A proactive approach to safety management

Healthcare systems have historically monitored the incidence of error and harm in order to assess how safe our health services are. But as other industries have found, reliance on outcome measures without a deeper understanding of how these are brought about – by design or luck – may lead to a false sense of safety.

Our recent report, Using safety cases in industry and healthcare, argues for a more proactive approach to safety management. It looks at the use of ‘safety cases’ in six safety-critical industries and makes pragmatic recommendations for the adoption of safety cases in healthcare. Here we take a look at the key points from the report.

What are safety cases?

Safety cases were developed by the oil, nuclear and rail industries in response to their own high-profile inquiries into safety failures, which demonstrated that reliance on outcome measures and compliance with regulatory standards alone was not enough. Now accepted best practice, indeed mandatory for most UK safety-critical industries, the safety case is a risk-based argument with supporting evidence to demonstrate that services are operating at an agreed level of safety.

A safety case consists of three key elements: claims, arguments and evidence. In general it should clearly describe the following: 

• the safety objectives that are to be achieved (ie what is an acceptable level of safety)
• hazards that have been identified and how the risk they pose has been assessed
• risk control measures that have been put in place
• evidence that the risk control measures are successfully reducing the risk in actual practice.

Many healthcare professionals will already be familiar with at least some of these elements, and will have experience of applying these in some form to the improvement of high-risk activities such as use of medical devices. The safety case provides a framework for extending this rigour to all clinical processes.

Benefits for healthcare

Unlike performance management dashboards, which aggregate and summarise data, safety cases increase the depth of scrutiny by gathering evidence on safety from a range of sources, including risk assessments, incident reporting, human factors analysis and operational experience. Local intelligence is essential as it enables healthcare teams to focus on targeted interventions that take local circumstances into account. 

As safety cases can look in detail at hypothetical scenarios, they avoid the potential for blame that sometimes occurs when actual patient safety failures are discussed. This can make them less daunting for healthcare professionals.

Dr Mark-Alexander Sujan from Warwick Medical School, who led the research, says:

‘Safety cases have the potential to radically change how we assess whether an organisation is safe. It is possible that safety cases will allow us to move from compliance-based assessments to one where organisations are assessed on their ability to proactively manage risks and prevent incidents occurring in the future’. 

Testing the approach

We are already testing how this approach could work in healthcare through our Safer Clinical Systems programme. Eight healthcare organisations are preparing their own safety cases addressing different clinical processes.

Early evidence from the sites is encouraging. For example, a team from Royal United Hospital Bath is aiming to improve reliability and safety of medication for people with Parkinson’s disease admitted to hospital – recognising that timely medication is critical for these patients and delays can contribute to falls, dehydration and other harms. The safety case approach allowed them to structure their safety management activities and to identify the types of evidence they would need to construct a credible argument that their process is safe.  

Next steps

Adopting safety cases can support organisations to understand whole systems and to focus on the highest risks in their locality. As in the other safety critical industries, safety cases may also be used by regulators to assess the presence of safety, rather than the absence of harm.

This approach is really promising for healthcare. The UK is a leader in terms of technical expertise and practical experience in the use of safety cases in other industries. It’s time to seize this opportunity to learn from other industries how to get a comprehensive picture on safety within a clinical system before a failure occurs.