STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

WILLIAM L. MILLS, M.D., )

)

Petitioner, )

)

vs. ) CASE NO. 91-4754F

) DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF MEDICINE, )

)

Respondent. )

)

FINAL ORDER

Pursuant to notice, final hearing in the above-styled case was held in Orlando, Florida, on August 29, 1991, before Robert E. Meale, Hearing Officer of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Attorney Launa K. Rutherford

Taraska, Grower, et al. Post Office Box 538065

Orlando, Florida 32853-8065

For Respondent: Mary B. Radkins, Senior Attorney

Department of Professional Regulation 1940 North Monroe Street

Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792

STATEMENT OF THE ISSUE

The issue in this case is whether, under Section 57.111, Florida Statutes, Petitioner is entitled to attorneys' fees and costs incurred in the defense of a disciplinary proceeding.

PRELIMINARY STATEMENT

By Petition for Costs and Attorneys Fees filed July 29, 1991, Petitioner requests a final order awarding attorneys' fees and costs incurred in the defense of DOAH Case No. 90-5298, which was dismissed by a Notice of Voluntary Dismissal served June 17, 1991. Petitioner alleges that he was entitled to an award of $7765 in attorneys' fees and $753.80 in costs.

In its Response to Petition for Attorney's Fees and Costs filed August 20, 1991, Respondent agrees with all but one of the material allegations of the petition, including that the fees and costs requested were reasonable in amount. The sole issue Respondent identifies for resolution is whether its actions were substantially justified. On this point, Respondent asserts that, when it initiated DOAH Case No. 90-5298, there was a reasonable basis in law and fact

for filing the Administrative Complaint. The response further states that the justification for the initial charges was not eliminated because, after discovery, Respondent determined that it could not "prevail by the clear and convincing standard demanded at formal hearing "

At the hearing, neither party called any witnesses. Respondent offered into evidence three exhibits, which were admitted into evidence. The undersigned took official notice of the entire contents of DOAH Case No. 90- 5298.

Neither party ordered a transcript. Each party filed a proposed final order. Treatment of the proposed findings isdetailed in the appendix.

FINDINGS OF FACT

1. On September 2, 1988, an 83-year-old female was admitted to West Orange Memorial Hospital with recurrent rectal bleeding and complaints of pain in the low back and left hip. The patient also reported pain while sitting or lying due to a subcutaneous nodule in the left buttock.

   
   

2. As noted in the patient's history dictated by Petitioner on September 12, 1988, the patient had numerous admissions to the hospital for rectal bleeding and previously had been diagnosed as suffering from angiodysplasia. These notes also reflect that the patient had recently undergone a colonoscopy and upper endoscopy, which were negative.

   
   

3. The notes of N. Alar, M.D., which were dictated on September 3, 1988, indicate that he had seen the patient in consultation for evaluation of lower gastrointestinal bleeding. The notes disclose that the patient had complained of bloody bowel movements. The notes record a history of diverticulosis and angiodysplasia of the colon.

   
   

4. Following a colonoscopy and polypectomy, Petitioner excised the nodule on September 11. The procedure took place at the hospital bed of the patient where her left buttock was prepped and draped in sterile fashion prior to the making of a two-inch incision. Following the removal of the nodule, the area was cleaned, the wound was closed, and sterile dressing was applied. There was no break in technique during the procedureand sterility was maintained. The nodule was later determined to be an area of fat necrosis that had undergone dystrophic calcification.

   
   

5. The following day, the patient developed severe respiratory distress and expired. Her final principal diagnoses were anemia secondary to gastrointestinal bleeding, arteriosclerotic heart disease, hypertension, and clostridium with septicemia. A Serious Incident Report was filed on November 29, 1988, and Respondent commenced an investigation on January 11, 1989, to determine if Petitioner's practice was below applicable standards.

   
   

6. The first time that Petitioner's case appeared at a Probable Cause Panel Meeting of the Board of Medicine was on May 11, 1990. The following Panel members were present: Chair Robert Katims, M.D.; Marilyn Wells, M.D., and Gilbert Rodriguez. Also present were Assistant Attorney General M. Catherine Lannon and Respondent's attorneys, Carlos Ramos and Stephanie Daniel.

   
   

7. At the commencement of the meeting, Ms. Lannon explained the respective roles of herself and Respondent's attorneys. In general, she was present to advise the Panel as to its legal duties under applicable statutes and rules.

   Respondent's attorneys were available to respond to questions involving specific investigations.

   
   

8. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting insufficient time to review them.

   
   

9. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file and Respondent's recommendation in the form of a draft administrative complaint or closing order, as appropriate.

