05-004576PL Department Of Health, Board Of Medicine vs. Manuel Alvarado, M.D. Status: Closed Recommended Order on Friday, June 9, 2006.

Summary: Respondent violated the "standard of care" by failing to evaluate an adequate amount of data from the internal fetal heart monitor.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 05 - 4576PL

)

MANUEL ALVARADO, M.D., )

)

Respondent. )

_________________________________)

RECOMMENDED ORDER

P ursuant to notice, a formal hearing was held in this case

before Larry J. Sartin, an Administrative Law Judge of the

Division of Administrative Hearings, on April 6 and 7, 2006, in

Tavares, Florida.

APPEARANCES

For Petitioner: Lynne A. Quimby - Pennock

Ass istant General Counsel

Office of General Counsel

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Carl Motes, Esquire

Arnold, Matheny & Eagan, P.A.

605 East Robeinson Street, Suite 730

Orlando, F lorida 32801

STATEMENT OF THE ISSUE

The issue in this case is whether Respondent, Manuel

Alvarado, M.D., committed violations of Chapter 458, Florida

Statutes, as alleged in an Administrative Complaint issued by

Petitioner, the Department of Health, on July 19, 2005, in DOH

Case Number 2004 - 00926, and amended by Order entered March 31,

2006; and, if so, what disciplinary action should be taken

against his license to practice medicine in Florida.

PRELIMINARY STATEMENT

On or about July 19, 2005, the Depart ment of Health filed

an Administrative Complaint against Respondent Manuel Alvarado,

M.D., an individual licensed to practice medicine in Florida,

before the Board of Medicine, in which it alleged that Dr.

Alvarado had committed violations of Section 458.3 31(1)(t),

Florida Statutes (2003). 1 Respondent disputed the allegations of

fact contained in the Administrative Complaint and requested a

formal administrative hearing pursuant to Sections 120.569(2)(a)

and 120.57(1), Florida Statutes (2005). 2

On December 16 , 2005, the matter was filed with the

Division of Administrative Hearings with a request that an

administrative law judge be assigned to conduct proceedings

pursuant to Section 120.57(1), Florida Statutes (2005). The

matter was designated DOAH Case Num ber 05 - 4576 PL and was

assigned to Administrative Law Judge Charles C. Adams. The case

was transferred to the undersigned on or about April 4, 2006 .

The final hearing was scheduled to be held on March 1 4 and

15 , 200 6 , by Notice of Hearing entered Jan uary 1 0 , 200 6 . The

hearing was subsequently continued in response to a Joint Motion

for Continuance filed February 17, 2006. The final hearing was

rescheduled for April 6 and 7 , 2006.

On March 30, 2006, Petitioner's Motion to Amend

Administrative Complaint was filed. In the Motion Petitioner

sought leave to amend paragraphs 5 and 8 of the Administrative

Complaint to ref lect that the date of the events alleged therein

started was "August 1 8 , 2003" rather than "August 1 9 , 2003."

The Motion was granted by Order entered March 31, 2006.

On March 31, 2006 , a Joint Pre - hearing Stipulation was

filed by the parties. The Joint Pre - hearing Stipulation

contains "Facts Admitted and Requiring No Proof." Most of t hose

admissions have been incorporated into the Findings of Fa ct of

this Recommended Order and have been identified as "Admitted

Facts."

At the final hearing Petitioner presented the testimony of

Patient O.C., Anna W. Wimberly, R.N., 3 and Penny Da nna, 4 M.D.,

who was accepted as an expert in this matter. 5 Petitione r

offered and had admitted Petitioner's Exhibits 1 through 3. 6

Respondent testified on his own behalf and presented the

testimony of Shivakumar S. Hanubal, M.D . Dr. Hanubal was

accepted as an expert in obstetrics and gynecology. Respondent

also offered a nd had admitted Respondent's Exhibits 1 and 2.

Respondent's Exhibit 1 is the one - volume T ranscript of the

deposition testimony of Alfre d H. Moffett, Jr., M.D.

Joint Exhibits 1 and 2 were also offered by the parties and

were admitted.

The two - volume Transc ript of the final hearing was filed on

May 5 , 2006. By Notice of Filing Transcript entered May 8 ,

2006, the parties we re informed that the Transcript had been

filed and that their proposed recommended orders were to be

filed on or by May 15 , 2006. Both p arties filed proposed

recommended orders on May 15, 2006. The proposed orders of both

parties have been fully considered in rendering this Recommended

Order.

On June 1, 2006, Respondent filed Exceptions to

Petitioner's Proposed Recommended Order. On June 5, 2006,

Petitioner filed Petitioner 's Motion to Strike Respondent's

"exceptions to Petitioner's Proposed Recommended Order."

Petitioner has pointed out that the time to file "exceptions" is

after a recommended order is entered and the place to file is

w ith the agency. Petitioner has represented that Respondent has

no objection to the Motion and it is, therefore, granted. No

consideration has been given to the exceptions .

FINDINGS OF FACT

A. The Parties .

1. Petitioner, the Department of Health (herei nafter

referred to as the "Department"), is the agency of the State of

Florida charged with the responsibility for the investigation

and prosecution of complaints involving physicians licensed to

practice medicine in Florida. § 20.43 and Chs. 456 and 458,

Fla. Stat. (2005). (Admitted Fact s ).

