The Issue The issues in this case are whether Respondent, a physician specializing in gastroenterology, (a) mistakenly gave a patient an upper endoscopy, thereby committing the disciplinable act of performing a "wrong procedure"; and/or (b) failed to confirm the intended procedure, allegedly a colonoscopy, before performing the alleged "wrong procedure," in violation of the "pause rule." If Respondent committed these offenses, or either of them, it will be necessary to determine an appropriate penalty.
Findings Of Fact At all times relevant to this case, Respondent Aryama Devi Sharma, M.D., was licensed to practice medicine in the state of Florida. Dr. Sharma has practiced in Broward County for nearly 20 years and has privileges at Broward General Medical Center (the "Hospital") in Fort Lauderdale, Florida. She is board-certified in gastroenterology and internal medicine. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Sharma. 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. Sharma committed two such offenses when she performed an upper endoscopy on a patient named G.R., instead of a colonoscopy as originally planned. The crux of this case is whether, as the Department contends, Dr. Sharma made a mistake and performed the "wrong procedure" on G.R., or whether, alternatively, Dr. Sharma deliberately changed the plan for G.R. and intentionally performed the upper endoscopy, as she maintains. As will be seen, the resolution of this essential dispute of material fact drives the ultimate determinations regarding whether Dr. Sharma performed a wrong procedure; (b) failed to obey the "pause rule," which requires a physician to stop and confirm the intended procedure and the patient's identify before proceeding; or (c) committed both of these disciplinable offenses. The events giving rise to this case began in the summer of 2007, when G.R.'s primary care physician, Dr. Valerie Solomon, referred G.R., then 60, to Dr. Sharma for a routine colonoscopy, which was overdue. As a result of this referral, Dr. Sharma saw G.R. for the first time on August 1, 2007. During this office visit, Dr. Sharma assessed G.R. and, while doing so, recorded pertinent medical information in her notes for inclusion in the patient's file. Dr. Sharma's contemporaneous notes report, for example, that G.R. complained of a change in bowel habits, occasional constipation, bloating, and heartburn. Dr. Sharma also wrote that G.R. was taking a prescription medicine called Actos for diabetes, as well as antacids as needed. Dr. Sharma performed routine abdominal and rectal examinations on G.R., who did not refuse to undergo either. (Had G.R. refused these examinations, Dr. Sharma would have discharged her from her practice.) In conducting the abdominal examination, Dr. Sharma discovered that G.R. had mild epigastric tenderness, which can be indicative of gastritis (an infection or inflammation of the stomach) or peptic ulcer disease. The rectal examination revealed occult blood——that is, blood invisible to the naked eye——in G.R.'s stool. Based on these examinations, Dr. Sharma formulated three working diagnoses: (a) occult G.I. bleeding, for which she wanted to rule out (as possible causes) cancer, polyps, and diverticulitis; (b) dyspepsia, for which she wanted to rule out peptic ulcer disease, gastroesophageal reflux disease (GERD), and Helicobactor pylori (H. pylori) infection; and (c) diabetes mellitus. These working and differential diagnoses are documented in Dr. Sharma's office notes. Dr. Sharma recommended that G.R. undergo both an upper endoscopy and a colonoscopy. Following her routine practice, Dr. Sharma explained both of these procedures to G.R., using anatomical posters in her examination room as visual aids. Dr. Sharma wrote in her office notes as follow: Plan on colonoscopy. Patient will need EGD [meaning esophagogastroduodenoscopy——in other words, an upper endoscopy], colonoscopy. Procedures explained to patient. All risks, benefits, complications and alternatives explained. [Patient] understands and agrees to proceed. Plan on EGD/colonoscopy. Schedule for colonoscopy. Dr. Sharma testified credibly, and the undersigned finds, that G.R. consented to have both procedures done. For no particular reason, it was decided that the colonoscopy would be performed first, and Dr. Sharma's staff accordingly made an appointment for G.R. to have a colonoscopy at the Hospital on August 23, 2007. Dr. Sharma signed an order for the colonoscopy, using a preprinted form for endoscopy procedures (including EGD), which was delivered to the Hospital the next day.1 On the morning of August 23, 2007, G.R. arrived at the Hospital to have the colonoscopy for which she had been scheduled. G.R. was seen upon admission by Christine Bomeisl, R.N., who obtained a medical history and checked G.R.'s vital signs. Ms. Bomeisl noted on a form called the Same Day Unit Flow Sheet that G.R. had arrived at 9:15 a.m., and that the patient reportedly had taken the laxative Fleet's Phospho-soda that day (as part of the colonoscopy prep) and vomited.2 At 9:40 a.m., G.R. signed a Consent for Operative and Invasive Procedures form, which authorized Dr. Sharma to perform a colonoscopy. Ms. Bomeisl witnessed G.R. sign the written consent form. At a few minutes past 10:00 a.m., Dr. Sharma gave G.R. a preoperative physical, during which she took a brief medical history. Pre-op visits of this nature are part of Dr. Sharma's routine practice. G.R. complained to Dr. Sharma of nausea, vomiting, and abdominal pain, which Dr. Sharma documented contemporaneously, on a form called the Short Form History and Physical Medical Clearance (the "Pre-op Form"), as "60 yr old with dyspepsia." On the line where the Pre-op Form called for entry of the patient's "chief complaint/present illness," Dr. Sharma wrote: "abdominal bloating." Upon learning that G.R. had vomited earlier and continued to be nauseas, Dr. Sharma became concerned about performing a colonoscopy. This was because, if G.R. vomited while under sedation, she might aspirate the contents of her stomach. Additionally, it was more urgent under the circumstances, in Dr. Sharma's medical judgment, to investigate G.R.'s abdominal symptoms immediately and to defer the colonoscopy, which could wait. Accordingly, Dr. Sharma decided to change the original plan and perform an upper endoscopy on G.R. that morning instead of a colonoscopy.3 Dr. Sharma explained the upper endoscopy procedure to G.R., informing G.R. that she would be putting a scope down G.R.'s esophagus to look into G.R.'s stomach in an attempt to find the cause of her acute distress. Dr. Sharma told G.R. that she would take tissue for a biopsy, if necessary. G.R. agreed with this change in the plan and verbally consented to the upper endoscopy.4 Dr. Sharma wrote on the Pre-op Form that the "procedure" to be performed was "EGD + Bp" [i.e. upper endoscopy with biopsy] and that the "plan" was "EGD + Bp." In addition, Dr. Sharma checked the "yes" box next to statement: "Risks, benefits, alternatives, & complications explained."5 Dr. Sharma told Hensylene Previlor, the nurse who was preparing patients for endoscopic procedures that morning, that G.R. would be having an upper endoscopy. From that point forward, all of the members of the team involved in implementing Dr. Sharma's order proceeded with the correct understanding that Dr. Sharma intended to perform an upper endoscopy on G.R.6 G.R. was brought into the procedure room shortly before 11:00 a.m. Consistent with the Hospital's procedure for positioning a patient for an upper endoscopy, G.R. was lying on her side, facing the endoscope, her feet pointed towards the door. Thus, when Dr. Sharma entered the room, G.R. was prepared for an upper endoscopy. Two nurses assisted Dr. Sharma with the upper endoscopy, Veronica Jacob, R.N.; and Tasha Nunziato, R.N. Ms. Jacob was the "paper-side" nurse responsible for documenting the procedure. Ms. Nunziato was the "scope-side" nurse, meaning that her job was to assist Dr. Sharma with the endoscope and to help place any biopsy tissues into the correct containers. At the outset, before the "time-out" was taken (when the team pauses to confirm the intended procedure and the patient's identity), and prior to the patient's receipt of anesthesia, Dr. Sharma once again explained to G.R. that she would be performing an upper endoscopy to investigate G.R.'s