00-004183PL Department Of Health, Board Of Medicine vs. Aiden Matthew O`rourke, M.D. Status: Closed Recommended Order on Friday, January 26, 2001.

Summary: Department failed to prove standard of care or that surgeon deviated from standard of care in performing hepatic resection. Department failed to prove that medical records did not justify treatment. Administrative Complaint should be dismissed.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 00-4183PL

)

AIDEN MATTHEW O'ROURKE, M.D., )

)

Respondent. )

__________________________________)

RECOMMENDED ORDER

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

on December 11 and 12, 2000, in Miami, Florida, before Patricia

Hart Malono, the duly-designated Administrative Law Judge of the

Division of Administrative Hearings.

APPEARANCES

For Petitioner: Eric S. Scott, Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Rose Marie Antonacci-Pollock, Esquire

Mihcaud Buschmann

33 Southeast 8th Street

Boca Raton, Florida 33432-6121

STATEMENT OF THE ISSUE

Whether the Respondent committed the violations alleged in

the Administrative Complaint dated August 30, 2000, and, if so,

the penalty that should be imposed.

PRELIMINARY STATEMENT

In a two-count Administrative Complaint dated August 30,

2000, the Department of Health ("Department") charged Aiden

Matthew O'Rourke, M.D., with having violated Section 458.331(1),

Florida Statutes, with respect to the treatment he provided to

patient R.F. In Count I, the Department charged that

Dr. O'Rourke failed 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, in violation of Section

458.331(1)(t), Florida Statutes, by failing to anticipate and

plan for excessive blood loss during R.F.'s surgery; failing to

take appropriate intraoperative measures to stop R.F.'s blood

loss; failing to consult a cardiologist preoperatively regarding

R.F.'s condition; failing to anticipate the cirrhotic state of

R.F.'s liver; and/or inappropriately electing to proceed with a

non-anatomic hepatic resection in spite of R.F.'s blood loss.

In Count II, the Department charged that Dr. O'Rourke failed to

keep written medical records documenting a preoperative

assessment of R.F., documenting appropriate preoperative

planning, and/or documenting R.F.'s existent medical conditions,

in violation of Section 458.331(1)(m), Florida Statutes.

Dr. O'Rourke timely requested a hearing pursuant to

Sections 120.569 and 120.57(1), Florida Statutes, and the

Department forwarded the matter to the Division of

Administrative Hearings for assignment of an administrative law

judge. Following notice, the hearing was held on December 11

and 12, 2000.

At the hearing, the Department presented the testimony of

Dorothy Grisham and John W. Kilkenny, III, M.D. Petitioner's

Exhibits 1 through 4 were offered and received into evidence.

Dr. O'Rourke testified in his own behalf and presented the

testimony of Danny Sleeman, M.D. Respondent's Exhibits 1

through 3 were offered and received into evidence.

The two-volume Transcript of the hearing was filed with the

Division of Administrative Hearings on December 20, 2000, and

the parties timely filed proposed findings of fact and

conclusions of law, which have been considered in preparing this

Recommended Order.

FINDINGS OF FACT

Based on the oral and documentary evidence presented at the

final hearing and on the entire record of this proceeding, the

following findings of fact are made:

1. The Department of Health, Board of Medicine, is the

state agency charged with regulating the practice of medicine in

Florida. Section 20.43 and Chapters 455 and 458, Florida

Statutes (1997).

2. Dr. O'Rourke is, and was at the times material to this

proceeding, a physician licensed to practice medicine in

Florida, having been issued license number ME 0044786. He has

been in private practice in Fort Lauderdale, Florida, since 1985

and was board-certified by the American Board of Surgery in 1987

and re-certified in 1997. Dr. O'Rourke has been the Chief of

Surgery at Broward General Medical Center since 1997.

