The Issue This is a license discipline case in which a medical doctor is charged by administrative complaint with five counts of violations of paragraphs (h), (k), (m), and (t) of Section 458.331(1), Florida Statutes (1988 Supp.).
Findings Of Fact Findings based on parties' stipulations The Respondent, Vladimir Rosenthal, M.D., (hereinafter "Respondent" or "Dr. Rosenthal") is, and at all material times was, a medical doctor, license number ME 0045574, who practiced at 1320 South Dixie Highway, Coral Gables, Florida. Dr. Rosenthal at all material times owned the business operating as Today's Women Medical Center located at 1320 South Dixie Highway, Suite 1070, Coral Gables, Florida. On or about November 3, 1988, Dr. Rosenthal performed an elective abortion on patient B.F. under general anesthesia. On or about November 3, 1988, Dr. Rosenthal ordered a pathology report of the products of the procedure performed on patient B.F. The pathology report regarding patient B.F. bears the date November 8, 1988. The pathology report revealed no chorionic villi and recommended a "close follow-up" of the patient. Missed abortion and continued pregnancy is a recognized risk of early (first trimester) abortions. Patient B.F. suffered no harm as a result of the November 3, 1988, procedure. On or about December 7, 1988, patient B.F. presented to Dr. Rosenthal. On or about December 7, 1988, patient B.F.'s uterus was examined and found to be enlarged. Subsequently, a repeat pregnancy test was performed on patient B.F., which revealed she was still pregnant. On or about December 10, 1988, Dr. Rosenthal performed a second abortion on patient B.F. with positive results. Patient B.F. suffered no harm as a result of the December 10, 1988, procedure. Findings based on evidence at hearing The Respondent specializes in the area of gynecology, but does not practice obstetrics. In the course of his medical practice he regularly performs first trimester abortions. The Respondent is very experienced in the performance of first trimester abortions. In recent years he has averaged five thousand (5,000) such procedures per year. Patient B.F. normally goes to Dr. Nahid Mansoori for routine treatment of gynecological matters. Patient B.F. was seen by Dr. Mansoori on October 28, 1988, with a history of a missed menstrual period. Dr. Mansoori examined the patient and observed that the patient had an enlarged uterus and appeared to be 5 or 6 weeks pregnant. The patient expressed an interest in having an abortion. Because Dr. Mansoori does not perform abortions, she referred patient B.F. to the Respondent. Dr. Mansoori also referred patient B.F. to Dr. Martin S. Goldstein for an ultrasound examination. Dr. Mansoori referred patients to the Respondent on a regular basis. She did so for several reasons, including the facts that (a) patients she referred to the Respondent uniformly reported back to her that they were pleased or satisfied with the services they received from the Respondent, (b) none of her patients had complained about their treatment by the Respondent, and (c) none of the patients she had referred to the Respondent had experienced any infection or problems. On October 31, 1988, Dr. Martin S. Goldstein performed an ultrasound examination of patient B.F. On the basis of that ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 6 weeks, 0 days. Dr. Goldstein also concluded and reported that patient B.F. had an intrauterine pregnancy, thus ruling out an ectopic pregnancy. On November 3, 1988, patient B.F. went to the Respondent's clinic at 1320 South Dixie Highway for the purpose of having an abortion. The Respondent remembers this particular patient because she was a medical professional and her husband was an attorney. Because of their respective professions, the Respondent was extra careful to explain everything involved in the process to both B.F. and her husband. He especially explained to both of them the importance of a post-abortion follow up examination at either the Respondent's clinic or at the office of the patient's regular gynecologist. Patient B.F. said that she would return to Dr. Mansoori, her regular gynecologist, for the follow up examination. When patient B.F. went to the Respondent's clinic on November 3, 1988, she told the Respondent that she had had an ultrasound examination. The Respondent called Dr. Mansoori and Dr. Mansoori told him that the results of the ultrasound examination indicated a "gestational age" 1/ of six weeks and that the ultrasound examination confirmed an intrauterine pregnancy. Dr. Mansoori also mentioned that her clinical examination of patient B.F. indicated a "gestational age" of five or six weeks. Upon manual examination of the patient, the Respondent concluded, and noted in the patient's medical record, that patient B.F.'s uterus was enlarged to a size consistent with a "gestational age" of five weeks. Later that same day, the Respondent performed an abortion procedure on patient B.F. Following the abortion procedure, patient B.F. took antibiotic medication for several days, which medication had been prescribed and/or dispensed by the Respondent. The Respondent ordered a pathology report of the products of the abortion procedure performed on patient B.F. on November 3, 1988. The Respondent does not order pathology reports on all of his patients, but he did so in this case because it was an early pregnancy, and also because he wanted to take extra care in view of the professions of B.F. and her husband. The pathology laboratory is supposed to call Dr. Rosenthal on all "abnormal" reports. Sometimes the laboratory fails to call and sometimes the laboratory fails to send a written report. The Respondent has established office procedures for handling laboratory reports to try to prevent any reports from going astray and to identify those that do go astray so that follow up activity may be taken. Pursuant to the Respondent's established office procedures, all laboratory reports received at the clinic must be seen and signed by the Respondent before being placed in a patient chart. When a patient returns for her follow up visit, the laboratory report is reviewed during the course of that visit. If a laboratory examination has been ordered, but there is no laboratory report in the chart at the time of the follow up visit, the laboratory is called by telephone. The Respondent usually makes these calls himself. Pursuant to the Respondent's established office procedures, missing laboratory reports for patients who do not return for follow up visits or who return to their regular physicians for follow up visits are picked up when monthly reports to the Department of Health and Rehabilitative Services are compiled and submitted. In order to complete these monthly reports, a log is kept of every patient who has an abortion procedure performed at the Respondent's clinic. The information kept in the log and reported to DHRS includes: the date of surgery, the estimated "gestational age" of the patient, whether a pathology report was ordered, the results of the pathology report, and the date the pathology report was received by the clinic. Such forms were in use at the time B.F. was a patient at the Respondent's clinic. If any pathology reports "fell through the cracks," they were picked up each month when the reports were prepared. The reports are usually prepared on the ninth or tenth of each month. The implementation of these office procedures for the purpose of following up on laboratory reports is sufficient to comply with applicable standards of medical care. The pathology laboratory prepared a report regarding the material removed from patient B.F. during the November 3, 1988, abortion procedure. The written laboratory report was dated November 8, 1988. The most significant finding noted on the laboratory report was "no chorionic villi." Because of this finding, the laboratory report also stated: "close follow up of patient is recommended." The significance of the notation of "no chorionic villi" is that it indicates that the pathology laboratory examination did not reveal evidence of any fetal tissue or other "products of conception." The need for close follow up in this instance is because the absence of chorionic villi can be due to a number of different things. 2/ On November 18, 1988, patient B.F. went to Dr. Mansoori's office for a post-abortion follow up visit. At that time the patient was complaining of a vaginal "yeast" infection, a not uncommon occurrence following a course of antibiotic medication. Dr. Mansoori treated the patient's "yeast" infection with a prescription for Monistat Vaginal Cream. Dr. Mansoori's medical records for that day also include the following notations regarding the patient B.F.: "Had abortion by Today's Woman. Post AB check up O.K." 3/ Dr. Mansoori told patient B.F. to get back in touch with her if the patient missed her next menstrual period. On December 6, 1988, patient B.F. called Dr. Mansoori to report that she had missed her menstrual period. Dr. Mansoori advised her to return to the Respondent and patient B.F. agreed to do so. Dr. Mansoori called the Respondent to advise him that patient B.F. would be returning because she had missed her menstrual period. Dr. Mansoori also arranged for another ultrasound examination to be performed on patient B.F. by Dr. Goldstein. On December 7, 1988, patient B.F. returned to the Respondent's clinic where she was seen and examined by the Respondent. Examination revealed that the patient's uterus was mildly enlarged. A pregnancy test administered that day indicated that the patient was still pregnant. On December 7, 1988, the Respondent realized that he did not have a report from the pathology laboratory, so he called the laboratory and was advised that the most significant finding of the pathology report was "no chorionic villi." The substance of the telephone conversation with the pathology laboratory was noted in the patient's medical record. When he made the telephone call to the pathology laboratory on December 7, 1988, the Respondent had not received the laboratory's written report dated November 8, 1988, 4/ nor had he been otherwise advised of the results of the pathology study of the materials removed during the November 3, 1988, abortion procedure. On December 8, 1988, Dr. Martin S. Goldstein performed a second ultrasound examination of patient B.F. On the basis of the second ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 11 weeks, 6 days. This second gestational age was three days older than one would have predicted based on the October 31, 1988, ultrasound examination. In both of the ultrasound examinations of patient B.F., Dr. Goldstein relied upon the "crown rump" measurement as the basis for his estimate of "gestational age." On December 10, 1988, when patient B.F. returned to the Respondent's office for the second abortion procedure, the Respondent conducted a clinical examination of the patient before commencing the procedure. On the basis of his own clinical examination of the patient, the Respondent was of the opinion that patient B.F.'s "gestational age" was 8 or 9 weeks. He reported this on the "Physical Exam" portion of the patient's chart by writing "8-9" beside the entry for uterus. After the patient was anesthetized and the Respondent could examine her while she was more relaxed, the Respondent further examined the patient's uterus and was of the opinion that its size corresponded to a "gestational age" of 8 weeks. He noted this opinion in the "Operative Notes" portion of the patient's chart. It was, and continues to be, the Respondent's opinion that his December 10, 1988, estimates of the patient's "gestational age" were correct. Although he was aware of Dr. Goldstein's ultrasound examination which reported a somewhat older "gestational age," the Respondent had confidence in his own clinical findings and relied on his own clinical findings, which he duly recorded in the patient's medical chart. Relying on his own estimate of "gestational age," the Respondent performed the abortion procedure on December 10, 1988, on patient B.F. with a number eight suction tip. The abortion procedure was accomplished successfully and without any difficulty or complication. A report from a pathology laboratory confirmed that the December 10, 1988, abortion procedure was successful. 