abdominal complaints. Ms. Nunziato gave another explanation of the procedure, similar to Dr. Sharma's, before inserting a bite block into G.R.'s mouth. G.R. never objected to having an upper endoscopy or denied having experienced the abdominal discomfort being cited as the reason for the procedure. Dr. Sharma initiated the time-out at about 11:00 a.m. by announcing that it had begun. Everyone stopped talking and focused on the process. Ms. Nunziato examined G.R.'s identification band and read aloud the patient's name, medical record number, and birth date and verified this information with G.R. Ms. Nunziato asked G.R. if Dr. Sharma were her doctor. G.R. said "yes." Ms. Nunziato asked G.R. if she agreed that an upper endoscopy would be performed on her, and G.R. answered "yes." Ms. Jacob, too, asked G.R. whether she were there for an upper endoscopy. G.R. replied that she was.7 Ms. Jacob consulted the endoscopy nursing record during the time-out to verify the intended procedure. This record indicated correctly that G.R. was to have an upper endoscopy in accordance with Dr. Sharma's most recent treatment order, which had countermanded the original order for a colonoscopy. (Unbeknown to Dr. Sharma, however, Ms. Jacob did not review the Consent for Operative and Invasive Procedures form that G.R. had signed that morning, pursuant to which G.R. authorized Dr. Sharma to perform a colonoscopy. Dr. Sharma was unaware that G.R. had not signed a written consent concerning the upper endoscopy.) Ms. Jacob documented that a time-out had been conducted for an EGD at 11:00 a.m. Anesthesia for the upper endoscopy was started at 11:05 a.m. The procedure commended at 11:06 a.m. and was finished at 11:08 a.m. During the upper endoscopy, Dr. Sharma found a hiatal hernia, gastritis, and antral erosions. Dr. Sharma also removed some tissue from G.R.'s stomach wall for biopsy. In her postoperative procedure note, Dr. Sharma wrote that it was her plan to have G.R. "be followed up in my office, at which time the biopsies will be discussed and if the patient is Helicobactor pylori positive, then the patient will be treated for that." After the upper endoscopy was performed, Ms. Jacob took G.R. to the recovery room, where Jackie Johnson, R.N., took over the care of G.R. Ms. Johnson reviewed G.R.'s chart, including the endoscopy report. When she noticed that G.R.'s discharge paperwork was for a colonoscopy patient, Ms. Johnson asked G.R. to identify the procedure that had been performed on her. G.R. told Ms. Johnson that she had undergone a colonoscopy. Ms. Johnson then left G.R. to report the discrepancy in the paperwork to the charge nurse.8 Eventually, the unit secretary was sent to retrieve Dr. Sharma to sort the matter out. Upon being alerted to a potential problem, Dr. Sharma went to the recovery room and found G.R. there. G.R. asked Dr. Sharma about the results of the colonoscopy. Dr. Sharma replied that she had performed an upper endoscopy as they had discussed earlier that morning.9 G.R. said she thought she was to have had both procedures. Because G.R. did not want to prepare again for a colonoscopy or take another day off from work, Dr. Sharma agreed, after consulting with the anesthesiologist, to perform a colonoscopy on G.R. later that day, which was done. The pathologist who performed the biopsy on G.R.'s tissue samples found that G.R.'s stomach contained "abundant organisms consistent with H. pylori." This caused the pathologist to diagnose chronic active Helicobactor pylori gastritis. An H. pylori infection can cause dyspepsia, the symptoms of which include abdominal pain, bloating, heartburn, and vomiting. On August 24, 2007, G.R. saw Dr. Solomon, apparently for a previously scheduled appointment. G.R. told her primary care physician that the results from the previous day's procedures should be sent to Dr. Solomon, so that she (G.R.) would not need to see Dr. Sharma again. G.R. reported being upset about what had happened at the Hospital the day before; she told Dr. Solomon that she had expected to have only a colonoscopy. G.R. was scheduled to return to Dr. Sharma's office for a follow-up appointment on September 5, 2007, to discuss the results of the endoscopic procedures. G.R. did not keep this appointment. Shortly thereafter, Dr. Sharma made several attempts to contact G.R. by telephone but failed to reach her. On September 19, 2007, Dr. Sharma informed Dr. Solomon of G.R.'s biopsy results and the H. pylori infection discovered during the upper endoscopy procedure. Dr. Solomon called G.R. after receiving a copy of the pathology report and prescribed G.R. the antibiotic Prevpac to treat the H. pylori infection. Dr. Solomon documented in the patient's chart that she had prescribed Prevpac for G.R. Dr. Sharma spoke with G.R. by telephone on September 26, 2007. During this conversation, which is documented in the patient chart that Dr. Sharma maintained on G.R., Dr. Sharma confirmed with G.R. that Dr. Solomon had prescribed an antibiotic to treat G.R.'s H. pylori infection.10 Ultimate Factual Determinations G.R. checked into the Hospital on the morning of August 23, 2007, expecting to have a colonoscopy pursuant to Dr. Sharma's order. Dr. Sharma countermanded the preexisting order for a colonoscopy, however, with a superseding order announced verbally at around 10:00 a.m., which called for G.R. to have an upper endoscopy. Because Dr. Sharma had previously told G.R. that G.R. would need to have an upper endoscopy so that Dr. Sharma could determine the cause of the abdominal discomfort G.R. had been experiencing, the order for an upper endoscopy did not come out of the blue. Dr. Sharma did not make a mistake when she performed an upper endoscopy on G.R. at around 11:00 a.m. on August 23, 2007. Rather, the upper endoscopy that Dr. Sharma performed was the procedure she intended to perform, pursuant to the order she herself had given respecting G.R.'s treatment plan. The upper endoscopy, in short, was the right procedure. Dr. Sharma neither performed nor attempted to perform a wrong procedure, and therefore she is not guilty of committing an offense punishable under section 456.072(1)(bb), Florida Statutes. Before Dr. Sharma performed the upper endoscopy, she and the team paused, in compliance with Florida Administrative Code Rule 64B8-9.007(2)(b), to confirm the patient's identity, the intended procedure, and the procedure site. Accordingly, Dr. Sharma is not guilty of committing an offense punishable under section 458.331(1)(nn), Florida Statutes.
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. Sharma not guilty of the charges set forth in the Administrative Complaint. DONE AND ENTERED this 16th day of February, 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 16th day of February, 2011.
Findings Of Fact 1. The Administrative Law Judge’s findings of fact are hereby approved, adopted, and incorporated herein as amended by the exceptions granted. 2. There is competent, substantial evidence to support the Administrative Law Judge’s findings of fact as amended and adopted by the Board. EXCEPTIONS TO CONCLUSIONS OF LAW 1. Petitioner filed an exception to 453 of the RO wherein the ALJ concluded that Petitioner did not satisfy its burden of proof. The exception to 453 is granted., The record overwhelmingly supports by clear and convincing evidence that ‘ Respondent breached the standard of care. Respondent was responsible for the care and treatment of this patient. Respondent's responsibility to his patient as attending physician and surgeon of record required him to review the patient's records so that this error would not occur under his supervision. 2. Petitioner filed an exception to 455 of the RO wherein the ALJ concluded that the record failed to establish that Respondent breached any applicable standard of care, and that there was no evidence that Lankau committed any errors-or omissions which were connected in any way to the wrong site surgery. The exception to 455 is granted as not being supported by competent substantial evidence. Paragraph 55 is stricken, and is replaced with the following conclusion of law: The record in this case establishes that Lankau breached the standard of care. 10 3. Respondent filed an exception to {55 of the RO and requested that the findings in {55 be considered a finding of fact rather than conclusion of law. The exception is denied.