2. Respondent, Manu e l Alvarado , M.D., is, and was at the

times material to this matter, a physician licensed to practice

medicine in Florida, having bee n issued license number ME 59124 .

(Admitted Fact s ). Dr. Alvara do has been licensed in Florida

since 1991 . Dr. Alvarado's mailing address of record is 1414

East Main Street, Leesburg, Florida 34748. (Admitted Fact s ).

Dr. Alvarado has practiced medicine in Leesburg, Florida since

June 1991.

3. Dr. Alvarado is boar d - certified in Obstetrics and

gynecology. (Admitted Fact s ).

4. No evidence that Dr . Alvarado has previously been the

subject of a license dis ciplinary proceeding was offered.

B. Patient O.C .

5 . At issue in this case is Dr. Alvarado's treatment of

Patie nt O.C ., on August 18 and 19, 2003 .

6 . Patient O.C. at the times relevant in this case was 25

years of age.

7 . Patient O.C., at all times relevant, was pregnant.

This was Patient O.C.'s first pregnancy. After becoming

pregnant, Patient O.C. utilized Ad vanced Obstetrics and

Gynecology (hereinafter referred to as "Advanced") for pre - natal

care. Advanced, located in Leesburg, Florida, was at the times

relevant to this matter a group practice conducted by Shivakumar

S . Hanubal, M.D., and Dr. Alvarado.

8 . Patient O.C. was attended primarily by Dr. Shivakumar,

but she was also seen on one or two occasions for pre - natal care

by Dr. Alvarado.

C. Patient O.C. w as a High - Risk Patient .

9. Patient O.C. was considered to be a "high - risk" patient

due to three fact ors.

10 . First, Patient O.C. was obese. When she first

reported for pre - natal care she weighed approximately 285

pounds. Her weight increased to between 300 and 330 pounds by

August 18, 2003 .

11 . Obesity is considered a "high - risk" factor because

obese patients generally have a higher risk for gestational

diabetes, preeclampsia, 7 and a large fetus. Additionally,

obesity results in additional problems during labor including an

increased incidence of cesarean section delivery.

12 . Secondly, Patient O.C. was diagnosed with gestational

diabetes , which occurs in some women during pregnancy.

13 . Gestational diabetes can cause the baby to be large or

"macrosomic , " which in turn can cause complications dur ing

delivery. It can also cause an excess amount of a mniotic fluid,

referred to as polyhydramnios. There is also a higher rate of

fetal mortality when gestational diabetes is present.

Gestational diabetes can, however, be controlled and, in the

case of Patient O.C., it was.

14 . Finally, Patient O.C. smoke d cigarettes. She smoked

both before and during her pregnancy.

15 . Smoking reduces oxygenation to the uterus, placenta,

and the fetus. This increases the risks of intrauterine birth

growth restriction and increases the risk of placental abruption

(where the placental sheers off the wall of the uterus) as well.

16 . Dr. Alvarado was aware that Patient O.C., due to her

weight, the gestational diabetes, and her smoking, was a "high

risk " patient. The evidence failed to prove that Dr. Alvarado

failed to con sider this fact in his treatment of Patient O.C.

D . The Events of August 18, 2003 .

17 . On August 18, 2003, Patient O.C. noticed that she had

begun to discharge mucus with pinkish streaks/dark brown spots .

(Admitted Facts). Becoming concerned, she telep honed Advanced,

and after speaking with someone at Advanced's answering service,

received a telephone call from Dr. Alvarado , who was the " on

call " obstetrician at Leesburg Regional Medical Center

(hereinafter referred to as "Leesburg Regional") that day.

(Admitted Facts). Dr. Alvarado was also the on - call physician

for Advanced. Dr. Alvarado had arrived at Leesburg Regional at

approximately 6:00 a.m., August 18, 2003, where he remained

until sometime after 2:15 a.m., August 19, 2003. (Admitted

Facts).

18 . Dr. Alvarado spoke with Patient O.C. , who advised him

of the mucus discharge. When he asked whether she had felt any

fetal movement, she indicated that the baby was moving but "not

as usual." 8 (Admitted Facts). Dr. Alvarado advised her to go to

the labor room of Leesburg Regional for a non - stress test. 9

(Admitted Facts). Dr. Alvarado contacted the labor room to

report that Patient O.C. was to be evaluated and asked that a

non - stress test be performed on her and that he be informed of

the results. (Admitted Facts ).

19 . As directed, Patient O.C. presented to the Leesburg

Regional maternity u nit at approximately 8:05 p.m. (Admitted

F acts), after initially reporting to the emergency room.

20 . Dr. Alvarado was contacted about Patient O.C. at about

8: 30 p.m. , at which time he gave a verbal order to place a n

external fetal heart monitor on Patient O.C. (Admitted Facts).

21. A fetal heart monitor measures the heart beat of a

fetus. The measurements are recorded continuously on a fetal

heart rate monit or strip. Initially, upon placement of a

monitor , a "base line" rate is determined. The base line rate is

the mean heart rate per minute of the fetus measured over

approximately a ten - mi nute interval. A "normal" base line heart

rate will range from 120 be ats to 160 beats per minute.

22. Once the base line heart rate is established , the heart

rate of the fetus is monitored for expected vari ations in the

heart beat rate . It is normal for the heart beat rate to

accelerate and decelerate from the base line rate over an

extended period of time.

23. In additio n to monitoring the fetal heart beat rate,

the contractions of the mother are also monitored.