5/ The prevailing standards of acceptable care do not require a physician to order a pathology examination of the material removed during the course of a routine first trimester abortion procedure. In an abortion procedure involving a very early pregnancy, a physician may wish to order such a pathology examination in order to be more certain as to the results of the procedure, but it is a matter of physician preference, rather than a requirement. A physician who orders a pathology examination of the material removed during a first trimester abortion procedure has an affirmative duty to follow up on the examination and find out the results of the examination within a reasonable period of time. 6/ The Respondent's follow up on December 7, 1988, on the results of the pathology examination of the material removed from patient B.F. during the November 3, 1988, procedure was reasonable under the circumstances. 7/ The Respondent's delay until December 7, 1988, before following up on that pathology examination was not a departure from applicable standards of medical care. 8/ The Respondent's medical records for patient B.F. justify the course of treatment of the patient. The use of ultrasound examination as a method of estimating "gestational age" is not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of ultrasound examination are accurate within a margin of error of plus or minus two weeks. 9/ Clinical or manual examination of a patient as a method of estimating "gestational age" is also not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of clinical or manual examination of a patient are accurate within a margin of error of plus or minus two weeks, if done by an experienced physician. It is not a departure from applicable standards of medical care for an estimate of "gestational age" to vary from the actual "gestational age" by as much as plus or minus two weeks when the estimate is based on the physician's clinical or manual examination of the patient. A reasonably prudent physician who is experienced in clinical or manual examination of patients for the purpose of estimating "gestational age" should rely on his own findings, even if those findings appear to conflict with findings based on ultrasound examination. Such a physician should also note his own findings on the patient's medical records, regardless of what is reported by the ultrasound. There is no great discrepancy between the estimate of "gestational age" reported in Dr. Goldstein's ultrasound report of December 8, 1988, and the Respondent's estimate of "gestational age" on December 10, 1988. The Respondent's notations in patient B.F.'s medical records on December 10, 1988, to the effect that her pregnancy was of a "gestational age" of eight weeks was an honest notation of the Respondent's clinical judgment and was not a statement the Respondent knew to be false. 10/ Similarly, those notations were not deceptive, untrue, or fraudulent representations. On or about August 3, 1989, the Respondent's clinic, known as Today's Woman Medical Center, located at Suite 1070, 1320 South Dixie Highway, Coral Gables, Florida, was inspected by an employee of the Office of Licensure and Certification of the Department of Health and Rehabilitative Services. 11/ At the time of that inspection the Respondent was not present at the clinic, there were no procedures being performed at the clinic, and there were no patients at the clinic.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be entered in this case DISMISSING all charges against the Respondent, Vladimir Rosenthal, M.D. DONE AND ENTERED this 2nd day of October, 1992, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of October, 1992.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 26th day of January, 2010.
Findings Of Fact The Respondent Gonzalez The Respondent Maria B. Gonzalez is a medical doctor holding Florida license number ME 0028019. She has been licensed to practice medicine in Florida since 1975. Prior to the instant proceeding, her license to practice medicine has never been suspended or revoked. The Respondent has taken and passed the written test for board certification as a specialist in obstetrics and gynecology, but was refused permission to complete the exam because her privileges had by then been suspended by Hollywood Memorial Hospital. During the course of her practice in Cuba and Florida, the Respondent has delivered approximately 2,000 babies. To her knowledge, she has never had a maternal or infant death occur during her practice. The Respondent's practice at Memorial Hospital was highly unusual in that almost half of her patients were Medicaid. As a result, Respondent encountered difficulties in dealing with some of the members of the medical staff at Memorial since she believed that her patients medical interests should take precedence over their ability to pay for services. 1/ The Respondent's provisional staff privileges at Memorial were suspended on July 28, 1982, based upon a review by an ad hoc committee of the hospital's obstetrics and gynecology staff, of six cases, five of which form the basis of the instant proceeding. In deciding to terminate the Respondent, the ad hoc committee considered pertinent medical records and statements from witnesses but did not hear the direct testimony of the Respondent. When the decision was made by Memorial to terminate the Respondent, the hospital informed the Petitioner of this fact pursuant to Section 458.337, Florida Statutes, which requires that the Department be notified when any physician has been disciplined by a licensed hospital for any act that constitutes a violation of Chapter 458, Florida Statutes. Count One Aida M. Astiazarian On December 25, 1981, the Respondent performed a bilateral tubal ligation on Aida M. Astiazarian, a patient who had vaginally delivered an infant several hours prior to the operation. During the procedure, the Respondent was assisted by Dr. Purificacion D. Catini, a surgical assistant. The patient was anesthetized by Dr. Gary Karch. The tubal ligation on Astiazarian began with the opening of the abdominal cavity. Several adhesions from prior surgery and two small bleeders were noticeable, specifically a bleeder on the anterior abdominal wall and on the anterior surface of the uterus. The Respondent ligated the bleeder on the anterior abdominal wall and controlled the oozing from that source. The Respondent elected not to suture or ligate the oozing on the anterior surface of the uterus as recommended by Dr. Catini and instead used a four-by-four inch section of Gelfoam to control the bleed. The Gelfoam was applied with a laparotomy paid and removed after a few minutes. Believing that hemostasis had been achieved, the Respondent closed the abdominal cavity. Unlike the Respondent, Dr. Catini believed that hemostasis had not been achieved since she noticed some oozing still occurring after the Gelfoam was applied. Following the operation the patient's hemoglobin, hematocrit and blood pressure began to fall. The likely cause of these symptoms was an intra- abdominal bleed or ooze. The patient was transfused with several units of blood and discharged from the hospital. Although a reasonably prudent physician would not close a patient with an active ooze or bleed, the record fails to establish that the Gelfoam was ineffective and the Respondent knew or should have known that hemostasis had not been achieved. 2/ Uterine oozing in a postpartum patient can occur without any negligence by a treating physician. The loss of blood which occurred following this operation is not inconsistent with the Respondent's assertion that hemostasis had occurred and that sometime later the clot had become dislodged, thereby causing the bleed which resulted in the administration of two units of blood. Count Two Jaclyn R. Osier On December 28, 1981, the Respondent performed a postpartum tubal ligation on Jaclyn R. Osier. She was assisted during the procedure by Dr. David Gordon. During the operation, a tear in the broad ligament occurred and the patient began to hemorrhage profusely. The tear of the broad ligament which occurred during the procedure was an inherent risk of surgery and does not, by itself, demonstrate negligence by the Respondent. The Respondent extended the incision and located one of the bleeders; however, due to the nature of the tear and the physical condition of the patient, she was unable to locate and control other bleeders which were deeper in the abdomen. Due to the blood loss experienced by the patient, Dr. Gordon determined that additional help was needed. He left the operating room and sought assistance from Dr. Raymond Nolan. When Dr. Nolan arrived, he made an additional extension of the incision and with assistance from the Respondent and Dr. Gordon, he was successful in locating the deep bleeders and achieving hemostasis. Under the circumstances, it was appropriate medical practice for either the Respondent or Dr. Gordon to seek additional help when the patient's bleeding was not under control. As noted by Dr. Nolan "...Just as two heads are better than one, four hands are better than two." (Tr. at 369.) Significantly, Dr. Nolan, a surgeon who had operated with the Respondent on this case as well as others, did not believe that the Respondent's license should be revoked based on his actual experiences with the Respondent. Following this incident, Dr. Nolan did not have any immediate concern that the Respondent had acted improperly. Although Dr. Nolan later voted to suspend the Respondent's hospital privileges at Memorial, his vote was based on the recommendation of the hospital's ad hoc committee rather than his own personal experiences with the Respondent or his own independent review of pertinent medical records. The intra-operative complication which occurred in this particular case was not the result of the Respondent's negligence. When the Respondent was unable to control the bleeding with Dr. Gordon after the incision had been extended, another surgeon was called to assist. The Respondent's inability to control the bleed prior to Dr. Nolan being called, does not constitute negligence under the circumstances of this case. Count Three Linda Jones On May 28, 1982, at 9:45 p.m., Linda Jones, a high risk and postdate patient was admitted to Memorial. The Respondent examined the patient on the morning of May 29, 1982, and found her to be in labor. The practice at Memorial was that provisional staff physicians, such as the Respondent, handle all service or indigent patients. Linda Jones had been handled by Dr. Kast, another provisional staff physician. On the day the Respondent examined the patient, she was covering for Dr. Kast, who had asked as a courtesy to be relieved until 1:30 p.m. The labor and delivery of pregnant service patients at Memorial are handled by nurse/widwives, unless a complication arises which requires a surgical procedure. The patient was scheduled for a normal vaginal delivery. She was doing well and was placed on a fetal monitor. At approximately 12:25 p.m., the patient started having episodes of decelerations. Nurse/Midwife Jean Tease, R.N., turned off the Pitocin which had been administered and turned the patient to relieve the decelerations. The patient continued to progress until approximately 1:22 p.m., when rapid decelerations on the fetal monitor were observed. At approximately 12:00 p.m. the Respondent left Memorial to attend a wedding in Fort Lauderdale which was a twenty minute drive from the hospital. She notified the nursing staff where she was going so that she could respond if needed. 