Solutions in Sight

Executive Summary

The United States has a poor childbirth safety record, likely due in part to the failure of obstetrics practitioners to develop and adhere to standardized practices. In the past 15 years, methods to improve perinatal safety have been developed and adopted at certain organizations. These initiatives have been remarkably successful at reducing infant deathsand other adverse outcomes, according to the providers’ reports. But this cause forcelebration is tempered by experts’ agreement that generally accepted best practices have not been comprehensively implemented across the country. This would appear to yield a conclusion that otherwise avoidable tragic events are likely continuing to occur where practices with demonstrated track records of reducing harms have not been put into place.

Childbirth Safety Outcomes in the United States Are Dismal Compared to Other Wealthy Nations

About 4 million babies are born in the United States every year and nearly 25,000 die during their first year of life. The CIA World Factbook ranked the U.S. infant mortality rate 56th among countries and territories in 2014, at 6.2 deaths per 1,000 births. That was nearly twice the rates of France, Italy and Spain (which each were at 3.3 per 1,000) and nearly three times the rate of Japan (2.1 per 1,000). Reducing the U.S. infant mortality rate to the levels of France, Italy and Spain would save more than 10,000 lives a year.

Meanwhile, the United States is one of the few countries in the world with a rising maternal mortality rate. In the past quarter century, the U.S. ranking in that indicator has fallen from 22nd in the world to 60th.

Several Findings Call the Quality of U.S. Obstetric Care Into Question

Although quality of care is not the only explanation for the dismal statistics on the safety of childbirth in the United States, evidence suggests that it is likely at least partially to blame.

For instance, outcomes vary greatly by provider. Even after accounting for demographicdifferences and other factors out of providers’ control, deliveries at low-performing hospitals are two to five times more likely to involve unexpected medical complications as those at high-performing hospitals, a study published in Health Affairs in 2014 concluded.

“Our finding of a large gap in quality in obstetrical care between high- and low-performing hospitals has important policy implications for maternal health,” the authors of the study wrote. “If this performance gap could be narrowed, it could lead to substantial improvements in obstetrical outcomes for large numbers of women.”

Many experts have faulted the obstetrics profession for having inconsistent practice patterns. This has been illustrated in widely varying frequency in the use of cesarean section deliveries. A national study of a year’s births published in Health Affairs in 2013 found that the cesarean rate varied by provider from 7.1 percent to 69.9 percent for all deliveries and from 2.4 percent to 36.5 percent for low-risk pregnancies. The fifteenfold variation for low-risk pregnancies “indicated a wide range in obstetric care practice patterns across hospitals and signaled potential quality concerns,” the researchers wrote.

Concerns over obstetrics practitioners’ varying practice patterns are consistent with criticisms of the medical profession as a whole. In 1999, the prestigious Institute of Medicine shocked the nation by reporting that between 44,000 and 98,000 U.S. patients were dying every year because of avoidable medical errors. Among the IOM’s conclusionswas that most medical errors were caused by “faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them.”

A Corpus of Practices Has Been Developed Over the Past 15 Years to Improve Childbirth Safety

In sync with the medical profession’s effort to heed the IOM’s call for improved systems andin response to concerns over medical malpractice litigation, obstetricians and other health care quality specialists have over the past 15 years developed several related practices aimed at reducing adverse outcomes in childbirth.

These practices, each of which has sought to foster standardization, fit into three broad categories:

1. Conducting training in communications and empowering all employees to speak up if they perceive an unsafe situation. Such training programs often incorporate simulations of emergency medical events. A study by the Joint Commission, which accredits hospitals to be eligible to receive Medicare payments, found that problems in communications figured in 65 percent of catastrophic events involving childbirth.
2. Implementing “bundles,” which are groups of essential practices that must be used in scenarios posing special risks, such as when inducing labor.
3. Reducing unnecessary cesarean section deliveries. Although recognized as medically necessary in certain instances, experts generally agree that the rate of cesarean deliveries in the United States is too high. Cesarean use has risen from 21 percent of deliveries in the mid-1990s to nearly 33 percent in recent years. A consensus exists that cesarean procedures pose health risks to mothers and babies, and should only be undertaken for medical reasons. Numerous studies have concluded that cesareans are sometimes initiated for nonmedical reasons, such as convenience for either the doctor or patient, or compensation for providers.

Related to items 2 and 3 above, a concerted campaign in recent years has sought to eliminate elective deliveries by inductions or cesareans prior to 39 weeks of gestation. The American Congress of Obstetricians and Gynecologists (ACOG), the primary professional association of obstetricians, has since 1979 recommended against initiating delivery before 39 weeks unless medically necessary. But many practitioners ignored this advice, and the rate of deliveries at 37 and 38 weeks (elective and otherwise) rose from 20 percent in 1990 to nearly 29 percent in 2006, before tapering off to just under 25 percent in recent years. Numerous studies have found that the risk of complications for babies born from normal pregnancies at 37 weeks is significantly greater than for those born at 39 weeks.

