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. He is past chair of the Committee on Professional Liability for the American College of Obstetricians and Gynecologists (ACOG) and has served on ACOG’s Patient Safety and Quality Improvement Committee.
The Doctors Company conducted a study of claims and lawsuits involving neonatal injuries occurring in labor and delivery. The purpose was to identify issues associated with the allegation “delay in treatment of fetal distress.” It is hoped that the results of this study will lead to a decrease in these types of injuries. Of the 247 neonatal injury claims that closed from 2007 through 2011, 89 claims (36 percent) included the allegation “delay in treatment of fetal distress.” (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:
- Hypoxic-ischemic encephalopathy and severe birth asphyxia (80 percent)
- Cerebral palsy (6 percent)
- Subdural/cerebral hemorrhage (6 percent)
- Conductive/sensory hearing loss (3 percent)
- Stillbirth of unspecified condition (3 percent)
The claims review revealed the following:*
- Nurses failed to identify the fetal heart rate (FHR) tracing (usually Category II or III) as predictive of metabolic acidemia (11 percent). (Earlier terminology described these tracings as nonreassuring.)
- Nurses recognized FHR tracing as predictive of metabolic acidemia but failed to timely notify the attending physician (20 percent).
- Physicians did not go to the hospital after receiving calls from nurses with information about FHR tracings predictive of metabolic acidemia (14 percent). In most cases, it was noted that nurses did not activate the chain of command when physicians did not respond to the request.
- Physicians who were aware of concerning FHR tracings did not make a timely decision to initiate a cesarean section (43 percent).
- Patient injury was due to undetermined causes (20 percent).
- Physicians used other interventions (vacuum extraction or forceps) to facilitate delivery when these concerning patterns were identified (20 percent).
- Cesarean sections were ordered but delayed (staff or operating room unavailable) (6 percent).
- The case abstract specifically referenced that physicians disagreed with nurses’ interpretations of FHR tracings (2 percent). This number may be higher based on the number of cases in which physicians failed to go to the hospital when called by the nurse (14 percent).
Studying these cases, we have identified multiple factors that may contribute to an adverse outcome and subsequent allegation of delay in treatment of fetal distress. Several emerging themes point to risk mitigation strategies that might help avoid 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 (OVD), and monitoring the newborn after operative delivery. The following is a more comprehensive description of the components associated with these themes:
- Ensure preparedness.
- Every physician should become familiar with National Institute of Child Health and Human Development (NICHD) nomenclature and participate in regular fetal monitoring learning activities with the nursing staff. This includes the identification of patterns that are predictive of metabolic acidemia associated with the loss of moderate variability and absence of accelerations.
- Establish the technology to view monitor tracings when the physician is out of the hospital.
- Conduct drills/simulation training in the performance of emergency cesarean delivery in less than 30 minutes, if needed.
- Establish a system of anesthesia coverage, backup surgical assistant availability, and operating team and room readiness for performance of rapid cesarean delivery in less than 30 minutes.
- 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 and the technical skills of operative vaginal delivery.
- Communicate in real time.
- Have the ability to view the tracing (by computer, fax, or other technology) if a nurse calls with a concern about the tracing.
- Engage in dialogue about the tracing, 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?”
- Develop an effective chain-of-command policy that will be readily activated if conflicts cannot be resolved by conventional means.
- Avoid second-stage traps.
- When the patient is in the second stage, 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)1 with modifications:
- 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 (EFW), and determine the fetal position and station.
- Document this information.
- Predetermine the maximum application time and number of pop-offs.
- Establish communication codes. (These codes are communication tools used by physicians and nurses to show safety concerns and the need for reevaluation of the situation without alarming the patient.)
- Make an exit strategy known and available.
- The resuscitation team is available.
- Communication codes are determined.
- Use the five “T”s as another approach similar to the IHI vacuum bundle for establishing an operative vaginal delivery policy:
- Timing—when and under what conditions to consider OVD. Use ACOG’s recommended definitions of a prolonged second stage as a guideline:
- 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 #17, June 2000, Operative Vaginal Delivery)
- Technique—have established expertise in use of instrumentation and skills in application.
- Traction—determine the maximum number of pop-offs and total time of application.
- Talking—teamwork interaction with regard to OVD.
- Termination—when to stop and implement an exit strategy.
- 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 (i.e., the ability to perform a rapid cesarean delivery) before an instrumental delivery is attempted. Ascertain the ability to perform a cesarean delivery in less than 30 minutes.
- Implement a protocol for care of the newborn after vacuum delivery.2
- 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.
Our study 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.