STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 98-3728

)

ROLANDO R. SANCHEZ, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, an expedited formal hearing was conducted in this case on September 8-9, 1998, in Tampa, Florida, before Lawrence P. Stevenson, a duly designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Albert Peacock, Esquire

John E. Terrel, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Grover C. Freeman, Esquire

Jon M. Pellett, Esquire Freeman, Hunter & Malloy

201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602

STATEMENT OF THE ISSUE

The issue presented for decision in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on July 28, 1998.

PRELIMINARY STATEMENT

By Administrative Complaint dated July 28, 1998 (the “Complaint”), Petitioner alleged that Respondent, a licensed physician, violated provisions of Chapter 458, Florida Statutes, governing medical practice in Florida. The Complaint was filed subsequent to an Order of Emergency Suspension of License entered against Respondent on July 9, 1998. Respondent did not challenge the emergency suspension of his license in this proceeding.

The Complaint comprises five counts, all relating to an incident in which Respondent mistakenly inserted a central venous line in patient J.P. rather than in D.M., the intended recipient, who shared a room with J.P. in Vencor Hospital Central Tampa (“Vencor Hospital”).

Count One alleges that Respondent failed to keep written medical records justifying the course of treatment of patients

J.P. and D.M., in that Respondent’s medical records contained inadequate and incomplete patient histories and physical examinations, and contained inadequate notes regarding interaction with the patient prior to placement of the central venous line, all in violation of Section 458.331(1)(m), Florida Statutes.

Count Two alleges that Respondent performed professional services that were not authorized by J.P. or her legal representative, in that he performed an unauthorized invasive surgical procedure on J.P. without her informed consent or that of her designated health care surrogate, in violation of Section

458.331(1)(p), Florida Statutes.

Count Three alleges that Respondent practiced medicine below the standard of care by failing to ensure that J.P. was the proper recipient of his care, and by performing an unauthorized invasive surgical procedure on J.P., in violation of Section 458.331(1)(t), Florida Statutes.

Count Four alleges that Respondent violated a previous final order of the Board of Medicine issued on or about January 26, 1996, by failing to follow the procedures set forth in his probationary terms for correctly identifying a patient prior to surgery, by failing to have specific discussion with J.P. prior to the administration of anesthesia, by failing to mark the planned surgical site with indelible ink, and by failing to report his mistaken surgery or the suspension of his Vencor Hospital privileges to the Board of Medicine, all in violation of Section 458.331(1)(x), Florida Statutes.

Count Five alleges that Respondent misrepresented and concealed material facts during a disciplinary process by failing to report the relevant facts to the Board of Medicine during his probation, and by affirmatively representing to the Board of Medicine that he was in full compliance with all of his probationary terms, in violation of Section 458.331(1)(gg), Florida Statutes.

At the final hearing, Respondent made an oral motion to strike Counts Four and Five of the Complaint, under authority of Arias v. Department of Business and Professional Regulation, 710 So. 2d 655 (Fla. 3d DCA 1998), dismissed 718 So. 2d 167 (Fla.

1998). The undersigned reserved ruling on the motion. As

discussed more fully in the conclusions of law below, the motion is granted as to Count Four and denied as to Count Five.

Petitioner forwarded the Complaint to the Division of Administrative Hearings on August 18, 1998, requesting the assignment of an Administrative Law Judge and the conduct of a formal hearing pursuant to Sections 120.569 and 120.57, Florida Statutes. The matter was assigned to the undersigned, who set the case for final hearing on September 8-9, 1998.

At the final hearing, Petitioner presented the testimony of Lisa Cotroneo, Fortune Ndukwe, and Mary Shogreen, all of whom were registered nurses on duty at Vencor Hospital when the incident occurred; David Vallejo, an X-ray technician at Vencor Hospital; David Shatz, M.D., and Stephen Michel, M.D., both accepted as experts in general surgery; Crystal Griffin, Medical Compliance Officer with the Board of Medicine; and Richard Hess, an investigator with the Agency for Health Care Administration.

Petitioner’s exhibits 1, 1A, 1B, 2, 2A, 2B, and 3-11 were admitted into evidence.

Respondent testified on his own behalf and presented the testimony of Elizabeth Rood, Theresa Williams, and Virginia Lanford, all of whom were registered nurses at Vencor Hospital; Stacy Dampier, a health unit coordinator at Vencor Hospital; Michael Blazicek, an attorney who has represented Respondent; Enrique Ginzberg, M.D., and Sharad Patel, M.D., both accepted as experts in general surgery; Peter Shute, R.N., accepted as an expert in general nursing practice and utilization review and risk

management; and John Delgado, M.D., Bienvenido Yangco, M.D., and Gustavo Serano, M.D., all of whom testified as to Respondent’s character and as to standard practices in the community for patient identification. Respondent’s exhibits 1-5 and 7-17 were admitted into evidence, including the deposition testimony of Osvaldo Contarini, M.D., and Debora Martoccio, R.N.

A transcript of the proceeding was filed on September 28, 1998. Petitioner filed a proposed recommended order on

October 8, 1998. Respondent filed a proposed recommended order on October 9, 1998.

