The Issue Whether Respondent's license to practice medicine should be suspended, revoked or the licensee otherwise disciplined for alleged violations of Chapter 450, Florida Statutes, as set forth in the Amended Administrative Complaint dated March 1, 1984. The Amended Administrative Complaint in this proceeding alleges that Respondent, either individually or in concert with other attending physicians, ordered or prescribed certain nephrotoxic drugs to a patient who suffered from renal impairment, "that Respondent failed to appropriately monitor such medication or its effects," and that the patient suffered renal failure and vestibular and cochlear impairment. It is alleged in the complaint that Respondent therefore violated Section 458.331(1)(t) Florida Statutes, by committing gross or repeated malpractice or failure to practice medicine at an acceptable level of care, skill, and treatment. The complaint also alleges that Respondent altered patient records by inserting false laboratory reports, additional progress notes, and other additions, and failed to appropriately document the justification for the patient's course of treatment, in violation of Section 458.331(1)(i),(1), and Florida Statutes. At the hearing, Petitioner presented the testimony of 9 witnesses and submitted 7 exhibits in evidence. Respondent called 5 witnesses, and the parties stipulated to the expected testimony of Dr. Maynard Taylor. During the course of the hearing, Petitioner introduced into evidence a deposition of Respondent which was taken in a civil proceeding in the Pasco County Circuit Court to which Respondent was not a party, but which involved the same medical treatment provided to patient Michael Marotta that resulted in the Administrative Complaint herein. (Petitioner's Exhibit 3) The Hearing Officer determined that any admissions made by the Respondent that are reflected in the deposition were admissible in this proceeding pursuant to Section 90.803(18), Florida Statutes. Petitioner submitted a posthearing list of purported admissions contained in the deposition, and Respondent filed a response thereto conceding that some of the statements by Respondent constituted admissions and that others did not. Those statements of Respondent which are deemed to constitute admissions are included in the following findings of fact. Petitioner also sought to have its Request for Admissions deemed admitted pursuant to Rule 1.370, Florida Rules of Civil Procedure, due to Respondent's untimely response thereto. Respondent opposed Petitioner's request on the ground that his response was timely under the rules of discovery and, even if such rules were inapplicable in an administrative proceeding, he should be granted relief due to excusable neglect or inadvertence. Although Respondent's claims are not deemed meritorious, certain of the requests for admissions which were denied by Respondent were not in conformance with the evidence presented at the hearing. Those admissions which are properly considered to be within the scope of discovery requests are reflected in the following findings of fact. The proposed recommended orders filed by the parties have been fully considered and those portions thereof not adopted herein are considered to be either unnecessary or irrelevant, or unsupported in law or fact.
Findings Of Fact Respondent Nrisingha Das Mukherjee is licensed to practice medicine in the State of Florida, and was so licensed at all times material to the allegations in the Amended Administrative Complaint. On October 1, 1979, Michael Marotta, then sixty years old, was admitted to the West Pasco Hospital, New Port Richey, Florida, by Dr. Jack Lund. His complaints were a severe cough and chest pains. He had experienced shortness of breath with increasing severity for several days prior to admission, with a productive cough and generalized malaise. He had a long-standing pulmonary history, including tuberculosis at age twenty, with right lower partial lobectomy in 1949. He had been treated for hypertension since 1954 or 1955. The physician's admission diagnosis was bronchial pneumonia. (Testimony of Michael Marotta, Reines, Petitioner's Exhibit 1) During Marotta's hospitalization, it was determined by Dr. Lund that he had cancer of the colon. Dr. Lund then contacted the Respondent on October 9, 1979, for assistance with the surgical management of the patient. Respondent determined that surgery was required, but called in Dr. Jeffrey Reines, a cardiologist and internist, for a consultation on October 10, 1979. (Testimony of Lund, Reines, Petitioner's Exhibit 1) Dr. Reines examined the patient and his consultation report reflected impressions of atherosclerosis, possible coronary artery obstructive disease, chronic restrictive pulmonary disease, chronic obstructive pulmonary disease, resolving bronchitis or pneumonia, tachycardia, probable cecal carcinoma and an abnormal cardiogram. He found that the patient was a high-risk candidate for the contemplated surgical procedure because of his cardiac status and poor pulmonary status, and therefore felt it might be necessary to postpone the surgery for a short period of time for transfusional therapy, pulmonary function testing, and pulmonary psysiotherapy. (Testimony of Reines, Petitioner's Exhibit 1) As a result of Dr. Reines' recommendations, surgery was postponed until October 15, 1979, at which time Respondent performed an exploratory laparotomy, a hemicolectomy, and a cholecystectomy on patient Marotta. During surgery, the patient experienced an episode of bradycardia for a short period of time whereby there was a decrease in the patient's heart rate and blood pressure. (Testimony of Reines, Petitioner's Exhibit 1) After surgery, the patient suffered acute renal failure and he was transferred on October 16, 1979, to Community Hospital in New Port Richey for dialysis treatment. Since that time, he has had to remain on dialysis, and additionally has suffered impairment in balance and hearing functions. Marotta had never previously experienced kidney, balance or hearing problems. (Testimony of Reines, Michael Marotta, Marie Marotta, Petitioner's Exhibit 1) Prior to the time that Respondent entered the case on October 9, 1979, Dr. Lund had prescribed drug therapy, including garamycin, penicillin, lasix, and lanoxin. Additionally, the patient was given an IV pyelogram (IVP) and cholecystogram which are used to determine kidney and gallbladder functions. Respondent prescribed erythromycin, neomycin, keflin, and utilized a neomycin wash during surgery. Prior to surgery, Respondent had also ordered an aminoglycocide for the purpose of cleansing the bowel of gram negative organisms. Dr. Reines had also ordered garamycin for the patient prior to surgery. After surgery, Respondent prescribed teflin, gentamycin, and lasix. However, all drugs were discontinued on October 16, 1979. (Testimony of Reines, Petitioner's Exhibit 1) The antibiotic and other drugs used in the treatment of Marotta are potentially nephrotoxic, particularly when used by patients with impaired renal function. In addition otoxicity can occur in patients with preexisting renal damage who are treated with garamycin. It is therefore necessary that close monitoring of renal function be maintained even in patients with normal renal function if they develop evidence of nitrogen retention, as shown by laboratory tests. Neomycin presents similar problems and concurrent use of the two drugs, together with diuretics such as lasix, should be monitored closely for patients with impaired renal function. (Testimony of Willey, Petitioner's Exhibit 1, 4) Tests performed on Michael Marotta when he was admitted to West Pasco Hospital indicated that there might be some kidney function impairment. However, during the course of treatment, his kidneys were monitored by standard tests and his kidney function was deemed to be adequate until subsequent to the surgical procedure. Conflicting evidence was received at the hearing concerning the adequacy of such testing. In addition, false BUN and creatinine test results purporting to have been performed on October 3, 5, and 7, 1979, were prepared and made a part of Marotta's medical record by an unknown person at an unknown time subsequent to the period of hospitalization. However, it is found that insufficient evidence was presented to establish that Respondent failed to adequately monitor the patient's condition during the period in which he provided treatment. (Testimony of Willey, Reines, Stadnitski, Shaneyfelt, Downey, Barr, Abbey, Petitioner's Exhibits 1, 3-5, 7) Although the medications ordered by Respondent, in conjunction with those ordered by the other physicians in the case had potential nephrotoxic effect, it is found that they were administered as necessary to prevent serious infection in a patient who had advanced cancer. In such a situation, every effort must be made to prevent such infection by the use of antibiotics. In the opinion of an expert in the field of surgery, Dr. Joseph Abbey, the use of such medications in such an instance constitutes a calculated risk which is acceptable if the patient is well hydrated and monitored closely. His opinion conforms with that of Dr. Reines, the internist, who testified that the patient was in a life-threatening situation due to his overall poor physical condition which justified use of the medications in question because all of the patient's organs were threatened and he otherwise would have been subjected to peritonitis. He also felt that if the patient had been taken off diuretics, he probably would have gone into congestive heart failure. Since the patient had acute tracheal bronchitis, he felt that no less toxic antibiotics could have been given to the patient than were used during the course of treatment. (Testimony of Abbey, Reines) Dr. Reines was also of the belief that the patient's renal failure was exclusively caused bye the bradycardia episode that had occurred during surgery. This opinion was disputed by Petitioner's expert pathologist, Dr. Edward Willey, who testified that the kidney failure had been caused by the cumulative effects of toxic drugs and dyes administered to the patient. He was, of the opinion that the period of bradycardia had a relatively insignificant effect on the patient's renal condition. However, the nephrologist who examined Marotta on October 16, 1979, was of the view that renal failure was "probably secondary to possible hypotensive episode intra-operatively and nephrotoxic drugs." (Testimony of Reines, Willey, Petitioner's Exhibit 1) At some undetermined time after Respondent had made original entries in Marotta's medical records, he made additional entries on various pages concerning various laboratory tests that had been made during the course of treatment. No evidence was presented that these late entries were inaccurate or misleading. Additional late entries were made on several pages of the record, including the signed patient consent to surgery form on October 14, 1979. Paragraph 6 of the printed form reflected that the nature and purpose of the operation, possible alternative methods of treatment, the risks involved, and the possibility of complications had been fully explained. At the bottom of the form in handwriting, Respondent had added a handwritten note stating that he had explained in detail the pros and cons of surgery to the patient, and that the mortality and morbidity of the surgery and medical treatment had been discussed. In several other instances, Respondent had added similar notes in handwriting on pages of the record stating that he had discussed with the patient and/or his family the "bad risks involved for surgery and medical management," "the risk of surgery in the face of poor lung function and kidney function," and "Bowel prep with neo and Erythromicin discussed with patient - risk explained." At least one of these late entries had been made sometime in 1981 after the records had been numbered by hospital personnel. One of the other entries reflected the correction of the erroneous date of "10/10/80" to 10/10/79. All of the entries purported to have been made on dates during October 1979. Although it is not unusual for physicians to make late entries to complete the hospital records after a patient is discharged, and to date the delayed entry as the date that treatment was given, normally this is accomplished in a relatively short period of time unless there are multiple physicians involved in the case. It would be rare that an entry was dated over a year after discharge of the patient. Both Michael Marotta and his wife denied that they were ever advised by Respondent that the medications in question were dangerous to or could affect the kidneys. (Testimony of Shaneyfelt, Robinson, Michael Marotta, Marie Marotta, Petitioner's Exhibits 1, 6) Respondent has a reputation in the local medical community as a competent and respected surgeon since his arrival in New Port Richey some five or six years ago. (Testimony of Marlow, Lincer, Wright, Stipulated testimony of Abbey)
Recommendation A hearing was held in the above captioned matter, after due notice, at New Port Richey, Florida, on March 13-14, 1984, before Thomas C. Oldham, Hearing Officer.
