The Issue The issues in this case are whether the allegations of the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2005). At all times material to this case, the Respondent was a physician licensed by the State of Florida, holding license number 59702 and was board-certified in obstetrics and gynecology. The Respondent owned, and practiced medicine at, EPOC Clinic, 609 Virginia Drive, Orlando, Florida. On December 19, 2005, Patient S.B. presented to the EPOC Clinic to inquire about terminating a pregnancy, but elected not to proceed with the termination at that time. On February 3, 2006, S.B. returned to the EPOC Clinic, having decided to terminate the pregnancy. A sonogram was performed, and S.B. was determined to be approximately 18 to 19 weeks gestation. At that time, she executed consent forms for pregnancy termination by medication, and dilation and extraction (D&E). Patient S.B. had been pregnant three times previously and had birthed three children, each delivered live by cesarean section. The patient's pregnancy termination was scheduled to commence on February 4, 2006, but S.B. was late in arriving at the clinic, and the procedure was rescheduled for February 6, 2006. The patient returned to the EPOC Clinic as rescheduled. While at the EPOC Clinic on February 6 and 7, 2006, S.B. received medical care and treatment primarily from the Respondent and from Carmita Etienne, a medical assistant working at the clinic. The termination was initiated with the use of "Cytotec," a drug that causes cervical dilation and uterine contractions, and which generally results in passage of the fetus into the vaginal vault. Cytotec is commonly used in medication-based pregnancy termination. It is known to increase the potential for uterine rupture during labor and delivery, the risk for which is noted within the relevant consent documents executed by the patient. Cytotec tablets, in 200 microgram dosages, were administered orally to the patient by the Respondent's medical assistant. S.B. received 200 micrograms of Cytotec at 10:00 a.m. on February 6, 2006, and received the same dosage at four-hour intervals through 10:00 a.m. on February 7, 2006, at which time the patient's cervix remained undilated. The Respondent thereafter escalated the frequency of the Cytotec to every two hours, and the drug was administered two additional times on February 7, 2006, at noon and 2:00 p.m. According to progress notes contained in the medical records, S.B. complained of discomfort on February 6, 2006, at 7:45 p.m. and on February 7, 2006, at 3:00 a.m. Discomfort or pain is a typical element of labor, and S.B.'s discomfort was not unexpected. Demerol, a controlled substance, is routinely used to relieve pain during medical procedures, including pregnancy terminations. The medical assistant relayed S.B.'s reports of discomfort to the Respondent. The Respondent ordered Demerol on both occasions to relieve S.B.'s pain. A physician must be properly registered with the U.S. Drug Enforcement Administration (DEA) to order the administration of Demerol to a patient. The Respondent was not properly registered with the DEA on February 6 or 7, 2006. At the hearing, the Respondent denied that he ordered the Demerol. He testified that he was serving as a conduit between his medical assistant and another physician, Dr. Harry Perper, who also worked at the clinic and who was apparently properly registered with the DEA. The Respondent's testimony on this issue was not persuasive and has been rejected. The evidence failed to establish that Dr. Perper ordered the administration of Demerol to the patient or that the Respondent merely relayed such orders from Dr. Perper to the medical assistant. The Respondent asserted that he had not been registered with the DEA since 2002 and that everyone at the clinic knew he could not order controlled substances. The patient's progress notes, created contemporaneously with the patient's treatment at the clinic, explicitly state that the orders for Demerol came from the Respondent. The medical assistant who created the progress notes testified that she preferred talking to the Respondent rather than Dr. Perper and that the directions she received for the patient's Demerol came from the Respondent. The Respondent's assertion that he did not order the Demerol was not credible and has been rejected. The Demerol was administered by the medical assistant through injection of the medication into S.B.'s buttocks, and the patient's pain was reduced. The medical assistant denied that she personally administered the Demerol to the patient. Her denial was not credible and has been rejected. The progress notes also state that the patient complained of "right side" pain at 3:00 p.m. on February 7, 2006. At approximately 3:45 p.m. on February 7, 2006, the patient was apparently examined by Dr. Perper, who wrote "SROM" in the progress notes, signifying that a "spontaneous rupture of membranes" had occurred and indicating that the patient's "water had broken." He also documented his observation that a fetal part was protruding from the cervix into the vagina. By that evening, the patient's termination was not completed. At approximately 7:00 p.m. on February 7, 2006, the medical assistant moved the patient into a procedure room at the Respondent's direction. The instruments to perform a D&E were present in the procedure room. The Respondent began to perform an examination of S.B. to assess the situation and determine whether the termination procedure should be completed by D&E. The Respondent utilized a speculum to open the patient's vagina and performed a sonogram on the patient's abdomen to identify the location of the fetus. The fetus was observed to be within S.B.'s uterus. The Respondent observed a fetal part protruding through the cervical os into the vagina. In order to examine the extent of cervical dilation, he detached the part from the fetus by grasping the part with a "Hearn" instrument and twisting the instrument. After he detached the part, he withdrew the instrument and the part from the patient. The Petitioner alleged that the Respondent "apparently" attempted a D&E. The evidence failed to support the allegation. The evidence failed to establish that the Respondent pulled on the exposed fetal part in an attempt to extract the fetus from the uterus. The evidence failed to establish that the Respondent inserted the Hearn or any other instrument into the patient's cervix or uterus. After removing the fetal part from the vagina, the Respondent placed the part on a tray. Almost immediately thereafter, the Respondent's reviewed the ultrasound image and observed that the image indicated the fetus was no longer fully contained within the uterus. The Respondent understood that the ultrasound image indicated a potential uterine perforation or rupture and, appropriately, concluded that the situation could be life- threatening for the patient. He quickly contacted the Arnold Palmer Hospital to arrange for emergency transfer of S.B. to the hospital. The Respondent also spoke to two practitioners at the hospital. Initially, he spoke by telephone to Dr. Pamela Cates, a resident physician at the hospital. Dr. Cates did not have the authority to admit the patient to the hospital and directed the Respondent to talk to Dr. Norman Lamberty, the "Ob/Gyn" physician on call and present at the hospital. The Respondent spoke by telephone to Dr. Lamberty, who agreed to accept the transfer of the patient from the clinic to the hospital. The Respondent failed to inform either Dr. Cates or Dr. Lamberty that he had removed a portion of the fetus from the patient at the clinic. While waiting for an ambulance to arrive to transport the patient, the Respondent wrote a note to be transported to the hospital with the patient. Although in the note he documented the treatment provided to the patient at the clinic, he failed to include the removal of the fetal part in the note. The Respondent testified that he did not document his removal of the fetal part because he did not believe it was significant to the medical care the patient would receive at the hospital. S.B. was transported to the hospital along with some of her medical records from the clinic and the Respondent's handwritten note. None of the documentation indicated that a part of the fetus had been removed at the clinic. After S.B. arrived at the hospital, Dr. Lamberty removed the fetus and completed the abortion procedure. Dr. Lamberty also repaired a cervical laceration and performed a hysterectomy. He noted that the uterine rupture occurred on the patient's right side and that the fetus was located not "floating" in the abdomen but "between two layers of tissue on the right side of the pelvis." The evidence failed to establish that the cervical laceration occurred while the patient was at the clinic or that it was caused by treatment the patient received at the clinic. Upon removing the fetus, Dr. Lamberty observed that the fetus was incomplete and that a portion of the fetal leg was missing. Dr. Lamberty began efforts to locate the missing part, which he reasonably presumed remained in the patient. Dr. Lamberty's concern regarding the missing part was that potential exposure of the part to the patient's vagina would have contaminated the part with bacteria and that a risk of infection would be presented by leaving the part within the patient's pelvis or abdomen. Dr. Lamberty was unable to locate the missing part, and, thereafter, radiological studies, including X-rays and a CT scan, were performed in an unsuccessful attempt to locate the part. The patient remained hospitalized and on February 10, 2006, a second surgical procedure was performed on the patient, this time to remove a "Jackson-Pratt" drain that had been improperly sutured into the patient's abdomen at the time of the hysterectomy. The second surgery was unrelated to the search for the missing part. Also on February 10, 2006, the hospital contacted the clinic to inquire as to the missing part and was advised that the part had been removed by the Respondent at the clinic.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding James S. Pendergraft IV, M.D., in violation of Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), and imposing a penalty as follows: a two-year period of suspension followed by a three-year period of probation and an administrative fine of $20,000.00. DONE AND ENTERED this 21st day of September, 2009, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 21st day of September, 2009. COPIES FURNISHED: Greg S. Marr, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Kenneth J. Metzger, Esquire Metzger, Grossman, Furlow & Bayo, LLC 1408 North Piedmont Way Tallahassee, Florida 32308 Kathryn L. Kasprzak, Esquire Fowler White Boggs Banker, P.A. 200 South Orange Avenue, Suite 1950 Orlando, Florida 32801 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following Findings of Fact: The Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0031545. The Respondent practices in south Florida as a cardiologist. The Respondent treated patient William Dean from 1979 through 1982. William Dean died of heart failure on August 30, 1982. Following Mr. Dean's death, his wife, Elizabeth Dean, obtained from Respondent copies of Dean's medical records. On July 2, 1983, Elizabeth Dean filed a complaint by letter with the Department of Professional Regulation against the Respondent. As a result of Mrs. Dean's complaint, the Petitioner began an investigation of the Respondent and notified Respondent of same. In addition, Mrs. Dean sued the Respondent for malpractice. During the investigation by Petitioner, copies of Mr. Dean's records were obtained from the Respondent. When the records obtained by Petitioner were compared with the earlier records obtained by Mrs. Dean, it was discovered that Respondent had made at least two additions to them. After being notified of the complaint and investigation, the Respondent added entries to the progress notes on Mr. Dean for November 12, 1981 and May 15, 1982. Among other things, the additions to the progress notes indicated that Respondent had advised Mr. Dean to take a stress test and angiogram and that Dean had refused. The Respondent dictated Mr. Dean's patient Expiration Summary, which appears in the hospital's patient charts, on October 17, 1983, fourteen months' after Mr. Dean's death. Humana Hospital Cypress, where Mr. Dean died, requires that physicians prepare patient expiration summaries within thirty (30) days after the patient's death.