Spurred by lobbying efforts by the March of Dimes Foundation and accumulation of research evidence, nongovernmental organizations and Medicare have in the past half- decade begun requiring providers to report on their rates of early-elective deliveries. Meanwhile, several insurance companies and state governments have recently instituted policies of reducing or eliminating payments for these deliveries. This effort has achieved significant, but not complete, success. The Leapfrog Group reported that the rate of early- elective deliveries fell from 17 percent of all births in 2010 to less than 5 percent in 2013. Medicare reported a 64 percent drop from 2010 to 2013. But rates among states still vary from 2 percent to 22 percent, the National Quality Forum reported in 2014.

Results of Safety Initiatives at Select Institutions Show Remarkable Success

This report recounts initiatives to improve safety in childbirth at four health care organizations. These organizations’ inclusion in this report does not mean that they are the only ones to institute obstetric safety programs. The initiatives enumerated here resulted in remarkable reductions in untoward outcomes for patients, according to the organizations’reports. For example:

Hospital Corporation of America, the largest obstetrical health delivery system in the United States, reported:

• Maternal fatalities from pulmonary embolism were reduced by 86 percent;
• Maternal deaths from hypertension were reduced by 77 percent;
•  Overall maternal deaths, excluding patients who entered the hospital with terminal

  conditions, declined by 19 percent; and

• Obstetrics litigation claims were reduced by two-thirds.

  New York Presbyterian Hospital-Weill Cornell Medical Center, which delivers about 5,000 babies a year, reported:

• Incidence of hypoxic-ischemic encephalopathy, a brain injury caused by oxygen deprivation, was 98 percent lower than the national average;
• Sentinel events, which refer to unexpected occurrences involving death or serious physical or psychological injury, were cut to zero during the final two years reported upon; and
• Obstetrics litigation costs were reduced by 99 percent.
  Ascension Health, the third-largest health care network in the United States, reported:

  Reducing incidence of birth trauma at its safety program’s pilot sites by 85 percent over the first three years and to zero in the fourth year. (Birth trauma refers to harm to a newborn that requires medical intervention.);

•   Achieving a systemwide 33 percent reduction in its birth trauma rate in the first two years after broadening its initiative to each of its 43 hospitals; and
• Reducing neonatal fatalities (referring to death in the first 28 days of life) by nearly 50 percent in first two years of systemwide implementation of its safety program.

  Premier Inc., a health care alliance, reported that a safety initiative encompassing 16 of its member institutions was successful in:

• Reducing birth trauma among full-term newborns by 74 percent;
• Reducing birth hypoxia and asphyxia, which are associated with causing brain

  damage, by 31 percent; and

• Achieving a 38 percent reduction in preventable neonatal intensive care unit

  admissions of full-term babies.

  The Ascension and Premier initiatives were bolstered in 2010 when both were awarded $3 million grants from the federal government’s Agency for Healthcare Research and Quality (AHRQ) to continue and expand their safety programs. Results from those grant-funded research projects have not yet been released, except in anecdotes. However, numerous papers incorporating data from the projects are forthcoming, individuals familiar with the grants have told Public Citizen.

  Meanwhile, AHRQ has issued a $5.4 million grant to Research Triangle Institute (RTI) to use findings from the AHRQ grant-funded projects and other sources to create a perinatal safety program, then implement it in 50 hospitals.

  Adoption of Standardized Practices Is Not Comprehensive

  Measuring the degree of adoption of safety practices is challenging for various reasons, but experts agree that implementation of recommended safety practices is not comprehensive. The highly varying use of cesareans and the rise in the past two decades of early-electivedeliveries support a conclusion that the obstetrics profession’s adherence to standards hasbeen inconsistent. In response to an inquiry from Public Citizen, ACOG described adoption of “updated and new best practices” as “variable.”

  Conclusion

  The extraordinary progress of some institutions in reducing adverse outcomes in childbirth is cause for celebration. However, indications that methods with demonstrated records of success have not been comprehensively implemented suggest that otherwise avoidable tragic events are likely continuing to occur at non-adopting hospitals.

  Some experts credit the obstetrics profession in recent years with improving its adherence to standardized practices, such as in reducing early-elective deliveries. They attribute much of this progress to reporting requirements and changes to payment policies. The success of these methods should serve as a model for stakeholders to compel adherence to other proven safety practices.