In the 11 years since the Institute of Medicine reported ubiquitous problems with the quality and safety of patient care in the United States, efforts been made to improve health care. Obstetrics and gynecology has made some improvements; however, similar to other areas of health care, progress has been slow. The major deterrents are complexities in our health care system and culture and an immature science of safety and quality that makes measurement and evaluation of progress difficult. This article describes the efforts that have been made in obstetrics and gynecology to identify causes or factors that contribute to adverse outcomes, to develop measures of quality and safety, and to make improvements. It also offers a framework to help organize patient safety research and improvement. Finally, this article offers ways the American Congress of Obstetricians and Gynecologists can organize and support future work.
The tipping point for the patient safety movement occurred in late 1999 when the Institute of Medicine reported ubiquitous problems with the quality and safety of patient care in the United States. Although their findings were based on several studies that had been done in the previous decade, the Institute of Medicine report finally grabbed the health care community and public attention. Since then, a flurry of quality improvement and patient safety efforts have been made on a local, national, and global scale. Nonetheless, progress has been slow. This sluggish progress stems from the complexity of our health care system and culture and from an immature science of safety and quality that makes measurement and evaluation of progress difficult.
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Obstetrics and gynecology in the United States has made some improvements in patient outcomes. The fetal mortality rate has declined by an average of 1.4% annually from 1990-2003 but has leveled off with 6.22 fetal deaths per 1000 live births in 2004 and 2005. Hemorrhage-related deaths during pregnancy are also declining; however, maternal deaths from preexisting medical conditions (eg, cardiovascular, pulmonary, neurologic) are rising. Moreover, the maternal mortality rate in 2006 was 13.3 deaths per 100,000 live births, which is far from the Healthy People 2010 projected goal of ≤3.3 deaths per 100,000 live births. Nevertheless, severe morbidity from complications and pregnancy-related conditions is reportedly 50 times more common than maternal death.
Although the field has made progress, the benefits to patients from the public investment in biomedical research fall far short of what is possible. This is largely because health care has grossly underinvested in the science of health care delivery. For every dollar the United States spends finding new genes and new drugs, it spends 2 pennies ensuring that patients actually receive those therapies. The delivery of health care is viewed too often solely as an art rather than also as a science. Most academic medical centers abound with basic and clinical researchers; few centers have similar experts in the science of health care delivery (particularly rare are human factors and systems engineers, sociologists, psychologists, anthropologists, and health services researchers). Patients still experience preventable harm from diagnostic errors, procedure-related mistakes, teamwork failures, and our failure to deliver recommended therapies. For example, studies estimate that only 80% of patients who are at risk for preterm birth receive the recommended course of antenatal corticosteroids.
The field of obstetrics and gynecology is cognizant of the need to improve quality and patient safety and is engaged actively in improvement efforts. The American College of Obstetricians and Gynecologists (ACOG) published a manual a decade ago about quality improvement in women’s health care. Efforts have been made to identify preventable obstetric errors and the causes of mortality and morbidity and to offer indicators of patient safety. Some studies suggest that between 28% and 50% of maternal deaths are preventable. The science of how to measure preventable harm, however, is still immature and should be a research priority. Because much maternal morbidity and death occurs in patients with preexisting medical problems and because pregnancy is preventable and approximately one-half of pregnancies are unplanned, maternal and infant morbidity and mortality rates may be reduced with improved access to desired contraception and sterilization. For example, only slightly more than one-half of women who request postpartum tubal ligation actually have the procedure performed during their hospital stay.
A wide range of causes or factors that contribute to adverse patient outcomes have been identified. One study found that hemorrhage, hypertension, pulmonary or amniotic fluid embolisms, infection, and preexisting chronic conditions were the leading causes of death among pregnant women between 1991 and 1997. Moreover, the most common preventable errors described in the study by Clark et al were failure to control hypertensive patient blood pressure, to diagnose and treat pulmonary embolism adequately in women with preeclampsia, and to monitor vital signs and hemorrhage adequately after cesarean section delivery. Many of these errors result from teamwork and communication failures and correspond with the causes of death that were described in the study by Berg et al. Importantly, hemorrhage during labor and delivery is a major cause of maternal morbidity and death; pulmonary embolism is 1 of the top 3 causes of postpartum death among mothers.
