The Issue Whether Respondent failed to timely file its application for the renewal of its abortion clinic license, as alleged in the Administrative Complaint. If so, may the Agency for Health Care Administration (Agency) fine Respondent for failing to timely file its renewal application. If the Agency is authorized to impose such a fine, should it exercise such authority. If so, what is the amount of the fine it should impose.
Findings Of Fact Based upon the evidence adduced at hearing and the record as a whole, the following findings of fact are made: At all times material to the instant case, Respondent operated an abortion clinic located in Dade County, Florida, at 3250 South Dixie Highway, Coconut Grove, Miami, Florida (Coconut Grove Clinic). License number 693 constituted authorization from the Agency to Respondent to operate the Coconut Grove Clinic for the one-year period specified in the license. License number 693 had an effective date of March 22, 1995, and an expiration date of March 21, 1996. On or about December 22, 1995, the Agency sent Respondent the following letter: In reviewing our records, we note that the facility's abortion clinic license expires on 03/21/96. We are enclosing a copy of Form 3130-1000, Licensure Application, which should be completed and returned to this office along with the appropriate licensure fee of $250.00, pursuant to Rule 59A-9.020 Florida Administrative Code, made payable to the Agency for Health Care Administration. Incorrect or incomplete information will not be accepted, and the application will be returned. The application must be received on or before 01-21-96, sixty (60) days prior to the expiration of the current license to comply with section 390.016(1), Florida Statutes. Your attention to this request will facilitate processing your renewal license. The letter was delivered to Respondent on December 28, 1995. The General Manager of the Coconut Grove Clinic, Carmen Penaloza, filled out the Licensure Application and gave it to Respondent's Chief Operating Officer, Dr. Vladimir Rosenthal, for his signature. After Dr. Rosenthal affixed his signature to the Licensure Application, he returned the document to Penaloza for mailing to the Agency. The Licensure Application was completed and signed prior to January 21, 1996. Some time after January 21, 1996, the Agency notified Respondent that it had no record of having received a completed and signed Licensure Application from Respondent.1 Accordingly, Penaloza filled out and Dr. Rosenthal signed another Licensure Application. This completed and signed Licensure Application was received by the Agency on April 25, 1996. On or about May 21, 1996, the Agency issued Respondent License number 0786, authorizing Respondent to operate the Coconut Grove Clinic for the one-year period beginning March 22, 1996, and ending March 21, 1997. On June 3, 1996, the Department issued an Administrative Complaint announcing its intention to fine Respondent $1,000.00 for filing its application to renew its license to operate the Coconut Grove Clinic "ninety-five (95) days late."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency issue a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 10th day of October, 1997, in Tallahassee, Leon County, Florida. STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 10th day of October, 1997.
The Issue Whether on or about March 6, 1978, the Respondent, Ronald M. Tauber, D.O., performed an abortion on Gloria Small at the Orlando Birthing Center, Orlando, Florida; during the course of which procedure, the patient's uterus was perforated and other complications ensued and despite an agreement from a hospital staff member at Orange Memorial Hospital, Orlando, Florida, between that staff member and Respondent to allow the transfer of the patient, Small, to Orange Memorial Hospital for emergency treatment the Respondent did not transfer the patient to the hospital until March 7, 1978, and further, that notwithstanding an emergency hysterectomy operation performed at that hospital, Gloria Small died. It is alleged that should the above-stated facts be proven, the Respondent, Ronald M. Tauber, D.O., would have failed to demonstrate satisfactory professional skill, judgment or knowledge expected of him and to have exhibited an inability to practice osteopathic medicine with reasonable skill and safety and that his professional conduct departed from minimal standards of acceptable and prevailing osteopathic medical practice, in violation of Subsections 459.14 (2)(c) and (m), Florida Statutes. (The Administrative Complaint in this cause contained paragraphs 1 and 2 which were dismissed by the undersigned with leave for the Petitioner to amend. The Petitioner did not undertake such an amendment and the paragraphs 1 and 2 of the Administrative Complaint were not considered in the course of the hearing. Paragraph 5 of the Administrative Complaint was stricken and has not been considered. The phrase found in paragraph 3 of the Administrative Complaint which is constituted of the language "as well as other abortion procedures" was stricken and was not the subject of consideration in the course of the administrative hearing. Finally, the Petitioner moved to withdraw any reference to the substantive allegations found in paragraph 4 of the Administrative complaint pertaining to Subsections 459.14(2)(h), (k), and (n), Florida Statutes, and that motion was granted without opposition from the Respondent.)
Findings Of Fact This cause comes on for consideration based upon the Administrative Complaint filed by the Petitioner, State of Florida, Department of Professional and Occupational Regulation, Florida State Board of Osteopathic Medical Examiners, against Ronald M. Tauber, D.O., Respondent. The date of that Administrative Complaint is April 24, 1978. The dispute to be resolved in the hearing process is as set forth in the issue statement of this Recommended Order. To that end, a formal hearing was held in accordance with the provisions of Subsection 120.57(1), Florida Statutes, during the course of which, testimony and other evidence were presented by the parties. The Petitioner, State of Florida, Department of Professional and Occupational Regulation, Florida State Board of Osteopathic Medical Examiners, is an agency of the State of Florida whose purpose is that of licensure and regulation of those individuals who practice osteopathic medicine in the State of Florida. The Respondent, Ronald M. Tauber, D.O., is licensed by the Petitioner in the State of Florida to practice osteopathic medicine and his license number is 3430. At all times pertinent to the Administrative Complaint, Dr. Tauber was so licensed. The facts in the case reveal that the Respondent in the month of March, 1978, was practicing osteopathic medicine in a facility located at 419 North Magnolia, Orlando, Florida. This particular structure was a building with approximately 9,000 square feet of office space which Dr. Tauber used in the practice of his specialty, obstetrics and gynecology. His type facility has been referred to as a "free standing clinic" that offers among other services elective abortions, to include those performed in the late first trimester or early second trimester of the patient's pregnancy. Some of the equipment in the installation included a maternal fetal monitor, a cardiac monitor and defibulator which were part of a crash cart. The crash cart also contained items for resuscitation of adults and infants, including drugs, tubes, scopes, Laryngoscopes and Ambu bags. There was an operating room with an operating-obstetrical table. There were sources of sterilization by gas and steam. The office also contained instruments for minor gynecologic surgery, to include abortions and laparoscopy. There was an office area used by the Patient Education Coordinator- Counselor who was a member of the Respondent's staff. This Counselor conferred with prospective abortion patients concerning the pros and cons of such a procedure, to include alternatives to pregnancy termination. The office contained a laboratory which had equipment for the performance of blood counts, cultures, urine tests, other chemistry tests, blood typing and blood cross-matching. In connection with the blood work-ups, there was a blood bank refrigerator; however, no arrangements had been consummated for the storage of blood in that refrigerator prior to the abortion which was performed on the patient, Gloria Small, the subject of this complaint. In a related area, the Respondent intended to employ an anesthetist who would give Dr. Tauber the capability of utilizing general anesthesia in his operative procedures. This arrangement had not been made on or before March 6, 1978, and the abortion performed on Gloria Small was without the benefit of any form of general anesthesia. The personnel who worked in the facility in March, 1978, included a full-time registered nurse, a number of part-time registered nurses; a full-time licensed practical nurse, a number of part-time licensed practical