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.
Findings Of Fact 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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." 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. 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. 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. 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). 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." 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. . . . 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. 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. 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. 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. 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. 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. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. . . . Petitioner subsequently commenced the present case by filing a Petition for Costs and Attorneys Fees on July 29, 1991.
The Issue The issue for determination is whether Petitioner should be awarded a certificate of need authorizing the establishment of cardiac catheterization laboratory services at its facility in Port Charlotte, Florida. As a result of stipulations of the parties presented at hearing, matters for consideration were limited to whether Petitioner meets the criteria of availability of funds for capital expenditures for the project in accordance with Section 381.705(1)(h), Florida Statutes; and whether Petitioner has shown the existence of need for additional services by any existing medically underserved groups in the service area.
Findings Of Fact The parties have stipulated that Petitioner does not meet the criteria of Section 381.705(1)(a), Florida Statutes, because there is no numeric need for the program established by any agency rule formula and that no emergency or other not normal circumstances exist, including problems of geographic, financial or programmatic access, justifying the program in the absence of such enumerated need. Petitioner's agreement to this stipulation was conditioned upon an assumption that previous Certificates of Need, formerly granted by final orders of Respondent to other entities in previous batching cycles and now the subject of legal appeals by Petitioner in the appellate court, will eventually be confirmed by that court to have been properly issued. The parties have stipulated that Petitioner, as the result of nonexistence of numeric or nonnumeric need, has not met criteria regarding its ability to provide quality care, a requirement of subparagraph (c) of Section 381.705(1), Florida Statutes; has not met criteria regarding availability and adequacy of other health care facilities in the applicant's service district, a review component set forth in Section 381.705(1)(d), Florida Statutes; has not met criteria regarding immediate and long term financial feasibility of Petitioner's proposal, a requirement of Section 381.705(1)(i), Florida Statutes; has not met criteria regarding the impact of the proposed project on the costs of providing such health services, a requirement of Section 381.705(1)(l), Florida Statutes; and has not met criteria, as required by Section 381.705(2)(a)-(d), Florida Statutes, regarding alternative services, efficiency of existing services, alternatives to new construction or the likelihood of patients obtaining the proposed service in the absence of Petitioner's proposal. The parties have stipulated that review requirements of subparagraphs (e), (f), (g), (j), and (k) of Section 381.705(1), Florida Statutes, are found not to be applicable to this proceeding. Those subparagraphs relate, respectively, to economics of shared services, need for special services, need for research and educational facilities, special needs of health maintenance organizations and needs of entities serving residents outside the service area. The parties have stipulated that the criteria ofSection 381.705(1)(b), Florida Statutes, has not been met because they were not addressed or challenged by Petitioner. However, Petitioner does contest the accessibility by medically underserved groups of existing and approved providers in the service district. With the exception of the availability of funds for capital and operating expenditures related to the project in Petitioner's application and the extent to which the proposed services will be accessible to all residents of the service district, further stipulation between the parties also establishes that the review criteria contained in Section 381.705(1)(h), Florida Statutes, does not apply to this proceeding. Portions of Rule 10-5.011(b), Florida Administrative Code, relating to accessibility of services to residents of the service district are also excepted from consideration in this proceeding by the parties' stipulation. By stipulation of the parties, it is established that the review requirement of Section 381.705(1)(l), Florida Statutes, relating to the probable impact of the proposed project on the cost of providing services proposed by Petitioner, is met. The parties' stipulation further establishes that requirements of Section 381.705(1)(m) and Section 381.705(1)(n), Florida Statutes, have been met. These statutory subparagraphs relate, respectively, to methods and costs of proposed construction, and Petitioner's past and proposed provision of health care services to medicaid and medically indigent patients. Petitioner is a separate, albeit subsidiary,corporation from its parent, Bon Secours Health Systems, Inc., (Bon Secours) a "not for profit" corporation based in Marriottsville, Maryland. Approximately 80 percent of the total project cost of $1,450,000 cost is expected to come from the parent organization and not Petitioner's corporation. The project has been approved by Petitioner's corporation and management approval has been granted by Bon Secours, subject only to final board approval and reevaluation by the parent