3. In early 1996, R.F., a 65-year-old woman, was referred

to Dr. O'Rourke by Dr. Rajendra P. Gupta, a physician who had

treated R.F. at the Broward General Medical Center Clinic

("Clinic") in 1995 and early 1996. The purpose of the referral

was for a surgical consultation regarding a mass on R.F.'s

liver. 1/

4. Dr. O'Rourke first saw R.F. at the Clinic on

February 14, 1996, and on February 21, 1996, R.F. returned to

see Dr. O'Rourke for preoperative testing. Dr. O'Rourke

examined R.F., took a patient history, and ordered several

preoperative tests. Dr. O'Rourke also reviewed R.F.'s medical

records from the Clinic and her hospital chart from Broward

General Medical Center ("Broward General"). These documents

included, among other things, the record of prior consultations

with physicians at Broward General, the films from a recent

M.R.I. and a recent CT scan, and the results of a CT-guided

biopsy, x-rays, sonograms, blood tests, and an esophageal

endoscopy. The CT-guided biopsy did not confirm or rule out the

possibility that the mass on R.F.'s liver was cancerous.

However, because tests showed that R.F.'s alpha-fetoprotein

levels 2/ were abnormal, Dr. O'Rourke considered the mass to

be a cancerous tumor and, therefore, lethal.

5. Based on the results of the tests ordered by Dr. Gupta

and by Dr. O'Rourke and on the information in R.F.'s medical

records and hospital chart, Dr. O'Rourke decided that it would

be appropriate to perform an exploratory laparotomy on R.F. to

evaluate the mass and, if indicated, perform a right hepatic

segmentectomy, or resection, to remove the mass. Dr. O'Rourke

explained the gravity of the situation to R.F. and told her that

he wanted to perform exploratory surgery to determine if the

mass on the liver could be removed and to remove it, if

possible. R.F. discussed the proposed surgery with her family

and notified Dr. O'Rourke that she would have the surgery.

6. In deciding that an exploratory laparotomy was

appropriate for R.F., Dr. O'Rourke considered and evaluated the

risk that R.F. would have excessive bleeding during the

procedure. The presence of significant cirrhosis of the liver

is one indication that a patient might bleed excessively during

a hepatic resection. 3/ The results of the esophageal

endoscopy performed on R.F. in October 1995 did not show the

presence of esophageal varices, nor did the results of R.F.'s CT

scan show the presence of ascites. Both of these conditions are

indicative of portal hypertension, which is increased blood

pressure in the portal triad that provides blood to the liver.

4/ Portal hypertension is caused by a slowing of the blood flow

through the liver, which is, in turn, caused by cirrhosis of the

liver. Because there was no evidence of portal hypertension in

R.F.'s test results, there was no conclusive preoperative

evidence that R.F.'s liver was cirrhotic. 5/

7. Nonetheless, based on other indications in R.F.'s

medical records and test results, Dr. O'Rourke considered it

highly probable that R.F.'s liver was cirrhotic. R.F. was at

high risk of cirrhosis because she had a positive hepatitis

profile for Hepatitis B and C, because she had a probable

primary cellular carcinoma in the liver, and because her

outpatient medical records revealed a persistent elevation of

cellular enzymes in her liver. However, the extent of R.F.'s

cirrhosis could not be precisely determined through preoperative

testing; it could only be conclusively determined

intraoperatively. The more important consideration in

Dr. O'Rourke's evaluation of R.F. as a candidate for an

exploratory laparotomy and possible hepatic resection was the

functional ability of R.F.'s liver. There was no preoperative

evidence that R.F.'s liver function was abnormal; her PT levels

and her bilirubin levels, both important indicators of liver

function, consistently tested within the normal range.

8. Dr. O'Rourke also considered the possibility that

R.F.'s tumor was particularly vascular, 6/ which would also

indicate that R.F. would bleed excessively during surgery. It

is not possible to determine conclusively before surgery if a

tumor is vascular; that determination can only be made once the

tumor is visible and can be manipulated. However, there was no

preoperative evidence that R.F.'s tumor was particularly

vascular. R.F. tolerated a CT-guided biopsy of the liver prior

to surgery; there was nothing in the biopsied tissue that

indicated the tumor was particularly vascular, nor was there any

significant bleeding as a result of the biopsy. This would

indicate that R.F.'s tumor was not particularly vascular.

9. Dr. O'Rourke did not request a preoperative cardiology

consultation for R.F. because there were no indications of a

cardiac risk in her medical records or in her test results.

