STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 97-3363

)

SAMIR NAJJAR, M.D., )

)

Respondent. )

) DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 97-3442

)

SAMIR NAJJAR, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Upon due notice, this cause came on for formal hearing on April 28-30, 1998, in Jacksonville, Florida, before Ella Jane P. Davis, a duly assigned Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Albert Peacock, Esquire

Agency for Health Care Administration 2727 Mahan Drive

Tallahassee, Florida 32317-4229

For Respondent: Bruce Lamb, Esquire

Shear, Newman, Hahn and Rosencranz, P.A. Post Office Box 2378

Tampa, Florida 33601

STATEMENT OF THE ISSUE

Whether disciplinary action should be taken against Respondent's license to practice medicine based on:

1. The allegations of the Administrative Complaint in DOAH Case No. 97-3363, pertaining to patient R.W., of violations of Sections 458.331(1)(q), Florida Statutes, [failure to appropriately prescribe in the best interest of the patient]; 458.331(1)(t), Florida Statutes, [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]; and Section 458.331(1)(m), Florida Statutes, [failure to keep medical records justifying the course of treatment of the patient during his care of the patient]; and

   
   

2. The allegations of the Administrative Complaint in DOAH Case No. 97-3442, pertaining to patient N.W., of violating Section 458.331(1)(t), Florida Statutes, [failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances].

PRELIMINARY STATEMENT

On December 24, 1996, the Petitioner filed an Administrative Complaint against the Respondent in AHCA Case No. 95-01594, which became DOAH Case No. 97-3442. On June 24, 1997, the Petitioner filed an Administrative Complaint against the Respondent in AHCA Case No. 95-05043, which became DOAH Case No. 97-3363. Both cases were referred to the Division of Administrative Hearings in

July 1997 and were consolidated for formal hearing.

At formal hearing, Petitioner presented the oral testimony of John M. Harvey, M.D.; Vinod Patel, M.D.; Bonifacio T. Floro; Vickie Lynn Browning; Janet May Bryan; Kevin Murphy;

Donna Hughes; Jennifer Stephenson; Barbara Walsh; and

Earl Manion, P.A., and had 11 exhibits admitted into evidence. Two of these exhibits were the deposition testimony of Georges El Bahri, M.D., and of Janissa Ellis.

Respondent had six exhibits admitted in evidence and presented the oral testimony of Vernod Adams, M.D.;

Angela McKenzie; Kent Corral, M.D.; David Watkins; Richard Edward Spaulding; and Linda Eady Turner. One of Respondent's exhibits was the deposition testimony of Thomas F. Hegert, M.D.

Respondent also testified on his own behalf.

A transcript was filed in due course and all timely filed Proposed Recommended Orders have been considered in preparation of this Recommended Order.

FINDINGS OF FACT

1. Respondent is a licensed medical physician in the State of Florida and has been licensed in Florida at all times material under license number ME0041782.

2. Respondent is Board-certified in internal medicine, and his area of specialty is pulmonary medicine.

   AHCA Case No. 95-5043;

   DOAH Case No. 97-3442; Patient R.W.

3. On or about November 5, 1990, Patient Mr. R.W. suffered a work-related accident resulting in a very significant injury to his back, including a complete disc herniation.

4. On November 10, 1990, orthopedic surgeon Georges El Bahri, M.D., performed major spinal surgery, including a complete laminectomy of L4, L5, disc excision of L5, S1, and exploratory surgery in the region of S1 on R.W. at Memorial Medical Center in Jacksonville, Florida. This surgery was of an emergency nature to prevent paraplegia.

5. Prior to this surgery, R.W. was referred by Dr. El Bahri to Respondent on a pulmonary consult for surgical clearance because R.W. was suffering from chronic pulmonary disease, (CPD).

6. R.W. experienced genitourinary dysfunction (a dysfunction of the genitalia or urinary organs) as a result of his accident, and he saw a urologist, Mohammed N. Mona, M.D., for treatment.

7. On November 22, 1990, a second surgery was required for removal of a previously unidentified disc fragment.

8. Dr. El Bahri recommended a spinal fusion. Evaluation by a second orthopedic surgeon indicated that R.W. had suffered a 30 percent disability of the body as a whole related to his orthopedic injuries. The second orthopedic surgeon also suggested a bone fusion.

9. A spinal fusion operation would have exposed R.W. to a risk of loss of lower body function, and he declined the

   operation.

   
   

10. Dr. El Bahri referred R.W. to Respondent to provide continuing care for R.W.'s pulmonary problem.

11. Without surgery, R.W.'s back pain would continue to be severe and intractable. Dr. El Bahri had tried multiple alternative modalities of pain management with R.W. during the period of time that he participated in R.W.'s care, including use of a cane, weight reduction, corset, body brace, physical therapy, and a transcutaneous epidural nerve stimulator unit (TENS). Dr. El Bahri also had prescribed pain mediation for R.W. An implanted nerve stimulation device had been recommended, but

    R.W. declined it.

    
    

12. Dr. El Bahri and Respondent consulted concerning efforts to control R.W.'s pain. Dr. El Bahri made Respondent aware of the various alternative pain modalities that he had tried.

13. At some point, it was agreed between Dr. El Bahri and Respondent that where there is intractable pain requiring prescription drugs, one physician should assume primary care.

