The Issue The issues presented for decision herein are whether or not the Respondent's physician license number ME 0034228 should be disciplined based on allegations set forth hereinafter in detail, that he violated various provisions of Section 458.331, Florida Statutes, as set forth in the consolidated administrative complaints filed under DOAH Case Numbers 83-1819 and 84-3052, as amended.
Findings Of Fact Based on my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent is a licensed physician and has been issued license number ME 0034228 in the State of Florida. Between December 31, 1981, and at least December 1982, Respondent's license to practice medicine was placed on inactive status because of nonpayment of licensing fees. (Petitioner's Exhibit 10 and TR page 31) During the above-referenced time periods, Respondent performed or aided in the performance of medical abortions in Miami, Florida, including ones relating to Janet Lee Miller, Myrtha Baptiste, and Yvonne Bruno. (TR pages 326- 347 and 350- 377) On dates that Respondent performed or assisted in the performance of medical abortions previously mentioned, Respondent did not have an active license to practice medicine in the State of Florida. Myrtha Baptiste died following an abortion. In conjunction with criminal investigations of the death of Myrtha Bactiste, Respondent was interviewed by Nelson Andreu, a homicide detective with the City of Miami Police Department and George Sanchez, who was then an investigator with the State Attorney's Office. During the course of those interviews, Respondent advised Andreu and Sanchez that he had personally mailed in the items required for renewal of his license and that, as far as he knew, his license was valid. Megaly Lorenzo, a secretary in the Santa Rosa Medical Center where Respondent worked in 1981 and 1982, testified that Respondent gave Lorenzo his renewal fees in cash for 1982. Lorenzo did not renew Respondent's license because she forgot to. She informed Respondent of that omission during 1983. (TR pages 309-312) When Megaly Lorenzo renewed a license, she received a wallet-sized license from the Board of Medical Examiners which was then placed in the mirror in the offices at the Santa Rosa Medical Center. Between approximately January 15, 1981 and December 1982, Respondent worked as a physician at the Women's Care Center located at 5601 Biscayne Boulevard, Miami, Florida. At times material hereto, Hipolito Barreiro was the owner and director of Women's Care Center. At all times material hereto, Hipolito Barreiro was not licensed to practice medicine in the State of Florida. (Petitioner's Exhibit 3 and testimony of Elaine Prater, TR page 268) Between approximately January 15, 1981, and December 1982, Barreiro was engaged in the practice of medicine at the Women's Care Center located at 5601 Biscayne Boulevard, Miami, Florida. During the relevant time period, Hipolito Barreiro performed various procedures which constitute the practice of medicine. As example, during February 1982, Barreiro inserted an intrauterine contraceptive device into Carmen Moses' cervix. In July 1982, Barreiro gave Patricia Humbert an injection and later performed an abortion on Humbert. In September 1982, Barreiro performed a gynecological examination on Etta Annette Brown to determine the status of her pregnancy. In December, 1982, Respondent performed a vaginal examination on Debra Plez confirming the fact that Plez was 6 1/2 months pregnant. Barreiro gave Plez a prescription, placed an IV in Plez's arm and finally performed an abortion on her (Plez). Elaine Prater, an employee at the Women's Care Center, observed Barreiro perform abortions on several occasions while Respondent was employed as a physician at the Women's Care Center. Respondent would sign patient charts as the physician performing the abortion when, in fact, the abortion was performed by Barreiro. These occurrences would usually take place in those instances where Respondent either arrived at work late or left work early. Additionally, it was noted that Respondent maintained a separate list of those patients on whom he performed an abortion and those patients for whom he had not operated or aborted. Ms. Prater acknowledged that Respondent was confronted on several occasions by her (Prater) and Trudy Ellis about his practice of signing charts for those patients whose abortions he had not performed. Finally, Respondent admitted to Roger Stefins that he knew that Barreiro was not licensed to practice medicine in Florida. Also, evidence reveals that Respondent confronted Barreiro on more than one occasion asking, "Haven't I told you not to examine girls before?" (TR page 80) As stated, Respondent maintained a separate list of patients on whom he had performed abortions for his own use. (See Petitioner's Exhibits 3 and 4) On several occasions, Respondent was presented "physician's reports of the termination," for abortions performed by Barreiro and was asked to sign the reports as a "physician" performing the termination. Respondent signed these reports even though he knew that the actual abortions had been performed by Barreiro. (TR pages 269-275) Respondent knew, or should have known, that the abortions had been performed by Barreiro as he was on duty, and because the patients would already be in the recovery room when he (Respondent) arrived for work. (TR page 278) During May 1982, Yvonne Bruno, a twenty-eight year old Haitian woman, went to the Women's Care Center for the purpose of having an abortion performed. Initially, Bruno went to the Women's Care Center on May 4, 1982, with $160. She was told to come back to the Center on the following Saturday, May 8, 1982, with $200. Bruno was not examined during that initial visit. On May 8, 1982, Ms. Bruno returned for the purpose of having an abortion. She only had $190. After arriving at the clinic, Bruno changed into a paper gown. Bruno signed several papers on May 8, 1982. One such paper was a sheet entitled, "Important Information Which Every Patient Should Know Concerning The Termination Of Pregnancy Procedure," which was a form maintained by the Women's Care Center. On the information sheet, Bruno's last menstrual period was listed as January 23, 1982. The appointment date for Bruno's abortion was listed on the information sheet as "5-9-82." In addition to the information sheet, Bruno also signed a form giving her consent for the Respondent to perform a pelvic examination. The consent form bore the date "5-8-82." Finally, Bruno signed a "Patient Information And Medical History" form which was dated May 9, 1982. (Petitioner's Exhibit 8) On May 8, 1982, Respondent performed an abortion on Bruno, using the dilation and aspiration method, followed by curretage. During the course of the abortion, Bruno's uterus was perforated. Respondent knew that Bruno's uterus was perforated almost immediately following perforation. (Petitioner's Exhibits 3, 4, 8, 9 and testimony of Pedro Ramos) On the physician's report of the termination, the term of Yvonne Bruno's pregnancy was listed as twelve (12) weeks. The form indicated that the termination was performed on May 9, 1982. Examination of the facts reveal that this was incorrect. The physician's report of the termination for Bruno indicated that the following complications occurred: "Complications: After aspirations with vacuum, the use of curette reveals perforation of uterus. We stop the operation and the patient is taken to the hospital." The physician's report of the termination for Bruno was signed by Respondent. (Petitioner's Exhibit 8) Ms. Bruno awoke after the abortion and was put in the recovery room. She was cold and experienced stomach pain more severe than she ever experienced before. The pain was persistent. Bruno informed the doctor who performed the abortion that she was having pains while she was still in the recovery room at the Women's Care Center. (TR pages 360-362) While Bruno was in the recovery room, the doctor who performed the abortion told Bruno that she has something in her uterus and that he (the doctor) had cleaned it out. He told Bruno that if she felt any more pain to call him, regardless of time. He also gave Bruno the telephone numbers for his house and the clinic. (TR pages 361, 362) Ms. Bruno remained at the Women's Care Center in the recovery room only long enough for a taxi to arrive. Immediately upon being taken to the recovery room, her friend, Amelia Ingrid Previle, called for a taxi. Bruno was in the recovery room less than an hour. While in the recovery room, Ms. Bruno's condition was not monitored. That is, no one took her blood pressure, respiration or pulse rates. (TR pages 363, 364 and 367-370) When the taxi arrived, Ms. Bruno left the Women's Care Center unable to walk because "her feet were so heavy." Therefore, the taxi driver and her friend, Previle, had to help Bruno to her friend's car. (TR pages 362, 363) It took Ms. Bruno approximately 15 minutes to get home from the Women's Care Center. When she arrived home, she felt intense pain which she credited to the fact that perhaps she had not eaten before she went to the Center. She drank tea and put some ice on her stomach. Bruno's pain intensified and her friend, Previle, started trying to contact Respondent in the late afternoon on May 8, 1982, by phone. Previle continued to try to contact the doctor until the early morning on May 9, 1982. When Previle finally contacted the doctor, Bruno was directed to come to the Women's Care Center. Bruno did so and, upon arrival at the Women's Care Center, she was given a pill. She was then taken to American Hospital in Miami, Florida. At approximately 6:30 a.m. on May 9, 1982, Hipolito Barreiro contacted Pedro M. Ramos, a physician specializing in gynecology and informed him that he had an abortion clinic. Barreiro also told Ramos that "they" thought that "they" had perforated a uterus during an abortion. Dr. Ramos agreed to meet the patient at the emergency room of American Hospital. (TR pages 326, 327) Once Dr. Ramos arrived at American Hospital, he attempted to obtain a patient history from Bruno; however, this was difficult because of Bruno's limited ability to speak English. With the help of Barreiro and Previle, Dr. Ramos was able to obtain some information. However, on the patient history, Dr. Ramos made the notation that "unable to verify (past illness) properly. Pt. speaks little english." (TR pages 329, 350-377 and Petitioner's Exhibit 9) When Dr. Ramos arrived at American Hospital, he was given the following patient history for Bruno: "25-year old black female complaining of abdominal pain of 4-6 hours onset with fever (? chills) with brownish discharge from vagina after an abortion performed on May, 1983 . . ." (Testimony of Pedro Ramos, M.D. and Petitioner's Exhibit 9) Based on the available information, Dr. Ramos diagnosed Bruno as suffering from a perforated uterus and possibly peritonitis. After performing the necessary laboratory tests, Bruno was taken to surgery for an exploratory laparotomy which revealed a perforated uterus. The uterus was perforated at the fundus on the right side. The perforation was more than 4 centimeters long. The exploratory laparotomy also revealed fetal parts in Bruno's abdomen. Dr. Ramos found at least the head and spine remaining in Bruno's abdomen. (TR page 329 and Petitioner's Exhibit 9) After the exploratory laparotomy, Dr. Ramos also determined that, in addition to the items noted above, an inflammation process had begun (peritonitis), affecting Bruno's ovaries. Dr. Ramos removed the fetal parts from Bruno's body, irrigated the area and performed a complete hysterectomy, removing both the ovaries and uterus which were beyond repair. The head of the fetus removed from Bruno's uterus measured four centimeters by two centimeters. Therefore, Dr. Ramos opined that the fetus would have been approximately 17 to 18 weeks of age. At this stage of development, fetal parts are very hard. When suction is applied to the uterus, the solid parts are moved around. The fetal parts are, at this stage, too large to go through the suction tube and remain in the uterus after suction. Following the use of suction, curretage follows. The manipulation of the curette in the uterus will then result in movement of the fetal parts. Usually, it is the spine or an arm which actually causes the perforation. By manipulating the fetal parts, the physician can cause the fetal part to perforate the uterine wall which is very soft at this stage. Bleeding can be ascertained through a monitoring of the patient's vital signs and by observation of the patient's general appearance. (TR page 224) In determining how long a patient should be monitored after an abortion has been performed, it is important to know the stage of pregnancy. With an early pregnancy, i.e., 10 - 12 weeks, the patient may be observed for a shorter period of time. Where there are no complications, the patient should be observed for between 1/2 to 1 hour. (TR pages 222 - 225) With an advanced pregnancy, i.e., one in the second trimester, the patient should be monitored for two hours after the abortion is completed. The patient might be monitored for a longer period of time if there are difficulties after the abortion is completed. Monitoring should include checking vital signs such as blood pressure, pulse and respiration rates and checking the patient for hemorrhaging and infection. Usually, with a perforated uterus, the patient experiences abdominal pain immediately following the abortion. A doctor who recognizes that he has perforated a uterus during an abortion should transfer the patient to the hospital for observation. If a patient complains of severe abdominal pain immediately upon completion of an abortion, the doctor should observe the patient until the pain disappears or until the cause of the pain is determined and dealt with. In this regard, Respondent admitted that he perforated Bruno's uterus during the performance of an abortion. (Petitioner's Exhibit 3, pages 20-23) Noteworthy is the fact that Respondent, when questioned by Investigator Stefins, an Assistant State Attorney, stated that punctures of the uterine wall should never be treated in the clinic and that on the occasions when he punctured a uterus, he would take that patient to the hospital. Perforation of a uterus is not, in and of itself, malpractice or negligence. It is below minimal standards of care, skill and treatment for a reasonably prudent physician to fail to carefully monitor a patient, by checking blood pressure, pulse and respiration rates, as well as checking the patient's general appearance after an abortion performed during the second trimester, for a sufficient period of time to determine the existence of complications. If the patient complains of persistent abdominal pain, it is below minimally acceptable standards of care, skill and treatment, as recognized by reasonably similar prudent physicians, under such conditions as are described above to release the patient without first carefully monitoring the patient until the pain disappears or until cause of the pain can be determined and dealt with. (Testimony of Doctors Ghali and McLeod)
Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby recommended that the Respondent's physician license number ME 0034228 shall be suspended for a period of two years and a civil penalty of $2000 shall be imposed. RECOMMENDED this 12th day of July, 1985, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1985.
