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
Findings Of Fact Respondent, Marty Johnsey (Johnsey), was at all times material hereto licensed as a registered nurse in the State of Florida, having been issued license number 1766782. From November 10, 1986, to November 25, 1986, Johnsey was employed as a certified registered nurse anesthetist at Broward General Medical Center, Fort Lauderdale, Florida. On November 24, 1986, while on duty at Broward General, Johnsey was observed by Dr. Alfredo Ferrari, an anesthesiologist, to be in a rigid and cyanotic condition. Dr. Ferrari immediately summoned assistance, and Johnsey was placed on a stretcher, given respiratory assistance, and taken to the emergency room. While in the emergency room, Johnsey was administered Naloxone, a specific narcotic antagonist used to reverse the effects of synthetic narcotics such as Sufentanil. Within minutes of being administered Naloxone, Johnsey began to breath normally, wake up, and relate to his environment. A urine sample taken from Johnsey on November 24, 1986, as well as a syringe found by Dr. Ferrari next to Johnsey when he first assisted him, were subsequently analyzed and found to contain Sufentanil. Sufentanil is a synthetic narcotic analgesic, and a Schedule II controlled substance listed in Section 893.03(2)(b), Florida Statutes. Under the circumstances, the proof demonstrates that on November 24, 1986, Johnsey, while on duty at Broward General, was under the influence of Sufentanil to such an extent that he was unable to practice nursing with reasonable skill and safety.
Recommendation Based on the forgoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered imposing an administrative fine of $250.00, suspending the license of respondent until such time as he can demonstrate that he can safely practice his profession, followed by a one year term of probation. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 11th day of May, 1988. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of May, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-0115 Petitioner's proposed findings of fact are addressed as follows: 1. Addressed in paragraph l. 2-3. Addressed in paragraph 2. 4-7. Addressed in paragraph 3. 8-10. To the extent pertinent, addressed in paragraph 4. 11-15. Addressed in paragraph 5. Otherwise rejected as subordinate. 16. Addressed in paragraph 7. COPIES FURNISHED: Michael A. Mone', Esquire Mr. Marty Johnsey Department of Professional 180 Skyline View Drive Regulation Collinsville, Illinois 62234 130 North Monroe Street Tallahassee, Florida 32399-0750 Judie Ritter, Executive Director William O'Neil Department of Professional General Counsel Regulation Department of Professional Board of Nursing Regulation Room 504, 130 North Nonroe Street 111 East Coastline Drive Tallahassee, Florida 32399-0570 Jacksonville, Florida 32201 =================================================================
Findings Of Fact The Respondent Gonzalez The Respondent Maria B. Gonzalez is a medical doctor holding Florida license number ME 0028019. She has been licensed to practice medicine in Florida since 1975. Prior to the instant proceeding, her license to practice medicine has never been suspended or revoked. The Respondent has taken and passed the written test for board certification as a specialist in obstetrics and gynecology, but was refused permission to complete the exam because her privileges had by then been suspended by Hollywood Memorial Hospital. During the course of her practice in Cuba and Florida, the Respondent has delivered approximately 2,000 babies. To her knowledge, she has never had a maternal or infant death occur during her practice. The Respondent's practice at Memorial Hospital was highly unusual in that almost half of her patients were Medicaid. As a result, Respondent encountered difficulties in dealing with some of the members of the medical staff at Memorial since she believed that her patients medical interests should take precedence over their ability to pay for services. 1/ The Respondent's provisional staff privileges at Memorial were suspended on July 28, 1982, based upon a review by an ad hoc committee of the hospital's obstetrics and gynecology staff, of six cases, five of which form the basis of the instant proceeding. In deciding to terminate the Respondent, the ad hoc committee considered pertinent medical records and statements from witnesses but did not hear the direct testimony of the Respondent. When the decision was made by Memorial to terminate the Respondent, the hospital informed the Petitioner of this fact pursuant to Section 458.337, Florida Statutes, which requires that the Department be notified when any physician has been disciplined by a licensed hospital for any act that constitutes a violation of Chapter 458, Florida Statutes. Count One Aida M. Astiazarian On December 25, 1981, the Respondent performed a bilateral tubal ligation on Aida M. Astiazarian, a patient who had vaginally delivered an infant several hours prior to the operation. During the procedure, the Respondent was assisted by Dr. Purificacion D. Catini, a surgical assistant. The patient was anesthetized by Dr. Gary Karch. The tubal ligation on Astiazarian began with the opening of the abdominal cavity. Several adhesions from prior surgery and two small bleeders were noticeable, specifically a bleeder on the anterior abdominal wall and on the anterior surface of the uterus. The Respondent ligated the bleeder on the anterior abdominal wall and controlled the oozing from that source. The Respondent elected not to suture or ligate the oozing on the anterior surface of the uterus as recommended by Dr. Catini and instead used a four-by-four inch section of Gelfoam to control the bleed. The Gelfoam was applied with a laparotomy paid and removed after a few minutes. Believing that hemostasis had been achieved, the Respondent closed the abdominal cavity. Unlike the Respondent, Dr. Catini believed that hemostasis had not been achieved since she noticed some oozing still occurring after the Gelfoam was applied. Following the operation the patient's hemoglobin, hematocrit and blood pressure began to fall. The likely cause of these symptoms was an intra- abdominal bleed or ooze. The patient was transfused with several units of blood and discharged from the hospital. Although a reasonably prudent physician would not close a patient with an active ooze or bleed, the record fails to establish that the Gelfoam was ineffective and the Respondent knew or should have known that hemostasis had not been achieved. 2/ Uterine oozing in a postpartum patient can occur without any negligence by a treating physician. The loss of blood which occurred following this operation is not inconsistent with the Respondent's assertion that hemostasis had occurred and that sometime later the clot had become dislodged, thereby causing the bleed which resulted in the administration of two units of blood. Count Two Jaclyn R. Osier On December 28, 1981, the Respondent performed a postpartum tubal ligation on Jaclyn R. Osier. She was assisted during the procedure by Dr. David Gordon. During the operation, a tear in the broad ligament occurred and the patient began to hemorrhage profusely. The tear of the broad ligament which occurred during the procedure was an inherent risk of surgery and does not, by itself, demonstrate negligence by the Respondent. The Respondent extended the incision and located one of the bleeders; however, due to the nature of the tear and the physical condition of the patient, she was unable to locate and control other bleeders which were deeper in the abdomen. Due to the blood loss experienced by the patient, Dr. Gordon determined that additional help was needed. He left the operating room and sought assistance from Dr. Raymond Nolan. When Dr. Nolan arrived, he made an additional extension of the incision and with assistance from the Respondent and Dr. Gordon, he was successful in locating the deep bleeders and achieving hemostasis. Under the circumstances, it was appropriate medical practice for either the Respondent or Dr. Gordon to seek additional help when the patient's bleeding was not under control. As noted by Dr. Nolan "...Just as two heads are better than one, four hands are better than two." (Tr. at 369.) Significantly, Dr. Nolan, a surgeon who had operated with the Respondent on this case as well as others, did not believe that the Respondent's license should be revoked based on his actual experiences with the Respondent. Following this incident, Dr. Nolan did not have any immediate concern that the Respondent had acted improperly. Although Dr. Nolan later voted to suspend the Respondent's hospital privileges at Memorial, his vote was based on the recommendation of the hospital's ad hoc committee rather than his own personal experiences with the Respondent or his own independent review of pertinent medical records. The intra-operative complication which occurred in this particular case was not the result of the Respondent's negligence. When the Respondent was unable to control the bleeding with Dr. Gordon after the incision had been extended, another surgeon was called to assist. The Respondent's inability to control the bleed prior to Dr. Nolan being called, does not constitute negligence under the circumstances of this case. Count Three Linda Jones On May 28, 1982, at 9:45 p.m., Linda Jones, a high risk and postdate patient was admitted to Memorial. The Respondent examined the patient on the morning of May 29, 1982, and found her to be in labor. The practice at Memorial was that provisional staff physicians, such as the Respondent, handle all service or indigent patients. Linda Jones had been handled by Dr. Kast, another provisional staff physician. On the day the Respondent examined the patient, she was covering for Dr. Kast, who had asked as a courtesy to be relieved until 1:30 p.m. The labor and delivery of pregnant service patients at Memorial are handled by nurse/widwives, unless a complication arises which requires a surgical procedure. The patient was scheduled for a normal vaginal delivery. She was doing well and was placed on a fetal monitor. At approximately 12:25 p.m., the patient started having episodes of decelerations. Nurse/Midwife Jean Tease, R.N., turned off the Pitocin which had been administered and turned the patient to relieve the decelerations. The patient continued to progress until approximately 1:22 p.m., when rapid decelerations on the fetal monitor were observed. At approximately 12:00 p.m. the Respondent left Memorial to attend a wedding in Fort Lauderdale which was a twenty minute drive from the hospital. She notified the nursing staff where she was going so that she could respond if needed. 3/ Nurse Tease contacted both Dr. Kast and Respondent when the patient's symptoms began to worsen. The Respondent returned the call and when informed of the problem, advised Tease that she would return to the hospital. The Respondent was returning to the hospital via Interstate 95 when it began to rain very heavily. Her front brakes froze and her car was immobile. While it continued to rain, Respondent pulled over on the side of the Interstate and attempted to flag down help. A wrecker operator stopped and towed her car to a service station where it was repaired. Meanwhile, since the Respondent had not arrived at Memorial as she had stated, Nurse Tease placed a page for any obstetrician in the hospital, and Dr. David Lessin responded. Dr. Lessin performed an emergency cesarean section and produced a living baby. The Amended Administrative Complaint does not allege that the Respondent was negligent in leaving the hospital; rather it charges that the Respondent breached a duty owed to this patient by failing to come to the hospital until approximately four hours after advising hospital personnel that she was in route. Due to mechanical problems with her car and the weather, it was impossible for the Respondent to return to the hospital to attend this patient. The Respondent believed that Dr. Kast was on duty after 1:30 p.m., and she knew she could not arrive at the hospital before that time. Under the circumstances, her actions regarding this patient were not negligent. Count Four Ramona Cardullo Ramona Cardullo was admitted to Memorial on the morning of May 28, 1982. Mrs. Cardullo was pregnant with her third child who was ultimately successfully delivered by cesarean section. Prior to this pregnancy, Mrs. Cardullo had experienced significant difficulties during the delivery of her two other children. Her first child, who was born following induced labor in Texas, was a month post-mature. Her second child was delivered at Memorial by another obstetrician following induced labor. The second child was delivered through the use of forceps. The problems which Mrs. Cardullo encountered in her two previous pregnancies resulted from a uterine dysfunction in which her cervix failed to dilate sufficiently to permit a normal delivery. When Mrs. Cardullo came to the Respondent during her third pregnancy, she related her previous obstetrical history and its attendant difficulties to the Respondent. In addition to her historical problems, Mrs. Cardullo had also gained 80 pounds during her third pregnancy. When Mrs. Cardullo began her prenatal care, she was living in Hollywood, Florida, with her husband. During her pregnancy, the couple moved to Wauchula, Florida. Since Mrs. Cardullo did not believe that Wauchula had appropriate hospital facilities, she commuted to Fort Lauderdale from Wauchula during the last three months of her pregnancy. The Respondent, however, was unaware that Mrs. Cardullo had moved from Hollywood. On May 28, 1982, Mrs. Cardullo, while home in Wauchula, began passing membranes and started to go into labor. She informed her husband that she was in labor, and called the Respondent. After driving from Wauchula, the couple met the Respondent at Memorial where the patient was examined. The examination revealed that Mrs. Cardullo was not dilating and the Respondent told her to begin walking. She walked around the hospital until later that afternoon, when tests were performed by the Respondent to ensure that the baby was okay. The Respondent put the patient in the labor room and began Pitocin to augment her labor. A nurse in the labor room told Mrs. Cardullo that other patients needed the room more than she did and contacted another physician who ordered the Pitocin to be turned off and the patient sent home. Mrs. Cardullo and her husband returned to Wauchula while she was still in labor. Approximately three hours after arriving home, Mrs. Cardullo began passing "... a lot of stuff." (Tr. at 900.) Mr. Cardullo called the Respondent, informed