Errors create a case for improvement

The nature of human and system errors that lead to adverse outcomes has been investigated in complex systems, such as the commercial aviation industry and the nuclear power industry. These organizations are collectively known as “high-reliability organizations” (HROs), and detailed descriptions can be found in safety literature.1 High-reliability organizations are defined as high-risk error-intolerant systems that repeatedly carry out potentially dangerous procedures with minimal error. High-reliability organizations understand circumstances that are likely to lead to adverse events known as “error-producing conditions” (EPCs). After careful analysis of accidents and near-miss incidents, sets of these conditions have been established with the use of mathematical modelling of contributing factors.2,3

As business practices are increasingly applied to medicine, many have argued that healthcare could be viewed through the lens of an HRO. Technological advances in healthcare and evidence-based practices have improved care for our patients; however, now more than ever, we are aware of errors and the ways in which they compromise patient safety. Over a decade ago, The Institute of Medicine disclosed that error is a significant cause of death in the United States that accounts for 44,000 to potentially as many as 98,000 deaths annually.4,5 This magnitude makes errors more lethal than motor vehicle collisions, breast cancer, and AIDS.6 In Canada, approximately 7.5% of hospital admissions will result in an adverse event.7 What is more surprising than the frequency of these events is the realization that up to one-third of these events are highly preventable. Perhaps less surprising is the fact that most of these highly preventable events do not result from individual negligence but from the failure of systems and teams.

Five hallmarks of HROs that account for their less than expected number of accidents are: 1) preoccupation with failure; 2) reluctance to simplify interpretations; 3) sensitivity to operations; 4) commitment to resilience; and 5) deference to expertise. Together, these qualities are termed “mindfulness”.8

The most important EPCs common to all HROs are fatigue, high-risk low-frequency events, time pressures, normalization of deviancy, poor supervision, faulty perception of risk (injury severity), and task overload.2 In order to transform its “mindfulness”, the healthcare system must mitigate these EPCs. For example, the complexity of managing a trauma patient highlights the potential EPCs that can put patient safety at risk (Table 1).

Table 1 Common errors and error-producing conditions (EPCs) in trauma management
Full size table

Technical and nontechnical skills for patient safety

There is widespread recognition that all physicians and healthcare professionals require a broader set of competencies beyond medical expertise to improve the healthcare system. Medical knowledge and procedural ability map to a larger group of competencies that the simulation community commonly referred to as technical skills.9 These technical skills were the focus of most undergraduate and postgraduate curricula until the turn of the last century. Continuing medical education programs continue to focus nearly exclusively on technical skills. With the greater acknowledgement of system errors and their contribution to significant morbidity and mortality, there is a growing understanding that all healthcare professionals require another set of competencies. Task management, teamwork, leadership, situational awareness, and decision-making are some of the identified behaviours that may mitigate the risk of EPCs.10 In contrast to the traditional technical skills, the simulation community conventionally refers to these competencies as nontechnical skills (Table 2). Nontechnical skills have been identified as particularly important in emergency and crisis situations, which are dynamic, evolving, and require constant re-assessment.11

Table 2 Healthcare definitions of nontechnical skills10
Full size table

For physicians, in particular, regulatory bodies and professional colleges internationally have developed taxonomies of the required competencies to articulate and define further these broad technical and nontechnical skills. In Canada, we are most familiar with the CanMEDS competency framework, which defines competence over seven domains of equal importance but is recognized to centre on medical expert.12 The CanMEDS framework has been integrated into the lifelong learning model, which recognizes the need for ongoing continuous professional development. Thus, by definition, maintaining competence is dynamic and cannot be conferred for a lifetime based on static undergraduate or postgraduate examinations from a single point in time.13 In an attempt to extend the concept of competencies to teams, the Canadian Patient Safety Institute developed patient safety competencies that complement the non-medical expert competencies in CanMEDS and address safety beyond the level of the individual14 (Table 3).

Table 3 Effective simulation modalities to teach Canadian interprofessional patient safety competencies
Full size table

Perhaps the most important consequence of identifying these nontechnical skills or non-medical expert competencies is the recognition that they are not inherent despite being based on behaviour.15 Any teaching of these competencies is accomplished informally in the clinical setting and probably attributed most to role modelling from mentors. Delivery of nontechnical skills solely by this process is potentially flawed as it is based on many assumptions. First, it assumes that faculty supervisors are experts in these competencies. Second, as mentioned earlier, many of these skills are required most during emergency or crisis situations, which are increasingly rare in modern day medicine. Finally, learning based entirely on role modelling may perpetuate negative learning where less than ideal behaviours can spread without assessment, feedback, and correction.16 Ideally, role modelling should be complemented with other education modalities.