3/ Nurse Tease contacted both Dr. Kast and Respondent when the patient's symptoms began to worsen. The Respondent returned the call and when informed of the problem, advised Tease that she would return to the hospital. The Respondent was returning to the hospital via Interstate 95 when it began to rain very heavily. Her front brakes froze and her car was immobile. While it continued to rain, Respondent pulled over on the side of the Interstate and attempted to flag down help. A wrecker operator stopped and towed her car to a service station where it was repaired. Meanwhile, since the Respondent had not arrived at Memorial as she had stated, Nurse Tease placed a page for any obstetrician in the hospital, and Dr. David Lessin responded. Dr. Lessin performed an emergency cesarean section and produced a living baby. The Amended Administrative Complaint does not allege that the Respondent was negligent in leaving the hospital; rather it charges that the Respondent breached a duty owed to this patient by failing to come to the hospital until approximately four hours after advising hospital personnel that she was in route. Due to mechanical problems with her car and the weather, it was impossible for the Respondent to return to the hospital to attend this patient. The Respondent believed that Dr. Kast was on duty after 1:30 p.m., and she knew she could not arrive at the hospital before that time. Under the circumstances, her actions regarding this patient were not negligent. Count Four Ramona Cardullo Ramona Cardullo was admitted to Memorial on the morning of May 28, 1982. Mrs. Cardullo was pregnant with her third child who was ultimately successfully delivered by cesarean section. Prior to this pregnancy, Mrs. Cardullo had experienced significant difficulties during the delivery of her two other children. Her first child, who was born following induced labor in Texas, was a month post-mature. Her second child was delivered at Memorial by another obstetrician following induced labor. The second child was delivered through the use of forceps. The problems which Mrs. Cardullo encountered in her two previous pregnancies resulted from a uterine dysfunction in which her cervix failed to dilate sufficiently to permit a normal delivery. When Mrs. Cardullo came to the Respondent during her third pregnancy, she related her previous obstetrical history and its attendant difficulties to the Respondent. In addition to her historical problems, Mrs. Cardullo had also gained 80 pounds during her third pregnancy. When Mrs. Cardullo began her prenatal care, she was living in Hollywood, Florida, with her husband. During her pregnancy, the couple moved to Wauchula, Florida. Since Mrs. Cardullo did not believe that Wauchula had appropriate hospital facilities, she commuted to Fort Lauderdale from Wauchula during the last three months of her pregnancy. The Respondent, however, was unaware that Mrs. Cardullo had moved from Hollywood. On May 28, 1982, Mrs. Cardullo, while home in Wauchula, began passing membranes and started to go into labor. She informed her husband that she was in labor, and called the Respondent. After driving from Wauchula, the couple met the Respondent at Memorial where the patient was examined. The examination revealed that Mrs. Cardullo was not dilating and the Respondent told her to begin walking. She walked around the hospital until later that afternoon, when tests were performed by the Respondent to ensure that the baby was okay. The Respondent put the patient in the labor room and began Pitocin to augment her labor. A nurse in the labor room told Mrs. Cardullo that other patients needed the room more than she did and contacted another physician who ordered the Pitocin to be turned off and the patient sent home. Mrs. Cardullo and her husband returned to Wauchula while she was still in labor. Approximately three hours after arriving home, Mrs. Cardullo began passing "... a lot of stuff." (Tr. at 900.) Mr. Cardullo called the Respondent, informed her of his wife's condition, and stated that they were coming back to the hospital. The couple arrived at Memorial on May 30, 1982, and Mrs. Cardullo was readmitted. Although Mrs. Cardullo's labor had continued throughout this period, her cervix had not dilated. The Respondent discussed a cesarean with the patient, who had requested the procedure be done based on her vaginal experiences in two prior pregnancies, and decided to attempt to dilate the cervix before performing surgery. Approximately ten hours after Mrs. Cardullo's readmission and five hours after her water had broken, the Respondent came to the conclusion that the Pitocin was not working since the patient's cervix still had not dilated properly and that a cesarean would be necessary. Mrs. Cardullo had no problems with the cesarean delivery and was pleased with the quality of care she received from the Respondent. Mrs. Cardullo stated that the Respondent was different from other doctors she had encountered in that she believed the Respondent cared about her and her problems. The Respondent's care and treatment of Mrs. Cardullo was appropriate considering the patient's prior medical history. The only criticism that could be directed toward the Respondent in her handling of the Cardullo case is that she waited too long to perform the cesarean by not giving sufficient consideration to the input from her patient. Count Five Elina Carrasco On December 17, 1982, the Respondent performed an abdominal hysterectomy on Elina Carrasco at International Hospital in Miami, Florida. During the procedure the Respondent was assisted by Dr. Francisco Sarmiento. The patient had a large amount of fibrous tissue and adhesions from prior abdominal surgery which made it difficult for the Respondent to visualize the operative site. The adhesions which surrounded the uterus, bladder, omentum, intestines, the right ovary, a segment of the left fallopian tube, and the abdominal wall, had formed a mass which required dissection to reach the pelvic cavity. While dissecting the mass of adhesions, the Respondent cut the patient's illiac vein which was located underneath the adhesions, thus causing the operative field to fill with blood. While Dr. Sarmiento placed his finger on the vein to stop the bleed, Respondent requested and placed a hemostatic clamp on the vein and requested a cardiovascular team to assist. At the time of the surgery, the practice at International was to place regular surgical clamps on a surgical tray rather than non-crushing clamps, when a standard gynecological procedure was performed. Accordingly, the sterile surgical tray which was prepared for this patient did not contain non-crushing clamps, although such clamps were available at the hospital. The surgical clamp was left on the patient only until the cardiovascular team arrived. Because a crushing clamp had been used, Dr. Junco, the surgeon who repaired the severed vessel, felt that a crush type injury to the underlying artery which was immediately adjacent to the severed vein, had occurred. The pathology report does not indicate that any clots or sections of artery were removed from the patient, although the operative records indicated two small clots were removed from the artery. The crush injury was not severe in that after the insertion of a fogarty catheter, proximal and distal blood flow was restored without requiring the removal of the crushed portion of the artery. Dr. Junco closed the vein and repaired the artery. After surgery, the patient improved and was discharged from the hospital on December 30, 1982, in stable condition. The basis of the charge against the Respondent in her care and treatment of Ms. Carrasco involves essentially one issue; whether it was below the standard of care for the Respondent to clamp the patient's vein with a device which could and did cause a crush injury to an underlying artery, 4/ in order to control bleeding from the illiac vein. In retrospect, the wiser course in this case would have been to take the time to obtain a non-crushing clamp from the rotating nurse while Dr. Sarmiento controlled the bleed through use of finger pressure. The unfortunate event which occurred in this case did not result from any lack of surgical or other skills by the Respondent. The Petitioner has characterized the Respondent's reaction to the transected artery and use of a hemostatic clamp as panic, while the Respondent has characterized it as a desire to use the first clamp available to control the bleeding as quickly as possible. Additionally, the Respondent needed Dr. Sarmiento to assist and while he was holding the artery, he was obviously unable to offer any other form of help. Under these circumstances, the Respondent's use of a hemostatic clamp does not demonstrate that she "panicked" in the operating room or that her decision to use the clamp fell below an acceptable standard of care. Count Seven Deborah J. Cox On June 6, 1982, the Respondent examined Deborah J. Cox and was present with her in the labor room throughout the patient's labor. The fetus was first on an external and then an internal monitor throughout labor. The Respondent requested that Dr. Antonio Mata, a neonatologist, be present for the delivery. When Dr. Mata came into the labor room, he checked the fetal monitor and noticed signs of moderate fetal distress. The combination of Pitocin, which was administered to the patient, and distressive labor, placed stress on the fetus as indicated by the fetal monitoring strips. The patient was transferred from the labor room to the delivery suite. In an effort to deliver the baby which was exceptionally large, it was necessary for the Respondent to use forceps because the baby's head was high and the mother's uterine surface remained thick even though she was well dilated. When the forceps were applied, the baby went into severe distress. The Respondent called for an emergency cesarean section, but the operating assistant was not available. Since it was necessary to deliver the baby as quickly as possible to avoid a stillbirth or permanent damage, the Respondent reapplied the forceps and attempted delivery. The baby was a very difficult delivery due to its size. It became stuck in the birth canal which required that the Respondent rotate its shoulders to effectuate delivery. While manipulating the baby, shoulder dystocia occurred. The Respondent elected not to perform the cesarean when it was first indicated, because of a hospital rule which prohibited the performance of a cesarean section without the presence of a surgical assistant. Due to the continuing difficulties she had encountered at Memorial, she was understandably reluctant to violate a hospital rule which would have subjected her to additional problems at Memorial. However, notwithstanding the legitimacy of the Respondent's personal concerns, the best interests of this patient required that a cesarean section be performed as soon as it became evident that the baby was not tolerating labor and that a vaginal delivery would place added and unnecessary stress on both the mother and child. The decision not to perform a cesarean, and instead deliver the baby vaginally through the use of forceps, created a situation which resulted in the fetus being born with an Apgar rating of 0 and possible permanent injury. By failing to perform a cesarean section when it was medically indicated, the Respondent's care and treatment of Deborah J. Cox fell below acceptable standards of obstetrical practice.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent (1) guilty of violating Count Seven of the Amended Administrative Complaint; (2) dismissing Counts One, Two, Three, Four and Five of the Amended Administrative Complaint; and (3) placing her on probation for six months subject to the condition that during this period she be required to practice obstetrics and/or gynecology under the general supervision of a board certified physician. DONE and ENTERED this 18th day of November, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Department of Administration Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 1983.