Other Judicial Opinions Pursuant to Section 120.569, Florida Statutes, any substantially affected person is hereby notified that they may appeal this Final Order by filing one copy of a Notice of Appeal with the clerk of the Department of Health and by filing the filing fee and one copy of the Notice of Appeal with the District Court of Appeal within 30 days of the date this Final Order is filed. 12 CERTIFICATE OF SERVICE | HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Mail to CHARLES A. LANKAU, MD, c/o W. Sam Holland, Esquire, 200 S. Biscayne Bivd., Suite 800, Miami FL 33131, and Florence Synder Rivas, Division of Administrative Hearings, 1230 Apalachee Parkway, Tallahassee FL 32399-1550 and and by inter-office mail to Nancy Snurkowski, Chief-Practitioner Regulation, Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee FL 32308-5403 and Lisa Pease, Senior Attorney-Appeals, Agency for Health Care Administration, 2727 Mahan Drive, Ft. Knox #3, Tallahassee FL 32308, this tiff, day of _(\41- A__) 2002. F:\USERS\ADMIN\LEE\MEDICINE\ORDERS\LANKAU2.02.wpd 13
The Issue The issue to be determined is whether Respondent violated sections 458.331(1)(m) and 458.331(1)(bb), Florida Statutes (2008),1/ as alleged in the Administrative Complaint 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 20.42 and chapters 456 and 458, Florida Statutes. At all times material to the allegations in the Administrative Complaint, Respondent was a medical doctor licensed in the State of Florida, having been issued license number ME 98868. At the time of alleged incident, Respondent was board certified in anesthesiology. He is now also board certified in pain management. On February 10, 2009, Respondent was working at the Tallahassee Outpatient Surgical Center (TOSC). His duties included performing interventional pain management procedures. Patient C.C. was, at the time of the incident, a 50- year-old male. On February 10, 2009, he was admitted to TOSC for a dorsal medial nerve branch block at the right cervical levels 5/6/7. Respondent was scheduled to perform the procedure. Linda Dix was a nurse at TOSC who was present during C.C.'s procedure. She described the process for admission and preparation for surgery at TOSC, which included each patient receiving a plan, an order for surgery, and an informed consent form. C.C.'s plan, which Respondent signed, indicated that he was to receive a right-side medial nerve branch block at cervical levels 5/6/7. A medial nerve branch block may also be called a dorsal medial branch block. The procedure is a diagnostic block to rule out the level and type of pain the patient is experiencing. In this case, C.C.'s medical records indicate that C.C. had a left- side medial nerve branch block performed one month prior to this scheduled procedure, and had received relief from pain. When a medial nerve branch block is performed, the patient is placed in the prone position on the procedure table, and prepped with a cleaning solution such as Betadine or chorhexidene. There is more than one way to perform the procedure itself. However, a c-arm fluoroscope is used to identify the cervical levels. Sometimes, the physician will numb the skin in a subcutaneous needle pathway before inserting the needle that is going to be advanced to the medial branch nerve. The decision to do so, for Respondent, includes consideration of the size of the patient, and how far the final needle will need to be advanced. While the needle for numbing the skin and the needle for the procedure itself are the same size, they may be different lengths depending on how much tissue will be penetrated. The medial branch nerve lies against the lateral, or side, of the vertebral body, and the fluoroscope guides the needle to the vertebral body. Once the needle makes contact with bone, the physician will aspirate to ensure it is not in a blood vessel. In this case, Respondent was aware of the patient plan and the patient was already draped when he entered the procedure room. C.C. had been prepped and the c-arm fluoroscope was positioned consistent with the method used by another surgeon who had worked at TOSC. Respondent requested that the technician position the fluoroscope in a true lateral position rather than a posterior oblique position. A pause procedure was performed, in which Respondent participated and acknowledged agreement. He used a needle as a marker to show where to inject the numbing medication. However, Respondent placed the needle on the left as opposed to the right side. Respondent began injecting Lidocaine into C.C.'s left side. Before he could finish the injection, Ms. Dix asked him to explain how the medication was going to reach the right-side nerve branches from the location of the injection. Respondent realized at that point that he had injected the Lidocaine into the wrong site for a right-side medial nerve branch block. Respondent immediately stopped injecting the Lidocaine. At that point, .25 ml of Lidocaine had been injected. Lidocaine is a numbing agent. Respondent explained the error to the patient, and then completed the procedure on the correct side. There is no dispute that the correct procedure, and the only procedure intended to be performed, was to be performed on the right side. There is also no dispute that a small amount of Lidocaine was injected into the left side. In the nurse's notes contained in C.C.'s medical records for TOSC, under Intraoperative medication, it is noted that .25 ml of Lidocaine was injected on the left side, and 3 ml of Lidocaine was injected on the right. Also noted are other medications used during the procedure. On the page of the medical records containing the surgical plan (Petitioner's Exhibit 2, page 32) dated February 10, 2009, a list of medications used during the procedure includes .25cc of Lidocaine on the left, and 3cc of Lidocaine on the right, with the notation "local." Respondent signed this page of C.C.'s medical records. In addition, an incident report separate from the medical records was generated. Respondent's procedure notes, which were dictated on February 16, 2009, make no mention of the injection of Lidocaine on the left side. He testified that he did not view the numbing of the left side as part of the procedure itself, but rather part of the preparation of the patient. Specifically, he testified: Q. And where in here did you document the injection of the lidocaine into the left side? A. It was not documented in the procedure note. That only reflects the procedure that was performed on the correct side. Q. And why didn't you document that you injected lidocaine into the incorrect side in this procedure note that you're required to prepare? A. I have no particular reason for not doing it. We were doing 20-plus procedures a day, and I was just dictating and keeping up with the procedure notes, and I only dictated what was performed on the correct site. The chart had documented the error, and we had done the appropriate procedures for reporting the medical error, and so I relied on the rest of the chart to the complete the record as a whole.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That the Board of Medicine enter a final order finding that Respondent violated section 456.072(1)(bb), as alleged in Count I of the Administrative Complaint; that it find Respondent did not violate section 458.331(1)(m), as alleged in Count II; and that as a penalty for Count I Respondent receive a letter of concern, pay a $2,500 fine, attend five hours of risk management continuing medical education, present a one-hour lecture on wrong-site surgery, and perform 50 hours of community service. DONE AND ENTERED this 29th day of December, 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 29th day of December, 2010.
The Issue Whether Respondent should be disciplined for alleged violations of provisions of Section 458.331(1), Florida Statutes.
Findings Of Fact At all times material to the allegations of this administrative complaint, the Respondent has been a licensed physician in the State of Florida. He is a board certified obstetrician and gynecologist. Nothing in this record suggests Respondent has ever been disciplined in connection with the performance of his duties as a physician. The Petitioner is the state agency charged with the responsibility of regulating licensed physicians. In September of 1991, the patient, J.P., a sixty-seven year old postmenopausal female, presented to her primary care physician, Dr. Cavanaugh, with complaints of abdominal pain and pain on intercourse. Dr. Cavanaugh is board certified in general internal medicine, geriatrics, and quality assurance and utilization review. He has been licensed in Florida since 1981 or 1982 and, at the time of this examination, was employed by an HMO. Dr. Cavanaugh performed a physical examination for J.P. which included a pelvic exam and a pap smear taken from her uterus. It was evident to Dr. Cavanaugh that the patient was not posthysterectomy. In the course of the exam, Dr. Cavanaugh felt what he believed to be a left ovarian mass in the patient, J.P. Given his concern over the suspected mass and the pain (which the patient reported had been for several months), Dr. Cavanaugh referred the patient to the Medical Park Diagnostic Center for a CT scan. The CT scan was performed on September 20, 1991, and Dr. Farmer, a radiologist at the Medical Park Diagnostic Center, issued a radiological report which incorrectly indicated that the patient had undergone a prior hysterectomy. Dr. Farmer's report further indicated a left adnexal mass of ovarian origin. Dr. Farmer's report provides, in pertinent part: THE PATIENT APPEARS STATUS POST HYSTERECTOMY. THERE IS A COMPLEX APPEARING 6.5 X 5.0 X 4.0 CM PELVIC MASS WHICH DEMONSTRATES SIGHTLY DIMINISHED INTERNAL ATTENUATION AND APPEARING SOMEWHAT BILOBULAR SUGGESTING A THICKENED PERIPHERAL BORDER WHICH DEMONSTRATES MILD CONTRAST ENHANCEMENT. IT IS UNCERTAIN WHETHER THE PATIENT HAD BOTH OVARIES REMOVED AT THE PREVIOUS HYSTERECTOMY. NEITHER A RIGHT NOR A LEFT OVARY ARE DISTINCTLY IDENTIFIED ALTHOUGH THE LEFT PELVIC MASS MAY BE ADNEXAL IN NATURE ARISING FROM THE LEFT OVARY. IN ADDITION, THERE IS A SOMEWHAT ILL-DEFINED AREA OF SOFT TISSUE FULLNESS WHICH MEASURES 3 X 2 