The Issue The issues to be determined are whether Respondent violated the applicable standard of care in the practice of dentistry in violation of section 466.028(1), Florida Statutes, as alleged in the Administrative Complaints filed in each of the consolidated cases; and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, Board of Dentistry, is the state agency charged with regulating the practice of dentistry in the state of Florida, pursuant to section 20.43, and chapters 456 and 466, Florida Statutes. Stipulated Facts Respondent is a licensed dentist in the state of Florida, having been issued license number DN14223 on or about December 1, 1995. Respondent’s address of record is 530 East Howard Street, Live Oak, Florida 32064. Respondent was licensed to practice dentistry in the state of Florida during all times relevant to the administrative complaints underlying this case. Patient T.C. was a patient of Respondent. Patient S.S. was a patient of Respondent. Patient G.H. was a patient of Respondent. Patient J.D. was a patient of Respondent. Patient J.A.D. was a patient of Respondent. Other Findings of Fact On July 23, 2004, Respondent entered into a Stipulation in Department Case No. 2002-25421 to resolve an Administrative Complaint which alleged violations of section 466.028(1)(m), (x), and (z). The Stipulation was adopted by a Final Order, dated January 31, 2005, which constitutes a first offense in these cases as to each of the sections cited. On September 21, 2007, the Department issued a Uniform Non-disciplinary Citation for an alleged violation of section 466.028(1)(n), related to the release of patient dental records. The Department offered no evidence of its disposition and, in any event, since these cases do not involve alleged violations of section 466.028(1)(n), the citation is of no consequence in establishing a penalty in these cases under Florida Administrative Code Rule 64B5-13.005(1). On January 19, 2017, the Department issued an Administrative Complaint in Case No. 2015-10804 for alleged violations of section 466.028(1)(m), (x), and (mm). The Department offered no evidence of its disposition of the Administrative Complaint and, as a result, the Administrative Complaint is of no consequence in establishing a penalty in these cases under rule 64B5-13.005(1). On January 19, 2017, the Department issued an Administrative Complaint in Case No. 2015-23828 for alleged violations of section 466.028(1)(m), (x), and (z). The Department offered no evidence of its disposition of the Administrative Complaint and, as a result, the Administrative Complaint is of no consequence in establishing a penalty in these cases under rule 64B5-13.005(1). Case No. 19-2898PL - The T.C. Administrative Complaint Patient T.C. was a patient of Respondent from June 14, 2011, to on or about August 12, 2013. During the period in question, Respondent owned Smile Designs, a dental practice with offices in Jacksonville, Lake City, and Live Oak, Florida. The Department, in the T.C. Administrative Complaint, recognized that “Respondent, along with an associate, [Dr. Morris], are . . . licensed dentists known to work at Respondent’s practice.” The Department’s expert witness, Dr. Brotman, was also aware that Dr. Morris practiced with Respondent. Patient T.C. suffered a stroke in 2009. During the period that she was seen by Respondent, she was in “decent health,” though she was on medication for her post-stroke symptoms, which included a slight problem with aphasia, though she was able to communicate. The stroke and the aphasia are neurological issues, not mental health issues. Patient T.C. was accompanied by her husband, L.C. during her visits to Respondent’s practice. He generally waited in the waiting area during Patient T.C.’s procedures though, as will be discussed herein, he was occasionally brought back to the treatment area. L.C. testified that he had never been advised that Patient T.C. experienced a seizure while under Respondent’s care, and had no recollection of having been told that Patient T.C. ever became unresponsive. Patient T.C. died in 2015. Count I Case No. 19-2898PL, Count I, charges Respondent with failing to immediately refer Patient T.C. to a medical professional or advise Patient T.C. to seek follow-up care for the management of what were believed to be seizures while Patient T.C. was in the dental chair. From Patient T.C.’s initial visit on June 14, 2011, through her visit on September 23, 2011, Patient T.C. was seen at Respondent’s practice on five occasions. Respondent testified that the office was aware of Patient T.C.’s history of seizures because the medical history taken at her first visit listed Diazapam, Levetiracetam, Diovan, and Lyrica as medications being taken by Patient T.C., all of which are seizure medications. Nonetheless, the dental records for the four visits prior to September 23, 2011, provide no indication that Patient T.C. suffered any seizure or period of non- responsiveness during those visits. On September 23, 2011, Patient T.C. presented at Smile Designs for final impressions for crowns on teeth 20, 21, 28, and 29. Respondent testified that she was not the treating dentist on that date. Patient T.C. was given topical anesthetics, and her pulse and blood pressure were checked. The treatment notes then provide, in pertinent part, the following: Patient had seizures on the dental chair - may be due to anxiety. Seizures last 2-3 minutes. No longer. After 30 minutes, patient was calm. Able to proceed with dental procedure . . . . During seizures pt. was responsive; she was able to respond to our commands. The medical records substantiate Respondent’s unrebutted testimony that she was not the treating dentist at the September 23, 2011, appointment. The June 14, July 19, and October 7, 2011, treatment notes made by Respondent all start with “Dr. Gerry,” and are in a notably different style and format from the September 23, 2011, treatment notes. The preponderance of the evidence establishes that Dr. Morris, and not Respondent, was the treating dentist when Patient T.C. experienced seizures on September 23, 2011. Much of Dr. Brotman’s testimony as to Respondent’s violation of a standard of care was based on his interpretation that, since the September 23, 2011, notes did not specifically identify the treating dentist (as did the other treatment notes described above), the notes must be presumed to be those of the business owner. Neither Dr. Brotman nor the Department established a statutory or regulatory basis for such a presumption and, in any event, the evidence adduced at hearing clearly rebutted any such presumption. Dr. Brotman testified that if another dentist had been identified in the records as having performed the treatment on September 23, 2011, that may have changed his opinion. The evidence established that Dr. Morris performed the treatment on September 23, 2011. Thus, Dr. Brotman’s opinion that Respondent violated the applicable standard of care was effectively countered. The T.C. Administrative Complaint charged Respondent with failing to comply with the applicable standard of care on September 23, 2011. The Department failed to establish that Respondent was the treating dentist on September 23, 2011, and, in fact, a preponderance of the evidence demonstrated that she was not. Thus, the Department failed to establish that Respondent violated the standard of care for failing to refer Patient T.C. to an appropriate medical professional for her seizures as alleged in Count I of the T.C. Administrative Complaint. Count II Case No. 19-2898PL, Count II, charges Respondent with delegating the task of intraoral repair of Patient T.C.’s partial denture to a person not qualified by training, experience, or licensure to perform such intraoral repair. July 17, 2012 Repair On July 17, 2012, Patient T.C. presented to Respondent because her lower partial denture was broken and the O-ring was out. The device included a female end within Patient T.C.’s jaw, and a male end with a plastic “gasket” on the denture. Respondent testified that the repair of the partial denture was performed outside of Patient T.C.’s mouth. Then, at the next scheduled visit, the treatment plan was for Respondent to “eval/repair partial denture on lower arch.” Respondent offered unrebutted testimony that “Tia of precision attachments” performed no work in Patient T.C.’s mouth. Dr. Brotman testified that, in his opinion, any repair of a precision attachment must be done by placing the attachment in the patient’s mouth to align with the teeth. However, Dr. Brotman did not know what kind of repair was done on July 17, 2012. He indicated that if a gasket or housing is missing, it can be repaired with an acrylic. Dr. Brotman testified that if acrylic was placed in the denture outside of the patient’s mouth, it would not be a violation of Florida law. The Department failed to prove, by clear and convincing evidence, that Respondent delegated the task of adjusting or performing an intraoral repair of Patient T.C.’s partial denture to “Tia” or any other unlicensed person on July 17, 2012, as alleged in Count II of the T.C. Administrative Complaint. June 11, 2013 Repair On June 11, 2013, Patient T.C. presented to Respondent for an evaluation of her lower precision partial denture. Patient T.C. complained that the partial denture did not have the metal housing to connect it with the bridges to its sides. Patient T.C. was a “bruxer,” i.e. she ground her teeth, and had worn out the denture’s metal attachment. Respondent evaluated the situation, and decided to attempt a chairside repair or replacement of the denture’s male attachments. If the chairside repair was unsuccessful, a complete new partial denture would have to be prepared by a dental laboratory. Respondent attempted the chairside repair. Respondent testified that she instructed her dental assistant to add acrylic into the slot where the male attachment was to be placed in the denture. There was no evidence of any kind to suggest that the dental assistant then placed the denture into Patient T.C’s mouth. Because too much acrylic was placed in the denture, it became stuck in Patient T.C.’s mouth. Patient T.C. became understandably upset. Her husband, L.C., was brought into the room, Patient T.C. was administered local anesthesia, and the precision partial denture was removed. Respondent’s testimony regarding the incident was generally consistent with her prior written statement offered in evidence. Dr. Brotman testified that making repairs to a precision denture must be performed by a licensed dentist, except for placing acrylic into the denture outside of the patient’s mouth, which may be done by a non-dentist. The evidence was insufficient to demonstrate that Respondent’s dental assistant did anything more than place acrylic into the denture outside of Patient T.C.’s mouth. The Department failed to prove, by clear and convincing evidence, that Respondent delegated the task of adjusting or performing an intraoral repair of Patient T.C.’s partial denture to her dental assistant on June 11, 2013, as alleged in Count II of the T.C. Administrative Complaint. Case No. 19-2899PL - The S.S. Administrative Complaint Count I Case No. 19-2899PL, Count I, charges Respondent with violating section 466.028(1)(m) by: Failing to keep a written record of Patient S.S.’s medical history; and/or Failing to keep an accurate written record of any consent forms signed by Patient S.S. Count II Case No. 19-2899PL, Count II, charges Respondent with violating section 466.028(1)(x) by: Failing to adequately diagnose decay in tooth 30; Failing to adequately diagnose the condition of the roots of tooth 30; Failing to adequately obturate the canals of tooth 30 during root canal treatment; Failing to adequately obturate the canals of tooth 31 during root canal treatment; Failing to take a new crown impression of tooth 31 following changes to the tooth’s margins; and/or Failing to adequately assess and correct the crown on tooth 31 when the fit was compromised. On May 15, 2014, Patient S.S. presented to Respondent for a root canal and crown on tooth 30. Upon examination, Respondent advised Patient S.S. that she also needed a root canal and a crown on tooth 31. Patient S.S. denied that she was required to provide her medical history at the May 15, 2014, office visit, or that she was provided with an informed consent form prior to the root canal on tooth 30. Respondent’s records do not include either a medical history or an informed consent form. However, the records, which were offered as a joint exhibit, were not accompanied by a Certificate of Completeness of Patient Records, including the number of pages provided pursuant to Respondent’s investigatory subpoena, as is routine in cases of this sort, and which was provided with the records of the subsequent dentists involved in Patient S.S.’s care. Many of the records offered in these consolidated cases, including Respondent’s licensure file, include the certification attesting to their completeness. The records for Patient S.S. do not. Petitioner elicited no testimony from Respondent establishing the completeness of the records. The records offered were, by appearance, not complete. Respondent indicated that medical history and consent forms were obtained. Entries in the records introduced in evidence indicate “[m]edical history reviewed with patient” or the like. Entries for May 16, 2014, provide that “[c]rown consent explained and signed by patient” and “root canal consent explained and signed by patient.” The record for June 4, 2014, indicates that “[r]oot canal consent form explained to and signed by patient.” Patient S.S. testified that she had no recollection of having filled out a medical history, or of having signed consent forms after having Respondent’s recommended course of treatment explained to her. However, Patient S.S.’s memory was not clear regarding various aspects of her experience with Respondent and with subsequent providers. Much of her testimony was taken from notes she brought to the hearing, and some was even based on what she read in the Administrative Complaint. Her testimony failed to clearly and convincingly establish that Respondent failed to collect her medical history or consent to treatment. Respondent testified that, at the time Patient S.S. was being seen, her office was in the midst of switching its recordkeeping software and converting records to digital format. The new company botched the transition, and by the time the issue was discovered, many of the records being converted to digital format were lost, in whole or in part. Respondent surmised that, to the extent the records were not in her files provided to the Department, that they were affected by the transition. The greater weight of the evidence suggests that medical history and signed consent forms were provided. Given the issues regarding the records as described by Respondent, and given the Department’s failure to produce a certification or other evidence that the records it was relying on to prove the violation were complete, the Department failed to meet its burden to prove, by clear and convincing evidence, that Respondent failed to keep a written record of Patient S.S.’s medical history and signed consent forms. Respondent also testified that the office notes were supplemented with handwritten notations made when a patient returned for a subsequent appointment. Several of Patient S.S.’s printed records carried handwritten notes. Respondent testified that those notes were made at some time in 2014 after Patient S.S.’s first office visit up to the time of her last visit, and were based on further discussion with Patient S.S. However, those records, Joint Exhibit 2, pages 1 through 17, bear