her of his wife's condition, and stated that they were coming back to the hospital. The couple arrived at Memorial on May 30, 1982, and Mrs. Cardullo was readmitted. Although Mrs. Cardullo's labor had continued throughout this period, her cervix had not dilated. The Respondent discussed a cesarean with the patient, who had requested the procedure be done based on her vaginal experiences in two prior pregnancies, and decided to attempt to dilate the cervix before performing surgery. Approximately ten hours after Mrs. Cardullo's readmission and five hours after her water had broken, the Respondent came to the conclusion that the Pitocin was not working since the patient's cervix still had not dilated properly and that a cesarean would be necessary. Mrs. Cardullo had no problems with the cesarean delivery and was pleased with the quality of care she received from the Respondent. Mrs. Cardullo stated that the Respondent was different from other doctors she had encountered in that she believed the Respondent cared about her and her problems. The Respondent's care and treatment of Mrs. Cardullo was appropriate considering the patient's prior medical history. The only criticism that could be directed toward the Respondent in her handling of the Cardullo case is that she waited too long to perform the cesarean by not giving sufficient consideration to the input from her patient. Count Five Elina Carrasco On December 17, 1982, the Respondent performed an abdominal hysterectomy on Elina Carrasco at International Hospital in Miami, Florida. During the procedure the Respondent was assisted by Dr. Francisco Sarmiento. The patient had a large amount of fibrous tissue and adhesions from prior abdominal surgery which made it difficult for the Respondent to visualize the operative site. The adhesions which surrounded the uterus, bladder, omentum, intestines, the right ovary, a segment of the left fallopian tube, and the abdominal wall, had formed a mass which required dissection to reach the pelvic cavity. While dissecting the mass of adhesions, the Respondent cut the patient's illiac vein which was located underneath the adhesions, thus causing the operative field to fill with blood. While Dr. Sarmiento placed his finger on the vein to stop the bleed, Respondent requested and placed a hemostatic clamp on the vein and requested a cardiovascular team to assist. At the time of the surgery, the practice at International was to place regular surgical clamps on a surgical tray rather than non-crushing clamps, when a standard gynecological procedure was performed. Accordingly, the sterile surgical tray which was prepared for this patient did not contain non-crushing clamps, although such clamps were available at the hospital. The surgical clamp was left on the patient only until the cardiovascular team arrived. Because a crushing clamp had been used, Dr. Junco, the surgeon who repaired the severed vessel, felt that a crush type injury to the underlying artery which was immediately adjacent to the severed vein, had occurred. The pathology report does not indicate that any clots or sections of artery were removed from the patient, although the operative records indicated two small clots were removed from the artery. The crush injury was not severe in that after the insertion of a fogarty catheter, proximal and distal blood flow was restored without requiring the removal of the crushed portion of the artery. Dr. Junco closed the vein and repaired the artery. After surgery, the patient improved and was discharged from the hospital on December 30, 1982, in stable condition. The basis of the charge against the Respondent in her care and treatment of Ms. Carrasco involves essentially one issue; whether it was below the standard of care for the Respondent to clamp the patient's vein with a device which could and did cause a crush injury to an underlying artery, 4/ in order to control bleeding from the illiac vein. In retrospect, the wiser course in this case would have been to take the time to obtain a non-crushing clamp from the rotating nurse while Dr. Sarmiento controlled the bleed through use of finger pressure. The unfortunate event which occurred in this case did not result from any lack of surgical or other skills by the Respondent. The Petitioner has characterized the Respondent's reaction to the transected artery and use of a hemostatic clamp as panic, while the Respondent has characterized it as a desire to use the first clamp available to control the bleeding as quickly as possible. Additionally, the Respondent needed Dr. Sarmiento to assist and while he was holding the artery, he was obviously unable to offer any other form of help. Under these circumstances, the Respondent's use of a hemostatic clamp does not demonstrate that she "panicked" in the operating room or that her decision to use the clamp fell below an acceptable standard of care. Count Seven Deborah J. Cox On June 6, 1982, the Respondent examined Deborah J. Cox and was present with her in the labor room throughout the patient's labor. The fetus was first on an external and then an internal monitor throughout labor. The Respondent requested that Dr. Antonio Mata, a neonatologist, be present for the delivery. When Dr. Mata came into the labor room, he checked the fetal monitor and noticed signs of moderate fetal distress. The combination of Pitocin, which was administered to the patient, and distressive labor, placed stress on the fetus as indicated by the fetal monitoring strips. The patient was transferred from the labor room to the delivery suite. In an effort to deliver the baby which was exceptionally large, it was necessary for the Respondent to use forceps because the baby's head was high and the mother's uterine surface remained thick even though she was well dilated. When the forceps were applied, the baby went into severe distress. The Respondent called for an emergency cesarean section, but the operating assistant was not available. Since it was necessary to deliver the baby as quickly as possible to avoid a stillbirth or permanent damage, the Respondent reapplied the forceps and attempted delivery. The baby was a very difficult delivery due to its size. It became stuck in the birth canal which required that the Respondent rotate its shoulders to effectuate delivery. While manipulating the baby, shoulder dystocia occurred. The Respondent elected not to perform the cesarean when it was first indicated, because of a hospital rule which prohibited the performance of a cesarean section without the presence of a surgical assistant. Due to the continuing difficulties she had encountered at Memorial, she was understandably reluctant to violate a hospital rule which would have subjected her to additional problems at Memorial. However, notwithstanding the legitimacy of the Respondent's personal concerns, the best interests of this patient required that a cesarean section be performed as soon as it became evident that the baby was not tolerating labor and that a vaginal delivery would place added and unnecessary stress on both the mother and child. The decision not to perform a cesarean, and instead deliver the baby vaginally through the use of forceps, created a situation which resulted in the fetus being born with an Apgar rating of 0 and possible permanent injury. By failing to perform a cesarean section when it was medically indicated, the Respondent's care and treatment of Deborah J. Cox fell below acceptable standards of obstetrical practice.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent (1) guilty of violating Count Seven of the Amended Administrative Complaint; (2) dismissing Counts One, Two, Three, Four and Five of the Amended Administrative Complaint; and (3) placing her on probation for six months subject to the condition that during this period she be required to practice obstetrics and/or gynecology under the general supervision of a board certified physician. DONE and ENTERED this 18th day of November, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Department of Administration Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 1983.
The Issue The issue presented for decision in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on July 28, 1998.
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: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license no. ME 0031639 on October 26, 1977. Respondent is board certified in general surgery and has worked and trained as a general and vascular surgeon. Respondent has practiced medicine in Tampa since 1988. Respondent offered testimony establishing that his peers respect his ability as a surgeon. Until 1996, Respondent had not been the subject of disciplinary action by the Board of Medicine or by any other licensing entity. On January 26, 1996, the Board of Medicine issued a final order in Division of Administrative Hearings Case No. 95-3925, imposing discipline on Respondent’s license to practice medicine. Case No. 95-3925 involved two separate incidents in which Respondent performed surgical procedures that had not been specifically consented to by the patients. In the first incident, Respondent removed the severely diseased left leg of the patient when the signed consent to surgery was for removal of the right leg. The patient was well known to Respondent, and it was understood between Respondent and the patient that both legs would eventually require amputation. In the second incident, Respondent removed a toe that had become dislocated during a debridement of the patient’s foot. The toe was connected only by ligament and necrotic tissue, and Respondent removed it during the debridement procedure rather than waiting to obtain specific consent for its removal. In the final order, the Board of Medicine concluded that Respondent had violated Sections 458.331(1)(p) and (t), Florida Statutes, by failing to obtain proper consent from a patient and by practicing medicine below the standard of care. Based on these conclusions, the Board of Medicine imposed the following relevant disciplinary measures: Respondent’s license to practice medicine is REPRIMANDED. Respondent shall pay an administrative fine in the amount of $10,000 to the Board of Medicine, within one year of the date this Final Order is filed. Respondent’s license to practice medicine in the State of Florida is SUSPENDED for a period of 6 months including the time served under the emergency suspension. Respondent shall submit a practice plan prior to reinstatement to be approved by the Board’s probation committee. Within 6 months of the effective date of this Final Order, Respondent shall have an independent, certified risk manager review Respondent’s practice. Specifically, this independent consultant shall review the Respondent’s practice concerning preoperative procedures including patient consent. This consultant will prepare a written report addressing Respondent’s practice. Such report, if necessary, will include suggested improvements of the quality assurance of Respondent’s practice. Respondent will submit this report to the Board’s Probation Committee with documentation that demonstrates compliance with the suggestions enumerated in the consultant’s report. Upon reinstatement, Respondent’s license to practice medicine in the State of Florida shall be placed on PROBATION for a period of two years, subject to the following terms and conditions: Respondent shall comply with all state and federal statutes, rules and regulations pertaining to the practice of medicine, including Chapters 455, 458, 893, Florida Statutes, and Rules 59R, Florida Administrative Code. Respondent shall appear before the Probation Committee at the first meeting after said probation commences, at the last meeting of the Probation Committee preceding termination of probation, quarterly, and at such other times requested by the committee. Respondent shall be noticed by the Board staff of the date, time and place of the Board’s Probation Committee whereat Respondent’s appearance is required. Failure of the Respondent to appear as requested or directed shall be considered a violation of the terms of this Probation, and shall subject the Respondent to disciplinary action. * * * 6. Respondent shall not practice except under the indirect supervision of a physician fully licensed under Chapter 458 to be approved by the Board’s Probation Committee.... The responsibilities of a monitoring physician shall include: Submit quarterly reports, in affidavit form, which shall include: Brief statement of why physician is on probation. Description of probationer’s practice. Brief statement of probationer’s compliance with terms of probation. Brief description of probationer’s relationship with monitoring physician. Detail any problems which may have arisen with probationer. * * * Respondent shall submit quarterly reports in affidavit form, the contents of which shall be specified by the Board. The reports shall include: Brief statement of why physician is on probation. Practice location. Describe current practice (type and composition). Brief statement of compliance with probationary terms. Describe relationship with monitoring/supervising physician. Advise Board of any problems. * * * 11. Respondent understands that during this period of probation, semi-annual investigative reports will be compiled by the Agency for Health Care Administration concerning his compliance with the terms and conditions of probation and the rules and statutes regulating the practice of medicine. On January 31, 1996, Respondent submitted to the Board of Medicine the practice plan required by the final order. The practice plan named Joseph Diaco, M.D., as Respondent’s monitoring physician, and stated that Dr. Diaco would review twenty percent of Respondent’s patient charts. The practice plan stated that Respondent would comply specifically with all the terms and conditions of the final order, and with the recommendations of the certified risk manager. The practice plan further stated: ... Dr. Sanchez will have specific discussions with his surgical patients prior to any anesthesia being administered, wherein he will discuss the intended surgical procedure again, and will have the intended surgical site marked with indelible ink. The record does not document that the Board of Medicine’s Probation Committee formally approved Respondent’s practice plan, or addressed the terms of the practice plan in any way. Such approval is presumed from the fact that Respondent appeared before the Probation Committee on several occasions subsequent to filing the practice plan, and the record does not indicate that the Probation Committee registered any objection or suggested any modifications to the practice plan. Respondent made the required