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.
The Issue The central issue in this case is whether the Respondent committed the violations alleged in the administrative complaint; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent holds an active license to practice medicine, license number ME 0030238 (Physician). Respondent's practice is limited to what he has described as "cosmetic" surgery, but which is considered plastic or reconstructive surgery. Typically, Respondent performs elective surgery for cosmetic purposes to breasts, abdomen, buttocks, face (eyes, lips, cheeks), or hips. In August, 1990, the patient, V.A., presented to the Respondent for a pre-operative consultation and examination. At the time, V.A. was interested in having liposuction, breast enlargement, and an abdominoplasty. Due to her medical history, V.A. was an extremely poor candidate for an abdominoplasty. The pre-operative history and physical examination performed by Respondent as reflected in the records maintained by Respondent for the patient, V.A., were inadequate. No records supporting a complete physical examination and history have been provided. The pre-operative medical records maintained for the patient, V.A., do not support the course of treatment proposed for the procedures to be performed. Respondent did not order a pre-operative lab work-up for the patient, V.A. Such lab order would normally consist of a complete blood count, a urinalysis, electrolytes, blood sugar, blood nitrogen test, and a mammogram or breast examination since the breasts were to be augmented. Respondent relied on lab test results for V.A. which were approximately three months old. Respondent believes that the reliance on tests up to six months old would be acceptable since he only performs surgery on healthy patients. Respondent performed no independent examination of V.A. to verify she was "healthy," prior to surgery. Failing to obtain current lab tests of the types described above before performing elective surgery of the nature sought by V.A. constitutes the practice of medicine below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. On or about August 30, 1990, Respondent performed the following procedures on V.A.: liposuction; breast enlargement; and an abdominoplasty. In order to perform the procedures noted, Respondent used general anesthesia so that V.A. was under anesthesia for six hours. During that time, Respondent opened V.A.'s abdomen, removed tissue, removed adipose tissue from various parts of the patient's body, injected fat tissue into the patient's breasts, cheeks and hands, and closed the abdominal wound with stitches. The surgical or operative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe the procedures performed. The Respondent was released to go home approximately two hours after the surgery. The postoperative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe how the patient was able to be discharged in so short a time after surgery. V.A. returned to Respondent's office numerous times following the surgery. V.A. sustained an infection and complications from the wound to her abdomen that took months to heal. Respondent treated the infection by scraping the wound and attempting to re-stitch it on at least two occasions. V.A. sustained necrosis which is the death of tissue and which complicated the healing of the abdomen wound. The loss of skin from necrosis is much more likely to occur when the patient has scarring. Given V.A.'s medical history (scarring throughout the areas), the necrosis was almost inevitable. Two procedures are available under the circumstances applicable to V.A.: allowing the wound to heal without stitches or to use a skin graft. The procedure used by Respondent (stitching the infected area) fell below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. Injecting fat tissue for breast augmentation is inappropriate. Since it is common for the fat tissue to die after injection, the injected tissue then appears on a mammograph as a mass of suspicious origin. That is, it is difficult to differentiate from a breast mass that is a medical problem from that of the dead fat tissue. As a result, biopsies may be required to verify the mass content. In fact, V.A. has already had to have such a procedure following the augmentation performed by Respondent. Respondent also conducted a pre-operative interview with a patient, P.T. P.T. was a radio talk show host at the time and suggested that the station, she and Respondent could all benefit from a campaign wherein she would have liposuction, the Respondent would receive her endorsement through advertising, and the station would have advertising paid for by the Respondent's clinic. In an attempt to negotiate the terms of the advertising campaign, P.T., an advertising executive with the radio station, Respondent's office manager, and Respondent met together to discuss the project. Respondent wanted a multifaceted campaign requiring P.T. to undergo more than just the liposuction she sought. Respondent's scope for the campaign included many of the surgeries his clinic offered. While discussions continued for the advertising campaign terms, P.T. underwent pre-operative testing which included a blood test, medical history forms, and photographs. During an office consultation in anticipation of surgery, Respondent requested that P.T. allow him to examine her. Unlike a previous examination which had occurred without incident with someone in the room, Respondent closed and locked his office door and requested that P.T., who was alone with Respondent, stand near his desk. When she complied, he leaned forward and raised her dress over her breasts. Next he unhooked her bra and pulled it over her breasts. Respondent proceeded to poke and prod P.T. across her breasts and abdomen during which time P.T. presumed it was for medical purposes. P.T. became uncomfortable when the prodding which continued became more like a caress. She attempted to presume Respondent was merely checking the texture of her skin but became increasingly uncomfortable with his touch. P.T.'s discomfort accelerated when she realized Respondent had placed his face in her vaginal area and was licking her. She immediately attempted to pull away. Respondent grabbed her on the breast and, as P.T. put it, "in the crotch." P.T. struggled with Respondent who made several sexually inappropriate comments to her. As P.T. attempted to regain her composure and close her clothes, the Respondent's office manager knocked on the door. On hearing the office manager, Respondent released P.T. and went to unlock the door. At the time of the foregoing incident, P.T. was the Respondent's patient. Respondent did not maintain appropriate medical records for the course of treatment proposed for the patient, P.T. Respondent's course of conduct with the patient, P.T., fell below the standard of care a reasonably prudent physician would pursue for treatment of this patient. Respondent attempted to engage a patient in a sexual activity. P.T. did not consent to the activity described above.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Agency for Health Care Administration, Board of Medicine enter a final order finding the Respondent guilty of violating Sections 458.331(1)(j), (m), and (t), Florida Statutes, and imposing the following penalties in accordance with the guidelines set forth by rule: revocation of the license together with an administrative fine in the amount of $15,000.00. DONE AND ORDERED this 16th day of August, 1995, in Tallahassee, Leon County, Florida. JOYOUS D. PARRISH Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3609 Rulings on the proposed findings of fact submitted by the Petitioner: 1. Paragraphs 1 through 56 are accepted as accurate as to the facts but not necessarily the form for findings of fact. Typically, findings of fact should not recite testimony. Rulings on the proposed findings of fact submitted by the Respondent: 1. None submitted. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Kenneth J. Metzger Senior Attorney Agency for Health Care Administration/Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Leon Doyan, M.D. 2817 E. Oakland Park Boulevard Fort Lauderdale, Florida 33306
