does not disagree with that

perception.

76. Conceptually, h aving considered the testimony of

Respondent and the experts, it would be acceptable to proceed on

an oral report , if one had been made, a report that the

pregnancy test was negative. 3/

77. Otherwise , t he physical examination of the patient

prior to surgery, the results of the ultrasound , and the

observations intr a - ope ratively made by Respondent did not

indicate that the patient was pregnant. There was no necessity

to make an examination under anesthesia . E ven if made , it would

not necessarily lead to the conclusion that the patient was

pregnant , taki n g into account o ther information known by

Respondent .

Mitigation/ Aggravation

7 8. The outcome here was that the patient underwent a

hysterectomy when she was pregnant , an adverse result.

79 . There is no indication that Respondent has ever been

disciplined in Flori da or other jurisdictions while practicing

medicine.

CONCLUSIONS OF LAW

8 0 . The Division of Administrative Hearings has

jurisdiction over the parties and the subject matter of this

proceeding in accordance with Sections 120.569 , 120.57(1) and

456.073(5) , Florida Statutes (200 6).

8 1 . Respondent is a licensed physician in Florida. He was

issued the license by the Department. The license number is

ME 66312 .

8 2 . Through the Administrative Complaint, Respondent has

been accused of the failure to pract ice medicine with the level

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

reasonably prudent similar physician as being acceptable under

similar conditions and circumstances. The manner of the alleged

violation is that Respondent fell below the s tandard:

a. by failing to ascertain the results of

Patient T.D. 's pre - operative pregnancy test

prior to performing a hysterectomy on

Patient T.D. and; and/or

b. by performing a hysterectomies on

Patient T.D. when Patient T.D. was pregnant.

8 3 . As a consequence , Respondent is alleged to have

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

states in pertinent part:

(1) The following acts constitute grounds

for . . . disciplinary action, as specified

in s. 456.072(2):

* * *

(t) . . . 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. . . . As used in this

paragraph, . . . ' the fail ure 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, ' shall not be construed

so as to require more than one inst ance,

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

o f the board finding a violation under this

paragraph shall specify whether the licensee

was found to have committed . . . ' failure

to practice medicine with that level of

care, skill, and treatment which is

recognized as being acceptable under simila r

cond itions and circumstances,' . . . and any

publication by the board must so specify.

84 . This hearing has been held recognizing the procedural

expectations set forth in Section 456.073(5), Florida Statutes

(2006), which states:

(5) A formal hearing before an

administrative law judge from the Division

of Administrative Hearings shall be held

pursuant to chapter 120 if there are any

disputed issues of material fact. The

determination of whether or not a licensee

has violated the laws and rules regulating

th e profession, including a determination of

the reasonable standard of care, is a

conclusion of law to be determined by the

board, or department when there is no board,

and is not a finding of fact to be

determined by an administrative law judge.

The admin istrative law judge shall issue a

recommended order pursuant to chapter 120.

. . .

85 . In accordance with Section 458.331(1)(t), Florida

Statutes (2003), in this Recommended Order it must be specified

whether Respondent failed to practice medicine with that level

of care, skill and treatment which is recognized as being

acceptable under similar conditions and circumstance s.

Ultimately, the Board in its Final Order determine s whether

Respondent violated Section 458.331(1)(t), Florida Statutes

( 2003 ), as to the issue of pursuit of a reasonable standard of

care, a legal conclusion. § 456.073(5), Fla . Stat . ( 2006 ). But

not before findings of fact have been made concerning

Respondent 's alleged "failure to practice medicine with that

level of care, skill an d treatment which is recognized as being

acceptable under similar conditions and circumstance s," to

include the underlying facts that relate to patient care and the

opinion of experts on standard of care.

86 . This is a disciplinary case, and for that re ason

Petitioner bears the burden of proof. That proof must be

sufficient to sustain the allegations in the Administrative

Complaint by clear and convincing evidence. Se e Department of

Banking and Finance , Division of Securities and Investor

Protection v. Osborne Stern and Co. , 670 So. 2d 932 (Fla. 1996);

and Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987) . The term

clear and convincing evidence is explained in the case In re:

Davey , 645 So. 2d 398 (Fla. 1994) , quoting , with approval from

Slomowitz v. Wa lker , 429 S o . 2d 797 (Fla. 4th DCA 1983).

