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 issues in this case are whether Respondent violated section 458.331(1)(m), Florida Statutes, by failing to keep legible medical records that justify the course of treatment of a patient, as set forth in the Second Amended Administrative Complaint, and, if so, what is the appropriate sanction.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2015). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458. Dr. Velilla is a licensed physician in the state of Florida, having been issued license number ME 98818. Dr. Velilla's address of record is 12709 Miramar Parkway Miramar, Florida 33027. Dr. Velilla has been a medical director at Evolution MD since the summer of 2010. Dr. Velilla was licensed to practice medicine in the state of Florida during all times relevant to Petitioner's Second Amended Administrative Complaint. Dr. Velilla is Board-certified in internal medicine by the American Board of Internal Medicine. On or about December 29, 2010, Patient C.A. consulted with Dr. Velilla regarding possible abdominal liposuction and fat transfer to the gluteal area. These are cosmetic surgery procedures, undertaken with the object of enhancing the patient's appearance, and are purely elective. On or about February 10, 2011, Dr. Velilla performed an evaluation of Patient C.A. and ordered routine pre-operative laboratory studies. The laboratory report prepared by First Quality Laboratory indicated readings within normal limits for blood urea nitrogen (BUN) at 19.8 and creatinine serum at .7, but an abnormally high BUN/creatinine ratio reading of 30.43. It showed an abnormally high globulin reading at 3.40, an abnormally low INR reading of .79, an abnormally low MCH reading of 25.2, and an abnormally low MCHC reading of 30.7. On or about February 15, 2011, Dr. Velilla reviewed Patient C.A.'s pre-operative laboratory report results. He placed a checkmark next to the high BUN/creatinine reading and the low INR reading. He wrote "Rev." with the date and signed his name on each page. Dr. Velilla testified that he performed a glomerular filtration rate test, a calculation used to check on the functioning of the kidneys, and the result indicated normal renal function. He testified that a BUN/creatinine ratio outside of the normal range could be caused by several factors, and that after his assessment, the reading was not of concern to him in proceeding to surgery. Dr. Velilla did not make any notation on Patient C.A.'s medical records to indicate how or why he concluded that the abnormal BUN/creatinine ratio reading was not of concern. On February 24, 2011, Patient C.A. filled out a "General Consent" form. Patient C.A. agreed to disclose her medical history, authorized the release of medical records for certain purposes, agreed to use skin care products as directed, and acknowledged possible side effects from the use of skin care products. The form also stated, "I understand that Cesar Velilla, M.D. P.A. services generally consist of a series of treatment [sic] to achieve maximum benefit, and this consent shall apply to all services rendered to me by Cesar Velilla, M.D., P.A., including ongoing or intermittent treatments." On February 24, 2011, Patient C.A. filled out a "Medical History" form. Patient C.A. indicated she was not under the care of a dermatologist, did not have a history of erythema ab igne, was not on any mood-altering or anti-depression medication, had never used Accutane, had never had laser hair removal, had no recent tanning or sun exposure, had no thick or raised scars from cuts or burns, and had never had local anesthesia with lidocaine. The form did not ask for information about any prior abdominal procedures, previous liposuction treatments, multiple pregnancies, or abdominal hernias. On February 24, 2011, Patient C.A. signed a "Consent for Laser-Assisted Lipolysis Procedure SLIM LIPOSCULPT." The form did not include consent for fat transfer to the gluteal area or describe risks or possible complications of that procedure. Patient C.A. also signed a "Consent for Local Aneshesia [sic]" form. As Dr. Obi testified, the risks from a fat transfer procedure are generally the same as those of the liposuction procedure; although with a fat transfer, you have additional potential for fat embolism. On or about February 24, 2011, Dr. Velilla performed liposuction of the abdomen and thighs with fat transfer to the gluteal area on Patient C.A. at Evolution MD. Patient C.A.'s liposuction was not the "Slim Liposculpt" laser-assisted procedure. The testimony was clear that the "Slim Liposculpt" procedure would use a laser to melt the fat before liposuction, which could not be done on Patient C.A. because the fat was to be transferred. There was testimony that a laser could be used to improve skin retraction, however. As Dr. Velilla testified, Patient C.A. had requested the fat transfer in addition to the liposuction prior to the procedure. Dr. Velilla discussed the risks of both the liposuction and the fat transfer with Patient C.A., and she consented to have the procedure done. As Dr. Velilla testified, this consent was later documented on the operative report prepared sometime after the surgery and dated February 24, 2011, the date of the surgery. Dr. Velilla's testimony was supplemented by the operative report, which stated in pertinent part: The patient requested liposuction with fat transfer and understood and accepted risks including but not exclusive to bleeding, infection, anesthesia, scarring, pain, waves, bumps, ripples, contour deformities, numbness, skin staining, fluid collections, non- retraction of the skin, deep venous thrombosis, fat embolism, pulmonary embolism, death, necrotizing fasciitis, damage to surrounding structures, need for revision surgery, poor aesthetic result and other unexpected occurrences. No guarantees were given or implied and the patient had no further questions prior to the procedure. Other options including not having surgery were discussed and dismissed by the patient. The operative report adequately documented Patient C.A.'s earlier oral informed consent for liposuction with fat transfer. Patient C.A. did not execute a written informed consent for the fat transfer prior to the procedure. Dr. Velilla also noted in the operative report that the "patient physical examination and pre-operative blood work were within normal limits." Neither the operative report nor any other documentation indicated whether a complete physical examination or a focused physical examination was given, or what that examination consisted of. Patient C.A. was scheduled for a second liposuction procedure on her arms on February 26, 2011. It was decided to defer the procedure on her arms to this later date in order to keep the amount of lidocaine at a safe level during the initial procedure. On or about February 26, 2011, Patient C.A. presented to Evolution MD with complaints of nausea and mild pain. Dr. Velilla was not at the Evolution MD office. Mild pain is to be expected on the second day after a fat transfer procedure, and nausea can be anticipated in some patients who are taking opiods, as had been prescribed for Patient C.A. There was insufficient competent evidence in the record to support a finding that Patient C.A.'s symptoms were unusual or that Dr. Velilla was ever informed of more serious symptoms in Patient C.A. that day. Dr. Velilla spoke by telephone with an Evolution MD staff member about Patient C.A.'s symptoms and instructed the staff member to ask Patient C.A. to wait for his arrival at the office. A "Progress Note" signed on February 26, 2011, by Ms. Amanda Santiago, of Dr. Velilla's office, indicated that Patient C.A. said the pain and nausea were "due to the Vicodin." The note indicates that Dr. Velilla was called, that he stated he might stop the Vicodin and start Patient C.A. on Advil or Tylenol for pain, and that he asked that Patient C.A. be prepared for surgery. The note does not indicate that Dr. Velilla directed that Patient C.A.'s vital signs be taken, or that they were taken. The note states that Patient C.A. decided not to have the procedure on her arms done and that Dr. Velilla was again called. The note indicates that he asked the staff to take pictures of Patient C.A. and ask her to wait for him to arrive. Dr. Velilla did not order Evolution MD staff to take Patient C.A.'s vital signs. Her vital signs were not recorded by Evolution MD staff on February 26, 2011. Contrary to Dr. Velilla's request, Patient C.A. left Evolution MD on February 26, 2011, prior to Dr. Velilla's arrival at the office, and Evolution MD staff were unable to contact her. On or about February 27, 2011, Patient C.A. presented to Coral Springs Medical Center where she was admitted with a diagnosis of severe dehydration, intravascular volume depletion, diarrhea, nausea, and vomiting. Subsequently, Patient C.A. was admitted to the intensive care unit. Patient C.A. remained hospitalized until March 31, 2011. Standards and Ultimate Facts Dr. Obi is a surgeon specializing in plastic surgery. He does not conduct laser-assisted liposuction, but performs what is known as "wet" or "super wet" liposuction, as was performed by Dr. Velilla in this case. He has been a Diplomate of the American Board of Plastic Surgery since 1982. Dr. Obi reviewed Patient C.A.'s medical records from Evolution MD, other related records, and the Second Amended Administrative Complaint. Taken as a whole, Dr. Obi's testimony with respect to the medical history documented for Patient C.A. was not clear and convincing. He testified that Patient C.A. was undergoing a significant operative procedure and that it involved multiple anatomic areas. He also noted that the history did not include information as to whether Patient C.A. had prior abdominal surgical procedures, earlier liposuction, multiple pregnancies, or abdominal hernias. He testified that this information could indicate increased risks of injury and that this relevant history must be documented. Dr. Obi stated that in his opinion the patient history did not meet the minimum standards of the medical records rule. On the other hand, Dr. Obi seemed to have only a partial understanding of what the medical records rule required, and he had no opinion on whether the patient history justified the course of treatment of Patient C.A.--the actual statutory standard that Dr. Velilla was charged with violating in the Second Amended Administrative Complaint: Q. What does the rule say? A: What does the rule say? The medical record rule I believe requires – I can't tell you verbatim what it says. It requires adequate documentation so that in the event that the care of a patient has to be transferred to another healthcare professional the documentation is adequate that the patient, that the professional could immediately step in and take over. Q: Okay. You believe that's part of either the statute or the rule enacted by the Board of Medicine? A: If the Board of Medicine is the group responsible for the medical record rule, then I would say yes. Q: Okay. Have you reviewed what has been alleged in the amended administrative complaint, or second amended administrative complaint, as to the statutory provision for medical record adequacy? A: The statutory, I'm not sure that I have. * * * Q: And do you believe that the records fail to justify the course of treatment of the patient with those history findings? A: That's not what I said. I didn't say it failed to justify. What I said is it wasn't complete. Q: Okay, do you have an opinion as to whether the records fail to justify the course of treatment of the patient? A: No. Q: You don't have an opinion. Okay, thank you. In contrast, Dr. Soler testified that in his opinion the patient history that was documented as part of Patient C.A.'s medical records did justify her course of treatment. With respect to the physical examination, Dr. Obi noted that there was only a single line in the operative record stating that the physical examination was within normal limits. He noted that the documentation did not indicate what had been examined and did not record any specific findings or results of any examination that was conducted. However, he never offered an opinion that the record of the physical examination failed to justify the course of treatment of Patient C.A. Dr. Soler testified that in his opinion, the record of the physical examination did justify the course of treatment of the patient. Petitioner did not show by clear and convincing evidence that the documentation of Patient C.A.'s medical history and physical examination failed to justify her course of treatment. Dr. Obi testified that the medical records should have contained more evaluation or explanation of the abnormal laboratory report results: Q: And so was the check mark, when coupled with that note in the pre op, or in the operative report, sufficient documentation of Dr. Velilla's evaluation of the of the patient's pre-operative lab results? A: In my opinion, no. Q: And what do you base that on? A: If you have an abnormal result, I think it is incumbent on you – it – depending on what the abnormality is, and depending on what your interpretation of that abnormality is, it's incumbent to explain it. Sometimes you need to repeat the tests. Sometimes it may be perfectly within normal limits, but on the laboratory sheet, if it says that it's high, or out of the range of normal, I think other than just check mark, I think you just acknowledge what your thoughts are. Q: And do you remember if there was anything abnormal in Patient C.A.'s pre-operative laboratory results? A: There was one area that I commented on. That was the BUN-creatinine ratio. Q: And what is the BUN-creatinine ratio? A: It's just a ratio of some parameters dealing with kidney function. Q: Okay, and what does that lab result tell you about a patient, if anything? A: Well, you know, it can call your attention to the area, I mean, it can tell you, you know, that the patient has some renal issues. It can tell you that the patient is, you know, potentially dehydrated, it can tell you that the patient, you know, is within normal. But if the values are – if one value is high and the other one is low, it may give you a, a high reading. And that's understandable, but all you need to do is document that. It was Dr. Obi's opinion that the medical records failed to contain a sufficient evaluation or explanation of the abnormal BUN/creatinine ratio laboratory result. He acknowledged that the abnormal result was not necessarily indicative of a renal problem. However, Dr. Obi also testified: Q: Okay. Do you have an opinion as to whether those records are adequate to justify the course of treatment of the patient? A: The failure to document the thought process on this ratio would, in and of itself, not prevent or preclude the operative procedure from being done, if that's your question. At best, Dr. Obi's testimony was thus ambiguous as to whether or not failure to include an explanation of the abnormal laboratory result failed to justify the course of treatment of Patient C.A. Dr. Soler testified that no other documentation or chart entry was required to address the lab report value in order to justify proceeding with the surgery. Dr. Sandler testified that the BUN/creatinine ratio was a renal-related test, but does not itself indicate kidney malfunction. Dr. Sandler also testified that in his opinion, no other documentation was needed prior to proceeding with the surgical procedure. The Department did not clearly and convincingly show that the documentation in the medical records relating to abnormal laboratory results failed to justify the course of treatment of Patient C.A. Dr. Obi testified that Dr. Velilla had a duty to order the taking of Patient C.A.'s vital signs since he was not yet in the office when she returned on February 26, 2011, the date the second liposuction had been scheduled. He testified that if the medical records rule "requires doing what's appropriate at each visit," then Patient C.A.'s records did not meet the requirements of that rule. He testified that if Patient C.A. was an "outlier" in that her symptoms were uncommon, the standard of care required that Patient C.A.'s vital signs be taken. Dr. Obi admitted that there was no documentation in the medical records to suggest that Dr. Velilla had ordered the staff at Evolution MD to take Patient C.A.'s vital signs, but he testified that the order should have been given and that it should have been documented. Dr. Obi testified that there was no written documentation of an informed consent for the fat transfer and that the consent for the "Slim Liposculpt" procedure was consent for a procedure that was not done. Again, Dr. Obi seemed unfamiliar with the specific requirements of the medical records rule: Q: And is, is the –is a written documentation of the fat transfer required by the medical record rule in this case? A: In terms of the actual requirement, it would be my opinion that it should be required. Now, I can't say if it says that for every procedure, every surgical procedure, every invasive procedure, that a written consent must be documented; because obviously, you now, the patient consented. It's implied that the patient consented because she showed up for the procedure. Dr. Obi testified that he was aware that the operative report contained statements that Patient C.A. had been informed of the risks of the fat transfer procedure and that she had specifically consented. He admitted he was unsure as to "which board, or organization, or outfit" requires a written informed consent. Aggravating and Mitigating Factors No evidence was introduced to show that Dr. Velilla has had any prior discipline imposed. There was no evidence that Dr. Velilla was under any legal restraints in February 2011. It was not shown that Dr. Velilla received any special pecuniary benefit or self-gain from his actions in February 2011. It was not shown that the actions of Dr. Velilla in this case involved any trade or sale of controlled substances. On May 17, 2014, Dr. Velilla received a certificate showing completion of an FMA educational activity conducted in Jacksonville, Florida, entitled "Quality Medical Record Keeping for Health Care Professionals."