The Issue Whether the Respondent committed the acts attributed to her and whether such acts constitute a violation of the statutes and rules.
Findings Of Fact Carolle L. Baya is a licensed lay midwife holding a license issued by the Petitioner. Exhibit 1 is a composite of certified copies of birth certificates of babies at whose births Ms. Baya attended. Ms. Baya was very late on over 17 occasions in initiating the registration of the birth of a child whom she had delivered. On two additional occasions, she was so late that a delayed certificate of birth had to be prepared. Frances Friedl was seen by Dr. Sudesh Metah, M.D., at the hospital on April 9, 1988, at 8:30 a.m., for delivery of her first baby. She had been admitted through the emergency room and referred to obstetrics where Dr. Metah was the on-call doctor. When initially seen at the hospital, Ms. Friedl was in active labor. From the admission notes prepared by the labor and delivery nurse, Ms. Friedl started labor between 5:00 and 6:00 p.m. on April 8, 1988; and her water broke about 12:30 a.m. on April 9, 1988. Ms. Baya stated to Dr. Metah when Ms. Friedl was admitted that she had done a pelvic examination at 3:30 a.m. and had determined that Ms. Friedl was in second stage labor. The patient confirmed this information. Although Ms. Friedl had been and was pushing, the birth of the baby had not and was not progressing. At 8:30 a.m. when the doctor saw her, she was fully dilated and the baby had not descended into the birth canal. Ms. Friedl had remained in second stage labor over four hours before admission to the hospital. Dr. Metah considered two (2) hours of second stage labor long enough, with medications, epidural anesthesia, and with progress towards delivery by the patient. Dr. Metah considered three (3) hours to be the maximum for a woman to remain in second stage labor without medical intervention. Dr. Metah had to rotate the baby, who was in a vertex posterial presentation, in order for the baby to be delivered. The baby was a female, 7 pounds, 5-1/2 ounces, with Apgars of 9-10 or 9-9. 1/ She was born 1-1/2 hours after the mother's admission to the hospital. The baby was delivered as soon as possible at the hospital. Ms. Baya did not transport Ms. Friedl to the hospital until four hours after Ms. Friedl was fully dilated and in second stage labor. Annette Louise Zivkovic was admitted to Memorial Medical Center emergency room with obstetric complications in active labor. Her physician, Dr. Sager, was present when she was admitted. Ms. Baya, her midwife, was also present when Ms. Zivkovic was admitted. Admission notes state that Ms. Baya assisted the patient for three hours but that the patient was unable to deliver. Dr. Sager was present at admission and performed a vaginal examination. He determined that Ms. Zivkovic was dilated to "Station 4." The patient stated that she was very scared and her arms and legs were stiff when she had contractions. The patient was unable to push effectively and assist in delivery. The admission notes indicate she was in active labor three hours before being taken to the hospital. The Labor and Delivery Summary indicates that the patient was admitted at 4:25 p.m. on January 2, 1989. She was delivered at 4:41 p.m. She had been in labor since 1:00 p.m. There is no evidence that Ms. Baya knew that Ms. Zivkovic was staining or that she did not have Ms. Zivkovic assessed. The Petitioner's expert midwife, Ms. Richter, testified. A delay of over two hours in referring a patient who was in active labor and had not delivered was unprofessional conduct. Karen Evans was admitted to the hospital via the emergency room and delivered by C-section by Dr. Wooden because the baby was in fetal distress. When delivered, the baby's head was molded into the pelvis. A bad odor from the uterus indicated interuterus infection. Ms. Evans had a high white blood count which was consistent with an infection. Ms. Evans reported to the doctor that she had been leaking fluid for two weeks. Ms. Evans was admitted to the hospital by the emergency squad, who had been requested by Ms. Baya. The doctor stated that the midwife called the medical squad when she realized that she had a complicated patient in labor with fetal distress. Ms. Evans' labor-began at 10:30 a.m., according to Ms. Baya's reports to the patient; and Ms. Evans was admitted to the hospital at 10:30 p.m. for emergency delivery of the baby by C-Section. The baby was delivered approximately 1-1/2 hours later, at 11:57 p.m. The Petitioner's medical expert's opinion was that Ms. Evans should have been referred when it was determined that her water was leaking and should have been referred to the doctor long before she had been in active labor for 12 hours. There was no evidence that Ms. Baya knew or should have known that Ms. Evans was leaking ambiotic fluid. The baby's head being molded into the pelvis is a sign of prolonged labor. There is evidence that Ms. Baya knew that Ms. Evans had been in active labor for over 12 hours. There is no evidence that Ms. Baya knew that Ms. Evans had unexplained vaginal bleeding. There was no credible evidence that Ms. Baya failed to do metabolic screening on M.K. 2/ failed to provide accurate information on the birth certificate of M.K.'s child; or provided care to M.K., who was at high risk.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is therefore, RECOMMENDED that: The Petitioner revoke the license of the Respondent; and The Petitioner suspend the revocation upon demonstration by Ms. Baya that she has taken refresher courses in midwifery and can practice safely and in accordance with all applicable statutes and rules. DONE AND ENTERED this 17th of February, 1992, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of February, 1992.