   
   

10. When Petitioner's case was announced, Mr. Ramos stated that Respondent recommended the Panel find probable cause and direct the filing of an Administrative Complaint. Mr. Ramos explained that the proposed Administrative Complaint alleged that Petitioner practiced medicine below the acceptable level of care when he excised a nodule from a patient's left buttock while the patient was lying on a hospital bed. Also, Mr. Ramos stated, medical records failed to reflect a rectal examination upon admission.

    
    

11. Terming it a "terrible case," Panel member Wells moved to find probable cause and issue the Administrative Complaint. Mr. Ramos stated that Petitioner "wasn't sterile." Transcript of May 11 meeting, page 5. Chair Katims asked if Petitioner had surgical privileges. Ms. Lannon responded by restating Dr. Katims' question whether Petitioner may have performed the procedure in a hospital bed because he lacked surgical privileges. Dr. Wells expressed interest in this point. The motion was then passed without further discussion.

    
    

12. The materials available to the Probable Cause Panel on May 11, 1990, included a letter dated March 15, 1989,from Joseph R. Goggin, M.D., who is a board certified surgeon. Retained by Respondent to opine as to the standard of care, Dr. Goggin reviewed the file materials and stated in part:

    
    

    I find it hard to believe that the patient's hospital bed in a usual hospital room would be considered sterile. [Petitioner's] statements throughout both the Discharge Summary and in the chart itself state that the wound infection clostridium perfringens and staph coagulase negative was

    self-inflicted by the patient following the surgical procedure. I cannot believe that this is true. Clostridium perfringens is not a normal flora found in the human colon.

    Neither is staph coagulase negative. I would suspect that if the patient had contaminated the wound with her own stool, we would have seen mixed cultures with numerous other bacteria involved. One must assume that because of the pure cultures of clostridium perfringens and staph coagulase negative that a break in sterile technique occurred. I think this occurred because the patient underwent the procedure in her hospital bed and not in a sterile operating environment.

13. Dr. Goggin's letter concludes that the hospital changed its policy so that all procedures involving excision be performed in a "completely sterile environment." The letter adds:

    
    

    If this policy was not in place prior to the procedure, I don't believe that the licensee violated the standard of care as it applied to this hospital. However, most of us would believe that any invasive procedure of this nature should probably be performed in a sterile environment.

    
    

14. The letter from Dr. Goggin also faults Petitioner for his failure to obtain a rectal examination upon admission of the patient, even though she had been complaining of rectalbleeding. In terms of the timeliness of Petitioner's diagnosis of clostridium, Dr. Goggin concedes, "I don't think that an earlier diagnosis would have changed this patient's final outcome."

    
    

15. The records available to the Probable Cause Panel on May 11, 1990, also included a letter from Respondent to Petitioner advising him that he is the subject of a complaint and inviting him to provide a written explanation. In response, and included in the records available on May 11, were a letter dated April 25, 1989, from Petitioner; a statement dated April 25, 1989, from the attending nurse corroborating that sterility was maintained during the excision of the nodule; and a letter dated July 3, 1989, from James J. McClelland, M.D., whose letterhead indicates that he is a member of a group of infectious disease control consultants.

    
    

16. Petitioner's letter states that invasive procedures, such as subclavian insertions, chest tube placements, and lumbar punctures for spinal taps, are commonly performed in the hospital bed. The letter restates the procedures followed to maintain sterility and asserts that the contamination had to take place subsequent to the dressing of the wound, such as by the patient inadvertently loosening the dressing through normal movement in the bed.

    
    

17. Dr. McClelland's letter states that, following review of the medical records, he finds that Petitioner "followed the normal standard of care in performing this procedure . . .." The letter explains:

    
    

    [C]lostridial infections in sepsis are well reported in the literature to have occurred after many sterile procedures, using standard medical care and that the presence of the clostridial infection does not imply substandard care. It should be noted that clostridial organisms can colonize the skin, often times in higher numbers below the waist, and that this organism entered the wound in the postoperative period.

    
    

    The record showed that [Petitioner] followed the standard care to prevent contamination of the wound by his prep and subsequent dressing of the wound. In regard to the question con- cerning a break in sterile technique and the findings of pure cultures of Clostridium perfringens and staph coagulase negative, it

    could also [be] assumed that a break in sterile technique would result in multiple other organisms being present in the wound.

    
    

    It should also be noted that the Clostridium perfringens organism can colonize the gastrointestinal tract, as well as the skin, and in itself does not exclude this as a potential pathophysiologic mechanism for her subsequent sepsis. The potential for the woman to have developed this overwhelming infection, whether the surgical procedure was performed in the office, a hospital bed, or the operating room, all exist and cases have been reported associated with all settings.

    There is no evidence I can see that [Petitioner] deviated from what would be considered normal procedure in removing this nodule from the patient's buttocks.