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 dismissing the Second Amended Administrative Complaint against the professional license of Dr. Cesar Augusto Velilla. DONE AND ENTERED this 8th day of June, 2016, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of June, 2016.
The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Carl Fromhagen, M.D., based on allegations that he violated Subsections 458.331(l)(k),(m) and (t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1956 and issued License No. ME 0007027. Respondent is board-certified in Obstetrics and Gynecology (1967). He is 74 years old and now has an office- based practice treating only gynecological patients. Patient K. B., a 46-year-old female, first presented to Respondent on September 6, 1990, with menopausal complaints. Her patient's history reflects that she reported a family history of breast cancer. On February 12, 1992, Patient K. B. presented to Respondent with complaints of a mass in her left breast. Respondent palpated a mass in K. B.'s left breast and, although he did not note the size of the mass in his office records, the records contain a diagram showing the location of the mass. Petitioner testified that it was his practice that when he discovered a mass of less than 2.5 centimeters, he did not describe the size because its too hard to identify the exact dimensions smaller than an inch. Respondent ordered a mammogram for Patient K. B. which was performed on February 19, 1992, and was interpreted as revealing no evident neoplasm (cancer). Respondent saw Patient K. B. in his office on the following dates (after the mammogram): March 30, 1992; May 21, 1992; August 31, 1992; April 19, 1993; April 27, 1993; May 4, 1993; May 11, 1993; May 18, 1993; September 21, 1993; and November 16, 1993. In addition, Patient K. B. had telephone contact with Respondent's office staff to have prescriptions refilled and was mailed examination reminder notes. Patient K. B. testified that she and Dr. Fromhagen discussed the breast mass "every checkup, every time I was there." She inquired about a follow-up mammogram and Dr. Fromhagen indicated that she could wait two years. He did not mention a biopsy, excision, or referral to another physician at anytime. Patient K. B. and Respondent agree that Respondent examined and palpated the breast mass during her physical examinations which took place approximately every six months. During civil litigation that preceded the instant administrative hearing, it became apparent that there were two different sets of office records for Patient K. B. Patient K. B. testified that during the civil action she brought against Respondent in 1996, Respondent had produced medical records, purported to be hers that did not accurately reflect her treatment. She recalled that upon comparing the medical records Respondent had produced in the civil action with the records she had obtained from Respondent's office in December 1994, she discovered that Respondent had "augmented" her records, which she reported to her attorney. In May 1994, the offices of Dr. Paul Straub, who became Patient K. B.'s new treating physician as a result of a change in her group health insurance, requested her medical records from Dr. Fromhagen's office. Dr. Fromhagen testified in the instant hearing that "at the time . . . I compared the chart [Patient K. B.'s records] with . . . 'day sheets' and because I felt the records did not reveal everything that Dr. Straub should be aware of, I rewrote certain portions of them to reflect things that were on the day sheets that I hadn't already written down and then [in May 1994] sent the records to Dr. Straub." Patient K. B. testified that, "the night before my surgery" [December 1994] she received a call from Dr. Fromhagen's office asking if they could send her records to Dr. Straub. In the course of that discussion, Patient K. B. advised that she had been diagnosed with breast cancer and was scheduled for surgery. That same evening, shortly after the phone discussion with Dr. Fromhagen's office, Patient K. B. went to Dr. Fromhagen's office and obtained a copy of her medical records. These records did not contain the "rewritten portions" Dr. Fromhagen reported as having been done in May 1994. Dr. Fromhagen testified that he started keeping "day sheets" when he first started practicing in 1960. The "day sheets" (Respondent's Exhibit 2) are essentially a daily calendar organized by time which lists the name of patients to be seen that day and then notes such as "ovarin cyst," "vaginitis," "preg?" These "day sheets" were not mentioned in either of Dr. Fromhagen's depositions taken in 1996 in the civil action. In Petitioner's Exhibit 10, a July 3, 1997, letter to M. S. Sutton, an Agency for Health Care Administration investigator, Dr. Fromhagen attempts to explain his record- keeping practice for patients, Dr. Fromhagen acknowledges rewriting his charts and states, "I would carefully review the chart and address any portions that I felt were not completely explanatory, or that I thought need information to assist the subsequent physician. I now understand that I should have noted the changes as late entries and dated them the date written." No mention was made of "day sheets" in this letter. Dr. Fromhagen testified during a deposition taken in the civil action that his standard practice was "to make entries in the chart right away," that he never put it off, and that he had not done anything different in Patient K. B.'s case. Dr. Fromhagen acknowledged that during a deposition taken in the civil action he had incorrectly testified that he had not made changes in Patient K. B.'s medical record. The following is a comparison of the significant difference between Petitioner's Exhibit 9, Patient K. B.'s original medical record, and Respondent's Exhibit 3, Patient K. B.'s "augmented" medical record. Please note: Patient K. B. became Dr. Fromhagen's patient on September 6, 1990. No changes were made in the "Gynecologic History and Physical Examination" (Patient K. B.'s medical record) on any entry until March 30, 1992. Changes are highlighted. Date: March 30, 1992 Original record: "Mammogram was neg. palpation indicates mass much smaller. Will follow" Augmented record: "Mammogram reported as no evidence of neoplasm. Palpation indicates to me that mass is smaller. Discussed removing it" Date: May 21, 1992 Original record: "Dysuria General Malaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Augmented record: "Dysuria. Mailaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Date: August 31, 1992 Original record: "Introital lesions. Pelvic area feels congestion and cramping sensation. Pelvic- ulcers-blisters at introitus but very small. Herpes? Rx Zoirax" Augmented record: "Introital lesions. Lower abd cramping. Pelvic - herpetic ulcers at introitus. Rx Ziorax" Date: April 19, 1993 Original record: "Last mammogram revealed no concern. Dysuria. Frequent UTI. Had a cysto before. Rhinorrhea. Vulvar irritation. GenPE. Breasts unchanged. Pelvic - fungus. Rx She has Monistat. Urine - pus Macrodantin. RV Cysto" Augmented record: "Last mammogram revealed no neoplasm but mass still present and I suggested another x-ray now or removal of mass if she wishes. Dysuria. Has frequent UTIs. Had a Cysto before. Rhinorrhea. Vulvar irritation. Gen PE - nasal turbinates swollen. Breasts unchanged. Pelvic-fungus. Rx she has Monistat for fungus. Macrodantin RV Cysto" Date: April 27, 1993 Original record: "Cysto: stricutre. Proximal urethra & trizone inflamed and granules. Bladder capacity - first desire to void at 200 c.c. RV dilations" Augmented record: "Cysto-urethral stricture. Proximal urethra & trizone inflamed & granular. Urethra L46. Bladder capacity - first desire to void at 200 cc. Rx RV dilations" Date: May 18, 1993 Original record: "No urinary complaints now. Sounded #32 irrigated AgNO3. This concludes dilations" Augmented record: "No urinary complaints now. Sounded #32, irrigated AgNO3. This concludes diations. She has not gotten this years mammogram yet" Date: October 11, 1993 Original record: "Rem sent" [entry made by office staff]" Augmented record: "Reminder note sent - Exam due." [entry made by office staff]" Date: November 16, 1993 Original record: "On Premarin.625. Starting to awaken in the middle of the night again Nervous. No flashes. Bladder OK. New glasses. Trouble adjusting to fidders bifocals. GenPE, breasts & pelvic unchanged. Pap change to Premarin 1.25" Augmented record: "On Premarian.625. Starting to awaken in the middle of the night again. Very nervous. No flashes. Bladder OK. Finds it hard to adjust to her new bifocals. Gen PE unchanged. Breasts - mass still present. Again suggested she get a yearly mammogram or have mass excised. She has not arranged for a mammogram as she said she would. Pelvic unchanged. Rx Increased dose of Premarian to 1.25" The entries made in patient K. B.'s "augmented" record (Respondent's Exhibit 3) were not noted to be "late entries" nor were they dated. Both expert witness opined that this fell below the standard of care. Most of the "late entries" made by Respondent in the "augmented" record (Respondent's Exhibit 3) are a self-serving attempt by Respondent to create the impression that he had encouraged Patient K. B. to have follow-up mammograms or to have the breast mass excised. If the "augmented" record (Respondent's Exhibit 3) was a true reflection of the treatment rendered Patient K. B. by Respondent, his treatment could possibly have met the "standard of care." I find that the "augmented" record does not reflect the treatment Patient K. B. received, but that the original record (Petitioner's Exhibit 9) is the more credible document and accurately reflects Respondent's treatment of Patient K. B. Dr. Nelson, who testified as an expert witness, testified that Dr. Fromhagen fell below the standard of care in that (relying on both the original record and "augmented" record) between March 30, 1992, and April 13, 1993, he did not "deal with the breast mass, did not report discussion of treatment options with the patient, did not order a follow-up mammogram within 12 months." Again relying on both records, Dr. Nelson testified that Dr. Fromhagen fell below the standard of care for maintaining medical records when he failed to record his examination of Patient K. B.'s breasts and palpation of the mass which he reported as having been done "every visit she made." Both Dr. Von Thron, who also testified as an expert witness, and Dr. Nelson agreed that the standard of care requires that for any revision of medical records, if a change is made, a line is made through the original so it can be read and then the correction is made and the change is dated and initialed. If an additional statement is entered into the medical record, it should be dated and initialed. Dr. Fromhagen did not date or initial the changes or additions to Patient K. B.'s medical record when he created the "augmented" record. Both expert witnesses testified that this fell below the standard of care for medical record-keeping. Dr. Von Thron, referring to the original record, opined that Dr. Fromhagen did not comply with the standard of care for essentially the same reasons as expressed by Dr. Nelson. He opined that the "augmented" record indicates that Dr. Fromhagen complied with the standard of care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is Recommended that the Board of Medicine enter a final order finding Respondent guilty of violating Subsections 458.331(1)(k), (m), and (t), Florida Statutes (1993), and imposing the following: A $1,000.00 fine for each violation, for a total of $3,000.00; and A one-year suspension followed by two years' probation; Ten hours of continuing medical education in ethics; An appropriate medical education course in medical record-keeping. DONE AND ENTERED this 5th day of March, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK 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 5th day of March, 2001. COPIES FURNISHED: George Thomas Bowen, II, Esquire Law Offices of Donald Weidner, P.A. 11265 Alumni Way, Suite 201 Jacksonville, Florida 32246 John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues are whether Respondent is guilty, in his care of each of several patients, of failing to perform a statutory or legal obligation by performing unnecessary diagnostic tests, failing to keep legible medical records justifying the course of treatment, exercising influence on the patient to exploit the patient for the financial gain of Respondent or a third party, prescribing legend drugs other than in the course of his professional practice, and failing to practice medicine in accordance with the applicable level of care. If Respondent is guilty of any of these violations, an additional issue is what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician in Florida, holding license number ME 51631. At all material times, Respondent has been Board-certified in ophthalmology. Respondent has not previously been disciplined. From 1996 to 1998, to supplement his income from the practice of ophthalmology in Deerfield Beach, Florida, Respondent worked at the Metabolic Treatment Center in Ft. Myers, typically receiving patients twice weekly at the center. At the Metabolic Treatment Center, Respondent typically saw patients whose many complaints had not been resolved by other physicians. The treatment philosophy of the Metabolic Treatment Center and its staff, including Respondent, was to check for and treat the metabolic component of patients' disorders. While Respondent worked at the Metabolic Treatment Center, between one and three physicians worked at the center, although Respondent, rather than another physician, typically saw his patients. Respondent's employment at the center ended shortly after the persons who owned it when he started working there sold it to a publicly traded corporation. After the change in ownership, Respondent did not like the new chief operating officer of the Metabolic Treatment Center. Respondent claims that he declined an offer from the chief operating officer to become the medical director of the center. Problems multiplied at the center until, one day, management abruptly locked out the staff and closed the center. In September 1999, the corporation owning and operating the Metabolic Treatment Center was administratively dissolved by the Florida Department of State. In subsequent litigation between Respondent and the Metabolic Treatment Center, Respondent obtained a circuit court order requiring the center to turn over medical records to him, but this order appears to have resulted in little, if any, actual relief, and the court case was closed in February 1999 without Respondent's obtaining copies of extensive medical records. Neither party disputes the fact that, while employed at the Metabolic Treatment Center, Respondent kept handwritten medical notes on each patient whom he saw. Respondent testified that these brief handwritten notes constituted less than five percent of the chart entries that he made on each patient. Respondent testified that he supplemented his handwritten notes, which he made while seeing a patient, by dictating or otherwise inputting more elaborate notes into a computer at the center. Petitioner contends that the handwritten notes were the only medical