either a date or a “print” date of March 12, 2015. Dr. Brotman testified that he knew of no software on the market that would allow contemporaneous handwriting on electronic records. Thus, the evidence is compelling that the handwritten notes were made on or after the March 12, 2015, date on which the records were printed, well after Patient S.S.’s last office visit. A root canal involves removing a tooth’s pulp chamber and nerves from the root canals. The root canals are smoothed out and scraped with a file to help find and remove debris. The canals are widened using sequentially larger files to ensure that bacteria and debris is removed. Once the debris is removed, an inert material (such as gutta percha) is placed into the canals. A “core” is placed on top of the gutta percha, and a crown is placed on top of the core. The risk of reinfection from bacteria entering from the bottom of an underfilled tooth is significantly greater than if the tooth is filled to the apex of the root. Patient S.S. returned to Respondent’s office on May 16, 2014, for the root canal on tooth 30 and crown preparations for teeth 30 and 31, which included bite impressions. Temporary crowns were placed. Respondent’s printed clinical notes for May 16, 2014, gave no indication of any obstruction of the canals, providing only the lengths of the two mesial and two distal root canals. Respondent’s hand-written notes for May 16, 2014 (which, as previously explained, could have been made no earlier than March 12, 2015), stated that the canals were “[s]ealed to as far as the canal is open. The roots are calcification.” Dr. Brotman indicated that the x-rays taken on May 15, 2014, showed evidence of calcification of the roots. However, Dr. Brotman convincingly testified that the x-rays taken during the root canal show working-length files extending to near the apices of the roots. Thus, in his opinion, the canals were sufficiently open to allow for the use of liquid materials to soften the tooth, and larger files to create space to allow for the canals to be filled and sealed to their full lengths. His testimony in that regard is credited. Patient S.S. began having pain after the root canal on tooth 30 and communicated this to Respondent. On June 5, 2014, Patient S.S. presented to Respondent to have the crowns seated for teeth 30 and 31. Patient S.S. complained of sensitivity in tooth 31. The temporary crowns were removed, and tooth 31 was seen to have exhibited a change in color. The area was probed, which caused a reaction from Patient S.S. Respondent examined the tooth, and noted the presence of soft dentin. A root canal of tooth 31 was recommended and performed, which included removal of the decay in the tooth’s dentin at the exterior of the tooth. Respondent’s removal of decay changed the shape of tooth 31, and would have changed the fit of the crown, which was made based on the May 16, 2014, impressions. There were no new impressions for a permanent crown taken for tooth 31 after removal of the decayed dentin. Respondent testified that she could simply retrofill the affected area with a flowable composite, which she believed would be sufficient to allow for an acceptable fit without making new bite impressions and ordering a new crown. There was no persuasive evidence that such would meet the relevant standard of performance. Temporary crowns were placed on teeth 30 and 31, and placement of the permanent crowns was postponed until the next appointment. Upon completion of the tooth 31 root canal on June 5, 2014, x-rays were taken of the work completed on teeth 30 and 31. Dr. Brotman testified that the accepted standard of care for root canal therapy is to have the root canal fillings come as close to the apex of the tooth as possible without extending past the apex, generally to within one millimeter, and no more than two millimeters of the apex. His examination of the x-rays taken in conjunction with Respondent’s treatment of Patient S.S. revealed a void in the filling of the middle of the distal canal of tooth 31, an underfill of approximately five millimeters in the mesial canal of tooth 31, an underfill of approximately four millimeters in the distal canal of tooth 30, and an underfill of approximately six millimeters in the two mesial root canals of tooth 30. The x-ray images also revealed remaining decay along the mesiobuccal aspect of the temporary crown placed on tooth 31. His testimony that the x-ray images were sufficiently clear to provide support for his opinions was persuasive, and was supported by the images themselves. A day after the placement of the temporary crowns, they came off while Patient S.S. was having dinner in Gainesville. She was seen by Dr. Abolverdi, a dentist in Gainesville. Dr. Abolverdi cleaned the teeth, took an x-ray, and re-cemented the temporary crowns in place. Patient S.S. next presented to Respondent on June 10, 2014. Both of Patient S.S.’s permanent crowns were seated. The permanent crown for tooth 31 was seated without a new impression or new crown being made. Patient S.S. was subsequently referred by her dentist, Dr. James Powell, to be seen by an endodontist to address the issues she was having with her teeth. She was then seen and treated by Dr. John Sullivan on July 25, 2014, and by Dr. Thomas Currie on July 29, 2014, both of whom were endodontists practicing with St. Johns Endodontics. As to the pain being experienced by Patient S.S., Dr. Sullivan concluded that it was from her masseter muscle, which is consistent with Respondent’s testimony that Patient S.S. was a “bruxer,” meaning that she ground her teeth. Dr. Sullivan also identified an open margin with the tooth 31 crown. His clinical assessment was consistent with the testimony of Dr. Brotman. The evidence was clear and convincing that the defect in the tooth 31 permanent crown was an open margin, and not a “ledge” as stated by Respondent. The evidence was equally clear and convincing that the open margin was the result of performing a “retrofill” of the altered tooth, rather than taking new bite impressions to ensure a correct fit. As a result of the foregoing, Respondent violated the accepted standard of performance by failing to take a new crown impression of tooth 31 following the removal of dentin on June 4, 2014, and by failing to assess and correct the open margin on the tooth 31 crown. Radiographs taken on July 25, 2014, confirmed that canals in teeth 30 and 31 were underfilled, as discussed above, and that there was a canal in tooth 31 that had been missed altogether. On July 29, 2014, Dr. Currie re-treated the root canal for tooth 31, refilled the two previously treated canals, and treated and filled the previously untreated canal in tooth 31. The evidence, though disputed, was nonetheless clear and convincing that Respondent failed to meet the standard of performance in the root canal procedures for Patient S.S.’s teeth 30 and 31, by failing to adequately diagnose and respond to the condition of the roots of tooth 30; failing to adequately fill the canals of tooth 30 despite being able to insert working-length files beyond the area of calcification to near the apices of the roots; and failing to adequately fill the canals of tooth 31 during root canal treatment. The Administrative Complaint also alleged that Respondent failed to adequately diagnose decay in tooth 30. The evidence was not clear and convincing that Respondent failed to adequately diagnose decay in tooth 30. Case No. 19-2900PL - The G.H. Administrative Complaint Case No. 19-2900PL charges Respondent with violating section 466.028(1)(x) by failing to adequately diagnose issues with the crown on tooth 13 and provide appropriate corrective treatment. On May 15, 2014, Patient G.H. presented to Respondent with a complaint that she had been feeling discomfort on the upper left of her teeth that was increasingly noticeable. Respondent diagnosed the need for a root canal of tooth 13. Patient G.H. agreed to the treatment, and Respondent performed the root canal at this same visit. Patient G.H. also had work done on other teeth to address “minor areas of decay.” On July 7, 2014, Patient G.H.’s permanent crowns were seated onto teeth 8, 9, and 13, and onlay/inlays placed on teeth 12 and 14. On July 29, 2014, Patient G.H. presented to Respondent. Respondent’s records indicate that Patient G.H. complained that when she flossed around tooth 13, she was getting “a funny taste” in her mouth. Patient G.H.’s written complaint and her testimony indicate that she also advised Respondent that her floss was “tearing,” and that she continued to experience “pressure and discomfort” or “some pain.” Respondent denied having been advised of either of those complaints. Respondent flossed the area of concern, and smelled the floss to see if it had a bad smell. Respondent denied smelling anything more than typical mouth odor, with which Patient G.H. vigorously disagreed. Respondent took a radiograph of teeth 11 through 15, which included tooth 13 and the crown. The evidence is persuasive that the radiograph image revealed that the margin between tooth 13 and the crown was open. An open margin can act as a trap for food particles, and significantly increases the risk for recurrent decay in the tooth. Respondent adjusted the crown on tooth 9, but advised Patient G.H. that there was nothing wrong with the crown on tooth 13. She offered to prescribe a rinse for the smell, but generally told Patient G.H. that there were no complications. Patient G.H. began to cry and, when Respondent left the room, got up from the chair and left the office. Respondent indicated in her testimony that she would have performed additional investigation had Patient G.H. not left. The contemporaneous records do not substantiate that testimony. Furthermore, Respondent did not contact Patient G.H. to discuss further treatment after having had a full opportunity to review the radiograph image. On March 10, 2015, after her newly-active dental insurance allowed her to see a different in-network provider, Patient G.H. sought a second opinion from Dr. Ada Y. Parra, a dentist at Premier Dental in Gainesville, Florida. Dr. Parra identified an open distal margin at tooth 13 with an overhang. Dr. Parra recommended that Patient G.H. return to Respondent’s practice before further work by Premier Dental. Patient G.H. called Respondent’s office for an appointment, and was scheduled to see Dr. Lindsay Kulczynski, who was practicing as a dentist in Respondent’s Lake City, Florida, office. Patient G.H. was seen by Dr. Kulczynski on March 19, 2015. Upon examination, Dr. Kulczynski agreed that the crown for tooth 13 “must be redone” due to, among other defects, “[d]istal lingual over hang [and] open margin.” The open margin was consistent with Patient G.H.’s earlier complaints of discomfort, floss tearing, and bad odor coming from that tooth. The evidence was persuasive that further treatment of Patient G.H. was not authorized by Respondent after the appointment with Dr. Kulczynski. Dr. Brotman credibly testified that the standard of care in crown placement allows for a space between the tooth and the crown of between 30 and 60 microns. Dr. Brotman was able to clearly identify the open margin on the radiograph taken during Patient G.H.’s July 29, 2014, appointment, and credibly testified that the space was closer to 3,000 microns than the 30 to 60 microns range acceptable under the standard of performance. His testimony is accepted. An open margin of this size is below the minimum standard of performance. The evidence was clear and convincing that Respondent fell below the applicable standard of performance in her treatment of Patient G.H., by seating a crown containing an open margin and by failing to perform appropriate corrective treatment after having sufficient evidence of the deficiencies. Case No. 19-2901PL - The J.D. Amended Administrative Complaint Case No. 19-2901PL charges Respondent with violating section 466.028(1)(x) by: Failing to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, extent of available bone support, and/or root locations; Failing to lift, or refer for lifting of, Patient J.D.’s sinus before placing an implant in the area of tooth 14; Failing to appropriately place the implant by attempting to place it into a curved root, which could not accommodate the implant; Failing to react appropriately to the sinking implant by trying to twist off the carrier instead of following the technique outlined in the implant’s manual; and/or Paying, or having paid on her behalf, an indemnity in the amount of $75,000 as a result of negligent conduct in her treatment of Patient J.D. Patient J.D. first presented to Respondent on June 28, 2014. At the time, Respondent was practicing with Dr. Jacobs, who owned the practice. Patient J.D. had been a patient of Dr. Jacobs for some time. Respondent examined Patient J.D. and discovered problems with tooth 14. Tooth 14 and tooth 15 appeared to have slid into the space occupied by a previously extracted tooth. As a result, tooth 14 was tipped and the root curved from moving into the space. Tooth 14 had been filled by Dr. Jacobs. However, by the time Respondent examined it, the tooth was not restorable, and exhibited 60 percent bone loss and class II (two millimeters of movement) mobility. Respondent discussed the issue with Patient J.D., and recommended extraction of the two teeth and replacement with a dental implant. Patient J.D. consented to the procedure and executed consent forms supplied and maintained by Dr. Jacobs. The teeth at issue were in the upper jaw. The upper jaw consists of softer bone than the lower jaw, is more vascular, and includes the floor of the nose and sinuses. The periapical radiographs taken of Patient J.D. showed that he had a “draped sinus,” described by Respondent as being where “the tooth is basically draped around the sinuses. It’s almost like they’re kind of one.” Prior to Patient J.D., Respondent had never placed an implant in a patient with a draped sinus. The x-rays also indicated that, as a result of the previous extraction of teeth and the subsequent movement of the remaining teeth, the roots of tooth 14 were tipped and curved. The evidence was persuasive that Respondent did not fail to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, the extent of available bone support, and the configuration of the roots. Dr. Kinzler testified credibly that the pneumatized/draped sinus, the 60 percent bone loss around tooth 14, and the tipped and curved roots each constituted pre- operative red flags. Respondent extracted teeth 14 and 15. When she extracted the teeth, she observed four walls. She was also able to directly observe the floor of the sinus. She estimated the depth of the socket to be 12 millimeters. Sinus penetration is a potential complication of implant placement. Being able to see the sinus floor was an additional complicating factor for implant placement. Dr. Kinzler credibly testified that if Respondent was going to place an implant of the size she chose (see below), then the standard of care required her to first do a sinus lift before placing the implant. A sinus lift involves physically lifting the floor of a patient’s sinus. Once the sinus has been lifted, material typically consisting of granulated cortical bone is placed into the space created. Eventually, the bone forms a platform for new bone to form, into which an implant can be inserted. The evidence established that the standard of care for bone replacement materials is to place the material into the space, close the incision, and allow natural bone to form and ultimately provide a stable structure to affix an implant. The implant may then be mechanically affixed to the bone, and then biologically osseointegrate with