X 2 CM LYING JUST SUPERIOR TO THE APPARENT VAGINAL CUFF WHICH MAY BE RELATED TO THE LEFT ADNEXAL MASS OR MAY BE A RESIDUAL RIGHT OVARY. * * * CLINICAL CORRELATION WITH THESE FINDINGS AND IF NOT PERFORMED PREVIOUSLY, CORRELATIVE SONOGRAPHY OF THE PELVIS MAY BE BENEFICIAL. THE APPARENT LEFT ADNEXAL MASS MAY REPRESENT A CYSTADENOMA/CARCINOMA AND APPEARS TO PRODUCE SIGHT EFFACEMENT OF THE PARTIALLY CONTRAST FILLED URINARY BLADDER. [Capitalization in original text] It is undisputed that prior to September 20, 1991, J.P. had not undergone a hysterectomy. The "correlative sonography" mentioned in Dr. Farmer's report refers to a sonogram which is a noninvasive diagnostic procedure. On or about September 24, 1991, Dr. Cavanaugh received Dr. Farmer's report and scheduled a conference with J.P. During such conference Dr. Cavanaugh advised J.P. that the CT scan had indicated a mass of ovarian origin. Further, he recommended that she see Dr. Yankow, the Respondent, for further examination and possible surgery. Also on this date Dr. Cavanaugh had the patient give a blood sample for a CA 125 test. The CA 125 test results may indicate cancer. In this case, J.P.'s CA 125 test result was negative. Such result does not rule out cancer. Similarly, J.P.'s pap smear test results were negative. Dr. Cavanaugh did not schedule a sonogram or any other diagnostic procedure for J.P. Sensing some urgency, Dr. Cavanaugh personally contacted Respondent and scheduled J.P. to see him the next day. Respondent was under contract to the HMO and had been recruited by Dr. Cavanaugh to provide gynecological services for the group. On September 30, 1991, J.P. presented to Dr. Yankow through Dr. Cavanaugh's referral. At that time, Respondent received Dr. Farmer's radiological report of the CT scan. Respondent performed a history and a physical examination on J.P. which included a pelvic exam. Based upon the pelvic exam it was evident to Dr. Yankow that J.P. was not posthysterectomy. During the course of Respondent's pelvic exam of the patient, he noted what he believed to be a left ovarian mass. Respondent also noted that J.P.'s uterus was anteverted and anteflexed. Based upon his exam of J.P., Respondent knew or should have known that the Dr. Farmer's report was premised, in part, on an erroneous assumption (that the patient was posthysterectomy). Respondent did not recommend or order a sonogram for the patient. Respondent did not recommend or order a laparoscopy for the patient. A laparoscopy is the insertion of a fiber optic apparatus which is normally inserted near the umbilicus so that visualization and/or operative procedures can be performed within the pelvis. A laparoscopy is generally considered less invasive than a laparotomy. The Respondent recommended that J.P. undergo an exploratory laparotomy. The laparotomy would allow the physician to rule out or confirm cancer and surgically remove it during one procedure. In October, 1991, J.P. was admitted to Larkin General Hospital in Miami, and Respondent performed the laparotomy on J.P. The laparotomy was described in Respondent's operative report as: a transverse incision in the lower abdomen going through the skin, subcutaneous tissue, fascia, peritoneum and entering the abdominal cavity. Such procedure is considered invasive surgery. At the time of the surgery, J.P.'s ovaries were found to be free of disease and normal. A one or two centimeter piece of inflamed fatty tissue was removed by Respondent which pathology determined was infarcted fatty tissue. All concerns regarding cancer were relieved. Prior to performing the laparotomy Respondent did not contact Dr. Farmer regarding the CT scan report. Respondent believed the pertinent part of such report was the confirmation of the mass and did not believe the fact that it was premised on an erroneous assumption would make any difference. Respondent did however, after-the-fact, write to Dr. Cavanaugh regarding the patient. Such letter provided, in part: In reviewing the report of the CAT scan of Mrs. P. [name appears in the original], I realize that the second paragraph starts off that the patient appears [status post hysterectomy]. You and I examined this patient and we both realized that she had not had a hysterectomy. In view of this, all it would have taken was a phone call to Medical Park and this mass that was seen on CAT scan would naturally be her uterus. Any cystic structure that may have been seen in the cul-de-sac most likely was diverticular disease as she thought she had diverticular disease. I have spoken with Dr. Farmer and let him know that I really felt that both you and I and he combined, dropped the ball on this one. He was led to believe that she had had a hysterectomy and you and I both examined the patient and knew that she had not and we let this go by. I just thought you would like to know this. [Emphasis in original text] When Respondent made the decision to recommend the laparotomy, he believed two physicians (himself and Dr. Cavanaugh) had clinically noted the mass and that the CT scan had also indicated one. Under the facts of this case, given the patient's age and medical history (postmenopausal and complaints of pain), it was reasonable for the physicians treating this patient to be concerned about the possibility of cancer. In hindsight, additional diagnostic procedures such as a sonogram or a laparoscopy might have ruled out the need for surgery. In hindsight, contact with Dr. Farmer by either Dr. Cavanaugh or Dr. Yankow might have changed the radiological report and the course of conduct undertaken. Respondent's failure to avail himself of other diagnostic procedures does not, however, under the facts of this case, rise to the level of failing 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. Respondent's medical records for this patient support the course of treatment for the patient and candidly admit that, with the clearer vision only hindsight affords, all three physicians might have taken different tacks had they known then what they now do. Under the practices utilized in 1996, a sonogram would be ordered in instances such as J.P.'s case. However, in 1991, the sonogram was not always ordered to confirm a CT scan.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Agency for Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint against this Respondent. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 24th day of January, 1997. JOYOUS D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of January, 1997. APPENDIX Rulings on the proposed findings of fact submitted by the Petitioner: Paragraphs 1 through 27, 29 and 30 are accepted. With regard to paragraph 28, it is accepted that Respondent could have used ancillary less invasive procedures to attempt diagnosis; otherwise rejected as contrary to the weight of the evidence. Rulings on the proposed findings of fact submitted by the Respondent: Paragraphs 1 through 18, and 22 are accepted. To the extent that paragraphs 19, 20, 21 are supported by the testimony of Dr. Penalver, such paragraphs are rejected as not supported by the evidence; otherwise where consistent with the findings of fact and conclusions of law noted above, they are accepted. COPIES FURNISHED: Kevin W. Crews Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jonathan P. Lynn, Esquire Two Datran Center, PH I & II 9130 South Dadeland Boulevard Miami, Florida 33156 Dr. Marm Harris Executive Director Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact The parties Petitioner, Agency for Health Care Administration, Division of Quality Assurance, Board of Medicine, formerly Department of Business and Professional Regulation, Board of Medicine, is the state government licensing and regulatory agency charged with the responsibility and duty of regulating the practice of medicine pursuant to the laws of the State of Florida, in particular Section 20.42, Florida Statutes, Chapters 120, 455 and 458, Florida Statutes, and the rules promulgated pursuant thereto. Chapter 93-129, Laws of Florida. Respondent, Muhammad S. Mustafa, M.D., is now and was at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0047360. Respondent was licensed by endorsement on October 7, 1985, but did not, ostensibly, actively engage in the practice of medicine in the State of Florida until September 14, 1988. 4/ Respondent's last known address, as of the date of hearing, was 8245 North Nebraska Avenue, Tampa, Florida 33604. Respondent received his medical degree from the Oklahoma University School of Medicine in 1970, performed an internship from 1970 to 1971 at the Altoona Hospital, Altoona, Pennsylvania, did a four-year residency in general surgery from 1971 to 1975 at The Cleveland Clinic, Cleveland, Ohio, and started practice as a sole practitioner in Cleveland, Ohio, in November 1975. Respondent's practice consisted of general surgery and family medicine, and he practiced in a predominately blue collar neighborhood until his license to practice medicine was revoked by the State Medical Board of Ohio, as discussed infra. While practicing in Cleveland, respondent had staff privileges at St. Vincent Charity Hospital, Luthern Medical Center, St. John's Hospital, and St. John's Westshore Medical Center, but by May 1988 had restricted his practice to Luthern Medical Center and St. John's Hospital. Respondent resigned his staff privileges at Luthern Medical Center and St. Johns in December 1989. The Ohio charges On May 11, 1988, the State Medical Board of Ohio, the licensing authority for medicine in the State of Ohio, notified respondent that it proposed to take disciplinary action against his certificate to practice medicine and surgery in Ohio. The gravamen of the Board's charges were as follows: That respondent's prescribing practices with regard to approximately 83 difference patients, as well as his overall prescribing as reflected by a listing entitled "Total Drug Amounts by Drug, Year and Month," constituted: "Failure to use reasonable care discrimination in the administration of drugs" and "failure to employ acceptable scientific methods in the selection of drugs or other modalities for treatment of disease," as those clauses are used in Section 4731.22(B)(2), Ohio Revised Code; "Selling, prescribing, giving