records that Respondent prepared for each patient. The Administrative Law Judge credits Petitioner's contention. Respondent attributed the loss of the more detailed medical records to the sudden termination of his relationship with the Metabolic Treatment Center and the subsequent refusal of the center's owners to allow Respondent access to these computer-stored records. It is impossible to credit Respondent's claim, at least to the extent of inferring the existence of extensive, detailed records for each of the patients in question. Respondent knew that any data that he inputted into a computer at the Metabolic Treatment Center were in jeopardy, unless he made copies of the computer files. As a self- described "per diem" physician at the center, Respondent knew that, at anytime, he could lose access to the facility and the computer-stored data at the facility. Before his abrupt termination, Respondent had encountered growing problems with the new Metabolic Treatment Center owners. Familiar with computer hardware and software, Respondent easily could have made copies of the computer files containing the medical records of his patients, but he failed to do so, and he cannot adequately explain this failure. The "failure" is because no such more detailed records ever existed. Respondent does not appear to have been especially attentive to detail, at least when practicing metabolic therapy at the Metabolic Treatment Center. In certain respects, the underlying conflict in these cases is between Respondent, practicing--holistically--metabolic therapy, and Petitioner's expert, Dr. Elton Shapiro, practicing--analytically-- endocrinology. Whatever else may be said of Respondent's holistic methodology, it cannot be said that a single tree ever blocked his view of the vast forest. At one point during the hearing, Respondent misread simple data on a chart. At no point during the hearing did Respondent claim the smallest recollection of any detail about any of the several patients involved in these cases. Although Petitioner's delay in prosecuting these cases would have presumably contributed to Respondent's failure to recall the details of his care for these patients, it is unusual that Respondent would lack any recollection whatsoever of any of the four patients who were clearly under his care at the center. Respondent claims to have spent an hour and a half with each new patient--a claim that is not credited--but nothing else in his testimony or the record contradicts the impression created by other aspects of the record of a high-volume practice at the Metabolic Treatment Center. A high-volume practice was not conducive to the kind of detailed record-keeping that Respondent claims to have undertaken. As Respondent himself testified, the center's management supplied him with forms that identified packages of lab tests, so that a single package combined useful tests with tests of little value, given the complaints, history, and findings concerning a particular patient. Respondent's ready acceptance and use of these test packages also militate against a finding that he attended closely to detail in his metabolic therapy practice. Discrediting Respondent's claim of a vast trove of detailed medical records does not mean that the present records are complete or even unaltered. Respondent's relations with the new owners of the Metabolic Treatment Center deteriorated to the point of hostility. A significant possibility exists that, following the cessation of operations at the center, existing medical records were not safeguarded and some records were lost. Likewise, records may have been altered. One record in these cases bears a handwritten printing of Respondent's name, misspelled. Another bears an awkward depiction of Respondent's letterhead from his east-coast opthamological practice--of which Respondent plausibly disclaims any knowledge. Although the Administrative Law Judge excluded records that appeared altered, some handwritten notes, lab results, and other materials may be missing from the present records. In making the findings below, the Administrative Law Judge has considered--patient-by-patient, entry-by-entry--all reasonable bases for inferences of the existence of other medical records, such as other handwritten notes or lab reports, that would support the quality of care that Respondent may have provided to any patient. The primary effect of this inferential process has been not to find, after examination of the admitted medical records, that the omission of a record of a patient history means that Respondent did not take one. With one minor exception, the sole basis for the admission of the medical records that have been admitted is Respondent's testimony identifying specific pages of records. The medical records adequately identified by Respondent are contained exclusively in Petitioner Exhibit 9, which is the transcript of Respondent's deposition taken, while he was still represented by counsel, on November 17, 2005. Attached to the transcript are about 300 pages of copies of purported medical records. (These pages are numbered 1-222 and 24-105.) The transcript discloses which records, by page number, that the Administrative Law Judge found that Respondent had adequately identified. After reviewing all of the evidence, the Administrative Law Judge has determined that he improperly admitted at the hearing other medical records. These records, which Respondent has never identified adequately, came from two main sources, although the original source in all cases was (or should have been) the Metabolic Treatment Center. The sources of these excluded records are of insufficient reliability to justify their admission. None of the patients themselves identified their medical records. Petitioner obtained the excluded records, which Respondent has never adequately identified, from two sources. First, Petitioner obtained some of the records from J. H., who is a cost-control employee of the insurer whose concerns led to the investigations that culminated in these cases. J. H. contacted Respondent during the course of her investigation into the reasonableness of the testing and treatment ordered by Respondent. In an odd twist, Respondent invited J. H. to assume the role of a patient at the center, and J. H. accepted his invitation. Presumably, Respondent took a history, made physical findings, and may have recommended a plan of treatment for the insurance investigator, who then, presumably foregoing the treatment plan, caused herself to be included among the 11 patients who eventually formed the subject of DOAH Case No. 04-4111PL. (As noted above, Petitioner has dropped its allegations concerning investigator/patient J. H.) The Administrative Law Judge finds that medical records produced exclusively from the insurer or J. H. lack sufficient reliability, under the facts of these cases, including the unusual involvement of the insurer's investigator in producing facts on which to prosecute Respondent, to justify their admission. Second, Petitioner obtained some records from Respondent's former attorney, who testified briefly at the final hearing. However, the source or sources of these records are unclear in the record. Given the age of these cases, the lack of proof concerning the preparation and custody of the putative medical records, and the fact that Respondent's former attorney obviously obtained the records from one or more other sources, it is impossible to find that the records identified by counsel are sufficiently reliable as to admit them into evidence. Only one category of medical records, besides those adequately identified by Respondent, is sufficiently reliable to be admitted into evidence. This category comprises those few records that Dr. Shapiro testified at the hearing were linked in time and content to other records already adequately identified by Respondent. This post-hearing exclusion of additional evidence affects only C. M. among the nine patients remaining in these two cases. For C. H., P. G., Sarah B., and S. A., Petitioner relied exclusively on the medical records attached to Petitioner Exhibit 9, substantial portions of which Respondent adequately identified. For B. H.-M., G. H., L. L., and R. B., Petitioner acknowledged at the hearing that it was relying exclusively on testimony because no records pertaining to these patients had been admitted. The absence of any acknowledgement by Respondent that he treated B. H.-M., G. H., L. L., R. B., or C. M., coupled with the absence of any admitted medical records for these five patients, preclude any factfinding about Respondent's care of these patients, or even that Respondent cared for them at all. Petitioner has therefore failed to prove any of the alleged violations concerning these five patients. C. H., a 46-year-old female, presented at the Metabolic Treatment Center for an initial visit on June 6, 1996. For C. H., pages 3 and 5-26 under tab "C. H." in Petitioner Exhibit 9 are admitted. On June 6, Respondent performed a physical examination of C. H. that revealed nothing of clinical significance. Under "impression," Respondent noted "pending labs & NCV." "NCV" is a study of nerve conduction velocity. An NCV study measures the speed of conduction of a nerve, which is an indication of the nerve's condition. C. H. completed an 11-item checklist for her health history and symptoms. Her history reported mitral valve regurgitation and prolapse, fibromylagia, and hypoglycemia. However, C. H. circled the "no" response to the question, "Do you have diabetes?" On another form, C. H. denied having had any of the listed conditions. C. H. also completed a checklist circling "yes" or "no" next to each of 14 symptoms and 11 conditions. C. H.'s symptoms included dizziness, chest pain, numbness in hands or feet, back pain, neck pain, shortness of breath, "a feeling that your heart skips a beat," "a fluttering sensation in your heart," fatigue, weight gain, inability to lose weight, depression and menstrual problems. C. H. indicated that her history did not include any of the listed conditions. Prior to sending C. H. to obtain NCV studies from another physician working for the Metabolic Treatment Center, Respondent completed a Metabolic Treatment Center form entitled, "Letter of Medical Necessity." The purpose of the form, according to the preprinted contents, is for Respondent to certify that services are "medically necessary" and "reasonable and necessary." The form shows that Respondent ordered NCV studies of the upper and lower extremities by the Metabolic Treatment Center to rule out peripheral neuropathy, possibly of a diabetic nature. Dr. Martin S. Goldstein of the Metabolic Treatment Center performed the NCV studies on the date of the initial visit. Bearing the date of June 6, 1996, and the heading, "Metabolic Treatment Center," the report states that a "slowed conduction is demonstrated" for the left upper extremity. The report includes the impression of "peripheral neuropathy." Respondent never addressed the question of diabetes according to the medical records. Blood work performed on June 7, 1996, June 28, 1996, and July 24, 1996, revealed that glucose was in the normal range and serum insulin was normal on June 7 and July 24, but high on June 28. The records do not indicate whether Respondent ruled out diabetes, as was his documented intent on the original office visit, nor do the records contain any discussion of Respondent's conclusions from this repeated blood work, if he did not feel that he could rule out diabetes. The portion of the rule-out diagnosis mentioning diabetes merely faded out of the records, except, of course, for repeated blood work that typically assists a practitioner in diagnosing diabetes. At least as to Respondent's handling of the question of diabetes, Petitioner proved that the medical records fail to justify the course of treatment following a rule-out diagnosis of peripheral neuropathy, possibly of a diabetic nature. Petitioner also proved that Respondent's ordering of the NCV studies was unnecessary and excessive, despite the abnormality disclosed in the upper left extremity. The salient facts are: 1) Respondent ostensibly ordered the NCV studies to rule out peripheral neuropathy, possibly of a diabetic nature; 2) the NCV studies revealed likely peripheral neuropathy of the upper left extremity; and, most importantly, 3) Respondent's medical records contain no discussion of the meaning of the abnormal finding from the NCV study of the upper left extremity. Notwithstanding the abnormal NCV finding, Respondent failed to refer C. H. to a neurologist, undertake treatment himself, or document why he was taking neither action. Respondent's failure to act on the abnormal finding proves that he never intended to do anything if the NCV studies uncovered anything wrong, as one did. Additionally, Respondent ordered the NCV studies without first testing C. H.'s sensory or motor functions and despite the patient's denial of any tingling in the arms or legs. The evidence establishes that C. H.'s tests were unnecessary and excessive. By failing to act on the abnormal NCV finding, Respondent failed to conform to the applicable standard of care. However, Petitioner's standard of care allegations cite only inappropriate and excessive testing, failing to perform an appropriate history and physical examination, and inappropriately and inaccurately diagnosing C. H. The excessive testing with respect to the NCV studies, discussed above, is better described as a failure to conform to a statutory duty than a failure to satisfy the applicable standard of care. Other excessive testing, discussed immediately below, is better described as the exploitation of a patient for financial gain. For the reasons noted in the Conclusions of Law, below, it is impossible to conclude that Respondent's failure to act on the abnormal NCV result violates the applicable standard of care because of the absence of a specific allegation to this effect. The blood work of June 28 and July 24, 1996, was excessive for several reasons. In most cases, items tested were normal when first tested on June 7, but this first round of blood work was generally appropriate. However, no medical reason existed to retest such items three weeks later or one month after the second round of blood work. For example, Respondent ordered an iron reading on June 7, despite any basis to suspect anemia. The reading was normal, but Respondent retested it on June 28 and July 24--on which occasions, iron remained within the normal range. Respondent tested amylase on all three occasions--despite any complaint, such as acute abdominal pain, that would suggest pancreatitis and justify a test for amylase--and on all three occasions amylase levels were normal. As noted above, Respondent tested serum insulin on all three occasions, again for no apparent reason, after the initial test was normal and the second test revealed only a slight elevation. Respondent ordered additional tests that were unnecessary in connection with the above-described blood work. Items tested unnecessarily include prolactin (absent any problem with excessive milk production), cortisol (especially as it was not a suppression test, but was a random test, which is useless), ACTH (especially because it was ordered before any cortisol abnormality was found), DHEA (absent any