Improving Ambulatory Patient Safety: Title and subTitle BreakLearning From the Last Decade, Moving Ahead in the Next

The 1999 Institute of Medicine report To Err Is Human: Building a Safer Health System¹ launched the modern patient safety movement by estimating a large number of yearly error-related deaths among hospitalized patients in the United States.¹ But 12 years later, there are no reliable data on how many patients in the United States are injured or die each year because of errors in ambulatory settings. The number may be substantial; 52% of paid medical malpractice claims in 2009 were for events in the outpatient setting, and two-thirds of these claims involved major injury or death.²

More than 10 years ago, a group of experts convened by the Agency for Healthcare Research and Quality (AHRQ) reported that “medical error and injury are substantial in ambulatory care, [but] there has been little systematic research specifically aimed at patient safety questions in ambulatory care.”³ To jump-start a new research agenda, the conferees made 11 specific recommendations. Virtually none have been implemented.

Marking the 10-year anniversary of To Err Is Human recently, experts have noted some modest improvements in hospital safety while emphasizing the “frustratingly” slow pace of change despite substantial investments in research and numerous policy and regulatory activities.⁴ However, in ambulatory safety no such multifaceted efforts have been made and there are few data to suggest any improvement; in fact, there are few data at all.

A recent review of research on ambulatory safety between 2000 and 2010, including published literature, private initiatives, government grants, and legislative and regulatory efforts,⁵ found that major gaps persist in understanding of ambulatory safety and virtually no credible studies have shown how to improve it; studies have come mainly from a few unique centers and largely rely on self-reported data.

The reasons for this relative lack of studies on ambulatory safety are diverse. Inpatient safety consumed many of the available resources, researchers tend to work in academic hospitals and focus on the inpatient setting rather than the ambulatory setting, and other infrastructure for ambulatory safety research is diffuse or nonexistent. Compounding these factors are some inherent differences between the inpatient and outpatient settings. In particular, hospitalized patients experience more errors of commission, such as surgical injuries, whereas errors of omission, such as diagnostic delays, are a greater concern in outpatient facilities,⁶ which could contribute to a sense that errors that occur during inpatient care have more serious ramifications. Also, the role of patients in self-care is often more complex in the ambulatory setting, making the study of adverse events more difficult than in the inpatient setting.

Following this “lost decade” in ambulatory safety, a new, refocused national agenda is needed. The following proposal suggests national adoption of 5 core aims for improving ambulatory patient safety, to be accomplished over the next 10 years.

First, collect basic data on how many patients experience health care–related harms in the ambulatory setting by conducting a large national study on the epidemiology of ambulatory patient safety. Epidemiologic studies of inpatient error were helpful for understanding inpatient safety and critical for building public support for efforts to improve. The concept of a national ambulatory safety study was raised by the AHRQ conferees 10 years ago but was seen as posing logistic and political challenges and deemed “valuable, but not essential to improving ambulatory patient safety.”³ In retrospect, this judgment was probably incorrect. A national incidence study on the epidemiology of ambulatory patient harms is an essential starting point for efforts to improve safety in the outpatient arena. This investigation should use accepted tools, like an outpatient global trigger tool to screen for errors, followed by chart review to detect harms in a large sample of ambulatory clinic settings, including ambulatory practices affiliated with large systems, like Kaiser or the Department of Veterans Affairs, as well as small, office-based practices.

Second, identify an early achievable goal. Although research on ambulatory safety is relatively meager, some valuable lessons have been learned. Attention and resources should be focused on issues for which research suggests early success is likely. For example, lack of timely follow-up among outpatients with abnormal laboratory and imaging test results is a common error in the ambulatory arena, which leads to harms, and there are promising ways to track and improve performance in this regard.⁷ A coordinated campaign would be needed, however, including the adoption of new performance measures (eg, the National Quality Forum has endorsed a number of ambulatory quality measures but none on the follow-up of abnormal test results) and support for outcome testing of interventions.

Third, engage patients and their families as equal members of ambulatory safety improvement teams. Recent and future changes in health care delivery often have patients assuming more responsibility for managing their own care. The effects of these changes on safety may be substantial and are certain to be marked by unintended consequences. While the 2001 AHRQ consensus conferees urged research on whether patients might be able to report reliably on safety in the ambulatory setting,³ patients and families can and should do more than detect errors. The experiences of patients and families regarding ways to improve their capacity to help ensure safe care deserve special focus. There are also roles for community organizations in ensuring safe care; however, these organizations often have been overlooked because they have had little presence in the inpatient setting. These organizations should receive greater attention in the ambulatory setting.

Fourth, link the agenda for ambulatory safety to related high-profile initiatives to improve inpatient safety. Specifically, the current focus on care transitions and reducing hospital readmissions⁸ should emphasize, study, and support the critical roles of ambulatory care clinicians in ensuring patient safety before, during, and after hospitalizations. Such an emphasis would acknowledge that admissions to and discharges from a hospital are, functionally, handovers of patient care responsibilities between hospital-based teams and teams of outpatient care practitioners. Much could be done to improve the coordination and functioning of outpatient teams, building on what has been learned from inpatient team-building efforts. For instance, initiatives such as medication reconciliation should focus on closing the loop between inpatient and outpatient medication management.⁹

Fifth, although the 2001 AHRQ consensus conferees encouraged “demonstration” projects, the subsequent lack of such projects demonstrates the need for networks of ambulatory clinics capable of conducting research. One reason little research has been conducted on ambulatory safety is that there is little infrastructure to support this research. Most major studies in this area are from ambulatory centers linked with large inpatient facilities, often academic in nature, although most ambulatory care does not take place in academic medical centers. During the next 10 years, a national system of clinics and practices should be developed as ambulatory safety laboratories. These centers should be properly equipped and resourced to conduct experiments with new models of care, reporting systems, and other ambulatory safety interventions.¹⁰

Many other aspects of ambulatory patient safety must be addressed beyond these proposed 5 core aims. As examples, the safety of outpatient anesthesia is an increasing concern; failure to diagnose remains a more common problem in ambulatory care than in the hospital setting; there are safety risks as well as benefits of health information technology in the ambulatory setting; more research is needed on safe patterns and methods of communication with patients and within and across teams and organizations; and the overuse of ambulatory medical services should be explored as a safety issue. A national focus on achieving the proposed 5 core aims could help provide the interest, infrastructure, and support needed to address these and many other issues in ambulatory patient safety in a more productive manner.