Chapter 3. Safety and Quality: The Guiding Principles of Patient-Centered Care

1. The patient should be the focus of anesthesia care.

2. The goal of anesthesia care must be to ensure that no patient is harmed.

3. Preventing harm is challenging because care is complex and serious adverse events are relatively rare and often the result of many causes rather than a single one.

4. Serious adverse events are usually the result of weaknesses in the "system" of anesthesia care, not the fault of incompetent clinicians.

5. To prevent adverse events, a strategy is needed, not simply vigilance.

6. Organizations, departments, and groups must use a top-down approach and a commitment to creating a safe environment and system for safety.

7. Safety must be the number 1 priority to create an organization that operates at the highest level of reliability.

8. Anesthesia professionals must employ a broad array of safety tactics.

9. Teamwork and communication among the perioperative caregivers are critical components of patient safety.

Anesthesia providers develop a comfort with their craft, despite its inherent dangers. Over time, the administration of potentially lethal drugs, the management of apnea, and the control of altered physiologic systems become almost routine. With experience, they may even take for granted the inherently hazardous art and science of rendering patients insensible to pain, unconscious, and paralyzed. Yet patients do not take anesthesia for granted. To the contrary, they fear the possibility of experiencing pain or awareness, as well as the potential for death or other serious complications.1,2 They also fear what professionals might consider "minor complications"; patients often view postoperative nausea and vomiting as dreaded and prominent complications associated with the procedure.

This chapter focuses on patient safety and quality and is based on the principle that the patient is the center of care. The person or team performing the procedure will have medical requirements that are embedded in the anesthetic plan, but the patient's concerns, fears, values, and expectations also must be addressed. Although that may seem obvious, historically, the design of health care systems, including anesthesia care, has been centered on the needs and convenience of the providers and the facility. The underlying concept was that quality of care alone was enough, whereas quality of service (ie, "patient centeredness") was relatively insignificant in the process. That concept is changing, and this chapter begins by emphasizing that patient perceptions must be considered in the design of a safe, high-quality anesthetic experience.

The patient's most fundamental needs are for high quality and complete safety. Meeting these expectations demands knowledge, skills, and continuous vigilance. Equally important is a system that ensures safe practitioners; provides the appropriate drugs, technologies, policies, and procedures to foster safe practice; monitors performance of the entire process (including both outcomes and patient satisfaction); identifies safety and quality problems; and implements corrections. All of these demand a culture of safety and quality at all levels of the system, a culture that supports these needs not just in words but in deeds and actions.

In 2001, an Institute of Medicine (IOM) committee identified patient safety, quality of care, and patient-centered care (ie, individualized care) as progressively increasing levels of excellence in the overall health care process.3 This view is consistent with the tenets of other organizations that serve the public while dealing with potentially lethal outcomes (eg, the commercial aviation industry). In short, safety is the foundation on which quality (eg, the application of evidence-based approaches) and then patient-centeredness are built, but all are required to meet the goal of highest-quality care.

The demands for quality and safety start with the patient's needs guided by the needs of the physicians performing the procedure (medical, surgical, or diagnostic) that requires anesthesia care. Sometimes these are competing expectations, requiring thoughtful tradeoffs based on essential priorities. When balancing these tradeoffs, involvement of the patient is a key to positive patient satisfaction with the overall process.

Every subsequent chapter in this text has the delivery of safe and high-quality care as its primary objectives. This chapter defines a strategy and generic principles for achieving these objectives, centering on the patient while also meeting the other demands of modern perioperative care. Subsequent sections in this book provide specific elements of evidence-based anesthesia care that are required to meet these strategic objectives.

The key terms commonly used to discuss quality and patient safety include the following:

• Patient-centered care encompasses the qualities of compassion, empathy, open and complete communication, and responsiveness to the needs and preferences of each patient.3
• Quality of care is the extent to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.4
• Patient safety is the avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the processes of health care. These events include "errors," "deviations," and "accidents." Safety emerges from the interactions among the components of the system; it does not reside in a single person, device, or department. Improving safety depends on learning how safety emerges from the interactions of the components through analysis of "near misses" and adverse outcomes or injuries. Patient safety is a subset of health care quality.5
• Quality improvement. The US Agency for Healthcare Research and Quality defines high-quality health care as "doing the right thing, at the right time, in the right way."6 Quality improvement is the process used by individuals and organizations to ensure that these goals are met through a system of constant scrutiny, measurement, review, and revision.7
• Adverse event is an injury caused by medical management that results in measurable disability.8
• Accident is an unplanned, unexpected, and undesired event, usually with an adverse consequence.9
• Error is when a planned sequence of mental or physical activities fails to achieve its intended outcome and these failures cannot be attributed to the intervention of some chance agency.10
• Near miss is an event or situation that could have resulted in an accident, injury or illness but did not, either by chance or through timely intervention.7 Also known as close call or near hit.
• Human factors refers to the scientific discipline concerned with understanding interactions among humans and other elements of a system, and to the profession that applies theory, principles, data, and methods to design so as to optimize human well-being and overall system performance.11
• Risk management is the clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury to patients, staff, and visitors, and to identify, evaluate, and reduce the risk of loss to the organization itself.12

The concepts of quality and safety are a continuum. Some view safety as a subset of quality; most agree that quality care must be founded on safe care. One important difference is that quality is generally measured in terms of success in achieving desired outcomes, whereas safety is measured in failures, particularly catastrophic failures. Success in achieving the desired outcomes includes not only a safe experience but also one that incorporates the elements of evidence-based medicine, especially because personal provider experience is almost never adequate to evaluate either the overall positive or negative consequences of a specific drug, technique, or procedure. Because anesthesia is generally not therapeutic, complete safety must be the most important goal of every anesthetic. This means a goal that no patient is caused any injury or complication from the effects of the overall anesthesia encounter. This may seem unattainable. But, as described later, adopting such lofty goals and committing to achieve them leads to greater safety and better care.

To the benefit of all, quality and safety have attained increasing importance in modern health care. There is a rich history of attention to the processes of improving care. Those activities can be traced to the work of Donebedian, who developed principles by which quality can be measured and improved for health care in general, but with specific applications to hospital care.13 It was only in the late 1990s that the concept of patient safety was raised to prominence in the broad health care environment, a result of a landmark study of medical error.14 Yet, in anesthesia, patient safety has a much richer history. Indeed, the specialty of anesthesiology is often identified as the earliest adopter of patient safety principles, and it is lauded for achieving dramatic improvements in outcomes (see "Anesthesia Risk and Accidents" for the history of patient safety in anesthesia).

The concepts of patient safety, quality improvement, and risk management are related but have important distinctions. Patient safety is focused on prevention of injury. Quality improvement generally deals with the broader spectrum of quality, including the success of treatments. Risk management historically was directed at managing the aftermath of adverse outcomes, especially to manage legal issues, malpractice, and avoidance of financial loss for insurers. But modern risk management is focused on proactive patient safety, based on the principle that prevention of injuries via error reduction and system improvements reduces the adverse events from which malpractice awards arise.

Because safety focuses on preventing rare events, it is much harder to develop an evidence base for actions that create safety. Randomized controlled trials, although possible for testing many types of quality improvement practices, are almost unheard of for trials of safety practices. Many safety initiatives arise from investigation of serious adverse events. More intuitive arguments and judgments guide the implementation of safety principles.

The roots of safety run deep in anesthesiology. Dating to the first survey of anesthetic deaths,15,16 there has been a regular and continuous self-examination within the anesthesia profession to understand the causes of harm and how to prevent them. In the modern era of health care, anesthesia was the specialty that coined the term patient safety, which is now in the lexicon of health care and broadly applied to all medical disciplines.