finding of masculinization), and human growth hormone (in the absence of any indication of an abnormality in growth hormone). Petitioner proved that Respondent ordered unnecessary and excessive tests to exploit C. H. for financial gain. On June 13, 1996, Respondent saw C. H. for the first time after her initial visit a week earlier and started her on Cytomel, 5 mcg each, four times daily. Cytomel is T3, a synthetic thyroid hormone. T3 combines in the blood with another thyroid hormone, T4, to regulate the metabolism of the cells within the body. Normally, when these hormones fall too low in the blood, the pituitary gland produces thyroid stimulating hormone (TSH), which stimulates the thyroid gland to produce more T3 and T4. The June 7 blood work revealed that total T3 and TSH were well within the normal range, although T4 was either at the low range of normal or just below the normal range. The June 28 and July 24 blood work showed values only for total T3, which were again well within the normal range. Without any support in the medical records except a notation of "low energy," Respondent elected to commence thyroid hormone supplementation. Within a week after starting on this prescription, C. H. had reduced the frequency of taking the Cytomel to three times daily due to heart palpitations, which is a known side effect of the drug. However, during an office visit on June 27, Respondent advised C. H. to resume taking Cytomel--5 mcg, five times daily--obviously after learning of the heart palpitations, but before obtaining the results of the June 28 lab work showing a normal total T3 level. C. H. discontinued taking Cytomel on July 11, 1996, due to feelings of fatigue. On August 9, 1996, C. H. reported, for the first time, that she "feels great," although, judging from the medical records, her recovery seems to have been spontaneous. Petitioner proved that Respondent's initial prescription of Cytomel was inappropriate and outside the course of practice because the blood work indicated normal values for the relevant hormones. The medical records contain no trace of a discussion of why Respondent would prescribe T3 for a patient with these values, complaints, and history. Not only was the Cytomel useless, but, for C. H., it produced cardiac side effects. If Petitioner had alleged the inappropriate prescription of thyroid medications as a basis for an alleged violation of the applicable standard of care, as it did with respect to C. M. and S. A., Petitioner would also have proved that the increased prescription of Cytomel, on June 27, violated the applicable standard of care. The resumption of the Cytomel prescription on June 27 departed from the applicable standard of care because Respondent knew that the Cytomel had produced a potentially dangerous side effect, and he ordered C. H. to increase the dosage of Cytomel before he had even seen the results of the blood work done the following day--which results again showed a normal total T3 level. Respondent's treatment plan, if it fact it can be called a plan, seems completely unrelated to C. H. and the findings of any physical examination and lab work or the complaints and history that she related to Respondent. Not surprisingly, her recovery seems similarly unrelated to any treatment plan. However, Petitioner failed to allege the prescription of thyroid medication as a basis for an alleged violation of the applicable standard of care as to C. H. Petitioner failed to prove the three alleged grounds for an alleged violation of the applicable standard of care. Petitioner failed to prove that the history or physical examination was inadequate or that the only diagnosis in the records--a rule-out diagnosis--was inaccurate or inappropriate. Although Petitioner proved some inappropriate and excessive testing, this improper testing is best described as a failure to perform a statutory obligation, with respect to the NCV studies, and as the financial exploitation of a patient, as to the repeated and unjustified blood work. Thus, as to C. H., Petitioner proved a failure to perform a statutory obligation, a failure to maintain adequate medical records, the exploitation of a patient for financial gain, and the inappropriate prescription of a thyroid replacement medication, but not a violation of the applicable standard of care. P. G., a 43-year-old female, presented at the Metabolic Treatment Center for an initial visit on July 3, 1997. For P. G., pages 43-44 (top), 47-48, and 55-69 under tab "P. G." in Petitioner Exhibit 9 are admitted. Following a physical examination, Respondent noted diminished deep tendon reflexes at the right and left dorsal pedal sites, right and left biceps sites, right and left post- tibial sites, and right and left poplyteal sites. Respondent obtained a history that included high blood pressure and heart disease, as well as a family history of heart disease. P. G. complained particularly about depression, pain, swelling in the joints for five years, faulty memory, joint pain, and poor concentration. She also complained of fatigue, numbness, tingling, and muscle aches. Petitioner failed to prove a violation of the applicable standard of care for a failure to perform an adequate physical examination or history. Respondent made a working diagnosis of hypothyroidism, hypertension, endocrine gland disorder, and chronic fatigue. He also made a rule-out diagnosis of pituitary access disorder. Respondent ordered blood work and directed P. G. to record her basal temperature daily. Petitioner failed to prove a violation of the applicable standard of care for a misdiagnosis, at this point in Respondent's care of P. G. Petitioner's expert witness described NCV studies that Respondent ordered of P. G.'s upper and lower extremities on July 3, but Petitioner failed to prove that these studies took place. The portion of the medical records (p. 45 under tab "P. G." in Petitioner Exhibit 9) discussing the results of the NCV studies was not admitted into evidence, and the NCV reports themselves were not offered into evidence. Petitioner failed to prove a failure to perform a statutory obligation for ordering unnecessary NCV studies. The blood work resulting from a collection occurring on July 8, 1997, revealed elevated glucose and cholesterol components. Earlier blood work done in January 1997 revealed elevated cholesterol components, but not glucose. The July 1997 lab work reported normal levels of total T3, T4, and TSH, which are consistent with the results of the January 1997 lab work for T4 and TSH (T3 was not tested in January 1997). In ordering the blood work for July 7, Respondent ordered analysis of insulin, iron, cortisol, growth hormone, and prolactin. For the reasons discussed in connection with C. H., Petitioner proved that these tests were medically unnecessary. Petitioner thus proved that Respondent exploited P. G. for financial gain in ordering all of these unnecessary tests. P. G. returned to Respondent's office on July 11 to discuss the results of the blood work. Respondent diagnosed her with, among other conditions, hypothyroid "both by temperature and symptoms." Although Respondent noted the thyroid readings from the July 7 blood work, he failed to discuss the relationship between these normal readings and his diagnosis of hypothyroid. Petitioner thus proved that the medical records do not justify the course of treatment. Additionally, distinct from this shortcoming in the medical records, Petitioner proved that Respondent inaccurately diagnosed P. G. with hypothyroidism and thus failed to satisfy the applicable standard of care. The lab work relating to P. G.'s thyroid function resembles the NCV studies of C. H. in terms of a lack of medical necessity. In the case of C. H., Respondent ordered the NCV studies for a reason other than to assist in diagnosis because, when they disclosed an abnormality, he ignored the positive finding and took no action. In the case of P. G., Respondent ordered the thyroid tests for a reason other than to assist in diagnosis because, when they revealed no problems with thyroid function, he ignored the negative finding and proceeded as he presumably would have if the tests had produced a positive finding of thyroid abnormality. Petitioner has proved that the blood work on thyroid function lacked medical justification and was unnecessary, and Respondent thus failed to perform a statutory obligation. On July 11, Respondent started P. G. on Cytomel, "0.5" mcg, four times daily. (An error in the sequencing of Respondent's medical records under tab "P. G." in Petitioner Exhibit 9 places immediately after the page describing the July 3 visit a page noting an increase in the dosage of Cytomel. Given the presence of an August 22 entry on this latter page, it is obvious that the page containing the entry increasing the Cytomel should have followed the page that ends with the July 31 visit.) Also on the July 11 office visit, Respondent started P. G. on human growth hormone. The July 7 blood work did not support this treatment because Respondent failed to test for human growth hormone either after exercise stimulation or glucose suppression. The value for human growth hormone in the July 7 blood work appears to be within the normal range. At the next office visit, which took place on July 31, 1997, Respondent also increased P. G.'s Cytomel to 10 mcg four times daily and ordered her to take human growth hormone on a cycle of five days on and two days off. As on July 11, Respondent, on July 31, lacked any justification to prescribe Cytomel or human growth hormone to P. G. Petitioner proved that Respondent inappropriately prescribed controlled substances to P. G. However, this finding applies only to the prescription of Cytomel because Petitioner never alleged that Respondent inappropriately prescribed human growth hormone. Although the inappropriate prescription of Cytomel probably would also constitute a violation of the applicable standard of care, Petitioner did not make such an allegation regarding P. G. Thus, as to P. G., Petitioner proved a failure to perform a statutory obligation, a failure to maintain adequate medical records, the exploitation of a patient for financial gain, the inappropriate prescription of a thyroid replacement medication, and the violation of the applicable standard of care. Sarah B., a 52-year-old female, presented at the Metabolic Treatment Center for an initial visit on September 5, 1996. For Sarah B., pages 72-80 and 87 under tab "Sara [sic] B." in Petitioner Exhibit 9 are admitted. No patient history was admitted into evidence, but it is impossible to infer from this omission that Respondent failed to obtain an appropriate patient history. Completed forms were present for other patients, the forms seem to have been readily available for completion by patients (not Respondent), and completed forms, which supplied numerous conditions or complaints that the patient had only to recognize and mark, set the stage for metabolic treatment of these numerous conditions or complaints. The records document Respondent's physical examination of Sarah B. on September 5, 1996, and disclose no abnormalities. Under "impression," Respondent stated, "pending labs and NCV." Petitioner failed to prove a violation of the applicable standard of care for a failure to perform an adequate physical examination or history. Performed on September 5, the NCV studies, again performed by Dr. Goldstein of the Metabolic Treatment Center, find a "mild focal peripheral neuropathy." Respondent next saw Sarah B. on September 12 and 20, 1996, but his notes omit any mention of the neuropathy. Once again, Respondent failed to treat the condition revealed by the NCV studies, refer the patient to a neurologist, or at least explain why he was taking no action. For the reasons discussed in connection with C. H., Petitioner proved that the NCV studies ordered by Respondent lacked medical justification and were unnecessary, and Respondent thus failed to perform a statutory obligation. Respondent ordered analysis of cortisol, DHEA, human growth hormone, iron, prolactin, and amylase. The records reveal no justification for these tests. Petitioner proved that Respondent exploited Sarah B. for financial gain. The September 5 blood work revealed normal values for T4, total T3, and TSH. Despite the absence of any thyroid abnormalities, on September 12, Respondent started Sarah B. on Cytomel, 5 mcg, four times daily. Respondent's notes reveal no reason why he started Sarah B. on Cytomel and lack even the specificity of the notes on the same issue with respect to P. G. Petitioner proved that the medical records fail to justify the course of treatment. However, Respondent discontinued the Cytomel one week later. Although the notes fail to explain the reason for his action, Respondent's prompt discontinuation of Cytomel demands more proof than Petitioner has provided, if it were to prove that the weeklong prescription of Cytomel was inappropriate or, had Petitioner pleaded the prescription of Cytomel as a violation of the applicable standard of care, deviated from the applicable standard of care. Thus, as to Sarah B., Petitioner proved a failure to perform a statutory obligation, a failure to maintain adequate medical records, and the exploitation of a patient for financial gain, but not the inappropriate prescription of a thyroid replacement medication or the violation of the applicable standard of care. S. A., a 53-year-old female, presented at the Metabolic Treatment Center for an initial visit on June 3, 1998. For S. A., pages 88-90, 92, 97-99, and 100-06 under tab "S. A." in Petitioner Exhibit 9 are admitted. After performing a physical examination, which included pulses and reflexes of the extremities, Respondent formed the impression that S. A. probably suffered from peripheral neuropathy. As is the case with Sarah B., no patient history is contained in the medical records, but, for the reasons stated above, it is impossible to find that Respondent failed to take a history. Petitioner thus failed to prove a violation of the applicable standard of care by failing to perform an appropriate physical examination or history. S. A. is dissimilar to the above-described patients in several respects. First, according to the testimony of Dr. Shapiro, S. A. suffered from hypothyroid disorder, so the ordering of blood work to assess thyroid function and the prescribing of thyroid supplement were appropriate. Second, judging from the medical records, Respondent did not order NCV studies. Third, S. A. was an uncooperative patient. Fourth, the lab reports on the blood work are substantially illegible, likely due to poor copying, with the result that it is impossible to read the values and ranges for particular items that are tested and, in some cases, read the items themselves. In general, no clear picture of the findings, diagnoses, and treatment plan emerges from the record, with the sole exception stated in the following paragraph. The sole exception is that it is clear from the records that Respondent, again, ordered tests of numerous items, such as testosterone (absent masculinization), prolactin, cortisol, growth hormone, and blood type, that were unnecessary. Petitioner thus proved that Respondent exploited S. A. for financial gain, but failed to prove the remaining S. A.-related allegations.