corporation on an annual basis until the actual capital expenditure is incurred. Petitioner's parent corporation uses either a line of credit or goes to the tax exempt bond market to meet capital expenditure needs. The bond market is utilized when capital needs exceed $15 million for the year. Whether the funding source for Petitioner's project would come from a line of credit or bond financing would not be known until the actual year in which the expenditure is incurred. Bon Secours includes Petitioner in its obligated group which consists of a system-wide master trust indenture established in 1985. The group consists of eight hospitals and three long term care facilities. Weaker entities in the group have the benefit of the credit strength of the group's entire system. In this regard, Bon Secours enjoys a Standard & Poors and Moodys' bond rating of A+ and A-1, respectively. The corporation is a good credit risk with a strong financial position and good earnings record. Over the next five years, Bon Secours has the ability to raise in excess of $100,000,000 in the bond market for funding purposes, inclusive of the project which is the subject of theseproceedings. Although final approval of Petitioner's project by Bon Secours' board of directors is expected shortly, that approval had not occurred at the time of final hearing. As a result, the proof fails to establish that Bon Secours is committed to provide financing for Petitioner's project. Petitioner presented expert testimony regarding accessibility by medically underserved groups to Petitioner's and other cardiac catheterization programs. Petitioner's expert placed the size of the medically indigent population, a subcategory of the medically underserved group, at six to seven percent of the total population of the service area. Due to the lack of specificity of the methodology used in arriving at the cited percentage figure, no credibility can be ascribed to that population percentage. However, both Respondent and Petitioner concede the existence of this group in the district service area sought to be served by Petitioner's project. Petitioner has not established whether the medically indigent population is denied access to cardiac catheterization programs within the district service area. While Petitioner's hospital is a medicaid provider with a proactive policy of aiding the medically indigent, the availability of cardiac catheterization services exist for this group at Intervenor's medical center facilities, located only five miles from Petitioner's hospital. Intervenor is also a medicaid provider. The proof fails to establish that medicaid patients or medically indigentpatients are presently denied or turned away from Intervenor's facility. Further, the duplication of such services at Petitioner's hospital could effectively reduce the number of cardiac catheterization procedures required for the medical staff of Intervenor's laboratory to maintain proficiency. In point of fact, there is unused cardiac catheterization capacity at Intervenor's facility. As established by Intervenor's exhibit number one, there were 562 cardiac catheterization procedures performed at Intervenor's facility in 1988. The State Health Plan recites a minimum goal of 600 such procedures a year as a proficiency measurement; the Local Health Plan maintains that a minimum of 300 procedures should be performed to insure proficiency.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying Petitioner's application for approval of a cardiac catheterization Certificate of Need. DONE AND ENTERED this 29th day of June, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Fl 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of June, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-3. Adopted in substance, except that part (l) of proposed finding 3 was met by Petitioner. 4.-5. Addressed in part. To the extent that the last sentence of proposed finding 5 suggests the establishment of final approval by the parent corporation, it is rejected. 6. Accepted with the exception of approval by the parent corporation. The record supports a finding of approval by management of that corporation, but not the board of directors. 7.-8. Adopted in substance. Adopted in part, remainder rejected due to witness's inability to support her calculations as to percentages of the population within the service district classified as medically indigent. Addressed in part, remainder unnecessary to conclusion. Addressed in part, remainder rejected on basis of relevancy. Addressed. Rejected on basis of relevancy. Addressed in part, remainder rejected as argumentative and speculative. Respondent's Proposed Findings. 1.-2. Rejected. Treated in preliminary discussion. 3.-21. Adopted in substance. 22.-23. Adopted by reference. 24.-25. Addressed in substance. 26.-30. Adopted by reference. 31.-33. Adopted by reference. Intervenor's Proposed Findings. 1.-3. Adopted in substance. 4. Rejected as unnecessary. 5.-9. Adopted in substance. 10. Adopted by reference. 11.-12. Adopted in substance. COPIES FURNISHED: Joseph R. Buchanan, Esq. Suite 900, Sun Bank Building 777 Brickell Avenue Miami, FL 33131 Edgar Lee Elzie, Jr., Esq. 215 South Monroe Street, Suite 804 Tallahassee, FL 32301 E. G. Boone, Esq. 1001 Avenida del Circo Venice, FL 34284 Gregory L. Coler Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Sam Power Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Miller, Esq. General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, in Tallahassee, Florida. CHARLES C. ADAMS, 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 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
The Issue The issues are whether Respondent failed to maintain emergency medications, in violation of Florida Administrative Code Rule 59A-9.0225(1), and failed to ensure that a defibrillator was available for immediate use, in violation of Florida Administrative Code Rule 59A-9.0225(2). If so, another issue is the penalty that should be imposed.