the bone. In order to seal off Patient J.D.’s sinus, Respondent used Bond Bone, which she described as a fast-setting putty-like material that is designed to protect the floor of the sinus and provide a scaffold for bone to grow into. She did not use cortical bone, described as “silly sand,” to fill the space and provide separation from the sinus because she indicated that it can displace and get lost. Respondent’s goal was to place the implant so that it would extend just short of the Bond Bone and Patient J.D.’s sinus. She also intended to angle the implant towards the palate, where there was more available bone. Bond Bone and similar materials are relatively recent innovations. Dr. Fish was encouraged by the possibilities of the use of such materials, though he was not familiar with the Bond Bone brand. The evidence was clear and convincing that, although Bond Bone can set in a short period, and shows promise as an effective medium, it does not currently meet minimum standards of performance for bone replacement necessary for placement and immediate support of an implant. Bond Bone only decreases the depth of the socket. It does not raise the floor of the sinus. As such, the standard practice would be to use a shorter implant, or perform a sinus lift. Respondent was provided with an implant supplied by Dr. Jacobs. She had not previously used the type of implant provided. The implant was a tapered screw vent, 4.7 millimeters in diameter, tapering to 4.1 millimeters at the tip with a length of 11.5 millimeters. Respondent met with and received information from the manufacturer’s representative. She used a 3.2 millimeter drill to shape the hole, as the socket was already large enough for the implant. The 3.2 millimeter drill was not evidence that the receiving socket was 3.2 millimeters in diameter. Respondent then inserted the implant and its carrier apparatus into the hole. The implant did not follow the root, and had little bone on which to affix. The initial post-placement periapical radiograph showed “placement was not correct.” Despite Respondent’s intent, the implant was not angled, but was nearly vertical, in contrast with the angulation of the socket which was tipped at least 30 degrees. Given the amount of bone loss, and the other risk factors described herein, the risk of a sinus perforation, either by having the implant extend through the root opening or by a lateral perforation through one of the sides of the socket, was substantial. After adjusting the implant, Respondent went to remove the carrier. The carrier would not release, and the pressure exerted caused the implant to loosen and begin to sink through the Bond Bone. Dr. Kinzler testified credibly that, because of the mechanics of the implant used, had it been surrounded by bone, it would not have been possible for the implant to become loose. In his opinion, which is credited, the loosening of the implant was the result of the lack of bone to hold it in place. Respondent was so intent on removing the carrier that she was not paying attention to the implant. As a result, she screwed the implant through the Bond Bone and into Patient J.D.’s sinus. By the time she realized her error, the implant had sunk in to the point it was not readily retrievable. She was hesitant to reaffix the carrier “because [she] knew [she] had no support from the bone, that it was just a matter of air.” Nonetheless, she “stuck the carrier back in, but it would not go back in.” She then turned to get forceps or a hemostat but, by that time, the implant was irretrievably into Patient J.D.’s sinus. At the hearing, Respondent testified that she could have retrieved the implant but for Patient J.D. doing a “negative pressure sneeze” when the implant was already into the sinus. At that point, she stated that the implant disappeared into Patient J.D.’s sinus, where it can be seen in Petitioner’s Exhibit 9, page 35. There is nothing in Respondent’s dental records about Patient J.D. having sneezed. Respondent further testified that Patient J.D. “was very jovial about it,” and that everyone in the office laughed about the situation, and joked about “the sneeze implant.” That the patient would be “jovial” about an implant having been screwed into his sinus, resulting in a referral to an oral surgeon, and that there was office-wide joking about the incident is simply not credible, particularly in light of the complete absence of any contemporaneous records of such a seemingly critical element of the incident. Respondent believed that the implant must have been defective for her to have experienced the problem with removing the carrier, though her testimony in that regard was entirely speculative. There is no competent, substantial, or persuasive evidence to support a finding that the implant was defective. After determining that the implant was in Patient J.D.’s sinus, Respondent informed Patient J.D. of the issue, gave him a referral to an oral surgeon, prescribed antibiotics, and gave Patient J.D. her cell phone number. Each of those acts was appropriate. On July 29, 2014, an oral surgeon surgically removed the implant from Patient J.D.’s sinus. Patient J.D. sued Respondent for medical malpractice. The suit was settled, with the outcome including a $75,000.00 indemnity paid by Respondent’s insurer on her behalf. The Office of Insurance Regulation’s Medical Malpractice Closed Claims Report provides that the suit’s allegations were based on “improper dental care and treatment.” The evidence was not clear and convincing that Respondent failed to meet the minimum standards of performance prior to the procedure at issue by failing to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, extent of available bone support, and/or root locations prior to the procedure. The evidence was clear and convincing that Respondent failed to meet the minimum standards of performance by failing to lift, or refer for lifting of, Patient J.D.’s sinus before placing the implant in the area of tooth 14, and by placing the implant into a curved root which could not accommodate the implant. The placement of Bond Bone was not adequate to address these issues. The evidence was clear and convincing that Respondent failed to meet the standard of care by failing to pay attention while trying to twist off the carrier and by failing to appropriately react to the sinking implant. The evidence was clear and convincing that Respondent paid, or had paid on her behalf, an indemnity of $75,000 for negligent conduct during treatment of Patient J.D. The perforation of Patient J.D.’s sinus was not, in itself, a violation of the standard of care. In that regard, Dr. Kinzler indicated that he had perforated a sinus while placing an implant. It was, however, the totality of the circumstances regarding the process of placing Patient J.D.’s implant that constituted a failure to meet the minimum standards of performance as described herein. Case No. 19-2902PL - The J.A.D. Amended Administrative Complaint Count I Case No. 19-2902PL, Count I, charges Respondent with violating section 466.028(1)(x) by: Failing to take adequate diagnostic imaging prior to placing an implant in the area of Patient J.A.D.’s tooth 8; Failing to pick an appropriately-sized implant and placing an implant that was too large; and/or Failing to diagnose and/or respond appropriately to the oral fistula that developed in the area of Patient J.A.D.’s tooth 8. Count II Case No. 19-2902PL, Count II, charges Respondent with violating section 466.028(1)(m) by: Failing to document examination results showing Patient J.A.D. had an infection; Failing to document the model or serial number of the implant she placed; and/or Failing to document the results of Respondent’s bone examination. Patient J.A.D. first presented to Respondent on March 3, 2016. His first appointment included a health history, full x-rays, and an examination. Patient J.A.D.’s complaint on March 3, 2016, involved a front tooth, tooth 8, which had broken off. He was embarrassed by its appearance, and desired immediate care and attention. Respondent performed an examination of Patient J.A.D., which included exposing a series of radiographs. Based on her examination, Respondent made the following relevant diagnoses in the clinical portion of her records: caries (decay) affecting tooth 7, gross caries affecting fractured tooth 8, and caries affecting tooth 9. Patient J.A.D. was missing quite a few of his back teeth. The consent form noted periodontal disease. The evidence is of Patient J.A.D.’s grossly deficient oral hygiene extending over a prolonged period. A consent form signed by Patient J.A.D. indicates that Patient J.A.D. had an “infection.” Respondent indicated that the term indicated both the extensive decay of Patient J.A.D.’s teeth, and a sac of pus that was discovered when tooth 8 was extracted. “Infection” is a broad term in the context of dentistry, and means any bacterial invasion of a tooth or system. The consent form was executed prior to the extraction. Therefore, the term “infection,” which may have accurately described the general condition of Patient J.A.D.’s mouth, could not have included the sac of pus, which was not discovered until the extraction. The sac of pus was not otherwise described with specificity in Respondent’s dental records. A pre-operative radiograph exposed by Respondent showed that tooth 8 had a long, tapering root. Respondent proposed extraction of tooth 8, to be replaced by an immediate implant. The two adjacent teeth were to be treated and crowned, and a temporary bridge placed across the three. Patient J.A.D. consented to this treatment plan. The treatment plan of extracting tooth 8 and preparing the adjacent teeth for crowns was appropriate. Respondent cleanly extracted tooth 8 without fracturing any surrounding bone, and without bone adhering to the tooth. When the tooth came out, it had a small unruptured sac of pus at its tip. Respondent irrigated and curretted the socket, and prescribed antibiotics. Her records indicated that she cleaned to 5 millimeters, although a radiograph made it appear to be a 7 millimeter pocket. She explained that inflammation caused the pocket to appear larger than its actual 5 millimeter size, which she characterized as a “pseudo pocket.” She recorded her activities. The response to the sac of pus was appropriate. Respondent reviewed the earlier radiographs, and performed a physical examination of the dimensions of the extracted tooth 8 to determine the size of the implant to be placed into the socket. Dr. Kinsler and Dr. Fish disagreed as to whether the radiographic images were sufficient to provide adequate information as to the implant to be used. Both relied on their professional background, both applied a reasonable minimum standard of performance, and both were credible. The evidence was not clear and convincing that Respondent failed to take adequate diagnostic imaging prior to placing an implant to replace Patient J.A.D.’s tooth 8. Respondent placed an implant into the socket left from tooth 8. The implant was in the buckle cortex, a “notoriously thin” bone feature at the anterior maxilla. The fact that it is thin does not make it pathological, and placement of an implant near a thin layer of bone is not a violation of the standard of performance as long as the implant is, in fact, in the bone. The implant used by Respondent was shorter than the length of tooth 8 and the tooth 8 socket, and did not have a full taper, being more truncated. The evidence of record, including the testimony of Dr. Kinzler, indicates that the length of the implant, though shorter than the tooth it was to replace, was not inappropriate. The evidence of record, including pre-extraction and post-implantation scaled radiographs offered as a demonstrative exhibit, was insufficient to support a finding that the implant diameter was too great for the available socket. Patient J.A.D. felt like the implant was too close to the front of his maxillary bone because it felt like a little bump on the front of his gums. That perception is insufficient to support a finding that the placement of the implant violated a standard of performance. Subsequent x-rays indicated that there was bone surrounding the implant. Clinical observations by Respondent after placement of the implant noted bone on all four walls of the implant. Her testimony is credited. The evidence that the tooth 8 implant was not placed in bone, i.e., that at the time the implant was placed, the implant penetrated the buccal plate and was not supported by bone on all four sides, was not clear and convincing. Respondent’s records document the dimensions and manufacturer of the implant. Implants are delivered with a sticker containing all of the relevant information, including model and serial number, that are routinely affixed to a patient’s dental records. It is important to document the model and serial number of implants. Every implant is different, and having that information can be vital in the case of a recall. Patient J.A.D.’s printed dental records received by the Department from Respondent have the implant size (5.1 x 13 mm) and manufacturer (Implant Direct) noted. The records introduced in evidence by the Department include a page with a sticker affixed, identified by a handwritten notation as being for a “5.1 x 13mm - Implant Direct.” (Pet. Ex. 11, pg. 43 of 83). The accompanying sticker includes information consistent with that required. Dr. Fish testified to seeing a sticker that appears to be the same sticker (“The implant label of 141, it just has the handwritten on there that it should be added.”), though it is described with a deposition exhibit number (page 141 of a CD) that is different from the hearing exhibit number. Dr. Fish indicated the sticker adequately documented the implant information. The evidence was not clear and convincing that the sticker was not in Patient J.A.D.’s records, or that Respondent failed to document the model or serial number of the implant she placed. Later in the day on March 3, 2016, Patient J.A.D. was fitted for a temporary crown, which was placed on the implant and the adjacent two teeth, and Patient J.A.D. was scheduled for a post-operative check. Patient J.A.D. appeared for his post-operative visit on March 10, 2016. He testified that he was having difficulty keeping the temporaries on, and was getting “cut up” because the two outer teeth were sharp and rubbed against his lip and tongue. Respondent noticed that Patient J.A.D. was already wearing a hole in the temporary. Since Patient J.A.D. was missing quite a few of his back teeth, much of his chewing was being done using his front teeth. His temporaries were adjusted and reseated. On March 17, 2016, Patient J.A.D. was seen by Respondent for a post-operative check of the tooth 8 extraction and implant placement. The notes indicated that Patient J.A.D. had broken his arm several days earlier, though the significance of that fact was not explained. He was charted as doing well, and using Fixodent to maintain the temporary in place. The records again noted that Patient J.A.D. had worn a hole in the back of the tooth 9 temporary crown. A follow up was scheduled for final impressions for the permanent crowns. On March 10 and March 17, 2016, Patient J.A.D. complained of a large blister or “zit” that formed over the area above the end of the implant. Patient J.A.D. had no recollection of whether Respondent told him he had an infection. He was prescribed antibiotics. The evidence was not clear and convincing that the “zit” was causally related to the placement of the implant. Patient J.A.D. also testified that the skin above tooth 9 was discolored, and he thought he could almost see metal through the skin above his front