Safety analysis over time: seven major changes to adverse event investigation

In many cases, the time period encompassed by safety analysis will need to be extended to examine a significant portion of the patient’s journey through the healthcare system, exploring the safety of the patient journey through time. This is different to simply examining the causal history of factors that led to the occurrence of one particular event. Many patients suffer significant harm because of multiple small failures that accumulate throughout their care, rather than a single dramatic failure at one point in time [24, 28‐30]. We already understand that after an incident we need to look back to the series of factors that combined to create a single harmful event—for instance, a young doctor is unsupervised at night with inadequate equipment, a difficult team and a very sick patient. More often though, in the care of a patient over time, we see a progressive degradation in care due to a combination of errors and system vulnerabilities that accumulate over a long period.

Amalberti and colleagues [31, 32] have previously argued that we should extend the time frame of analysis to consider an ‘event journey’. However, to examine safety over longer time periods, particularly in community settings, we now believe that we should speak simply of the patient journey. This will require looking back through the medical history of the patient in search for all events that have defined the patient’s journey and contributed to the final outcome, whether or not these events have been perceived as serious at the time they occurred or whether the problem was detected and resolved. In this scenario, we will need to try to understand, without the benefit of hindsight, both the benefits and risks of certain courses of action and how sometimes risks will be knowingly and acceptably taken because of the benefits incurred. A simple but important example is the frail person who elects to stay at home rather than be cared for in a residential setting; this course is medically more risky, but the risks are outweighed by the wider social and psychological benefits.

The suggestion that we might extend our analysis to longer time periods raises a number of questions about the definition and identification of events that would be suitable and productive for analysis. The word ‘incident’ does not seem entirely appropriate when considering a series of events that might gradually unfold over several months and some new terminology might be required. We might instead speak of a ‘safety analysis of the patient journey’ over a particular time period. We would also need to identify the trigger events which might lead to such analyses. In the first instance, these might be familiar adverse events which on initial inspection suggest a long genesis. In time, we might be able to identify unsafe periods of patient care, although this is not easy with current information systems.

Identifying periods of time when care has been unsafe is difficult with current systems firstly because they are not oriented to detecting problems of this kind and secondly because most healthcare staff will only be aware of particular episodes within the patient journey. One potential solution is to analyse some incidents that are selected by patients rather than by professionals to gain a wider coverage of the landscape of potential problems. Incidents currently selected for analysis by professionals tend to be those that have the most immediate and most visible impact in a particular clinical context. The longer term problems that patients can experience as they receive care across different clinical settings over long periods of time are invisible to most professionals not because they are unwilling to see them but simply because the information is not readily available [33, 34].

We already know that patients and families are able to reliably identify adverse events that have not been detected by professionals. Patients have been shown in a number of studies to report errors and adverse events accurately and to provide additional information not available to healthcare professionals [34‐37]. We suggest that events considered for analysis should be selected from the patient’s point of view as well as by professionals. We do not yet know what other kind of events might be identified as worthy of investigation by patients and families but they may be quite different from those identified by professionals. Developing methods to identify significant events identified by patients will be challenging and will likely require collaboration between families and professionals to select events and thematic issues that provide the most fruitful insights [38].

The inclusion of patients and families in both selection and analysis is likely to profoundly affect both the focus and findings of safety analyses. We might anticipate for instance that much more attention will be given to psychological and social issues, that communication and the coordination of care between providers [34] will be a dominant theme and that the cognitive and emotional demands of caring will emerge as a safety issue in its own right.

Healthcare organisations have finite resources for safety investigation and analysis, and these resources are frequently consumed by the demands of outside agencies. Staff can become understandably frustrated and burdened by requirements for time-consuming incident investigation carried out without adequate time or sufficient training. Much greater investment in training in safety analysis is certainly needed [15]. But more fundamentally, much more care and attention needs to be paid in selecting which incidents would be suitable for extensive analysis, particularly in terms of the likely improvements to patient safety. The depth and extent of the analysis conducted should ideally be proportionate to the value of the potential learning and improvements that are likely to result.