Although R.F. had diagnoses of systemic hypertension and of

atrial fibrillation, both of which are very common, the

hypertension was controlled by Accupril and a diuretic, and

neither the hypertension nor the atrial fibrillation would

indicate the need for a cardiology consultation. R.F.'s EKG was

interpreted as borderline; and there were no indications in her

medical records that R.F. had ischemic heart disease. In

addition, the anesthesiologist who was to administer anesthesia

to R.F. during the surgery did not request a cardiology

consultation. 7/ Had the anesthesiologist been concerned about

R.F.'s cardiac fitness to tolerate general anesthesia, he or she

would likely have cancelled or deferred the surgery.

10. The only documentation of the location of the hepatic

mass that Dr. O'Rourke included in R.F.'s medical records was a

notation that the indicated procedure was a right hepatic

segmentectomy. However, even though Dr. O'Rourke did not more

precisely set forth the location of the mass in the

documentation, he knew the exact location of the mass from

having examined the film of the CT scan and of the M.R.I.

performed on January 3, 1996, which showed an "ovoid solitary

mass along the dome of the right lobe of the liver." In

addition, the report of the sonogram performed on November 21,

1995, which was available to and reviewed by Dr. O'Rourke,

showed a "focal mass on the diaphragmatic surface of the right

lobe of the liver."

11. On February 27, 1996, Dr. O'Rourke performed

exploratory surgery on R.F. to determine the resectability of

the liver tumor. Ultimately, Dr. O 'Rourke performed a non-

anatomic hepatic resection to remove the tumor.

12. Dr. O'Rourke prepared adequately for the possibility

that R.F. would experience blood loss during the exploratory

laparotomy. As noted above, however, there were no preoperative

indicators that R.F. would experience excessive blood loss.

Dr. O'Rourke requested that a cell saver be available in the

operating room during R.F.'s surgery, 8/ and the

anesthesiologist ordered R.F.'s blood to be typed and screened

to identify the correct blood type. Dr. O'Rourke did not order

R.F.'s blood to be typed and cross-matched, which provides the

most specific information about the particular type of blood

required by the patient. Although the better practice is to

have the patient's blood typed and cross-matched prior to

surgery, it takes only ten minutes to obtain typed and cross-

matched blood from the blood bank should the patient lose more

blood than can be replaced by the cell saver. 9/

13. R.F.'s blood pressure was monitored during the surgery

by an arterial line, and good access was provided for the

introduction of fluids into R.F. through two intravenous lines

placed by the anesthesiologist, one 16-gauge line and one

18-gauge line. Dr. O'Rourke did not place a "central line," o r

central venous pressure ("CVP") line, 10/ into R.F.

preoperatively. The anesthesiologist usually makes the decision

to insert a CVP line preoperatively, and, in R.F.'s case,

Dr. O'Rourke agreed with the anesthesiologist that it was not

necessary. Some surgeons routinely insert CVP lines

preoperatively when performing an exploratory procedure such as

Dr. O'Rourke was performing on R.F.; other surgeons prefer to

wait until they are sure that they will perform the hepatic

resection because there are a multitude of risks attendant to

the insertion of a CVP line, a bleeding pneumothorax being the

most common. 11/

14. Dr. O'Rourke began the exploratory laparotomy by

opening R.F.'s belly and removing scar tissue that resulted from

prior surgery. He dissected into the abdomen, down to the

fascia, and again removed scar tissue that resulted from prior

surgery. He divided the falciform ligament and removed it at

the point where it attaches to the liver, a procedure that is

necessary before the liver can be mobilized. Dr. O'Rourke moved

the falciform ligament further up to its diaphragmatic

attachment so that he could have full access to the dome of the

liver, where R.F.'s tumor was located.

15. Once the falciform ligament was separated from the

liver, Dr. O'Rourke palpated the tumor and determined that it

was very fragile and tended to crumble.

