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.
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 The issues to be resolved in this proceeding concern whether the Respondent has failed to practice medicine at the level of care, skill, and treatment recognized by reasonably prudent, similarly-situated physicians, by allegedly failing to appreciate the nature of a complaint, failing to order a proper diagnostic test, and failing to make a timely referral to an appropriate specialist, as well as whether the Respondent failed to keep adequate medical records documenting a rationale for his diagnosis of the patient, in alleged violation, respectively, of Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes.
Findings Of Fact The Petitioner is an agency of the State of Florida charged with regulating the practice of medicine and enforcing the licensure and practice standards contained in Chapter 458, Florida Statutes, and appurtenant rules. The Respondent, at all times material to this proceeding, has been a licensed physician in the State of Florida holding license number ME 0032003. On or about October 3, 1986, Patient #1, a thirty-five year-old male, presented to the Respondent's office with complaints of testicular pain, swelling, and a lump in the vicinity of the left testicle. The patient was seen by Dr. Laski, a physician (M.D.) employed by the Respondent. Dr. Laski examined the patient and diagnosed him as suffering from epididymitis. Epididymitis is an inflammation of the epididymis, which is a series of tubules that runs from the testicle to the vas deferens. The epididymis partially surrounds the testicle but is not actually a part of the testicle itself. The epididymis is part of the scrotal structures, and is attached to and continuous with the testicle, both being located within the scrotum. Patient #1 related that while working at his job as a truck driver, he was straining, trying to lift or move a 427-pound hot tub, when he felt pain and swelling in the left testicle, associated with a small lump. Upon diagnosing epididymitis, Dr. Laski started a treatment regimen of antibiotic and anti- inflammatory medications. He required the patient to return in four to five days. Dr. Laski saw the patient the second time on October 8, 1986 with continued complaints of left testicular pain. Dr. Laski again continued the same diagnosis and treatment. On October 13, 1986, Patient #1 again presented to Dr. Laski with continued left testicular pain with a small mass on the left testicle. Dr. Laski continued his diagnosis of epididymitis and continued the antibiotic and anti-inflammatory medications, although he changed the type of antibiotic prescribed. The patient visited a fourth time on October 17, 1986, and Dr. Laski found a tender nodule over the left testicle but also found that the remainder of the symptoms, consisting of pain and swelling, had disappeared. Dr. Laski found on the patient's first and fourth visits to him, and noted in the medical records, a mass or nodule on the left testicle; however, on the fourth visit, he found that the acute symptoms had disappeared. Dr. Laski still felt the nodule, which he could not ascribe to anything related to the purported accident experienced by the patient. Therefore, Dr. Laski felt that a urologist would be the appropriate person to see, "to take no chances and to make sure that there was not something else." Dr. Laski, accordingly, noted in his records that a referral to a urologist was in order. This was on Friday afternoon, October 17, 1986. The Respondent's office staff apparently made an attempt to refer the patient to a urologist that afternoon but was unsuccessful, due to the inability to contact the urologist's office. Apparently, the patient was instructed to call the Respondent's office the following Monday or Tuesday concerning the referral appointment. The patient maintains that he called the Respondent's office on Tuesday and was told that they could not send him to a specialist until the Respondent himself saw the patient. The Respondent disputes this and states that there is no such policy in his office that he had to see any patient before referral out to a specialist could occur. In any event, on October 22, 1986, Dr. Laski saw the patient again and called in the Respondent, who also examined the patient. The evidence of record does not indicate clearly why the Respondent took over the care and treatment of the patient from Dr. Laski at this point; however, that was apparently the case. When the Respondent initially saw Patient #1 on October 22, 1986, the Respondent did not enter in his medical records information which would either affirm or negate the presence of a mass or nodule, as identified by Dr. Laski. The Respondent testified, however, that he felt something "because, here, I'm palpating something, yes." Because he felt something in the left testicle, the Respondent ordered a urinalysis. The urinalysis was a routine "dipstick" urinalysis without microscopic slide or culture evaluation for bacteria. The Respondent testified that he wanted the urinalysis as diagnostic information because he was "palpating something". He did the urinalysis by dipstick method, such that he was able to evaluate the color, quality, and specific gravity of the urine sample. The results were negative. Dr. Carmichael testified, however, that the Respondent should have gone farther and done a microscopic evaluation in which white blood cells, if present, could have been visualized in the urine sediment. Dr. Carmichael testified that a urine culture could have been performed even though the patient had already been through two different antibiotic courses, because, as it was the Respondent's feeling that the epididymitis had not yet been resolved, there was the possibility of the presence of a type of bacteria which had not been affected by the antibiotics already administered. According to Dr. Carmichael, if the culture grew out of a pathogenic organism, "you would then have a very good likelihood that that is a causative organism, and you could tell what drug to use." The urinalysis, however, as Dr. Carmichael established, would not rule out epididymitis. The microscopic urinalysis, if done, could have been normal and the culture could have been negative; and epididymitis could still have been present. However, the lack of these tests contributed to the Respondent's inadequate assessment of the patient's status. The Respondent had Patient #1 visit a second time on November 5, 1986. On the second visit, the Respondent found, and the medical records showed, that there was a small area of "prominence" (nodule) in the epididymis. The Respondent chose to continue to observe the patient, however, to continue the prescription of the anti-inflammatory medication and ordered the patient to return in one month. Dr. Carmichael opined that another diagnostic procedure could have been used with the patient, presenting in this status at this point in his treatment course, which could have helped differentiate whether there was actually a definite mass present or not. That is, the Respondent could have ordered an ultrasound test, a procedure which uses high-frequency sound waves to outline areas of soft tissue that will not be depicted on x-rays. Dr. Herold, the Respondent's expert witness, acknowledged that ultrasound could be ordered if there is some uncertainty in the doctor's mind about the diagnosis, although he opined that it would not be the usual procedure to order an ultrasound test when the doctor suspects epididymitis to be the problem. Here, the Respondent still felt comfortable with his diagnosis of epididymitis. However, in the face of Dr. Laski's finding on October 17, 1986 that there was some sort of nodule present and that he was uncertain enough to feel the need to refer the patient to a specialist, it was established by Dr. Carmichael that if the ultrasound had been ordered of the genital area, it could confirm the diagnosis of epididymitis or, correspondingly, whether an actual tumor was present at that time. In any event, the Respondent's treatment plan as of November 5, 1986 was to continue observation and order Patient #1 to return in one month. The patient failed to return until January 12, 1987, for unexplained reasons. On that date, the Respondent examined the patient and immediately noted a hard, non-tender mass in the area of the epididymis. The Respondent then immediately referred the patient to a urologist, Dr. Antar, who testified on behalf of the Petitioner. On