teeth. Patient J.A.D. next appeared at Respondent’s office on June 2, 2016, for final impressions. Respondent concluded that the site had not healed enough for the final impression. She made and cemented a new temporary, and set an appointment for the following month for the final impression. Patient J.A.D. did not return to Respondent. On September 28, 2016, Patient J.A.D. presented to the office of Dr. Harold R. Arthur for further treatment. The records for that date indicate that he appeared without his temporary restoration for teeth 7 through 9, stating that he had several at home, but they would not stay on. Dr. Arthur probed a “[s]mall (1.0 x 1.0 mm) red spot in facial keratinized gingiva communicating with implant.” After probing the opening in the gingiva and the “shadow” in the gingiva, he believed it was at the center of the implant body and healing screw. Dr. Arthur’s dental records for Patient J.A.D. over the course of the following year indicate that Dr. Arthur made, remade, and re-cemented temporary crowns for teeth 7, 8, and 9 on a number of occasions, noting at least once that Patient J.A.D. “broke temps” that had been prepared and seated by Dr. Arthur. On December 1, 2016, Patient J.A.D. was reevaluated by Dr. Arthur. He noted the facial soft tissue at the implant was red, with an apparent fistula. A periapical radiograph was “unremarkable.” The temporary crowns, which were loose, were removed, air abraded to remove the cement, and re-cemented in place. Patient J.A.D. was prescribed an antibiotic. He was again seen by Dr. Arthur on December 13, 2016. The temporary on tooth 9 was broken, which was then remade and re-cemented. The fistula was smaller but still present. Patient J.A.D. was seen by Dr. Arthur on February 2, 2017, with the tooth 9 temporary crown fractured again. The fistula was still present. Patient J.A.D. advised that “the bone feels like it’s caving in around where she put that implant.” That statement is accepted not for the truth of the matter asserted, but as evidence that the complaint was first voiced in February 2017. On April 4, 2017, more than a year after the placement of the implant, Patient J.A.D was seen by Dr. Arthur. Dr. Arthur determined that the implant for tooth 8 was “stable and restorable in current position.” The fistula was still present and, after anesthesia, a probe was placed in the fistula where it contacted the implant cover screw. Although Dr. Arthur replaced the implant abutment, he ultimately placed the final crown on the implant placed by Respondent, where it remained at the time of the final hearing. The fact that incidents of Patient J.A.D. breaking and loosening the temporary crowns that occurred with Respondent continued with Dr. Arthur supports a finding that the problems were, more likely than not, the result of stress and overuse of Patient J.A.D.’s front teeth. On October 24, 2016, a series of CBCT radiographs was taken of the implant and its proximity to tooth 7. Dr. Kinzler testified that, in his opinion, the implant was of an appropriate length, but was too large for the socket. Much of his testimony was based on the October 24 radiograph and his examination of the resulting October 29, 2016, report. Although the report indicated that there was minimal bone between the implant and the root of tooth 7, and that the buccal cortex appeared thinned or eroded, those observations are of limited persuasive value as to whether the standard of performance was met almost eight months prior. Patient J.A.D. obviously worked, and overworked, his dental appliances. Without more, the evidence is not clear and convincing that his subsequent and repeated problems, including “thinned or eroded” bone in the buccal cortex, were the result of a violation of the standard of performance in the sizing and placement of the tooth 8 implant by Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Dentistry, enter a Final Order: Dismissing the Administrative Complaint in Case No. 19-2898PL and the Amended Administrative Complaint in Case No. 19-2902PL; With regard to Case No. 19-2899PL: 1) dismissing Count I of the Administrative Complaint; 2) determining that Respondent failed to comply with the applicable standard of performance in the care and treatment of Patient S.S. by: failing to adequately diagnose the condition of the roots of tooth 30; failing to adequately obturate the canals of tooth 30 during root canal treatment; failing to adequately obturate the canals of tooth 31 during root canal treatment; failing to take a new crown impression of tooth 31 following changes to the tooth’s margins; and failing to adequately assess and correct the crown on tooth 31 when the fit was compromised, as alleged in Count II of the Administrative Complaint; and 3) determining that Respondent did not fail to comply with the applicable standard of performance in the care and treatment of Patient S.S. by failing to adequately diagnose decay in tooth 30, as alleged in Count II of the Administrative Complaint; With regard to Case No. 19-2900PL, determining that Respondent failed to comply with the applicable standard of performance in the care and treatment of Patient G.H. by seating a crown containing an open margin on tooth 13 and failing to adequately diagnose issues with the crown on tooth 13, and by failing to perform appropriate corrective treatment after having sufficient evidence of the deficiencies, as alleged in the Administrative Complaint; With regard to Case No. 19-2901PL: 1) determining that Respondent failed to comply with the applicable standard of performance in the care and treatment of Patient J.D. by: failing to lift, or refer for lifting of, Patient J.D.’s sinus before placing an implant in the area of tooth 14; failing to appropriately place the implant by attempting to place it into a curved root which could not accommodate the implant; failing to react appropriately to the sinking implant by trying to twist off the carrier instead of following the technique outlined in the implant’s manual; and paying, or having paid on her behalf, an indemnity in the amount of $75,000 as a result of negligent conduct in her treatment of Patient J.D., as alleged in the Amended Administrative Complaint; and 2) determining that Respondent did not fail to comply with the applicable standard of performance in the care and treatment of Patient J.D. by failing to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, extent of available bone support, and/or root locations; Suspending Respondent’s license in accordance with rule 64B5-13.005(1)(x) and rule 64B5-13.005(3)(e), to be followed by a period of probation, with appropriate terms of probation to include remedial education in addition to such other terms that the Board believes necessary to ensure Respondent’s practical ability to perform dentistry as authorized by rule 64B5- 13.005(3)(d)2.; Imposing an administrative fine of $10,000; and Requiring reimbursement of costs. DONE AND ENTERED this 31st day of January, 2020, in Tallahassee, Leon County, Florida. S E. GARY EARLY 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 31st day of January, 2020. COPIES FURNISHED: George Kellen Brew, Esquire Law Office of George K. Brew Suite 1804 6817 Southpoint Parkway Jacksonville, Florida 32216 (eServed) Kelly Fox, Esquire Department of Health 2585 Merchant’s Row Tallahassee, Florida 32311 (eServed) Octavio Simoes-Ponce, Esquire Prosecution Services Unit Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed) Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed) Jennifer Wenhold, Interim Executive Director Board of Dentistry Department of Health Bin C-08 4052 Bald Cypress Way Tallahassee, Florida 32399-3258 (eServed) Louise Wilhite-St. Laurent, General Counsel Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed)
The Issue Whether or not Respondent failed to assure that a management staff person completed a required food service management training course and used proscribed bed side rails in an adult congregate living facility in violation of Section 400.419(3)(c), Florida Statutes.
Findings Of Fact At times material hereto, Respondent has been licensed to operate an adult congregate living facility (ACLF) pursuant to Chapter 400, Part II, Florida Statutes and Chapter 10A-5, Florida Administrative Code. On May 18, 1987, Diane Cruz, a representative of Petitioner, conducted an inspection of Respondent's facility. Ms. Cruz cited Respondent for failure to complete a food service management training course and the deficiency was memorialized in a written report of deficiencies received by Respondent on June 22, 1987. The survey report established a correction deadline of July 18, 1987. On January 7, 1988, Tammy Smith, also a representative of Petitioner, conducted an inspection of Respondent's facility which inspection revealed that neither Respondent nor any other staff member or designated management person had completed a food service management training course. Respondent completed a food service management training course on January 27, 1988, or approximately eight months after the correction deadline set forth by Petitioner in its May 18, 1987, inspection. Respondent did not request an extension of time to complete the requirement that a food service management training course be completed by a management employee. During Ms. Smith's inspection of Respondent's ACLF on January 8, 1988, Smith observed both full and three-quarter side bed rails being used in the facility. This deficiency was discussed with Respondent and was noted in Smith's written inspection survey report which was received by Respondent on February 2, 1988. Immediate correction of the deficiency was required and was noted on the survey report. On February 25, 1988, Sharon McCray, Petitioner's investigator, conducted a routine follow up inspection of Respondent's facility. Ms. McCray's inspection revealed that a full bed rail was still in use on one of the beds and that a three-quarter bed rail was in the facility. During the hearing, Respondent maintains that she was confused regarding the type of bed rail which is permitted in a ACLF and the circumstances under which a bed rail is permissible. Petitioner presented several survey reports and each report contains an invitation to contact the surveyor in the event that Respondent or a health care provider had any question regarding any citations noted on the survey reports. Respondent never requested clarification of the noted deficiencies on any of the deficiencies for which she was cited in the survey reports. Also, Petitioner admits that she both obtained and read the pertinent rules and statutes relative to operation of ACLFs prior to submitting her application for licensure in 1986. Respondent admits that the bed rails were in the facility at both the January and February, 1988 inspections by Petitioner. During the hearing, Patrick Hagen testified that the bed with the full size rails was donated by a local health agency and that it was not in use in the ACLF. Additionally, Respondent introduced a copy of a physician's order for a bed rail for one resident dated June 19, 1987. Mr. Hagen immediately took the rails off the bed with the full rails on it however they continued to use the second bed with the three-quarter (approximate 30 inches long)1 rail.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: Petitioner enter a Final Order imposing an administrative fine against Respondent in the amount of $500.00 payable to Petitioner within thirty days of entry of its Final Order. DONE and ENTERED this 6th day of July, 1990, in Tallahassee, Leon County, Florida. JAMES E. BRADWELL 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 6th day of July, 1990. Copies furnished to: Edward A. Haman, Esquire Department of Health and Rehabilitative Services 7827 North Dale Mabry Highway Tampa, Florida 33614 Amelia M. Park, Esquire 11311 North Armenia Avenue Tampa, Florida 33612 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Petitioner Hans Steiner is the owner and operator of Am-Swiss Coffee Shop, which is located in the lobby of an office building in Miami, Florida. There are no bathrooms on the lobby floor of that office building. The nearest bathrooms to the coffee shop are located on the second floor of the office building, and the bathroom facilities in that building are kept locked. Petitioner has placed signs within the coffee shop indicating the location of the bathrooms and the manner in which the keys will be issued. Petitioner's coffee shop has access from the street and, therefore, can be open even when the offices in that building are closed. Petitioner's patrons include employees and visitors from that office building, from the office building next door, and the public. Petitioner's coffee shop is not incidental to another occupancy. A patron wishing to use the toilet facilities while at the coffee shop would first obtain a key and would then exit the restaurant establishment, travel down a hallway approximately 20 feet, take an elevator to the second floor, and then travel approximately another 20 feet to where the bathroom facilities are located. Petitioner holds a license as a take-out facility but has been refused an eat-in license due to the location of the toilet facilities. The management of the office buildings is responsible for maintaining and cleaning the bathrooms, not Petitioner. Rule 10D-9.028 is incorporated into Rule 10D-7 13.027(5), Florida Administrative Code. Footnote No. 10 of Rule 10D-9.028(21)(o) requires an eating establishment to have toilet facilities on the same floor as that establishment. The relevant portion provides as follows: All toilet rooms shall be of easy and convenient access to both patrons and employees, and shall be located on the same floor of the premises served and under the responsible direction of the management of the premises served. Rule 10D-9.028 became effective on January 1, 1977, and was most recently amended in 1981. The substance of the rule was contained in former rule 10D-9.08 which was amended in 1976. Toilet facilities have been required to be located on the same floor as the eating establishment since at least 1976. Patrons of eating establishments may need to use the restroom while at the establishment. Some patrons such as the elderly, infirm, handicapped, pregnant women, and small children may have greater need of restroom facilities. They may have more difficulty finding the toilet facilities and may experience bladder or bowel failure in the eating establishment if the facilities are not accessible. Patrons of eating establishments may become ill at the establishment and need to vomit. Some types of food poison or food allergy cause persons to vomit within a few moments from ingesting that food. If facilities are not immediately accessible, patrons may vomit in the eating establishment. The presence of vomit, urine, or feces in an eating establishment creates a health hazard. It is more difficult for patrons to locate a restroom which is on a different floor from the eating establishment than one which is on the same floor. Washing of hands is the single most important step that can be taken to prevent the spread of bacteria in the food service context. It breaks the fecal-oral chain by preventing germs on hands from being ingested through the mouth. Readily-accessible handwashing facilities for both employees and patrons are important to the prevention of the spread of disease-causing bacteria. There are sound health reasons for requiring toilet facilities to be on the same floor as the eating establishment. In addition to all of the health reasons, it is more convenient for patrons to have restrooms on the same floor as the floor on which the eating establishment is located.