24. When a contraction occurs, it is expected that the

fetal heart rate will decelerate abruptly. This decelerati on is

normal and is considered reassuring if the deceleration abruptly

ends in les s than 30 seconds after it begins .

25. A primary purpose for monitoring contractions and the

fetal heart rate is to give the physician assurances that the

fetus is not exper iencing hypoxia ( lack of oxygen to the brain ) .

26. While variable decelerat ions and accelerations in

heart beat are expected and considered reassuring, a "late"

deceleration is not. A "late" deceleration is a decline in the

heart rate from the base line wh ich takes place just after the

peak o f a contraction and last s for 60 seconds or more. A late

deceleration can be an indication of fetal hypoxia if it is

followed persistently by other late decelerations and a lack of

good variability between such events.

27 . Fetal heart rate monitors may be placed external ly or

internal ly . An external monitor is placed on the mother's

stomach and utilizes Doppler waves which are projected at the

fetus and are then interpreted by computer to determine the

fetal heart rat e.

28. An internal monitor requires that the mother's

membrane be ruptured, releasing the amniotic fluid , and that the

cervix is dilated at least one or two centimeters . An electrode

is then placed directly on the scalp of the fetus. Contractions

may al so be mo nitored internally using an intrauterine pressure

catheter that records the actual pressure of contractions.

29 . Dr. Alvarado's instructions to place an external

monitor on Patient O.C. were followed b y Ann Willis Wimberly,

R.N. Due to Patient O. C.'s size, however, it was difficult to

obtain a good reading of the fetal heart rate or Patient O.C.'s

contractions . Patient O.C. was also some what noncompliant with

her care, causing further difficulty obtaining accurate

readings .

30 . Nurse Wimberly al so took and recorded a "history" of

Patient O.C., including her weight and the facts that she had

gestational diabetes, smoked a pack of cigarettes a day,

reported " brownish stuff " coming out of her, and had experienced

pelvic pressure that day.

31 . Nurse Wimberly performed a vaginal examination of

Patient O.C. and reported that she was "closed, thick [sic]

minus three, palatable" which means that Patient O.C.'s cervix

was not open, she was not thinning out, and the baby was still

high up and ballottable, which in turn means there was fluid

around the baby.

32 . At 8:30 p.m. Dr. Alvarado evaluated Patient O.C. and

reviewed the fetal heart monitor strip . (Admitted Facts ). The

baby's fetal heart rate base line was determined to be between

160 and 170 beats 10 per minute. (Admitted Facts). This heart

rate was above the normal base line expected for a fetal heart

base line rate . At this point, the fetal heart monitor had

recorded some accelerations, but no decelerations.

33. Patient O.C. had only been monito red for approximately

10 to 15 minutes at the time Dr. Alvarado reviewed the fetal

heart rate monitoring strips. This was, as Dr. Alvarado

acknowledged at hearing, an inadequate period of time to get

adequate data.

34 . At 8:40 p.m., Dr. Alvarado left Pat ient O.C. to attend

to a patient in labor. (Admitted Facts). At this time Patient

O.C. was essentially stable and the baby's heart rate was

essentially within the base line established upon Dr. Alvarado's

initial review of the fetal heart monitor strip. (Admitted

Facts).

35 . Nurse Wimberly continued to monitor Patient O.C.'s

fetal heart rate and found that she was experiencing variable

accelerations and decelerations, which were reassuring.

36 . At approximately 8:50 p.m., Patient O.C. experienced

four decelerations. Between 8:50 p.m. and 10:00 p.m., nothing

wa s recorded following a few decelerations. Dr. Danna was

unable to identify the decelerations as "late , " in part due to

the lack of good contraction information. This period was

followed by readi ngs which Dr. Danna described credibly as "very

sketchy over the next one [strip panels] an d the next one and

next one, very sketchy." Transcript, Volume I, Page 148, Lines

8 - 9. From then until early the next morning, there continued to

be what may have been late decelerations, but due to the

inadequacy of the data as to Patient O.C.'s contractions, Dr.

Danna was unable to state convincingly that late decelerations

were in fact taking place.

37 . A nitrazine test was performed on Patient O.C. at

approxima tely 10:30 to 10:35 p.m. when Patient O.C. complained

of brownish fluid leaking out . A nitrazine test measures the pH

level in the vagina. The test was positive. This is an

indication that delivery should occur within 24 hours. 11

38 . At 11:16 p.m., a nu rse called Dr. Alvarado and

informed him that the baby was moving well. (Admitted Facts).

Patient O.C. had denied any further contractions and asked to go

home. (Admitted Facts). The nurse informed Dr. Alvarado of

these facts. Dr. Alvarado was attendi ng another patient and

asked Patient O.C. to wait for his evaluation before going home.

(Admitted Facts).

E . The Events of August 19, 2003 .

39 . At 12:31, a.m., August 19, 2003, Dr. Alvarado attended

Patient O.C. (Admitted Facts). When he entered the ro om in

which Patient O.C. was located , Patient O.C. was sitting on the

end of the bed ready to go home. (Admitted Facts). The

external fetal heart monitor had been removed and she denied

having any contractions. (Admitted Facts). Patient O.C.'s

"signifi cant other," however, reported more leaking of fluid.

(Admitted Facts). Dr. Alvarado was informed that a second

nitrazine test was positive. (Admitted Facts).