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 Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is Michael D. Fox, M.D. Respondent is board certified in obstetrics and gynecology. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 66312. Respondent's address is 3627 University Boulevard, South, Suite 200, Jacksonville, Florida 32216-4211. At all times material to this complaint, Respondent provided professional services as an employee of North Florida Gynecologic Specialists in Jacksonville, Florida. On or about September 26, 2003, Patient T.D. presented to Respondent with a history of worsening pelvic pain and abnormal menstrual bleeding. On or about October 6, 2003, Respondent and Patient T.D. agreed that Patient T.D. would undergo a hysterectomy. On or about October 22, 2003, during a pre-operative examination, Respondent ordered pre-operative lab studies, including a urine pregnancy test, for Patient T.D. On or about October 27, 2003, Respondent performed a total abdominal hysterectomy on Patient T.D. During Patient T.D.'s hysterectomy, Respondent took a specimen from Patient T.D., which was sent to pathology for evaluation. On or about October 29, 2003, a microscopic examination of the surgical specimen was performed that revealed Patient T.D. was pregnant at the time Respondent performed the hysterectomy on Patient T.D. Respondent did not ascertain the correct results of Patient T.D.'s pre-operative pregnancy test prior to performing the October 27, 2003, hysterectomy on Patient T.D. Respondent's Care of Patient T.D. Respondent attended medical school at the University of Alabama, Birmingham, Alabama. He did a four-year residency in obstetrics and gynecology (ob/gyn) in Jackson, Mississippi, and a two-year sub-specialty fellowship in reproductive endochrinology in Lexington, Kentucky. He is board-certified in reproductive endochrinology and ob/gyn. At present his specialty is reproductive endochrinology. Respondent has experience in performing hysterectomies and the pre-operative evaluations associated with those surgeries. Respondent does 30 to 40 hysterectomies a year. That number represented his experience in 2003. The principal reason for performing hysterectomies in his practice, is associated with sub-specialty interests, surgery for endometriosis and adenomyosis, a co-disease with endometriosis. Respondent has privileges to practice in hospitals in the Jacksonville, Florida area. In particular, he has privileges at St. Vincent's, St. Luke's, Baptist, Baptist Beaches, Memorial and Shands hospitals. He performs surgeries in all those hospitals. The hospitals where Respondent practices have computer systems that allow access to laboratory records and other forms of information associated with patient care. Although he has access to the computer systems in the facilities, his routine is to obtain laboratory information in the hospital setting from other persons involved in the patient care. He asks those persons to find out the information for him and report the finding(s). Respondent would have access to the patient hospital record, as well as a source for obtaining laboratory information. Respondent routinely looks at the patient hospital record in preparing for surgery. Concerning Patient T.D., the subject of this proceeding, when seen by Respondent she was described as a young female, of child-bearing age who presented with chronic pain. She had pain with periods which Respondent found to be characteristic of adenomyosis. She had pre-cycle pain approximately a week prior to her menses, another characteristic of adenomyosis. The patient had irregular bleeding that is an indication of adenomyosis. The patient was found to have an enlarged uterus, the primary source of her pain on the examination. This visit with Respondent, that formed the basis for his impression, took place on September 26, 2003. On the initial visit Respondent also obtained a history consistent with endochrine disorder causing irregular cycles. In the patient's case, the cycles extended as much as 60 days in relation to her periods. Based upon his initial impression, Respondent did not find evidence that Patient T.D. was pregnant. The patient told Respondent that she had no desire for fertility. At that time, she did not report having a partner, nor did she indicate that she was sexually active. To further evaluate the Patient T.D.'s condition and complaints, Respondent ordered an ultrasound test. That study was performed on October 2, 2003, and a gynecological ultrasound report rendered. Based upon the report, Respondent held to the view that the report showed evidence of adenomyosis. There was a mild and moderate enlargement of the uterus, which Respondent found to be consistent with adenomyosis. The patient had had a prior pregnancy and delivery and Respondent found the depiction on the ultrasound of a mild enlargement of the uterus consistent with the prior pregnancy and delivery. On their next visit, Respondent discussed the choice of a hysterectomy or some other form of surgery that did not involve a hysterectomy, to treat the endometriosis and relieve her symptoms. That visit took place on October 6, 2003. On October 22, 2003, Respondent met the patient again. He reviewed the details of what he believed was the underlying disease and potential treatments in discussion with the patient. The patient indicated that she wanted to proceed with the hysterectomy. That choice having been made, the surgery was discussed between the patient and Respondent and the necessary paperwork was started to arrange for the surgery in the hospital. When preparing for surgery Respondent ordered a pregnancy test to verify whether the patient was pregnant or not. The nature of the test was a urine pregnancy test under Respondent's preoperative orders given October 22, 2003. The specimen was collected on October 22, 2003, and received by Memorial Hospital (Memorial), Jacksonville, Florida, where the hysterectomy was to be performed. The test result was positive for pregnancy. The point in time that the result was revealed to Respondent will be discussed beyond this reference to the result. On October 27, 2003, Respondent began his surgery cases at Memorial at 7:30 a.m. On that date there was no indication in the patient record or chart maintained in his office practice that reflected information concerning the pregnancy test result, nor was that information found in the hospital chart related to Patient T.D. Absent the information, Respondent testified that he asked the circulating nurse at Memorial about the result of the pregnancy test. That was Tracy Lloyd, R.N. According to Respondent, the nurse went away to check the result and as Respondent describes "subsequently told me it was negative." No further effort was made by Respondent to confirm the oral report that Respondent says was made by the nurse. Respondent did not document the results of Patient T.D.'s pre-operative pregnancy test in the medical record. It was not his habit to write that type of a pre-operative note. Respondent testified that Ms. Lloyd told him about the pregnancy test results while in the holding area in the presence of the patient. Respondent commented that his question to the nurse would have been "What are the results of the pregnancy test?"1/ Aside from the results of the pregnancy test, nothing in the patient's condition, known to Respondent, led him to believe that the patient was pregnant. When the laparoscopic surgery commenced, Respondent did not perform an examination of the patient under anesthesia, given his recent examination of the patient in his office and the results of the ultrasound. Moreover, Respondent does not believe that such an examination under anesthesia would reveal anything other than the adenomyosis and the endometriosis which conformed to his preoperative diagnosis. On that subject, the later examination of the specimen on October 29, 2003, revealed that Patient T.D. had an early pregnancy, estimated as 4 to 5 weeks. In Respondent's opinion, in a 4-to 5-week pregnancy, the uterus would not normally achieve the size of a uterus that was reported on the ultrasound as mildly enlarged, not pregnant. Mildly enlarged refers to a 6 to 8 weeks' pregnancy. Respondent expected to see an enlarged uterus because of the adenomyosis which could be anticipated to cause an inflammatory response in the wall of the uterus, softening the uterus and giving it an appearance that would be similar to an early pregnancy. The rounded globular description of the findings during surgery were consistent with the expectations in addressing cases involving adenomyosis, according to Respondent. Returning to the surgical specimen obtained in Patient T.D.'s case, it was examined through surgical pathology conducted by Robert E. Barnes, M.D. A report was rendered. The report explains that in the examination of the specimen, the endometrium, "gestational endometrium with products of conception" were present. This was the finding related to Patient T.D.'s pregnancy. Dr. Barnes, is a board-certified pathologist in anatomic and clinical pathology. He describes his findings pertaining to Patient T.D., the gestational endometrium with products of conception, as referring to an early embryo, the endometrium showing changes associated with pregnancy. In his opinion the pregnancy was between 10 and 16 days following conception. When Dr. Barnes contacted Respondent on October 29, 2003, to advise of his findings in the pathology. It was a brief conversation and he does not recall the details. After the revelation concerning the pathology, Respondent's office staff found the information concerning the results of the urine pregnancy test in the hospital chart retained in the computer at Memorial. This finding was made around November 4, 2003. In a section within the report on the pregnancy test it refers to the "Result" and underneath that, the word "POSITIVE" is entered referring to pregnancy. When it was discovered that the hysterectomy had been performed while the Patient T.D. was pregnant, at her post- surgery scheduled office visit, a discussion was held with the patient concerning the "checks and balances" in place to avoid the problem. That refers to the surgery at a time the patient was pregnant. Respondent talked to the patient about counseling, or something similar, given the outcome in the case. As a result of the error, steps were taken within Memorial to address this circumstance. The Respondent and the Memorial Department of OB/GYN made changes, by requiring a pre- operative pregnancy test as protocol, that established a urine pregnancy test within 72 hours of surgery. That test would be performed by the nurses in the holding area. Respondent now orders a blood pregnancy test which is a more sensitive test to determine pregnancy. Expert Opinion Jose Cortes, M.D., is board-certified in ob/gyn, licensed to practice in Florida. He was recognized as a expert in ob/gyn for purposes of expressing his opinion about the care Respondent provided Patient T.D. Dr. Cortes has done hysterectomies in his practice, as recent as June 2006. He was called upon to render an opinion concerning the care Respondent provided Patient T.D. involving her hysterectomy. He had access to material concerning her care involved with this case. Dr. Cortes' impression of Respondent's medical treatment of the patient in the beginning, was that it was adequate and correct, with the proper evaluation performed and an appropriate decision made for surgery. Dr. Cortes expressed the opinion that in performing a hysterectomy on a woman who is of child-bearing age, which Patient T.D. was, a physician should order a pre-operative pregnancy test. In reviewing Patient T.D.'s records Dr. Cortes did not find a record documenting that the pregnancy test was ascertained by Respondent, referring to the test results. In his experience the results of the preoperative tests would be reflected in the patient's medical records as a matter of custom. Respondent, according to Dr. Cortes, could have obtained the results of the pre-operative pregnancy test for Patient T.D. by a fax to his office, a copy obtained through a computer, laboratory printouts sent to Respondent's office, and a copy of the pre-operative laboratory results obtained by the hospital placed in its medical record. Dr. Cortes stated the position that an experienced ob/gyn, and Respondent fits that category, could reasonably be expected to rely upon an oral report from a nurse as to the results of the pregnancy test, before entering the operating room, in the area of the pre-operative alcove as the patient is being interviewed by the physician. Dr. Cortes goes on to explain that if the conversation with the nurse in the presence of the patient was in the operating room holding area, then the pregnancy test