87 . Given the penal nature of this case, Section

458.331(1)(t), Florida Statutes (2003), has been strictly

constructed. Any ambiguity favors the Respondent . See State v.

Pattishall , 99 Fla. 296 and 126 So. 147 (Fla. 1930), and Lester

v. Department of Professional and Occupationa l Regulation, State

B o a rd of Medical Examiners , 348 So. 2d 923 (Fla. 1st DCA 1977).

88 . As referred to previously, the disciplinary response

that may be imposed should Res pondent be found in violation of

Section 458.331(1)(t), Florida Statutes (2003), is set forth in

Section 456.072(2), Florida Statutes ( 2003 ), which states:

(2) When the board . . . finds any person

guilty . . . of any grounds set forth in the

applicable practice act, . . . it may enter

an order imposing one or more of the

following penalties:

* * *

(b) Suspension or permanent revocation of a

license.

(c) Restriction of practice or license,

including, but not limited to, rest ricting

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,

restr icting 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 welfare.

(d) Imposition of an administrative fine

not to exceed $10,000 for e ach 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 fine of

$10,000 per count or offense.

(e) Issuance of a reprimand or letter of

c oncern.

(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 u ndergo

treatment, attend continuing education

courses, submit to be reexamined, work under

the supervision of another licensee, or

satisfy any terms which are reasonably

tailored to the violations found.

(g) Corrective action.

(h) Imposition of an adm inistrative fine in

accordance wi th s. 381.0261 for violations

regarding patient rights.

(i) Refund of fees billed and col lected

from the patient or a third party on behalf

of the patient.

( j) Requirement that the practitione r

undergo remedial education.

In determining what action is appropriate,

the board, . . . must first consider what

sanctions are necessary to prote ct the

public or to compensate the patient. Only

after those sanctions have been imposed may

the disciplining authority consider and

include in the order requirements designed

to rehabilitate the practitioner. All costs

associated with compliance with or ders

issued under this subsection are the

obligation of the practitioner.

89 . Clear and convincing evidence was presented to show

that Respondent failed to practice medicine with that level of

care, skill , and treatment which is recognized by a reasonab ly

prudent similar physician as being acceptable under similar

conditions and circumstance s. When Respondent failed to

ascertain the results of Patient T.D. 's pre - operative pregnancy

test and then proceeded to perform the hysterectomy, this was

below the standard of care .

9 0 . Florida Administrative Code Rule 64B8 - 8.001 sets forth

disciplinary guidelines for a licensed violation associated with

Section 458.331(1)(t), Florida Statutes ( 2003 ). For a first

offense the suggested range of punishment is from a one - year

probation to revocation and an administrative fine from

$1,000.00 to $10,000.

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

addresses aggravating and mitigating circumstance s in

determining an appropriate punishment where it states:

(3 ) Aggravating and Mitigating

Circumstances. Based upon consideration of

aggravating and mitigating factors present

in an individual case, the Board may deviate

from the penalties recommended above. The

Board shall consider as aggravating or

mitigating f actors the following:

(a) Exposure of patient or the public to

injury or potential injury, physical or

otherwise: none, slight, severe, or death;

(b) Legal status at the time of the

offense: no restraints, or legal

constraints;

(c) The number of counts or separate

offenses established;

(d) The number of times the same offense or

offenses have previously been committed by

the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction

and the length of practice;

(f) Pecuniary benefit or self - gain inuring

to the applicant or licensee;

(g) The involvement in any violation of

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

controlled substances for trade, barter or

sale, by a licensee. In such cases, the

Board will deviate from the penalties

recommended above and impose suspension or

revocation of licensure.

(h) Any other relevant mitigating factors.

Patient T .D. was injured by the Resp ondent 's choice in providing

treatment. There w ere no legal re straints or constraints placed

on Respondent at the time of the violation. The violation

concerns a single count and a significant failure in judgment.