Recommendation RECOMMENDED that the Board of Medicine enter a final order dismissing DOAH Case No. 04-3222PL and dismissing all counts in DOAH Case No. 04-4111PL, except the four counts alleging the financial exploitation of C. H., P. G., Sarah B., and S. A.; the three counts alleging the failure to perform a statutory obligation regarding C. H., P. G., and Sarah B.; the three counts alleging the failure to maintain adequate medical records regarding C. H., P. G., and Sarah B.; the two counts alleging inappropriate prescriptions to C. H. and P. G.; and the one count alleging a violation of the applicable standard of care as to P. G. For these violations, the Board should enter a final order imposing an administrative fine of $29,000 against Respondent and placing his license on probation for five years. DONE AND ENTERED this 5th day of May, 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 5th day of May, 2006. COPIES FURNISHED: Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Dr. M. Rony Francois, Secretary Department of Health 4052 Bald Cypress Way, BIN A00 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Irving Levine Department of Health Prosecution Services Unit 4052 Bald Cypress Way, BIN C65 Tallahassee, Florida 32399-3265 Marvin Reich 1979 West Hillsboro Road Deerfield Beach, Florida 33442
The Issue The central issue in this case is whether the Respondent committed the violations alleged in the administrative complaint; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent holds an active license to practice medicine, license number ME 0030238 (Physician). Respondent's practice is limited to what he has described as "cosmetic" surgery, but which is considered plastic or reconstructive surgery. Typically, Respondent performs elective surgery for cosmetic purposes to breasts, abdomen, buttocks, face (eyes, lips, cheeks), or hips. In August, 1990, the patient, V.A., presented to the Respondent for a pre-operative consultation and examination. At the time, V.A. was interested in having liposuction, breast enlargement, and an abdominoplasty. Due to her medical history, V.A. was an extremely poor candidate for an abdominoplasty. The pre-operative history and physical examination performed by Respondent as reflected in the records maintained by Respondent for the patient, V.A., were inadequate. No records supporting a complete physical examination and history have been provided. The pre-operative medical records maintained for the patient, V.A., do not support the course of treatment proposed for the procedures to be performed. Respondent did not order a pre-operative lab work-up for the patient, V.A. Such lab order would normally consist of a complete blood count, a urinalysis, electrolytes, blood sugar, blood nitrogen test, and a mammogram or breast examination since the breasts were to be augmented. Respondent relied on lab test results for V.A. which were approximately three months old. Respondent believes that the reliance on tests up to six months old would be acceptable since he only performs surgery on healthy patients. Respondent performed no independent examination of V.A. to verify she was "healthy," prior to surgery. Failing to obtain current lab tests of the types described above before performing elective surgery of the nature sought by V.A. constitutes the practice of medicine below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. On or about August 30, 1990, Respondent performed the following procedures on V.A.: liposuction; breast enlargement; and an abdominoplasty. In order to perform the procedures noted, Respondent used general anesthesia so that V.A. was under anesthesia for six hours. During that time, Respondent opened V.A.'s abdomen, removed tissue, removed adipose tissue from various parts of the patient's body, injected fat tissue into the patient's breasts, cheeks and hands, and closed the abdominal wound with stitches. The surgical or operative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe the procedures performed. The Respondent was released to go home approximately two hours after the surgery. The postoperative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe how the patient was able to be discharged in so short a time after surgery. V.A. returned to Respondent's office numerous times following the surgery. V.A. sustained an infection and complications from the wound to her abdomen that took months to heal. Respondent treated the infection by scraping the wound and attempting to re-stitch it on at least two occasions. V.A. sustained necrosis which is the death of tissue and which complicated the healing of the abdomen wound. The loss of skin from necrosis is much more likely to occur when the patient has scarring. Given V.A.'s medical history (scarring throughout the areas), the necrosis was almost inevitable. Two procedures are available under the circumstances applicable to V.A.: allowing the wound to heal without stitches or to use a skin graft. The procedure used by Respondent (stitching the infected area) fell below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. Injecting fat tissue for breast augmentation is inappropriate. Since it is common for the fat tissue to die after injection, the injected tissue then appears on a mammograph as a mass of suspicious origin. That is, it is difficult to differentiate from a breast mass that is a medical problem from that of the dead fat tissue. As a result, biopsies may be required to verify the mass content. In fact, V.A. has already had to have such a procedure following the augmentation performed by Respondent. Respondent also conducted a pre-operative interview with a patient, P.T. P.T. was a radio talk show host at the time and suggested that the station, she and Respondent could all benefit from a campaign wherein she would have liposuction, the Respondent would receive her endorsement through advertising, and the station would have advertising paid for by the Respondent's clinic. In an attempt to negotiate the terms of the advertising campaign, P.T., an advertising executive with the radio station, Respondent's office manager, and Respondent met together to discuss the project. Respondent wanted a multifaceted campaign requiring P.T. to undergo more than just the liposuction she sought. Respondent's scope for the campaign included many of the surgeries his clinic offered. While discussions continued for the advertising campaign terms, P.T. underwent pre-operative testing which included a blood test, medical history forms, and photographs. During an office consultation in anticipation of surgery, Respondent requested that P.T. allow him to examine her. Unlike a previous examination which had occurred without incident with someone in the room, Respondent closed and locked his office door and requested that P.T., who was alone with Respondent, stand near his desk. When she complied, he leaned forward and raised her dress over her breasts. Next he unhooked her bra and pulled it over her breasts. Respondent proceeded to poke and prod P.T. across her breasts and abdomen during which time P.T. presumed it was for medical purposes. P.T. became uncomfortable when the prodding which continued became more like a caress. She attempted to presume Respondent was merely checking the texture of her skin but became increasingly uncomfortable with his touch. P.T.'s discomfort accelerated when she realized Respondent had placed his face in her vaginal area and was licking her. She immediately attempted to pull away. Respondent grabbed her on the breast and, as P.T. put it, "in the crotch." P.T. struggled with Respondent who made several sexually inappropriate comments to her. As P.T. attempted to regain her composure and close her clothes, the Respondent's office manager knocked on the door. On hearing the office manager, Respondent released P.T. and went to unlock the door. At the time of the foregoing incident, P.T. was the Respondent's patient. Respondent did not maintain appropriate medical records for the course of treatment proposed for the patient, P.T. Respondent's course of conduct with the patient, P.T., fell below the standard of care a reasonably prudent physician would pursue for treatment of this patient. Respondent attempted to engage a patient in a sexual activity. P.T. did not consent to the activity described above.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Agency for Health Care Administration, Board of Medicine enter a final order finding the Respondent guilty of violating Sections 458.331(1)(j), (m), and (t), Florida Statutes, and imposing the following penalties in accordance with the guidelines set forth by rule: revocation of the license together with an administrative fine in the amount of $15,000.00. DONE AND ORDERED this 16th day of August, 1995, in Tallahassee, Leon County, Florida. JOYOUS D. PARRISH 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 16th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3609 Rulings on the proposed findings of fact submitted by the Petitioner: 1. Paragraphs 1 through 56 are accepted as accurate as to the facts but not necessarily the form for findings of fact. Typically, findings of fact should not recite testimony. Rulings on the proposed findings of fact submitted by the Respondent: 1. None submitted. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Kenneth J. Metzger Senior Attorney Agency for Health Care Administration/Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Leon Doyan, M.D. 2817 E. Oakland Park Boulevard Fort Lauderdale, Florida 33306
Findings Of Fact Respondent is a licensed medical doctor holding a license to practice medicine in the State of Florida issued by the Board of Medical Examiners, Department of Professional Regulation. The Petitioner is a governmental agency charged with enforcing the provisions of Chapter 458, Florida Statutes, and related rules which regulate the licensure standards and status pertaining to medical doctors in the State of Florida, and enforcing the practice standards for licensed medical doctors embodied in Chapter 458, Florida Statutes. Steven Jones has been employed as a detective in the Narcotics Department of the City of Miami Beach Police Department for approximately three and one-half years. He is a ten-year veteran of the law enforcement profession. In December 1982, an investigation was initiated to determine whether allegations of misprescribing scheduled controlled substances made by a confidential informant against Dr. Ramos, the Respondent, were true. On December 16, 1982, Detective Jones entered the medical offices of the Respondent and asked to see Dr. Ramos. The Respondent's receptionist asked him to fill out a patient information sheet. On this sheet or form he indicated his name was "Steven James." He was then taken to the Respondent's office and met the Respondent. He told the Respondent that he was a construction worker, had recently experienced turmoil in his domestic life, and also suffered from a lumbo-sacral sprain. The Respondent then asked him if he had back pain and, after asking him general questions about his health and whether he suffered from any major illnesses, took out his prescription pad and wrote prescriptions for three medications. Other than the general questions the doctor asked him about his health, no detailed medical history was taken from Mr. Jones and there was no physical examination performed by Dr. Ramos or anyone else, except that his weight and height were recorded. No blood pressure reading was taken. After Dr. Ramos asked Mr. Jones if he had a backache, to which Mr. Jones responded in the affirmative, Dr. Ramos stated that he would prescribe something for the backache and something for stress that caused the backache, and something to sleep at night. Although no blood pressure was taken, Dr. Ramos did ask the patient how his blood pressure was, and the patient answered that it was "fine." The doctor then prescribed 60 tablets of valium, 60 placidyl tablets and 40 darvocet tablets. The only medical history provided in writing to the doctor concerned the name, address and employment, medical insurance information and answers to questions on the form concerning allergies. Additionally, the patient noted that he had been taking "valium" or "valium." Upon receiving the prescriptions, Steven Jones paid Dr. Ramos $40 and left his office. Detective Jones again visited Dr. Ramos' office on February 2, 1983. Upon arriving at the office he was escorted into an examining room by the Respondent's assistant, who was also his wife. While Mr. Jones was seated in the examining room, an assistant placed a blood pressure tourniquet or cuff on the patient's arm, leaving it there four to five minutes, when she ultimately returned to the room and informed Steven Jones that the doctor was ready to see him. The blood pressure tourniquet or arm band was never actually inflated by the Respondent or assistant, and no blood pressure reading was ever taken on this visit. Upon going into the Respondent's office, Mr. Jones was asked by Dr. Ramos about how he was feeling and the "patient" requested stronger pain medication. The doctor refused to do this, saying in effect that the patient, Mr. Jones, would have to be admitted to a hospital before the Respondent could prescribe stronger pain medication. Again, on this office visit no social or medical history was taken, and no physical examination was conducted at all. The Respondent asked the patient if he wanted the same prescriptions he had obtained at his December visit, and the patient answered in the affirmative. There was no discussion between the patient and the Respondent or anyone else concerning the patient's condition or progress between the December visit and this February visit. There was no discussion concerning the need for future treatment. The Respondent simply, at that point, wrote the same prescriptions given at the December visit. The next visit by Detective Steven Jones, a/k/a Steven James, occurred on May 25, 1983, at the Respondent's medical offices. The same medical assistant recognized Jones immediately when he came into the office and asked him if he was there for the same reason, to which he replied in the affirmative. He was then escorted straight to Dr. Ramos' office, who asked him if he wanted the same medication again, to which he assented. There was no discussion at all about his condition and how it may have progressed since the February visit, nor was there any discussions about future prospects for treatment, what treatment if any, was being considered or what it was designed to accomplish. The Respondent simply wrote three prescriptions once again, for valium, placidyl and darvocet, Schedule IV controlled substances. Except for the first visit, there was never any discussion of back pain nor any discussion concerning symptoms of insomnia and nervousness in this patient. Onelia Padron testified for Respondent. She has known the Respondent for many years and has worked for him as a technician for approximately a year. She was working in his office in December 1982, as an x-ray technician and in the performance of blood tests, blood pressure readings and physical therapy. She remembered Detective Jones coming to the office in December 1982, and testified that she did not take a blood pressure reading at the December visit, but did so at the February visit. Her specific memory of taking the blood pressure reading in February was not clear, however. She remembers specifically that his blood pressure was normal at the February visit and testified that she was sure that Dr. Ramos wrote down the blood pressure of the patient in his medical chart for the February visit. The patient medical