Risk management

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Risk management






Human error models


Human error can be considered in two ways: the person approach and the systems approach. Traditionally, the person approach has been the dominant approach used in health care. This focuses on the errors of individuals, blaming them for forgetfulness, inattention, carelessness, negligence or recklessness. It has been widely acknowledged that blaming individuals does not encourage reporting and learning from errors, and the development of an effective risk management culture within healthcare settings depends critically on establishing an open reporting culture.


During the past decade, there has been increased interest to understand how management practices and other workplace factors impact on patient safety. The systems approach acknowledges that humans are imperfect and errors are to be expected, even in the best organizations. Rather than focusing on the individual, the systems approach concentrates on the conditions under which individuals work, trying to build defences to avoid errors or to mitigate their effects. James Reason (2000) classified medical errors into two types, active and latent failures, where active failures are unsafe acts (e.g. dispensing the wrong drug) committed by individuals who are at the ‘sharp end’ of health care, while latent failures are more distant from the actual incident and reflect failures in management or other organizational factors.



Active failures


Active failures take a variety of forms, such as slips, lapses, mistakes and procedural violations, as shown in Figure 10.1.



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Figure 10.1 Reason’s (2000) four-stage model of human error theory.


Slips occur when there has been a lack of attention, despite the fact that the individual has all the necessary skills to complete the task successfully. Lapses involve memory failures, such as forgetting your intentions or omitting planned actions. In contrast, mistakes happen when we are in conscious control of the situation, but successfully execute the wrong plan of action. For instance, selecting the wrong plan can come about because of an incorrect assessment of the situation, such as arriving at the wrong diagnosis for an individual asking for an effective treatment for an ‘upset stomach’.


Violations, on the other hand, involve deliberate deviations from the procedures or best way of performing a task, such as not following SOPs (see Ch. 11) within the pharmacy. Several types of violations have been described, which are outlined in Box 10.1.



Each of these error types (slips, lapses, mistakes, violations) requires different strategies to be implemented to avoid similar events occurring in the future. Better system defences, such as redesigning the workplace, can help to minimize slips and lapses. Improved training and rigorous checking procedures can prevent some mistakes. Developing relevant procedures and protocols, ensuring effective implementation with the provision of the necessary resources and support are all important in promoting compliance and therefore avoiding procedural violations.



Latent failures


Latent failures are those whose adverse consequences may lie dormant, only becoming evident when they combine with other factors. These usually stem from poor decisions, made at a different time and place, by more senior members of the organization or people operating at a different level, such as the headquarters of a pharmacy chain. Latent failures have two kinds of adverse effect: they can lead to error and violation provoking conditions in the workplace (e.g. time pressures, understaffing, inadequate equipment, inexperience) or they can create weaknesses in the defences (e.g. unworkable procedures or design problems).


The investigation of many threats to patient safety has shown that there are usually multiple causes and they tend to occur when there is an unfortunate combination of active and latent failures. Reason (2000) proposed the ‘Swiss cheese’ model to illustrate how accidents can occur within systems. This analogy compares the defensive layers of the system to layers of Swiss cheese, each having holes that represent safety failures. The presence of holes in one slice may not result in an accident because the other slices act as safeguards. However, the holes in the layers may temporarily line-up, creating an opportunity for an accident. Figure 10.2 shows how multiple failures in the pharmacy setting can result in patient harm.




Risk management tools


There are a number of useful techniques that can be used to help understand the underlying causes of adverse events and help identify actions that can be put in place to avoid similar events occurring in the future. For instance, root cause analysis (RCA) provides a framework to reflect on an actual or potential error, working back across the sequence of events. RCA aims to uncover the underlying, contributory and causal factors that resulted in an error, and also understand better the protective factors that may have prevented harm from occurring. It is important to include all those involved in the incident in order clearly to map out the chronology of events. The analysis is then used to identify areas for change and possible solutions, to help minimize the reoccurrence of the event in the future. Various methods can be used for RCA including the use of a ‘fishbone diagram’, in which each of the ‘bones’ reflect different system failures, or the use of timelines where a chronological chain of events is mapped and tracked.


Failure modes and effects analysis (FMEA) is a systematic tool for evaluating a process and identifying where and how it might fail. It also assesses the relative impact of different types of failure and so prioritizes which areas need attention first. In addition, it can be used to assess the likelihood of the event reoccurring following changes to the system. The FMEA process involves:


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Jun 24, 2016 | Posted by in PHARMACY | Comments Off on Risk management

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