History of Patient Safety in Anesthesia

The history of safety in anesthesiology may have begun with the first description and review of an anesthetic death—that of Hannah Greener, who died during administration of chloroform for amputation of her large toe in 1848.17 Although outcome studies were reported over the years, it was not until the landmark study of Beecher and Todd that a large population was sampled and specific causality suggested.18 Other studies followed during the 1950s and 1960s, with a focus generally on the morbidity and mortality associated with general or regional anesthesia, and the cause of death or serious injury in surgical patients.19,20

Safety interventions in the 1950s and 1960s focused on the development of safety features of anesthesia equipment. Features such as the fail-safe system for protecting against loss of oxygen supply pressure and pin-indexing of gas cylinders to prevent their being interchanged are still in use today.

The concept of "patient" safety arose in the early 1980s, in response to several factors. The first study of the contribution of human error in anesthesia was reported in 1978, followed by larger studies that focused on the sources of errors and strategies for their prevention.21,22 In these studies, Cooper et al studied "critical incidents" to elucidate the mechanisms of what were then called anesthesia "mishaps" as being multidimensional, resulting from a number of errors and other contributing factors to each event. Other reports described attributes of a specific event, disconnection in the breathing circuit, and a generic contributor to critical events, the relief of one anesthesia provider by another. Several studies replicated the methods and general findings in other settings and countries.23,24

A "crisis" of increasing costs for malpractice insurance for anesthesiologists prompted intense interest in tort reform and in reducing the number of adverse events that led to claims. The American Society of Anesthesiologists (ASA), under its then president, Ellison C. Pierce Jr, MD, led this initiative, which resulted in the formation of the Anesthesia Patient Safety Foundation in 1985.25 Its activities represented the first organized efforts in health care to address patient safety as a single topic. The ASA later sponsored studies of closed malpractice claims, which led to numerous reports about causes of the most severe adverse events and their trends.26

Many efforts contributed to what appears to be a substantial reduction in catastrophic adverse anesthesia outcomes among relatively healthy patients.27 Among these were improvements in educational programs, safer drugs and equipment, more intense patient monitoring (especially oxygen analyzers, pulse oximetry, and capnography), and new technologies for managing difficult airways (a specific contributor to numerous severe adverse outcomes). Standards and guidelines for anesthesia care also played a role in reducing adverse events. The Harvard Medical School Department of Anaesthesia promulgated the first standards for care in 198628; these were later adopted by the ASA as national standards. It is claimed that these standards are associated with a reduction in serious outcomes among ASA physical status (ASA-PS) 1 and 2 patients in the ensuing years.28 Many other standards and guidelines followed. Box 3-1 summarizes key milestones in the path to safer anesthesia care.

A national movement in patient safety was catalyzed by the 1999 publication of the IOM report To Err Is Human: Building a Safer Healthcare System.14 It and subsequent reports recommended fundamental changes in the health care system to combat a problem with deep roots in the way patient care is organized (or disorganized), particularly the culture of health care that did not place a high priority on the overall safety of patients relative to the delivery of specific services. Anesthesiology was singled out in the IOM's report, and in other writings, as the one specialty that addressed patient safety early and with positive results.

Current State of Knowledge of Anesthesia Risk and Relationship to Error

There is a general belief that the risk of preventable death or injury from anesthesia is relatively low compared with many other medical and nonmedical risks. Yet there are no accurate estimates of the rate of adverse outcomes in general or for an individual patient presenting with specific risk factors. One reason is that there are no standard methods for assigning causality appropriately among numerous factors that include anesthesia, surgery, the facility (and its systems), and the patient's disease. Particularly in the United States, the fear of malpractice claims hinders reporting and open, candid discussion of errors. Federal legislation, similar to that enacted in Australia in the late 1980s, now protects voluntary reporting.29 Despite the absence of strong evidence, estimates of the risk of untoward outcome to a relatively healthy patient are believed to be on the order of 1 in 100,000 patients.30,31 However, for patients presenting at greater risk, the risk may be on the order of 1 in 10,000, which is not different from early estimates for all patients.30,32 Thus there remains substantial room for improvement in the overall safety of anesthesia. Chapter 25 has a comprehensive discussion of risk, mortality, and morbidity.

Most people, both in and out of health care, seek to assign blame to specific individuals for specific lapses in performance associated with an adverse event. Yet the evidence demonstrates that most injurious accidents are typically complex events for which there is no single cause.33-35 Although it would be possible to envision a scenario in which a specific act by one individual led to an accident, assigning such pinpoint causality is not a useful approach to accident prevention. Substantial research is targeted at learning how accidents occur and how humans are involved in that process. The science emerging from that research supports the concept that there are few simple solutions for prevention of accidents. However, it offers possible strategies and tactics for lowering the potential for accidents, by preventing human error and its precursors (ie, the factors that promote and propagate errors), and by creating resilience in systems to respond to those errors that will inevitably occur despite the best of intentions and preventive actions.

The goal of adverse-event-free anesthesia care can be achieved only by applying a broad spectrum of prevention strategies and building resilience throughout the entire system of anesthesia care, for the overall system is no stronger than its weakest links. This section examines several models and issues at the organizational and human levels to inform our thinking about designing for failure.

The "System" of Anesthesia Care

Whereas anesthesia could be viewed simply as a single provider administering drugs to a single patient, that narrow perspective does not represent the much more intricate and multidimensional processes that characterize care delivery. Rather, the anesthesia encounter consists of several components that comprise the "system of anesthesia care." The anesthesia processes can be thought of broadly in three phases: preanesthetic planning and preparation, provision of anesthesia for the procedure, and postanesthesia care. Within each of these phases, the anesthesia provider(s) performs a set of tasks intended to provide quality care for the patient, surgeon, or other operator, and the health care organization. Achieving safety and quality requires that these anesthesia activities be synchronized with the needs of other providers, allied health professionals, technical staff, support staff, hospital or organization programs, and, especially, with the patient's needs and expectations. The interactions between all of these components comprise a "system" of care that has yet to be fully modeled for the perioperative experience. Further, this "anesthesia system" takes place within a system of systems that includes the overall course of care, and numerous elements of this larger system may interact with anesthesia care at multiple points in the delivery process; such interactions often contribute to a less-than-optimal experience for the patient.

The Accreditation Council for Graduate Medical Education (ACGME) has established a set of 8 competencies that must be met for all medical trainees.36 One competency is to understand and know how to practice within a system of health care. That requirement arose in recognition of the interdependencies among all the members of the care team and the larger system in which they operate. In the case of anesthesia, that implies having an understanding of the requirements and needs of all other participants in the perioperative system and implementing an anesthesia plan that appropriately meets these various needs, rather than acting individually in an introverted fashion.

