Legal Review & Commentary

Allegation: Failure to perform hysterectomy causes death; $950,000 settlement in New York

By Radha V. Bachman, Esq. Suzanne Gruszka, RN, MAS, CLNC, LHRM

Buchanan, Ingersoll & Rooney PC Administrator, Clinical Support Services

Tampa, FL Health Central

Ocoee, FL

News: A pregnant woman presented to a hospital emergency department (ED) for delivery of her third child. Because of her high-risk pregnancy, the woman was scheduled for a cesarean. The cesarean was performed, followed by a hysterectomy. However, complications arose during the hysterectomy, and the woman slipped into a coma and died three days later. The hospital settled with the woman's family for $950,000.

Background: A 43-year-old factory worker was pregnant with her third child and presented to a hospital for delivery. The woman suffered from placenta accreta, a condition where the placenta attaches itself too deeply into the wall of the uterus. A common risk of placenta accreta during delivery is the possibility of hemorrhaging during manual attempts to detach the placenta. As a result of this condition, the woman was scheduled for a cesarean. Ultimately, the woman went into labor, and a cesarean was performed, followed by a hysterectomy due to a ruptured placenta. Complications arose following the hysterectomy, and the woman slipped into a coma, later dying.

A lawsuit was filed against the hospital, claiming medical malpractice for the hospital physician's failure to timely start the hysterectomy. The plaintiff alleged that due to the woman's condition, a hysterectomy tray, blood transfusions, and other necessary medical devices should have been prepared in the event a hysterectomy was found to be necessary. According to records, the child was born at 2:46 p.m., and the hysterectomy was not performed until 30 minutes later, despite the fact that the hemorrhage occurred at 2:49 p.m. However, interviews with the hospital's anesthesiologist revealed that he or she had no recollection of the time the procedure was performed and had not completed any notes regarding the procedure. A nursing note identified that the completion time of the hysterectomy was 3:49 p.m. This was, however, crossed out and replaced with "3:15 p.m." The plaintiff argued that someone had crossed out the correct time of completion in an attempt to hide the delay.

The defense denied negligence, and the obstetrician testified that the hysterectomy was performed timely. Defense counsel contended that the hemorrhage and later death were unfortunate risks associated with the woman's condition.

What this case means to you: The woman in this case was diagnosed with placenta accreta prior to delivery. According to the American Pregnancy Association, 1 in 2,500 pregnancies result in this condition. The specific cause of placenta accreta is unknown, but it can be related to previous cesarean deliveries. The woman in this case was pregnant with her third child; however, it is unclear as to her previous obstetric history. According to the literature, a cesarean delivery increases the possibility of a future placenta accreta. The more cesareans, the greater the incidence.

The risks of placenta accreta to the mother include hysterectomy, which is a common therapeutic intervention, but the results involve the loss of the ability to conceive. There is nothing a woman can do to prevent placenta accreta, and little can be done to treat the condition once diagnosed. If the placenta accreta is severe enough, a hysterectomy may be needed. This condition is associated with massive blood loss at the time of delivery. The peripartum management of the patient should be by a multidisciplinary team to help reduce morbidity and mortality.

According to the American College of Obstetricians and Gynecologists (ACOG), postpartum hemorrhage is a complication associated with placenta accreta. Postpartum hemorrhage is one of the top five causes of maternal mortality. Ninety percent of accretas have postpartum hemorrhage, and 50% of those result in a hysterectomy. The key management issues are early detection — and immediate and appropriate intervention. There is a potential for massive blood loss, which could be > 2,500 cc. If this situation is not managed urgently and appropriately, it has a 50% mortality rate.

One of the issues identified in the case background information includes the timeliness of the surgical intervention. The clinical information presented demonstrates the importance of emergent treatment, including a plan for a hysterectomy. The surgical team needs to be competent and have all of the necessary equipment at the time of the cesarean.

According to The Joint Commission (TJC), the hospital and its staff must conduct a pre-procedure verification, which includes making sure that related equipment is available prior to the start of the procedure. This would include required blood products, implants, devices, and/or special equipment for the procedure (UP.01.01.01 EP 2).

The second issue is the lack of documentation present in the medical record. The delivery is noted to be at 2:46 p.m., and the hysterectomy information states it was performed 30 minutes after; however, the hemorrhage was documented in the record at 2:49 p.m. The anesthesiologist had no recollection of the time when the procedure was performed and had not completed any documentation regarding the procedure. This is not in compliance with the TJC Standard PC. 03.01.05, which states that the hospital monitors the patient during operative or other high-risk procedures and/or during the administration of moderate or deep sedation or anesthesia. The Element of Performance (EP) #1 in this standard states, "During operative or other high-risk procedures, including those that require the administration of moderate or deep sedation or anesthesia, the patient's oxygenation, ventilation, and circulation are monitored continuously." TJC Standard RC. 02.01.03 EP #8, states that the medical record contains the following postoperative information: vital signs, level of consciousness, any medications, including IV fluids and any administered blood, blood products, and blood components, any unanticipated events or complications, and the management of those events. EP #15 requires that the hospital keep a complete and up-to-date operating room register that is, "inclusive of total time of operations."

According to the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs) for Hospitals and Anesthesia services, the delivery of anesthesia services must include an intraoperative anesthesia record. Likewise, the American Society of Anesthesiology (ASA) Statement on Documentation of Anesthesia Care (Oct. 22, 2008) states that, "documentation is a factor in the provision of quality care and is the responsibility of an anesthesiologist." Intraoperative anesthesia is a time-based record of events where the following items are recorded: patient's vital signs, doses of drugs and agents used; and the times of administration, types, and amounts of fluids used, including blood and blood products and the times of administration; and the technique and patient position, IV lines and airway devices inserted and the location, unusual events during the administration of anesthesia, and the status of the patient at the conclusion of anesthesia.

The ASA further states in the Standards For Basic Anesthetic Monitoring, Standards and Practice Parameters (Oct. 25, 2005) that during all anesthetics, the patient's oxygenation, ventilation, circulation, and temperature shall be continually evaluated.

Based on the interviews with the hospital anesthesiologist, it appears that he or she did not comply with TJC Standards, the CMS CoPs, the ASA Statements on Basic Anesthetic Monitoring nor the ASA Statement on Documentation of Anesthesia Care. In most facilities, the anesthesia record is quite detailed and is time-based. It would be quite unusual to have nothing in the record to support the care given during this time period. The lack of documentation could lead one to believe that the team was not ready to perform the hysterectomy immediately following the cesarean. A hemorrhage occurred during the operative period and, based on the research, was most likely a significant blood loss. The only postoperative information given on this patient was that she slipped into a coma and died three days later. This may have been a result of the blood lost during the procedure and the apparent delay.

The final issue is that the nurse who completed the notes identified the completion time of the hysterectomy as 3:49 p.m. This was later crossed out and replaced with the time 3:15 p.m. The change in the entry suggests that it was done to hide a delay. Usually, if an entry is incorrect, it is crossed out, the error is noted next to the entry, the correct entry is documented, and the initials of the person making the change to the entry are noted. It appears that this common documentation correction process was not followed.

The settlement by the defense appears appropriate in this case. There were several system failures involving the scope of practice of the physicians and nurses under the circumstances.

Reference

• Supreme Court, Second Judicial Circuit, Kings County, New York, No. 16281/08.