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 The issue is whether Respondent is guilty of failing to practice in accordance with the applicable standard of care or failing to keep adequate medical records and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 44240. He has been licensed in Florida since 1984. Respondent has practiced plastic surgery, particularly cosmetic plastic surgery, for the past 22 years. Respondent is certified by the American Board of Plastic Surgery in plastic surgery. He was also certified in Advanced Cardiac Life Support (ACLS) at the time of the surgery in question. The Board of Medicine previously disciplined Respondent by Final Order filed September 1, 1995, pursuant to a Consent Agreement into which the parties had entered. The Consent Agreement arose from allegations that Respondent had failed to remove a sponge from a breast during breast augmentation surgery. Respondent did not admit the allegations, but agreed to pay a $2000 fine and attend ten hours of continuing medical education. The Administrative Law Judge admitted this evidence strictly for the purpose of penalty, not liability. Respondent performs plastic surgery at the Cosmetic Surgery Center in Fort Lauderdale. The 5000 square-foot facility contains three examination rooms, two operating rooms, one recovery room, and an overnight hospital. Another physician also operates at the Cosmetic Surgery Center, which employs a wide range of staff, including a patient coordinator, nurse practitioner, and a certified register nurse anesthesiologist (CRNA). In the past, the Cosmetic Surgery Center retained a CRNA to assist in surgery on an as-needed basis. However, since mid-2005, the Cosmetic Surgery Center has regularly employed a CRNA after the Board of Medicine issued an Order of Emergency Restriction of License on June 8, 2005. Issued in response to the incident described below, the emergency order requires, among other things, that Respondent employ a CRNA or M.D. anesthesiologist to administer anesthesia at all surgeries, unless the surgery will involve Level I sedation. The emergency order also requires Respondent to obtain an unqualified surgical clearance from every patient's primary care physician. Respondent has performed over 10,000 procedures using Level II sedation over 25 years. Level II sedation leaves the patient conscious, but tranquil, and responsive to painful stimulus or verbal command. Level III sedation leaves the patient unconscious. This case involves a 50-year-old female, S. B., who presented to Respondent's office on July 9, 2003, to discuss the possibility of an abdominoplasty, breast augmentation, and arm lift. Respondent had previously performed an abdominoplasty, which is also known as a tummy tuck, on S. B.'s daughter, who wanted to make a present of cosmetic surgery for her mother. After examining S. B., Respondent recommended against any work on the arms, as the surgical scars would outweigh the benefits of the surgery for S. B. During this initial office visit, Respondent took a history from S. B., who had three children and was employed as a receptionist for a local roofing company. S. B. stated that her general health was good, and she had never had significant complications from any surgery. She reported that her only medical problem was hypertension and that she consequently took clonidine and Lasix. She stated that she had never reacted badly to general or local anesthesia, did not bruise easily, and did not bleed excessively from cuts. The form asked the patient to list intoxicating or mind-altering drugs, and S. B. did not list any. At no time during the July 9 visit did S. B. express an intent to proceed with the surgery, and, in fact, she was undecided at the time and remained so for several months. Respondent next saw S. B. on December 11, 2003, when she presented at his office for a pre-operative examination. Respondent again discussed the surgical procedures. During this visit, S. B.'s blood pressure was 210/112, which was too high for Respondent to perform elective surgery. Instead, he discussed with S. B. the need to control her blood pressure and learned that she had quit taking her blood pressure medication. Respondent told S. B. to see her primary care physician to control the blood pressure. Respondent's notes document S. B.'s blood pressure, the referral, and the purpose of the referral. In anticipation of surgery on December 23, 2003, Respondent prescribed on December 11, 2003, fifteen 500-mg tablets of Duricef, fifteen 10-mg tablets of Lorcet, and fifteen 30-mg tablets of Restoril. Duricef is an antibiotic. An analgesic, Lorcet combines 10 mg of hydrocodone, an opioid, with acetaminophen. Restoril, or temazepam, is a sedative in the benzodiazepine family and is similar to Valium. Respondent typically prescribes these or similar medications, so that his patients can fill them prior to surgery and take them following surgery. On December 11, 2003, Respondent also ordered pre- surgical lab work. The lab report, dated December 12, 2003, states that S. B.'s values were largely normal. However, S. B.'s prothrombin time (PT), which measures clotting time, was very slightly elevated. The normal range for this parameter for this laboratory is 11-13 seconds, and the PT for S. B. was 14.8 seconds. However, the International Normalization Ratio (INR), which normalizes results among labs and tissue samples, was 1.4, which is within the normal range, as was the partial thromboplastin time (PTT), which is another measure of clotting time. S. B.'s red blood cell count was very slightly high (6.13 as compared to a range of 4.2-6.1 units per liter). Also very slightly low were S. B.'s M.C.V. (79.0 as compared to a range of 80.0-99.0 units), M.C.H. (26.3 as compared to a range of 27.0-31.0 units), and M.C.H.C (32.7 as compared to a range of 33.0-37.0 units per liter). Very slightly high was S. B.'s R.D.W. (15.4 as compared to a range of 11.5-15.0 percent). Except for the red blood cell count, the other parameters pertain to precursors of cells. The next day, Respondent added to the pre-operative prescriptions two 5-mg tablets of Mephyton, which is vitamin K. The medical records contain no discussion of why Respondent added vitamin K the day after he had ordered the other pre- operative medications. Most likely, this information would have been contained in Respondent's notes, which are in a handwritten scrawl that is partly illegible. Clearly, though, Respondent's notes fail to disclose the purpose of ordering Respondent to take vitamin K. Respondent testified that he was responding to the PT value, explaining that he gives vitamin K to patients with borderline clotting studies, so that the patients will not experience as much bruising and swelling. More important than the records' failure to contain an explanation for the ordering of vitamin K is their failure to address the high PT value in Respondent's plan of treatment for S. B. Even if only borderline high and more suggestive of problems involving only bruising and swelling, the PT raised a clotting issue, which is of obvious importance given the nature of the contemplated surgery. Respondent's records must address this issue and the impact, if any, on the contemplated surgery. In retrospect, the PT abnormality proved irrelevant. S. B. did not display any clotting problems or excessive bleeding during the surgery. At the hearing, Respondent explained the limitations of a PT value, especially when it is unaccompanied by an abnormal INR, although Respondent obviously thought enough of the PT test to order one for S. B. More cogent is Respondent's explanation at the hearing that the absence of any reported history of bleeding or bruising outweighed any concerns raised by a slightly elevated PT value, but this persuasive analysis is nowhere to be found in the medical records. Petitioner argues alternatively, though, that the slightly elevated PT value should have alerted Respondent to cirrhosis, which is discussed in more detail below. At the pre- operative stage, at least, the history, findings, and complaints did not support a diagnosis of cirrhosis. In his pre-operative physical examination, Respondent found no evidence of jaundice or edema. S. B.'s anemia had resolved. Her history lacked any indication of liver disease, nor did S. B. complain of any symptoms consistent with cirrhosis. These facts, as well as the information supplied by S. B.'s primary care physician, justified Respondent's failure to explore the possibility of liver disease prior to proceeding with surgery. Nor did the circumstances impose a duty on Respondent to include in the medical records a plan of treatment that addressed the possibility of cirrhosis. The facts reasonably known to Respondent did not raise the possibility of cirrhosis, any more than they raised the possibility of heroin use by S. B. It is thus irrelevant to Respondent's documentation duties, although not necessarily to her death approximately 30 hours after the end of the surgery, that S. B. suffered from some degree of cirrhosis and used heroin. On December 31, 2003, S. B.'s primary care physician completed a "Medical Clearance" form, even though Respondent had not requested a medical clearance, but had required only that the physician do what was necessary to get S. B.'s blood pressure under control. On the form, S. B.'s primary care physician noted that S. B.'s past history consisted of hypertension and, in June 2000, anemia. The addition of the date implied that S. B. no longer suffered from anemia--a fact borne out by her elevated red blood cell count. On the form, the primary care physician noted that her blood pressure was 160/98 and pulse was 80, changed one of S. B.'s blood pressure medications, and cleared her for surgery under local and general anesthesia, "once BP < 150/90." Two items on the Medical Clearance form support Respondent's decision not to investigate the possibility of liver disease before performing surgery. First, as noted above, the form indicates that S. B.'s anemia had resolved. It would be reasonable to assume that S. B.'s primary care physician was especially attentive to indicators of anemia or liver disease given this history. Second, the Medical Clearance indicates that S. B.'s primary care physician had ordered a comprehensive metabolic panel, which would include tests of liver function. The absence of any further contact from the primary care physician implies that the comprehensive metabolic panel revealed nothing of importance as to liver function, and the function of the liver is obviously important--not its post- mortem condition. On January 15, 2004, S. B. presented at the Cosmetic Surgery Center for an abdominoplasty with liposuction to the waist area. Respondent's scrawled notes do not disclose why he or S. B. decided not to proceed with the breast augmentation. In the pre-operative evaluation, which is initialed by Respondent, S. B.'s pulse was 95, and her blood pressure was 162/96, with the notation that she was nervous. Her rating on the American Society of Anesthesiologists (ASA) scale is I, meaning that she has no disease. Respondent concedes that her hypertension warranted a II, which means some systemic disease, but not threatening. However, the mis-rating on the ASA scale is irrelevant because it did not impact her treatment or outcome. The pre-operative evaluation contains two other notations of interest. First, Respondent planned for S. B. to remain overnight at the Cosmetic Surgery Center, rather than to discharge her to home on the day of the surgery or transfer her to a hospital. Thus, her remaining at the facility the night of the surgery did not suggest an unusually difficult surgery or recovery. Second, Respondent found S. B. fit for surgery under I.V. sedation in the office, rather than local or general anesthesia. Obviously, the pre-operative evaluation reports a blood pressure in excess of the maximum listed in the medical clearance that Respondent had received from S. B.'s primary care physician. Respondent's medical records fail to address this discrepancy and the broader issue of S. B.'s blood pressure, which was about the same as it was when she visited her primary care physician, but considerably lower than when she last visited Respondent. Respondent could and did reasonably exercise his own medical judgment and proceed with surgery despite a blood pressure in excess of the maximum on the medical clearance, but given this recommendation, S. B.'s extremely elevated blood pressure a month earlier, the challenges of maintaining reasonable blood pressure levels intra- and post- operatively, and S. B.'s hypertensive condition, Respondent was required to document his reasoning for proceeding with surgery despite the relatively high blood pressure. At hearing, Respondent offered a persuasive explanation of why he proceeded to perform the surgery despite a blood pressure reading over 150/90. Attributing the elevated blood pressure (and pulse) to adrenalin-producing anxiety, not hypertension, Respondent decided that he would be able to control S. B.'s blood pressure adequately during surgery with sedatives and blood pressure medication. Considerable evidence indicates that S. B. was a very nervous patient. S. B.'s pulse was also quite rapid on both visits. As was the case with the PT value, it is easier to credit Respondent's reasoning given hindsight, as he successfully controlled S. B.'s blood pressure during surgery. During surgery, Respondent's nurse practitioner, Michelle Huff, monitored heart function by an EKG, blood oxygenation and pulse by a disposable pulse oximeter, blood pressure, and respiration. During the surgery, Respondent was also assisted by Tiffany Archilla, a certified surgical technologist. At Respondent's direction and under his supervision, Nurse Hoff, administered the following drugs immediately before and during surgery: Diprivan, which is an anesthetic whose specific effect depends on rate of administration; Versed, which is a sedative; Robinul, which controls nausea; Ancef, which is an antibiotic; fentanyl, which is an analgesic and anesthetic; and labetalol, which controls blood pressure. Nurse Huff also administered oxygen and nitrous oxide, which is an anesthetic. Nurse Huff had been working at the Cosmetic Surgery Center for only two months at the time of S. B.'s surgery. Nurse Huff is not a CRNA, but is an advanced registered nurse practitioner and has been a registered nurse for 14 years. At the time of the hearing, she had been employed for three years at the Cosmetic Surgery Center, where she also had completed an internship. She estimates that she has participated in over 1000 surgical procedures involving Level II sedation. At 8:40 a.m., Nurse Huff administered 2.5 mg of Versed, 0.2 mg of Robinul, and 1.0 g of Ancef. At 8:45 a.m., Nurse Huff started the oxygen, nitrous oxide, and Diprivan drip. The oxygen was in a two-liter bottle, and the nitrous oxide was in a four-liter bottle. The Diprivan was 500 mg in a 500 cc solution. During the surgery, Nurse Huff administered all of this Diprivan, as well as all of another 200 mg of Diprivan in a 250 cc solution, given S. B.'s resistance to sedation. In most cases, and probably in this one, Respondent uses a microchamber, which releases microdrips at the rate of 60 drops per minute. Respondent does not administer Diprivan by means of an infusion pump, which would offer more precise control of the rate of infusion. The records do not indicate the rate of administration of the Diprivan. However, Respondent rarely finds it necessary to discontinue Diprivan during surgery, and its clinical effect wears off after only about three minutes following its discontinuation, so the patient arouses quickly after Diprivan is stopped. Thus, the failure to record the rate of administration of the Diprivan is immaterial. At 8:45 a.m., Nurse Huff also administered 100 mg of fentanyl, which was followed by 50 mg doses at 8:50 a.m., 8:55 a.m., 9:05 a.m., 9:35 a.m., 9:45 a.m., 10:05 a.m., and 10:10 a.m. S. B. thus received a total of 450 mg of fentanyl. The surgery commenced at 9:30 a.m. At the start of surgery, Respondent administered subcutaneously at the surgical site 150 cc of one percent lidocaine, which is a local anesthetic, with epinephrine at 1/200,000. The epinephrine prevents the body from quickly absorbing the lidocaine. S. B.'s blood pressure had varied between 8:40 a.m. and 9:30 a.m. It started at 164/97, but was 135/85 15 minutes later. Her blood pressure remained at 145/85 from 9:00 a.m. to 9:10 a.m. At the time of surgery, S. B.'s blood pressure was 162/88. In response to the start of surgery and reflective of S. B.'s level of anxiety, her blood pressure surged to 180/95 at 9:45 a.m., and Respondent directed Nurse Huff to administer 2.5 mg of labetalol at this time. S. B.'s blood pressure reached 190/80 at 10:00 a.m., five minutes after Nurse Huff had administered another 2.5 mg of