Models of Organizational Failure

James T. Reason is perhaps the most widely cited author for overall conceptual thinking about the mechanisms of human error and system failures, although his work is founded on the basic work of Rasmussen. Their thinking derives from research in high-hazard industries, such as nuclear power, aviation, and chemical manufacture. Gaba has offered insightful interpretations of this work and other research as it applies specifically to anesthesia practice.35 The basic concepts are relatively simple: Accidents are not unidimensional; rather, they are the result of the interaction of several elements; each accident is somewhat unique in the way that elements combine to result in injury. (Note that in the context of "safety," we are addressing only those adverse outcomes that could be prevented given the application of current knowledge; death or injury that appears to be caused primarily by the patient's disease process or the unpredictable influences of drugs or operation likely cannot be altered by safety interventions.) Reason depicted the process of accident evolution in what is widely referred to as the "Swiss cheese" model (Fig. 3-10).10

The "Swiss cheese" model illustrates that accidents are typically the result of a series of events that include precursors, which trigger or allow the chain of events that result in the final (active) adverse event. Reason termed these precursors latent errors. This concept is now widely accepted in understanding health care system failures. Latent factors exist regularly in any work environment. They have the potential for initiating or propagating an evolving accident. Examples are failure to maintain equipment or replace obsolete equipment, selection of low-quality supply items, poor scheduling practices that promote haste or fatigue, and case scheduling and staffing models that allow assignment of relatively inexperienced clinicians to unfamiliar cases or high-risk patients. Cultural influences are an important source of latent failures. Examples include the pressure to proceed with cases in remote locations where the resources are insufficient to meet minimal anesthesia safety requirements, pressures to move rapidly to avoid "turnover delays," pressures to assign an inexperienced provider to a case to "keep the schedule moving," a hostile atmosphere within an operating room that limits communication of concerns about quality and safety, and failure to heed a patient's warnings or concerns. Latent errors rarely lead to an immediate accident. Rather, they can be seen as a lurking enemy, or, as Reason called them, "resident pathogens," awaiting the circumstances that will combine to produce a catastrophic outcome, often in ways that are unusual and what may be called "unpredictable." Avoiding the consequences of latent errors requires broad defenses and resilience throughout the system, to mitigate evolving failure that results from alignment of the "holes in the cheese."

Reason's model highlights the need for broad and varying mechanisms to trap errors and failures during the patient's health care encounter and thus mitigate or prevent the full cascade from unfolding. His work on managing risk begins at the organizational level and offers a spectrum of strategies and tactics for accident prevention. Both the attitude and actions of the organization and each individual in the chain of care can either bolster or undermine those defense mechanisms.

There is a competing theory that postulates that prevention is not always possible or even probable. The normal accident theory (NAT), as described by Perrow,32 characterizes some industrial systems as particularly resistant to strategies for prevention of catastrophic accidents if the systems are both complex and "tightly coupled"; that is, the connections between processes are such that one quickly affects the other in ways that can evolve into an accident that is not predictable by deterministic analysis. Fortunately, although all the patient and provider processes involved in anesthesia administration may create a "complex" system, they are not usually "tightly coupled" to the extent envisioned in Perrow's model, although it may occur in certain high-risk patients whose disease processes present a less stable condition. Still, Perrow's NAT provides many lessons for anesthesia practice and for constructing resilient systems to minimize the potential for accidents. Of special concern is that some protections and safety features can actually make systems more complex, mask impending problems, and impart a false sense of security. Further, certain prevention or mitigation strategies may affect other parts of the system in unanticipated ways and thus lead to new, unexpected risks. Anesthesia has many examples: Pulse oximetry can lead to practicing closer to the edge of acceptable levels of oxygenation or inappropriate assumptions that a functioning pulse oximeter implies adequate blood flow as well, automated noninvasive blood pressure monitors can fail to cycle and thus continue to present falsely high readings even in the presence of blood loss, or alarms on anesthesia monitors may be turned off to avoid "distraction" during the procedure. Moreover, the relative safety of anesthesia itself has been called an "insidious hazard," for some become complacent about anesthesia care and vigilance and assume that nothing will go wrong, based on prior experience.22 The development of complacency about safety based on prior experiences has led to major disasters in a variety of organizations; a prime example is the loss of the orbiter ("shuttle") Columbia on February 1, 2003. The Columbia Accident Investigation Board identified a number of contributing latent factors that resulted in complacency within the National Aeronautics and Space Administration (NASA), including the acceptance of "normal deviation" and the loss of checks and balances that should have guided NASA safety efforts; many of these latent factors resulted from the lack of serious events in the years immediately preceding the loss of Columbia.37

Reason's commentary about creating effective defenses against accidents fits well for anesthesia:

If eternal vigilance is the price of liberty, then chronic unease is the price of safety. Studies of high-reliability organizations—systems that have fewer than their share of accidents—indicate that the people who operate and manage them tend to assume that each day will be a bad day and act accordingly. But this is not an easy state to sustain, particularly when the thing about which one is uneasy has either not happened or has happened a long time ago, and perhaps in another organization. Nor is this Cassandra-like attitude likely to be well received within certain organizational cultures.34

Models of Human Error/Failure

The modern theory of accident causality and safety views the human as a component of a system. Most experts now tend to play down the operator's responsibility for accidents, perhaps because so often the attention and blame has been so heavily directed at those who are at what Cook and Woods term the sharp end of the pyramid of accident control.38 In fact, there is substantial evidence about human error and how humans interact with systems in diverse ways to either help or hinder the accident process. The vast majority of research has been in industry, most notably aviation and nuclear power applications, but there has been substantial investigation in anesthesia, where some of the earliest studies of human error and human factors in health care are found.

The studies of critical incidents mentioned earlier identified the basic issue of human error as a component of what were termed mishaps. Factors associated with mishaps, what would now be called latent factors, were identified, such as lapses in training, equipment design weaknesses, and the contribution of fatigue. In these and other areas, the science of human performance and human factors has revealed much more about the weaknesses of humans and the many ways in which we can fail, including how system design and other factors can influence our performance and conspire to weaken even the most expert clinician.

There has been a strong reliance on "vigilance" during anesthesia as the primary approach to error prevention, so much that the word is the motto of the ASA. Vigilance means sustaining attention.39 It has been defined as having 3 components: alertness, selection of information, and conscious effort. It is a much more complex process than is immediately apparent, and vigilance is the subject of much investigation in many fields that require sustained attention to ensure safety and performance. The observant practitioner is aware of some of the many ways that vigilance can be thwarted and performance degraded. Further, vigilance is only one of a complex set of elements that comprise safe anesthesia practice.

Human error in general is the subject of intense investigation in the fields of human factors, ergonomics, and industrial psychology. Again, James Reason provided an overview of the subject.10 Performance is defined at 3 levels: skill based, rule based, and knowledge based. Error is defined as the failure of planned actions to achieve their desired ends without the intervention of some unforeseeable event. Errors are divided into 2 main types: slips and mistakes (Box 3-2). The thoughtful practitioner will consider that his or her slips and mistakes vary in type and cause, most of all recognizing that all forms of error require efforts toward prevention, or mitigation of their consequences because errors occur despite the best of efforts.

Many factors influence vigilance and performance (performance-shaping factors), including fatigue and sleep deprivation, environmental influences, production pressures, human-interface design, and teamwork. Other factors associated with adverse events in anesthesia that either may promote errors or foster their propagation have been identified.21,22 We consider some as examples of the issues that anesthesia providers must address to maintain accident-free performance throughout a professional career. Measures to prevent performance decrement or to help maintain optimal performance are described in "Creating Safety at the Organizational and Department Level."

Fatigue and Sleep Deprivation

There is evidence (in trainees) that shows an association between sleep deprivation and human errors, including lack of attention to task, serious auto accidents, and medical errors involving both diagnosis and treatment.39-41 There are many examples of large-scale industrial accidents where sleep deprivation or fatigue was identified as a major contributing factor.

Howard et al reviewed the literature on sleep and fatigue with particular reference to anesthesia.42 Among the key findings were the following: (1) Inadequate sleep degrades performance, (2) individuals require different amounts of sleep to feel awake and alert, (3) the failure to obtain adequate sleep results in a sleep "debt" that is cumulative and can only be diminished by sleep to pay back the debt, (4) circadian rhythms have an important influence both on the tendency to sleep and the ability to sleep; the circadian lull associated with degraded performance is between 2 and 6 am and 2 and 6 pm, and (5) stimulants such as caffeine can aid in maintaining alertness and wakefulness, but side effects must be understood to use these effectively.43

Transitions among Care Providers ("Handoffs" or "Handovers")

There are conflicting findings about the impact of handoffs among anesthesia providers to mitigate the effects of fatigue, boredom, hunger, and so forth. Cooper et al examined critical incidents associated with relief of one anesthesia provider by another.44 They concluded that, overall, relief provided more benefit from detecting undiscovered problems than harm from transferring responsibility to a provider with less serial knowledge of the specific patient and procedure. These conclusions were verified by interpretation of data from a similar study by Short et al.45 More recently, Arbous et al found that a change of anesthesiologists was associated with a greater incidence of severe morbidity and mortality.46 Yet routine breaks are generally found to be useful and necessary in anesthesia and in high-hazard industries. Provisions for adequate transfer of critical information and situational awareness are required. Cooper suggested a specific set of guidelines for conduct of handoffs, which was recently updated.47,48 The hazards of transitions in care are now more widely recognized in health care and receiving increasing attention for remediation.49,50 More handoffs now occur among trainees as a result of ACGME work-limitation requirements that are intended to mitigate the consequences of sleep deprivation and fatigue.