The Issue Respondent is charged in Count I of the Administrative Complaint with failure to properly examine, diagnose, and treat the patient Lynne McMurry; failure to keep adequate written medical records regarding treatment; providing treatment to the patient which was neither necessary nor justified; and failing to properly inform the patient of Respondent's medical diagnosis and by so doing violating Section 458.331(1)(t), Florida Statutes, in that she failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Upon the same factual allegations, Count II alleges violation of Section 458.331(1)(o), exercising influence on a patient or client in such a manner as to exploit the patient or client for financial gain. Upon the same factual allegations, Count III charges violation of Section 458.331(1)(1) by making deceptive, untrue, or fraudulent representations in the practice of medicine or by employing a trick or scheme in the practice of medicine when such trick or scheme fails to conform to the generally prevailing standards of treatment in the medical community. Upon the same factual allegations, Count IV charges a violation of Section 458.331(1)(n) by failing to keep written medical records justifying the course of treatment of a patient. Upon the same factual allegations, Count IV charges a violation of Section 458.331(1)(i) by making or filing a report the Respondent knows to have been false.
Findings Of Fact No evidence was adduced at formal hearing to prove up the threshold issue of jurisdiction by licensure. No prehearing stipulation of the parties established paragraph 2 of the Administrative Complaint alleging that at all times material hereto Respondent was a licensed physician in the state of Florida, having been issued license number ME0037967. No requests for admission within the record establish this essential allegation as fact. No answers to interrogatories to establish this fact were read into evidence at the hearing. Respondent saw Lynne McMurry on four occasions. Respondent saw this 113 pound 39 year old female on April 17, 1984, and took a complete medical history. On April 24, 1984, Respondent's notes reflect that Respondent recorded McMurry's blood pressure and glucose level and did a urinalysis. They also reflect that vitamin B-complex was prescribed. There is no indication within the notes of whether this vitamin was administered orally, intramuscularly, or otherwise. However, it appears from the testimony that both experts assumed the B complex was administered by injection on that date. The notes reveal that on May 8, 1984, Respondent performed a lesion removal (described in testimony as the excision of a mole) and recorded test scores for urine, glucose, hematocrit, and hemoglobin. It may be inferred that the tests were done in Respondent's office on blood and urine samples provided by Ms. McMurry. According to Respondent's notes, she again saw McMurry on May 22, 1984, recorded her weight as reduced to 110 pounds, and again prescribed vitamin B-complex. Attached to these notes are copies of the test results recorded plus a breast thermography done on April 24, 1984, and one testing panoramic dated April 17, 1984. No notes were recorded by Respondent for April 17, 1984, beyond the medical history previously mentioned. Insurance claims for these treatments were made by Respondent based on diagnoses of "fibrocystic breast disease" and "hypotension." Petitioner's witness, Dr. Stanley L. Weiss, an osteopathic physician, has concentrated much of his study, practice, and writing in the Respondent's field of bariatric medicine (weight control and eating disorders) and his deposition (P-1) has been accepted as the opinion of an expert witness in review of medical records and medical matters. Dr. Weiss' background includes the policing of medical insurance claim fraud through the Florida Blue Shield Review Committee. Respondent's witness, Dr. Lionel R. Blackman, medical physician and past Medical Director of Lakes Hospital, Lake Worth, Florida, has many years of reviewing physicians' and hospital records, both in hospital peer reviews and in offices where usually only one physician reviews his or her own notes. He testified orally on behalf of Respondent. Dr. Blackman is also accepted as similarly qualified to render expert testimony on review of medical records and on medical matters. Dr. Weiss' criticism of Respondent's notes was solely related to his perception that they fail to contain sufficient information. He specifically found no malpractice in the treatment given, the records kept, or the claims made, but was concerned with the scarcity of what he felt would be adequate progress notes in the chart if another doctor had to review them. He conceded that a comprehensive history and physical examination form had been filled out on April 17, 1984, but expressed concern due to the appearance of several different handwritings on that physical examination form, as though a nurse, physician's assistant, and/or the Respondent herself had partially completed the form. He objected to lack of documentation for the necessity of multiple diagnostic procedures without additional comment within the notes covering actual physical evaluation, patient response to therapy, what therapy had been, and what the future plan of therapy would be. Reviewing the same notes of Respondent, Dr. Blackman considered them sufficient for office practice. He assumed from the notes that the patient being treated was a basically healthy patient without pathology, since no pathology was noted. Under these conditions, he further assumed that the B-complex prescription was used as a general tonic. He stated that one was required to assume Ms. Murry was generally sound because one could not assume a treatment for vitamin deficiency had been undertaken since B-complex vitamin .deficiency is exceedingly rare. He testified as one experienced in reviewing office notes that for office notes, the proper standard is that negative findings need not always be recorded. In short, Dr. Weiss found the notes less than adequate, unsatisfactory, and below common standards, and Dr. Blackman found them adequate, satisfactory, and meeting common standards for office notes. Without conceding any inadequacy of her records, Respondent explained that at the time the various notes had been made, her standard procedure was to personally do the patient history and physical examination while a physician's assistant transcribed the notes from her dictation during her personal "hands- on" examination. Since the complaint was filed, she has discovered everything she orally dictated was not written down by the single assistant she employed in 1984 and since them she has hired two better-trained assistants and has instituted a personal review of each chart at the close of each day's examinations. Respondent has an excellent reputation in the local medical community of West Palm Beach and has served on a number of community service teaching and writing projects. Last year she obtained 98 continuing medical education credits. Although never specifically stated, the undersigned infers all or most of these hours impinge on improving Respondent's record keeping skills. There is no suggestion from any source that the Respondent's diagnoses were in error or that the B-complex did or even could have produced an undesirable result in the patient, Lynne McMurry. Nothing within this record supports the allegations of violations as charged in Counts I, II, III, or V.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is, RECOMMENDED that the Board of Medical Examiners enter a Final Order dismissing with prejudice all Counts against Respondent. DONE and RECOMMENDED this 24th day of April, 1987, at Tallahassee, Florida. ELLA JANE P. DAVIS, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 1987. COPIES FURNISHED: Dorothy Faircloth, Executive Director Florida Board of Medicine 130 North Monroe Street Tallahassee, Florida 32301 H. Scott Hecker, Esquire 517 Southwest First Avenue Fort Lauderdale, Florida 33301 Deborah J. Miller, Esquire 2100 Ponce de Leon Boulevard Suite 1201 Coral Gables, Florida 33134 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Joseph A. Sole, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues in this case are whether Respondent, a physician specializing in obstetrics and gynecology, committed medical malpractice in delivering a baby and/or failed to maintain medical records justifying the course of the mother's treatment; if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action.
Findings Of Fact At all times relevant to this case, Respondent Mark N. Scheinberg, M.D., was licensed to practice medicine in the state of Florida. He is board-certified in obstetrics and gynecology. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Scheinberg. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Scheinberg committed two such offenses——namely, medical malpractice and failure to keep records justifying the course of treatment——in connection with the vacuum-assisted vaginal delivery of an infant born to Patient L.G. on February 2, 2005, at West Boca Medical Center. The crux of this case (though not the sole issue) is whether, as the Department contends, the standard of care required Dr. Scheinberg to perform a Caesarean section ("C- section") on L.G. due to the passage of time, instead of allowing her to continue to labor for approximately 13 hours and, ultimately, deliver vaginally. The events giving rise to this dispute began on February 1, 2005, at around 11:00 a.m., when L.G., whose pregnancy was at term, checked into the hospital after having experienced ruptured membranes. At 12:30 p.m. that day, L.G. signed a form bearing the title "Authorization for Medical and/or Surgical Treatment," which manifested her consent to a vaginal delivery or C-section together with, among other things, "such additional operations or procedures as [her physicians might] deem necessary." Immediately above L.G.'s signature on the form is an affirmation: "The above procedures, with their attendant risks, benefits and possible complications and alternatives, have been explained to me " The evidence is not clear as to when, exactly, Dr. Scheinberg first saw L.G., but that fact is unimportant. The medical records reflect that at 8:30 p.m. on February 1, 2005, Dr. Scheinberg gave a telephone order to initiate an IV push of the antibiotic Ampicillin; therefore, he had taken charge of L.G.'s care by that time. The nurses' notes indicate that at 10:00 p.m., L.G.'s cervix had dilated to "rim" or approximately nine centimeters—— meaning that the dilation was complete, or nearly so. At this time, and throughout the duration of L.G.'s labor, an external fetal heart monitor was in place to detect and record the baby's heartbeats and the mother's uterine contractions. An intrauterine pressure catheter ("IUPC")——a device that precisely measures the force of uterine contractions——was not inserted into L.G.'s uterus at any time during this event. The Department argues (although it did not allege in the Complaint) that, at some point during L.G.'s labor, the standard of care required Dr. Scheinberg either to place an IUPC or perform a C-section. Pet. Prop. Rec. Order at 10, ¶36. The Department's expert witness, Dr. John Busowski, testified unequivocally and unconditionally, however, that the standard of care does not require the use of an IUPC. T. 36. The undersigned credits this evidence and finds that Dr. Scheinberg's nonuse of an IUPC did not breach the standard of care. Dr. Scheinberg conducted a physical at around 2:00 a.m. on February 2, 2005, which included taking L.G.'s complete history and performing a vaginal examination. L.G.'s cervix remained dilated to approximately nine centimeters, and her labor had not substantially progressed for about four hours. Dr. Scheinberg noted in L.G.'s chart that the baby was in the posterior position at 2:00 a.m. The Department argues, based on Dr. Busowski's testimony, that as of 2:00 a.m., the standard of care required [Dr. Scheinberg to] choose one of the following options: (1) watch the patient for a few more hours to allow for progress; (2) place an IUPC to determine the adequacy of Patient L.G.'s contractions; (3) start Pitocin without the placement of an IUPC; or (4) perform a C- section. Pet. Prop. Rec. Order at 9-10, ¶ 32. The Department contends that Dr. Scheinberg breached the standard of care by choosing "simply to watch the patient for approximately 10 more hours"—— which was tantamount to "choosing to do nothing." Id. at 10, ¶¶ 33-34. In fact, Dr. Scheinberg chose to watch the patient, which was, according to Dr. Busowski, within the standard of care. Obviously, at 2:00 in the morning on February 2, 2005, Dr. Scheinberg did not choose to wait for 10 more hours, because at that point he (unlike the parties to this litigation) did not know what was about to happen. The nurses' notes reflect that L.G. was under close observation throughout the early morning hours, and that Dr. Scheinberg was following the situation. At 4:30 a.m., L.G. was set up to push and at 4:45 a.m. was pushing well. At 6:15 a.m., the notes indicate that Dr. Scheinberg was aware of the mother's attempts to push. At 6:45 a.m., he reviewed the strips from the fetal heart monitor. At 7:45 a.m., he was present and aware of L.G.'s status. From 7:00 a.m. until 8:00 a.m., no contractions were identifiable on the external monitor. At 8:00 a.m., however, L.G. was comfortable and pushing well. She stopped pushing at 8:30 a.m., but remained comfortable. Dr. Scheinberg then ordered the administration of Pitocin, a medicine which is used to strengthen contractions and hasten delivery. Although the Department faults Dr. Scheinberg for giving L.G. Pitocin at this relatively late stage of her labor, Dr. Busowski (the Department's expert witness) admitted being unable to say "that Dr. Scheinberg should have started Pitocin earlier " T. 72. The Department therefore has no clear evidential basis for second-guessing Dr. Scheinberg's professional judgment in this particular, and neither does the undersigned. At 9:10 a.m., L.G. resumed pushing. The baby's fetal heart tones (heartbeats) were stable. L.G. continued pushing, with her family present, until around 11:00 a.m., at which time Dr. Scheinberg discussed the situation with the patient and her family. Dr. Scheinberg explained to L.G. or her husband the risks of, and alternatives to, performing a vacuum-assisted vaginal delivery. Either L.G. or her husband gave verbal consent to the use of a vacuum device to assist in the delivery. Between 11:00 a.m. and 11:10 a.m., the fetal heart monitor detected some variable decelerations, meaning a decrease in heart rate that could be a sign of fetal distress. Dr. Scheinberg delivered the baby at 11:23 a.m., using a vacuum device to help pull the infant out of the birth canal. In his post-operative notes, Dr. Scheinberg wrote that his "pre-operative diagnosis" was "+3 station — prolonged second stage 2½ hrs." As a "post-operative diagnosis," Dr. Scheinberg recorded, "same + tight cord." He reported the following "findings": "tight cord cut on perineum[;] mec[onium] aspirated on perineum."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Dr. Scheinberg not guilty of the charges set forth in the Complaint. DONE AND ENTERED this 20th day of June, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM 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 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of June, 2011.