Findings Of Fact Based upon all of the evidence, including the pleadings and stipulated record, the following findings of fact are determined: On November 7, 1989, the Department of Professional Regulation (DPR) received a copy of a Serious Incident Report (SIR) prepared by Alachua General Hospital in Gainesville, Florida. The SIR was filed pursuant to law and indicated that a newborn infant baby had died at the hospital on September 16, 1989, while under the care of petitioner, Thomas B. B. Benton, a licensed medical doctor and pediatrician. After the SIR was received, a DPR investigator conducted an investigation of the incident, including interviews with petitioner, six involved nurses, the obstretrician at delivery, and the pediatrician who responded to the emergency code at the hospital. The investigator also obtained the medical records of the mother and baby. On February 22, 1990, a one hundred seventeen page investigative report, consisting of the investigator's notes, medical records, SIR, and other related information, was issued. A copy of the investigative report was given to a board certified pediatrician on August 24, 1990, who reviewed the report and records with a focus on petitioner's care and treatment of his patient. The consulting physician was asked to answer nine specific questions, including whether petitioner prepared and kept written medical records justifying the course of treatment of the patient and whether petitioner met the applicable standard of care in his examination, diagnosis and treatment of the patient. Also asked were questions pertaining to whether petitioner had adquately assessed the patient's condition, whether it was inappropriate to place the patient in the regular nursery without a monitor, and whether it was inappropriate for petitioner to not inform the on-call doctor of the patient's condition. In response to this charge, the consultant prepared a twelve page analysis of the case with responses to each of the nine questions. The analysis contained an ultimate conclusion that petitioner had failed to meet the applicable standard of care with regard to his diagnosis and treatment of the baby and, with respect to the adequacy of his records, petitioner had failed to document his medical records with a definitive treatment plan and with reasons for not ordering certain tests on the infant. The investigative report and consultant's analysis were given to a probable cause panel on January 28, 1991. The panel was composed of two doctors and a lay person, all members of respondent, Board of Medicine (Board). After a discussion of the report and analysis, which the record shows was a meaningful inquiry, the panel found, by a 2-1 vote, probable cause that a violation of Subsections 458.331(1)(m) and (t), Florida Statutes, had occurred. Those subsections impose requirements that a physician keep adequate written medical records and adhere to the appropriate standard of care. The panel also recommended that DPR issue an administrative complaint. It is noted that the two panel members voting in favor of prosecution expressly relied on the consultant's report. On February 6, 1991, a two-count administrative complaint was issued by DPR alleging that petitioner had violated subsections 458.331(1)(m) and (t) in several respects. As to subsection 458.331(1)(m), the complaint alleged he had failed to document his reasons for not ordering a cardiac/apnea monitor, had failed to document his reasons for not ordering studies to assess the patient for the possibility of sepsis, and had failed to document a definitive plan of treatment. As to subsection 458.331(1)(t), it need only be said that the complaint alleged generally that petitioner failed to adhere to the standard of care while treating the infant. After petitioner requested a formal hearing to contest the charges, the complaint was forwarded to the Division of Administrative Hearings and was assigned Case No. 91-2367. Several months prior to hearing, DPR amended its first count in the complaint to delete the two allegations that respondent failed to document reasons for not ordering certain tests. In lieu thereof, it added an allegation that there was a contradiction between petitioner's recorded plans to closely monitor the infant and his subsequent conduct, an allegation also based on an alleged violation of subsection 458.331(1)(m). This amendment was made after petitioner had filed a motion to compel discovery seeking the basis for the two factual allegations and whether they contravened the holding in Breesmen v. Department of Professional Regulation, 567 So.2d 469 (Fla. 1st DCA 1990). Conceding as much that they did, the Board thereafter filed an amended complaint. Because the Board was a party to that case, and the issuance of the opinion predated the panel's meeting, it must be assumed that the panel and its counsel were aware, or should have been aware, of the case's holding when the matter was considered. Therefore, the Board's decision to bring the two deleted charges in Count I was not substantially justified. After an evidentiary hearing was conducted, a recommended order was issued on November 7, 1991, recommending that the complaint be dismissed with prejudice. This recommendation was adopted in toto by the Board and a final order dismissing the complaint was issued on February 25, 1992. The recommended and final orders are reported in Department of Professional Regulation v. Benton, 14 F.A.L.R. 1924 (Board of Medicine, February 22, 1992). Because no appeal was taken, the Board's order is now final. Petitioner contends that the consultant's analysis is at odds with the information available to the probable cause panel and thus the panel's reliance on the analysis resulted in a flawed decision to prosecute. More specifically, petitioner focused on that part of the analysis which concluded that he failed to perform certain follow-up tests on the patient, failed to place the patient on a monitor or under closer supervision in the nursery, and failed to inform the on-call physician about the patient's medical problems. All relate to the general charge in Count II that he failed to conform to the appropriate standard of care. To support her conclusion that petitioner failed to perform certain follow-up tests, the consultant noted that at the time of birth, the patient's mother had had a fever for several days and the infant was at risk for sepsis (infection), the infant had known neurologic abnormalities, the mother had experienced placental abruption and thus the child may have had anemia, and the child was at risk for respiratory problems from possible meconium aspiration. Although the medical records showed that the mother's fever had actually subsided before the C-section was performed, the mother had experienced fever for several days just prior to the date of delivery and was on antibiotics. The records also reflected that the child had neurologic abnormalities, meconium staining was present at birth, and the mother had a partial placental abruption during delivery. Therefore, the consultant's analysis as to this allegation was substantially in accord with the medical records, and the panel had a reasonable basis in fact to bring this charge. The complaint also alleged that petitioner failed to adequately monitor the baby after it was placed in the nursery. This allegation was drawn from a recommendation by the consultant, whose conclusions were based on two considerations. First, the infant had known neurologic abnormalities and other risk factors, as discussed in the previous finding. Second, the consultant opined that the regular nursery was a "busy nursery", the nurses did not have "many years of nursing experience", and "all worked (in the newborn nursery) less than one year". The latter opinion was predicated on certain investigative notes and the consultant's review of statements made by six nurses. Petitioner asserts that because the investigator failed to record the work experience of a senior nurse and failed to interview two nurses who were on duty in the nursery the night of the infant's death, and the consultant failed to note that several of the nurses had been licensed for more than two years, the recommendation was flawed. However, it is noted that the consultant did not rely exclusively on the purported lack of experience on the part of the nursing staff in reaching her conclusion but placed equal reliance on the notion that the baby's history and risks warranted giving the baby special post-delivery supervision. Therefore, the report contains a factual basis to support the consultant's conclusion and thus the panel had a reasonable basis in fact to bring this charge. Petitioner next contends that the recommendation to charge him with failing to adhere to the standard of care because of his failure to inform the on-call physician about the patient's condition and history was likewise at odds with the real facts. In making this argument, he points to findings in the recommended order which found in favor of petitioner on this issue and to that portion of the baby's medical records which recorded his condition while in the nursery. Again, however, the consultant reached this conclusion based on the baby's "history and status", and thus she had a factual basis to support her opinion. Therefore, the panel's decision to prosecute this alleged breach of care was substantially justified. The parties have stipulated that petitioner is a small business party as defined by Subsection 57.111(3)(d), Florida Statutes, he was the prevailing party in the underlying disciplinary action, his attorney's fees and costs incurred in defending against the action are reasonable but are limited to the statutory cap of $15,000, and at least $4,000 was incurred in defending Count I while at least $15,000 was incurred in defending Count II. They have further agreed that there are no special circumstances that would make an award of attorney's fees and costs unjust.