    
    

18. As a result of the deliberations of the Probable Cause Panel on May 11, 1990, Chair Katims executed a Memorandum of Finding of Probable Cause. In the memorandum, the Panel finds that probable cause was found of a violation of Section 458.331(1)(t) and (m).

    
    

19. By Administrative Complaint filed August 24, 1990, commencing DOAH Case No. 90-5298, Respondent alleged that thesurgical wound on the left buttock developed pure cultures of clostridium perfringens and staph coagulase negative, "indicating a break in sterile technique." The Administrative Complaint alleges that the patient was admitted with rectal bleeding, but the records fail to disclose that a rectal examination was performed upon admission. The Administrative Complaint alleges that the hospital involved has since changed its policy to require all procedures involving excision to be performed in a "completely sterile environment."

    
    

20. Based on the foregoing allegations, Count One of the Administrative Complaint alleges that Petitioner violated Section 458.331(1)(t) by failing to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician when Petitioner excised the nodule in the "environment of [the] patient's hospital bed, which is not a sterile operating environment." Count Two alleges that Petitioner violated Section 458.331(1)(m) by failing to keep medical records--namely a rectal examination upon admission-- justifying the course of treatment of the patient.

    
    

21. On September 26, 1990, Respondent filed a motion to amend the Administrative Complaint to delete the allegation about the change in the hospital procedure as irrelevant. The motion was granted.

    
    

22. On October 9, 1990, Respondent also filed responses to interrogatories. In support of the assertion that the hospital bed is not a sterile operating environment,Respondent stated that it would rely upon the following witnesses: Petitioner, the attending nurse, Dr. Goggin, and the medical records custodian. In their entirety, the responses disclose that Respondent had not obtained expert advice other than that set forth above.

    
    

23. In response to a letter dated December 28, 1990, requesting an opinion and providing all file materials, Respondent's attorney Randolph Collette

    received a seven-page letter dated January 3, 1991, from E. Rawson Griffin, III,

    M.D. Dr. Griffin is Board-certified in family practice.

    
    

24. After an extensive recitation of the patient history taken by Petitioner, Dr. Griffin traces the subsequent actions of Petitioner, noting that pathological examination of the biopsied tissue detected "no particular serious abnormalities." Dr. Griffin opines:

    
    

    . . . my first opinion is that overall I find that [Petitioner] followed the basic standard of care in doing a history and physical examination, writing progress notes which justified the treatment, provided a surgical procedure in which he documented proper sterilization, surgical technique and postoperative wound care and that he obtained proper informed consent and signed this informed consent. Based on this review, I feel that the standard of care which is outlined in DeGowan and DeGowan's as well as what any reasonable physician would follow, was pretty much followed. The only criticism that I can find is again that there are no progress notes which may have been made by the covering physician. I also found that it was interesting that [Petitioner] did do progress notes on days that other physicians did not and I felt that this indicated that he was following the patient properly. It should also be emphasized that he did a three page dictation which was a discharge summary which basically outlined the facts of the case and I found this discharge summary to adequately summarize the events as they had occurred.

    
    

25. In answering specific questions posed to him by Respondent, Dr. Griffin responds affirmatively to the question whether Petitioner met the applicable standard of care in his examination, diagnosis, and treatment of the patient. Dr. Griffin opines that the bedside location of the procedure did not violate the applicable standard of care. In this regard, Dr. Griffin notes the cost-effectiveness of method of treatment, as well as the documentation of proper anaesthesia, preparation of tissue, proper technique, and proper sterile dressings.

    
    

26. As to Petitioner's failure to perform a rectal examination, Dr. Griffin notes that a colonoscopy polypectomy was performed. Again referring to the DeGowan and DeGowan treatise, Dr. Griffin observes that, in some cases, a routine or basic examination is inappropriate. One of the primary purposes of a rectal examination is to detect rectal bleeding, but the patient presented with obvious signs of rectal bleeding. Dr. Griffin concludes that a rectal examination by Petitioner might not have produced any more information, so the trauma associated with repeated rectal examinations was unnecessary. Under the circumstances, Dr. Griffin opines that the records justify Petitioner's failure to perform a rectal examination upon admission of the patient.

27. Dr. Griffin also discredits the findings of a Dr.Khouzan who, based upon what he described as a "very careful review of the chart," found "very severe purulent material." Dr. Griffin notes that this finding was contradictory to multiple other chart entries and concludes that Dr. Khouzan did not in fact examine the patient.

    
    

28. Respondent's attorney Randolph Collette received a four-page letter dated January 8, 1991, from Stephen J. Nelson, M.A., M.D., whom Respondent had also retained for an opinion by letter dated December 28, 1990. Dr. Nelson is an Assistant Clinical Professor of Pathology at the University of Miami. He is also an Associate Medical Examiner for Broward County and Attending Neuropathologist.