record of Detective Jones a/k/a James, however, does not reveal that a blood pressure reading was taken at the February visit. Although the witness claims to have taken a blood pressure reading on the patient on his February 1983 visit, the testimony of Detective Jones reveals that no blood pressure reading was taken; although the blood pressure cuff or tourniquet was applied to his arm, it was simply not used. This may account in part for Ms. Padron's mistaken memory of actually taking the blood pressure reading. Her memory may be less than accurate due to passage of time. The testimony of Detective Jones to the effect that no blood pressure reading was taken, when considered with the Respondent's own medical records which do not reveal a blood pressure reading being taken, renders the finding inescapable that no blood pressure reading was taken at the February, 1983 visit and that Ms. Padron, after the passage of over a year, has a less- than-specific, inaccurate memory about the occasion and thus her testimony with regard to this visit is not credible. Rita Ramos, the Respondent's wife, acts as the office receptionist who makes and maintains the medical records for the Respondent. She performs no medical duties, however, she is well acquainted with her husband's handwriting and, of course, her own handwriting, and established that the word "valium" on Petitioner's Exhibit 2 and the word "valium" on Petitioner's Exhibit 6 were not written by her or her husband. She maintains that she specifically remembers the patient (Detective Jones) coming to visit Dr. Ramos on December 16, 1982, and she specifically remembers the doctor conducting a full physical examination and writing at least four lines of notes in the patient's record. She did not take a blood pressure on this patient in either December or February, however, and could not give an adequate explanation of how she could perform all her administrative record-keeping and maintenance duties and still have time to continually watch through the open door of her husband's office to see the physicals performed on approximately 20 patients a day, including Jones, and especially then to be able to remember the details of that one specific patient's visit in December 1982, over a year prior to the hearing. Although this witness supposedly remembered the doctor "always" conducting physical examinations on the first visit by a patient, and specifically conducting a head, eyes and ears examination on the first visit of Detective Jones, given the inherent interest of the patient in this case, the fact that her memory must be suspect regarding a specific patient's visit on a specific date more than a year prior to the hearing, and her own testimony that no irregularity or memorable occurrence happened during the visit of that patient to stimulate her recall, her memory of that event must be deemed less than accurate and therefore her testimony concerning the physical examination cannot be found credible by this Hearing Officer. Dr. Ramos testified on his own behalf. He stated that his standard practice is to interview and examine each patient and that he was especially suspicious of the subject patient who came in wearing earrings and boots. He interpreted his abbreviated notes on the patient's chart to reveal that the patient was 5'8" tall and weighed 145 pounds, had a blood pressure of 120 over 80 and a pulse of 80, and a normal sinus rhythm with no heart murmur and no abnormal respiratory signs. The doctor additionally interpreted his handwritten notes containing his own abbreviations, to reveal that the patient's eyes were normal, neck supple, with normal ears, nose, throat and a fair complexion. Although the patient asked for a stronger medication on at least one of the visits, including quaaludes, the doctor refused, informing the patient that he could not legally prescribe such for him in Florida. The doctor also testified that he remembered that on the second visit in February 1983, Ms. Padron took the blood pressure of the patient. He contends that he did not record the blood pressure reading because it was the same as the first time, that is, the December 1982 visit. No blood pressure was taken or recorded at the December 1982 visit, however, and none is revealed in the doctor's record for that visit. Although the doctor testified that on the February visit he believed that the patient might be trying to trick him and might be an undercover law enforcement officer, he still prescribed the same controlled substance prescribed earlier, with no additional physical examination made nor physical findings recorded in the patient records. He repeated the same instructions as to use of those drugs and the reasons for taking those drugs, but did not record any physical findings related to that visit. By his own admission, he did not ask the patient what had occurred in his medical history between December and February and did not ask questions concerning the success of his previously prescribed course of treatment. If indeed, the Respondent believed that the patient could be an undercover law enforcement officer and thus attempting to trick the doctor into misprescribing drugs for him, one might think that the doctor would take pains to make a thorough physical examination and to thoroughly record his findings and conclusions in the medical records he maintained, instead of failing to document his physical findings and conclusions and continuing to prescribe those drugs over a period of months. Thus, the testimony of Dr. Ramos is not supportive of a finding that a thorough physical examination, including the taking of blood pressure readings at each patient visit and, (in view of the low back pain complaint) straight leg raise tests, tests for impairment of sensation in extremities and other parameter checks, was actually conducted on the patient. Dr. John Handwerker, M.D., testified as an expert witness for the Petitioner. He has served as first chairman of the Department of Family Practice at the University of Florida Family and Community Medicine programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami, and is assistant professor of pharmacology at the University of Miami. He is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of family practice. The drug Darvocet and Darvocet N-100 is a Schedule IV controlled substance, according to the schedule established in Chapter 893, Florida Statutes. Darvocet is characterized by some habituating influence, together with some problems with withdrawal. Its use is contraindicated with tranquilizers, such as valium, which was also prescribed in conjunction with it by Respondent for the patient involved herein. Valium, which is known generically as diazepam, is also a Schedule IV controlled substance and is a sedative or anti-anxiety drug with a wide variety of potentially adverse drug interactions, including darvocet. It can be mildly addictive, has a depressant effect on the central nervous system and is also a muscle relaxant. Placidyl is a short-term drug used in sleep disorders. It is only indicated for use for a maximum of seven days. It is classed as an oral hypnotic, and is a Schedule IV controlled substance pursuant to Chapter 893, Florida Statutes. Prior to prescribing any of these drugs, a physician should take a full history from a patient, and perform a thorough physical examination. The history should include the patient's chief complaint with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract, and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck and chest and back regions. Further, if the patient requests these or other drugs specifically, a check should then be made for "track marks" and other evidence of prior drug abuse or usage. If the patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substances at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological involvement, including straight leg raise tests, impairment of sensation tests in the extremities and other neurological inquiries. Such a full history and a physical examination is necessary prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely the pain symptoms. Dr. Handwerker, upon being questioned concerning the December 1982 visit of Detective Jones to the Respondent's office, posing as a 29-year-old construction worker complaining of lower back pain and insomnia, established that if a doctor performed no physical examination of such a patient, or only a cursory one, and took a history which in essence elicited only the complaint of injury (aside from the non-medical personal background information) that it would amount to inappropriate prescribing of the subject drugs if the patient was given these drugs in the manner prescribed to Detective Jones. The Respondent simply made insufficient findings upon which to base the decision to prescribe those drugs. Such prescribing without an adequate physical examination or the obtaining of detailed patient medical history would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. The continued prescribing of these drugs at the February and May visits of this patient, without any discussion or consideration of the effect the previous course of treatment had had on the patient, other than a simple question by the Respondent concerning how the patient was feeling, also constitutes inappropriate prescribing of scheduled controlled substances and demonstrates a failure to conform to the generally accepted and prevailing standards of medical practice in the Dade County community. It was similarly established that the medical records failed to justify the course of treatment afforded this patient. Especially regarding the lack of a physical examination at each visit, and the failure to elicit any further medical history on the latter two visits. Even if a full physical examination and history was conducted on the first visit in December 1982, which was not the case, there would still be required an interim update and recording of physical findings related to the patient's experience since the December visit. Notes should have been made in the patient records regarding how the medications were affecting the patient and his pain problem, including notes reflecting that a physical examination had been performed, involving all vital signs, which was not the case with this patient. Not only does the generally accepted and prevailing standard of medical practice in Dade County require that an initial, thorough physical examination including the blood pressure and pulse and the eliciting of a detailed medical history be performed, as well as update physical examinations at later visits to check the progress of the patient under the treatment program; the failure to note the findings in the patient records constitutes a failure to conform to generally accepted and prevailing standards of medical practice for the Dade County community. Dr. Alfred March testified as an expert witness for Respondent, but agreed that the same detailed medical history and examination described by Dr. Handwerker is required before the practitioner should prescribe scheduled controlled substances in the same manner as done by the Respondent. Dr. March was unable to ascertain from simply reviewing the medical records of the Respondent, the reason or justification for the prescribing of any of the drugs on the three dates in question, and established that the medical records of the doctor should always justify the course of treatment for a patient. Indeed, Dr. March established that if a patient came in complaining of a backache, then such would be inappropriate prescribing without the performance of x-rays of the affected area and a full neurological examination, neither of which was performed by the Respondent in this case. Dr. Ramos has never been subjected to disciplinary proceedings in the past, and his past professional record reveals that his medical practice has been characterized by sincere concern for his patients and the highest respect of his colleagues. The subject drugs involved are Schedule IV controlled substances, which are of the class of drugs characterized by the least serious ramifications for patients, if misused. It is to the doctor's credit that when the undercover detective, Mr. Jones, attempted to persuade him to prescribe more powerful medication such as quaaludes, the doctor vigorously protested such a course of treatment and refused to do so, citing his belief that indeed it was illegal to do so in Florida.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefor
The Issue This is a license discipline case in which the Petitioner seeks to have disciplinary action taken against the Respondent on the basis of allegations that the Respondent has violated subparagraphs (m) and (t) of Section 458.331(1), Florida Statutes, by failing to keep written medical records justifying the course of treatment, and by failing to practice medicine with the appropriate level of care, skill, and treatment.
Findings Of Fact The Respondent, David Zufi, M.D., is and has been at all times material to this proceeding a licensed physician in the State of Florida, having been issued license number ME 0014856. The Respondent's last known address is 641 Reinaute Avenue, Coral Gables, Florida 33156-2345. The Respondent was and is a Board Certified plastic surgeon certified by the American Board of Plastic and Reconstructive Surgery since 1976. At all times material to this case, Dr. Ricardo Samitier-Cardet 1/ was the primary care physician or the attending physician for the Patient C.R. The Patient C.R. had sought out Dr. Samitier for the purpose of having several cosmetic surgical procedures performed; procedures which for a patient with a normal health history would have been minor cosmetic procedures. At all times material to this case, Dr. Samitier was a licensed practicing physician in the State of Florida. Dr. Samitier has never been Board Certified in any area of medicine. Dr. Samitier self-designated himself as a "cosmetic surgeon." At all times material to this case, the Respondent was unaware of any pending charges against Dr. Samitier. 2/ Prior to Friday, May 1, 1992, the Respondent was acquainted only marginally with Dr. Samitier. For a period of six months the Respondent had in the past rented office space one day a week to Dr. Samitier for consultation purposes. The Respondent had also spoken to Dr. Samitier a few times at meetings of the Coral Gables Hospital staff. The Respondent and Dr. Samitier had never shared any type of professional relationship with regard to the medical care of any patient. There were no referrals of patients between the two doctors, nor had the Respondent ever acted as a consultant in any capacity for Dr. Samitier prior to Friday, May 1, 1992. The Respondent had never visited Dr. Samitier's office prior to Friday, May 1, 1992. Dr. Samitier's medical records for the Patient C.R. include the following historical details. The patient had had an aortic valve replacement approximately twenty years earlier and had no history of angina. The patient was taking Coumadin, 5 mg. daily. The patient had no history of bleeding or hematomas and had normal erections. On Friday, May 1, 1992, at approximately 9:00 p.m., Patient C.R. underwent a Suction Assisted Lipectomy to the face, neck, and trunk, plus Circumferential Autologous Penile Engorgement (CAPE), which was performed by Dr. Samitier at Dr. Samitier's office. At the time of the foregoing surgical procedure Patient C.R. was a 47-year-old male who had previously undergone two open heart procedures, had a permanent pacemaker inserted, had a prosthetic aortic valve, and had been on Coumadin therapy for approximately twenty years. 