appearances before the Probation Committee. Respondent and Dr. Diaco submitted the required quarterly reports to the Board of Medicine, and Dr. Diaco fulfilled the monitoring requirements of the practice plan. Periodically during the probation period, Mr. Richard Hess, an investigator with the Agency for Health Care Administration, would contact Respondent and Dr. Diaco to inquire as to Respondent’s practice and compliance with the terms of probation. Mr. Hess would inquire regarding such matters as the submission of quarterly reports, the payment of the administrative fine, and the current locations at which Respondent was practicing. Mr. Hess would submit his reports to the Agency for Health Care Administration and to the Board of Medicine, and these reports were used to supplement the information submitted directly by Respondent and Dr. Diaco. Based upon the information he was provided by Respondent and Dr. Diaco, Mr. Hess never found Respondent out of compliance with the terms of his probation. On the morning of November 2, 1997, an order was entered at Vencor Hospital by the primary treating physician for placement of a central venous line for patient D.M., an 80 year- old female patient. A central venous line is most often placed for access to the circulatory system for the provision of medications and/or fluids when the peripheral venous system is not available for such use. A central venous line may be ordered if the patient has no veins remaining for the insertion of a peripheral catheter, or for extended access, such as when a patient requires a long-term cycle of antibiotics for a bone infection. Patient D.M. required the central line for antibiotics to treat infected ulcerations on her lower extremities. The placement of a central line may be performed by any licensed physician, though surgeons are often called in to perform the procedure for primary physicians. Two physicians who teach at the University of Miami testified that third-year residents are allowed to perform the procedure with only indirect supervision. Dr. Diaco testified that nurse practitioners may perform the procedure under the supervision of a physician. The procedure is performed at the patient’s bedside, not in an operating room. No general anesthesia is required. A local anesthetic is administered at the point of insertion. The entire procedure takes two to three minutes to perform. The central line may be placed in at least three locations in the body: the leg, the neck, or the collarbone. In the case of D.M., Respondent placed the line by way of the collarbone. A needle is inserted under the clavicle and into the vein that unites with the jugular vein to form the second largest vein in the human body, the superior vena cava. Using a guide wire, a catheter is threaded through the subclavian vein and placed inside the superior vena cava. Prior to performance of the procedure, the patient’s head is typically placed lower than her feet in what is called the Trendelenburg position. If the patient has a feeding tube, it is typically turned off prior to the procedure to prevent aspiration of tube material. Proper placement of the central line is confirmed by X- ray taken immediately after the procedure. Such confirmation of placement is necessary due to the risks associated with incorrect placement. The most immediate risk is pneumothorax, the puncturing of the patient’s lung. Other less common complications are blood loss, cardiac arrest, infection, and irregular heartbeat. The consensus of the experts who testified at hearing was that the procedure poses no greater risk of complication for elderly patients such as D.M., but that elderly patients who do suffer complications may have a harder time recovering than would younger, more robust patients. D.M. was an 80 year-old female patient who shared Room 218 at Vencor Hospital with J.P., an 89 year-old female patient. D.M. and J.P. were of the same general age, ethnic origin, and gender. They had similar medical problems, including bilateral lower extremity decubiti and ulcerations. D.M. was able to understand conversation and could verbally communicate with staff. D.M. signed on her own behalf the consent form for the insertion of the central venous line. The signature on the consent form was obtained by and witnessed by Elizabeth Rood, a registered nurse on duty during the day of November 2, 1997. Ms. Rood testified that she believed D.M. was rational enough to sign the form on her own behalf. Vencor Hospital policy dictated that informed consent be obtained from the patient by the surgeon who was to perform the procedure. The nursing employees of Vencor Hospital and Respondent all testified that, despite the stated policy, it was common practice at the time for nurses to obtain the signatures of patients on the consent forms. The express terms of Respondent’s practice plan also required Respondent to have “specific discussions with his surgical patients prior to any anesthesia being administered. ” J.P. suffered from organic brain syndrome and was generally unable to communicate verbally. J.P. was unable to give consent for surgical procedures on her own behalf. Ms. Rood obtained D.M.’s signature on the informed consent form at about 10:00 a.m. Shortly thereafter, hospital staff contacted Respondent to inform him of the order and request that he perform the placement of the central line. Respondent replied that he was unable to perform the procedure at that time because of a more urgent consultation at St. Joseph’s Hospital, but would come to Vencor Hospital later to perform the procedure. Shortly before the start of the nursing night shift, the central line cart with supplies for the procedure was brought by the day supervisor to the second floor of Vencor Hospital and placed outside Room 218. Lisa Cotroneo was the night charge nurse. When she arrived for her shift, she received report from the day charge nurse. That report indicated that D.M. was to receive a central line placement at some time during the evening. The nursing staff at Vencor was divided into teams of two or three nurses assigned to particular rooms on the floor. Team three was responsible for Room 218. At the start of the night shift, Nurse Cotroneo informed two of the three nurse on team three, Donna Maranto and Fortune Ndukwe, that a central line was to be placed on patient D.M. that evening. Nurse Cotroneo did not inform the third nurse, Mary Shogreen, because Nurse Shogreen was a pool nurse called in to work on short notice and had not yet arrived for her shift. Nurse Shogreen was the nurse on team three who was assigned primary care duties for the patients in Room 218. Nurse Shogreen was later informed by Nurse Ndukwe that one of her patients would be receiving a central line placement that evening. Nurse Shogreen testified that she intended to check with the charge nurse to confirm the order for a central line placement, but that she never did so. At around 8:00 p.m., Respondent telephoned the nursing unit to inform the charge nurse that he was on his way to perform the placement of the central line. Nurse Cotroneo conveyed this information to Nurses Maranto and Ndukwe, and told them to be sure everything was ready for Respondent’s arrival. Respondent arrived at Vencor Hospital shortly after 8:00 p.m. and proceeded to the second floor nursing station, where he asked for and received the chart for patient D.M. He reviewed the chart, which contained the signed consent form and the order for placement of the central line. After reviewing the chart, Respondent inquired as to the location of D.M. and the nurse who would assist him in the procedure. Respondent was told that D.M.’s nurse was down the hall. Respondent walked down the hall and approached a group of three or four nurses. Respondent did not know any of them. He informed the group that he was Dr. Sanchez and was there to perform the central line placement. One of the nurses, later identified as Mary Shogreen, told him she was ready for him. She led him down the hall toward Room 218. Respondent paused at the central line cart outside Room 218 to pick up a pair of surgical gloves and the kit used for the central line placement. When Respondent entered the room, he observed Nurse Shogreen already at the bedside. The room was dark, save for a single light over the bed of the patient where Nurse Shogreen was working. Respondent saw that Nurse Shogreen was turning off the feeding tube to the patient, a common precursor to performance of a central line placement. Respondent walked to the other side of the patient’s bed and addressed the patient by the name of D.M. He told her that he was Dr. Sanchez and that her physician had asked him to insert a central venous catheter in her. Respondent looked into the patient’s eyes and realized she was not comprehending what he said. Nurse Shogreen was standing directly across the bed and could hear Respondent’s efforts to talk to the patient, including his addressing that patient as “D.M.” Respondent asked Nurse Shogreen if the patient was “always like this,” i.e., unresponsive. Nurse Shogreen answered that she had never had the patient before, but believed that was the usual condition of the patient. It would not be unusual for an elderly patient such as D.M. to be communicative and able to understand and sign a consent form at 10:00 a.m., but then be uncommunicative in the evening. The medical community informally refers to this phenomenon as "sundown syndrome." Respondent told Nurse Shogreen to assist him in placing the patient in the Trendelenburg position, and to get a rolled towel to place between the patient’s shoulder blades. While Nurse Shogreen was getting the towel, Respondent examined the patient’s neck and chest. Nurse Shogreen returned with the towel, but was unable to adjust the bed into Trendelenburg position. Respondent told her to go get another nurse who knew how to work the bed. She brought in Nurse Ndukwe, who was also unable to get the bed into the proper position. At length, they found a certified nurse assistant who was able to place the bed into position. Neither Nurse Shogreen nor Nurse Ndukwe expressed any concern to Respondent regarding the identity of the patient. Nurse Ndukwe had received an explicit report concerning the fact that patient D.M. was to receive a central line placement. Nurse Shogreen had heard Respondent address the patient as D.M. Respondent completed the procedure, which took about one minute. He proceeded to the nurse’s station and ordered the standard X-ray to confirm the proper placement of the central line, completed the consult form, and dicated both his consultation report and operative report. Nurse Shogreen remained behind in the room to clean up after the procedure. She made notations in the bedside chart of patient J.P., the mistaken recipient of the central line. Even at this point, Nurse Shogreen did not realize that the wrong patient had received the central line. The findings as to events in Room 218 on the evening of November 2, 1997, were based on the testimony of Respondent. Nurse Shogreen testified that it was Respondent who led the way into the room, Respondent who proceeded to the wrong bed, and Respondent who prevented Nurse Shogreen from going out to get the patient’s chart to confirm her mental condition after questioning by Respondent. Nurse Shogreen agreed with Respondent’s version of the problems with getting the bed into proper position, but testified that Respondent was so angry and in such a hurry that he performed the central line placement before the staff was able to place the bed in the proper position. Based on both the substance of the testimony and the demeanor of the witnesses, it is found that Respondent’s version of events is more believable, and that Respondent is a more credible witness than Nurse Shogreen. The undersigned is unable to credit testimony that a physician of Respondent’s skill and experience would plunge ahead into the room and commence a procedure on a patient he had never seen, without doing anything to ascertain her identity. The undersigned finds it more plausible that Respondent followed Nurse Shogreen’s lead, observed the visual cues she was providing, and assumed that the patient to whom Nurse Shogreen attended was in fact patient D.M. Respondent's proffer of testimony regarding inconsistencies in Nurse Mary Shogreen's testimony before the Peer Review Committee was disregarded in formulating these findings of fact. Several physicians offered expert testimony as to whether it is within the standard of practice for a surgeon to rely on his assisting nurse for patient identification. Dr. David Shatz, an associate professor of surgery at the University of Miami, testified that any surgeon must be absolutely sure he is working on the right person. He testified that once Respondent was unable to get a verbal response from the patient, he should have asked the nurse if he was speaking to patient D.M. Dr. Shatz concluded that it is a deviation from the standard of care to perform a procedure on a noncommunicative patient without checking the patient’s identification bracelet. Dr. Stephen Michel agreed that Respondent failed to meet the standard of care by placing the central line in the wrong patient. Dr. Michel’s other conclusions regarding the events in question cannot be credited because he admitted he was assuming that Dr. Sanchez was not permitted by the terms of his probation to be working in Vencor Hospital at all. This assumption was incorrect, and colored the remainder of his conclusions. Dr. Enrique Ginzburg, also an associate professor of surgery at the University of Miami, testified that a surgeon is usually unfamiliar with the patient in a central line placement, and stated that he could not remember the last time he checked an identification bracelet when the nurses were in the room with him. He agreed that it would be easy to check the armband, but that physicians simply do not check the armband if nurses are present to identify the patients. Dr. Jerry Diehr, an anesthesiologist at St. Josephs Hospital in Tampa, testified that a reasonably prudent physician would do what Respondent did. He stated that he relies on nurse identifications in similar circumstances, and that it is common practice for physicians to do so. Dr. Diehr testified that physicians rely on nurses for all manner of patient identification. He noted that care is often dictated by telephone calls. When a nurse calls him and tells him about the condition of his patient, the underlying assumption is that the nurse has correctly identified the patient and adequately reported the condition. Physicians may base their entire course of treatment on such reports from nurses, and