    
    

29. Acknowledging the receipt of relevant file materials, Dr. Nelson states:

    
    

    [The patient's] terminal hospital course is an example of anaerobic Clostridium perfrin- gens cellulitis, and probable myonecrosis, following surgery. The onset is sudden, dramatic, and often fatal with an incubation period of 6-72 hours. There are five types of Clostridium perfringens, A-E, separated according to their production of four major lethal exotoxins. The most important exotoxin is . . . (alpha) toxin, or lecithinase-C, because of its lethal, dermonecrotic, and hemolytic activity. Such wounds classically display no pus because the enzyme lecithinase attacks cell membranes and literally dissolves any and all cells (including inflammatory cells) that are in its path. Other Clostridial exotoxins include collagenase, protease, deoxyribonuclease, hyaluronidase, and a hemolysin. Bacteremia is present in about

    15 percent of cases.

    
    

    [The patient's] wound is described in multiple places throughout her medical recordas having a serosanguinous drainage. A "thin

    blood-stained exudate" is the usual classic textbook description. I'm not sure what

    Dr. N. Khouzan was referring to . . . when he says that his "careful review of the chart revealed a very severe purulent material

    . . .." His review couldn't have been that awfully careful as there is no mention of "a very severe purulent material," and he incorrectly identified the species of Clostridium he was hoping to treat as being Clostridium tetany (sic) which causes tetanus, rather than Clostridium perfringens which was one of the organisms cultured from [the patient's] excisional wound (along with coagulase-negative Staphylococcal spp.). I

    can only hope that Dr. Khouzan is not an infectious disease specialist. . . .

    
    

30. Dr. Nelson opines that the presence of Clostridium perfringens was not necessarily evidence of substandard care. To the contrary, Dr. Nelson finds that Petitioner, trained as an orthopedic surgeon, "adequately assessed and documented [the patient's] signs and symptoms." Additionally, Dr. Nelson states that Petitioner properly performed the excisional biopsy himself; although devoting his practice to family/general medicine, Petitioner was trained as a surgeon in orthopedics.

    
    

31. The bedside site of the excisional procedure did not bother Dr. Nelson, who states that the operating room is "justifiably reserved for more complex procedures." Dr. Nelson questions whether the procedure was performed at bedside or in a nearby "procedure room," where it was scheduled to be performed according to one of the records provided to Dr. Nelson. Dr. Nelson explains that the procedure rooms can easily be prepared for sterile procedures like excisional biopsies.

    
    

32. Dr. Nelson's letter concludes:

    
    

    Clostridial spp. are ubiquitous to the human body. They most often become

    disease-producing and self-perpetuating when the oxygen tension in tissues is lowered, as with an abscess, decubital ulcers, or other cause of tissue necrosis and/or devitaliza- tion. Debilitated patients are at a higher risk of developing Clostridial infections.

    Intestinal disorders, most commonly malig- nancies, permit Clostridium perfringens invasion and replication, resulting in severe local or, rarely, septicemic Clostridial disease. The most likely source of Clostridium perfringens in [the patient's] excisional biopsy wound is local fecal contamination, though systemic invasion

    cannot be absolutely ruled out. [The patient] could have developed the infection from an iatrogenic injury during the colonoscopy on 9/4/88 . . . from which the adenomatous polyp was snared. Or from [the patient's]

    long-standing diverticulosis with the infection spreading from the abdomen to the wound. These are unlikely scenario, given her medical history and hospital course, but it would have been an easy task to have ruled these out by the performance of an autopsy.

    
    

33. On January 11, 1991, Respondent requested that the final hearing set for January 29, 1991, be cancelled and the case abated to allow Respondent to return the case to the Probable Cause Panel for reconsideration. In the absence of objection from Petitioner, the motion was granted and the case was abated until March 10, 1991.

    
    

34. At the Probable Cause Panel Meeting of the Board of Medicine conducted on February 22, 1991, the following members of the Panel were present: Chair

    George P. Vitale; Fuad Ashkar, M.D.; and Margaret Skinner, M.D. Ms. Lannon was present, aswere Mr. Ramos, and Respondent's attorneys Larry McPherson, and Susan Londgard.

    
    

35. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting in sufficient time to review them. Ms. Lannon then invited the Panel members to ask questions or request material if they encountered a case for which they had not read the materials or were otherwise unfamiliar with.

    
    

36. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file.

    
    

37. When Petitioner's case was announced, Mr. Ramos stated that the case was before the Panel for reconsideration after a previous Panel finding of probable cause and the subsequent filing of an administrative complaint. Mr. Ramos explained:

    
    

    We have brought this case back for your consideration, because discovery revealed that two expert opinions state that the Respondent's excision of the nodule in the bedside of the patient was not below the acceptable standard of care.