or about January 19, 1987, Dr. Antar evaluated the patient and determined that surgery was immediately necessary, because his immediate impression was that the mass was cancerous. Blood tests revealed that the tumor markers were very high, and Dr. Antar felt that there was no reason to observe further. Three days later, Dr. Antar performed a radical orchiectomy on the left testicle (removal of the testicle). The testicular tumor was a teratoma. A teratoma is a tumor which appears to be benign but behaves like a malignancy. Moreover, however, a biopsy of a lymph node from the left side of the patient's neck showed three elements of cancer: the teratoma, embryonal cancer cells, and choriocarcinoma cancer cells. Dr. Antar established that all three indications were coming from the left testicle. Thus, the cancer had metastasized from the left testicle to the lymph system. However, Dr. Antar established that through chemotherapy the cancer cells which had migrated were eliminated, since this type of cancer, although it is virulent, is particularly amenable to chemotherapy. The medical records show that the Respondent saw the patient on three occasions; October 22, 1986, November 5, 1986, and January 12, 1987. The patient had also been seen by Doctor Laski independently of the Respondent for the first four visits and in conjunction with the Respondent's initial examination on October 22, 1986. Thus, Dr. Laski, before the Respondent, had seen the patient four times in three weeks. It was Dr. Laski's judgement that the symptoms of the acute problem had gone away but that, because a nodule remained which Dr. Laski could not explain, he should be referred to a urologist. The Respondent then took over his care for unexplained reasons but did not carry out Dr. Laski's recommendations for a urological evaluation by a specialist. The Respondent contended in his testimony that he would always honor another physician's recommendation but did not specifically indicate in his testimony or in the medical record why Dr. Laski's recommendation that a urologist be consulted and see the patient was not carried out. Even though, in fact, the Respondent noted in his subsequent examinations the prominence in the left testicle, he simply continued to diagnose the problem as epididymitis and elected to continue to "observe". The medical record prepared by Dr. Laski included the recommendation that the patient be referred to a urological specialist. Thus, the Respondent should have known of this recommendation whether or not he actually conversed with Dr. Laski about the referral (the record does not indicate whether they actually conversed about this subject or not). In any event, as shown by Dr. Carmichael, the Respondent's notes in the medical record do not provide any explanation or justification for merely continuing to observe the patient. The medical records prepared by the Respondent do not support his decision not to follow up and have the patient actually referred to a urologist and not to conduct further tests or investigation of the left testicle, such as an ultrasound test. Given the course of treatment by the Respondent, consisting merely of continuing to observe for another month, along with the continuing of a prescription for an anti-inflammatory, with the unexplained inconsistent deletion of the prescription for an antibiotic, even though the Respondent believed that the epididymitis was continuing; the medical record kept by the Respondent for the patient did not justify this course of treatment. He did not order any further diagnostic tests and yet, according to the record, ignored the recommendation that a specialist consultation be effected. All three of the medical experts testifying established that such a tumor could have initially presented as epididymitis. Dr. Carmichael opined that when a person has a lump or soreness in the testicle, he frequently tries to relate it to some type of activity, like lifting or straining. He opined that the usual presenting complaint of a testicular tumor would be a lump, with some sort of soreness or discomfort. Dr. Antar, the urologist who ultimately saw the patient and operated, testified that people with testicular cancer can present as having epididymitis. Dr. Antar testified that they need to be treated with antibiotics for two to three weeks, to be rechecked to be sure the epididymitis is dissolved and that the testicle has returned to normal. Dr. Herold also opined that the inflammation of epididymitis can occur as a result of trauma or as a reaction to the presence of a tumor. If the Respondent had such an awareness, as described by these experts, he did not act on it, however. He elected merely to continue the anti-inflammatory medication and part of the course of treatment already tried by Dr. Laski, in spite of the fact that his employee and colleague had already shown, and entered in his medical record, that the rest of the supposed epididymitis symptoms had disappeared, that there still remained a tenderness and small mass on the left testicle and that a consultation with a specialist was in order. Respondent's reaction upon first seeing the patient on October 22nd was that there was a tenderness in the left testicle and a swelling in the epididymitis, as well. The Respondent's testimony and his medical records simply do not explain why he ignored Dr. Laski's recommendation that a specialist see the patient and be consulted, if all he himself was going to do, at least for the ensuing one and one-half months, was to continue the anti- inflammatory therapy the patient had already been given.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners finding that the Respondent has violated Section 458.331(1)(t), Florida Statutes, as found and concluded above, for which a penalty of a $1,000.00 fine and one year's probation should be imposed. It is FURTHER RECOMMENDED that the Final Order determine that Section 458.331(1)(m), Florida Statutes, has been violated, for which the penalty of a reprimand and administrative fine in the amount of $500.00 be imposed. It is FURTHER RECOMMENDED that, as to both Counts, that 20 hours of continuing medical education in the area of oncology and five hours in the area of risk management, over and above that required for licensure, be imposed. DONE AND ENTERED this 5th day of April, 1994, in Tallahassee, Florida. P. MICHAEL RUFF 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 6th day of April, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-930 Petitioner's Proposed Findings of Fact: 1-8. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on the subject matter. Rejected, as subordinate to the Hearing Officer's findings of fact on the subject matter. 11-20. Accepted. Respondent's Proposed Findings of Fact: Respondent did not submit numbered proposed findings of fact and it is, therefore, difficult to rule on the proposed findings of fact specifically. Nevertheless, the first two paragraphs of the proposed findings of fact are accepted. The third paragraph is, for the most part, established by the evidence of record. However, it is rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter to the extent that they differ from the proposed findings of fact in the third paragraph in the Respondent's proposed findings of fact. The fourth paragraph of the Respondent's proposed findings of fact is accepted but not necessarily for the material import the Respondent proposes. COPIES FURNISHED: Barbara Whalin Makant, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Northwood Centre, Suite 60 Tallahassee, FL 32399-0792 James Facciolo, Esquire KENT, HAYDEN, ET AL. 200 West Forsyth Street Suite 1330 Jacksonville, FL 32202 Dr. Marm Harris, Executive Director Board of Medicine Department of Business and Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire General Counsel Department of Business and Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact At all times pertinent to the issues herein, the Board of Medicine was the state agency responsible for the licensing of physicians and the regulation of the practice of medicine in this state. Respondent was licensed as a physician in Florida and holds license number ME 0017915. He practices medicine, specializing in psychiatry, in Clearwater, Florida. He is board certified in that specialty. On September 7, 1987, Patient #1, a 55 year old married female, whose husband had recently separated from many years in the armed service of the United States, came to see Respondent at his office, complaining