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.
The Issue The issue is whether, in his treatment of patient H.M., Dr. Sewell failed to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent, similar physicians as acceptable under similar conditions and circumstances.
Findings Of Fact Jesse Q. Sewell, III, M.D., is a licensed physician in the State of Florida, holding license ME0028694. He has been licensed for eleven years. On or about February 11, 1986, Dr. Sewell was the treating physician for H.M. When H.M. visited his office, Respondent performed a pelvic examination and concluded that the patient was not pregnant, and prescribed a legend drug for birth control, Ortho- Novum. No test was done to determine if H.M. was pregnant because Dr. Sewell regarded those tests as an unnecessary expense to the patient. Dr. Sewell did not instruct the patient to wait until her next menstrual period to begin to take the birth control pills. Rather, he told H.M. to discontinue the pills if she did not have a period by the time she finished the first packet of pills. At the time of the examination, the patient was already six to eight weeks pregnant. By failing to perform a urine or blood pregnancy test on February 11, 1986, the care rendered by Dr. Sewell fell below that level of care, skill and treatment recognized as appropriate by reasonably prudent physicians. Under proper care, a urine or blood pregnancy test would have been ordered and Dr. Sewell would have instructed the patient not to use the birth control pills until she had had a period. It is generally recognized that birth control pills should not be prescribed for anyone who is pregnant or suspected of being pregnant. Dr. Sewell relies on six articles from medical journals to demonstrate that there is no discernible risk to a woman or fetus when taking birth control pills prior to, during or after conception. These articles include: Smithells, R.W. (1981) "Oral Contraceptives and Birth Defects," 23 Journal of Developmental Medical Childhood Neurology at 369; Rothman, K.J., and Louik, C. (1978), "Oral Contraceptives and Birth Defects," 299 The New England Journal of Medicine, at 522; Harlap, S. and Eldor, J. (1980), "Births Following Oral Contraceptive Failures," 55 Journal of Obstetrics and Gynecology at 447; Savolainen, E., Saksela, E. and Saxen, L. (1981) "Teratogenic Hazards of Oral Contraceptives Analyzed in a National Malformation Register," 140 American Journal of Obstetrics and Gynecology at 521; Cuckle, H.S. and Wald, N.J. (1982), "Evidence against Oral Contraceptives as a Cause of Neural-Tube Defects," 89 British Journal of Obstetrics and Gynecology, at 547; Harlap, S., Shiono, P.H., and Ramcharan, S. (1985), "Congenital Abnormalities in the Offspring of Women Who Used Oral and Other Contraceptives Around the Time of Conception," 30 International Journal of Fertility at 39. Dr. Sewell's contention that the current medical literature indicates no statistically significant risk to a woman taking birth control pills prior to, during or after conception, is accepted. The deposition testimony of Dr. Edward J. Zelnick was entered by the Board of Medicine. Dr. Zelnick indicated that the failure to perform a blood or urine pregnancy test and starting the patient on birth control pills without testing to determine whether or not the patient was pregnant was imprudent practice, and fell below community standards. He went on to testify that Dr. Sewell's action did not constitute malpractice because it resulted in no injury. In determining whether or not the care rendered failed to meet community standards, it is not relevant that the patient was not harmed. A patient may be fortunate enough to suffer no ill effects even though the care provided was substandard. The issue is quality of the care, not the severity of any injury which may or may not result from inadequate care. Whether the patient suffered an injury, and if so, whether that injury was severe is an appropriate consideration in assessing any penalty for failure to practice medicine with that level of care and skill recognized as appropriate by similar physicians. The testimony of Dr. Zelnick that a pelvic examination was insufficient, that urine or blood pregnancy test should have been performed, and the patient should have been informed not to use the birth control pills until after a period, is persuasive. Even if no injury was caused, it is obviously useless for a physician to prescribe oral contraceptives for a patient who, already being pregnant, requires no protection against conception. Accordingly, a physician ought to determine whether the patient is pregnant before prescribing oral contraceptives.