40 . Dr. Alvarado examined Patient O.C., performing a

nitrazine test and reviewed her fetal he art monitor strip.

(Admitted Facts). The nitrazine test was again positive.

41 . Dr. Alvarado decided to admit Patient O.C. to Leesburg

Regional. (Admitted Fact). 12

42 . While the results of the external fetal heart monitor

were not conclusive, Nurse Wim berly became concerned enough with

the results to suggest to Dr. Alvarado that she was seeing

decelerations which she characterized as sometimes "variable"

and sometimes "late." This conversation took place at

approximately 12:50 a.m. Dr. Alvarado disagr eed with Nurse

Wimberly's characterization of the decelerations as "late."

Nurse Wimberly did not insist nor record in her notes that there

were late decelerations because of the difficulty she was

experiencing getting a good reading from Patient O.C., bo th of

the fetal heart beat rate and Patient O.C.'s contractions.

4 3 . At 1:02 a.m., Dr. Alvarado was called to attend to

another patient. (Admitted Facts).

4 4 . At 1:12 a.m., Patient O.C. was placed back on an

external fetal heart monitor. (Admitted Facts ).

45 . At 1:50 a.m., Dr. Alvarado returned and examined

Patient O.C. (Admitted Facts). Nurse Wimberly discussed with

Dr. Alvarado the difficulty she was experiencing attempting to

monitor the baby's fetal heart beat rate with an external

monitor. Dr. Al varado agreed that an internal monitor was

necessary.

46 . Dr. Alvarado artificially ruptured Patient O.C. ' s ,

membrane to place the fetal scalp electrode and intrauterine

monitor. 13 (Admitted Facts). Although Patient O.C. was not in

labor when he ruptured her membrane, Dr. Alvarado's plan was to

induce labor at 6 :00 a.m. if Patient O.C. did not go into active

labor by then. (Admitted Facts).

47 . When Dr. Alvarado ruptured Patient O.C.'s membrane,

m econium - stained amniotic fluid was noted. (Admitted Fact s).

Meconium is a bow e l movement which occurs in the amniotic sac .

The presence of meconium in the amniotic fluid is an indicator

that there may be some stress on the part of the fetus.

According to Dr. Danna, the presence of meconium :

does not necessar ily mean you have to rush

the patient to the operating room and do a

deliver. It depends on how the fetal

monitoring strip looks, but it could

indicate some stress and your awareness has

to be heightened that this is a high risk

labor and you need to pay attention to the

fetal monitoring strip for evidence of

hypoxia. There is also risks of meconium

aspiration where the baby aspirates the

meconium into the lungs and that could be

very serious.

Transcript, Volume I, Page 139, Lines 22 - 25, and Page 140, Li nes

1 - 4.

48 . Although there was meconium present, t he evidence in

this case fail ed to prove the extent to which its presence was

an indication that Patient O.C.'s fetus was in distress at the

time Patient O.C.'s membrane was ruptured . T he evidence also

f ailed to prove when the bowel movement which the meconium

evidenced took place.

49 . Dr. Alvarado had, prior to rupturing Patient O.C.'s

membrane, performed a vaginal examination and found her to be

two and a - half centimeters dilated and to have progressed from

th ick to 80 percent thinned out.

50 . Dr. Alvarado placed an electrode on the baby 's scalp

to monitor the baby's heart rate and an intrauterine pressure

catheter in Patient O.C. to monitor Patient O.C. 's contractions.

(Admitted Facts). The intraute rine pressure catheter placement

was completed at approximately 2:00 a.m. From that time on, the

fetal heart rate monitoring strips were more precise.

51 . At 2:15 a.m. Patient O.C. was experiencing

contractions every one to three minutes for 60 seconds a nd the

fetal heart rate was 150 to 160. (Admitted Facts).

52 . Dr. Alvarado, once the internal fetal heart monitor

and the intrauterine pressure catheter were placed, only

reviewed the resulting fetal heart monitor strip for

approximately 15 minutes. He did so , despite his testimony at

hearing that the strip should be monitored for at least an hour.

Dr. Alvarado was asked the following questions and gave the

following responses in this regard:

Q. Okay. Why did you ask them to continue

monitoring her?

A. Well, you cannot make a judg ment with

ten - minute tracings. Every patient that

goes to the hospital -- even with no

concern, nor risk factor, or anything like -

- will be monitored for at least one hour.

She just arrived. She had only about ten

minute s by the time that the nurse got to

her and put the monitor on. It was only

about ten or fifteen minutes. We needed to

know a little bit longer what was going on.

Transcript, Volume II, Page 229, Lines 14 - 23. Whi le this

testimony dealt with the initial external monitoring of Patient

O.C. , the facts in this case proved that, because the initial

monitoring of Patient O.C. was problematic and to a large extent

unreassuring, and giv en the fact that she was a high - risk

patient, Dr. Alvarado was in error when he assumed that he

already had sufficient data to leave Patient O.C. after only

approximately 15 minutes of data from the internal monitoring.

53 . Dr. Alvarado returned to the Leesburg Regional

emergency room at 2:15 a.m. to attend to patients and

subseq uently left for his home, which is located less than five

minutes from the hospital. (Admitted Facts).

54 . After Dr. Alvarado left Patient O.C., Nurse Wimberly

continued to monitor the fetal heart rate strip. The fetal

heart rate continued to be general ly the same evidenced by the

external monitoring strips.

