STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 98-5652

)

MANUEL ORTEGA-ELIAS, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly-designated Administrative Law Judge, William J. Kendrick, held a formal hearing in the above-styled case on

May 18 and 19, 1999, in Fort Lauderdale, Florida.

APPEARANCES

For Petitioner: Richard M. Ellis, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Jonathan P. Lynn, Esquire

Stephens, Lynn, Klein & McNicholas, P.A.

301 East Las Olas Boulevard, Suite 800 Fort Lauderdale, Florida 33301

STATEMENT OF THE ISSUE

At issue in this proceeding is whether Respondent committed the offense set forth in the Administrative Complaint and, if so, what penalty should be imposed.

PRELIMINARY STATEMENT

On November 13, 1998, Petitioner issued an Administrative

Complaint whereby it alleged that Respondent violated the provisions of Subsection 458.331(1)(t), Florida Statutes, by having "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." Such charge was predicated on Respondent's treatment of a patient, identified as Patient A. T., who died of complications associated with Neisseria meningitidis septicemia (a bacterial infection) on May 1, 1994. The gravamen of the charge is Petitioner's contention that Respondent failed to meet the applicable standard of care because he failed to acknowledge, as a differential diagnosis or cause of A. T.'s presentation, the likelihood of bacterial infection and failed to order, at a minimum, a complete blood count with differential to rule-out or confirm such possible cause.

Respondent filed an Election of Rights which disputed the factual allegations contained in the Administrative Complaint, and on December 29, 1998, Petitioner referred the matter to the Division of Administrative Hearings for the assignment of an administrative law judge to conduct a hearing pursuant to Sections 120.569, 120.57(1), and 120.60(5), Florida Statutes.

At hearing, Petitioner called Lucian K. DeNicola, M.D., as a witness, and Petitioner's Exhibits 1-9 were received into evidence.1 Respondent testified on his own behalf and called Blaise L. Congeni, M.D., as a witness. Respondent's Exhibits 1

and 2 were received into evidence.2

The hearing transcript was filed June 30, 1999, and the parties were accorded 10 days from that date to file proposed

recommended orders. Both parties elected to file such proposals and they have been duly-considered.

FINDINGS OF FACT

The parties

1. The Department of Health, Division of Medical Quality Assurance, Board of Medicine (Department), is a state agency charged with the duty and responsibility for regulating the practice of medicine pursuant to Section 20.43 and Chapters 455 and 458, Florida Statutes.

2. Respondent, Manuel Ortega-Elias, is, and was at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0061620. Respondent is board-certified in pediatrics and neonatology. Patient A. T.

3. Patient A. T. (hereinafter A. T. or Ashley) was the product of a twin pregnancy and born prematurely (at 31 weeks gestation) at Plantation General Hospital on December 19, 1993. Delivery was by cesarean section (due in part to breach presentation) and on delivery A. T. was assigned Apgar scores of 1, 7, and 8, at one, two, and five minutes, respectively.

4. The Apgar scores assigned to A. T. are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritability, and color, with each category being assigned a score ranging from the lowest score of

   0 through a maximum score of 2. As noted, at one minute, A. T.'s Apgar score totalled 1, with heart rate being graded at 1, and respiratory effort, muscle tone, reflex irritability, and color being graded at 0. A. T. was resuscitated (given oxygen by bag and mask) and by two minutes of delivery her Apgar score had improved to 7, and by five minutes of delivery had improved to 8.

5. A. T. experienced a number of complications secondary to her nine-week prematurity, including respiratory distress syndrome (due to a lack of surfactant), and was intubated and accorded mechanical ventilation from birth until she was four days old. A. T. also presented with apnea (a failure to initiate or maintain pulmonary ventilation) and bradycardia (slow heart rate) due to the immaturity of her nervous system, and was prescribed aminophyllin to stimulate respiration. Finally, as an apparent complication of the stress of delivery, A. T. developed a Grade 3 to 4 intraventricular hemorrhage bilaterally, and on January 11, 1994, a ventriculo-peritoneal shunt (VP shunt) was implanted to address a persistent accumulation of cerebrospinal fluid within the skull (hydrocephalus). Ultimately, A. T. was discharged on February 3, 1994, following a 45-day admission, but continued on apnea and bradycardia monitors.