Some tragic events must be investigated because the patient and family need an explanation and support; this is right and necessary, and healthcare organisations have a moral responsibility to respond to families who have suffered [39‐41]. However, these are not necessarily the events which provide the greatest insights into the strengths and vulnerabilities of the healthcare system. For the purposes of safety improvement, a fairly drastic ‘triage’ process should be carried out. Some issues can be reviewed fairly rapidly by a clinical team in a team meeting, while others with wider implications may require longer and more extensive analysis possibly coordinated  across multiple organisations [42]. At present, the main criteria for choosing incidents within organisations is the severity of outcome, although at national level, investigations may be prioritised because they are addressing issues that have widespread implications for the whole system of care [43, 44]. Severity of outcome could remain a criterion for longer term analyses, but we might also want to prioritise events that were likely to reveal problems not highlighted in current systems; these would certainly include problems that arose within the patient’s home, breakdowns in coordination of care across providers and difficulties in transitions between providers of care.

Such long-term analyses would be resource intensive. We suggest however that an extensive analysis of 10 incidents a year across clinical settings would provide just as rich an understanding of the landscape, richer than 100 rushed and formulaic analyses. A deep investigation of 10 incidents in a given clinical area over a year would reveal enough insight for several years’ worth of further exploration and improvement. Findings from such analyses must then be considered in the context of other safety relevant information [45] and the longer term organisational strategy for improving the quality and safety of care.

Applying a more proportionate approach to prioritising analytic resources also requires a flexible portfolio of analytic strategies. For example, productive analyses of minor issues can be carried out rapidly in a few minutes in a team meeting [39] or perhaps used as the basis for reflection in a larger clinical or organisational meeting. Where more detailed analysis may be required, escalating approaches such as concise analysis tools [42], a rapid SWARM analysis [46] through to system level reviews [47]. These all represent different approaches to reflection and investigation of safety issues at different levels across an organisation, which is foundational practice in other safety critical industries [43]. The critical point is to triage incidents and events and customise an appropriate degree of inquiry.

Analyses and reports should identify, and indeed celebrate, good treatment as well as pointing out failures in the care process [48, 49]. More subtly, we also need to pay more attention to both successes and failures of detection, anticipation and recovery [4]. There is much to learn from the ability of the system to detect and recover from failures and close calls [38, 50]. For example, in addition to identifying failures and contributory factors, we could instead ask ‘what successes and failures of response and recovery occurred in the care of this patient?’ and ‘how we can we improve detection and recovery in settings such as these?’ These questions are fundamental to understanding how safety functions and risk controls work effectively—and how they break down [9]. They are also central to many prospective risk analysis methods, such as Bow Tie analysis [51] and Failure Mode and Effects Analysis [52]. Bow Tie analysis, for instance, has been extensively used in the aviation sector to identify and communicate risk information effectively. Carrying out a prospective analysis of a safety risk using the Bow Tie method involves asking a structured set of questions prospectively addressing the nature of a hazard, the circumstances that lead to danger, the impact of loss of control and the means of recovery and mitigation of any harms. Bow Tie diagrams illustrate a hazard, the undesirable event, trigger events (threats) and potential outcomes; they also show the risk controls put in place to minimise the risk. Failure Modes and Effects Analysis, occasionally used in healthcare, [53‐55] is another analytical method that provides a systematic and structured approach to identifying potential sources and consequences of failure. A key stage of this method involves identifying how potential failures might be detected and responded to if they actually occur.

We should also give serious consideration to examining events and episodes where a successful recovery occurred which would be supportive of staff morale and also instructive in revealing successful adaptive strategies, such as ‘good catch’ programmes in healthcare that seek to analyse and understand events where staff effectively detected and recovered from potentially harmful events [56]. This would have implications both for our understanding of events and, more importantly, for the recommendations which follow such analyses which might expand to include a much stronger focus on developing detection and recovery strategies.

The original ALARM/LONDON protocol proposed that, after the initial care delivery problems were identified, each should be analysed separately to consider the contributory factors [11]. In a sequence of problems, different sets of contributory factors may be associated with each specific problem. For instance, a nurse might fail to ask for advice about a deteriorating patient due to inexperience, poor supervision and deficiencies in teamwork; in contrast, the same patient might later fail to receive the correct medication, but this might be due to inadequate staffing and poor organisation of care. With an analysis over a relatively short timescale, this more complex analysis may not be carried out and all the contributory factors may be considered together; in fact, techniques such as the fish bone causal diagram actively promote the aggregation of all contributory factors into a single amalgam. Much of the value of mapping out the complex patterns of factors and conditions that underlie safety issues is therefore lost, as fine-grained explanations of how events evolve and interlink can instead give way to simplistic lists [57]. However, this more subtle perspective becomes much more important with a longer timescale as a series of problems may be identified which are clearly separated in time and context. Each of these can be separately analysed using the ALARM grid to build up a much more detailed picture of system vulnerabilities.