nurses; a full-time certified operating room technician; a part-time licensed practical nurse who functioned as a LaMaze instructor and other functions associated with the maternity aspect of the facility; a medical records librarian; a receptionist; a full-time housekeeper; a part-time maintenance man and a business advisor/bookkeeper. Dr. Tauber had arranged for backup personnel in the persons of a pediatrician in the child delivery cases and a medical doctor who specialized in obstetrics and gynecology. These individuals were to assist in the procedures at the clinic and to cover for Dr. Tauber when Dr. Tauber was unavailable. However, the medical doctor in the field of obstetrics and gynecology did not have hospital privileges and neither did Dr. Tauber. There were two other physicians who had agreed to give hospital coverage for Dr. Tauber in complicated cases, but this arrangement excluded abortion procedures. On March 2, 1978, the patient, Gloria Small, was seen by Dr. Tauber and he accepted her case. Ms. Small requested a pregnancy termination and sterilization. During his initial interview and examination, the Respondent took the patient's personal history and conducted a physical examination and determined that the patient was pregnant approximately fourteen to fifteen weeks according to the gestational size. In addition to the physical examination, Dr. Tauber counseled the patient about the abortion and sterilization procedures and indicated alternatives to those procedures and the risks involved in each course that might be pursued. The patient indicated a desire to go forward with the abortion and sterilization procedures and in preparation for the procedures the Respondent ordered certain laboratory work, including hematology; type and Rh and urinalysis. This lab work was performed. Subsequent to this time, the patient was seen by the office counselor and continued to indicate her desire to have the procedures performed and the patient was scheduled for the procedures to be conducted on March 6, 1978. When the patient arrived on the morning of March 6, 1978, she was prepared for the abortion and sterilization procedures to the extent of being sterilly cleaned and having a medication administered to relax the patient. (At the time the Respondent performed the abortion and sterilization procedures on the patient, he had performed a significant number of these procedures before.) When the patient was presented in the operating room, she had been administered Nisentil in the amount of 40 milligrams. This is an analgesic drug designed to decrease the pain during the procedure. The patient was also given Atropine, a parasympathetic, to slow down the digestive track and to decrease the chance of nausea and to retard salivation. Intravenous lines were opened and the patient was given compositions of fluids which had a mineral and sugar content. The doctor was assisted by a scrub technician and there was a circulating registered nurse available. The procedures began at approximately 12:00 noon and were concluded at 1:25 p.m. The patient was dialated and the suction cannula was placed in the uterus and the suction machine turned on, at which point the materials in the uterus began to flow into the suction machine. In view of the advanced stage of the pregnancy, it was then necessary to place various instruments, ring forceps, to withdraw the pregnancy tissue. In the course of the manipulations, placental tissue was observed being brought down. At that point, the patient began to bleed heavily. Dr. Tauber placed the ring forceps into the uterus and the ring forceps went beyond normal depths expected in such an examination of the uterus. This preliminary procedure led to the eventual verification that a perforation had occurred. At this juncture, the doctor was working in the cervical canal. The doctor's response to the apparent perforation was to place the laparoscope and attendant instrument into the abdomen, setting up the procedure with a local anesthesia. When this action was taken, the Respondent, using a fallopian applicator (which was to be used in the sterilization procedure) lifted the uterus and saw a perforation two to four centimeters in length in the right posterior aspect of the lower uterine segment. At this point of observation, the perforation was not bleeding. There was a certain amount of blood in the lower dependent portion of the abdomen which did not measure more than 25 cc and this was consistent with a perforation that was not bleeding. The operating room technician was allowed to visualize the perforation through the laparoscope and the medical doctor who specialized in obstetrics and gynecology was called to assist. While the Respondent was waiting for the arrival of the backup physician, he allowed the operating room technician to assist him by viewing through the laparoscope while the Respondent turned to the vaginal aspect of the procedure and entered the uterus. During the process of the evacuation of the remaining placental tissue, the Respondent placed an instrument through the performation a second time; however, no additional bleeding was observed at that point. The bleeding which had been observed initially had slowed to a continuous ooze and this amount of bleeding caused the Respondent to observe the area of the perforation for an additional period of thirty minutes or more to confirm that the bleeding was not increasing in volume. The backup physician also observed the area of the perforation and consulted with the Respondent about the complication. The dialation and evacuation procedure was completed and the fallope rings applied and when the Respondent was convinced that he didn't have bleeding intra-abdominally, the patient was packed by placing gauze-type material in the vagina, thereby promoting pressure against the bleeding area. (The sequence of observations through the laparoscope that have been mentioned before occurred after the packing had been placed.) During the pendency of the observation, no blood was observed to be coming through the packing. Contemporaneous to the observations, fluids were used to replace the high blood loss. That amount of blood loss was believed to be in the amount of 1500 cc. When the complications occurred in the course of the operation, there was a drop in blood pressure and an increase in the pulse rate. In addition, the pre-operative hemoglobin was 13.5 g.m. as compared to 9.5 g.m. post- operative, and the hemoglobin ranged from around 8.2 g.m. through the higher 8.0 g.m. and lower 9.0 g.m., from the period immediately following the operation until around 5:00 p.m.., March 7, 1978. A more complete detail of the change in blood pressure, pulse rate and hemoglobin count may be found in Petitioner's Composite Exhibit No. 1, which is a copy of the Respondent's case records on the patient, Gloria Small. From an examination of all the vital signs, the patient was hypovolemic to the extent of being in hypovolemic shock following the aforementioned procedures. At the conclusion of the operation, Dr. Tauber instructed his staff to monitor the patient closely, and she remained on the cardiac monitor which had been employed during the operative procedures and the patient's vital signs, to- wit, blood pressure and pulse, were checked frequently. In addition, the staff was instructed to catherize the patient after six hours if the patient did not void and to record the amount of fluid intake and output and to observe the patient for vaginal bleeding. The patient was also given fluids to include dextrose and water and Normasol M, together with certain medication. These instructions were carried out by the staff. Dr. Tauber continued to give the patient fluids and to consider whether the patient should be transfused with whole blood. Around 3:00 p.m. on March 6, 1978, Dr. Tauber decided to infuse the patient with whole blood. He contacted the managing director of the Central Florida Blood Bank to attempt to gain the permission of that organization to provide whole blood for the benefit of the patient, Gloria Small. There had been some preliminary contact with the blood Bank about providing blood for patients of Dr. Tauber, but that arrangement had not been finalized prior to Gloria Small's operation. The managing director conferred with the medical director of the blood bank and a decision was made to honor Dr. Tauber's request for blood. Some delay ensued due to a mix-up on the part of Dr. Tauber's staff on the question of labeling the samples; nonetheless, this problem was rectified and at 6:10 p.m., and again at 7:25 p.m., blood was delivered for the benefit of the patient, Gloria Small, and that blood was infused into the patient. Contrary to the recollection of the Respondent, there is no record of further units of blood being requested by the Respondent, Dr. Tauber, for the benefit of the patient, Gloria Small, and, therefore, officially no such request was made of the blood Bank during the pendency of Dr. Tauber's treatment of the patient. As a consequence, the