Chapter 12. Patient Safety in the Ambulatory Setting

The point has been well made that while most of the patient safety literature focuses on hospital errors, most healthcare is delivered in office settings. Consider this: for every one hospitalized patient, 28 people visit a physician's office.1 Nevertheless, the early emphasis on patient safety in the hospital was natural: the stakes are higher, errors are more visible, and the resources to research safety problems and implement solutions are all greater there.

The scope of potential errors is also broader in the hospital. Although both settings are beset by medication and laboratory errors, and both inpatient and outpatient errors center on transitions of care and communication problems, the ambulatory setting will see fewer surgical errors (although the rapid increase in outpatient surgery makes these a growing problem) and healthcare-associated infections, pressure ulcers, and blood clots are lesser concerns. Moreover, the research focus on hospital safety also reflects the disproportionate emphasis by academic health centers on hospital care.

But interest in ambulatory safety is growing rapidly, accompanied by a number of new research and practice initiatives. Recent studies have shown that nearly 10% of adverse events occur in physician offices;2 adverse drug events and diagnostic errors are particularly common.3,4 Growing experience from outpatient-based patient safety networks indicates that ambulatory practices should focus on two main risky areas: prescription medications and the processing of lab, x-ray, and diagnostic tests.5,6 Both areas will likely be transformed by the implementation of ambulatory electronic health records and computerized prescribing, presently being driven in the United States by incentive payments to office practitioners who implement information technology (IT) systems that meet certain standards of functionality and interoperability.7,8

Sarkar et al. have proposed a model for ambulatory safety9 modified from the Chronic Care Model described by Wagner et al.10 It encompasses the three interrelated roles and relationships that influence outpatient safety:

• The role of the community and health system
• The relationship between patients and providers
• The role of patient and caregiver behaviors

The model emphasizes that ambulatory safety involves more than simply improving the flow of laboratory tests and consultations (as important as it is to fix the many problems in these systems). Errors and adverse events may relate to problems in each of these areas, and the patient's role is particularly important. Far more than in the hospital, in the ambulatory setting some patients may become unwitting participants in the genesis of errors, while others may assume some degree of responsibility for catching mistakes (Chapter 21).

This chapter highlights some of the emerging literature on ambulatory safety and reflects on some of the differences between the hospital and the clinic that may impact efforts to improve safety in the latter setting.11

In the ambulatory world, the pace is slower and the rhythm more predictable (generally driven by a patient visit schedule) than in the hospital. The average error in the office is less consequential, because patients are less fragile and their medications and procedures are less potent (although the cumulative impact of errors may be surprisingly large because the volume is so high). In the hospital, much of the “action” centers on the patient's room—when the patient travels, the distances are relatively short (to the operating room, to the radiology department) and the patient remains within the same system. In the ambulatory environment, on the other hand, the patient may travel many miles to obtain a test or see a specialist, often traversing practices that use different information systems and have vastly different clinical and operational cultures and policies (Chapter 8).

The structural and organizational differences may be even more important than the clinical ones. In all but the tiniest hospital, the scale is such that it is possible to have individuals on staff who specialize in safety-related tasks (Chapter 22). For example, even a modest-sized hospital is likely to have a quality officer, a compliance officer, a risk manager, and several IT experts. A larger hospital will have armies of people in these departments, and may even employ a human factors specialist and a patient safety officer. In the average small office practice, a physician (or nurse or practice administrator) will wear all of these hats. Moreover, because none of these specialized staff members generate patient care revenue, the ability of a small practice to support them is far more limited than in the hospital (of course, they don't produce revenue in the hospital either, but they can be cross-subsidized by lucrative activities that do).

There are other important policy and cultural differences that influence ambulatory safety. Office practice is less highly regulated, and, because most of the care takes place behind closed doors (with just doctor and patient in the room), it is easier for errors to avoid the light of day. Even the cultural issues (Chapters 9 and 15) have a very different flavor. For example, consider programs that aim to improve physician–nurse relationships and dampen the steep authority gradients that are often present in healthcare settings. In American hospitals (where the physician is usually self-employed while the nurse works for the hospital), the shape of such programs is likely to be very different from the office, where the doctor is frequently the nurse's employer.

Many of these differences would appear to favor the hospital as an environment to establish a flourishing patient safety enterprise. However, the ambulatory setting also has unique advantages. First, simplification, standardization, and the implementation of IT may yield more palpable efficiency advantages. When a single clerk or nurse is working with three physicians in an office practice, the impact of implementing a standard procedure for following up lab results is often profound. And the office space freed up by converting to a paperless medical record system can yield major economic advantages for a practice. Second, efforts to engage patients in helping to ensure their own safety are more likely to be productive (Chapter 21), because ambulatory patients are less apt to be mentally slowed by their disease or medications or distracted by anxiety. In addition, ambulatory patients are better able to intervene (because there are fewer tests and procedures and the pace is slower) when they see something amiss.