No indication was given that Respondent has comm itt ed this same

offense at any other time. Respondent has no disciplinary

history. Respondent has not experienced pecuniary benefit or

self - gain as a result of the violation. None of the violations

conce rn themselves with the provision of controlled substances

by the Respondent .

RECOMMENDATION

Based upo n the findings of facts found and the conclusions,

it is

RECOMMENDED:

That a final order be entered finding Respondent in

violation of Section 458.331(1)( t ), Florida Statutes (200 3 ), and

imposing an administrative fine of $10,000.00, requiring

Responde nt to take a course on Ri s k Management for physicians,

and issuing a letter of reprimand.

DONE AND ENTERED this 22nd day of June , 200 7 , in

Tallahassee, Leon County, Florida.

S

___________________________________

CHARLES C. ADAMS

Administrative La w Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 22nd day of June , 200 7 .

ENDNOTES

1/ Recollection of the doctors and nurses on duty at Memorial

at the time this patient was being cared for at the hospital:

Tracy Lloyd, R.N., became a registered nur se in 1988 and

was licensed in Florida in 1999. She worked in the perinatal

operating room a t Memorial when Patient T.D. had her

hysterectom y.

On October 27, 2003, Ms. Lloyd was the circulating nurse.

She helped get the operating room ready befo re surgery,

including the sterile supplies. She went to the holding area

and interviewed patients before taking them back to the

operating room where she assisted them onto the operating

table ( s ) , and assisted the anesthesi ologist with induction. She

was responsible for filling out operating room paperwork.

Ms. Lloyd has no recollection of being involved in the

treatment of Patient T.D. on the date in question. According to

the chart for Patient T.D. and upon Ms. Lloyd's recollection she

reviewed all of the documents in the chart including the pre - op

holding record. The documents in the chart would include lab

results. If any lab results were missing, the practice was for

Ms. Lloyd to go to the holding room nurse and let her know that

the labs we re not in the chart and to wait until they were

printed out. She has no recollection of that approach in

Patient T.D. 's case. When asked if she had any discussion with

Respondent about lab results in the patient 's case, she replied

"I do not remember."

Ms. Lloyd said that she did not remember informing

Respondent that Patient T.D. was not pregnan t or providing any

information on that subject to Dr. Jason Brian Widrich , the

anesthesiologist in the case.

The occasion upon which Ms. Lloyd v aguely recalls finding

out about Patient T.D. 's pregnancy , was sometime after the

conclusion of the hysterectomy surgery , when told by her

supervisor that the results of the pathology showed the products

of conception. After being told about the results o f the

pathology , Ms. Lloyd had no conversation(s) with Respondent and

Dr. Widrich on the subject.

Ms. Lloyd was in attendance during the hysterectomy surgery

performed on Patient T.D. by Respondent .

Ordinarily, when Ms. Lloyd worked in the o perating room she

would interview the patient, using the preoperative assessment

checklist and assess the preoperative anesthesia questionnaire

for the anesthesio logist, verbally verify the nature of the

procedure with the patient and the consent. Ms. Llo yd would

review the lab work in the chart. If a positive pregnancy test

was found, her practice would be to communicate that finding

with to surgeon as well as the anesthesiologist . On this

occasion she has no recollection or record of having done that.

Michelle Davis Singleton, R.N., became a registered nurse

in 1994. On October 27, 2003 , she was responsible for pre - op

paperwork at Memorial and did the paperwork for Patient T.D.

She also worked in the recovery room on that shift. The

hospital' s patient chart for Patient T.D. refers to a urine

pregnancy test, CBC and a chest x - ray . Nurse Singleton signed

this form as part of the pre - op orders. It was her

responsibility to check to see that those orders were completed

by looking in the computer . She has no independent recollection

of what may have been done in Patient T.D. 's case.

Normally n urse Singleton would print out the results of a

laboratory test , such as the urine test and put them in the

patient chart. Sometimes it would be ne cessary to call the lab

to obtain the results when the results were not yet in the

computer.

By markin g "other: HCG" in a box on Patient T.D. 's chart

at Memorial , Ms. Singleton was indicating that the pregnancy

test had been completed but she does not recall whether she

obtained the results of that test.