Environmental Factors

Many environmental factors can affect the performance of the anesthesia provider. Among these are noise, extremes of temperature and humidity, lighting, and toxic vapors.51 Listening to music or reading during anesthesia administration are controversial issues with conflicting tradeoffs.52,53 There are no robust studies in health care or simple extrapolations from studies in other fields to guide the development of evidence-based standards. Rather, good judgment appears to be the best guideline. Background music can alleviate stress and boredom, but different musical tastes may lead to varying effects among the operating team. Loud music or other noises can obscure verbal communications and be especially disruptive during periods of high workload or management of critical events. Similarly, reading, texting, e-mailing, and so on in the operating room could alleviate boredom during uneventful intervals, but these could also foster a lack of vigilance and alertness. They appear especially problematic intuitively and would be difficult to justify during an accident investigation involving pilots, air traffic controllers, train operators, or anesthesia providers, among others.

Human Factors and Human Interface Design

Human factors engineering (HFE) is a broad topic that encompasses all of the different aspects of the ways in which humans interact with systems.54 The importance of human factors, especially the design of the human–machine interface, is well known in other fields but greatly underappreciated in health care.11 The goal of HFE is to "design tools, machines, and systems that take into account human capabilities, limitations, and characteristics."55 Given that anesthesia is technology intensive, human factors play an important role in prevention of errors and adverse outcomes.

Several studies have examined how the design of displays and of anesthesia alarms have an impact on equipment use and errors.51,56,57 The results indicate that technology is not generally well designed to accommodate the ways people use it. There are numerous examples of how the design of a device interface can be especially dangerous.58-60 The design of anesthesia monitors is particularly problematic. Anesthesia providers work in facilities that have various models or different suppliers of devices. For example, differences in software design or data displays can cause confusion and distract the provider from other important tasks that should be higher priority. A new standard requiring attention to human factors in the design of medical devices is intended to address these issues, but it will be years until the effects can be felt.61

Production Pressure

Production pressure refers to "overt or covert pressures and incentives on personnel to place production, not safety, as their primary priority."62 Based on a survey of anesthesiologists in California, Gaba et al reported that nearly half of the respondents had witnessed instances of what they believed to be unsafe actions by an anesthesiologist because of production pressure.62 These included internal pressures (eg, to foster good relations with a surgeon, accrue personal income) and external pressures (eg, proceed rather than cancel a case to appease patient or family, accept an unfamiliar patient or procedure to foster facility throughput).

Teamwork

The importance of good teamwork and communication is now more widely recognized in health care, especially for surgical teams. A substantial body of literature from high-hazard domains, especially aviation, and in health care demonstrates the value of teamwork for successfully preventing and managing critical situations.63-65 Gaba et al were the first to develop teamwork and crisis management training techniques for health care, adapting crew resource management (CRM) techniques from aviation for applications in anesthesia.66 These approaches have since been extended to nearly all health care settings but are particularly applicable to those where rapid action is required to successfully treat acute complex events, such as dire surgical emergencies.68

Box 3-3 lists some characteristics of effective teams.63,67,69 These definitions and characteristics, derived from other industries, generally apply to health care and to anesthesia practice. Good teamwork can prevent errors or mitigate their impact. Teamwork is vital to the successful management of critical events. The team within which anesthesia providers work varies depending on the setting, but it typically includes at least a surgeon, a circulating nurse, a surgical technician, and other support personnel, including environmental workers, technicians (eg, blood bank, laboratory, or radiology), and clerical personnel. Within the broad system of care, the team can include those who provide care pre- and postoperatively and specialists, such as radiologists, pathologists, and intensivists. The immediate operative team has been given the most attention for training and research.

Surgical teams have several distinguishing features that create obstacles to effective performance. The hierarchy in surgical care places physicians above other workers. It is common for surgeons to be accorded higher status and to assume a self-designated role of "captain of the ship." Whereas leadership is a key feature for team success, the person in that role should vary depending on the situation. Similarly, anesthesia providers may treat other team members as subordinates rather than colleagues. High-reliability organization (HRO) theory (see "The Elements of Safe, High-Quality Anesthesia Care/The High-Reliability Organization Model"), which is based on characteristics of organizations that function at high levels of safety, calls for a nonhierarchal culture in which the leader is the one with the most expertise, not the highest status. Conflict among these roles can complicate the management of acute operative events, especially when the care team does not work together regularly (eg, during nights and weekends when the care team consists of "night call" personnel from various work rosters).

CRM and team-building techniques have been applied for training teamwork skills and performance. There are different approaches to training, but the principles are generally the same. Teamwork needs should be assessed for the specific environment; all team members must be motivated and engaged in accepting the need for teamwork and agree about skills and behaviors they will adopt; those behaviors must be taught and practiced via drills and the behaviors assessed and periodically reinforced via more drills and didactic sessions.63,70

In anesthesia, simulation of the patient and environment in which anesthesia is administered has been used, both for motivation and for training of technical and nontechnical (behavioral) teamwork skills.71,72 There is some evidence that such sessions can effectively instill good team behaviors74 (see later discussion of simulation). Team training without simulation also is effective, as is the combination of both approaches.65,75

There are a seemingly infinite number of case reports of specific hazards and complications of anesthesia that were largely preventable, although a litany of isolated cases is perhaps less helpful than a series of organized observations. Studies of closed malpractice claims, funded by the ASA, have examined many of these events in a more systematic manner, one that assists in developing action plans for reducing risks. These closed claims studies have explored several categories of adverse outcomes, the most notable addressing errors related to airway management, monitoring, sudden cardiac arrest during spinal anesthesia, equipment failures, or nerve injuries.26,76,77

The Australian Incident Monitoring project analyzed 4000 critical events and developed an algorithm (COVER ABCD: A Swift Check) that accounts for the most common anesthetic emergencies (Box 3-4).78 Use of the mnemonic will prevent injury in most cases if specific practices are followed. A detailed review of even a substantial subset of these concepts is beyond the scope of this chapter. Rather, we present here examples of the types of failures that establish an argument for having organized principles for general prevention of errors. Analysis of these types of events also suggests tactics that could reduce the likelihood that these would become a trigger or propagator of an accident chain.

Adverse Respiratory Events

Events associated with management of respiration are the most serious remaining hazards in anesthesia, as evidenced by data from the ASA closed claims analyses.77 The three most common causes of death and brain damage are inadequate ventilation, esophageal intubation, and difficult tracheal intubation. The large majority of cases in the first two groups were judged to have been preventable if "better monitoring" had been used. For management of the difficult airway, prevention is more challenging. Peterson et al reported that "Persistent failed attempts at intubation were associated with an outcome of death or brain damage in claims in which a 'cannot ventilate and cannot intubate' emergency situation developed prior to surgical incision."79 They concluded that this was confirming evidence for limiting conventional ventilation efforts to 3 attempts before using other strategies. Despite substantial advances in technologies that aid endotracheal intubation and some helpful, although far from foolproof, methods of airway assessment, there remain many opportunities for unanticipated difficulties with airway management, tracheal intubation, and effective ventilation (see Chapters 10 and 36). Each is an opportunity for a serious adverse outcome. Although airway management skills are greatly emphasized during training, there is great variance in experience and abilities among anesthesia providers, as are the opportunities to practice emergency skills. Thus periodic retraining and practice in the application of difficult airway management protocols is prudent. (This is an example of the value of simulation as a tool for learning and maintaining skills that may be needed infrequently but are essential for patient safety.)

