The Issue The issues in this case are whether Respondent violated Subsections 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2005),1 and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2004), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency in Florida charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Amended Administrative Complaint, Dr. Pendergraft has been a licensed physician in the State of Florida, having been issued license No. ME 59702. Dr. Pendergraft is board-certified in Obstetrics and Gynecology. He does not have hospital privileges in Florida. At all times material to the Amended Administrative Complaint, Dr. Pendergraft, alone or with one or more partners, owned and operated Orlando Women’s Center, Inc. (OWC), a clinic located in Orlando specializing in abortions. OWC is not a hospital. At all times relevant to the Amended Administrative Complaint, Dr. Pendergraft did not have a current, valid Drug Enforcement Administration (DEA) number. On June 3, 2005, R.W. presented to her primary care physician symptoms of weight gain, fatigue, and lack of a menstrual period for several months. R.W. was a marathon runner and had experienced a delay in her menstrual cycle before because of her strenuous training. She had been taking oral contraceptives. At that time, her primary care physician did not diagnose R.W. as being pregnant. A couple of weeks after her visit with her primary care physician, R.W. still had not regained her menstrual cycle and took a home pregnancy test. The results of the home pregnancy test were positive. R.W. contacted her primary care physician, who ordered laboratory tests for R.W. Laboratory tests were conducted on June 14, 2005, and June 21, 2005. Both tests confirmed the pregnancy. R.W. was referred to Bert Fish Medical Center for an ultrasound on June 21, 2005. The ultrasound showed that R.W. was pregnant. The physician who prepared the diagnostic imaging report based on the ultrasound stated in the report: There is a single intrauterine fetus with an estimated gestational age of 24.5 weeks. Positive fetal heartbeat is present at 142 beats per minute. However, there is severe oligohydiamnios with no positive fetal movement. Gestational age is usually calculated from the first day of the last menstrual period (LMP) of the pregnant woman. On average, the last menstrual cycle occurs two weeks prior to conception. Thus, the gestational age that is determined by the LMP is actually two weeks more than the date of conception.2 When the LMP is unknown, fetal measurements are used to calculate the gestational age. Oligohydramnios means a lack of amniotic fluid. Amniotic fluid is basically the fetus’ urine. A lack of amniotic fluid can be caused by the lack of kidneys or obstructed kidneys, rupture of the membranes, or a malfunction of the placenta. The lack of amniotic fluid makes it difficult to assess the fetal measurements using ultrasound. R.W. was referred to an obstetrician, Dr. P.C., who admitted R.W. to Halifax Medical Center for routine laboratory work and an obstetrical ultrasound. The ultrasound was performed on June 22, 2005, and showed that the fetus was in a breech presentation, there was markedly decreased amniotic fluid, the bowel was abnormal, and the ventral wall was suspicious. Based on the ultrasound, it appeared there was gastroschisis or omphalocele. Gastroschisis occurs when the abdominal wall of the fetus does not close properly and the intestines are outside the body. Omphalocele is a herniation of the intestines, and a sac-like structure covers the intestines outside the abdominal wall. The assigned gestational age estimated by the physician reviewing the ultrasound was 25 weeks and five days.3 R.W. was referred to a perinatologist in Jacksonville. Another ultrasound was performed on June 23, 2005. The assigned gestational age was 25 weeks and six days, which would mean that the age of the fetus was 23 weeks and six days from conception.4 The lack of amniotic fluid and the position of the fetus made it difficult to determine the actual gestational age of the fetus. The perinatologist reported the following to Dr. P.C.: At this time, an ultrasound examination was performed which showed a single living fetus in breech presentation. There is no amniotic fluid which precluded an adequate examination of fetal anatomy. The right kidney and bladder were visualized essentially excluding diagnosis of renal agenesis. A normal appearing 4 chamber structure was seen which visually appears to occupy more than 50% of the chest cavity. This is also very difficult to evaluate due to the position of the baby. There appears to be an anterior abdominal wall defect most likely a gastroschisis, however, again this is impossible to evaluate in great detail. Of importance and further complicating the problems in this case, is the biometry. Measurements of head circumference and cerebellum are consistent with 30 weeks, however, the femur length is consistent with 25 weeks. The fact that this patient has been amenorrheic since October when she could be up to 34 weeks gestation is significant. We don’t know the exact gestation but it is of concern that there is a dramatic difference between the extremities, abdomen, and head circumference as well as the cerebellum. This points to a growth retardation process. Doppler studies of the umbilical circulation were slightly elevated but if there had been placental disfunction I would have expected an absent diastolic component which was not the case. * * * [M]y biggest concern has to do with the anhydramnios and the fact that we don’t know for how long this process has been active. Pulmonary hypoplasia is a strong consideration given the size of the chest and the virtual absence of fluid. Nevertheless, not knowing for how long she has not had fluid is difficult to quote her a risk. The second area of concern is that of the appearance of a structural abnormality. Typically gastroschisis is not associated with a chromosomal anomaly, however, given the discrepancies in biometries and the absence of amniotic fluid, I wonder if this is not a gastroschisis or if it is, part of a more complex situation. The perinatologist conveyed his findings to Dr. P.C., who discussed the situation with R.W. R.W. decided to terminate the pregnancy. The office notes of Dr. P.C. stated, “It was felt by me and my partners that facilitating delivery of this non-viable child was appropriate.” Dr. P.C. called Dr. Pendergraft to discuss the case. Dr. Pendergraft agreed to help, and Dr. P.C. gathered R.W.’s medical records to send to Dr. Pendergraft. On July 7, 2005, R.W. presented to Dr. Pendergraft at OWC. R.W. filled out an information sheet and listed the first day of her last normal period as January 5, 2005.5 R.W. filled out the appropriate consent forms, which a counselor reviewed with her. R.W.’s vital signs were taken and laboratory tests were performed by staff at OWC. Dr. Pendergraft’s notes stated that the sonogram showed severe growth restriction of the fetus. He further indicated that there was a possibility of severe pulmonary hypoplasia and risk of life-threatening sudden health issues or probable fetal, prenatal demise. Dr. Pendergraft wrote in his notes that R.W.’s PMD OB/GYN physician concurred with the maternal health reasons for the termination of the pregnancy. On July 7, 2005,6 at approximately 4:27 p.m., Dr. Pendergraft administered Digoxin into the heart of the fetus to stop the fetal heart beat. Dr. Pendergraft and his medical assistant, S.M., monitored the fetal heart beat using a sonogram until the fetal heart stopped. The procedure was documented on a form used by the OWC entitled “Second Trimester Medical Procedure.” On the form, it is noted that the patient was evaluated on July 7, 2005, and found to be 27 to 28 weeks pregnant, which is 25 to 26 weeks from conception. According to T.S., a medical assistant employed by Dr. Pendergraft, the handwriting which indicates the estimated length of the pregnancy belongs to Dr. Perper, a colleague of Dr. Pendergraft. Both Dr. Perper and Dr. Pendergraft signed the form. After the Digoxin procedure was completed, R.W. was taken to a private room and given Cytotec to induce labor. S.M. continued to administer Cytotec and monitor R.W. until 8:30 p.m., when T.S. relieved S.M. At approximately 12:30 a.m., on July 8, 2005, R.W. developed a fever and the administration of Cytotec was discontinued. T.S. administered Ibuprofen to R.W. to lower the fever. At 1:30 a.m., T.S. noted that R.W. was having some cramping. T.S. wrote the following in the progress notes: “I have a standing order from Dr. Pendergraft for 2 cc Demerol [with] 1 cc Phenergran.” This order was to alleviate the pain from the cramping. At the final hearing, T.S. stated that the note was not totally accurate, because the standing order was from Dr. Perper and not Dr. Pendergraft because Dr. Pendergraft did not have DEA authorization. She attributes the error in her notes to her 20-year working relationship with Dr. Pendergraft and her automatically thinking of Dr. Pendergraft in terms of standing orders. The standing order itself was not submitted into evidence. The evidence is not clear and convincing that Dr. Pendergraft gave the standing order for the Demerol and Phenergran. At 4:30 a.m., the cramping had increased. T.S. gave R.W. an injection of 2 cc of Demerol with 1 cc of Phenergran. At 6:30 a.m., R.W. delivered the fetus and placenta at the same time inside an empty water sack. The products of conception, which included the fetus, membranes, and placenta weighed 800 grams. The weight of the products of conception was recorded on a form used by the OWC, entitled “Clinic Examination of Products of Conception.” The form listed the preoperative estimate of gestational age to be 28 weeks, which would be 26 weeks from conception. Dr. Pendergraft was one of the signatories on the form. Dr. Pendergraft charged R.W. $12,000 for the procedure. Although, both Dr. Pendergraft and his associate Dr. Perper, felt that, preoperatively, the gestational age of the fetus was between 27 and 28 weeks, Dr. Pendergraft did not transfer R.W. to a hospital. Jorge Gomez, M.D., testified as an expert witness on behalf of the Department. Dr. Gomez is board-certified in obstetrics and gynecology and in maternal-fetal medicine. Dr. Gomez opined that on July 7, 2005, the age of the fetus from conception was 27 weeks. His opinion was based on biparietal diameter (BPD), the head circumference, the size of the cerebellum, and the femur length. He discounted the abdominal circumference because the abdominal wall defect would result in a less reliable measurement of the age of the fetus. The abdominal wall defect would cause the measurement to be smaller than would be expected for the age of the fetus. Jay Neil Plotkin, M.D., testified as an expert witness for Dr. Pendergraft. Dr. Plotkin has been a licensed physician for 37 years and is board-certified in obstetrics and gynecology. Dr. Plotkin has not treated patients for four years and has not performed an abortion in six or seven years. It was Dr. Plotkin’s opinion that the abortion occurred during the second trimester rather than the third trimester. His opinion is based on the combined fetal and placental weight at time of delivery. He concluded that the gestational age at the time of delivery was 24 weeks, which would translate to 22 weeks of pregnancy from conception. He used a chart to determine the age based on the weight of the fetus, but he did not know if the chart was based on normal fetuses or included fetuses with abnormalities such as the one at issue. Dr. Pendergraft also called Steven Warsof, M.D., as an expert witness. Dr. Warsof is an obstetrician/gynecologist with a subspecialty in maternal-fetal medicine. He has spent most of his professional career pursuing academic issues in obstetrical ultrasonography. It was his opinion that R.W.’s pregnancy was in the second trimester. He also based his opinion on the weight of the products of conception after delivery. Based on the evidence presented, it is clear and convincing that R.W. was in her third trimester of pregnancy when she had the abortion. The only two doctors who placed the pregnancy in the second trimester based their opinions on the weight of the fetus and placenta at the time of delivery. Because of the complications of R.W.’s pregnancy, it is clear that the fetus had not developed normally and was underweight for its age. There had been a lack of amniotic fluid which is essential to development of the fetus. Based on his office records, it is also clear and convincing that Dr. Pendergraft was under the impression that R.W. was in her third trimester of pregnancy when he performed the abortion. The medical records of Dr. Pendergraft do not contain a written certification from two physicians that within a reasonable degree of medical probability the termination of R.W.’s pregnancy was necessary to save the life or preserve the health of R.W. The evidence established that Dr. Pendergraft wrote in his notes that there was a risk of life-threatening, sudden health issues. Assuming he was referring to the health issues of the pregnant woman, this note could be considered a certification that to a degree of medical probability that the abortion was necessary to preserve the health of R.W. However, there is no written certification from another physician that that was the case, and the note of Dr. Pendergraft that R.W.'s primary care physician concurred with the maternal health reasons for termination of the pregnancy is not a written certification from another physician. The medical records kept by Dr. Pendergraft do not contain a written certification that there is a medical necessity for emergency medical procedures to terminate the pregnancy and that no other physician is available for consultation. No evidence was presented concerning the allegations in Counts IV, V, and VI of the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Dr. Pendergraft guilty of violations of Subsection 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t)1., Florida Statutes; dismissing Counts IV, V, and VI of the Amended Administrative Complaint; suspending his license for one year followed by three years of probation with indirect monitoring; imposing an administrative fine of $10,000.00; and denying his motion for attorney's fees pursuant to Subsection 120.595(1)(b), Florida Statutes. DONE AND ENTERED this 26th day of October, 2007, 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 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 2007.