The Issue The issues in this case are whether Respondent, a dentist, failed to maintain adequate records regarding his treatment of patient M.C. and/or provided M.C. dental care, including root canal therapy, that fell below minimum standards of performance, as Petitioner alleges; if so, whether (and what) disciplinary action should be taken as a result.
Findings Of Fact Introduction At all times relevant to this case, Respondent Steven Courten, D.D.S., was licensed to practice dentistry in the state of Florida. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed dentists such as Dr. Courten. In particular, the Department is authorized to file and prosecute an administrative complaint against a dentist, as it has done in this instance, when a panel of the Board of Dentistry has found that probable cause exists to suspect that the dentist has committed a disciplinable offense. Here, the Department alleges that Dr. Courten committed two such offenses. In Count I of the Complaint, the Department charged Dr. Courten with the offense defined in section 466.028(1)(m), alleging that he failed to keep written dental records justifying the course of treatment of a patient named M.C. In Count II, Dr. Courten was charged with incompetence or negligence—again vis-à-vis M.C.—allegedly by failing to meet the minimum standards of performance in diagnosis and treatment when measured against generally prevailing peer performance, an offense under section 466.028(1)(x). The Material Historical Facts M.C. and Respondent have known each other personally since the 1960s, when they attending grade school together. In 1992, Respondent began providing dental services to M.C. Respondent performed dental services for M.C. during two time periods, from 1992-1995 and again from 2001-2009. The Complaint specifically limits the allegations against Respondent to the care and treatment provided to M.C. from April 30, 2005 through 2009. Respondent treated M.C. under a financial arrangement whereby Respondent would receive payment from M.C.'s dental insurance, when such coverage was available. Although M.C. had a co-pay obligation that varied over the years, Respondent would forgive the same. The primary, but uncharged, event giving rise to this case occurred on November 15, 2009. On that occasion, M.C. presented to Respondent and a dispute arose over tooth number 2, which was no longer in M.C.'s mouth and was composed of 18 karat gold. Respondent proposed a course of treatment to include re- cementing the same. M.C. expressed his desire to simply take possession of the tooth and Respondent refused. Thereafter, M.C. submitted a handwritten, unsigned complaint to the Department of Health alleging that Respondent was practicing dentistry out of his home, in unsanitary conditions, and in a manner that was below the standard of care. As part of the subsequent investigation, on or about January 21, 2010, a subpoena with an accompanying certificate of completeness of records was served on Respondent. In response, Respondent provided the Department with M.C.'s records and the executed certificate of completeness on or about February 8, 2010. A dispute exists between the parties regarding whether Respondent, in response to the subpoena and as attested by Respondent in the certificate of completeness, provided to the Department all of the records comprising M.C.'s chart. Respondent was not charged, however, with failing to make available to the Department copies of documents in the possession of Respondent which related to M.C., a separate disciplinable offense pursuant to section 466.028(1)(n). Therefore, he is not subject to discipline in this case for any shortcoming concerning said dispute. The Charges A thorough dissection of the instant Complaint is a required exercise in this case. Paragraph 5 provides that, "[t]he Respondent's continuing care from April 30, 2005 onward is the subject of this Amended Administrative Complaint." Consistent with that limitation, Paragraphs 6 through 9 allege that Respondent performed root canals and crownwork on October 15, 2005; January 15, 2009; and February 20, 2009, concerning teeth numbers 5, 7, and 20, respectively. Paragraph 20 alleges that Respondent did not use a rubber dam for isolation during the root canal treatments of teeth numbers 5, 7, and/or 20. Paragraph 24 alleges that Respondent did not obtain sufficient radiographs for evaluation of the root canal treatments of teeth numbers 5, 7, or 20. Paragraph 11 is interpreted by the undersigned as an attempt to allege that Respondent did not document radiographs or radiographic results in the written treatment record concerning teeth numbers 2 and 10 on the visit of November 15, 2009. The balance of the factual allegations contained within the Complaint under the headings of "Medical History," "Radiograph Sufficiency and Margin Evaluation," "Radiographic Examination Documentation," "Periodontal and Soft Tissue Care," and "Statements in the Alternative" fail to refer to a specific treatment, examination, date, or tooth. The undersigned has interpreted said allegations to apply exclusively to the course of treatment contained within the time limitation consistent with paragraph 5. As noted above, the charges against Respondent are set forth in the Complaint under two counts. In Count I, the Department accused Respondent of failing to keep adequate dental records, an offense disciplinable pursuant to section 466.028(1)(m). The Department alleged that, in the course of treating M.C., Respondent violated the recordkeeping requirements in six particulars, which are identified in paragraph 47, subparagraphs a) through f) of the Complaint. In Count II, the Department charged Respondent with dental malpractice, which is punishable under section 466.028(1)(x). Seven particulars of alleged incompetence or negligence in the treatment of M.C. are set forth in paragraph 51, subparagraphs a) through g). Several of the allegations in paragraphs 47 and 51 are parallel to one another, so that, when aligned side-by-side, they can be examined in logical pairs. Generally speaking, the Department's theory in relation to each allegation-pair can be expressed as follows: Where the circumstances required that the dental act "X" be done for M.C. to meet the minimum standards of performance as measured against generally prevailing peer performance, Respondent failed to do X, thereby violating the standard of care. Respondent also failed to record doing X in the patient's record, thereby violating the recordkeeping requirements. The parallel propositions comprising each allegation- pair are mutually exclusive. For example, if Respondent did not, in fact, do X, then he might be found to have violated the standard of care, if the Department were successful in proving, additionally, that, under the circumstances, X was required to be done to meet the minimum standards of performance. If Respondent did not do X, however, he obviously could not be disciplined for not recording in M.C.'s chart that he actually performed X. (If a dentist were to write in a patient's chart that he performed X when in fact he had not performed X, he would be making a false record; that would be a recordkeeping violation, but it is not the sort of misconduct with which the Department has charged Respondent.) Conversely, if Respondent in fact did X and failed to note in M.C.'s chart having done X, then—if the law required Respondent to document the performance of X—he would be guilty of a recordkeeping violation. The specific charges against Respondent are reproduced in the table below, which places the corresponding allegation- pairs side-by-side in separate rows. For ease of presentation, the undersigned has reordered the allegations to some extent. An empty cell denotes the absence of a corresponding allegation. The Department charges Respondent as follows: Count II, ¶ 51: Alleged Standard-of-Care Violations Count I, ¶ 47: Alleged Recordkeeping Violations 1 a) [F]ail[ing] to perform a comprehensive periodontal examination b) Respondent's notes do not include a comprehensive periodontal examination 2 b) [F]ail[ing] to perform sufficient, if any, soft tissue examination c) Respondent's notes do not include the results of a soft tissue examination 3 c) [F]ail[ing] to provide for, adequately document, and/or receive, informed consent for the multiple root canal treatments provided to Patient M.C. 4 d) [F]ail[ing] to use a rubber dam and/or provide adequate justification for not using a rubber dam 5 e) [F]ail[ing] to properly evaluate the obturation of his root canal treatments on one or more occasions 6 f) [F]ail[ing] to properly evaluate the margins of his crown placements 7 g) [F]ail[ing] to take adequate diagnostic comprehensive radiographs necessary to properly diagnose, treatment plan and/or perform the necessary treatments. treatment that was performed [F]ail[ing] to maintain labels or mounting for the radiographic records; [F]ail[ing] to document findings, interpretations, or diagnostic results of his radiographic examinations; [F]ail[ing] to take or maintain adequate diagnostic comprehensive radiographs necessary to justify the 8 a) Respondent's notes do not include an appropriate medical history Radiographs The Department presented the testimony of Thomas Shields, D.D.S., on issues relating to the standard of care and record keeping. Dr. Shields was shown to have formulated his opinions based upon the review of information provided him by the Department. Included within the Department's information was an envelope that contained 51 individual radiographs. The radiographs appeared to be originals that were not mounted, labeled, or dated. As a result, it was not possible for Dr. Shields to follow the treatment sequence provided by Respondent to M.C. Dr. Shields, in turn, opined that Respondent failed to meet the minimum standards for the profession of dentistry because 1) he could not discern evidence of full mouth radiographs; and 2) he could not discern that the radiographs were sufficient to adequately treat M.C. He further opined, based upon the loose radiographs received, that Respondent failed to meet standards for record-keeping because, although there are many radiographs, same are not described in the records. A pivotal dispute exists, however, concerning whether the radiographs used for the diagnosis and treatment of M.C., and the cardboard mounts in which they were originally placed, were provided by Respondent and/or received by the Department. Respondent credibly maintains that the subject radiographs were submitted to the Department on four cardboard mounts that included the dates of exposure, as well as minimal descriptions. Respondent further credibly avers that when the same were returned to him, after having been copied by a third- party copying service utilized by the Department, the mounts were absent and the order and sequencing of the radiographs were altered. The evidence presented with regard to the standard of care violations contained in paragraphs 51(e) and (g) and the record-keeping violations contained in paragraphs 47(d), (e), and (f) does not clearly and convincingly demonstrate that Respondent failed to 1) take radiographs to properly evaluate the obturation of M.C.'s root canal treatments; or 2) take adequate diagnostic comprehensive radiographs necessary to properly diagnose, treatment plan and/or perform the necessary treatments. The evidence further fails to prove clearly and convincingly that Respondent failed to 1) maintain labels or mounting for the radiographic records; 2) document findings, interpretations, or diagnostic results of his radiographic examinations; or 3) take or maintain adequate diagnostic comprehensive radiographs necessary to justify the treatment that was performed. Respondent is, therefore, not guilty of the charges as alleged in paragraphs 51(e) and (g) or paragraphs 47(d), (e), and (f). Comprehensive periodontal examination Dr. Shields, from review of the available records, opined that Respondent failed to perform a proper periodontal examination. The basis for this opinion is, again, exclusively premised upon the lack of documentation contained in M.C.'s medical chart. The evidence does not clearly and convincingly establish any minimum standards of performance that Respondent failed to meet, under the facts of this case, in examining or addressing M.C.'s periodontal condition. As a result, Respondent is not guilty of the standard-of-care violation alleged in paragraph 51(a). The evidence does, however, clearly and convincingly establish that Respondent failed to maintain the results of any such periodontal examination, and, therefore, Respondent is guilty of the record-keeping violation as set forth in paragraph 47(b). Soft tissue/oral pathology Dr. Shields, from review of the available records, opined that there was no evidence that Respondent performed a soft tissue or oral cancer examination. The basis for this opinion is, again, exclusively premised upon the lack of documentation contained in M.C.'s medical chart. The evidence does not clearly and convincingly establish any minimum standards of performance that Respondent failed to meet, under the facts of this case, in examining M.C. As a result, Respondent is not guilty of the standard-of-care violation alleged in paragraph 51(b). The evidence does, however, clearly and convincingly establish that Respondent failed to maintain the results of a soft tissue analysis and cancer screening. Indeed, Respondent conceded that while he performed a soft tissue analysis and conducted an oral cancer screening, he did not chart the results because there were no findings.3/ Accordingly, Respondent is guilty of the record-keeping violation as set forth in paragraph 47(c). Informed consent With regard to paragraph 51(c), the evidence is insufficient to prove clearly and convincingly that Respondent failed to provide for, adequately document, and/or receive, informed consent