The previously mentioned organizational structure of most American outpatient practices can become another advantage. In many hospitals, the doctors are not particularly invested in the safety enterprise (because they use the hospital to provide care but don't own the organization), whereas most office practices in the United States are owned by the physicians themselves. The old saying “nobody ever washes a rented car” helps explain the challenge faced by those who try to engage office-based or other nonemployed physicians in hospital safety efforts (Chapter 22).

The implications of these ambulatory versus hospital differences will be important as we turn our attention to outpatient safety. Most clinics will be able to identify a relatively small number of common but risky practices on which to focus their safety efforts, such as medication prescribing, follow-up of laboratory and x-ray test results, and communication with referring physicians and hospital providers. Gordon Schiff, in a far-reaching discussion of a delayed diagnosis of a renal mass, highlights a number of Swiss cheese–related (Chapter 2) problems, along with the many opportunities for improvement in ambulatory test follow-up (Table 12-1).12

Note that a robust electronic backbone is only one component of an improved system. As with IT in all healthcare settings, it is relatively easy—natural, even—to think of IT as the Holy Grail: “if we just had a good IT system” is a common refrain. And there is no question that the need for such systems exists—just consider these sobering statistics:

• In a typical week, the average primary care physician is responsible for following up on 800 chemistry/hematology tests, 40 radiographs, and 12 pathology specimens.13
• Forty percent of patients have hospital test results that return after hospital discharge, with both hospital and primary care physicians often unaware of the (sometimes crucial) results.14
• Fewer than half of primary care physicians are satisfied with their system for managing test results, more than four in five reports having had at least one test result “they wished they had known about earlier” in the prior two months.15
• More often than not, some crucial piece of information (lab and radiology results, consultant and pathology reports, procedure notes, and more) is missing in primary care visits.16 Another study showed that information from one outpatient visit was available at the next visit less than one-quarter of the time.17

Unfortunately, early evidence from ambulatory IT implementations demonstrates that IT is not a panacea. One primary care group nearly broke up over the challenges that accompanied implementing a new system (after the dust settled, none of the physicians could imagine going back to paper, though).18 More sobering, several recent studies have found persistently high rates of errors in both medication and radiology information flow even after IT implementations,19–21 and thus far there is no evidence that the presence of an ambulatory health record is associated with improved quality.22

At the same time, it is inconceivable that we can achieve highly reliable ambulatory care without effective IT. These sobering results simply illustrate, as always, that building and implementing IT is harder than it looks, that systems need to evolve based on provider and patient feedback, and that human factors need to be considered in the development and implementation of these systems (Chapters 7 and 13). Given both the limitations of IT systems and the fact that most ambulatory practices will not have them for the next few years, Nancy Elder's commonsensical steps that can be taken to improve ambulatory medication and test management safety are worth reviewing (Tables 12-2 and 12-3).5

The role of the patient is crucial in ambulatory safety, particularly since patients spend so little time with their providers. Strong emphasis should be placed on patient education (using proven methods such as the “teach back”23) and empowerment, with particular attention paid to the issues of health literacy and cultural differences. We will discuss these in more detail in Chapter 21.

Overall, improving safety in the ambulatory setting will not necessarily be harder or easier than in the hospital, just different.11 As with much of the patient safety field, which often involves extrapolating experiences (Table P-1) from other settings (i.e., Will crew resource management, which worked so well in commercial aviation, work in the labor and delivery suite? Will bar coding, which works so well in the supermarket, actually decrease medication errors?), it will be important to remain sensitive to the differences in structure and culture as we try to translate what we know about safety from the hospital to the office setting.

While ambulatory safety was all-but-ignored during the first few years of the safety movement, research funders, accreditors, regulators, and specialty societies have come to appreciate its importance, as have patients and their advocates. All these stakeholders are beginning to exert their influence in this setting, so the next few years will see far more patient safety activity in the ambulatory arena, and far more pressure to improve.

• Until recently, the patient safety field's focus has been on hospital safety. Attention is now shifting to the ambulatory setting.
• Efforts to improve ambulatory safety should initially focus on decreasing medication errors and improving the management of test results.
• In approaching ambulatory safety, it will be important to appreciate major clinical, structural, and organizational differences between the hospital and the office. These include the inability to support specialized experts in many safety-related areas, and the employer–employee relationship between physicians and many nurses and other staff found in most U.S. office practices.
• The development and implementation of effective IT tools is essential to improving ambulatory safety, particularly in the areas of medication management and test results handling. Early experience with ambulatory IT has been sobering, with unexpectedly high rates of errors. Effective systems will need to integrate provider and patient feedback and take better account of human factors.