The Issue At issue in this proceeding is whether Respondent, Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care (“Bread & Roses”), provided services in excess of the scope of its license by providing abortions to five patients beyond the first trimester of pregnancy, as alleged in the Administrative Complaint.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following Findings of Fact are made: AHCA is the state agency responsible for the licensing of abortion clinics and the enforcement of the statutes and rules governing their operations in Florida, pursuant to chapter 390 and chapter 408, part II, Florida Statutes. Bread & Roses is a women’s health care clinic licensed to provide first-trimester abortions pursuant to chapter 390, Florida Statutes, and Florida Administrative Code Chapter 59A-9. Kimberly Smoak is AHCA’s field office supervisor. She is based in Tallahassee and supervises the operations of AHCA’s field offices throughout the state. Kriste Mennella is an AHCA field office manager based in Alachua, who reports directly to Ms. Smoak. On or about August 5, 2015, Ms. Smoak directed Ms. Mennella’s office to conduct an unannounced “monitoring” survey of Bread & Roses and to send Ms. Smoak her survey report before the end of the day. Ms. Mennella personally conducted the survey. Ms. Mennella arrived at Bread & Roses at 12:45 p.m. on August 5, 2015, to conduct the survey. She requested and reviewed utilization reports and medical records for 16 patients for whom Bread & Roses had provided abortion services within the previous year. Section 390.0112(1) provides the following reporting requirement: The director of any medical facility in which any pregnancy is terminated shall submit a monthly report to the agency which contains the number of procedures performed, the reason for same, the period of gestation at the time such procedures were performed, and the number of infants born alive during or immediately after an attempted abortion. The agency shall be responsible for keeping such reports in a central place from which statistical data and analysis can be made. (Emphasis added). Chapter 390 does not define the terms “gestation” or “pregnancy.” Section 390.011(11) defines “third trimester” to mean “the weeks of pregnancy after the 24th week of pregnancy.” From this definition, it is possible to infer that the first trimester includes the first 12 weeks of pregnancy and that the second trimester includes the second 12 weeks of pregnancy. Consistent with this inferred definition, rule 59A- 9.019(14) provides as follows: (14) “Trimester” means a 12-week period of pregnancy. First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period). Second Trimester. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation. Third Trimester. That portion of pregnancy beginning with the 25th week of gestation. (Emphasis added). Ms. Mennella found the following in the clinic’s utilization reports for five of the 16 patients in the survey sample: Patient #5: no last normal menstrual period (“LNMP”) recorded; ultrasound reflected 13 weeks of pregnancy. Patient #7: no LNMP recorded; ultrasound reflected 13.2 weeks1/ of pregnancy. Patient #8: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. Patient #9: no LNMP recorded; ultrasound reflected 13 weeks of pregnancy. Patient #15: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. During the survey, the clinic manager for Bread & Roses, who prepares the clinic’s utilization reports, explained to Ms. Mennella that the “weeks” reflected on Bread & Roses’ utilization reports reflected the length of pregnancy as counted from the first day of the LNMP. Therefore, all five of the patients’ abortions were within the 14-week window afforded by rule 59A-9.019(14)(a). Ms. Mennella documented her conversation with the clinic manager in her formal survey notes and in her August 5, 2015, formal survey report to Ms. Smoak. At the conclusion of the survey, Ms. Mennella reported to Ms. Smoak by telephone, though Ms. Mennella testified that she could not recall the details of the discussion. At 4:50 p.m. on August 5, Ms. Mennella telephoned Kristin Davy, the owner and director of Bread & Roses. Ms. Mennella told Ms. Davy that AHCA had determined that Bread & Roses had acted in violation of its license by performing second-trimester abortions, based on the clinic’s utilization reports and the medical records reviewed by Ms. Mennella during the on-site survey. Ms. Davy replied that AHCA’s conclusion was incorrect because the weeks and days recorded on the ultrasound reports measured from the first day of the LNMP, meaning that all five of the questioned procedures had been performed within the first trimester of pregnancy. After her discussion with Ms. Davy, Ms. Mennella submitted her formal survey report to Ms. Smoak. Ms. Mennella’s survey notes and her survey report to Ms. Smoak each documented Ms. Davy’s dispute of AHCA’s conclusion and her explanation of the ultrasound reports. At 6:15 p.m. on August 5, Ms. Mennella faxed a letter to Ms. Davy with the heading, “Notice of Activity Without Proper Licensure.” The letter stated that AHCA had determined that Bread & Roses was providing services beyond the scope of its license. The letter did not attach a copy of Ms. Mennella’s survey report nor any other document reflecting the specifics of AHCA’s allegations regarding the clinic’s operation. Ms. Mennella made a follow-up visit to Bread & Roses on August 19 to determine whether there had been any more procedures performed that appeared to be beyond the scope of the clinic’s license. Based on her review of the clinic’s files, she determined that there had not. On September 1, 2015, AHCA faxed to Bread & Roses a letter signed by Ms. Mennella reporting the findings of its survey and requiring the facility to file a corrective action plan. The letter was accompanied by a statement of deficiencies recorded during Ms. Mennella’s August 5 survey. The statement of deficiencies stated that Bread & Roses had performed services beyond the scope of its license as follows: For sampled patients #5, #7, #8, #9 and #15, no date was recorded for the last normal menstrual period (LMP); however, the ultrasound reflected weeks of gestation in excess of 12 as documented in the patients’ records. Ms. Mennella’s documentation of her conversations with the office manager and Ms. Davy were excised from the version of the survey report faxed to Bread & Roses on September 1, 2015. Ms. Mennella had no explanation for this deletion, and testified that she could not recall whether she told Ms. Smoak about the explanations offered by the office manager and Ms. Davy as to the meaning of the ultrasound reports. Ms. Mennella’s letter of September 1 directed Bread & Roses to submit a written corrective action plan to AHCA by the close of business on September 4, 2015. The letter stated that the corrective action plan must do the following, at a minimum: * Demonstrate procedures are in place to ensure that first trimester abortions are not performed: In excess of 14 weeks (up to but not including the 105th day) from the last normal menstrual period (LNMP), and in excess of the 12th week (up to but not including the 91st day) of gestation; or When LNMP is not determined or not documented, abortions are not performed beyond the 12th week (up to but not including the 91st day) of gestation. * Educate staff to ensure that when reporting pursuant to rule 59A-9.034, F.A.C., on the online reporting system, that the field titled “WEEKS OF GESTATION” is correctly completed using “weeks of gestation” as that phrase is used in rule 59A-9.019, F.A.C., and not erroneously using the last normal menstrual period. On September 3, 2015, one day prior to expiration of the deadline for submission of Bread & Roses’ corrective action plan, AHCA filed the Administrative Complaint that initiated this proceeding. The Administrative Complaint seeks to impose an administrative fine of $2,500 on Bread & Roses, or $500 for each instance in which AHCA alleges that the clinic performed an abortion during the second trimester, beyond the scope of its license. Bread & Roses submitted a responsive letter to AHCA shortly after 1:00 p.m. on September 4, 2015. The letter, written and signed by Ms. Davy, stated as follows, in relevant part: This letter responds to your letter dated September 1, 2015, which requested a summary of a corrective action plan demonstrating two things: First, that procedures are in place to ensure that first trimester abortions are not performed in excess of 14 weeks from the last normal menstrual period (LNMP), and Second, that staff are educated to report “WEEKS OF GESTATION”--in the monthly online ITOP reports, filed pursuant to rule 59A- 9.034, F.A.C.--“using ‘weeks of gestation’ as that phrase is used in rule 59A-9.019, F.A.C.,” and not using LNMP. As to the first requirement, Bread & Roses has always provided abortion care only through and including 13.6 weeks LNMP, or 13 completed weeks and 6 days as measured from LNMP. Our staff records the date that the woman remembers for her LNMP if and only if she remembers such a date (and if she had such a date: some women do not menstruate, such as when using certain contraceptives). If the woman did not have or does not remember the date of her LNMP, we do not include such a date in her record. Regardless of whether she remembers such a date, we do not determine the length of her pregnancy based on that memory. Rather, in accordance with the standard of care, we determine the length of her pregnancy based on ultrasound examinations. Please be aware that--again, as is absolutely standard practice throughout Florida and the U.S.--our ultrasound machine provides a length of pregnancy as measured from LNMP. In other words, based on the measurements of the embryo or fetus, the ultrasound machine produces an estimated length of pregnancy as measured from LNMP. Our corrective plan of action is to ensure that henceforth, in all medical records, all staff include “LMP” [sic] after each indication of length of pregnancy, including when staff record the results of an ultrasound examination. As to the second requirement, for clarity, here is the relevant regulation: “First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period).” 59A-9.019(14)(a), F.A.C. Based on your letter dated September 1, 2015, all staff will now report “WEEKS OF GESTATION” in the monthly online [Induced Termination of Pregnancy or “ITOP”] reports using “weeks of gestation” as measured not from LNMP, but from two weeks after LNMP. In other words, we will henceforth report an abortion at 13.1 weeks LNMP as an abortion at 11.1 weeks in the online field for “WEEKS OF GESTATION.” The ITOP form referenced in the letter is a monthly summary report filed by the clinic with AHCA regarding the timing of the abortion procedures performed at the clinic. Printed examples of the forms were submitted into evidence by AHCA. The form sets forth three reporting categories: “up to 12 weeks,” “13 to 24 weeks,” and “25 and over weeks.” The form, at least in the printed version submitted by AHCA, uses neither the term “pregnancy” nor “gestation.” At the hearing, Ms. Davy testified that she wrote the corrective action plan to ensure there would be no more misunderstanding about what Bread & Roses was doing. She was adamant that Bread & Roses was not performing second-trimester abortions. She stated that the clinic was not changing its medical standards, but was clarifying its reports to AHCA. From that point forward, Bread & Roses would include “LNMP” after every notation of length of pregnancy in its medical records, and its ITOP reports to AHCA would subtract the two-week LNMP interval. Ms. Davy testified that the corrective action plan was implemented on the day it was submitted to AHCA. Ms. Davy further testified that Bread & Roses had been submitting its reports to AHCA in the same manner for the ten years in which it has restricted its license to first- trimester abortions. She had always understood that “weeks of gestation” on the ITOP form was meant to be dated from the first day of the last normal menstrual period, which is standard