    Dr. El Bahri, as the orthopedic surgeon who could not get R.W. to agree to further surgery, deferred to Respondent who was treating R.W.'s chronic pulmonary problems. Dr. El Bahri and Respondent agreed that Respondent would prescribe analgesic and other medications for management of R.W.'s intractable pain.

14. R.W.'s first office visit with Respondent was on May 3,

    1991, and his last office visit was on June 16, 1993.

    
    

15. Petitioner alleged violations by Respondent both as to level of care and the keeping of medical records because he did not perform and record a full physical for R.W. at or about the time of R.W.'s first office visit. However, Dr. Harvey, testifying on behalf of Petitioner, as well as Dr. Corral, testifying on behalf of Respondent, agreed that it would not be necessary for Respondent to repeat a complete history and physical on R.W. between the November 1990 hospital consultation and physical and the May 3, 1991, office visit. Dr. Harvey would have allowed a ten-month delay, and Dr. Corral felt no further complete physical was necessary for treatment of a chronic condition so long as there was evidence of frequent office visit evaluations.

16. All the medical expert witnesses faulted Respondent's office records if they did not physically contain the hospital consultation sheets, and there is reason to believe that Respondent's office records did not include the consultation sheets until after R.W.'s death. Likewise, I do not find the other, later brief notes in Respondent's office records of partial examinations by Respondent or by his Physician's Assistant to constitute sufficient alternative documentation under the circumstances. See, infra. Therefore, to this degree, Respondent's records did not justify his course of treatment of R.W.

17. R.W. presented to Respondent with multiple problems: intractable back pain secondary to his injuries, chronic obstructive pulmonary disease (CPD-COPD), a history of smoking a pack and a half of cigarettes every day for 25 years, impotency, back surgery, hyperlipidemia, and labile hypertension. "Hyperlipidemia" means high cholesterol and trigylcerides. "Labile hypertension" refers to erratic high blood pressure. At

    
    

    205 pounds, R.W. also was overweight, but not "morbidly obese" for his height and age.

18. While under Respondent's care, R.W. continued to suffer from intractable back pain secondary to his injury, anxiety, and situational depression.

19. On April 10, 1992, while under Respondent's care, R.W. underwent a psychiatric evaluation at the University of Florida Health Sciences Center in Jacksonville, Florida. The psychiatrist, Ernest C. Miller, M.D., prepared a report dated June 9, 1992, in which he indicated that R.W. suffered adult situational disorder with chronic depression. He recommended "psychiatric contact." Respondent facilitated the workers' compensation insurance carrier's referral of R.W. to the psychiatrist for evaluation. Respondent's office records are deficient on this matter, but it appears most likely from the evidence as a whole that R.W. did not follow up on the psychiatrist's recommendation for psychiatric counseling because

    his workers' compensation employer-carrier declined to pay for any further psychiatric care.

20. Although Dr. Harvey testified that Respondent should have tried to talk R.W. into psychiatric counseling, the evidence as a whole falls short of demonstrating that Respondent bore any professional responsibility to force R.W. into psychiatric care or counseling against R.W.'s will and at R.W.'s own expense.

    
    

21. The psychiatrist recommended tricyclic anti- depressants. Respondent prescribed tricyclic anti-depressants as well as other drugs described infra.

22. Respondent obtained consultations of specialists, including two orthopedic physicians and a neurosurgeon.

23. Respondent also tried additional alternative modalities of pain management, including Marcaine (analgesic) trigger point injections, and topical anesthetics.

24. Despite Petitioner's charge that Respondent's care of

    
    

    R.W. was substandard due to his failure to refer R.W. to a pain management specialist, I find that between Dr. El Bahri and Respondent, most acceptable pain management modalities were attempted with R.W, and Respondent's failure to refer R.W. to a pain management specialist did not fall below the professional standard of care. In making this finding of fact, I have given weighted consideration to Dr. Harvey's testimony that there was

    no other pain management besides drugs unless Respondent could talk R.W. into psychiatric counseling or surgery, or retrying a TENS unit, and to Dr. Corral's testimony that it was not necessary for Respondent to consult with a pain specialist because the patient had refused all invasive and some non- invasive pain management and that anything other than invasive pain management could be done for R.W. by the Respondent.

25. During the period of time R.W. was under Respondent's care, Respondent prescribed to him analgesic medications for pain. He also prescribed anti-depressant, anti-anxiety, and muscle relaxant medications. It is with the quantity of these prescriptions, the inter-action of the drugs prescribed, and the failure to record these prescriptions in Respondent's office records for R.W. that the Petitioner finds fault.

26. Between April 21, 1992, and July 6, 1993, Respondent wrote R.W. in excess of 30 prescriptions for pain management and depression. Dispensation of these prescriptions, including approved refills, exceeded 4,000 tablets. However, during this period of time, Respondent also recorded 11 office visits: 4/21/92, 5/15/92, 5/18/92, 5/20/92, 6/18/92, 8/21/92, 11/9/92, 2/1/93, 4/5/93, 5/4/93, and 6/16/93.

27. Based on a "Pharmacy Profile," R.W. received the following medications prescribed by Respondent between April 21, 1992, and July 6, 1993.