labetalol. By 10:10 a.m., S. B.'s blood pressure was down to 125/75, where it remained for the remainder of the surgery. S. B.'s other vitals remained good during the surgery. Oxygenation saturation remained over 96 percent, mostly 97 and 98 percent. Respiration remained around 18. Pulse ran in proportion to blood pressure, but settled within the range of 80-90 once S. B.'s blood pressure stabilized at 10:10 a.m. Blood loss was minimal during the surgery. Typically, a patient may lose 200-300 cc of blood, but S. B. lost only 150 cc. Proceeding conservatively, Respondent did not try to tighten the muscle wall, as he found, once he had made the incisions, that S. B. did not require this procedure. The liposuction removed 200 cc, including 150 cc of fat. Anesthesia ended at 11:05 a.m., and surgery ended at 11:10 a.m. During the surgery, S. B. had received 2000 cc of fluids. At all times, S. B. remained active and alert. Evidencing S. B.'s level of alertness during surgery was her high oxygen levels at all times during surgery and the necessity of additional Diprivan. At 11:20 a.m., S. B. was transported by stretcher from the operating room to the recovery room. At this time, her oxygen level was 98 percent, her blood pressure was 179/97, her pulse was 96, and her respiration was 16. At 11:30 a.m., S. B. received 2.5 mg of labetalol. At 11:35 a.m., S. B. was complaining of anxiety, so she received 2.5 mg of Valium. At 11:40 a.m., a nurse emptied her Foley catheter of 1600 cc of clear yellow urine. At this time, S. B.'s blood pressure was 184/105, her pulse was 95, her respiration was 16, and her oxygen level was 96 percent. She received another 2.5 mg of labetalol. At 11:45 a.m., S. B. received another 2.5 mg of Valium. At 12:15 p.m., S. B.'s blood pressure was 164/92, and she received clonidine 0.1 mg to reduce her blood pressure. Fifteen minutes later, S. B.'s blood pressure dropped to 143/88. She fell asleep at 1:00 p.m., but awoke an hour later, complaining of pain. She then received 75 mg of Demerol with 6.25 mg of Phenergan, which controls nausea. At 2:30 p.m., S. B. complained again of pain. Her blood pressure had risen to 189/78, so she received another clonidine 0.1 mg. Fifteen minutes later, a nurse emptied S. B.'s Foley catheter of 1400 cc of clear urine. S. B.'s blood pressure was 170/100, and the nurse notified Respondent of this reading. The nurse gave S. B. 10 mg of Procardia, which reduces high blood pressure. At 3:00 p.m., S. B. received 2.5 mg of labetalol and 2.5 mg of Versed. Fifteen minutes later, S. B. was transferred by stretcher to the overnight room with a blood pressure of 141/60, pulse of 96, and respiration of 16. By 3:45 p.m., S. B.'s blood pressure was 125/59, and she was asleep. Thirty minutes later, S. B. was watching television, and her blood pressure was 141/78. After complaining of pain, S. B. received 100 mg of Demerol with 12.5 mg of Phenergan at 4:50 p.m. At 5:10 p.m., S. B.'s blood pressure rose to 163/94, and her pulse was 108. She received another 10 mg of Procardia at this time. At 6:00 p.m., S. B.'s blood pressure was down to 142/88. Two hours later, after she complained of insomnia, S. B. received 30 mg of Restoril. At 9:15 p.m., S. B. complained of abdominal pain. She received 100 mg of Demerol and 25 mg of Phenergan. At 11:30 p.m., S. B. received 30 mg of Restoril for insomnia and 10 mg of Lorcet for pain. At 1:20 a.m. on January 16, S. B. was sleepy. Two hours later, her blood pressure was 148/70. At 5:30 a.m., after an uneventful night, S. B. complained of abdominal pain and received another 10 mg of Lorcet. At 7:00 a.m., her intravenous line was discontinued. Alert and oriented, S. B. walked in the hall and received another clonidine 0.1 mg. A nurse emptied her Foley catheter of 400 cc of urine and removed the Foley catheter. At discharge at 8:00 a.m., Respondent examined the wound and found no evidence of bleeding, as he changed the dressing. At this time, S. B.'s blood pressure was 147/70 and pulse was 108. S. B. was transported by wheelchair to her daughter's car. S. B. and her daughter arrived at S. B.'s home at about 9:00 a.m. on January 16, 2004. After spending the morning with her mother, the daughter left the home and returned at 1:00 p.m. Having forgotten the house key, the daughter knocked on the door, and S. B. had to crawl to the door due to her lack of strength. The daughter assisted her mother to bed. Mid- afternoon, the daughter left her mother to run some errands. When the daughter returned home shortly before 6:00 p.m., she found her mother unresponsive and curled into a fetal position on the floor with blood present on the bed sheets and nightshirt that she was wearing. The daughter immediately called 911 and requested an ambulance. The emergency management technicians (EMTs) arrived at S. B.'s home at 6:23 p.m. and found her as her daughter had found her. S. B. was in full cardiac arrest. The EMTs found S. B. cold to the touch with fixed and dilated pupils. They found a "small amount" of blood oozing from the staples in the lower stomach. The two surgical drains in the upper stomach contained no discharge. Blood had soaked the bandage and run down both legs to thigh level. The EMTs estimated blood loss at about 500 cc. The EMTs also found the Restoril and Lorcet in the doses that Respondent had prescribed pre-operatively. The EMTs attempted unsuccessfully to resuscitate S. B. and transported her to the hospital where she was pronounced dead on arrival at 6:35 p.m. The medical examiner conducted an autopsy on January 17, 2004, at which time blood and urine samples were taken for toxicological analysis. The toxicology report notes that a gas chromatography/mass spectrometry procedure revealed the presence of 6-MAM, which is a metabolite of heroin and demonstrates conclusively that S. B. consumed heroin or, much less likely, 6-MAM; morphine, which is another indicator of heroin, at a concentration of 0.22mg/L; methadone at a concentration of less than 0.05 mg/L; meperidine, which is Demerol (a narcotic analgesic) at a near-toxic concentration of 0.98 mg/L; diazepam, which is Valium, at a concentration of less than 0.05 mg/L; nordiazepam, which is a metabolite of Valium, at a concentration of less than 0.05 mg/L; temazepam, which is, as noted above, Restoril or another metabolite of diazepam, at a concentration of 0.29 mg/L; and hydrocodone, which is one of the two ingredients, as noted above, of Lorcet, at a concentration of 0.05 mg/L. A drug's half-life is the amount of time for its potency to be reduced by half. Three to four half-lives are required for the complete elimination of a drug. Because various conditions can affect the half-lives of drugs, such as liver disease as to drugs eliminated substantially through metabolism by the liver, half-lives are stated as average ranges. Relevant half-lives are: Demerol--2-24 hours; diazepam--21-37 hours; hydrocodone--3.4-8.8 hours; and temazepam--3-13 hours. Diprivan and fentanyl have very short half-lives and were not detected by the toxicologist. The half- life of 6-MAM is also very short, about 6-25 minutes, leading the toxicologist who performed the report for the medical examiner to testify that S. B. had consumed heroin not more than two hours before her death. The same toxicologist testified that the detected concentration of Demerol was six times the therapeutic level. (This testimony is credited over the testimony of the Deputy Chief Medical Examiner that the concentration of 0.98 mg/L is only twice the therapeutic level.) Given a half-life of 2-24 hours, all that can be said with certainty is that S. B. suffered even greater concentrations of Demerol--possibly much greater--prior to the near-toxic concentration found by the toxicologist. Undoubtedly, the heroin and methadone that S. B. consumed were not prescribed by Respondent. Undoubtedly, S. B. had access to Demerol that Respondent had not administered. Respondent could not have reasonably have anticipated, based on the circumstances, that S. B. would consume heroin, methadone, and toxic or near-toxic amounts of Demerol, in addition to her prescribed medications, within 12 hours of her release from the Cosmetic Surgery Center. Just as an illegal drug user has the right to treatment in accordance with the applicable standard of care, so a physician has a right to expect behavior on the part of his patient that is at least consistent with the instinct of self-preservation. The autopsy determined that S. B. died of a combined drug overdose of heroin, temazepam, Valium, methadone, Demerol, and hydrocodone. Contributing causes of death were hypertension, abdominal wall hemorrhage, and cirrhosis. As to the hypertension, the autopsy report states that S. B. suffered from mild arteriosclerotic cardiovascular disease. As to the abdominal wall hemorrhage, the autopsy report states that S. B. was in status--post-tummy tuck and liposuction. As to the cirrhosis, the autopsy report states that S. B. suffered from severe fatty metamorphosis of the liver. The autopsy report concludes that the manner of death was an accident. Of the drugs that combined to kill S. B., Respondent clearly did not administer or prescribe the heroin or methadone. Although Respondent administered Demerol at the dosages of 75 mg at 2:00 p.m. 100 mg at 4:50 p.m., and 100 mg at 9:15 p.m., all on January 15, the near-toxic Demerol found in S. B. at the time of her death was not due to these doses, but due, at least in large part, to Demerol that S. B. obtained from other sources. The hydrocodone and temazepam were probably derived, at least in part, from the Lorcet and Restoril that Respondent prescribed for post-operative use. Unfortunately, the record does not reveal how many pills of each that the EMTs found at the S. B.'s home, so it is impossible even to infer how much of each medication that S. B. took while at home during the afternoon of January 16 immediately preceding her death. Not much hydrocodone was found in S. B., and the 10 mg of Lorcet given at 11:30 p.m. on January 15 and 10 mg of Lorcet given at 5:30 a.m. on January 16 would have been nearly eliminated by the time of S. B.'s death, given the short half-life of hydrocodone. Considerably more temazepam was found in S. B., but the 30 mg of Restoril given at 8:00 p.m. and 30 mg of Restoril given at 11:30 p.m. would have been nearly eliminated by the time of S. B.'s death, given the short half-life of temazepam. Clearly, in the two or three hours before she died, S. B. took heroin, methadone, and Demerol. Clearly, the fentanyl that she had last received at 10:10 a.m. on the prior day and the Diprivan that she had last received at 11:05 a.m. on the prior day had long cleared her system before she took the heroin, methadone, and Demerol. S. B. accidentally took her own life by taking these three drugs. The record does not suggest that hemorrhaging from the surgical site was due to some failure on Respondent's part. Instead, it appears more likely that falling from the bed or possibly convulsing from the drug overdose, S. B. may have reopened the incision site. The record does not suggest that cirrhosis materially extended the half-lives of any medications that Respondent administered. S. B. efficiently eliminated the Valium that Respondent administered. The record does not explain why she would not as efficiently eliminate other drugs metabolized primarily by the liver. The record does not suggest that Respondent's management of S. B.'s hypertension intra- and post-operatively had any bearing on her demise. Her blood pressure stabilized late in the afternoon of January 15, and nothing in the record suggests that anything that transpired on that day concerning S. B.'s hypertension caused an acute crisis that resulted in her death. As to Count I, Respondent did not depart from the applicable standard of care. S. B. never fell below Level II sedation; she was always responsive to pain and attempts to communicate. S. B. proved difficult to sedate even to Level II. On these facts, it is impossible to find even that it was reasonably likely, at the outset of the procedure, that S. B. would reach Level III sedation. Additionally, as to Count I, Respondent competently managed S. B.'s hypertension intra- and post-operatively. Based on the circumstances, Respondent correctly determined that the slight elevation of PT would not interfere with clotting or endanger the patient's safety and correctly determined that the other five slight abnormalities in the lab report were immaterial to patient safety in the contemplated surgical procedure. Respondent was thus not required to obtain additional tests or to obtain a consultation for the slight PT abnormality. Based on the physical examination and lab results, including those ordered by the primary care physician, insufficient evidence of liver abnormality existed to preclude the administration of the acetaminophen contained in Lorcet. Further, the standard of care does not preclude the prescription of acetaminophen to all patients with any kind of liver disease. As to Count II, Respondent's medical records fail to document adequately why he proceeded to operate despite S. B.'s failure, pre-operatively, to reach a blood pressure of less than 150/90, why he administered vitamin K pre-operatively, and, most importantly, how he had assimilated the PT abnormality in his treatment plan for S. B. As noted above, at hearing, Respondent amply supplied all of this information--the problem is that he never bothered to do so in the medical records. Although these deficiencies in medical records did not contribute in any way to S. B.'s death, they are material failures to justify the course of treatment. In contrast to the detailed records of Nurse Huff intra-operatively and the post-operative records prepared by nurses, Respondent's notes, and thus the records themselves, do not approach the minimum level of detail necessary to justify the course of treatment in this case. As to Count III, Respondent did not administer or cause to be administered excessive or inappropriate quantities of Diprivan. As to Count IV, Respondent did not improperly delegate professional duties, with respect to the administration of Diprivan, to a registered nurse who was not a CRNA. At all times, Respondent adequately supervised and monitored the administration of this short-acting sedative. The record does not support Respondent's claim of prejudice resulting from any delay in the prosecution of this case. Any claim of prejudice due to delay is undermined by Respondent's failure to demand an immediate hearing due to the imposition of an emergency restriction on his license.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order dismissing Counts I, III, and IV of the Administrative Complaint, finding Respondent guilty of a single violation of Section 458.331(1)(m), Florida Statutes, suspending his license for 30 days, placing his license on probation for two years, requiring him to complete successfully continuing medical education on medical records, and imposing an administrative fine of $10,000. DONE AND ENTERED this 25th day of August, 2006, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 2006. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin AO2 Tallahassee, Florida 32399-1701 John E. Terrel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Lewis W. Harper Brew and Harper, PL 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 George Kellen Brew Brew and Harper, P.L. 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 Patricia Nelson Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399