Recommendation It is RECOMMENDED that Dr. Sewell be found to have violated Section 458.331(1)(t), Florida Statutes, that he be fined $250, placed on probation for three months, and required to complete three hours of continuing medical education in the prescription of legend drugs, including birth control drugs. DONE AND ORDERED this 20th day of October, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of October, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-2567 The following are my rulings on the proposed findings of fact submitted by the parties pursuant to Section 120.59(2), Florida Statutes (1985). Rulings on Petitioner's Proposed Findings: Adopted in finding of fact 1. Adopted in finding of fact 2. Adopted in finding of fact 3. Adopted in findings of fact 5 and 7. Adopted in findings of fact 5 and 7. The gist of this finding is adopted in finding of fact 4 by stating the period of pregnancy as of the time of Dr. Sewell's examination and prescription of Ortho-Novum for the patient. Rulings on Respondent's Proposed Findings: The argument contained in Dr. Sewell's letter of September 28, 1987 is dealt with in finding of fact 6, adopting Dr. Sewell's argument that there is no statistically significant risk to a woman or her fetus in taking birth control pills prior to, during or after conception. Nonetheless, his actions constitute malpractice for the reasons stated in findings of fact 7 through 10. See also the Conclusions of Law. COPIES FURNISHED: Peter Fleitman, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Jesse Quimby Sewell, 111, M.D. 2855 Overseas Highway Marathon, Florida 33050 Ms. Dorothy Faircloth Executive Director Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issues are whether Respondent is guilty of violations of Section 458.331(1)(k), (m), and (t) in the practice of medicine and, if so, what penalty the Board of Medicine should impose.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0033129. His license was originally issued on August 2, 1978, and remains current. There is no prior discipline against Respondent. Respondent has been certified for over 15 years by the American Board of Obstetrics and Gynecology. His practice has been devoted to obstetrics and gynecology. In 1990, Respondent was a member of a large group practicing obstetrics and gynecology in Cape Coral. Respondent was performing about 100 breast examinations a week. On the evening of April 10, 1990, D.W., who was 30 years old at the time, discovered a mass that felt like a marble in her right breast during a breast self-examination. She was upset and cried most of the night, fearful that she had breast cancer. Early the next morning, she made an appointment with Respondent's group for a breast examination later that day. A regular patient of another member of Respondent's group, who was unavailable on April 11, D. W. had last been seen by a member of Respondent's group on February 6, 1990, when her regular physician gave her an annual examination. Her breast examination at the time was normal. During the visit, the physician or nurse reviewed breast self-examination techniques with her. The physician started D. W. on birth control pills and directed her to return for a follow-up visit in two months. The April 11 office visit was devoted exclusively to addressing D. W.'s complaint of a lump in her breast. Respondent examined D. W.'s breasts with D. W. lying down and then sitting up. He felt nothing. While sitting up, D.W. guided Respondent's hand to the mass in the right breast. Still feeling nothing, Respondent remarked that the breast was somewhat fibrous. Respondent explained to D. W. that fibrocystic disease is something that women sometimes get in their breasts and it is nothing to worry about. In fact, at least 80 percent of all women in their 30s undergo fibrocystic changes in the breast. Respondent did not reach a specific diagnosis as a result of the April 11 office visit. The handwritten entries in Respondent's medical records--the complaint and blood pressure appearing to have been written by a nurse--read in their entirety: 4-11-90 Pt. c/o lump in R breast. BP--100/60 no mass found somewhat fibrous [Respondent's initials] Respondent did not advise D. W. to return to the office for a follow-up visit at a prescribed interval or if she detected the same mass or any changes in the mass. D. W. next visited Respondent's group on April 11, 1991, for her annual visit. She was seen by another physician in the group. D. W. told the physician of the lump in her breast and said that it was getting larger. The physician conducted a breast examination and felt a mass about two centimeters in diameter. Concerned about the mass, the physician scheduled an aspiration for diagnostic purposes. The results of the procedure disclosed severely atypical cells that were suspicious for carcinoma. The physician referred her to a surgeon, who first saw D.W. on May 2, 1991. The surgeon performed a breast biopsy on May 9. The biopsy revealed an infiltrating ductal carcinoma of the breast. Based on the biopsy findings, the surgeon conducted on May 17 a right modified radical mastectomy. The excised tumor measured 2.1 centimeters along its longest diameter. D. W. underwent chemotherapy and has had no recurrence of the cancer in the five years since the surgery. There are two sets of allegations concerning D.W.'s medical records. The first set of allegations is that Respondent fraudulently altered D. W.'s medical records. Someone in Respondent's office later typed the following addition to the records of D. W. immediately beneath the handwritten entry quoted above: D[.] came to the office today having felt a lump in her right breast. I could not feel anything, although her breast was somewhat fibrous. I told her to continue to check her breast and come back if she felt it again. [Respondent's initials/typist's initials-- {both typed}] Petitioner failed to prove that Respondent dictated or typed the note in the preceding paragraph or that he authorized the addition of this note to D.W.'s medical records. The intent in adding the note was fraudulent as to the third sentence, which is the only sentence in the note that is untrue. But Petitioner failed to prove that Respondent was in any way involved in the fraud. The second set of allegations concerning the medical records involves the adequacy of the records. Specifically, Petitioner alleges that Respondent failed to keep medical records justifying the course of treatment and violated the applicable standard of care by failing to keep adequate medical records. These allegations are best considered together with the remaining allegation, which is that Respondent violated the applicable standard of care by failing to recommend follow-up examinations and treatments for D. W.'s complaint of a lump in her breast. A violation of the applicable standard of care is the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The standard of care in this case pertains to the practice in early 1990. Petitioner nowhere alleges that Respondent violated the applicable standard of care by failing to detect the mass of which D.W. complained. Petitioner's expert witness, Dr. Harvey Gardy, conceded that such a failure would not necessarily violate the standard of care. Nor is it clear that the mass of which D.W. complained in April 1990 developed into the tumor removed from her breast a year later. The mass of which D. W. complained in April 1990 was in the three o'clock position, and the excised tumor was in the 12 o'clock position. Breast tumors do not change location, except to the extent that they grow, although patients conducting self- examinations may have difficulty locating the tumor with precision. Also, the excised tumor could have grown from an impalpable size in April 1990 to its size at the time of the mastectomy a year later. The second set of medical records allegations and the lone