    
    

    Furthermore, the information related by the patients--by our expert as to the source of the patient's infection is contradicted by recognized medical treatises and the opinion of an infections disease control specialist, and that has been included in the packet.

    That came after discovery.

    
    

    And, therefore, the Department has recommended that we close this case without further prosecu- tion.

    
    

    Transcript of February 22 meeting, page 7.

    
    

38. Panel member Skinner then indicated that she had noticed that the two expert opinions were from a Broward County assistant medical examiner and a family practitioner. She said that she would like to see an opinion from someone who is "Board certified in internal medicine with a subspecialty of infectious diseases, and I would like to see that . . . before we move to do away with this case. This case is heinous . . .." Id. at page 8.

    
    

39. Panel member Skinner complained that the experts did not have any medical records and that her records were incomplete. For instance, she said that she did not know the size of the incision or if a nurse documented erythema or "crud" in the wound. She thus moved that the case

    
    

    be brought back with the medical records with an opinion specifically from somebody

    Board-certified in internal medicine with a sub-specialty in infectious diseases and be

    brought back to the Panel, because one of the things that is not in the [Administrative Complaint] is failure to recognize [Clostridium perfringens].

    
    

    Id. at pages 8-9.

    
    

40. Ms. Lannon responded that the standard of care would be a reasonably prudent similar physician, "so unless [Petitioner] was Board-certified in infectious diseases, he wouldn't be held to that standard of care. He would be held to the standard of care of a similar physician." Id. at page 9.

    
    

41. Panel member Skinner answered that Petitioner is an "orthopedist practicing family practice." Id. Dr. Skinner then asked if Petitioner had surgical privileges at the hospital at which the incident took place. She suggested that the status of Petitioner's surgical privileges could be an "attributing cause." Id.

    
    

42. Panel member Ashkar stated that he agreed with Dr. Skinner. Dr. Ashkar noted that one of the materials in the file indicated that the hospital had since changed its policies, or possibly had done so, in terms of excision procedures being performed in a completely sterile environment.

    
    

43. In response to a question posed by Ms. Lannon, Panel members Skinner and Ashkar stated that they would proceed with an administrative complaint if they find "it's a standard-of-care violation." Id. at page 11. Dr. Ashkar added that a previous probable cause panel had good cause when it caused the filing of the Administrative Complaint, and the new panel should proceed with it.

    
    

44. Dr. Skinner requested that the Administrative Complaint be expanded to include an allegation that Petitioner failed to recognize the presence or possible presence of a staph infection. Dr. Skinner conceded that she did not have the medical records, so she did not know if Petitioner did a wound culture. She also did not have the nurses' notes, so she did not know if they made if obvious that something was wrong with the wound.

    
    

45. At this point, Mr. McPherson reminded the Panel that the case had been before a probable cause panel previously. He added that three expert opinions determined that there was "no standard-of-care violation." Id. at page 12. Ms. Lannon disagreed with Mr. McPherson, and Panel members Skinner and Ashkar agreed with Ms. Lannon. Dr. Ashkar stated that Dr. Goggin opined that there was a standard-of-care violation and that the incident forced the hospital to change their policies. Ms. Lannon cautioned that a change in policy would not establish a violation in the first place. Dr. Ashkar responded by referring to the standard-of-care issue and quoting Dr. Goggin as follows:

    
    

    ". . . the patient probably should have had the surgical procedure performed in a sterile environment under the usual conditions found in an operating room suite where there are sterile instruments, and that the wound infection here is probably due to doing it outside that kind of a setting."

    Id. at page 13.

    
    

46. Ms. Lannon asked the Panel what they thought about Dr. Nelson's opinion that Petitioner could be regarded as overutilizing the operating room by performing the excision procedure there. Dr. Skinner admitted that the Panel's problem was that they did not know the size of the excision. She added that the experts differed as to the appearance of the wound, which went toward the failure to recognize a serious problem.

    
    

47. Mr. Ramos suggested that the Panel table the case so that Respondent could provide the Panel with the medical records, which everyone agreed had not been included in thepackage supplied to the Board members prior to the meeting.

    
    

48. Concluding their discussion of the case at the February 22 meeting, Panel member Ashkar rejected Dr. Nelson's opinion because, absent an emergency, Dr. Ashkar had "never heard of [performing the subject excision procedure in a hospital bed] recently ywayay." Id. at page 16. Dr. Skinner restated her concern about Petitioner's failure to recognize the complication. Ms. Lannon suggested that an orthopedic specialist who had examined the specialist possibly could provide needed information as to the size and nature of the nodule on the patient's hip.