results would have to have been documented in the patient chart to find the oral report acceptable. Those test results as reported would have had to be entered by the physician in the patient chart to meet the standard of care upon the oral report.2/ Later on, Dr. Cortes in his testimony seems to subscribe to the view that an oral report by the nurse as to the pregnancy test results would meet the standard of care, assuming that the Respondent in this case was provided an oral report. In the testimony at hearing, Dr. Cortes also said that obtaining an oral report or verbal report on test results, in an emergency situation, would meet the standard of care. By contrast, in elective surgery, such as that being performed on Patient T.D., it would be such that there was ample time to review a chart and laboratory studies before the patient was brought into the surgical suite. Generally stated, Dr. Cortes accepts that physicians frequently rely upon oral information imparted by nurses in performing surgeries, be they elective or emergent, but without an oral report this concession is not important. Regardless of the pre-conditions for Respondent to receive and rely on an oral report of the results of the pregnancy test, without an oral report, there being no other basis for Respondent's knowledge of the pregnancy test results, it was below standards to proceed with the hysterectomy. This view is taken from Dr. Cortes' testimony. Dr. Cortes expressed the opinion that it was below the standard of care to not ascertain the results of the patient's pre-operative pregnancy test prior to performing a non-emergent hysterectomy, that is an elective hysterectomy. Dr. Cortes expressed the opinion that it was below the standard of care for Respondent to perform a hysterectomy on Patient T.D. while she was pregnant in an elective setting. In addition to the results of the pregnancy test, Dr. Cortes believes that Respondent had other opportunities to detect the pregnancy, including an examination of the patient while she was under anesthesia during the surgery, and would have allowed a comparison of the results at the time of surgery against previous examinations that Respondent had performed on the patient. In referring to the previous examinations compared to an examination under anesthesia, this included the results of the ultrasound performed on October 2, 2003. Dr. Cortes does agree that the underlying condition visualized under anesthesia could be associated with prior pregnancy or the pre-operative diagnosis of adenomyosis. Dr. Cortes believes that Respondent's medical records, in the context of what could have been found upon an examination under anesthesia during the surgery, could be consistent with a possible pregnancy. A change seen in the pelvic examination at surgery would create an opportunity to evaluate and raise in the Respondent's mind any doubt concerning pregnancy. A slight increase in the size of the uterus between September 26, 2003, and October 27, 2003, is what is being referred to, promoting clinical judgment about possible pregnancy. Bryan Cowen, M.D. specializes in ob/gyn and reproductive endochrinology. He practices at the University of Mississippi in Jackson, Mississippi. He is a professor and chair in the Department of OB/GYN and has been for five years. He has been affiliated with the University of Mississippi for 24 years. He did his undergraduate work at the University of Colorado in Boulder, Colorado, and attended medical school in Denver, Colorado. Dr. Cowen is licensed to practice medicine in Mississippi and is board-certified. Dr. Cowen has performed a number of hysterectomies during his career. Dr. Cowen is familiar with the standard of care applicable for physicians such as Respondent, in the evaluation of patients suspected of endometriosis and adenomyosis and the considerations for treatment by hysterectomy. He is also familiar with the standard of care in relation to pre-operative testing and the associated duties of physicians when ordering such tests. In preparing to testify in this case, Dr. Cowen examined the Memorial medical records, Respondent's office records, and the depositions of Respondent, Dr. Freeman, Dr. Widrich, Dr. Barnes, and Dr. Cortes. With this information in mind, Dr. Cowen was able to provide an opinion concerning the standard of care in relation to the treatment provided by Respondent to Patient T.D. That opinion was that Respondent did not breach the standard of care in that he met due diligence in the process by the pre-operative laboratory-ordered, and pre- operative evaluation and assessment. Speaking to the September 26, 2003, office visit, Dr. Cowen saw nothing on the physical examination to indicate to him that Patient T.D. was pregnant. Concerning the ultrasound that was conducted on October 2, 2003, Dr. Cowen's opinion is that Respondent's assessment that Patient T.D. had adenomyosis based upon presentation, was confirmed by the ultrasound, the overall impression being that the Patient T.D. was not pregnant at that time. The further visit by the patient prior to the hysterectomy did not reveal anything in the history or physical examination that would suggest that Patient T.D. was pregnant, according to Dr. Cowen. On October 22, 2003, the pregnancy test was ordered by Respondent. The arrangement of ordering the test, sending the patient for pre-operative evaluation and laboratory tests is a common practice in Dr. Cowen's experience. In the instance where Respondent did not get a call from the pre-admission testing as to any abnormal results in the pregnancy test, and no report reflecting in the patient chart that the results were normal, Dr. Cowen commented on the need to check the laboratory results before taking the patient into the operating room. Based on Dr. Cowen's experience, there was no necessity to personally lay eyes on the test results to ascertain those results. He recognizes that his hospital may be different from Memorial in its expectations but he believes that Respondent followed Memorial's policy in accepting the report of a nurse as to the results of the pregnancy test. Dr. Cowen's opinion relies upon the factual predicate that Respondent was told by a nurse that the pregnancy test was negative, to the extent that is not true, and it has not been found as a fact, his opinion is without foundation. Further, Dr. Cowen believes that in the setting where surgery is being performed in other than an emergency, it is a sufficient practice to rely upon an oral report of a nurse concerning laboratory results, such as the outcome in the pregnancy test for Patient T.D. In his experience he has relied upon nurses to report both in an emergent and non-emergent settings. He goes on to describe how those reports come back to the medical records and the physician signs off, which did not occur in this case. Dr. Cowen was asked to express his opinion about the value of an examination under anesthesia as an assist to understanding the underlying condition of the Patient T.D. Dr. Cowen does not believe that this would provide additional information. In his experience most physicians have abandoned examinations under anesthesia. If a better insight is needed an ultrasound is the best choice. To Dr. Cowen, an examination under anesthesia does not relate to standard of care, it is in relation to an individual practitioner's protocol. An ultrasound used in this case, a transvaginal ultrasound, may have shown the gestational sack at the time of the hysterectomy but proceeding on the basis that a negative pregnancy test had been established and other findings during the course of the operation, as well as the preoperative record, would not indicate the necessity for an ultrasound in this case, at that time, the place in time where the hysterectomy was being performed. Dr. Cowen did not find anything in the intra-operative findings that would suggest to Respondent that the Patient T.D. was pregnant. Overall Dr. Cowen believes that Respondent met the standard of care in addressing the case of Patient T.D., who probably had polycystic ovarian disease, irregular cycles, was without a sexual partner by history, used condoms for contraception, had an ultrasound that confirmed a slightly enlarged uterus and had symptoms compatible with adenomyosis or endometriosis. Respondent discussed the treatment options, made an appropriate pre-operative evaluation, learned that the lab results for pregnancy were negative (an erroneous assumption), and therefore, he met the standard of care, according to Dr. Cowen. Ultimately, Dr. Cowen believes that it is essential to determine whether a patient is pregnant prior to performing a non-emergent/elective hysterectomy, which was not done here. Wyatt McNeill, M.D., testified. He is an ob/gyn practicing in Jacksonville, Florida, who in the past has had privileges at Memorial. He has performed hysterectomies at that facility. Dr. McNeill graduated from Florida State University. He graduated from the University of Miami Medical School. He is licensed in the state of Florida and is board-certified in ob/gyn. Dr. McNeill is familiar with the standard of care in relation to preoperative laboratory work done before a hysterectomy. Dr. McNeill is familiar with the standard of care applicable to Respondent in the evaluation of Patient T.D. for hysterectomy, knowing after the fact that the patient was found to be pregnant. To familiarize himself with the facts of this case, Dr. McNeill examined the hospital records of Memorial, Respondent's office records, various depositions, to include that of Dr. Cortes and the anesthesiologist and pathologist, before providing testimony. He also examined the testimony of the nurses involved in the care before offering his opinions. Concerning the patient history, objective and subjective evidence available, Dr. McNeill did not believe that there was anything to suggest that Patient T.D. was pregnant. In particular, Dr. McNeill comments on the history and physical done by Respondent, counseling, laboratory evaluation, and the decision beyond that to proceed with the surgery. Dr. McNeill found the ultrasound results consistent with a patient, who by history had a previous child and had the complaints expressed in the report concerning the September 26, 2003, visit with Respondent. Nothing in the ultrasound results compared to the findings in the operative report indicated to Dr. McNeill that the patient needed to be examined under anesthesia. The use of the examination under anesthesia is a training regimne for residents and students, in his experience. It has no utility beyond that application, in Dr. McNeill's opinion. Dr. McNeill believes that an oral report of the results of the pregnancy test meets the standard of care. As with others, Dr. McNeill assumes that Respondent was told the test results, which is not found. There was no further duty by Respondent to investigate those results having been told. In Dr. McNeill's opinion, the test results are either positive or negative, they are highly accurate. A negative test result means that the patient is not pregnant. No further duty is established beyond that realization, according to Dr. McNeill. In summary, there is no disagreement among the experts that Respondent is expected to ascertain the results of the preoperative pregnancy test before performing the hysterectomy and it would be inappropriate to perform the hysterectomy without those results. Respondent does not disagree with that perception. Conceptually, having considered the testimony of Respondent and the experts, it would be acceptable to proceed on an oral report, if one had been made, a report that the pregnancy test was negative.3/ Otherwise, the physical examination of the patient prior to surgery, the results of the ultrasound, and the observations intra-operatively made by Respondent did not indicate that the patient was pregnant. There was no necessity to make an examination under anesthesia. Even if made, it would not necessarily lead to the conclusion that the patient was pregnant, taking into account other information known by Respondent. Mitigation/Aggravation The outcome here was that the patient underwent a hysterectomy when she was pregnant, an adverse result. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of facts found and the conclusions, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), and imposing an administrative fine of $10,000.00, requiring Respondent to take a course on Risk Management for physicians, and issuing a letter of reprimand. DONE AND ENTERED this 22nd day of June, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of June, 2007.
The Issue Whether disciplinary action should be taken against Respondent for alleged violation of Section 458.1201(1)(m) Florida Statutes, as set forth in Petitioner's complaint.