55 . At 2:22 a.m., the baby's fetal heart rate dropped into

the 90's for 60 seconds, before returning to the base line.

(Admitted Facts). Dr. Alvarado was not notified of this drop.

(Admitted Fact s).

56 . At 2:30 a.m. Patient O.C. complained of pain and

Dr. Alvarado was notified. (Admitted Facts).

57 . At 2:43 a.m., the fetal heart rate exhibited a clear

late deceleration, dropping for approximately 40 seconds.

(Admitted Facts). Dr. Alvarado was notified. (Admitted Facts).

Nurse Wimberly recog nized the decelerations and initiated

routine interventions but failed to notify Dr. Alvarado.

(Admitted Facts).

58 . Between 3:58 a.m. and 4:15 a.m., the chart shows

several more fetal heart monitor late decelerations and nurse

"fails to notify" Dr. Alvarado of any. (Admitted Facts).

59 . The following, while of little relevance, are included

in this Recommended Order because they are "Admitted Facts":

a. At 4:20 a.m. Nurse Wimberly left Dr. Alvarado a message

on his home phone answering machine that Dr. Hanubal was coming

to the Leesburg Memorial to deliver Patient O.C.'s baby. 14

b . Dr. Alvarado was not notified of Patient O.C.'s req u est

that Dr. Hanubal deliver the baby.

c. The nurse informed Dr. Hanu bal about the decelerations

and he ordered an emergency cesarean section, which was

performed at approximately 4:50 a.m.

d. The chart reflects the b aby was pronounced dead at

6:40 a.m. Dr. Alvarado does not know what resuscitation efforts

were undertaken . Dr. Alvarado arrived in a labor room at

7:00 a.m. for a cesarean, and was surprised with the news and

fact that he was never notified.

e. A cesarean is the surgical delivery of an infant

through an incision in the mother's abdomen and uterus.

F. The A dministrative Complaint .

60. On July 19, 2005, the Department filed an

Administrative Complaint in which it alleged that Dr. Alvarado,

in his treatment of Patient O.C., had violated Section

458.331(1)(t), Florida Statutes, which requires that a physician

practice medicine with "that level of care, skill, and treatment

which is recognized by a reasonable prudent similar physician as

being acceptable under similar co nditions and circumstances . .

. ." (hereinafter referred to as the "Standard of Care").

61. In paragraph 26 of the Administrative Complaint, it

has been alleged that Dr. Alvarado violated the Standard of Care

by one or more of the following:

(a) Failing to accurately diagnose

Patient O.C.'s condition;

(b) Failing to remain in the hospital

after initiating labor by rupturing Patient

O.C.'s membranes;

(c) Failing to accurately diagnose fetal

heart distress;

(d) Failing to accurately diagnose [the]

risk to [the] fetus when meconium fluid was

noted upon rupture of membranes.

6 2 . While D r. Alvarado has raised an issue as to whether

the Administrative Complaint is constitutionally vague, an issue

which this forum has no jurisdiction to address, 15 he did not

request a more definite statement from the Department during

this proceeding.

G . Dr . Alvarado's Violation of t he Standard of Care .

63 . Dr. Alvarado's treatment and care of Patient O.C. as

described in this Recommended Order and based upon the credited

opinion of Dr. Danna , violated th e Standard of Care as alleged

in paragraph s 26(a) and (b) of the Administrative Complaint.

64. The evidence failed to prove that Dr. Alvarado's

treatment and care of Patient O.C. violated the Standard of Care

as alleged in paragraphs 26(c) and (d) of the Administrative

Complaint.

65 . As to Dr. Alvarado's d iagnosis of Patient O.C., in

most respects his diagnosis was within the Standard of Care.

His Proposed Findings of Facts and Conclusions of Law,

paragraphs A1 through A4 accurately describe incidents where his

diagnosis of Patient O.C. was adequate. Wher e Dr. Alvarado

violated the Standard of Care is when he failed to adequately

reevaluate her condition through the results of the internal

fetal heart monitor and the intrauterine pressure catheter . As

explained by Dr. Danna, Dr. Alvarado violated the Stan dard:

A. Because of the strip or her fetal

heart monitor continued to deteriorate and

there was no res olu tion of her late

d ec e lerations. Once he monitored her using

the fetal scalp IUPC [intrauterine pressure

catheter] , it should have been re - evaluated

by him soon after that to see if those late

dec el erations revolved [sic].

Q. How soon after he had applied the IUPC

should she have been re - evaluated?

A. At least within thirty minutes to an

hour.

Q. Do you believe that to be the standard

of p ractice with respect to obstetrical

patients at this point?

A. Yes.

Transcript, Volume I , Page 162, Lines 15 through 25. She also

stated the following in this regard :

I believe that a reasonable physician

would have re - evaluated the strip once the

internal leads were placed, the scalp lead

and the intrauterine pressure catheter, and

re - evaluated the strip to see if these

issues of non - reassuring surveillance

resolved and if they didn't resolve then a

cesarean section should have been ordered,

especi ally, since she was remote from

delivery.

Transcript, Volume I, Page 160, Lines 16 through 22.

