What can Safety Cases offer for patient safety? A multi-site case study

Why it matters

The Safety Case is an approach to safety management used in some safety-critical industries, such as transport and mining. A Safety Case document typically describes an operational context, identifies potential hazards within it and their consequences, describes the risk controls put in place to address them, and accounts for any residual risk. It has been developed to make the case that risk has been reduced to a level ‘as low as reasonably practicable’ (ALARP). When used as a regulatory technique, Safety Cases are then presented to a regulator who either grants the organisation a licence to operate or asks for further assessments and/or risk mitigation.

The use of Safety Cases in healthcare is currently limited to areas such as development of medical devices and information systems. To further the evidence base for their use, we looked at the first documented attempt to apply Safety Case methodology to clinical pathways.

Our approach

We evaluated the Safer Clinical Systems programme, carried out from 2011 to 2016, and funded by the Health Foundation. This initiative, which engaged nine hospitals in the UK, was designed to enhance the safety and reliability of clinical pathways by applying insights from different safety-critical sectors. The main objective of the program was to enable participating organisations to improve their clinical pathways through a structured methodology for identifying risks. The Safety Case was a centrepiece of the programme.

Our mixed-methods evaluation includes documentary analysis of 13 Safety Cases produced by participating organisations and 143 interviews with project teams and organisations’ senior leaders.

What we found

Key benefits of the Safety Case approach included the potential to highlight the risks affecting clinical pathways – teams and senior leaders appreciated having these hazards incorporated into a single document. Sometimes, the Safety Case also helped uncover hazards that were not known before. However, compiling a Safety Case wasn’t always a straightforward task. Teams often struggled to master the risk assessment and analysis techniques required.

Though clinical teams were able to identify some problems that they could fix through their own efforts, they also identified many hazards and risks that frontline staff couldn’t address themselves. Safety Case were sometimes used as a way to attract the attention of senior leaders and make a case for more support or better resourcing, although some issues were even beyond senior leaders’ control.

Senior leaders recognised that Safety Cases were useful for providing an in-depth, system-wide account of risks in the system – but weren’t as confident in their ability to provide assurance, and it wasn’t always clear how to mitigate risks to as low as reasonably practical. They also faced the dilemma as to whether to prioritise fixing the risks identified in Safety Cases over other pressing issues, including those that had already resulted in harm. Some senior leaders felt that compiling Safety Cases for a specific clinical system could divert energy and resources from other urgent problems in the organisation.

While some risks picked up by Safety Cases (typically those affecting discrete pathways which were easy to isolate) were tackled relatively easily, others were more complex and widespread, with roots in institutional and organisational vulnerabilities beyond the scope of control of Safer Clinical Systems teams. Some risks couldn’t be resolved or mitigated at all by organisations, for example because they would require larger system change.

By the end of the programme, members of project teams and senior leadership in participating organisations saw the Safety Case as a valuable approach, but also highlighted practical difficulties with its implementation.

The approach is promising in principle, but substantial challenges need to be addressed before it’s deployed. There needs to be cautious implementation and rigorous empirical evaluation before attempting to transfer these methodologies into healthcare settings, and it won’t be appropriate to ‘drag and drop’ the approach from other safety-critical sectors.