further treatment which Dr. Tauber gave the patient, Gloria Small, was without the benefit of the immediate availability of further units of blood. As previously stated, Dr. Tauber did not have hospital privileges and had not made any prior arrangement for the patient to be turned over to a physician with hospital privileges, in the event a medical emergency arose which required the hospitalization of the patient, Gloria Small. His first effort at making such an arrangement occurred between 5:00 and 5:30 on March 6, 1978, when he contacted a Dr. Lassiter, a resident in obstetrics and gynecology at the Orange Memorial Hospital, Orlando, Florida. The purpose of such conversation was to arrange for the patient to transfer if her condition worsened. Dr. Lassiter was unable to make this arrangement and it was only after the physician in charge had been conferred with that it was arranged for the patient, Gloria Small, to be accepted at Orange Memorial Hospital. This agreement was reached by the Respondent and the physician in charge, one Dr. Herran. Dr. Herran then confirmed this agreement with Dr. Lassiter, the resident, and instructed Dr. Lassiter to accept the patient, Gloria Small, if she were transferred and to immediately notify Dr. Herran if such transfer did occur. Dr. Tauber left his clinic around midnight of the morning of March 7, 1978, and left the patient in charge of a staff nurse. He returned to the hospital on the morning of March 7, 1978, and the patient's condition remained stabilized until approximately 5:00 p.m. on March 7, 1978. Up until that point, the bleeding that had been experienced following the initial hemorrhage was slight, and it was decided to remove the packing which had been placed at the conclusion of the operation. Most of the packing had been removed and there was no sign of bleeding, when a substantial hemorrhage took place in the cervical canal. At that point, Dr. Tauber repacked and made arrangements for an emergency ambulance, to transfer the patient to the hospital, and to notify Dr. Herran. The patient's vital signs began to deteriorate and during the transportation of the patient from Dr. Tauber's facility to Orange Memorial Hospital, the patient began to show marked signs of hypevolemic shock. Upon arriving at the Orange Memorial Hospital, the patient became the charge of that hospital staff and Dr. Tauber was no longer responsible, although he stayed with the patient and offered assistance, which was declined. The events which transpired at the Orange Memorial Hospital evidenced an inordinate delay on the part of the staff in properly administering to the needs of the patient. Whether this significantly contributed to the patient's ultimate demise is unresolved, but having arrived at the hospital in a condition where her body was already at a low ebb and unable to tolerate further insult, the patient died following a hysterectary performed in the Orange Memorial Hospital. The principal factor in that death was hypovolenic shock. Out of these events, the Petitioner has charged Dr. Tauber with a failure to demonstrate satisfactory professional skill, judgment or knowledge in the treatment of the patient, Gloria Small, and the accusation that Dr. Tauber has exhibited an inability to practice osteopathic medicine with reasonable skill and safety and that his professional conduct departed from minimal standards of acceptable and prevailing osteopathic medical practice. The particular substantive allegations which remain to be considered at this time are found in Subsections 459.14(2)(c) and (m), Florida Statutes, which state the following: 459.14 Refusal, revocation and suspension of license, etc.-- (c) Gross malpractice or the inability to practice osteopathic medicine with reasonable skill and safety. In enforcing this paragraph the board shall, upon just cause shown, have authority to compel a physician to submit to a mental or physical examination to be conducted by physicians designated by the board, such examination to be at the expense of the board. Failure or refusal of a physician to submit to such an examination when so directed by the board shall constitute an admission of his inability to practice osteopathic medicine with reasonable skill and safety. (m) A finding by the board that the indivi- dual is guilty of immoral or unprofessional conduct. Unprofessional conduct shall include any departure from, or failure to conform to, the minimal standards of acceptable and prevail- ing osteopathic medical practice, without regard to the injury of a patient, or the committing of any act contrary to honesty, whether the same is committed in the course of practice or not. In addressing the question of the application of these substantive standards set forth above to the facts reported in this case, the parties have offered the testimony of a number of persons within the profession of osteopathic medicine and other physicians who are medical doctors. An analysis of their testimony in view of the accusations in this cause establishes that the Respondent has evidenced an inability to practice ostepathic medicine with reasonable skill and safety within the meaning of Subsection 459.14(2)(c), Florida Statutes, and is likewise guilty of unprofessional conduct for departing from minimal standards of acceptable and prevailing osteopathic medical practice within the community where he practiced as required by Subsection 459.14(2)(m), Florida Statutes. The facts that led to these conclusions are those which show that the Respondent went forth with the dialation and evacuation and sterilization procedures of Gloria Small at a time when he did not have hospital privileges and at a time when he was unassociated with those persons who would have the necessary hospital privileges to address complications which might occur during these procedures, which complications might need immediate and well-defined access to a hospital facility. In addition, the possibility existed that the patient would need whole blood and other products associated with fluid replenishment and the Respondent had failed to make adequate arrangements for such eventuality, which failure caused undue delay in the infusion of the whole blood in the patient, Gloria Small. The problem in this case concerning the lack of readily available blood or blood products constituted a violation of the aforementioned standards on the part of Dr. Tauber and the very fact that Dr. Tauber had not made the prior arrangements to have available such blood or blood products constituted a further violation of the aforementioned standards. In a related area, that condition which would cause a necessity of the infusion of blood, to-wit, hypovolemic shock, had not adequately been anticipated, in violation of the necessary standards, even if you assume that Dr. Tauber made a sufficiently prompt response to the patient's hypovolemic condition which occurred following Dr. Tauber's operative procedures. Had the blood been needed more promptly, the Respondent was not prepared. There was considerable debate on the question of the necessity to transport the patient, Gloria Small, to a hospital following the substantial hemorrhage which occurred in the dialation and evacuation and sterilization procedures. After close scrutiny, it does not appear that the Respondent was remiss for not transferring the patient to Orange Memorial Hospital as opposed to the occasion when he did transfer her, remiss within the meaning of a violation of a standard set forth in Chapter 459, Florida Statutes. The procedures which Dr. Tauber used in discussing the case with his patient, Gloria Small, and providing other counseling do not violate provisions of Chapter 459, Florida Statutes, nor is the act of perforation itself and the contemporaneous management of that perforation in violation of Chapter 459, Florida Statutes. Likewise, the response which Dr. Tauber made in the second emergency on March 7, 1978, when the bleeding occurred did not violate the provisions of Chapter 459, Florida Statutes. Finally, it cannot be determined from this record whether Dr. Tauber could have avoided the confusion which took place after the patient was transferred to Orange Memorial Hospital, by earlier coordination with Dr. Herran; and in view of the fact that the patient was no longer his charge once she had been admitted to Orange Memorial Hospital, there can be no responsibility, within the meaning of Chapter 459, Florida Statutes, for those events which transpired when the patient was admitted to Orange Memorial Hospital. The parties have availed themselves of the opportunity to submit findings of fact, conclusions of law and recommendations and these offerings have been reviewed prior to the rendition of this Recommended Order and to the extent that they are not inconsistent with the Recommended Order, they have been utilized in aid of the preparation of this Recommended Order. To the extent that these proposals are inconsistent with the Recommended Order, they are hereby specifically rejected.