Findings Of Fact Respondent Fahmy M. Rizk is a physician licensed in the State of Florida who engages in the general practice of medicine at Fort Myers Beach, Florida. (Testimony of Respondent) During the fall of 1976, Joyce Weidner, Cape Coral, Florida, who was then twenty years old, was a patient of Respondent. Although she could recall making six office visits, Respondent's records reflect that only four were made during the months of October and November, 1976. On October 14, she first saw Respondent with complaints of pain in her left chest area when swallowing. At that time, she told him that she had epilepsy and was taking Dilantin for that condition. Respondent determined that she was suffering from gastritis and prescribed medication. On her next visit, Respondent prescribed a course of treatment for acne that was present on the patient's face, chest and back. During a subsequent visit on November 2, 1916, presumably to check the progress of the acne treatment, Mrs. Weidner returned to Respondent's office at which time he took her into an examining room and instructed her to disrobe. She did so and covered herself with a sheet until he returned. He proceeded to place her feet in stirrups on the examining table and conduct an internal pelvic examination with no one else in the room. He pressed her abdomen and asked her if she suffered any pain there, and she answered in the affirmative. She asked him if anything was wrong and he said something "vague" about her kidneys. After the examination, he asked her to return in two weeks. On November 16, she returned and again he told her to disrobe when in the examining room. He remained in the room while she did so and gave her nothing to cover herself with at this time. The door was closed and no one was present in the room except the patient and Respondent. Respondent again conducted an internal examination, but did not wear a rubber glove on his hand. After inserting his finger into her vagina, be then proceeded to rub her clitoris and to hold and "roll" the nipple of each breast in turn with the fingers of his other hand. During this time, he asked her if she enjoyed sexual relation with her husband and whether she desired to climax more or less often. During the examination, she had expressed concern to Respondent that her nipples might be abnormally large. While holding the right nipple, Respondent said words to the effect that her nipples would be very nice for a man to suck. At some time during the examination, Respondent may have asked her if she ever had any discharge from the nipples. After the examination was concluded, Mrs. Weidner dressed and left the office. She thereafter reported the incidents to the Lee County Medical Association who advised her to contact Petitioner. She thereafter filed a complaint with Petitioner in December, 1976 Mrs. Weidner made her complaint because she believed that Respondent's conduct toward her was unethical and "very degrading." (Testimony of Weidner, Respondents' Exhibit 5) Respondent's office records concerning Mrs. Weidner do not disclose that Respondent conducted a pelvic examination during the November 2 visit. His notes concerning the November 16 visit reflect that he had observed that her nipples were more prominent than usual and examined them with his fingers to see if there was any discharge. He also recorded that she said her mother has the same form of nipples and asked him in an emotional state if he found any abnormalities but that he assured her they were normal. His records show that he examined her vagina, cervix and ovaries and found them to be normal. (Respondent's Exhibit 3) Respondent denied in his testimony that he had given Mrs. Weidner an internal examination of her female organs during the November 2 visit. However, he testified that during the course of his treatment for her acne, he had observed that she had abnormal nipples, and he was concerned about the possibility of cancerous tumors in the breast because acne is sometimes a symptom of such a condition. He therefore examined her breasts during the November 16 visit in order to determine if there was any discharge from the nipples. Since she was concerned about the shape of her nipples and those of her mother, and due to her history of epilepsy, he did not wish to upset her regarding the possibility of tumors. To reassure her, he told her that her nipples would be very nice for her children to suck and also that her husband would be happy to suck them. He claimed that he wore a rubber glove on his right hand when examining her vagina, but no glove on the other hand which was on the abdomen. He denied touching her clitoris during the examination. Although he concede that he had asked if she had a normal sex life to determine if she ever had bleeding or pain, he denied that he had asked her if she enjoyed having sex with her husband. He admitted that there was no third person in the room during the November 16 examination of Mrs. Weidner. Respondent further acknowledged that he had been sent a letter by Petitioner after the Weidner complaint concerning examinations of female patients, and that he had written to the executive director of Petitioner stating that he would not perform any further such examinations without the presence of a third person. (Testimony of Respondent, Petitioner's Exhibit 1. Respondent's Exhibit 3) There are some endocrine hormonal causes for acne and one of these could be ovarian tumors which are hormonally active. (Testimony of Howington) It is found that although there was sufficient medical justification for Respondent to examine Mrs. Weidner's breasts and perform a pelvic examination on November 16, 1976, there was no such justification for his improper and suggestive remarks as related by the patient and admitted in part by Respondent. Neither was there any valid medical reason for rubbing her clitoris with his hand. Mrs. Weidner's recitation of the events that transpired while under Respondent's care are accepted as fact and Respondent's denials are not deemed credible. Although Mrs. Weidner's testimony concerning the number of office visits was imprecise, there is no dispute that she visited Respondent on November 2 and 16, 1976, when the improper acts occurred. On July 14, 1977, Mrs Maureen Abel, than twenty-five years old, of Fort Myers, Florida, became a patient of Respondent for treatment of a chronic skin rash. The rash was present on her chest, arms, back and stomach. During that visit, Respondent took her into his examining room with no one else present, had her pull down the top of her garment and examined the rash with a magnifying glass. He asked her if she had a problem with nervousness and she replied in the negative. During the course of further questioning, she informed him that she normally ha irregular menstrual periods. She also told him that she had a prescription for medicine from another doctor which she took when several months elapsed without a menstrual period. Respondent told her that she should be on birth control pills to regulate her period and that that would control the rash. He told her to return in ten days when he would get her started on birth control pills. He further prescribed medication for the rash. She returned on July 23 and informed Respondent that she thought she might be pregnant because he had not had a regular period and was feeling nauseous. He took her into the examining room, told her to take her clothes off and lie on the table. She did so, but there was no robe or other covering for her body. Respondent, with no third party present, examined her breasts stomach, and proceeded to perform a pelvic examination. He said that everything was normal and she did not appear to be pregnant, but had indigestion which was causing the nausea. He prescribed medication for the indigestion, gave her a four month supply of birth control pills, and told her to return in a month. On August 26, Mrs. Abel returned and told Respondent that her rash had not gone away and that she was still feeling somewhat sick. She also told him that she had taken the birth control pills but did not have a period, and was having a vaginal discharge which caused itching and concerned her. She informed him that she was gaining weight, and he said that she should go on a strict diet. He then escorted her to the examining room and closed the door. No one else was present in the room. He told her to take her clothes off and, as she did so, he took each piece of clothing and hung it on the back of a door. He told her to lie down on the examining table and, after she did so, he examined her breasts and stomach. He then "fluffed up" her pubic hair with his fingers and told her he was going to give her an internal examination. He placed her feet in the stirrup which were too far apart and caused some pain to her left leg. He did not adjust the stirrups, but massaged her left leg and the pain disappeared. He then put on rubber gloves and did an internal examination. During the course of the examination, he told her that he felt something there and wanted to take a culture. She agreed and he proceeded to insert an instrument into her vagina for this purpose. After taking the specimen and discarding the instrument, he began examining her vulva area with his fingers telling her that she was very inflamed and infected. He began rubbing the vulva area and, while doing so, told her that she was very dirty there and that she should use a mixture of peroxide and water every night to clean the area. She was insulted at this comment. He continued rubbing this area and she asked him if he knew what he was doing. He replied that he was checking for inflammation. Respondent then started rubbing her clitoris and asked her what kind of orgasms she had and if they were rapid or slow. She informed him that she was able to control herself and then told him that he was hurting her in order to get him to cease his actions. He then took her legs out of the stirrups, rubbing his hand on her left leg, up her left side to the stomach, over her breasts and to her left cheek which he patted several times. She saw his face coming towards her and jumped up and got off the table. He then grabbed her by her left arm and pulled her over by the scales, telling her that he wanted to weigh her, and directed her to stand on the scales. She did so and then dressed and left the office after paying Respondent's wife, his receptionist, the charge of $43.00. A few days later she cancelled payment on the check, but nevertheless made a claim to her insurance carrier for this amount. She thereafter sought the advice of another physician on September 22, 1977, who told her she was 16 weeks pregnant. She delivered the baby on March 10, 1978. Mrs. Abel was upset and angry that Respondent had "played" with her "private area." (Testimony of Abel, Respondent's Exhibits 5, 7-9) Respondent testified that at no time did Mrs. Abel complain of nausea or raise the possibility that she was pregnant, nor did he perform an internal examination of her on July 23. His office records for that date merely reflect that she had gas and indigestion and that he prescribed contraceptive pills. He further testified that on the August 26th visit, she complained of heavy discharge and itching of her genitals and that his internal examination on that date revealed the existence of a malodorous discharge with inflamed internal vaginal walls, and that he took a sample for culture and sensitivity. His office notes support testimony in this respect. Respondent maintained that his wife was present in the examining room to assist him in taking the specimen for laboratory analysis. She corroborated his testimony in this regard. He denied weighing the patient, advising her to use peroxide for the discharge, or rubbing her leg while in the stirrup. He further denied hanging up her clothes prior to the examination, or touching her abdomen, breast and cheek at the end of the examination. He conceded that he told her she was and showed her the speculum covered with discharge and told her to smell it because it had a bad smell and was a very bad infection. He further denied rubbing her clitoris and testified that this would have been impossible to do because she was so inflamed. He did, however, examine the vulva area for she presence of infection. He testified that it was necessary to open the vulva with one hand while inserting the speculum with the other in order to avoid taking hair with the speculum which would hurt the patient, but that he did not make the movement with his hand on her pubic hair as recounted by Mrs. Abel. Laboratory examination of the vaginal discharge sample revealed the presence of escherichia coli. (Testimony of Respondent, supplemented by Respondent's Exhibit 6, Testimony of M. Rizk) It is found that although there was sufficient medical justification for Respondent to perform pelvic examinations of Mrs. Abel on July 23 and August 26, 1977, there was no justification for his improper and suggestive remarks as related by the patient nor was there any valid medical reason for rubbing her clitoris. Mrs. Abel's recitation of the events that transpired while under Respondent's care are accepted as fact. Respondent's denials and the testimony of his wife supporting such denials in part are not deemed credible. Neither are Respondent's office records considered reliable or worthy of supporting Respondent's denials of improper conduct as described by Mrs. Abel. In response to hypothetical questions posed to Petitioner's medical experts, it was their opinion that the actions of Respondent with respect to both Mrs. Weidner and Mrs. Abel constituted immoral and unprofessional conduct and failed to conform to the standards of acceptable and prevailing medical practice in the community. The hypothetical questions were based on the words and actions of Respondent as described in the testimony of Mrs. Weidner and Mrs. Abel. It was the opinion of one expert, however, that Respondent's failure to diagnose Mrs. Abel's pregnant condition did not constitute unprofessional conduct under the circumstances. Respondent's motion to strike the testimony of these exerts based on the fact that they had reviewed summaries of Petitioner's prehearing investigation of the patients' complaints was denied because both experts testified in response to facts contained solely in the hypothetical questions and did not independently rely upon additional facts contained in the investigative reports. (Testimony of Howington, Purvis) Respondent practiced medicine Egypt for approximately twenty-five years. He came to the United States in 1971 and served as medical director of a state hospital in Kansas for approximately three and one-half years. He came to Florida some two years ago, and after being licensed in the state, started to practice in the Fort Myers area in June of 1976. A number of his former patients have written to him expressing gratitude for his professional services. (Testimony of Respondent, Respondent Exhibit 10)
Recommendation That Petitioner suspend the license of Respondent to practice medicine for a period of two years pursuant to subsection 458.1201(3)(a)4, Florida Statutes, for violation of subsection 458.1201(1)(m), Florida Statute. DONE and ENTERED this 18th day of September, 1978, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Richard C. McFarlain A. Russell Bobo 610 Lewis State Bank Building Tallahassee, Florida 32301 James A. Franklin, Jr. Post Office Box 280 Ft. Myers, Florida 33902 George S. Palmer, M.D. Executive Director Board of Medical Examiners Oakland Building, Suite 220 2009 Apalachee Parkway Tallahassee, Florida 32301