Nurse Singleton has no recollection of communicating with

Respondent concerning Patient T.D. on October 27, 2003 .

Specifically, she has no recollection of telling Respondent that

Patient T .D. was either pregnant or not pregnan t on that date,

nor does she recall telling Dr. Widrich whether the patient was

pregnant or not pregnant on that date.

Another nurse that cared for Patient T.D. on the date at

issue, was Debra N. Floyd, R.N . The patient was turned over for

care from n urse Singleton to n urse Floyd on October 27, 2003 .

It would have been normal practice for Nurse Singleton to tell

Nurse Floyd the results of the pregnancy test , be it a negative

or positive result. Nurse Sing leton is not certain whether she

told Nurse Floyd the results of the pregnancy test on

October 27, 2003 , in relation to Patient T.D.

Nurse Singleton recognizes that if the pregnancy test had

been positive, she would have typically communicated w ith the

Respondent because it would indicate a "red flag." A report

concerning the outcome of the pregnancy test would not have been

made without looking at the lab results. Nurse Singleton does

not believe that she would have been mistaken about positiv e

results being perceived as negative results in the pregnancy

test.

Debra N. Floyd, R.N. was licensed in 1983. On October 27,

2003 , Nurse Floyd was also involved with pre - op care for the

patient. Nurse Floyd has no recollection of any results of a

pregnancy test for Patient T.D. that may have been in the chart

at Memorial . Generally stated, Nurse Floyd has no recollection

of whether the patient was pregnant on the date that she saw

Patient T.D. Nurse Floyd is uncertain concerning whether she

sa w the Respondent on October 27, 2003 prior to the surgery on

Patient T.D.

Normal protocol would require n urse Floyd to look at an

electronic record to determine the lab results if they were

missing in the patient 's chart.

Nurse Floyd found out that Patient T.D. was pregnan t a

couple of weeks after the surgery.

Again, Jason Brian Widrich, M.D., was the anesthesiologist

during Patient T.D. 's surgery. Respondent and Dr. Widrich did

not speak concerning whether Patient T.D. was pregnan t or not

before surgery . Dr. Widrich did not overhear a nurse tell

Respondent about the results of the urine pregnancy test related

to Patient T.D. Dr. Widrich did not find out that Patient T.D.

had been pregnant at the time of the hysterectomy until a f ew

weeks later. In performing his duties , Dr. Widrich did not

review Respondent 's orders in Patient T.D. 's case. Dr. Widrich

acted independently in making determinations about anesthesi a

management for the patient.

Michael L. Freeman, M.D., is a board - c ertified obstetri cian

and gynecolog ist involved with Patient T.D. 's care during the

date s pertinent to the case. He saw Patient T.D. on October 2,

2003 , and assisted in the hysterectomy. Dr. Freeman does not

believe that he had any discussion with Respon dent about Patient

T.D. 's care prior to the surgery. When in the operating room,

there was no discussion between Respondent and Dr. Freeman

concerning the urine pregnancy test.

Having considered Respondent 's testimony and that of the

other witnesses involved in the patient care, Respondent 's

testimony that he was told that the pregnancy test was negative

is rejected. It is not found credible.

2/ This latter reference to the need for the physician to

document is outside the allegations in the Adm inistrative

Complaint .

3/ Petitioner made a prima facie showing that those test

results were not known by Respondent before proceeding with the

hysterectomy, the hypothetical presented to Dr. Cortes ,

Petitioner 's witness, to the effect that the test r esults were

kno wn before proceeding to surgery notwithstanding . Respondent

failed to establish in his defense that he knew the result

before performing the hysterectomy.

COPIES FURNISHED :

Jennifer L. Forshe y, Esquire

Irving Levine , Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Mary Bland Love , Esquire

Scott Pauzar, Esquire

Gobelman, Love, Gavin & Wasilenko

815 South Main Street, Suite 300

Jacksonville , Fl orida 32207

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

Josefina M. Tamayo, General Counsel

De partment of Health

4052 Bald Cypress Way , Bin A02

Tallahassee, Fl orida 32399 - 1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the final order in this case.