Conclusions The attending nurse's actions and inactions fell below the standard of professional care applicable under the circumstances. The consequences of a below normal fetal heart rate are so critical that, even if the nurse was suspicious that the monitor was not working properly, her proper response should have been to take immediate steps to determine whether the fetus was in distress, to intervene with resuscitation measures if needed, and to alert a doctor. Her failure to take appropriate action was negligence and was the proximate cause of the injuries suffered by Janaria. South Broward Hospital District, doing business as Memorial Regional Hospital, is liable as the nurse's employer. There are many reasons for entering into a settlement agreement other than the perceived merits of the claim and, therefore, I am not precluded from reviewing the terms of the parties' settlement agreement in this matter and determining whether they are reasonable under the totality of the circumstances. In this case, the settlement amount is far less than the usual jury verdict for injuries of this nature. Had this case involved a private hospital, the settlement amount would probably have been much larger. Therefore, I believe it would be fair and reasonable for the Senate to pay an award of $550,000 (or 50 percent more than the agreed settlement amount). ATTORNEY’S FEES AND LOBBYIST’S FEES: In compliance with s. 768.28(8), F.S., the Claimants' attorneys will limit their fees to 25 percent of any amount awarded by the Legislature. However, Claimants’ attorneys did not acknowledge their awareness of the provision of the bill that limits attorney’s fees, lobbyist’s fees, and costs to 25 percent of the award. They propose a lobbyist's fee that would be an additional 6 percent of any award. OTHER ISSUES: The bill should be amended to correct the name of the defendant to South Broward Hospital District. Of the two annuity options presented by the Claimants' attorney, I believe the option that guarantees payment for 40 years is the better option. In addition, because Shakima Brown received nothing in the settlement, I believe the bill should specify that, in the event that Janaria dies before the trust fund is exhausted, the balance in the trust fund should go to Ms. Brown. The District stated that paying a claim in the amount of $300,000 would not impair its ability to provide normal services. RECOMMENDATIONS: For the reasons set forth above, I recommend that Senate Bill 38 (2008) be reported FAVORABLY, as amended. Respectfully submitted, cc: Senator Ted Deutch Representative Kelly Skidmore Faye Blanton, Secretary of the Senate Bram D. E. Canter Senate Special Master House Committee on Constitution and Civil Law Tony DePalma, House Special Master Counsel of Record
The Issue The issue for consideration in this hearing is whether Respondent's license to practice osteopathic medicine in Florida should be disciplined because of the matters alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the allegations herein, the Board of Osteopathic Medicine was the state agency in Florida responsible for the licensing of osteopathic physicians and for the regulation of the practice of osteopathic medicine in this state. By stipulation, the parties agreed that Respondent was, at all times material hereto, a licensed osteopathic physician in the State of Florida. On May 1, 1990, Patient #1, (R.C.) presented to the Respondent at his office in Orlando for treatment of obesity. At that time, the Respondent, who holds himself out as a specialist in and was determined to be an expert in the field of bariatric medicine, (weight control), had the weight, blood pressure and pulse rate of the patient taken, and other measurements made. At that time, the patient was 6'2" tall and weighed 196 pounds. His blood pressure was 124 over 76, and his pulse rate was 70. He had a waist measurement of 38 1/2" and a hip measurement of 40". As a part of the case history taken of the patient, it appeared that he had no significant matters to report except for the fact that he had periodic shortness of breath and members of his family had had both high blood pressure and heart trouble. There were no other contraindications to treatment. Respondent conducted an examination of the patient and determined that the patient had had liposuction in the stomach area and breasts approximately one year previously, and that he got little exercise, yet smoked 2 1/2 packs of cigarettes per day. He was a reformed alcoholic and felt he was in good general health. Respondent's evaluation of the patient at the time was that he appeared to look well. The medical records reflect the word, "CORPUL", which is an acronym for cardiac/pulmonary, and in connection therewith, Respondent noted that the patient's condition was "excellent." As a part of his initial work up, the Respondent drew blood from the patient which was forwarded to a laboratory for analysis, and he also did a cardiogram. Though the cardiogram appeared "grossly normal" there was some minor irregularity which the Respondent felt necessitated further evaluation. Therefore, the cardiogram was sent to a cardiologist, Dr. Arnold, for evaluation. The report of the cardiologist indicated that the cardiogram was essentially normal with a "PR" interval at the upper limit of normal. Before the report was returned by the cardiologist, Respondent prescribed certain medications for this patient. Because the patient had high sodium levels in his blood, the Respondent prescribed a diuretic. He also prescribed Thyroglobulin, a specialized form of thyroid medication to aid the patient's metabolism mildly and safely. In addition, he prescribed 30 mg of Obazine per day to be taken in the morning as an appetite supressant; potassium chloride for extra potassium; and Phentermine, another appetite supressant to be taken in the afternoon. For after supper medication, Respondent prescribed a medication for digestion and to increase bile flow, and a 1/2 gram of Phenobarbitol to relax the patient in order to reduce his habit of snacking, and provided a detoxifying agent for the liver. These were the only drugs prescribed at that time. Respondent also, however, instructed the patient that he must not have any further liposuction. In the opinion of Dr. Weiss, the Board's expert in the field of bariatric medicine, the use of the secretary to transcribe the Respondent's verbal comments regarding his patients into the record is not inappropriate. However, the use of the word, "CORPUL" followed by the word, "excellent" seems to fall somewhat below standard, in his opinion. In this case, an acceptable standard would be for the physician to put into the chart exactly the details of the evaluation, and the word, "excellent" does not say much. Notwithstanding the fact that records show the patient's pulse rate and blood pressure, they did not show that the Respondent palpated the patient's chest or listened to the heartbeat. Therefore, the use of the word, "excellent" in this case is below standard. Respondent's records also include the word, "dispense", followed by several medications which Respondent prescribed for the patient. There was no indication in the record why each of these medications was prescribed. Dr. Weiss concludes this is a deficiency in that the record does not show that the Respondent actually examined the patient before medicating him, even though Respondent indicated he had done so. In fact, the only comment as to the patient's general health is made by the secretary, not by a physician or a nurse. Further, though Respondent indicated at hearing that the patient suffered from emphysema, there is no indication anywhere in the notes that that condition existed. Dr. Weiss also noted that the Respondent prescribed medication for a thyroid condition but there appears, from the medical record kept by the Respondent, no reason to treat a thyroid condition. There is no indication that the patient demonstrated any of the clinical signs of hyperthyroidism. By the same token, a prescription for Phenobarbitol, to be taken in small quantities at the hour of sleep, is well within standards if proper indications for that use are noted. Here, according to Dr. Weiss, in Respondent's records there is no indication as to why the substance was dispensed. Respondent's testimony at hearing provides justification, and there is no challenge to the actual prescription, but the medical record is insufficient in that it fails to show the reason for the dispensing of any of the specific medications prescribed. The Respondent's next contact with his patient was by telephone on May 17, 1990 when the patient indicated that the blue Phenobarbitol tablet was making him feel like he was dying. According to the records, the patient was nervous, "hyped-up" and his chest was tight. The medical note entered by the secretary indicates that she had spoken with the Respondent about the patient and the Respondent said for the patient to take one-half capsule with food. If that worked, the patient could return to a full dose. According to Dr. Weiss, this is "far, far below the standard of care", especially when the patient was, as here, showing signs of cardiac problems in the sense of shortness of breath and tightness in the chest, A prudent physician, according to Dr. Weiss, would have stopped medication entirely, had the patient come to the office, or, if an emergency problem existed, told the patient to go to the hospital by ambulance. This is the case here, especially since the cardiogram report had not been received from the cardiologist. If the Respondent felt either inadequate to interpret the cardiogram or that the cardiogram showed some irregularity, he should not have recommended drugs to the patient, as he did here, which affected the heart. In that regard, Dr. Weiss opines, it is impossible to treat all patients within a standard template or protocol, as it appears Respondent did, since all patients are individuals. On May 14, 1990, the patient again telephoned Respondent's office requesting a list of all medications he was then taking. At that point, the patient indicated he was at a cardiologist's office, (Dr. Latif), and needed to know the name of the drugs he was taking. Respondent's secretary asked the patient if this were an emergency visit, and the patient indicated it was not. Because the patient would not volunteer any information or answer directly any of the questions of the secretary, she suggested that Respondent call him right back at the cardiologist's office and the patient agreed. However, before the Respondent could call back, the patient departed Dr. Latif's office, apparently having decided he could not afford the cardiologist's fee. The patient records reflect, in Respondent's handwriting, that the patient had told him he was at the cardiologist's because the cardiogram was borderline abnormal and he had been worrying about it since it was taken. Respondent's notes on this matter reflect he assured the patient that the cardiologist's report indicated there was no problem. The patient then indicated he felt fine and had gone to Dr. Latif only for a check up. Respondent contends he discussed with the patient his exercise regimen and advised him not to get overheated while on any of the medications he was taking. The entry relating to the May 29, 1990 visit reflects that the patient had lost approximately 10 pounds and his blood pressure was down but his pulse rate was up somewhat. The note indicates that the patient "feels fine and is happy with the Obazine" which Respondent had prescribed for him. By observation, Respondent noted that the patient "looks well" and again, the notation "CORPUL excellent" in Respondent's hand, along with a change of some of the medications administered, is listed in the record with no reason being shown for either the change or the continuation. This is below standard. According to Dr. Weiss, the details rather than the conclusion should be reflected in the records. The next appointment with the patient was on June 29, 1990 when the records reflect the patient had lost weight and his blood pressure remained good, but there was no indication of what his pulse rate was. The records reflect certain changes at the restaurant where the patient was working interfered with his sleep; that he was winning at the dog track and planned to go to Las Vegas; but that he was hungry after exercising in the evening and asked for a stronger pill to take in the morning with breakfast. The patient indicated that the Esidrix 50 mg made his heart race. In response, according to the records in the Respondent's handwriting, Respondent reduced the strength of the Esidrix dose from 50 mg to 25 mg and changed the Phenobarbitol from blue to yellow. According to Dr. Weiss, the secretary's notes contain certain information but not all that is necessary. Weiss noted that the patient requested a stronger appetite supressant even though it is noted that the lighter dose made his heart race. A more prudent physician, in Dr. Weiss' opinion, practicing at the level of standard of care, would have discontinued any medication which made the patient's heart race and would have done a cardiogram or at least would have checked the patient's pulse. Here the record fails to reflect that the pulse rate was taken. If a doctor is made aware of that condition, he should look into it, and there is no indication, from the medical records, that this was done. According to Weiss, this is grossly incorrect. In fact, there is no indication that Respondent even examined the patient before making any change in his medictions, and that, in itself, would be a deviation from standard. Respondent indicates that if he made any entry on a patient's record in his own hand, it was done as a result of an examination of the patient. In this case, however, if respondent did examine the patient, he made no reference in the notes as to why he did what he did nor did he make any record of his rationale or reasoning. This is below standard. When the patient was informed that Respondent would not be able to keep the appointment scheduled for July 17, 1990, he indicated he had changed his schedule and needed a change in the times of taking and the strengths of his medications. When the patient did come in his blood pressure was taken along with his weight but there was no indication he pulse rate was measured, and the medical records in the Respondent's handwriting reveal certain changes to medications which do not show either details of the change or the reason therefor. Again, appetite supressants were dispensed, as was a tension reducer, without any physical examination being reflected in the records. The patient was again seen in the office by Respondent on August 22, 1990, and the records for this visit reflect not only the weight but also the blood pressure reading and the pulse rate. Respondent contends that the entry relating to the pulse is in his handwriting and made as a result of an examination, as is the word "excellent" following the note, "CORPUL" in that entry. According to Dr. Weiss, the secretary noted in the record, and it so appears, that the patient was having problems with his bowels. Nonetheless, the records show no details of any examination as a result of this complaint, notwithstanding Respondent's assertion at hearing that whenever he makes an entry in the record he has examined the patient. On October 1, 1990, even after the patient missed his September 20, 1990 appointment, the Respondent authorized his staff to mail a one month supply of prescription medications to the patient. According to Dr. Weiss, this is not within standards, and the medical record does not show why the drugs were mailed, nor does it say which medications were dispatched this way. Weiss contends one can assume it was the same regimen as previously prescribed, but in his opinion, it is inappropriate to do this in a metropolitan area, and to do so is well below the standard of care. This is so especially in light of the previous racing heart beat, the arrythmia and the patient's physical complaints. From Respondent's comment in the record, "this time only", it would appear Respondent recognized the riskiness of his actions, so Weiss believes. On October 29, 1990, the patient again came to Respondent's office and his weight, blood pressure and pulse rate were taken. The secretary noted no problems and that the patient looked well. Respondent noted in his own hand that the cardiac pulmonary condition was excellent and also noted that the patient might be getting a new restaurant. According to Dr. Weiss, this is meaningless to anyone other than the person who wrote it since there is nothing in the record which indicates what the entry means. When the patient came to the office on November 26, 1990, his weight and blood pressure were taken but there is no indication his pulse rate was measured nor is there any entry on the form for that date in the Respondent's hand. According to Dr. Weiss, the prescription for Xanax, which appears to be in the handwriting of the secretary, showed no indication that the patient was examined or, if he was, any clinical findings or clinical reason for the prescription. Again, on December 26, 1990, the patient was weighed and his blood pressure taken, but no pulse entry was made. Again, there appears to be no entry in the Respondent's hand, including the CORPUL description, which is left blank. From this, it is assumed the Respondent did not see the patient. R.C. missed his scheduled appointment on January 21, 1991, and when he appeared at Respondent's office on February 11, 1991, his blood pressure and his weight were noted, but there was no indication the Respondent saw the patient. In fact, the secretary's note indicates the Respondent approved a one month medication pickup but there is no entry in Respondent's hand. From this it would appear the medications were dispensed without the patient having seen the doctor, and in the opinion of Dr. Weiss, this is incorrect practice and below standard. When the patient came in on April 19, 1991, he was seen by the Respondent; his weight, blood pressure and pulse were taken, and at least one of his medications was changed. On this date, Respondent prescribed a tranquilizer, Tranxene. Again, the