for the multiple root canal treatments provided to M.C. The patient, whose testimony was often disjointed, conceded that he was adequately informed of the root canal treatments: Q. Did Dr. Courten always explain what he was going to do and the procedure prior to the work with you? Did he sit down and explain to you what your problem was and how to correct it? * * * A. I understand. The way things went it wasn't an issue of what he was going to do as to how much time we had to do it. Are you comfortable with this? You know, these are our options, you know, for this one. The undersigned finds that Respondent provided sufficient informed consent to M.C. regarding the treatment provided. For that reason alone, Respondent is not guilty of this alleged standard-of-care violation. Further, the failure to obtain informed consent is a disciplinable offense under section 466.028(1)(o) and thus is not punishable under section 466.028(1)(x), which states the offense Respondent has been accused of committing. For this additional and independent reason, Respondent cannot be found guilty of the standard-of- care violation alleged in paragraph 51(c). Rubber dam utilization Dr. Shield opined that Respondent failed to meet the minimum standard of dental care in Respondent's failure to use a rubber dam when performing root canals on M.C. As Dr. Shield testified, a rubber dam has three functions: 1) to prevent any objects from entering the airway or being aspirated or swallowed; 2) to protect the tissue surrounding the subject tooth from the adverse materials used such as hypochlorite; and 3) to keep the operating field as sterile as possible. Dr. Shield testified that the utilization of a rubber dam is the minimal standard of care. Respondent conceded that a rubber dam is mandatory, is within the standard of care, and to be used whenever possible. Respondent testified, however, that in four or five instances he did not use a rubber dam, because in those particular instances, it was contra-indicated. He further testified that he used a rubber dam "probably, only, maybe two times, possibly, in the ten or so root canals because there were situations where the root was too small or the decay was too far sub-gingival." In the balance of occasions, Respondent employed an alternate aseptic protocol, called Isolite. Respondent's alternate aseptic protocol caveat to the standard of care—utilizing a rubber dam—is rejected and Dr. Shield's opinion is accepted. With regard to the standard-of-care allegation set forth in paragraph 51(d), the evidence is sufficient that Petitioner proved by clear and convincing evidence that Respondent failed to meet the minimum standard of dental care in failing to use a rubber dam when performing root canals on M.C. Appropriate medical history The Complaint alleges, in paragraph 47 (a), that Respondent's notes do not include an appropriate medical history. In support of this allegation, Petitioner avers that although a medical history was partially obtained in August 20, 1992 (outside the time limitation established by the Complaint), Respondent never updated the medical history. While a review of the chart reveals a limited initial medical history, from the perspective of the undersigned, the same is insufficient to establish a finding that it was not an "appropriate medical history." This conclusion is buttressed by the fact that no evidence was submitted, outside of the chart itself, to support Petitioner's position that it was inappropriate. Thus, Petitioner has not established by clear and convincing evidence the record keeping violation as stated in paragraph 47(a).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Dentistry enter a final order finding Respondent guilty of the record-keeping violations alleged in paragraphs 47(b) and (c) of the Complaint (failure to record periodontal, soft tissue, and oral pathology examinations) and the standard-of-care violation alleged in paragraph 51(d) of the Complaint (failure to utilize a rubber dam); finding Respondent not guilty of the remaining violations; and imposing the following penalties: issuance of a letter of concern; remedial education reasonably related to the topics of recordkeeping, endodontics, and ethics; and a fine of $2500.00. DONE AND ENTERED this 26th day of March, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE 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 26th day of March, 2013.
The Issue Whether Respondent committed the violations alleged in the Administrative Complaint. If so, what punitive action should be taken against him.
Findings Of Fact Based upon the evidence adduced at hearing and the record as a whole, the following findings of fact are made: Petitioner is a state government licensing and regulatory agency. Respondent is now, and has been since August 8, 1975, licensed to practice medicine in the State of Florida. He holds license number ME 0025748. Respondent specializes in urology. L. H. is a former patient of Respondent's. She first presented to Respondent on June 20, 1994, complaining of recurring urinary tract infections. At the time, she was 65 years of age. L. H. had very few symptoms. She did tell Respondent, however, that she had had a fever associated with an infection about a month prior to the visit. Respondent conducted a physical examination of L. H.. He found no abnormalities other than a tight or stenotic urethra. A catherized urine specimen was taken from L. H. Laboratory testing revealed a white blood cell count of 20 to 25, with 3 plus bacteria, and the presence E-coli. These results were indicative of an infection in the area of the bladder. The ordinary medical response to such an infection is treatment with an antibiotic. L. H. was already being treated with an antibiotic (Cipro) that had been prescribed by the physician who had referred her to Respondent. Respondent prescribed additional antibiotic treatment for L. H. In addition, an intravenous pyelogram (IVP) was scheduled and performed. The results of the IVP were normal. Respondent next saw L. H. on July 18, 1994, for a scheduled cystoscopy. (She had a previous appointment for a cystoscopy which she had cancelled.) Another urinalysis was performed during L. H.'s July 18, 1994, visit. It revealed that she had "persistent white blood cells," with a trace of bacteria. Accordingly, during the visit, L. H. was given a strong antibiotic Gentamicin, which was administered intramuscularly prior to the cystoscopy. L. H. was also administered a local anesthetic, Xylocaine, prior to the cystoscopy. A cystoscopy is a visual examination of the bladder (performed by the examining physician) using an endoscopic device known as a cystoscope, which is placed in the bladder through the urethra. Cystoscopes are either rigid or flexible. A rigid cystoscope's magnification is twice that of a flexible cystoscope. Moreover, a rigid cystoscope provides more illumination than a flexible cystoscope. A flexible cystoscope, however, causes less patient discomfort, particularly in male patients, than does a rigid cystoscope. Respondent (who has performed thousands of cystoscopies and has seen many different types of lesions in the bladder in the years he has practiced medicine) used a rigid cystoscope (with glass fibers) to examine L. H. Upon looking in L. H.'s bladder with the cystoscope, he observed multiple lesions (ten to twelve in number). The largest of the lesions present in L. H.'s bladder was considerably larger and different in appearance than the others. It was approximately three centimeters in diameter, cauliflower-shaped, and blister-like. Respondent told L. H. during the cystoscopy that he was not sure what the lesions were and that he needed to biopsy them to learn more about them. He sought L. H.'s consent to perform such a biopsy procedure during her office visit that day. Such a biopsy procedure would have cost an additional $100.00 and could have been quickly performed by Respondent, who routinely performs such procedures in his office on a daily basis. Upon being told by Respondent that she had lesions in her bladder, L. H. became very emotional. She advised Respondent that she did not want him to perform the biopsy procedure that day. After the completion of the cystoscopy, L. H. got up from the examining table and got dressed. Her husband then entered the examining room. Respondent told L. H.'s husband (in L. H.'s presence) that the cystoscopy had revealed multiple lesions or tumors in L. H.'s bladder, but that the lesions were most likely benign, inflammatory growths (perhaps indicative of an abnormal connection between the bladder and large intestine) and not cancerous. He cautioned, however, that he needed to biopsy the lesions to make sure that they were not cancerous.2 After conferring with L. H. and her husband, Respondent scheduled L. H. for a follow-up biopsy (to be performed with a resectoscope) for July 28, 1994. He also prescribed a continuing course of treatment with antibiotics for L. H. L. H. and her husband then left Respondent's office. She never returned as a patient. Respondent maintained written records regarding his care and treatment of L. H. These records contain sufficient information to enable a neutral third party to ascertain the nature of, and justification for, the treatment he rendered. Following her July 18, 1994, visit to Respondent's office, L. H. spoke about the visit with her son-in-law, who is a urologist. L. H.'s son-in-law recommended that L. H. see another urologist, Peter J. Egerton, M.D., to obtain a second opinion. L. H. presented to Dr. Egerton on July 20, 1994. Dr. Egerton performed a cystoscopy using a flexible cystoscope to examine L. H. He found no evidence of lesions in L. H.'s bladder and so advised L. H. Dr. Egerton's written report of his examination of L. H. reads as follows: PROCEDURAL NOTE [L. H.] July 20, 1994 PREOPERATIVE DIAGNOSIS: Rule out bladder tumor. POST OPERATIVE DIAGNOSIS: No bladder tumor. PROCEDURE: Flexible cystoscopy Surgeon: Peter J. Egerton, M.D. Assistant: Gloria Gose, R.N. ANESTHESIA: Local Xylocaine CONDITION: Stable PROCEDURE: The patient was brought to the cysto suite and placed in the foreleg position. She was prepped and draped in the usual manner. A #16 french flexible scope was passed into the bladder. There were no obvious tumors, stones or masses seen and there was clear efflux. The bladder was then reexamined, and no 3cm lesion could be found as described. The scope was removed and the patient tolerated the procedure well and left the cysto suite in satisfactory condition. After her visit to Dr. Egerton's office, L. H. again spoke with her son-in-law, who suggested that L. H. go see yet another urologist, Thomas Suits, M.D., for a third opinion. L. H. presented to Dr. Suits on July 21, 1994. Dr. Suits performed a cystoscopy during L. H.'s visit. (It is unclear from the record whether he used a rigid cystoscope or a flexible cystoscope to examine L. H.) Dr. Suits' written report of the L. H.'s July 21, 1994, visit to his office reads as follows:3 Procedure- July 21, 1994 CYSTOSCOPY: Scope placed with difficulty. Urethra extremely injected. Bladder trabeculated, grade 1 to 2/4. Ureteral orifices slit type, clear Efflux. Bladder mucosa slightly erythematous consistent with recent cystitis. There are no bladder diverticulum. There are no bladder cancers, polyps or other evidence of malignancy. PVR 20ccs. POST PROCEDURE UROFLOW UROFLOW: PEAK: 9 AVERAGE 5 VOIDED: 131 IMPRESSION: Urethral stenosis. Recurrent urinary tract infection No evidence of bladder tumor. PLAN: Macrobid HS Premarin Cream to urethra nightly. Prosed DS prn. Follow-up 1 month. Uroflow, PVR. Possible dilatation. A urine specimen taken from L. H. during her July 21, 1994, visit to Dr. Suits' office was provided to Palm Beach Pathology for analysis. The cytology report prepared by Palm Beach Pathology reads as follows: NON-GYN CYTOLOGY SPECIMEN: Urinary Tract-Bladder (catherization) CYTOLOGIC EVALUATION: Cancer Reading: Abnormal changes COMMENTS: Clusters of degenerated slightly atypical urothelial cells and candida (?contaminant). L. H. remained under Dr. Suits' care. Subsequent examinations and testing revealed no abnormalities suggesting that L. H. was suffering from cancer of the bladder. L. H. has never had any tumors surgically removed from her bladder. Although it is very improbable, it is nonetheless possible that a blister-like lesion or tumor three centimeters in diameter, such as the one Respondent observed in L. H.'s bladder on July 18, 1994, may disappear in two or three days time. This is particularly true if the lesion is the product of an infection and the patient is being treated with an antibiotic, as was L. H. When Respondent reported that he had observed such a lesion (along with other lesions) in L. H.'s bladder during his cystoscopic examination of L. H. on July 18, 1994, he was not being untruthful. He actually saw during the examination what reasonably appeared to be a three centimeter lesion, as well as smaller lesions, in L. H.'s bladder. While these lesions may not have been present or observed by Dr. Egerton and Dr. Suits when they conducted their cystoscopic examinations of L. H. on July 20, 1994, and July 21, 1994, respectively, the lesions had been there, as Respondent had accurately reported, at the time of Respondent's July 18, 1994, examination of the patient. The evidence fails to establish that, in connection with his care and treatment of L. H., Respondent in any way acted in a manner that was inconsistent with what a reasonably prudent urologist would have recognized as being acceptable and appropriate under the circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board issue a final order dismissing the Administrative Complaint against Respondent in its entirety. DONE AND ENTERED this 16th day of February, 1998, in Tallahassee, Leon County, Florida. STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 16th day of February, 1998.
Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in Florida. At all times material to this case, the Respondent has been a physician in the state, holding Florida license number ME0031630. The Respondent is a well-trained vascular surgeon. During his residency, he served as chief resident at New York University. From 1982 to 1986, he taught surgery and was director of the hyperbaric chamber program at Einstein College of Medicine in New York. The Respondent moved to Tampa in 1988 and has worked as a general and vascular surgeon since his move. The Respondent is board certified in general surgery and has been recertified in his specialty. He has an excellent reputation as a surgeon. W. K., Patient number 1. At all times material to this case, Patient number 1 was a 51 year old male with a history of severe peripheral vascular disease including peripheral neuropathy and nephropathy, hypertension, coronary artery disease, severe atherosclerosis, insulin dependent diabetes, and bilateral leg swelling. On February 2, 1995, Patient number 1 was examined at University Community Hospital in Tampa, Florida. The examination revealed that no pulse was present at the popliteal level of either foot. Early gangrenous changes were present at the patient's right foot. Both feet were cold to the touch. Based on the February 2 examination, Patient number 1 was diagnosed with congestive heart failure secondary to ischemic heart disease, chronic renal insufficiency secondary to diabetic neuropathy, anemia, hypertension, peripheral vascular disease with early gangrenous changes to the right foot, and diabetic peripheral bilateral neuropathy in both extremities. On February 10, 1995, Patient number 1 was evaluated by the Respondent. Based on his review of the patient's arterial vascular studies, the Respondent recommended that the patient undergo "jump" bypass surgery. The patient had previously undergone bypass surgery and declined to do so again, electing instead to receive treatment by medical therapy. The medical therapy was unsuccessful. Patient number 1's right leg remained swollen and painful. The pain was persistent and severe, and interfered with his mobility. The Respondent was called for another consultation. On February 17, 1995, Patient number 1 presented to the Respondent for evaluation of the continuing pain in the lower right extremity. At that time, the patient and the Respondent discussed surgical amputation of the affected right extremity. The patient decided to undergo the amputation. Patient number 1 signed a consent for a right leg below knee, and possibly above knee, amputation. On any given day, multiple surgical procedures are performed in a hospital's surgical facilities. At Tampa Community Hospital, surgeries are scheduled by a clerk who enters the patient's information into the facility's records. The records are maintained on computers. The surgeries scheduled to be performed in the facility each day are identified on a printed surgical schedule which is generated from the computer records created by the clerk. For each surgery scheduled during the day, the surgical schedule identifies the assigned operating room, the surgical procedure, and the names of the patient, surgeon, and anesthesiologist. At University Community Hospital (UCH), the operating rooms are configured in a "U" shape. A control desk in the center of the "U" is staffed by an assistant nurse manager and a secretary. A copy of the printed surgical schedule is located at the control desk. Information from the surgical schedule is written onto a "blackboard" located at the control desk. The printed surgical schedule for February 20, 1995 incorrectly stated that Patient number 1 was to undergo a left below knee amputation. The evidence fails to establish the cause for the original incorrect identification of the procedure. At approximately 3:30 a.m. on February 19, 1995, Annette Beede, a pool nurse engaged in stocking and cleaning activities at UCH, received a telephone call from an unidentified person Ms. Beede identified as a floor nurse from the floor where Patient number 1 was housed. A pool nurse is one called in to fill a need for staff beyond the normal staffing levels of a hospital. The caller informed Ms. Beede that the surgery was incorrectly identified on the schedule. The caller told Ms. Beede that Patient number 1 was to undergo a right leg amputation. According to proper hospital procedure, any change to a surgical schedule must be submitted by the surgeon or his office. There is no evidence that the Respondent or his office was aware of or attempted to correct the erroneous surgical schedule. Ms. Beede corrected the copy of the surgical schedule she had and initialed her correction. Ms. Beede's corrected copy remained on a clipboard which was given to the nurse who relieved her from duty at about 11:00 a.m. on February 19, 1995. Ms. Beede did not verbally discuss the change with the relief nurse. There is no evidence as to why Ms. Beede was the nurse to whom the call was directed. Proper procedure for the change would be that the amended surgical schedule would remain on the clipboard at the control desk until it was taken into the operating room by the circulating nurse. At Tampa Community Hospital, multiple copies of surgical schedules were apparently made. Some circulating nurses had their own copies of surgical schedules. Copies of surgical schedules were also sometimes taped to walls in operating rooms or placed on operating tables. A separate and uncorrected copy of the February 20 surgical schedule was placed in the operating room where Patient number 1's procedure would be performed. The schedule placed in the room stated that Patient number 1's left leg was to be amputated. The blackboard at the control desk indicated that the patient's left leg was to be amputated. On February 20, 1995 at about the time Patient number 1 was being taken to the operating suite area, the Respondent was "making rounds" at the hospital. The Respondent was paged and told that Patient number 1 was being brought to the operating room. After hearing that the patient was on his way to the surgical area, the Respondent proceeded towards the lounge where surgeons generally wait to be called into the operating rooms. Patient number 1 was wheeled to an area just outside the operating room, where he was met by Willie Mae Jones, a circulating nurse. A circulating nurse is responsible for assuring that the surgical process operates smoothly. She is responsible for identifying the correct patient for surgery and for talking to the patient prior to surgery to ascertain his condition. Ms. Jones spoke to the patient and found him to be alert. She discussed the procedure. He identified his right leg as the correct amputation site. Ms. Jones noted the information provided by the patient in his hospital records. As Ms. Jones talked to the patient, the Respondent passed nearby, waived to the patient, and entered the lounge area. On February 20, 1995, the Respondent did not discuss the procedure with the patient prior to the surgery. The effective standard of care did not require the Respondent to speak to the patient at that time. Prior to the surgery, Ms. Jones was responsible for "prepping" the appropriate area for surgery. In this case, prepping included cleaning the leg with an antiseptic solution. A leg holder was used to position and stabilize the leg prior to cleaning. The patient's left leg was edemous and ulcerated. At Ms. Jones' direction, her assistant placed the patient's left leg in the holder. In preparing a patient for an amputation, the appearance of an extremity, without additional review of records, is not an appropriate indicator of whether it is the correct extremity to be amputated. After the leg was secured, it was removed from the leg holder at the direction of the nurse anesthetist in order to permit the spinal anesthesia to take effect. After the patient was anesthetized, the anesthesiologist replaced the left leg into the holder. Ms. Jones prepped Patient number 1's left leg. The rest of the patient's body, including his right leg, was draped with a sheet or blanket. After the administration of anesthesia was complete and the patient was draped, the Respondent, having finished scrubbing, entered the room and the surgical procedure began. Normally, operating room personnel work from 7:00 a.m. to 3:00 p.m. By the time the amputation of Patient number 1's leg began, it was 5:45 p.m. The Respondent had reviewed the incorrect blackboard information and the incorrect written surgical schedule prior to the surgery. The effective standard of care did not require that the Respondent review the patient's medical records or the executed consent form prior to the surgery. He did not review the documentation. As the surgery began, the nurse anesthetist inquired as to the pre- operative diagnosis. The Respondent replied "ischemic left lower extremity." Ms. Jones recorded the Respondent's statement in the appropriate position on the patient's surgical record. While the operation was in progress, Ms. Jones recorded the surgical procedure as a "left below knee amputation," based on the information provided by the Respondent to the surgical team during the procedure. While the Respondent was amputating the patient's lower left leg, Ms. Jones began to review Patient number 1's medical records. She noticed that the patient's medical history and consent identified the correct amputation site as the patient's right leg. Ms. Jones, who had been facing away from the operating area of the room, turned towards the area where the surgery was taking place. She looked under the draped blanket. She began to cry and the surgical team then discovered that the wrong leg was being amputated. After a momentary pause, the amputation, having passed the stage at which it could have been reversed, was completed. After the patient was sufficiently recovered from the surgery, the Respondent entered the recovery area and discussed the mistake with the patient. The patient was subsequently transferred to Tampa General Hospital where his right leg was amputated. Prior to it's amputation, the patient's left leg was also affected by poor circulation. There is evidence that the condition of the patient's left leg was as deteriorated as that of his right leg. He had previously been treated for left leg pain. It is likely that at some future point, Patient number 1's left leg would have required additional treatment and possibly amputation. Notwithstanding the condition of the left leg, at the time it was amputated, Patient number 1 relied on it for mobility. There is no evidence that the Respondent and Patient number 1 discussed amputation of any portion of the patient's left leg. The applicable standard of care requires that a surgeon verify that the appropriate site is prepared prior to surgery and that the correct surgical procedure is performed. On February 20, 1995, the Respondent failed to meet the standard of care by failing to verify that the appropriate site had been prepared for surgery and by amputating the incorrect extremity. The applicable standard of care requires that a surgeon obtain the written consent of a patient prior to performing a surgical procedure. On February 20, 1995, the Respondent failed to meet the appropriate standard of care by performing a surgical procedure for which he did not have the written consent of the patient. Although there is evidence that errors by persons other than the Respondent contributed to the amputation of the improper extremity, there is no credible evidence to establish that such errors excuse the Respondent's failure to meet the appropriate standard of care. M. S., Patient number 2. At all times material to this case, Patient number 2 was a 69 year old female with a history of diabetes, end stage renal failure requiring hemodialysis, pericarditis, severe peripheral vascular disease, and osteomyelitis. Osteomyelitis is an infection which results in the decay of bone mass and soft tissue. In 1993, four toes of Patient number 2's left foot had been amputated due to infection and to osteomyelitis. The infections were a result of her diabetes and poor vascularization to the affected tissues. At all times, Patient number 2 was very concerned about keeping her limbs intact and was extremely resistant to amputation of her legs. The previous toe amputations were an attempt to maintain the integrity of her limb. On April 11, 1995, the Respondent amputated the fifth toe from Patient number 2's right foot. She was suffering from inoperable vascular disease in her right leg. The toe was necrotic and infected. The April 11th amputation was performed using typical amputation technique. An elliptical incision was made at the base of the toe, the bleeding was controlled, the bone was cut through above the metatarsal head, tendons were sliced and the toe was removed. Sutures were used to close the wound. The toe removed during the April 11th amputation was sent as one piece to the hospital pathology department. After the amputation of the fifth toe, the patient's infection continued. On June 30, 1995, she was admitted to Town and Country Hospital in Tampa, Florida. At the time of her admission, she was suffering from spiking fever related to the infection in her right foot. Upon examination, the Respondent determined that the site of the amputation was necrotic and infected. A foul smelling fluid drained from the wound. The foot was swollen. An x-ray revealed abnormality in the area of the right fourth toe. There were erosions around the area of the toe indicating likely infection and osteomyelitis. The Respondent performed a limited removal of necrotic tissue at the patient's bedside and ordered tests and medical treatment to confirm the condition. The patient's physicians were concerned that the infection would become more pervasive and could cause increasing medical problems. The Respondent discussed Patient number 2's condition with other physicians who were involved in her care. The possibility of a right below knee amputation was discussed with the physicians as was the removal of the remaining toes from her right foot. The Respondent believed that removal of her remaining toes was not appropriate because the right foot was not viable. Patient number 2's primary care physician spoke with her about the need to resolve the continuing infection in her right foot and discussed below knee amputation of the leg. She remained very concerned about losing her leg and emphasized to her physician that she wanted to save the limb. The patient's physician discussed with the Respondent a transmetatarsal amputation, involving removal of part of her right foot. However, given the vascular problems in her right leg, the Respondent determined that the procedure would be unlikely to heal adequately. The Respondent discussed amputation with Patient number 2, who declined to have her leg amputated. The Respondent then discussed