of severe headaches, loneliness, depression, and a lowering of self esteem. She had been referred to him by physicians at the U.S. Coast Guard Station Dispensary. Respondent examined Patient #1 and found her to be of limited intelligence, considerably overweight, anxious, depressed and confused. She was ashamed of her new status in life as a result of her husband's inability to find work and was experiencing difficulties with him and her children. She was suffering from severe insomnia. Respondent's examination of Patient #1 was limited. He was satisfied with the medical work-up which had been conducted by his colleagues at the Dispensary. Because he was consulting psychiatrist for that facility, he knew all the physicians there and was familiar with the caliber of their work. Based on the medical information furnished him from the Dispensary and his own examination, he diagnosed Patient #1 as suffering a major depression and a psychogenic pain disorder manifested by headaches and insomnia. He developed a treatment plan for the patient which included a wide variety of psychotherapy interventions, the first of which was to effect relief of the symptoms. This included clarification of relationships, interpretation of dreams and fantasies, and allowed for catharsis. When Respondent found out that empathy and intervention alone would not work on this patient, and he had established a relationship with her, he started psychotropic medications including Elavil, the drug of choice for this type of condition in 1988. Elavil is a "superb" antidepressant. While the antidepressant factor is "cranking in", the medication also works as a sedative. For this reason, it is normally prescribed for administration at bedtime. Patient #1 responded to this course of treatment and she and the Respondent established a good and friendly working relationship, which he noted in his April 4, 1988 letter and treatment report to the Coast Guard and to CHAMPUS. In that treatment report, however, Respondent noted Patient #1 had a suicidal ideation. The term "suicidal ideation" does not import that the patient was, at that time, seriously considering suicide. Her mentioning suicide was but an overcompensation - more an alerting statement of depression and sadness with emptiness and angst. She never indicated to Respondent any thought of or plan to commit suicide. Patient #1 thrived for many months in Respondent's therapy. She complained often of her impoverished condition, however, and as a result, he wrote prescriptions for her in such a way that they could be filled at the Coast Guard dispensary without charge. This required writing prescriptions for more tablets of a drug at a lower strength which was stocked by the Dispensary. It was a surprise to him to learn, later on, that she was filling her prescriptions at Eckerds. Throughout the period he treated her, Dr. Fireman prescribed psychotropic drugs for Patient #1, which consisted primarily of amitriptyline, (Elavil), and butalbital, (Fiorinal), in varying strengths, and, at times, in compounds with other substances. As was noted previously, Elavil is an antidepressant with sedative effects. The recommended daily dose for a patient in an outpatient setting is indicated as 150 mg by the Physicians' Desk Reference, (PDR), which also recommends suicidal patients not be allowed unrestricted access to it because of the danger of intentional overdose. Other qualified psychiatrists who testified, including Dr. Spreyhe and Dr. El Yousef, indicate up to 300 or even 350 mg/day may be appropriate. As Dr. Spreyhe noted, it is not so much the daily dose on any given day which is pertinent but the aliquot over an extended period. In that regard, he notes, Dr. Fireman's prescriptions for both Elavil and Fiorinal were within recommended maximums and, therefore, within the appropriate standard of care. Fiorinal is a barbiturate anti-anxiety agent and muscle relaxant with habit forming potential. Fiorinal #3 contains codeine, a legend drug and narcotic. Generally, according to Dr. El Yousef, it should be dispensed for use at a rate of between 8 to 12 tablets per day over the short term, but over a 9 month period he would prescribe between 4 and 9 tablets per day. Pharmacy records indicate that over the period he treated patient #1, Respondent gave her numerous prescriptions for both Elavil and Fiorinal which, at first glance, appear to be excessive. For example, the records reflect that on December 29, 1987, Respondent wrote prescription number 390073 for 100 Elavil 25 mg tablets. Though the prescription clearly indicates no refills were authorized, and the back of the prescription form, where refills are noted by the pharmacist, fails to reflect any refills were authorized by the physician, the pharmacy records indicate two additional dispensings by the pharmacy for 100 tablets each on January 11 and April 20, 1988. There is no evidence to indicate how these additional fillings came about; who arranged for them, or who received them. On February 22, 1988, Respondent wrote prescription number 394289 to the patient for 12 Fiorinal #3 tablets. Again the prescription form authorizes no refills and the back of the prescription form indicates but one coordinated refill but the pharmacy records show the prescription was filled twice - once on April 6, 1988 and once on April 23, 1998. Only the latter is annotated. On March 3, 1988, Respondent wrote prescription number 397144 to the patient for 60 Fiorinal tablets. While the doctor's refill note reflects none were allowed, the computer printout sticker for the bottle reflects 2 refills were authorized. The back of the prescription form shows no refills annotated thereon as required, but the pharmacy's computer listing of all prescriptions indicates the prescription was refilled on May 28 and again on June 3, 1988. No further explanation is given. Prescription number 396378, written to the patient by Respondent on March 14, 1988 for 50 Fiorinal tablets, reflects no refills authorized by the physician nor does the reverse of the form bear any refill annotations. Nonetheless, the pharmacy records as shown on the computer printout indicates a refill on March 27 and April 6, 1988 with no explanation therefore. Before the last refill, however, Respondent wrote prescription number 397091 to the patient on March 29, 1988, for 21 Fiorinal #2, later approved for #3's. He also, on April 4, 1988, wrote prescription number 398853 for 35 Fiorinal tablets. Respondent claims he would not authorize a refill of a prior prescription for the same medication for which he is writing a new prescription, and, since neither of the refills of the earlier prescription properly reflect any physician authorization, it is so found. On May 2, 1988, Respondent wrote prescription 399717 for 50 Fiorinal tablets, and prescription 399718 for 100 Elavil 25 mg tablets. Both reflect Respondent's instruction that no refill be given, and neither form bears an annotation for authorized phone refills. Yet, the pharmacy's computer printout indicates that the prescription for Elavil was written on May 31, 1988 even though the bottle sticker shows it was filled on May 3, 1988. On August 1, 1988, Respondent wrote prescription 405572 for 100 Fiorinal and 475573 for 100 Elavil 100 mg tablets. Both were filled the next day but neither form bears any annotation of authorized refill, consistent with the physician's instructions. On August 16, 1988, Respondent prescribed another 100 Fiorinal by Prescription 406536. It was not refilled. On August 29, 1988, Respondent wrote prescription 407201 for 150 Elavil 50 mg tablets to patient #1, and number 407202 for 100 Fiorinal tablets. Both prescription forms clearly reflected no refills, but the back of the forms reflect refills were authorized. The Elavil prescription was refilled on September 10, 1988 by pharmacist Ivan Funkhouser who contends he refilled on the basis either of a call to or from the doctor's office. He cannot recall which. He also, at the same time, refilled the Fiorinal prescription under the same conditions. The Elavil prescription was filled again, this time for 225 tablets, on September 30, 1988, by pharmacist Robert Wivagg who also indicated phone refills made only on the basis of a call to or from the physician's office. In this case, however, he believes that because of the amounts involved, he would have spoken to the physician himself before filling the prescription. He cannot be sure of this, however, and Respondent denies having ever prescribed 225 Elavil