Monitoring and Alarms

Failure to monitor the patient adequately is an important contributor to anesthesia-adverse events. Aside from failures of vigilance, which are often related to performance-shaping factors, monitoring technology design and lack of experience with technology can contribute to adverse outcomes. There are numerous ways in which pulse oximetry, capnometry, and automated noninvasive blood pressure monitors can give false information, leading to missed or incorrect diagnoses. The failure to use alarms has led to a requirement in the relevant standard that when a pulse oximeter is used, the variable pulse pitch tone and low-threshold alarm of the oximeter must always be audible.80 Similarly, when capnography or capnometry is used, the end-tidal carbon dioxide alarm must be audible.

Medication Errors

Medication errors are among the most frequent errors in anesthesia and in health care practice in general.22 Similarity of drug names, containers, and label colors contribute to the ease by which such errors can be made, especially during periods of high stress. Dosing errors are also common and related to the frequent need for individual numerical calculations when drawing and mixing drugs for bolus administration or intravenous infusion. Choosing the wrong form of drug (eg, among various insulin formulations), flushing a catheter with a solution containing another potent drug, and confusion in the programming of infusion pumps are other examples of ways in which patients can be injured.

An obvious recommendation for prevention of some medication errors is to admonish the provider to read the label carefully.81 Another tactic is to read each label 3 times. Yet human factors issues are widely recognized as contributing greatly to medication errors, especially because of similarity of drug names, the small or obscure print on vials or ampules, and the failure to organize medication carts optimally to avoid errors. Distractions and production pressure also are likely contributors to medication errors. No universal remedy for prevention has been identified. There is a standard for label colors and grouping by drug type, but some argue that it is unlikely to be effective and, if anything, all drug labels should be in black and white to force careful reading of the drug identity and concentration.82 Numerous health care organizations are implementing barcode technology to address this hazard in other clinical environments, but this is not in wide use in anesthesia practice.

Errors in Diagnosis

Diagnostic errors are likely underreported because of the difficulty in their identification. Yet it is likely that diagnostic errors occur, especially during the management of critical events. Gaba has described 3 forms of fixation errors, including "this and only this" (fixating on a single diagnostic possibility to the exclusion of others, a form of "tunnel vision"), "everything but this" (searching among many possibilities but not including the real explanation), and "everything's OK" (persistent belief that there is no problem in spite of substantive signs there is a problem).66

Equipment Errors and Failures

Current anesthesia machines and associated technology incorporate substantial safety features (see Chapter 39), which have been developed over decades in response to specific series of patient injuries associated with failure or misuse of equipment. Equipment failure is frequent and can occur in many ways, but it rarely causes injury directly.21,80,81 When there is an equipment-associated injury, it is more likely to be from misuse than from overt failure of a device. Whereas the end user may be at fault, human factors research dictates that causes related to the design of technology and the lack of training and practice are equally, if not more, responsible. Among the legendary failures associated with poor human factors are the failure to turn on a ventilator that was briefly suspended during measurement of cardiac output or performance of radiologic studies, or the accidental, unnoticed disconnection of an intravenous or arterial pressure cannula leading to blood loss or failure of fluid or drug administration. Users can reduce hazards by ensuring they obtain adequate training before using a new device, conducting a systematic pre-use inspection of devices, and using backup monitoring devices as aids to vigilance. Never turning off an alarm is an essential precept to safe care.

Errors Associated with a Lack of Standard Practice and Unusual Situations

The complexities of anesthesia create many opportunities for preventable adverse events caused by unusual circumstances or pitfalls. Goldhaber-Feibert and Cooper, taking from a convenient sample of clinician experiences, offer numerous examples48:

• A Passy-Muir valve, a form of "talking" tracheotomy tube, left on a tracheostomy when inflating the cuff to deliver positive-pressure ventilation causes repeated inflation of the patient's lungs with no mechanism for exhalation.
• An emergency can arise during transport of the intubated patient if the tracheal tube is accidentally dislodged.
• Administration of undiluted phenytoin (Dilantin) by rapid intravenous infusion can cause refractory hypotension, arrhythmias, and death.
• Administration of undiluted potassium by rapid intravenous infusion can cause ventricular fibrillation and cardiac arrest.
• Neostigmine given without an antimuscarinic drug (eg, glycopyrrolate) can cause asystole/severe bradycardia and atrioventricular block, and can be fatal.
• Inadvertent intravascular injection of local anesthetics during a nerve block can cause neurologic and cardiac toxicity, which can be fatal (especially with bupivacaine).
• Air embolism can occur during the placement or removal of central venous catheters.
• Limb necrosis can develop if the tourniquet used for intravenous placement or blood draw is left on the anesthetized patient for a prolonged period.
• Intracranial pressure (ICP) may be increased if a ventriculostomy drain is connected to a pressurized bag of heparinized saline (in a patient who likely already has a high ICP).

Even though these situations are likely obvious to experienced clinicians, they might occur under periods of stress and might not be obvious to the uninformed neophyte. Learning may arise haphazardly in the absence of a systematic approach to training.

What is quality as applied to health care? "Quality" is an abstract concept, with little intrinsic meaning. Rather, it represents the extent to which the expectations of health care consumers are met by health care providers, whether that consumer is the patient, a professional colleague, the payer, or the facility that provides resources for the care delivery. In this context, the "consumer" of anesthesia services includes not only the patient but the surgeon or other operator who requires anesthesia services to perform a diagnostic or therapeutic procedure.

Numerous definitions of quality exist, but a widely accepted definition is that of the IOM, which we noted earlier: Quality is the "extent to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."4 Thus quality represents not a distinct entity or end point but a continuum in the process of meeting the rational expectations of others who interact with the providers of health care services. Two major concepts are inherent in the IOM definition of quality: measurement (ie, "outcomes") and evidence-based care (ie, "current professional knowledge"). Inherent in the definition of quality is the view that safety is the essential foundation for quality and that high-quality practice cannot be achieved in the absence of safe practice. Figure 3-2 illustrates these concepts. Another definition is that of the Agency for Health Care research, also noted previously: Quality is "doing the right thing, at the right time, in the right way, for the right person—and having the best possible results."

Donabedian, a leader in the genesis of the quality movement, proposed that quality could be evaluated by examining its major components: structure, process, and outcomes.13 Structure involves the facilities and environment in which care is delivered (eg, governance, policies and procedures, and specific details, such as cleanliness, attractiveness, ease of access, noise levels, privacy); process involves how care is actually delivered, including the interactions between clinicians and patients (eg, the elements of communication including listening, sensitivity, compassion, the development of trust); outcomes involves measures of results of the care provided (eg, mortality, morbidity, speed of recovery). Inherent in these evaluations of quality are the patients' perspectives on each of these areas; thus the role of the consumer (especially the patient) in the evaluation of health care quality has increased considerably in recent years.

The IOM went further in defining quality, by identifying 6 desired characteristics of health care. Thus high-quality care should be safe, timely, effective, efficient, equitable, and patient centered (often abbreviated as STEEEP, for ease of recall). Here, also, the concepts of measurement and current knowledge are apparent throughout.