The Issue The ultimate issues in this case are whether Respondent violated Section 458.331(1)(m) and (t), Florida Statutes (1997), respectively, by failing to keep medical records that justify the course of treatment and by failing 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; and, if so, what penalty, if any, should be imposed against Respondent's license to practice medicine. (All chapter and section references are to Florida Statutes (1997) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43 and Chapters 455 and 458. Respondent is licensed as a medical physician in Florida pursuant to license number ME0050478. Respondent has been a Board-certified plastic surgeon at all times material to this proceeding. The Administrative Complaint involves one patient who undertook elective plastic surgery. The record identifies the patient as E.O. in order to preserve the patient's confidentiality. In summary, the Administrative Complaint alleges that Respondent departed from the acceptable standard of care by: failing to perform the surgical procedure elected by E.O.; performing a surgical procedure other than the procedure E.O. authorized; failing to document a reason for changing the procedure; failing to advise the patient of the risks associated with the procedure performed; performing breast augmentation with implants that were too large; and failing to document a reason for using the larger implants. On December 31, 1997, E.O. presented to Respondent for consultation regarding reconstruction of her left breast. At the time, E.O. was approximately 48 years old. E.O.'s medical history included an abdominal hysterectomy, a biopsy of the right breast, two biopsies of the left breast, and a diagnosis of cancer in the left breast. A partial mastectomy of the left breast and radiation therapy resulted in significant scarring. The left breast had a concave, depressed area in the left side. The depressed area extended from the upper part of the breast, near the outer pectoral muscle, halfway to the nipple. The nipple on the left breast was pulled to the outside toward the depressed area. E.O. also suffered ptosis, i.e., the appearance of drooping, that was not related to her medical history. The radiation therapy to the left breast had caused a burn injury that left internal scar tissue. The scar tissue was not pliable and was not suitable for manipulation during plastic surgery. During E.O.'s initial visit with Respondent on December 31, 1997, Respondent noted E.O.'s prior medical history and radiation treatment. He noted the bilateral ptosis and the left breast deformity. Respondent recommended bilateral implants for the purposes of reconstructing the left breast and for achieving symmetry between the breasts. Respondent and E.O. did not agree on a plan of treatment during the initial visit but did agree to a second visit. On January 16, 1998, E.O. presented to Respondent for her second visit. After further consideration of E.O's case, Respondent made a specific recommendation of bilateral augmentation with prostheses, in the form of implants, and a latissimus dorsi flap (LDF) procedure to correct the depression in the left breast. An LDF procedure would have resected, or removed, the scarring in the left breast and would have replaced the resulting divot with healthy tissue. Respondent would have obtained healthy tissue by moving a flap of tissue and muscle from the patient's back underneath the patient's outer tissue layers and placing the flap internally in the left breast. E.O. agreed with Respondent's recommendation. E.O. agreed to the bilateral augmentation because Respondent advised her that an implant in her right breast was necessary to achieve appropriate symmetry. E.O. did not agree to the augmentation because she wanted larger breasts. Respondent assured E.O. that her breast size would increase only about one-half cup. Respondent's records do not include a reference to the size of the implants to be used. Respondent indicated he would seek preauthorization from the insurer for the LDF procedure with prosetheses. The LDF procedure required E.O. to stay overnight in the hospital following surgery. Surgery that omitted the LDF procedure could have been performed in "same-day" surgery. Respondent and E.O. did not discuss or agree upon any plan of treatment. On January 21, 1998, E.O. presented to Respondent for a third time. E.O.'s husband, L.O., was also present. Respondent discussed the LDF procedure with E.O. and L.O. Respondent stated that he believed the LDF procedure was necessary to fill-in the left breast after Respondent resected the radiated tissue as part of the reconstruction of E.O.'s left breast. Respondent, E.O., and L.O. did not discuss other treatment options. On January 21, 1998, Respondent requested authorization from E.O.'s insuror for breast reconstruction surgery that included an LDF procedure with the use of a prosthetic implant. On February 12, 1998, E.O. presented to Respondent for a fourth time. E.O. had additional questions about the surgery that included questions regarding the insurance coverage for the surgery. E.O. and Respondent did not discuss the LDF procedure or other treatment options. Respondent scheduled the surgery for February 26, 1998, at the Columbia Regional Medical Center Southwest Hospital ("Columbia" or the "hospital"). On February 24, 1998, E.O. presented to Columbia for a preoperative workup. At the preoperative workup, E.O. executed a written informed consent document that authorized Respondent to perform a, "Lat Flap with implant left Breast and Right endoscope augmentation." Respondent also signed the informed consent. E.O. did not consent to another procedure different from that stated in the informed consent. Nor did E.O. and Respondent agree upon a different procedure. Hospital records, including the Short-Stay History and Physical completed on the day of surgery and signed by Respondent, show that the procedure to be performed was an LDF procedure with implants. The hospital records are devoid of any indication that E.O. did not wish to undergo the LDF procedure or that E.O. expressed any reservations about the procedure. On the morning of February 26, 1998, E.O. fully expected to undergo the LDF procedure. E.O. presented to Columbia anticipating an overnight hospitalization that was consistent with an LDF procedure. E.O. brought with her the personal belongings she would need for an overnight hospitalization. The applicable standard of medical care required Respondent to perform the LDF procedure so long as it was medically reasonable to do so. On February 26, 1998, Respondent performed surgery on E.O. that included an implant in each breast. However, Respondent did not perform the LDF procedure. Rather, Respondent created breast flaps by incising existing scar tissue and utilizing the incised scar tissue to fill in the depression in the left breast. Respondent did not resect the scar tissue and replace it with healthy tissue. Immediately after the surgery, Respondent advised L.O., without explanation, that Respondent did not perform the LDF procedure and that E.O. was doing well. Columbia discharged E.O. on the same day of surgery. During the trip home in their car, L.O. advised E.O. that Respondent did not perform the LDF procedure. E.O. was surprised but groggy from medication. No medical reason prevented Respondent from performing the LDF procedure. Respondent encountered no difficulties or complications during surgery that precluded the LDF procedure. Moreover, there were medical reasons not to incise the scar tissue and use it to fill in the depression in the left breast. Irradiated scar tissue is not well vascularized, is not pliable, and is not easy to manipulate. The only reason that Respondent offered for failing to perform the LDF procedure was that E.O. expressed concern over the procedure. Respondent testified that E.O. expressed her concern to Respondent when Respondent was in the holding area marking E.O.'s breasts for surgery. The holding area is an area that is physically separate from the operating room. E.O. did not expressly ask Respondent not to perform the LDF procedure. Rather, Respondent inferred that E.O. did not want him to perform the LDF procedure. As Respondent testified during cross examination: Q. And you had a conversation with her wherein she expressed some concern about the latissimus dorsi flap procedure; is that correct? A. The tenor of her conversation indicated some concern. She did not say to me please don't do it, but the tenor of her conversation was that there was concern when I was marking her for it. Transcript (TR) at 624. Respondent claims that the conversation with E.O. occurred when Respondent was in the holding area marking E.O. for surgery. Respondent's testimony during cross examination is illustrative. Q. And your testimony is that, is the holding area an area different than the actual operating room. A. Yes. * * * Q. I would like for you to look to the first line of this operative report, under procedures. It says the patient was brought to the operating room, and marked in the sitting position, then laid supine. A. Yes. Q. Doesn't that note say that you did not mark this patient in the holding area, but you marked her in the operating room? A. It sure does. And are you telling me today that this is in error? A. That is absolutely in error. I have never marked a patient in the operating room. TR at 625. Respondent's claim that he had a conversation with E.O. in the holding area before surgery is refuted by E.O. The testimony of E.O. concerning this factual issue is credible and persuasive. The testimony of E.O. is consistent with the operative report stating that E.O. was marked in the operating room rather than in the holding area. Respondent did not see E.O. in the holding area prior to surgery and did not have a conversation with E.O. in which E.O. expressed some concern over the LDF procedure. E.O. received preoperative medication in the holding area and was not capable of carrying on a conversation with Respondent in the operating room and was not capable of making an informed consent to a different procedure. If it were determined that Respondent had a conversation with E.O. in the holding area while marking her for surgery, there was ample time to amend the informed consent document to reflect a different treatment plan agreed to by E.O. and Respondent. The actual surgery performed by Respondent was a procedure that was different from the LDF procedure authorized by E.O. The actual surgical procedure performed by Respondent was not a lesser included procedure of the LDF procedure. The applicable standard of care would have required Respondent to amend the informed consent document under the facts and circumstances testified to by Respondent. An informed consent should include all anticipated treatment options. The informed consent signed by E.O. and Respondent did not include any options to the LDF procedure. Even if it were determined that the actual procedure performed is a lesser included procedure of the LDF procedure, E.O. did not consent to the lesser included procedure. The performance of a lesser included procedure for which E.O. was not informed and to which E.O. did not consent departs from the applicable standard of care. The procedure performed by Respondent during surgery increased the risk of failure and the need for subsequent surgery by using scar tissue rather than resecting the scar tissue and using healthy tissue to fill in the left breast. Respondent failed to inform E.O. of the increased risk of the procedure actually utilized by Respondent. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. First, Respondent failed to perform the procedure that E.O. authorized. Second, Respondent performed a procedure that placed implants in E.O.'s irradiated left breast without resecting the irradiated scar tissue. Third, Respondent failed to inform E.O. of the increased risk associated with the procedure Respondent utilized during surgery. Finally, Respondent failed to document in the records a reason or rationale for performing a surgical procedure other than the LDF procedure authorized by the patient. Prior to surgery, Respondent agreed to use the smallest implants possible. During surgery, Respondent placed very large implants in E.O.'s breasts. Respondent used a 480 cc implant in the left breast and a 460 cc implant in the right breast. Respondent used the large implant in the left breast, rather than the LDF, in an attempt to stretch the tissue, including the scar tissue, and to fill in the depression in the left breast. Respondent used the large implant in the right breast for symmetry. E.O. did not consent to the use of large implants in either breast. Rather, E.O. authorized the smallest implants possible. Respondent utilized implants that increased E.O.'s cup size from a small C cup to a DD cup. The weight and volume of the large implants stretched E.O.'s skin and exacerbated her ptosis. After surgery, E.O.'s clothes did not fit. A DD cup size was sometimes too small. An accepted method of determining the effect of implants is to sit the patient up on the operating table prior to completing surgery. Respondent did not sit E.O. up on the operating table to view the effect of the implants. Respondent had a complete range of implant types and sizes available for use during surgery. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. Respondent utilized implants that were not authorized by E.O. by placing overly large implants in E.O.'s breasts. Respondent failed to utilize the implants authorized by E.O. by failing to use the smallest implants possible. Respondent failed to document in the records a reason or rationale for using implants other than those authorized by E.O. Respondent's failure to practice medicine in accordance with the applicable standard of care caused substantial harm to E.O. At the first postoperative visit on March 2, 1998, E.O. asked Respondent why he did not perform the LDF procedure. Respondent stated that he had determined that E.O. could do without the LDF procedure. E.O. also expressed concern over the large size of her breasts. Respondent explained that the large size was attributable to swelling and that it would take several months for the swelling to dissipate. Until that time, it was impossible to assess the final result. During subsequent visits on March 11 and 18 and on April 3, 1998, E.O. expressed concern over the size and appearance of her breasts. However, she continued to trust Respondent and to accept his assurances that she needed to be patient and allow the swelling to go down before forming any final opinions regarding the outcome of the surgery. During a visit on May 1, 1998, Respondent examined E.O. and acknowledged that the procedure actually performed on February 26, 1998, did not produce the desired result. The implant and incised scar tissue had not stretched and filled in the left breast. Respondent advised E.O. that she needed the LDF procedure. E.O. elected for Dr. Brueck to perform reconstruction surgery on her. However, problems with insurance coverage delayed the surgery until July 11, 2000. The surgery included bilateral reconstruction with bilateral implant and mastopexy. E.O.'s breast size was a B cup after surgery. E.O. was very pleased with the results of the surgery.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, in accordance with the terms of Petitioner's PRO, that Petitioner enter a Final Order finding Respondent guilty of violating Section 458.331(1)(m) and (t); issuing a written reprimand; imposing a fine of $5,000; and requiring Respondent to complete, within one year, 20 hours of continuing professional education above and beyond that required to maintain licensure. DONE AND ENTERED this 18th day of March, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 18th day of March, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Britt Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Carol A. Lanfi, Esquire 1000 Riverside Avenue, Suite 800 Jacksonville, Florida 32204 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent failed to timely file its application for the renewal of its abortion clinic license, as alleged in the Administrative Complaint. If so, may the Agency for Health Care Administration (Agency) fine Respondent for failing to timely file its renewal application. If the Agency is authorized to impose such a fine, should it exercise such authority. If so, what is the amount of the fine it should impose.
Findings Of Fact The Agency issued an administrative complaint on June 3, 1996, stating an intent to impose an administrative fine in the amount of One Thousand ($1,000.00) Dollars against A Doctor's Office for Women North, Inc., d/b/a A Doctor's Office for Women North (hereinafter referred to as "Respondent"), charging violations of Chapter 390, Florida Statutes, and Rule 59A-9, Florida Administrative Code, as grounds for the imposition of the administrative fine and advising the Respondent of its right to request an administrative hearing. Respondent was served a copy of the administrative complaint on June 4, 1996, by U.S. Certified Mail, Return Receipt Requested, but failed to respond or request a hearing within twenty one (21) days of receipt of notice of the action of the Agency as required pursuant to Section 120.57, Florida Statutes, and Rule 10-2.36, Florida Administrative Code. Respondent is licensed to operate at 1100 N.E. 125th Street, North Miami, Florida 33161, as an abortion clinic in compliance with Chapter 390, Florida Statutes, and Chapter 59A-9, Florida Administrative Code. Respondent has operated such that: (a) The Respondent has violated the provisions of Chapter 390, Florida Statutes, in that License Number 685 was issued to the Respondent for the period of 2/28/95 through 2/27/96. Respondent's application for renewal was due to be received by the Agency on 12/29/95, sixty days prior to expiration; however, it was received on 02/26/96, which was (54) days late. This is in violation of Section 390.016(1), Florida Statutes. Notice was provided in writing to the Respondent of the violations set forth above in paragraph 4(a).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency issue a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 9th day of October, 1997, in Tallahassee, Leon County, Florida. STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 9th day of October, 1997.