away, or administering drugs for other than legal and legitimate therapeutic purposes," as that clause is used in Section 4731.22(B)(3), Ohio Revised Code; and "A departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in Section 4731.22(B)(6), Ohio Revised Code. That as to Patient 152 respondent did between March 27, 1984 and December 12, 1985, and again between November 13, 1986 and April 1, 1987, prescribe controlled substance stimulants when the patient either gained weight or failed to lose weight, contrary to the provisions of Section 4731.22(B)(2), (3) and (6), Ohio Revised Code. The Board further charged that respondent's billing to Patient 152's insurance company for services rendered between March 27, 1984 and December 15, 1986, reflected a diagnosis of "hypertension, obesity, ingrown toenail, nerves, low back pain, and arthritis" when there was no indication in respondent's record that he had treated the patient for any condition other than obesity. Such conduct was alleged to constitute "publishing a false, fraudulent, deceptive or misleading statement," as that clause is used in Section 4731.22(B)(5), Ohio Revised Code, and the "obtaining of, or attempting to obtain money or anything of value by fraudulent misrepresentation in the course of practice," as that clause is defined in Section 4731.22(B)(8), Ohio Revised Code. That as to Patient 151 respondent did between February 21, 1979 and April 17, 1986, and again between November 13, 1986 and April 1, 1987, prescribe controlled substances and stimulants when the patient either gained weight or failed to lose weight, contrary to Section 4731.22(B)(2), (3) and (6), Ohio Revised Code. The Board further alleged that on respondent's billing to Patient 151's insurance company for services rendered between January 10, 1984 and November 13, 1986, the diagnosis of "menopause; arthritis; glossitis; bronchitis; hypertension; nerves; and chest wall pain" were entered when the majority of services rendered by respondent were for "obesity," a diagnosis not listed, and his records contain no indication that she was being treated for hypertension, nerves or arthritis. Moreover, an EKG and "comprehensive office exam" performed on November 13, 1986 and billed under a diagnosis of "chest wall pain" were in fact performed as part of the physical required prior to starting the diet program. Such conduct was alleged to violate Section 4731.22(B)(5) and (8), Ohio Revised Code. That respondent's reports and billing to two different attorneys with regard to Patient 140 (who had been involved in accidents in June and November 1985) reflected dates of service and patient complaints which were not reflected in the medical records. Such conduct was alleged to violate Section 4731.22(B)(5) and (8), Ohio Revised Code. That respondent prescribed controlled substances for Patient 241 in 1979, 1982 and 1983 through 1985 contrary to Section 4731.22(B)(2), (3) and (6), Ohio Revised Code, in that the patient had admitted to respondent in 1979 that he was addicted to Codeine and in 1985 that he was addicted to Percocet. Respondent was alleged to have first prescribed Percocet in 1983, upon the patient's complaint of back pain, without noting any physical exam or findings, and had continued prescribing it on a regular basis well into 1985. His prescribing of Codeine-based medications and Percocet continued after the patient's admission of addiction to those substances. Finally, citing 13 different patients as examples, the Board alleged that respondent routinely kept inadequate patient records which did not reflect examinations performed or physical findings made to justify the medications prescribed or dispensed; prescribed controlled substances and dangerous drugs based upon patient requests for medications or patient complaints, often without utilizing appropriate testing or other methods for evaluating the validity or etiology of the complaints; and routinely prescribed controlled substance stimulants for weight loss over extended periods of time without regard to whether or not the patient demonstrated weight loss. Such conduct was alleged to violate Section 4731.22(B)(2), (3) and (6), Ohio Revised Code. Moreover, respondent's acts or omissions with regard to certain prescriptions written on or after November 17, 1986, for patients 25, 34, 130, 166, 265, and 276, were alleged to constitute violations of Rules 4731-11-02 and/or 4731-11-04, Ohio Administrative Code, and therefore Section 4731.22(B)(20), Ohio Revised Code. The aforesaid notice of charges dated May 11, 1988, advised respondent of his right to request a hearing on the matter, his right to appear at such hearing in person or through his attorney, to present his position and argument, and to present evidence and examine witnesses appearing for or against him. Respondent timely requested such hearing, and was represented by counsel. The subject charges were heard before Wanita J. Sage, Esquire, Hearing Examiner for the State Medical Board of Ohio, on September 18, 1988. Thereafter, the Hearing Examiner rendered an extensive recommendation, which contained findings of fact, conclusions and an order. Such findings of fact sustained the charges filed against respondent, and are contained in petitioner's exhibit 2. The recommendation, which summarized the factual findings, concluded: The acts, conduct, and/or omissions of Muhammad S. Mustafa, M.D., as set forth in the above Findings of Fact, constitute: "Failure to use reasonable care discrimination in the administration of drugs" and "failure to employ acceptable scientific methods in the selection of drugs or other modalities for treatment of disease", as those clauses are used in Section 4731.22(B)(2), Ohio Revised Code; "Selling, prescribing, giving away, or administering drugs for other than legal and legitimate therapeutic purposes", as that clause is used in Section 4731.22(B)(3), Ohio Revised Code; and/or "A departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established", as that clause is used in Section 4731.22(B)(6), Ohio Revised Code. The testimony and evidence presented in this Matter amply establish that Dr. Mustafa, in the routine course of his practice, prescribed controlled substances and dangerous drugs for patients for excessive periods of time, without establishing valid medical indication or diagnosis. He prescribed potentially addictive controlled substances, often in dangerous combinations, for patients for years without adequately evaluating their complaints or attempting alternative therapies. In the case of Patient 241, Dr. Mustafa admitted that he had prescribed Codeine for this patient for a period of over one month in 1979 as treatment for his admitted Codeine addiction. Several years later, Dr. Mustafa began prescribing Percocet upon this same patient's complaint of back pain, without any evidence of evaluation, and continued to do so over a two-year period. When Patient 241 then admitted that he was addicted to Percocet, Dr. Mustafa continued to prescribe it for three addi- tional months as treatment for his addiction. Such prescribing contravenes both federal and state laws, including each of those provisions listed above. Dr. Mustafa's claim that there was no adequate treatment program available in 1979 does not satisfactorily explain his prescribing for Patient 241's addiction in 1985. The patient records clearly demonstrate Dr. Mustafa's willingness to prescribe whatever patients requested, even when objective data indicated that there was no valid medical indication for such drugs and no medical basis for the patients' complaints. In the case of Patient 36, Dr. Mustafa liberally prescribed synthetic thyroid hormone at her request, despite the fact that he had obtained tests showing her thyroid levels to be normal. He provided this same patient with narcotic pain medications, even when her complaints of pain were apparently related to urinary tract infections, menstrual cramps, or other conditions which would not appear to justify the use of controlled substances. In the case of Patient 308, Dr. Mustafa prescribed combinations of controlled substances and dangerous drugs, including narcotic analgesics, tranquilizers, hypnotics, barbiturates, antipsychotics, tricyclic antidepressants, and stimulants, even though he was aware that her complaints generally [had] no physical cause, but rather stemmed from emotional problems. On one occasion, he actually telephoned in a prescription for Compazine for Patient 308 when she was in the hospital under the care of another physician for treatment of a drug overdose. Even though Dr. Mustafa was admittedly aware that she had been hospitalized on three occasions due to drug overdoses, he continued afterwards to prescribe dangerous combinations of drugs for her, including the substances on which she had overdosed. In the case of Patient 130, Dr. Mustafa regularly prescribed and administered large amounts of narcotic analgesics over an approximately four year period. Dr. Mustafa admitted that Patient 130 was chemically dependent on narcotics, but claimed they were necessary to control his back pain. Yet, the patient record clearly indicates that Dr. Mustafa made no effort to independently evaluate or diagnose, but rather relied solely upon this patient's representations as justi- fication for his inappropriate prescribing in response to this patient's requests for addictive drugs. Furthermore, the patient record indicates that Dr. Mustafa abruptly discontinued prescribing pain medications and tranquilizers for Patient 130 in early 1987. In general, the patient records demonstrate lack of independent evaluations by Dr. Mustafa of patients' complaints of pain, for treatment of which he prescribed large amounts of controlled medications for excessive periods of time. Such prescribing violates each of the above provisions of law. Further, the patient records of Patients 152, 151, 25, 26, 36, 218, 236 and 265 support the State's allegations that Dr. Mustafa routinely prescribed controlled substance stimulants for weight loss purposes over extended periods of time, whether or not a patient demonstrated weight loss. Dr. Mustafa admitted that it had been his standard practice to prescribe a controlled