16. Dr. O'Rourke then mobilized R.F.'s liver. 12/ When

he did so, the tumor ruptured, and R.F. started to bleed from

the posterior of the liver. R.F.'s blood pressure fell

dramatically, a condition known as hypotension, and she became

unstable. Dr. O'Rourke's first priority was to stop the

bleeding and stabilize R.F.'s blood pressure, and he decided to

pack the liver, the most extreme technique used to stop bleeding

in or around the liver. Unfortunately, once a patient

undergoing hepatic surgery begins to bleed, it is very difficult

to stop the bleeding. 13/

17. The Pringle maneuver is one technique that can be used

to control bleeding in and around the liver. This technique

requires dissecting around the portal triad and clamping the

hepatic artery and the portal vein in order to stop temporarily

the blood flow from the portal triad into the liver.

Dr. O'Rourke's decision to pack R.F.'s liver rather than at tempt

the Pringle maneuver was based on several factors. First, R.F.

had a significant amount of scar tissue on her anterior

abdominal wall, and Dr. O'Rourke anticipated that, given her

rapidly deteriorating condition, it would take too much time to

dissect through the scar tissue to expose the portal triad.

Second, the Pringle maneuver provides only a temporary solution

because the portal triad can be clamped and the blood flow into

the liver stopped for no more than 15 minutes at a time; the

maneuver can be repeated if necessary when working with a

healthy liver but it is very risky to do so when working with a

cirrhotic liver such as R.F.'s. Third, although it can be

helpful to a surgeon trying to find the source of bleeding to

temporarily stop the blood flow from the portal triad,

Dr. O'Rourke already knew that the bleeding originated in the

posterior of the liver, behind the tumor.

18. At the same time that Dr. O'Rourke was packing the

liver, the anesthesiologist was resuscitating R.F. with fluids

and calling the blood bank to order cross-matched blood.

19. After packing the liver, Dr. O'Rourke observed the

site of the bleeding for 15 to 20 minutes, during which time the

bleeding decreased slightly but not significantly. R.F.'s

parameters did not improve, and Dr. O'Rourke decided to close

the abdomen. After closing the abdomen, Dr. O'Rourke inserted a

CVP line; the CVP line was inserted primarily for the purpose of

more quickly introducing fluids and blood products into R.F.

Once he had placed the CVP line, Dr. O'Rourke assisted the

anesthesiologist in attempting to resuscitate R.F. by the rapid

infusion of fluid and blood. At this point, Dr. O'Rourke

anticipated that R.F. would stabilize, and, once she had

stabilized, Dr. O'Rourke intended to wait 24-to-48 hours, reopen

the abdomen, remove or replace the lap packing, and close the

abdomen without removing the tumor. He decided that, when he

re-opened the abdomen, it would be too risky to proceed with the

tumor resection because of the likelihood that R.F. would again

begin bleeding.

20. Dr. O'Rourke's plans changed because R.F.'s blood

pressure did not significantly improve after approximately 20

minutes, and the degree of her hypotension was out of proportion

to her actual blood loss, which Dr. O 'Rourke estimated as 300-

to-400 cubic centimeters. Under these circumstances,

Dr. O'Rourke felt that he had two alternatives: to do nothing

and let R.F. die or to re-explore the liver. He, therefore, re-

opened the incision, removed the packing, and confirmed that the

packing had not controlled the bleeding. When packing fails to

control the bleeding, the surgeon has a serious problem and a

limited number of options: The surgeon can temporarily stop the

flow of blood into the liver by using the Pringle maneuver; the

surgeon can extend the incisions under the ribs or into the side

and fully mobilize the liver 14/ to expose its posterior and

possibly locate the source of the bleeding; or, the surgeon can

remove the tumor to try to gain access to the vessels that are

bleeding so that they can be suture- ligated.

21. Dr. O'Rourke had already rejected the Pringle maneuver

as too time-consuming and unlikely to be successful in stopping

the bleeding. He decided not to fully mobilize the liver

because R.F.'s liver was cirrhotic, and therefore somewhat

brittle, so that, had he attempted to mobilize the liver fully,

he risked exacerbating the bleeding. In any event, the tumor

was completely accessible to Dr. O'Rourke without fully

mobilizing the liver.