The Issue Whether Respondent violated sections 458.331(1)(m), (q), and (t), Florida Statutes (2007-2011), and, if so, what discipline should be imposed.
Findings Of Fact The Parties DOH is the state agency charged with regulating the practice of licensed physicians pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. DOH is pursuing sanctions against Respondent based on her provision of medical care to patients A.M., C.B., and P.A. At all times relevant to this case, Respondent was licensed as a medical doctor within the State of Florida, having been issued license number ME 59800. Respondent is board certified by the American Board of Internal Medicine with a specialty in Infectious Disease. Respondent received her medical degree from Christian Medical College in India in 1984. Her medical career, according to her curriculum vitae, includes the following places of employment: 1996 Bay Area Primary Care 1997 American Family and Geriatrics 1998 Faculty appointment at University of South Florida – voluntary 2/99-11/99 Veteran’s Administration (Medical Officer on Duty) 1993-present Private Practice Respondent’s June 30, 2014, deposition testimony was that she is currently working as a medical provider at Fort Tryon Rehab and Nursing Home in New York, and prior to that she was working at a walk-in clinic in Queens, New York. Respondent testified that she currently resides in Pinellas Park, Florida. In 2008, Respondent’s Florida practice, Bay Area Infectious Disease (BAID), was located at 5840 Park Boulevard, Pinellas Park, Florida, and most recently at 1527 South Missouri Avenue, Clearwater, Florida. Each practice location is now closed. Respondent later testified that she had a practice located at 6251 Park Boulevard, Pinellas Park, Florida, which is also closed. Jamie Carrizosa, M.D. (Dr. Carrizosa) is a board- certified internal medicine and infectious disease physician who testified as an expert for DOH. Prior to his retirement in July 2011, Dr. Carrizosa had an active medical practice including hospital privileges. He is currently an Associate Professor of Medicine at the University of Central Florida, teaching first and second year students in the areas of microbiology and immunology. While in private practice, he treated patients with suspected skin infections, MRSA skin infections, candidiasis and other types of skin diseases. Issa Ephtimios, M.D. (Dr. Ephtimios) is a board- certified physician in internal medicine, infectious diseases and infection control who testified as an expert for Respondent. He is an attending physician at Sacred Heart Hospital, West Florida Hospital, Baptist Hospital, and Select Specialty Hospital in Pensacola, Florida. DOH Case No. 2009-13497 (DOAH Case No. 13-0595PL) On October 8, 2008, A.M. presented to Respondent with complaints of fatigue, headaches, and moodiness, according to a History and Physical Medi-Forms document. A BAID contract for services and an authorization for BAID to disclose protected health information (PHI) were executed on October 8. Within the records there was a diagram that contained pictures of a front and back body diagram and the handwritten words: “fatigue cold sweats fevers headaches.” Neither A.M.’s name nor the date appeared on the diagram, yet Respondent identified the diagram as belonging to A.M. and showing A.M.’s small lesions. On October 9, A.M. executed a Bay Area Infectious Disease and Infusion, PLC, “CONSENT FOR TREATMENT” form. Respondent’s progress notes are generally listed in the S.O.A.P. format.16/ The following appeared on one of A.M.’s October 9th Progress Notes: S: Complaint: MRSA,17/ headecha [sic], she like [sic] to talk W Dr. Pimple on but [sic] 3 rounds Zyvox, [illegible] c/o lethargic, gain wt, fatigue, headaches Pale, feets [sic] not Percocet –[illegible].” O: Exam: Ht 5.6” Wt 172 Age 16 M/F BMI T BP 118/64 P 65 R PO2 99_ Gluc A: General Appearance: WNL/18 HEENT: WNL Neck: WNL Chest: WNL Breast: WNL Heart: WNL Lungs: WNL Abdomen: WNL Genitalia: WNL Skin: WNL + multiple abcees [sic] Spine: WNL Extremities: WNL [All the “WNL” were typed capital letters.] DIAGNOSIS: Skin Abcess- Buttock, leg MRSA – Community Acquired P: PLAN: Vancomycin 1 gr daily [illegible] A second Progress Note for A.M., also dated October 9, contains the same information in the “S” and “O” portions, but at the “A” portion, it has no notations other than the pre-printed “WNL” at the “Skin” section, and it does not contain a “Diagnosis.” Respondent admitted that there were times when she would “complete records later on.” Respondent’s progress notes for A.M. from October 10 through October 16 were in a slightly different SOAP format. A.M.’s October 10 Progress Note reflects the following: S: Complaint: Vanco reaction O: Examination: BP P T R HT WT PO2 Glucose General Appearance; Awake alert,orientedx3 Head: Normocephalic atraurmatic EENT: PERLA, EOMI,Sclera-non-icteric, conjunctiva-pink Neck: Supple, no JVD. No Lymph nodes Heart: S1 S2 normal, murmurs Lungs: clear Abdomen: Soft, no masses, no tenderness, BS+, no hepatomegaly, no splenomegaly Left Lymph-inguinal: WNL Right Lymph-inguinal: WNL Extremities: No clubbing, cyanosis, edema Neurological: Motor-5/5, sensory-5/5, Deep tendon reflexes 2+ Cranial nerves Intact Skin: no rashes + circled Abscess Muskuloskeletal: WNL CLINICAL ASSESSMENT: MRSA, Skin Abcess CVIO PLAN: Zyvox A.M.’s progress notes between October 11 and 31, 2008, reflect various subjective complaints regarding her skin conditions. The physical examinations for each day do not contain consistent information regarding A.M.’s blood pressure, her height, weight, respirations, PO2, and glucose. On two days the “skin” section reflected “no rashes,” yet the clinical assessment reported “Skin Abces – improvely” [sic] or just “skin abcess.” On three progress notes (October 17, 18 and 20, 2008), there is a hand-written notation at the “Heart” section which indicates that A.M. might have a heart murmur, yet in the diagnosis section there is no mention of a heart issue or endocarditis.19/ All other progress notes regarding the “heart” contain the pre-printed “WNL.” A.M.’s IV/IM procedure notes beginning on October 10 and continuing through October 31, each reflect “heart murmur” in the diagnosis section along with “MRSA Skin abcess.” Respondent testified that she felt justified in using IV Vancomycin because A.M. was “doing the heart murmur.” However, Respondent’s initial plan included Vancomycin before any heart murmur was detected or assessed. Vancomycin is a prescription medication used to treat staphylococcal infections, and is usually utilized for more serious infections such as endocarditis. Zyvox is a prescription medication that comes in either an IV or oral form used to treat infections. Respondent claimed that there were missing medical records for A.M. However, with respect to patient A.M., Respondent claimed a progress note (part of the history and physical exam) from October 8 was the only medical record that was missing. Respondent then asserted that A.M. brought in her primary doctor’s referral which reflected A.M.’s treatment, including the medication prescribed; yet those medical records are not present. Respondent further testified that she “usually” puts prior treatment provider records in her patient’s file. Respondent maintained that she kept a lot of A.M.’s medical records on a computer that was bought in January 2001. However, that computer crashed in October 2011. A computer crash is plausible; however, the DOH subpoena was properly issued and served on Respondent on January 28, 2010, more than nine months before the alleged computer crash. Respondent then claimed that she “did not have access to that computer, which later crashed,” followed by her claim that “that practice was closed and when they came here, we only had the old, whatever, paper records.” Respondent’s position on these records was disingenuous at best. Respondent claimed that A.M. was seen and her medical records were at a different location (6251 Park Boulevard) than where the subpoena was served (5840 Park Boulevard).20/ Respondent then claimed the records that were moved from one facility to another facility could not be located. Respondent alluded to a potential police report regarding an alleged theft of medical records and other office items; however, nothing substantiated that, and Respondent’s testimony about possible criminal activity is not credible. Respondent admitted that some of A.M.’s medical records, specifically progress notes, were pre-printed, and that she wrote on some of the progress notes. In the progress notes dated October 10, 11, 13 through 18, 20 through 25, and 27 through 30, the handwriting appears to be the same, except for the change in each date. Further, Respondent confirmed A.M.’s 18 pages of progress notes of Vancomycin administration, yet distanced herself from them by saying “sometimes the charts were completed later on, so it’s possibility that it -- that it -- you know, it’s progress notes for the IV administration, but – um . . . the dates are written by nurses, so I don’t -- I don’t know.” Respondent’s inability or unwillingness to identify who may have written on A.M.’s progress notes and her avoidance in answering direct questions or claiming she did not recall the patient (and then discussing the patient) greatly diminished her credibility. Respondent claimed that there were “some verbal changes” she gave that were in a “set of nursing records,” which were not present. Any “changes” or directions given by Respondent should have been contained within her medical records for the care of A.M. Respondent maintained that her diagnosis of A.M. was based on Respondent’s total clinical picture of A.M., including A.M.’s “symptoms, her presentation, her lesions, her course -- she’d had repeated courses of oral antibiotics, and was getting recurrence.” Yet, Respondent also claimed A.M. “came in with these culture results from the primary, and that’s how the staff . . . it states MRSA, because it was already documented MRSA.” Standard of Care Respondent was required to practice medicine in her care of A.M. with “that level of care, skill, and treatment which is recognized in general law related to health care licensure.” Based on the credited opinions of Dr. Carrizosa, Respondent’s treatment and care of A.M. violated the standard of care for the following reasons. A reasonably prudent health care provider suspecting a patient has MRSA would observe the abrasion(s), culture the abrasion (MRSA), send the culture out for laboratory confirmation, prescribe oral antibiotics, and if the MRSA does not respond to the oral antibiotics, prescribe and administer IV antibiotics. Dr. Carrizosa noted that Respondent did not provide a description of A.M.’s abscesses, did not indicate that A.M.’s abscesses were drained, incised, cleaned or bandaged, or that Respondent provided any patient education to A.M. Although labs were ordered, there was no request for a bacterial culture or for an antimicrobial susceptibility test to be completed. Dr. Carrizosa expressed concern that young people can eliminate antibiotics within six to eight hours and there is a need for monitoring their medications to ensure they maintain a therapeutic level. Dr. Carrizosa opined that Respondent did not meet the standard of care in her treatment of A.M. The evidence clearly and convincingly establishes that Respondent violated the standard of care applicable to an infectious disease practitioner. Respondent presented the deposition testimony of Dr. Ephtimios. Dr. Ephtimios reviewed the same records as Dr. Carrizosa. Dr. Ephtimios admitted he had several lengthy conversations with Respondent