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint December 19, 2005, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2009). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2009). At the times pertinent to this proceeding, Dr. Achong was a physician licensed by the State of Florida, having been issued license number ME38304, and his medical office was located at 690 East 49th Street, Hialeah, Florida. Dr. Achong specialized in obstetrics and gynecology, although he was not board-certified in these areas of practice. Dr. Achong has not previously been the subject of disciplinary action by the Board of Medicine, and he is not currently practicing medicine, having retired with a disability in 2006. At the times pertinent to this proceeding, Dr. Achong had hospital privileges at Hialeah Hospital and at North Shore Medical Center ("Medical Center"). Both facilities had his home telephone number and his beeper number. It was his practice to keep his beeper close to him at all times. When he was in the delivery room, it was his practice to give his beeper to the circulating nurse, who would be responsible for alerting him whenever someone tried to reach him on his beeper. The beeper he used in 2004 gave only the telephone number of the person trying to reach him, but he was able to recognize the number of Hialeah Hospital and the Medical Center. On February 12, 2004, Patient L.H. went to her gynecologist, Ramon Hechavarria, M.D., for a routine examination. Patient L.H. was, at the time, a 27-year-old who was 32 weeks' pregnant, and she had previously had one live birth. Dr. Hechavarria's examination revealed that Patient L.H.'s blood pressure was elevated, and Dr. Hechavarria admitted her to Medical Center for 24 hours for observation. On February 12, 2004, Dr. Hechavarria ordered blood and laboratory tests done in the Medical Center. The blood tests included a Disseminated Intravascular Coagulopathy ("DIC") profile and a Fibrinogen Degradation Profile ("FDP"); the results of these blood tests were normal. Patient L.H.'s hemoglobin and her platelet count were normal, and, although there was a slight trace of protein in her urine, that is considered normal. On February 13, 2004, Dr. Hechavarria discharged Patient L.H. with a diagnosis of chronic hypertension and a prescription for 250 milligram tablets of Aldomet, to be taken three times per day. Aldomet is a medication that treats hypertension by lowering the blood pressure. Patient L.H. was in good, stable condition when she was discharged on February 13, 2004. Readings from a fetal heart monitor taken during the time Patient L.H. was in the Medical Center indicated that the fetus was alive. Dr. Hechavarria considered Patient L.H.'s to be a high risk pregnancy in part because of her hypertension but also because she came in late for prenatal care, missed two appointments, and was overweight. Dr. Hechavarria left town for a vacation on February 13, 2004, and Dr. Achong was to cover his patients during his absence under an arrangement whereby Dr. Hechavarria and Dr. Achong provided coverage for each other when one or the other was out of town or otherwise unavailable to see patients. Under the arrangement, Dr. Achong was expected to go to the hospital if one of Dr. Hechavarria's patients were in labor or if a patient were to go to the emergency room complaining of vaginal bleeding or any other obstetrical or gynecological condition. Whenever coverage of patients was passing from one physician to the other, Dr. Hechavarria and Dr. Achong advised each other of any patient that was in the hospital for gynecological, obstetrical, or any other medical reason. They did not advise each other of patients that had recently been discharged from the hospital, and, therefore, Dr. Hechavarria did not discuss Patient L.H. with Dr. Achong because she had been discharged from the Medical Center before Dr. Achong began covering Dr. Hechavarria's patients. Patient L.H. presented at the Medical Center at approximately 2:00 a.m. on February 15, 2004, complaining of abdominal pains. She was seen by labor and delivery nurse Jennifer Williams, a registered nurse with 20 years' nursing experience, with 13 years' experience in the Medical Center's labor room, and with training as a mid-wife. Nurse Williams had worked with Dr. Achong at the Medical Center since 1991. Subsequent to Patient L.H.'s arrival at the Medical Center, Nurse Williams interviewed her, took her medical history, examined her, and entered the pertinent information on the Medical Center's Admission Assessment. The Admission Assessment form was dated February 15, 2004, and the time was noted as 2:45 a.m. The time written by Nurse Williams' signature on the Admission Assessment form was 3:00 a.m., and it appears that the information was obtained and entered on the form between 2:00 a.m. and 3:00 a.m. Pertinent to this matter, Nurse Williams maintained several other documents recording Patient L.H.'s condition and observations and actions taken by Nurse Williams relating to Patient L.H. Nurse Williams began maintaining a Labor Flow Record at 2:07 a.m. and she made periodic entries on the Labor Flow Record related to, among other things, Patient L.H.'s vital signs, the results of vaginal examinations and fetal monitoring, uterine activity, and pain intensity at different times during the night and morning. In addition, Nurse Williams entered on the Labor Flow Record the time and content of her communications with Dr. Achong; the first recorded contact between Dr. Achong and Nurse Williams was recorded on the Labor Flow Record as 2:30 a.m. Nurse Williams also maintained Progress Notes in which she recorded her observations of Patient L.H. and her conversations with Patient L.H. The first entry in the Progress Notes was at 2:35 a.m.2 Nurse Williams' Progress Notes reflect that, at 2:35 a.m., Patient L.H. advised Nurse Williams that she had contractions and believed she had been in labor since 6:00 p.m. the previous evening but had waited to come to the Medical Center until she was certain she was in labor. Patient L.H. also reported abdominal pain in her upper abdomen that did "not go away," and Nurse Williams observed that Patient L.H. was distressed by the pain in her abdomen. Patient L.H. also told Nurse Williams that she had no ruptured membranes or vaginal bleeding. Nurse Williams noted that she examined Patient L.H. and felt contractions but was unable to detect a fetal heart tone. Nurse Williams reported in the Admission Assessment form that Patient L.H. was having uterine contractions of moderate intensity and 60 seconds' duration, that her cervix was dilated 1-to-2 centimeters, that she had vaginal bleeding that was bright red, that her blood pressure was 159/118, which she described as "elevated," and that Patient L.H.'s abdominal pain was the "worse" pain on a pain scale ranging from 1 to 10; there is, however, no indication on the Admission Assessment form that the pain was constant. Nurse Williams also noted on the Admission Assessment form that she heard no fetal heart rate. Although the time noted on the Admission Assessment form was 2:45 a.m., it is apparent from a review of the relevant records that the information included on the Admission Assessment form was obtained by Nurse Williams over a period of time extending from the time Patient L.H. presented to her until 3:00 a.m., the time on the Admission Assessment form beside Nurse Williams' signature. Nurse Williams reported in the "Physician /CNM in/Called Report" section of the Labor Flow Record that she contacted Dr. Achong at 2:30 a.m. and conveyed to him the following information: "[P]atient arrived in ER c/o contractions since 6 pm last night & observation that no FHT [fetal heart tone] and contractions palpated." Nurse Williams telephoned Dr. Achong using his home telephone, even though his beeper number was also on file at the Medical Center. There is nothing in the report Nurse Williams gave to Dr. Achong at 2:30 a.m. that would require that he proceed to the Medical Center and examine Patient L.H., and he did not violate the standard of care by failing to do so. Because Dr. Achong did not know Patient L.H., Nurse Williams' normal procedure would have been to advise Dr. Achong of Patient L.H.'s history, including the medications she was taking, and her vital signs, including her blood pressure. No notation appears in the Labor Flow Record to confirm that she gave Dr. Achong this information during her conversation with him at 2:30 a.m., nor is there a notation in the 2:30 a.m. entry in the Labor Flow Record that Nurse Williams told Dr. Achong about the results of her examination of Patient L.H.'s cervix, Patient L.H.'s complaint of abdominal pain, or the presence of vaginal bleeding of bright red blood.3 Nurse Williams indicated in her entry in the "Physician/CNM in/Called Report" section of the Labor Flow Record that Dr. Achong ordered a "stat," or expedited, obstetrical sonogram during the 2:30 a.m. contact with Nurse Williams. The purpose of the obstetrical sonogram was to determine if the fetus was alive. Although not noted in the Labor Flow Record, the Labor and Delivery Orders form completed by Nurse Williams indicates that, at 2:30 a.m., Dr. Achong ordered a complete blood count, which is routine with a patient in labor; a DIC profile; and a Comprehensive Metabolic Panel ("CMP"). The Labor and Delivery Orders form contains standard orders for a woman in labor, but the DIC profile and the CMP tests were not included on the form but were ordered specifically by Dr. Achong. A DIC profile is used to determine if a patient has a problem with blood clotting. The DIC includes an assessment of prothrombin time and partial thromboplastin time, both of which indicate different levels at which a patient's blood is able to clot. It is important to know whether a woman in labor and delivery has a clotting problem, or coagulopathy, because of the danger of bleeding, and the classic situation in which DIC profiles are ordered is when there is fetal demise. Because Patient L.H. had the high risk factors of overweight and hypertension and because Nurse Williams could detect no fetal heart tone, Dr. Achong's order for the DIC profile was appropriate and met the standard of care. It is also appropriate to order a DIC profile when there is a concern about placental abruption, which is the separation of the placenta from the walls of the vagina. A placental abruption causes a great deal of bleeding, and can cause death when not treated, because the fetus is still in the womb and the uterus is not able to contract and constrict the large blood vessels that attach to the placenta. Although hypertension is one risk factor for placental abruption, the symptoms of placental abruption also include fetal demise, bleeding, constant pain, a decrease in hematocrit, and a number of other conditions. There is no indication in Patient L.H.'s medical records that Dr. Achong had sufficient information at 2:30 a.m. that would indicate that Patient L.H. had a possible placental abruption, and he ordered the DIC profile because of the lack of fetal heart tones.4 The CMP includes tests for kidney and liver function and for uric acid. It is used to determine if a woman has pre-eclampsia, or pregnancy-induced hypertension. Given Patient L.H.'s history of hypertension and the level of her blood pressure as reflected in the Admission Assessment form, Dr. Achong's order for the CMP was appropriate and met the standard of care in ordering the CMP. All orders for blood tests for women in labor and delivery are treated as "stat" orders and are processed ahead of all other test orders except those from the emergency room. When the situation warrants, a physician may order that the tests be performed more quickly than the usual "stat" order would require, and it would be possible to obtain blood-test results within 45 minutes. There is, however, no indication in Patient L.H.'s medical records that Dr. Achong had any information at 2:30 a.m. that might indicate that he should further expedite Patient L.H.'s blood tests. Nurse Williams reported in her Progress Notes that, at 2:40 a.m., Patient L.H. reported a "gush of something down there," and Nurse Williams noted that she observed a large amount of blood; there is, however, no notation in the Progress Notes regarding the color of the blood. Nurse Williams also included a notation in the Progress Notes that Patient L.H.'s cervix was "3cm dilated, 50% effaced, -3 station" to describe the progress of Patient L.H.'s labor. Nurse Williams reported in the Labor Flow Record that she contacted Dr. Achong at 2:45 a.m. and conveyed to him the following information: "Dr. Achong notified of gush of vaginal bleeding. VE [vaginal examination] 2-3, 50% effaced, -3 station and that we are awaiting sonogram." The results of Nurse Williams' vaginal examination of Patient L.H. showed that Patient L.H. was in active labor. The information that Patient L.H. experienced a "gush of vaginal bleeding" did not indicate to Dr. Achong that there was anything more than one episode of bleeding, which he attributed to an especially heavy "bloody show," which is the bleeding that occurs when the cervix is dilating. The notation indicates that Dr. Achong told Nurse Williams to call him if Patient L.H. went to delivery. The information conveyed to Dr. Achong at 2:45 a.m., as reflected in the notation in the Labor Flow Record, was not sufficient to indicate that Patient L.H. was not proceeding through labor normally to a vaginal delivery of the dead fetus, which is preferred over delivery by a Cesarean Section. Nurse Williams did not include in her records a notation that she advised Dr. Achong that the "gush of vaginal bleeding" consisted of a large amount of bright red blood, which would have been an indication of a possible placental abruption. Some bleeding is normal during labor, but it is usually a dark color from having been in the uterus and in a small amount or tickle, although there could be a "gush of blood" during normal labor. When Dr. Achong was advised by Nurse Williams that Patient L.H. had a "gush of blood," however, it was his responsibility to inquire into the amount of blood, the color of the blood, and the persistency of the bleeding to determine if Patient L.H. was proceeding with normal labor or if she was experiencing a hemorrhage or other abnormal condition. Nurse Williams made no entries in the Progress Notes for Patient L.H. between 2:40 a.m. and 3:40 a.m., when she reported that the ultrasound had been completed. She further noted in her Progress Notes: "Report of no fetal heart tones to Dr. Achong. Orders given." Nurse Williams additionally made a notation in the Labor Flow Record that, at 3:40 a.m., she contacted Dr. Achong and reported to him the following: "Ultrasound report No FHT's given to Dr. Achong. Orders received." Nurse Williams did not, however, indicate in her notations what orders were given. Nurse Williams contacted Dr. Achong through his home telephone number, which was normal procedure during the nighttime hours. When the sonographer, that is, the person performing the sonogram, entered Patient L.H.'s room to perform the sonogram, he noted that Patient L.H. was sitting upright in bed, was combative, and was in a lot of pain. He also noted that there was a fair amount of blood on the bed sheets. The sonographer was able to get Patient L.H. to lie on the bed, and he performed "a very short ultrasound,"5 and pulled the machine out of the room and into the hall. He powered the machine back up and read the numbers off the worksheet on the machine. He confirmed that the fetus was dead and that the placenta appeared to be balled up rather than lying smoothly against the uterine wall, as is normal. While he was writing down the information from the worksheet on the machine, Nurse Williams approached him and told him that she had Dr. Achong on the telephone. He told her that he had "a placental abruption and fetal demise."6 He then wrote up his report, left a copy for Nurse Williams, and went downstairs to process the sonogram images.7 The results of the sonogram were reported on a form headed "Obstetrical Preliminary Report," which was completed by the sonographer. A radiologist is usually present at the Medical Center during daytime hours to read sonograms, but on the off-hours, it is the practice of the sonographer to present a sonographer's impression of what was seen during the sonogram. The sonographer who performed the sonogram on Patient L.H. noted on the report that her history included obesity, hypertension, heavy vaginal bleeding, and contractions. He included the following comments in the report: "Ant/Rt [unintelligible] placenta appears to be 'balled up[.]' Suggestion of placental abruption," and, on a separate line, "NO FETAL HEART MOTION SEEN PT IS COMBATIVE." Finally, at the bottom of the report, the sonographer noted that a copy