6. In addition to the foregoing complications associated with prematurity, A. T. also presented with an immature immune system. Pertinent to this case, given her degree of immaturity (9 weeks), A. T. continued to be highly susceptible (high risk)

   for bacterial infection on April 30, 1994.

   
   

7. On April 30, 1994, at approximately 4:45 p.m., A. T., accompanied by her mother, presented to the emergency room at Coral Springs Medical Center, Coral Springs, Florida. At the time, her mother advised the triage nurse that A. T. had a fever, with decreased appetite. The mother also stated that "baby is not herself," was "sleeping more than usual," and was "not eating much." The mother further advised that the infant's twin "sister has bad cold." Weight was recorded as 11.03 pounds, temperature as 103.2 degrees Fahrenheit, heart rate as 160 beats per minute, and respiratory rate as 38 respirations per minute.

8. Respondent was notified at 5:05 p.m. and saw A. T. at 5:20 p.m. At the time, Respondent recorded the following history from the mother:

   4 [month old] female infant with a history of prematurity[,] A/B [apnea and bradycardia][,] on A/B monitoring at home and hydrocephalus S/P [status-post] VP shunt placement who presents fever, runny nose, nasal congestion and coughing of 1 day duration[.] She also has been moaning and has decreased her intake somewhat. No diarrhea or vomiting according to mother.

   Respondent recorded the following results of his physical examination:

   PE [physical examination]: Active, alert, slightly irritable, not in distress

   HEENT [head, eyes, ears, nose, and throat]- VP shunt, valve pumps well. TM's [tympanic membranes of the ear] are clear . . . [without] injections or exudate. Slightly hyperemic [reddened] throat . . . [without] exudates.

   Lungs- transmitted URT [upper respiratory tract] sounds otherwise clear to [auscultation]

   Heart- RR [regular rate and rhythm]. No [murmur].

   Abd [abdomen]- S & D [soft and depressible], no distension, visceromegaly or masses.

   Ext [extremities]- good pulses, no edema or cyanosis

   Neurologic- good cry, suck, grasp, tone and reflexes. No gross asymmetries or deficits.

9. Respondent's physical examination was essentially unremarkable and offered no explanation as to a source of infection that would account for her high fever (referred to as "fever without source"). Indeed, A. T. did not appear toxic, septic, or extremely ill, and her skin did not demonstrate evidence of petechiae or rashes which are frequently, although not always, associated with bacterial infection. Under such circumstances, one possible explanation, given A. T.'s congestion and her sibling's current illness, was to attribute the fever to a cold (a viral infection); however, most colds do not typically cause such a high fever as A. T. demonstrated. In contrast, approximately 10 percent of children who present with fever without source (even without A. T.'s increased risk factors) test positive for bacterial infection. Moreover, some bacterial infections (such as the one A. T. was subsequently shown to have had) can present as a common cold or with influenza-like signs.3 Consequently, bacterial infection could not be discounted absent, at least, a urinalysis and a complete blood count (CBC).4 Nevertheless, Respondent did not record bacterial infection as a

   differential diagnosis and did not order a urinalysis, complete blood count, or other testing to exclude bacterial infection as the cause for A. T.'s presentation. Instead, without benefit of testing (available on-site) to rule out bacterial infection, Respondent diagnosed A. T. as suffering from a cold (viral syndrome) and upper respiratory infection.

10. While A. T. may have suffered a cold and upper respiratory infection, subsequent testing would demonstrate that she also suffered from a bacterial infection or, more specifically, Neisseria meningitidis bacteremia, a universally fatal disease if not treated.5 Here, by failing to recognize or record bacterial infection as a differential diagnosis, and failing to order appropriate testing before excluding bacterial infection as a probable cause of A. T.'s presentation, Respondent 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.