The Issue The issues in this case are whether Respondent violated section 458.331(1), Florida Statutes, by committing medical malpractice or by failing to keep legible medical records that justify the course of treatment of a patient, as set forth in the Amended Administrative Complaint, and, if so, what is the appropriate sanction.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2015). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458. At all times material to the complaint, Dr. Tsinker was a licensed medical doctor within the state of Florida, having been issued license number ME 39408. Dr. Tsinker's address of record is 2500 East Hallandale Beach Boulevard, Suite 207, Hallandale Beach, Florida 33160. D.G. was pregnant and sought care from Bellymama Midwifery Services (Bellymama Midwifery). On May 16, 2013, she signed a Bellymama Midwifery Services VBAC Consent Form. It generally advised of risks and benefits in attempting a vaginal birth after having had a cesarean section (VBAC). It included the following statements, among others: 3. I understand that 70-80% of women who undergo VBAC will successfully deliver vaginally, and that this percentage increases in relation to the amount of support women receive in making the decision to try a VBAC. * * * 7. The exact frequency of death or permanent injury to the baby when the uterus ruptures is uncertain, but has been reported to be as high as 50% in cases of complete rupture. * * * 9. Probable contraindications to VBAC include a classical uterine incision, multiple gestations, and breech. Each of these statements on the form was initialed by D.G. At the end of the form was a place for the patient to choose to either attempt VBAC or elect a repeat cesarean, as well as a place to explain that choice. After the form's statement "I want to attempt a VBAC because," the following entry was made in script, "I don't agree that my previous C-section was necessary and I disagree w/ interventions for the sake of convenience." D.G.'s printed name and her signature appear at the bottom of the form. At hearing, D.G. testified that the cesarean section with her first daughter had been a difficult experience. The baby had complications arising from induction which led to the emergency cesarean. D.G. stated that she wished to avoid interventions unless they were medically necessary. D.G.'s first prenatal visit was conducted on May 17, 2013, by Corina Fitch, R.N., a licensed midwife. Nurse Fitch has a degree in midwifery and provides prenatal care and assistance with home deliveries. She has worked with many patients wanting to attempt a VBAC. D.G. testified that after it was determined, at about 35 and one-half weeks gestation, that the fetus was in breech position, she had a discussion with Nurse Fitch as to the best way to proceed. They decided that they should wait to see if the baby changed position. Nurse Fitch testified that the baby did change to vertex position, but then changed again, back to breech. Nurse Fitch testified that she had advised D.G. generally of the risks and benefits of a vaginal delivery and that she specifically briefed D.G. about some of the additional risks of TOLAC1/ with a breech presentation, but not completely: Well, I think that I-–according to what I told you before, I didn't give her all the risks. I talked about cord prolapse, and I talked about head entrapment. So, potentially, no, she did not receive enough information. At slightly over 40 weeks, D.G. telephoned Nurse Fitch to advise that her water had broken (spontaneous rupture of membrane (SROM)). D.G. and Nurse Fitch decided that D.G. should to go to the hospital to deliver there. Based upon information that Dr. Tsinker had successfully delivered breech babies vaginally, D.G. and her husband had decided to seek care from Dr. Tsinker. Nurse Fitch called Dr. Tsinker. She told Dr. Tsinker that D.G. was a 37-year-old pregnant woman at 40 weeks and four days gestation, that D.G. had previously undergone a cesarean section with her first child, that the fetus was in frank breech presentation, and that she wished to deliver vaginally if possible. Nurse Fitch testified that she did not believe that her conversation with Dr. Tsinker included discussion about consent forms or whether the patient had been advised of the risks of attempting a VBAC under all of these circumstances. However, Nurse Fitch testified that Dr. Tsinker had accepted patients from her before and that she always provided a copy of the consent form that her patients signed to him on those occasions, so he was generally familiar with the consent form. Dr. Tsinker agreed to accept D.G. as a patient. Records of Bellymama Midwifery dated December 10, 2013, indicate: Received T.C. from pt reporting SROM @ 10 a.m., mild cramping. Home visit made. FHT's 140's, all VS WNL, baby in breech presentation, VE done to report findings to OB for transfer of care, 1 cm, 100%, 0 station. Dr. Tsinker called as pt desires vaginal birth, he agreed to do delivery, pt transported to hospital in own car in stable condition for augmentation and delivery, CF. At about 1247 hours on December 10, 2013, D.G. presented to the Broward Health Medical Center in Fort Lauderdale with ruptured membrane and fetus in breech position. Her husband was with her. Based upon communications from Dr. Tsinker, she was expected, and the hospital had the admissions paperwork ready for her. D.G. signed a General Consent form at the time of her admission. At about 1320 hours, a labor assessment was conducted by nursing staff. It indicated, among other things, that the reason for admission was spontaneous rupture of membrane, that D.G. was calm, and that her obstetrical history included a previous cesarean section due to low amniotic fluid at 37 weeks. Electronic fetal monitoring begun at 1317 hours showed no decelerations and active movement. Examination confirmed that the fetus was in breech presentation. D.G. told the nursing staff that she wanted to labor without pain medications. The LD-Flowsheet BG indicates that at about 1334 hours, Dr. Tsinker was made aware of the examination and that he issued orders. Dr. Tsinker testified that he was told that the baby was in frank breech position and that there was only "mild" labor activity. Dr. Tsinker testified that he gave the order to start D.G. on oxytocin (or Pitocin). A Maternal Child Inter-Disciplinary Patient Education Record indicates that D.G. was advised of potential side effects from the use of Pitocin at about 1400 hours. This was the only entry in the "Medications" content area. The form contains the initials "SY" and contains a signature that appears to read "Simone Young, RN." The form contains no mention of misoprostol (or Cytotec). D.G. signed a Vaginal Delivery Consent form at about 1410 hours on December 10, 2013. The form had Dr. Tsinker's name filled in and, in a typed line which had been added, indicated that he was authorized to perform "delivery of baby, possible cesarean section, possible use of forceps or vacuum extractor, possible episiotomy." The form itself contained no information about the risks of vaginal delivery, no information about the risks of vaginal delivery after cesarean section, and no information about the risks of vaginal delivery after cesarean section with a baby in breech presentation. The only provision related to risks stated: The Physician has explained to me, and I understand, the potential benefits, risks, or side effects of the procedure, including potential problems related to recuperation; the likelihood of achieving goals; the reasonable alternatives to the procedure; and the relevant risks, benefits, and side effects related to alternatives, including the possible results of not having the procedure. The document contains a signature in the "witness" space which appears to read "S. Young, RN." It was uncontroverted, however, that D.G. had not actually talked with the attending physician about anything before she signed the form. Dr. Tsinker testified that it is his signature which appears at the bottom of the form in the "Physician Signature" space. While there was some question about the date Dr. Tsinker signed the form, this is of no significance. The form does not show that Dr. Tsinker advised D.G. of the risks of TOLAC under her circumstances, and its statement that this had been done was completely rebutted by all of the other evidence, including testimony of Dr. Tsinker. Dr. Tsinker never advised D.G. of the particular risks involved in a vaginal delivery, given her previous cesarean section and breech presentation. He never advised her that a cesarean section was indicated. Further, he admitted that D.G. never told him she was unwilling to have a cesarean section. He simply assumed, based upon the information that had been provided to him by others, that she would decline a cesarean section even if he strongly recommended it to her. He testified that he came to that conclusion because: The patient never, A, asked me any additional questions that she may have had--you know I'm not her mind reader--at time when she was admitted and I showed up after that, right. She knew about her right to ask these questions and to have them answered to her full satisfaction. When I showed up, she didn't have that opportunity when she came in because I wasn't there. But when I showed up, she had all in the world opportunity, if she was even a little bit still in the dark or had reservations or any problems, she had the opportunity to ask me that and I would have definitely given her a complete answer. She never mentioned she had regret her opinion or she wants to stop and revert to a cesarean section, or to do anything but to continue the trial of TOLAC. Some of D.G.'s medical records, such as the medications list, suggest that misoprostol, a drug used to make the patient more receptive to oxytocin, was never ordered in D.G.'s case. Other records suggest that it may have been administered to D.G. Dr. Tsinker stated in response to interrogatories and testified at hearing that misoprostol was not used in D.G.'s case. As for entries appearing to indicate that misoprostol was discontinued, Dr. Tsinker's uncontroverted testimony was that you cannot "discontinue" misoprostol because it is introduced intravaginally in the form of a small pill. The only drug that could be discontinued is oxytocin, which is introduced intravenously. Dr. Tsinker maintained that any references to "discontinue" are references to oxytocin, not misoprostol. He further maintained that misoprostol is used when the cervix needs ripening and noted that, in this case, it was already thinned, with D.G's records showing 100 percent effacement, so that there would have been no need to order misoprostol. Hospital records of Pharmacy Orders reference that administration of Pitocin through continuous infusion began at 1514 hours. An accompanying note provided, "6 milliunit/min = 0.3 mL/min = 18 mL/hr – Start at 6 milliunit/min. Increase by 3 milliunit Q15 min until contractions are Q2 min apart, 40 sec in duration & moderate to strong by palpation – continuous infusion (not to exceed 20 MU/min). Hold for non reassuring FHR pattern or tachysystole." Dr. Tsinker did not perform an examination of D.G. in order to determine whether D.G.'s fetus was in frank, footling, or some other breech position prior to the administration of Pitocin to D.G. As Dr. Tsinker testified, he had been informed that the fetus was in frank breech position. There was some conflicting evidence as to whether the fetus was in frank breech or in foot breech position. The Discharge Summary form, dictated by Dr. Siegel and signed by Dr. Tsinker, indicates that the "patient was delivered vaginally, foot breech," and the Newborn Consultation form of Dr. Otero similarly had a block indicating "foot breech" checked. However, Nurse Fitch testified that she determined the baby was in frank breech position earlier, and, consistent with the testimony of Dr. Tsinker, the Baby's Delivery Record indicated "Breech Position: Frank." Norman Donald Diebel, M.D., later testified that although he could not be sure, he concluded that the baby was in frank breech position. Dr. Tsinker had never met D.G. in person, or spoken to D.G. prior to December 10, 2013. He saw her for the first time around 1635 hours on that day. At some point, Dr. Tsinker prepared an OB/GYN History and Physical form. It was dated December 10, 2013, but no time was given. No pelvic examination was recorded which could be used to determine when it was prepared. As Dr. Tsinker admitted, the notes are untimed and mostly abbreviated. It records the presentation as "breech" and the membranes as "ruptured." While it has a few spaces left blank, it was substantially completed, albeit with little detail. During D.G.'s labor, Dr. Tsinker did not dictate or write any progress notes. Dr. Tsinker maintained that because he believed everything was progressing well, he did not think it necessary. At 2031 hours, the flowsheet records Dr. Tsinker at bedside and indicates that he reviewed the fetal strip. At 2051 hours, the flowsheet records that Dr. Tsinker responded to a page and was "notified/updated" and notes that there were "no new orders." Nurse Radhiya Walther could not remember these entries when asked about them, or recall if they were in fact entered about ten hours after the events they describe. Dr. Tsinker disputed that he was ever contacted at this time. At 2130 hours, the flowsheet records that "augmentation D?c'd unable to continuously monitor doula and pt instructed to assist with FHR monitoring while on ball." Nurse Walther stated she discontinued oxytocin because the patient was sitting on the ball, and she was unable to monitor the strip. She admitted in cross-examination that if oxytocin was discontinued, the physician should be notified. She admitted that the records did not indicate that Dr. Tsinker was notified. The fetal monitor strip indicates noticeable loss of variability in the trace and some early decelerations. These were not yet clear signs of fetal distress, but as Dr. Diebel testified, would have caused a reasonably prudent obstetrician/gynecologist to remain with the patient. At 2203 hours, the flowsheet records a vaginal exam by Dr. Tsinker, with dilatation at 10 cms, and effacement at 100 percent. Dr. Tsinker requested that D.G. demonstrate how she was going to push so that he could evaluate the effectiveness of her pushing. D.G. testified later, "Dr. Tsinker asked me to push, I attempted to push with all of my might, they were unproductive pushes. He told me continue to labor, I'll come back later and he left the room." Dr. Tsinker testified that at that time he directed the delivery nurse to have D.G. start pushing, but neither D.G. nor Nurse Walther recall that order. Additional comments recorded for this time indicate "Dr. Tsinker at bedside strip reviewed Pt attempted pushing will labor down." Nurse Fitch, who had arrived in the labor and delivery room about 2000 hours, did not recall Dr. Tsinker ever telling D.G. or the labor and delivery nurse that D.G. could "labor down." As Nurse Fitch testified: I don't recall that. What I do recall is, when [Dr. Tsinker] left the room, she was very distraught because the exam was extremely painful and she didn't have a sensation to push that was very-–she tried. She gave it her best. And she said "Corina, I don't know if I can do this." And the nurse-—I remember the nurse saying, "Don't worry. There's no urgency. We'll just let her wait till she has the urge. Nurse Walther recalled that D.G. stated she did not want to push because she did not feel any pressure, which is why Nurse Walther recorded the "labor down" comment. Nurse Walther testified she would have called Dr. Tsinker if she had felt this was contrary to his orders in any way, but she did not, because she had not been told to make the patient push. D.G. spent much of her labor on the birthing ball, next to the bed. With D.G. in this position, it was more difficult to monitor fetal heart rate because the monitoring belts can more easily shift and not provide clear readings. Also, D.G., who declined a bedpan, made several trips to the bathroom. Portions of the fetal monitor strips have missing or sketchy readings. By 2230 hours on December 10, 2013, D.G.'s fetal monitor had begun to show clear signs of fetal distress, evidenced by late decelerations. D.G. was never advised by anyone that there were signs of fetal distress, or told of the advisability of having a cesarean section in light of that new information. At 2300 hours, under "Interventions," in D.G.'s records, it is stated that "IV Bolus; Discontinue Uterine Stimulants; O2 On; other Interventions – Please Annotate Annotation: Pitocin remains off O2 remains in place." At 2304 hours, the flowsheet records "MD notified that patient is on ball and unable to get cont tracing and having