Recommendation In view of all the facts and circumstances, it is recommended that the Respondent, Ronald M. Tauber, D.O., have his license to practice osteopathic medicine in the State of Florida suspended for a period of two (2) years. DONE AND ENTERED this 10th day of May, 1979, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings Room 101, Collins Building 530 Carlton Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Ronald C. LaFace, Esquire Post Office Box 1752 Tallahassee, Florida 32302 Michael Sigman, Esquire Suite 1515 CNA Tower Orlando, Florida 32801 Roy Lucas, Esquire 1055 Thomas Jefferson Street, N.W. Suite 604 Washington, D.C. 20007 Samuel Weiss, Esquire 1180 Hartford Building 200 East Robinson Street Orlando, Florida 32801
The Issue This is a license discipline case in which a medical doctor is charged by administrative complaint with five counts of violations of paragraphs (h), (k), (m), and (t) of Section 458.331(1), Florida Statutes (1988 Supp.).
Findings Of Fact Findings based on parties' stipulations The Respondent, Vladimir Rosenthal, M.D., (hereinafter "Respondent" or "Dr. Rosenthal") is, and at all material times was, a medical doctor, license number ME 0045574, who practiced at 1320 South Dixie Highway, Coral Gables, Florida. Dr. Rosenthal at all material times owned the business operating as Today's Women Medical Center located at 1320 South Dixie Highway, Suite 1070, Coral Gables, Florida. On or about November 3, 1988, Dr. Rosenthal performed an elective abortion on patient B.F. under general anesthesia. On or about November 3, 1988, Dr. Rosenthal ordered a pathology report of the products of the procedure performed on patient B.F. The pathology report regarding patient B.F. bears the date November 8, 1988. The pathology report revealed no chorionic villi and recommended a "close follow-up" of the patient. Missed abortion and continued pregnancy is a recognized risk of early (first trimester) abortions. Patient B.F. suffered no harm as a result of the November 3, 1988, procedure. On or about December 7, 1988, patient B.F. presented to Dr. Rosenthal. On or about December 7, 1988, patient B.F.'s uterus was examined and found to be enlarged. Subsequently, a repeat pregnancy test was performed on patient B.F., which revealed she was still pregnant. On or about December 10, 1988, Dr. Rosenthal performed a second abortion on patient B.F. with positive results. Patient B.F. suffered no harm as a result of the December 10, 1988, procedure. Findings based on evidence at hearing The Respondent specializes in the area of gynecology, but does not practice obstetrics. In the course of his medical practice he regularly performs first trimester abortions. The Respondent is very experienced in the performance of first trimester abortions. In recent years he has averaged five thousand (5,000) such procedures per year. Patient B.F. normally goes to Dr. Nahid Mansoori for routine treatment of gynecological matters. Patient B.F. was seen by Dr. Mansoori on October 28, 1988, with a history of a missed menstrual period. Dr. Mansoori examined the patient and observed that the patient had an enlarged uterus and appeared to be 5 or 6 weeks pregnant. The patient expressed an interest in having an abortion. Because Dr. Mansoori does not perform abortions, she referred patient B.F. to the Respondent. Dr. Mansoori also referred patient B.F. to Dr. Martin S. Goldstein for an ultrasound examination. Dr. Mansoori referred patients to the Respondent on a regular basis. She did so for several reasons, including the facts that (a) patients she referred to the Respondent uniformly reported back to her that they were pleased or satisfied with the services they received from the Respondent, (b) none of her patients had complained about their treatment by the Respondent, and (c) none of the patients she had referred to the Respondent had experienced any infection or problems. On October 31, 1988, Dr. Martin S. Goldstein performed an ultrasound examination of patient B.F. On the basis of that ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 6 weeks, 0 days. Dr. Goldstein also concluded and reported that patient B.F. had an intrauterine pregnancy, thus ruling out an ectopic pregnancy. On November 3, 1988, patient B.F. went to the Respondent's clinic at 1320 South Dixie Highway for the purpose of having an abortion. The Respondent remembers this particular patient because she was a medical professional and her husband was an attorney. Because of their respective professions, the Respondent was extra careful to explain everything involved in the process to both B.F. and her husband. He especially explained to both of them the importance of a post-abortion follow up examination at either the Respondent's clinic or at the office of the patient's regular gynecologist. Patient B.F. said that she would return to Dr. Mansoori, her regular gynecologist, for the follow up examination. When patient B.F. went to the Respondent's clinic on November 3, 1988, she told the Respondent that she had had an ultrasound examination. The Respondent called Dr. Mansoori and Dr. Mansoori told him that the results of the ultrasound examination indicated a "gestational age" 1/ of six weeks and that the ultrasound examination confirmed an intrauterine pregnancy. Dr. Mansoori also mentioned that her clinical examination of patient B.F. indicated a "gestational age" of five or six weeks. Upon manual examination of the patient, the Respondent concluded, and noted in the patient's medical record, that patient B.F.'s uterus was enlarged to a size consistent with a "gestational age" of five weeks. Later that same day, the Respondent performed an abortion procedure on patient B.F. Following the abortion procedure, patient B.F. took antibiotic medication for several days, which medication had been prescribed and/or dispensed by the Respondent. The Respondent ordered a pathology report of the products of the abortion procedure performed on patient B.F. on November 3, 1988. The Respondent does not order pathology reports on all of his patients, but he did so in this case because it was an early pregnancy, and also because he wanted to take extra care in view of the professions of B.F. and her husband. The pathology laboratory is supposed to call Dr. Rosenthal on all "abnormal" reports. Sometimes the laboratory fails to call and sometimes the laboratory fails to send a written report. The Respondent has established office procedures for handling laboratory reports to try to prevent any reports from going astray and to identify those that do go astray so that follow up activity may be taken. Pursuant to the Respondent's established office procedures, all laboratory reports received at the clinic must be seen and signed by the Respondent before being placed in a patient chart. When a patient returns for her follow up visit, the laboratory report is reviewed during the course of that visit. If a laboratory examination has been ordered, but there is no laboratory report in the chart at the time of the follow up visit, the laboratory is called by telephone. The Respondent usually makes these calls himself. Pursuant to the Respondent's established office procedures, missing laboratory reports for patients who do not return for follow up visits or who return to their regular physicians for follow up visits are picked up when monthly reports to the Department of Health and Rehabilitative Services are compiled and submitted. In order to complete these monthly reports, a log is kept of every patient who has an abortion procedure performed at the Respondent's clinic. The information kept in the log and reported to DHRS includes: the date of surgery, the estimated "gestational age" of the patient, whether a pathology report was ordered, the results of the pathology report, and the date the pathology report was received by the clinic. Such forms were in use at the time B.F. was a patient at the Respondent's clinic. If any pathology reports "fell through the cracks," they were picked up each month when the reports were prepared. The reports are usually prepared on the ninth or tenth of each month. The implementation of these office procedures for the purpose of following up on laboratory reports is sufficient to comply with applicable standards of medical care. The pathology laboratory prepared a report regarding the material removed from patient B.F. during the November 3, 1988, abortion procedure. The written laboratory report was dated November 8, 1988. The most significant finding noted on the laboratory report was "no chorionic villi." Because of this finding, the laboratory report also stated: "close follow up of patient is recommended." The significance of the notation of "no chorionic villi" is that it indicates that the pathology laboratory examination did not reveal evidence of any fetal tissue or other "products of conception." The need for close follow up in this instance is because the absence of chorionic villi can be due to a number of different things. 