Authors: Mohamed Mahmoud, M.D. et al
ASA Monitor 02 2018, Vol.82, 18-21.
Serious medical errors and harm can occur in any health care organization and no one should believe that “this event could and should never happen at my institution.” As humans, we all make errors. Vigilance, working harder or simply “doing our best” is not sufficient to ensure and sustain patient safety. When a safety event occurs it usually includes a series of human errors that are unfortunately often supported by system or culture failures which enable, or encourage the mistake. The important consequence from any mistake should be an assessment of why it happened, since the majority of medical errors are multifactorial and attributable to system flaws, processes, and conditions that foster human error or fail to prevent them.1
The last decade has seen a significant growth of diagnostic or interventional procedures that are replacing many surgical procedures. Delivering anesthesia and sedation in non-operating room anesthesia (NORA) areas for these procedures has been associated with a comparatively higher risk of mortality than those anesthetics in the operating room (O.R.), emphasizing the need to realize opportunities to improve safety.2,3 Inadequate preoperative assessment, preparation and post-procedure care, failure to handle emergencies, adverse drug events, miscommunications during hand off and transitions in care, are just a few examples of potentially preventable errors can occur in these locations. Some of the changes required to prevent these adverse events include a commitment to achieve zero patient harm, a fully functional culture of safety throughout the organization, and a system oriented team-based care model using technology, informatics and quality improvement (QI) science in our daily work.
This review explores how a high reliability anesthesia service can be achieved by adopting several specific change initiatives.
What can we learn from high-reliability organizations?
High-Reliability Organizations (HROs) such as aviation and nuclear industries, are examples of organizations with processes that have extremely low failure rates, particularly because failures come at an extremely high human cost. These organizations share five values in common: preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, and commitment to resilience and deference to expertise. A key component of success in these organizations is the “collective mindfulness” of all workers, working as a team with the intent to look for, and report, even small problems or unsafe conditions (without fear of reprisal) before they pose a substantial risk to the organization and, hopefully, when they are easy to fix.4 This environment fosters a positive perceptions of psychological safety, teamwork, leadership and comfort discussing errors.5
The Joint Commission, the Agency for Healthcare Research and Quality and the Institute for Healthcare Improvement have embraced the concept of HRO and are advocating for its implementation in health care.6,7 A high reliability anesthesia service in any NORA location requires a system to compensate for human error by making it harder for providers to make an error and easier for them to perform properly, with safeguards to improve human performance.
Dekker states that “human error is never at the root of your safety problems … human error is the effect of trouble deeper inside your system.”8 The science of safety analytics has developed considerably during the past three decades, particularly in the aviation and nuclear industries. Root Cause Analysis (RCA) and Failure Modes and Effects Analysis are examples of tools that can assist organizations in strengthening analysis of adverse events. The RCA team should be composed of members familiar with patient safety and not those directly involved in the case. The mission of this team is to answer four core questions: What happened? Why did it happen? What action can we take to prevent it from happening again? How will we know if the action we took made a difference?
The goal of the RCA team is not to point blame at individuals, but rather to insert processes into the system in order to prevent the error from occurring again. By looking for the root cause, inadequacies or flaws in the system will be discovered. Rarely is a significant adverse outcome the fault of one person, device or system alone. The Swiss Cheese Model of Accident Causation, adopted from Reason, identifies accidents as the result of successive layers of defenses, barriers and safeguards being breached.9,10 Careful analysis of the precursors to, as well as the events which occurred during the adverse event, must analyze specific weaknesses in safety protocols or procedures, and then redesign the system to avoid future error. Redesigning the protocols and procedures will not guarantee safety, unless they are followed and amended if necessary. For example, a review at one institution demonstrated a decrease in sedation-related adverse events rate after the implementation of Joint Commission Procedural Sedation and Analgesia Guidelines.11 In contrast, a review of sedation practice in other institutions revealed that they do not follow their own guidelines and recommendations for competency, emergency preparedness and physiologic monitoring.12,13
QI in anesthesiology is no longer a research fascination. Rather, institutions strive to improve safety by training anesthesiologists on QI and safety analytics. With increasing economic pressure for cost containment and efficiency in the context of quality care, sedation/anesthesia providers must master their medical knowledge with QI methodology in NORA locations. This methodology has now been largely incorporated into anesthesia practice. Adoption requires leadership support and a team approach to embrace transparency and open communication.
QI projects require a framework for improvement. This framework provides the critical scaffolding for outlining a process; identifying problems; and testing, evaluating, implementing and communicating the changes. The Model for Improvement is a popular framework. In this model the process starts by asking three questions of change to frame a project: What are we trying to accomplish? How will we know that a change is an improvement? What changes can we make that will result in improvement? These questions are evaluated by designing experiments known as small tests of change, or plan-do-study-act (PDSA) cycles.14 For example, this application of QI methodology in NORA locations has been recently reported to prevent medical errors and minimize hypothermia for NORA patients in radiology.