Nontechnical skills must be formally taught, and in fact, probably more time is required to develop curriculum for these skills because they are more difficult to teach and assess than their technical skill counterparts.17 Without balanced curriculum design, the challenge in teaching nontechnical skills for patient safety can result in their overall marginalization. The biggest challenge to engage learners in these important competencies through conventional didactic instruction is the lack of context. Contextualizing these concepts can be beneficial for both faculty and learners as it can ease the instructional difficulties of teaching behaviours and facilitate sharing important mental models.18-20 By definition, most of these nontechnical skills are not practiced in isolation by any professional. An important aspect of translating mental models to a clinical context is incorporating an interprofessional faculty and audience. A mixed faculty and audience provide a variety of perspectives to appreciate the required communication and collaborative competencies. Other industries (i.e., military and aviation) have embraced interprofessional models for training.21 Team training in healthcare has included simulation to provide the appropriate context for interprofessionals to improve patient safety.19,22,23

Simulation modalities available for patient safety

Simulation can provide a forum for contextualized learning. As it relates to healthcare, simulation is defined as a technique rather than as a technology. It amplifies real patient experiences in a fully interactive manner.24 Simulation is an educational tool amongst many modalities that can improve patient safety directly by guiding clinical practice or indirectly through best education practice. While simulation is not the only tool in the arsenal of workplace or work-based contextualized lifelong learning, there is growing evidence that it is a powerful tool.

Over the last three decades, it has become more common to have trainees learn skills in medical history taking and physical examinations using standardized patients and to have them learn procedural skills using animal models.25 In the 21st century, advancements in engineering have ushered in a new era of simulator technology, including more complex partial-task trainers (i.e., models that replicate reality in a limited fashion to teach a specific delineated skill, such as central line placement or thoracentesis) and virtual reality simulators for surgical and procedural skills (i.e., hardware and software that provide haptic feedback for performing realistic laparoscopic cholecystectomy, bronchoscopy, colonoscopy, and echocardiography).

As mentioned previously, most consider that the strength of simulation to improve patient safety lies in modalities that address systems and team competence. For the anesthesiologist working in the operating room, patient safety is best addressed by mannequin-based simulation—the mode of simulation we pioneered and with which we are most familiar.26

The development of mannequins has advanced significantly over the last two decades, and software advances have allowed the most advanced mannequins to recognize injection of medications or therapeutic maneuvers, such as cardiac massage, and to respond in an appropriate physiologic manner. When preprogrammed responses are not available, mobile technology allows real-time physiologic manipulation; however, it would be a mistake to focus on these technological mannequins to improve safety alone. In fact, instead of precise replication, there is mounting evidence that only lower fidelity may be needed to approximate a simulator’s true anatomy and physiology.27-29 Patient safety educators dedicated to improving nontechnical skills focus their programs on improving the environmental fidelity of their scenarios.

Environmental fidelity refers to the relationship between the simulation learning environment and the setting in clinical practice.30 Improving the environmental fidelity means incorporating all the structural and mechanized elements that would be present in the management of similar scenarios in the clinical realm. As discussed, the most important aspect is assembling a similar interprofessional cohort that would manage patients in the clinical environment. Fidelity is enhanced when the interprofessional team is dressed as they would be for clinical activities. This can be particularly important for the anesthesiologist, as it forces the team to address communication barriers unique to our environment, such as role identification and the interpretation of non-verbal cues when offered behind masks and surgical gowns. The costs to re-create all of these important clinical elements in a simulation centre can be prohibitive. In-situ simulation in an actual clinical setting can mitigate these costs, with the only expenses being the simulator, human resources, and disposables. This approach also potentially addresses barriers in assembling interprofessional teams for an educational activity during working hours. Recent advances in wireless technology have facilitated operationalizing in situ simulation, and they are recognized as solutions to increasing fidelity in the absence of simulation centre resources.

When live interaction between different health professions is unavailable, current research is also preserving fidelity by practicing communication and collaboration in a virtual environment.31,32 From isolated settings, doctors, nurses, and other allied health professions can work together online in the management of Web-based patient scenarios.33 While fidelity may not be optimized as in a live environment, this interprofessional learning supports the importance of team interaction and may be particularly applicable to the geography of Canada.