must be able to rely on the nurses for such identification and reporting. Dr. Diaco strongly opined that physicians must be able to rely on nurses for patient identification. It is the nurse’s responsibility to identify the correct patient when the physician does not know the patient. Dr. Diaco testified that if physicians cannot rely on nurses for such basic information as the identity of their patients, they may as well live in the hospital and administer their own medications. Peter Shute, an expert in general nursing practice, opined that the three nurses on duty at Vencor Hospital on the evening of November 2, 1997, were negligent in their duty to know the patients on their assigned unit. He testified that Nurse Shogreen was particularly negligent, because she had not received full report on her patients, found out that one of her patients was to receive a central line placement that evening, but did not immediately obtain a full report and take steps to ensure that all preparations had been made. The weight of the evidence is that it was within the standard of care under the conditions and circumstances for Respondent to rely on Nurse Shogreen’s identification of the patient. This finding does not minimize the fact that Respondent bears ultimate responsibility for the performance of an invasive procedure on a patient who did not give informed consent. After Respondent dictated his notes and left the hospital, David Vallejo, the X-ray technician, came to the floor to obtain the X-ray ordered by Respondent. He discovered that the patient who received the central line was J.P., not D.M. Mr. Vallejo went to the nurse’s station and informed Nurse Cotroneo, who called the nursing supervisor to come to the room with her. Nurse Cotroneo and the supervisor confirmed that both patients in Room 218 were wearing their identification bracelets. The nursing supervisor called J.P.’s primary physician, who ordered an X-ray, which confirmed that J.P. suffered no ill effects from the placement of the central line. He also ordered removal of the central line, which was accomplished without incident. Respondent was informed of the error by telephone. He came to Vencor Hospital the next day, November 3, 1997, and documented the error in the medical records of both D.M. and J.P. On that day, a different surgeon performed the central line placement on D.M. All of the expert witnesses agreed that Respondent’s charting and recording of the incident, both before and after he learned of the error, were adequate and indicated no effort to conceal the facts of the situation. The experts also agreed that marking the intended surgical site with indelible ink serves no purpose in a central line placement. Petitioner's own expert, Dr. Shatz, stated that marking the site of a central line placement would be "silly." On November 3, 1997, Vencor Hospital suspended Respondent’s hospital staff privileges pending an investigation of the incident. Respondent immediately contacted Dr. Diaco, his indirect supervisor, as soon as he learned of the error. Respondent fully informed Dr. Diaco of the facts of the situation. Dr. Diaco told Respondent that he did nothing wrong and that “the nurse is in big trouble.” Respondent also sought the counsel of his attorney, Michael Blazicek. Mr. Blazicek conferred with Dr. Diaco, and also concluded that this was a nursing problem, not a standard of care problem for Respondent. The results of the hospital’s internal Peer Review Committee review seemed to bear out the opinions of Dr. Diaco and Mr. Blazicek. On November 26, 1997, Respondent was restored to full privileges at Vencor Hospital. Nurse Shogreen received verbal counseling and a one-day suspension for failure to render proper treatment to the correct patient. Vencor Hospital’s “Root Cause Analysis Team” found that nursing protocols should be changed to prevent a recurrence of patient misidentification. Patients would henceforth be identified by bed letter designation. Identification of the patient and consent to treatment would be verified by two people, one of whom must be a hospital employee. On November 17, 1997, the quality review manager of Vencor Hospital submitted an Adverse or Untoward Incident Report (Code 15) regarding the incident, pursuant to Sections 395.0197(6) and 641.55(6), Florida Statutes. A Code 15 Report is a report of serious adverse incidents in licensed facilities. The Code 15 Report identifies the physicians and nurses involved by their license numbers, and identifies the patient and facility. It describes the nature of the incident and all actions taken by the hospital in response to the incident. The purpose of the Code 15 Report is to notify the Agency for Health Care Administration and the Department of Health within 15 days of a serious adverse incident so the Agency may review the incident and begin an investigation. Respondent appeared before his Probation Committee on November 13, 1997. At this time, Respondent knew that the hospital would be filing a Code 15 Report, though it had not actually done so. Respondent was still on summary suspension at Vencor Hospital, pending review. Prior to his Probation Committee appearance, Respondent conferred with his attorney, Mr. Blazicek, who counseled him to answer any questions forthrightly, but not to volunteer information about the incident to the Probation Committee. This advice was based on the facts that the incident was still under investigation, that there had been no finding of wrongdoing by Respondent, and that summary suspension was a standard procedure for such incidents indicating no conclusions as to ultimate responsibility. Mr. Blazicek testified that he knew Respondent still had one more written quarterly report to file in January 1998. He reasoned that if the hospital's investigation resulted in adverse findings, Respondent could report the incident in that later filing. The Probation Committee raised no questions as to the Vencor Hospital incident, and determined that Respondent’s probation would terminate as scheduled upon payment of the administrative fine. Respondent did not volunteer information about the incident or the summary suspension. Respondent and Dr. Diaco filed their final quarterly reports in January 1998. Neither of them reported the Vencor Hospital incident. Respondent reported that he was in full compliance with all probationary terms. By the time the final quarterly reports were received, the Department of Health was aware of the Code 15 Report. Nonetheless, the Department issued an Order of Termination on February 2, 1998, finding that Respondent had satisfactorily completed the term of his probation as of January 26, 1998.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that the Department of Health, Board of Medicine enter a final order determining that Rolando R. Sanchez has violated Section 458.331(1)(p), Florida Statutes, and suspending his license for a period of nine months from the date of the Order of Emergency Suspension of License, imposing a fine of $2,500.00 and placing Respondent on probation for a period of two years from the date the suspension expires. DONE AND ENTERED this 24th day of November, 1998, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of November, 1998. COPIES FURNISHED: Albert Peacock, Esquire John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A-02 Tallahassee, Florida 32399-1703 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast Bin A-02 Tallahassee, Florida 32399-1703 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. He holds License No. ME 0019700. Respondent received his medical degree overseas and did his residence in obstetrics and gynecology at Bayfront Medical Center in St. Petersburg, Florida. He is neither board certified nor board eligible. For the past eight plus years Respondent's practice has been limited to terminating pregnancies at All Women's Health Clinic at Tampa, Florida. He has performed in excess of 15,000 abortions. One reason given by Respondent for so limiting his practice is the cost of medical malpractice insurance. Since he has no private practice, Respondent gave up admitting privileges at hospitals in the area. Without malpractice insurance, he would not be given staff privileges. On August 23, 1986, A. L., a pregnant 16 year old, entered All Women's Health Center, Tampa, to have her pregnancy terminated. A. L. had noted on her history statement that her last menstrual period started some eight weeks ago. Respondent first saw A. L. when he entered the procedures room at All Women's Health Center and commenced his examination prior to instituting abortion procedures. With respect to the examination the testimony varied widely. Diane Roberts, LPN, who was performing the duties of physician's assistant during the procedure, initially told the investigators that the examination lasted only a couple of seconds and consisted of a vaginal examination with two fingers of the right hand in the vagina while the abdomen was palpated with the left hand. At the hearing, Roberts testified that she wasn't paying much attention to the patient during the examination, didn't recall telling investigator the examination only took a couple of seconds, and recalled Respondent telling A. L. several times to relax. Respondent testified he performed a normal vaginal examination. The examination was longer than usual because A. L. wasn't relaxed and tensed her stomach muscles which made the uterus more difficult to palpate; and that following his examination he determined the gestational age of the fetus to be 12 weeks. Respondent testified he also checked the patient's heart and lungs before commencing the pelvic examination. A. L. testified that Respondent palpated her abdomen with two hands, but did not check heart and lungs or do a pelvic examination. A. L. had an earlier pregnancy terminated the previous year when the doctor did a pelvic examination with two fingers in the vagina while the abdomen was palpated with his other hand. The patient was ultimately determined to be 28 to 30 weeks pregnant. Largely because of the large error in gestational age, it is concluded that Respondent performed only a perfunctory examination on A. L. Had he conducted the proper examination, it is inconceivable that he, an experienced gynecologist, could underestimate the gestational age of the fetus by some four months. The magnitude of this error is illustrated by Respondent's testimony that a 12 week fetus is approximately 3 inches long and weighs 30 grams, while a 28 week fetus is approximately 14 inches long and weighs 1100 grams. Respondent started the procedure thinking he was aborting a 12 week fetus with the patient on the table and feet in the stirrups. After the instruments were inserted and the procedure started, Respondent concluded the fetus was 16 weeks, obtained a larger curette, then determined the fetus was more likely 20 weeks, again changed curette, and after removing fluid and part of an arm Respondent concluded that the gestational age of the fetus was some 28 weeks and required hospitalization to complete the procedure. Mistakes in determining gestational age can be made by a prudent physician if: (1) the patient is obese; (2) if the uterus is very soft and the extremities difficult to locate; (3) if the baby has a low fluid volume; (4) if the patient is very tense; or, (5) if the head of the fetus is felt and not the uterus. Here A. L. was more thin than obese which should have greatly facilitated palpation of the abdomen to determine the size of the uterus. Accepting the testimony that she was tense during the examination, and the earlier pregnancy would cause the uterus to be soft, no experienced gynecologist should conduct an examination of a patient such as A. L. and err on the magnitude here involved. Further, if the examination was difficult, the procedure should not have commenced until Respondent was reasonably positive of the gestational age of the fetus. One indication Respondent received that the fetus was older than 12 weeks was the quantity of fluid drawn. Further, no experienced gynecologist should mistake the head of the fetus as the extremity of the uterus on a patient such as A. L. Once Respondent determined the fetus was more than 16 weeks along, he called Dr. Barile, a gynecologist with admitting privileges at Humana Women's Hospital, Tampa, to request he remain available in case Respondent needed to send A. L. to a hospital. When Respondent determined the gestational age of the fetus' was more than 26 weeks, he again called Barile who suggested it would be better to refer the patient to an obstetrician. Respondent then telephoned his backup obstetrician and found she was on vacation, and a doctor with whom Respondent was not acquainted was taking her calls. Since A. L. was stable and in no apparent distress, Respondent called Dr. Klein, a pediatrician with admitting privileges at Bayfront Memorial Hospital in St. Petersburg. Dr. Klein agreed to take care of the patient by having his associate, who had the duty that day, meet the patient at Bayfront. A. L. had been brought to the clinic by her brother, and Respondent concluded A. L. could be safely transported to Bayfront by automobile and suggested her brother drive her. The brother demurred on the ground that his car overheated and might not make the 40-odd mile trip to Bayfront safely, but another brother had a more reliable car. The other brother was called and agreed to take his sister to Bayfront and stated that he would be at the clinic in about 10 minutes. Approximately 1 hour and 15 minutes later this brother arrived, and A. L. was started to the brother's car. At this time she appeared unsteady, and Respondent concluded she should go to Bayfront by ambulance. When a Hillsborough ambulance service was called, they told Respondent of the policy whereby they could not transport a patient out of Hillsborough County and that he should contact a Pinellas County ambulance service to perform the desired transportation. Respondent then called a Pinellas County ambulance service who arrived about an hour later to take A. L. to Bayfront where she was met by Dr. Yeshnick, the associate of Dr. Klein, who admitted the patient. Between the time Respondent determined the abortion could not be performed at the clinic until A. L.'s arrival at Bayfront Hospital, some 6 hours had elapsed. Of the approximately 15,000 abortions that Respondent has performed, less than 5 became emergencies that required removal from the clinic to a hospital. Respondent's backup procedures for emergencies were adequate. On August 23, 1986, A. L. was in the third trimester of her pregnancy, and the abortion was not necessary to save the life or preserve the health of A. L.