remaining standard of care allegation focus not on Respondent's alleged failure to detect and diagnose the mass of which D. W. complained, but on Respondent's alleged failure to respond adequately to D. W.'s complaint, even after he could not independently verify the mass. The applicable standard of care did not require Respondent to order further testing at the time to rule out a cancerous growth when he could not feel the mass. D. W. was not in a high-risk category for breast cancer based on her young age, three past pregnancies, and relevant family history. She displayed no physical signs of breast cancer. The physician conducting a breast examination is looking for a dominant or distinct mass--an isolated lump distinct from surrounding breast tissue. Respondent felt only fibrous changes. The applicable standard of care did not require that a physician order further diagnostic testing each time the physician detected a fibrous mass in a breast. Fibrous changes are not indicative of breast cancer. Petitioner has failed to prove that the applicable standard of care was any different when the patient claimed to have felt a distinct mass that the physician is unable to verify. It is more practical to direct a patient to return for a follow-up examination than to order potentially expensive tests. However, Petitioner failed to prove that the applicable standard of care required that a physician, failing to detect a mass in a patient not in a high-risk category for breast cancer, direct her to return to the office at a specified interval, such as two or three months later. Even less onerous than diagnostic testing or return office visits is the physician's direction that the patient return to the office if she feels the mass again or any changes in the mass. However, Petitioner failed to prove that the applicable standard of care required even this sensible precautionary direction from a physician. Testifying unpersuasively that the standard of care required the setting of a follow-up appointment, Dr. Gardy failed to testify at all whether the standard of care required Respondent to tell D. W. to return if she detected the mass again in a self-examination. One of Respondent's expert witnesses, Dr. Pierre Bouis, testified clearly on direct that the applicable standard of care did not require Respondent to direct D. W. to return if she felt the mass again (Tr. p. 125). On cross-examination, Dr. Bouis returned to the same issue and answered affirmatively the following, poorly worded question: Now, isn't it true that you also believe that it's an appropriate standard of care to tell a patient who presents under the same set of fact that she should keep checking herself and return if she feels it again or continue to feel it? Although there are many levels of care, there is a single applicable standard of care, which, if violated, justifies the imposition of discipline. By using "an," Petitioner's counsel suggested multiple standards of care and left open the possibility that the standard to which Dr. Bouis referred in his answer was aspirational, rather than mandatory. Respondent's other expert witness, Dr. J. Kell Williams, testified clearly that Respondent's failure to direct D. W. to return if she felt the lump again did not violate the applicable standard of care (Tr. pp. 43 and 52). Dr. Williams conceded that the better practice would have been to direct the patient to return (TR. pp. 43, 46, and 47), but he did not equate this practice with the applicable standard of care. In the absence of evidence establishing this sensible precaution as the applicable standard of care, Petitioner has failed to prove by clear and convincing evidence that the applicable standard of care required Respondent to advise D. W. that she should return to the office if she felt the mass again or any changes in the mass. The medical records are adequate for the limited purpose of the April 11 visit. They describe the findings and adequately outline Respondent's examination of D. W. They justify the course of treatment--which was effectively no treatment--for the reasons set forth in the preceding paragraphs. For the reasons set forth above, Petitioner has failed to prove by clear and convincing evidence the material allegations of the Administrative Complaint.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. ENTERED on May 31, 1996, in Tallahassee, Florida. ROBERT E. MEALE, 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 on May 31, 1996. APPENDIX Rulings on Petitioner's Proposed Findings 1-3: adopted or adopted in substance, except she told him about the lump. Respondent never saw a lump. 4: adopted or adopted in substance, except that Respondent did not feel the marble-like mass that D. W. felt. Respondent felt only fibrocystic changes in the breast. 5-9 (second sentence): adopted or adopted in substance. 9 (remainder): rejected as irrelevant and recitation of testimony. 10-11 (second sentence): adopted or adopted in substance. 11 (remainder): rejected as irrelevant and recitation of testimony. 12-13 (first sentence): adopted or adopted in substance. 13 (remainder)-15: rejected as subordinate. 16 (first sentence): adopted or adopted in substance. 16 (second sentence)-17: rejected as recitation of evidence. 18: adopted or adopted in substance, as distinguished from the 2 cm tumor within the larger excised mass. 19: rejected as subordinate. 20: rejected as unsupported by the appropriate weight of the evidence. 21: rejected as irrelevant with respect to applicable standard of care. 22: rejected as unsupported by the appropriate weight of the evidence. The questions posed Dr. Bouis were ambiguous as to whether he was describing the better practice or the applicable standard of care. 23-24: rejected as irrelevant with respect to applicable standard of care. 25: rejected as subordinate and irrelevant. 26: rejected as subordinate. 27: rejected as unsupported by the appropriate weight of the evidence. 28: rejected as subordinate. 29-32: adopted or adopted in substance. 33: rejected as subordinate. 34: rejected as unsupported by the appropriate weight of the evidence. 35: rejected as subordinate. 36-38: rejected as subordinate and recitation of testimony. 39: rejected as unsupported by the appropriate weight of the evidence. 40: rejected as recitation of testimony. 41-43: rejected as unsupported by the appropriate weight of the evidence. 44-45: rejected as irrelevant. 46: adopted or adopted in substance. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-54034 Steven Rothenburg, Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Bruce D. Lamb Shear Newman 201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602
The Issue The issues in this case are whether the allegations of the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Respondent is a licensed medical doctor, holding license number 44726. At all times material to this case, the Respondent was a physician holding board certifications in internal medicine, hematology, and oncology. Patient 1 was a patient of another hematologist, Dr. Thomas Katta. On March 17, 2003, Dr. Katta had Patient 1 admitted via the patient's internist (Dr. Frank Leiva) to Sand Lake Hospital in Orlando. The patient was anemic and thrombocytopenic and had been previously diagnosed with autoimmune hemolytic anemia, the treatment for which was transfusion. Failure to transfuse a person suffering from autoimmune hemolytic anemia can lead to death, and such a transfusion had been ordered for the patient. Dr. Katta apparently had personal obligations for the evening of March 17, 2003, and for the following day, and, in the late afternoon of March 17, 2003, he asked the Respondent to "cover" his hospitalized patients. The Respondent agreed to do so. Dr. Katta's office transmitted a list of the patients by fax to the Respondent's office. The list contained the full names and locations of Dr. Katta's other