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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
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The High-Reliability Organization Model
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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:
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- 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.
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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.
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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).
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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.
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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.
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Creating Safety at the Organizational and Department Level
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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.
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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.
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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.
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Practical Elements for the Practitioner for Producing Safe, High-Quality Patient Care
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Importance of Instilling Values of Patient Safety, Quality and Patient Centeredness
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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.
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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.
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Maintaining Vigilance and Mitigating Performance Decrement
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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.
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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.
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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.
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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
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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
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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.
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Preoperative Assessment and Planning
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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.
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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
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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.
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Applying Systematic Crisis Management Techniques
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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:
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- 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.
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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.
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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.
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Following Standards and Practice Guidelines
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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.
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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.
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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
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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
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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.
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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.