The Issue At issue in this proceeding is whether Respondent, Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care (“Bread & Roses”), provided services in excess of the scope of its license by providing abortions to five patients beyond the first trimester of pregnancy, as alleged in the Administrative Complaint.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following Findings of Fact are made: AHCA is the state agency responsible for the licensing of abortion clinics and the enforcement of the statutes and rules governing their operations in Florida, pursuant to chapter 390 and chapter 408, part II, Florida Statutes. Bread & Roses is a women’s health care clinic licensed to provide first-trimester abortions pursuant to chapter 390, Florida Statutes, and Florida Administrative Code Chapter 59A-9. Kimberly Smoak is AHCA’s field office supervisor. She is based in Tallahassee and supervises the operations of AHCA’s field offices throughout the state. Kriste Mennella is an AHCA field office manager based in Alachua, who reports directly to Ms. Smoak. On or about August 5, 2015, Ms. Smoak directed Ms. Mennella’s office to conduct an unannounced “monitoring” survey of Bread & Roses and to send Ms. Smoak her survey report before the end of the day. Ms. Mennella personally conducted the survey. Ms. Mennella arrived at Bread & Roses at 12:45 p.m. on August 5, 2015, to conduct the survey. She requested and reviewed utilization reports and medical records for 16 patients for whom Bread & Roses had provided abortion services within the previous year. Section 390.0112(1) provides the following reporting requirement: The director of any medical facility in which any pregnancy is terminated shall submit a monthly report to the agency which contains the number of procedures performed, the reason for same, the period of gestation at the time such procedures were performed, and the number of infants born alive during or immediately after an attempted abortion. The agency shall be responsible for keeping such reports in a central place from which statistical data and analysis can be made. (Emphasis added). Chapter 390 does not define the terms “gestation” or “pregnancy.” Section 390.011(11) defines “third trimester” to mean “the weeks of pregnancy after the 24th week of pregnancy.” From this definition, it is possible to infer that the first trimester includes the first 12 weeks of pregnancy and that the second trimester includes the second 12 weeks of pregnancy. Consistent with this inferred definition, rule 59A- 9.019(14) provides as follows: (14) “Trimester” means a 12-week period of pregnancy. First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period). Second Trimester. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation. Third Trimester. That portion of pregnancy beginning with the 25th week of gestation. (Emphasis added). Ms. Mennella found the following in the clinic’s utilization reports for five of the 16 patients in the survey sample: Patient #5: no last normal menstrual period (“LNMP”) recorded; ultrasound reflected 13 weeks of pregnancy. Patient #7: no LNMP recorded; ultrasound reflected 13.2 weeks1/ of pregnancy. Patient #8: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. Patient #9: no LNMP recorded; ultrasound reflected 13 weeks of pregnancy. Patient #15: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. During the survey, the clinic manager for Bread & Roses, who prepares the clinic’s utilization reports, explained to Ms. Mennella that the “weeks” reflected on Bread & Roses’ utilization reports reflected the length of pregnancy as counted from the first day of the LNMP. Therefore, all five of the patients’ abortions were within the 14-week window afforded by rule 59A-9.019(14)(a). Ms. Mennella documented her conversation with the clinic manager in her formal survey notes and in her August 5, 2015, formal survey report to Ms. Smoak. At the conclusion of the survey, Ms. Mennella reported to Ms. Smoak by telephone, though Ms. Mennella testified that she could not recall the details of the discussion. At 4:50 p.m. on August 5, Ms. Mennella telephoned Kristin Davy, the owner and director of Bread & Roses. Ms. Mennella told Ms. Davy that AHCA had determined that Bread & Roses had acted in violation of its license by performing second-trimester abortions, based on the clinic’s utilization reports and the medical records reviewed by Ms. Mennella during the on-site survey. Ms. Davy replied that AHCA’s conclusion was incorrect because the weeks and days recorded on the ultrasound reports measured from the first day of the LNMP, meaning that all five of the questioned procedures had been performed within the first trimester of pregnancy. After her discussion with Ms. Davy, Ms. Mennella submitted her formal survey report to Ms. Smoak. Ms. Mennella’s survey notes and her survey report to Ms. Smoak each documented Ms. Davy’s dispute of AHCA’s conclusion and her explanation of the ultrasound reports. At 6:15 p.m. on August 5, Ms. Mennella faxed a letter to Ms. Davy with the heading, “Notice of Activity Without Proper Licensure.” The letter stated that AHCA had determined that Bread & Roses was providing services beyond the scope of its license. The letter did not attach a copy of Ms. Mennella’s survey report nor any other document reflecting the specifics of AHCA’s allegations regarding the clinic’s operation. Ms. Mennella made a follow-up visit to Bread & Roses on August 19 to determine whether there had been any more procedures performed that appeared to be beyond the scope of the clinic’s license. Based on her review of the clinic’s files, she determined that there had not. On September 1, 2015, AHCA faxed to Bread & Roses a letter signed by Ms. Mennella reporting the findings of its survey and requiring the facility to file a corrective action plan. The letter was accompanied by a statement of deficiencies recorded during Ms. Mennella’s August 5 survey. The statement of deficiencies stated that Bread & Roses had performed services beyond the scope of its license as follows: For sampled patients #5, #7, #8, #9 and #15, no date was recorded for the last normal menstrual period (LMP); however, the ultrasound reflected weeks of gestation in excess of 12 as documented in the patients’ records. Ms. Mennella’s documentation of her conversations with the office manager and Ms. Davy were excised from the version of the survey report faxed to Bread & Roses on September 1, 2015. Ms. Mennella had no explanation for this deletion, and testified that she could not recall whether she told Ms. Smoak about the explanations offered by the office manager and Ms. Davy as to the meaning of the ultrasound reports. Ms. Mennella’s letter of September 1 directed Bread & Roses to submit a written corrective action plan to AHCA by the close of business on September 4, 2015. The letter stated that the corrective action plan must do the following, at a minimum: * Demonstrate procedures are in place to ensure that first trimester abortions are not performed: In excess of 14 weeks (up to but not including the 105th day) from the last normal menstrual period (LNMP), and in excess of the 12th week (up to but not including the 91st day) of gestation; or When LNMP is not determined or not documented, abortions are not performed beyond the 12th week (up to but not including the 91st day) of gestation. * Educate staff to ensure that when reporting pursuant to rule 59A-9.034, F.A.C., on the online reporting system, that the field titled “WEEKS OF GESTATION” is correctly completed using “weeks of gestation” as that phrase is used in rule 59A-9.019, F.A.C., and not erroneously using the last normal menstrual period. On September 3, 2015, one day prior to expiration of the deadline for submission of Bread & Roses’ corrective action plan, AHCA filed the Administrative Complaint that initiated this proceeding. The Administrative Complaint seeks to impose an administrative fine of $2,500 on Bread & Roses, or $500 for each instance in which AHCA alleges that the clinic performed an abortion during the second trimester, beyond the scope of its license. Bread & Roses submitted a responsive letter to AHCA shortly after 1:00 p.m. on September 4, 2015. The letter, written and signed by Ms. Davy, stated as follows, in relevant part: This letter responds to your letter dated September 1, 2015, which requested a summary of a corrective action plan demonstrating two things: First, that procedures are in place to ensure that first trimester abortions are not performed in excess of 14 weeks from the last normal menstrual period (LNMP), and Second, that staff are educated to report “WEEKS OF GESTATION”--in the monthly online ITOP reports, filed pursuant to rule 59A- 9.034, F.A.C.--“using ‘weeks of gestation’ as that phrase is used in rule 59A-9.019, F.A.C.,” and not using LNMP. As to the first requirement, Bread & Roses has always provided abortion care only through and including 13.6 weeks LNMP, or 13 completed weeks and 6 days as measured from LNMP. Our staff records the date that the woman remembers for her LNMP if and only if she remembers such a date (and if she had such a date: some women do not menstruate, such as when using certain contraceptives). If the woman did not have or does not remember the date of her LNMP, we do not include such a date in her record. Regardless of whether she remembers such a date, we do not determine the length of her pregnancy based on that memory. Rather, in accordance with the standard of care, we determine the length of her pregnancy based on ultrasound examinations. Please be aware that--again, as is absolutely standard practice throughout Florida and the U.S.--our ultrasound machine provides a length of pregnancy as measured from LNMP. In other words, based on the measurements of the embryo or fetus, the ultrasound machine produces an estimated length of pregnancy as measured from LNMP. Our corrective plan of action is to ensure that henceforth, in all medical records, all staff include “LMP” [sic] after each indication of length of pregnancy, including when staff record the results of an ultrasound examination. As to the second requirement, for clarity, here is the relevant regulation: “First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period).” 59A-9.019(14)(a), F.A.C. Based on your letter dated September 1, 2015, all staff will now report “WEEKS OF GESTATION” in the monthly online [Induced Termination of Pregnancy or “ITOP”] reports using “weeks of gestation” as measured not from LNMP, but from two weeks after LNMP. In other words, we will henceforth report an abortion at 13.1 weeks LNMP as an abortion at 11.1 weeks in the online field for “WEEKS OF GESTATION.” The ITOP form referenced in the letter is a monthly summary report filed by the clinic with AHCA regarding the timing of the abortion procedures performed at the clinic. Printed examples of the forms were submitted into evidence by AHCA. The form sets forth three reporting categories: “up to 12 weeks,” “13 to 24 weeks,” and “25 and over weeks.” The form, at least in the printed version submitted by AHCA, uses neither the term “pregnancy” nor “gestation.” At the hearing, Ms. Davy testified that she wrote the corrective action plan to ensure there would be no more misunderstanding about what Bread & Roses was doing. She was adamant that Bread & Roses was not performing second-trimester abortions. She stated that the clinic was not changing its medical standards, but was clarifying its reports to AHCA. From that point forward, Bread & Roses would include “LNMP” after every notation of length of pregnancy in its medical records, and its ITOP reports to AHCA would subtract the two-week LNMP interval. Ms. Davy testified that the corrective action plan was implemented on the day it was submitted to AHCA. Ms. Davy further testified that Bread & Roses had been submitting its reports to AHCA in the same manner for the ten years in which it has restricted its license to first- trimester abortions. She had always understood that “weeks of gestation” on the ITOP form was meant to be dated from the first day of the last normal menstrual period, which is standard industry practice. No other surveyor ever told her that she was filling the forms out incorrectly or had attempted to infer that the clinic was operating beyond the scope of its license. AHCA’s most recent routine survey of Bread & Roses, prior to the August 5 survey, had been performed on February 14, 2015. No deficiencies had been found. AHCA presented no evidence to counter Ms. Davy’s credible testimony that Bread & Roses had been submitting its ITOP reports in the same manner for the previous ten years without incident. AHCA presented no evidence to explain why it suddenly believed that Bread & Roses’ ITOP reports showed that the clinic was performing second-trimester abortions. Ms. Davy testified that Bread & Roses does not rely on a patient’s reported LNMP to measure length of pregnancy because such reports are inherently unreliable. Thus, whether or not a patient’s medical record includes a patient-reported LNMP is of no importance to the length of pregnancy reported on the ITOP. In all cases, Bread & Roses reports length of pregnancy as measured by the ultrasound machine. Bread & Roses owns the ultrasound machine used in its clinic. Ms. Davy testified that she had the machine calibrated at the time of purchase, about a year and a half ago. The machine is checked annually by North Florida Biomedical Services. Bread & Roses’ written policies and procedures include the following, under the heading “Sonography”: A sonogram will be performed on all patients. Bread and Roses performs abortion procedures in the first trimester, up to 13 weeks 6 days from the last menstrual period. A sonogram will determine how many weeks the patient is from the last menstrual period. If a patient is 14 weeks or over she will be referred to an alternate clinic. Mary E. Raum, M.D., is a gynecologist and has been the medical director at Bread & Roses for 15 years. She has practiced gynecology since 1983. Dr. Raum performs all of the ultrasound and abortion procedures done at Bread & Roses. She performed the ultrasound procedures on each of the five patients at issue in this case. Dr. Raum testified that the “ultimate determinant” as to whether a patient is in the first or second trimester is the ultrasound. She stated that the ultrasound is “definitive” and has become the standard of care for assessing the length of pregnancy. Dr. Raum testified that the ultrasound equipment she was using met standards for such equipment. She had no