The relationships among providers are key elements in the care process, especially in an era when complex care management is provided by specialists and subspecialists who focus on specific aspects of care. That complexity often leads to communication lapses and fragmentation without subsequent integration into a coordinated system of care that focuses on the patient's needs for understanding, planning, and decision making. Thus patients often rate communication as one of the most important components in the evaluation of quality health care, whereas physicians often rate technical abilities as considerably more important than communication.85

Eliminating these lapses in communication is essential for both patient compliance and patient satisfaction; eliminating the lapses benefits both process and outcome in the delivery of care. Further, it minimizes the frustrations that patients and families experience as a result of conflicting or inadequate communications among professionals, leading to mistrust of the provider by the consumer. Finally, the development of relationship-centered care teams, in which all parties have developed a pattern of open communication and mutual respect and trust, increase both safety and quality in multiple industries, including health care.86

These concepts apply as much to the discipline of anesthesiology as to other disciplines in health care. Anesthesia providers, as individuals and departments, must institute these principles, including practical measurement of outcomes and the development of relationship-centered clinical teams, if they expect to practice at the higher levels of the quality spectrum (ie, beyond the fundamental level of safe practice).

Creating a safe, high-quality practice of anesthesia depends on a combination of broad strategies and effective tactics for day-to-day work. Many models for establishing safe environments and practices and for ensuring quality have been described, but there is no empirical evidence from controlled studies to demonstrate that a specific model is superior to others. Still, there is face validity from qualitative studies in specific industries and organizations to suggest that having an overall systematic approach leads to both safer and higher-quality care. Indeed, a combined report from the National Academy of Engineering and the IOM emphasized that systems approaches to health care delivery were most likely to transform health care to deliver the goals of safe, timely, effective, efficient patient-centered care in the future.87

The High-Reliability Organization Model

Although several models have been promulgated for managing quality (see Chapter 25), there are fewer directed primarily at safety. For the latter, the concept of the high-reliability organization (HRO) was formulated from observations in highly hazardous industries that, despite operating under conditions of high risk, have many fewer serious accidents than expected.88,89 Such industries included naval aviation and nuclear power. Weick and Sutcliffe further describe how organizations can be successful if they appropriately "manage uncertainty."90 Gaba applied these concepts to health care.35 Weick and Sutcliffe90 lists the following elements that characterize a typical highly reliable organization:

• Preoccupation with failure: Despite its good safety records, an HRO will constantly look for any signs of weak systems or impending failure. An HRO assumes that failure is imminent and plans for the worst. In anesthesia, this extends to organizational and individual planning for potential failures or problems in every procedure.
• Reluctance to simplify interpretations: Managers often look for simple answers to problems. In an HRO, interpretations are more nuanced; skepticism about apparent explanations is encouraged. Rather than simply blaming the people who are the proximal agents in a causal chain of events, an HRO seeks to understand the latent failures that led to an individual's failure to perform flawlessly.
• Sensitivity to operations: An HRO pays close attention to how work actually gets done on the frontline rather than merely proposing solutions that appear reasonable from a distance. Cook and Woods wrote about the danger of ignoring the ways in which workers must act to do their jobs, often needing to circumvent rules made by managers or regulators who do not understand the complexity and challenges in health care systems.37
• Commitment to resilience: The HRO understands that regardless of its best efforts, things do go wrong and people do make mistakes. An HRO "develop[s] capabilities to detect, contain, and bounce back from those inevitable errors that are part of an indeterminate world." In the operating room, this translates to ensuring adequate backup of personnel, supplies, and equipment.
• Deference to expertise: During a crisis in an HRO, decision making falls to the person most experienced in dealing with that kind of problem (ie, situational leadership), not to the most senior person. A good leader seeks out that expertise rather than squelching disagreement or demanding loyalty.

Another critical feature of an HRO is that safety is the highest priority among all concerns. That is, the interests of production and speed are not allowed to supersede the need to ensure safety.35 Another element of HROs, one that has direct implications for anesthesia practice, is the need for intensive and regular training, especially with simulation.87 For high-hazard industries that face rare events requiring expertise to avoid an adverse outcome, frequent training and practice are essential; all of these conditions are met in the practice of anesthesiology.

HROs are also noted for organizational learning, especially from accidents and near misses. Health care recently embraced the process of root cause analysis (RCA).12 An RCA is applied to unusual, potentially harmful events in an effort to understand the many elements that contribute to an event and use the findings to design and implement corrective interventions (see Chapter 26 for more detail on RCA). Failure mode and effect analysis (FMEA) is one of several industry techniques to study new processes proactively before an adverse event occurs.92 The FMEA is used to identify potential failure modes and key points where barriers are needed to minimize the potential for failure (see Chapter 26 for a more detailed discussion of RCA and FMEA as risk-reduction strategies).

Vaughan described the concept of "normalization of deviance" that arises when an otherwise safe organization drifts into unsafe conditions.93 In analyzing the sociologic features of the disintegration of the Challenger orbiter ("shuttle") in 1986, Vaughan identified how NASA, under intense financial and political pressures, evolved from an organization that had once highly valued safety to one that gave production a higher priority. This led to what she called a "normalization of deviance" in the way engineers made decisions about safety issues. Rather than demanding that assurance of safety was the highest priority at each step, the "burden of proof" had shifted—to cancel or delay a launch, engineers were asked to prove that conditions were unsafe, where previously, to allow a launch, they were required to prove that each item was safe. This critical shift in emphasis has direct applications to anesthesia and surgery.

To ensure safety, strategies and tactics must be implemented at all levels throughout an organization, from senior management to bedside provider. That process has two major elements of responsibility: the organization and the individual.

Creating Safety at the Organizational and Department Level

The organization is responsible for creating a safe culture throughout its various levels (Chapter 26 focuses on quality improvement at the department level). Culture is the "shared values and beliefs that interact with an organization's structures and control systems to produce behavioral norms."34 More simply stated, it is "the way we do things around here." Cultural characteristics are usually deeply ingrained, not immediately visible, and often difficult to modify. Yet it is the culture that defines the overall commitment to safety of an organization. Although highest reliability can likely only be achieved within a consistent culture of safety across an organization, the perioperative subcultures and anesthesia practices and departments can establish strong safety cultures within their sphere of influence. Mohr et al refer to these smaller elements as "microsystem environments" and emphasizes that safety and quality must be applied at these levels, as well as in the more global "macrosystems environments" (ie, it must be brought from the corporate or departmental office to the bedside to be effective).94 In contrast, the individual practitioner working in various environments (eg, locum tenens practice) may find it difficult to achieve an overall high-quality safe practice in an organization that gives only lip service to safety.

There is a growing literature about safety culture (also referred to as climate; the terms are similar but not synonymous) in health care.95,96 One technique to assess the organizational culture is to conduct periodic surveys. Helmreich and Merritt reported on use of one survey instrument, the Operating Room Management Questionnaire, and compared attitudes of surgeons to pilots, whose safety culture is generally believed to be superior to that found in many industries as a result of long-standing attention to safety training and interventions.97 Although there are many similarities with pilots, surgeons appear to have attitudes that are not aligned with safety science, such as a perception that their performance is not affected by fatigue. Flin et al reported on results of a survey from anesthesia departments in the United Kingdom with a similar finding about the effects of stress and fatigue.98 Although perceptions of teamwork were generally positive, only 65% of respondents perceived that operating room personnel worked well together as a team. Respondents also reported variable compliance with procedures and policies. Similar findings have been replicated for operating room teams.98 Notably, physicians and nurses have different perceptions of the quality of teamwork by their colleagues—physicians generally rate themselves as much better team players than do their nursing colleagues.