during which time she provided additional information to Dr. Ephtimios that was not in A.M.’s written records regarding “the rationale for using the Vancomycin.” Respondent shared additional information with Dr. Ephtimios yet failed to recall or remember the patient during her own deposition testimony. Dr. Ephtimios’ opinion is not credible. Respondent’s deposition behavior lessens her credibility. Medical Records Medical records are maintained for a number of reasons. Primarily, medical records are necessary for the planning of patient care; for continuity of treatment; and to document the course of the patient’s medical evaluation, treatment, and progression through treatment. Further, medical records should document any communications between health care providers, and they serve as a basis for health care providers to be paid by either the patient or another party. See, rule 64B8-9.003. The medical records of A.M.’s contact with Respondent’s office between October 8, 2008, and October 31, 2008, do not meet Florida’s standards for medical records. A.M.’s records do not describe the abscesses, do not indicate if any of the abscesses were drained, incised, or cultured. Respondent failed to provide any assessment of a staph infection or provide any laboratory support for the use of the medication administered. Respondent did not document A.M.’s possible heart murmur, and failed to provide a diagnostic basis for endocarditis. Further portions of the medical record are illegible. There is no clear indication that Respondent provided A.M. with any education on her condition. Inappropriate Drug Therapy Respondent authorized the administration of Vancomycin and/or Zyvox to a 16-year-old female without adequately monitoring A.M.’s condition, or documenting the need for such use. Respondent’s failure to document the need for Vancomycin through appropriate or adequate testing was not in the best interest of A.M. DOH Case No. 2011-06111 (DOAH Case No. 14-0514PL) On February 28, 2011, patient C.B., a 42-year-old female, presented to Respondent with complaints of food allergy issues, and gastrointestinal problems, gas, bloating, and other stomach issues.21/ When she presented to Respondent in February 2011, C.B. did not have any concerns about candida or thrush.22/ Respondent prescribed a Medrol Pak (a steroid) and directed C.B. to have lab tests for the candida antibody and an immune system panel. One week later, C.B. again presented to Respondent. C.B. did not have any of the symptoms for a chronic yeast infection such as vaginal itching or thrush. Respondent advised C.B. that she had a chronic yeast infection and her immune system required treatment. However, Respondent did not prescribe any medication to C.B. at that time. On March 14, 2011, C.B. returned to Respondent’s office and received Immunoglobulin23/ via an intravenous (IV) line. On March 22, 24 and 25, 2011, C.B. received IV Ambisome.24/ Thereafter, C.B. developed a rash on her arm where the IV had been placed and a papule on her stomach. C.B. declined further IV treatments because she did not think the medication was working. On March 29, Respondent prescribed VFEND25/ to C.B. On March 30 and 31 and April 1, 2011, C.B. was a “no show” at Respondent’s office. Yet each of C.B.’s progress notes contained information regarding C.B.’s general appearance. Respondent testified that those progress notes are preprinted forms and would be adjusted upon a patient’s examination. On April 4, 2011, Respondent’s progress note for C.B. reflects “Discuss with patient in detail, patient complains of one papule, advised patient about candidiasis, GI tract not responding to azoles. Complains of diarrhea, abdominal symptoms, wants IV meds.” C.B.’s progress note dated April 5, 2011, reflects under the “S: COMPLAINT: No show - Refused to get PICC line out. Patient walked out yesterday. Patient was told to wait for dressing change. Patient states to receptionist she will come today.” Respondent elected to document on April 5, something that happened on April 4, despite the fact that the progress note for April 4 reflected a discussion with C.B. On April 11, 2011, C.B. presented a request for her medical records to Respondent’s staff. C.B. received copies of her medical records and provided them to DOH. Respondent testified as to C.B.’s 2011 presentation and Respondent’s course of treatment, including what medications were prescribed. Respondent confirmed that an undated “History and Physical” (H&P) for C.B. was C.B.’s “initial history and physical” created from a template. This H&P purports to reflect that C.B. was “discharged [from Respondent’s practice] for misbehavior . . . was in jail. . . [and] begging [for Respondent] to help her.” This H&P also contained Respondent’s physical examination of C.B., which was recorded on a “Progress Note” of the same date. Differences in the two records of the same date exist. C.B. testified that she has never been in jail and that she had not been discharged from Respondent’s practice. C.B. is found to be a credible witness. Respondent’s testimony is not credible. Respondent averred that she discussed C.B.’s vaginal itching with C.B. during the March 7, 2011, office visit, yet Respondent did not prescribe any medications for C.B. C.B.’s first IV immunoglobulin was administered on March 14, a week later. Respondent claims she discussed her care and treatment with C.B. on Wednesday, March 23, 2011. C.B. did not see Respondent on March 23, as C.B. went to Respondent’s office located on Park Boulevard in Pinellas Park and that location was closed. C.B. found out that Respondent was working at an address in Clearwater. C.B. did not have adequate time to get to that Clearwater location before it closed for the day. Thus, C.B. missed the appointment on that day. C.B.’s candid and succinct testimony is credible. Respondent testfied that certain medical records for C.B. were missing: anything that was documented electronic or anything -- any reports or any old records, old reports, it doesn’t contain anything. And she came in for the treatment of a disease that’s been existing since 2006, so a lot of workup that’s done in the prior years for -- which is the relevant basis of the treatment at this point is not there. Respondent was not clear which medical records were missing. C.B. had not been a patient of Respondent for approximately two years. Respondent’s reliance or purported reliance on C.B.’s “old records, old reports” without adequate confirmation of C.B.’s current health issues via appropriate work-ups, laboratory studies and tests falls below the reasonably prudent similar health care provider standard. Standard of Care Respondent was required to meet the same standard of care as outlined in paragraph 25 above. Dr. Carrizosa’s testimony was clear, concise, and credible. He did not appear to have any prejudice against Respondent as a person, but was concerned about how she was practicing medicine. Based on the credited opinions of Dr. Carrizosa, Respondent’s treatment and care of C.B. violated the standard of care for the following reasons. Respondent failed to practice in such a manner as to determine within a reasonable degree of medical certainty that C.B. had systemic candida as was diagnosed by Respondent. Further, the laboratory results were not positive for an antimicrobial sensitivity culture taken from C.B. Additionally, C.B.’s complete blood count (CBC) and the differential count, which included neutrophils and lymphocytes, were normal. The administration of Ambisome, the most expensive of all the drugs available, was not warranted as C.B. did not have systemic candidiasis. Further, the immunoglobulin treatment was inappropriate as there was no evidence that C.B. had an immune dysfunction. Medical Records Dr. Ephtimios also provided an opinion on behalf of Respondent. Dr. Ephtimios had a discussion with Respondent regarding the care and treatment provided to C.B. outside the medical records provided. Dr. Ephtimios admitted that he does not use a Medrol Pak in his practice; he does not feel comfortable practicing immunology (and would have referred C.B. out to an immunologist.) Dr. Ephtimios would not have ordered the laboratory tests that Respondent ordered; his understanding of what candidiasis means may differ from Respondent’s, and he speculated on what he thought Respondent “meant” in several instances. Dr. Ephtimios provided a somewhat exhaustive approach to the various forms of candidiasis; however, he qualified each approach. Each physician practices medicine using their own skill set and different methods of providing clinical assessments and treatment. However, Dr. Ephtimios provided various qualifiers to his opinion which rendered it less credible. The basis for creating, maintaining and retaining medical records is expressed in paragraph 25 above. The medical record of C.B.’s contact with Respondent’s office during this time does not meet Florida’s standards for medical records. C.B.’s records do not reflect an appropriate evaluation, as they fail to analyze C.B.’s main complaints, they fail to analyze the previous evaluations of C.B., and her physical exams were incomplete. DOH Case No. 2011-17799 (DOAH Case No. 14-0515PL) According to Respondent, patient P.A., a 38-year-old female, was “an ongoing patient [of hers] for over ten years.” Respondent saw P.A. between February 2008 and December 2011. Respondent provided medical records to DOH regarding P.A. However, Respondent admitted she did not provide all P.A.’s medical records because “a lot of records were missing,” and Respondent knew “at one point when they were very old records in the 6251 office some of them were also shredded.” Respondent further claimed in response to additional questioning about her shredding statement, [B]ecause the statute says, you know, after three years, so I’m not sure if the -- because I know some of the records were shredded by one of the secretaries. * * * The one [statute] which says once a practice is closed retain records for three years. Respondent identified one of P.A.’s progress notes (dated January 26, 2011) as “our procedure note,” but when asked “What was going on here according to these notes,” Respondent answered: “It’s hard to say. It’s not my handwriting.” Respondent could read the handwriting, but had “no clue” who wrote the progress note. Further, Respondent was unable to state if P.A. was administered either the gentamicin 40 milligrams or the clindamycin 600 milligrams as listed on the progress note. Medical Records The basis for creating, maintaining and retaining medical records is expressed in paragraph 25 above. In this instance, the testimony of Respondent clearly and convincingly proves Respondent violated section 458.331(1)(m) and rule 64B8-9.003. No evidence was presented that Respondent has been previously disciplined.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a Final Order finding that Respondent, Neelam Uppal, M.D., violated section 458.331(1)(m), (q) and (t), Florida Statutes; suspending her license for six months followed by two years probation with terms and conditions to be set by the Board of Medicine; imposing an administrative fine of $10,000.00; requiring the successful completion of a course or courses to make, keep and maintain medical records; requiring a course in professional responsibility and ethics, and such other educational courses as the Board of Medicine may require; and assessing costs as provided by law. DONE AND ENTERED this 17th day of September, 2014, in Tallahassee, Leon County, Florida. S LYNNE A. QUIMBY-PENNOCK 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 17th day of September,2014.