of the report was given to Nurse Williams. There was no notation as to the time the sonographer gave the report to Nurse Williams, but, even if she had the report, she did not read it to Dr. Achong; rather, she put the copy of the report in Patient L.H.'s chart for Dr. Achong to review when he came to the hospital and gave him only a verbal report. Nurse Williams did not tell Dr. Achong during the 3:40 a.m. telephone conversation that the sonographer had reported a possible placental abruption.8 Dr. Achong was familiar with and had treated placental abruptions prior to February 15, 2004, and he always treated patients with placental abruptions on an emergency basis because both the mother and the baby could die if treatment was not received as soon as possible. Had Nurse Williams advised Dr. Achong that the sonographer had told her that he found a placental abruption or that the sonogram report included a reference to a possible placental abruption, he would have gone to the Medical Center immediately. At 3:45 a.m., Nurse Williams noted in her Progress Notes that she gave Patient L.H. Nubain and Phenergan for her painful contractions. There is no mention of continued vaginal bleeding in this entry in the Progress Notes. At 4:15 a.m., Nurse Williams noted in her progress notes that Patient L.H. was sleeping quietly and was relaxed and that Pitocin had been administered in accordance with Dr. Achong's orders. Pitocin is used to induce labor, augment labor, or to stop bleeding. In this case, Dr. Achong ordered the Pitocin to regulate Patient L.H.'s contractions. There is no mention in the 4:15 a.m. entry in the Progress Notes of continued vaginal bleeding. The next entry in Nurse Williams' Progress Notes was made at 5:15 a.m., when Nurse Williams reported that she had observed vaginal bleeding, that a vaginal examination showed dilation of four centimeters, and that Patient L.H. was very restless and moving around the bed. Nurse Williams received the laboratory report showing the results of the blood tests ordered by Dr. Achong at or around 5:00 a.m. According to the laboratory report, the blood for these tests was drawn at or about 3:20 a.m.; the report did not show any critical values in the blood sample. Nurse Williams attempted to contact Dr. Achong to convey these results to him. She noted on the Labor Flow Record that, at 5:15 a.m. "Dr. Achong beeped re lab results. Phone message left on home phone to call LR [Labor Room]." Nurse Williams made another entry on the Labor Flow Record that, at 6:55 a.m., she left a "message to Dr. Achong answering machine at home re labor progress update and labs." Dr. Achong was not, however, at home to receive the telephone calls or the messages. At or about 5:00 a.m. on February 15, 2004, Dr. Achong received a telephone call on his home telephone from Hialeah Hospital advising him that one of his patients or one of Dr. Hechavarria's patients was in active labor and about to deliver. Shortly after receiving the telephone call, Dr. Achong left his home to travel to Hialeah Hospital. He carried his beeper with him, but he did not receive any calls on the beeper. When he arrived at Hialeah Hospital and prepared to go into the delivery room, he gave it to the circulating nurse in case he should receive a beeper call while he was in the delivery room. Nurse Hayes, who had replaced Nurse Williams when Nurse Williams' shift had ended at 7:00 a.m., made a notation on the Labor Flow Record that, at 7:15 a.m., she called Dr. Achong and left a message. At 7:25 a.m., while he was in the delivery room, Nurse Hayes called his beeper. The circulating nurse had his beeper, and she notified him that he had received a call and told him the number. He recognized the number of the Medical Center, and he told the nurse to call the Medical Center and let them know that he was in the delivery room at Hialeah Hospital. Nurse Hayes asked that he call back as soon as possible. Blood for additional blood tests was drawn at or about 7:30 a.m., and the results, which were available within 15 minutes, showed several critical values that indicated that Patient L.H. was entering coagulopathy. At 7:38 a.m., as soon as he finished the delivery, he called the Medical Center and spoke with Nurse Hayes, who gave him a report on the status of Patient L.H. She told him that Patient L.H. had heavy bleeding and that the vaginal examination showed no change in the cervix. Dr. Achong ordered the Pitocin turned off. When Dr. Achong arrived at the Medical Center at 7:56 a.m., he found Patient L.H. very combative, bleeding, and with very bad vital signs. He ordered a "stat" Cesarean Section and ordered a blood transfusion. Patient L.H. died at 8:38 a.m., before any of the measures ordered by Dr. Achong could be implemented. The cause of death was recorded as placental abruption. Summary In summary, the evidence presented by the Department is not of sufficient weight to establish that Nurse Williams conveyed to Dr. Achong the information necessary for him to conclude that he should personally conduct a clinical evaluation of Patient L.H.; that he should consider the possibility that Patient L.H. had placental abruption; or that he should have provided medical assistance to Patient L.H. prior to his contact with Nurse Hayes at 7:38 a.m. Nurse Williams' Progress Notes report only two remarkable items: There were no fetal heart tones detected by physical examination or by sonogram; and, at 2:40 a.m., Patient L.H. reported a "gush of something" and Nurse Williams observed a large amount of blood. Neither Nurse Williams' entries in the Labor Flow Record regarding her contacts with Dr. Achong nor her testimony, to the extent that it has been found persuasive, is sufficient to establish that she advised Dr. Achong that she had observed a large amount of red blood at 2:40 a.m. or that the sonographer detected a possible placental abruption in the sonogram. Finally, Nurse Williams did not follow the protocol that required her to contact Dr. Achong through his beeper when she did not get an answer on his home telephone; she tried his beeper only once, at 5:15 a.m., and when she failed to reach him, left three messages on his home telephone. The Department presented no evidence to establish that Nurse Williams attempted to reach Dr. Achong by beeper between 5:15 a.m. and 7:55 a.m., the time of her last call to Dr. Achong's home telephone. Furthermore, the Department did not present evidence of sufficient weight to establish that Dr. Achong failed to initiate the appropriate procedures after he arrived at the Medical Center and examined Patient L.H. at or around 8:00 a.m. The evidence presented by the Department is, however, of sufficient weight to establish that Dr. Achong should have questioned Nurse Williams further when she advised him at 2:45 a.m. that she had observed a "gush" of vaginal bleeding. Even though vaginal bleeding may not be not unusual during labor, a report of a "gush" of blood should have alerted Dr. Achong to a potential problem. Although a physician practicing obstetrics is meeting the standard of care when relying on labor room nurses to advise him or her of the clinical status of labor and delivery patients and of any unusual symptoms exhibited by the patients, it is also incumbent on the physician to inquire further if a patient is presenting unusual symptoms. The persuasive evidence establishes that Dr. Achong violated the standard of care when he failed to ask Nurse Williams for additional information on Patient L.H.'s status during their 2:45 a.m. telephone conversation. Had he inquired further, Dr. Achong would have been alerted to the possibility that Patient L.H. had a placental abruption and would have gone to the hospital to provide appropriate care for Patient L.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order finding that Dr. Achong violated Section 458.331(1)(t), Florida Statutes, by failing to elicit further information from Nurse Williams regarding the gush of blood she observed in Patient L.H and imposing the following penalties: Issuance of a letter of reprimand; Imposition of administrative fine in the amount of $2,500.00; and Six months' probation under such conditions as the Board of Medicine determines appropriate, should Dr. Achong ever resume the practice of medicine. DONE AND ENTERED this 4th day of January, 2010, in Tallahassee, Leon County, Florida. PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of January, 2010.
The Issue The issue presented is whether Respondent is guilty of the allegations set forth in the Administrative Complaint, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0020248. Respondent is a board- certified pathologist who completed a residency in obstetrics and gynecology in Venezuela and practiced in the field of obstetrics and gynecology in South America for almost five years before coming to the United States. On April 20, 1991, patient J. B., a 27-year-old female, came to A Woman's Care, where Respondent was then employed, for the purpose of terminating her pregnancy. She indicated on a patient history form that the date of her last menstrual period was January 30, 199l. According to the medical records from A Woman's Care, she did not express any uncertainty or equivocation with respect to that date. One method of determining gestational age is based on calculating from the last menstrual period, assuming that the patient's history is reasonably reliable. With a history of a last menstrual period on January 30, 1991, the gestational age of the fetus on April 20, 1991, based upon a calculation by dates, was seven weeks. After obtaining a history from the patient with respect to the date of the last menstrual period, the physician needs to perform a bi-manual examination of the patient in order to assess the size of the uterus and to confirm the history given by the patient. Although the bi-manual examination is a reasonably reliable method of assessing the stage of pregnancy, it is a subjective examination and can sometimes be difficult. There is an acknowledged inaccuracy with respect to that clinical evaluation. The most accurate method of determining the gestational age of a fetus is through ultrasound examination. An ultrasound is performed when there is uncertainty as to the gestational age, such as when the patient does not know the date of her last menstrual period or when there is inconsistency between the patient's disclosed date and the physician's bi-manual examination. There is a general correlation between the size of the uterus in centimeters on bi-manual examination and gestational age in weeks. It is important to determine the gestational age of the fetus before performing a termination of pregnancy because the gestational age is the determining factor in deciding the size of the instruments to be used in the procedure and the amount of tissue to be removed. Respondent performed a bi-manual examination of the patient and recorded that his examination revealed a uterus consistent with an approximately seven-week gestation. Because the gestational age by dates and the results of the bi-manual examination both indicated a seven-week pregnancy and were consistent, Respondent did not order an ultrasound examination for the purpose of determining gestational age. On April 20, 1991, Respondent performed a termination of pregnancy on patient J. B. after the patient was informed of the possible risks of the procedure and after the patient signed a Patient Informed Consent Form. That Form detailed the possible risks, including infection and incomplete termination. Based upon the patient's history and the bi-manual examination and his conclusion that the patient was approximately seven-weeks pregnant, Respondent used an 8 mm Vacurette to terminate patient J. B.'s pregnancy. An 8 mm Vacurette is an appropriately-sized device to terminate a seven-week pregnancy. After completing the procedure, Respondent submitted the tissue obtained to a pathologist who determined that three grams of tissue had been submitted, consisting of products of conception and chorionic villi. The pathology report revealed what would reasonably be expected as a result of the termination of a seven-week pregnancy. After the procedure, the patient was given written instructions for her care and was discharged from A Woman's Care at 10:35 a.m. On April 21, 1991, at approximately 6:30 a.m., the patient's grandmother telephoned A Woman's Care to advise that the patient was complaining of dizziness and pain. The patient was advised to take Tylenol and call back if she continued to feel sick. At approximately 7:30 a.m., the patient's grandmother called again to advise that the patient was going to go to the hospital. On April 21, 1991, at 1:25 p.m., patient J. B. arrived at the Emergency Room at North Shore Medical Center with a temperature of 104.3 degrees, an elevated white blood cell count, chills, lower abdominal pain, and spotting. The patient was seen during her North Shore admission by Dr. Ramon Hechavarria, a physician certified in obstetrics and gynecology, and by Dr. Tomas Lopez, a general surgeon. Dr. Lopez noted in his consultation report that a pelvic bi-manual examination that he performed on April 21 showed an enlarged uterus corresponding to approximately 11-12 weeks' gestation. An ultrasound examination done on April 21 revealed a uterus measuring 11.0 x 7.8 x 7.8 centimeters and a viable intra- uterine pregnancy which was estimated by the radiologist to be 13-14 weeks' gestational age. On April 22, the patient underwent termination of her pregnancy by Dr. Hechavarria who noted in his operative report that both the pelvic ultrasound and a bi-manual examination revealed an intra-uterine pregnancy of about 11 weeks with a live fetus. An ultrasound performed intra-operatively confirmed that all fetal tissue had been removed and that there were no perforations. Infection and an incomplete termination are two of the recognized complications resulting from terminations of pregnancy. The fact that a patient suffers an infection or an incomplete termination does not, per se, indicate any negligence on the part of the physician. Respondent did not fall below the recognized standard of care by failing to perform an ultrasound on patient J. B. His examination revealed a gestational age consistent with the date identified by the patient as the date of her last menstrual period. Accordingly, there was no need to perform an ultrasound. Respondent did not fall below the recognized standard of care by misjudging the gestational age of the fetus. It is not uncommon for a physician to misjudge the length of gestation by several weeks. For example, Drs. Lopez and Hechavarria concluded the fetus had a gestational age of 11 weeks; yet, the ultrasound reported 13-14 weeks. Respondent did not fall below the recognized standard of care by using the wrong size of equipment to perform the termination of pregnancy. He used the proper equipment consistent with his judgment as to the length of gestation.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED THAT a Final Order be entered finding Respondent not guilty of the allegations and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 25th day of July, 1997, at Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 25th day of July, 1997. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jonathon P. Lynn, Esquire Stephens, Lynn, Klein & McNicholas, P.A. Two Datran Center, Penthouse II 9130 South Dadeland Boulevard Miami, Florida 33156 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
The Issue This case concerns an administrative complaint brought by the State of Florida, Department of Professional Regulation, against Respondent, charging violations of provisions of Chapter 458, Florida Statutes. In particular, it relates to the treatment of the patient Sandra Gilhousen in the placement of an IUD and in the performance of an abortion. Respondent is also charged with misprescription of a controlled substance, Ionamin, for that patient. Respondent is also charged with misprescription of Ionamin, Demerol and Quaalude for the patient Betty Boling. Finally, Respondent is accused of misprescription of Demerol for the patient Margo Stewart. These allegations are more completely described in the conclusions of law.
