Dr. Larry Veltman and Darrell Ranum explore the patient safety issues and risk factors surrounding obstetrical claims. Dr. Veltman, a board certified ob/gyn who practiced in Portland, Oregon, for more than 30 years, has served on the board of the National Perinatal Information Center/Quality Analytic Services since 2010 and is a member of the Board of Directors of the American Society for Healthcare Risk Management (ASHRM). He is past chair of the Committee on Professional Liability for the American College of Obstetricians and Gynecologists (ACOG) and currently serves on ACOG’s Patient Safety and Quality Improvement Committee and on The Doctors Company Obstetrics Advisory Board.
In 2012, The Doctors Company conducted a study of claims and lawsuits involving neonatal injuries occurring in labor and delivery. The purpose of the study was to identify issues associated with the allegation “delay in treatment of fetal distress.” It was hoped that the results of that study would lead to a decrease in these types of injuries.
In April 2019, we conducted a second study using the same methodology to determine if changes had occurred in the practice patterns affecting the types of injuries suffered by neonates in labor and delivery. We identified some positive changes.
In the 2019 study, we analyzed 356 claims or suits that closed from 2012 through 2018 that alleged neonatal injuries. (In the 2012 study, we analyzed 247 claims that closed from 2007 through 2011 that alleged neonatal injuries.) Of the cases in the 2019 study, 35 percent had an allegation of delay in treatment of fetal distress (36 percent in the 2012 study). Although the term “fetal distress” is vague and no longer recommended, the allegation of delay in treatment remains an important concept in understanding these claims and lawsuits.
The final diagnoses for neonatal patients in this category include the following:
- Hypoxic-ischemic encephalopathy and severe birth asphyxia (76 percent in 2019; 80 percent in 2012).
- Placental separation and hemorrhage (4 percent in 2019; 0 percent in 2012).
- Compression of umbilical cord (3 percent in 2019; 0 percent in 2012).
- Chorioamnionitis affecting fetus (3 percent in 2019; 0 percent in 2012).
- Subdural or cerebral hemorrhage (2 percent in 2019; 6 percent in 2012).
- Meconium aspiration syndrome (2 percent in 2019; 2 percent in 2012).
- Fetal blood loss (2 percent in 2019; 0 percent in 2012).
- Stillbirth, unspecified condition (2 percent in 2019; 2 percent in 2012).
The claims review revealed the following reasons for delay in treatment of fetal distress (FIGURE 1):*
- Nurses failed to identify the fetal heart rate (FHR) tracing (usually Category II or III) as predictive of metabolic acidemia (17 percent in 2019; 11 percent in 2012). (Earlier terminology described these tracings as “nonreassuring.”)
- Nurses recognized FHR tracings as predictive of metabolic acidemia but failed to timely notify the attending physician (20 percent in 2019; 20 percent in 2012).
- Physicians did not go to the hospital after receiving calls from nurses with information about FHR tracings predictive of metabolic acidemia (10 percent in 2019; 14 percent in 2012).
- Physicians who were aware of concerning FHR tracings did not make a timely decision to initiate cesarean sections (29 percent in 2019; 43 percent in 2012).
- Physicians used other interventions (forceps or vacuum) to facilitate delivery when Category II or III tracings were identified (5 percent in 2019; 20 percent in 2012).
- Cesarean sections were ordered but delayed (staff or operating room unavailable) (2 percent 2019; 6 percent 2012).
- The case abstracts specifically referenced that physicians disagreed with nurses’ interpretations of FHR tracings (0 percent in 2019; 2 percent in 2012).
- Patient injury was due to undetermined causes (45 percent in 2019; 20 percent in 2012).
Several differences were noted between the two studies. Two categories for delay in treatment did not show improvement as a percentage of these cases. In the first category, nurses failed to identify FHR tracings (usually Category II and III) as predictive of metabolic acidemia in a higher percentage of cases in the 2019 study (17 percent versus 11 percent in 2012). In the second category, nurses who recognized FHR tracings as predictive of metabolic acidemia failed to timely notify the attending physician in the same percentage of cases (20 percent in 2019 and 20 percent in 2012). This may indicate the need for more frequent training of nurses on interpretation of FHR tracings and physician notification.