doubt that the equipment was functioning properly. AHCA offered no evidence to dispute Dr. Raum’s assessment of the ultrasound equipment. Dr. Raum described her manner of performing the ultrasound procedure as follows: The patient is laying [sic] flat. I always hope that I can get an adequate image abdominally so the patient doesn’t have to have a vaginal probe. But there are times when that is necessary. The abdomen is spread with the ultrasonic gel, and then the probe, which is called a transducer--that is what actually emits the sound waves which are higher than the human ear can hear . . . . [A]s soon as I see what I feel to be a good representative picture where I can measure the pertinent structures, it’s frozen, and then I select, on the possible measurements, the appropriate one. Early on, the most appropriate ones are either the gestational sac or the crown-rump length, which is measured from the top of the head to the end of the tailbone, if you will. There is an algorithm that is programmed into the ultrasound machines which then translates those two measurements into the date of the pregnancy from the first day of the last menstrual period. Dr. Raum testified as to the care she takes in performing the ultrasound measurement. If she is uncertain, she will take several measurements until she has the most accurate possible measurement. Dr. Raum frankly tells her patients that if the measurement is even one day beyond the 14-week limit, she will not perform the abortion. AHCA did not call any witness to explain the basis for the Administrative Complaint. The facts alleged are that the medical records for the five patients at issue do not contain an LNMP date, and that the sonogram in the medical record of each of the five patients reflects “weeks of gestation in excess of 12.” AHCA presented no evidence in support of its allegation concerning the length of gestation. It might have been reasonable at the time of Ms. Mennella’s survey for the agency to read the ITOP reports and the patient records and suspect a problem. However, it was not reasonable for the agency to disregard the reasonable explanations provided by the Bread & Roses office manager and by Ms. Davy. Ms. Mennella herself could not say why AHCA decided to file an administrative complaint alleging that Bread & Roses performed five second-trimester abortions, or why her documentation of her conversations with the office manager and Ms. Davy were excised from the final version of her survey report. AHCA’s theory of the case appears to be that the lack of a handwritten notation of “LNMP” in the five medical records at issue requires a conclusion that the days and weeks shown on the face of the sonogram reflect a length of pregnancy as measured from the date of “conception” or “gestation,” rather than the LNMP. This premise is unfounded, and the failure of the premise destroys the logic of AHCA’s theory. The ultrasound measures the same thing, whether or not the medical record contains a patient-reported LNMP date. The evidence presented at the hearing showed that the ultrasound dates the pregnancy from the LNMP, and that Bread & Roses’ ITOP reports were based on the ultrasound results. The missing LNMP notes are a red herring. AHCA’s case consisted largely of an argument premised on applying the dictionary definition of the term “gestation” to the medical records of Bread & Roses, which do contain a “Patient Procedure Record” that makes reference to “gestation” in the section regarding the physician’s examination of the evacuated tissue post-abortion. Indeed, if these abortions had been performed after 13 weeks of “gestation,” as that term is defined in some medical dictionaries,2/ then they would have been beyond the first trimester. However, Ms. Davy testified that, consistent with standard medical practice, the term “gestation” on the Patient Procedure Record means, and has always meant, length of pregnancy as measured from the first day of the LNMP. Ms. Davy stated that she has amended the Patient Procedure Record to add “LNMP” after every indication of length of pregnancy, in order to prevent any future misunderstandings. Dr. Raum testified that medical practitioners generally do not attempt to measure the length of pregnancy from the date of conception because that date is difficult, if not impossible, to determine in an accurate and reliable fashion, except perhaps in cases of in vitro fertilization. AHCA’s own rule appears to recognize this difficulty by defining the “first 12 weeks of pregnancy” as equivalent to the “first 14 completed weeks from the last normal menstrual period.” In light of the overwhelming factual evidence that Bread & Roses did not in fact perform second trimester abortions, the dictionary definition of “gestation” was an insufficient basis for finding a violation. AHCA made no attempt at a factual, as opposed to a logical, demonstration that these were second-trimester abortions. AHCA presented no testimony or documentary evidence refuting the credible evidence presented by Bread & Roses that the sonograms show on their face that the pregnancies for each of the five procedures at issue were first trimester pregnancies and within the scope of Bread & Roses’ license. AHCA has argued that it should be allowed to show, in the alternative, that Bread & Roses’ clinical records were not accurately documented because they showed more than 12 weeks of “gestation” for each of the five sampled patients, in both the sonograms and the Patient Procedure Record, in violation of rule 59A-9.031, which requires that clinical records must be “complete” and “accurately documented.” It is noted that, prior to the hearing, AHCA made a motion to file an Amended Administrative Complaint that would have included a second count alleging a recordkeeping violation. This motion was denied by Order dated February 26, 2016. At the start of the final hearing, AHCA renewed its motion while also arguing that it was not necessary to amend the Administrative Complaint in order to raise the recordkeeping issue. The motion was again denied, but AHCA was given some leeway to pursue its theory that the original Administrative Complaint embraced a recordkeeping allegation. Even if the Administrative Complaint could be said to include an allegation regarding inaccurate recordkeeping,3/ AHCA did not prove anything more than that it misread the clinical records and ITOP reports of Bread & Roses and then refused to listen to Bread & Roses’ explanation. The evidence established that Bread & Roses had submitted the ITOP forms to AHCA every month for ten years in substantially the same form with no indication from AHCA that there was a problem. The evidence also established that the term “gestation” in the Patient Procedure Records was used in its usual medical sense, i.e., the length of pregnancy as measured from the first day of the LNMP. Bread & Roses amended its Patient Procedure Record form and changed its method of reporting the ITOP not because of any recordkeeping failure on its part, but in an effort to appease AHCA and forestall any further misunderstanding.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint against Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care. DONE AND ENTERED this 28th day of April, 2016, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 2016.
The Issue The issue in this case is whether Petitioner’s claim for medical treatment by Dr. Gutovitz should be paid under the terms of her state health insurance plan.
Findings Of Fact Petitioner was, at all times relevant hereto, an employee of the State of Florida, receiving medical benefits under the State Employees’ HMO Plan (the “Health Plan”). In January 2015, Petitioner contacted North Florida OBGYN Associates, P.A. (the “Doctor’s Office”), to schedule a doctor’s appointment. A computer screenshot provided by the Department indicates that the purpose of the appointment was to “discuss infertility/endometriosis.” An appointment was scheduled for March 22, 2015. Upon arrival at the Doctor’s Office, Petitioner filled out an intake sheet. She stated the purpose of her visit was for the problems of “endo & checkup.” She indicated that she was not currently using birth control. As part of her medical history, she indicated: migraine headaches, reflux/IBS/ulcer, endometriosis, and infertility. Upon completion of his examination and treatment of Petitioner, Dr. Gutovitz dictated his “History & Physical Report” notes on the visit. He stated as follows: The patient is a 29 year old female who presents for a preconceptual consultation. LMP date: (2/25/2015) The frequency of cycles is monthly. The duration of menses is less than 3 days. The menstrual flow is moderate. The patient has never been able to conceive. The patient has been unable to conceive after 2 years of unprotected intercourse. Intercourse has been occurring twice per week. There has been associated abdominal pain, pain on intercourse, breast tenderness (only when she is on her period) and cramping (only in the morning and then will go away). Vitamin and mineral intake: currently on prenatal vitamins (taking Women’s one a day, vitamin b-12, vitamin d, calcium). Nutrition: normal /adequate. Unknown. There is a medical history of endometriosis dx at the 20 by Dr. Samuel Christian). Pt. presents to discuss conception. She and her partner have been trying to [get] pregnant for 2 years. She reports at age 21 she had a laparascopy for pain and was diagnosed with severe endometriosis and advised to have a hysterectomy. She had no follow up treatment, was not put on OCP. She continue to pain with menses, with intercourse and sometimes throughout the cycle. She does have regular cycles about 28 days apart. The partner has never had any children. He did have an injury to his scrotum about 7 years ago (fell off a truck onto some sharp object that “ripped open my scrotum in an L shape”), had stitches, significant swelling. Discussed components of conception –- ovulation, pathway and semen. Referral to the FIRM [Florida Institute of Reproductive Management] for SA [sperm analysis], and recommended consultation with Dr. Freeman. Suggest laparascopy. CPT for the pelvic pain. If covered by insurance, encouraged patient to have surgery done with Dr. Freeman. However, if not covered (if considered fertility intervention), would be happy to perform this surgery. Discussed fertile time in cycle, timing and frequency of intercourse. Brief review of fertility interventions. Pt happy with this information, will proceed to AS and schedule consultation with Dr. Freeman. Also discussed patient’s weight. Discussed healthy diet and exercise. Pt considering gastric sleeve procedure. Discussed some of the pros and cons of this being performed before or after fertility intervention. Pt likely to postpone surgery at this point. Dr. Gutovitz listed “Infertility, Female” as the diagnosis. The plan of treatment called for the patient to “Follow up with reproductive endocrinologist.” There is no mention of treatment for endometriosis. It is clear from Dr. Gutovitz’s notes that the purpose of the visit was to discuss infertility. Although endometriosis was mentioned, it was merely in a medical historical context. Following her visit to the Doctor’s Office, Petitioner made an appointment with Dr. Freeman (as advised by Dr. Gutovitz during the March 22 visit). She visited Dr. Freeman’s office on April 15, 2015. Dr. Freeman’s intake sheet on the patient indicates the chief complaint as “Primary infertility, endometriosis/pelvic pain.” Dr. Freeman discussed the infertility issue, but noted “[Petitioner] is interested in further evaluation and treatment but most interested in control of her pelvic pain.” Nonetheless, he noted that Petitioner’s husband would undergo a semen analysis to determine his fertility potential. About a week later, Petitioner presented again to Dr. Freeman for a follow-up visit. The doctor again addressed and discussed her pelvic pain and how it might be treated. He noted, “[Patient] is completely self-pay for fertility treatment and wishes to defer on HSG currently to see if tubal patency exists.” He concludes his notes on that visit with: At this point in time, [Petitioner] will forward results of her primary care physician’s lab work over to our office. Once this occurs, we will meet for reconsultation and likely undergo several cycles of empiric ovulation induction as a first step. If she does not become pregnant with that, then we will likely perform HSG to evaluate for tubal patency and consider the possibility of surgery. At the conclusion of the visit, they were understanding of the above, in agreement with the plan and rationale and had no additional questions or concerns. Empiric ovulation induction is a fertility treatment that induces ovulation. An HSG procedure uses dye to assess whether the fallopian tubes are blocked, i.e., whether there is tubal patency. Again, the doctor’s notes and comments address Petitioner’s endometriosis and pelvic pain, but his primary focus is on the infertility issue. Petitioner contends the two physicians simply misunderstood her needs or made a mistake when coding her office visits. The preponderance of evidence does not support her contention. Petitioner’s testimony concerning her claim was not persuasive. The Health Plan under which Petitioner was insured contains an exclusion of payment for infertility treatments. Section VI, Limitations and Exclusions, of the State Employees’ HMO Plan specifically excludes payment for “infertility treatment and supplies,” including testing, diagnostic procedures, and treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Management Services denying Petitioner's claim for reimbursement of payments relating to her medical treatments by Dr. Gutovitz. DONE AND ENTERED this 7th day of March, 2016, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN 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 7th day of March, 2016. COPIES FURNISHED: Nesha Butterfield 2545 Chesterbrook Court Jacksonville, Florida 32224 Gavin D. Burgess, Esquire Department of Management Services Suite 160 4050 Esplanade Way Tallahassee, Florida 32399-0950 (eServed) J. Andrew Atkinson, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part Il, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The Election of Rights form advised of the right to an administrative hearing. 