hospitalized patients, but identified Patient 1 only by last name and diagnosis ("AIHA"). The fax did not indicate the patient's first name or gender and did not specifically identify the patient's location. The Respondent made no attempt to obtain additional information from Dr. Katta or his staff. The lab work performed upon admission to the hospital indicated that the patient was severely anemic and had a critically low platelet count. At approximately 6:30 p.m. on March 17, 2003, the Respondent received a telephone call through her answering service from a hospital nurse who reported that the patient was severely anemic and that there were problems obtaining a proper blood match for the transfusion. The Respondent advised the nurse to call the blood bank and tell them to find the least incompatible blood and get the transfusion done. The Respondent did not inquire as to the patient's name or location. At about 10:19 p.m. on March 17, 2003, the Respondent was again contacted by a hospital nurse, who advised that the patient was short of breath and had tachycardia at 133 beats per minute. The nurse also advised that the blood bank had been unable to find an appropriate match for the previously ordered transfusion and that the transfusion remained uncompleted. The Respondent directed the nurse to contact the patient's primary care physician or the cardiologist on call, but did not ask the identity of either practitioner. The nursing notes indicate that the Respondent stated that she did not provide treatment for tachycardia and did not believe that Dr. Katta did either. The Respondent also advised the nurse to call the blood bank and direct them to find the least incompatible blood and perform the transfusion. The Respondent did not inquire as to the patient's name or location and provided no other direction to the reporting nurse. On the next day, March 18, 2003, at about 6:15 a.m., the Respondent was contacted by a hospital nurse, who advised that the transfusion had still not taken place. The Respondent took no action and provided no direction to the reporting nurse. The Respondent did not inquire as to the patient's name or location. Later during the morning of March 18, 2003, the Respondent attempted to locate the patient while making her rounds but was unsuccessful. In attempting to locate the patient, the Respondent talked with various hospital personnel, but had no information other than the patient's last name and diagnosis. Based on her inability to obtain any additional information, the Respondent assumed that the patient had been transfused and discharged. The patient had not been discharged, but had been transferred to an intensive care unit in the hospital. The transfusion had not yet occurred. Patient 1 died on March 20, 2003. The Respondent was unaware of the patient's death until she saw Dr. Katta at the hospital, at which time he questioned her about the patient and informed her that the patient was dead. The Petitioner presented the testimony of Dr. Howard Abel, M.D., regarding whether the Respondent met the standard of care in her treatment of the patient. Dr. Abel's testimony regarding the standard of care issues is credited and is accepted. As to the issue of the uncompleted transfusion, the evidence establishes that the transfusion did not occur while the Respondent provided hematological care for Patient 1. The Respondent should have personally contacted the blood bank to identify the cause of the inability to provide blood for the transfusion and determine whether another option was available. The Respondent should have responded to the 10:19 p.m. call on March 17 by personally examining the patient and reviewing the history and lab test results. While the Respondent's directive to contact a cardiologist was not inappropriate, breathing difficulties and tachycardia are symptomatic of severe anemia for which hematological care was required. If the Respondent determined that the symptoms were cardiac-related, the Respondent should have personally made the cardiology referral and provided the information to the cardiologist. The Respondent did not do so and was unaware of the cardiologist's identity. A review of additional lab test results including observation and evaluation of blood smears would have provided useful information as to whether the patient's condition was deteriorating and to whether the patient was developing thrombotic thrombocytopenic purpura ("TTP"), a serious condition which, left untreated, is fatal in not less than 90 percent of cases. The blood smears had been performed by the time of the phone call, but the Respondent reviewed no lab test results and made no inquiries related to the results. The failure to review lab test results may have delayed a diagnosis of TTP. While there was some disagreement between testifying witnesses as to whether or not the patient had TTP, Dr. Katta ordered that the patient be treated for TTP immediately upon his return on March 19, 2003, and there is no evidence that Dr. Katta treated the patient for TTP without reasonable cause to do so. The evidence clearly establishes that the Respondent failed to review the patient's test results that could have provided timely and useful information regarding the patient's condition. As to the Respondent's failure to locate the patient on March 18, 2003, the Respondent testified that the patient's last name was common, but the Respondent had not called Dr. Katta at the time she received the faxed list of his hospitalized patients to obtain additional identifying information. The Respondent did not request the information from the nursing staff during any of the telephone calls and made no effort to obtain the information prior to arriving at the hospital to make her rounds. The Respondent would have become aware of the patient's location had she attended to the patient's breathing difficulties and tachycardia on the night of March 17. She would have also likely reviewed the medical records and would have become aware of the admitting physician as well as other information regarding the patient's condition. The Respondent consulted with hospital personnel on March 18, 2003, in attempting to identify those patients admitted by Dr. Katta. There were approximately ten to 12 other hospitalized patients with the same last name, none of which had been admitted by Dr. Katta. The Respondent was unaware that the patient had been admitted under Dr. Leiva's name. The Respondent did not visit the ten to 12 patients with the same last name to locate the one for which she was responsible. The Respondent did not contact the blood bank, which had been having difficulty providing transfusion blood to the patient. It is reasonable to assume that the blood bank, charged with the responsibility to provide the appropriate blood supplies to the patient, would have been aware of the patient's location, and could have provided it to the Respondent. The Respondent made no effort to identify patients located in the hospital's intensive care units, despite the critical nature of the patient's condition at last report. Had she done so, she would have located the patient. The Respondent presented testimony that it was not uncommon for a physician, unable to locate a hospitalized patient, to routinely assume that the patient has been appropriately treated and has been discharged, or is deceased. However, the Respondent testified that it was unusual for her not to be able to identify and locate a patient. Even assuming that such practice is routine, it is unlikely that such an assumption could reasonably be made in the case at issue here, where the Respondent did not know the patient's name, had never seen the patient, had personally reviewed no medical records, was unable to find anyone in the hospital who could provide her with any information, and at last communication with the nursing staff had been told that a critically-needed transfusion had not occurred. The testimony is not credited and is rejected.