The Issue Whether Respondent engaged in medical malpractice, failed to keep legible medical records, exploited a patient for financial gain, or accepted or performed the professional responsibilities of an oncologist that he knew, or had reason to know, he was not competent to perform; and if so, what is the appropriate sanction.
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida who are accused of violating chapters 456 and 458, Florida Statutes. Respondent is licensed as a medical doctor in the state of Florida, having been issued license number ME 80412. At all times material to this proceeding, Respondent was the sole owner and sole physician at Holistic Family Medicine (HFM), a medical practice located at 9325 Glades Road, Suite 104, Boca Raton, Florida 33434. The charges against Respondent arise from Respondent's treatment of patient S.S. (S.S.) from March 17, 2011, until her death on February 10, 2013. M.S., S.S.'s mother, was present during all of S.S.'s medical appointments and was involved in all of S.S.'s medical decisions. Facts Related to S.S.'s Medical History In the spring of 2011, S.S., a 23-year-old female archeology student from Loxahatchee, Florida, suffered from a multitude of medical issues. At that time, S.S. was frustrated with her current primary care physician (PCP), Robert Federman, M.D., and treating sub-specialists because she felt that they were ignoring what she identified as her most pressing symptom, an excruciating pain in her side. Due to her frustration, S.S. sought a second opinion from Respondent at HFM on March 17, 2011. M.S. learned about Respondent from an employee at Whole Foods grocery store.2/ During her first appointment at HFM, S.S. told Respondent she was recently diagnosed with peripheral t-cell lymphoma (PTCL) by the University of Miami (UM), but that she was waiting on a second opinion from the H. Lee Moffitt Cancer Center & Research Institute (Moffitt). S.S. expressed skepticism at the PTCL diagnosis. Approximately nine months before S.S. first presented to Respondent, she suffered from unrelenting diarrhea, nausea, and vomiting. In September 2010, Dr. Federman referred S.S. to a gastroenterologist to diagnose these complaints. The gastroenterologist's attempt to diagnose S.S.'s persistent diarrhea, nausea, and vomiting eventually led to the discovery of several abnormal masses in S.S.'s abdomen. This discovery initiated a flurry of radiographic studies and biopsies that ultimately revealed cancerous cells in S.S.'s lymph nodes, consistent with PTCL. S.S. was provisionally diagnosed with PTCL by Deborah Glick, M.D., a UM hematologist during a consultation appointment on February 3, 2011. During the appointment, Dr. Glick indicated to S.S. that PTCL is a very aggressive cancer and that S.S. would likely die in a matter of months. S.S. did not agree with Dr. Glick's prognosis, so she decided to see another oncologist/hematologist. S.S. presented to Abraham Schwarzberg, M.D., a new oncologist/hematologist on February 8, 2011, to continue her ongoing work-up and management of her PTCL.3/ On February 16, 2011, after discussing S.S.'s biopsy results with UM pathology specialists, Dr. Schwarzberg recommended S.S.'s slides be reviewed at Moffitt because her case "ha[d] been a very complicated and tough case to make a diagnosis on." On February 25, 2011, S.S. traveled across the state for an oncology consultation at Moffitt, located in Tampa, Florida. Dr. Lubomir Sokol, M.D., an oncologist/hematologist employed by Moffitt advised S.S. that the long-term prognosis of PTCL patients treated with standard chemotherapy is not satisfactory. However, Dr. Sokol suggested that S.S. did not have PTCL, given the aggressive nature of the disease and her lack of symptoms at that time. Dr. Sokol requested S.S. submit her biopsy slides for review by Moffitt's pathologists, as well as by a world-renowned hemapathology expert specializing in lymphoma at the National Institutes of Health/National Cancer Institute (NCI), Dr. Elaine Jaffe. Dr. Sokol also requested S.S. undergo extensive staging exams. These exams, including a bone marrow biopsy, were negative--indicating that S.S.'s disease had not yet progressed to her bone marrow. Initial Meeting with Respondent – March 17, 2011 Of the foregoing information provided to Respondent by M.S. and S.S. during the March 17, 2011, initial appointment, Respondent only documented that S.S.'s bone marrow biopsy was negative; a seemingly insignificant detail compared to S.S.'s pending diagnosis of cancer and dire prognosis.4/ By the time S.S. spoke to Respondent on March 17, 2011, she had been told by various physicians that her biopsies were inconclusive, negative for cancer, and positive for cancer. S.S. was also told that she had PTCL and that she may not have PTCL. Finally, S.S. was told that she may die as a result of her malignancy in a matter of months. Any skepticism or doubt harbored by S.S. was completely understandable. Respondent encouraged S.S.'s skepticism by indicating to her that cancer was "low on his list" of S.S.'s possible concerns. Respondent shared a story regarding his uncle, a medical doctor who was successfully sued for $8.1 million for erroneously providing chemotherapy to a patient who did not have cancer. Respondent recommended S.S. undergo additional blood work ordered by him, so that he could have a better understanding of what was going on. Before her next appointment with Respondent, S.S.'s abdominal pain intensified, such that she presented to the Emergency Room and was admitted to Palms West Hospital (PWH) on March 28, 2011. S.S. underwent a CT scan that revealed a distended gallbladder, as well as masses in her abdomen near her liver and pancreas.5/ Ultimately, S.S.'s excruciating abdominal pain was attributed to a diseased gallbladder that needed to be immediately surgically removed. When Respondent learned of S.S.'s upcoming surgery, he told M.S. that he would get S.S.'s operative report and see S.S. in follow-up after her surgery. S.S.'s gallbladder was removed on April 1, 2011, and she was discharged with instructions to follow up with her PCP. After the surgery, S.S.'s frustration with Dr. Federman peaked, which prompted her to terminate her doctor-patient relationship with him. Although no formal notice was sent to Dr. Federman from S.S., Dr. Federman was informed by M.S. that she and S.S. were "going a different way" for her treatment. S.S. never made another appointment with Dr. Federman. Conversely, S.S. fortified her trust in Respondent and relied nearly exclusively on him for all of her future medical advice, recommendations, referrals, guidance, and treatment. Post-Surgery Follow Up with Respondent - April 7, 2011 Accordingly, on April 7, 2011, S.S. presented to Respondent for a "post-op" follow-up visit, at which Respondent discussed S.S.'s recent blood work results with her. Notably, Respondent failed to document anything concerning her post-op follow-up, aside from the paltry comment "gallbladder surgery." That same day, after S.S. left HFM, Dr. Sokol, from Moffitt, called M.S. and indicated that S.S.'s diagnosis was changed from PTCL to Hodgkin's lymphoma (HL). HL is a much less aggressive form of cancer and has a very high potential to be cured when treated. M.S. immediately updated Respondent about S.S.'s new diagnosis. Respondent indicated that he was "underwhelmed at the possibility of HL," but Respondent nevertheless assumed his role as S.S.'s PCP and attempted to coordinate care with Dr. Sokol. Request for Referral to Mayo – May 16, 2011 Because S.S. had now been presented with two conflicting diagnoses (PTCL and HL), S.S. researched cancer centers in Florida and decided to obtain a third opinion6/ from the Mayo Clinic (Mayo) in Jacksonville, Florida. On May 16, 2011, M.S. informed Respondent that S.S. made an appointment herself for a consultation at Mayo on June 1, 2011. M.S. requested that Respondent send a letter to Mayo, so he could be listed as a doctor that Mayo could contact regarding S.S.'s progress. Respondent wrote "refer to Mayo" on a prescription pad and mailed it the same day. Request for PET Scan – June 2011 On June 1, 2011, S.S. presented to Vivek Roy, M.D., an oncologist/hematologist at Mayo for consultation. Dr. Roy told S.S. that the Mayo pathologists would review her biopsy slides since there was a debate about the exact diagnosis. Dr. Roy asked S.S. to obtain an updated PET scan.7/ On June 14, 2011, Respondent again assumed his role as S.S.'s PCP by attempting to facilitate an updated PET scan for Dr. Roy. On June 20, 2011, Respondent received the PET scan report indicating that S.S.'s malignancy progressed to her pelvic region. As of this date, Respondent clearly knew S.S. was suffering from some form of lymphoma. On June 22, 2011, Dr. Roy confirmed the HL diagnosis and recommended S.S. receive ABVD chemotherapy.8/ S.S. elected to receive treatment locally and scheduled an appointment with Neal Rothschild, M.D., an oncologist/hematologist located in Palm Beach Gardens, Florida. S.S. presented to Dr. Rothschild on June 27, 2011, to discuss chemotherapy and the ongoing management of her HL. Respondent's Attribution of S.S.'s symptoms to Mold – June 2011 A few days before S.S.'s appointment with Dr. Rothschild, M.S. asked Respondent if it were possible that a "toxic something" was causing all of S.S.'s symptoms, including her swollen lymph nodes. Instead of telling M.S. that S.S.'s symptoms, including her swollen lymph nodes, were more likely caused by her untreated cancer, Respondent suggested that S.S.'s house be tested for mold. On July 5, 2011, S.S. presented to Respondent for a "check-up" and to discuss the little bit of mold that was found in her home. During the appointment, S.S. mentioned to Respondent that she met with Dr. Rothschild to discuss chemotherapy for her HL. Respondent reiterated to S.S. that cancer was "low on his list" of possible medical concerns. Respondent indicated that S.S.'s tests showing she had increased lymphocytes9/ were not indicative of cancer, especially since he did not see any "Reed- Sternberg" cells.10/ Respondent insinuated that oncologists often overreact to the presence of lymphocytes and recommend chemotherapy before making an actual diagnosis. Respondent further insinuated that Dr. Rothschild may not be a competent oncologist. Respondent recommended S.S. pursue her "mold allergy" issues and referred her to Daniel Tucker, M.D., a local allergist. Respondent also provided S.S. with a letter addressed to Dr. Rothschild wherein he emphasized that "mold could be causing all of [S.S.'s] symptoms and exam findings." As instructed, S.S. presented to Dr. Tucker on July 12, 2011, and continued to follow-up with him until November 2011. Dr. Tucker diagnosed S.S. with mold allergies and recommended a series of life-style modifications to reduce her mold allergy symptoms. Discontinuation of Oncologist/Hematologist Care – July 2011 S.S. believed Respondent's assessment that her symptoms were actually caused by allergies. Accordingly, S.S. only pursued treatment for her allergies, with the understanding that Respondent would refer her to a new oncologist/hematologist of his choosing if he thought she needed to pursue cancer treatment. On July 28, 2011, S.S. cancelled her follow-up appointment with Dr. Rothschild. M.S. indicated to Dr. Rothschild that S.S. wanted to resolve her "mold issues" before pursuing chemotherapy treatment. S.S. never returned to Dr. Rothschild or any other oncologist/hematologist for treatment. Instead, S.S. stayed under the care of Respondent, who spent the next year and a-half attempting to find the "cause" of S.S.'s symptomatic complaints. In contrast to Respondent's