Section seven is about methods and tools for evaluating adverse events. There are several common tools that are used to assess and evaluate risk and adverse events depending on the reporting avenues. Healthcare organizations need information about their failures that occur at every level. And as a result, with good methods for reporting and evaluating, the system will continue to improve. Reporting processes can be structured. In some settings, they may be voluntary. The ideal system that is informed by the patient safety culture has a voluntary system that is non-punitive and non-blaming. In some institutions, this might be framed as a just culture. But ideally, all reporting occurs for the sake of improvement. Now there are some places where reporting is mandated, such as if a sentinel event occurs and you report to the joint commission, or events of abuse in the hospital, and those may have to be reported to a government authority. But potential liabilities need to be reported. Professional violations may need to be reported to things like the National Practitioner Data Bank. But ideally, from a patient safety standpoint, what is being reported internally are deviations from particular processes or observations. Even those near misses should be reported. Even those things that are held up by the actual layers of Swiss cheese and do not fall through the holes. These may include occurrences of poor teamwork, poor medication administration, laboratory errors, or when the wrong food tray is brought to a patient. That may be a near miss, but it also could be an adverse event. And these sorts of things are the stuff that should be reported internally. In the system's interest, being attentive to operations, no issue is not important. And many systems have shown that internal reporting can lead to quality improvement. On the other hand, it's very hard to get individuals to report. As Dr. Robert Simon once wrote, medical errors that diminish the quality of care may not necessarily violate the standard of care. And it's important to remember that. That reporting an incident or reporting a finding isn't necessarily the same as reporting a violation or a dereliction. There have been attempts to make reporting occur outside of hospitals, such as the Near Miss Project in New York State, which has been a good way to develop information and data surrounding errors in that state. It's important to remember that from a quality improvement perspective, in most hospital situations, settings, what is reported is protected. The Patient Safety Quality Improvement Act of 2005 designated patient safety data given to qualified patient safety organizations as privileged and confidential. So one should check with their hospital system to make sure that this is the case and then feel better about reporting. When thinking about reporting, it's important to remember that confidentiality needs to be thought about. But it's not necessarily absolute. There certainly are going to be web-based ratings of physicians out there. But more importantly, patient safety organizations share the goal of improving safety and quality for healthcare delivery. There are many different organizations that could be patient safety organizations. And also those are supported by the Affordable Care Act. When thinking about errors, again, let's remember what is an error. When someone is trying to do the right thing, but ends up doing the wrong thing. It's a non-deliberate deviation. And it differs from a violation, which is a deliberate intentional movement away from the standard of care. Bad outcomes are not necessarily errors. And not all errors lead to adverse events. Actions that do not go as intended or where the action is the wrong action may be errors. A mistake is a failure of planning. And it, too, does not always lead to an adverse event. When an adverse event has occurred leading to a sentinel event, or even in cases where it's not a sentinel event, one good way of investigating what happened is the root cause analysis. A formal review of an adverse event. This was initially developed to analyze industrial accidents. And a root cause analysis is now widely used in healthcare. A central tenet is that identifying underlying problems in the system will, that increase the likelihood of errors, need to be identified. And so it is a structured manner of analyzing such events. One may ask, what happened? Who was involved? When did it happen? Where did it happen? What was the severity or the potential for harm? What is the likelihood of reoccurrence? And what were the consequences? It was developed in the Veterans Administration system. A root cause analysis is a retrospective review. And it's also meant to be done by an interprofessional team. In the VA system, there has been a severity assessment code to help triage those events to see which ones necessarily need to be dealt with first. But again, the focus is on the system's level vulnerabilities and not on individual performance. The model examines multiple factors that may affect the individual, such as communication, training, fatigue, scheduling, rosters, environment, equipment, rules, policies, and barriers. All of those things that we talked about earlier that have an effect on patient safety or the likelihood of errors. Another manner to investigate errors prospectively is called failure modes effects analysis. It's done to identify potential contributing factors for potential adverse events in the future. It asks, where did the system fail? By contrast, the root cause analysis asks, why did the system fail? Morbidity and mortality conferences are other processes by which adverse events can be evaluated, as well as the probable risk assessment. And there are examples of probable risk assessment methodology on various websites that can be accessed. This is the end of this section. In the next section, we talk about medication errors and how to prevent them.

adverse events

healthcare organizations

reporting processes

quality improvement

root cause analysis