    
    

49. The motion was clarified to include consideration of amending the Administrative Complaint to include an allegation that Petitioner failed to recognize timely the patient's clostridium infection and to investigate whether Petitioner had surgical privileges. The Panel voted unanimously in favor of the motion and tabled the case.

    
    

50. By Status Report filed March 5, 1991, Respondent advised that the Probable Cause Panel had tabled the case at its February, 1991, meeting in order to obtain additional information.

    
    

51. At the Probable Cause Panel Meeting of the Board of Medicine conducted on May 4, 1991, Panel members present were Chair Vitale, Dr. Skinner, and Dr. Ashkar. Mr. Ramos and two of Respondent's investigators were present, as was Assistant Attorney General Edwin Bayo substituting for Ms. Lannon. Each of the Panel members indicated that he or she had read the file materials.

    
    

52. When Petitioner's case came up, Mr. Ramos noted that the case had been in front of the Panel "a couple of times," most recently February 22, 1991. Transcript of May 4 meeting, page 4. Mr. Ramos added that one of Respondent's attorneys had pursued all the issues identified by the Panel at the last meeting.

    
    

53. Mr. Ramos stated:

    
    

    Discovery reveals that the [Respondent's] expert's opinion was incorrect. That was the initial expert on which we depended on to file an Administrative Complaint. Dr. Nelson and Dr. Griffin have opined since then that the procedure performed in this case does not constitute the practice of medicine below the acceptable level of care.

    
    

    And at our last meeting, the Panel was informed on the foregoing, and it requested

    that an expert on infectious disease be obtained, and to obtain information as to the respondent's hospital privileges. There's two letters that are part of your packet from the hospital that says the subject did have hospital privileges. And as to the infectious disease person, the only person we have is the one on record, which is on the subject side of this case and [Respondent's attorney] tried to find someone. If you guys know someone for future reference, we need to know about it, because . . .

    
    

    Id. at pages 4-5.

    
    

54. Panel members Ashkar and Skinner offered to provide Mr. Ramos with some names. Then Dr. Skinner confessed that she was still troubled about several things involving the case. She again raised the question why Petitioner failed to recognize the serious infection, clostridium perfringens. Sherestated the other issue concerning whether Petitioner was wrong to remove the cyst in the hospital bed.

    
    

55. Addressing the first issue, Mr. Ramos said that Respondent could not obtain an expert opinion on whether Petitioner was culpable in his failure to recognize the infection. Dr. Skinner again offered to give Respondent the names of possible experts. Mr. Ramos responded that the process would take time, and, in the meantime, "we have this doctor in this position." Id. at page 6.

    
    

56. Dr. Ashkar offered to contact the proposed expert and expedite the process, so the Panel could accept the expert's credentials at the next Board meeting at the end of May. Mr. Ramos said they could move fast on the case, so Dr. Skinner moved to table the case again.

    
    

57. Dr. Skinner noted that they needed to consider the issue whether Petitioner improperly incised the abscess at the hospital bed. She asked that Respondent's attorneys pose to the expert two questions: was it below the standard of care to incise the abscess in the bed and was there a failure to recognize a potential danger. Dr. Ashkar distinguished between the removal of a nodule that is a simple ganglion, an ingrown hair, or a sebaceous cyst, on the one hand, and the draining of an abscess with a "very deadly bacteria in it in a general ward," on the other hand. Id. at page 8.

    
    

58. Mr. Ramos answered that the case would depend entirely on the expert. The first expert was dated andcontradicted by treatises. Dr. Ashkar responded that it would have been more acceptable if a surgeon without access to an operating room performed the excision in a sterile setting other than an operating room. In any event, it was, in Dr. Ashkar's opinion, improper to perform the procedure in a general ward where infectious diseases are a recurring problem. Id. at pages 8-9. Dr. Skinner agreed that the situation was worse because Petitioner had operating privileges.

    
    

59. Dr. Skinner then moved to table the case pending acquisition of expert witness, and again, . . . I would ask him all the ques- tions you asked the other expert witness. Noting that he did have operating room privileges.

    The second corner of the question that wasn't asked, is, is if it was failure to recognize an additional problem with this wound below the standard of care.

    
    

    Id. at page 10. The Panel then voted unanimously to table the case.

    
    

60. Respondent filed a second Status Report on May 20, 1991, and advised that the Probable Cause Panel again tabled the case at its April, 1991, meeting in order to obtain an additional expert opinion. Petitioner objected to further abatement and requested that the case be dismissed. At the same time, Petitioner requested attorneys' fees and costs.

    
    

61. By Order Setting Case for Hearing entered June 12, 1991, the request to dismiss was denied, the request for attorneys' fees and costs was denied, and the final hearing resetfor July 15, 1991. By Notice of Voluntary Dismissal filed June 18, 1991, Respondent dismissed the DOAH Case No. 90-5298 and the Division closed its file by Order entered the following day.