    Drug Prescribed Dosage/Quantity Dates Filled

    
    

    Diazepam	10mg	50	06/16/93
    Amitriptyline	50mg	30	07/24/92
    	50mg	30	08/11/92
    	50mg	30	09/23/92
    	50mg	30	10/20/92
    	50mg	30	11/20/92
    	50mg	30	12/16/92
    	100mg	30	02/01/93
    	100mg	30	03/03/93
    	100mg	30	04/02/93
    	100mg	30	05/03/93
    	150mg	30	05/07/93
    	100mg	30	06/02/93
    	100mg	30	06/25/93

    
    

    Drug Prescribed	Dosage/Quantity	Dates Filled
    Lorcet Plus	100	06/18/92
    	100	07/15/92
    	100	08/11/92
    	90	09/11/92
    	90	10/07/92
    	90	11/09/92
    	90	12/07/92
    	90	12/31/92
    	90	01/29/93
    	100	03/01/93
    	100	04/02/93
    	100	05/03/93
    	100	05/07/93
    	100	06/07/93
    	100	07/06/93
    Roxicet 5/325	40	04/05/93
    Clorazepate	100	04/05/93
    Xanax	1mg 100	04/22/92
    	100	05/26/92
    	100	07/09/92
    	100	08/11/92
    	100	10/07/92
    	100	11/09/92
    	100	12/07/92
    	100	12/31/92
    	100	01/29/93
    	100	03/01/93
    	100	04/02/93
    	100	05/03/93
    	100	06/07/93
    	100	07/06/93
    Acetaminophen	500mg 100	09/11/92
    	100	10/20/92
    	100	11/20/92
    	100	12/05/92
    	100	02/10/93
    Notriptyline	50mg 120	09/11/92
    	120	10/20/92
    	120	01/18/93
    Carisoprodol	350mg 100	05/07/93
    	100	07/06/93

28. Xanax, Lorcet Plus, Amitriptyline, Clorazepate, Roxicet, Diazepam, and Carisoprodol are Central Nervous System (CNS) depressants and several, including Xanax and Diazepam (Valium), are benzodiazepines.

29. When taken together, CNS depressants can produce additive CNS effects.

30. Benzodiazepines are drugs which are in a class of structurally related compounds. They have sedative, anti- convulsant, and skeletal muscle relaxant properties and are used for the treatment of anxiety and other purposes.

31. Using several benzodiazepines together can also be fatal, because the patient may develop a tolerance to the drug and ultimately consume toxic dosages.

32. Xanax is a Schedule IV legend drug used to treat anxiety disorders. It produces additive CNS depressant effects when administered with other CNS depressants.

33. Lorcet Plus is a Schedule III legend drug which contains Hydrocodone. It is used for treating moderate to moderately severe pain. If used with other CNS depressants, it can produce additive CNS depression.

34. Amitriptyline is a legend drug and a trycyclic anti- depressant. It can enhance the effects of alcohol, barbiturates, and CNS depressants. It can aggravate heart conditions.

35. Clorazepate is a Schedule IV benzodiazepine legend drug indicated for the treatment of anxiety disorders. It has a CNS

    
    

    effect. Clorazepate should not be administered to patients with indications of drug dependencies.

36. Roxicet is a Schedule II legend drug which has a high potential for abuse and has a currently accepted, but severely restricted, medical use. It can produce dependency of the morphine type.

37. Diazepam is a Schedule IV drug indicated for the treatment of anxiety disorder. It is a form of Valium and is a CNS depressant.

38. Nortriptyline is a legend drug that is a tricyclic anti-depressant.

39. Carisoprodol is a legend drug that is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is a CNS depressant.

40. R.W. died unexpectedly at his home on July 9, 1993. Petitioner contends that because the prescribed medications were not listed in R.W.'s chart at the material times, the prescriptions and renewals were given by Respondent without any reference to a medical record which would allow Respondent or any physician to provide R.W. with sufficient warnings or information regarding the combined use of these drugs and/or to appropriately monitor or limit R.W.'s simultaneous intake of the CNS depressants, and that, whether one concludes that R.W. died due

    to multiple drug toxicity or as a result of a myocardial infarction is not critical, but that Respondent's care and treatment was so careless as to create an environment in which

    R.W. was an "accident waiting to happen."

    
    

41. All the testifying medical experts agreed that Respondent should have given R.W. medication overdose and interaction warnings. Respondent claims to have orally warned

    R.W. and R.W.'s wife concerning R.W.'s prescriptions, but it is not disputed that prior to R.W.'s death, R.W.'s chart/medical records in Respondent's office did not contain adequate notations of oral medication overdose and interaction warnings. Dr. Corral testified that not all such warnings must be recorded.

42. It is also undisputed that prior to R.W.'s death, his chart/records in Respondent's office did not contain adequate notes on the drugs prescribed by Respondent.

43. In his office practice, Respondent had established a system whereby requests for refills of medications previously prescribed to patients would be documented on a separate IO9 drug tally sheet or "day sheet" by Respondent's staff. Sometime during each work day, Respondent would review the list of requested refills, and approve or deny each by making a written notation on the "day sheet." Respondent's staff would then telephonically authorize the pharmacy to refill only those prescriptions that Respondent had authorized in writing.

44. By making a written notation approving requested

    refills, Respondent was creating a record of drugs he prescribed.

    
    

45. Under Respondent's system, his staff members were then supposed to transpose the refill information from the "day sheet" onto each patient's individual medical record chart.