6 6 . Dr. Alvarado also failed to meet the Standard of Care

when he left Leesburg Memorial as soon after ru pturing Patient

O.C.'s membrane as he did . This viol ation is predicated on the

same error committed by Dr. Alvarado , which is the basis of his

violation of the Standard of Care in his failure to properly

diagnose Patient O.C.'s condition. Again, Dr. Alvarado's

violated the Standard of Care when he went hom e from the

hospital because he failed to adequately monitor the fetal heart

monitoring strip for an adequate period of time after the

inter nal heart monitor was initiated before he did so.

6 7 . Dr. Alvarado's position on this issue misses the mark.

Dr. Al varado has argued that there was no testimony from any

expert that a doctor must remain at a hospital after initiating

labor by rupturing a patient's membranes. Dr . Alvarado also

argued that it is acceptable for a physician to rely upon a

trained obstetri cal nurse who can notify him of a patient's

condition. While these arguments are correct, Dr. Alvarado

failed to establish that it was within the Standard of Care to

leave a patient in Patient O.C.'s condition without first

obtaining adequate fetal heart monitoring data and data from the

intrauterine pressure catheter.

6 8 . The evidence failed to prove that Dr. Alvarado

violated the Standard of Care by failing to diagnose fetal heart

distress. The evidence failed to prove clearly and convincingly

that Pat ient O.C.'s fetus suffered fetal heart distress.

6 9 . Finally, Dr. Alvarado did not violate the Standard of

Care by failing to accurately diagnose the risk to Patient

O.C.'s baby when he noted meconium fluid upon rupture of Patient

O.C.'s membranes. Even the Department's expert agreed.

Dr. Danna, when asked whether Dr. Alvarado violated the Standard

of Care when he failed "to accurately diagnose the risk to the

fetus when meconium fluid was noted upon the rupture of those

membranes" answered as follows: "I don’t think that is -- no, I

don't think that is the case." Transcript, Volume 1, Page 163,

Lines 15 and 16.

CONCLUSIONS OF LAW

A. Jurisdiction .

70 . The Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding a nd of

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

456.073(5), Florida Statutes (2005).

B. The Charges of the Administrative Complaint .

7 1 . Section 458.331(1), Florida Statutes, authorizes the

Board of Medicine (hereinafter referred t o as the "Board"), to

impose penalties ranging from the issuance of a letter of

concern to revocation of a physician's license to practice

medicine in Florida , if a physician commits one or more acts

specified therein.

7 2 . In its Administrative Complain t , as amended , the

Department has alleged that Dr. Alvarado has violated Section

458.331(1)(t), Florida Statutes.

C. The Burden and Standard of Proof .

7 3 . The Department seeks to impose penalties against Dr.

Alvarado through the Administrative Complaint that include

suspension or revocation of his license and/or the imposition of

an administrative fine. Therefore, the Department has the

burden of proving the specific allegations of fact that support

its charge that Dr. Alvarado violated Section 458.331(1 ) (t),

Florida Statutes, by clear and convincing evidence. Department

of Banking and Finance, Division of Securities and Investor

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

Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987); Pou v.

Depa rtment of Insurance and Treasurer , 707 So. 2d 941 (Fla. 3d

DCA 1998); and Section 120.57(1)(j), Florida Statutes

(2005)("Findings of fact shall be based on a preponderance of

the evidence, except in penal or licensure disciplinary

proceedings or except as otherwise provided by statute.").

7 4 . What constitutes "clear and convincing" evidence was

described by the court in Evans Packing Co. v. Department of

Agriculture and Consumer Services , 550 So. 2d 112, 116, n. 5

(Fla. 1st DCA 1989), as follows:

. . . [ C]lear and convincing evidence

requires that the evidence must be found to

be credible; the facts to which the

witnesses testify must be distinctly

remembered; the evidence must be precise and

explicit and the witnesses must be lacking

in confusion as to t he facts in issue. The

evidence must be of such weight that it

produces in the mind of the trier of fact

the firm belief or conviction, without

hesitancy, as to the truth of the

allegations sought to be established.

Slomowitz v. Walker , 429 So. 2d 797, 800

(Fla. 4th DCA 1983).

See also In re Graziano , 696 So. 2d 744 (Fla. 1997); In re

Davey , 645 So. 2d 398 (Fla. 1994); and Walker v. Florida

Department of Business and Professional Regulation , 705 So. 2d

652 (Fla. 5th DCA 1998)(Sharp, J., dissenting).

D. Section 458.331(1)(t), Florida Statutes; The Standard

of Care .

7 5 . Section 458. 331(1)(t), Florida Statutes, defines the

following disciplinable offense:

(t) . . . [T]he failure to practice

medicine with that level of care, skill, and

treatment which i s recognized by a

reasonably prudent similar physician as

being acceptable under similar conditions

and circumstances. . . .

7 6 . In paragraph 26 of the Administrative Complaint, it

has been alleged that Dr. Alvarado violated the Standard of Care

by one o r more of the following:

(a) Failing to accurately diagnose

Patient O.C.'s condition;

(b) Failing to remain in the hospital

after initiating labor by rupturing Patient

O.C.'s membranes;

(c) Failing to accurately diagnose fetal

heart distress;

(d ) Failing to accurately diagnose [the]

risk to [the] fetus when meconium fluid was

noted upon rupture of membranes.

7 7 . The evidence has clearly and convincingly proved that

Dr. has violated the Standard of Care as alleged in

paragraphs 26(a) and (b) as described in the Findings of Fact.