11. At 6:05 p.m., April 30, 1994, Respondent discharged

    
    

    A. T. to her mother's care. Instructions on discharge were to give Tylenol every three-to-four hours as needed for fever; feedings of Pedialyte or formula ad lib (as much as she would take); and to follow-up with Dr. Virdee, A. T.'s pediatrician, in the morning, or sooner, if her condition deteriorated or fever persisted, if her intake or urine out-put decreased, or if she experienced any other problem. The infant was also prescribed Rondec-DM drops, a decongestant and cough suppressant, as needed.

12. Following discharge, A. T.'s mother made three telephone calls to Dr. Virdee between 9:30 p.m., April 30, 1994, and 2:00 a.m., May 1, 1994. Dr. Virdee logged the telephone calls as follows:6

    4/30/94 9:30 pm: Call from mom. Ashley's apnea monitor keeps going off. Ashley crying & screaming. Told mom ok to take off monitor provided parents keep under observation.

    Call back if more. Mom said that it had been considered to D/C the apnea monitor at some recent visits.

    
    

    5/1/94 12:24 am: Call from mom. Ashley won't sleep. Screaming & crying. Advised parents to take turns in observing Ashley. Ø fever Ø new changes. Suggested that mom take Ashley back to ER for re-eval at any

    time so that she could feel more comfortable.

    
    

    5/1/94 2 AM: Received . . . call to my home from mom. Mom v[ery] distraught. Said Ashley not sleeping. No fever. Did not mention any vomiting. Again suggested that she may take Ashley back to ER if she desired but reassure her that I would see Ashley first thing in the morning in the office.

    Dad said that mom may take her to the ER.

    
    

13. At approximately 2:12 a.m., May 1, 1994, A. T., accompanied by her mother, again presented to the emergency room at Coral Springs Medical Center. At the time, the triage nurse noted A. T.'s heart rate as 188 beats per minute and respiratory rate as 80 respirations per minute. A. T. was described as "grossly cyanotic," with respiratory distress, nasal flaring, retractions, cold skin, poor capillary refill, and poor air exchange. A. T. was immediately moved to a room for treatment, with Dr. Morgen noted at bedside. Dr. Morgen's notes were, as follows:

    PMH [past medical history]- hydrocephalus, VP shunt, 31 weeks born. Mother states was seen in ER earlier tonight and [discharged]. Has been vomiting ("her guts out") with high fever. Apnea monitor going off for last hour . . . [with] changes in color for

    1 hour.

    Dr. Morgen's physical observations were as follows: Child crying actively

    Grossly cyanotic over entire body Entire skin mottled Cap refill >6 sec. Heart-Tachycardic RR 80 & nonlabored Lungs- sound congested

    Abd[omen]- soft, . . . [normal bowel sounds]. . . .

    Skin- no rash, poor skin turgor, cool Moving all extremities

    Critical care- cyanosis improved immediately

    . . . [with oxygen]. Still mottled cool skin.

    Fluid bolus started & taken immediately to ICU [intensive care unit] with Dr. Ortega [Respondent} present.

    
    

    Dr. Morgen's diagnostic impression was septic shock. Such impression was accurate as subsequent developments would confirm the presence of a profound bacterial infection.

14. A. T. was taken to the ICU at about 2:33 a.m., May 1, 1994, and admitted at 2:45 a.m. Respondent performed a physical examination which indicated a temperature of 96.4 degrees Fahrenheit (rectal), a heart rate of 138, blood pressure of 97 over 63, and a respiratory rate of 50. Respondent noted A. T. to be hypoactive, awake, in moderate respiratory distress, and acutely ill. At 2:50 a.m., A. T. was intubated endotracheally and started on mechanical ventilation.

15. At 3:15 a.m., Respondent wrote a number of orders for

    
    

    A. T.'s care. For lab tests, Respondent's orders included a CBC (complete blood count) differential, blood culture, and urine culture. Other orders included an arterial blood gas analysis

    stat (immediately). However, such studies could not be performed since, due to her state of shock, and related poor periferal profusion, A. T.'s blood could not be drawn. Respondent's orders also included Vancomycin, an antibiotic; however, it could not be administered because the staff were unable to obtain vein access.