industry practice. No other surveyor ever told her that she was filling the forms out incorrectly or had attempted to infer that the clinic was operating beyond the scope of its license. AHCA’s most recent routine survey of Bread & Roses, prior to the August 5 survey, had been performed on February 14, 2015. No deficiencies had been found. AHCA presented no evidence to counter Ms. Davy’s credible testimony that Bread & Roses had been submitting its ITOP reports in the same manner for the previous ten years without incident. AHCA presented no evidence to explain why it suddenly believed that Bread & Roses’ ITOP reports showed that the clinic was performing second-trimester abortions. Ms. Davy testified that Bread & Roses does not rely on a patient’s reported LNMP to measure length of pregnancy because such reports are inherently unreliable. Thus, whether or not a patient’s medical record includes a patient-reported LNMP is of no importance to the length of pregnancy reported on the ITOP. In all cases, Bread & Roses reports length of pregnancy as measured by the ultrasound machine. Bread & Roses owns the ultrasound machine used in its clinic. Ms. Davy testified that she had the machine calibrated at the time of purchase, about a year and a half ago. The machine is checked annually by North Florida Biomedical Services. Bread & Roses’ written policies and procedures include the following, under the heading “Sonography”: A sonogram will be performed on all patients. Bread and Roses performs abortion procedures in the first trimester, up to 13 weeks 6 days from the last menstrual period. A sonogram will determine how many weeks the patient is from the last menstrual period. If a patient is 14 weeks or over she will be referred to an alternate clinic. Mary E. Raum, M.D., is a gynecologist and has been the medical director at Bread & Roses for 15 years. She has practiced gynecology since 1983. Dr. Raum performs all of the ultrasound and abortion procedures done at Bread & Roses. She performed the ultrasound procedures on each of the five patients at issue in this case. Dr. Raum testified that the “ultimate determinant” as to whether a patient is in the first or second trimester is the ultrasound. She stated that the ultrasound is “definitive” and has become the standard of care for assessing the length of pregnancy. Dr. Raum testified that the ultrasound equipment she was using met standards for such equipment. She had no doubt that the equipment was functioning properly. AHCA offered no evidence to dispute Dr. Raum’s assessment of the ultrasound equipment. Dr. Raum described her manner of performing the ultrasound procedure as follows: The patient is laying [sic] flat. I always hope that I can get an adequate image abdominally so the patient doesn’t have to have a vaginal probe. But there are times when that is necessary. The abdomen is spread with the ultrasonic gel, and then the probe, which is called a transducer--that is what actually emits the sound waves which are higher than the human ear can hear . . . . [A]s soon as I see what I feel to be a good representative picture where I can measure the pertinent structures, it’s frozen, and then I select, on the possible measurements, the appropriate one. Early on, the most appropriate ones are either the gestational sac or the crown-rump length, which is measured from the top of the head to the end of the tailbone, if you will. There is an algorithm that is programmed into the ultrasound machines which then translates those two measurements into the date of the pregnancy from the first day of the last menstrual period. Dr. Raum testified as to the care she takes in performing the ultrasound measurement. If she is uncertain, she will take several measurements until she has the most accurate possible measurement. Dr. Raum frankly tells her patients that if the measurement is even one day beyond the 14-week limit, she will not perform the abortion. AHCA did not call any witness to explain the basis for the Administrative Complaint. The facts alleged are that the medical records for the five patients at issue do not contain an LNMP date, and that the sonogram in the medical record of each of the five patients reflects “weeks of gestation in excess of 12.” AHCA presented no evidence in support of its allegation concerning the length of gestation. It might have been reasonable at the time of Ms. Mennella’s survey for the agency to read the ITOP reports and the patient records and suspect a problem. However, it was not reasonable for the agency to disregard the reasonable explanations provided by the Bread & Roses office manager and by Ms. Davy. Ms. Mennella herself could not say why AHCA decided to file an administrative complaint alleging that Bread & Roses performed five second-trimester abortions, or why her documentation of her conversations with the office manager and Ms. Davy were excised from the final version of her survey report. AHCA’s theory of the case appears to be that the lack of a handwritten notation of “LNMP” in the five medical records at issue requires a conclusion that the days and weeks shown on the face of the sonogram reflect a length of pregnancy as measured from the date of “conception” or “gestation,” rather than the LNMP. This premise is unfounded, and the failure of the premise destroys the logic of AHCA’s theory. The ultrasound measures the same thing, whether or not the medical record contains a patient-reported LNMP date. The evidence presented at the hearing showed that the ultrasound dates the pregnancy from the LNMP, and that Bread & Roses’ ITOP reports were based on the ultrasound results. The missing LNMP notes are a red herring. AHCA’s case consisted largely of an argument premised on applying the dictionary definition of the term “gestation” to the medical records of Bread & Roses, which do contain a “Patient Procedure Record” that makes reference to “gestation” in the section regarding the physician’s examination of the evacuated tissue post-abortion. Indeed, if these abortions had been performed after 13 weeks of “gestation,” as that term is defined in some medical dictionaries,2/ then they would have been beyond the first trimester. However, Ms. Davy testified that, consistent with standard medical practice, the term “gestation” on the Patient Procedure Record means, and has always meant, length of pregnancy as measured from the first day of the LNMP. Ms. Davy stated that she has amended the Patient Procedure Record to add “LNMP” after every indication of length of pregnancy, in order to prevent any future misunderstandings. Dr. Raum testified that medical practitioners generally do not attempt to measure the length of pregnancy from the date of conception because that date is difficult, if not impossible, to determine in an accurate and reliable fashion, except perhaps in cases of in vitro fertilization. AHCA’s own rule appears to recognize this difficulty by defining the “first 12 weeks of pregnancy” as equivalent to the “first 14 completed weeks from the last normal menstrual period.” In light of the overwhelming factual evidence that Bread & Roses did not in fact perform second trimester abortions, the dictionary definition of “gestation” was an insufficient basis for finding a violation. AHCA made no attempt at a factual, as opposed to a logical, demonstration that these were second-trimester abortions. AHCA presented no testimony or documentary evidence refuting the credible evidence presented by Bread & Roses that the sonograms show on their face that the pregnancies for each of the five procedures at issue were first trimester pregnancies and within the scope of Bread & Roses’ license. AHCA has argued that it should be allowed to show, in the alternative, that Bread & Roses’ clinical records were not accurately documented because they showed more than 12 weeks of “gestation” for each of the five sampled patients, in both the sonograms and the Patient Procedure Record, in violation of rule 59A-9.031, which requires that clinical records must be “complete” and “accurately documented.” It is noted that, prior to the hearing, AHCA made a motion to file an Amended Administrative Complaint that would have included a second count alleging a recordkeeping violation. This motion was denied by Order dated February 26, 2016. At the start of the final hearing, AHCA renewed its motion while also arguing that it was not necessary to amend the Administrative Complaint in order to raise the recordkeeping issue. The motion was again denied, but AHCA was given some leeway to pursue its theory that the original Administrative Complaint embraced a recordkeeping allegation. Even if the Administrative Complaint could be said to include an allegation regarding inaccurate recordkeeping,3/ AHCA did not prove anything more than that it misread the clinical records and ITOP reports of Bread & Roses and then refused to listen to Bread & Roses’ explanation. The evidence established that Bread & Roses had submitted the ITOP forms to AHCA every month for ten years in substantially the same form with no indication from AHCA that there was a problem. The evidence also established that the term “gestation” in the Patient Procedure Records was used in its usual medical sense, i.e., the length of pregnancy as measured from the first day of the LNMP. Bread & Roses amended its Patient Procedure Record form and changed its method of reporting the ITOP not because of any recordkeeping failure on its part, but in an effort to appease AHCA and forestall any further misunderstanding.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint against Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care. DONE AND ENTERED this 28th day of April, 2016, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON 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 28th day of April, 2016.
Findings Of Fact At all times pertinent to the allegations herein, the Petitioner, Board of Medicine, was the state agency in Florida charged with the licensing and regulation of physicians in this state. Respondent, Dr. Lewis Sidney Wolf, was at all times pertinent licensed as a physician in Florida. Dr. Wolf took his medical degree at the university of Bologna, in Italy, and thereafter did his internship and residency training at hospitals in New York. He has been in the private practice of obstetrics and gynecology since 1977 and though not Board certified, has limited Board eligibility. Upon completion of the required continuing medical education courses he will be eligible to sit for the Board examination. He was employed as a physician at the Aware Woman's Medical Center, (Center), an abortion clinic in Port St. Lucie, Florida, from May, 1987 to October 8, 1990. During that time he had no responsibility for administration or the business affairs of the Center. On January 5, 1990, he saw L. S., (Patient 1), a 19 year old rather tall woman on whom he had done a previous abortion, who had come in for termination of another pregnancy. He recalls her as being normal both mentally and physically. His physical examination of the patient consisted of listening to her heart and lungs and doing a bi-manular pelvic examination. This includes placing one hand in the patient's vagina to feel the cervix and the other hand on the patient's abdomen at the top of the uterus. By doing this, the physician can see how big the uterus is and feel for any abnormality caused by pregnancy or fibroids. Respondent's examination of this patient showed she had a regular, smooth and symmetrical, if large, uterus. Since other tests had shown she was pregnant, he decided to terminate it at her request. Respondent's initial examination caused him to estimate the fetus size was larger than 9 weeks. He therefore suggested the patient be given a sonogram to determine with some accuracy how big it was. However, since the patient was so tall, and this can be deceiving as to uterus size, and because his assistant, Candace Dye, the clinic administrator who, incidentally, had no medical training, disagreed with him, and because the procedure was already scheduled and a sonogram, which had to be done outside the office, would be costly