3. The parties have since entered into the attached Settlement Agreement. (Ex. 2) Based upon the foregoing, it is ORDERED: 1. The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The Respondent shall pay the Agency $5,000. If full payment has been made, the cancelled check acts as receipt of payment and no further payment is required. If full payment has not been made, payment is due within 30 days of the Final Order. Overdue amounts are subject to statutory interest and may be referred to collections. A check made payable to the “Agency for Health Care Administration” and containing the AHCA ten-digit case number should be sent to: Office of Finance and Accounting Revenue Management Unit Agency for Health Care Administration 2727 Mahan Drive, MS 14 Tallahassee, Florida 32308 3. Conditional licensure status is imposed on the Respondent beginning on February 15, 2013 and ending on March 15, 2013. 1 Filed August 27, 2013 2:59 PM Division of Administrative Hearings ORDERED at Tallahassee, Florida, on this 28-day of Arpt 2013. wie Elizabg¢th Dudek, Bery etary Agency for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and eos Final Order was served on the below-named persons by the method designated on this7S" ry of Ld / ; , 2013. ane Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 [ Jan Mills Finance & Accounting Facilities Intake Unit Revenue Management Unit (Electronic Mail) (Electronic Mail) Andrea M. Lang, Senior Attorney Margaret Chamberlain, Esq. Office of the General Counsel Attorney for Respondent Agency for Health Care Administration Kitch Drutchas Wagner Valitutti & Sherbrook (Electronic Mail) 2379 Woodlake Drive, Suite 400 Okemos, Michigan 48864 (U.S. Mail) | STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case Nos. 2013002508 SA-PG - VERO BEACH LLC d/b/a PALM GARDEN OF VERO BEACH Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against SA-PG - VERO BEACH LLC d/b/a PALM GARDEN OF VERO BEACH (hereinafter “Respondent”), pursuant to Sections 120.569 and 120.57 Florida Statutes (2012), and alleges: NATURE OF THE ACTION This is an action against a skilled nursing facility to impose an administrative fine of FIVE THOUSAND DOLLARS ($5,000.00) pursuant to Section 400.23(8)(b), Florida Statutes (2012), based upon two (2) Class II deficiencies and to assign conditional licensure status beginning on February 15, 2013, and ending on March 15, 2013, pursuant to Section 400.23(7)(b), Florida Statutes (2012). The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. The original certificate for the standard license is attached as Exhibit B and is incorporated by reference. JURISDICTION AND VENUE 1. The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2012). EXHIBIT 1 2. The Agency has jurisdiction over the Respondent pursuant to Section 20.42, Chapter 120, and Chapter 400, Part II, Florida Statutes (2012). 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 4. The Agency is the regulatory authority responsible for the licensure of skilled nursing facilities and the enforcement of all applicable federal and state statutes, regulations and rules governing skilled nursing facilities pursuant to Chapter 400, Part II, Florida Statutes (2012) and Chapter 59A-4, Florida Administrative Code. The Agency is authorized to deny, suspend, or revoke a license, and impose administrative fines pursuant to Sections 400.121 and 400.23, Florida Statutes (2012); assign a conditional license pursuant to Section 400.23(2), Florida Statutes (2012); and assess costs related to the investigation and prosecution of this case pursuant to Section 400.121, Florida Statutes (2012). 5. Respondent operates a 180-bed nursing home, located at 1755 37" Street, Vero Beach, Florida 32960, and is licensed as a skilled nursing facility, license number 1415096. Respondent was at all times material hereto, a licensed skilled nursing facility under the licensing authority of the Agency, and was required to comply with all applicable state rules, regulations and statutes. COUNTI The Respondent Failed To Ensure Physician Orders Shall Be Followed As Prescribed in Violation Of Rule 59A-4.107(5), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law, all physician orders shall be followed as prescribed, and if not followed, the reason shall be recorded on the resident’s medical record during that shift. Rule 59A- 4.107(5), Florida Administrative Code. 8. On or about February 11, 2013 through February 15, 2013, the Agency conducted a Licensure Survey of the Respondent’s facility. 9. Based on observation, interview and record review, it was determined the facility failed to follow physician orders for catheter placement, pain medication and skin sweeps for one (1) of twenty eight (28) residents, specifically Resident number ninety six (96), which resulted in significant pain for the resident. 10. Resident number ninety six (96) was admitted on January 7, 2013 with diagnoses to inclide urinary retention and urethral erosion. An observation was made of Resident number ninety six (96) on February 13, 2013 at 8:30 a.m. and Resident number ninety six (96) was holding his/her hands over his/her genital area. 11. A review of the medical record documented a physician order dated January 25, 2013 for Keflex 250mg by mouth four (4) times daily for seven (7) days for urethral erosion and lidocaine jelly 2% to the urethra as needed four (4) times a day. The February Physician Order Sheet documented; keep the catheter up and taped to abdomen and positioned out of top of pants. There is an order on the Physician Order Sheet for weekly skin assessment due Friday on the 3:00 p.m. to 11:00 a.m. shift. 12. Catheter care was observed on February 13, 2013 at 8:33 a.m. As the Certified Nursing Assistant started to perform the catheter care, Resident number ninety six (96) moved into the fetal position and started moaning and grunting. The Certified Nursing Assistant stated this is normal for Resident number ninety six (96). As the Certified Nursing Assistant moved the resident’s scrotum, the left groin area was noted to be bright red and patchy. Resident number ninety six (96) yelled out and tried crossing his/her legs. Resident number ninety six (96) was not asked if he/she was in pain. The Certified Nursing Assistant drew back the foreskin of the penis and it appeared to be bright red and excoriated. The resident was moaning when touched, mumbling “Oh God “. Resident number ninety six (96) kept crossing his/her legs and trying to get back into the fetal position and the Certified Nursing Assistant would reposition the resident onto his/her back to wash the catheter and genital area. At one point, Resident number ninety six (96) lifted his/her head and groaned loudly with a grimace on his/her face and his/her eyes bulging. At this point the Certified Nursing Assistant asked Resident number ninety six (96) if he/she was in pain. The resident stated “a little “. Lidocaine Jelly 2% was not applied to the urethra. The catheter was then brought out the bottom of the adult brief, not anchored to any anatomical site. 13. In. an interview with the Registered Nurse who was providing care for Resident number ninety six (96) on February 13, 2013 at 9:01 a.m., the Registered Nurse stated that she would check the catheter to make sure it is patent and positioned properly. The Registered Nurse checked for exudate on the penis and checked the indwelling catheter to make sure it was draining properly. The Registered Nurse stated that the catheter was positioned properly. The catheter was still threaded through the bottom of the adult brief and not taped to Resident number ninety six’s (96) abdomen. 14. A review of the February Medication Administration Record revealed no lidocaine jelly 2% listed. The Treatment Administration Record documented “keep Foley catheter taped to abdomen and position out of top of pants." The last skin sweep documented is February 1, 2013 and did not document anything about redness to the groin area. 15. In an interview with the Unit Manager at 9:28 a.m. on February 13, 2013, the Unit Manager acknowledged that there is an order written for lidocaine jelly 2% that was not transcribed onto the Medication Administration Record. The Unit Manager also verified that there was nothing in the chart to indicate a rash or redness to the groin of Resident number ninety six (96) nor was the weekly skin sweep done as ordered on February 8, 2013. 16. | The Unit Manager went with the surveyor to assess Resident number ninety six (96) at 9:35 a.m. The Unit Manager acknowledged that the catheter tubing was not taped to Resident number ninety six’s (96) abdomen, nor was it up and over the top of the adult brief. The Unit Manager also acknowledged excoriation in the left groin and penis. Resident number ninety six (96) would still flinch and moan when touched, and the Unit Manager stated he/she was in pain. 17. Resident number ninety six (96) was observed with the Licensed Practical Nurse on February 14, 2013 at 11:03 a.m. Resident number ninety six (96) was fidgeting in the wheelchair. When asked, Resident number ninety six (96) stated the catheter did not feel okay. The catheter was angled downwards through the leg of the brief and not taped to the abdomen as ordered. The Licensed Practical Nurse acknowledged the catheter tubing was incorrectly placed and not taped to the abdomen as ordered. 18. The Agency determined that this deficient practice compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. The Agency cited Respondent for a Class II deficiency as set forth in Section 400.23(8)(b), Florida Statutes (2012). 19. A Class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more Class I or Class Il deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. 20. Based upon the above findings, the Respondent’s actions, inactions or conduct constituted an isolated Class II deficiency pursuant to Section 400.23(8)(b), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent pursuant to Sections 400.23(8)(b), and 400.102, Florida Statutes (2012). COUNT IL The Respondent Failed To Ensure The Right To Receive Adequate And Appropriate Health Care in Violation of Section 400.022(1)(I), Florida Statutes (2012) 21. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 22. Pursuant to Florida law, all licensees of nursing home facilities shall adopt and make public a statement of the rights and responsibilities of the residents of such facilities and shall treat such residents in accordance with the provisions of that statement. The statement shall assure each resident the following: The right to receive adequate and appropriate health care and protective and support services, including social services; mental health services, if available; planned recreational activities; and therapeutic and rehabilitative services consistent with the resident care plan, with established and recognized practice standards within the community, and with rules as adopted by the Agency. Section 400.022(1)(), Florida Statutes (2012). 23. Onor about February 11, 2013 through February 15, 2013, the Agency conducted a Licensure Survey of the Respondent’s facility. 24. Based on observation, interview and record review, it was determined the facility failed to provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being for three (3) of twenty eight (28) residents, specifically Resident number ninety six (96), Resident number three hundred five (305) and Resident number two hundred forty two (242), regarding failure to assess and manage pain for a resident with an urethral erosion and two (2) residents with no medical justification for their catheters respectively. 25. Resident number ninety six (96) was admitted on January 7, 2013 with diagnoses to include urinary retention and urethral erosion. An observation was made of Resident number ninety six (96) on February 13, 2013 at 8:30 a.m. to be holding his/her hands over his/her genital area. 26. Catheter care was observed on February 13, 2013 at 8:33 a.m. As the Certified Nursing Assistant started to perform the catheter care, Resident number ninety six (96) moved into the fetal position and started moaning and grunting. The Certified Nursing Assistant stated this is normal for the resident. As the Certified Nursing Assistant moved Resident number ninety six’s (96) scrotum, the left groin area was noted to be bright red and patchy. Resident number ninety six (96) yelled out and tried crossing his/her legs. Resident number ninety six (96) was not asked if he/she was in pain. The Certified Nursing Assistant drew back the foreskin of the penis and it appeared to be bright red and excoriated. The resident was moaning when touched, mumbling “Oh God “. Resident number ninety six (96) kept crossing his/her legs and trying to get back into the fetal position and the Certified Nursing Assistant would reposition the resident to wash the catheter and genital area. At one point, Resident number ninety six (96) lifted his/her head and groaned loudly, with a grimace on his/her face and the eyes bulging. At this point the Certified Nursing Assistant asked Resident number ninety six (96) if he/she was in pain. The resident stated “a little “The catheter was then brought out the bottom of the adult brief, not anchored to any anatomical site. 27. There is a Pain Evaluation in Advanced Dementia sheet in Resident number ninety six’s (96) chart that has the residents name on it but is not filled out. Based on the criteria listed on the form, the combination of "repeated calling out, loud moaning or groaning, crying", "facial grimacing" and "rigid, fists clenched, knees pulled up, pulling or pushing away" indicates distressing pain. On February 14, 2013 at 1:13 p.m., the Director of Nursing acknowledged the form was in the chart and should have been filled out. 28. ‘In an interview with the Registered Nurse on February 13, 2013 at 9:01 a.m., the Registered Nurse stated that she would first give Resident number ninety six (96) medications, then she would check Resident number ninety six’s (96) catheter to make sure it is patent and positioned properly. The Registered Nurse checked for exudate on the penis and checked the indwelling catheter to make sure it was draining properly. The Registered Nurse stated that the catheter was positioned properly and did not assess the groin or pull back the foreskin to properly assess the penis. Resident number ninety six (96) was still moaning and the nurse asked if he/she was in pain but the resident said no. Resident number ninety six (96) appeared more relaxed in bed, not grimacing. The Registered Nurse stated the Certified Nursing Assistant was supposed to tell the nurse when the resident stated he/she is in pain. 29. A review of the medical record documented a physician order dated January 25, 2013 for Keflex 250mg by mouth four (4) times daily for seven (7) days for urethral erosion and lidocaine jelly 2% to the urethra as needed four (4) times a day. The February Physician Order Sheet documented keep the catheter up and taped to abdomen and positioned out of top of pants. 