Root cause analysis for Clostridium difficile infections: is it time for change?

The Institute of Medicine report in the USA in 1999, To Err Is Human, heralded the emergence of patient safety and prevention of errors as a key public health issue. This landmark report recognised that most errors reflect system problems and that systems to learn from errors were critical to improve safety (Institute of Medicine, 2000). In the UK, the National Patient Safety Agency (NPSA) was formed in 2001 with the remit to monitor and report on patient safety incidents, including prescribing errors, in the NHS, although the functions of the NPSA were transferred to the NHS Commissioning board in 2012. The NPSA, with its focus on investigating adverse events in healthcare, introduced the NHS to the concept of root cause analysis (RCA). This is intended to be a structured process that aims to identify breakdowns in processes or systems that contributed to an adverse event occurring and support the development of actions that will correct the problems and prevent the occurrence of another adverse event. In the almost two decades since the formation of the NPSA and the widespread introduction of RCA to the vocabulary of clinical staff, it has become the mainstay of infection incident investigation. The study by Saaed et al. in this issue of JIP describes the application of RCA to determining lapses of care related to cases of toxigenic Clostridium difficile in England. In two years, the infection prevention and control team were involved in an astonishing 291 RCAs investigating cases of C. difficile. The authors do not calculate the costs of conducting all these RCA, only the costs of the second level of RCA involving a multidisciplinary team forum. This level of investigation was applied to 84 cases and these RCA alone were estimated to cost as much as £51,670. Of course, in the context of the financial penalties applied to NHS Trusts in England for breaching the ‘target’ number of cases of C. difficile they are ‘allowed’ to report in a year, some of these costs can be offset by identifying cases where no lapses of care occurred (NHS Improvement, 2017). Such cases can be deducted from the Trust official ‘count’ of cases and thus reduce the risk of potential financial penalties. In the analysis, in this Trust only £20,000 was saved in this way.

Another interesting aspect of the study is how the required approach to undertaking RCA in this context misrepresents the principles of the method (NHS Improvement, 2017). As the authors point out, the lapses of care identified by these RCA primarily reflected factors that could potentially increase the risk of transmission from the cases under investigation to another case, rather than the intended purpose of an RCA: to identify lapses of care that might have contributed to the patient acquiring the infection (the ‘root causes’). Thus, the most frequent ‘lapses’ identified involved delays in assessment, management, documentation or taking/processing samples. None of these were ‘root causes’ of the infection in question and the authors do not suggest there was evidence of cross-transmission linked to these ‘lapses in care’. The actions taken in response to the findings of the RCA are primarily focused on education, audit and feedback but, given that the same lapses in care were repeatedly identified, the effectiveness of these actions is apparently limited. This is not surprising given that the RCA process that Trusts are required to follow is focused on avoidance of penalties.

Identifying system failures that give rise to cases should represent the first step in the process. The second, and more critical step, is implementing actions to address unsafe conditions and prevent their future occurrence. In order to reflect the importance of this step, the National Patient Safety Foundation has renamed the process RCA squared (RCA²) or Root Cause Analysis and Action (National Patient Safety Foundation, 2016). The National Patient Safety Foundation makes a number of key recommendations for improving the effectiveness of the RCA², including processes for approving and reviewing progress of actions at a senior level in the organisation, formation (and resourcing) of appropriate RCA teams that do not include individuals involved in the event, and the application of a broad range of RCA tools in both the investigation process and the development of corrective actions.

Peerally et al. (2016) recognise the importance of seeing RCA not as a single technique but as a set of approaches and tools drawn from the field of human factors and safety science. These scientific underpinnings are critical to the success of the process. Human factor ergonomics tells us that system change is multifactorial requiring adjustments to be made to the environment, organisation, equipment and people, and that strategies such as process simplification and standardisation are more likely to achieve system change than education and training (Cafazzo et al., 2012).

Peerally et al. (2016) also highlight another problem with RCA that is reflected in the approach to cases of C. difficile, that rather than identifying ‘latent and active factors’ contributing to the genesis of the adverse event, the investigation instead becomes a ‘linear narrative’ and leaves aside the complex interacting factors that contributed to the problem. This is particularly relevant to these infections which now commonly occur as sporadic cases in acute care settings, with many acquired from environmental, food, people or animals sources in the community (Eyre et al., 2013). System change across both the healthcare economy and public health arena is required to reduce acquisition and address factors that increase the risk of developing disease associated with the organisms. This is where the powerful tools of an RCA process embedded in human factors and safety science is likely to exert greatest effect on the problem. However, as Peerally et al. point out, the drive to produce a report in the required timeline and prescribed fashion results in the report becoming the end product rather than a deeper analysis of the wider problems that contribute to the problem.

The National Patient Safety Foundation (2016) also recommend that organisations should have risk-based prioritisation in place to identify adverse events requiring RCA review. The work of Saaed et al. illustrates the significant resources that are being devoted to a flawed RCA process. The epidemiology of C. difficile has radically changed since monitoring and surveillance systems were established, with an 80% decline in reported cases since 2006 and an emerging understanding of disease acquisition (Dingle et al., 2017). Perhaps the time has come to reconsider how RCA can be applied more effectively to address this complex problem.