22. Dr. O 'Rourke decided that, under the circumstances,

the best chance of saving R.F. was to remove the tumor, thereby

gaining access to the posterior of the liver and to the hepatic

veins, which he suspected were the source of the bleeding. Once

the tumor was removed, he could suture- ligate the blood vessels

from which the bleeding originated. Accordingly, Dr. O'Rourke

performed a non-anatomic hepatic resection. He found that the

tumor resection itself was easy and presented no problems. He

individually suture- ligated the vessels that provided the

tumor's blood supply and brought the bleeding down to a low

level. Dr. O'Rourke felt that he had controlled the bleeding,

and R.F.'s hepatocrit level was brought back to a low-normal,

but acceptable, level. Nonetheless, R.F.'s blood pressure did

not improve and actually deteriorated.

23. Despite the successful efforts to control the bleeding

and the efforts to resuscitate R.F. by transfusing blood and

fluids, her condition continued to deteriorate, and she was

pronounced dead at 6:23 p.m. on February 27, 1996. Dr. O'Rourke

spoke with R.F.'s family and told the family members that the

amount of R.F.'s blood loss did not explain why her blood

pressure fell so low or why her condition continued to

deteriorate in spite of his having controlled the bleeding and

in spite of the efforts to resuscitate her with blood and

fluids. He asked the family for permission to do an autopsy to

determine what had happened. The family refused, although they

later had a private autopsy done at Jackson Memorial Hospital in

Miami, Florida. The cause of death stated in the autopsy report

was "[e] xsanguination post subtotal hepatic resection."

24. The evidence submitted by the Department is not

sufficient to establish with the requisite degree of certainty

that Dr. O'Rourke failed to keep adequate medical records to

justify the course of his treatment of R.F. Because R.F. was a

Clinic patient, Dr. O'Rourke had access to the medical records

kept since her first consultation with Dr. Gupta i n

October 1995, as well as access to all of the results of the

tests performed on her from October 1995 through the date of

surgery. In the record of his examination of R.F., Dr. O'Rourke

included her surgical history, her medical history, a list of

the medications R.F. was taking, and the results of his physical

examination of R.F. His proposed treatment of R.F. was

identified in the documentation as a right hepatic resection.

Taken altogether, the documentation in this case adequately

justifies Dr. O'R ourke's decision to do an exploratory

laparotomy and a right hepatic resection, if indicated, and

there is no evidence that additional documentation was required.

15/

25. The evidence presented by the Department is not

sufficient to establish with the requisite degree of certainty

that Dr. O'Rourke's preoperative examinations, testing, or

planning fell below that level of care, skill, and treatment

that is recognized by a reasonably prudent similar physician as

being acceptable under similar conditions and circumstances.

a. R.F.'s medical records and chart establish that she was

given a battery of pre-operative tests, and the Department's

expert witness could not identify any additional pre-operative

test that should have been given. Dr. O'Rourke exami ned the

patient and noted the results of his examination, as well as the

medications she was taking, on the Outpatient/Short Stay Record.

Dr. O'Rourke knew the exact location of the mass on R.F.'s

liver, he adequately noted the location of the tumor as the

right posterior lobe of the liver, and he knew that, although

R.F.'s liver was most likely cirrhotic, her liver function was

normal, albeit low normal. A pre-operative cardiology consult

was not indicated by R.F.'s medical records or test results.

b. It is uncontroverted that Dr. O'Rourke's decision to do

an exploratory laparotomy on R.F. was not inappropriate.

Dr. O'Rourke anticipated that R.F. would suffer blood loss

during the surgery, and he planned for the anticipated blood

loss by ordering a cell saver for the operating room. Although

Dr. O'Rourke perhaps should have had R.F.'s blood typed and

cross-matched prior to the surgery, his failure to do so did not

appreciably delay the delivery of additional blood to R.F.

26. The evidence presented by the Department is not

sufficient to establish with the requisite degree of certainty

that Dr. O'Rourke's intraoperative efforts to control R.F.'s

bleeding fell below that level of care, skill, and treatment

that is recognized by a reasonably prudent similar physician as

being acceptable under similar conditions and circumstances.