46. The aforementioned system for approval of requested refills and documentation thereof is an acceptable means of documenting refill information on medications for individual patient charts, but it was not followed in this instance.

47. Vickie Browning, as receptionist and "front office" staff member, was primarily responsible for the transfer of the medication information from the day sheets to individual patient charts. Periodically, when she got backed up with telephone calls or otherwise behind in her work, Ms. Browning simply threw away piled-up day sheets without transferring the prescription information to individual patient charts. In making this finding of fact, I have noted the clear testimony of another staff member, Angie McKenzie, who saw Ms. Browning throw away a pile of prescription day sheets, but who admittedly did not advise Respondent of what was going on. I also have considered Linda Eady Turner's testimony that Ms. Turner saw a pile of day sheets in the trash can on a single occasion. I also have carefully scrutinized Ms. Browning's testimony, which by candor and demeanor, internal inconsistencies, and motivation to fabricate,

    I find to be unreliable and incredible.

    
    

48. Despite R.W.'s 11 office visits during the material period of time, during each of which Respondent presumably reviewed R.W.'s chart, Respondent did not become aware that prescription refill information was not being recorded in R.W.'s chart. Likewise, Respondent did not become aware that prescription refill information was not being recorded in any patient charts until he reviewed R.W.'s medical chart after R.W.'s death.

49. As the medical professional ultimately responsible for accuracy of medical records and treatment of his patients, Respondent should have noted the gaps on R.W.'s and other patients' charts before he did. For the same reasons, he should have known, prior to R.W.'s death, that his system was not being followed.

50. After R.W.'s death, the Duval County Medical Examiner confiscated drugs from R.W.'s home and created a Medication Log containing the following drugs: Xanax 1 mg, 1-1/2 pills remaining; Amitriptyline 150 mg, 1 remaining; Amitriptyline 100 mg, 8 remaining; Ketoproten 75 mg, 61 remaining, Zantac 150 mg, 1 remaining; Amoxicillin 500 mg, 1 remaining; Helotestin 10 mg, 9 remaining; Lorcet Plus tablets, 88 remaining; Carisoprodol 350 mg, 54 remaining; Xanax 1 mg, 88-1/2 remaining; Carisoprodol 350 mg, 97 remaining; and Hydrocodone, 27 remaining. All of these drugs were prescribed by Respondent.

51. Laboratory tests performed on R.W. revealed the presence of Amitriptyline, Hydrocodone, Nordiazepam (which is from Diazepam), Carisoprodol, and Xanax.

52. Respondent was quickly embroiled in legal actions arising out of R.W.'s death. Upon discovering that prescription refill information relating to R.W. had not been recorded by his staff on R.W.'s chart, Respondent instructed members of his staff to obtain prescription information from the pharmacy, and recreate a medication list for R.W.'s chart. He further advised his staff to record any recollections they had which related to interactions of any staff members and R.W. or R.W.'s wife.

53. Once his staff had completed the prescription information recreation, Respondent placed a note on the recreated records, identifying them as recreations and not contemporaneous notes. He also advised his attorney and the attorney representing the estate of R.W. of the recreated records. This would logically show no intent to, or conspiracy by, Respondent to fabricate or falsify patient records, but merely an intent and effort to recreate prescription information for his defense at trial. In making this finding of fact, I have again discounted Ms. Browning's testimony for the reasons previously cited.

54. All testifying medical experts agreed that it is professionally acceptable for a medical physician to add notes as an addendum, provided the physician indicates the date of additional notes and clearly shows that they are not

    contemporaneous.

    
    

55. At the request of one of R.W.'s relatives employed in the Sheriff's Office, the Assistant Medical Examiner for Duval County, Dr. Bonafacio Floro, performed an autopsy on R.W.'s corpse. He opined that the immediate cause of R.W.'s death was "multiple drug toxicity," although he noted "arteriosclerotic disease" as a secondary, or contributing, cause of death. He also speculated that one or more prescription drugs could have caused a myocardial infarction.

56. In formulating his opinion on the proximate cause of R.W.'s death, Dr. Floro relied almost exclusively on laboratory tests performed by the Duval County Medical Examiner's Office and by an outside laboratory revealing the presence of several drugs in R.W.'s blood. The results of the drug tests performed by the Duval County Medical Examiner's Office and the outside laboratory are inconsistent, but this is largely a difference without a distinction. By either test, R.W.'s blood level of Hydrocodone would be "lethal" as established by a generally accepted medical text, and his blood level of Xanax would be "toxic" as established by the same generally accepted medical text. This medical text, however, is basically only a catalogue of drug toxicity levels in persons already dead.

57. According to Dr. Venard Adams, however, all of the drugs in R.W.'s blood at the time of his death were at therapeutic levels, except for Hydrocodone, which was at the low

    end of the generally accepted lethal range, and this level might not be lethal for one who had developed a tolerance for several drugs. Dr. Adams's opinion on this score was shared by Dr.

    Thomas F. Hegert. Each of these physicians are also Florida Medical Examiners.

58. Dr. Floro's conclusion that multiple drug toxicity was the proximate cause of R.W.'s death also was not shared by the other medical experts, and Dr. Floro conceded that he had no opinion on where the line is crossed between achieving therapeutic levels and toxic or lethal levels in living patients with increased medicinal tolerance.