3/ Coumadin is an anticoagulant drug which is taken to prolong a patient's blood clotting time. A patient maintained on long-term Coumadin therapy is at increased risk for clotting when the Coumadin is discontinued. The Patient C.R.'s long-term Coumadin anticoagulation therapy was made necessary by the fact that he had a prosthetic aortic valve. Before performing surgery on a patient with a history of cardiac problems such as those presented by the Patient C.R., a surgeon should obtain a cardiac clearance by means of consultation with a cardiologist. Dr. Samitier did not obtain a cardiology consultation prior to the surgery on the Patient C.R. 4/ A Prothrombin Time Test is a test which is utilized to evaluate a patient's blood clotting time. A Prothrombin Time Test should have been performed on the Patient C.R. immediately before the surgery on May 1, 1992. The test was not performed at that time. 5/ A Prothrombin Time Test was performed on the Patient C.R. about two weeks prior to the surgery. The Patient C.R. was a high risk patient who should never have been considered a candidate for elective surgery due to his history of cardiac problems, his prosthetic aortic valve, and his long-term Coumadin therapy. 6/ The two primary risks for a patient like Patient C.R. are that if his coagulation rate is substantially slower than normal the patient is at risk of uncontrollable bleeding at the surgery sites and if his coagulation rate becomes normal or slower than normal he is at risk of clot formation on his prosthetic aortic valve. Either condition can produce serious consequences, even fatality. On Friday, May 1, 1992, at approximately 11:30 p.m., which was approximately two hours after completion of the surgical procedure, the Patient C.R. began bleeding from his right cheek. It was a slow venous oozing bleed. The patient was taken back to the operating room where Dr. Samitier attempted without success to stop the bleeding with digital pressure. At approximately 2:30 a.m. on Saturday, May 2, 1992, by which time the bleeding from the patient's right cheek had persisted for approximately three hours, Dr. Samitier placed an emergency telephone call to the Respondent to request assistance in controlling the bleeding from a right buccal stab incision. The Respondent discussed the matter briefly with Dr. Samitier and told Dr. Samitier to try to control it with pressure. A few minutes later the Respondent became concerned that Dr. Samitier might need more assistance and called him back. During the second telephone call Dr. Samitier made it clear that he would feel more comfortable if the Respondent came to his office. The Respondent went to Dr. Samitier's office, arriving at approximately 3:00 a.m. on Saturday, May 2, 1992. Upon arrival, the Respondent discussed the situation with Dr. Samitier, obtained patient history information from Dr. Samitier, examined the patient, and promptly applied digital pressure with an adrenaline pad. The Respondent and Dr. Samitier alternated in the application of digital pressure and the bleeding stopped in approximately twenty minutes. There is no evidence that the patient was bleeding from any of the other surgical sites. While the Respondent was at Dr. Samitier's office, the Respondent did not review Dr. Samitier's medical chart on the Patient C.R. because he did not feel it was necessary to do so. During the entire time that the Respondent was examining, evaluating, and treating the Patient C.R., Dr. Samitier was right beside the Respondent providing the Respondent with information and answering the Respondent's questions about the patient. Under these circumstances, especially in view of the Respondent's limited role in the care of the patient, it was reasonable for the Respondent to rely on the oral information provided by Dr. Samitier and it was not necessary for the Respondent to review the written chart. 7/ Dr. Samitier advised the Respondent that the Patient C.R. had been on maintenance Coumadin and that the Coumadin had been discontinued three days prior to the surgery. Dr. Samitier also advised the Respondent that no pre- operative Prothrombin Time Test had been performed immediately prior to the surgery, and that the Patient C.R. had a pacemaker. At the time the Respondent was applying pressure to stop the oozing bleed, the Respondent was unable to communicate with the Patient C.R. because the patient was sedated with Nubain, a synthetic pain killer. Dr. Samitier explained to the Respondent that he had used Nubain during the surgical procedure and had also administered Nubain post-operatively when the patient had complained of pain during the course of Dr. Samitier's efforts to control the cheek bleeding prior to calling the Respondent. The Respondent's examination of the Patient C.R. included an examination of all of the surgical wounds inflicted during the procedures performed by Dr. Samitier, which included the cheeks, the portion of the neck immediately under the chin, and the lower abdominal area. No significant bruising or swelling was noted and no bleeding was detected at any of the incision sites other than the right buccal site which had occasioned Dr. Samitier's call to the Respondent. The Respondent looked for hematomas and ecchymosis and discoloration. There was no evidence that the patient had any generalized bleeding or hematoma at the time the Respondent was examining or treating him. During the entire time the Respondent was at Dr. Samitier's office in the early morning hours of Saturday, May 2, 1992, the Patient C.R. was connected to various monitors, all of which gave readings within normal ranges. The patient's blood pressure and pulse rate were both checked and found to be within normal ranges. While the Respondent was at Dr. Samitier's office during the early morning hours of Saturday, May 2, 1992, the Respondent discussed with Dr. Samitier the fact that the most prudent course of treatment for the Patient C.R. would be to hospitalize the patient. Dr. Samitier agreed that hospitalization would be the most prudent course, but then told the Respondent that he could not hospitalize the patient because the patient had told Dr. Samitier that he would not, under any circumstances, agree to be admitted to a hospital. Dr. Samitier also told the Respondent that the patient had said he did not want the nature of his operation to be disclosed to his wife or family members. During this discussion Dr. Samitier also disclosed to the Respondent that Dr. Samitier did not have admitting privileges at any hospital. In view of Dr. Samitier's reluctance to hospitalize the patient at that time, the Respondent told Dr. Samitier that Dr. Samitier should continue to monitor the patient and observe him clinically and if the vital signs or clinical observations demonstrated any deterioration of the patient's condition, or if the patient changed his mind about hospitalization, Dr. Samitier should call the Respondent and the Respondent would arrange to have the patient admitted into Coral Gables Hospital where the Respondent had admitting privileges. The Respondent also discussed with Dr. Samitier the need for a consultation with a cardiologist or hematologist in the event the patient were to be hospitalized. The Respondent emphasized the need for such a consultation before any action was taken to modify the patient's coagulation status. The Respondent's suggestions to Dr. Samitier regarding the future care and management of the Patient C.R. were appropriate under the circumstances. During the visit to Dr. Samitier's office during the early morning hours of Saturday, May 2, 1992, the Respondent did not recommend to Dr. Samitier that he have a Prothrombin Time Test performed on the Patient C.R. Although such a test might have been useful in the management of the patient's condition if the patient had been hospitalized, it is doubtful that the test would have served any useful purpose while the patient remained at Dr. Samitier's office. Under the circumstances, the failure to recommend a Prothrombin Time Test was not a departure from acceptable standards of medical practice. After the bleeding stopped, the Respondent remained at Dr. Samitier's office for at least two hours waiting to see if there was any recurrence of the bleeding. During that time period the Respondent examined the Patient C.R. several times to monitor his status and check for any bleeding. There was no recurrence of the bleeding from the patient's right cheek, nor was there any visible bleeding from any of the other surgical wounds. Sometime between 5:00 a.m. and 6:00 a.m. on Saturday, May 2, 1992, the Respondent left Dr. Samitier's office and returned to the Respondent's home. Dr. Samitier remained at his office to monitor and otherwise care for the Patient C.R. Dr. Samitier never contacted the Respondent to request that the Respondent arrange for the hospitalization of the Patient C.R. At approximately noon on Saturday, May 2, 1992, the Respondent was driving in his car a few blocks from Dr. Samitier's office. Because he was near Dr. Samitier's office, the Respondent decided to stop by Dr. Samitier's office to see how the patient was doing instead of making a telephone call later. The Respondent arrived at Dr. Samitier's office unannounced and inquired as to the status of Patient C.R. Dr. Samitier told the Respondent that the patient was doing fine, that his vital signs remained stable, that he was up and about, that he had taken oral sustenance, and that he had passed urine. Dr. Samitier also told the Respondent that the Respondent did not need to see the patient. After the foregoing discussion, Dr. Samitier invited the Respondent to observe a penile engorgement procedure Dr. Samitier was getting ready to perform on another patient. While walking with Dr. Samitier to the operating room, the Respondent had a brief glimpse of the Patient C.R. sitting up in bed in a small room. The Respondent continued on with Dr. Samitier and watched Dr. Samitier perform a penile engorgement procedure on another patient. After watching that procedure, the Respondent left Dr. Samitier's office. During the noon visit to Dr. Samitier's office on Saturday, May 2, 1992, the Respondent did not examine or treat the Patient C.R. On Sunday morning, May 3, 1992, at approximately 1:10 a.m., the Respondent received a telephone call from Dr. Samitier's office advising him that the Patient C.R. had gone into cardiac arrest. The Respondent went to Dr. Samitier's office. When the Respondent arrived at Dr. Samitier's office, the Patient C.R. was already being treated by emergency medical technicians. The emergency medical technicians told the Respondent that his services or assistance in the care of the patient were not needed and that they were going to transport the patient to Mercy Hospital. The emergency medical technicians took the Patient C.R. to Mercy Hospital where he was pronounced dead in the Emergency Room. The Respondent did not examine or treat the Patient C.R. during the early morning hours of Sunday, May 3, 1992. Later that same day an autopsy was performed on the body of the Patient C.R. The Respondent and Dr. Samitier attended the autopsy. The medical examiner did not come to any conclusion as to the cause of the patient's death. The Respondent did not document any of his contact with the patient C.R. in Dr. Samitier's office chart because the Respondent did not think it was necessary for him to do so. The Respondent thought it was sufficient for him to make his own record of what he did in the form of a consultation report. In the normal course of events he would have written such a report the following Monday when he got to his office, which seems to be a common practice of physicians who perform consultation services away from their own offices on weekends. There is no clear and convincing evidence that under the circumstances of this case the Respondent was required to write anything in Dr. Samitier's medical records concerning the Patient C.R. There is no established practice in this regard because it is very rare for a physician to perform consultation services in the office of another physician. Further, although consultation reports are virtually always prepared following formal consultations, when a consulting physician is called in for a very limited purpose, performs his services in the presence of the primary care physician or the attending physician, and orally advises the primary care physician or the attending physician what he has discovered or done, the consulting physician often does not prepare any written report at all, but leaves it to the primary care physician or the attending physician to memorialize what was discovered or done in the patient's chart. During the late afternoon or early evening of May 3, 1994, after the autopsy of the Patient C.R., the Respondent wrote a historical recapitulation of his involvement with the care and treatment of the Patient C.R. The record prepared by the Respondent on May 3, 1992, documents the Respondent's involvement in the care and treatment of the Patient C.R. The record demonstrates the Respondent's observations, recommendations, treatment, and the reasons why the Respondent did not get involved in all aspects of the patient's care. The record prepared by the Respondent on Sunday, May 3, 1992, was sufficiently timely to comply with applicable standards of medical care and record-keeping. The information contained in that record was sufficient to comply with applicable standards of medical care and record-keeping. The Respondent was called by Dr. Samitier for the limited function of stopping an oozing venous bleeding from an incision wound in the right cheek of the Patient C.R. The Respondent's consultation in this regard was of an informal nature and was limited in scope. His treatment of stopping the bleeding with direct pressure with an adrenalin pad was an appropriate course of treatment for the condition he was called to resolve. The Respondent was not at any time the primary care physician or attending physician for the Patient C.R.; that responsibility was at all material times the responsibility of Dr. Samitier. By assisting Dr. Samitier to stop the bleeding from one incision wound, the Respondent did not undertake, nor did he become responsible for, the overall care and management of the patient. Inasmuch as the nature of the consultation the Respondent was asked to perform was limited in scope, the Respondent's examination of the Patient C.R. was sufficient. Under the circumstances of this case it was not necessary for the Respondent to perform a comprehensive physical examination. The Respondent's authorized role in the care of the Patient C.R. was complete when he departed between 5:00 and 6:00 a.m. on the morning of Saturday, May 2, 1992. He had performed all he had been authorized to perform and, although he had offered to do more (such as arrange for the patient to be hospitalized), his offer of further assistance was rejected by Dr. Samitier. When the Respondent paid his courtesy visit to Dr. Samitier's office at about noon on Saturday, May 2, 1992, the Respondent did not have permission or authority from anyone to examine or treat the Patient C.R. At that time Dr. Samitier expressly told the Respondent that the Respondent did not need to see the patient. Under those circumstances, the Respondent had neither authority nor obligation to examine the Patient C.R. at the time of his noon visit on Saturday, May 2, 1992.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine enter a Final Order in this case dismissing all charges against the Respondent. DONE AND ENTERED this 9th day of January, 1995, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 January, 1995.