substance anorectic upon a diet patient's initial visit, without first attempting to achieve weight loss through other means, such as diet or nutritional counseling. In addition, Dr. Mustafa often prescribed Lasix, a diuretic, for weight control purposes. As indicated by the testimony of Dr. Junglas, there is no valid medical indication for the use of a diuretic for weight loss. Such pre- scribing of diet medications also violates each of the above provisions of law. Certainly, both the patient records and the testimony of Dr. Mustafa support the Board's allegations that Dr. Mustafa, in the routine course of his practice, kept inadequate patient records which did not reflect examinations performed or physical findings made to justify the medications he prescribed or dispensed to his patients. Although Dr. Mustafa appeared to claim that he had done examinations or made physical findings which justified the medications he prescribed, he stated that he simply didn't have time to write down everything he knew about his patients. The patient records generally reflect only patient requests for refills of medications, non-specific patient complaints, and lists of drugs prescribed or administered by Dr. Mustafa. They are generally devoid of evidence of appropriate diagnostic testing; documentation as to the nature or severity of the patient's reported pain, illness, or injury; evidence of investigation of alter- native therapies; thorough histories, physical examinations, and diagnoses; in short, infor- mation necessary to assure that the patient receives appropriate treatment. Such records evidence Dr. Mustafa's violations of each of the above provisions of law. As indicated by the testimony of Dr. Donald Junglas, Dr. Mustafa's treatment with regard to each of the 17 patients whose records were reviewed at hearing violates each of the above provisions of law. Further, the prescriptions identified as State's Exhibits #6A through #6H and summarized by the "Prescription List by Patient Number" and the listing of "Total Drug Amounts by Drug, Year, and Month" (State's Exhibit #1) indicate that Dr. Mustafa's inappropriate, long-term prescribing of controlled substances was not confined to those 17 patients, but rather was common in his practice. Dr. Mustafa's prescribing of controlled substances for weight reduction for Patients 152 and 151 after November 17, 1986, constitutes "violating . . ., directly or indirectly, . . . any provisions of this chapter or any rule promulgated by the Board", as that clause is used in Section 4731.22(B)(20), Ohio Revised Code, to wit: Rule 4731-11-04, Ohio Adminis- trative Code, as in effect on and after November 17, 1986. Rule 4731-11-04(B) requires that a physician's use of controlled substances for purposes of weight reduction in the treatment of obesity be only as an adjunct in a regimen of weight reduction based on caloric restriction. It further requires the physician to determine, before instituting treatment with a controlled substance, that the patient has made a "substantial good-faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification, and exercise, without the utilization of controlled substances, and that said treatment has been ineffective. Further, the physician must obtain a thorough history, perform a thorough physical examination, and rule out the existence of any recognized contradictions to the use of the controlled substance. Further, according to this rule, the physician may not initiate or must discontinue utilizing controlled substances immediately upon determin- ing that the patient has failed to lose weight while under treatment with a controlled substance over a period of 14 days, such determination to be made by weighing the patient at least every fourteenth day. Dr. Mustafa's prescribing of Schedule IV anorectics for Patients 152 and failed to meet these requirements. Patient testified that he had never tried dieting before seeing Dr. Mustafa. Dr. Mustafa's lecturing Patient 152 about snacking does not constitute the institution of a regimen of weight reduction based on caloric restriction. The documentation in the patient records, parti- cularly in the case of Patient 151, fails even to establish that these patients' overweight constituted obesity which might have justified the use of a controlled substance in the event that other treatment methods had been proven ineffective. Further, Dr. Mustafa failed to discontinue prescribing Schedule IV anorectics for Patients 152 and 151 when they failed to lose weight, as required by Rule 4731-11-04(B). In fact, although Dr. Mustafa admittedly become aware of this Rule in December, 1986, he prescribed Schedule IV anorectics for Patient 152 when he demonstrated weight gains on February 5, March 5, and April 1, 1987, and he prescribed Schedule IV anorectics for Patient 151 when she demonstrated failure to lose weight on January 9, February 5, and March 5, 1987. Pursuant to Rule 4731-11-04(C), Ohio Adminis- trative Code, Dr. Mustafa's violations of Rule 4731-11-04(B) also violate Sections 4731.22(B)(2), (B)(3), and (B)(6), Ohio Revised Code. Further, Dr. Mustafa's prescribing for Patients 25, 34, 130, 166, 265, and 276, on and after November 17, 1986, constitutes "violating . . ., directly or indirectly . . . any provisions of this chapter or any rule promulgated by the Board", as that clause is used in Section 4731.22(B)(20), Ohio Revised Code, to wit: Rules 4731-11-02 and/ or 4731-11-04, Ohio Administrative Code, as in effect on and after November 17, 1986. With respect to patient 25, Dr. Mustafa violated Rule 4731-11-04(B) by prescribing the Schedule IV controlled substance Fasin 30 mg. for purposes of weight reduction on both December 19, 1986, and February 13, 1987, without: instituting a regimen of weight reduction based upon caloric restriction, first determining the ineffectiveness of other methods of weight reduction, or determining whether or not she failed to lose weight by weighing her at least every fourteenth day. Further, Dr. Mustafa violated Rule 4731-11-02(D) by telephoning in a prescription for 30 Tranxene 7.5 mg., a Schedule IV anxiolytic, for Patient 25 on April 2, 1987, without documenting any exam- ination, evaluation, diagnosis, or purpose for this controlled substance. On seven occasions from November 19, 1986, through April 29, 1987, Dr. Mustafa prescribed Vicodin, a Schedule III narcotic analgesic, for Patient 34 without documenting any examination, evaluation, diagnosis, or purpose for his use of this addictive controlled substance. In fact, four of these prescriptions were issued after Dr. Mustafa had discussed with Patient 34 the addictiveness of Vicodin and the need for him to take less of it. Such acts and omissions violate both paragraph (C) and (D) of Rule 4731-11-02. Dr. Mustafa's acts and omissions with regard to Patient 130 also constitute violations of both paragraphs (C) and (D) of Rule 4731-11-02. Without documenting any examination, evaluation, diagnosis, or purpose other than the patient's requests for pain medication, Dr. Mustafa administered IM injections of Demorel 100 mg., a Schedule II narcotic analgesic, to Patient 130 on December 13, 1986, January 6, 1987, and April 7, 1987. In addition to the Demerol injection, he also prescribed 100 Tylenol #4, a Schedule III narcotic analgesic, for this patient on April 7, 1987, solely upon Patient 130's request for pain medications for vacation. Dr. Mustafa had previously notified this patient on January 12 that he would prescribe no more tranquilizers or pain medications for him. Dr. Mustafa admitted at hearing that this patient had been chemically dependent upon narcotics, though he claimed that he had needed them to control his pain. Upon Patient 166's request, without document- ing any examination, evaluation, diagnosis, or purpose, Dr. Mustafa prescribed for her 100 Vicodin, a Schedule III narcotic analgesic, on December 24, 1986, and 50 Vicodin on January 29 and again on April 23, 1987. Such acts violate Rule 4731-11-02(D). With respect to Patient 265, Dr. Mustafa initiated treatment with Adipex-P, a Schedule IV stimulant anorectic controlled substance, on December 9, 1986, without first determining the effectiveness of other methods of weight reduction, without instituting a regimen of weight reduction based on caloric restriction, and without obtaining a thorough history or performing a thorough physical examination to rule out the existence of any contradiction. Dr. Mustafa continued to prescribe Apidex-P through April 31, 1987, without weighing Patient 265 at least every fourteenth day and without immediately discontinuing such treatment when this patient showed a weight gain on February 10, 1987. Such acts and omissions violate Rule 4731-11-04(B). Furthermore, from December 9, 1986, through May 11, 1987, Dr. Mustafa prescribed Valium for her on three occasions, two of which prescriptions he telephoned in. On five occasions during this period, he prescribed Darvon Compound 65 for her, including one occasion when Patient 265 indicated that she had 30 tablets left from a previous prescription, two occasions where Dr. Mustafa provided her with postdated prescriptions, and one occasion where he telephoned in a prescription. At no time did Dr. Mustafa document any examination, evaluation, diagnosis, or purpose other than the patient's stated complaint, for his prescribing of these controlled substances. Such acts and omissions constitute violation of both paragraphs (C) and (D) of Rule 4731-11-02. In an approximately five month period from November 17, 1986, through April 28, 1987, Dr. Mustafa prescribed for or administered to Patient 276 a total of 519 dosage units of controlled substances, including: 25 Demerol 50 mg., a Schedule II narcotic analgesic; 2 IM injections of Demerol 50 mg.; 2 IM injections of Demerol 75 mg.; 60 Fiorinal, a Schedule III barbiturate analgesic; and 430 Darvocet N-100, a Schedule IV narcotic analgesic. Of these, 230 dosage units were prescribed by telephone. Throughout this period, Dr. Mustafa failed to document examination, evaluation, diagnosis, or purpose for this prescribing other than patient requests and complaints. On one occasion, he did note a physical finding of severe pain and tenderness