Extrapolating from the earlier descriptors of an HRO, we can imagine that a safe perioperative culture demonstrably places safety as its priority with regular meetings of the group and teams; organizational learning via reporting systems that are open, fair, and nonpunitive; a formal and active quality improvement process; by implementing corrective actions on learning of unsafe practices; having policies and procedures defining standard operations; have regular training for common emergencies; being nonhierarchical during emergencies; rewarding those who raise safety concerns and have open discussions about those concerns; having processes for briefing and debriefing about near misses and adverse events; having standard processes for communication among providers especially for transitions in care; and using other similar processes and attributes. Relatively few organizations have these attributes, especially those related to multispecialty analyses of the causes of errors and adverse events; too often these analyses take place in parallel processes that result in the allocation of blame rather than resolution of the root causes that are embedded in the larger system, or the interfaces between services or providers.

Practical Elements for the Practitioner for Producing Safe, High-Quality Patient Care

Importance of Instilling Values of Patient Safety, Quality and Patient Centeredness

Safety demands that each individual, as well as the organization, make preventing any injury or harm to the patient the highest priority. For the individual clinician, a continual commitment to safe practice includes avoidance of unnecessary risk taking and avoidance of corner cutting, an almost unending anticipation of what might go wrong, projection of actions in anticipation of failure, and, above all, mindfulness. Weick and Sutcliffe describe mindfulness for HROs as organizing in such a way as to "better notice the unexpected in the making and halt its development."90 The concept applies equally to the individual practitioners and members of the perioperative care team.

Clinicians have a good reason aside from patient safety to be being eternally mindful: Those who lead, design, and manage local care systems may have an equal or greater responsibility for an adverse event. But when systems fail, blame is usually assigned, fairly or not, to the clinician closest to the last action in the chain. Protecting oneself from the impact of system failures is, if nothing else, an act of self-preservation.

Maintaining Vigilance and Mitigating Performance Decrement

Although vigilance cannot be relied on solely to protect the patient from harm, it remains the strongest underpinning of safety in anesthesia. This requires that the anesthesia provider must maintain alertness and be aware of, compensate for, and counteract the forces working against vigilance. This, too, requires mindfulness about the state of one's own vigilance.

Fatigue and sleep deprivation are probably the most common causes of lapses in vigilance. Howard et al have recommended several "fatigue countermeasures,"42 and a 2009 IOM report has explored this in detail.100 Such countermeasures include education about the effects of fatigue on vigilance, limiting duty hours to avoid fatigue, using good sleep hygiene (regular bedtime and wakeup time; restricting alcohol, caffeine, and nicotine use; creating good conditions for sleep), rest breaks, strategic napping, and selected medications, if necessary.

There is little evidence to support a specific time between breaks, but awareness of a fatigued state can suggest when a break is needed. Naps are often inconsistent with daily clinical routines but may be appropriate when routines are disrupted or during "on-call" intervals. Optimal nap times are on the order of 45 to 60 minutes to improve alertness while minimizing sleep inertia on awakening. Napping is best done when circadian rhythms are enabling sleep (between 2 and 6 pm and 2 and 6 am) and is more difficult to do when circadian rhythms are encouraging wakefulness. The evidence that napping improves performance of flight crews is strong enough that appropriate napping is recommended during long duration flights.102 Caffeine can be used judiciously to compensate for fatigue.42 Excessive use or inappropriate timing of caffeine use can have the negative consequence of preventing subsequent sleep.

Relief breaks, either during a procedure or at a change of shift, are a double-edged sword, providing an opportunity to identify an undiscovered problem or to create a new problem because of lesser situational awareness by the relieving provider.44,45 Although it is widely recommended that a preplanned protocol be followed to optimize information transfer during the handoff, the evidence for the effectiveness of such handoffs or how they should be conducted is lacking in anesthesia or elsewhere in health care.47,48,103 Until such evidence is established, local procedures must suffice. These can be informed by the procedures found to be effective in other high-hazard industries.49,104

Teamwork

The importance of anesthesiologists integrating into the larger system of team-based care was described earlier. Although teamwork can be seen as a subset of working within a system of care, it also includes specific practices for optimizing safety. Box 3-3 lists some of the recommended practices of high-performance teams in non–health care domains. Various forms of teamwork training have been implemented in health care, and there is evidence to demonstrate its effectiveness at improving teamwork performance and some evidence that it improves outcomes.104 The preoperative checklist developed by the World Health Organization's Safe Surgery program is specifically intended to promote teamwork and has been demonstrated to be effective in improving surgical outcomes.106,107 All anesthesia professionals should actively and seriously participate in the preoperative briefing that uses a form of the WHO checklist.106

Preparation

The failure to prepare adequately for anesthesia administration often contributes to anesthesia critical incidents.21,22,108 Preparation encompasses a large set of issues, including complete preoperative assessment (see "Preoperative Assessment and Planning"); ensuring availability of emergency drugs, equipment, and supplies; checking out the function of equipment (especially using the recommended procedure for ensuring functionality of the anesthesia machine109); and ensuring communication pathways in the event of an emergency.

Preoperative Assessment and Planning

Preoperative assessment and planning involves evaluation of the patient and development of the anesthesia plan that includes the anesthetic technique, the requirements for monitoring, and the plans for postoperative care, all of which must be consistent with the wishes of the patient and the needs of the surgeon or other operator (eg, radiologist, cardiologist), and the resources of the facility. (Preoperative evaluation is considered in Chapter 6, and for specific conditions in Chapters 9-24.) Similarly, an anesthetic plan must be developed that is consistent with both patient wishes and operator requirements, and with the plans for postoperative care. Chapter 7 addresses the development of the anesthetic plan in detail.

Monitoring

Because failure to monitor is so often associated with adverse outcomes, this issue deserves special attention. The safe practitioner follows the standards promulgated by the ASA except in truly extraordinary situations, and should those occur, he or she documents the reason for noncompliance. Critical alarms should never be disabled.110

Human Factors

Although the individual anesthesia provider has little control over the design of equipment and local systems, he or she does have substantial control over many of the human factors features that are part of the environment. Attention to the organized arrangement of supplies and drugs, especially adherence to consistent labeling of drugs, and establishing and adhering to local standards are examples. Care to keep arterial and intravenous cannulae and monitoring cables orderly, ensuring reasonable lighting, and reducing clutter, noise, and distractions are general, sound safety practices. Control of noise levels and background music can be contentious issues among staff, surgeons, and anesthesia providers, who sometimes are urged to compromise the principle that patient safety takes preeminence. Reasonable efforts should be made to reach compromise, and music should be discontinued during management of critical events.

Applying Systematic Crisis Management Techniques

Anesthesia crisis resource management (ACRM) is an organized set of principles for managing crisis situations in anesthesia. Adapted by Gaba et al from CRM in aviation, it consists of several founding principles for effective management of acute events.66,74,111,112 Although there is no single adopted standard, the following principles are generally applicable:

• Seek assistance early and quickly—inform others on the surgical team and call for extra assistance as soon as unusual circumstances are recognized.
• Establish clarity of roles for each person involved in management of the event; especially identify who will manage the event (event manager).
• Use effective communication processes, including reading back of instructions, being clear to whom directions are being given.
• Use resources effectively and identify what additional resources (people, supplies, equipment, transportation, etc) are available to manage the situation.
• Maintain situational awareness and avoid fixations, which is perhaps the most challenging task as situational awareness is difficult to retrieve once it is lost. Having one person act as event manager, observing the big picture rather than becoming immersed in the details, is thought to be effective.

The algorithm of ABCD COVER swift check discussed earlier (Box 3-4) should be available for reference. Simulation has been shown to be an effective for learning and maintenance of CRM skills.

Infection Control

Care in the safe use and sterility of all anesthesia systems is essential, especially in the modern hospital environment where hospital-acquired infections with resistant organisms (eg, methicillin- or vancomycin-resistant Staphylococcus aureus organisms) are increasingly common. Adherence to carefully timed protocols for antibiotic administration in the perioperative interval reduces postoperative wound infection.113 Surgical wound infection rates are increased 3-fold by hypothermia and reduced by increased perioperative oxygen administration.114,115 The importance of using strict sterile technique protocols for placing central venous catheters and other venous or arterial access are now well documented.116 There is simply no excuse for laxity in adherence to following proscribed protocols.