Findings Of Fact At all material times, Respondent has operated, under the jurisdiction of Petitioner, a licensed abortion clinic facility, bearing license number 899. The facility in question is located in North Miami Beach. At the time of the surveys described below, Respondent also operated another facility in south Miami, but that facility is not involved in this case. All references to "facility" will therefore refer to the North Miami Beach location. On June 8, 2010, one of Petitioner's surveyors conducted a relicensure survey of Respondent's facility. As is typical of such surveys, this survey was unannounced. During the survey, the surveyor discovered three expired medications in the facility: 0.2 mg Isuprel®--expired August 2009, 0.4 mg atropine--expired February 2010, and an unspecified dosage of nalbuphone--expired February 2010. These expired medications were on a shelf in the operating room. During the survey, the surveyor also discovered that the facility did not have a defibrillator. At the conclusion of the survey, the surveyor conducted an exit conference with the sole employee present at the facility. During this conference, the surveyor explained these deficiencies and gave Respondent until July 8, 2010, to correct them. Subsequently, the surveyor prepared a report showing these violations and confirming that the deadline for correcting both deficiencies was July 8, 2010. On April 21, 2011, the surveyor returned, again unannounced, to the facility to conduct a followup survey and again found only one employee present at the facility. During this survey, the surveyor discovered three expired medications in the facility: one 500-ml IV bag of Lactated Ringer's-- expired April 2009, 1 mg atropine--expired November 2010, and 2% lidocaine hydrochloride injection--expired November 2010. The surveyor found these expired medications in a locked storage box on the crash cart, which is the cart used for medical emergencies. During the followup survey, the surveyor also discovered that the facility did not have a defibrillator. On the dates of both surveys, the facility did not have any surgical procedures scheduled. Also, no patients were present at anytime during either survey. During each survey, the surveyor selected five dates at random to determine if the facility had performed any second- trimester abortions, and she found that no such procedures had been performed on any of these dates. For this reason, the surveyor did not cite the facility for any violations that are contingent on the actual performance of second-trimester abortions--such as, the failure to have a registered nurse in the recovery room. Similarly, because no patient was present during the surveys, the surveyor testified that she did not cite the facility for a failure to maintain anaesthesia equipment in the operating room; the surveyor explained that the anaesthesiologist brings his or her own equipment when attending a surgical procedure. The surveyor explained that she cited Respondent for the deficiencies alleged in this case because they are contingent upon licensure only, not licensure and the actual performance of second-trimester abortions. At the time of each survey, regardless of the level of patient activity, the facility was open and capable of supporting the procedures for which it is licensed. Dr. Rosenthal offered an explanation for each of the deficiencies cited in this case. As he testified, the expired medications found during the followup survey were in a locked storage box maintained by a certified registered nurse anesthetist, who had not worked at the facility for several years, but had never returned to retrieve her storage box. However, Dr. Rosenthal's explanation does not account for why the surveyor missed the Lactated Ringer's IV fluid during the original relicensure survey, if, in fact, she did miss this item. (The other two items were not expired at the time of the earlier survey.) Notwithstanding any shortcoming in Dr. Rosenthal's explanation, more importantly, the record fails to establish the absence of current emergency medications and IV fluids at the facility. As noted below, the cited rule requires that the facility contains these items; as long as it does, the cited rule is not violated by the presence of expired medications and fluids at the facility. The presence of such expired items is insufficient, especially when the standard of proof, as noted below, is clear and convincing evidence, to support an inference that adequate, current medications and IV fluids were not also available at the facility. As Dr. Rosenthal testified, at the time of both surveys, Respondent maintained a single defibrillator, which he transferred from one facility to another, depending on which facility was to be the site of surgical procedures on a given day. This explanation is not responsive to the requirement of a defibrillator at each facility.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of failing to maintain a defibrillator and imposing an administrative fine of $500 for this violation and dismissing the charge pertaining to expired medications and IV fluids. DONE AND ENTERED this 10th day of July, 2012, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of July, 2012. COPIES FURNISHED: Vlad Van Rosenthal A Medical Office for Women Suite 402 909 Northeast 163rd Street Miami, Florida 33160 Nelson E. Rodney, Esquire Agency for Health Care Administration Suite 300 8333 Northwest 53rd Street Miami, Florida 33166 nelson.rodney@ahca.myflorida.com Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Elizabeth Dudek, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308