in the back, radiating downward; however, no further evaluation was done and no diagnosis was indicated. On another occasion, Dr. Mustafa noted a diagnosis of severe migraine headache, but failed to state any information upon which that diagnosis was based. In view of the addictiveness and volume of the substances so prescribed, it is concluded that Dr. Mustafa's acts and omissions with regard to Patient 276 constitute violations of both paragraphs (C) and (D) of Rule 4731-11-02. Pursuant to Rule 4731-11-04(C), Ohio Administ- rative Code, Dr. Mustafa's violations of Rule 4731-11-04(B) also violate Sections 4731.22(B)(2), (B)(3), and (B)(6), Ohio Revised Code. Pursuant to Rule 4731-11-02(F), Ohio Adminis- trative Code, Dr. Mustafa's violations of Rule 4731-11-02(C) and (D) also violate Sections 4731.22(B)(2) and (B)(6), Ohio Revised Code. Further, in view of the nature and/or amounts of the drugs prescribed and the circumstances with regard to such prescribing, Dr. Mustafa's acts and omissions with regard to Patients 130, 265, and 276 are found to constitute purposeful, knowing, or reckless violations of paragraph (C), and thus, pursuant to paragraph (F), also violate Section 4731.22(B)(3), Ohio Revised Code. Dr. Mustafa's acts, conduct, and/or omissions, as set forth in Findings of Fact #7 and #13, above, constitute: "Publishing a false, fraudulent, deceptive, or misleading statement", as that clause is used in Section 4731.22(B)(5), Ohio Revised Code; and "The obtaining of, or attempting to obtain, money or anything of value by fraudulent misrepresentations in the course of practice", as that clause is used in Section 4731.22(B)(8), Ohio Reviewed Code. Claim forms submitted by Dr. Mustafa or his office staff to insurers for reimbursement for Dr. Mustafa's services for both Patient 152 and Patient 151 reported diagnoses for which he had not treated those patients. The fact that diagnoses appeared on claim forms, but not in the patient records, cannot be attributed merely to Dr. Mustafa's poor documentation. Although Dr. Mustafa's patient records clearly indicate that the EKG's done in November, 1986, were part of physical examinations for initiation of diet programs, these EKG's were claimed under diagnoses of hypertension for Patient 152 and chest wall pain for Patient 151. In fact, the "Weight Reduction Program" form contained in Patient 152's file indicates that he had no history of hypertension or heart disease. It must be concluded that false diagnoses were reported for purposes of obtaining reimbursement from the insurer for performance of these routine tests. Although not included in the Board's allegations, it is noted that a similar billing was submitted on behalf of another patient reviewed in this Matter, Patient 25 (See Finding of Fact #19). Although Dr. Mustafa denied knowledge of or responsibility for these false billings, copies of the claims, many of which were signed by Dr. Mustafa, were made a part of the patients' records. Furthermore, contrary to Dr. Mustafa's contentions, he is responsible for the billing procedures of his office. It must be concluded that Dr. Mustafa knew or should have known of the fraudulent billings submitted on behalf of Patients 152 and 151. Further, Dr. Mustafa's acts, conduct, and/or omissions, as set forth in Findings of fact #15 and #16, above, constitute: "Publishing a false, fraudulent, deceptive or misleading statement", as that clause is used in Section 4731.22(B)(5), Ohio Revised Code; and "The obtaining of, or attempting to obtain, money or anything of value by fraudulent misrepresentations in the course of practice", as that clause is used in Section 4731.22(B)(8), Ohio Revised Code. Dr. Mustafa submitted billings and reports of Patient 140's attorneys, listing dates of service and fees not reflected in the patient record. In addition, he billed both attorneys for a January 28, 1986, office visit. Dr. Mustafa's attempts to explain these discrepancies are not convincing. The reports to the attorneys listed no specific treatments or medications for the dates reported; thus, they could not be adequate substitutes for clinical notes which Dr. Mustafa claimed to have recorded on separate cards. Further, Dr. Mustafa claimed that he had made clinical notes on cards, later discarded, because Patient 140 had come to his home, rather than to his office, for treatment; yet he had earlier testified that his office was in his home (Tr. at 41). Also, Dr. Mustafa's attempt to blame his receptionist for the double billing of the January 28, 1986, visit is not well taken. Dr. Mustafa signed the reports submitted to both attorneys and was responsible for their accuracy. It is evident that the billings submitted to Patient 140's attorneys for reimbursement for professional services fraudulently misrepresented the extent of and fees for Dr. Mustafa's services. Although not part of the Board's charges, it is further noted that the patient record for Patient 166 contains a billing submitted to an attorney which contains both dates of service and fees which are not reflected in the patient record (see Finding of fact #31). * * * * * The testimony and evidence in this Matter sub- stantially shows that Dr. Mustafa, in the routine course of his practice, engaged in inappropriate, indiscriminate prescribing of controlled substances and dangerous drugs. The patient records evidence his willingness to prescribe at the patient's request, without regard for medical indications or patient welfare. In at least one case, he admittedly prescribed narcotics to a known addict for an inappropriate period of time without referring him to an authorized treatment program. Both the State's exhibits and the testimony of its expert, Dr. Junglas, rob Dr. Mustafa's claim, that his prescribing was in accordance with acceptable community standards for the time, of credence. Dr. Mustafa admitted that he had ignored the warnings of drug manufacturers and FDA labeling with regard to his long-term prescribing of controlled substances, relying on information he claimed to have obtained from his colleagues. At best, Dr. Mustafa's prescribing practices reflect a willful ignorance of the properties and effects of drugs. Neither willful ignorance nor the lack of moral character demonstrated by Dr. Mustafa's fraudulent billings would seem to be remediable. PROPOSED ORDER It is hereby ORDERED that the certificate of Muhammad S. Mustafa, M.D., to practice medicine and surgery in the State of Ohio shall be and is hereby REVOKED. This Order shall become effective thirty (30) days from the date of mailing of notification of approval by the State Medical Board of Ohio, except that Dr. Mustafa shall immediately surrender his United States Drug Enforcement Administration certificate and shall not order, purchase, prescribe, dispense, administer, or possess any controlled substances, except for those prescribed for his personal use by another so authorized by law. Further, in the interim, Dr. Mustafa shall not undertake treatment of any individual not already under his care. Wanita J. Sage Attorney Hearing Examiner The Hearing Examiner's proposed findings of fact, conclusions and order were adopted by the State Medical Board of Ohio on December 6, 1989. Respondent appealed the Board's order through the courts and on May 4, 1992, the Ohio Supreme Court refused respondent's request that it take jurisdiction of the case. Consequently, the order of the State Medical Board of Ohio revoking respondent's license to practice medicine became effective June 15, 1992. Other matters At hearing, respondent offered the opinion of Adnan E. Mourany, M.D., Soundiah Selvaraj, M.D., and Marcello Mellino, M.D., by way of deposition (Respondent's exhibits 9-11), concerning respondent's reputation as a physician. Dr. Mourany is licensed to practice medicine in the State of Ohio, as well as Indiana, Minnesota and New York, and has practiced since 1986. He is Chairman of Surgery and Chief of Otolarynology at St. John's Westshore Hospital, and has known respondent professionally and personally since 1979. Dr. Selvaraj is licensed to practice medicine in the State of Ohio, and has practiced since 1974. he is Chief of Internal Medicine and Ambulatory Care at the Luthern Medical Center, and has known respondent professionally since 1976. Dr. Mellino is licensed to practice medicine in Ohio, and has practiced for 13 years. He is a cardiologist, and has known respondent professionally since 1978. It was the opinions of Doctors Mourany, Selvaraj and Mellino that respondent was an excellent surgeon who enjoyed a reputation as a good physician. 5/ At hearing, respondent also presented proof that during medical school he received an award from the Governor of Oklahoma for having performed volunteer work with charitable organizations, and that during his practice in Cleveland he received a ten-year service award from Luthern Medical Center and an award from the United States Senate recognizing his volunteer work for the Cleveland Foundation. Respondent also participated in two projects in Cleveland, one in 1983 and one in 1987, to treat patients without charge. All such activities predated the charges filed by the Ohio Board of Medicine. Since revocation of his Ohio license, respondent attended three courses of continuing medical education programs. The first, "Medical Malpractice and Risk Management--1993," was apparently completed in October 1993; the second, "AIDS and Florida Law--1993," was apparently completed in October 1993; and the third, "Surgical Education and Self-Assessment Program," was apparently completed in November 1993. Other than having attended such courses, respondent's activities since the revocation of his Ohio license do not appear of record.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered revoking respondent's license to practice medicine in the State of Florida. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 12th day of September 1994. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of September 1994.
The Issue The issue in this case is whether the medical license issued to the Respondent, Manuel Escobar, should be revoked or otherwise penalized based upon the acts alleged in the Administrative Complaint.