2/ On November 18, 1988, patient B.F. went to Dr. Mansoori's office for a post-abortion follow up visit. At that time the patient was complaining of a vaginal "yeast" infection, a not uncommon occurrence following a course of antibiotic medication. Dr. Mansoori treated the patient's "yeast" infection with a prescription for Monistat Vaginal Cream. Dr. Mansoori's medical records for that day also include the following notations regarding the patient B.F.: "Had abortion by Today's Woman. Post AB check up O.K." 3/ Dr. Mansoori told patient B.F. to get back in touch with her if the patient missed her next menstrual period. On December 6, 1988, patient B.F. called Dr. Mansoori to report that she had missed her menstrual period. Dr. Mansoori advised her to return to the Respondent and patient B.F. agreed to do so. Dr. Mansoori called the Respondent to advise him that patient B.F. would be returning because she had missed her menstrual period. Dr. Mansoori also arranged for another ultrasound examination to be performed on patient B.F. by Dr. Goldstein. On December 7, 1988, patient B.F. returned to the Respondent's clinic where she was seen and examined by the Respondent. Examination revealed that the patient's uterus was mildly enlarged. A pregnancy test administered that day indicated that the patient was still pregnant. On December 7, 1988, the Respondent realized that he did not have a report from the pathology laboratory, so he called the laboratory and was advised that the most significant finding of the pathology report was "no chorionic villi." The substance of the telephone conversation with the pathology laboratory was noted in the patient's medical record. When he made the telephone call to the pathology laboratory on December 7, 1988, the Respondent had not received the laboratory's written report dated November 8, 1988, 4/ nor had he been otherwise advised of the results of the pathology study of the materials removed during the November 3, 1988, abortion procedure. On December 8, 1988, Dr. Martin S. Goldstein performed a second ultrasound examination of patient B.F. On the basis of the second ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 11 weeks, 6 days. This second gestational age was three days older than one would have predicted based on the October 31, 1988, ultrasound examination. In both of the ultrasound examinations of patient B.F., Dr. Goldstein relied upon the "crown rump" measurement as the basis for his estimate of "gestational age." On December 10, 1988, when patient B.F. returned to the Respondent's office for the second abortion procedure, the Respondent conducted a clinical examination of the patient before commencing the procedure. On the basis of his own clinical examination of the patient, the Respondent was of the opinion that patient B.F.'s "gestational age" was 8 or 9 weeks. He reported this on the "Physical Exam" portion of the patient's chart by writing "8-9" beside the entry for uterus. After the patient was anesthetized and the Respondent could examine her while she was more relaxed, the Respondent further examined the patient's uterus and was of the opinion that its size corresponded to a "gestational age" of 8 weeks. He noted this opinion in the "Operative Notes" portion of the patient's chart. It was, and continues to be, the Respondent's opinion that his December 10, 1988, estimates of the patient's "gestational age" were correct. Although he was aware of Dr. Goldstein's ultrasound examination which reported a somewhat older "gestational age," the Respondent had confidence in his own clinical findings and relied on his own clinical findings, which he duly recorded in the patient's medical chart. Relying on his own estimate of "gestational age," the Respondent performed the abortion procedure on December 10, 1988, on patient B.F. with a number eight suction tip. The abortion procedure was accomplished successfully and without any difficulty or complication. A report from a pathology laboratory confirmed that the December 10, 1988, abortion procedure was successful. 5/ The prevailing standards of acceptable care do not require a physician to order a pathology examination of the material removed during the course of a routine first trimester abortion procedure. In an abortion procedure involving a very early pregnancy, a physician may wish to order such a pathology examination in order to be more certain as to the results of the procedure, but it is a matter of physician preference, rather than a requirement. A physician who orders a pathology examination of the material removed during a first trimester abortion procedure has an affirmative duty to follow up on the examination and find out the results of the examination within a reasonable period of time. 6/ The Respondent's follow up on December 7, 1988, on the results of the pathology examination of the material removed from patient B.F. during the November 3, 1988, procedure was reasonable under the circumstances. 7/ The Respondent's delay until December 7, 1988, before following up on that pathology examination was not a departure from applicable standards of medical care. 8/ The Respondent's medical records for patient B.F. justify the course of treatment of the patient. The use of ultrasound examination as a method of estimating "gestational age" is not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of ultrasound examination are accurate within a margin of error of plus or minus two weeks. 9/ Clinical or manual examination of a patient as a method of estimating "gestational age" is also not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of clinical or manual examination of a patient are accurate within a margin of error of plus or minus two weeks, if done by an experienced physician. It is not a departure from applicable standards of medical care for an estimate of "gestational age" to vary from the actual "gestational age" by as much as plus or minus two weeks when the estimate is based on the physician's clinical or manual examination of the patient. A reasonably prudent physician who is experienced in clinical or manual examination of patients for the purpose of estimating "gestational age" should rely on his own findings, even if those findings appear to conflict with findings based on ultrasound examination. Such a physician should also note his own findings on the patient's medical records, regardless of what is reported by the ultrasound. There is no great discrepancy between the estimate of "gestational age" reported in Dr. Goldstein's ultrasound report of December 8, 1988, and the Respondent's estimate of "gestational age" on December 10, 1988. The Respondent's notations in patient B.F.'s medical records on December 10, 1988, to the effect that her pregnancy was of a "gestational age" of eight weeks was an honest notation of the Respondent's clinical judgment and was not a statement the Respondent knew to be false. 10/ Similarly, those notations were not deceptive, untrue, or fraudulent representations. On or about August 3, 1989, the Respondent's clinic, known as Today's Woman Medical Center, located at Suite 1070, 1320 South Dixie Highway, Coral Gables, Florida, was inspected by an employee of the Office of Licensure and Certification of the Department of Health and Rehabilitative Services. 11/ At the time of that inspection the Respondent was not present at the clinic, there were no procedures being performed at the clinic, and there were no patients at the clinic.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be entered in this case DISMISSING all charges against the Respondent, Vladimir Rosenthal, M.D. DONE AND ENTERED this 2nd day of October, 1992, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of October, 1992.