59. Except for Dr. Floro, all of the other medical experts testified that the Respondent's prescriptions for R.W. continued to be mostly the same types and amount of each drug from R.W.'s first visit to his last; that Respondent's prescriptions did not exceed reasonable amounts of each individual medication; that in some cases the amounts Respondent prescribed were less than the maximum amounts permissible for individual medications; and that the prescriptions, if taken as prescribed, should not have exceeded reasonable amounts for their purpose.

60. Dr. Corral considered Respondent's use of all the drugs together to be common practice. Dr. Hegert considered the combination of drugs selected by Respondent to be appropriate within current chronic pain management therapy and effective, in that because of the combination and amounts Respondent used,

    Respondent would not have had to prescribe even stronger pain medications which have a greater potential for addiction than those Respondent actually used. Dr. Hegert also found no indication that the drug levels in R.W.'s blood at death, as indicated by the laboratory reports, were any different than the probable levels R.W. had experienced over a considerable period of time.

    
    

61. Although Dr. Floro reviewed some cut sections of the deceased's heart, Dr. Floro did not clearly acknowledge evidence of an acute myocardial infarction.

62. Cut sections of R.W.'s heart were prepared with a special stain by Dr. Hegert and microscopically viewed. These sections revealed myocardial injury, "clear evidence" of an acute myocardial infarction. Dr. Hegert concluded that R.W. died of acute myocardial infarction secondary to severe coronary artery disease.

63. There are a few pills from R.W.'s last prescriptions which are unaccounted for, but this is insufficient under the facts of this case to assume that R.W. consumed more pills than the labels prescribed or that excessive use of a single prescription drug or several prescription drugs triggered his myocardial infarction. In light of the testimony of a borderline nature for R.W. of the Hydrocodone level and the probable therapeutic level of the other drugs, there is no clear and

    convincing evidence that R.W. exceeded the labeled dosage. There is certainly no clear evidence that if R.W. exceeded the labeled dosage, he did so because of Respondent's failure to warn him.

    Finally, there is no clear and convincing evidence that Respondent's prescription practice rendered R.W. chemically dependent on prescription drugs.

    AHCA Case No. 95-01594;

    DOAH Case No. 97-3363; Patient N.W.

    
    

64. Mrs. N.W. had been a patient of Respondent since April 17, 1992.

65. Approximately a year before April 6, 1994, N.W. had required hospitalization due to severe gastroenteritis. At that time, she was hospitalized for re-hydration and attendant care. Thereafter, until April 6, 1994, N.W. enjoyed reasonably good health, except that she suffered from systemic lupus and erythema.

66. On Wednesday, April 6, 1994, N.W. presented to Respondent's office with complaints of having eaten bad ham at a picnic, nausea, vomiting, and diarrhea for several days. These were similar symptoms to those at her hospitalization the year before. Long-term nausea, vomiting, and diarrhea can cause severe dehydration. Respondent recommended that N.W. be hospitalized for re-hydration. N.W. and her husband refused, accepting instead a prescription for antibiotics.

67. On Friday, April 8, 1994, N.W. was not improved and

    either she or her husband contacted Respondent's office. Respondent's office was advised that N.W. had continued to suffer from nausea, vomiting, and diarrhea since her Wednesday office visit. N.W. then accepted Respondent's recommendation, and directions were given for her to be directly admitted to Memorial Medical Center (hospital) in Jacksonville, Florida, without first being seen at Respondent's office.

68. N.W. was admitted to the hospital at approximately 4:30 p.m.

69. Patients suffering from dehydration can develop hypovolemia (low blood volume) and can appear very ill and develop low blood pressure (hypotension); high or low heart rate (tachycardia or bradycardia); and become cold and clammy. These symptoms are also consistent with a myocardial infarction, although high heart rate is more common than bradycardia with a myocardial infarction.

70. Appropriate treatment of hypovolemia is re-hydration through the administration of intravenous (IV) fluids.

71. N.W. ultimately died four days later on April 12, 1994, from congestive heart failure initiated by a myocardial infarction which had most probably occurred sometime around noon on April 8, 1994, prior to her admission to the hospital.

72. All witnesses concur that the only period of time that is material to the charges against Respondent is approximately 4:00 p.m. April 8, 1994 to 8:00 a.m. April 9, 1994. The thrust

    of the Administrative Complaint is that the information of an abnormal EKG and abnormal cardiac enzymes were repeatedly relayed to Respondent by telephone and that he failed to timely take aggressive action.

73. Sometime subsequent to April 9, 1994, the nursing progress notes covering the period of time from approximately 8:00 p.m. April 8, 1994, until approximately 7:00 a.m. April 9, 1994, were found to be missing. Subsequently, the hospital's Risk Management staff directed that the nursing notes be recreated. The recreated notes were reviewed by the Risk Management staff and the hospital attorney. They were dissatisfied with them as being too subjective. At their instruction, a second set of nursing notes was recreated. However, Risk Management and the hospital attorney ultimately included the first set of recreated notes in N.W.'s hospital chart, believing that the first set of recreated notes would be more accurate because they were closer in time to the events charted.