Findings Of Fact Based upon my observation of the witnesses, their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I make the following findings of fact: Respondent is and has been at all times material hereto, a licensed physician having been issued license number ME002062A, by the State of Florida. Sometime in the fall of 1984, the patient, L.T., went to a clinic where the Respondent had an office to discuss having a lipectomy. The clinic is owned by Julio Ceaser. While there is hearsay testimony that Julio Ceaser is not a licensed physician, there is no competent substantial evidence indicating whether or not Julio Ceaser is a licensed medical professional. The Respondent had an office at the clinic and frequently performed facelifts there. However, lipectomies were not performed at this clinic. During the patient's first visit to the clinic, Julio Ceaser explained to her that a lipectomy would have to be done outside the clinic by another doctor and discussed the possibility of the patient having a full face lift at the clinic. During this first visit to the clinic, the patient decided to have the facial surgery. The patient did not meet with the Respondent during this visit. Prior to having facial surgery, the patient paid $3,000.00 to Julio Ceaser. The Respondent was not involved in the financial negotiations with the patient and there is no evidence establishing how much money the Respondent was paid for his services. While the patient claims that she understood the $3,000.00 she paid to Julio Ceaser would cover both the facial surgery and a lipectomy, there is no evidence that the Respondent ever agreed to perform a lipectomy for this patient nor that he was aware of the financial arrangements that had been made between the patient and Julio Ceaser. Moreover, it is not clear that the patient's belief regarding the services she was to receive for the $3,000.00 was justified or that she was in any way misled in this regard. Prior to having facial surgery, pre-operative photos were taken of the patient. However, these photos cannot be located and are not included in the patient's medical records. On the day of the surgery, the patient signed an informed consent form. However, while the patient had some discuss ions with Julio Ceaser prior to the surgery, the exact nature of those discussions was not established. It is not clear whether Julio Ceaser ever discussed with the patient the potential complications and risks of the surgery. In any event, the Respondent did not explain to the patient the surgical procedures that he was going to employ nor did he discuss with her the potential complications and risks of the surgery. Respondent's failure to speak directly with the patient regarding the potential complications and risks of the surgery falls below the standard of care expected of plastic surgeons in this community. On November 2, 1984, the Respondent performed a face lift operation on the patient, L.T. Julio Ceaser assisted with the surgery and gave the patient an intravenous injection and an IV. In performing the facial surgery, the Respondent used straight-line pre-auricular incisions which were approximately three quarters of an inch in front of the patient's ears. While the location of these incisions would be acceptable for a male patient because they can be hidden along the facial hair of the patient, such incisions on a female patient fall below the standard of care to be expected of a plastic surgeon in this community. As a result of the Respondent's placement of the incisions, the patient's pre-auricular scars are more visible than they would have been if the incisions had been properly placed. Respondent's expert witness testified that there are some surgeons in this community who utilize a straight pre-auricular line of incision for a full facelift. However, Petitioner's expert, whose opinion is credited, testified that such an incision has been obsolete since at least the mid-1970's and does not comport with the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. After the first surgery was completed on November 2, 1984, the patient was left with very noticeable scars below her ears and on her neck. The evidence did not clearly establish the cause of these scars which were an unacceptable complication of the surgery. While all facelifts result in some scarring, the location, size and visibility of the scars below the ear were a bad result and needed to be corrected. Respondent performed a second operation on the patient on May 10, 1985 in an effort to excise these scars. In this second procedure, Respondent did not properly address the problem of excess scarring and caused substitute scarring instead. As a result of the second operation, the patient has folds of skin underneath her ear which are very noticeable and unsightly. By virtue of Respondent's actions, the patient has suffered permanent scarring. To what extent this condition can be hidden or corrected by further surgery or other efforts has not been established of record. Prior to the second surgery the patient attended some therapy sessions that were intended to reduce the scarring. However, she was not satisfied with the results and refused to attend any more sessions. There is no evidence establishing the impact of the failure to attend any further sessions. The patient has suffered permanent nerve damage in her face which is most likely the result of the accidental cutting of a nerve during one of the facial surgeries performed by the Respondent. The cutting of a facial nerve reflects an incision that was much too deep for this type of surgery and falls below the standard of care expected of a plastic surgeon in this community. After the first surgery, the Respondent did not see the patient during the 10 day period immediately following the surgery. However, Julio Ceaser did visit the patient and change her bandages in the days following the surgery. As set forth above, Julio Ceaser's medical training or lack thereof was not established by competent substantial evidence. The patient has scars behind her ears which could have been the result of the sutures not being timely removed. However, the sutures were removed approximately one and one half weeks after the surgery. The removal of the sutures within this time frame was not below the standard of care. Therefore, the evidence fails to demonstrate that the scars behind the ears were the result of substandard care by Respondent. There was very poor recording of the patient's vital signs during the surgical procedure. The patient's blood pressure and heart rate were noted in 15 minute intervals. While such intervals may be acceptable under normal circumstances, there is evidence that the patient's blood pressure dropped very significantly during the surgery. In view of this occurrence, more frequent notations of the patient's vital signs should have been included in the medical records. Pre-operative photographs of the patient were taken prior to the first surgery. Pre-operative photos are an essential part of the documentation that is expected to be included in the medical records of a patient seeking plastic surgery. However, the pre-operative photographs of patient L.T. are not included in her medical records, and no competent proof was offered to explain why these photographs were not included. Although the patient signed a form referred to as an "informed consent", that form cannot be located and is not contained in the patient's medical records.
Recommendation Based on the forgoing Findings of Fact and Conclusions of Law it is: RECOMMENDED that the Department of Professional Regulation, Board of Medicine, enter a Final Order which finds Respondent guilty of the violations alleged in Counts One and Four of the Administrative Complaint, dismisses Counts Two and Three, imposes an administrative fine in the amount of $2,500, and suspends Respondent's license for a period of one year followed by a three (3) year term of probation. DONE AND ORDERED this 3rd day of August, 1989 in Tallahassee, Leon County, Florida. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of August, 1989.
The Issue The issue is whether Respondent's Florida license to practice medicine should be revoked for malpractice under section 458.331(1)(t), Florida Statutes (2006).
Findings Of Fact Respondent is licensed to practice medicine in Florida, holding license number ME 66823. He is a radiologist and is certified by the American Board of Orthopedic Radiology and Diagnostic Radiology. On June 17, 2004, the Board of Medicine (Board) disciplined Respondent's medical license by issuing a letter of concern, imposing a $15,000 fine, assessing $4,010.59 in costs, requiring eight hours of continuing medical education, and prohibiting him from treating or prescribing medication to members of his family. On or about October 4, 2006, while working at Drew Medical, Inc., Respondent performed a diagnostic procedure called an intravenous pyelogram (IVP) without tomograms for Patient G.P., who had complained of right-side pain and had a history of kidney stones. An IVP without tomograms is a series of time- lapse x-rays using a dye material to provide radiographically contrasting images to detect a stone in a kidney or ureter. The resulting x-ray images revealed a partial obstructing stone in the right-side kidney/ureter area, which Respondent detected and reported. One of the resulting x-ray images contained an anomaly having the classical appearance of an abdominal aortic aneurysm, including conspicuous tissue displacement and rim calcification. It had an elongated, water balloon-type appearance with calcifications on one of the walls. It was alarming or life- threatening in size, such that it could cause death by bleeding. Respondent did not mention the aneurysm in his report or recommend any further evaluation of the anomaly. Although he was tasked to look for kidney stones, Respondent's failure to report the aneurysm or recommend any further evaluation of the anomaly fell below the level of care, skill, and treatment that is recognized by reasonably prudent, similar physicians as being acceptable. Patient G.P. was admitted to Orlando Regional Hospital with a ruptured abdominal aortic aneurysm on October 6, 2006. Attempts were made to repair the rupture, but they were not successful. The patient died on October 12, 2006. By his conduct in disappearing without a trace, despite the diligent efforts of DOH to find him, and not participating in any manner in the hearing he requested to dispute the Administrative Complaint, Respondent effectively abandoned his license to practice medicine in Florida.
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 Respondent guilty of medical malpractice, revoking his medical license, and imposing a $10,000 administrative fine. DONE AND ENTERED this 25th day of July, 2012, in Tallahassee, Leon County, Florida. S J. LAWRENCE JOHNSTON 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 25th day of July, 2012. COPIES FURNISHED: Greg S. Marr, Esquire Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Robert Dean Marshall, M.D. Apartment 310 400 East Colonial Drive Orlando, Florida 32803 Robert Dean Marshall, M.D. 5987 Southwest Moore Street Palm City, Florida 34990 Jennifer A. Tschetter, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Joy Tootle, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