The Issue The issues in 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 At issue in this proceeding is whether Respondent, Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care (“Bread & Roses”), provided services in excess of the scope of its license by providing abortions to five patients beyond the first trimester of pregnancy, as alleged in the Administrative Complaint.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following Findings of Fact are made: AHCA is the state agency responsible for the licensing of abortion clinics and the enforcement of the statutes and rules governing their operations in Florida, pursuant to chapter 390 and chapter 408, part II, Florida Statutes. Bread & Roses is a women’s health care clinic licensed to provide first-trimester abortions pursuant to chapter 390, Florida Statutes, and Florida Administrative Code Chapter 59A-9. Kimberly Smoak is AHCA’s field office supervisor. She is based in Tallahassee and supervises the operations of AHCA’s field offices throughout the state. Kriste Mennella is an AHCA field office manager based in Alachua, who reports directly to Ms. Smoak. On or about August 5, 2015, Ms. Smoak directed Ms. Mennella’s office to conduct an unannounced “monitoring” survey of Bread & Roses and to send Ms. Smoak her survey report before the end of the day. Ms. Mennella personally conducted the survey. Ms. Mennella arrived at Bread & Roses at 12:45 p.m. on August 5, 2015, to conduct the survey. She requested and reviewed utilization reports and medical records for 16 patients for whom Bread & Roses had provided abortion services within the previous year. Section 390.0112(1) provides the following reporting requirement: The director of any medical facility in which any pregnancy is terminated shall submit a monthly report to the agency which contains the number of procedures performed, the reason for same, the period of gestation at the time such procedures were performed, and the number of infants born alive during or immediately after an attempted abortion. The agency shall be responsible for keeping such reports in a central place from which statistical data and analysis can be made. (Emphasis added). Chapter 390 does not define the terms “gestation” or “pregnancy.” Section 390.011(11) defines “third trimester” to mean “the weeks of pregnancy after the 24th week of pregnancy.” From this definition, it is possible to infer that the first trimester includes the first 12 weeks of pregnancy and that the second trimester includes the second 12 weeks of pregnancy. Consistent with this inferred definition, rule 59A- 9.019(14) provides as follows: (14) “Trimester” means a 12-week period of pregnancy. First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period). Second Trimester. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation. Third Trimester. That portion of pregnancy beginning with the 25th week of gestation. (Emphasis added). Ms. Mennella found the following in the clinic’s utilization reports for five of the 16 patients in the survey sample: Patient #5: no last normal menstrual period (“LNMP”) recorded; ultrasound reflected 13 weeks of pregnancy. Patient #7: no LNMP recorded; ultrasound reflected 13.2 weeks1/ of pregnancy. Patient #8: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. Patient #9: no LNMP recorded; ultrasound reflected 13 weeks of pregnancy. Patient #15: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. During the survey, the clinic manager for Bread & Roses, who prepares the clinic’s utilization reports, explained to Ms. Mennella that the “weeks” reflected on Bread & Roses’ utilization reports reflected the length of pregnancy as counted from the first day of the LNMP. Therefore, all five of the patients’ abortions were within the 14-week window afforded by rule 59A-9.019(14)(a). Ms. Mennella documented her conversation with the clinic manager in her formal survey notes and in her August 5, 2015, formal survey report to Ms. Smoak. At the conclusion of the survey, Ms. Mennella reported to Ms. Smoak by telephone, though Ms. Mennella testified that she could not recall the details of the discussion. At 4:50 p.m. on August 5, Ms. Mennella telephoned Kristin Davy, the owner and director of Bread & Roses. Ms. Mennella told Ms. Davy that AHCA had determined that Bread & Roses had acted in violation of its license by performing second-trimester abortions, based on the clinic’s utilization reports and the medical records reviewed by Ms. Mennella during the on-site survey. Ms. Davy replied that AHCA’s conclusion was incorrect because the weeks and days recorded on the ultrasound reports measured from the first day of the LNMP, meaning that all five of the questioned procedures had been performed within the first trimester of pregnancy. After her discussion with Ms. Davy, Ms. Mennella submitted her formal survey report to Ms. Smoak. Ms. Mennella’s survey notes and her survey report to Ms. Smoak each documented Ms. Davy’s dispute of AHCA’s conclusion and her explanation of the ultrasound reports. At 6:15 p.m. on August 5, Ms. Mennella faxed a letter to Ms. Davy with the heading, “Notice of Activity Without Proper Licensure.” The letter stated that AHCA had determined that Bread & Roses was providing services beyond the scope of its license. The letter did not attach a copy of Ms. Mennella’s survey report nor any other document reflecting the specifics of AHCA’s allegations regarding the clinic’s operation. Ms. Mennella made a follow-up visit to Bread & Roses on August 19 to determine whether there had been any more procedures performed that appeared to be beyond the scope of the clinic’s license. Based on her review of the clinic’s files, she determined that there had not. On September 1, 2015, AHCA faxed to Bread & Roses a letter signed by Ms. Mennella reporting the findings of its survey and requiring the facility to file a corrective action plan. The letter was accompanied by a statement of deficiencies recorded during Ms. Mennella’s August 5 survey. The statement of deficiencies stated that Bread & Roses had performed services beyond the scope of its license as follows: For sampled patients #5, #7, #8, #9 and #15, no date was recorded for the last normal menstrual period (LMP); however, the ultrasound reflected weeks of gestation in excess of 12 as documented in the patients’ records. Ms. Mennella’s documentation of her conversations with the office manager and Ms. Davy were excised from the version of the survey report faxed to Bread & Roses on September 1, 2015. Ms. Mennella had no explanation for this deletion, and testified that she could not recall whether she told Ms. Smoak about the explanations offered by the office manager and Ms. Davy as to the meaning of the ultrasound reports. Ms. Mennella’s letter of September 1 directed Bread & Roses to submit a written corrective action plan to AHCA by the close of business on September 4, 2015. The letter stated that the corrective action plan must do the following, at a minimum: * Demonstrate procedures are in place to ensure that first trimester abortions are not performed: In excess of 14 weeks (up to but not including the 105th day) from the last normal menstrual period (LNMP), and in excess of the 12th week (up to but not including the 91st day) of gestation; or When LNMP is not determined or not documented, abortions are not performed beyond the 12th week (up to but not including the 91st day) of gestation. * Educate staff to ensure that when reporting pursuant to rule 59A-9.034, F.A.C., on the online reporting system, that the field titled “WEEKS OF GESTATION” is correctly completed using “weeks of gestation” as that phrase is used in rule 59A-9.019, F.A.C., and not erroneously using the last normal menstrual period. On September 3, 2015, one day prior to expiration of the deadline for submission of Bread & Roses’ corrective action plan, AHCA filed the Administrative Complaint that initiated this proceeding. The Administrative Complaint seeks to impose an administrative fine of $2,500 on Bread & Roses, or $500 for each instance in which AHCA alleges that the clinic performed an abortion during the second trimester, beyond the scope of its license. Bread & Roses submitted a responsive letter to AHCA shortly after 1:00 p.m. on September 4, 2015. The letter, written and signed by Ms. Davy, stated as follows, in relevant part: This letter responds to your letter dated September 1, 2015, which requested a summary of a corrective action plan demonstrating two things: First, that procedures are in place to ensure that first trimester abortions are not performed in excess of 14 weeks from the last normal menstrual period (LNMP), and Second, that staff are educated to report “WEEKS OF GESTATION”--in the monthly online ITOP reports, filed pursuant to rule 59A- 9.034, F.A.C.