74. The copy of a 7:32 p.m. April 8, 1994, electrocardiogram (EKG) report currently in the hospital chart, which indicates an acute myocardial infarction, was not the copy of the EKG interpretation that was originally placed in N.W.'s hospital chart during the period of time that N.W. was hospitalized on April 8, 1994. The EKG copy in the hospital chart is a copy that has been interpreted by a cardiologist,

    Benjamin C. Olive, M.D.

    
    

75. The undersigned has had the benefit of considering both sets of recreated notes, the witnesses' testimony, and all other exhibits admitted in evidence. In making the following Findings of Fact, the undersigned has compared, considered credibility, and weighed all elements of the record.

76. After initial evaluation by hospital nursing staff,

    
    

    N.W. was evaluated at approximately 7:30 p.m., by Earl Manion, Respondent's Physician's Assistant. Mr. Manion noted, among other things, that because N.W.'s abdominal pain was very high up into the sternum, cardiac involvement should be investigated.

    Mr. Manion gave appropriate orders for initial laboratory and radiological evaluation of N.W. A CPK test is part of a standard chemistry panel done for all admittees, but the initial tests ordered by Mr. Manion included the performance of an EKG and blood chemical studies including cardiac enzyme testing (CPK-MB).

77. At Memorial Medical Center, as in many facilities, EKGs are initially interpreted by a computer program, which provides a printed verbal interpretation of the EKG. Hospital nurses are not expected to interpret the line configurations on EKGs. Standard procedure is for them to notify the admitting physician of the computer's printed verbal interpretation.

78. Mr. Manion did not remain on the cardiopulmonary floor to which N.W. was initially assigned (Three South Tower) to read the results of the tests he had ordered. He anticipated that

    Respondent would shortly be making rounds and would see the test results for himself. He did not relay his cardiac concerns to Respondent or tell Respondent that he had ordered a CPK-MB instead of a CPK test.

79. In fact, Respondent did not make rounds that evening, and there was no requirement that he should do so.

80. Lay persons normally refer to a myocardial infarction as a "heart attack." Persons can suffer from a myocardial infarction and, dependent upon its severity, they may not even be aware it has occurred.

81. A myocardial infarction may be classified as "acute," meaning "recent" or "on-going," or it may be classified as "chronic," meaning "old" or "in the past." If it is an old infarction, no immediate physician response is necessary.

82. The first EKG performed on N.W. printed out the verbal interpretation of "consider inferior infarct, age undetermined." This result is not an acute myocardial infarction alert. This result was reported telephonically to Respondent by Donna Hughes,

    R.N. Nurse Hughes was the first nurse significantly involved in N.W.'s care, and was the responsible nurse between admission and midnight on April 8, 1994.

83. The CPK-MB test results came in subsequent to Ms. Hughes' first telephone call to Respondent, so she made a second telephone call to Respondent about 10:30 p.m. on April 8, 1994. She subsequently recreated notes to the effect that she related

    to Respondent that N.W. showed "elevated cardiac enzymes," but in her testimony, Ms. Hughes confirmed that she recalled telling Respondent only that the "CPK" was elevated.

84. Despite reports by N.W.'s husband that his wife's face "was turning colors," neither nurse Hughes nor Physician's Assistant Manion observed such a phenomenon. In fact, to them,

    N.W. denied any chest pain or chest tightness. Nurse Hughes did not believe that N.W. was having a myocardial infarction during her shift.

85. Chemical tests can be performed on a patient's blood for various enzymes that are released into the bloodstream as a result of stress on muscle systems. Various enzymes and "bands" of enzymes reflect stress or damage to different muscle systems.

86. A CPK is an enzyme test that may indicate damage to muscles in the body generally, or more specifically, damage to skeletal muscles. It may also reflect systems' reactions to injected anti-vomiting medications, which N.W. had received. A CPK-MB (or CK-MB) band is a more specific enzyme test that is indicative of stress or damage to the heart muscle.

87. The CPK-MB (or CK-MB) band is appropriately referred to as a "cardiac enzyme test."

88. The CPK is not appropriately referred to as a "cardiac enzyme test."

89. There is no clear and convincing evidence that Nurse Hughes advised Respondent that the CPK-MB or CK-MB was elevated.

    It is more likely that she only correctly identified that the test was a "cardiac enzyme test" in her recreated notes.

90. Because Respondent was aware of N.W.'s past history of gastroenteritis and that N.W. had been suffering from vomiting, including retching, and had received intra-muscular injections of anti-nausea medication, and because retching and intra-muscular injections can result in an elevated CPK, it would be reasonable for him to discount the results of a CPK, which he did during the second phone call from Nurse Hughes. He ordered an increase in the potassium IV.

91. Jennifer Stephenson, R.N., was a graduate nurse (G.N.) performing nursing care for N.W. on Three South Tower after midnight on April 8, 1994. She involved the charge nurse and the nurse coordinator due to her G.N. status and due to her concern for N.W.'s condition. She placed a telephone call to Respondent's "service" but did not speak to him. When Respondent returned the telephone call, his call was received by Tess Bunal,

    R.N. He denied that any clear information about the CPK-MB or about a new EKG was given to him in this phone call. During this phone call, Respondent authorized the transfer of N.W. to the Telemetry Unit (Three Central) for closer monitoring.

92. The Telemetry Unit is a monitored unit with heart pattern displayed at each bedside and at a monitor bank. It provides one staff nurse for every three to four patients. It is only one step down from an intensive care floor.