    
    

62. On July 10, 1991, Respondent received the opinion of another expert, Stephen M. Kreitzer, M.D., who had been retained by letter dated June 26, 1991. In relevant part, Dr. Kreitzer's letter states:

    
    

    The bacteria [to which the patient succumbed] are present in the skin and certainly the elderly with diminished circulation to the skin are more prone to these types of infec- tions. These types of infections can certainly occur under the sterile conditions surgery or they can occur with any break of the skin on their own. It certainly is within the standard of care to remove the type of nodule removed by [Petitioner] in an

    outpatient center, hospital in-patient bedside, or in a physician's office.

    
    

    There is no evidence to suggest [Petitioner] violated Surgical Infectious Disease Guidelines. . . .

    
    

    Sepsis was recognized by the Emergency Room physician and the care of the septic patient was begun by the Emergency Room physician. [Petitioner] continued that care in the Intensive Care Unit. Appropriate cultures and the broadened spectrum antibiotics were prescribed.

    
    

    In my opinion, the patient contracted the Clostridium and Staph bacteria from unfortu- nate skin entry. Skin entry can occur from an intravenous site, or wound such as that involved with the nodule removal, joint injection by an Orthopedist which occurred during this hospitalization and finally, colonoscopy and polypectomy with mucosal

    contamination and septicemia. Bacteria induced septicemia have been documented in all of the above instances and is well recognized. . . . Because of the timing of this patient's sepsis, it is unlikely that the trigger point injection or colonoscopy had anything to do with the patient's subse- quent septicemia and demise. Regardless, there is no evidence in the chart that the patient contracted the infection because of the procedure or treatment falling below the standard of care. [Emphasis added.]

    
    

    The applicable standard of care comes into question with this case because of both record keeping and the admitting orders. The patient did not have a history and physical dictated at the time of admission, but rather that was delayed until the 12th of September. Although rectal exam was not included, since the

    admitting orders included the consultation with the Gastroenterologist who obviously would per- form the rectal exam and colonoscopy, the patient need not have undergone a rectal exami- nation necessarily upon admission. . . .

    
    

63. Petitioner subsequently commenced the present case by filing a Petition for Costs and Attorneys Fees on July 29, 1991.

    
    

    CONCLUSIONS OF LAW

    
    

64. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties. Sections 57.111(4) and 120.57(1), Florida Statutes. (All references to Sections are to Florida Statutes.)

    
    

65. Section 57.111(4)a) provides:

    
    

    Unless otherwise provided by law, an award of attorney's fees and costs shall be made to a prevailing small business party in any adjud- icatory proceeding or administrative proceed- ing pursuant to chapter 120 initiated by a state agency, unless the actions of the agency were substantially justified or special cir- cumstances exist which would make the award unjust.

    
    

66. The only issue in this case is whether the disciplinary proceeding against Petitioner was substantially justified. If not, Petitioner is entitled to an award of attorneys' fees and costs in the amount of $8518.80, which Respondent concedes is reasonable in amount. Under Section 57.111(3)(e), a proceeding is "substantially justified" if "it had a reasonable basis in law and fact at the time it was initiated by a state agency."

    
    

67. In general, Petitioner has the burden of proving his entitlement to an award. However, the burden of going forward with the evidence is on Respondent

    as to the question of substantial justification. Department of Professional Regulation v. Toledo Realty, Inc., 549 So. 2d 715 (Fla. 1st DCA 1989).

    
    

68. In this case, Respondent has failed to show that, at the time that it filed the original Administrative Complaint, there was a reasonable basis in law and fact to prosecute Count Two. The medical records were clearly sufficient. The omission of a rectal examination upon admission was beyond question unavailable as a ground for discipline, even under a preponderance of evidence standard. 1/ The patient's lower gastrointestinal complaints, including rectal bleeding, were well documented, as were the causes. She was seen in consultation the day following her admission, and a colonoscopy was performed without delay. There was no reason to subject the patient, already in pain, to the additional pain of a rectal examination.

    
    

69. The case turns on whether there was a reasonable basis in law and fact for Count One, which alleges that Petitioner violated the applicable standard of care in excising the nodule at the patient's hospital bed. This is a much closer question.

    
    

70. Dr. Goggin devotes part of his letter to rebutting Petitioner's assertion in the medical records that the patient contaminated the wound with her own stool. There is clearly a reasonable basis in fact for Dr. Goggin's opinion in this regard and the Panel's reliance on his opinion. However, it does not necessarily follow, even if the patient did not self-contaminate, that she contracted the fatal infection from a break in sterile technique, as Dr. Goggin "assume[s]." The bacteria could have entered the skin during the post- operative period through no fault of Petitioner, regardless where the excision procedure had been done.