16. At 4:15 a.m., Respondent wrote the following progress note:

    . . . ABG's are still pending due to unsuccessful arterial puncture attempts. The infant's temperature has continued to decrease in spite of multiple attempts to warm her up. She has not responded well to volume challenges. . . . I've spoken to the mother and informed her about the critical condition of the infant with a guarded prognosis.

17. At 5:00 a.m., May 1, 1994, A. T. presented with sudden onset of bradycardia and died, despite efforts to resuscitate her. Autopsy results disclosed the cause of death as Waterhouse- Friderichsen Syndrome (bilateral adrenal hemorrhage) secondary to an overwhelming septicemia (systemic disease associated with the presence and persistence of pathogenic microorganisms or their toxins in the blood) caused by Neisseria meningitidis (a bacterial infection). If timely addressed, Neisseria meningitidis can be successfully treated with a variety of antibiotics.

    CONCLUSIONS OF LAW

    
    

18. The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of these proceedings. Sections 120.569, 120.57(1), and 120.60(5), Florida Statutes.

19. Where, as here, the Department proposes to take punitive action against a licensee, it must establish grounds for disciplinary action by clear and convincing evidence. Section

    120.57(1)(h), Florida Statutes (1997), and Department of Banking and Finance v. Osborne Stern and Co., 670 So. 2d 932 (Fla. 1996). "The evidence must be of such weight that it produces in the mind of the trier of fact a 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). Moreover, the disciplinary action taken may be based only upon the offenses specifically alleged in the administrative complaint. Cottrill v. Department of Insurance, 685 So. 2d 1371, 1372 (Fla. 1st DCA 1996)("Predicating disciplinary action against a licensee on conduct never alleged in the administrative complaint or some comparable pleading violates the Administrative Procedures Act.") See also Kinney v. Department of State,

    501 So. 2d 129 (Fla. 5th DCA 1987); Sternberg v. Department of Professional Regulation, Board of Medical Examiners, 465 So. 2d 1324 (Fla. 1st DCA 1985); and Hunter v. Department of Professional Regulation, 458 So. 2d 844 (Fla. 2d DCA 1984). Finally, in determining whether Respondent violated the provisions of Section 458.331(1)(t), Florida Statutes, as alleged in the administrative complaint, one "must bear in mind that it is, in effect, a penal statute. . . . This being true, the statute must be strictly construed and no conduct is to be regarded as included within it that is not reasonably proscribed by it." Lester v. Department of Professional and Occupational Regulations, 348 So. 2d 923, 925 (Fla. 1st DCA 1977).

20. Pertinent to this case, Section 458.331(1), Florida Statutes, provides that the Board of Medicine may discipline a licensee, if it has been shown that the licensee is guilty of:

    (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. . . .

    
    

21. Here, Petitioner demonstrated with the requisite degree of certainty, that, given A. T.'s presentation, Respondent violated the provisions of Subsection 458.331(1)(t), Florida Statutes, by having failed to acknowledge, as a differential diagnosis or cause of A. T.'s presentation, the likelihood of bacterial infection and by having failed to order, at a minimum, a complete blood count (CBC) with differential to rule-out or confirm such possible cause. Having reached such conclusion, it remains to resolve the appropriate penalty that should be imposed.

22. Pertinent to the penalty phase, Rule 64B8-8.001, Florida Administrative Code, establishes the penalty guidelines, as well as aggravating and mitigating circumstances, to be considered by the Board of Medicine when it elects to take disciplinary action against a practitioner. Gadsden State Bank v. Lewis, 348 So. 2d 343 (Fla. 1st DCA 1977)(Agencies must honor their own substantive rules until they are amended or abrogated.)

    1. Williams v. Department of Transportation, 531 So. 2d 994 (Fla. 1st DCA 1988)(Agency is required to comply with its

       disciplinary guidelines in taking disciplinary action against its employees.) For a violation of Subsection 458.331(1)(t), Florida Statutes, Rule 64B8-8.001(2)(t)3, Florida Administrative Code, provides for a penalty "[f]rom two (2) years probation to revocation or denial, and an administrative fine from $250.00 to

       $5,000.00." Aggravating and mitigating factors to be considered are set forth in subparagraph (3) of the rule, as follows:

       1. Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;

       2. Legal status at the time of the offense: no restraints, or legal constraints;

       3. The number of counts or separate offenses established;

       4. The number of times the same offense or offenses have previously been committed by the licensee or applicant;

       5. The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;

       6. Pecuniary benefit or self-gain inuring to the applicant or licensee;

       7. 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 penalties recommended above and impose suspension or revocation of licensure.