30. A review of the February Medication Administration Record revealed no lidocaine jelly 2% transcribed. The Treatment Administration Record documented “keep Foley catheter taped to abdomen and position out of top of pants. The last skin sweep found is February 1, 2013 and did not document anything about redness to the groin or penis. 31. Inan interview with the Unit Manager at 9:28 a.m. on February 13, 2013, the Unit Manager acknowledged that there is an order written for lidocaine jelly 2% that is not listed in the Medication Administration Record. The Unit Manager also verified that there was nothing in the chart to indicate a rash or redness to the groin of Resident number ninety six (96). 32. The Unit Manager went with the surveyor to assess the resident at 9:35 a.m. The Unit Manager acknowledged that the catheter tubing was not taped to Resident number ninety six’s (96) abdomen, nor was it up and over the top of the residents’ adult brief. The Unit Manager also acknowledged excoriation in the left groin and penis. The Unit Manager acknowledged Resident number ninety six (96) was acting as if he/she was in pain, groaning and guarding his/her genitals when touched. 33. In an interview with the Director of Nursing on February 13, 2013 at 2:42 p.m., the Director of Nursing stated Resident number ninety six (96) was transferred to the Reflections unit for behaviors of yelling and screaming and was given a care plan to reflect the behaviors. The Director of Nursing stated Resident number ninety six (96) is not necessarily in pain; this is just how the resident acts. In a subsequent interview with the Director of Nursing on February 14, 2013 at 1:13 p.m., she acknowledged the care plan indicates Resident number ninety six (96) had behaviors of resisting care, not yelling and screaming. The Director of Nursing also stated she was unable to find any documentation in the chart that indicates Resident number ninety six (96) had yelling behaviors. 34. — A nurse's note dated January 22, 2013 documented that Resident number ninety six (96) had pain which was manifested by fidgeting and shouting out intermittently. Routine pain medication was given and the effect was good with decreased fidgeting and decreased shouting. 35. The pain assessment dated January 7, 2013 documented under the question “Does the patient/resident exhibit any non-verbal signs that would indicate pain?” Moaning is checked off. Under nursing interventions, no evidence of pain is checked off. The monthly summary dated February 12, 2013 indicated Resident number ninety six (96) is alert and confused, quiet and cooperative with a flat affect. Resident number ninety six’s (96) speech is listed as difficult. 36. A review of the fourteen (14) day Minimum Data Set assessment with an Assessment Reference Date of January 24, 2013 revealed Resident number ninety six (96) was severely impaired with cognition. No behavioral symptoms are exhibited, including screaming and disruptive sounds. The Minimum Data Set identified Resident number ninety six (96) as having pain occasionally in five (5) of the seven (7) previous days with a level of five (5) out of ten (10). 37. In an interview with Resident number ninety six (96), the Licensed Practical Nurse on February 14, 2013 at 11:03 a.m. stated the catheter is to be positioned up over the brief and taped to the abdomen to prevent further irritation to the urethra. Resident number ninety six (96) has had a catheter for a long time. Because Resident number ninety six (96) is confused, the Licensed Practical Nurse stated she would watch for grimacing or fidgeting as signs of pain and that Resident number ninety six (96) tried to stand on his/her own if the catheter is placed incorrectly. The Licensed Practical Nurse stated that the staff does not use yelling as an indicator for pain because Resident number ninety six (96) often yells. Because Resident number ninety six (96) was trying to stand up in the activity room, the Licensed Practical Nurse brought him/her back into the room to check on the catheter. The resident stated to the nurse that the catheter "does not feel ok". Resident number ninety six (96) kept crossing his/her legs and fidgeting in the chair. A Certified Nursing Assistant came into the room to assist the Licensed Practical Nurse stand up Resident number ninety six (96). Resident number ninety six (96) stood to have his/her pants pulled down and his/her brief opened. The catheter was angled down and not taped to the abdomen as ordered. This was acknowledged by the Licensed Practical Nurse. When the nurse touched Resident number ninety six (96) he/she would yell out. There was also tape tangled in the pubic hair and as the nurse tried to remove it, Resident number ninety six (96) yelled out “It hurts a lot “. Resident number ninety six (96) kept trying to grab the nurse to make her stop but the Certified Nursing Assistant held his/her hands still. The catheter was then placed correctly. Resident number ninety six (96) stated he/she felt much better when the catheter was properly positioned. 38. Anobservation on February 12, 2013 at 3:25 p.m. revealed Resident number two hundred forty two (242) lying in bed. A Foley catheter (indwelling urinary drainage devise) was observed at bedside draining. 39. A review of the record revealed Resident number two hundred forty two (242) was admitted to the facility on December 31, 2012 with diagnoses to include urinary tract infection, functional decline, hypertension, deep vein thrombosis, anemia, hyperlipidemia, and renal insufficiency. A review of the Nursing Evaluation dated December 31, 2012 documented the existence of the Foley catheter. A review of the admitting physician's orders documented, "Catheter Orders" and further documented the ordered care and treatment for the catheter. A further review of the physician orders revealed the next order related to the Foley was not until nine (9) days after admission. This order was dated January 8, 2013 for the discontinuing of the catheter. A final review of the record lacked any evidence of a diagnosis or medical justification for the Foley catheter. 40. During a review of the record and interview with the Director of Nursing on February 15, 2013 at 9:30 a.m., the Director of Nursing agreed there was no valid diagnosis or medical justification for the Foley catheter for Resident number two hundred forty two (242) upon admission to the facility. When asked the standard procedure related to catheter use the Director of Nursing stated that they try to have the catheters discontinued within a few days of admission to their facility. 41. A review of the facility policy and procedure titled "Urinary Catheters" documents, “Procedure: 1. Eliminate indwelling urinary catheters when possible. 2. Use catheters only when they must be used, and only with documented medical justification by a physician." 42. During an interview on February 11, 2013 12:37 p.m., the Registered Nurse caring for Resident number three hundred five (305) was asked if the resident had a Foley catheter and the diagnosis or medical justification for the catheter. The Registered Nurse stated, "There is no valid reason for the catheter, Resident number three hundred five (305) came with it from the hospital. I'm going to call! the doctor to see if it can be removed." 43. An observation of Resident number three hundred five (305) on February 12, 2013 at approximately 11:45 a.m. revealed the resident sitting in a wheel chair at the nurse's station. Although the bag that holds and covers the Foley catheter for dignity purposes was noted, the Foley catheter was not present. 44. A review of the record documented Resident number three hundred five (305) was admitted to the facility from an acute care hospital on January 31, 2013 having sustained a cerebral vascular accident/stroke and subdural hematoma. Admitting diagnoses included diabetes, hypertension, left ventricle thrombus, hyperlipidemia, and intermittent atrial fibrillation. The record documented the existence of the Foley catheter upon admission to the facility as per the nursing evaluation dated January 31, 2013, the plan of care and in daily nursing notes from admission through February 11, 2012. A review of the plan of care dated January 31, 2013 for the indwelling catheter specifically documented the intervention "Identify documentation in the medical record which substantiates use of indwelling catheter, if absent confer with MD". An order to discontinue the Foley catheter was obtained on February 11, 2013 after surveyor questioning. A final review of the record lacked any diagnosis or medical justification for the catheter for Resident number three hundred five (305). 45. During an Interview on February 13, 2013 at approximately 4:00 p.m., the Unit Manager for the 300 unit was asked the procedure for residents admitted to the facility with a Foley catheter. The Unit Manger stated that the normal practice is to evaluate the resident and ask the physician for an order to discontinue the catheter within a few days of admission. The Unit Manager agreed that Resident number three hundred five (305) had a Foley catheter thirteen (13) days after admission to the facility with no appropriate diagnosis or medical justification. 46. A review of the facility policy and procedure titled "Urinary Catheters" documents, "Procedure: 1. Eliminate indwelling urinary catheters when possible. 2. Use catheters only when they must be used, and only with documented medical justification by a physician." 47, The Agency determined that this deficient practice compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. The Agency cited Respondent for a Class II deficiency as set forth in Section 400.23(8)(b), Florida Statutes (2012). 48. A Class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more Class I or Class II deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. 49. Based upon the above findings, the Respondent’s actions, inactions or conduct constituted an isolated Class II deficiency pursuant to Section 400.23(8)(b), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent pursuant to Sections 400.23(8)(b), and 400.102, Florida Statutes (2012). COUNT Il Assignment Of Conditional Licensure Status Pursuant To Section 400.23(7)(b), Florida Statutes (2012) 50. The Agency re-alleges and incorporates by reference the allegations in Count I. 51. The Agency is authorized to assign a conditional licensure status to nursing home facilities pursuant to Section 400.23(7), Florida Statutes (2012). 52. Due to the presence of one (1) Class I deficiency, the Respondent was not in substantial compliance at the time of the survey with criteria established under Chapter 400, Part II, Florida Statutes (2012), or the rules adopted by the Agency. 53. The Agency assigned the Respondent conditional licensure status with an action effective date of February 15, 2013. The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. 54. The Agency assigned the Respondent standard licensure status with an action effective date of March 15, 2013. The original certificate for the standard license is attached as Exhibit B and is incorporated by reference. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the Respondent conditional licensure status for the period beginning February 15, 2013 and ending on March 15, 2013 pursuant to Section 400.23(7)(b), Florida Statutes (2012). CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the following relief against the Respondent as follows: 1. Make findings of fact and conclusions of law in favor of the Agency. 2. Impose an administrative fine against the Respondent in the amount of FIVE THOUSAND DOLLARS ($5,000.00.). 3. Assign conditional licensure status to the Respondent for the period beginning on February 15, 2013, and ending on March 15, 2013. 4. Assess costs related to the investigation and prosecution of this case. 5. Enter any other relief that this Court deems just and appropriate. Respectfully submitted this A¢-u day of ne , 2013. A ee ee cae J ‘Andrea M. Lang, Assistant General Counsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 NOTICE RESPONDENT IS NOTIFIED THAT IT/HE/SHE HAS A RIGHT TO REQUEST AN ADMINISTRATIVE HEARING PURSUANT TO SECTIONS 120.569 AND 120.57, FLORIDA STATUTES. THE RESPONDENT IS FURTHER NOTIFIED THAT IT/HE/SHE HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT IN THE ATTACHED ELECTION OF RIGHTS. ALL REQUESTS FOR HEARING SHALL BE MADE AND DELIVERED TO THE ATTENTION OF: THE AGENCY CLERK, AGENCY FOR HEALTH CARE ADMINISTRATION, 2727 MAHAN DRIVE, BLDG #3, MS #3, TALLAHASSEE, FLORIDA 32308; TELEPHONE (850) 412-3630. THE RESPONDENT IS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING IS NOT RECEIVED BY THE AGENCY FOR HEALTH CARE ADMINISTRATION WITHIN TWENTY-ONE (21) DAYS OF THE RECEIPT OF THIS ADMINISTRATIVE COMPLAINT, A FINAL ORDER WILL BE ENTERED BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form were served to: Anthony Brunicardi, Administrator, SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach, 1755 37" Street, Vero Beach, Florida 32960, by United States Certified Mail, Return Receipt No. 7011 1570 0002 1695 8511 and to Capitol Corporate Services, Inc., Registered Agent, SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach, 155 Office Plaza Drive, Suite A, Tallahassee, Florida 32301, by United States Certified Mail, Return Receipt No. 7011 1570 0002 1695 8528 on this ‘S &_ day of Wg , 2013. Net FP On od Andrea M. Lang, Assistant General‘Cdunsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 Copies furnished to: Anthony Brunicardi, Administrator SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach 1755 37" Street Vero Beach, Florida 32960 (U.S. Certified Mail) Andrea M. Lang, Assistant General Counsel Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Capitol Corporate Services, Inc. Registered Agent for SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach 155 Office Plaza Drive, Suite A Tallahassee, Florida 32301 (US. Certified Mail) Bernard Hudson, Health Services and Facilities Consultant Supervisor Bureau of Long Term Care Services Long Term Care Unit Agency for Health Care Administration 2727 Mahan Drive, Building #3, Room 1213B Tallahassee, Florida 32308 (Electronic Mail) Arlene Mayo-Davis Field Office Manager Agency for Health Care Administration 5150 Linton Boulevard, Suite 500 Delray Beach, Florida 33484 (Electronic Mail)