A recent prospective observational study cited that approximately 1 in 20 perioperative medication administrations, and every second operation, resulted in a medication error and/or an adverse drug event. More than one-third of these errors led to patient harm, and the remaining two- thirds had the potential for patient harm.15 56,000 adverse events, 710 deaths, and 87 incidences of intraoperative awareness associated with the use of infusion devices alone were reported to United States FDA from 2005 to 2009.16 Errors related to the programming and operation of information devices can have catastrophic circumstances in NORA.17 The common reasons for intravenous medication infusion errors include incorrect programming of weight or dose, programming the incorrect medications, and override of alerts by providers without recognizing an error. By using PDSA cycles, a recent QI project showed that utilizing a brief two-person verification approach can reduce medication errors attributable to wrong infusion pump programming.18
Our primary goal is patient safety, but at times efficiency, a secondary goal, may compete with this primary goal. One example of this scenario is the haste to decrease turnover time may lead to a neglect in performing a safety check. The willingness of personnel to speak up and identify a patientsafety concern is critically important to maintain safety in all anesthesia environments. The concept of doing a challenge and response checklist to prevent errors for patients undergoing MRI has been examined by applying QI methodology. The authors of this project created a reproducible model of care which involves multiple checklists at high-risk points to ensure the patient; team and equipment are correctly configured at every key transition stage in the patient journey in the operating room and in the radiology suite.19 A recent QI project examined the variables associated with post-imaging hypothermia in neonatal intensive care unit (NICU) infants undergoing MRI concluded that applying QI principles decreased the occurrence of hypothermia in NICU infants undergoing MRI scanning from 65 percent to 18 percent.20
Any organization that strives for zero patient harm must invest in QI, empower the “front line” to make decisions, provide opportunities to report errors, unsafe conditions, and near misses, and promote in multidisciplinary teamwork to promote and enhance safe care. Extreme vigilance and delivering care to the best of our ability alone will never eliminate errors.
Seventeen years have passed since the Institute of Medicine’s report To Err Is Humangalvanized a national movement to improve the quality and safety of patient care. Adapting and applying high-reliability science used by the aviation, manufacturing, and nuclear industries is essential to enable us to reach the levels of quality and safety that the institute of medicine called for. One of the most important reasons cited for the improvement in the safety of aviation industry has been the routine use of simulation in the training of pilots. Medical simulation is emerging as a powerful interactive and innovative education tool capable of exploring technical, behavioral and systems issues within health care.21,22 Simulation enacts a participative clinical event for the purpose of learning, practicing, evaluating, testing and understanding human actions.21 Practitioners can learn in simulation without putting patients at risk and also incorporate a review of educational content and debriefing by an expert facilitator to drive learning.21 A recent study supports the notion that patient safety was enhanced when simulation was incorporated into training.23 Simulation can also address “latent error” identification such as patient vulnerabilities in complex health care environments.24
Solutions for Safety
Despite the increased attention towards patient safety, many patients still suffer preventable harm every day. Lack of reliable data on patient safety at the national level, difficulty in engaging providers in patient safety improvement initiatives, and challenges in redesigning and improving complex health care systems and processes are few examples of why we are still struggling with patient safety. An example of a recent national effort to overcome some of these obstacles is the creation of The Children’s Hospitals’ Solutions for Patient Safety National Children’s Network. This collaborative effort among children’s hospitals is currently working on eliminating serious harm across all children’s hospitals. Since 2012, this effort has led to an estimated savings of more than $148.5 million and saved 9,093 children from serious harm, with a consistent upward trend in harm prevented every month (as of June 2017).
The rate of critical events in anesthesia is thus exceptionally low. More data is needed from a collection of institutions to provide greater precision concerning incidence, causation, statistical analysis, and process control to mitigate events. Expanding the adverse event analysis and reporting to national programs such as the American Society of Anesthesiologists Closed Claims Study, the Perioperative Cardiac Arrest (POCA) project and Wake-Up Safe is essential to decreasing the incidence of critical events in patients undergoing anesthesia.25
In conclusion, employing the cultural transformation strategies of high-reliability industries to anesthesia practice can significantly reduce harm. Best intentions are not enough. We must apply the lessons learned from HROs. We need to encourage QI capability in our organizations through education and the use of high-reliability processes, such as standardization, information technology, and automation. Larger prospective studies that evaluate the relationship between the use of these high-reliability processes and improved patient outcomes are critical to advancing safe patient and provider care.
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