       8. Any other relevant mitigating factors.

23. Here, the Department suggested, as the penalty for the violation found, that the final order "place Respondent on probationary status concerning his practice of medicine in the State of Florida, impose a professional competency evaluation as a condition of satisfying said probation [and] impose an administrative fine of $5,000.00.7 That portion of the proposal which requests the order "impose a professional competency evaluation as a condition of satisfying said probation" is not supported by the proof or rule. See Rule 64B8-8.001(2)(t)(3), Florida Administrative Code. Compare Rule 64B8-8.001(2)(t)(1) and (2), Florida Administrative Code. The balance of the

Department's proposal is consistent with Section 458.331(2), Florida Statutes, and the Department's penalty guidelines.

Consequently, there being no apparent reason to deviate from that portion of the Department's recommendation, its proposed penalty is accepted as appropriate. Walker v. Department of Business and Professional Regulation, 705 So. 2d 652 (Fla. 5th DCA 1998)(Penalty imposed was within Florida Real Estate Commission's statutory authority and would not be disturbed.)

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that a final order be rendered which finds Respondent guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint.

It is further RECOMMENDED that for such violation the final order place Respondent on probation for a term of two years, subject to such reasonable terms as the Board of Medicine may specify, and impose an administrative fine of $5,000.00.

DONE AND ENTERED this 27th day of July, 1999, in Tallahassee, Leon County, Florida.

WILLIAM J. KENDRICK

Administrative Law 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 27th day of July, 1999.

ENDNOTES

1/ Respondent's objection to Petitioner's Exhibit 9 as hearsay was noted on the record, and Petitioner's Exhibit 9 was received into evidence subject to the limitations of Subsection 120.57(1)(c), Florida Statutes. See Orasan v. Agency for Health Care Administration, 668 So. 2d 1062 (Fla. 1st DCA 1996).

2/ Petitioner's objection to Respondent's Exhibit 2 as hearsay, was noted on the record, and Respondent's Exhibit 2 was received into evidence subject to the limitations of Subsection 120.57(1)(c), Florida Statutes.

3/ Petitioner's Exhibit 6, at page 31.

4/ If the CBC was greater than a 15,000 white blood count, then a blood culture would be ordered to confirm the bacterial infection. As noted, one in ten infants could reasonably be expected to evidence infection and are generally given empiric or prospective antibiotics (while awaiting the results of the blood culture) to treat the ten percent chance that they are infected. Here, it is likely that A. T.'s CBC would have exceeded a 15,000 white blood count and that, had empiric intervention been applied, her infection may have been successfully addressed.

5/ While universally fatal if not treated, the bacteria is also very sensitive to a number of commonly-used antibiotics.

Consequently, if promptly treated it is seldom fatal.

6/ Dr. Virdee did not keep contemporaneous notes and created the log the following day, after A. T.'s death. Consequently, the reliability of the log entries is debatable.

7/ The Department also recommended an assessment of costs as provided for by Section 455.624(3), Florida Statutes; however, it offered no proof, at hearing, regarding what costs, if any, it incurred. Consequently, there is no record basis on which to make a recommendation concerning a cost award.

COPIES FURNISHED:

Richard M. Ellis, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

Jonathan P. Lynn, Esquire

Stephens, Lynn, Klein & McNicholas, P.A.

301 East Las Olas Boulevard, Suite 800

Fort Lauderdale, Florida 33301

Tanya Williams, Executive Director Board of Medicine

Department of Health 1940 North Monroe Street

Tallahassee, Florida 32399-0750

Pete Peterson, General Counsel Department of Health

Bin A02

2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701

Angela T. Hall, Agency Clerk Department of Health

Bin A02

2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703

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.

Docket for Case No: 98-005652

Orders for Case No: 98-005652