Improvement was noted as a smaller percentage of claims resulting from physician failure to go to the hospital to assess patients when requested by nurses (third category). Anecdotal evidence seems to indicate that the growth of supportive cultures in hospitals in which physicians train with nurses and engage in effective communication may be influencing this category. A second reason why this group of allegations may have decreased is the growth of the obstetric (OB) hospitalist movement—which means that a physician is always on the perinatal unit and able to respond to emergencies.1
A significant shift was noted in the fourth category, “Physicians aware of concerning FHR tracings did not make timely decisions to do cesarean sections.” This category of delay in treatment decreased from 43 percent in the 2012 study to 29 percent in the 2019 study. Our interpretation is that physicians and nursing teams are better prepared to respond to crisis situations and don’t hesitate to take appropriate action. The widespread implementation of drills and simulation training is an important component of obstetrical safety, especially for obstetrical emergencies. This may have also contributed to the decrease in claims.
In the fifth category, physicians appeared to have developed exit strategies, such as preparing for cesarean sections, when attempting operative vaginal deliveries (OVD) with Category II and III FHR tracings. The percentage of cases in which physicians used other interventions (forceps or vacuum) to facilitate delivery when Category II or III tracings were identified dropped from 20 percent in the 2012 study to 5 percent in 2019 study.
In the sixth category, there were fewer instances of operating rooms or staff not being available (2 percent in 2019 versus 6 percent in 2012). We believe that this is a function of planning ahead and developing exit strategies, such as cesarean sections, before attempting OVD.
In the 2019 study, there were no examples of disagreement in interpretation of FHR tracings (there were 2 percent in 2012) between nurses and physicians (the seventh category). We don’t know if disagreements were not documented or if training together reduced the potential for different interpretations.
The most dramatic shift was in the eighth category, “patient injury was due to undetermined causes.” The 2012 study showed 20 percent of cases in this category. The 2019 study revealed that experts were unable to identify a clear cause of neonatal harm in 45 percent of cases. This indicates that a smaller percentage of neonatal injury claims were due to what the experts identified as substandard care.
Studying these cases, we have identified multiple factors that may contribute to an adverse outcome and a subsequent allegation of delay in treatment of fetal distress. Several emerging themes point to risk mitigation strategies that might help in avoiding neonatal injuries.
These themes include the ability to identify FHR patterns that are predictive of metabolic acidemia, the importance of effective communications between physicians and nurses, the ability to perform a rapid cesarean delivery, the timing and safety of operative vaginal delivery, and monitoring the newborn after operative delivery. The following provides a more comprehensive description of the risk mitigation strategies associated with these themes:
- Ensure preparedness.
- Obtain physician credentialing in electronic fetal monitoring (EFM) as recommended by ACOG. Every physician should be trained in National Institute of Child Health and Human Development (NICHD) nomenclature and participate in regular fetal monitoring learning activities with the nursing staff. This includes identifying patterns that are predictive of metabolic acidemia associated with the loss of moderate variability and absence of accelerations. Many organizations are requiring this credentialing as a condition for obtaining obstetrical privileges.
- Establish the technology to view monitor tracings when the physician is out of the hospital.
- Conduct drills/simulation training in performing emergency cesarean delivery.
- Establish a system of anesthesia coverage, backup surgical assistant availability, and operating team and room readiness for performance of rapid cesarean delivery.
- Consider the value of having in-house physicians as a safety net for obstetrical emergencies.
- Hold CME programs for the entire staff with up-to-date information about safety measures and the technical skills of OVD.
- Prepare the team and the operating room for an immediate cesarean section should it become necessary when OVD is attempted and fails. Obtain consent for cesarean section at the same time consent is obtained for OVD.
- Increase training for nurses to improve the “speak-up” climate of the unit to ensure that physicians are notified and brought into the decision-making process early in the course of evaluating any changes in maternal or fetal status.
