Patient Safety and Quality Measurement in Obstetric Care

Patient Safety

Frequency of Preventable Obstetric Adverse Events

Many studies that have sought to determine the frequency of preventable obstetric adverse events have used retrospective designs and studied in detail the cases in which adverse outcomes have occurred. The overall frequency of preventable adverse events on a given obstetric unit cannot be determined from these studies. This is particularly true given that adverse events, such as administration of a medication to which the patient is stated to be allergic, may occur that do not result in an actual adverse outcome (e.g., anaphylactic shock). However, these studies do give insight into the frequency with which the adverse outcome may have been preventable when such an outcome occurs.

Geller and colleagues analyzed cases of morbidity and mortality that occurred at their institution. These cases included those with severe and “near-miss” morbidity. It should be emphasized that so-called near-miss morbidity is not so named because a woman nearly misses having morbidity but because she nearly misses a mortal event. Thus in their framework, maternal morbidity has a spectrum of severity, and none is more severe than near-miss morbidity. In their study, morbid and mortal events were often found to be preventable, and a preventable event was defined as one that could have been avoided by any action or inaction on the part of the health care provider (e.g., mismanagement of patients and failure or delay in diagnosis), the system (e.g., failure in communication), or the patient (e.g., noncompliance). Moreover, women who had the most adverse outcomes were more likely to have had preventable events: 16% of cases with severe morbidity were judged preventable versus 46% of near-miss events and 41% of mortal events.

Berg and colleagues focused exclusively on maternal deaths that occurred in North Carolina. They studied the circumstances surrounding the pregnancy-related deaths of 108 women between 1995 and 1999. Deaths were considered potentially preventable if (1) preconception care and counseling could have improved outcome, (2) the patient had not adhered to medical advice, (3) the structure and functioning of the health care system was suboptimal, or (4) clinical care was not satisfactory. In their study, 40% of deaths were considered to be preventable, although this frequency significantly differed on the basis of the primary underlying cause of death. For example, 93% of deaths related to hemorrhage but only 22% of deaths related to cardiomyopathy were thought to be preventable.

White and associates examined 90 cases that resulted in litigation and in which the claims had been closed. It should be noted that these cases included both gynecology and obstetrics cases, although the majority were related to obstetrics. In their study, 78% of these cases were thought to have a contributing factor that was potentially avoidable. Clark and colleagues also analyzed claims data and focused only on those claims related to perinatal care. Their findings were quite similar to those of White and associates; specifically, they noted that 70% of cases were potentially preventable and related to the care the patient received in the hospital.

Forster and coworkers did attempt to quantify the frequency of adverse events that occur on an obstetric unit through the use of a prospective study. These investigators placed an observer—trained to ascertain poor patient outcomes, procedural errors, and unsafe working conditions—in the labor-and-delivery unit during the weekday hours of a 6-week period. Cases of concern that were ascertained by the observer were then further evaluated by a multidisciplinary team. The primary outcome of the study was the occurrence of a “quality problem,” defined as the occurrence of either an adverse event—that is, an adverse outcome due to health care management as opposed to progression of natural disease—or a potential adverse event (i.e., “defective processes that have a high likelihood of causing harm”). Of the more than 400 patients who were cared for during the study period, 5% experienced a quality problem (i.e., 2% had an adverse event and 3% had a potential adverse event). Sixty-six percent of the adverse events that occurred were judged to be due to errors in health care delivery.

Factors That Contribute to Preventable Adverse Events

The existing literature would suggest that multiple contributors are involved in the occurrence of adverse obstetric events. Data from the Joint Commission, for example, illustrate the contributions that multiple factors make in the occurrence of major adverse maternal and perinatal outcomes. For example, their analysis of major maternal adverse events revealed multiple root causes, including lack of adequate communication, training, staffing, and patient assessment. Other investigators similarly have found that preventable adverse events or potential events cannot be traced to one simple and easily remediable cause but are multifactorial and due to a complex interplay of factors. Geller and colleagues have demonstrated the many different factors present at both the provider and systems level and that have contributed to adverse events.

Despite many factors that have been implicated in the occurrence of preventable adverse events, it is worth noting that communication and “systems” issues that transcend simple individual error have consistently been found to be predominant etiologies in the occurrence of these events. Systems issues is a term referring to problems that stem not from one individual's actions but from the interconnected relationships of people and institutional policies. With regard to the sentinel events in maternal care analyzed by the Joint Commission, a communications issue was judged to be a root cause in over 80% of cases. This frequency far outstripped the next most frequent factors, competency and patient assessment, which were present in fewer than 40% of cases. In their review of closed claims, White and associates noted that inadequate communication among providers was the single most common preventable factor associated with the claim. Similarly, in their prospective study, Forster and colleagues noted that “systems” issues were the most common reason that their trained observer was alerted to further assess for the possibility of a quality problem.

Approaches to Improve Obstetric Safety

The previous discussion highlighting the different factors that contribute to patient safety suggests that efforts to improve safety may require multiple different approaches. The potential need for a multifaceted approach is further suggested by the different levels within an organization at which these factors can manifest. Specifically, key components required for the prevention of adverse events occur at (1) the individual level, such as the level of education or training provided to workers; (2) the group level, as with team effectiveness and communication; and (3) the structural level, such as the standardization of processes within an organization. Correspondingly, attempts to enhance patient safety within obstetrics have utilized, in general, several different types of modalities. The theoretic underpinning to believe that these modalities should be effective—as well as the evidence supporting their use with a focus on obstetrics—is discussed further on.