--“using ‘weeks of gestation’ as that phrase is used in rule 59A-9.019, F.A.C.,” and not using LNMP. As to the first requirement, Bread & Roses has always provided abortion care only through and including 13.6 weeks LNMP, or 13 completed weeks and 6 days as measured from LNMP. Our staff records the date that the woman remembers for her LNMP if and only if she remembers such a date (and if she had such a date: some women do not menstruate, such as when using certain contraceptives). If the woman did not have or does not remember the date of her LNMP, we do not include such a date in her record. Regardless of whether she remembers such a date, we do not determine the length of her pregnancy based on that memory. Rather, in accordance with the standard of care, we determine the length of her pregnancy based on ultrasound examinations. Please be aware that--again, as is absolutely standard practice throughout Florida and the U.S.--our ultrasound machine provides a length of pregnancy as measured from LNMP. In other words, based on the measurements of the embryo or fetus, the ultrasound machine produces an estimated length of pregnancy as measured from LNMP. Our corrective plan of action is to ensure that henceforth, in all medical records, all staff include “LMP” [sic] after each indication of length of pregnancy, including when staff record the results of an ultrasound examination. As to the second requirement, for clarity, here is the relevant regulation: “First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period).” 59A-9.019(14)(a), F.A.C. Based on your letter dated September 1, 2015, all staff will now report “WEEKS OF GESTATION” in the monthly online [Induced Termination of Pregnancy or “ITOP”] reports using “weeks of gestation” as measured not from LNMP, but from two weeks after LNMP. In other words, we will henceforth report an abortion at 13.1 weeks LNMP as an abortion at 11.1 weeks in the online field for “WEEKS OF GESTATION.” The ITOP form referenced in the letter is a monthly summary report filed by the clinic with AHCA regarding the timing of the abortion procedures performed at the clinic. Printed examples of the forms were submitted into evidence by AHCA. The form sets forth three reporting categories: “up to 12 weeks,” “13 to 24 weeks,” and “25 and over weeks.” The form, at least in the printed version submitted by AHCA, uses neither the term “pregnancy” nor “gestation.” At the hearing, Ms. Davy testified that she wrote the corrective action plan to ensure there would be no more misunderstanding about what Bread & Roses was doing. She was adamant that Bread & Roses was not performing second-trimester abortions. She stated that the clinic was not changing its medical standards, but was clarifying its reports to AHCA. From that point forward, Bread & Roses would include “LNMP” after every notation of length of pregnancy in its medical records, and its ITOP reports to AHCA would subtract the two-week LNMP interval. Ms. Davy testified that the corrective action plan was implemented on the day it was submitted to AHCA. Ms. Davy further testified that Bread & Roses had been submitting its reports to AHCA in the same manner for the ten years in which it has restricted its license to first- trimester abortions. She had always understood that “weeks of gestation” on the ITOP form was meant to be dated from the first day of the last normal menstrual period, which is standard industry practice. No other surveyor ever told her that she was filling the forms out incorrectly or had attempted to infer that the clinic was operating beyond the scope of its license. AHCA’s most recent routine survey of Bread & Roses, prior to the August 5 survey, had been performed on February 14, 2015. No deficiencies had been found. AHCA presented no evidence to counter Ms. Davy’s credible testimony that Bread & Roses had been submitting its ITOP reports in the same manner for the previous ten years without incident. AHCA presented no evidence to explain why it suddenly believed that Bread & Roses’ ITOP reports showed that the clinic was performing second-trimester abortions. Ms. Davy testified that Bread & Roses does not rely on a patient’s reported LNMP to measure length of pregnancy because such reports are inherently unreliable. Thus, whether or not a patient’s medical record includes a patient-reported LNMP is of no importance to the length of pregnancy reported on the ITOP. In all cases, Bread & Roses reports length of pregnancy as measured by the ultrasound machine. Bread & Roses owns the ultrasound machine used in its clinic. Ms. Davy testified that she had the machine calibrated at the time of purchase, about a year and a half ago. The machine is checked annually by North Florida Biomedical Services. Bread & Roses’ written policies and procedures include the following, under the heading “Sonography”: A sonogram will be performed on all patients. Bread and Roses performs abortion procedures in the first trimester, up to 13 weeks 6 days from the last menstrual period. A sonogram will determine how many weeks the patient is from the last menstrual period. If a patient is 14 weeks or over she will be referred to an alternate clinic. Mary E. Raum, M.D., is a gynecologist and has been the medical director at Bread & Roses for 15 years. She has practiced gynecology since 1983. Dr. Raum performs all of the ultrasound and abortion procedures done at Bread & Roses. She performed the ultrasound procedures on each of the five patients at issue in this case. Dr. Raum testified that the “ultimate determinant” as to whether a patient is in the first or second trimester is the ultrasound. She stated that the ultrasound is “definitive” and has become the standard of care for assessing the length of pregnancy. Dr. Raum testified that the ultrasound equipment she was using met standards for such equipment. She had no doubt that the equipment was functioning properly. AHCA offered no evidence to dispute Dr. Raum’s assessment of the ultrasound equipment. Dr. Raum described her manner of performing the ultrasound procedure as follows: The patient is laying [sic] flat. I always hope that I can get an adequate image abdominally so the patient doesn’t have to have a vaginal probe. But there are times when that is necessary. The abdomen is spread with the ultrasonic gel, and then the probe, which is called a transducer--that is what actually emits the sound waves which are higher than the human ear can hear . . . . [A]s soon as I see what I feel to be a good representative picture where I can measure the pertinent structures, it’s frozen, and then I select, on the possible measurements, the appropriate one. Early on, the most appropriate ones are either the gestational sac or the crown-rump length, which is measured from the top of the head to the end of the tailbone, if you will. There is an algorithm that is programmed into the ultrasound machines which then translates those two measurements into the date of the pregnancy from the first day of the last menstrual period. Dr. Raum testified as to the care she takes in performing the ultrasound measurement. If she is uncertain, she will take several measurements until she has the most accurate possible measurement. Dr. Raum frankly tells her patients that if the measurement is even one day beyond the 14-week limit, she will not perform the abortion. AHCA did not call any witness to explain the basis for the Administrative Complaint. The facts alleged are that the medical records for the five patients at issue do not contain an LNMP date, and that the sonogram in the medical record of each of the five patients reflects “weeks of gestation in excess of 12.” AHCA presented no evidence in support of its allegation concerning the length of gestation. It might have been reasonable at the time of Ms. Mennella’s survey for the agency to read the ITOP reports and the patient records and suspect a problem. However, it was not reasonable for the agency to disregard the reasonable explanations provided by the Bread & Roses office manager and by