variable decelerations. Pt instructed to return to bed." Under care provider status it is recorded, "Responded to Page; Report Given; In Department; Notified/Updated See SBAR; No New Orders." Dr. Tsinker again disputes that he was given this notification. Nurse Walther stated she could not remember how Dr. Tsinker was notified. She could not recall if Dr. Tsinker showed up personally in response, or called. She could not remember if she repeated the call to him. The flowsheet records a late deceleration at 2316 hours and another at 2320 hours. As Nurse Walther acknowledged in cross-examination, repetitive late decelerations are dangerous and constitute "category 3," the most serious category. Nurse Walther stated she did not know if she notified Dr. Tsinker after these decelerations. She later conceded that three late decelerations constitute an emergency that required that the attending physician be notified. Nurse Walther testified she walked outside to tell the charge nurse, but could not recall what the charge nurse told her in response. There was no evidence of any actions taken by the charge nurse. Under Additional Comments at 2330 hours, it is noted, "Pt found off monitor in restroom, family at bedside safety precautions maintained. Pt instructed to return to bed, assisted to Labor Bed." Nurse Walther's testimony was generally not very clear or credible and many of the entries in the flowsheet record are found to be unreliable, especially those concerning events that supposedly took place after the visit at 2203 hours by Dr. Tsinker. The stored fetal strip, incomplete in places as it is, is the best evidence of the progress of labor. It was not clearly shown that Dr. Tsinker ever reviewed the fetal monitor strip or was otherwise made aware of the late decelerations occurring after 2200 hours at any time before his return to the room shortly before midnight. When Dr. Tsinker returned to the room before midnight, D.G. and Nurse Fitch were in the bathroom. He asked D.G. to come out. The patient was returned to bed. At about 0003 hours, D.G. was placed in foot pedals and partially elevated. Under Additional Comments, it is noted "audable fhr 147 pt prepped for pushing Dr. Tsinker." The Mother's Delivery Record prepared by Nurse Walther indicated that the Neonatal Intensive Care Unit (NICU) was called at midnight and arrived at 0005 hours. Dr. Tsinker asked D.G. to push. There was some difficulty in hearing the fetal heart monitor. It was a fairly quick delivery, taking about 11 minutes or so. On December 11, 2013, around 0014 hours, D.G. delivered a stillborn male infant. NICU recorded "0" for all Apgar score factors at both one minute and five minutes after birth. Despite multiple efforts, the NICU was unable to resuscitate the baby. The efforts of the NICU team caused D.G. to have feelings of panic; she testified that she was expecting to hear a baby crying and did not realize until then that there was any issue. After about 20 minutes or half an hour, the NICU team came to D.G.'s bedside and informed her that they were unable to resuscitate the baby. A Vaginal Delivery Summary form completed by Dr. Tsinker and dated December 11, 2013, at 1214 hours, briefly described the placenta, blood loss, laceration, and suturing after delivery, as well as the failure of the NICU team to resuscitate the stillborn child, but it said almost nothing of the labor and delivery itself, noting only that Dr. Tsinker "assisted breech delivery" and that the Apgar scores were "0" at one and five minutes. There was no evidence of any other delivery note prepared by Dr. Tsinker. Dr. Tsinker did not talk with D.G. after the delivery, or at any time on December 11, 2013, although D.G. had been requesting to speak with him to find out what had happened. On the morning of December 12, 2013, Dr. Tsinker came to D.G.'s hospital room, but D.G. was in the bathroom. Dr. Tsinker told D.G.'s husband that he would return. D.G. came out of the bathroom and waited for Dr. Tsinker to return. When he did not, D.G. went to the nurse's station and again asked to see him. When D.G. learned that he was no longer in the ward, she asked for her discharge papers. Dr. Tsinker appeared, and they returned to D.G.'s room. In the brief discussion about the course of labor and delivery which followed, D.G. believed that Dr. Tsinker was insensitive and blamed her for the outcome. After receiving further care not relevant to this case, D.G. was discharged from Broward General Medical Center at 1220 hours on December 12, 2013. Standards Dr. Diebel is an obstetrician/gynecologist who has been licensed in Florida since 1977. He is board-certified by the American Board of Obstetrics and Gynecology and was an examiner for the board for 18 years. He has previously served as an expert witness in administrative proceedings for the state of Florida. Dr. Diebel is an expert in obstetrics/gynecology and has knowledge, skill, experience, training, and education in the prevailing professional standard of care recognized as acceptable and appropriate by reasonably prudent obstetricians/gynecologists in Florida. Dr. Diebel reviewed D.G.'s medical records from Broward Health, the fetal monitor tracings, the midwife records, the autopsy report, and the Amended Administrative Complaint filed in this case. As Dr. Diebel testified, a vaginal delivery after cesarean section has some risks, but they are still performed. A vaginal delivery with breech presentation has some risks, but they are performed. However, he testified that to attempt a VBAC with a breech presentation was below the standard of care recognized as acceptable and appropriate by reasonably prudent obstetricians/gynecologists in Florida. As Dr. Diebel testified, you have two risky procedures, and "nobody would recommend" doing TOLAC and breech together. While Dr. Diebel acknowledged that this standard of care was not expressly set forth in American Congress of Obstetricians and Gynecologists' Practice Bulletin Number 115, August 2010, entitled "Vaginal Birth After Previous Cesarean Delivery," Dr. Diebel's testimony was clear and convincing and is credited.2/ Dr. Diebel credibly testified that it was below the standard of care to place the burden on the patient to "ask" about a cesarean section. The standard of care in labor and delivery requires that there be an agreement between the physician and the patient, as a part of which the patient is clearly presented with the potential hazards of what she is about to undertake. Dr. Tsinker should have discussed the potential benefits and risks of D.G. undergoing TOLAC, as well as the option to elect a repeat cesarean delivery, with D.G. as soon as possible after her arrival at the hospital. As Dr. Diebel testified, Dr. Tsinker should have advised D.G. that it was a very risky procedure for D.G. to undergo TOLAC because the baby was in breech position, that this is not currently an acceptable procedure, and that she should have a cesarean section. The standard of care required Dr. Tsinker to advise D.G. of the additional risks involved in attempting a VBAC due to her breech presentation. It was Dr. Tsinker's responsibility to fully explain those risks, recommend a cesarean section, and affirmatively ascertain and document her response. Dr. Diebel testified that if a patient refused to follow the physician's recommendations or was uncooperative in this regard: You would document it profusely if a patient- –you know, I explain to the patient that this is what's happening, this is what can happen, this is what the effects can be. I explained all that, she expressed understanding. Yeah, if only to cover myself, I want it to be very clear that we had this discussion and still her decision was otherwise. Dr. Tsinker's testimony that he believed that others had previously had discussions with D.G. about these risks and benefits did not satisfy this standard of care. Dr. Tsinker failed to have the appropriate discussions with D.G. or to document them, as he was required to do. Dr. Diebel's testimony that misoprostol should not be used to induce labor in patients who have had an earlier cesarean delivery was unrefuted and is accepted. Dr. Diebel also testified that the ordering of Pitocin for D.G. violated the standard of care. This conclusion was contested, however, and the basis for Dr. Diebel's conclusion was not carefully explained. While Dr. Diebel did describe risks of uterine rupture, as well as risks of causing contractions to be too close together, it was not explained in what way these risks were unique or increased with a TOLAC with breech presentation. Dr. Diebel testified: Q. Are there any risks associated with administering Pitocin to a patient attempting trial of labor after cesarean with breech presentation? A. Well, you won't find papers devoted to that particular thing, because it is not done. It's not-–breeches are not allowed to have a TOLAC. * * * Q. Why would it not be done? Why would Pitocin not be given in that situation? A. Well, because you wouldn't allow the situation to happen to begin with. Q. Right. A. Where you've got a breech and a previous cesarean section. So there'd be no reason to give Pitocin. This explanation does not provide a logical basis to support a separate charge of medical malpractice. Accepting Dr. Diebel's position that simply undertaking a TOLAC with breech constitutes medical malpractice, it does not follow that every other related, but distinct, element in the labor and delivery procedure would necessarily constitute a separate violation of the standard of care. Dr. Diebel acknowledged that it was appropriate to use a little Pitocin in a (non-breech) TOLAC where the patient is not having any contractions, but that it is run for only a short time, and then once the patient is in labor, discontinued. Dr. Diebel then contrasted that limited use with what was done in this case: In this situation, it was continued all day, even though she was having, in some place on the tracing, contractions a minute to a minute and a half apart, which are too close together. The basis of Dr. Diebel's concern with the use of Pitocin in this case thus appears to be that it was used for too long. However, that was not the charge in this case. The evidence was not clear or convincing that initially ordering Pitocin for D.G., as opposed to continuing its administration for too long, constituted medical malpractice. Dr. Diebel's testimony that D.G.'s admission history and physical was inadequately documented was not clear and convincing. He noted that the form was not properly timed, but the form itself appeared to be substantially completed, and Dr. Diebel did not sufficiently elaborate on what additional information should have been present. Dr. Diebel testified that the standard of care requires that a physician keep progress notes during the labor of their patients. Under cross-examination, Dr. Diebel admitted that as long as everything was going well, there was no need to write a progress note. However, he also testified that the fetal monitor indicated that after 1700 hours, everything was not going well in D.G.'s case. There were missed signals on the monitor, a loss of variability in the trace, and some decelerations before 2200 hours. It was undisputed that Dr. Tsinker failed to keep any progress notes on D.G.'s labor. Under these circumstances, Dr. Diebel's testimony that Dr. Tsinker failed to maintain adequate progress notes was clear and convincing. Dr. Diebel also credibly testified that Dr. Tsinker's delivery note describing what took place during D.G.'s delivery was inadequate. The stillborn child created a duty for Dr. Tsinker to fully document what took place during the course of labor and delivery, with careful attention to documentation of any possible factors that it might appear in retrospect to have contributed to the tragic outcome. Dr. Tsinker's Vaginal Delivery Summary, while briefly describing the placenta, blood loss, laceration, and suturing after delivery, as well as the failure of the NICU team to resuscitate the stillborn child, says almost nothing of the labor and delivery itself, noting only that Dr. Tsinker "assisted breech delivery" and that the baby was stillborn. This was not sufficient under the circumstances. Dr. Tsinker was charged with violating the standard of care in performing as an obstetrician/gynecologist during D.G.'s labor and delivery, and he failed to keep medical records reflecting his participation in the treatment of D.G. during that time. Prior Discipline No evidence was introduced to show that Dr. Tsinker has had any prior discipline imposed upon his license. Dr. Tsinker was not under any legal restraints on December 10, 2013. It was not shown that Dr. Tsinker received any special pecuniary benefit or self-gain from his actions on December 10, 2013. It was not shown that the actions of Dr. Tsinker on December 10, 2013, involved any trade or sale of controlled substances. On August 25, 2014, Dr. Tsinker completed an independent self-study course in Advanced Electronic Fetal Monitoring offered by PESI, Inc., consisting of 6.25 hours of instructional content. On April 6, 2015, Dr. Tsinker completed medical continuing education courses Documentation 154 and Documentation 155, consisting of one hour and two hours of instructional content, respectively, offered by OnlineContinuingEd, LLC.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine finding that Dr. Simion Tsinker violated sections 458.331(1)(m) and (t), Florida Statutes (2013), as charged in the Amended Administrative Complaint; suspending his license to practice medicine for a period of four months; imposing an administrative fine in the amount of $20,000; and requiring that he complete continuing medical education as deemed appropriate by the Board. DONE AND ENTERED this 12th day of February, 2016, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of February, 2016.
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 Whether Respondent, an abortion clinic, failed to maintain emergency medications and related supplies in violation of Florida Administrative Code Rule 59A-9.0225(1) and the penalty, if any, that should be imposed.
Findings Of Fact At all times relevant to this proceeding, Respondent has been licensed as an abortion clinic authorized to perform first and second trimester abortions. The facility at issue in this proceeding is located in North Miami Beach, Florida. Ms. Ody conducted an unannounced inspection of the subject facility on April 21, 2011. Ms. Herne was the only other person at the facility during the inspection. Ms. Ody determined that medications inside an orange box located in the subject facility that served as a crash cart included emergency medications that were out-of-date. Those medications were one 500-ml bag of Lactated Ringer's Intravenous Solution (expired April 2009), a one-mg vial of Atropine (expired November 2010), and one 2 percent Llidocaine Hydrochloride injection (expired November 2010). The crash cart belonged to a certified registered nurse anesthetist, who had worked at the facility at one time. That person had not worked at the facility for several years, and had not returned to claim her property. Dr. Rosenthal's efforts to contact that person were unsuccessful. Dr. Rosenthal and Ms. Herne testified, credibly, that they considered the contents of the crash cart to be that of the former employee and they had never used or attempted to use the contents of the crash cart. On April 21, 2011, the facility had no surgical procedures planned, and no patients were present. On September 12, 2011, Ms. Ody and Ms. Render inspected the subject facility. Ms. Herne was the only other person present during the inspection. During the course of their inspection, they found three bottles of antiseptic located inside of a cabinet in the facility's operating room. Each bottle contained the name Humco Strong Iodine. Two of the bottles of iodine expired in August 1995 and the third bottle expired in May 2005. The three bottles of iodine were not used for surgical procedures. The testimony of Ms. Herne and Dr. Rosenthal established that the iodine was used solely to reduce the odor of infectious waste, which was put in a small container in the operating room until it could be transferred to a larger container in an adjacent room. On September 12, 2011, the facility had no surgical procedures planned, and no patients were present. Petitioner failed to prove that the subject facility did not have appropriate emergency medications or supplies on either of the inspection dates.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the charges against A Medical Office for Women, Incorporated, d/b/a Medical Office for Women set forth in its Administrative Complaint. DONE AND ENTERED this 31st day of July, 2012, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 31st day of July, 2012.
