Patient Safety Primer
"There is no statistic that can quantify what it's like to tell an 18-month-old that his mother is never coming home." Charles Johnson
Pregnancy and birth are normal physiologic processes that often require support rather than medical intervention. There are nearly 4 million annual births in the United States, the vast majority of births occur in hospitals, and nearly one-third are by cesarean delivery. Since most US births occur in hospitals, childbirth is subject to typical patient safety threats such as medication errors. Yet, in addition to typical threats to patient safety, pregnancy, childbirth, and the postpartum year present a complex set of safety challenges involving potential underuse, overuse, misdiagnosis, omission, and emotional harm.
The unique adaptations of pregnancy involve dramatic physiologic changes across all body systems. Many of these changes result in signs and symptoms that can make it more challenging to distinguish normal "discomforts of pregnancy" (or postpartum) from changes that would be concerning in a nonpregnant adult. During pregnancy and birth, patients' signs, symptoms, and health concerns are often minimized or discounted by clinicians. Patients experience discrimination in health care encounters on the basis of race/ethnicity, marital, and socioeconomic status, and may not receive adequate information about their care. These factors can lead to misdiagnosis or outright failure to recognize signs and symptoms of serious illness.
In addition, vital signs, physiologic indices, and laboratory values are altered such that findings that are "normal" for an adult can be grossly abnormal in pregnancy, labor, or postpartum, which can similarly lead to failure to recognize clinical deterioration or serious illness. Moreover, labor and birth themselves are highly dynamic and situations can change rapidly. Thus, patients are at risk for underuse or omission if they do not receive the right care for their condition, or do not receive the right care quickly enough in an emergency. Finally, more than half of rural US counties do not have hospital-based obstetric services, adding to the threat.
Patients may also be at risk via overuse of interventions. For example, cesarean delivery rates vary widely, with the liability and policy environments contributing to a substantial increase in use of cesarean delivery. While the optimal cesarean delivery rate is unknown, the increase in cesarean delivery rates has not improved maternal or neonatal outcomes and contributes to maternal morbidity. Finally, patients report a variety of situations that make them feel unsafe during labor and birth, and they can experience birth as traumatic whether or not they have serious complications.
The Centers for Disease Control and Prevention (CDC) currently estimates that there are approximately 700 pregnancy-related deaths each year in the US. The national pregnancy-related mortality ratio has increased from 7.2 deaths per 100,000 live births in 1987 to 17.2 deaths per 100,000 live births for the years 2011–2015 (range 15.9–18.0); 31% of these deaths occurred prenatally, 36% during birth or within 1 week of birth, and 33% between 1 week and 1 year after birth. There are substantial racial/ethnic and socioeconomic disparities in pregnancy-related mortality, illustrated in Table 1. Furthermore, severe maternal morbidity (e.g., hysterectomy, massive transfusion, unplanned ICU admission) is 50 times more common than maternal mortality, has been increasing, and is subject to similar health disparities.
Based on close analysis of deaths in 13 states, the CDC estimates that approximately 3-in-5 maternal deaths each year—about 420 deaths—were likely preventable. This is consistent with multiple studies showing more than 50% of maternal deaths evaluated had at least some possible preventability, and that multiple opportunities for improvement and prevention of morbidity and mortality exist at the policy, system, facility, clinician, and patient levels (Table 2). For example, in a study of the relationship between hospital birth volume and progression of severe maternal morbidity to maternal death (failure to rescue), investigators found that—after adjusting for patient characteristics and comorbidities—the hospital where the birth took place was the most important contributor to failure to rescue.
Table 1. Pregnancy-Related Deaths, by Sociodemographic Characteristics—Pregnancy Mortality Surveillance System, United States, 2011–2015.
|Characteristic||No. of Pregnancy-related deaths||Pregnancy-related mortality ratio*|
|Race/Ethnicity† (N = 3,400)|
|Native American/Alaska Native||62||32.5|
|Age group (yrs) (N = 3,409)|
|Highest level of education (N = 2,938)|
|Less than high school||572||19.8|
|High school graduate||1,090||24.2|
|College graduate or higher||501||9.4|
|Marital status (N = 3,371)|
|* Number of pregnancy-related deaths per 100,000 live births.|
|† Women identified as white, black, Native American/Alaska Natives, or Asian/|
|Pacific Islanders were not Hispanic. Hispanic women could be of any race.|
|Petersen EE, Davis NL, Goodman D, et al. MMWR Morb Mortal Wkly Rep. 2019;68:423-429.|
Table 2. Maternal Mortality Review Committee–Identified Contributing Factors and Strategies to Prevent Future Pregnancy-Related Deaths—Maternal Mortality Review Committees, 13 States, 2013–2017.