Dr. O'Rourke's decisions to pack the liver to control the

bleeding and then, when that failed, to remove the tumor in an

effort to expose the vessels that were bleeding were not

inappropriate under the circumstances. Although there were

options other than packing available to help control the

bleeding, Dr. O'Rourke rejected these options as too time-

consuming, as temporary solutions, as unnecessary, or as

unlikely to be successful. Dr. O'Rourke's decision to remove

the tumor to gain access to the vessels that were the source of

the bleeding and to attempt to stop the bleeding by suture-

ligating these vessels was a decision that could only have been

made intraoperatively, based on all of the information available

to Dr. O'Rourke at the time. Although R.F. was very unstable,

the cell-saver was recycling the blood she was losing and re-

infusing it, and R.F. was receiving other blood products and

fluids. Given the available options, Dr. O'Rourke's decision

was not inappropriate.

CONCLUSIONS OF LAW

27. The Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding and of

the parties thereto pursuant to Sections 120.569 and 120.57(1),

Florida Statutes (2000).

28. Section 458.331, Florida Statutes (1996), provides in

pertinent part as follows:

1) The following acts shall constitute

grounds for which the disciplinary actions

specified in subsection (2) may be taken:

* * *

(m) Failing to keep written medical

records justifying the course of treatment

of the patient, including, but not limited

to, patient histories; examination results;

test results; records of drugs prescribed,

dispensed, or administered; and reports of

consultations and hospitalizations.

* * *

(t) Gross or repeated malpractice or the

failure to practice medicine with that level

of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances. The board

shall give great weight to the provisions of

s. 766.102 when enforcing this paragraph.

As used in this paragraph, "repeated

malpractice" includes, but is not limited

to, three or more claims for medical

malpractice within the previous 5-year

period resulting in indemnities being paid

in excess of $10,000 each to the claimant in

a judgment or settlement and which incidents

involved negligent conduct by the physician.

As used in this paragraph, "gross

malpractice" or "the failure to practice

medicine with that level of care, skill, and

treatment which is recognized by a

reasonably prudent similar physician as

being acceptable under similar conditions

and circumstances," shall not be construed

so as to require more than one instance,

event, or act. Nothing in this paragraph

shall be construed to require that a

physician be incompetent to practice

medicine in order to be disciplined pursuant

to this paragraph.

* * *

(3) In any administrative action against

a physician which does not involve

revocation or suspension of license, the

division shall have the burden, by the

greater weight of the evidence, to establish

the existence of grounds for disciplinary

action. The division shall establish

grounds for revocation or suspension of

license by clear and convincing evidence.

29. In its Administrative Complaint, the Department seeks

the revocation or suspension of Dr. O'Rourke's license to

practice medicine and/or the imposition of an administrative

fine. Therefore, the Department has the burden of proving the

allegations in the Administrative Complaint by clear and

convincing evidence. Section 458.331(3), Florida Statutes

(1996). See also Department of Banking and Finance, Division of

Securities and Investor Protection v. Osborne Stern and Co. , 670

So. 2d 932 (Fla. 1996); and Ferris v. Turlington , 510 So. 2d 292

(Fla. 1987).

30. Judge Sharp, in her dissenting opinion in Walker v.

Florida Department of Business and Professional Regulation , 705

So. 2d 652, 655 (Fla. 5th DCA 1998)(Sharp, J., dissenting),

reviewed recent pronouncements regarding clear and convincing

evidence:

Clear and convincing evidence requires more

proof than preponderance of evidence, but

less than beyond a reasonable doubt. In re

Inquiry Concerning a Judge re Graziano ,

696 So. 2d 744 (Fla. 1997). It is an

intermediate level of proof that entails

both qualitative and quantative [sic]

elements. In re Adoption of Baby E.A.W. ,

658 So. 2d 961, 967 (Fla. 1995), cert.

denied , 516 U.S. 1051, 116 S. Ct. 719, 133

L. Ed. 2d 672 (1996). The sum total of

evidence must be sufficient to convince the

trier of fact without any hesitancy. Id.

It must produce in the mind of the trier of

fact a firm belief or conviction as to the

truth of the allegations sought to be

established. Inquiry Concerning Davie , 645

So. 2d 398, 404 (Fla. 1994).