On October 8, 1998, Petitioner filed a Motion to Strike Testimony Concerning Peer Review. Respondent filed a response to the motion on October 13, 1998. The motion to strike is denied on the basis that the contested testimony does not fall within the restrictions set forth in Section 395.0193(7), Florida Statutes.

FINDINGS OF FACT

Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made:

1. Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes.

2. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued

   license no. ME 0031639 on October 26, 1977.

   
   

3. Respondent is board certified in general surgery and has worked and trained as a general and vascular surgeon.

4. Respondent has practiced medicine in Tampa since 1988. Respondent offered testimony establishing that his peers respect his ability as a surgeon. Until 1996, Respondent had not been the subject of disciplinary action by the Board of Medicine or by any other licensing entity.

5. On January 26, 1996, the Board of Medicine issued a final order in Division of Administrative Hearings Case

   No. 95-3925, imposing discipline on Respondent’s license to practice medicine.

6. Case No. 95-3925 involved two separate incidents in which Respondent performed surgical procedures that had not been specifically consented to by the patients.

7. In the first incident, Respondent removed the severely diseased left leg of the patient when the signed consent to surgery was for removal of the right leg. The patient was well known to Respondent, and it was understood between Respondent and the patient that both legs would eventually require amputation.

8. In the second incident, Respondent removed a toe that had become dislocated during a debridement of the patient’s foot. The toe was connected only by ligament and necrotic tissue, and Respondent removed it during the debridement procedure rather than waiting to obtain specific consent for its removal.

9. In the final order, the Board of Medicine concluded that Respondent had violated Sections 458.331(1)(p) and (t), Florida Statutes, by failing to obtain proper consent from a patient and by practicing medicine below the standard of care. Based on

   these conclusions, the Board of Medicine imposed the following relevant disciplinary measures:

   Respondent’s license to practice medicine is REPRIMANDED.

   
   

   Respondent shall pay an administrative fine in the amount of $10,000 to the Board of Medicine, within one year of the date this Final Order is filed.

   
   

   Respondent’s license to practice medicine in the State of Florida is SUSPENDED for a period of 6 months including the time served under the emergency suspension.

   
   

   Respondent shall submit a practice plan prior to reinstatement to be approved by the Board’s probation committee.

   
   

   Within 6 months of the effective date of this Final Order, Respondent shall have an independent, certified risk manager review Respondent’s practice. Specifically, this independent consultant shall review the Respondent’s practice concerning preoperative procedures including patient consent. This consultant will prepare a written report addressing Respondent’s practice. Such report, if necessary, will include suggested improvements of the quality assurance of Respondent’s practice. Respondent will submit this report to the Board’s Probation Committee with documentation that demonstrates compliance with the suggestions enumerated in the consultant’s report.

   
   

   Upon reinstatement, Respondent’s license to practice medicine in the State of Florida shall be placed on PROBATION for a period of two years, subject to the following terms and conditions:

   
   

   1. Respondent shall comply with all state and federal statutes, rules and regulations pertaining to the practice of medicine, including Chapters 455, 458, 893, Florida Statutes, and Rules 59R, Florida Administrative Code.

      
      

   2. Respondent shall appear before the

Probation Committee at the first meeting after said probation commences, at the last meeting of the Probation Committee preceding termination of probation, quarterly, and at such other times requested by the committee. Respondent shall be noticed by the Board staff of the date, time and place of the Board’s Probation Committee whereat Respondent’s appearance is required. Failure of the Respondent to appear as requested or directed shall be considered a violation of the terms of this Probation, and shall subject the Respondent to disciplinary action.

* * *

6. Respondent shall not practice except under the indirect supervision of a physician fully licensed under Chapter 458 to be approved by the Board’s Probation Committee.... The responsibilities of a monitoring physician shall include:

1. Submit quarterly reports, in affidavit form, which shall include:

   
   

   1. Brief statement of why physician is on probation.

      
      

   2. Description of probationer’s practice.

      
      

   3. Brief statement of probationer’s compliance with terms of probation.

      
      

   4. Brief description of probationer’s relationship with monitoring physician.

      
      

   5. Detail any problems which may have arisen with probationer.

* * *

1. Respondent shall submit quarterly reports in affidavit form, the contents of which shall be specified by the Board. The reports shall include:

   
   

   1. Brief statement of why

      physician is on probation.

      
      

   2. Practice location.

      
      

   3. Describe current practice (type and composition).

      
      

   4. Brief statement of compliance with probationary terms.

      
      

   5. Describe relationship with monitoring/supervising physician.

      
      

   6. Advise Board of any problems.

      
      

      * * *

      
      

      11. Respondent understands that during this period of probation, semi-annual investigative reports will be compiled by the Agency for Health Care Administration concerning his compliance with the terms and conditions of probation and the rules and statutes regulating the practice of medicine.

      
      

2. On January 31, 1996, Respondent submitted to the Board of Medicine the practice plan required by the final order. The practice plan named Joseph Diaco, M.D., as Respondent’s monitoring physician, and stated that Dr. Diaco would review twenty percent of Respondent’s patient charts.