debridement of the right foot with the patient. Debridement is a procedure where necrotic tissue is surgically removed by a scalpel or scissors. The debridement of tissue requires exercise of the surgeon's clinical judgement and discretion. Ideally, a surgeon removes necrotic material to the point where normal bleeding begins to occur. In this case, the purpose of the debridement was to remove the necrotic tissue and attempt to restrain the infection. On July 6, 1995, Patient number 2 executed her consent to a debridement of her right foot. There is no credible evidence that the Respondent discussed with the patient the removal of the fourth toe on her foot during the debridement. The debridement was scheduled for July 7, 1995, but was postponed when the patient developed pneumonia. On July 10, 1995, the debridement was again discussed by the Respondent with the patient, who remained in emotional turmoil and was concerned about saving her foot and leg. On July 10, 1995, the patient met with an infectious disease doctor who noted an increased white blood count (indicating an active infection) and a non-healing wound which displayed necrotic changes. The desirability of a transmetatarsal amputation was again discussed, because the physician believed antibiotics would be insufficient to control the infection. Again the patient declined the amputation. The debridement was scheduled for July 11, 1995. On that day, a surgical nurse, Margaret Pratt, spoke to the patient about the procedure. The patient said the Respondent was to remove dead tissue from her foot. Ms. Pratt saw that the toe appeared to be necrotic and marginally attached to the foot. Based on her view of the toe, Ms. Pratt discussed with the Respondent whether she needed to obtain the patient's consent for removal of the toe. The Respondent said he was not going to amputate the toe. Continuing to be concerned, Ms. Pratt spoke to her supervisor, Kathy Dzikowski, about the condition of the toe and the Respondent's intentions. Ms. Dzikowski contacted the Respondent to discuss his intentions. He continued to indicate that he planned only to debride the foot. Another nurse, preparing for the procedure, asked the Respondent if he needed a large "Horsley" bone cutter. He replied that he did not need a large bone cutter. On July 11, 1995, the debridement procedure was performed. Using a number 10 blade scalpel, the Respondent removed necrotic tissue from the bottom and then from around the "ball" of the patient's right foot. The Respondent also debrided the right side of the patient's right fourth toe. The Respondent then prepared to debride the left side of the toe. Holding the blade in this right hand, and grasping the fourth toe with his left hand, the Respondent pulled the toe to the right to access the area between the third and fourth toe, in order to debride the left side of the fourth toe. As he grasped the toe, the bone of the toe disconnected from the metatarsal joint and was connected only by tendon and necrotic tissue. There is no evidence that the toe was in proper condition to be saved. Using the scalpel, the Respondent cut the tendon and removed the toe. After the toe was removed, the joint and bone were exposed from the wound. The Respondent took a small clipper called a "ronguer" and removed the top of the metatarsal joint. The ronguer is part of the standard set of surgical instruments which is set out for use during debridement. The removal of the bone was medically indicated, given the condition of the foot. After the toe was removed, the toe was handed to Ms. Pratt, who was receiving the debrided tissue at a table facing away from the operating site. She inquired as to how to label the material. The Respondent told her to label it as "debridement of right foot." Because the toe was visibly a toe, he assumed that she was referring to the remaining tissue which had been removed. Apparently assuming that the Respondent was attempting to conceal the removal of the toe, Ms. Pratt asked her supervisor how the tissue should be labeled, and was told to label it as "toe and debridement." There is no credible evidence that the Respondent attempted to conceal the fact that a toe had been removed. The toe was clearly identifiable and visible in the debrided material. Everyone in attendance at the surgery was aware that the toe had been removed. After the removal of the necrotic toe, the Respondent continued the debridement and completed the procedure. Immediately following completion of the procedure, the Respondent dictated his operative report, which identified the procedure as "debridement of right foot and amputation of fourth toe." After the patient recovered from the procedure, the Respondent discussed the procedure with her. He told her that her toe had fallen off (or words to that effect) during the debridement. He also discussed the manipulation, dislocation and subsequent removal of the toe. It is reasonable for a physician to speak to a patient in non-medical terminology in order to provide information which can be easily understood by the patient. The evidence fails to establish that the Respondent attempted to conceal the nature of the procedure from the patient. All of the tissue removed from the patient, including the toe, was sent to the hospital pathology department for examination. There is no evidence that the Respondent attempted to obstruct or prevent the delivery of any debrided material to pathology. Pathological review of the toe is consistent with debridement performed by sharp dissection; however, the toe joint reveals no sharp dissection other than at the metatarsal head, which was removed by clippers after the dislocation and removal of the digit. A toe amputation generally results in a one-piece specimen as the toe is usually removed by cutting through the bone above the metatarsal joint. The specimen in this case was in two pieces, the piece that disconnected from the joint, and the joint section which was cut off by the Respondent after the dislocation and removal of the digit. The technique used in the July 11, 1995 procedure was not standard for amputation. The Respondent removed the necrotic tissue from the toe. There is no reason to have debrided the toe had he planned to remove it entirely. The toe was not removed using bone cutters. The evidence fails to establish that the Respondent intended to amputate the toe prior to beginning the debridement procedure on July 11, 1995. The evidence establishes that due to the condition of the patient's foot, the Respondent should have known that the toe could become disconnected and should have obtained the patient's consent for removal of the toe, if and when the disconnection occurred. It would be reasonable to consider, given the patient's osteomyelitis, that during the debridement, the toe bone could have fractured, or that the tissue, tendon, fascia and capsule of the toe could be eroded or weakened, resulting in dislocation or separation of the toe from the normal anatomic position. According to an expert for the Respondent, a planned debridement resulting in an amputation of the toe after it disengages or dislocates is not unique, and in fact has occurred in his personal experience. The Respondent did not discuss with the patient the possibility that the toe could disconnect and have to be removed during the procedure. The standard of care for obtaining surgical consent requires that a surgeon discuss the risks and benefits of an operative procedure with the patient. In this case, although the Respondent discussed the risks and benefits of the surgery with the patient, he did not address the possibility that the necrotic toe could become disconnected and have to be removed. The consent form executed by Patient number 2 does not authorize the Respondent to amputate the toe if it detached from the foot during the debridement. Although the consent form authorized by the patient permitted the Respondent to act beyond the boundaries in the event of "unusual circumstances," the evidence fails to establish that the disconnection of a necrotic toe during the debridement of this patient's right foot can reasonably be identified as an unusual circumstance. The Petitioner asserts that at the time the toe became disconnected, the surgical procedure should have been halted, the patient allowed to recover and that the Respondent should have obtained the patient's consent to remove the detached necrotic toe. Given the circumstances of this case, the Petitioner's assertion is unreasonable. After the debridement, the condition of the patient's did not improve. It remained infected and necrotic. Eventually, a right below knee amputation was performed on Patient number 2.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order determining that Rolando Roberto Sanchez has violated Sections 458.331(1)(p) and (t), Florida Statutes, and suspending his license for a period of two years from the date of the Emergency Order of Suspension, imposing a fine of $15,000 and placing the Respondent on probation for a period of five years from the date upon which the suspension expires. Further, during the period of probation, the Respondent shall not perform any surgical procedure without the direct supervision of a licensed physician who, prior to the commencement of the surgery, shall certify that the anatomical site which has been prepared for surgery is correct. DONE and RECOMMENDED this 19th day of October, 1995, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM 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 19th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-3925 To comply with the requirements of Section 120.59(2), Florida Statutes, the following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact were inappropriately numbered and set forth in separate sections. For purposes of the following, the proposed findings have been re-numbered consecutively beginning from the section titled "FACTS," and are accepted as modified and incorporated in the Recommended Order except as follows: 20-21. Rejected, subordinate. 22. Rejected as to "good medical practice" of cited witness, irrelevant. 30. Rejected as to Ms. Pratt's expertise or knowledge which would establish that the toe "would come off" if the foot were touched, not supported by the greater weight of the evidence. 33-34. Rejected, not supported by the greater weight of credible and persuasive evidence. The implication is that the Respondent requested that the witness obtain a "Horsley" bone cutter to permit removal of the toe. The evidence fails to establish that a Horsley bone cutter was obtained by the witness, notwithstanding her assertion that the Respondent directed her to do so. The evidence fails to establish that the witness could clearly view the procedure. The witness did not see the toe being debrided prior to the toe's dislocation from the foot; however, the evidence establishes that the toe was debrided. 35. Rejected, cumulative. Rejected, contrary to the greater weight of credible and persuasive evidence. Rejected, irrelevant. There is no credible evidence that in postoperative notation, the Respondent attempted to conceal the surgical procedure performed on Patient number 2. The cited witness acknowledged that her recollection of the conversation with the Respondent was not an exact quoting of his remarks. Rejected, immaterial. There is no credible evidence that the children were authorized to consent to any procedure on behalf of the patient. Rejected, contrary to the greater weight of credible and persuasive evidence. Rejected, recitation of testimony is not finding of fact. Rejected, subordinate. 45. Rejected, recitation of testimony is not finding of fact. 46-47. Rejected, cumulative. Rejected, recitation of testimony is not finding of fact. Rejected, cumulative. Rejected, recitation of testimony is not finding of fact. Rejected, unnecessary. 52-53. Rejected, recitation of testimony is not finding of fact. Respondent The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 8. Rejected, unnecessary. Goes to the credibility of his testimony which has been determined in, and is reflected by, the Findings of Fact set forth herein. 10-11. Rejected, subordinate. 22. Rejected, subordinate. 23-24. Rejected, irrelevant. The evidence fails to establish that such "reasonable reliance" relieves a surgeon of responsibility for performance of an improper procedure. 26. Rejected as to assertion that "ninety percent" of Florida surgeons "would have made the same mistake," not supported by credible evidence. 31-33. Rejected, subordinate. Rejected. There is no evidence that on February 20, 1995, the Respondent performed any review of medical records or examined the patient whatsoever prior to beginning the surgery. Rejected, unnecessary. 42. Rejected, not supported by the weight of credible and persuasive evidence. 43-48. Rejected, cumulative. 51. Rejected as to race of patient, immaterial. 63. Rejected, irrelevant. 66-70. Rejected, cumulative. Rejected, subordinate. Rejected, recitation of testimony is not finding of fact. Rejected, subordinate. Rejected, recitation of testimony is not finding of fact. Rejected, irrelevant. There is no credible evidence as to Ms. Pratt's knowledge that the toe "might fall off" of the foot. Rejected, recitation of testimony is not finding of fact. Rejected, subordinate. Rejected, recitation of testimony is not finding of fact. 105-107. Rejected, subordinate. 108-110. Rejected, unnecessary. 112. Rejected, contrary to the greater weight of credible and persuasive evidence. Rejected, cumulative. Rejected, contrary to the greater weight of credible and persuasive evidence. 120-121. Rejected, contrary to the greater weight of credible and persuasive evidence. There is no credible evidence that the patient was told that the toe could dislocate and require removal during the debridement, or that "debridement of a right foot can include removal of digits, including portions of the mid-foot." 122. Rejected, contrary to the greater weight of credible and persuasive evidence which establishes that the disarticulation was not unique or unpredictable. 125-127. Rejected, immaterial. 128-141. Rejected, unnecessary, irrelevant. These proposed findings are based on Respondent's Exhibit number 13, a collection of Final Orders issued by the Petitioner (or a predecessor agency) wherein various physicians were the subject of disciplinary action. None of the cited cases involved the incorrect and complete surgical amputation of an extremity, or involve the failure to reasonably anticipate the possible complications of a procedure and the failure to obtain consent from the patient to resolve the complication. The cited cases involve factual situations sufficiently distinguished from those at issue in this case. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Michael K. Blazicek, Esquire STEPHENS, LYNN, KLEIN & McNICHOLAS, P.A. 4350 West Cypress Street, Suite 700 Tampa, Florida 33607