Any safety analysis begins by comparing what actually happened with what ideally should have happened. Indeed, it is typically a dramatic mismatch between what was expected and what actually happened that alerts organisations to a serious safety problem in the first place [58]. Analysing incidents in terms of the gap between the way work is expected to be done and what actually occurs is a central strategy in detecting the early signs of emerging safety problems [59‐61]. Comparing how work is actually done and how it is imagined is one of the primary learning opportunities offered by incident analysis in other industries [43]. For example, in airline incident reporting and investigation systems, safety investigators assume that knowledge of organisational practice is always partial and imperfect and so focus considerable attention on identifying any discrepancies between the practices that are described in incident reports and those that are specified in formal manuals and standard procedures. Even minor discrepancies, such as the order in which bolts are routinely replaced in a maintenance task, can cause serious concern. These discrepancies will typically prompt a detailed investigation of the nature of the ‘real-world’ practical work involved, along with careful examination of the formal procedures that are intended to guide this work, to ensure that both are aligned, reliable and mutually supportive [43, 62].

Analysing this mismatch allows broader reflection on the nature of the problems identified and wider system vulnerabilities. However, typically, the accepted standard of care is taken as a given and the analysis examines reasons for departure from that standard. The conclusion of the investigation may simply be that staff did not comply with standard procedures without any consideration of the workability of those procedures [63] or the context and circumstances in which the care was delivered. Adherence to processes and standards is rightly ingrained in the professional training of nurses and other professions which may make such reflections appear non-professional. Investigations therefore need to look more closely not only at the reasons for departures from standard procedures but at the standards and procedures themselves [64]. This is a subtle but important change of analytic stance. When analytical efforts are directed at identifying and understanding the mismatch between expected organisational work and the real situated practices of professionals, it simultaneously allows both to be updated, improved and revised. There is potential for using this perspective more actively in longer term reviews of safety issues to highlight the workability or unworkability of the intended care processes and so to develop smarter ways of working that are more aligned to human capacities.

Investigations have to be completed in a timely manner and the immediate priority is often to provide assurance to hospital patient safety committees, commissioners and regulators that action plans have been generated and recommendations have been implemented. In their turn, committees and regulators seek assurance that the plan has been actioned in a timely manner, an approach which is guaranteed to encourage simple recommendations that avoid thorny system problems. Reviews of recommendations generated by incident analysis have found that most recommendations are weak and few address fundamental system issues [5, 21, 44]. There is little understanding that people-focused solutions [65, 66] like adding in another double-check, re-writing the safety procedure, creating a new safety procedure or sending out an email reminder to staff are weak and will not in themselves lead to sustained improvements. Studies of successful improvement and behaviour change suggest that even when basic procedures are very well understood considerable work is needed both to understand reasons for non-compliance and to bring about change. Such changes, in the case of hand hygiene for instance, often require long term multi-faceted interventions which embrace cognitive, social and emotional determinants of behaviour all set within a wider organisational strategy with highly visible leadership commitment [67‐70].

Analysts use frameworks of contributory factors to guide the investigation of incidents and we may need to also use frameworks of solutions and interventions to ensure that all potentially relevant interventions are considered [71]. We have previously distinguished five broad strategies each associated with a family of interventions [4]. The first two strategies aim to optimise care, improving both safety and efficiency; the first strategy is to target specific harms or specific clinical processes and the second aims at the improvement of the underlying work systems and processes. These two broad strategies are complemented by strategies that are more concerned with detecting and responding to risk and which assume, particularly in a time of rising demand and financial austerity, that care will often be delivered in difficult working conditions. These three additional strategies are risk control; monitoring, adaptation and response; and mitigation. Each of these is associated with a family of specific interventions. Reports after incident analyses typically consider only a very few of the dozens of potential strategies and interventions available. The development of frameworks of contributory factors 20 years ago [7] helped us structure investigation and ensure a comprehensive exploration of relevant issues; we now need to draw on a menu of safety interventions which we can review when considering what actions might be required following analyses of patient journeys.