Findings Of Fact William J. Lee, M.D., is a physician licensed to practice medicine in the State of Florida according to licensure by the State of Florida, Department of professional Regulation, Board of Medical Examiners, License No. ME012345. At all times relevant to this cause, he has held that license and has practiced general medicine and general surgery at Jacksonville Beach, Florida. Dr. Lee is a graduate of Emory University in 1958 and received an M.D. degree from Emory in 1964. His internship was done at the University of Florida, followed by residency and general surgery at the University of Florida from 1965-1968, which was completed at the Duval Medical Center in Jacksonville, Florida, in 1969. After appropriate service of the subject administrative complaint, Respondent made a timely request for formal hearing pursuant to Subsection 120.57(1), Florida Statutes. SANDRA GILHOUSEN On January 5, 1983, Sandra Gilhousen went to the office of Respondent in Jacksonville Beach, Florida, for purposes of the placement or insertion of an IUD. She filled out a patient history information form to the extent as reflected in a copy of that form found in Petitioner's composite Exhibit No. 5, admitted into evidence. That information included home address, employment status, occupation, phone number and age. No information was given or requested on the subject of her past medical history, other than Dr. Lee asking if she suffered any allergies. During the examination process and the subsequent placement of the IUD, the patient indicated that her menstrual cycle had concluded two or three days before, when in fact, she had missed a normal cycle and had suspicion of being pregnant. When the Respondent placed the IUD, there was some seepage of blood indicating to him that the menstrual cycle had just concluded as the patient had indicated. On the other hand, the uterus was enlarged which was consistent with pregnancy. The uterus was found to be mildly boggy upon the placement of the Intrauterine Device. It was the expectation of the patient that the placement of the IUD would cause her to abort the fetus. No pregnancy test was performed prior to the placement of the IUD and no laboratory work was done. These procedures were not performed, according to Lee, because he believed her when she said she had just concluded menses and she had a healthy appearance. Prior to the placement of the Intrauterine Device, Dr. Lee checked the patient's blood pressure, lungs, masses in the abdominal cavity and for pelvic irregularities. None of the results of these observations were recorded in her records with Dr. Lee. The notations in her record related to the visit simply indicates insertion of IUD and the cost of that service plus the cost of the device. At the conclusion of the procedure, Dr. Lee gave the patient a pamphlet related to the IUD and asked for her to make a return visit to make certain there were no complications. The patient Gilhousen and an acquaintance, Betty Boling, returned to Dr. Lee's office on January 7, 1983. The purpose of the visit was not the return visit contemplated by Dr. Lee related to the IUD. On this occasion, Gilhousen was provided a prescription for Ionamin, a medication which is a controlled substance used for weight control. Prior to being provided this prescription from Dr. Lee for 30 units in 30 milligram amounts, the blood pressure of the patient was taken. A copy of the prescription may be found as Petitioner's Exhibit No. 1, admitted into evidence. At that time, the patient weighed less than on the date of the final hearing in this cause. On the final hearing date, the patient was 5'5" tall and weighed 120 pounds. The patient Gilhousen had been weighed before the prescription was given but the weight is not recorded in her records held by Dr. Lee. No indication whatsoever is made of the prescription of the Ionamin or of any examination given prior to prescribing that substance. Dr. Lee did not do a full-scale examination, more than blood pressure and weight, when he prescribed the Ionamin, because in his mind he had observed the patient through an examination two days before when he placed the IUD. A pregnancy test was performed after January 5, 1983, not by Dr. Lee, and Gilhousen had her pregnancy confirmed. She then requested Dr. Lee to perform an abortion, with the understanding that the procedure would have to be done at the convenience of Dr. Lee, in that she did not wish to pay for that service immediately. Dr. Lee was made aware of the results of the pregnancy test prior to subsequently performing the requested abortion. He expected that he would be able to gain the assistance of Betty Boling when he performed that procedure. After a telephone conversation on the evening of January 14, 1983, Gilhousen went to Dr. Lee's office around 8:30 p.m. for the purpose of having the abortion done. As with the case with the IUD, no written consent was given to have the abortion done. Nonetheless, it was discussed with Dr. Lee and it was the desire of the patient Gilhousen to have the abortion. When Gilhousen arrived, the Respondent was smoking marijuana and asked her if she would be interested in marijuana, hashish or cocaine, which she declined. Dr. Lee was unattended by other staff at this time and throughout the abortion procedure. The patient was taken to a patient examining room and placed on an examining table where the abortion was done by D&C. The room had an operating light, necessary instruments to conclude the procedure, an electrocardiogram, suction devices, epinephrines, IV fluids and emergency drugs. No monitoring equipment was used during the procedure other than checking her blood pressure. Blood pressure had been checked prior to the procedure and Dr. Lee had listened to the patient's heart and lungs and a pelvic examination had been made. The procedure took approximately 40 minutes and the observation was made by Dr. Lee that the pregnancy was in the range of four to five weeks. No pregnancy test or laboratory work was done prior to the termination. Laboratory tests were not done because, according to Dr. Lee, this was Betty Boling's friend who didn't have any money. A pregnancy test was not done because Dr. Lee felt that this was an additional expense not necessary in that he believed the patient when she said that she had been informed of a positive pregnancy test. Missing information through laboratory work included Rh typing and a hemoglobin test. Related to the hemoglobin test, Dr. Lee observed that the patient's outward appearance was acceptable and that the mucous membranes had good color. Dr. Lee recognized the possibility of Rh factor problems in the sense of the mother being negative and the father positive as it might affect the next pregnancy of the patient pertaining to Rh incompatibilities. Again, the Rh testing was not done for financial reasons. Moreover, per Lee, the patient wanted the procedure done on that evening and the patient, as he understood it, did not wish to become pregnant in the future. Being unable to locate Betty Boling to assist, Dr. Lee decided to go forward with the procedure without an attendant being present. The patient was given Valium to calm her nerves and Dr. Lee utilized Stadol and Phenergan for sedation and as analgesic. Through this combination, the patient was placed in a sort of "twilight condition" on a plane which made her unconscious, but not a deep unconscious state. While giving her this medication, he asked her if she felt "sexually aroused." In Petitioner's Exhibit No. 5, the amounts and types of medication are recorded in the patient's chart and it is noted that the D&C was done and tolerated well. It is also noted that the patient was picked up by a friend and the charge of the procedure is given. Ergotamine was given to retract the uterus and minimize bleeding. No other information is recorded in the patient's chart. The patient's recovery from the medications in terms of regaining consciousness took longer than might be expected given the amount of medication. Notwithstanding the patient's slow recovery, Dr. Lee left the patient unattended later in the evening for reason that he felt that she was "ready to go home." After leaving the patient unattended, Respondent tried to gain the assistance of Betty Boling to take her home. Boling did not agree. When Dr. Lee returned to his office, which is also his place of residence, visitors came by and he consumed alcohol with those people. He then left a second time to make purchases at a store and when he returned, a Mr. Hobbs, who was a friend of Gilhousen, had arrived to pick the patient up. Hobbs observed Lee staggering and with slurred speech, indications of intoxication. Hobbs and Dr. Lee took Gilhousen to a car and she left with Hobbs. Gilhousen came back to Dr. Lee's office on January 15, 1983, to pick up her car and asked Dr. Lee if she needed to be prescribed any antibiotics for her post procedural circumstance. He told her that this would not be necessary at present and advised her to monitor her temperature. As reflected in Petitioner's composite Exhibit No. 5, Gilhousen was later seen at Memorial Hospital of Jacksonville related to her post abortion condition and was found to be acceptably recovering. It was noted on the basis of a pelvic sonogram that the abortion had been a success. Dr. Doris Newell Carson, M.D., a board-certified gynecologist and obstetrician, who practices in Jacksonville, Florida, was qualified as an expert and gave her medical opinion on the quality of the Respondent's performance in treating Ms. Gilhousen. Her testimony was premised upon an examination of the medical records of Dr. Lee pertaining to Sandra Gilhousen. Dr. Carson felt that in the insertion of an IUD, that Dr. Lee should have obtained the history of the patient's medical condition with particular emphasis on menstrual period and allergies because of the possibility of allergic reaction being brought about with the placement of the IUD. Physical examination was necessary to include heart, lungs, and abdomen and examination of the position of the uterus. In addition, it was necessary to take the blood pressure of the patient and to have laboratory work done related to hemoglobin, a gonorrhea culture and pap smear. Dr. Carson also felt that it was necessary to determine pregnancy by test, prior to the placement. All of these matters should be recorded in the patient records, per Dr. Carson. In addition, written permission should have been received prior to the placement of that IUD. Any physician who failed to do these things and document them, would have demonstrated less prudence than a reasonably prudent, similar physician. As established in prior facts found, Dr. Lee failed to record any of these matters and failed to obtain necessary medical history and to have necessary testing and laboratory work up envisioned by Dr. Carson. Her opinion as to what is needed for the placement of the IUD in the patient Gilhousen in order to achieve community standards in the place where Dr. Lee practiced is accepted. Based upon her opinion, Dr. Lee is found to have practiced medicine in the placement of that IUD with less care and skill than a reasonably prudent similar physician in his community would have been expected to give. Dr. Carson did not feel that Gilhousen, according to the patient's height and weight, needed Ionamin to control the patient's weight. Ionamin, a controlled substance, is a stimulatory drug which has addictive qualities, from Dr. Carson's understanding. The prescribing of the Ionamin on the information available to Lee was not the act of a prudent, similar physician who might be confronted with the same conditions and circumstances as Dr. Lee was when he prescribed Ionamin for Gilhousen, per Carson. Carson did not feel there was a medically justifiable reason for issuing the prescription of Ionamin. Moreover, Dr. Lee was deficient in the mind of Dr. Carson by not recording the issuance of the prescription in the patient's medical records. Dr. Carson's observations about Ionamin and the quality of Dr. Lee's performance in prescribing Ionamin to Gilhousen on January 7, 1983, are accepted. Dr. Carson was questioned on the matter of the abortion procedure which was performed on January 14, 1983. In giving her opinion, she was made aware of certain hypothetical facts related to the setting, time of day, nonavailability of a medical attendant, Dr. Lee's leaving the patient unattended, Respondent smoking marijuana and the offering of marijuana and other drugs to the patient, in addition to the matters set forth in the patient's record. In Dr. Carson's mind, a complete physical, including blood pressure, would be necessary prior to the termination; laboratory work, to include hemoglobin, to measure the amount of iron in the blood would be necessary; a CG culture and RH typing; and discussion with the patient as to allergies to medications would be necessary. In addition, a pregnancy test prior to termination would be indicated. The physician would also need a medical assistant in attendance and written permission would be necessary prior to the termination of the pregnancy. Dr. Carson would have used a D&E as opposed to D&C for termination of this early pregnancy and would not have used the form of anesthesia chosen by Dr. Lee. Her choice would have been a local block. Her testimony as to the choice of procedures and type of anesthesia does not lead to the conclusion that his choice of technique and anesthesia is below the level of care acceptable for a reasonably prudent, similar physician in the Jacksonville community. In Dr. Carson's opinion, it was inappropriate for Dr. Lee to smoke marijuana on the night of the abortion before conducting that procedure and to offer marijuana, hashish and cocaine to the patient. Dr. Carson felt that it was necessary to monitor blood pressure, and other vital signs related to pulse and respiration, the amount of flow from the site of the abortion and to give medication for pain as needed. Dr. Carson finds the act of leaving the patient unattended an unacceptable performance by Dr. Lee. Dr. Carson also believed that the patient's medical history, laboratory information and observations related to the physical examination should be recorded in the patient records and they were not. Per Dr. Carson, the failure to do those things she described related to the pregnancy termination would constitute substandard care to the patient, as would his use of marijuana and offering of illegal drugs to the patient. With the exception of Dr. Carson's opinions about the abortion technique, D&C, and type of anesthesia, her perception about appropriate care is accepted. By her description, this substandard care is tantamount to failure to provide care that a reasonably prudent, similar physician in a similar circumstance would have provided and Dr. Lee has not been sufficiently prudent in his treatment of Gilhousen on the date of the abortion, as shown in contrasting his performance as reported and Dr. Carson's idea of acceptable performance. BETTY BOLING Betty Boling requested assistance from Dr. Lee to control her weight. This request was made on January 7, 1983. Her blood pressure was checked and her weight taken. No other information was sought from the patient related to her history and no further examination was made of the patient as to her physical condition. Neither of these observations related to blood pressure and weight were recorded in her patient records, a copy of which may be found as Petitioner's composite No. 2, admitted into evidence. Boling was then prescribed 30 