tablets, regardless of strength, at one time. Mr. Lewis, the pharmacy expert, indicates that proper pharmacy practice would have allowed the pharmacist to issue fewer tablets than on the prescription but not more without express approval of the physician. The Fiorinal prescription, refilled on September 30, 1988, this time for 150 tablets, is not reflected on the prescription form though it is on the computer printout. Respondent denies that he ever called in prescriptions for Patient #1 because he never had to. She came to his office frequently enough that he was able to provide her with a new prescription for whatever medication she needed. Indeed, his medical office billing records reflect that in June, 1988 he saw her on June 6, 13, 20, and 27; in July, 1988 on July 5, 12, 19, and 26; and in August, 1988, on August 2, 9, 16, and 30. It would appear, therefore, that the refills of prescriptions reflected on the pharmacy computer printout either are in error or were arranged for under some unexplained process not involving Respondent. There appears to be no reason for him having had to authorize refills since he saw the patient so frequently, notwithstanding his comments to Ms. Sutton, during the investigation, that 90 percent of the refill calls are authorized by him personally, and only 10 percent through his secretary. There was no showing that the authorization comment Ms. Sutton recalls was related to this particular patient. Further, according to Ms. Maguire, Respondent's secretary, Respondent frequently refuses to grant refills, and, to her knowledge, he never gives refills to psychiatric patients. Since most, if not all Respondent's patients are psychiatric patients, this does not make sense. Respondent does not deny writing the two prescriptions on August 29, 1988. At that particular time patient #1 was planning a trip to New York to make peace with her dying mother. As a result, and since her headaches had gotten worse, as had her depression, he decided to increase her dosage of Elavil. This was a medical decision which is not in issue here. He admits that Elavil is a drug which is often used to commit suicide and that prescribed at even its lowest strength, a full prescription can be lethal. This became, therefore, an assessment problem wherein Respondent, the physician, had to evaluate the risk of the patient's depression against the benefits to be gained by the use of the drug. Respondent gave patient #1 enough Elavil to hold her through her visit up north. He had previously given her sixty 50 mg tablets to be taken 6 per day for a 300 mg dose at bedtime. He now told her not to use the 50 mg tablets any more and to destroy them. He believed she did. He then gave her a new prescription for one hundred and twenty 25 mg tablets for her trip. He unequivocally states that he never prescribes more than 300 mg/day of Elavil. He admits, however, that while she was on that dosage, he neither hospitalized her nor had blood work done on her. Respondent feels his original treatment plan and diagnosis were sufficient and his records pertaining to those factors were adequate. He uses checkoff forms because he believes they are the most open way of showing how he sees his patient and what he is doing for her. This same conclusion was reached by Dr. Spreyhe, another Board certified psychiatrist who is Clinical Professor of psychiatry at the University of South Florida Medical School, who has served as an expert witness for the Department in the past, and who continues to serve as a contract consultant for it and as a member of the Medical Advisory Committee of the Department. Examination of Respondent's medical records pertaining to Patient #1 indicates that the medical history and treatment plan are in the form of check sheets on which the physician makes no more than minimally worded entries. The Department's witness, Dr. Greener, an expert in the completeness of medical records, is of the opinion that Respondent's records should have reflected an initial detailed assessment of the patient's condition, including the reasons for her referral to him, a complete medical history, and a subsequent detailed mental status examination. This should be followed by a formulation of her problems and a treatment program. After the initial evaluation, according to Dr. Greener, the physician should make regular progress notes as to treatments, communications with others, phone calls received, prescriptions issued, and matters of that nature. This is done to memorialize the particulars for the patient and to keep a tally of which and how much of any drug is given to the patient. This would show over or under use as a possible flag as to how well the patient follows instructions or if the patient develops a use addiction problem. Based on Dr. Greener's review of Respondent's records for patient #1 and the prescription records relevant to her, he concluded those records were "totally inadequate." This conclusion is based on his opinion that the initial evaluation is cursory and without detail and there are few progress notes in the records. Those which are there are inadequate in detail and full of conclusions without the required supporting information such as drug side-effects, the patient's ability to follow instructions, follow-up, changes in dosages, and the like. He complains that Respondent's records do not really outline a plan of treatment designed specifically for that patient. For example, the forms used by Respondent are merely check-off forms even though, during the period, the patient was receiving continuing analgesic medications. From Respondent's records, it was impossible to determine how the patient was doing on the medications prescribed or whether additional medical evaluation was required. It is important to put this information in patient records to memorialize what is done and not just to keep the information in the treating physician's memory. Respondent denies that his initial evaluation and treatment plan, prepared by the use of form check sheets, is below standard. Dr. Spreyhe concluded the use of such check sheets is not inappropriate for the initial work-up of a patient and he opined that Respondent's forms, and the information thereon provide sufficient information for an independent understanding of the patient's situation and are within an appropriate standard of care. It is so found. However, the medical progress notes which make up the bulk of the remaining medical records are not so complete and, in Dr. Spreyhe's opinion are insufficient. Respondent concurs and admits this. It is so found. As to Respondent's prescribing practices, Dr. Greener is far more conservative than Respondent in prescribing Elavil. He starts with a low dose and gradually works up to a therapeutic level dosage depending upon the patient. He would start an average patient out at 25 mg/day and work up to a maintenance dose of 150 mg/day. Elavil is a dangerous drug and the doctor must closely monitor the patient for possible side effects and the direct effect it is having on the patient. It should never be ordered "prn", (as needed) when that designation relates to the amount to be taken. Based on Respondent's records for this patient, it would appear to Dr. Greener that the medication was being used improperly. There appears to have been no monitoring of the amount of the drug the patient was getting and it would appear that the patient was given the prerogative as to dose, which is not a good thing to do. In his opinion, a dose at 300 mg/day of Elavil is very and unnaturally high and he would not use so high a dose. He would do other tests first to see why the medication was not working at the lower dosage. As was seen before, however, other physicians of equal expertise disagree. Fiorinal is habit forming and, according to Dr. Greener, should be used only over the short term. If needed for a longer period, the patient should be reviewed to see why. The doctor must keep in mind the addictive properties of the drug. Here, Dr. Greener is of the opinion that Respondent prescribed excessive amounts of Fiorinal for patient #1. From January 27, 1988 through March 2, 1988, a period of 34 or 35 days, Respondent prescribed 302 tablets and Dr. Greener would be concerned that the patient was addicted. On March 21, 1988 Respondent prescribed another 50 tablets, and on March 27,1988, he prescribed 50 more followed by another 60 somewhat later and more after that. All of these were being prescribed for a patient whose records reflect she was doing "OK", and was "nicely stabilized". To Dr. Greener, this is just too much, especially for a patient who is obviously addicted and who appears to be taking the medication only to prevent withdrawal symptoms. By his prescription regimen, a patient would get no more than 10 tablets a day for no more than 4 to 5 days, and he would prescribe this drug for 9 months, as here, only with support for it in the patient records, including the opinions of other specialists to whom the patient would have been referred. While it is obvious Dr. Greener is more conservative in his approach to medication than is Respondent, the evidence does not clearly show Respondent's approach fell below standards. Dr. Spreyhe is of the opinion that the levels of Elavil and Fiorinal prescribed by Respondent for this patient were appropriate in both dosage and amounts. He has patients of his own who take such doses and he is not swayed by the PDR recommendations for dosage which, he believes, is too conservative. As for the Fiorinal, he would prescribe no more than 8 per day because there is some information that a patient may develop a tolerance for the substance. In any case, the drug is appropriate for the treatment of psychogenic headaches as were suffered by Respondent's patient here. Both W.L.P. and M.J.S. have been patients of Respondent. Both found him to be concerned and available. When patient #1 died, Ms. Sherman was in a therapy group with her. She did not appear to be suicidal and was looking forward to her proposed trip to New York. Patient #1 died on October 8, 1988. The report of the Hillsborough County Medical Examiner reflected her death as suicide from the combined effects of amitriptyline, (Elavil), butalbital, (Fiorinal), and salicylate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be issued herein, finding Respondent not guilty of all allegations except those relating to his failure to keep adequate medical records regarding Patient #1 as alleged in Count One, of which he is shown to be guilty, and imposing an administrative reprimand and a requirement for continuing medical education in the area of proper record keeping. RECOMMENDED this 31st day of August, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 93-5048 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 6. Accepted and incorporated herein. 7. Accepted as a restatement of witness testimony but not as a Finding of Fact. 8. Accepted as a restatement of witness testimony but not as a Finding of Fact. 9. & 10. Accepted that the medications were dispensed based on prescriptions written under the patient's name. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted as a restatement of witness testimony. - 18. Accepted and incorporated herein. Rejected as not a necessary conclusion to be drawn. Accepted. - 23. Accepted as restatements of witness testimony. Accepted and incorporated herein. - 26. Accepted and incorporated herein as pertaining to the dosage level of Elavil used and the balance accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted. & 32. Rejected as Findings of Fact, and found to be Conclusions of Law. FOR THE RESPONDENT: Accepted and incorporated herein. - 4. Accepted and incorporated herein. - 7. Accepted and incorporated herein. Accepted and incorporated herein. - 12. Accepted and incorporated herein. 13. & 14. Accepted. 15. & 16. Accepted and incorporated herein. 17. & 18. Accepted. 19. & 20. Accepted and incorporated herein. 21. Accepted. 22. This Proposed Finding of Fact is, in reality, a restatement of the evidence presented, in several subparagraphs, some of which are identified by letter and some of which are not. It is, however, accepted as an accurate restatement of the evidence admitted at hearing on this point, except where it becomes argument. 23. & 24. Accepted and incorporated herein. 25. First four sentences accepted and incorporated herein. Balance considered only as argument in support of the position taken. 26. Accepted and incorporated herein. 27. Accepted. 28. Rejected as a Conclusion of Law and not a Finding of Fact. 29. - 31. Accepted as basic findings. This does not go to their adequacy, however. 32. & 33. Rejected as contra to the weight of the evidence. & 35. Accepted as the substance of the witness' testimony. Accepted and incorporated herein. Accepted. Accepted. Rejected as a Conclusion of Law. COPIES FURNISHED: Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Suite 210 Tampa, Florida 33619 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue for consideration was whether the Respondent's license as a physician in Florida should be disciplined because of the alleged misconduct outlined in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the allegations contained herein, the Respondent, Moheb Ishad Girgis El-Far was licensed as a physician in Florida under license number ME 0026895, and the Board of Medicine was the state agency responsible for the licensing and monitoring of physicians in this state. At all times pertinent to the issues herein, Respondent practiced medicine with a specialty in obstetrics at his clinic located a 401 East Olympic Avenue, Punta Gorda, Florida. Patient 2, C.L., first went to see Respondent at his office in Punta Gorda in January, 1989 because she was pregnant and had heard he was delivering babies in his office. She was referred to the Respondent by the Sarasota Health Department when she indicated she wanted to have her child in a birthing center. During that first visit, the doctor and patient agreed on a treatment plan which would culminate with the baby's being delivered in his office and C.L. paid for this pursuant to their agreement. During the period of the patient's prenatal care with the Respondent, he told her her baby was due on August 30, 1987, and when labor began, she was to come to his office and bring her own sheets. On August 24, 1987, C.L. began her labor and went to Respondent's office as agreed. By the time she got there, she was about ready to deliver and a few minutes after her arrival, she did so in a birthing room with her husband present. At the time of the delivery, both Respondent's wife and Ms. L.'s boss, neither of whom played any part in the proceedings, were standing in the doorway to the birthing room. No nurse was present and C.L. cannot recall seeing any sterilization or resuscitation equipment in the room. C.L. experienced little pain during the delivery, which appeared to go smoothly. Afterwards however, Respondent told her she had sustained an inverted uterus and when Respondent attempted to remove the afterbirth, she started to hemorrhage. When this happened, Respondent gave her a shot and towels with which she was to try to stem the bleeding while he tried to correct the uterine problem. He was unsuccessful and thereafter called the paramedics who came to his office and took C.L. to St. Joseph's Hospital in Punta Gorda for treatment. Respondent did not treat her at the hospital because he had no hospital privileges. While there she required 6 units of blood and 2 units of plasma. At no time during the course of her prenatal care did Respondent advise her to go to the hospital. She fully recovered. C.L. was shown pictures of Respondent's office taken by Department investigators at some time subsequent to her delivery. With the exception of the fetal monitor which she had seen in his office, the pictures she saw bore little similarity to the condition of the office whenever she was there. Though the office was not as messy as the pictures show, she was, nonetheless concerned about its condition at the time of her delivery. The carpet was dirty and so was the aquarium. She could not do anything about it at that time, however, and it was not so bad as to cause her to feel unsafe. S.K., Patient 1, first went to the Respondent for her pregnancy care in November, 1987 on a referral from a friend. They agreed on a fee of $1600.00 for prenatal care and delivery in his office. During these initial discussions, Respondent did not discuss in detail with the patient the possibility of complications. He stated only that if there were complications, they could probably be treated in the office. S.K. went to Respondent's office about 6 times after that initial visit. During this period, on an early visit, Respondent gave her some medicine samples and a prescription for vitamins. When she asked about the cost, he said he would include the cost of the samples when he billed her insurance company. During these visits, she also saw his personal office, an examining room, and a small