previous concern over S.S.'s "scary" HL diagnosis and his alleged multiple attempts to interact and coordinate care with S.S.'s oncologists, after July 5, 2011, Respondent never discussed HL, lymphoma, cancer, oncologists, or chemotherapy with S.S. again.11/ While addressing her symptomatic complaints, Respondent never told S.S. that her symptoms could be caused by untreated HL, even when many of her symptoms were reasonably attributed to her progressive HL. Complaints of Back Pain – August 2011 On August 30, 2011, S.S. complained to Respondent about "back pain." Respondent diagnosed S.S. with lumbosacral neuritis12/ and prescribed Flector patches to treat the pain. Respondent assumed S.S.'s back pain was caused by mold without ever conducting an appropriate evaluation, including physical examination, or test to determine its cause. S.S. was charged $200.00 for the August 30, 2011, office visit. Complaints of Lymph Node Swelling – December 2011 On December 15, 2011, S.S. complained to Respondent about her lymph nodes and swelling. Respondent did not address S.S.'s lymph node or swelling concerns. Respondent failed to conduct and document a complete and appropriate physical exam of S.S.'s lymph nodes. S.S. was charged $425.00 for the December 15, 2011, visit. Concern Regarding Lymph Nodes, Pain, and Dysuria – March 2012 On March 5, 2012, S.S. complained to Respondent about pain in her side, pain in her lymph nodes resulting in sleeping trouble, urgency, and dysuria.13/ Respondent treated S.S.'s painful lymph nodes with low-dose naltrexone. Respondent assumed S.S.'s symptoms of urgency and dysuria were caused by a urinary tract infection (UTI) and prescribed antibiotics to treat the "UTI." UTIs are diagnosed with a urine culture or urinalysis. These tests are also useful in determining the strain of bacteria, which would dictate the most appropriate type of antibiotic to use. Respondent did not perform a urine culture or urinalysis before prescribing an antibiotic to treat S.S.'s UTI-like symptoms. Respondent did not perform and document a complete and accurate physical exam of S.S.'s lymph node swelling, noting where the swollen lymph nodes were located or any other appropriate documentation of the exam. S.S. was charged $205.00 for the March 5, 2012, appointment. Complaints of UTI-like Symptoms – May 2012 through January 2013 S.S. repeatedly complained to Respondent about UTI-like symptoms, including on May 3, 2012, May 10, 2012, May 16, 2012, June 27, 2012, and January 3, 2013. Each time, Respondent assumed S.S.'s symptoms were caused by a UTI and prescribed her antibiotics without ever performing a urine culture or urinalysis to confirm the diagnosis or determine which antibiotic would be most appropriate to prescribe. Respondent also considered that S.S.'s UTI-like symptoms may be caused by an uncommon antibiotic-resistant infection called interstitial cystitis. Continued Concerns Regarding Lymph Nodes – May 16, 2012 On May 16, 2012, S.S. presented to Respondent with complaints of enlarged lymph nodes. Respondent did not examine, document an examination of, or otherwise address S.S.'s enlarged lymph nodes. However, S.S. was charged $200.00 for the May 16, 2012, appointment. Swollen Legs – January 3, 2013 On January 3, 2013, S.S. complained to Respondent about swelling in her legs. Respondent assumed S.S.'s swollen legs were caused by an allergic reaction, without performing any diagnostic examination or tests to confirm his assumption. S.S. was charged $200.00 for the January 3, 2013, appointment. Abdominal Pain and Swelling – January 2013 On January 11, 2013, S.S. complained of abdominal pain and swelling. Respondent assumed S.S.'s pain and swelling were caused by an allergic reaction and prescribed an allergy medication to treat her pain and swelling. On January 12, 2013, S.S. again complained of swelling in her legs. Respondent assumed S.S.'s swollen legs were caused by an allergic reaction and prescribed her an allergy medication. On January 14, 2013, S.S. underwent blood work at Respondent's request. The blood work cost S.S. $575.00. When Respondent received S.S.'s blood work results, Respondent called S.S. in for an urgent appointment because he thought her blood work results were "striking" and really "weird."14/ Urgent Appointment – January 24, 2013 The blood work did not test S.S.'s iron levels. Regardless, Respondent felt S.S. was iron deficient and instructed his medical assistant (MA) to administer 100 mg of iron to her on January 24, 2013. S.S.'s blood work revealed that she had high calcium levels. Respondent considered that S.S.'s potential issue with her parathyroid hormone (PTH) was her "dominant concern" at that time. Respondent recommended S.S. receive more testing and suggested that she may need PTH surgery in Tampa. Respondent also determined that S.S. had issues with her DHEA, Vitamin D, and T3 levels and spent considerable time discussing these concerns. During the urgent appointment, S.S. complained of swelling in her legs accompanied by weakness. S.S.'s pain and swelling was so severe that she used a cane to assist her in walking and requested Respondent to assist her in obtaining a temporary parking permit. Respondent now assumed S.S.'s swollen legs were caused by water retention and prescribed a diuretic to treat S.S.'s swollen legs. At no time during this appointment did Respondent inquire about, or suggest, that S.S.'s symptoms were attributable to HL or its treatment. S.S. was charged $680.00 for the January 24, 2013, urgent appointment. On the same day, S.S. underwent more blood work at Respondent's request. The additional blood work cost S.S. another $355.00. Review of Blood work – February 2013 On February 5, 2013, when Respondent reviewed S.S.'s second set of blood work results, Respondent was confused by her results and indicated that he was going to review S.S.'s chart to "come up with a better idea of what is going on." Despite knowing of S.S.’s significant cancer diagnosis since June 2011, Respondent did not consider, or discuss with S.S., the possibility that S.S. had unusual results because she had cancer, or in the alternative, was undergoing chemotherapy treatment. S.S.'s blood work revealed that she had normal iron levels. Nevertheless, Respondent felt S.S. was iron deficient and instructed his MA to administer 100 mg of iron to her on February 7, 2013. S.S. was charged $150.00 for the iron shot. Patient's Death – February 10, 2013 When S.S. went to HFM for her shot, she was in significant distress related to pain and severe swelling in her legs. S.S. rapidly decompensated and died in the hospital three days later, on February 10, 2013. Respondent initially thought S.S. may have died either from an adverse reaction to the iron shot or a combination of pneumonia and sepsis causing respiratory failure. When the medical examiner who performed S.S.'s autopsy notified Respondent that S.S. died from complications of untreated HL, Respondent responded by saying that S.S. had never been definitively diagnosed with HL. Despite having reviewed S.S.'s radiographic, pathology, and oncology consultation reports indicating that S.S. had HL,15/ and having treated her symptoms indicative of progressed HL for nearly two years, Respondent refused to believe that S.S. had HL, choosing instead to believe that she presented "more like a [chronic fatigue] patient allergic to mold than a lymphoma patient." It was not until Respondent received the final autopsy report, several months after S.S. died, that Respondent was finally "satisfied" that S.S. had HL all along. Facts Related to the Standard of Care Violation Charles Powers, M.D., an expert in family medicine, offered testimony on the standard of care that a doctor providing primary care services to a patient in a family medicine practice setting is required to follow when a young patient is diagnosed with HL, a highly curable malignancy. Dr. Powers opined that the role of the PCP is to use his or her established relationship with the patient to facilitate and ensure that the patient receives appropriate treatment. In this case, Respondent's role as S.S.'s PCP was to ensure that S.S. received chemotherapy, or in the alternative, be fully informed of the consequences of foregoing chemotherapy. Stephen Silver, M.D., testified on behalf of Respondent and opined that Respondent's role in S.S.'s care was as an out-of-network, adjunct holistic doctor, more comparable to an acupuncturist or Reiki specialist than a medical doctor. Dr. Silver suggested that Respondent should not be held to the same standard as other family medicine doctors providing primary care services. Dr. Silver opined that because of Respondent's limited "adjunctive holistic" role, the standard of care in Florida did not require Respondent to be engaged in S.S.'s care and treatment with relation to her cancer. Dr. Silver based his opinion on the incorrect assumption that from March 2011 to February 2013, S.S. was under the care of her former PCP, Dr. Federman, and that Respondent provided strictly adjunctive holistic treatment to S.S.16/ Dr. Silver defined "holistic therapies" to include acupuncture, massage, nutritional therapies, vitamin therapies, and energetic medicine, such as Reiki. Dr. Silver specified that surgery and pharmaceuticals are not "holistic therapies," but instead fall in the realm of "traditional medical services." Respondent did not provide "strictly holistic" treatment to S.S. From March 2011 to February 2013, Respondent prescribed and recommended 27 substances to S.S. Of those substances, 15 of them were drugs (including legend drugs, compounded medications, and over-the-counter medications) and 12 were nutritional supplements/vitamins. Respondent also recommended that S.S. undergo surgery, was actively involved in S.S.'s post-operative care, and ordered two PET CT scans for S.S. Respondent never recommended S.S. receive massage therapy, acupuncture, or Reiki. Furthermore, it is clear that by May 2011, S.S. severed all ties from her former PCP and relied on Respondent to fulfill the role of her PCP. Therefore, Respondent was not providing strictly "adjunctive" care to S.S. Dr. Silver contends that Respondent could not have been S.S.'s PCP because he was "out-of-network" with S.S.'s insurance, did not advertise as a PCP, and had a very "holistically- oriented" medical intake form. However, a PCP is not simply defined as the doctor whose name appears on a patient's insurance card. Instead, the definition of a PCP is a fluid concept that includes the doctor whom the patient trusts to provide appropriate medical advice, guidance, recommendations, referrals, and treatment.17/ Under this definition, it is possible for even a sub-specialist to operate as a patient's PCP. Those involved in S.S.'s medical treatment, including M.S., Dr. Tucker, and Dr. Juste, believed that Respondent was S.S.'s PCP. Additionally, Respondent advertised that he offered concierge-level primary care services to his patients on his website. Respondent operated as S.S.'s PCP, regardless of whether he was out-of-network with her insurance provider, advertised as a PCP, or had a "holistic" intake form. Based on the foregoing, Dr. Silver's opinion, that Respondent is not required to adhere to the same standard of care as family medicine doctors in Florida, is rejected. Timely Referral When a PCP learns that a young patient is diagnosed with a highly curable malignancy, the standard of care in Florida requires the PCP to timely refer the patient to an oncologist/hematologist for chemotherapy treatment. This standard is applicable as long as the patient is not under the current care of an oncologist/hematologist. From July 2011 to February 