3. The practice plan stated that Respondent would comply specifically with all the terms and conditions of the final order, and with the recommendations of the certified risk manager.

4. The practice plan further stated:

   
   

   ... Dr. Sanchez will have specific discussions with his surgical patients prior to any anesthesia being administered, wherein he will discuss the intended surgical procedure again, and will have the intended surgical site marked with indelible ink.

5. The record does not document that the Board of Medicine’s Probation Committee formally approved Respondent’s practice plan, or addressed the terms of the practice plan in any way. Such approval is presumed from the fact that Respondent appeared before the Probation Committee on several occasions subsequent to filing the practice plan, and the record does not

   indicate that the Probation Committee registered any objection or suggested any modifications to the practice plan.

6. Respondent made the required appearances before the Probation Committee.

7. Respondent and Dr. Diaco submitted the required quarterly reports to the Board of Medicine, and Dr. Diaco fulfilled the monitoring requirements of the practice plan.

8. Periodically during the probation period, Mr. Richard Hess, an investigator with the Agency for Health Care Administration, would contact Respondent and Dr. Diaco to inquire as to Respondent’s practice and compliance with the terms of probation.

9. Mr. Hess would inquire regarding such matters as the submission of quarterly reports, the payment of the administrative fine, and the current locations at which Respondent was practicing.

10. Mr. Hess would submit his reports to the Agency for Health Care Administration and to the Board of Medicine, and these reports were used to supplement the information submitted directly by Respondent and Dr. Diaco.

11. Based upon the information he was provided by Respondent and Dr. Diaco, Mr. Hess never found Respondent out of compliance with the terms of his probation.

12. On the morning of November 2, 1997, an order was entered at Vencor Hospital by the primary treating physician for placement of a central venous line for patient D.M., an 80 year-

    old female patient.

13. A central venous line is most often placed for access to the circulatory system for the provision of medications and/or fluids when the peripheral venous system is not available for such use. A central venous line may be ordered if the patient has no veins remaining for the insertion of a peripheral catheter, or for extended access, such as when a patient requires a long-term cycle of antibiotics for a bone infection.

14. Patient D.M. required the central line for antibiotics to treat infected ulcerations on her lower extremities.

15. The placement of a central line may be performed by any licensed physician, though surgeons are often called in to perform the procedure for primary physicians. Two physicians who teach at the University of Miami testified that third-year residents are allowed to perform the procedure with only indirect supervision. Dr. Diaco testified that nurse practitioners may perform the procedure under the supervision of a physician.

16. The procedure is performed at the patient’s bedside, not in an operating room. No general anesthesia is required. A local anesthetic is administered at the point of insertion. The entire procedure takes two to three minutes to perform.

17. The central line may be placed in at least three locations in the body: the leg, the neck, or the collarbone. In the case of D.M., Respondent placed the line by way of the collarbone. A needle is inserted under the clavicle and into the vein that unites with the jugular vein to form the second largest vein in the human body, the superior vena cava. Using a guide

    wire, a catheter is threaded through the subclavian vein and placed inside the superior vena cava.

18. Prior to performance of the procedure, the patient’s head is typically placed lower than her feet in what is called the Trendelenburg position. If the patient has a feeding tube, it is typically turned off prior to the procedure to prevent aspiration of tube material.

19. Proper placement of the central line is confirmed by X- ray taken immediately after the procedure. Such confirmation of placement is necessary due to the risks associated with incorrect placement.

20. The most immediate risk is pneumothorax, the puncturing of the patient’s lung. Other less common complications are blood loss, cardiac arrest, infection, and irregular heartbeat. The consensus of the experts who testified at hearing was that the procedure poses no greater risk of complication for elderly patients such as D.M., but that elderly patients who do suffer complications may have a harder time recovering than would younger, more robust patients.

21. D.M. was an 80 year-old female patient who shared Room

    
    

    218 at Vencor Hospital with J.P., an 89 year-old female patient.

    
    

    D.M. and J.P. were of the same general age, ethnic origin, and gender. They had similar medical problems, including bilateral lower extremity decubiti and ulcerations.

22. D.M. was able to understand conversation and could verbally communicate with staff. D.M. signed on her own behalf

    the consent form for the insertion of the central venous line. The signature on the consent form was obtained by and witnessed by Elizabeth Rood, a registered nurse on duty during the day of

    November 2, 1997. Ms. Rood testified that she believed D.M. was rational enough to sign the form on her own behalf.

23. Vencor Hospital policy dictated that informed consent be obtained from the patient by the surgeon who was to perform the procedure. The nursing employees of Vencor Hospital and Respondent all testified that, despite the stated policy, it was common practice at the time for nurses to obtain the signatures of patients on the consent forms.

24. The express terms of Respondent’s practice plan also required Respondent to have “specific discussions with his surgical patients prior to any anesthesia being administered. ”

25. J.P. suffered from organic brain syndrome and was generally unable to communicate verbally. J.P. was unable to give consent for surgical procedures on her own behalf.

26. Ms. Rood obtained D.M.’s signature on the informed consent form at about 10:00 a.m. Shortly thereafter, hospital staff contacted Respondent to inform him of the order and request that he perform the placement of the central line. Respondent replied that he was unable to perform the procedure at that time because of a more urgent consultation at St. Joseph’s Hospital, but would come to Vencor Hospital later to perform the procedure.