record fails to indicate any reason for the prescription of a tranquilizer, especially in light of the fact that the note in the secretary's hand indicates that the patient was in a rush but was feeling good and looked well. The record of the May 15, 1991 visit shows that the patient was weighed and his blood pressure taken, but there is no indication of his pulse rate. The secretary noted that the patient was upset because of his girlfriend's diagnosis of breast cancer. In the Respondent's hand, a notation reflects a prescription for Tranxene again as a result of the patient's nervous condition. According to Weiss, this is the type of entry that should be made routinely, but there is no reference in the record to the patient's cardiac pulmonary status which had been routinely commented upon previously. The records also reflect that on July 21, 1991, without seeing the patient, Respondent prescribed a refill on the Tranxene, and called it in to the pharmacy. At this time, the patient had requested a 60 pill prescription with provision for a refill, but the medical note reflects the Respondent said "No." At hearing, Respondent claimed that his use of the word "no" is indicative of his recognition that the patient had a drug personality. This does not necessarily follow, but in any event, Respondent properly refused to give the patient more than a reasonable dose, and a prescription of 36 Tranxene, as given here, is not below standard. On June 1, 1992, there is an indication that the weight, blood pressure and pulse were taken, and it appears the patient had, over a year, gained approximately 25 pounds, though his blood pressure remained about the same. At this point, the note in the secretary's hand reflects that the patient was starting a new job, was feeling fine physically, and was coming off a three month hiatus between jobs. In the Respondent's hand, however, is a reference to Phenobarbitol white and another drug, CH, which is not identified. According to Dr. Weiss, this was two years since a cardiogram or blood profile had been taken, and to continue to prescribe drugs of this nature without any intervening testing of blood or heart evaluation falls below the appropriate standard of care. In fact, the record does not reflect at this visit that the Respondent evaluated the patient's cardiac condition because his description of the CORPUL status does not appear in the record. On July 7, 1992, according to the records, a telephone call to Respondent's office from the medical examiner of Volusia County indicated R.C. had died on June 17, 1992, and requesting the Respondent's medical records. The autopsy report, dated July 31, 1992, reflects that the cause of death was acute drug intoxication, and Respondent contends that this is justification for his refusal to give the patient all the various medications he wanted. A review of the post mortem toxicology relating to drugs found in the patient's urine and blood at the time of death indicates, however, that none of the drugs which were being prescribed by Respondent were found in the deceased's body on autopsy. Respondent is a longstanding practitioner of osteopathic medicine having been in practice since August, 1954. When R.C. first came to see him, on May 1, 1990, the patient's history was taken and recorded on the history form. The patient was 34 years old and claimed to be in fair health. It appears that the patient had moderate emphysema, and at that point and continuing thereafter, Respondent claims, he tried to get the patient to quit smoking. He did not, however, enter this fact in the patient's records. All other signs, however, were normal, except for the patient's blood which showed elevated levels of lipid concentration and low iron. In short, the patient's triglycerides were elevated and his thyroid levels were moderately low. The patient's cardiogram showed a small abnormality in the computer evaluation which Respondent sent to a cardiologist, Dr. Arnold, for interpretation. After the initial visit, and after giving the patient his standard dietary instructions and policies, the Respondent prescribed the medications previously described. According to Respondent, his normal practice was for the nurse to write down what the patient said while weight was taken and blood pressure measured. Respondent usually took the pulse rate. The term, "excellent", used in conjunction with the word "CORPUL" in the records related to heart function, not to the emphysema. Respondent admits that "perhaps" he should have entered the emphysema in the record. Respondent claims he entered all information regarding changes in prescriptions, yet a review of the records clearly shows this is not the case. Many of the entries in the records, which appear to be in the nurse's handwriting, including such things as the patient's reaction to pills on May 7, 1990, was based on Respondent's conversations with the patient which he thereafter recounted to the nurse to be placed into the records. It would appear, however, that there is some confusion whether the entries other than those placed therein by the Respondent, were by a nurse or by a secretary. This was not clarified by the evidence of record. Respondent admits that he does not keep the detailed records he would keep if he were practicing in a hospital situation. He is of the opinion that he is the only one to whom his records need make sense. Because in this case the patient was a friend of his, his need to make further and more detailed patient notes was even less that it would be ordinarily. He was aware of what he considered to be the patient's drug tendency and did not put it in the patient's record because he did not feel that he wanted to subject a friend to this type of record even though he recognized that medical records are, for the most part, confidential. On several occasions, Respondent admitted it was an omission to fail to place a pulse reading in the record or to fail to make certain comments, but he reiterated time and again, that in his opinion his notes did not have to reflect in any detail reasons or rationale for what he did. He consistently took the position that he knew what he did; that he was the only one who looked at the records; and to him, that was sufficient. On July 29, 1991, medications were dispensed after a telephone conversation with the Patient. Respondent claims this was because he had had an argument with the patient over the number of pills which could be furnished; 36 Tranxene tables as opposed to the 60 tablets requested. Respondent admits he authorized the prescription even though he did not see the patient at that time, and in fact did not see the patient again for almost a year. On June 1, 1992, when he again saw the patient, he refused to treat the patient further without another cardiogram and blood work. Nonetheless, Respondent admits, and the records reflect, that on that particular occasion, he allowed the patient to receive his normal prescription for medications, with some modifications, and he admits that all of these medications dispensed are not listed in the patient record. Respondent also admits he does not, and did not, in this case, dispense medications in a child-proof container, as is required by statute and rule. He claims this was because the patient requested they not be placed in a child-proof container, and introduced an entry on the back of the envelope containing the patient's medical records, bearing what purports to be the patient's signature, which so indicates. Respondent also claims that in a discussion with the chairman of the Board of Pharmacy, he determined that use of a crush-proof box in lieu of a child-proof container for these medications, which are, admittedly, controlled substances, was appropriate. Respondent feels that his care of this patient was within standards and that his prescriptions were dispensed with proper medical justification. He contends that R.C. was a hard patient to deal with, being both compulsive and anal retentive. In treating this patient, Respondent claims he used a modified Weintraub protocol, an accepted guideline for the prescription of appetite suppressants and believes he prescribed appropriate medications in appropriate quantities. Respondent also believes he adequately examined the patient before he prescribed any medications for him and contends he always saw the patient before he allowed him to have any more drugs. This has been shown not to be the case. Respondent agrees that a medical record should justify the course of treatment rendered to a patient. Everything should be justified but not, he claims, in as great a detail as in a hospital setting. Respondent is of the opinion that his records are such that a subsequent treating physician could take them and determine what clinical treatment was rendered to the individual without speaking with the Respondent. In addition to the daily narrative record, Respondent contends that the prescriptions are maintained in the records and should be examined in conjunction with the narrative record. If done, this would show what drugs were prescribed and in what amounts. However, it would not show why the prescription was issued initially, and this information is also not adequately laid out in the narrative records. Respondent claims he writes his chart for himself and not for others. Respondent recognizes he did not note any emphysema in his medical records. He also did not enter any instructions he gave to the patient to quit smoking in the medical records. He did not discuss in the records, or with the patient right away, that the patient should continue to exercise. He admits the records do not show that he reviewed Dr. Arnold's report on the cardiogram but only that he received it, and he admits that the records do not show the patient was retaining fluid in the stomach. In that regard, Respondent had recommended metahydrine, a diuretic, for the patient but he contends the record reflecting the patient had had liposuction also reflects that the patient was retaining fluid, and he believed this was sufficient recognition of that fact. This does not necessarily follow, however. Respondent admits that even a bariatric specialist could have had trouble determining from his records that fluid was in the stomach rather than elsewhere in the body. Respondent's treatment of this patient was evaluated by Dr. Wilmer L. Asher, a specialist in bariatric medicine practicing in Colorado for more than thirty years. In the course of his evaluation, Dr. Asher, who has known Respondent as a bariatric physician through the American Society of Bariatric Physicians for approximately twenty-five years, had the opportunity to evaluate Dr. Weiss' written report, the medical records in this case, the investigative report and Dr. Arnold's cardiographic report. Based on his evaluation of the entire file, Dr. Asher concluded that Respondent provided the patient with an adequate initial work-up, more than that usually done. The use of an electrocardiogram on an individual who had no apparent cardiovascular complaints at the time of work-up was above and beyond the norm. He also concluded that the Respondent's prescription, dispensing and administering legend drugs to this patient was neither inappropriate nor in excessive nor inappropriate quantities. Dr. Asher further concluded that on the basis of the Respondent's initial work-up, the diagnosis of obesity was appropriate and the plan of treatment Respondent developed was appropriate for this patient. He concludes that the medical records kept by the Respondent for this patient justified the course of treatment. There is no mention in the record of risk, but, in Dr. Asher's opinion, the medical management of an obese patient by a prudent bariatrician as Respondent, in Asher's opinion, involved a negligible amount of risk. Bariatricians do not ordinarily discuss risks associated with medical management of obesity. Therefore, he contends, Respondent's failure to do so was not below standard. Based on his thirty years of bariatric practice, Dr. Asher was able to find no evidence of Respondent's failure to meet applicable standards of care in his examinations, his diagnosis and his treatment of this patient. In that regard it should be noted that Dr. Asher admitted he was not specifically familiar with Florida standards but concluded they would, in all probability, be consistent with the medical standards in other states with which he is familiar. On October 29, 1992, the Department conducted an inspection of the Respondent's office because of his license as a dispensing physician. At that time, there were several discrepancies noted, one of which was that the Respondent's license to dispense drugs had expired. Respondent admits that this is the case, and that during the period from January, 1992 through October, 1992, he was not registered as a dispensing physician. He claims that he was under the impression that the renewal was automatic, and when he found it was not and his certificate had expired, he immediately sent in the required fee and the application for recertification, which was granted. It is so found. There were, however, other discrepancies discovered during the October 29, 1992 inspection, and these included a failure to properly label medications for dispensing; the sign indicating the availability of generic substitutes was not properly posted; all controlled substance refills were not properly initialed and dated; controlled substance prescriptions were not being properly maintained and purchase records for controlled substances were not maintained and readily recoverable. A follow-up inspection was conducted on July 13, 1994, and all previously identified discrepancies had been corrected. The inspection was considered to be satisfactory. At the hearing, Petitioner offered no evidence of any prior disciplinary action having been taken against the Respondent by the Board or any other regulatory body. Subsequent to the hearing, however, Petitioner moved the introduction of a record of a previous disciplinary action by the Board, the admission of which Respondent strongly resists. A review of the pleading reveals that the record in issue was missed in the agency's prior search of its records because it was filed under a misspelled name. Examination of the document itself does not indicate the alleged misconduct upon which it is predicated. All that can be discerned from a review of the matter objected to is that in 1987 Respondent entered into a stipulated settlement of another Administrative Complaint filed by the Board and that as a result thereof, Respondent was fined $2,000, reprimanded and placed on probation for two years under conditions dictated by the Board. Evidentiary acceptance of this prior action is granted over Respondent's objection with the understanding that it will not be considered on the disputed issue of the Respondent's guilt or innocence of the matters alleged in the instant Complaint but will be considered only if and after a finding of guilt of any of the misconduct alleged herein has been made, and then only as a matter in aggravation of punishment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent, Edwin Gettins, D.O. be found guilty of violating Sections 459.015(1)(x)(o)&(g), Florida Statutes, (other than utilizing an improper method of dispensing, for which he should be found not guilty); that he be reprimanded and ordered to pay an administrative fine of $4,000; and that his license to practice osteopathic medicine in Florida be placed on probation for two years under such terms and conditions as may be prescribed by the Board of Osteopathic Medicine. RECOMMENDED this 9th day of November, 1995, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 9th day of November, 1995. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1834 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 3. Accepted and incorporated herein. 4. & 5. Accepted and incorporated herein. - 8. Accepted and incorporated herein. Accepted. - 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. 15. - 25. Accepted and incorporated herein. & 27. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. - 32. Accepted. 33. & 34. Accepted but characterization of records as 35. - 37. "deficient" borders on being a Conclusion of Law. Accepted and incorporated herein. 38. Accepted. 39. Accepted. 40. Accepted. 41. First sentence accepted and incorporated herein. Second sentence accepted. 42. Accepted. 43. - 45. Accepted and incorporated herein. 46. Accepted. 47. Accepted. 48. - 50. Accepted and incorporated herein. 51. Accepted. 52. Accepted. 53. - 56. Accepted and incorporated herein. 57. Accepted. 58. Accepted. 59. - 62. Accepted and incorporated herein. 63. Accepted. 64. Accepted. - 69. Accepted and incorporated herein. Accepted. Accepted. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. - 84. Accepted and incorporated herein. Accepted. - 92. Accepted and incorporated herein. Accepted. - 97. Accepted and incorporated herein. 