Although treated in the Administrative Complaint as two

violations, both of the violations arise from the same error:

Dr. Alvarado failed to adequately reevaluate Patient O.C.'s

condition through the results of the int ernal fetal heart

monitor and the intrauterine pressure catheter. In particular,

he failed to wait until he had at least 30 to 60 minutes of data

from the internal monitors. By failing to do so, he failed to

make an adequate diagnosis and left for home b efore doing so.

E . The Appropriate Penalty .

7 8 . In determining the appropriate punitive action to

recommend to the Board in this case, it is necessary to consult

the Board's "disciplinary guidelines," which impose restrictions

and limitations on the exer cise of the Board's disciplinary

authority under Section 458.331, Florida Statutes. See Parrot

Heads, Inc. v. Department of Business and Professional

Regulation , 741 So. 2d 1231 (Fla. 5th DCA 1999).

7 9 . The Board's guidelines are set out in Florida

Adm inistrative Code Rule 64B8 - 8.001, which provides the

following "purpose" and instruction on the application of the

penalty ranges provided in the Rule:

(1) Purpose. Pursuant to Section

456.079, F.S., the Board provides within

this rule disciplinary gui delines which

shall be imposed upon applicants or

licensees whom it regulates under Chapter

458, F.S. The purpose of this rule is to

notify applicants and licensees of the

ranges of penalties which will routinely be

imposed unless the Board finds it neces sary

to deviate from the guidelines for the

stated reasons given within this rule. The

ranges of penalties provided below are based

upon a single count violation of each

provision listed; multiple counts of the

violated provisions or a combination of the

violations may result in a higher penalty

than that for a single, isolated violation.

Each range includes the lowest and highest

penalty and all penalties falling between.

The purposes of the imposition of discipline

are to punish the applicants or licen sees

for violations and to deter them from future

violations; to offer opportunities for

rehabilitation, when appropriate; and to

deter other applicants or licensees from

violations.

(2) Violations and Range of Penalties.

In imposing discipline upon a pplicants and

licensees, in proceedings pursuant to

Section 120.57(1) and 120.57(2), F.S., the

Board shall act in accordance with the

following disciplinary guidelines and shall

impose a penalty within the range

corresponding to the violations set forth

be low. The verbal identification of

offenses are descriptive only; the full

language of each statutory provision cited

must be consulted in order to determine the

conduct included.

80 . Florida Adminis trative Code Rule 64B8 - 8.001(2) goes on

to provide, in pertinent part, the following penalty guidelines

for the violation proved in this case: For a violation of

Section 458.331(1)(t), Florida Statutes, a range of relevant

penalties from two years’ probation to revocation, and an

administrative fine from $1,0 00.00 to $10,000.00.

8 1 . Florida Administrative Code Rule 64B8 - 8.001(3)

provides that, in applying the penalty guidelines, the following

aggravating and mitigating circumstances are to be taken into

account:

(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 factors the following:

(a) Exposure of pa tient or 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, Florida Statutes, of the

provision of controlled substances for

trade, barter or sale, by a licensee. In

such cases, the Board will deviate from the

penalti es recommended above and impose

suspension or revocation of licensure;

(h) Any other relevant mitigating

factors.

8 2 . In Petitioner's Proposed Recommended Order, the

Department has requested that it be recommended that the

following discipline be impo sed upon Dr. Alvarado's license:

a reprimand, $10,000.00 fine, suspension for

one year followed by probation for two years

with terms and conditions to be established

by the Board at the hearing when the

Recommended Order is presented, and a

minimum of 200 hours of community service

within two years of the entry of the Final

Order.

The Department has not explained in Petitioner's Proposed

Recommended Order what factors it relied upon in making the

foregoing recommendation other than to argue that Dr. Alvar ado

failed to respond to Nurse Wimberly's effort to locate him at

his home during the early hours of August 19, 2003 . The

Department's reliance on this apparent aggravating circumstance

is misplaced and ignores the evidence. While Nurse Wimberly did

tele phone Dr . Alvarado at approximately 4:20 a.m., she did so on

his "home" or "personal" telephone and not at the second home

telephone phone number , which Dr. Alvarado had instruct ed the

nurses to call, his cell - phone, or his pager. The pho ne number

which D r. Alvarado had instructed the nurses to use is one that

is dedicated for use in his practice. See Endnote 15.

8 3 . Having carefully considered the facts of this matter

in light of the provisions of Florida Administrative Code Rule

64B8 - 8.001, it is concl uded that the Department's suggested

penalty is excessive. First, Dr. Alvarado has committed only

one violation of the Standard of Care. Although characterized

in two different ways (failure to diagnose and going home too

early), the violation consist s o f one error: failing to review

the results of the internal monitors for a long enough period of

time. This is, therefore, Dr. Alvarado's first statutory

violation. Secondly, the evidence failed to prove why Patient

O.C.'s baby did not survive or what sp ecific role Dr. Alvarado's

error of judgment had in the baby's death, if any. Finally, n o

explanation of why Dr. Alvarado should be required to provide

community service has been given by the Department, and the

facts do not support such discipline.

RECOM MENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that the a final order be entered by the Board

of Medicine finding that Manuel Alvarado , M.D., has violated

Section 458.331(1)(t), Florida Statutes, as described in this

Recommended Order; issuing him a letter of concern; requiring

that he pay an administrative fine of $ 5,000.00; placing his

license to practice medicine on probation for two years; and

requiring that he attend continuing education classes in an

amount and of a nature to be determined by the Board.