Findings Of Fact The Respondent Gonzalez The Respondent Maria B. Gonzalez is a medical doctor holding Florida license number ME 0028019. She has been licensed to practice medicine in Florida since 1975. Prior to the instant proceeding, her license to practice medicine has never been suspended or revoked. The Respondent has taken and passed the written test for board certification as a specialist in obstetrics and gynecology, but was refused permission to complete the exam because her privileges had by then been suspended by Hollywood Memorial Hospital. During the course of her practice in Cuba and Florida, the Respondent has delivered approximately 2,000 babies. To her knowledge, she has never had a maternal or infant death occur during her practice. The Respondent's practice at Memorial Hospital was highly unusual in that almost half of her patients were Medicaid. As a result, Respondent encountered difficulties in dealing with some of the members of the medical staff at Memorial since she believed that her patients medical interests should take precedence over their ability to pay for services. 1/ The Respondent's provisional staff privileges at Memorial were suspended on July 28, 1982, based upon a review by an ad hoc committee of the hospital's obstetrics and gynecology staff, of six cases, five of which form the basis of the instant proceeding. In deciding to terminate the Respondent, the ad hoc committee considered pertinent medical records and statements from witnesses but did not hear the direct testimony of the Respondent. When the decision was made by Memorial to terminate the Respondent, the hospital informed the Petitioner of this fact pursuant to Section 458.337, Florida Statutes, which requires that the Department be notified when any physician has been disciplined by a licensed hospital for any act that constitutes a violation of Chapter 458, Florida Statutes. Count One Aida M. Astiazarian On December 25, 1981, the Respondent performed a bilateral tubal ligation on Aida M. Astiazarian, a patient who had vaginally delivered an infant several hours prior to the operation. During the procedure, the Respondent was assisted by Dr. Purificacion D. Catini, a surgical assistant. The patient was anesthetized by Dr. Gary Karch. The tubal ligation on Astiazarian began with the opening of the abdominal cavity. Several adhesions from prior surgery and two small bleeders were noticeable, specifically a bleeder on the anterior abdominal wall and on the anterior surface of the uterus. The Respondent ligated the bleeder on the anterior abdominal wall and controlled the oozing from that source. The Respondent elected not to suture or ligate the oozing on the anterior surface of the uterus as recommended by Dr. Catini and instead used a four-by-four inch section of Gelfoam to control the bleed. The Gelfoam was applied with a laparotomy paid and removed after a few minutes. Believing that hemostasis had been achieved, the Respondent closed the abdominal cavity. Unlike the Respondent, Dr. Catini believed that hemostasis had not been achieved since she noticed some oozing still occurring after the Gelfoam was applied. Following the operation the patient's hemoglobin, hematocrit and blood pressure began to fall. The likely cause of these symptoms was an intra- abdominal bleed or ooze. The patient was transfused with several units of blood and discharged from the hospital. Although a reasonably prudent physician would not close a patient with an active ooze or bleed, the record fails to establish that the Gelfoam was ineffective and the Respondent knew or should have known that hemostasis had not been achieved. 2/ Uterine oozing in a postpartum patient can occur without any negligence by a treating physician. The loss of blood which occurred following this operation is not inconsistent with the Respondent's assertion that hemostasis had occurred and that sometime later the clot had become dislodged, thereby causing the bleed which resulted in the administration of two units of blood. Count Two Jaclyn R. Osier On December 28, 1981, the Respondent performed a postpartum tubal ligation on Jaclyn R. Osier. She was assisted during the procedure by Dr. David Gordon. During the operation, a tear in the broad ligament occurred and the patient began to hemorrhage profusely. The tear of the broad ligament which occurred during the procedure was an inherent risk of surgery and does not, by itself, demonstrate negligence by the Respondent. The Respondent extended the incision and located one of the bleeders; however, due to the nature of the tear and the physical condition of the patient, she was unable to locate and control other bleeders which were deeper in the abdomen. Due to the blood loss experienced by the patient, Dr. Gordon determined that additional help was needed. He left the operating room and sought assistance from Dr. Raymond Nolan. When Dr. Nolan arrived, he made an additional extension of the incision and with assistance from the Respondent and Dr. Gordon, he was successful in locating the deep bleeders and achieving hemostasis. Under the circumstances, it was appropriate medical practice for either the Respondent or Dr. Gordon to seek additional help when the patient's bleeding was not under control. As noted by Dr. Nolan "...Just as two heads are better than one, four hands are better than two." (Tr. at 369.) Significantly, Dr. Nolan, a surgeon who had operated with the Respondent on this case as well as others, did not believe that the Respondent's license should be revoked based on his actual experiences with the Respondent. Following this incident, Dr. Nolan did not have any immediate concern that the Respondent had acted improperly. Although Dr. Nolan later voted to suspend the Respondent's hospital privileges at Memorial, his vote was based on the recommendation of the hospital's ad hoc committee rather than his own personal experiences with the Respondent or his own independent review of pertinent medical records. The intra-operative complication which occurred in this particular case was not the result of the Respondent's negligence. When the Respondent was unable to control the bleeding with Dr. Gordon after the incision had been extended, another surgeon was called to assist. The Respondent's inability to control the bleed prior to Dr. Nolan being called, does not constitute negligence under the circumstances of this case. Count Three Linda Jones On May 28, 1982, at 9:45 p.m., Linda Jones, a high risk and postdate patient was admitted to Memorial. The Respondent examined the patient on the morning of May 29, 1982, and found her to be in labor. The practice at Memorial was that provisional staff physicians, such as the Respondent, handle all service or indigent patients. Linda Jones had been handled by Dr. Kast, another provisional staff physician. On the day the Respondent examined the patient, she was covering for Dr. Kast, who had asked as a courtesy to be relieved until 1:30 p.m. The labor and delivery of pregnant service patients at Memorial are handled by nurse/widwives, unless a complication arises which requires a surgical procedure. The patient was scheduled for a normal vaginal delivery. She was doing well and was placed on a fetal monitor. At approximately 12:25 p.m., the patient started having episodes of decelerations. Nurse/Midwife Jean Tease, R.N., turned off the Pitocin which had been administered and turned the patient to relieve the decelerations. The patient continued to progress until approximately 1:22 p.m., when rapid decelerations on the fetal monitor were observed. At approximately 12:00 p.m. the Respondent left Memorial to attend a wedding in Fort Lauderdale which was a twenty minute drive from the hospital. She notified the nursing staff where she was going so that she could respond if needed. 3/ Nurse Tease contacted both Dr. Kast and Respondent when the patient's symptoms began to worsen. The Respondent returned the call and when informed of the problem, advised Tease that she would return to the hospital. The Respondent was returning to the hospital via Interstate 95 when it began to rain very heavily. Her front brakes froze and her car was immobile. While it continued to rain, Respondent pulled over on the side of the Interstate and attempted to flag down help. A wrecker operator stopped and towed her car to a service station where it was repaired. Meanwhile, since the Respondent had not arrived at Memorial as she had stated, Nurse Tease placed a page for any obstetrician in the hospital, and Dr. David Lessin responded. Dr. Lessin performed an emergency cesarean section and produced a living baby. The Amended Administrative Complaint does not allege that the Respondent was negligent in leaving the hospital; rather it charges that the Respondent breached a duty owed to this patient by failing to come to the hospital until approximately four hours after advising hospital personnel that she was in route. Due to mechanical problems with her car and the weather, it was impossible for the Respondent to return to the hospital to attend this patient. The Respondent believed that Dr. Kast was on duty after 1:30 p.m., and she knew she could not arrive at the hospital before that time. Under the circumstances, her actions regarding this patient were not negligent. Count Four Ramona Cardullo Ramona Cardullo was admitted to Memorial on the morning of May 28, 1982. Mrs. Cardullo was pregnant with her third child who was ultimately successfully delivered by cesarean section. Prior to this pregnancy, Mrs. Cardullo had experienced significant difficulties during the delivery of her two other children. Her first child, who was born following induced labor in Texas, was a month post-mature. Her second child was delivered at Memorial by another obstetrician following induced labor. The second child was delivered through the use of forceps. The problems which Mrs. Cardullo encountered in her two previous pregnancies resulted from a uterine dysfunction in which her cervix failed to dilate sufficiently to permit a normal delivery. When Mrs. Cardullo came to the Respondent during her third pregnancy, she related her previous obstetrical history and its attendant difficulties to the Respondent. In addition to her historical problems, Mrs. Cardullo had also gained 80 pounds during her third pregnancy. When Mrs. Cardullo began her prenatal care, she was living in Hollywood, Florida, with her husband. During her pregnancy, the couple moved to Wauchula, Florida. Since Mrs. Cardullo did not believe that Wauchula had appropriate hospital facilities, she commuted to Fort Lauderdale from Wauchula during the last three months of her pregnancy. The Respondent, however, was unaware that Mrs. Cardullo had moved from Hollywood. On May 28, 1982, Mrs. Cardullo, while home in Wauchula, began passing membranes and started to go into labor. She informed her husband that she was in labor, and called the Respondent. After driving from Wauchula, the couple met the Respondent at Memorial where the patient was examined. The examination revealed that Mrs. Cardullo was not dilating and the Respondent told her to begin walking. She walked around the hospital until later that afternoon, when tests were performed by the Respondent to ensure that the baby was okay. The Respondent put the patient in the labor room and began Pitocin to augment her labor. A nurse in the labor room told Mrs. Cardullo that other patients needed the room more than she did and contacted another physician who ordered the Pitocin to be turned off and the patient sent home. Mrs. Cardullo and her husband returned to Wauchula while she was still in labor. Approximately three hours after arriving home, Mrs. Cardullo began passing "... a lot of stuff." (Tr. at 900.) Mr. Cardullo called the Respondent, informed her of his wife's condition, and stated that they were coming back to the hospital. The couple arrived at Memorial on May 30, 1982, and Mrs. Cardullo was readmitted. Although Mrs. Cardullo's labor had continued throughout this period, her cervix had not dilated. The Respondent discussed a cesarean with the patient, who had requested the procedure be done based on her vaginal experiences in two prior pregnancies, and decided to attempt to dilate the cervix before performing surgery. Approximately ten hours after Mrs. Cardullo's readmission and five hours after her water had broken, the Respondent came to the conclusion that the Pitocin was not working since the patient's cervix still had not dilated properly and that a cesarean would be necessary. Mrs. Cardullo had no problems with the cesarean delivery and was pleased with the quality of care she received from the Respondent. Mrs. Cardullo stated that the Respondent was different from other doctors she had encountered in that she believed the Respondent cared about her and her problems. The Respondent's care and treatment of Mrs. Cardullo was appropriate considering the patient's prior medical history. The only criticism that could be directed toward the Respondent in her handling of the Cardullo case is that she waited too long to perform the cesarean by not giving sufficient consideration to the input from her patient. Count Five Elina Carrasco On December 17, 1982, the Respondent performed an abdominal hysterectomy on Elina Carrasco at International Hospital in Miami, Florida. During the procedure the Respondent was assisted by Dr. Francisco Sarmiento. The patient had a large amount of fibrous tissue and adhesions from prior abdominal surgery which made it difficult for the Respondent to visualize the operative site. The adhesions which surrounded the uterus, bladder, omentum, intestines, the right ovary, a segment of the left fallopian tube, and the abdominal wall, had formed a mass which required dissection to reach the pelvic cavity. While dissecting the mass of adhesions, the Respondent cut the patient's illiac vein which was located underneath the adhesions, thus causing the operative field to fill with blood. While Dr. Sarmiento placed his finger on the vein to stop the bleed, Respondent requested and placed a hemostatic clamp on the vein and requested a cardiovascular team to assist. At the time of the surgery, the practice at International was to place regular surgical clamps on a surgical tray rather than non-crushing clamps, when a standard gynecological procedure was performed. Accordingly, the sterile surgical tray which was prepared for this patient did not contain non-crushing clamps, although such clamps were available at the hospital. The surgical clamp was left on the patient only until the cardiovascular team arrived. Because a crushing clamp had been used, Dr. Junco, the surgeon who repaired the severed vessel, felt that a crush type injury to the underlying artery which was immediately adjacent to the severed vein, had occurred. The pathology report does not indicate that any clots or sections of artery were removed from the patient, although the operative records indicated two small clots were removed from the artery. The crush injury was not severe in that after the insertion of a fogarty catheter, proximal and distal blood flow was restored without requiring the removal of the crushed portion of the artery. Dr. Junco closed the vein and repaired the artery. After surgery, the patient improved and was discharged from the hospital on December 30, 1982, in stable condition. The basis of the charge against the Respondent in her care and treatment of Ms. Carrasco involves essentially one issue; whether it was below the standard of care for the Respondent to clamp the patient's vein with a device which could and did cause a crush injury to an underlying artery, 4/ in order to control bleeding from the illiac vein. In retrospect, the wiser course in this case would have been to take the time to obtain a non-crushing clamp from the rotating nurse while Dr. Sarmiento controlled the bleed through use of finger pressure. The unfortunate event which occurred in this case did not result from any lack of surgical or other skills by the Respondent. The Petitioner has characterized the Respondent's reaction to the transected artery and use of a hemostatic clamp as panic, while the Respondent has characterized it as a desire to use the first clamp available to control the bleeding as quickly as possible. Additionally, the Respondent needed Dr. Sarmiento to assist and while he was holding the artery, he was obviously unable to offer any other form of help. Under these circumstances, the Respondent's use of a hemostatic clamp does not demonstrate that she "panicked" in the operating room or that her decision to use the clamp fell below an acceptable standard of care. Count Seven Deborah J. Cox On June 6, 1982, the Respondent examined Deborah J. Cox and was present with her in the labor room throughout the patient's labor. The fetus was first on an external and then an internal monitor throughout labor. The Respondent requested that Dr. Antonio Mata, a neonatologist, be present for the delivery. When Dr. Mata came into the labor room, he checked the fetal monitor and noticed signs of moderate fetal distress. The combination of Pitocin, which was administered to the patient, and distressive labor, placed stress on the fetus as indicated by the fetal monitoring strips. The patient was transferred from the labor room to the delivery suite. In an effort to deliver the baby which was exceptionally large, it was necessary for the Respondent to use forceps because the baby's head was high and the mother's uterine surface remained thick even though she was well dilated. When the forceps were applied, the baby went into severe distress. The Respondent called for an emergency cesarean section, but the operating assistant was not available. Since it was necessary to deliver the baby as quickly as possible to avoid a stillbirth or permanent damage, the Respondent reapplied the forceps and attempted delivery. The baby was a very difficult delivery due to its size. It became stuck in the birth canal which required that the Respondent rotate its shoulders to effectuate delivery. While manipulating the baby, shoulder dystocia occurred. The Respondent elected not to perform the cesarean when it was first indicated, because of a hospital rule which prohibited the performance of a cesarean section without the presence of a surgical assistant. Due to the continuing difficulties she had encountered at Memorial, she was understandably reluctant to violate a hospital rule which would have subjected her to additional problems at Memorial. However, notwithstanding the legitimacy of the Respondent's personal concerns, the best interests of this patient required that a cesarean section be performed as soon as it became evident that the baby was not tolerating labor and that a vaginal delivery would place added and unnecessary stress on both the mother and child. The decision not to perform a cesarean, and instead deliver the baby vaginally through the use of forceps, created a situation which resulted in the fetus being born with an Apgar rating of 0 and possible permanent injury. By failing to perform a cesarean section when it was medically indicated, the Respondent's care and treatment of Deborah J. Cox fell below acceptable standards of obstetrical practice.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent (1) guilty of violating Count Seven of the Amended Administrative Complaint; (2) dismissing Counts One, Two, Three, Four and Five of the Amended Administrative Complaint; and (3) placing her on probation for six months subject to the condition that during this period she be required to practice obstetrics and/or gynecology under the general supervision of a board certified physician. DONE and ENTERED this 18th day of November, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Department of Administration Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 1983.