to the patient and would interfere with the scheduled procedure, he checked the patient again and concluded the fetus size was only 9 weeks. Since he felt that maybe the untrained layman was correct and since the termination procedure was the same up to 14 weeks as it was at 9 weeks, he assumed responsibility and decided to go ahead with the termination using a dilation and curettage. In this procedure, metal rods of increasing size are inserted into the cervical opening to dilate it after which a plastic tube with a hole on the side, (a cannula) is inserted into the uterus to remove the fetus by means of a vacuum aspirator, (suction). This procedure is not generally used to terminate a pregnancy of longer than 14 weeks. Page 10 of Petitioner's Exhibit 2, the patient records from the Center, reflect that Respondent's initial estimate of fetal size, as recorded by the nurse, was greater than 12 weeks and the Respondent at first ordered a size 12 cannula. However, after the cervix was dilated, Respondent ordered a 14 cannula because during dilation he felt the fetus was larger than anticipated. After the first aspiration, Respondent felt there was still some tissue left in the uterus and inserted the cannula again to get it. At this point, Respondent noticed some yellow fatty material in the aspirator which he believed came from the omentum, the outside of the uterus, and he believed that the cannula head had gone through the side of the uterus at the site of a scar from a previous caesarian section, (the patient had had two previous caesarian sections). This is the place where, according to Respondent, most perforations occur due to the weakening of the uterus as a result of those procedures. In the interim period between the removal of the cannula after the first insertion and the second insertion, because he could not get all the tissue out during that first insertion, Respondent used a placenta forceps to get the bony part of the fetus, (an arm), which would not go through the cannula. He then used the cannula the second time and cannot be sure if it was the forceps or the second application of the cannula that caused the perforation. In any case, when he realized that a perforation had occurred, he packed the uterus with gauze and called 911 to have the patient taken to the hospital. She subsequently recovered but lost one tube. Patient 2, a 41 year old female, reporting two prior deliveries, came to the Respondent for a pregnancy termination on October 28, 1989. At the time, she seemed quite nonchalant about the whole process. She reported having a fibroid uterus and claimed to have had a recent sonogram which showed a "VBD" of 5.1. The term "VBD" is incorrect for use in connection with a sonogram. The appropriate initials are "BPD", bi-parietal diameter, and a BPD of 5.1 correlates to a fetus age of in excess of 21.5 weeks. The patient also indicated that she had only had sexual relations twice in several years, the last of which was consistent with a pregnancy of far less duration that 20 weeks. Respondent did a bi-manular examination and estimated from that a gestational age of the fetus of 20 weeks. However, the patient's forms showed a sonogram had been done on October 21, 1989 and the uterus size given as a result thereof was 9. Respondent claims his estimate of 20 was for the uterus size, not the fetus size, and this is not inconsistent with the diagnosis of fibroid uterus which could, of itself, considerably increase the size of the uterus. In addition, Respondent claims his examination showed the uterus to be firm and in pregnancy, the uterus generally gets soft. Based on all the above, and given the fact that the Patient could not recall where the sonogram had been done, and the fact that she seemed reliable to him, Respondent concluded that the pregnancy was of only 9 weeks duration and agreed to terminate it by dilation and curettage. His description of the patient as reliable is not consistent with his other comments regarding her at the hearing wherein he described her as inconsistent and mixed up. In retrospect, at the hearing, he admitted he now realizes she was lying to him. As Respondent was preparing the patient for the procedure, he noted on her chart that the sonogram showed 5.1. This figure represents the diameter through the head of the fetus. He did not have a chart handy from which to extrapolate the sonogram figure to a fetal age. He asked his assistant, Michelle Trent Wimble to check it. She left the room and when she came back reportedly stated, "It's OK - it's only 11 weeks." In reality, Ms. Wimble did not look at the correct chart and the information she gave to the Respondent was incorrect. He did not verify it. In the termination, Respondent started with a size 12 cannula. Once the vacuum was initiated with that cannula, he shifted to a 14 and then requested a placenta forceps. He changed the size because, he asserts that once the patient was dilated, he realized the fetus was larger than he had anticipated and needed the larger size. Also, when he saw the amniotic sac he knew the pregnancy was further along than 11 weeks but because he was committed and could not let the patient go home like that, he had to continue. He broke the sac and tried to vacuum with a 16 mm cannula, the largest made, but was still unsuccessful. He then tried the forceps. When he saw the umbilical cord had prolapsed, and had removed a hand from the fetus, he knew it was much older than anticipated. Since it was obviously beyond the 14 weeks menstrual limit the Center set for abortions there, he called 911 to have the patient taken to the hospital for completion. Respondent has specialized in abortions not only for his 3 years at the Center, but at other clinics in New York, Tampa and Ft. Myers, where he filled in for another physician whose license was under attack. He has done over 5,000 abortions and claims to have experienced complications in only 4 of them. Each of these involved perforations of the uterus. According to Ms. Dye, who worked with Respondent for the three years he was at the Center, his problem rate was low. A perforation may occur as the result several different factors such as a tilting of the uterus or frequent prior pregnancies which weaken or soften the wall of the uterus. A perforation is also more likely in a woman who has had one or more caesarian sections. It is not necessarily due to negligence on the part of the physician though it may be. According to Respondent, most often it is not negligence but more a complication which occurs because of the anatomical arrangement of the pelvic organs. With regard to Patient 1, Respondent feels he did nothing wrong. Her records show that from her last menstrual period she would be 11 weeks pregnant based on her last period date of November 1, 1989. Also, from her history sheet he notes 2 reasons for her being a higher risk patient. She had had two caesareans sections and one prior abortion. She was 19 years old and had had 5 pregnancies. Therefore, he claims, her uterus had not had time to rest and could easily be perforated. In addition, as a result of his examination, he was quite comfortable with a 9 weeks fetal determination. Though she might have been slightly over that she was still within the limits for a suction abortion. He is also comfortable having done the bi-manual examination which he feels is generally reliable. Factors such as a tall patient can throw it off, however, he claims. With regard to Patient 1, Respondent claims there was nothing about her to alert him to danger. It is not usual to change cannulas in mid- procedure. It is done from time to time, especially in the first pregnancies of young women whose cervix are hard to dilate. He also claims it is not unusual to over or under estimate a pregnancy by 2 weeks. It is impossible to tell exactly how many weeks a patient is pregnant. Respondent admits a patient history sheet is important and it is important that the patient give honest information for it. Erroneous information from any source, if relied on by the physician, can result in injury to the patient. Patient 2 was a 41 year old woman at the time he saw her. This fact makes her a high risk patient for carrying the fetus to term. From the last menstrual period she reported, she would be 12 weeks pregnant. The sonogram results as passed to the Respondent was consistent with 11 weeks of pregnancy and with the menstrual history. Assuming her sexual history were correct, she could be no more than 16 weeks pregnant. Because the patient referred to a "VBD", similar in sound to "BPD", the correct term, Respondent considers it was reasonable for him to believe she had had a sonogram. Here, however, the Respondent stated at one point that at that time he did not believe her and if that is the case, it was improper for him to do the procedure on a patient who he did not believe had given him a correct history. Further, when a patient shows a history of prior pregnancies or caesarian sections, admittedly that patient is at a higher risk of perforation and the doctor should be more cautions and more prepared than otherwise. Respondent's performance in the two cases at issue here was reviewed by Dr. Edward J. Zelnick, himself an expert in the field of obstetrics and gynecology, who has done numerous pregnancy terminations in the past. His review consisted of an examination of the clinic and hospital records of both patients. In order to safely and properly terminate a pregnancy, it is necessary for the physician to know the size of the fetus. This can be determined by the history taken from the patient, by physical examination of the patient, including both palpation and bi-manual manipulation, and by sonogram. In the case of patient 1, Respondent performed a suction curettage. Before doing so, he accomplished a bi-manular examination and determined the fetus was 9 weeks of age. The records reflect that initially an ultrasound, (sonogram), was requested, but that order was rescinded. In the suction curettage the cervix is dilated with metal rods of increasing diameter and the cannula is then inserted to remove the fetus by suction. The size of the fetus determines the size of the suction tube to be used. Here, Respondent selected an 11 cannula which can be used generally with fetuses from 9 to 11 weeks of age. The records reflect that little tissue was obtained through the use of the cannula, so Respondent asked for and used a larger one. After the size of the cannula was increased, a placental forceps was used to remove a fetal extremity and a portion of the oventum, (a portion of fact attached to the intestine not generally found in the uterus). The presence of the oventum indicates that the wall of the uterus was perforated. Dr. Zelnick feels this perforation could have been avoided if more care had been utilized in the determination of the fetal size. There appeared to be a discrepancy between the appearance and the actual size and duration of the fetus. If the size was, as here, underestimated, the larger actual fetus prevented the doctor from getting the amount of tissue he expected. This could lead him to go deeper or in a different direction that she should go to get tissue. In light of this, Dr. Zelnick opined that the level of care rendered to Patient 1 by the Respondent was below standard because the final outcome and the manner of performance is not properly reflected in the records. Also, the wrong size instruments were used. Most important, however, is the failure to properly determine the size of the fetus. If the doctor is unsure of the fetal size, he should take further steps, through ultrasound or otherwise, to be more specific. Here, in Zelnick's opinion, the perforation occurred when the Respondent went into the uterus with the placental forceps. Once the perforation was noted, Respondent properly had the patient taken to the hospital where her abdomen was opened and her right fallopian tube and ovary were removed. In addition, her uterus was repaired. All this resulted in her being exposed to risk due to anesthesia, infection and hemorrhage. In addition, she unnecessarily lost her tube and ovary due to