27. Shortly before the start of the nursing night shift, the central line cart with supplies for the procedure was brought by the day supervisor to the second floor of Vencor Hospital and placed outside Room 218.

28. Lisa Cotroneo was the night charge nurse. When she

    arrived for her shift, she received report from the day charge

    nurse. That report indicated that D.M. was to receive a central line placement at some time during the evening.

29. The nursing staff at Vencor was divided into teams of two or three nurses assigned to particular rooms on the floor. Team three was responsible for Room 218.

30. At the start of the night shift, Nurse Cotroneo informed two of the three nurse on team three, Donna Maranto and Fortune Ndukwe, that a central line was to be placed on patient

    D.M. that evening. Nurse Cotroneo did not inform the third nurse, Mary Shogreen, because Nurse Shogreen was a pool nurse called in to work on short notice and had not yet arrived for her shift.

31. Nurse Shogreen was the nurse on team three who was assigned primary care duties for the patients in Room 218. Nurse Shogreen was later informed by Nurse Ndukwe that one of her patients would be receiving a central line placement that evening. Nurse Shogreen testified that she intended to check with the charge nurse to confirm the order for a central line placement, but that she never did so.

32. At around 8:00 p.m., Respondent telephoned the nursing unit to inform the charge nurse that he was on his way to perform the placement of the central line. Nurse Cotroneo conveyed this information to Nurses Maranto and Ndukwe, and told them to be sure everything was ready for Respondent’s arrival.

33. Respondent arrived at Vencor Hospital shortly after 8:00 p.m. and proceeded to the second floor nursing station,

    where he asked for and received the chart for patient D.M. He

    reviewed the chart, which contained the signed consent form and the order for placement of the central line.

34. After reviewing the chart, Respondent inquired as to the location of D.M. and the nurse who would assist him in the procedure. Respondent was told that D.M.’s nurse was down the hall.

35. Respondent walked down the hall and approached a group of three or four nurses. Respondent did not know any of them. He informed the group that he was Dr. Sanchez and was there to perform the central line placement. One of the nurses, later identified as Mary Shogreen, told him she was ready for him. She led him down the hall toward Room 218.

36. Respondent paused at the central line cart outside Room

    
    

    218 to pick up a pair of surgical gloves and the kit used for the central line placement.

37. When Respondent entered the room, he observed Nurse Shogreen already at the bedside. The room was dark, save for a single light over the bed of the patient where Nurse Shogreen was working. Respondent saw that Nurse Shogreen was turning off the feeding tube to the patient, a common precursor to performance of a central line placement.

38. Respondent walked to the other side of the patient’s bed and addressed the patient by the name of D.M. He told her that he was Dr. Sanchez and that her physician had asked him to insert a central venous catheter in her. Respondent looked into the patient’s eyes and realized she was not comprehending what he

    said.

39. Nurse Shogreen was standing directly across the bed and could hear Respondent’s efforts to talk to the patient, including his addressing that patient as “D.M.”

40. Respondent asked Nurse Shogreen if the patient was “always like this,” i.e., unresponsive. Nurse Shogreen answered that she had never had the patient before, but believed that was the usual condition of the patient.

41. It would not be unusual for an elderly patient such as

    
    

    D.M. to be communicative and able to understand and sign a consent form at 10:00 a.m., but then be uncommunicative in the evening. The medical community informally refers to this phenomenon as "sundown syndrome."

42. Respondent told Nurse Shogreen to assist him in placing the patient in the Trendelenburg position, and to get a rolled towel to place between the patient’s shoulder blades. While Nurse Shogreen was getting the towel, Respondent examined the patient’s neck and chest.

43. Nurse Shogreen returned with the towel, but was unable to adjust the bed into Trendelenburg position. Respondent told her to go get another nurse who knew how to work the bed. She brought in Nurse Ndukwe, who was also unable to get the bed into the proper position. At length, they found a certified nurse assistant who was able to place the bed into position.

44. Neither Nurse Shogreen nor Nurse Ndukwe expressed any concern to Respondent regarding the identity of the patient. Nurse Ndukwe had received an explicit report concerning the fact

    that patient D.M. was to receive a central line placement. Nurse Shogreen had heard Respondent address the patient as D.M.

45. Respondent completed the procedure, which took about one minute. He proceeded to the nurse’s station and ordered the standard X-ray to confirm the proper placement of the central line, completed the consult form, and dicated both his consultation report and operative report.

46. Nurse Shogreen remained behind in the room to clean up after the procedure. She made notations in the bedside chart of patient J.P., the mistaken recipient of the central line. Even at this point, Nurse Shogreen did not realize that the wrong patient had received the central line.

47. The findings as to events in Room 218 on the evening of November 2, 1997, were based on the testimony of Respondent. Nurse Shogreen testified that it was Respondent who led the way into the room, Respondent who proceeded to the wrong bed, and Respondent who prevented Nurse Shogreen from going out to get the patient’s chart to confirm her mental condition after questioning by Respondent. Nurse Shogreen agreed with Respondent’s version of the problems with getting the bed into proper position, but testified that Respondent was so angry and in such a hurry that he performed the central line placement before the staff was able to place the bed in the proper position.