The Issue 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
Findings Of Fact Respondent Anila Poonai began her medical education in her native land, India, and, in 1960, she received a medical degree from Bombay University. After an internship in Bombay, she spent three months in training in the United Kingdom, before travelling to Georgetown, Guyana, to become a resident medical officer at the public hospital there. After two years in Guyana, she returned to England where, in 1964, she passed a post-graduate examination. As a result of a residency in obstetrics and gynecology and a satisfactory showing on the requisite examinations, she became a member, in 1969, of the Royal College of Obstetrics and Gynecology. All told, respondent has spent six years as a resident in obstetrics and gynecology. From England, she travelled to the University of the West Indies in Kingston, Jamaica. At the University of the West Indies, she was senior registrar in obstetrics and gynecology and, for six months, acting lecturer in obstetrics and gynecology. In 1973, she and her husband, who is a general surgeon, moved to Cleveland, Ohio. Respondent has not sought certification by the American College of Obstetrics and Gynecology. She testified that the American College of Obstetrics and Gynecology recognized her membership in the Royal College of Obstetrics and Gynecology as an equivalent certification. Until moving to Port St. Joe, she worked as a house physician in St. Alexis and Hillcrest hospitals in Cleveland. Respondent and her husband moved to Florida at the invitation of the Board of Trustees of the Municipal Hospital of Port St. Joe. The Board wanted to upgrade the Hospital. Almost from the time of their arrival, respondent and her husband found themselves at the center of controversy. Respondent's husband testified that, when he and respondent began work at the Municipal Hospital of Port St. Joe, in August of 1976, norms of practice at the Hospital were "miles below standard" and that the medicine practiced by other physicians in the community was "about 25 years" out of date. Whether true or false, this view, and its blunt articulation, may account for the friction respondent and her husband experienced in their relationships with some of the nurses and physicians with whom they came into contact. Being the only such specialist on the staff, respondent was named chief of obstetrics and gynecology at the Municipal Hospital of Port St. Joe. In this capacity, she ordered drugs and other obstetric and gynecologic supplies for the Hospital. Chief of staff at the Hospital, from 1961, until the spring of 1977, was John Wayne Hendrix, who has practiced medicine in Port St. Joe for some three decades. During Dr. Hendrix' tenure as chief of staff, Dr. Orr of Wewahitchka, a general practitioner, was granted "courtesy privileges" at the Municipal Hospital of Port St. Joe. At all pertinent times, Hospital bylaws forbade a physician to whom only courtesy privileges had been granted, to attend a delivery, except under the supervision of the chief of obstetrics and gynecology. On March 27, 1977, in violation of the Hospital's bylaws, Dr. Orr attempted, for the first and only time, to deliver a baby in the Municipal Hospital of Port St. Joe. When Gloria Pippin, R.N., arrived to begin the 3 to 11 shift, Dr. Orr's patient was already in labor. At 9:30 that night, the patient's cervix was fully dilated; at 9:45 she was taken to the delivery room. At 11:00 Dr. Orr "did a saddle block," i.e., he administered a spinal anesthetic. Five minutes later he had finished an episiotomy. At quarter past eleven, he used Tucker-McClain forceps in an effort to extract the baby. That failing, he tried long Simpson forcens at 11:25 and Kielland forceps at ten minutes before midnight, March 27, 1977. The baby's head was too big for the mother's pelvis. Five minutes later, Ms. Pippin telephoned respondent, at Dr. Orr's request. Respondent expressed dismay that Dr. Orr had been permitted to begin, and asked Ms. Pippin to notify Dr. Hendrix of the situation. She herself telephoned Gerald Sullivan, the chairman of the Hospital's Board of Trustees. Afterwards, she and her husband, Dr. Parmanand Vijay Poonai, went to the Hospital. They arrived at approximately 12:40. Dr. Hendrix, who had considerable experience in performing Ceasarean sections, preceded them to the Hospital. By the time the Drs. Poonai reached the hospital, arrangements had been made for Dr. Orr's patient to be transferred to Panama City's Bay Memorial Hospital. At quarter past midnight, when Dr. Hendrix arrived at the hospital, the mother's blood pressure was 134/78. Ten minutes before she left in the ambulance, her blood pressure was 137/98 and her pulse was 112. At that time, the fetal pulse was 156. At 1:20 a.m., an ambulance left the Municipal Hospital of Port St. Joe for Panama City. When they reached Bay Memorial Hospital, the mother's vital signs and the infant's heart beat were within normal limits. Dr. Stephen Smith, the obstetrician who performed a Caesarean section upon the patient's arrival in Panama City, was the man of the hour. Mother and baby did well. For many years, it has been common to send women in labor to Panama City from Port St. Joe, and hundreds have made the trip. It takes a half hour to an hour to drive from the Port St. Joe hospital to the Panama City hospital. The longer a woman in the condition Dr. Orr's patient was in continues in labor, the greater are the chances of injury or death to the fetus and even to the mother. At no time did Dr. Hendrix telephone respondent on the night of the 27th or morning of the 28th. Neither Dr. Hendrix nor Dr. Orr ever asked respondent for assistance with Dr. Orr's patient. When respondent and her husband arrived at the Hospital early on the morning of March 28, 1977, neither Dr. Hendrix nor Dr. Orr spoke to either of them. Dr. Hendrix refused to speak to them, even though respondent addressed him and asked him specifically about Dr. Orr's patient. Both respondent and her husband remained at the Hospital until after the ambulance left for Panama City. It is unethical for one physician to intervene in the care of a patient whose treatment is being actively managed by another physician, unless requested. It may also be dangerous. On January 16, 1978, Dr. P. V. Poonai saw Beverly R. Bass in his office. Ms. Bass, who was born on December 15, 1951, told Dr. P. V. Poonai that a Dr. Vasquez of Port St. Joe (of whose wife Ms. Bass was a cousin) and other physicians had recommended a hysterectomy; that she had been passing blood clots for the preceding four months; that she had epigastric pain; that her most recent menstrual period was December 19, 1977; that she had two daughters and a son by three different men; that she wanted no more children; and that she wanted a hysterectomy both to prevent conception and to stop her bleeding. After examining her and finding an ovarian cyst and a slightly bulky uterus, Dr. P. V. Poonai prescribed hospitalization for a series of gastrointestinal X-rays to investigate the possibility of an ulcer, and for an obstetric and gynecologic consultation with respondent. On January 18, 1978, Ms. Bass entered the Municipal Hospital of Port St. Joe. An electrocardiogram was done. Dr. J. B. Harbison prepared a report of the X-rays taken as prescribed by Dr. P. V. Poonai. Respondent met Ms. Bass for the first time, in the Hospital, on January 19, 1978. She took Ms. Bass' history and examined her under general anesthesia, finding a left ovarian cyst, a normal cervix and a bulky anteverted uterus. Respondent recommended a dilatation and curettage (d & c) for diagnostic and therapeutic purposes, and, on the same day, Ms. Bass signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a d & c. The following day, January 20, 1978, respondent did perform a routine d & c. Afterwards, the curettings resulting from the procedure were transmitted to a pathologist. After examining this material, the pathologist prepared a tissue report, and stated, as the pathological diagnosis: SECRETORY PHASE, DYSFUNCTIONAL BLEEDING. NO EVIDENCE OF POLYPS, PREGNANCY OR MALIGNANCY OBSERVED IN THE SPECIMEN SUBMITTED. FRAGMENT OF ENDOCERVIX WITH SQUAMOUS METAPLASIA, ACUTE AND CHRONIC INFLAMATION. Petitioner's exhibit No. 2. On January 21, 1978, Ms. Bass left the hospital, with a final diagnosis of dysfunctional bleeding. Before discharging Ms. Bass, respondent instructed her to refrain from sexual intercourse and from douches for four to six weeks. Eight to ten days after her discharge, Ms. Bass resumed sexual intercourse. On February 2, 1978, respondent saw Ms. Bass at her office and discussed the pathologist's tissue report with her. She related to Ms. Bass her clinical impression of uterine fibroids and prescribed Orthonovum, a birth control pill, as an additional means of forestalling dysfunctional bleeding. On February 2, Ms. Bass reported no bleeding subsequent to the d & c. Respondent did not ask and Ms. Bass did not volunteer that she had failed to follow instructions to abstain from sexual intercourse. Although the birth control pills respondent prescribed were to be taken daily, Ms. Bass did not take one every day. Respondent next saw Ms. Bass on February 13, 1978, when her only complaint was of an upper respiratory tract infection. On March 4, 1978, Ms. Bass returned to respondent's office complaining of heavy breakthrough bleeding, and reported that she was passing blood clots. Respondent examined her and suggested a hysterectomy. Ms. Bass asked if she could enter the hospital on March 12, 1978, saying she could make arrangements for her children by then. Respondent administered no pregnancy test to Ms. Bass on March 4, 1978, or at any time thereafter. She thought none was necessary because she believed that Ms. Bass had followed her instructions. Respondent does not knowingly perform abortions, even for therapeutic purposes, on account of religious scruples. A d & c elicits inflamatory responses hostile to fertilization. Even when a pregnancy has begun, no pregnancy test will be positive before 41 days have elapsed since the last menstrual period. Some hospitals, like Jackson Memorial in Miami, require pregnancy tests before surgery as a matter of routine, but the Municipal Hospital of Port St. Joe had no such policy. On March 12, 1978, Ms. Bass was admitted to the Municipal Hospital of Port St. Joe. The following day respondent performed a hysterectomy and an incidental appendectomy. An appendectomy ordinarily accompanies this procedure. Respondent's pre-operative diagnosis was "menorrhagia and fibroid uterus," and her postoperative diagnosis, on March 13, 1978, was unchanged. This was the same condition specified on the form consent to diagnostic and treatment procedures which Ms. Bass signed on March 12, 1978, authorizing respondent to perform a hysterectomy. Ordinarily, a surgeon performing a hysterectomy removes the uterus intact, as respondent did in the case of Beverly Bass. After its removal but while still intact, Ms. Bass' uterus yielded no additional information pertinent to the diagnosis of her condition. The uterus was sent to a pathologist. After examining the uterus, the pathologist prepared a tissue report and stated, as the pathological diagnosis: APPENDIX WITH FIBROUS OBLITERATION (DISTAL) AND FOCAL FIBROUS ADHESIONS. LUTEAL CYST OF LEFT OVARY, BENIGN. PARATUBAL CYST, BENIGN, RIGHT. ENLARGED UTERUS (205 GMS) WITH: ENDOMETRIUM: CHANGES RELATED TO PREGNANCY (HYPERSECRETORY GLANDS AND DECIDUAL REACTION). ACUTE ENDOMETRITIS. ANGULAR IMPLANT OF PLACENTA ASSOCIATED WITH UNDERLYING NECROSIS AND ACUTE INFLAMMATION OF DECIDUA, ACCOMPANIED BY HEMATOMAS. CHORION-AMNIONITIS, ACUTE, NECROTISING ASSOCIATED WITH NECROSIS OF GROUPS OF CHORION VILLI. EMBRYO, APPROXIMATELY 4-6 WEEKS OLD. FLUID BLOOD PRESENT IN UTERINE CAVITY. MYOMETRIUM: HYPERTROPHY (FUNCTIONAL). CERVIX: ACUTE AND CHRONIC CERVICITIS ASSOCIATED WITH SQUAMOUS METAPLASIA OF THE ENDOCERVICAL LINING, FOCAL. SQUAMOUS CELL HYPERPLASIA OF ECTOCERVIX, BENIGN. MUCUS CYSTS. When the pathologist opened the uterus, he found an enlarged cavity partly occupied by a ruptured ovisac. Extruded through the perforation, hanging outside of the ovisac from the umbilical cord, was an embryo 1.8 centimeters long. The placenta, which was acutely inflamed, adhered to the fundus at a right angle. Uterine rupture is inevitable if an angular pregnancy continues, but it is possible for an angular pregnancy to go to term, just as it is possible for a fetus to live after the ovisac has burst. In Ms. Bass' case, however, the embryo was probably non-viable at the time of the hysterectomy. The pathologist's report arrived while Ms. Bass was still in the hospital. Because respondent was upset on reading it, she asked Dr. P. V. Poonai to tell Ms. Bass what the pathologist had learned. Dr. P. V. Poonai did tell Ms. Bass, at which time she confirmed that she had engaged in sexual intercourse shortly after the d & c. Confusing an incipient pregnancy with a fibroid uterus is an occasional mistake any physician could make. An isolated mistake of this kind does not constitute a deviation from acceptable medical practice. The most conservative approach is to wait for two months after the patient has stopped taking birth control pills, before performing a "semi-elective" procedure, and to administer a pregnancy test beforehand. Several physicians testified, however, that they would not have ordered a pregnancy test before performing a hysterectomy in the circumstances of Ms. Bass' case. Respondent did not prepare the summary sheet at the end of Ms. Bass' stay after her March 12, 1978, admission, Chart No. 23622. Petitioner's exhibit No. 2A. The summary sheet that was prepared is not signed by anybody. When respondent asked for the chart in order to prepare a summary sheet, the Hospital's records custodian advised her that it was not with the other charts. When Beverly D. Stover was about three and a half months pregnant, she began seeing respondent. She saw her every month until November, when she began seeing her every two weeks. On her first visit, she told respondent she wanted to be sterilized after the birth of the child she was carrying, her second. At respondent's request, Mrs. Stover brought her husband to respondent's office, about six weeks before the baby was born. The three of them discussed Mrs. Stover's planned sterilization. On November 22, 1977, both Mr. and Mrs. Stover signed a form request for sterilization witnessed by two persons who were not called to testify at the hearing. On November 30, 1977, Mrs. Stover was admitted to the Municipal Hospital of Port St. Joe. On the day of her admission, she signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a bilateral tubal transection and ligation, and both she and her husband signed another form request for sterilization. At the time of the signing of the last two documents, Mrs. Stover told Sarah Maddux, the nurse who gave her the forms to sign, that she did not want to be sterilized unless her baby was normal. Ms. Maddux never relayed this oral reservation to respondent. It is impossible to tell, at the time of birth, whether an infant has a sense of smell, whether it is intellectually impaired, or