93. Upon N.W.'s arrival at the Telemetry Unit, Kevin Murphy, R.N. became the nurse involved in her care. Mr. Murphy spoke with Respondent at or about 1:40 a.m. on April 9, 1994, regarding N.W.'s EKG, low blood pressure, and increased heart rate. At that time, Nurse Murphy relied on another nurse's oral report that Respondent had already been informed of the elevated heart enzymes and also had been informed of the results of an abnormal EKG. Nurse Murphy recommended that N.W. be transferred to an intensive care unit, also known as a "cardiac care unit" (CCU). However, Mr. Murphy testified that he did not advise Respondent of the result of the EKG or any specific enzyme results, because he believed Respondent already had that information.

94. The Respondent rejected Nurse Murphy's recommendation to transfer N.W. to CCU. Instead, he gave orders to increase the IV.

    
    

95. Nurse Murphy was uncomfortable with Respondent's response to his recommendation. He closely monitored N.W. N.W.'s vital signs did not change markedly, but she continued to complain of nausea and even some chest tightness. Nurse Murphy ordered another EKG, which showed an "acute myocardial infarction." He again spoke with Respondent by telephone at approximately 3:40 a.m. on April 9, 1994, and again requested that N.W. be transferred to the intensive care unit. He did not

    inform Respondent of an EKG showing "acute myocardial infarction" or that the MB band was elevated. His testimony does not clarify whether he did or did not relay to Respondent any complaint of chest tightness. However, at Nurse Murphy's insistence, Respondent ordered N.W. transferred to CCU.

96. At no time on any of the three units (cardiopulmonary, telemetry, or cardiac care) did any nurse become sufficiently concerned about N.W.'s condition or about Respondent's responses so as to call on the hospital's "fail safe" procedures which included the opportunity to involve an on-call "intensivist."

97. At approximately 7:00 a.m. on April 9, 1994, a new nurse, Nurse Waples, began her shift on CCU. She contacted Respondent by telephone at 7:20 a.m. and advised Respondent clearly that N.W. was complaining of chest tightness, and of the results of the latest EKG. She also clearly stated that N.W. had an elevated CK-MB.

98. Respondent immediately gave appropriate orders for evaluation and treatment of a possible cardiac problem, including EKG, cardiac medication, oxygen, arterial blood gases, pulse oxymeter, and a cardiac consultation, and he proceeded directly to the hospital.

99. The Respondent saw N.W. in the hospital for the first time at 7:55 a.m. on April 9, 1994. At that time, he and a cardiologist correctly diagnosed her as having had an acute myocardial infarction and going into cardiogenic shock.

100. Respondent timely requested the participation of a cardiologist and provided appropriate orders for N.W.'s cardiac condition. He also appropriately monitored her status.

101. Nonetheless, N.W. ultimately went into congestive heart failure. After several unsuccessful treatment attempts, she died on April 12, 1994, at 5:33 p.m.

102. Petitioner's medical physician expert, Dr. Patel, testified that Respondent, in response to the several nurses' telephone calls concerning "elevated cardiac enzymes" and an abnormal EKG, should have either been in immediate personal attendance at N.W.'s bedside, or should have obtained a proper consultation with a cardiologist, and/or should have called on the intensivist provided by the hospital, and that Respondent's failure to take at least one of these courses of action constituted his failure to practice medicine with that level of care, skill, and treatment recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances.

     
     

103. Respondent's experts agreed that if Respondent had received clear notification of an "acute" condition by EKG, of an elevated CPK-MB or CK-MB, or of clear symptomatology such as chest pain, these were "red flags" telling Respondent that he should aggressively address a cardiac problem. However, all experts, even Dr. Patel, concurred that if the EKG had showed

     only "consider inferior infarct, age undetermined," that, alone, would not be sufficient to trigger an immediate response from Respondent.

104. Based on all he reviewed, which was not all of the evidence in this case, Dr. Patel acknowledged that if the information relayed by Nurse Waples had been given Respondent earlier he could have met the standard of care by merely requesting that the nurse call a cardiologist for a consultation or call the hospital's intensivist to see N.W. Under these circumstances, Respondent would not even have had to come into the hospital, and therefore his failure to respond could not be attributed to "laziness."

105. Because Respondent acted knowledgeably and appropriately when clearly informed of N.W.'s condition by Nurse Waples, Dr. Patel would not attribute Respondent's lack of response to lack of knowledge or ability.

106. Dr. Patel ultimately opined that because the first set of recreated notes showed repeated notifications to Respondent that N.W.'s blood pressure was falling while her heart rate was rising; this, with all the other information, including notification of chest tightness, should have resulted in a more aggressive response from Respondent, but he conceded that these symptoms occasionally are consistent with hypovolemia, and the undersigned notes that in testimony, only Nurse Murphy clearly testified that he notified Respondent of the disparity in blood

     pressure and heart rate, and did not specifically state that he mentioned chest tightness.

107. No witness clearly suggested that Respondent had an affirmative duty to inquire whether a CPK or CPK-MB had been administered to N.W., or to inquire if a second EKG had been performed after the first one, or to personally order a subsequent EKG based on the several phone calls as related by the testifying nurses.

108. No one testified that repeated phone calls from nursing staff by itself should have alerted Respondent to a myocardial infarction.