Ms. Davy. Ms. Mennella herself could not say why AHCA decided to file an administrative complaint alleging that Bread & Roses performed five second-trimester abortions, or why her documentation of her conversations with the office manager and Ms. Davy were excised from the final version of her survey report. AHCA’s theory of the case appears to be that the lack of a handwritten notation of “LNMP” in the five medical records at issue requires a conclusion that the days and weeks shown on the face of the sonogram reflect a length of pregnancy as measured from the date of “conception” or “gestation,” rather than the LNMP. This premise is unfounded, and the failure of the premise destroys the logic of AHCA’s theory. The ultrasound measures the same thing, whether or not the medical record contains a patient-reported LNMP date. The evidence presented at the hearing showed that the ultrasound dates the pregnancy from the LNMP, and that Bread & Roses’ ITOP reports were based on the ultrasound results. The missing LNMP notes are a red herring. AHCA’s case consisted largely of an argument premised on applying the dictionary definition of the term “gestation” to the medical records of Bread & Roses, which do contain a “Patient Procedure Record” that makes reference to “gestation” in the section regarding the physician’s examination of the evacuated tissue post-abortion. Indeed, if these abortions had been performed after 13 weeks of “gestation,” as that term is defined in some medical dictionaries,2/ then they would have been beyond the first trimester. However, Ms. Davy testified that, consistent with standard medical practice, the term “gestation” on the Patient Procedure Record means, and has always meant, length of pregnancy as measured from the first day of the LNMP. Ms. Davy stated that she has amended the Patient Procedure Record to add “LNMP” after every indication of length of pregnancy, in order to prevent any future misunderstandings. Dr. Raum testified that medical practitioners generally do not attempt to measure the length of pregnancy from the date of conception because that date is difficult, if not impossible, to determine in an accurate and reliable fashion, except perhaps in cases of in vitro fertilization. AHCA’s own rule appears to recognize this difficulty by defining the “first 12 weeks of pregnancy” as equivalent to the “first 14 completed weeks from the last normal menstrual period.” In light of the overwhelming factual evidence that Bread & Roses did not in fact perform second trimester abortions, the dictionary definition of “gestation” was an insufficient basis for finding a violation. AHCA made no attempt at a factual, as opposed to a logical, demonstration that these were second-trimester abortions. AHCA presented no testimony or documentary evidence refuting the credible evidence presented by Bread & Roses that the sonograms show on their face that the pregnancies for each of the five procedures at issue were first trimester pregnancies and within the scope of Bread & Roses’ license. AHCA has argued that it should be allowed to show, in the alternative, that Bread & Roses’ clinical records were not accurately documented because they showed more than 12 weeks of “gestation” for each of the five sampled patients, in both the sonograms and the Patient Procedure Record, in violation of rule 59A-9.031, which requires that clinical records must be “complete” and “accurately documented.” It is noted that, prior to the hearing, AHCA made a motion to file an Amended Administrative Complaint that would have included a second count alleging a recordkeeping violation. This motion was denied by Order dated February 26, 2016. At the start of the final hearing, AHCA renewed its motion while also arguing that it was not necessary to amend the Administrative Complaint in order to raise the recordkeeping issue. The motion was again denied, but AHCA was given some leeway to pursue its theory that the original Administrative Complaint embraced a recordkeeping allegation. Even if the Administrative Complaint could be said to include an allegation regarding inaccurate recordkeeping,3/ AHCA did not prove anything more than that it misread the clinical records and ITOP reports of Bread & Roses and then refused to listen to Bread & Roses’ explanation. The evidence established that Bread & Roses had submitted the ITOP forms to AHCA every month for ten years in substantially the same form with no indication from AHCA that there was a problem. The evidence also established that the term “gestation” in the Patient Procedure Records was used in its usual medical sense, i.e., the length of pregnancy as measured from the first day of the LNMP. Bread & Roses amended its Patient Procedure Record form and changed its method of reporting the ITOP not because of any recordkeeping failure on its part, but in an effort to appease AHCA and forestall any further misunderstanding.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint against Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care. DONE AND ENTERED this 28th day of April, 2016, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 2016.
Findings Of Fact Braylon Roberts was born on February 3, 2009, at St. Joseph’s Women’s Hospital located in Tampa, Florida. Braylon’s birth weight exceeded 2,500 grams. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Braylon. On July 1, July 9, and August 18, 2014, Dr. Willis performed a medical records review and wrote medical reports. In an affidavit dated December 29, 2014, he summarized his records review and opined as follows: In summary, labor was induced at term with an uncomplicated spontaneous vaginal delivery. The newborn was not depressed and required no resuscitation after birth. Hospital course was uneventful until DOL 2 when seizure activity was noted. MRI was consistent with cerebral stroke. The baby suffered a cerebral stroke at some time on DOL 2. Medical history of a normal spontaneous vaginal birth with no newborn depression and a normal initial newborn hospital course, suggests the stroke was not due to oxygen deprivation or mechanical trauma during labor, delivery or in the immediate post-delivery period. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post-delivery period. The additional records do not change any of the opinions expressed in the letter of 07/01/2014. The FHR monitor tracing does not suggest fetal distress during labor. This would be in agreement with the previous opinion that the newborn stroke did not result from oxygen deprivation during labor. NICA retained Raymond J. Fernandez, M.D. (Dr. Fernandez), a pediatric neurologist, to examine Braylon and to review his medical records. Dr. Fernandez examined Braylon on October 6, 2014. In a medical report regarding his independent medical examination of Braylon, Dr. Fernandez opined as follows: Braylon has a subtle (very mild) right hemiparesis that is not causing substantial motor impairment at this time and it is not predicted not [sic] to cause substantial motor impairment in the future. Speech is mildly to moderately delayed, but improving and he is improving with regard to basic learning skills in his regular kindergarten classroom setting. The ultimate outcome with regard to more complicated learning is indeterminate at this time, but he should continue to improve with appropriate input from teachers and family members. Braylon’s neurological injury was due to an ischemic stroke in the distribution of a branch of the left middle cerebral artery. His neurological injury was not caused by oxygen deprivation or mechanical injury due to an obstetrical event during labor, delivery, or in the immediate post delivery of [sic] resuscitation. Dr. Fernandez confirmed his opinion in an affidavit dated January 7, 2015.1/ A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain during labor, delivery, or the immediate post- delivery period. Dr. Willis’ opinion is credited. There are no contrary expert opinions filed that are contrary to Dr. Fernandez’s opinion that although Braylon has a subtle (very mild) right hemiparesis, it is not causing, and is not predicted to cause, substantial motor impairment. Further, Dr. Fernandez also opined that Braylon’s neurological injury was not caused by oxygen deprivation or mechanical injury due to an obstetrical event during labor, delivery, or in the immediate post-delivery or resuscitation. Dr. Fernandez’s opinion is credited.