98. Accepted. 99. Accepted and incorporated herein. 100. Accepted. 101. Accepted and incorporated herein. 102. Accepted. 103. - 107. Accepted and incorporated herein. 108. - 110. Accepted. 111. Accepted and incorporated herein. 112. - 115. Accepted. FOR THE RESPONDENT: Accepted and incorporated herein. Accepted and incorporated herein. Rejected as not being an accurate statement of facts in all cases. Accepted. Rejected as contra to the weight of the evidence. Rejected as contra to the weight of the evidence. COPIES FURNISHED: Britt Thomas, Esquire Agency for health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Wilson Jerry Foster, Esquire Suite 101-A 1342 Timberlane Road Tallahassee, Florida 32321-1775 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309 William H. Buckhalt Executive Director Board of Osteopathic Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the standard of care for the practice of optometry required that patient, J.P., be dilated by Respondent at the January 1998 appointment. Whether the standard of care for the practice of optometry required Respondent to note in patient J.P.'s patient record the reason for not dilating J.P. at the January 1998 appointment.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of optometry in the State of Florida. At all times material to this case, Respondent has been licensed as a certified optometrist in the State of Florida, holding license number 1734. Respondent practices optometry in Chattahoochee, Florida. Respondent received his Doctor of Optometry degree from the University of Alabama in Birmingham in 1982. He is licensed to practice optometry in Georgia and Florida, and in the latter since June of 1982. Respondent has been a certified optometrist in Florida since 1984-1985. Respondent specializes in diseases of the retina which include, but are not limited to, diabetes and hypertension. Respondent is engaged in the private practice of optometry, but also practices hospital-based optometry as a physician- consultant with Florida State Hospital. He has lectured and published extensively in the area of optometry, including issues on public health and the importance of high blood pressure and diabetes. Respondent sits on the Council on Optometric Education which is an 11-member board that accredits all of the optometry schools and residency programs in the United States and Canada. As a certified optometrist, Respondent is competent to perform a dilated fundus examination. Respondent's examination and treatment of J.P. Respondent provided optometry services to patient, J.P., a registered nurse, for the first time on February 21, 1989. This was J.P.'s initial patient visit. Respondent performed a dilated fundus examination on J.P. which indicated his peripheral retina was completely normal. J.P. did not report any history of high blood pressure/hypertension at that time. On August 20, 1990, Respondent performed a full and general examination of J.P.'s eyes and all of the components of that examination were recorded in J.P.'s patient record. J.P. did not report any history of hypertension at that time. No dilation was performed nor was it required. In late 1994, J.P. was working as a nurse at Florida State Hospital when a patient slapped him on the face. J.P. suffered a corneal abrasion. On December 13, 1994, Respondent examined J.P. Respondent diagnosed J.P.'s problem as "mild iritis," and medical treatment was afforded. Respondent performed a thorough examination of J.P.'s retina, including the peripheral examination with dilation. All aspects of the retina were within normal limits. There was no sign of any hypertensive changes at that time, nor any sign of any trauma related to the incident. J.P.'s injury resolved satisfactorily, and, J.P. had no further trouble whatsoever. J.P. was told to return in one week for a follow-up visit, but he did not. J.P. has not had any trouble with his eyes after the December incident and after being treated by Respondent in December of 1994. J.P. has had borderline high blood pressure/hypertension since he was a teenager. He started taking daily medication in 1990. J.P. advised Respondent of his hypertension and the nature of his medication on a form when he visited in 1994. J.P.'s hypertension was well-controlled with medication at the time of J.P.'s December 1994 visit through his next examination in January 1998. He suffers no symptoms from his high blood pressure/hypertension. J.P. returned to Respondent in January 1998 to obtain a prescription for reading glasses. J.P.'s January 1998 visit with Respondent was not his initial presentation or visit. J.P was questioned about his hypertension and J.P. told Respondent it was in good control. J.P. had been seeing Dr. Richardson, a local physician. Dr. Richardson refers patients with ocular complications of systemic diseases to Respondent for examination. Dr. Richardson, who was familiar with J.P.'s health, did not express any concern to Respondent regarding J.P.'s hypertension. Because Respondent had not examined J.P. for over two (2) years, he performed a comprehensive examination and all of the minimal procedures for vision analysis including consideration of J.P.'s patient history and visual acuity's, which were done and recorded. He performed an external examination, with a slit lamp, which was done and recorded. Respondent also performed a pupillary examination, which was recorded as normal. Visual field and confrontation testing were done and recorded. He also graded the blood vessel status for any abnormalities. He recorded the cup-to-disk ratio having performed an internal examination by direct ophthalmoscopy. There were no recorded arteriosclerotic changes, and no hypertensive retinopathy. He graded the ratio between the arteries and the veins, which was normal at two-thirds. An extra ocular muscle balance assessment was done. Respondent, using a direct ophthalmoscope, was able to view the majority of the retina and assess the blood vessel status for any signs of retinopathy, at which point there was no sign of retinopathy, which was consistent with the patient's history of having controlled hypertension. Tonometry was performed and the results for a glaucoma check recorded. Refraction was performed and results with acuity recorded. J.P. had no physical limitation or medical condition, such as diabetes, which may have required this examination. J.P.'s blood pressure or hypertension was reported as being in good control, and the record does not reveal otherwise. While performing the vision analysis, Respondent had a good view of the retina because J.P. did not have cataracts or other media opacities in the lens or cornea or vitreous of the eye that could cause problems seeing the retina, which might require dilation. Respondent also weighed the risks of dilation. Respondent's explanations for not performing the dilated fundus examination and for not noting same in J.P.'s patient chart are reasonable. A treatment plan was devised for J.P. and J.P. was apprised of the findings of the examination. Respondent advised J.P. to return in one year. J.P. did not return. Respondent issued a prescription for glasses for J.P. J.P. never encountered any unresolved medical problems nor encountered any medical problems with his eyes that resulted from the lack of a dilated fundus examination on his eyes in January 1998. This examination was not medically indicated. Standard of Care for performing a dilated fundus examination and notation in the patient's record A dilated fundus examination is performed to enable the optometrist to examine the anterior part of the eye, -- in particular, the peripheral part of the retina -- and to assess the condition of the lens, looking for cataracts, for example. Eyedrops are placed in the eye to enlarge or dilate the pupil. This helps the optometrist to view a larger area of the retina in greater detail than can be done without dilation of the pupil. Florida Administrative Code Rule 64B13-3.007 provides for "minimum procedures for vision analysis" and specifically subsection (2)(f) provides: "An examination for vision analysis shall include the following minimum procedures, which shall be recorded on the patient's case record . . .[i]nternal examination (direct or indirect ophthalmoscopy recording cup disc ratio, blood vessel status and any abnormalities) " Florida Administrative Code Rule 64B13-3.007(4), not referenced in the Amended Administrative Complaint, provides: "Except as otherwise provided in this rule, the minimum procedures set forth in paragraph (2) above shall be performed prior to providing optometric care during a patient's initial presentation, and thereafter at such appropriate intervals as shall be determined by the optometrist's sound professional judgment. Provided, however, that each optometric patient shall receive a complete vision analysis prior to the provision of further optometric care if the last complete vision analysis was performed more than two years before." Florida Administrative Code Rule 64B13-3.010 provides the "standard of practice for licensed optometrists." Subsection(10)(a) provides: "To be in compliance with Rule 64B13-3.007(2)(f), certified optometrists shall perform a dilated fundus examination during the patient's initial presentation and thereafter whenever medically indicated. If in the certified optometrist's sound professional judgement, dilation should not or can not be performed because of the patient's age or physical limitations or conditions, the reason(s) shall be noted in the patient's medical record." There is no cited agency precedent interpreting subsection (10)(a). The Board's expert, Kenneth Lawson, O.D., is a certified optometrist licensed to practice optometry in the State of Florida. He has been a consultant for the Board of Optometry for approximately three (3) years and has reviewed twenty-five (25) to thirty-five (35) cases involving complaints filed against optometrists. According to Dr. Lawson, Florida Administrative Code Rule 64B13-3.010(10)(a) was enacted in 1995 because there had been an ambiguity with respect to the dilation standard of care. It is Dr. Lawson's opinion that this rule requires a certified optometrist to perform a dilated fundus examination on every initial patient and where medically indicated. He interprets the word "initial" to mean the first time the patient is seen by the optometrist and also when the patient has not been examined by an optometrist for a period of three (3) years. Dr. Lawson opines that every patient becomes an initial patient every three (3) years if not examined and dilated within the three-year period. He also believes dilation is required during every visit if there has been trauma to the eye or if the patient has had a history of ocular trauma or other factors such as hypertension, regardless of whether the hypertension is under good control during each visit. See Conclusion of Law 46. As a rule, however, Dr. Lawson dilates every patient over sixty-five (65) years old every year and all patients under sixty-five (65) every two years. These time periods can vary depending on the health of the patient. For example, Dr. Lawson stated that there is a low risk or probability that hypertension would lead to blindness or impairment of visual acuity if the hypertension is well-managed by medication and the patient is younger than sixty (60). Dr. Lawson conceded that the Board's rule does not require dilation every year, only every three years. Dr. Lawson also opines that there should be some documentation on the patient's chart indicating why dilation was not performed. Dr. Lawson relied on the Physician's Current Procedural Terminology (CPT) textbook, volume IV, to support his position that an "initial" patient is one who has not received any services from the physician within a three-year period. Dr. Lawson believes that the words "initial" and "medically indicated," appearing in subsection (10)(a), are referenced by the three-year period. He concludes that it is the standard of care for dilation to be performed every three (3) years. However, the CPT instructs physicians on how to bill for procedures and enables an optometrist to receive a higher rate of reimbursement rate for the visit; it is not a standard of care. The textbook or physician code book was not offered in evidence and is not a credible source. Dr. Lawson's explanation of the relevant standard of care is not persuasive. Walter Hathaway, O.D. and Adam Gordon, O.D., M.P.H. testified on behalf of Respondent as expert witnesses. Dr. Hathaway is a certified optometrist in the State of Florida and has practiced for thirty-four (34) years. He has served as an expert reviewer for the State of Florida, Board of Optometry, and has served as an expert witness twelve (12) times. Dr. Hathaway opined that a dilation is required during the patient's initial evaluation or presentation and when medically indicated; for example, when the patient has a history of diabetes, flashes, or floaters, which indicates retinal detachment. Dr. Hathaway opined that a dilated fundus examination is not required in all cases where a patient reports a history of hypertension if the hypertension is under control. Dr. Hathaway was asked to consider a hypothetical set of facts based upon the facts of record regarding J.P.'s health and Respondent's examinations of J.P. Based on his professional judgment, Dr. Hathaway concluded that Respondent was not required to perform a dilated fundus examination on J.P. during the course of his examination on January 6, 1998. Dr. Gordon is a licensed optometrist in the State of Alabama, has practiced for eighteen (18) years, and has been a Clinical Associate Professor at the University of Alabama- Birmingham School of Optometry for sixteen (16) years. He also examines patients in a private group practice. Formerly, he served as a faculty member at Johns Hopkins University Hospital in Baltimore, Maryland. Dr. Gordon was also asked to consider a hypothetical set of facts based upon the facts of record regarding J.P.'s health and Respondent's examinations of J.P. and stated, that in his professional judgment, a dilated fundus examination was not medically indicated for this patient on January 6, 1998. Likewise, Dr. Gordon stated that this examination is not required on all patients reporting a history of hypertension. Conversely, he would consider dilation if the patient reported his or her high blood pressure was out of control or if he or she stopped seeing a physician or had stopped taking medication for the condition, factors absent here. It was not medically indicated for Respondent to automatically give J.P. a dilated fundus examination in January 1998, because J.P.'s hypertension was under control at that time. J.P. testified that his hypertension had been controlled with medication through and including his January 1998 visit with Respondent. Further, J.P. had no problems with his eyes after his 1994 visit with Respondent. A dilation examination may have been required if J.P.'s hypertension had been uncontrolled or if J.P. exhibited some other medical problem such as diabetes, or if J.P. had stopped taking prescribed medication. These factors are not present here. The weight of the evidence supports only one finding: there was no medical indication which would have required Respondent to perform a dilated fundus examination on J.P. during his January 1998 examination. The weight of the evidence supports Respondent's exercise of professional judgement in not performing a dilated fundus examination on J.P. during the January 1998 visit. The weight of the evidence proves that the standard of care set forth in Florida Administrative Code Rule 64B13- 3.010(10)(a) for performing a dilated fundus examination does not require this examination automatically every three (3) years. Rather, dilation should be performed during the "initial presentation," and when "medically indicated" based on the certified optometrist's exercise of sound professional judgment in light of the patient's medical history and current health. Further, the weight of the evidence proves that the standard of care set forth in Subsection (10)(a) does not require a certified optometrist to note in a patient record the reason why a dilated fundus examination was not performed unless dilation was not performed based solely on the patient's age or physical limitations or conditions, all absent here. The latter criteria are the only ones stated in the rule, and the weight of the evidence does not prove that additional criteria should be considered.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Amended Administrative Complaint filed against Respondent be dismissed with prejudice. DONE AND ENTERED this 6th day of December, 2000, in Tallahassee, Leon County, Florida. CHARLES A. STAMPELOS 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 6th day of December, 2000.
