Safe Care: Obstetrics
Given the tremendous emotional, financial, and reputational cost associated with adverse events in obstetrics (OB) and the steady reporting of obstetrics-related claims, MMIC established an initiative to determine how we could best serve our insureds in reducing risk and improving outcomes in this area. This Beacon addresses the risks associated with this specialty and the steps MMIC has taken to launch Safe Care:
Obstetrics. The three steps include:
- Identify Common Factors in OB Claims
- Perform Onsite Perinatal Patient Safety Assessments
- Implement the Safe Care: Obstetrics Program
Challenges in Obstetrics
A well-known author, national speaker, and obstetrician stood before an audience and began his presentation on Perinatal Safety by posing the question, “What’s the biggest problem with Obstetrics?” His response, “Most of the time the outcomes are normal.”1
He went on to explain that because major obstetric events occur infrequently and are unexpected, inaccurate processes (e.g., “work-arounds”) become the norm and the deterioration of adherence to professional standards may go undetected for long periods of time. Experts call this “normalization of deviance” and it’s one of the major focuses when striving to become a high reliability perinatal unit. High reliability perinatal units understand that successful outcomes are paradoxically considered as potentially dangerous and that preserving a constant awareness of the current state of patient care systems and processes is essential.2
Maintaining this constant awareness is challenging especially when the law of small numbers (“I’ve never experienced an event.”) lead clinicians to believe that their practice does not need to change even though they are not in compliance with current standards. The recognition of deviation from standards is often discovered through analysis of an adverse event and/or when a malpractice claim is filed and the event is scrutinized.3 Providing the best care for patients and the best defense against malpractice claims requires preventing or mitigating harm through adherence to evidence-based practice guidelines and the incorporation of reliable processes that help create a culture of patient safety.
Most every mother expects that her pregnancy will yield a perfect baby. When an adverse event occurs, it is often severe, permanent, and absolutely devastating.
Obstetric malpractice is often quoted as the most frequent and most expensive type of medical-malpractice litigation. This is due to the nature of obstetric injuries, which tend to be serious and long-lasting. Injured infants often need expensive, comprehensive medical care and often require lifelong care and assistance thus imposing a substantial financial and emotional burden on the family. This financial and emotional burden often prompts the initiation of obstetric malpractice litigation.3
Obstetrical malpractice impacts the OB provider, the perinatal nursing staff and the hospital providing the obstetric service. Though the data below is broken down by obstetrician, hospital, and nursing, it is clear that it takes a cooperative, prepared, and well-functioning obstetrical team to deliver safe and reliable perinatal care.
According to the most recent data from the PIAA (the insurance trade association representing medical professional liability (MPL) insurers), the average indemnity payment for OB/GYN physician claims is $437,781. This is the third highest average indemnity payment among all of the healthcare specialties ($335,578). Almost 80% of malpractice claims against OB/GYN physicians relate to events occurring during labor and delivery.4
The most expensive outcome for OB/GYN claims was brain damaged infant. Approximately 34% of the closed claims linked with this outcome resulted in indemnity payments totaling more than $107 million; the average indemnity payment was $885,246.
From the PIAA, more than three-quarters of the paid OB/GYN claims reported the event occurring in a hospital and accounted for 79% of the indemnity paid for all OB/GYN claims. Among these claims, 68% arose from events in a non-teaching hospital, but those that occurred in a teaching hospital resulted in a higher average indemnity payment ($556,872). Hospitals are often directly named in claims. Hospital professional liability insurance extends to employees including nursing. Rarely are specific employees named in a claim such as a nurse, pharmacist, etc.4
Some nurses carry their own professional liability insurance in addition to the coverage provided by the hospital. One study published in 2015 by Nurses Service Organization (NSO)/CNA (insurers providing coverage for nurses) noted that obstetricsrelated claims accounted for 9.8% of all claims. On average, NSO & CNA paid $397,064 for OB-related claims, which is more than double the overall average paid indemnity for all nurse closed claims of $164,586. Of all obstetrical injuries, fetal/infant birth-related brain injuries had the highest percentage of closed claims, representing 72.5% of all OB claims.
Our first step in our initiative was to review all of our claims over the last 15 years to identify the most common areas of risk and compare this to the findings from other MPL insurers. Upon review we determined that the most common risks include:
- Accurately interpret a Category II (or III) EFM tracing with subsequent failure to intervene appropriately and as indicated.
- Initiate correct shoulder dystocia maneuvers.
- Recognize and communicate declining maternal fetal status.
- Timely report a complication.
- Respond when notified of declining maternal fetal status.
- Invoke the chain of command when clinical disagreement occurs.
Our second step was to provide an on-site perinatal patient safety assessment to each of our hospitals with inpatient OB. This was accomplished between 2015 and 2017. Twenty-seven hospitals participated ranging from critical access hospitals to tertiary care facilities. Our goal was to help identify areas of risk and to recommend patient safety strategies to help address these.
In review of the data compiled from these assessments, the most frequent risks identified were found in the following three areas:
- Education and Training
- Vacuum-assisted Vaginal Delivery
- Induction and Augmentation of Labor
- Use of Misoprostol
- Use of Oxytocin
The following provides a brief summary of each core area and offers recommendations to reduce risk and improve patient safety.
I. Education and Training
Ineffective teamwork and communication failures contribute to 70% of adverse obstetric events. Success has been reported in reducing adverse events by providing multidisciplinary education in interpretation and management of the fetal heart rate patterns and in performing obstetrical emergency drills as part of a comprehensive perinatal patient safety program.
- Train and educate the perinatal team together (physicians, midwives, nurses) on:
- Electronic fetal monitoring and interpretation using the National Institute of Child Health and Human Development (NICHD) common language.