The Issue The issue is whether respondent's license as a medical doctor should be disciplined for the reasons stated in the administrative complaint, as amended.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: At all times relevant hereto, respondent, Bernardo G. Bilang, was a licensed medical doctor having been issued license number 0026846 by petitioner, Department of Professional Regulation, Board of Medicine (DPR or Board). He has been licensed by the Board since July 19, 1976. Respondent presently practices medicine at 1201 South Highland Avenue, Suite 11, Clearwater, Florida. His specialty, if any, is not of record. Around 10:45 p.m. on February 2, 1986, N.K., a seventy-four year old female, was transported by ambulance to the emergency room of Morton F. Plant Hospital, Inc. (hospital) in Clearwater, Florida. When admitted, she complained of nausea, diarreah, dehydration, vomiting, fatigue and not feeling well. Also, she had experienced some pain in her back. With the exception of the back pain, which had begun more than a day earlier, all other symptoms had begun on February 2. Doctor Linda L. Shaffer was the emergency room physician on duty on the evening of February 2. Doctor Shaffer initially observed that the patient looked "acutely ill." She examined the patient and found her to be coherent and alert but very weak, as evidenced by her lack of grip strength In slurred speech, the patient answered questions very faintly and generally in one word answers. As might be expected, the patient was dehydrated. Her vital signs at 11:00 p.m. here as follows: rectal temperature - 104.6 degrees; blood pressure 152 over 96; respiration - 24; and pulse - 101. She also had tenderness across the middle of the back on both sides but did not have a stiff neck. After a preliminary physical examination and history were completed, and while the patient remained in the emergency room area for a few hours, Dr. Shaffer ordered a chest x-ray, electrocardiogram, complete blood count, electrolyte panel, chemical profile, two tests of kidney function, blood cultures, and urinalysis. The patient was then placed on a cardiac monitor, had a foley catheter inserted to obtain a urine speciman, and was given tylenol to reduce her temperature. Also, an IV was started. After finding the chest to be essentially clear and the abdominal examination negative, Dr. Shaffer diagnosed the patient as follows: "fever/dehydration - possible sepsis?" The latter diagnosis (sepsis) meant the patient may have had either a bacterial or viral infection in her blood stream affecting her entire system in a "generalized way." For a seventy-four year old patient, sepsis is a serious condition and can be life threatening if not promptly treated. The normal treatment for sepsis is antibiotics, fluids, medicines to elevate the blood pressure and reduce the temperature, and occasionally the use of steroids. It is noted, however, that a viral infection will not respond to antibiotics. If the use of antibiotics is indicated, they must be started immediately to kill the infection. After concluding her examination, Dr. Shaffer ruled out the threat of cardiac arrest and believed the patient, although "seriously ill," was not suffering from a terminal ailment. Nonetheless, she was concerned with the patient's low white blood cell count (3500) which was indicative of an infection, and one more likely of a viral nature. At the same time, she knew that influenza "was quite prevalent at the time" and might produce symptoms like those experienced by N.K. However, she stuck by her preliminary diagnosis of a possible bacterial infection. Respondent was on call the evening of February 2 for patients such as N.K. who were admitted to the hospital but had no personal physician. 1/ He was telephoned by Dr. Shaffer at 1:20 a.m. on February 3 concerning the patient's status. After being told the patient's symptoms, vital signs, available test results (which did not include the blood cultures, urine culture and chemistry profile) and Dr. Shaffer's preliminary diagnosis respondent requested Dr. Shaffer to admit N.K. to the hospital. He then gave telephonic orders to the nurse regarding N.K.'s future treatment. At that point, responsibility for the patient shifted to respondent. Respondent's first orders at 1:25 a.m. were (a) the patient be given nothing by mouth except medications (b) the IV be continued, (c) she be given atrophine and phenergaan intramuscularly if diarrhea occurred, (d) she be given compazine, if necessary, for nausea and vomiting, and (e) she continue to be given ten grains of tylenol every four hours for her fever. The patient was then transferred from a critical care room to a room where more stabilized patients are kept. According to a nurse on duty that evening, she did not consider N.K. to be a "problem" patient who required extra care or attention. It is noted here that the patient records reflect that respondent initially suspected that N.K. might have the flu, a fairly common ailment in the area at that time. At 1:40 a.m., the patient's vital signs were as follows: blood pressure 124 over 80; respiration rate - 24; and pulse - 92. There is no indication that her temperature was taken at that time but the records indicate that an hour earlier, it had droped to 103.1 degrees. At 2:25 a.m., the patient was moved from an emergency room bed to a semi-private room in the general ward. At 3:05 a.m., N.K.'s temperature was again checked and found to be 103.5 degrees. At 4:00 am., the patient's condition had begun to seriously deteriorate. She manifested signs of being "very lethargic," that is, it was difficult to awaken her, and she appeared to be weaker on her left side. According to Dr. Shaffer, such a localized weakness was indicative of "some process" involving the patient's brain and spinal cord. Also, N.K. still had a rectal temperature reading of 103.5 degrees. At 5:40 am., N.K.'s fingers and toes became cyanotic, that is, they turned blue in color, indicating a lack of circulation. Also, she was confused and her lethargy continued. By then, her respiration rate had increased to 32, almost twice the normal rate. Her blood pressure (138 over 70) began dropping which was a sign of sepsis shock, that is, the peripheral blood vessels were dilating causing the pressure to drop and circulation to be impaired. At 6:05 am., the head nurse, believing there to be an emergency situation, spoke with respondent by telephone. She relayed the previous findings from 5:40 a.m. and noted that the patient's temperature had risen to 104.7 degrees while her blood pressure had dropped to 126 over 70. The nurse did not recall whether she was able to reach respondent immediately or if it took a few minutes for him to return the call. In any event, respondent gave telephonic orders that mandol, a second generation antibiotic, be given to the patient intravenously every six hours, and she be given one gram of solu-cortef, a steroid medication, for shock. Also, he ordered an arterial blood gas analysis and that N.K. be given oxygen by nasal cannula when necessary. Although the telephonic orders were given at 6:05 a.m., the drugs had to be requested and obtained (after mixing) from the hospital pharmacy. In some cases, it takes several hours to receive a drug from the pharmacy, particularly during other than normal daytime hours. The steroid IV was eventually started at 6:30 a.m. but the mandol was never received and administered. When the patient's condition did not improve and actually continued to deteriorate, respondent was telephoned again by a nurse at 6:40 a.m. By then, the patient's entire skin had turned a bluish color indicating very poor circulation. After being briefed by the nurse, including the results of the just received blood gas report, but still without knowing the precise cause of N.K.'s ailment, Dr. Bilang issued a "CMO" order. This means "comfort measures only" and that no aggressive steps, such as resuscitative measures, be taken by hospital personnel to prolong the life of the patient. According to Dr. Shaffer, had resuscitative steps been taken at that time, the patient's chances for survival were around "twenty percent, maybe less." The patient expired at 7:13 a.m. The primary cause of death was listed as meningococcial meningitis, a bacterial infection having a 70% to 80% mortality rate, and a "quite uncommon" infection in a seventy-four year old patient. Laboratory results obtained several days after the patient's death revealed she had gram-negative sepsis. Doctor Bilang arrived at the hospital and pronounced the patient dead at 7:20 a.m. This was the first time respondent had seen and examined the patient. Respondent then dictated a history and physical examination which appear in the patient records. These reports were based on information previously provided by others. On February 21, 1986 respondent dictated a discharge summary which indicated a pre mortem physical finding. This report was also placed in the expired patient's records. Several months later, respondent prepared a second physical examination and history for the patient. This was dictated on July 31, 1986 and again was based on the notes of other persons. However, respondent made the following note at the beginning of the physical examination and history: "Disregard above notes. Patient expired prior to my seeing her in the ward." Two medical experts testified on behalf of the Board. They are Drs. Matthew M. Cohen and Laurence Neufeld, both board certified family practitioners in Tallahassee and Tampa, Florida, respectively. A Shreveport, Louisiana board certified internist, Dr. John M. Brady, presented expert testimony on behalf of respondent. In addition, Dr. Linda L. Shaffer, an experienced physician, testified from her perspective as an emergency room physician at the hospital in question. As might be expected, the experts reached differing conclusions regarding respondent's treatment of the patient. Pertinent findings based on the experts' relevant testimony are made below. There was a consensus among the experts that the emergency room doctor's role is to pass on to the admitting physician all the information the doctor has gathered from the examination and tests. It is then the responsibility of the admitting physician to ask the emergency room doctor appropriate questions concerning the patient, order vital signs to be taken at specified intervals, and give other directions to the monitoring staff (nurses) concerning steps to be taken in the event of changes in the patient's condition. The experts also concluded that the primary physician, in preparing a history and physical examination of the patient, should not rely on the emergency room doctor's notes and findings but should personally conduct his own physical and history in a more thorough manner. This is especially true when, as here, the emergency room physician is unable to conclusively establish the cause of the patient's illness. In Dr. Cohen's opinion, respondent should have suspected meningitis at the outset of N.K.'s admission. This was because of her lethargy, high fever and back pain, all being symptoms associated with that infection. Doctor Cohen also noted that respondent was cognizant of Dr. Shaffer's preliminary diagnosis of possible sepsis, knew that pneumonia and urinary tract infection were not the causes of the infection, and still had no idea what caused N.K.'s infection. Given these considerations, Dr. Cohen opined that respondent should have ordered further tests to confirm N.K.'s ailment, such as a lumbar puncture (spinal tap), an X-ray of her abdomen, a reexamination of the abdomen or a head scan. Doctor Cohen further suggested that after those tests were completed, it would have been prudent for respondent to "employ a sort of antibiotic recipe for dealing with a septic, elderly person." In other words, he should have used a group of intravenous antibiotics that would cover most of the possible causes for that type of infection. In addition to the foregoing omissions, Dr. Cohen was of the opinion that Dr. Bilang erred further when, after receiving advice from the nurse at 6:05 a.m. and 6:40 a.m. concerning the patient's rapid deterioration in health, he failed to institute aggressive antibiotic therapy and instead prescribed mandol, a drug Dr. Cohen felt was too little, too late. According to Dr. Cohen, respondent compounded his mistakes by issuing a CMO order when the patient did not have a terminal illness and without consulting the patient's family. By engaging in the foregoing conduct, the expert concluded that respondent did not conform with minimally acceptable medical standards in the community. Doctor Cohen next opined that it was inappropriate for respondent to prepare a history and physical after the patient's death and to base those items on information gathered by others. He labeled these matters "false and misleading" and a deviation from the standard expected of a doctor. Doctor Neufeld initially pointed out that respondent erred by failing to start a broad spectrum (third generation) antibiotic regimen when he assumed responsibility for the patient at 1:20 a.m. According to the witness, such a regimen was called for because respondent was aware of the patient's age, high fever, slurred speech, dehydrated condition, the very strong possibility of sepsis, and his own inability to promptly obtain blood cultures from the laboratory to aid in confirming or ruling out various ailments. Further, respondent had no concrete evidence that the patient was suffering from the flu, an illness he initially thought N.K. might have. Even if respondent was unsure if the infection was viral or bacterial, Dr. Neufeld pointed out that respondent nonetheless should have assumed the patient was septic and started an antibiotic regimen until the cultures were received from the laboratory or the fever subsided. Moreover, even if the patient had a viral infection, the antibiotics would not have harmed her. By respondent waiting until 6:05 a.m., and then ordering mandol rather than a stronger drug, Dr. Neufeld opined that respondent fell below the minimum standard of care for community physicians. Doctor Neufeld stated further that respondent deviated from the same standard of care by issuing a CMO order when the patient did not have a terminal illness. Doctor Neufeld echoed Dr. Cohen's sentiments that the prevailing community standards did not call for a CMO order unless the patient was afflicted with a terminal, irreversible illness and only after a physical examination had been performed by the physician. Doctor Neufeld found the physical examination documented by Dr. Bilang on pages 10 and 11 and the accompanying discharge summary on pages 13 and 14 of the patient records to misleading since both erroneously suggested a pre mortem physical finding. Also, Dr. Neufeld opined that the medical records did not justify the course of treatment to the patient. However, the basis for this opinion is not clearly delineated in the record. Doctor Neufeld conceded that though he would have gone to the hospital at 1:20 a.m. to examine the patient, respondent did not violate the standard of care by evaluating the needs of the patient by telephone. Even so, Dr. Neufeld maintained that respondent should have ordered antibiotics after his consultation with Dr. Shaffer. The expert differed in one respect with Dr. Cohen and agreed with respondent that the records, at least at 1:20 am., did not call for a spinal tap or head scan, and respondent's failure to perform those tests at that time was acceptable. Finally, although he acknowledged that an order for a third generation antibiotic regimen at 6:05 a.m. might not have been mixed and ready for patient use by the time the patient expired, Dr. Neufeld opined that respondent still had a duty to use all available measures to keep her alive until the drugs were received. According to Dr. Shaffer, she observed Dr. Bilang on a day to day basis and considered him a "caring, competent, practicing physician." However, she stated that respondent was sometimes too busy" and overextended" himself. As a consequence, she was "concerned" that he was taking care of too many patients at the same time. Although she did not consider herself qualified to render an opinion, she opined that respondent did not deviate from the minimally acceptable standards for Clearwater area physicians when he failed to initially order antibiotics for N.K. at 1:20 a.m. This was because, if a physician was unsure if a patient had a viral syndrome or a bacterial septic condition, he might wait "a little bit of time" to see what course of treatment was required. Further, the decision to order antibiotics is a "judgment call" by a doctor and depends in part on two "iffy" tests, a lumbar puncture and a gram stain of the blood smear. The latter test result was not available until several days after the patient expired. According to Dr. Brady, respondent's course of treatment and overall conduct, with one exception, fell within the minimal acceptable standards of care for physicians. The exception pertained to respondent's issuance of a CMO order. After reviewing the patient's records, Dr. Brady concluded that respondent could not have known the patient was suffering from a bacterial infection since nothing in the physical examination was suggestive of meningococcemia, the organism affecting the patient. Thus, he concluded that the patient's illness was probably not diagnosable until shortly before she died. This was because the patient did not have a stiff neck (nuchal rigidity), purplish skin rash, or signs of shock, which are the normal indications of meningitis, and because the infection is extremely rare and has an incidence rate of only one case per one hundred thousand persons in a given year. Even so, he conceded that if the disease occurs, its physical signs can manifest in a very short period of time and could have begun shortly after the patient was first examined by the emergency room physician around 11:00 p.m. Once respondent recognized the severity of the patient's ailment, and prescribed mandol at 6:05 a.m., Dr. Brady agreed that mandol would not have had any beneficial effect on the patient even if administered immediately after being ordered. Instead, the witness would have ordered a third generation antibiotic which is more effective in treating gram negative rods. While he characterized respondent's choice of mandol as "not the best thing to do", he nonetheless said "it was not an unreasonable thing to do" given the circumstances. The expert next agreed with the Board experts that a CMO order is appropriate only when the patient has a terminal illness and has requested that no life-sustaining measures be used. In this case, he agreed that the patient records did not justify this action. He added, however, that the patient would probably have expired no matter what resuscitative efforts were undertaken. Finally, while Dr. Brady did not think respondent was attempting to falsify his records by copying the notes of others in preparing the post-mortem physical and patient history, he noted that respondent should have indicated on his February 3, 1986 notes that he was copying the records of others. Having evaluated the testimony of the experts, the undersigned has resolved the conflicts in favor of the Board. Accordingly, it is found that respondent fell below the minimum standard of care by failing to initially recognize the patient's septic condition and prescribing a comprehensive antibiotic regimen, by failing to institute the same regimen at 6:05 a.m. after becoming aware of her critical condition, and by issuing a CMO order at 6:40 a.m. when the patient did not have a terminal illness. Further, respondent filed reports on February 3 and 21, 1986 which he knew or should have known were misleading and false, namely, a patient history, physical examination and discharge summary prepared post mortem which suggested that such reports were based on pre mortem findings by respondent. Finally, it is found that the records maintained by respondent were inadequate to justify the issuance of a CMO order since the patient did not have a terminal illness. By stipulation approved by Board order dated October 30, 1987, respondent was reprimanded by the Board, paid a $1,000 fine, was placed on monitored probation for a year, and agreed to take twenty hours of continuing medical education in the area of prescribing medicinal drugs. Official Board records indicate that respondent's license still remains on a probationary status presumably because of the pending proceeding.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of the violations discussed in the Conclusions of Law portion of this Recommended Order, and that respondent's medical license be suspended for two years. DONE and RECOMMENDED this 11th day of July, 1989, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of July, 1989.