    
    

71. The question whether Respondent had a reasonable basis in law and fact to file Count One requires consideration of the nature of the proceeding that Respondent commenced. In a disciplinary proceeding, the burden of proof is on Respondent, which must prove the material allegations by at least apreponderance of the evidence. In other words, Respondent loses when the evidence fails to establish the means of infection, if, among the several possibilities, one or more do not involve a deviation from the applicable standard of care.

    
    

72. The medical records and attending nurse's statement tend to undercut reliance upon Dr. Goggin's opinion as a reasonable basis for filing Count One of the Administrative Complaint. The medical records and nurse's statement indicate that no break in sterile technique took place. These sources could be rebutted by other evidence, such as that there was no other way for the bacteria to enter the skin except through a break in sterile technique during the excision. However, Dr. Goggin's letter does not supply that evidence.

    
    

73. Dr. Goggin's letter only assumes that the infection took place during the excision procedure. The assumption appears to be based largely on his rejection of the possibility of self-contamination and ignores other possible means for bacteria to enter the skin, such as during later changes of the dressing. The letter displays little understanding of the nature of these infections and the means by which they can enter the skin.

    
    

74. Moreover, Dr. Goggin's letter is replete with qualifications. With respect to the critical portion of the letter quoted in Paragraph 12 of the Findings of Fact, the first sentence begins, "I find it hard to believe." The third sentence begins, "I cannot believe." The fifth sentence begins, "I wouldsuspect." The sixth sentence begins, "One must assume." The seventh

    sentence begins, "I think." The letter offers a highly equivocal conclusion that there was no violation of the standard of care as it applied to the subject hospital, although "most of us would believe" that an invasive procedure of this type "should probably" be performed in a sterile environment.

    
    

75. In contrast, the more detailed letter of Dr. McClelland finds unequivocally that Petitioner met the standard of care. His reasoning, in contrast to Dr. Goggin's, is informed by a more detailed knowledge of clostridial infections and the means by which they invade the body.

    
    

76. Nothing compelled the Panel to accept Dr. McClelland's opinion over Dr. Griffin's. The Panel could have required additional expert advice, which probably would have led to a decision not to file the Administrative Complaint. However, based upon the information available by the May 11 Panel meeting, the Panel did not have a reasonable basis in law and fact to file Count One of the Administrative Complaint.

ORDER

Based on the foregoing, it is hereby ordered that the Department of Professional Regulation pay William L. Mills the sum of $8518.80 for attorneys' fees and costs incurred in defending DOAH Case No. 90-5298.

DONE and ORDERED this 4th day of October, 1991, in Tallahassee, Florida.

ROBERT E. MEALE,Hearing Officer Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 4th day of October, 1991.

ENDNOTE

1/ Section 458.331(3) applies the preponderance standard of proof in cases in which Respondent does not seek revocation or suspension. Clear and convincing evidence is required only for cases in which Respondent seeks revocation or suspension. For purposes of this order, the undersigned has assumed that the preponderance standard would apply. To the extent that the more rigorous clear and convincing standard would apply, there would be corresponding less basis for Respondent to have commenced the disciplinary proceeding.

APPENDIX TO FINAL ORDER, CASE NO. 91-4754F

Treatment Accorded Petitioner's Proposed Findings

1-28: Adopted or adopted in substance except for date of filing of Administrative Complaint.

Treatment Accorded Respondent's Proposed Findings

1-33 and 36: Adopted or adopted in substance. 34-35 and 37: Rejected as irrelevant.

COPIES FURNISHED:

Attorney Launa K. Rutherford Taraska, Grower, et al.

P.O. Box 538065 Orlando, FL 32853-8065

Mary B. Radkins, Senior Attorney Department of Professional Regulation 1940 North Monroe Street

Northwood Centre, Ste. 60 Tallahassee, FL 32399-0792

Jack McCray, General Counsel Department of Professional Regulation 1940 North Monroe Street

Tallahassee, FL 32399-0792

Dorothy Faircloth, Executive Director Board of Medicine

1940 North Monroe Street Tallahassee, FL 32399-0792

NOTICE OF RIGHT TO JUDICIAL REVIEW

A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW PURSUANT TO SECTION 120.68, FLORIDA STATUTES. REVIEW PROCEEDINGS ARE GOVERNED BY THE FLORIDA RULES OF APPELLATE PROCEDURE. SUCH PROCEEDINGS ARE COMMENCED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE DIVISION OF ADMINISTRATIVE HEARINGS AND A SECOND COPY, ACCOMPANIED BY FILING FEES PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, OR WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.

Docket for Case No: 91-004754F

Orders for Case No: 91-004754F