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint December 19, 2005, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2009). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2009). At the times pertinent to this proceeding, Dr. Achong was a physician licensed by the State of Florida, having been issued license number ME38304, and his medical office was located at 690 East 49th Street, Hialeah, Florida. Dr. Achong specialized in obstetrics and gynecology, although he was not board-certified in these areas of practice. Dr. Achong has not previously been the subject of disciplinary action by the Board of Medicine, and he is not currently practicing medicine, having retired with a disability in 2006. At the times pertinent to this proceeding, Dr. Achong had hospital privileges at Hialeah Hospital and at North Shore Medical Center ("Medical Center"). Both facilities had his home telephone number and his beeper number. It was his practice to keep his beeper close to him at all times. When he was in the delivery room, it was his practice to give his beeper to the circulating nurse, who would be responsible for alerting him whenever someone tried to reach him on his beeper. The beeper he used in 2004 gave only the telephone number of the person trying to reach him, but he was able to recognize the number of Hialeah Hospital and the Medical Center. On February 12, 2004, Patient L.H. went to her gynecologist, Ramon Hechavarria, M.D., for a routine examination. Patient L.H. was, at the time, a 27-year-old who was 32 weeks' pregnant, and she had previously had one live birth. Dr. Hechavarria's examination revealed that Patient L.H.'s blood pressure was elevated, and Dr. Hechavarria admitted her to Medical Center for 24 hours for observation. On February 12, 2004, Dr. Hechavarria ordered blood and laboratory tests done in the Medical Center. The blood tests included a Disseminated Intravascular Coagulopathy ("DIC") profile and a Fibrinogen Degradation Profile ("FDP"); the results of these blood tests were normal. Patient L.H.'s hemoglobin and her platelet count were normal, and, although there was a slight trace of protein in her urine, that is considered normal. On February 13, 2004, Dr. Hechavarria discharged Patient L.H. with a diagnosis of chronic hypertension and a prescription for 250 milligram tablets of Aldomet, to be taken three times per day. Aldomet is a medication that treats hypertension by lowering the blood pressure. Patient L.H. was in good, stable condition when she was discharged on February 13, 2004. Readings from a fetal heart monitor taken during the time Patient L.H. was in the Medical Center indicated that the fetus was alive. Dr. Hechavarria considered Patient L.H.'s to be a high risk pregnancy in part because of her hypertension but also because she came in late for prenatal care, missed two appointments, and was overweight. Dr. Hechavarria left town for a vacation on February 13, 2004, and Dr. Achong was to cover his patients during his absence under an arrangement whereby Dr. Hechavarria and Dr. Achong provided coverage for each other when one or the other was out of town or otherwise unavailable to see patients. Under the arrangement, Dr. Achong was expected to go to the hospital if one of Dr. Hechavarria's patients were in labor or if a patient were to go to the emergency room complaining of vaginal bleeding or any other obstetrical or gynecological condition. Whenever coverage of patients was passing from one physician to the other, Dr. Hechavarria and Dr. Achong advised each other of any patient that was in the hospital for gynecological, obstetrical, or any other medical reason. They did not advise each other of patients that had recently been discharged from the hospital, and, therefore, Dr. Hechavarria did not discuss Patient L.H. with Dr. Achong because she had been discharged from the Medical Center before Dr. Achong began covering Dr. Hechavarria's patients. Patient L.H. presented at the Medical Center at approximately 2:00 a.m. on February 15, 2004, complaining of abdominal pains. She was seen by labor and delivery nurse Jennifer Williams, a registered nurse with 20 years' nursing experience, with 13 years' experience in the Medical Center's labor room, and with training as a mid-wife. Nurse Williams had worked with Dr. Achong at the Medical Center since 1991. Subsequent to Patient L.H.'s arrival at the Medical Center, Nurse Williams interviewed her, took her medical history, examined her, and entered the pertinent information on the Medical Center's Admission Assessment. The Admission Assessment form was dated February 15, 2004, and the time was noted as 2:45 a.m. The time written by Nurse Williams' signature on the Admission Assessment form was 3:00 a.m., and it appears that the information was obtained and entered on the form between 2:00 a.m. and 3:00 a.m. Pertinent to this matter, Nurse Williams maintained several other documents recording Patient L.H.'s condition and observations and actions taken by Nurse Williams relating to Patient L.H. Nurse Williams began maintaining a Labor Flow Record at 2:07 a.m. and she made periodic entries on the Labor Flow Record related to, among other things, Patient L.H.'s vital signs, the results of vaginal examinations and fetal monitoring, uterine activity, and pain intensity at different times during the night and morning. In addition, Nurse Williams entered on the Labor Flow Record the time and content of her communications with Dr. Achong; the first recorded contact between Dr. Achong and Nurse Williams was recorded on the Labor Flow Record as 2:30 a.m. Nurse Williams also maintained Progress Notes in which she recorded her observations of Patient L.H. and her conversations with Patient L.H. The first entry in the Progress Notes was at 2:35 a.m.2 Nurse Williams' Progress Notes reflect that, at 2:35 a.m., Patient L.H. advised Nurse Williams that she had contractions and believed she had been in labor since 6:00 p.m. the previous evening but had waited to come to the Medical Center until she was certain she was in labor. Patient L.H. also reported abdominal pain in her upper abdomen that did "not go away," and Nurse Williams observed that Patient L.H. was distressed by the pain in her abdomen. Patient L.H. also told Nurse Williams that she had no ruptured membranes or vaginal bleeding. Nurse Williams noted that she examined Patient L.H. and felt contractions but was unable to detect a fetal heart tone. Nurse Williams reported in the Admission Assessment form that Patient L.H. was having uterine contractions of moderate intensity and 60 seconds' duration, that her cervix was dilated 1-to-2 centimeters, that she had vaginal bleeding that was bright red, that her blood pressure was 159/118, which she described as "elevated," and that Patient L.H.'s abdominal pain was the "worse" pain on a pain scale ranging from 1 to 10; there is, however, no indication on the Admission Assessment form that the pain was constant. Nurse Williams also noted on the Admission Assessment form that she heard no fetal heart rate. Although the time noted on the Admission Assessment form was 2:45 a.m., it is apparent from a review of the relevant records that the information included on the Admission Assessment form was obtained by Nurse Williams over a period of time extending from the time Patient L.H. presented to her until 3:00 a.m., the time on the Admission Assessment form beside Nurse Williams' signature. Nurse Williams reported in the "Physician /CNM in/Called Report" section of the Labor Flow Record that she contacted Dr. Achong at 2:30 a.m. and conveyed to him the following information: "[P]atient arrived in ER c/o contractions since 6 pm last night & observation that no FHT [fetal heart tone] and contractions palpated." Nurse Williams telephoned Dr. Achong using his home telephone, even though his beeper number was also on file at the Medical Center. There is nothing in the report Nurse Williams gave to Dr. Achong at 2:30 a.m. that would require that he proceed to the Medical Center and examine Patient L.H., and he did not violate the standard of care by failing to do so. Because Dr. Achong did not know Patient L.H., Nurse Williams' normal procedure would have been to advise Dr. Achong of Patient L.H.'s history, including the medications she was taking, and her vital signs, including her blood pressure. No notation appears in the Labor Flow Record to confirm that she gave Dr. Achong this information during her conversation with him at 2:30 a.m., nor is there a notation in the 2:30 a.m. entry in the Labor Flow Record that Nurse Williams told Dr. Achong about the results of her examination of Patient L.H.'s cervix, Patient L.H.'s complaint of abdominal pain, or the presence of vaginal bleeding of bright red blood.3 Nurse Williams indicated in her entry in the "Physician/CNM in/Called Report" section of the Labor Flow Record that Dr. Achong ordered a "stat," or expedited, obstetrical sonogram during the 2:30 a.m. contact with Nurse Williams. The purpose of the obstetrical sonogram was to determine if the fetus was alive. Although not noted in the Labor Flow Record, the Labor and Delivery Orders form completed by Nurse Williams indicates that, at 2:30 a.m., Dr. Achong ordered a complete blood count, which is routine with a patient in labor; a DIC profile; and a Comprehensive Metabolic Panel ("CMP"). The Labor and Delivery Orders form contains standard orders for a woman in labor, but the DIC profile and the CMP tests were not included on the form but were ordered specifically by Dr. Achong. A DIC profile is used to determine if a patient has a problem with blood clotting. The DIC includes an assessment of prothrombin time and partial thromboplastin time, both of which indicate different levels at which a patient's blood is able to clot. It is important to know whether a woman in labor and delivery has a clotting problem, or coagulopathy, because of the danger of bleeding, and the classic situation in which DIC profiles are ordered is when there is fetal demise. Because Patient L.H. had the high risk factors of overweight and hypertension and because Nurse Williams could detect no fetal heart tone, Dr. Achong's order for the DIC profile was appropriate and met the standard of care. It is also appropriate to order a DIC profile when there is a concern about placental abruption, which is the separation of the placenta from the walls of the vagina. A placental abruption causes a great deal of bleeding, and can cause death when not treated, because the fetus is still in the womb and the uterus is not able to contract and constrict the large blood vessels that attach to the placenta. Although hypertension is one risk factor for placental abruption, the symptoms of placental abruption also include fetal demise, bleeding, constant pain, a decrease in hematocrit, and a number of other conditions. There is no indication in Patient L.H.'s medical records that Dr. Achong had sufficient information at 2:30 a.m. that would indicate that Patient L.H. had a possible placental abruption, and he ordered the DIC profile because of the lack of fetal heart tones.4 The CMP includes tests for kidney and liver function and for uric acid. It is used to determine if a woman has pre-eclampsia, or pregnancy-induced hypertension. Given Patient L.H.'s history of hypertension and the level of her blood pressure as reflected in the Admission Assessment form, Dr. Achong's order for the CMP was appropriate and met the standard of care in ordering the CMP. All orders for blood tests for women in labor and delivery are treated as "stat" orders and are processed ahead of all other test orders except those from the emergency room. When the situation warrants, a physician may order that the tests be performed more quickly than the usual "stat" order would require, and it would be possible to obtain blood-test results within 45 minutes. There is, however, no indication in Patient L.H.'s medical records that Dr. Achong had any information at 2:30 a.m. that might indicate that he should further expedite Patient L.H.'s blood tests. Nurse Williams reported in her Progress Notes that, at 2:40 a.m., Patient L.H. reported a "gush of something down there," and Nurse Williams noted that she observed a large amount of blood; there is, however, no notation in the Progress Notes regarding the color of the blood. Nurse Williams also included a notation in the Progress Notes that Patient L.H.'s cervix was "3cm dilated, 50% effaced, -3 station" to describe the progress of Patient L.H.'s labor. Nurse Williams reported in the Labor Flow Record that she contacted Dr. Achong at 2:45 a.m. and conveyed to him the following information: "Dr. Achong notified of gush of vaginal bleeding. VE [vaginal examination] 2-3, 50% effaced, -3 station and that we are awaiting sonogram." The results of Nurse Williams' vaginal examination of Patient L.H. showed that Patient L.H. was in active labor. The information that Patient L.H. experienced a "gush of vaginal bleeding" did not indicate to Dr. Achong that there was anything more than one episode of bleeding, which he attributed to an especially heavy "bloody show," which is the bleeding that occurs when the cervix is dilating. The notation indicates that Dr. Achong told Nurse Williams to call him if Patient L.H. went to delivery. The information conveyed to Dr. Achong at 2:45 a.m., as reflected in the notation in the Labor Flow Record, was not sufficient to indicate that Patient L.H. was not proceeding through labor normally to a vaginal delivery of the dead fetus, which is preferred over delivery by a Cesarean Section. Nurse Williams did not include in her records a notation that she advised Dr. Achong that the "gush of vaginal bleeding" consisted of a large amount of bright red blood, which would have been an indication of a possible placental abruption. Some bleeding is normal during labor, but it is usually a dark color from having been in the uterus and in a small amount or tickle, although there could be a "gush of blood" during normal labor. When Dr. Achong was advised by Nurse Williams that Patient L.H. had a "gush of blood," however, it was his responsibility to inquire into the amount of blood, the color of the blood, and the persistency of the bleeding to determine if Patient L.H. was proceeding with normal labor or if she was experiencing a hemorrhage or other abnormal condition. Nurse Williams made no entries in the Progress Notes for Patient L.H. between 2:40 a.m. and 3:40 a.m., when she reported that the ultrasound had been completed. She further noted in her Progress Notes: "Report of no fetal heart tones to Dr. Achong. Orders given." Nurse Williams additionally made a notation in the Labor Flow Record that, at 3:40 a.m., she contacted Dr. Achong and reported to him the following: "Ultrasound report No FHT's given to Dr. Achong. Orders received." Nurse Williams did not, however, indicate in her notations what orders were given. Nurse Williams contacted Dr. Achong through his home telephone number, which was normal procedure during the nighttime hours. When the sonographer, that is, the person performing the sonogram, entered Patient L.H.'s room to perform the sonogram, he noted that Patient L.H. was sitting upright in bed, was combative, and was in a lot of pain. He also noted that there was a fair amount of blood on the bed sheets. The sonographer was able to get Patient L.H. to lie on the bed, and he performed "a very short ultrasound,"5 and pulled the machine out of the room and into the hall. He powered the machine back up and read the numbers off the worksheet on the machine. He confirmed that the fetus was dead and that the placenta appeared to be balled up rather than lying smoothly against the uterine wall, as is normal. While he was writing down the information from the worksheet on the machine, Nurse Williams approached him and told him that she had Dr. Achong on the telephone. He told her that he had "a placental abruption and fetal demise."6 He then wrote up his report, left a copy for Nurse Williams, and went downstairs to process the sonogram images.7 The results of the sonogram were reported on a form headed "Obstetrical Preliminary Report," which was completed by the sonographer. A radiologist is usually present at the Medical Center during daytime hours to read sonograms, but on the off-hours, it is the practice of the sonographer to present a sonographer's impression of what was seen during the sonogram. The sonographer who performed the sonogram on Patient L.H. noted on the report that her history included obesity, hypertension, heavy vaginal bleeding, and contractions. He included the following comments in the report: "Ant/Rt [unintelligible] placenta appears to be 'balled up[.]' Suggestion of placental abruption," and, on a separate line, "NO FETAL HEART MOTION SEEN PT IS COMBATIVE." Finally, at the bottom of the report, the sonographer noted that a copy of the report was given to Nurse Williams. There was no notation as to the time the sonographer gave the report to Nurse Williams, but, even if she had the report, she did not read it to Dr. Achong; rather, she put the copy of the report in Patient L.H.'s chart for Dr. Achong to review when he came to the hospital and gave him only a verbal report. Nurse Williams did not tell Dr. Achong during the 3:40 a.m. telephone conversation that the sonographer had reported a possible placental abruption.8 Dr. Achong was familiar with and had treated placental abruptions prior to February 15, 2004, and he always treated patients with placental abruptions on an emergency basis because both the mother and the baby could die if treatment was not received as soon as possible. Had Nurse Williams advised Dr. Achong that the sonographer had told her that he found a placental abruption or that the sonogram report included a reference to a possible placental abruption, he would have gone to the Medical Center immediately. At 3:45 a.m., Nurse Williams noted in her Progress Notes that she gave Patient L.H. Nubain and Phenergan for her painful contractions. There is no mention of continued vaginal bleeding in this entry in the Progress Notes. At 4:15 a.m., Nurse Williams noted in her progress notes that Patient L.H. was sleeping quietly and was relaxed and that Pitocin had been administered in accordance with Dr. Achong's orders. Pitocin is used to induce labor, augment labor, or to stop bleeding. In this case, Dr. Achong ordered the Pitocin to regulate Patient L.H.'s contractions. There is no mention in the 4:15 a.m. entry in the Progress Notes of continued vaginal bleeding. The next entry in Nurse Williams' Progress Notes was made at 5:15 a.m., when Nurse Williams reported that she had observed vaginal bleeding, that a vaginal examination showed dilation of four centimeters, and that Patient L.H. was very restless and moving around the bed. Nurse Williams received the laboratory report showing the results of the blood tests ordered by Dr. Achong at or around 5:00 a.m. According to the laboratory report, the blood for these tests was drawn at or about 3:20 a.m.; the report did not show any critical values in the blood sample. Nurse Williams attempted to contact Dr. Achong to convey these results to him. She noted on the Labor Flow Record that, at 5:15 a.m. "Dr. Achong beeped re lab results. Phone message left on home phone to call LR [Labor Room]." Nurse Williams made another entry on the Labor Flow Record that, at 6:55 a.m., she left a "message to Dr. Achong answering machine at home re labor progress update and labs." Dr. Achong was not, however, at home to receive the telephone calls or the messages. At or about 5:00 a.m. on February 15, 2004, Dr. Achong received a telephone call on his home telephone from Hialeah Hospital advising him that one of his patients or one of Dr. Hechavarria's patients was in active labor and about to deliver. Shortly after receiving the telephone call, Dr. Achong left his home to travel to Hialeah Hospital. He carried his beeper with him, but he did not receive any calls on the beeper. When he arrived at Hialeah Hospital and prepared to go into the delivery room, he gave it to the circulating nurse in case he should receive a beeper call while he was in the delivery room. Nurse Hayes, who had replaced Nurse Williams when Nurse Williams' shift had ended at 7:00 a.m., made a notation on the Labor Flow Record that, at 7:15 a.m., she called Dr. Achong and left a message. At 7:25 a.m., while he was in the delivery room, Nurse Hayes called his beeper. The circulating nurse had his beeper, and she notified him that he had received a call and told him the number. He recognized the number of the Medical Center, and he told the nurse to call the Medical Center and let them know that he was in the delivery room at Hialeah Hospital. Nurse Hayes asked that he call back as soon as possible. Blood for additional blood tests was drawn at or about 7:30 a.m., and the results, which were available within 15 minutes, showed several critical values that indicated that Patient L.H. was entering coagulopathy. At 7:38 a.m., as soon as he finished the delivery, he called the Medical Center and spoke with Nurse Hayes, who gave him a report on the status of Patient L.H. She told him that Patient L.H. had heavy bleeding and that the vaginal examination showed no change in the cervix. Dr. Achong ordered the Pitocin turned off. When Dr. Achong arrived at the Medical Center at 7:56 a.m., he found Patient L.H. very combative, bleeding, and with very bad vital signs. He ordered a "stat" Cesarean Section and ordered a blood transfusion. Patient L.H. died at 8:38 a.m., before any of the measures ordered by Dr. Achong could be implemented. The cause of death was recorded as placental abruption. Summary In summary, the evidence presented by the Department is not of sufficient weight to establish that Nurse Williams conveyed to Dr. Achong the information necessary for him to conclude that he should personally conduct a clinical evaluation of Patient L.H.; that he should consider the possibility that Patient L.H. had placental abruption; or that he should have provided medical assistance to Patient L.H. prior to his contact with Nurse Hayes at 7:38 a.m. Nurse Williams' Progress Notes report only two remarkable items: There were no fetal heart tones detected by physical examination or by sonogram; and, at 2:40 a.m., Patient L.H. reported a "gush of something" and Nurse Williams observed a large amount of blood. Neither Nurse Williams' entries in the Labor Flow Record regarding her contacts with Dr. Achong nor her testimony, to the extent that it has been found persuasive, is sufficient to establish that she advised Dr. Achong that she had observed a large amount of red blood at 2:40 a.m. or that the sonographer detected a possible placental abruption in the sonogram. Finally, Nurse Williams did not follow the protocol that required her to contact Dr. Achong through his beeper when she did not get an answer on his home telephone; she tried his beeper only once, at 5:15 a.m., and when she failed to reach him, left three messages on his home telephone. The Department presented no evidence to establish that Nurse Williams attempted to reach Dr. Achong by beeper between 5:15 a.m. and 7:55 a.m., the time of her last call to Dr. Achong's home telephone. Furthermore, the Department did not present evidence of sufficient weight to establish that Dr. Achong failed to initiate the appropriate procedures after he arrived at the Medical Center and examined Patient L.H. at or around 8:00 a.m. The evidence presented by the Department is, however, of sufficient weight to establish that Dr. Achong should have questioned Nurse Williams further when she advised him at 2:45 a.m. that she had observed a "gush" of vaginal bleeding. Even though vaginal bleeding may not be not unusual during labor, a report of a "gush" of blood should have alerted Dr. Achong to a potential problem. Although a physician practicing obstetrics is meeting the standard of care when relying on labor room nurses to advise him or her of the clinical status of labor and delivery patients and of any unusual symptoms exhibited by the patients, it is also incumbent on the physician to inquire further if a patient is presenting unusual symptoms. The persuasive evidence establishes that Dr. Achong violated the standard of care when he failed to ask Nurse Williams for additional information on Patient L.H.'s status during their 2:45 a.m. telephone conversation. Had he inquired further, Dr. Achong would have been alerted to the possibility that Patient L.H. had a placental abruption and would have gone to the hospital to provide appropriate care for Patient L.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order finding that Dr. Achong violated Section 458.331(1)(t), Florida Statutes, by failing to elicit further information from Nurse Williams regarding the gush of blood she observed in Patient L.H and imposing the following penalties: Issuance of a letter of reprimand; Imposition of administrative fine in the amount of $2,500.00; and Six months' probation under such conditions as the Board of Medicine determines appropriate, should Dr. Achong ever resume the practice of medicine. DONE AND ENTERED this 4th day of January, 2010, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 4th day of January, 2010.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of alleged violations of Section 458.331(l)(m) and (t), Florida Statutes. In this regard it is alleged that the Respondent failed to keep medical records justifying the course of treatment of a patient and also failed to practice medicine with an acceptable level of care, skill and treatment.
Findings Of Fact The Respondent graduated from the University of Maryland Medical School in 1981 and then went on to State University of New York at Stoney Brook where he did an internship and residency for four years in general surgery. He was licensed in Florida in 1985 and, since then, has been practicing emergency medicine in Florida. In January 1992, patient H. G. was hospitalized at Parkway Regional Medical Center (Parkway) under the care of Malcolm G. Goldsmith, a board certified colorectal surgeon. The patient had been a patient of Dr. Goldsmith’s for two or three months prior to admission. The patient was hospitalized for the purpose of reconnecting his intestine after a prior colostomy with detachment of the rectum. Dr. Goldsmith admitted the patient and performed surgery on him. The patient was discharged from Parkway six days after the surgery. At that time he was on a regular diet, was having bowel movements and was ambulatory. The patient, upon discharge on January 27, 1992, remained the patient of Dr. Goldsmith and was given instructions regarding diet, activity, wound care, and pain medications, and was told to return in two weeks for removal of the staples or sutures. He was also instructed to let Dr. Goldsmith know about any unusual difficulties or problems. In the early morning of January 28, 1992, the Respondent was working the 7:00 p.m. to 7:00 a.m. shift at Pembroke Pines Hospital (PPH) when the patient presented with severe abdominal pain and nausea without emesis. The patient stated that he had recently had abdominal surgery, had been released the previous afternoon from the hospital, had been having bowel movements and had been tolerating food for a couple of days. The patient was awake, alert, and able to provide his history to the Respondent. The Respondent obtained a history from the patient and noted that he had a fever of 100.8. He then physically examined the patient’s abdomen noting in the medical record, “abdomen bowel sounds positive but decreased. Firm, distended diffused tenderness.” The Respondent also ordered a complete blood count (CBC) and an x-ray of the abdomen. Although he did not note his findings in the medical record, the Respondent read the x-ray as showing the patient had some dilated small bowel loops with some air-fluid levels which he interpreted as an ileus, a lack of proper motion of the small intestine. The Respondent read the CBC which showed a shift to the left which the Respondent interpreted as showing the patient having either an infeciton or aon inflammatory process going on. A shift to the left could be caused by sepsis which could be caused by a wound infection, which is not an unusual postsurgical event. At 5.55 a.m., after examination of the patient and reading the x-ray and laboratory report, the Respondent telephoned Dr. Goldsmith and consulted with him about the patient. He told Dr. Goldsmith of the results of his physical exam, the blood test results and his interpretation of the x-ray. After discussing the matter, the two physicians agreed that the patient should see Dr. Goldsmith later that same morning at Dr. Goldsmith’s office. Dr. Goldsmith did not have privileges at PPH. The Respondent then gave the patient a pain medication shot (effective for about four hours duration) and told the patient to follow up in four hours with Dr. Goldsmith or Dr. Schalen (the surgeon who was on call that day and on the staff at PPH). The Respondent then authorized the discharge of the patient, noting his diagnosis in the medical records as, “Abdominal pain secondary to surgery.” At discharge, the patient signed the following statement in his medical record: I acknowledge that I have been informed of and understand all of the instructions given to me and have received a copy thereof. I have been instructed to contact a physician as soon as possible for continued medical diagnosis and care, if indicated. I do not have any more questions at this time, but understand that I may call the Emergency Service Department at any time should I have any further questions or need assistance in obtaining follow up care. After being discharged from PPH, the patient delayed in contacting Dr. Goldsmith and was not seen by Dr. Goldsmith until 4:00 or 5:00 p.m. on January 28, 1992. At that time he was obviously sick primarily, in Dr. Goldsmith’s opinion, because he was dehydrated. Dr. Goldsmith ordered laboratory findings which showed a normal white cell count of 8,000 and a very minimal shift to the left. The patient did not have a fever and there were no signs in Dr. Goldsmith’s examination of the patient’s abdomen suggesting a peritoneal inflammatory process. According to both Dr. Mead and Dr. Goldsmith, the minimal shift to the left, late in the afternoon of the 28th is inconsistent with a diagnosis of sepsis. Sometime after being admitted to Parkway, and while under Dr. Goldsmith’s care, the patient died. His proximate cause of death was that he vomited, aspirated the vomitus into his lungs and sustained a cardiac arrest. Petitioner’s expert, Dr. Meade, agrees that Respondent is not responsible for the proximate cause of death of the patient. The Respondent went off duty at PPH at 7:00 a.m. Sometime after 8:00 a.m., after conducting an “overreading” of the x-ray, a PPH radiologist interpreted the x-ray as a probable 4444distal colonic obstruction, an interpretation different from that of the Respondent’s. The radiologist’s interpretation is inconsistent with the patient’s history of having bowel movements and tolerating food. The fact that the radiologist had a different interpretation of the x-ray is not proof of any deviation by Respondent from the standard of care required in this case. The Respondent was not notified of the radiologist’s interpretation and was not responsible for notification or recall of the patient after going off duty. PPH had a method for notification and recall of patients in such a situation. That system involved contacting the ER doctor on duty. The medical record shows that PPH staff left a message with the family late in the afternoon of January 28, after the patient had already been readmitted to Parkway Hospital, and spoke to the wife that evening regarding the radiologist’s findings. In his care of the patient, Dr. Galitz was responsible for judging the severity of the abdominal pain, the acuteness of the condition, and for determining whether to admit the patient to the hospital or release him. His physical examination and the tests and x-rays ordered were all appropriate. He appropriately undertook a “consultation” with the patient’s surgeon, Dr. Goldsmith, obtained his recommendation and advice and then decided to discharge the patient. If the patient is stable, it is appropriate to discharge him with a recommendation that he follow up in the morning with his doctor. At the time that the Respondent discharged the patient, he reasonably believed that the patient was stable and that discharge of the patient would not compromise his safety. It is clear from the evidence in this case that the Respondent secured and took into account all of the relevant facts available regarding the patient’s medical condition, consulted with the patient’s surgeon, and then made a reasonable and appropriate decision to discharge the patient to see his surgeon within four hours. The examination, consultation, test interpretations and decisions of Dr. Galitz in this case were consistent with the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine issue a Final Order in this case dismissing all charges against the Respondent. DONE AND ENTERED this 20th day of December, 1996, in Tallahassee, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 1996.