48. Based on both the substance of the testimony and the demeanor of the witnesses, it is found that Respondent’s version of events is more believable, and that Respondent is a more

    credible witness than Nurse Shogreen. The undersigned is unable to credit testimony that a physician of Respondent’s skill and experience would plunge ahead into the room and commence a procedure on a patient he had never seen, without doing anything to ascertain her identity. The undersigned finds it more plausible that Respondent followed Nurse Shogreen’s lead, observed the visual cues she was providing, and assumed that the patient to whom Nurse Shogreen attended was in fact patient D.M. Respondent's proffer of testimony regarding inconsistencies in Nurse Mary Shogreen's testimony before the Peer Review Committee was disregarded in formulating these findings of fact.

49. Several physicians offered expert testimony as to whether it is within the standard of practice for a surgeon to rely on his assisting nurse for patient identification.

50. Dr. David Shatz, an associate professor of surgery at the University of Miami, testified that any surgeon must be absolutely sure he is working on the right person. He testified that once Respondent was unable to get a verbal response from the patient, he should have asked the nurse if he was speaking to patient D.M. Dr. Shatz concluded that it is a deviation from the standard of care to perform a procedure on a noncommunicative patient without checking the patient’s identification bracelet.

51. Dr. Stephen Michel agreed that Respondent failed to meet the standard of care by placing the central line in the wrong patient. Dr. Michel’s other conclusions regarding the events in question cannot be credited because he admitted he was

    assuming that Dr. Sanchez was not permitted by the terms of his probation to be working in Vencor Hospital at all. This assumption was incorrect, and colored the remainder of his conclusions.

52. Dr. Enrique Ginzburg, also an associate professor of surgery at the University of Miami, testified that a surgeon is usually unfamiliar with the patient in a central line placement, and stated that he could not remember the last time he checked an identification bracelet when the nurses were in the room with him. He agreed that it would be easy to check the armband, but that physicians simply do not check the armband if nurses are present to identify the patients.

53. Dr. Jerry Diehr, an anesthesiologist at St. Josephs Hospital in Tampa, testified that a reasonably prudent physician would do what Respondent did. He stated that he relies on nurse identifications in similar circumstances, and that it is common practice for physicians to do so. Dr. Diehr testified that physicians rely on nurses for all manner of patient identification. He noted that care is often dictated by telephone calls. When a nurse calls him and tells him about the condition of his patient, the underlying assumption is that the nurse has correctly identified the patient and adequately reported the condition. Physicians may base their entire course of treatment on such reports from nurses, and must be able to rely on the nurses for such identification and reporting.

54. Dr. Diaco strongly opined that physicians must be able

    to rely on nurses for patient identification. It is the nurse’s responsibility to identify the correct patient when the physician does not know the patient. Dr. Diaco testified that if physicians cannot rely on nurses for such basic information as the identity of their patients, they may as well live in the hospital and administer their own medications.

55. Peter Shute, an expert in general nursing practice, opined that the three nurses on duty at Vencor Hospital on the evening of November 2, 1997, were negligent in their duty to know the patients on their assigned unit. He testified that Nurse Shogreen was particularly negligent, because she had not received full report on her patients, found out that one of her patients was to receive a central line placement that evening, but did not immediately obtain a full report and take steps to ensure that all preparations had been made.

56. The weight of the evidence is that it was within the standard of care under the conditions and circumstances for Respondent to rely on Nurse Shogreen’s identification of the patient. This finding does not minimize the fact that Respondent bears ultimate responsibility for the performance of an invasive procedure on a patient who did not give informed consent.

57. After Respondent dictated his notes and left the hospital, David Vallejo, the X-ray technician, came to the floor to obtain the X-ray ordered by Respondent. He discovered that the patient who received the central line was J.P., not D.M. Mr. Vallejo went to the nurse’s station and informed Nurse Cotroneo,

    who called the nursing supervisor to come to the room with her. Nurse Cotroneo and the supervisor confirmed that both patients in Room 218 were wearing their identification bracelets.

58. The nursing supervisor called J.P.’s primary physician, who ordered an X-ray, which confirmed that J.P. suffered no ill effects from the placement of the central line. He also ordered removal of the central line, which was accomplished without incident.

59. Respondent was informed of the error by telephone. He came to Vencor Hospital the next day, November 3, 1997, and documented the error in the medical records of both D.M. and J.P. On that day, a different surgeon performed the central line placement on D.M.

60. All of the expert witnesses agreed that Respondent’s charting and recording of the incident, both before and after he learned of the error, were adequate and indicated no effort to conceal the facts of the situation.

61. The experts also agreed that marking the intended surgical site with indelible ink serves no purpose in a central line placement. Petitioner's own expert, Dr. Shatz, stated that marking the site of a central line placement would be "silly."

62. On November 3, 1997, Vencor Hospital suspended Respondent’s hospital staff privileges pending an investigation of the incident.