2013, Respondent knew, or should have known, that S.S. was not under the care of a treating oncologist/hematologist and should have timely referred her to one, or ensured that she present to an oncologist/hematologist. Although Respondent suggested that he did refer S.S. to an oncologist, he eventually attempted to justify his failure to do so by alternatively asserting: 1) it was not his duty to refer S.S. to an oncologist; 2) it was unnecessary to refer S.S. to an oncologist because she was already under the care of an oncology "team"; and 3) it was unnecessary to refer S.S. to an oncologist because she adamantly refused to be treated for HL. At the final hearing, Respondent testified that he did not refer S.S. to an oncologist because he assumed she was under the care of Dr. Rothschild, receiving treatment as appropriate, from June 2011 until her death in February 2013. If it were true, why then would Respondent prescribe countless medications to S.S. without ever consulting her treating oncologist? Respondent himself testified that the treating oncologist needed every piece of information about the patient's concurrent treatment. Respondent's testimony in this regard simply is not credible. Respondent's testimony was also directly contradicted by his previous statements where he indicated that S.S. adamantly refused to undergo chemotherapy and that she rebuffed and resisted his attempts to encourage her to follow up with an oncologist. Respondent further contends that he went above-and- beyond his duty as a "holistic doctor" by "ensuring" S.S. went to Mayo for her consultation by writing "refer to Mayo Clinic" on a prescription pad (after S.S. already scheduled her appointment). However, Respondent never provided a definitive explanation for the purpose of this "refer to Mayo Clinic" document, and even at one point described it as a "back to school note" for S.S. to take to class. Based on these inconsistencies, Respondent's testimony regarding an oncology referral was not credible. M.S. testified that Respondent did not refer S.S. to an oncologist/hematologist, even though Respondent knew that S.S. was not under the care of one. M.S. also testified that S.S. was waiting on Respondent to refer her to an oncologist/hematologist if and when he decided that S.S. had lymphoma. M.S. testified that had Respondent referred S.S. to an oncologist/hematologist that he trusted, S.S. would have gone to that doctor for treatment. M.S.'s testimony was clear, concise, consistent, and credited. Respondent failed to timely refer S.S. to an oncologist/hematologist for appropriate treatment as soon as he knew or had reason to know that S.S. was not under the care of an oncologist/hematologist. Duty to Educate or Counsel After timely referring the patient to an oncologist/hematologist for treatment, if the doctor learns that the patient does not want to receive treatment, either because the patient is in denial of the diagnosis or simply does not want the treatment, the standard of care in Florida requires the PCP to educate or counsel the patient on the risks, including death, of foregoing potentially life-saving treatment, so that the patient can make a fully-informed decision. As the doctor counsels the patient, he or she must refrain from facilitating or encouraging the patient's denial of their diagnosis. Respondent stated that S.S. was in denial of her diagnosis of lymphoma long before she first came to see him and remained in denial of the diagnosis despite his multiple attempts to educate and counsel her. Specifically, Respondent claims he educated or counseled S.S. on May 12, 2011, May 16, 2011, March 5, 2012, May 16, 2012, and January 3, 2013. Any reference to these alleged discussions are absent from Respondent's notes. Respondent claims his advice was rebuffed, met with "stiff resistance," and that S.S. and her mother ultimately refused to believe that she had lymphoma. Respondent's statements were not credible because again, in direct contradiction to himself, Respondent testified at the final hearing that after July 5, 2011, he never spoke to S.S. about her lymphoma because he assumed S.S. was under the care of Dr. Rothschild and was receiving treatment as appropriate. In contrast, M.S. credibly testified that not only did Respondent never educate or counsel S.S. on the risks of not treating her lymphoma, he continuously undermined the recommendations and advice of the oncologists and facilitated S.S.'s skepticism toward her diagnosis. Indeed, instead of using his relationship with S.S. to assuage her fears related to her possibly life-threatening disease, Respondent expressed that he was "underwhelmed" with the possibility that she had lymphoma and repeatedly told S.S. that cancer was low on his list of possible medical concerns. Respondent further undermined the oncologists by indicating to S.S. that it would be potentially deadly to undergo chemotherapy if she did not actually have HL, despite knowing that S.S.'s confidence in her diagnosis was already very tenuous. Respondent failed to educate and counsel S.S. on the risks, including death, of failing to receive treatment for her HL. Symptoms When a patient makes a fully-informed decision to forego treatment of an otherwise terminal illness, such as HL, the standard of care in Florida requires the PCP to attribute the patient's symptoms that are reasonably caused by the malignancy to the malignancy. Additionally, the standard of care in Florida prohibits the PCP from attempting to find an alternate diagnosis for these symptoms, when the PCP knows that treatment for the alternate/secondary diagnosis would not change the patient's life expectancy. A June 20, 2011, Skull to Thigh PET CT scan of S.S. showed hypermetabolic masses and enlarged lymph nodes throughout S.S.'s body. These PET CT scan findings can only be attributed to a malignancy and are most consistent with HL. By June 2011, Respondent knew that S.S.'s HL had significantly progressed and included the involvement of her chest, abdomen, and pelvis. Respondent attributed these exam findings to S.S.'s allergies to mold, food, and drugs. As HL progresses throughout the body, it can cause the lymph nodes to enlarge. S.S. suffered from enlarged lymph nodes, a symptom reasonably attributed to HL. Respondent attributed S.S.'s enlarged lymph nodes to S.S.'s mold allergy. The enlarged lymph nodes can apply pressure on adjacent organs and structures, causing irritation and pain. S.S. suffered from back pain, a symptom that is reasonably attributed to HL. Respondent attributed S.S.'s back pain to S.S.'s mold allergy. S.S. suffered from abdominal pain, a symptom that is reasonably attributed to HL. Respondent attributed S.S.'s abdominal pain and swelling to an allergic reaction to an antibiotic, even though he had never seen this type of an allergic reaction to an antibiotic before. HL can suppress the immune system, making patients more susceptible to infections, like UTIs. HL can also mimic UTI symptoms if the lymph nodes in the patient's pelvic region are enlarged and pushing on the organs in the urinary tract. S.S. regularly experienced UTI-like symptoms like urgency and dysuria. These symptoms, whether they were caused by a UTI or from the pelvic lymph node involvement, are reasonably attributed to HL. Respondent attributed S.S.'s UTI-like symptoms to an infection without ever obtaining a urine culture or urinalysis to confirm his assumption. HL often causes swelling in patient's extremities by affecting the lymphatic system, which is used to transport fluids throughout the body. S.S. experienced extreme painful swelling in her legs, a symptom that was caused by her HL. Respondent attributed S.S.'s swollen legs to an allergic reaction. Respondent claims that he was "keenly" aware that S.S.'s symptoms could have been caused by HL and that he repeatedly informed S.S. of the same. However, Respondent claims that S.S. may have had concurrent illnesses that were causing similar symptoms and that it was not inappropriate for him to treat those symptoms. Interestingly, Respondent's notes do not reflect that he discussed with S.S. that her symptoms could be attributed to her untreated lymphoma. Despite being "keenly" aware that S.S. was suffering from untreated Stage III HL, Respondent often expressed bewilderment as to the cause of S.S.'s symptoms and repeatedly remarked that he wanted to "find out what was going on" and ordered blood work purportedly for that purpose. Due to the inconsistencies, Respondent's testimony is not credible. M.S. credibly testified that Respondent never indicated that any of these symptoms were likely caused by HL and that he spent time with S.S. trying to find the real cause of her symptoms. Respondent completely ignored S.S.'s existing HL diagnosis and instead believed that S.S. presented "more like a CFIDS[18/] patient allergic to mold than a lymphoma patient." Respondent failed to appropriately attribute S.S.’s symptoms to HL. Facts Related to Medical Records Violation During each office visit, Respondent should have created a progress note that included the subjective complaints of the patient, the objective observations of the patient (including a physical exam), an assessment of the patient's medical concerns, and a treatment plan (commonly referred to as "SOAP notes"). Included in these notes should be adequate justification for each diagnosis given and prescription given to the patient. Respondent failed to create or keep documentation of an adequate medical justification for the diagnoses he made and the treatment he provided to S.S. 134. On April 7, 2011, July 5, 2011, August 30, 2011, December 15, 2011, March 5, 2012, January 3, 2013, and January 24, 2013, Respondent failed completely to document the objective portion of the exam. Respondent also routinely failed to document adequate medical justification for the diagnoses or treatments rendered to S.S. Respondent failed to create or keep documentation in which he purportedly referred S.S. to an oncologist. Similarly, Respondent failed to create or keep documentation of his alleged educating or counseling of S.S. on the risks of foregoing chemotherapy treatment. Facts Related to Scope of Practice Respondent testified that he did not practice outside of the scope of his profession or perform or offer to perform professional responsibilities that he knows he is not competent to practice because he did not treat S.S. for cancer and did not offer to treat her for cancer. Petitioner offered the testimony of Roy Ambinder, M.D., an expert in oncology and hematology. Dr. Ambinder testified regarding the scope of practice for an oncologist and the standard of care for oncologists treating HL. Dr. Ambinder's testimony was clear, concise, consistent, and credited. It is not within the scope of practice for a family medicine physician to modify or reject an existing diagnosis of HL. Oncology is the study of cancer. A physician needs oncology training, experience, and a background in oncology to modify or reject an existing diagnosis of HL. Before modifying or rejecting an existing diagnosis of HL, a physician with the appropriate training, experience, and background would have to perform a physical exam, obtain blood work and additional radiographic studies, review past reports from the pathologists/oncologists, and review and interpret tissue biopsies. Respondent knew that five oncologists/hematologists, including specialists from Moffitt, NIH, and Mayo diagnosed S.S. with lymphoma. Respondent knew that he did not have the necessary qualifications, skill, training, education, or experience to modify or reject a diagnosis of HL. Yet, after harboring significant skepticism towards the diagnosis, Respondent