room where the patient's blood pressure was taken. She noted that the office was not as clean and orderly as others she had seen, and in fact, was usually in a state of disarray. On one occasion when Respondent examined her, he was wearing a wrinkled shirt with a blood spot on it. The next time she went for a visit, Respondent was wearing the same shirt. S.K. was shown pictures of Respondent's office taken by investigators and several were similar to conditions she observed there. His personal office was not well organized and there was clutter about but not as aggravated as appears in the photos. Based on her experience with other doctors, Respondent's office was far more untidy and in disarray but not necessarily nonsterile or unsafe. On February 5, 1988, S.K. went to Respondent's office because she was having pains and thought she was in labor. When she called him and explained her symptoms, he told her to come in and he examined her when she did. He gave her something to calm her and to try to stop her labor in an attempt to save her baby. He gave her a shot of demerol and put her in an examining room to lie down. She slept there for quite a while with her husband present. When she awoke she again began to have pains but Respondent would not give her any more medicine. After a while, the baby spontaneously delivered while Respondent was sleeping in another room. He was called but by the time he came in, the baby was dead. He asked S.K. if she wanted to see the fetus but she declined. After a period of recovery, she was released to return home. When this patient came into the office that day and it appeared she was going to deliver, her husband asked Respondent if he thought she should be in the hospital. Respondent replied that it was up to her because the baby, if delivered, was too premature to survive. The decision not to go to the hospital was hers. Respondent did not try to dissuade her from going. In fact, in most ways she considered Respondent's treatment of her to have been satisfactory. During the period she was in his office Respondent was in and out of the room checking on her. The only complaint she has relates to his handling of the fetus she delivered. About 2 weeks after delivery she again went to see Respondent at his office where he showed her her baby which he had preserved in a jar of formaldehyde. This was a strange and sad experience for her. Mr. K. basically confirms that testified to by his wife. While she was in labor or sleeping prior to the delivery, he wandered about the building into other parts of the clinic. He also rested in one of the examining or birthing rooms and observed the general state of cleanliness of the facility was poor. For example, the floor and rugs were spotted throughout with a dark stain and the examining table also had a dark stain on it. These stains looked to him like blood. In addition, the hallway carpets were dirty, there were bags off debris laying out, spare pieces of wood were stacked in the halls, and medical instruments were left out in the birthing and examining rooms. In his opinion, many of the pictures shown to him displayed scenes similar to what he saw when he was there with his wife. Both Dr. Borris and Dr. Marley agreed that Respondent's treatment of Ms. K. had no relationship to her miscarriage. By the same token, neither claims that his treatment of Ms. L.'s inverted uterus was inappropriate. Both agree, however, that other factors in Dr. El Far's operation of his practice as regards both patients failed to conform to generally accepted standards of care in providing obstetrical services. Specifically, he failed to have a nurse present during the delivery; he failed to have emergency equipment in the form of resuscitative and lifesaving equipment available to handle potential surgical complications which might have arisen; he had no emergency backup care available; and he had no hospital privileges in Punta Gorda, the area in which he was engaged in an obstetrical practice. Without those privileges, it was not prudent for him to undertake a delivery in the office. While the prenatal care of patient 1 was within standards, the balance of Respondent's practice was below standards because: the patient was not monitored while in the office; if the conditions as appearing in the pictures existed at the time he was seeing patients, he did not meet sanitation standards because of the general disarray.; he attempted a delivery in his office when a hospital was only 1.5 miles away, (not prudent in light of the patient's condition when there was no emergency to justify it); and his records were not complete. The standard of a reasonably prudent physician is the same regardless of the locality. Acceding to the wishes of a patient, when to do so is not in the patient's best interests, is not necessarily acceptable medical care. Mr. Cook, the Department's investigator, inspected Respondent's office on September 16, 1988, in the company of investigator Clyne, as a result of a call he received from an agent of the Florida Department of Law Enforcement who was then on the premises. When they arrived, they observed a female sitting on the couch in the waiting room changing a baby's diaper. From conversation he had with Respondent at the time, Mr. Cook inferred the lady was a patient. In addition to the previously mentioned lady and the state investigative personnel, Cook also noticed two children, who Respondent indicated were his, running freely about throughout the building. Cook examined the patient log maintained by Respondent for that day and noted that two patients were scheduled. Nonetheless, while he was there, there were no nurses, receptionists or office staff present. Though Respondent claims he did not have any patients that day, and though Cook did not see any other than the lady aforementioned, from the patient log and the fact that at least one patient was there, it is found that Respondent was engaged in at least a minimum practice and was available to see patients. Mr. Cook observed conditions in Respondent's office on the day in question that were inconsistent with a proper medical practice. Trash was not contained, food was left open, and dust and dirt were in evidence, all in the area where medical services were or would be rendered. Mr. Cook took photos and a video tape of the condition of Respondent's office. The photos were those shown to the two patients who testified herein and to Mr. K. Though he looked throughout the office, Mr. Cook could find no sterilization equipment, no general anesthesia equipment, no blood transfusion equipment, and no emergency resuscitation equipment. When asked about his sterilization capability, Respondent stated his "heater" was broken and in for repairs. When during a visit to Respondent in October, 1988, Ms. Clyne told him he needed sterilizer equipment, he indicated it had recently been purchased. On that visit, Respondent had a patient in the office. Ms. Clyne again went to Respondent's office on February 15, 1989 and observed it to be still in a state of disarray. Ms. Hampton, another Department investigator, visited with Respondent in his office on January 11, 1989 and found it to be unsatisfactory. The waiting area was cluttered, the carpet was dirty, the walls stained, and magazines were laying around. The clinic area was piled up with mail leaving no counter space. Respondent took Ms. Hampton on a tour through the office during which she observed the computer, patient records, and the typewriter to be unclean. Her examination of the halls, examining rooms, birthing rooms, and the like revealed that in one room, a sink had an unclean speculum in it and others were lying about. The paper on one examining table was soiled and when Respondent saw that, he quickly tore it off. The spread in one of the birthing rooms was soiled and the floor needed sweeping. Trash cans were not lined and needed cleaning. The covering on the baby examining table was soiled and there were bloody cotton balls on a table in the room. She, too, saw no evidence of any sterilization, anesthesia, or emergency resuscitation equipment. On this visit, Respondent indicated he was not seeing any new patients; only those former patients who were still pregnant. Respondent indicates that during the period from July 4 through September 16, 1988 he had closed up his office for an extensive vacation and was living in his office on that latter date. He does not deny that his office was in the condition as depicted in the photos when they were made but contends he has since cleaned it up and put new carpet down. During the period his office was closed, he referred his patients to other doctors and has not been actively practicing while waiting for his malpractice insurance to come through. Respondent also does not deny that the Certificate of Education form he signed and submitted to the Board was in error. He contends, however, that at the time he signed it he believed it to be a certificate of regular continuing education hours, not a certification used for approval for dispensing drugs. He also claims that at no time did he intend to defraud the Board, and when Ms. Clyne brought the error to his attention, he wrote to the Board explaining what had happened. He contends that when he affirmed the statement that he had the appropriate hours, he considered the "a" in "affirm" to be a negative prefix indicating he did not have the required hours. This contention is both ingenuous and unbelievable. It is found that Respondent well knew the meaning and effect of the certification he signed and his affixing his signature thereto was both false and with intent to mislead.