63. Respondent immediately contacted Dr. Diaco, his indirect supervisor, as soon as he learned of the error.

    Respondent fully informed Dr. Diaco of the facts of the situation. Dr. Diaco told Respondent that he did nothing wrong and that “the nurse is in big trouble.”

64. Respondent also sought the counsel of his attorney, Michael Blazicek. Mr. Blazicek conferred with Dr. Diaco, and also concluded that this was a nursing problem, not a standard of care problem for Respondent.

65. The results of the hospital’s internal Peer Review Committee review seemed to bear out the opinions of Dr. Diaco and Mr. Blazicek. On November 26, 1997, Respondent was restored to full privileges at Vencor Hospital.

66. Nurse Shogreen received verbal counseling and a one-day suspension for failure to render proper treatment to the correct patient.

67. Vencor Hospital’s “Root Cause Analysis Team” found that nursing protocols should be changed to prevent a recurrence of patient misidentification. Patients would henceforth be identified by bed letter designation. Identification of the patient and consent to treatment would be verified by two people, one of whom must be a hospital employee.

68. On November 17, 1997, the quality review manager of Vencor Hospital submitted an Adverse or Untoward Incident Report (Code 15) regarding the incident, pursuant to Sections 395.0197(6) and 641.55(6), Florida Statutes.

69. A Code 15 Report is a report of serious adverse incidents in licensed facilities. The Code 15 Report identifies the physicians and nurses involved by their license numbers, and identifies the patient and facility. It describes the nature of the incident and all actions taken by the hospital in response to the incident.

70. The purpose of the Code 15 Report is to notify the Agency for Health Care Administration and the Department of Health within 15 days of a serious adverse incident so the Agency may review the incident and begin an investigation.

71. Respondent appeared before his Probation Committee on November 13, 1997. At this time, Respondent knew that the hospital would be filing a Code 15 Report, though it had not

    actually done so. Respondent was still on summary suspension at Vencor Hospital, pending review.

72. Prior to his Probation Committee appearance, Respondent conferred with his attorney, Mr. Blazicek, who counseled him to answer any questions forthrightly, but not to volunteer information about the incident to the Probation Committee. This advice was based on the facts that the incident was still under investigation, that there had been no finding of wrongdoing by Respondent, and that summary suspension was a standard procedure for such incidents indicating no conclusions as to ultimate responsibility.

73. Mr. Blazicek testified that he knew Respondent still had one more written quarterly report to file in January 1998. He reasoned that if the hospital's investigation resulted in adverse findings, Respondent could report the incident in that later filing.

74. The Probation Committee raised no questions as to the Vencor Hospital incident, and determined that Respondent’s probation would terminate as scheduled upon payment of the administrative fine. Respondent did not volunteer information about the incident or the summary suspension.

75. Respondent and Dr. Diaco filed their final quarterly reports in January 1998. Neither of them reported the Vencor Hospital incident. Respondent reported that he was in full compliance with all probationary terms.

76. By the time the final quarterly reports were received,

    the Department of Health was aware of the Code 15 Report. Nonetheless, the Department issued an Order of Termination on February 2, 1998, finding that Respondent had satisfactorily completed the term of his probation as of January 26, 1998.

    CONCLUSIONS OF LAW

    
    

77. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this cause, pursuant to Sections 120.569, 120.57(1), and 455.225, Florida Statutes.

78. License revocation and discipline proceedings are penal in nature. The burden of proof on Petitioner in this proceeding was to demonstrate the truthfulness of the allegations in the Complaint by clear and convincing evidence. Section 458.331(3), Florida Statutes; Department of Banking and Finance v. Osborne Stern and Company, 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).

79. The “clear and convincing” standard requires:

    
    

    that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the testimony must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. 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). The findings in this case were made based on the standard set forth in Osborne Stern and Ferris.

80. Pursuant to Section 458.331(2), Florida Statutes, the Board of Medicine is authorized to revoke, suspend or otherwise discipline the license of a physician for violating the following relevant provisions of Section 458.331, Florida Statutes:

    (1)(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician... and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify 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)(p) Performing professional services which have not been duly authorized by the patient or client, or his or her legal representative, except as provided in s.

    743.064, s. 766.103, or s. 768.13.

    
    

    (1)(t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.... As used in this paragraph, “gross malpractice” or “the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances,” shall not be construed so as to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph.

    (1)(x) Violating any provision of this chapter, a rule of the board or department, or a lawful order of the board or department previously entered in a disciplinary hearing

    or failing to comply with a lawfully issued subpoena of the department.

    
    

    (1)(gg) Misrepresenting or concealing a material fact at any time during any phase of a licensing or disciplinary process or procedure.

    
    

81. Section 458.331(2), Florida Statutes, sets forth the scope of discipline available to the Board of Medicine for violations of Section 458.331(1), Florida Statutes:

    1. Refusal to certify, or certification with restrictions, to the department an application for licensure, certification, or registration.

       
       

    2. Revocation or suspension of a license.

       
       

    3. Restriction of practice.

       
       

    4. Imposition of an administrative fine not to exceed $5,000 for each count or separate offense.

       
       

    5. Issuance of a reprimand.

       
       

    6. Placement of the physician on probation for a period of time and subject to such conditions as the board may specify, including, but not limited to, requiring the physician to submit to treatment, to attend continuing education courses, to submit to reexamination, or to work under the supervision of another physician.