Perinatal death or permanent disability remains on The Joint Commission’s list of top 10 sentinel event types for 2008. In a 2004 alert, they identified a variety of causes for the 47 perinatal deaths or permanent disabilities that were reported between 1996 and 2003, which is likely a significant under reporting. Communication problems were the main causes in 72% of cases, with organizational culture (eg, hierarchy/intimidation, poor teamwork) noted as a barrier to effective communication in 55% of cases. Staff competency (47%), orientation and training (40%), inadequate fetal monitoring (34%), unavailability of monitoring equipment or drugs (30%) or prenatal information (11%), credentialing/privileging/supervising issues for physicians and nurse midwives (30%), and staffing (25%) were other causes that were identified by the Joint Commission.
Providers, government agencies, professional societies, and regulators have proposed or established measures or indicators of quality and safety. Table 1 gives a list of maternal and fetal complications or emergencies that occur during labor and delivery in which process measures could be developed. The Agency for Healthcare Research and Quality also has a list of hospital-level patient safety indicators with a portion of them applicable to perinatal and neonatal care ( Table 2 ). Finally, the Joint Commission has transitioned their patient safety goal of recognizing and responding to changes in a patient’s condition to the level of a standard in 2010 (PC.02.01.19) for critical access and other hospitals. This standard requires hospitals to have a written protocol/process that describes the early warning signs of a change or deterioration in a patient’s condition (made specific to a clinical area), when to seek assistance, and how to provide patients and families with a name and contact information should they have concerns about a patient’s condition. Like all fields, obstetrics and gynecology needs measures that are valid and reliable, meaningful to clinicians, and feasible to collect. This requires that physicians develop skills in measuring quality and lead efforts to develop measures. Too often, clinicians believe measures are thrust on them. When measures are not valid, clinicians should push back, but they should also work to develop better measures, measures that reflect clinical excellence and quality of care.
| Maternal | Fetal |
|---|---|
| Placental abruption | Indeterminate or abnormal fetal heart rate pattern/indeterminate or abnormal fetal status |
| Uterine rupture | Prolapsed umbilical cord |
| Magnesium sulfate toxicity | Uterine tachysystole |
| Eclampsia | Second-stage fetal intolerance to pushing |
| Amniotic fluid embolism | Shoulder dystocia |
| Postpartum hemorrhage | Emergent cesarean birth for nonreassuring fetal status |
| Indicator | Definition |
|---|---|
| Complications of anesthesia | Anesthetic overdose, reaction, or endotracheal tube misplacement |
| Death in low-mortality diagnosis-related groups | In hospital deaths of patients with <0.5% mortality rate; excludes trauma, immunocompromised, and cancer patients |
| Postoperative hemorrhage or hematoma | Postoperative hemorrhage, postoperative hematoma, postoperative control for hemorrhage (must occur on same day or after principal procedure), or drainage of hematoma; excludes immunocompromised or cancer patients |
| Selected infections because of medical care | Excludes immunocompromised or cancer patients |
| Transfusion reaction | Cases of transfusion reaction |
| Birth trauma: injury to neonate | Cases of birth trauma; excludes some preterm infants and infants with osteogenic imperfecta |
| Obstetric trauma | |
| Cesarean delivery | Cases of obstetric trauma (fourth-degree lacerations, other obstetric lacerations) |
| Vaginal delivery with instrument | Cases of obstetric trauma (fourth-degree lacerations, other obstetric lacerations) with instrument |
| Vaginal delivery without instrument | Cases of obstetric trauma (fourth-degree lacerations, other obstetric lacerations) without instrument |
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