whether it can see or hear. At 1:50 on the afternoon of November 30, 1977, Mrs. Stover was delivered of a daughter, Katrina. Respondent examined the eight pound two ounce infant for two minutes. She put her fingers in the infant's mouth, cleared a passage for air, and checked for a cleft palate. The child started crying. Respondent observed good muscle tone. Respondent clamped, then cut the umbilical cord. She inspected the baby all over, noticed puffiness on the child's back, which she attributed to the trauma of birth, and noticed that the baby's anal opening was smaller than normal, but was not alarmed. She thought she had seen even smaller such openings which had not affected function. Respondent placed Katrina on her mother's stomach, and asked Mrs. Stover whether she was ready for surgery. When Mrs. Stover answered affirmatively, at 1:55, anesthesia was administered, at respondent's direction. A nurse took the baby from respondent for cleaning. In contemporaneous notes, the nurse described the baby as apparently normal. In fact, Katrina had an imperforate anus or anoperitoneal fistula, and a lipoma on the sacral area of her back. These conditions were discovered a few hours later by a nurse in the Hospital nursery. The nurse brought both problems to the attention of Dr. Shirley R. Simpson, a physician who had been on the staff of the Municipal Hospital of Port St. Joe for approximately ten years and who happened to be in the Hospital at the time. Respondent had left Port St. Joe to meet her husband at the airport in Panama City. Examining Katrina at the nurse's request, Dr. Simpson mistook the lipoma for a meningomyocele. Dr. Simpson took no further action in the case, other than leaving word with the nurse for respondent to call her, until she furnished the Board of Medical Examiners Katrina's hospital chart. By that time, somebody had forged an entry in the nurse's notes for 1:50 P.M. on November 30, 1977, viz., "Appears to have NO rectal orifice-Dr. A. Poonai notified." Petitioner's exhibit No. 4. After her return from Panama City, on December 1, 1977, respondent correctly diagnosed the lipoma. At respondent's request, Dr. P. V. Poonai examined Katrina. After obtaining consent, Dr. P. V. Poonai, used surgical implements, when the baby was 16 hours old, to remove the obstruction which had prevented the expulsion of all but the merest drop of meconium during the first 16 hours of the baby's life. Although this emergency procedure solved the immediate problem and allowed the baby to defecate, further surgery has been necessary to move the anal opening to its norman site posterior of the dimple where Dr. P. V. Poonai made his incision. An imperforate anus occurs once in 5,000 births. The imperforation may or may not be visible, depending on its location. In the past five years, three infants with this problem have been born in Panama City. In each instance, the examining pediatrician did not discover the imperforation, which came to light some hours after birth, on account of the baby's failure to expel its first stool. In Katrina's case, however, the abnormality could be seen and its existence could be confirmed by an attempt to probe. The lipoma on Katrina's back measured less than four by five centimeters in area. It was a soft, skin-colored mass of benign, fatty tissue, which a pediatric surgeon has since removed. The trauma of birth sometimes causes edemas that resemble lipomas. No harm befell Katrina as a result of respondent's failure to diagnose either her lipoma or her anal abnormality at birth. Beverly Stover continued as a patient of respondent for some time after Katrina's birth. Respondent first saw a certain patient on September 19, 1977. This patient, who was born on June 1, 1907, suffered from diabetes mellitus and congestive heart failure, among other things. Two months earlier she had had a second pacemaker inserted. On her first visit to respondent, the patient complained of pain in her chest and of dysuria. She said she had difficulty retaining urine, but that she was unable to empty her bladder completely. In examining her, respondent discovered a moderate cystocele, which is a herniation of the bladder into the vagina. Respondent admitted her into the Municipal Hospital of Port St. Joe for treatment of her congestive heart failure, the cause of the chest pain. Congestive heart failure is not a disease of which people are cured, but it is a condition that may grow better or worse. When this patient's condition improved, respondent sent her home. Respondent saw her again in her office on October 3, 1977, when she complained of paroxysmal dyspnea and swollen feet. Respondent diagnosed superimposed congestive cardiac failure and prescribed a diuretic. On November 18, 1977, respondent admitted her to the hospital because symptoms like those she had complained of during the office visit persisted. On November 22, 1977, she was discharged. A similar episode resulted in rehospitalization from January 10, 1978, through January 19, 1978. The patient entered the hospital again, on February 12, 1978, with congestive cardiac failure. She complained about nocturnal incontinence and asked respondent to correct her bladder problem. At this time, respondent described the cystocele as large. After medical care which petitioner's own witness described as excellent, the patient's condition stabilized. Respondent testified that, in her judgment, the patient's general condition just before surgery was as good as it was likely ever to be. Nine days after she admitted the patient, respondent effected a repair of the cystocele by performing an anterior colporrhapy under local anesthetic. This procedure requires unusual surgical skill, and most surgeons do not attempt it. The repair of a cystocele is a therapeutic measure. In the absence of treatment, urine is likely to stagnate in the herniated portion of the bladder, and become a source of possibly serious infections. All surgical techniques for repairing cystoceles, other than the one employed by respondent, require general anesthesia. The risk from anesthesia to which respondent's patient was subjected was very moderate compared to the risk from general anesthesia. It was the same risk a person faces whose mouth is numbed by local anesthesia before a tooth is filled. Respondent had performed this operation 20 or 30 times before, and had performed it on her own mother, who was 75 years old and suffered from myocardial ischemia at the time. Sometimes, although decreasingly in recent years, a physician may employ a pessary as treatment for a cystocele. A pessary is a rubber or plastic solid that can be inserted in the vagina as a support for the intruding bladder. This is only a temporary measure, however, and involves a high risk of infection, which is the principal danger the cystocele itself poses. Respondent testified that her prescription for temporary relief was bed rest, since lying flat relieves the pressure that forces part of the bladder into the vagina. Respondent first saw another patient, the 29 year old mother of three children, on December 23, 1976. This patient was in the Municipal Hospital of Port St. Joe at the time, for a hemorrhoidectomy, and respondent was called in because the patient had complained of profuse, irregular and painful vaginal bleeding over a period of several years, and particularly during the preceding nine months to a year. The patient was anemic, according to tests run two days earlier. In July of 1976, the patient had been hospitalized on account of pelvic sepsis and bleeding. At that time, Dr. Simpson told her she would need a hysterectomy in the near future. She had been hospitalized for the same reasons in 1975. Respondent ordered a pap smear and an X-ray to locate a coil that had been inserted into the patient's uterus, as a contraceptive measure. When she recovered from the hemorrhoidectomy, the patient was discharged. After three weeks of severe menorrhagia, including two final days of heavy clotting, the patient was readmitted, on January 24, 1977, to the Municipal Hospital of Port St. Joe. Respondent had earlier prescribed iron pills. Perhaps as a result, the patient was no longer anemic. Respondent observed the patient's uterus "enlarged to about 10 weeks size with [what she thought was] fibroids. Petitioner's exhibit No. 6. Respondent ordered no pregnancy test. When an intrauterine device is in place, excessive vaginal bleeding is inconsistent with a viable pregnancy. An intrauterine device not only irritates the wall of the uterus, making conception unlikely, but also operates to abort incipient pregnancies, in the event of conception. With the intrauterine device still in place, on January 26, 1977, respondent performed a total abdominal hysterectomy and an incidental appendectomy, with conservation of both ovaries. Afterwards, the appendix, part of the cervix, and the uterus were sent to a pathologist. The pathologist examined these materials, and, on January 31, 1977, prepared a tissue report, in which he stated as the pathological diagnosis: APPENDIX WITH SEROSAL FIBROSIS, FOCAL (INCIDENTAL). ENDOMETRIUM: DECIDUA WITH EXTENSIVE NECROSIS ASSOCIATED WITH CHORIONIC VILLI (PREGNANCY) WHICH ARE LARGELY NON-VIABLE. SECRETORY ENDOMETRIUM WITH ACUTE AND CHRONIC ENDOMETRITIS. MYOMETRIUM: HYPERTROPHY, POSTERIOR. CERVIX: CHRONIC ENDOCERVICITIS AND MUCUS CYSTS. SLIGHTLY HYPERTROPHIC UTERUS (95 GRAMS). The pathologist found no evidence of fibroids. This demonstrates that respordent's clinical diagnosis of fibroids was inaccurate. One of the pathologists who routinely examined tissue removed by surgeons in the Municipal Hospital of Port St. Joe, Dr. Garcia-Rios, also routinely examined tissue removed by surgeons in other hospitals. Whenever a tissue report indicated disagreement between a clinical diagnosis and the pathological diagnosis, Dr. Garcia-Rios designated the tissue report "Code 3." The frequency of Code 3 tissue reports did not differ as between specimens removed by respondent and specimens Dr. Garcia-Rios examined which had been removed by other surgeons, taken as a group. From the presence of morphologically viable chorionic villi, the pathologist concluded that the patient had been pregnant. From pathological findings alone, he was unable to determine whether the pregnancy had terminated weeks or months earlier; or whether an ongoing microscopic pregnancy was interrupted by the hysterectomy. (Clinical evidence-excessive bleeding-ruled out the possibility of a viable pregnancy.) The pathologist's findings were consistent with, but did not conclusively establish the existence of, a placental polyp. Placental polyps may cause prolonged bleeding. Before surgery, respondent discussed three options with this patient: removal of the intrauterine device, removal of the intrauterine device followed by a d & c, and hysterectomy. The patient said that the presence or absence of an intrauterine device had made no difference in her bleeding problem in the past. She also told respondent that she wanted no more children, and that she wanted prompt, definitive treatment for her bleeding. After listening to explanations from respondent about the available options, the patient chose a hysterectomy. Respondent did not tell her that a hysterectomy was the only way to correct her problem. The patient testified that she has had no problems since her surgery; and that, knowing what the pathologist's tissue report subsequently revealed, she would make the same choice again, at least if it would not involve her as a witness in legal proceedings. Respondent initialled a summary sheet in the patient's chart, which stated the patient's final diagnosis as, inter alia, "FIBROID UTERUS [and] MENORRHAGIA." This final diagnosis fails to take the pathologist's tissue report into account, even though the tissue report routinely becomes part of the chart and presumably was available to respondent at the time she initialled the summary sheet. Respondent testified that she initialled this summary sheet as one of a group of documents, and that she did not read it beforehand. Any discrepancy between the tissue report and the final diagnosis would have been apparent to a knowledgeable reader. Without the tissue report, respondent would not necessarily have known that the pathologist's findings had demonstrated the error of her diagnosis of fibroid uterus. After controversy about this case arose, respondent caused an addendum to be prepared and incorporated into the chart, on August 16, 1978, and amended the discharge diagnosis to state, inter alia: "Menorrhagia, Chronic endometritis [and] Hypertrophy of the myometrium." This diagnosis is consistent both with respondent's clinical findings and with the pathologist's tissue report. In stating her amended discharge diagnosis, respondent took the tissue report, which had been incorporated into the chart, into account. This amended discharge diagnosis was not shown to be erroneous. On August 11, 1976, respondent saw Linda Whitfield for the first time. She came as a patient to respondent's office and related that her last menstrual period had taken place on June 26, 1976. Respondent examined her, observed a uterus of six weeks' size, and diagnosed early pregnancy. Respondent next saw Mrs. Whitfield in the emergency room of the Municipal Hospital of Port St. Joe on August 27, 1976, when her uterus looked to be of eight weeks' size. There Mrs. Whitfield told respondent that, while driving a tractor earlier in the day, she had experienced abdominal cramps and fairly heavy bleeding. Mrs. Whitfield did not report and respondent did not observe the passage of a fetus. Respondent diagnosed a threatened abortion (miscarriage) admitted Mrs. Whitfield to the Hospital, ordered bed rest, ordered that Mrs. Whitfield's urine be tested for the presence of chorionic gonadotropin, and prescribed an intramuscular injection of two cubic centimeters (cc.) of Depo-Provera (Upjohn's registered trademark for sterile medroxyprogesterone acetate suspension, U.S.P.). Although respondent did not specify the strength, she had ordered the Hospital's entire supply of Depo-Provera, and knew that the only strength on hand was 100 milligrams per milliliter. Depo-Provera is a synthetic progestational agent in an oily base. It has been commercially available for approximately 15 years. The 1971 Physicians' Desk Reference (PDR) reported that daily doses were indicated in the event of a threatened miscarriage. The 1972 PDR reported pregnancy as a contraindication for the use of Depo-Provera. (In 1972, respondent lived in Jamacia.) The 1976 PDR and the 1977 PDR, however, contain neither indications nor contraindications for Depo-Provera, in the event of pregnancy. The 1979 PDR reports pregnancy as a contraindication for the use of Depo-Provera. The phrase "missed abortion" describes the situation where a non- viable fetus remains in its mother's uterus. "Missed abortion" was named as a contraindication for Depo-Provera in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield. The contraindication of Depo-Provera for missed abortion reflected the view, generally shared in the medical community for many years but now rejected, that Depo-Provera acts to prevent uterine contractions and so make