Findings Of Fact At all times relevant hereto Lucy Jean Boggs Phelps, Respondent, was a registered nurse holding license number RN0941002 and was employed as charge nurse at AMI Town and Country Medical Center (AMI). On or about February 10, 1990, a 98 year old white male patient at AMI pulled out the Dobbhoff tube inserted that day into his small intestines. The doctor was notified, and he directed the Dobbhoff tube be reinserted in the stomach of the patient and to start feeding the patient 50 cc per hour. The order further provided for the patient's bed to be elevated at the head (a reverse trendlenberg) and to "x-ray tonight or early am to replace small bowel feeding tube." Pamela Bayne, LPN, received this order over the telephone, entered it on the doctor's order page and requested the floor nurse, Mary Metzger, RN, to replace the Dobbhoff tube. This was done, and the location of the tube in the stomach was verified by Bayne and Metzger by inserting air in the tube and listening with stethoscope over the abdomen. Also, the end of the tube was placed in a glass of water, and no air escaped which, if present, would indicate the tube was in the lung. Nevertheless, in compliance with her understanding of hospital policy, Metzger prepared the patient for x-ray and so notified Respondent who responded that, under the circumstances, x-ray was not necessary. AMI has a hospital policy procedure (Exhibit 1) whose subject is: ENTRAL FEEDING TUBE (DOBBHOFF) - INSERTION AND MAINTENANCE OF. The second paragraph thereof states: "A flat plate of the abdomen is to be obtained, and a radiologist or a physician confirmation of appropriate tube placement is needed prior to administering medications, feeding or irrigation through the tube. A physician's order must be written in the patient's medical record to authorize the x-ray." This policy goes on the outline the steps to follow in preparing the patient and inserting the Dobbhoff tube. After these procedures are accomplished and the tube inserted, Section 21 provides: Confirm stomach placement of the tube, while stylet is still in place, by introducing approximately 10-25 cc of air into the tube, using a 60 cc syringe, while listening with a stethoscope over the patient's stomach. Rumbling noise would indicate the tube is probably in the stomach. Aspirating stomach contents, using a 60 cc syringe, can also confirm stomach placement. However, this will not always be a good check since the tubes are small and sometimes aspirating contends is difficult. Section 24 provides for patient to be returned to a position of comfort and "if the tube is inserted for post-pyloric placement (naso-duodenal or naso- jejunal) place patient on right side as much as possible. This will facilitate tube passage due to anatomical structure." Section 25 provides: "For final confirmation of placement, obtain flat plate of abdomen order with an `as soon as possible' reading." AMI has another hospital policy procedure the subject of which is: LEVINE TUBE - FEEDING THROUGH (Exhibit 7). The purpose of the Levine tube is to provide nourishment by means of naso-gastric feeding when the patient cannot or will not take food in the usual manner. This tube is determined to be in the proper place by aspirating the stomach contents from the Levine tube or injecting 30 cc of air into the Levine tube while simultaneously listening to the stomach with a stethoscope for a gurgling sound. The Dobbhoff tube is a small flexible rubber tube, while the Levine tube is a larger, stiffer plastic tube. The Dobbhoff tube is more comfortable for the patient due to its softness and size than is the Levine tube. The Dobbhoff tube is more frequently used for feeding directly to the small intestine, while the Levine tube is used only to send material to the stomach. Respondent has inserted some 36 to 40 Dobbhoff tubes in her career and has never seen this tube used as a naso-gastric (stomach) feeder before this instance. The word ENTRAL to several witnesses meant simply, internal; to Respondent the word meant intestinal. Respondent testified that she once looked the word up in a dictionary to confirm this definition. However, this word is not contained in Webster's New Intercollegiate Dictionary (1977) or Dorland's Illustrated Medical Dictionary, Twenty-Sixth Edition (1985). Accordingly, it appears that this is either a coined or misspelled word used in some areas of the medical profession, but without an authoritative definition. Dorland's, supra, defines the word ENTAL as inner, central; derived form the Greek word entos and ENTERAL (Gr. enteron intestine) as within, by way of, or pertaining to the small intestine. All witnesses employed at AMI, except Respondent, understood the hospital policy expressed in Exhibit 1 to require an x-ray be taken before nourishment or medication is passed through a Dobbhoff tube whether the tube is inserted into the stomach or to the intestine. The reason for this is that the tube is very flexible and can kink back on itself, and the air test with stethoscope is not fool proof. Respondent understood an x-ray was required when the Dobbhoff tube was to be used for entral (intestinal) feeding as opposed to naso-gastric feeding when the tube is passed only into the stomach. The doctor's order entered in this case to "x- ray tonight or early am to replace small bowel feeding tube" leads some credence to this interpretation. In order to place the tube in the intestines, x-ray techniques are used by radiologists to visually so place the Dobbhoff tube. Following placement of the Dobbhoff tube in the stomach at 6:30 p.m., February 10, 1990, nurses notes show "feeding was started at 7 p.m. At 10 p.m. the patient was anxious/restless, full of fluid, suctioned. Dr. Rose called. 10:15 Dr. Frank notified of patient's condition. 10:40 tube feeding clamped. Patient remains anxious with labored breathing." (Exhibit 2). Subsequent thereto, an x-ray was taken which showed the Dobbhoff tube projected over patient's right lower lobe. The patient died 36 hours after the tube was clamped off (Exhibit 3). Primary cause of death was asphyxia secondary to aspiration of gastric contents. Essentially, the patient suffered sufficient stress from the material fed into his lung through the Dobbhoff tube to cause cardiac arrest. No evidence or explanation was submitted to describe how the air-stethoscope tests here conducted failed to insure the tube placement in the stomach. This elderly patient was admitted to the hospital February 6, 1990, suffering primarily from anemia. Accordingly, when the doctor on February 10 ordered the tube the patient had pulled out to be replaced to the stomach and later relocated to the intestine, Respondent correctly concluded that the doctor considered nourishment necessary for the patient. At this time, radiology had closed for the day and, except in an emergency, a radiologist was not available to read an x-ray. Respondent realized that the emergency room physician could read the x-ray to determine if the Dobbhoff tube was properly placed in the stomach, but had some reservations about the doctor's willingness to do so. All other witnesses considered it appropriate to request such an x-ray reading from the emergency room physician particularly since no special expertise is needed to make such a determination. Normally emergency room physicians are called on to read x-rays only in emergency situations. Four registered nurses opined that failure to follow hospital policy constitutes unprofessional conduct and does not meet the minimum standards of professional conduct for nurses. Respondent has been licensed as a registered nurse for 15 years, and this is the first disciplinary proceeding brought against her. Her supervisors at AMI who testified in these proceedings agreed that Respondent was sincere in her interpretation of Exhibit 1, but thought the policy was clear that, regardless of the tube placement, hospital policy required the taking of an x- ray to determine Dobbhoff tube placement prior to passing fluids, nourishment or medication through the tube.
Recommendation It is recommended that Lucy Jean Boggs Phelps be found not guilty of unprofessional conduct and these charges be dismissed. ENTERED this 14 day of November, 1990, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14 day of November, 1990. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-3828 Treatment accorded proposed findings submitted by Petitioner. 1 - 7. Accepted. 8. Rejected insofar as Dobbhoff tube placement in stomach. 10-11. Rejected due to the lack of specificity of hospital policy caused by use of the word "entral." Accepted. Rejected as unsupported by competent and substantial evidence. Accepted. COPIES FURNISHED: Lois B. Lepp, Esquire Department of Professional Regulation, Suite 60 1940 N. Monroe Street Tallahassee, FL 32399-0792 Thomas D. Casper, Esquire 4830 W. Kennedy Boulevard Suite 750 Tampa, FL 33609 Judie Ritter Executive Director Board of Nursing 504 Daniel Building 111 East Coastline Drive Jacksonville, FL 32202 Kenneth E. Easley General Counsel Department of Professional Regulation Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792