units, 30-milligram Ionamin by Dr. Lee. The record in this proceeding is left in the posture that the only basis of knowing the true circumstance of the patient Boling related to the need of weight reduction is her comment that she was overweight when she requested the provision of diet medication. This does not sufficiently justify the prescription of Ionamin and promotes the conclusion, based upon Dr. Carson's perception of the Gilhousen situation where Ionamin was prescribed, that there was no medical justification for prescribing Ionamin to Boling and that to do so was substandard care and not the care expected of a reasonably prudent, similar physician in dealing with the Boling case. (The prescription may be found in Petitioner's Exhibit No. 3.) On July 14, 1981, Dr. Lee prescribed for Betty Boling 30, 50-milligram Demerol units. On August 23, 1981, an additional 20, 50-milligram Demerol units were prescribed for Boling by Lee. On November 1, 1981, an additional 20, 50- milligram Demerol units were prescribed by Dr. Lee for Boling. On December 7 or 8, 1981, an additional 30, 50-milligram Demerol units were prescribed by Dr. Lee for the benefit of Boling. On December 7, 100, 300-milligram Quaaludes were prescribed for Boling by Dr. Lee. Finally, on February 19, 1982, 100 300- milligram units of Quaaludes were prescribed by Dr. Lee. The prescriptions of Demerol and Quaaludes may be found in Petitioner's composite Exhibit No. 3. Prescriptions indicate the basis for prescribing the Demerol was related to pain and the Quaaludes related to sleep. None of these prescriptions or the reason for the prescriptions are indicated in the patient records of Betty Boling, found as part of Petitioner's composite Exhibit No. 2, as a copy. Although Dr. Lee claimed to have conducted a physical examination on the patient before prescribing the Demerol and Quaaludes, that testimony is not believed. Moreover, Dr. Lee has no specific recollection of why he prescribed the Demarol for the patient as to the exact details. Dr. Lee had on occasion prescribed Demerol for migraine headaches for Boling. Dr. Lee indicated that other analgesic medication given for the migraine headaches had not been successful and that was why Demerol was used for the patient Boling. Dr. Lee's indication that he might not have entered the details of the prescription of Demerol and Quaaludes for Boling in her records on the occasions in question because of her concern that other persons who had access to her patient records not see those entries, is not tenable and is not accepted as fact. Especially in view of the fact that Boling does not have any recollection of such a request. Notwithstanding the risk to health in prescribing Quaaludes continually as recognized by Dr. Lee in his testimony at hearing, he prescribed Quaaludes in 100 units and in a further 100 units 70 days thereafter in the strongest dosage available. The methaqualone or Quaaludes were for purposes of assisting Boling in sleeping and the explanation given by Dr. Lee about the possibility of using more than one tablet per day within the 70 days in which the original 100 tablets had been prescribed is not accepted. Dr. Carson, after examining the Boling records, did not find any justification in the records for prescribing Demerol and Quaaludes, in the sense of a medical reason for such prescription. As Dr. Carson identified, Demerol is a narcotic analgesic, equivalent to morphine, with 60 milligrams of Demerol being comparable to 10 milligrams of morphine sulfate. Per Carson, Demerol is a drug highly susceptible to abuse, leading to addiction. For that reason, it is not appropriate for migraine headaches in that migraine headaches are repetitive in nature, thereby promoting greater chance of addiction. Demerol is a very potent respiratory depressant and can have allergic manifestations. Demerol and Quaaludes are Schedule II controlled substances. Quaaludes are a sedative which are used for inducing sleep and might be used for people suffering insomnia. Quaaludes have high potential for addiction and the substance became a street drug and has, since the time of this case, become illegal in the State of Florida. To use Demerol and Quaaludes together, according to Dr. Carson, would potentiate depression, thereby compounding effects of the drugs taken singularly. Dr. Lee's prescription of the Demerol and Quaaludes as described in the Boling circumstance, related herein, in the mind of Carson represented a failure of Lee to practice medicine with a level of care, skill and treatment recognized by reasonably prudent, similar physicians as being acceptable under similar conditions and circumstances and represented malpractice. It also was a prescription of controlled substance in bad faith not within the course of professional practice. These opinions by Dr. Carson, related to the Demerol and Quaaludes, and the practices of Dr. Lee in prescribing the substances for the patient Boling are accepted. MARGO STEWART No testimony was given related to the allegations found in Count Six pertaining to Margo Stewart and that count was abandoned by the prosecution.
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State of Florida, having been issued license number ME 0017602. He graduated from St. Louis University School of Medicine in 1966. He taught obstetrics and gynecology at the Portsmouth Naval Hospital in 1970-1972. He was board-certified in obstetrics and gynecology in 1972 and retired from the active practice of medicine in 1996. Licensed in Missouri, Virginia, and Florida, Respondent has never been disciplined by Petitioner or any other licensing authority. During his active practice of obstetrics and gynecology, Respondent specialized in high-risk obstetrics, i.e., the treatment of patients whose lives and pregnancies are at risk during the course of their pregnancy. He treated patients with diabetes, with heart disease, with blood disease, and with abnormal pregnancies such as ectopic pregnancies. He is well respected in the medical community, including by others who practice high-risk obstetrics. He enjoys a reputation for being a caring, concerned, intelligent, and capable physician. On November 30, 1993, R. C. was a 35-year-old patient who had been seen previously by Respondent's associate but not by Respondent. She had a long history of infertility and had been treated with fertility drugs. She had had one ruptured ectopic pregnancy that resulted in the removal of her right ovary. She had three failed attempts at in vitro fertilization. She reported to Respondent that she felt pregnant. She had taken three home pregnancy tests, which were positive. Her HMO primary care physician, following laboratory confirmation of her pregnancy, had referred her to Respondent. She advised Respondent that her last menstrual period was October 16, 1993. Respondent conducted a physical examination and agreed that she was pregnant. Her breasts were tender, and her uterus may have been a little soft but it was not enlarged. The presence of a normal-sized uterus at six weeks gestation, while not unusual, is one possible indication that a woman might have an abnormal pregnancy or be in the process of having a miscarriage. It raised the suspicion that the nature of her pregnancy, intra-uterine versus abnormal, must be considered by Respondent. However, enlargement of the uterus during pregnancy is different for each patient. Significantly, R. C. did not have any bleeding. She had no abdominal pain, and no adnexal masses were palpated. Essentially, she was asymptomatic for an abnormal pregnancy. Because of her history, Respondent considered R. C. to be at a higher risk for an abnormal or ectopic pregnancy than that expected for a normal female from the general population. It is generally understood that the risk of a repeat ectopic pregnancy is between 10 and 15 percent. Respondent was aware that even with an ectopic pregnancy, the uterus undergoes many of the changes associated with an early normal intra-uterine pregnancy, including an increase in uterine size and softening of the cervix. These changes occur as a result of the hormones circulating through the body during the early stages of pregnancy. Concerned since R. C. was at risk although asymptomatic, Respondent decided that the prudent course would be to evaluate R. C.'s pregnancy to rule out an ectopic or other abnormal pregnancy. Consequently, he took steps different from those that would be taken during a normal routine pregnancy. Respondent obtained an immediate quantitative human chorionic gonadotropin (hCG) value that day. The quantitative hCG is a diagnostic test available to physicians to evaluate the progress of a pregnancy when there is concern as to its nature. It is not a test that is ordered when there is no concern as to the nature of the pregnancy. The test measures the secretions of the placenta. It confirmed R. C.'s pregnant state and was an indicator of the presence of a placenta somewhere in her body. The hCG value was reported as 7,371. By itself, the hCG value told Respondent little about R. C.'s pregnancy. It did, however, provide some comfort that R. C. might have an intra-uterine pregnancy, particularly given her lack of symptoms for an ectopic pregnancy. It is generally understood that less than 25 percent of ectopic pregnancies have hCG values greater than 6,000. With an hCG value greater than 7,000, R. C. was in the group more likely to have an intra-uterine pregnancy. Her lack of symptoms also indicated that she had an intra-uterine pregnancy. It is generally understood that bleeding is present in over 85 percent of cases where there is an ectopic pregnancy. Pain is present in over 90 percent of the cases where there is an ectopic pregnancy, and over half of such women have palpable adnexal masses or lumps. R. C. was not experiencing any of what are known as the classic triad of symptoms for an ectopic pregnancy. Respondent obtained the hCG to be used as a baseline. The quantitative hCG is best used serially, and a single value has no real meaning in evaluating the nature of a pregnancy. By repeating the test at certain intervals, a physician can observe where the pregnancy might be going from a hormonal point of view. The initial value is a starting point from which other tests can be used to determine if the pregnancy is likely normal or abnormal. In an early normal intra-uterine pregnancy, the hCG values generally double approximately every 48 hours. Then, the rise begins to plateau, and the doubling time lengthens. To determine the course of a pregnancy, repeat tests of the hCG at set intervals can be an aid in the diagnosis of ectopic pregnancies. The possibility of an ectopic or other pathologic pregnancy exists when the hCG value fails to rise in accordance with the expectations of a normal intra-uterine pregnancy or does not rise at all. Although R. C. was asymptomatic, given her history, Respondent determined that he should obtain a repeat hCG and an ultrasound examination to confirm the presence of an intra- uterine pregnancy. He scheduled the repeat hCG and the ultrasound to be performed 7 to 10 days from that visit, or December 9, 1993. Respondent's plan of treatment was reasonable under the circumstances. If R. C. had had any of the classic symptoms consistent with an ectopic pregnancy, the standard of care would have required an immediate ultrasound. However, R. C. did not have any symptoms. It is a matter of physician judgment as to when an ultrasound examination and repeat hCG should be obtained for an asymptomatic patient. When there is no urgent need for the tests, the standard of care does not define the time frame in which the tests should be performed. Respondent wanted to wait another 7 to 10 days to allow for better visualization of the fetus on the ultrasound and to avoid a misinterpretation of the result of the repeat hCG test. By waiting, Respondent would likely obtain more useful information from the ultrasound than if the ultrasound were performed that day or during the next few days. He wanted to combine the findings of the ultrasound with the results of the repeat hCG test. Reasonably-prudent, similarly-trained physicians support Respondent's conclusions. The possibility of a misinterpretation of the hCG results is lessened by the passage of a reasonable period of time between tests. Before she left the office on November 30, 1993, R. C. was asked to contact Respondent in two days to obtain the results of her initial hCG test and to follow-up on her condition. On December 2, 1993, R. C. contacted Respondent. During their telephone conversation, R. C. expressed concern that her pregnancy might be in the fallopian tube rather than the uterus. Respondent wanted to calm her fears. He inquired as to how she was doing, and she reported that she was doing fine, no bleeding or pain. Generally, an ultrasound is not performed until at least the fifteenth or sixteenth week. After speaking with R. C. on December 2, 1993, Respondent continued with his plan to obtain an ultrasound evaluation of R. C. in her 7th or 8th week of gestation. Her history indicated that Respondent should confirm the nature of her pregnancy, and Respondent took those steps necessary to monitor and confirm R. C.'s condition. At approximately 6:00 p.m. on December 6, 1993, R. C. contacted Respondent's office and spoke with his midwife. R. C. complained that she was having some cramping that began after she had eaten a very heavy meal. This is not an unusual complaint during a pregnancy. R. C. reported that the cramping was resolving, but she just wanted to touch base with someone. The midwife advised her to go to the emergency room if the cramping worsened during that evening or if she was concerned. The midwife also advised R. C. that if she felt better by morning but not completely better, she should come in to the office. If she felt fine, she should keep her scheduled appointment for the ultrasound. The advice given to R. C. by the midwife was appropriate and consistent with the standard of care. R. C. began to experience severe lower abdominal pain on the morning of December 7, 1993, and was taken to the emergency room of Bethesda Memorial Hospital. She did not have any vaginal bleeding. Respondent was present in the hospital when R. C. arrived at the emergency room, and he came immediately upon being called. An ultrasound was performed and confirmed that the uterus was empty except for a pseudo-gestational sac. A viable ectopic pregnancy was seen in the left adnexal area with an estimated gestational age of 6 weeks. Respondent assessed R. C. as having a leaking tubal pregnancy, and he had her taken to surgery immediately following the ultrasound. Respondent removed her left tube and ovary and provided blood transfusions due to free blood found in the abdomen. R. C. experienced a fever following the surgery, but she recovered and was discharged from the hospital. Respondent's plan and action in evaluating R. C. on her November 30, 1993, visit to his office were in accordance with the standard of care, and were reasonable and appropriate. The patient's telephone report of doing well on December 2, 1993, strengthened Respondent's judgment that there was no immediate need to obtain an ultrasound and repeat hCG and that he could wait until those tests were likely to be reliable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 23rd day of February, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of February, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Britt Thomas, Esquire M. Rosena Hitson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602