Simulation-based education: how it works

The success of simulation as a learning modality can be summarized by four basic principles: pattern recognition, the interplay of emotions and learning, the effectiveness of debriefing, and the importance of deliberate practice.

First, pattern recognition has been defined as the probability and efficiency of retrieving an item from memory. Pattern recognition depends on the similarity of the conditions in which an item has been encoded to memory and the similarity of the conditions in which it needs to be retrieved.34 With simulation, a healthcare professional can be exposed not only to rarely encountered clinical scenarios but also to learning in an almost identical clinical context where the skills will be required.

Second, there is evidence that learning can be more constructive when emotions are engaged. With simulation, learners are often confronted with situations that spark curiosity, perplexity, and confusion that can enhance learning if managed well by faculty.35 Faculty development is required to manage the delicate balance of emotions and learning effectively through feedback from direct observations in a debriefing – a hallmark of simulation-based education.36

Simulation-based education is based on the experiential learning cycle where learners participate in a scenario or procedure and manage the entire task from the beginning to a predetermined end to the scenario.37 Following the scenario, a trained instructor provides feedback in a debriefing session, often with video playback, so learners can reflect on both the positive and negative aspects of their performance.38 The cycle is completed by allowing trainees the opportunity to compare their performances with their existing knowledge and also to participate in the same scenario or a similar scenario requiring the identical skills.39

Deliberate practice refers to a process that allows learners to focus on intensive practice of specific tasks in a controlled setting while receiving coaching and formative assessment through timely and thoughtful feedback from an expert supervisor.40 A main feature of deliberate practice is that it occurs over a long time period and requires many hours to advance from novice to expert. Expertise in medicine, as in athletics, chess, and music, is closely related to the amount of time devoted to deliberate practice.41 Simulation is ideal for deliberate practice because it offers standardized conditions and the ability to repeat the same tasks frequently without compromising patient safety.

Simulation-based education: maintaining competency

Recognizing the importance of deliberate practice is closely associated with acknowledging that even mastered skills will most likely decay if not exercised regularly.42 Almost every anesthesiologist will experience the stress of managing a difficult airway and, more specifically, the “can’t intubate, can’t ventilate” situation; however, with an incidence of approximately one in 10,000, both the technical and nontechnical skills required to manage these crises have not been rehearsed, practiced, or experienced in months or even years.43 Decay and attrition of skills is inevitable and demonstrable.44 Ultimately, it is equally important to develop lifelong learning strategies to manage crises as it is to manage knowledge translation and retention more effectively.45 Simulation may be a powerful enabler in the development of these strategies.

Furthermore, equally important as the development of education programs is the increasing need for physicians, as a self-regulated profession, to demonstrate accountability to the government and the public by creating assessment strategies that ensure they maintain their competence. Taxonomies of assessment, such as Miller’s pyramid, are useful to enable us to identify different levels of performance that may be assessed with different tools.46 With multiple-choice questions and oral examinations, we can assess the “knows” level of factual information. When designed to be rich in a clinical context, we can use the same tools to probe the integration of that knowledge into clinical judgement and decision-making, the “knows how” level of assessment.47 It has been suggested that simulation has advantages over other exam modalities in the domain of crisis management because it can assess what trainees would actually do rather than what they write or say, the “shows how” level of performance.48 More importantly, with simulation, we can potentially assess the competency of learners in a way that reflects actual clinical practice more closely than other assessment methods. By better replicating clinical practice, simulation allows for simultaneous assessment of multiple competencies, both technical and nontechnical. The “does” level of assessment can be performed only in the workplace where logistical and patient safety issues present challenges in this complex and dynamic setting. Thus, simulation may offer the best alternative to workplace assessment by providing a medium for work-based assessment.

Simulation research to demonstrate improved patient safety

Simulation has a great capacity to inform the patient safety movement and guide best practices for patient safety. Simulation can be used as an “object” of research, validating its efficacy as an educational tool, or it can be used as a “means” of research to study clinician performance in a patient-safe environment that is similar to the clinical setting.