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license to practice medicine in Florida be suspended for two years and that he thereafter be placed on probation for an additional period of three years under such terms and conditions as are imposed by the Board of Medicine. RECOMMENDED this 30th day of October, 1989, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of October, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO. 89-1507 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings Fact submitted by the parties to this case. For the Petitioner: 1.- 3. Accepted and incorporated herein. Accepted and incorporated herein. Rejected in so far as it editorializes on the condition of the clinic. While below standard, there was no evidence of health hazard to patients. 6.-8. Accepted and incorporated herein. 9. & 10. Accepted and incorporated herein. 11. & 12. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein Accepted and incorporated herein. Accepted. & 18. Accepted and incorporated herein. 19. Accepted. For the Respondent: 1. & 2. Accepted and incorporated herein. Accepted and incorporated herein. Accepted. Rejected as contra to the weight of the evidence. Rejected as contra to the weight of expert testimony. Rejected as contra to the weight of the evidence. Accepted in so far as it finds that Respondent's performance of medical procedures was within standard. Rejected as to the finding that overall care and practice was within standards. Accepted. COPIES FURNISHED: Larry G. McPherson, Jr., Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 David K. Oaks, Esquire The Professional Center 201 West Marion Avenue Suite 205, Box 3288 Punta Gorda, Florida 33950 Kenneth E. Easley General Counsel DPR 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine DPRB 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issues to be determined are whether Respondent overprescribed controlled substances and failed to maintain legible medical records as alleged in the Administrative Complaint and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, through its Board of Osteopathic Medicine, is the state agency charged with regulating the practice of osteopathic medicine in the state of Florida, pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to this proceeding, Richard D. Vitalis was a licensed osteopathic physician in the state of Florida, holding license number OS 4823. Respondent’s current address of record is 3774 China Grove Mews Lane, Fairfax, Virginia 22025. At all times material to the Administrative Complaint, Respondent was practicing as an osteopathic physician at All Family Medical in North Lauderdale, Florida, a licensed pain management clinic. On or about January 27, 2011, L.N., a 29-year-old female, and a resident of Biloxi, Mississippi, presented to Respondent at his Fort Lauderdale office with complaints of back pain. Between January 27, 2011, and August 3, 2011, L.N. presented to Respondent on seven occasions. L.N. indicated that she had previously been prescribed oxycodone 15 mg, oxycodone 30 mg, and Xanax 2 mg. She also indicated that she was dependent on her prescriptions, that she needed them every few hours, that she expected to need them the rest of her life, and that they were not helping resolve her medical problems. L.N. underwent a magnetic resonance imaging (MRI) study on January 27, 2011. The MRI diagnostic images showed that L.N.’s spine had no evidence of pathological disease. There was a normal alignment of the vertebral bodies without evidence of compression or spondylolisthesis. There was normal signal throughout the vertebral bodies and within the visualized spinal cord. There was no significant disc disease, evidence of spinal stenosis, or exiting nerve root impingement at L1-2, L2-3, L3-4, or L5-S1. Although the MRI depicted some annular disc bulging at L4-5, there was no spinal stenosis or neural foraminal stenosis. There was no pathology shown on the MRI, and it was, in general, “a normal MRI.” As such, the MRI would not provide support for a conclusion that L.N. would have been in pain. There were no diagnostic images in L.N.’s file to contravene the medical conditions shown in the MRI. The only evidence of anything requiring treatment was L.N.’s complaint of low back pain. Such a complaint would call for muscle relaxers, physical therapy, hot/cold packs, or ultrasound, rather than narcotic pain medications. There was no evidence in the medical records that L.N. exhibited signs of nerve root impingement with pain radiating down the leg. The records did not demonstrate that Respondent performed a comprehensive medical examination of L.N., or that Respondent performed any type of objective testing of L.N., including straight leg raises, checking for deep tendon reflexes, or palpation of the area of concern for spasms. The records did not contain an adequate medical history of L.N., including height, weight, temperature, pulse, respiration, blood pressure, age, date of birth, and medication lists, nor did they contain an assessment of L.N.’s chief complaint or plan of treatment. The intake from L.N.’s first visit to Respondent indicated that she was taking opioids and benzodiazepines, though there was no evidence of prescriptions or prescribing physicians for those substances. The records did not demonstrate that Respondent obtained records of prior treating physicians, nor was there any evidence of an effort to do so. The records do not demonstrate that Respondent consulted with any other physician which, in the case of treatment resulting from an MRI review, would fail to meet the standard of care. The records do not demonstrate that Respondent recommended alternative interventions for L.N.’s pain complaints, including physical therapy, which would have been appropriate, and within the standard of care given the normal MRI results. The only alternatives noted were “heat” and “massage” on January 27, 2011, and “heat” on June 23, 2011. Although it is possible that other alternative interventions were recommended, the illegibility of the intake forms prevents such a finding. The failure to recommend alternative interventions was a failure to meet the standard of care. On L.N.’s first visit to Respondent on January 27, 2011, a urine drug screen was performed. The drug screen tested positive for opioids and benzodiazepines. Subsequent to that first visit, Respondent performed no other drug tests. Such tests can confirm that the patient is taking prescribed medications, and not diverting them, and that the patient is not taking other non-prescribed medications. It is the medical standard of care to perform follow-up drug tests of patients when prescribing high doses of controlled substances, including opioids. The failure to closely monitor L.N. when prescribing high doses of opioids and benzodiazepines was a failure of the standard of care. Respondent did not communicate with L.N.’s pharmacy to ensure that she was not getting prescribed medicines from other doctors. Such information was, in 2010 and 2011, available from pharmacies. It was, during that period, the medical standard of care to communicate with the dispensing pharmacy. Respondent failed to meet that standard of care. There was no evidence to the contrary. Despite the fact that L.N. presented to Respondent with a stated history of opioid use and a positive drug screen, Respondent did not record L.N.’s medication history for the period up to her first visit with Respondent. The failure to take a medication history to substantiate the need and justification for the prescription of high-dose opioids is contrary to the 2010-2011 medical standard of care. Oxycodone was, during the relevant period, a Schedule II controlled substance with a high potential for abuse, and an accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Roxicodone is a brand name for oxycodone hydrochloride. It is a short-acting opioid that is rapidly absorbed. Short- acting opioids have a greater potential for abuse. Furthermore, prescription of short-acting opioids, such as Roxicodone, would not be within the standard of care for long-term, chronic pain such as that described by L.N. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. Alprazolam was, during the relevant period, a Schedule IV controlled substance, with a low potential for abuse, and an accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence. § 893.03(4), Fla. Stat. At L.N.’s initial January 27, 2011, visit, Respondent prescribed medications including 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. The prescribed doses and amounts were consistent with L.N.’s self-reported medications that she was then taking, presumably prescribed by “Dr. Sanchez” in Biloxi. Respondent’s plan of treatment listed the medications L.N. requested and recommended follow-up in one month. The records contain no individualized treatment plan. Respondent’s examination notes are entirely illegible. Respondent’s records lack copies of prescriptions issued to L.N. on January 27, 2011. A patient agreement and informed consent form was included in L.N.’s patient file, but was not signed by L.N. L.N. next presented to Respondent with complaints of chronic lower back pain on February 22, 2011. The intake form is largely illegible, though “overall feels well” is discernable. At that visit, Respondent prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in one month. Again, there was no individualized treatment plan, and the examination notes were largely illegible. L.N. presented to Respondent with further complaints of chronic lower back pain on March 22, 2011. The intake form is largely illegible, though “overall feels well” is discernable. Respondent again prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in one month. Again, there was no individualized treatment plan, and the examination notes were illegible. L.N. presented to Respondent on April 21, 2011. The intake form is largely illegible, though “overall feels well” is discernable. Respondent renewed L.N.’s previous prescriptions. L.N. next presented to Respondent with complaints of chronic lower back pain on May 19, 2011. The intake form is entirely illegible. Respondent prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in an illegible timeframe. There was no individualized treatment plan. Respondent’s examination notes were illegible and minimal. On June 23, 2011, L.N. presented to Respondent. The intake form, though largely illegible, appears to state that “pt feels good pain solved with meds.” The treatment prescribed by Respondent apparently having the desired effect, Respondent renewed L.N.’s prescription for 210 tablets of Roxicodone Oral 30 mg (though in two separate prescriptions for 180 tablets and 30 tablets, respectively), 120 tablets of Roxicodone Oral 15 mg, and 60 tablets of Xanax Oral 2 mg. The prescription originally called for 150 tablets of Xanax, but Respondent struck 90 of those. Respondent’s plan of treatment was medication refill and follow-up at the next appointment on July 23, 2011. A monthly medication dosage evaluation was completed for the June visit, as was a pain management treatment plan medical record. Those records provided little individualized information regarding L.N.’s plan of care. The pain management treatment plan form indicated that drug testing was completed; however, there were no results. L.N.’s final visit to Respondent occurred on August 3, 2011. She indicated, in what appears to be her handwriting, that she had used a “hot bath,” “heat,” and “some exercise.” Her treatment objective continued to be “complete resolution of pain with medication.” At that visit, Respondent prescribed 150 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 60 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment included only a list of medications. The pain management treatment plan form indicated that drug testing was completed; however, there were no results. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to practice medicine with that level of care, skill, and treatment recognized in general law as being acceptable under similar conditions and circumstances in his treatment of L.N. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent prescribed excessive and unnecessary amounts of Roxicodone and Xanax without a justifiable basis to do so, especially since the January 27, 2011, MRI report did not support a determination that L.N. was experiencing back pain so as to justify Respondent’s course of opioid treatment for L.N. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to create and maintain adequate and legible records supporting the course of treatment for L.N., or records documenting performance of a comprehensive physical examination of L.N. proportionate to her diagnoses. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to adequately monitor L.N.’s use of opioid therapies. The findings set forth herein are the result of Dr. Porcase’s undisputed expert testimony regarding the standard of care as it existed in 2010-2011, as well as the undersigned’s independent review of the record. Whether Respondent could have produced evidence to support his treatment of L.N. will remain a mystery, since Respondent essentially abandoned this proceeding. Despite challenging the Department’s Administrative Complaint, Respondent minimally and incompletely responded to written discovery, failed to meaningfully participate in Dr. Porcase’s deposition, twice refused to appear for his own deposition, despite personal service of the notice, and failed to make an appearance at the final hearing. In the absence of any testimony or evidence to counter that of the Department, the evidence presented by the Department, including the testimony of Dr. Porcase, was clear and convincing as to the matters set forth herein. Despite Respondent’s failure to actively contest the allegations in the Administrative Complaint, it must be recognized that the allegations concern a single patient over a total period of scarcely more than 6 months. There was no pattern of misconduct. Furthermore, Dr. Porcase acknowledged that the practices regarding the prescription of opioids in 2010-2011 were far different from those that exist today. Rather, “there was no standards that you were -- individualized your treatment to the pathology on imaging studies and patient’s complaints and their ability to function on medicine.” As to a doctor’s actions to rule out a patient’s drug-seeking behavior, he testified that “[i]t would be the individual physician having to make that determination based on his experience and diagnostic testing . . . and physical exam.” While the undersigned believes and gives weight to Dr. Porcase’s opinions regarding the standard of care, his testimony is equally compelling that the standard was not as clear-cut in 2010-2011 as it is in 2018. Though not affecting the ultimate findings regarding violations of law, it does affect the nature of the penalty that is warranted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Osteopathic Medicine, enter a final order: determining that Respondent violated sections 459.015(1)(x), 459.015(1)(t), and 459.015(1)(o); imposing an administrative fine of $2,000; issuing a letter of reprimand against Respondent’s license to practice osteopathic medicine; and awarding costs incurred in the prosecution of this case to the Department. DONE AND ENTERED this 15th day of May, 2018, in Tallahassee, Leon County, Florida. S E. GARY EARLY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2018. COPIES FURNISHED: Ann L. Prescott, Esquire Philip Aaron Crawford, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Richard D. Vitalis, D.O. 230 Caddie Court DeBary, Florida 32713 Richard D. Vitalis, D.O. 3774 China Grove Mews Lane Fairfax, Virginia 22025 Kama Monroe, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C-06 Tallahassee, Florida 32399-3257 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)