fetal expulsion less likely. The only indication stated in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield, was "[a]djunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma." Petitioner's exhibit No. 12B. Also on petitioner's exhibit No. 12B, under the heading "ADVERSE REACTIONS," is the statement: There is inferential evidence supporting the existence of an association between the administration of progestins early in pregnancy and the occurence of congenital malformations (see also WARNINGS). The referenced warning stated that "[u]sage in pregnancy is not recommended because of data indicating a possible association between administration of progestins early in pregnancy and congenital heart defects in the offspring." Petitioner's exhibit No. 12B. Mrs. Whitfield bled, off and on, during her first stay in the Hospital under respondent's care, until two or three days before her discharge. Because Mrs. Whitfield was bleeding on August 28, 1976, respondent prescribed an intra- muscular injection of one cc. of Depo-Provera. Altogether, respondent prescribed 1100 milligrams of Depo-Provera for Mrs. Whitfield over a 16 day period. She ordered administrations of two cc. doses of Depo-Provera on September 2, 1976, on September 4, 1976, on September 7, 1976, and on September 11, 1976, the day Mrs. Whitfield was discharged. At that time, respondent was hopeful that the pregnancy had been saved. At the time respondent prescribed Depo-Provera for Mrs. Whitfield, she believed she was aware of the inferential evidence referred to in the adverse reaction portion of petitioner's exhibit No. 12B. The evidence of which respondent was aware was the result of a retrospective study involving 10,000 mothers who took various hormonal substances during pregnancy and 10,000 mothers who did not. The number of deformed children born to mothers who had taken the hormonal substances exceeded by two percent the number of deformed children born to the mothers who had not. At the time she prescribed Depo-Provera for Mrs. Whitfield, respondent was one of a considerable number of physicians who believed that this drug could supply a hormonal deficiency that a woman faced with a threatened abortion (miscarriage) might lack, and which might be causing premature uterine contractions. Respondent weighed Depo-Provera's possibly teratogenic effect against its possibly ameliorative effect and made a conscientious professional judgment to prescribe Depo-Provera for Mrs. Whitfield. The 1971 PDR specifies a dosage of 50 milligrams day for threatened abortion, as long as symptoms persist. No dosages for threatened abortion are specified in the 1976 PDR, the 1977 PDR or on petitioner's exhibit No. 12B, the literature that accompanied each vial of Depo-Provera. When used to treat "inoperable, recurrent and metastatic endometrial carcinoma," Depo-Provera is prescribed in doses of 100 to 1000 milligrams at intervals of one week to one month. No evidence adduced at the hearing suggested that Depo-Provera has any known or suspected toxic effect on the mother, regardless of the dosage. Nor was it shown to have been scientifically established that Depo-Provera has had an adverse effect on any fetus, when administered to the mother, regardless of the dosage. It is no longer used in the case of threatened miscarriages because recent evidence suggests that it is inefficacious for this purpose. Outside of the United States, Depo-Provera is used as a contraceptive. While Mrs. Whitfield was in the Hospital, on August 29, 1976, respondent ordered a blood serum test to determine the level of chorionic gonadotropin. The results of this test, which respondent saw for the first time on September 16, 1976, were 6,554 milliunits of chorionic gonadotropine per milligram of test fluid. On September 16, 1976, Mrs. Whitfield came to respondent's office and complained of additional bleeding. At that time, a two minute slide test for pregnancy was performed, with negative results. Respondent examined Mrs. Whitfield and concluded that her pregnancy had miscarried despite the efforts to preserve it. She was admitted to the Municipal Hospital of Port St. Joe on September 17, 1976, with the diagnosis of "incomplete abortion," which was changed to "missed abortion," as the pre-operative diagnosis. On the day of her admission, additional pregnancy tests were ordered. A two minute test was negative, but a two hour test was positive. Every pregnancy test is fallible to some extent. These test results did not alter respondent's clinical judgment that the pregnancy had miscarried. A pregnancy test of a urine specimen can yield positive results from four days to two weeks after a pregnancy ends, and sometimes even later. It was undisputed that a result on a blood serum test for chorionic gonadotropin of 6,554 milliunits per milliliter virtually rules out a viable pregnancy of two or three months' duration, although the level may fall that low after the fifth month of a normal pregnancy. At eight to ten weeks, normal levels range from 46,000 to 60,000 milliunits per milliliter. Respondent performed a routine d & c on September 18, 1976. Fifteen grams of the resultant curettings were transmitted to a pathologist who reported "products of conception," but no embryo. Port St. Joe is not a prosperous town. At the time of the hearing, respondent and her husband were the only physicians in Port St. Joe who accepted patients on medicaid. Respondent has admitted patients approximately 500 times to the Municipal Hospital of Port St. Joe. During her time in Port St. Joe, respondent has treated numerous medicaid patients, and has delivered 249 babies. In one instance there was a neonatal fatality. This record compares favorably with a national average on the order of 12 neonatal fatalities per 1,000 births. Respondent has three articles in respectable technical journals to her credit, including two in "Obstetrics and Gynecology." On one she collaborated with her husband. They received 168 requests for reprints from interested persons in some 15 countries. The other article in "Obstetrics and Gynecology" she co-authored describes the first documented full-term pregnancy of a woman with diabetes mellitus, Addison's disease, and hyperthyroidism. The patient described in the article was under respondent's care for the duration of her pregnancy, which eventuated in a normal delivery.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner dismiss counts one, two, four, five and six of the administrative complaint. That petitioner reprimand respondent for her failure to diagnose the imperforation at the time of birth, in violation of Section 458.1201(1)(m), Florida Statutes (1978 Supp.), as alleged in count three of the administrative complaint. That, in all other respects, petitioner dismiss count three of the administrative complaint. DONE and ENTERED this 15th day of November, 1979, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 904/488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire 197 South Bronough Street Tallahassee, Florida 32301 J. Ben Watkins, Esquire Post Office Drawer 1814 Tallahassee, Florida 32302 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS IN RE: The License to Practice Medicine as a Physician of: CASE NO. 79-1144 ANILA POONAI, M.D. License No. 27070 /
The Issue Whether the Petitioner's renewal application for licensure to operate as an abortion clinic should be granted or denied.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the agreed facts contained in the Joint Prehearing Stipulation, and on the entire record of this proceeding, the following findings of fact are made: AHCA is the state agency responsible for licensing abortion clinics. See §§ 390.011(3); 390.012; 390.015; 408.802(3); and 408.806, Fla. Stat.1 The Medical Center of Broward is located at 6971 West Sunrise Boulevard, Suite 206, Plantation, Florida, and is licensed to operate as an abortion clinic pursuant to Chapter 390, Florida Statutes, and Florida Administrative Code Rule Chapter 59A-9. On February 16, 2007, AHCA conducted a survey at the Medical Center of Broward in conjunction with the Medical Center of Broward's application to renew its license to operate as an abortion clinic. The Medical Center of Broward refused to give the AHCA surveyor access to patient medical records during the inspection on February 16, 2007. In a letter dated February 20, 2007, Diane Reiland, AHCA's field office manager in Delray Beach, Florida, advised Dr. Rosenthal, the administrator of the Medical Center of Broward, that no deficiencies had been found during the re-licensure survey but that "the Agency will contact you regarding a decision on the medical records concern [sic] that was discussed during the Re-Licensure survey."2 Counsel for AHCA sent a letter to the Medical Center of Broward dated February 27, 2007, setting out a procedure for review of medical records that was agreed to by counsel for the Medical Center of Broward and counsel for AHCA. The procedure set out in the February 27, 2007, letter contemplated a return visit to the Medical Center of Broward by an AHCA surveyor, who would select a sample of approximately 10 clinic patients whose records would be reviewed. The surveyor was to remain at the Medical Center of Broward while office personnel redacted from the records all patient identifying information, and the AHCA surveyor was then to review the records for compliance with the applicable rules and statutes. On April 4, 2007, Deatrice Bartley, a health facility evaluator supervisor employed by AHCA, telephoned the Medical Center of Broward and confirmed an appointment for an AHCA surveyor to review medical records on April 5, 2007, at 9:30 a.m. Ms. Bartley asked the person with whom she spoke if any patients would be present at the time of the record review and was told that no patients would be present on the morning of April 5, 2007. Shortly after 8:00 a.m. on April 5, 2007, Ms. Bartley contacted Alexandra Pelin, a health facility evaluator employed by AHCA, via the cell phone AHCA provided Ms. Pelin. Ms. Bartley advised Ms. Pelin of the 9:30 a.m. appointment at the Medical Center of Broward to review medical records. Ms. Bartley further advised Ms. Pelin that the Medical Center of Broward's office opened at 9:00 a.m.3 After speaking with Ms. Bartley, Ms. Pelin left her home in Palm Beach County, Florida, and drove to the address at which the Medical Center of Broward's office in Plantation, Florida, was located. She arrived at the Medical Center of Broward's office at 9:50 a.m., and went to the second floor of the building, where the office was located. She tried to enter the office, but the office door was locked; she knocked on the door, but there was no answer. She also looked in the window of the office but did not see anyone inside. Ms. Pelin immediately called Ms. Bartley and told her that she was unable to enter the Medical Center of Broward's office. Ms. Bartley gave Ms. Pelin two telephone numbers that had been given to Ms. Bartley by the person she had spoken with at the Medical Center on April 4, 2007. It was Ms. Bartley's understanding that one phone number was for the Medical Center office located in Broward County, Florida, and that the other phone number was for a Today's Women Medical Center clinic located in Miami, Florida. At 9:55 a.m., Ms. Pelin placed a call to 954-792-9171, which was one of the numbers Ms. Bartley had given her.4 Ms. Pelin became confused when the call was answered, and she hung up and redialed the same number. Ms. Pelin's call was answered by the Medical Center of Broward's answering service. She was told by the answering service that someone would be at the office at about 10:30 a.m. The answering service also told her that they could not give her the telephone numbers of the physicians working at the Medical Center of Broward, who received telephone calls at the same number she had dialed. Ms. Pelin then telephoned Ms. Bartley again and gave Ms. Bartley the information Ms. Pelin had received from the answering service. Ms. Pelin suggested to Ms. Bartley that she wait until 10:45 a.m. for someone to arrive at the Medical Center of Broward's office, and Ms. Bartley agreed. Ms. Pelin waited in her car in the parking lot outside the Medical Center of Broward's office from 9:57 a.m. until 10:47 a.m. From her location in front of the building that housed the Medical Center of Broward's office, Ms. Pelin had a direct view of the office door, which was located on the second floor of the building. Ms. Pelin did not see anyone enter or leave the office through that door. Ms. Pelin's telephone records indicate that, at 10:44 a.m., she placed another call to 954-792-9171. She expected the call to be answered by the answering service, but, instead, someone in the Medical Center of Broward's office answered the telephone. Although Ms. Pelin had not seen anyone enter the Medical Center of Broward's office, the content of the telephone conversation led Ms. Pelin to conclude that the person was inside the Medical Center of Broward's office. Ms. Pelin talked with this person, who identified herself only as "Yersel," for approximately five minutes. Ms. Pelin asked if she was inside the office, and "Yersel" told Ms. Pelin that she was. "Yersel" told Ms. Pelin that Ms. Pelin could not come into the Medical Center of Broward's office because she was with a patient and that patients would be coming into the office that day. "Yersel" told Ms. Pelin that AHCA inspectors should come to the office before 10:30 a.m. because patients started arriving at that time. "Yersel" also confirmed with Ms. Pelin that she arrived at the office late that morning. After talking with "Yersel'", Ms. Pelin telephoned Ms. Bartley, who told her to contact AHCA's field office manager. Ms. Pelin did so, and the field office manager advised Ms. Pelin to leave the premises. Ms. Pelin left the parking lot of the Medical Center of Broward's office and drove to AHCA's field office in Delray Beach, Florida, where she arrived at 11:34 a.m.5 Although AHCA surveyors attempt to schedule appointments when no patients are present at an abortion clinic, the surveyors will conduct an inspection even if patients are present under certain circumstances. The surveyors attempt to conduct inspections in a manner that does not disrupt the business of the clinic, and they will try to find a place to work where they do not bother patients. Ms. Pelin could have reviewed the medical records on April 5, 2007, with the permission of the Medical Center of Broward but did not do so because she was told that she could not enter the office. It is AHCA's practice to deny an application to renew a license to operate an abortion clinic after two unsuccessful attempts to inspect the clinic's facility and patient medical records because AHCA has not been able to determine whether the clinic is in compliance with the statutes and rules governing such clinics.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying the application of Today's Women Medical Center of Broward for renewal of its license to operate an abortion clinic. DONE AND ENTERED this 30th day of May, 2008, in Tallahassee, Leon County, Florida. PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of May, 2008.