The “gold standard” in validating simulation for patient safety is translational science. Traditionally, translational science has referred to biomedical research that advances or accelerates the application of results from the laboratory to patient care.49 Simulation research meets the criteria of translational science when it can demonstrate that the learning in a simulation laboratory impacts actual patient care. The T1 realm of simulation research would exhibit performance improvements in the simulation environment, while the T2 realm would demonstrate that the learning in the simulation laboratory translates directly to improved performance on patients. The T3 realm of research would improve the overall health of patients and society.50 Given the breadth of simulation literature and the importance of translational science on patient safety, this discussion focuses on the T2 and T3 realms of simulation research.

Procedural skills simulators have garnered the most attention in the patient safety movement, and T2 research has demonstrated that skills learned on simulators reduce the risk of errors by trainees when compared with traditional apprenticeship models of medical education. For example, learning laparoscopic cholecystectomy surgery on virtual reality simulators has led to a demonstrable reduction in predefined errors on patients in the operating room when compared with conventional instruction.51,52 Even more powerful is T3 evidence that individual procedural competence can be mastered through using simulators to gain expertise in complications of sepsis caused by central venous catheter insertion and brachial plexus injuries due to shoulder dystocia.53-55 Further research will determine whether simulated performance of the skills or familiarity with a procedural process is most responsible for the reduction in errors and, consequently, the improvements in patient safety.56 Ultimately, re-creating the clinical context and practicing processes may be more essential than incorporating a particular procedural simulator technology into a curriculum.57,58

Validating mannequin-based simulation with T2 and T3 research is far more challenging. As discussed, mannequins are used predominantly to teach the management of clinical crises. Crises are clinical events that occur rarely but are “high-stakes” situations associated with significant morbidity and mortality. Since these situations are rare and unpredictable, it is difficult to measure the effectiveness of simulation education in the clinical context. Furthermore, there are ethical concerns involved in allowing trainees to manage a patient crisis fully without intervention from a senior clinician. As such, there is a paucity of prospective T2 and T3 research evaluating the impact of mannequin-based simulation on patient safety.

In a retrospective case control study, management of patients using the Advanced Cardiac Life Support (ACLS) techniques was examined and a comparison was made between the results of residents who had received training in a simulator and the results of those who had not.59 Results showed that residents who had learned on a simulator were more likely to adhere to the ACLS guidelines than those who had learned by more traditional methods. In a recent prospective randomized study, the effects of using simulation to train residents to wean patients from cardiopulmonary bypass were compared with the effects of using a traditional interactive seminar. This study showed that the residents trained with simulation were more successful in executing both the technical and nontechnical skills required to wean patients from cardiopulmonary bypass, and their skills were better retained compared with the residents trained in the traditional manner.60

By providing a similar mock complex clinical environment, simulation can provide a “means” to study and dissect the management of crises and procedures critically.44 By deconstructing our current practices, we may identify gaps and deficiencies that need to be addressed. Furthermore, simulation can provide an environment free from patient harm to study the introduction of new equipment and to learn strategies for effective and safe practice. Simulation can provide a platform and environment that better controls for confounding variables for stronger study designs in this area of research.

Ultimately, researchers will strive to examine the effects of simulation on patient morbidity and mortality, but the logistics and ethics of measuring outcomes prospectively have proven challenging for rare and unpredictable emergency situations. Nevertheless, Gaba has stated, “No industry in which human lives depend on the skilled performance of responsible operators has waited for unequivocal proof of the benefits of simulation [or crisis resource management] before embracing it.”61

Conclusion

Patient safety is the keystone of good patient care. In order to keep patients safe, healthcare professionals not only need safety competencies, they also need an understanding of the context in which errors occur. Error-producing conditions describe the context and environment where gaps in practice can lead to poor outcomes. Simulation is a powerful tool that can contextualize learning, assessment, and research of competencies and ultimately improve patient safety.

Key points

  • High Reliability Organizations (HROs) are preoccupied with potential failure; as a result, they have developed methods for effective management of unexpected situations in high-risk environments. Healthcare can be viewed through the lens of an HRO to address patient safety.

  • Technical skills (medical knowledge and procedural ability) and nontechnical skills are both required to mitigate Error Producing Conditions (EPCs).

  • Nontechnical skills include task management, teamwork, situation awareness, decision-making, and leadership. Nontechnical skills need to be taught.

  • Simulation-based education with interprofessional teams provides a context for learning nontechnical skills and facilitates sharing mental models. Environment fidelity is important as a context for learning.

  • Translational research is emerging to validate simulation-based education for patient safety.