    7. Issuance of a letter of concern.

       
       

    8. Corrective action.

       
       

    9. Refund of fees billed to and collected from the patient.

       
       

       In determining what action is appropriate, the board must first consider what sanctions are necessary to protect the public or to compensate the patient. Only after those sanctions have been imposed may the disciplining authority consider and include in the order requirements designed to

       rehabilitate the physician. All costs associated with compliance with orders issued under this subsection are the obligation of the physician.

       
       

82. Count One of the Complaint alleged that Respondent failed to keep written medical records justifying the course of treatment of patients J.P. and D.M., in that Respondent’s medical records contained inadequate and incomplete patient histories and physical examinations, and contained inadequate notes regarding

    interaction with the patient prior to placement of the central line, in violation of Section 458.331(1)(m), Florida Statutes.

83. Petitioner failed to establish the charges in Count One by clear and convincing evidence. Every physician who testified at the final hearing stated that Respondent’s recordkeeping was adequate for the relatively simple procedure involved. Save for the obvious error in the patient’s identity, there was no failure to keep proper medical records.

84. Count Two of the Complaint alleges that Respondent performed professional services that were not authorized by patient J.P. or her legal representative, in that he performed an unauthorized invasive surgical procedure on J.P. without her informed consent or that of her designated health care surrogate, in violation of Section 458.331(1)(p), Florida Statutes.

85. Petitioner did establish the charges of Count Two by clear and convincing evidence. There was no dispute that Respondent performed the placement of a central venous catheter on patient J.P. without her informed consent or that of her designated health care surrogate.

86. Count Three of the Complaint alleges that Respondent practiced medicine below the standard of care by failing to ensure that J.P. was the proper recipient of his care, and by performing an unauthorized invasive surgical procedure on J.P., in violation of Section 458.331(1)(t), Florida Statutes.

87. Petitioner failed to establish the charges of Count Three by clear and convincing evidence. The expert testimony was

    divided as to whether, under the facts as found above, Respondent practiced medicine below the standard of care in relying on Nurse Shogreen to identify the patient as the intended recipient of the central line. The weight of that testimony favored Respondent’s position that reliance on nurse identification is in accordance with the prevailing standard of care under similar conditions and circumstances.

88. The totality of the conditions and circumstances were such that Respondent had no question in his mind that he was operating on the correct patient, and had no reason to take the additional step of checking the patient’s identity bracelet. The visual cues provided by Nurse Shogreen, combined with the fact that neither she nor Nurse Ndukwe spoke up regarding the identity of the patient, led Respondent reasonably to believe he was dealing with the correct patient.

89. Count Four alleges that Respondent violated a previous final order of the Board of Medicine issued on or about

    January 26, 1996 by failing to follow the procedures set forth in his probationary terms for correctly identifying a patient prior to surgery, by failing to have specific discussion with J.P. prior to the administration of anesthesia, by failing to mark the planned surgical site with indelible ink, and by failing to report his mistaken surgery or the suspension of his Vencor Hospital privileges to the Board of Medicine, all in violation of Section 458.331(1)(x), Florida Statutes.

90. At the final hearing, Respondent made an oral motion to

    dismiss Count Four under authority of Arias v. Department of Business and Professional Regulation, 710 So. 2d 655 (Fla. 3d DCA 1998), dismissed 718 So. 2d 167 (Fla. 1998).

91. In Arias, the court reversed a final order of the Department of Business and Professional Regulation and dismissed the charge in the administrative complaint because the agency failed to comply with the legislative requirement that there be penalty guidelines in place, to alert licensees of proscribed actions and ensure consistency in penalties imposed. The licensee had been charged with a violation of the portion of Section 475.25(1)(b), Florida Statutes, prohibiting the violation of “a duty imposed upon her or him by law.” The agency’s implementing rule was entirely silent as to the range of penalties for this violation, leaving the licensee “in a predicament ripe for arbitrary and erratic enforcement” and without “standards sufficiently governed by the legislature as to constitute a judicially reviewable discretion.” 710 So. 2d at 659.

92. In the instant case, Section 458.331(5), Florida Statutes, requires the Board of Medicine to establish guidelines for the disposition of disciplinary cases involving specific types of violations. The Board of Medicine has adopted disciplinary guidelines for violations of Section 458.331(1)(x), Florida Statutes, in Rule 64B-8.001(2)(x), Florida Administrative Code: “From a reprimand to revocation or denial, and an administrative fine from $250.00 to $5,000.”

93. Setting forth a range of potential discipline “from a reprimand to revocation” essentially provides that a physician charged with a violation of Section 458.331(1)(x), Florida

    Statutes, is subject to any and all discipline allowed by Section 458.331(2), Florida Statutes. In terms of alerting licensees of proscribed actions and ensuring consistency in penalties imposed, the rule is the functional equivalent of providing no guideline at all.