|Level||Contributing factor||Strategies to address contributing factor|
|Community||Access to clinical care||Expand office hours, increase number of providers who accept Medicaid, increase availability and use of group prenatal care programs|
|Unstable housing||Prioritize pregnant and postpartum women for temporary housing programs|
|Lack of, or inadequate, transportation options||Strengthen or build systems to link persons to affordable transportation, or provide vouchers for transport to medical appointments|
|Improve availability of transportation services covered by Medicaid|
|Obesity and associated chronic disease complications||Improve access to healthy foods and enhance efforts to educate and promote healthy eating habits and weight management strategies|
|Health Facility||Limited experience with obstetric emergencies||Implement obstetric emergency simulation training for emergency department and obstetric staff members|
|Ensure emergency department staff members ask about recent pregnancy history and consult with obstetrician on call if patient is pregnant or has recently been pregnant|
|Lack of appropriate personnel or services||Provide telemedicine for facilities with no obstetric provider on-site|
|Ensure Medicaid managed care organizations' contracts include sufficient access to specialists for patients at high risk|
|Lack of guiding protocols or tools to help ensure quality care provision||Ensure sepsis, hemorrhage, and massive transfusion protocols are in place and followed by staff members|
|Implement applicable patient safety bundles|
|Implement systems to foster communication among multiple providers to ensure proper case coordination|
|Implement protocols for using patient navigators|
|Patient/Family||Lack of knowledge of warning signs or need to seek care||Improve counseling and use of patient education materials on warning signs and when to seek care, such as AWHONN Save Your Life discharge instructions|
|Implement a public education campaign to increase awareness of signs and symptoms of common complications|
|Nonadherence to medical regimens or advice||Standardize patient education to ensure providers relay consistent messages and implement techniques for|
|ensuring patient understanding, such as patient "teaching back" to the provider|
|Make education materials available in the clinic and online|
|Strengthen and expand access to patient navigators, case managers, and peer support|
|Ensure access to interpreter services when needed|
|Offer home health or social work follow-up services|
|Provider||Missed or delayed diagnosis||Repeat blood pressure measurement in a timely (and possibly manual) manner when initial blood pressure result is unexpected|
|Offer provider education on cardiac conditions in pregnant and postpartum women|
|Perform thorough evaluation of patients reporting pain and shortness of breath|
|Inappropriate or delayed treatment||Only perform cesarean deliveries when medically indicated|
|Implement a maternal early warning system|
|Lack of continuity of care||Improve care transition communication among obstetrician–gynecologists and other primary and specialty care physicians|
|System||Inadequate receipt of care||Develop policies to ensure pregnant women are transported to a hospital with an appropriate level of maternal care|
|Enlist state perinatal quality collaboratives to identify quality improvement procedures and periodic drills/simulation training for birth facilities, including obstetric emergency drills|
|Design education initiatives for emergency department staff members on the care of pregnant and postpartum women|
|Case coordination or management||Extend expanded Medicaid coverage eligibility for pregnant women to include 1 year of postpartum care|
|Create quality improvement entity to manage outpatient care gaps and improve care coordination|
|Implement a postpartum care transition bundle for better integration of services for women at high risk|
|Develop procedures for all hospitals to improve documentation of abnormal test results, plan for follow-up care, and management of conditions|
|Develop universal health record system that allows for sharing of medical records among hospitals|
|Guiding policies, procedures, or standards not in place||Develop protocol for timely referrals and consults|
|Ensure all hospitals within a health care system follow the same protocols and policies|
|Abbreviation: AWHONN = Association of Women's Health, Obstetric and Neonatal Nurses. Petersen EE, Davis NL, Goodman D, et al. MMWR Morb Mortal Wkly Rep. 2019;68:423-429.|
In 1999, Knox and colleagues laid the foundation for what is now a nationwide maternal safety movement with their early application of high reliability theory (see High Reliability Primer) to the inpatient birth setting (see maternal safety Annual Perspective). Over the past decade, a number of safety bundles specific to maternity care have been developed and disseminated through perinatal improvement collaboratives. This approach ultimately became a national one, through the Council on Patient Safety in Women's Health Care and the Alliance for Innovation on Maternal Health (AIM). Two important facets of high reliability are standardization and effective teamwork, including "mindful interdependence." These concepts are integrated into the national and regionally developed maternal safety bundles, which are designed around the "4Rs" to enhance readiness for, recognition of, response to, and reporting (learning from) safety threats and maternal complications. The safety bundles, resources, implementation guides, and related education modules are freely available online (Table 3).
Table 3. Maternal Safety Bundles.
With the volume of births that occur in hospitals and the high degree of preventability of hemorrhage- and hypertensive-related deaths, emergency response at birth and in the immediate postpartum period have been the focus of the majority of maternal safety initiatives to date. However, this has begun to shift through strong community-based advocacy; increased attention from policy makers and media; and stronger recognition of the distribution of deaths across the continuum of antenatal to the full postpartum year, and the role of inequity and structural racism in producing persistent maternal health disparities.
As of May 2019, the Council on Patient Safety in Women's Health Care has posted 11 maternal safety bundles and 4 safety tools, along with implementation guidance and an ongoing series of safety action webinars. The Agency for Healthcare Research and Quality (AHRQ) has an integrated perinatal safety toolkit that includes an implementation guide, and AIM provides support for bundle implementation in participating states. AHRQ is currently implementing and evaluating the integration of vital teamwork and communication strategies from this toolkit with two maternal safety bundles. The California Maternal Quality Care Collaborative, an early developer of maternal safety bundles and implementation strategies, recently launched a Birth Equity Collaborative to address the role of racism in birth disparities. The Health Resources and Services Administration funds multiple initiatives to improve maternal health outcomes and is initiating an AIM Community Care Initiative to address maternal safety outside of the hospital. There are also multiple state and national legislative initiatives aimed at addressing the crisis in maternal health.