- Obstetric emergencies (e.g., mock drills, simulation exercises) such as: shoulder dystocia, obstetric hemorrhage, emergency cesarean delivery, newborn resuscitation, maternal cardiac arrest.
- Individual communication skills and team collaboration, e.g., SBAR, TeamSTEPPS®, briefs, debriefs from emergency drills, handoffs, simulation.
II. Vacuum-assisted Vaginal Delivery (VAVD)
Use of a vacuum device can assist in accomplishing a safe delivery; however, there is significant risk with use of these devices to both the mother and fetus. Use of the vacuum extractor is associated with an increased incidence of neonatal trauma including cephalohematoma, intracranial hemorrhage, subgaleal hemorrhage, retinal hemorrhage, and hyperbilirubinemia. Maternal injuries include pain, vaginal and cervical lacerations, extension of the episiotomy, anal sphincter injuries, bladder trauma, etc.
Many of these injuries can be prevented by evaluating proper indications and patient selection, and by adherence to appropriate safety protocols.
- Standard practices should be in place for appropriate and safe performance of VAVD. The guidelines should include: alternative labor strategies, patient consent, high probability of success (estimated fetal weight, fetal station, and fetal position), maximum number of application and pop-offs predetermined, exit strategy available (ensure surgical team/resuscitation team readiness), required elements of medical record documentation, and communication with infant caregivers about use of the vacuum device.
- Credentialing standards must be in place for medical staff for use of vacuum devices. Nurses must be granted access to a list of providers with privileges to perform this procedure.
- The team should be prepared to perform a cesarean delivery and infant resuscitation if necessary.
- A quality improvement process should be in place to review all vacuum-assisted vaginal deliveries including neonatal and maternal complications.
III. Induction and Augmentation of Labor
The perinatal unit is responsible for establishing standard policies and procedures for induction and augmentation of labor including preparation and use of oxytocin and misoprostol. Implementing a labor induction policy will decrease maternal and fetal/neonatal risks associated with elective induction, reduce induction and cesarean rates, and increase spontaneous labor rates.
a. Use of Misoprostol
Misoprostol has been demonstrated to be an effective agent for cervical ripening and induction of labor on an inpatient basis. When given in high doses, misoprostol use has been associated with an increased rate of uterine tachysystole and meconium passage. Both fetal heart rate and uterine activity should be monitored carefully in these patients.
An evidence-based clinical policy should be in place for administration of misoprostol. At a minimum, the protocol should include: indications and contraindications; procedure, including dosage, frequency of administration, maximum number of doses, and the duration of fetal monitoring; and options for treatment of uterine tachysystole.
b. Use of Oxytocin
Review of medical malpractice claims reveals that oxytocin, which stimulates uterine contractions and induces labor, is involved in more than 50% of the situations leading to birth trauma. The Institute for Safe Medication Practices added oxytocin to its list of high-alert medications in 2007. High-alert medications have a heightened risk of harm if used in error and may require special safeguards to reduce the risk of error such as standardizing the ordering, storage, preparation, and administration process; and employing redundancies or double checks in the process of care.
Excessive dosage or hypersensitivity to the drug may result in uterine tetanic contraction or rupture of the uterus. All patients receiving intravenous oxytocin must be under continuous observation by trained personnel who have a thorough knowledge of the drug and are qualified to identify complications. A physician qualified to manage any complications should be immediately available. Use of continuous electronic fetal monitoring is recommended.
- An evidence-based clinical policy should be in place for administration of oxytocin for labor induction or stimulation. At a minimum the policy should include preparation and administration via a controlled infusion device, monitoring of the mother and fetus, management of uterine tachysystole, description of training and competency of personnel administering oxytocin, and readily available physician who has privileges to perform cesarean deliveries.
- Safety precautions for high-alert medications should be implemented.
- A quality improvement process should be in place to review all failed inductions.
MMIC’s Safe Care: Obstetrics Program
The third and final step in our initiative is our Safe Care: Obstetrics program which we introduced in the fall of 2017 and are offering to all of our hospitals with inpatient obstetrics. Safe Care: Obstetrics provides access to standardized education for clinical members of the perinatal care team through a state of the art online learning program and focuses on two types of labor and delivery events. The first is shoulder dystocia, a rare perinatal complication that is difficult to manage and appears without warning. The second focus is fetal assessment and monitoring as inadequate fetal monitoring is a root cause of approximately one-third of all cases of perinatal death and injury.
Achieving perinatal high reliability requires commitment to patient safety as the number one priority, interdisciplinary collaboration and team work, effective communication and elimination of hierarchy, rehearsing emergencies and anticipating unexpected events, and practicing in accordance with national recognized standards while remaining aware that normalization of deviance is a risk.5 Our Safe Care program is designed to help facilitate a culture of safety. We look forward to partnering with our hospitals on their journey to achieve safe and reliable perinatal care.
1,3 Larry Veltman, MD, FACOG, Approaching Perinatal Safety
2 Perinatal High Reliability G. Eric Knox, MD; Kathleen Rice Simpson, PhD, RN American Journal of Obstetrics & Gynecology 2010
3 The Causes and Implications of Obstetric Malpractice; International Journal of Basic and Applied Sciences, 4 (3) (2015) 320-32 Jahn Kassim, Puteri & Mohd Najid, Khadijah.
4 PIAA Specialty Specific Series OBGYN Surgery 2016 Edition
5 MONTH 2010 American Journal of Obstetrics & Gynecology PATIENT SAFETY SERIES Perinatal high reliability G. Eric Knox, MD; Kathleen Rice Simpson, PhD, RN