DONE AND ENTERED this 9th day of June , 2006, in

Tallahassee, Leon County, Florida.

S

___________________________________

LARRY J. SAR TIN

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 3 2399 - 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 Ad ministrative Hearings

t his 9th day of June , 2006.

ENDNOTES

1 / All references to Sections of the Florida Statutes are to the

2003 version unless otherwise noted.

2 / The Department of Health letter referring this matter to the

Division of Administrative Hearings indicates that a copy of

"Respondent's Petition for Hearing" was included with the

referral letter. While a copy of Respondent's "Response to

Administrativ e Complaint" was filed, the Petition was not.

3 / At the time of the events at issue in this case, Nurse

Wimberly's name was Anna Willis. At the time of the final

hearing of this matter, her name was Anna Willis Wimberly,

having subsequently married. Sh e will be referred to as Nurse

Wimberly in this Recommended Order.

4 / On page 3 of Volume I of the Transcript of the final hearing,

Dr. Danna is incorrectly identified as "Penny Anna, M.D."

5 / Dr. Danna was offered as "an expert in the standard of care

for OB patients in Florida." Because there was no objection,

the proffer was accepted. The proffered expertise, while

sounding more like an expertise in the law relevant to this

case, which Dr. Danna is not an expert in, has been viewed as

relating to D r. Danna's expertise in obstetrics and gynecology,

an expertise which justifies her giving opinions as to whether

Dr. Alvarado failed "to practice medicine with that level of

care, skill and treatment which is recognized by a reasonably

prudent similar phy sician as being acceptable under similar

conditions and circumstances." § 458.331(1)(t), Fla. Stat.

6 / Petitioner's Exhibit 3 is a composite exhibit consisting of

law pertinent to this matter. The exhibit was admitted even

though it does not constitute "evidence" pertinent to this case.

7 / The Preeclampsia Foundation defines "Preeclampsia" as

follows: " Preeclampsia is a disorder that occurs only during

pregnancy and the postpartum period and affects both the mother

and the unborn baby. Affecting at least 5 - 8% of all

pregnancies, it is a rapidly progressive condition characterized

by high blood pressure and the presence of protein in the urine.

Swelling, sudden weight gain, headaches and changes in vision

are important symptoms; however, some women wi th rapidly

advancing disease report few symptoms. "

http://www.preeclampsia.org/about.asp .

8 / Mucus discharge is not uncommon. When it is accompanied by

decreased fetal movement, however, a physician should have

heightened awareness of the patient.

9 / A non - stress test entails external fetal monitoring for 20

minutes. There should b e 15 beats over the fetus' base line

heart rate twice during the test to be considered reassuring.

10 / A baseline in excess of 160 beats per minute, such as

Patient O.C.'s fetus was experiencing, is referred to as

Tachycardia. Tachycardia can indicate maternal problems such as

fever or problems with the fetus such as some type of cardiac

abnormality. It can also be a sign of hypoxia on the part of

the fetus.

11 / There are Admitted Facts that "[a] nitrazine test was

performed on Patient O.C., and reported to Respondent as

negative." It is not clear whether this Admitted Fact is

accurate or, if it is, when the negative test occurred. Little

weight, therefore, has been give n to this admitted fact.

12 / Dr. Danna testified that because of the reported decrease in

fetal movement, the evidence of a ruptured membrane (positive

nitrazine test), Patient O.C. should have been admitted as early

as 10:35 p.m., August 18, 2003. She d id not, however, opine

that the failure to admit Patient O.C. until later constituted a

violation of Section 458.331(1)(t), Florida Statutes. Nor does

the Administrative Complaint allege that Dr. Alvarado's failure

to admit Patient O.C. earlier than he di d constituted a

violations of Chapter 458, Florida Statutes.

13 / Again, while Dr. Danna testified that Dr. Alvarado should

have ruptured Patient O.C.'s membrane and placed an internal

fetal heart rate monitor earlier than he did, she did not offer

any opi nion that his failure to do so constituted a violation of

Section 458.331(1)(t), Florida Statutes. Nor does the

Administrative Complaint contain such an allegation.

14 / Dr. Alvarado maintained two home telephone numbers. One was

used for personal phone calls. The other was one that was

dedicated to his practice. The nurses at the hospital had been

instructed to use his home telephone number that had been

dedicated for calls related to his practice. If unable to reach

him on that number, they were to c all him on his pager or his

cell - phone. Nurse Wimberly telephone d Dr. Alvarado at his

personal home telephone number. She made no effort to contact

him at the telephone number dedicated to his practice or to call

him on his cell - phone or his pager.

15 / Central Florida Investments, Inc. v. Orange County Code

Enforcement Board , 790 So. 2d 593 (Fla. 5th DCA 2001).; and

Department of Revenue v. Young American Builders , 330 So. 2d 864

(Fla. 1st DCA 1976).

COPIES FURNISHED:

Lynne A. Quimby - Pennock

Assistant General Counsel

Office of General Counsel

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Carl Motes, Esquire

Arnold, Matheny & Eagan, P.A.

605 East Robeinson Street, Suite 730

Orlando, Florida 32801

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Timothy M. Cerio, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Dr. M. Rony François, S ecretary

Department of Health

4052 Bald Cypress Way, Bin A00

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 recommended order. Any excep tions

to this recommended order should be filed with the agency that

will issue the final order in these cases.