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding Vasundhara Iyengar, M.D., in violation of Subsection 458.331(1)(t), Florida Statutes (2002), and imposing a penalty as follows: a three-year period of probation; a fine of $10,000; and such additional community service and continuing education requirements as the Department of Health determines necessary. DONE AND ENTERED this 31st day of January, 2008, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of January, 2008. COPIES FURNISHED: Jennifer Forshey, Esquire Dorys H. Penton, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 H. Gregory McNeill, Esquire Lowndes, Drosdick, Doster Kantor & Reed, P.A. Post Office Box 2809 Orlando, Florida 32802-2809 H. Roger Lutz, Esquire Lutz, Bobo & Telfair, P.A. 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent, Sanford L. Yankow, M.D., has been a physician licensed to practice medicine in the State of Florida. Respondent's license number is ME 0017585. Respondent is a Fellow of the American College of Obstetrics and Gynecology and is Board-certified in Obstetrics and Gynecology. He received his M.D. degree from the University of Miami School of Medicine in 1969 and then completed his internship and residency in obstetrics and gynecology at Jackson Memorial Hospital located in Miami. Dr. Yankow was the Chief Resident in Obstetrics and Gynecology from 1972 to 1973 and subsequently was an Instructor in the University of Miami Department of Obstetrics and Gynecology from July, 1973, through July, 1975. From 1975 through 1983, he was a Clinical Assistant Professor in the Department of Obstetrics and Gynecology at the University of Miami School of Medicine. Respondent is presently on the active staff of Baptist Hospital of Miami and is a member of the following hospital committees: Laser Committee, Tissue Committee, Cesarean Section Committee, PSCU Committee, Transfusion Committee, and Education Committee. He is a member of the American Fertility Society, the Miami OB/GYN Society, and the Florida Obstetrics and Gynecology Society. He is also a member of the Florida Medical Association, the Dade County Medical Association, and the American Medical Association. Respondent served as a medical consultant and expert witness to Petitioner, Department of Professional Regulation, from 1983 to 1985. The patient whose care is at issue in this case, S. E., was, at the time she was seen by Respondent, a 34-year-old married woman who was trying to get pregnant. S.E. was examined by Respondent on two occasions: June 20, 1983 and June 23, 1983. At the first examination of June 20, 1983, the patient filled out a new patient history questionnaire. This questionnaire was received by Respondent during the course of his examination, and his handwritten notations concerning the patient's history and examination appear on the back of this questionnaire. It is evident that Respondent reviewed the patient's questionnaire and discussed her history and presenting problems with the patient. Respondent also prepared typed progress notes pertaining to the patient's visits of June 20 and June 23, 1983. The progress notes also include an entry for June 22, 1983, when Respondent received and interpreted an HCG pregnancy test result. The patient came to see Respondent because she thought that she had just had a miscarriage. The medical records establish that the patient's last menstrual period was June 13, 1983, seven days prior to her office visit, and the patient continued to bleed. The patient also stated as part of her history that she had been trying to become pregnant, was two weeks late with her last period, and was using no contraception. The progress notes establish that the patient denied dysmenorrhea (painful periods), dyspareunia (painful intercourse), as well as post-coital or intramenstrual spotting. The patient's history also indicated that her mother has breast cancer, and that S. E. had irritable bowel syndrome. S. E. was not allergic to any medication, was not taking any, did not smoke or drink (except occasional wine), and did not use drugs. The patient did not indicate that she was experiencing pain, tenderness, or dizziness during either visit to Respondent's office. Respondent's notes regarding his physical examination of the patient on June 20 affirmatively state that the patient was "in no distress." Her weight was 110, and her blood pressure was 100/60. Respondent did a complete review of systems, including an HEENT (head, ears, eyes, nose, and throat), all of which were normal. He examined her neck, found her lungs clear, listened to her heart, examined her breasts, and found no masses or tenderness. Her nipples were erect and having no discharge. The abdominal exam revealed the abdomen to be soft and flat, with no masses and no tenderness. There was no tenderness of the back and no lymphadenopathy of the groin, and the extremities were normal. The pelvic examination revealed no masses or tenderness of the adnexa (the tubes and the ovaries). Her uterus was top normal size, anteverted, anteflexed, normal shape, and with consistency. The external genitalia and BUS glands were normal. Introitus marital was noted, with no lesions of the vagina. The pelvic examination also indicated bleeding from a slightly cyanotic cervix. The Respondent's diagnostic impression was a possible spontaneous abortion, which is commonly referred to as a miscarriage. Respondent's plan was to obtain a Beta HCG pregnancy test, get a pap smear, start the patient on basal body temperature charts, and obtain records from the patient's previous gynecologist. The Beta HCG and pap smear specimens were obtained during the first office visit of June 20, 1983. On June 22, 1983, Respondent received the HCG test result of 3440, which according to the laboratory performing the test indicates that the patient was in the fourth week of pregnancy. Respondent reiterated in his progress notes of June 22 that the uterus was top normal size, and Respondent concluded that with a serum HCG at 3440, the patient was in approximately the fourth week of pregnancy. He indicated that he would see her again in one to two weeks. On June 23, 1983, the patient returned. There is no indication that the patient returned because of pain or any new type of complaint. A second pelvic examination was performed on June 23, 1983, which also indicated that there were no adnexal masses. The uterus was anteverted, anteflexed, and was of normal size, shape, and consistency. Respondent repeated the Beta HCG pregnancy hormone test on June 23, and the results were reported on June 24, 1983. The Beta HCG report shows that the Beta HCG dropped from 3440 to 2100. Tracking the HCGs down until the level of pregnancy hormones reaches zero is appropriate to establish the regression of a pregnancy due to a spontaneous abortion or miscarriage. On June 27, 1983, the patient became shock-y and was taken to Hialeah Hospital. It was then discovered that the patient had a ruptured tubal pregnancy involving the proximal tube and part of the cornua. The patient was operated on and then did well. An "ectopic pregnancy" is a pregnancy which occurs outside the uterus and is usually located in a fallopian tube. When the pregnancy is located in a tube, it is referred to as a "tubal pregnancy." Subsequent to Respondent's care, it was discovered that this patient had an "interstitial" ectopic pregnancy. Only two percent of ectopic pregnancies are interstitial, and interstitial ectopics are the most difficult to diagnose. Petitioner offered proof through its expert witness, Dr. Robert Brauner, that Respondent committed medical malpractice by failing to diagnose and treat an ectopic pregnancy. On the other hand, the Respondent's expert witness, Dr. Manuel A. Penalver, testified by deposition that Respondent did not commit medical malpractice