the bleeding caused by the perforation. Since she now has only one tube and ovary, there is a possible diminishment in future fertility, but there is some doubt as to that happening. As to Patient 2, according to Dr. Zelnick, the Respondent established she was 9 weeks pregnant. The records show the result of the bi-manual examination showed 9 weeks, but they also reflect the patient had a sonogram and to Dr. Zelnick, it is unclear because the record of the sonogram showed a 5.1 BPD which is consistent with a 20 - 22 week pregnancy. In addition, the patient gave a history of only 2 sexual relations prior to the visit which is inconsistent with the other findings since the last intercourse would have been to 15 weeks prior to the visit which would not fit with a 9 week fetus finding. The nurse's note on the patient records indicate the only information the patient could give was that the sonogram showed a 5.1 LMP [sic]. In this case, Respondent also did a suction curettage initially using an 11 cannula. He then requested a 12 cannula and almost immediately went to a 14 which he then increased to a 16 which would be used for a 14 - 16 week fetus. When he failed to get an adequate tissue return, he used a placental forceps and saw a fetal extremity and umbilical cord. When he saw this, he realized the pregnancy was further advanced than expected and stopped the procedure and called for emergency services. This patient was also given an injection of Petosin, a drug used to contract the uterus, and an intravenous was attempted. She was taken to the hospital and treated for hemorrhage, hypertension and shock, and failure of her blood to coagulate. Hypertension is consistent with blood loss and it was subsequently noted in surgery that the patient had a uterine perforation. The patient was given an exploratory laparotomy and a total abdominal hysterectomy. The danger of anesthesia, infection, hemorrhage, and the loss of fertility as a result of the removal of her uterus are all negative results of the procedure. Dr. Zelnick is of the opinion that Respondent's treatment of patient 2 was below acceptable standards because the Respondent had an obligation to be certain of the age of the fetus before initiating action and did not do so. His omissions led to an unfortunate series of events which injured his patient. In fact, Dr. Zelnick goes so far as to classify Respondent's actions as gross negligence. The relative sizes of a 9 week and a 22 week fetus is so disparate that such a mistake as here is not reasonable. While a 9 week fetus is about the size of an orange, a 22 week fetus is about the size of a volley ball. While the existence of a uterine fibroid cyst can make the determination of fetal size more difficult, a doctor can make the determination. A fibroid cyst is hard and solid while a fetus is soft. In any case, if there is a question, a sonogram should be done. If the physician cannot be absolutely sure of the length of gestation by examination or history, he should take all necessary other steps to find out. If he does not, his failure constitutes negligence. Here, especially, the inconsistent BPD value, a figure with which any doctor routinely doing abortions should be familiar, should have tipped Respondent off to the need for more information. In addition, according to Dr. Zelnick, the Respondent's record keeping was poor. They do not accurately reflect or justify the procedures done on this patient. Dr. Zelnick admits that a uterine perforation is a complication which can occur without negligence on the part of the physician. Certain conditions, including an abnormality of the uterus can increase the risk, and by itself, a perforation is not necessarily bad care. If a patient has had 2 prior caesarian sections and 3 pregnancies, an attending physician could easily be slightly off in the age of the fetus. However, a doctor, as here, who does many abortions should be better at estimating the length of a pregnancy than one who does fewer. Respondent's expert, Dr. Dresden, also a Board certified obstetrician and gynecologist, who has performed over 10,000 abortions during his medical career, appeared on Respondent's behalf because, inter alia, he believes there is a grey area in the practice of medicine to which, in his opinion, the Department is not sensitive. It does not recognize differing methods of practice. He also contends that the mere fact a complication occurs which must be reported does not justify an indictment of the practitioner. Disciplinary action, in his opinion, should be reserved for cases of misconduct. As to Patient 1, Dr. Dresden feels that bi-manual examinations are quite difficult to do and are quite often inaccurate as to the length of gestation. The mistake made by Respondent here, as to the size of the fetus, is common. As to Patient 2, Dr. Dresden could see no reason for another ultrasound being taken. The government does not normally reimburse for it, and if, as here, he had found the incorrect estimate had been made and the instrument he was employing was too small, he'd go on with the procedure with a larger instrument. The is no relationship between the mis-diagnosis of size of the uterus and the risk of perforation except that there would be a greater weakness in the uterine wall in the case of a 20 week pregnancy. However, even a prudent doctor could end up perforating the wall of a uterus for a myriad of reasons. The position of the uterine cavity may be out of line, and if the instrument is not properly lined up, there is a greater risk of perforation. Also, a pregnant woman has softer uterine walls that are more easily perforated than a non- pregnant woman. Dr. Dresden could see nothing that Respondent could have done to avoid the perforations here nor does he believe Dr. Zelnick could accurately determine, from looking at the records, what instrument caused the perforation. If Patient 2 said she had had an ultrasound, he probably would have believed her. Most patients do not know enough to make up a story like that, he believes, and if he saw a record that the BPD was 5.1, he would ask a nurse or an assistant to look up the meaning of that reading and would rely on it. Here, based on what information he had about Patient 2, the 4 factors he took into consideration being better than the usual 2, he believes Respondent could have reasonably relied on the stated size of the fetus. He cannot say that Respondent used poor judgement in these cases notwithstanding his comment to the contrary in a prior letter to the Department regarding this case. By the same token, he cannot see any errors in Respondent's performance other than the mis-diagnosis of fetal size. The witness' prior professional record and his obvious antipathy toward the enforcement activities of the Department, cast some doubt on the value of his testimony, however. No evidence was presented with regard to the medical records of either patient in issue here to bear on the issue of their adequacy or inadequacy. Dr. Zelnick commented on his opinion that the records were poor, but no specific evidence of inappropriate recordation of the patients' conditions or other relevant matters was submitted to show them to be inadequate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license to practice medicine in Florida be suspended for a period of six months and until such time as he has satisfactorily completed the special purpose examination of clinical skills; that upon reinstatement of his license, he be placed on probation for a period of two years under such terms and conditions as is considered appropriate by the Board of Medicine; and that he pay a fine of $1,500.00 within six months of the reinstatement of his license. DONE and ENTERED in Tallahassee, Florida this 17th day of December, 1991. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1991. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-2969 The following constituted my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all the Proposed Findings of Facts submitted by the Petitioner herein. Respondent failed to submit Proposed Findings of Fact. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 10. Accepted and incorporated herein. 11. & 12. Accepted. Rejected. - 27. Accepted and incorporated herein. Rejected in that the Respondent's failure to ascertain the results of the sonogram is not evidence of poor record keeping. Rejected in that Respondent's failure to ascertain the gestational age of the fetus when facing conflicting information is not evidence of poor record keeping. & 31. Accepted and incorporated herein. COPIES FURNISHED: Larry McPherson, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Harold J. Ticktin 2106 Drew Street, Suite 102 Clearwater, Florida 34625 Jack McRay General Counsel DPR 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent failed to timely file its application for the renewal of its abortion clinic license, as alleged in the Administrative Complaint. If so, may the Agency for Health Care Administration (Agency) fine Respondent for failing to timely file its renewal application. If the Agency is authorized to impose such a fine, should it exercise such authority. If so, what is the amount of the fine it should impose.
Findings Of Fact Based upon the evidence adduced at hearing and the record as a whole, the following findings of fact are made: At all times material to the instant case, Respondent operated an abortion clinic located in Dade County, Florida, at 3250 South Dixie Highway, Coconut Grove, Miami, Florida (Coconut Grove Clinic). License number 693 constituted authorization from the Agency to Respondent to operate the Coconut Grove Clinic for the one-year period specified in the license. License number 693 had an effective date of March 22, 1995, and an expiration date of March 21, 1996. On or about December 22, 1995, the Agency sent Respondent the following letter: In reviewing our records, we note that the facility's abortion clinic license expires on 03/21/96. We are enclosing a copy of Form 3130-1000, Licensure Application, which should be completed and returned to this office along with the appropriate licensure fee of $250.00, pursuant to Rule 59A-9.020 Florida Administrative Code, made payable to the Agency for Health Care Administration. Incorrect or incomplete information will not be accepted, and the application will be returned. The application must be received on or before 01-21-96, sixty (60) days prior to the expiration of the current license to comply with section 390.016(1), Florida Statutes. Your attention to this request will facilitate processing your renewal license. The letter was delivered to Respondent on December 28, 1995. The General Manager of the Coconut Grove Clinic, Carmen Penaloza, filled out the Licensure Application and gave it to Respondent's Chief Operating Officer, Dr. Vladimir Rosenthal, for his signature. After Dr. Rosenthal affixed his signature to the Licensure Application, he returned the document to Penaloza for mailing to the Agency. The Licensure Application was completed and signed prior to January 21, 1996. Some time after January 21, 1996, the Agency notified Respondent that it had no record of having received a completed and signed Licensure Application from Respondent.1 Accordingly, Penaloza filled out and Dr. Rosenthal signed another Licensure Application. This completed and signed Licensure Application was received by the Agency on April 25, 1996. On or about May 21, 1996, the Agency issued Respondent License number 0786, authorizing Respondent to operate the Coconut Grove Clinic for the one-year period beginning March 22, 1996, and ending March 21, 1997. On June 3, 1996, the Department issued an Administrative Complaint announcing its intention to fine Respondent $1,000.00 for filing its application to renew its license to operate the Coconut Grove Clinic "ninety-five (95) days late."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency issue a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 10th day of October, 1997, in Tallahassee, Leon County, Florida. STUART M. LERNER 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 10th day of October, 1997.