109. Respondent's experts concurred that absent clear notification of an elevated CPK-MB, the information that N.W.'s EKG showed an old myocardial infarction did not require any response beyond the responses Respondent made.

     CONCLUSIONS OF LAW

     
     

110. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding, pursuant to Section 120.57(1), Florida Statutes, and Section 455.225, Florida Statutes.

     
     

111. Pursuant to Section 458.331(2), Florida Statutes, the Board of Medicine is empowered to revoke, suspend, or otherwise discipline the license of a medical physician for the following violations of Section 458.331, Florida Statutes:

     (1)(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.

     
     

     (1)(t) Being guilty of 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.

     
     

     (1)(q) Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his intent.

112. Petitioner Agency has the duty to go forward and prove the alleged violations by clear and convincing evidence. Ferris v. Turlington, 512 So. 2d 292 (Fla. 1987).

     AHCA Case No. 95-5043;

     DOAH Case No. 97-3442; Patient R.W.

     
     

113. With regard to R.W., Petitioner has failed to show by clear and convincing evidence that Respondent violated Sections 458.331(1)(t) or (q), Florida Statutes, by inappropriate prescribing practice or a substandard level of care, skill, and

     treatment.

     
     

114. Petitioner has, however, clearly and convincingly demonstrated that Respondent violated Section 458.331(l)(m), Florida Statutes, by failing to keep written medical records justifying his course of R.W.'s treatment. See Rule 21M-27.003, Florida Administrative Code.

115. While his medication recreation does not constitute fraud or fabrication, Respondent's overall records documentation is simply below professional standards and offends the statute.

116. Without the Pharmacy Profile recreation, Respondent's medication records are execrable. With it, his notes are not much better. The fact that he did not "catch on" to Ms. Browning's perfidity is not a defense; it supports proof of his violation. As primary treating physician, Respondent is required to know what goes on in his office, and the absence of medication information from all patient charts was a glaring clue Respondent did not recognize.

117. Additionally, Respondent's cursory documentation of even partial physicals and other evaluations in Respondent's office was poor. Failure to include in his office records papers related to the earlier hospital consultation containing his full history and physical on R.W. was more than a minor lapse.

118. Recording oral drug warnings is largely for the physician's self-protection and not the patient's benefit, but each of the other elements had the potential of harming the

     patient.

     
     

119. Clearly, no other health care professional could have reviewed Respondent's records and rendered continuing care therefrom.

     AHCA Case No. 95-01594;

     DOAH Case No. 97-3363; Patient N.W.

     
     

120. The Petitioner contends that the information of an abnormal EKG, elevated cardiac enzymes, vomiting, and nausea, as reported by the duty nurses to Respondent by telephone would have prompted a reasonably prudent physician to modify his initial treatment plan and to act more quickly and more aggressively in the care of N.W.

121. The standard of care evidenced by Respondent for N.W. is not the standard most people would seek in a primary treating physician. Most of us would hope and expect that our doctors would not ignore repeated phone calls from hospital nurses expressing concern over us. Such a scenario bespeaks arrogance, even if ignorance and laziness have been ruled out. However, herein, the concessions of Dr. Patel that accepting certain circumstances, Respondent's inaction could be within the accepted standard of care, together with the absence of any evidence that the repeated phone calls alone were enough to alert Respondent to initiate aggressive care, is similar to the situation in Hasbun v. Department of Health, 701 So. 2d 1235 (Fla. 3d DCA 1997), which did not result in adequate proof of a substandard care

     violation.

     
     

122. The evidence as a whole herein supports a conclusion that because there was not clear notification of an EKG showing an acute myocardial infarction or clear notification of elevated cardiac enzymes, or clear notification of heart and chest symptomatology, Respondent had no reason to modify his treatment.

RECOMMENDATION

Upon the foregoing findings of fact and conclusions of law, it is

RECOMMENDED that the Board of Medicine enter a Final Order

that

1. Finds Respondent not guilty of violating Section

   
   

   458.331(1)(t) in DOAH Case No. 97-3363 with regard to Patient N.W.

2. Finds Respondent not guilty of violating Sections 458.331(1)(q) and (t), in DOAH Case No. 97-3442 with regard to Patient R.W.

3. Finds Respondent guilty of violating Section 458.331(1)(m) Florida Statutes, in DOAH Case No. 97-3442 with regard to Patient R.W., and imposes a penalty of two months suspension of license followed by probation of Respondent's license for six months upon such terms and conditions as the Board may impose to correct his record-keeping, and imposes a

$1,000.00 fine. See Rule 21M-20.001(2)(m), Florida Administrative Code.

DONE AND ENTERED this 18th day of August, 1998, in Tallahassee, Leon County, Florida.

ELLA JANE P. DAVIS

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

Filed with the Clerk of the Division of Administrative Hearings this 18th day of August, 1998.

COPIES FURNISHED:

Bruce Lamb, Esquire

Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378

Tampa, Florida 33601

Albert Peacock, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive

Post Office Box 14229 Tallahassee, Florida 32317

Dr. Marm Harris, Executive Director Department of Health

Board of Medicine

1940 North Monroe Street Tallahassee, Florida 32399-0792

Angela T. Hall, Agency Clerk Department of Health

1317 Winewood Boulevard

Building 6

Tallahassee, Florida 32399-0700

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: 97-003363

Orders for Case No: 97-003363