or fall below the prevailing standard of care by failing to diagnose or treat an ectopic pregnancy. Both Dr. Brauner and Dr. Penalver were provided with the exact same information from which to formulate their expert opinions--a copy of Respondent's medical records. From this exact same information, the two experts have formulated diametrically opposed opinions. Petitioner's expert, Dr. Robert Brauner, is an obstetrician and gynecologist in private practice in Tampa. He has been Board-certified in Obstetrics and Gynecology since 1983. Dr. Brauner has practiced medicine in a solo practice since April, 1983. In 1981, he was in a two-person practice for a year and a half, and he then went to another two-person practice for a little over one year. He is a Diplomat of the National Board of Medical Examiners and has been a consultant in gynecology to the Tampa Veterans' Hospital since 1983. Dr. Brauner is on the quality assurance committee at Humana Women's Hospital in Tampa. Respondent's expert witness is the Chief of Gynecology at the University of Miami School of Medicine. Since 1984 Dr. Penalver has been a full-time member of the Department of Obstetrics and Gynecology at the University of Miami. He has been awarded tenure and is currently an Associate Professor of Medicine. Dr. Penalver is Board-certified in Obstetrics and Gynecology and is also Board-certified in Gynecologic Oncology. He has authored numerous articles and publications, including textbooks and textbook chapters in the field of gynecology. He has been the recipient of many awards and honors for his clinical and teaching abilities. Dr. Penalver is ultimately responsible for all gynecological admissions to Jackson Memorial Hospital. He sees patients every day and frequently deals with the subject of ectopic pregnancies in his practice, both through his hands-on treatment of patients, as well as through discussions on the subject during hospital rounds. It is concluded from a review of the credentials of Dr. Penalver and Dr. Brauner that Dr. Penalver excels in professional recognition among his peers and that his expert opinions should be given greater weight than those of Dr. Brauner. Dr. Penalver testified that Respondent's diagnosis of a possible spontaneous abortion (commonly known as miscarriage) was the correct diagnosis based upon the information then known and was not a deviation from the prevailing standard of care for a Board-certified obstetrician and gynecologist. Dr. Penalver went even further by stating that this would have been his own diagnosis if he had examined the patient on June 20, 1983. Respondent's plan to get a pap smear, get a Beta subunit, start the patient on basal body temperature charts, and get previous gynecological records was well-formulated and within the standard of care. This case involved a very unusual presentation for a tubal pregnancy. The presenting symptoms and findings in this particular patient were such that a qualified gynecologist acting within the standard of care should not have been expected to have discovered the ectopic pregnancy. Ectopic pregnancies usually present with pain and dizziness, accompanied by vaginal bleeding, and a positive pregnancy test. There were no complaints of pain or dizziness stated by the patient on either of her two visits to Respondent's office. To the contrary, the patient was affirmatively found to be "in no distress." Upon physical examination, the patient had no pelvic tenderness, no tenderness of her back, and no masses or tenderness of the adnexa (ovary and tubes). Adnexal masses and tenderness are common signs of an ectopic pregnancy. They were not noted in this patient. The history provided by the patient and the physical examination performed by the doctor were inconsistent with an ectopic pregnancy. Instead, the history, physical examination, and Beta HCG tests were consistent with an early three to four week pregnancy that was in the process of miscarrying. It was most likely that this was a three to four week pregnancy, but, even assuming that this was a seven, eight, or nine week pregnancy as contended by Petitioner, Respondent did not breach the standard of care pertaining to the diagnosis and treatment of an ectopic pregnancy. Although the patient indicated that she had an irritable bowel syndrome, this was historical information. Respondent was made aware of her irritable bowel syndrome and included the condition in his progress notes along with other historical matters such as breast cancer in the patient's mother and the patient's allergies. If this was a current complaint, Respondent would have described the condition differently in his progress notes. Respondent ordered the appropriate laboratory test, the Beta HCG subunit testing for the pregnancy hormone. This test revealed an HCG level of 3440 on June 20, which according to the laboratory's own criteria, correlated with a four week pregnancy. The HCG result was consistent with Respondent's finding during the pelvic examination of a top normal sized uterus and correlated with Respondent's diagnosis of a spontaneous abortion. The drop of the HCG from 3440 to 2100 as occurred in this case was also consistent with a miscarriage and was inconsistent with an ectopic pregnancy. In an ectopic pregnancy, it would be expected that the HCG would be rising, but not at the rate of a normal pregnancy. The standard of care utilized by obstetricians and gynecologists in 1983 did not require that Respondent order an ultrasound of this patient. An ultrasound is not diagnostic and would not discover an ectopic pregnancy when the HCG level is below 6000. Respondent did not deviate from the standard of care by failing to provide ectopic precautions to the patient since an ectopic pregnancy should not have been suspected, based upon the patient's history and physical examination. Respondent did not deviate below the prevailing standard of care for Board-certified obstetricians and gynecologists in 1983 by failing to diagnosis or treat an ectopic pregnancy in this patient, S. E.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty of the allegations contained within the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 29th day of July, 1991, at Tallahassee, Florida. LINDA M. RIGOT 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 29th day of July, 1991. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 90-7859 Petitioner's proposed findings of fact numbered 1-6, 8, 14, 20, and 35 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 7, 10-13, 15, 16, 19, 22-24, 26-29, 31, 33, 34, and 44 have been rejected as not being supported by the weight of the evidence in this cause. Petitioner's proposed finding of fact numbered 9 has been rejected as being subordinate to the issues involved in this cause. Petitioner's proposed findings of fact numbered 17, 18, and 21 have been rejected as being unnecessary for determination of the issues herein. Petitioner's proposed findings of fact numbered 25, 30, 32, and 36-43 have been rejected as not constituting findings of fact but rather as constituting recitation of the testimony, argument of counsel, or conclusions of law. Respondent's proposed findings of fact numbered 2-34 and 36- 51 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting a conclusion of law. Respondent's proposed findings of fact numbered 35 and 52-60 have been rejected as being unnecessary for determination of the issues herein. COPIES FURNISHED: Mark A. Dresnick, Esquire 2400 One Biscayne Tower Two South Biscayne Blvd. Miami, Florida 33131 Richard A. Grumberg, Senior Attorney Department of Professional Regulation Northwood Centre 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Dorothy Faircloth, Executive Director Department of Professional Regulation Northwood Centre 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation Northwood Centre 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792