94. It is concluded that Arias applies in this instance, that Rule 64B-8.001(2)(x), Florida Administrative Code, does not provide meaningful notice of likely penalties or a mechanism to ensure consistent application of penalties, and that Count Four of the Complaint must therefore be dismissed.

95. Even if Count Four were not dismissed, Petitioner failed to establish the charges contained therein by clear and convincing evidence. The facts established that Respondent violated no specific term of his probation in the method he employed to identify the patient. The facts established that Respondent attempted to have a specific discussion with patient J.P., but that she was unresponsive. The medical experts unanimously testified that no purpose would be served by marking the site of a central line insertion with indelible ink.

96. As to the failure to report the Vencor Hospital incident to the Board of Medicine, the final order of January 26, 1996, required Respondent to advise the Board of any “problems.” Neither the final order nor any rule of the Board of Medicine defines the term “problem.” Both the monitoring physician and Respondent’s legal counsel ensured Respondent that any “problem” was that of Nurse Shogreen, not Respondent. The subsequent

    actions of the Peer Review Committee of Vencor Hospital seemed to bear out this opinion. After his vindication and the restoration of his full privileges, Respondent rationally believed there was no “problem” to report, particularly since the Code 15 Report had already been submitted to the Agency for Health Care Administration and the Department of Health.

97. It might have been better practice for Respondent to err on the side of caution and report his summary suspension at the November 13, 1997, meeting of the Probation Committee. However, Respondent cannot be held clearly and convincingly to have violated a duty to report undefined “problems” because he failed to volunteer the facts of his summary suspension pending review of the incident.

98. Count Five alleges that Respondent misrepresented and concealed material facts during a disciplinary process by failing to report the relevant facts to the Board of Medicine during his probation, and by affirmatively representing to the Board of Medicine that he was in full compliance with all of his probationary terms, in violation of Section 458.331(1)(gg), Florida Statutes.

99. Respondent made an oral motion at the hearing that Count Five should be dismissed under authority of Arias. This motion is denied, because Rule 64B-8.001(2)(gg), Florida Administrative Code, does provide a meaningful range of discipline: “From denial or revocation of license with ability to reapply upon payment of $1,000.00 fine to denial of license

    without ability to reapply.”

    
    

100. Petitioner failed to establish the charges in Count Five by clear and convincing evidence. As noted in the discussion of Count Four above, it was by no means clear under the circumstances that Respondent was required to report the incident as a “problem” under the terms of the final order, because he was given no definitional guidance as to the term “problem.” Respondent’s failure to volunteer information cannot be termed “concealment,” when Respondent completely, accurately and promptly reported the incident in the medical record, and when Respondent was aware the incident had been reported to both the Agency for Health Care Administration and the Department of Health.

101. Rule 64B-8.001(3), Florida Administrative Code, provides aggravating or mitigating factors to be considered in imposing a penalty upon a licensee. A mitigating factor relevant to this proceeding is the degree of actual injury to the patient (none). Aggravating factors are: degree of potential injury to victim (slight); the number of times the same offense has previously been committed by the licensee; and the disciplinary history of the licensee. Here, the aggravating factors outweigh the mitigating factor.

102. Of particular concern is the disciplinary history of Respondent, who in 1996 was suspended for six months, reprimanded, and placed on probation in part for performing unconsented procedures in violation of Section 458.331(1)(p),

     Florida Statutes. However understandable or excusable Respondent's actions may be under the conditions and circumstances, the fact remains that Respondent has now twice allowed himself to be placed in the position of performing an invasive surgical procedure without the patient's consent.

103. The range of penalties for violation of Section 458.331(1)(p), Florida Statutes, is from a reprimand to two years

     suspension, and an administrative fine from $250.00 to $5,000.00. Rule 64B-8.001(2)(p), Florida Administrative Code.

104. Based upon the totality of the circumstances, it is concluded that an appropriate penalty would be a nine-month suspension, including the time served under the emergency suspension, followed by probation for a period of two years, and the payment of an administrative fine in the amount of $2,500.00.

RECOMMENDATION

Upon the foregoing findings of fact and conclusions of law, it is recommended that the Department of Health, Board of Medicine enter a final order determining that Rolando R. Sanchez has violated Section 458.331(1)(p), Florida Statutes, and suspending his license for a period of nine months from the date of the Order of Emergency Suspension of License, imposing a fine of $2,500.00 and placing Respondent on probation for a period of two years from the date the suspension expires.

DONE AND ENTERED this 24th day of November, 1998, in Tallahassee, Leon County, Florida.

LAWRENCE P. STEVENSON

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 24th day of November, 1998.

COPIES FURNISHED:

Albert Peacock, Esquire John E. Terrel, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy

201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602

Angela T. Hall, Agency Clerk Department of Health

2020 Capital Circle, Southeast Bin A-02

Tallahassee, Florida 32399-1703

Pete Peterson, General Counsel Department of Health

2020 Capital Circle, Southeast Bin A-02

Tallahassee, Florida 32399-1703

Tanya Williams, Executive Director Board of Medicine

Department of Health Northwood Centre

1940 North Monroe Street Tallahassee, Florida 32399-0750

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: 98-003728

Orders for Case No: 98-003728