31. Based on the findings of fact herein, the Department

has failed to satisfy its burden of proving by clear and

convincing evidence that Dr. O'Rourke violated

Section 458.331(1)(m), Florida Sta tutes (1996), by failing "to

keep written medical records justifying the course of treatment

of the patient." The evidence establishes that the medical

records kept for R.F. include her medical and surgical history,

the drugs that she was taking at the time of the surgery, the

results of Dr. O'Rourke's physical examination, and the results

of the many tests administered to R.F. between October 1995 and

February 27, 1996. In the absence of evidence that any

additional records were required, these records would appear to

be adequate to justify Dr. O'Rourke's decision to do an

exploratory laparotomy and perform a right hepatic resection to

remove the mass that was located on the right posterior lobe of

R.F.'s liver.

32. The Department's burden with respect to its charge

that Dr. O'Rourke violated Section 458.331(1)(t), Florida

Statutes, is proof by clear and convincing evidence that

Dr. O'Rourke failed "to practice medicine with that level of

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

prudent similar physician as being acceptable under similar

conditions and circumstances". The Department cannot meet this

burden without first establishing the standard of care against

which Dr. O'Rourke's acts and/or omissions can be judged. See

McDonald v. Department of Professional Regulation, Board of

Pilot Commissioners , 582 So. 2d 660, 670 (Fla. 1st DCA

1991)( Zehmer, J., specially concurring)(When an agency charges a

professional with the "failure to exercise the degree of care

reasonably expected of [such] a professional, the agency must

present expert testimony that proves the required professional

conduct as well as the deviation therefrom."); accord Purvis v.

Department of Professional Regulation , 461 So. 2d 134, 136 (Fla.

1st DCA 1984). Here, the proof offered by the Department did

not establish what a reasonably prudent surgeon would do in

circumstances similar to those in this case, and, accordingly,

the proof did not identify the manner in which Dr. O'Rourke

deviated from the standard of care. 16/ The evidence presented

by the Department, therefore, does not support a finding that

the decisions made by Dr. O'Rourke were either incorrect or not

among the options that were acceptable under the circumstances.

Consequently, based on the findings of fact herein, the

Department did not satisfy its burden of proving by clear and

convincing evidence that Dr. O'Rourke violated

Section 458.331(1)(t), Florida Statutes (1996).

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Board of Medicine enter a final

order dismissing the Administrative Complaint against Aiden

Matthew O'Rourke, M.D.

DONE AND ENTERED this 26th day of January, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

PATRICIA HART MALONO

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 26th day of January, 2001.

ENDNOTES

1. The liver is located in the upper right portion of the

abdominal cavity and is the largest organ in the abdominal

cavity. The liver functions as a filtration system for the

body, and therefore, it is an extremely vascular organ, having a

significant amount of blood flow through it both from the body's

arterial system and from the gut. The liver is composed of two

lobes, the right lobe and the left lobe, which are further

broken down into the lateral and median right and left lobes.

In a healthy liver, a lobe of the liver can be removed without

significant damage to the other lobe, and the procedure by which

a lobe is removed is called a lobectomy. The liver is further

divided into eight discrete segments, which, for the most part,

do not share blood vessels or blood flow, such that a segment

can be removed from a healthy liver without interrupting the

blood flow to the rest of the liver. The procedure for removing

a segment of the liver is referred to as a segmentectomy.

2. Alpha-fetoprotein levels are known as "tumor markers"

because abnormal levels are indicative of a hepatic tumor.

3. Cirrhosis of the liver is the generalized scarring of the

liver that occurs secondary to the inflammatory response of the

liver when fighting disease. The scar tissue is firm, almost

brittle, and is distributed throughout the liver, so that there

are "islands" in the liver that are functioning, surrounded by

damaged tissue. The extent to which a cirrhotic liver functions

depends on the amount of liver tissue that has been replaced by

scar tissue.

4. The portal triad consists of the hepatic artery, the portal

vein, and the main bile duct.

5. R.F.'s autopsy report revealed that she had esophageal

varices, but this information was not available to Dr. O'Rourke

preoperatively.