reviewed S.S.'s pathology reports and radiographic studies and rejected S.S.'s HL diagnosis. Therefore, Respondent acted in the role of an oncologist, regardless of whether he actually treated, offered to treat, or advertised that he could treat S.S. for cancer. Respondent acted beyond the scope of his practice by law and performed professional responsibilities that he knew he was not competent to perform by rejecting S.S.'s existing diagnosis of HL. Facts Related to Financial Exploitation Violation Respondent knew, or should have known, that S.S. had lymphoma. Respondent knew that the only approved effective treatment for HL is chemotherapy and that if left untreated, HL will cause a patient's untimely death. Despite knowing that S.S. had HL, Respondent tried to find an alternate diagnosis to explain S.S.'s symptoms. M.S. and S.S. trusted Respondent to make medical decisions in S.S.'s best interest, such that Respondent was able to convince M.S. and S.S. that S.S.'s symptoms were caused by something other than HL, thus necessitating additional appointments and blood work. Between August 30, 2011, and February 7, 2013, Respondent addressed S.S.'s symptoms, which were reasonably caused by HL, with a variety of symptomatic treatments that Respondent knew, or should have known, would not have affected S.S.'s HL or extended her life expectancy. Respondent's MA administered S.S. $300.00 worth of InFed injections when he knew, or should have known, that S.S. was not iron-deficient and that iron would not have addressed S.S.'s fatal illness. Even if S.S. was iron-deficient, iron supplements would not have extended S.S.'s life expectancy. Respondent ordered $930.00 worth of blood work testing for S.S. when he knew or should have known that additional blood work would not have affected the established diagnosis of HL and that any diagnosis derived from the lab results would not have extended S.S.'s life expectancy. Respondent charged S.S. $1,760.00 in appointment fees over a one and a-half year period. During these appointments, Respondent treated S.S.'s symptomatic complaints with treatments that Respondent knew, or should have known, would not have addressed S.S.'s HL. Moreover, even if the treatments appropriately addressed a secondary diagnosis, Respondent knew, or should have known, that these consultations and recommended treatments would not have extended S.S.'s life expectancy. Accordingly, S.S. and her family paid Respondent and HFM approximately $2,990.00, in pursuit of treatment that Respondent influenced them to believe was necessary, appropriate, and would lead to or improve S.S.'s health. Respondent benefitted financially from the payments remitted to him and HFM by S.S. Facts Related to Aggravating Factors Respondent's conduct resulted in significant harm, including the extended suffering and ultimate death, of patient S.S. Petitioner entered a Final Order against Respondent's license in DOH Case No. 2008-00890 for violations of Sections 458.331(1)(t), and 458.331(1)(m), Florida Statutes (2003-2004). The Final Order constitutes discipline against Respondent's license.19/
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated sections 458.331(1)(t), 458.331(1)(m), 458.331(1)(n), and 456.072(1)(o), Florida Statutes, as charged in Petitioner's Second Amended Administrative Complaint; imposing a fine of $16,000.00; requiring repayment of $2,990.00 to the estate of S.S.; revoking Respondent's license to practice medicine; and imposing costs of the investigation and prosecution of this case. The undersigned reserves jurisdiction to rule on Daniel Tucker’s Application and Motion for Award of Expert Witness Fees. DONE AND ENTERED this 29th day of April, 2016, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 29th day of April, 2016.
The Issue The question presented is whether Respondent violated Section 456.072(1)(bb), Florida Statutes (2006), or Section 458.331(1)(nn), Florida Statutes (2006), by means of violating Florida Administrative Code Rule 64B8-9.007(2)(b), and if so, what penalty should be imposed?
Findings Of Fact Petitioner is the state agency charged with the licensing and regulation of medical doctors pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Respondent was a medical doctor licensed by the State of Florida, having been issued license number ME 70981. Respondent is also certified by the American Board of Internal Medicine with a subspecialty in interventional cardiology. No evidence was presented to indicate that Respondent has ever been disciplined by the Florida Board of Medicine. On March 12, 2007, Dr. Elsakr was caring for two patients at Halifax Medical Center (Halifax). Patient M.D. was an 84-year-old Caucasian female born on March 22, 1922. F.E. was an 82-year-old Caucasian female born on February 5, 1925. Both women were scheduled for cardiac procedures to be performed on March 12, 2007, but only F.E. was scheduled for a cardiac catheterization. M.D. and F.E. shared the same semi-private room at Halifax. During the night before the scheduled procedures, one of the patients asked to be moved away from the window, and as a result, the two patients' bed locations were reversed. Halifax had procedures in place related to the transport of patients from one area of the hospital to another. The policy required that a staff member referred to as a transporter was required to check at least two patient identifiers on the patient's arm band to confirm a patient's identity. The arm band contains four identifiers: the patient's name, date of birth, a medical record number and a visit number. While any of the four may be used, the patient's name and date of birth are preferred. Patient M.D. was supposed to be transported for a heart catheterization the morning of March 12. However, the hospital policy regarding patient identification was not followed, and the wrong patient, M.D. as opposed to F.E., was transported to the catheterization lab (cath lab). Apparently, the transporter relied on the room and bed placement of the patient as opposed to following the protocol for affirmatively checking the patient identifiers. Once a patient was transported to the cath lab for a procedure, Halifax had a separate "pause" or "time out" protocol designed to ensure that the correct patient was present and the correct procedure was performed. The procedure was designed to be consistent with standards provided by the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission for Accreditation of Hospitals, and the practices used by other hospitals. After transport and before a sterile field was created, the patient would be prepared for the procedure. As part of that preparation, a nurse was supposed to verify the patient's identity and confirm with another staff member that the patient's chart was the appropriate chart. The chart would then be provided to the person referred to as the recorder located in the adjacent control room outside the sterile field. The control room is separated from the sterile field by a plexi-glass wall, through which the recorder can observe everything taking place in the cath lab. The recorder would create a chronological log of the procedure, documenting the exact time when events took place. The physician performing the procedure would not necessarily be in the cath lab at the time the nurse verified the patient's identity. The chronological log for M.D. does not indicate that the patient's identity was confirmed or if it was confirmed, who confirmed it. Once a patient was prepped and draped, and the sterile field created, the recorder would call out the patient's name, procedure, procedure equipment, site and side of the procedure to be performed. The accuracy of the information was to be confirmed by a staff member saying "yes" or nodding his or her head. This procedure was considered by the hospital to be its "time out" procedure. The physician would be present but not actually participate in the time out, and would observe the time- out taking place. In this case, although the recorder called out F.E.'s name and the procedure she was scheduled to have, M.D. was actually present. Notwithstanding this error, an unidentified staff member either nodded or verbally confirmed that the information recited by the recorder was correct. Dr. Elsakr arrived at the cath lab after the patient was prepped but before the time out called by the recorder. He was present, but did not verbally participate, in the time out process. Before it took place, he met with the recorder in the control room to review the medical chart prior to the procedure. The medical chart reviewed was for F.E. After the time out, Dr. Elsakr approached the patient and stood near her head. By this time, the patient was fully draped, with blankets and surgical drapes covering all of her body except the surgical entry area (in this case her groin) and a portion of her face. Dr. Elsakr spoke to the patient, calling her by the first name of the patient F.E., and telling her, "[F.], this is Dr. Elsakr. I'm going to get started with your heart cath. Okay?" This interaction was consistent with his standard practice before he began a procedure, in order to give patients a level of comfort. M.D. did not initially respond to the name F., but said "yes" in response to Dr. Elsakr's question. He then moved down to the groin area, again called her by name (F.E.'s first name), and told her what she would feel as he started the procedure. She nodded her head and the procedure was begun. A catheterization was completed on the right side of the heart and begun on the left side. At that point, staff reported to Dr. Elsakr that the patient was the wrong patient. The procedure was immediately stopped. Dr. Elsakr immediately informed the patient, the patient's daughter, and the patient's primary care physician. He also noted the mistake on M.D.'s medical chart. Halifax Hospital undertook an investigation of the events leading to the procedure. The purpose of its investigation was to determine whether there was a breach in hospital safety protocols and to prevent any recurrence of the error. Dr. Donald Stoner, Halifax's Chief Medical Officer, testified that the fault lay with hospital staff, and not with Dr. Elsakr, and that if he had been the doctor involved, he likely would have done the same things as Dr. Elsakr. Halifax accepted full responsibility for the incident and independently compensated the patient for the incident. The hospital also determined that it would be inappropriate for Dr. Elsakr to be subject to any discipline for the incident by Halifax with respect to his privileges. Immediately after discovering that the wrong patient had the heart cath, Dr. Elsakr instructed that the patient should not be charged in any way for the procedure. While patient M.D. clearly could have been harmed by having to undergo the procedure, information about her condition was obtained that was actually a benefit to her.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That the Florida Board of Medicine enter a Final Order finding that Respondent, Ashraf Elsakr, M.D., violated Section 456.072(1)(bb), Florida Statutes, and Section 458.331(nn), Florida Statutes by means of violating Florida Administrative Code Rule 64B8-9.007(2)(b). As a penalty, it is recommended that the Board issue a letter of concern, and impose a $5,000 fine. In addition, Respondent should be required to obtain five hours in continuing medical education in the area of risk management, perform 25 hours of community service, and give a one-hour lecture on performing procedures on the wrong patient. DONE AND ENTERED this 30th day of June, 2010, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 30th day of June, 2010.