Following Standards and Practice Guidelines

The ASA has established a large set of practice standards and guidelines.117 Standardizing practices across providers is widely accepted as a critical component for safety and reliability. Box 3-5 lists common practice standards. Each practitioner is obligated to be familiar with such guidelines and apply them appropriately in his or her practice. Similarly, health care facilities are required to establish local policies and procedures to ensure standardization of basic practices. These, too, must be known and followed.

Periodic Training

Because critical events are relatively rare and demand expert and effective treatment, it is important to practice skills periodically. Schwid and O'Donnell demonstrated that advanced cardiac life support skills are generally maintained for only approximately 6 months.118 Periodic training includes practice in management of the unanticipated difficult airway, generic skills in ACRM, and drills for operating room fires and other specific anesthetic emergencies, such as malignant hyperthermia.

Simulation

Simulation is used increasingly throughout health care to address many of the issues in this chapter. Simulation has been applied in many high-hazard industries for years, but its applications in health care arose from pioneering work in anesthesia.71,119 Simulation is a technique that replicates reality in ways that allow deliberate, repetitive practice for many applications. It can use technologies that represent clinical care with relatively high or low clinical, environmental, or psychological fidelity depending on the training objectives and philosophy.120 Increasingly sophisticated mannequin and task trainers are now used widely. Yet simpler task trainers suffice for many purposes (eg, for learning basic intubation or difficult airway management skills, skills in placing central venous catheters, regional anesthesia). A variety of computer-based simulators and trainers have been shown to be effective for obtaining knowledge and skills for the management of acute events.121

For patient safety, simulation is especially useful for training novices without exposing patients to risk. As well, it can be used for periodic training for the purposes noted previously, particularly for training in the management of critical events using the CRM concepts described earlier. One of several models of computer-controlled mannequin is used to simulate the patient, whose physiology, anatomy, and life signs can be varied to simulate normal or abnormal situations.71,73 In high-fidelity simulation, props and actors are used to create realism, which is believed to strengthen the engagement of the learners. The early applications were for the anesthesia "crew" of the larger surgical team. More recently, simulations have involved training for entire operative teams. In addition to other skills, these CRM training sessions reinforce the concept that all team members are expected to communicate openly and without hesitation regarding safety-related matters. Examples include confirming a directive (eg, "heparin, xx units, has been administered," "I'm confirming that these are Mrs. Jones's radiographs"), to speaking out when a concern for safety exists (eg, "Are you sure you should be prepping the right hand? The consent says left." or "Have you noticed that this patient's blood pressure has been falling over the past several minutes?"). Training sessions use patient care scenarios to elicit treatment and behavioral responses from the individuals or teams being trained. Debriefing using videotapes of the session are conducted to review actions. Simulation training has been demonstrated to be effective across a variety of clinical domains for improving both clinical/technical and behavioral skills.69,74,122

Most academic anesthesia training programs now have either their own designated simulation programs or share resources with other departments in their hospitals or communities. Simulators of various types are being deployed in hospitals of essentially all types of sizes. Although there are no data on the actual numbers of simulation programs, there is a growing community of simulation professionals, evidenced by the existence of a society and journal.

Effective in 2010, the American Board of Anesthesiology requires a simulation training experience with both technical and behavioral crisis management practice for maintenance of certification of anesthesia credentials (MOCA).123 The ASA led a process for endorsing anesthesia simulation programs that are qualified to offer that training. Currently, the simulation requirement is purely formative (ie, skill enhancing). It is likely that the experience of other industries will be repeated and, after sufficient validation, some summative (ie, pass or fail) requirements may well be implemented. The very use of simulation is a sign of a move toward a deeper culture of safety in anesthesia and other clinical disciplines.

Patients increasingly are being urged to take a role in ensuring the safety of their own care, as well as being involved in patient safety by their health care providers.124 Anesthesia professionals should encourage and assist in this because it benefits everyone. Providers should also be concerned with the patient's perceptions of the quality of care and consider more than just the needs of the direct surgical process. There are several ways in which these goals can be achieved.

To encourage patient involvement, actions can be taken to foster "patient-centered communication," which has been defined as including the following125:

• Eliciting and understanding the patient's perspectives—concerns, ideas, expectations, needs, feelings, and functioning.
• Understanding the patient within his or her unique psychosocial context.
• Reaching a shared understanding of the problem and its treatment with the patient that is concordant with the patient's values.
• Helping patients share power and responsibility by involving them in choices to the degree that they wish to be involved.

What specific things can anesthesia providers do to involve patients in their own care that will not just improve satisfaction but also safety? Consider the following:

• Tell the patient as much as practical (assessing how much the patient can handle knowing) about the process of anesthesia care the patient will experience.
• Provide information preoperatively about the process of anesthesia care and expectations; several references are available on the Internet in addition to books and pamphlets.
• Encourage the patient to speak up if the patient does not understand something or believes something is inappropriate, such as drugs being given, absence of handwashing or glove wearing.
• Involve the patient's family members in care whenever practical.
• Advise the patient to contact you if there are any concerns or possible side effects after the anesthetic.
• In concert with other providers, disclose errors and adverse events (a strategy that enhances trust and decreases skepticism in concerned patients).
• Involve patients on committees that involve the design of anesthetizing locations and in the process of patient flow and family communication in such facilities.

The concepts of quality, safety, and patient-centeredness are prominent themes throughout American health care, and they have been embraced by patients and affirmed by third-party payers, specialty societies, and health care organizations, both governmental and private. Despite the increased focus on these factors, the goals have yet to be met, especially because most initiatives have focused on individual practitioners or within specific disciplines. To achieve the full goals of quality and safety, the processes must include systematic approaches that cross the boundaries of specialties, clinical services, and facilities. In short, the delivery of care must be recognized as a complex matrix of interactions among multiple providers, including both clinicians and facilities, all interacting with one another in a system of systems. The specialty of anesthesiology is a leader in the development of patient safety approaches within its discipline; the next steps involve building safety and quality into this larger system of care. Anesthesia providers can contribute significantly to achieving these goals by participating fully in the system-of-systems approach, as well as by building highly reliable microsystems within their department or group. These approaches are best understood by adopting a patient-centered approach, whereby all providers interpret the integrated care process from the patient's viewpoint and include that viewpoint in the design and delivery of care.

• Kohn LT, Corrigan JM, Donaldson MSE. To Err Is Human: Building a Safer Healthcare System. Washington, DC: National Academy Press; 1999.
• Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment failures in anesthesia management: considerations for prevention and detection. Anesthesiology. 1984;60(1):34-42.
• Reason J. Managing the Risk of Organizational Accidents. Aldershot, Hants, UK: Ashgate Publishing; 1997.
• Baker DP, Salas E, King H, et al. The role of teamwork in the professional education of physicians: current status and assessment recommendations. Jt Comm J Qual Patient Saf. 2005;31(4):185-202.
• Gaba D, Fish K, Howard S. Crisis Management in Anesthesiology. Philadelphia, PA: Churchill Livingstone; 1994.
• Gaba DM, Howard SK, Fish K, et al. Simulation-based training in anesthesia crisis resource management (ACRM): a decade of experience. Simul Gaming. 2001;32(2):175-193.
• Two chapters: Impact of duty hours on resident well-being. Strategies to reduce fatigue risk in resident work schedules. In: Ulmer C, Wolman DM, Johns MME, eds. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Washington, DC: National Academies Press; 2009:159-178 and 217-262, respectively.