6. A vascular tumor is one that has a very rapid growth rate

and requires a very rich blood supply to sustain its growth.

7. The anesthesiologist always conducts an independent

assessment of the patient because, although the surgeon and the

anesthesiologist work together, each must assess a different

risk. The surgeon must assess the risk to the patient of a

surgical procedure, and the anesthesiologist must assess the

risk to the patient of anesthesia. If indicated, an

anesthesiologist will request a cardiology consultation.

8. A cell saver is used to recover the blood that a patient

loses during surgery. The blood is suctioned into a chamber in

the cell saver, washed and filtered, and re-infused into the

patient. Use of a cell saver eliminates the possibility of

blood transfusion reactions.

9. It should be noted as well that, once blood is typed and

cross-matched, the blood is committed to the particular patient

and must be discarded if it is not used.

10. A CVP line is essentially a large intravenous line, and its

primary function is to allow the rapid introduction of fluids

into the patient's blood stream. A CVP line also can be used to

monitor venous blood pressure, although a CVP line has limited

use as a monitoring device. Once a patient starts bleeding

heavily during surgery, it is not necessary to have a CVP line

placed to know that the patient's blood pressure is low.

11. The Department's expert testified that it was below the

acceptable standard of care for Dr. O'Rourke to fail to insert a

CVP line into R.F. preoperatively to allow monitoring of R.F.'s

venous pressure; this testimony is not persuasive, however,

because the expert did not explain why it would have been

necessary during the exploratory portion of the surgery to

monitor R.F.'s venous pressure.

12. This is a technique by which the surgeon slides his hand

around the side of the liver, lifts it, and places lap pads

behind the liver to raise it into the abdominal cavity where it

can be worked on more easily than if it were left in its normal

anatomic position.

13. The Department's expert witness testified that it is often

helpful to lower a patient's blood pressure during the

dissection of the liver, because the patient would likely lose

less blood during the surgery with lowered blood pressure than

with higher blood pressure. In the opinion of the Department's

expert, Dr. O'Rourke fell below the standard of care in failing

to consider lowering R.F.'s blood pressure through medication

during the surgery. This opinion is not credited because the

Department's expert testified only that the technique is "often

helpful"; he failed to explain how Dr. O'Rourke's failure to use

the technique was below the acceptable standard of care.

14. This involves completely removing the liver from its

anatomic position so that the entire liver is accessible.

15. The Department's expert witness testified that Dr. O'Rourke

failed to document adequately his preoperative planning, but

there was no evidence establishing a standard for such

documentation. In any event, the gist of the expert's testimony

regarding Dr. O'Rourke's failure to document preoperative

planning seems to be that, because he did not list in the

medical records each test result he considered, each risk he

considered, each technique he considered and rejected, and each

step he intended to take during the exploratory laparotomy and

possible hepatic resection, Dr. O'Rourke failed to plan

adequately for R.F.'s surgery. The extent to which Dr. O'Rourke

adequately planned for R.F.'s surgical procedure is an issue

separate from the sufficiency of his medical records.

16. The Department's expert testified as to his ultimate

conclusions that, in various respects, Dr. O'Rourke's treatment

of R.F. deviated from the acceptable standard of care. He then

supported these conclusions with testimony that merely

identified various options available to Dr. O'Rourke, things

Dr. O'Rourke could have done, techniques that might have been

helpful for Dr. O'Rourke to use, and procedures that the expert

himself might use in similar situations. The Department's

evidence did not, however, identify those things that a

reasonably prudent surgeon must do under circumstances similar

to those in this case, nor did the evidence establish those

things that a reasonably prudent surgeon must not do under

circumstances similar to those in this case.

COPIES FURNISHED:

Eric S. Scott, Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

Rose Marie Antonacci-Pollock, Esquire

Mihcaud Buschmann

33 Southeast 8th Street

Boca Raton, Florida 33432-6121

Tanya Williams, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk

Department of Health

4052 Bald Cypress Way

Bin A02

Tallahassee, Florida 32399-1701

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way

Bin A02

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this R ecommended O rder. Any exceptions

to this R ecommended O rder should be filed with the agency that

will issue the F inal O rder in this case.