- Develop an effective escalation policy (chain of command) with training and support to ensure it is willingly utilized when necessary.2
- Communicate in real time.
- View the tracing (through Internet access) if a nurse calls with a concern about the tracing.
- Engage in dialogue about the tracing using NICHD terminology, and assign a category and care plan that both the physician and the nurse agree upon. Pay attention to the presence of moderate variability and accelerations when assigning Category II or III.
- Ask the nurse if he or she wants the physician to see the patient. If the answer is yes, the physician should go to the hospital without delay. If the answer is no, the physician should ask, “Are you sure?”
- Invoke the chain-of-command policy if conflicts cannot be resolved by conventional means.
- Avoid second-stage traps.
- Do not regard tracings that would be of concern in the first stage of labor as normal for the second stage. This applies especially to recurrent variable decelerations.
- Implement a vacuum bundle as advocated by the Institute for Healthcare Improvement (IHI)3, with modifications offered below:
- Consider alternative labor strategies.
- Prepare the patient.
- Discuss the risks and document consent.
- Ensure physical preparedness (empty bladder).
- Determine if there is a high probability of success.
- Estimate the fetal weight and determine the fetal position and station.
- Document this information.
- Predetermine the maximum application time and number of pop-offs.
- Establish communication codes to be used by physicians and nurses to show safety concerns and the need for reevaluation of the situation without alarming the patient.
- Be able to perform an immediate cesarean delivery if the OVD fails.
- Ensure that the resuscitation team is available.
- Use predetermined communication codes.
- Use the eight “T”s as another approach similar to the IHI vacuum bundle for establishing an operative vaginal delivery policy:4
- Timing—Use ACOG’s recommended definitions of a prolonged second stage as a guideline for when and under what conditions to consider vacuum-assisted vaginal delivery (VAVD):
- For nulliparous women, a lack of continuing progress for three hours with regional anesthesia or two hours without regional anesthesia.
- For multiparous women, a lack of continuing progress for two hours with regional anesthesia or one hour without regional anesthesia. (ACOG Practice Bulletin #154, November 2015, Reaffirmed 2018, Operative Vaginal Delivery)
- Turning—Consider manual rotation.
- Talking—Confer with the patient regarding the risks, benefits, and alternatives.
- Technical expertise in the operator—Verify knowledge of instrumentation, correct application, pressures, and axis of traction.
- Teamwork—Have ongoing communications between team members in the delivery room with regard to fetal status, safety concerns, and notifications and requests for additional resources.
- Termination—Predetermine when to stop OVD and proceed to cesarean delivery: limits to the number of pop-offs, total time of vacuum application, and lack of descent of the fetal head with appropriate traction, based on having situational awareness and an exit policy.
- The newborn—Have the resuscitation team present for the delivery and an observation protocol for the newborn after delivery.
- Template—Employ established standards for complete and appropriate documentation of the operative delivery.
- Be reluctant to attempt instrumental delivery in the face of a Category III tracing or a tracing that does not have moderate variability and accelerations.
- Have an exit strategy before an instrumental delivery is attempted. Ascertain the ability to perform an emergency cesarean delivery.
- Implement a protocol for care of the newborn after vacuum delivery:5
- Monitor the infant’s vital signs, color, and behavior.
- Do not place a cap on the infant’s head for 24 hours.
- Measure the newborn’s head circumference at birth and at hourly intervals for four hours.
- Examine the newborn for scalp swelling consistent with caput, subgaleal hematoma, or cephalohematoma.
- If physical signs demonstrate possible newborn compromise, notify the physician and monitor blood pressure, heart rate, and vital signs.
- Check the newborn’s hematocrit.
As shown in Figure 1, our studies revealed recurring themes in cases with adverse outcomes alleging delays in treatment of fetal distress.
Addressing these themes proactively and in real time should become a strategic activity for physicians and nurses who staff obstetrics departments. Increased readiness for and recognition and management of complications, improved communications, and required technical skills should all work in concert to reduce the likelihood of these difficult and tragic outcomes.