Providers of NHS-funded care have almost 12 months from now to radically change the way they respond to and learn from patient safety incidents.

The existing Serious Incident Framework, with its thresholds for investigation and set timelines, is being replaced by a more flexible, improvement-focused system called the Patient Safety Incident Response Framework (PSIRF).  With the final version of the PSIRF now published, there is much for providers to do ahead of autumn 2023, when they will be expected to have completed the move to the PSIRF.

In this briefing, we look at the headline changes, their potential impact and what your organisation needs to be doing now in readiness.

What’s changing?

Under the PSIRF, we will no longer be talking about ‘serious incident investigations’ or ‘root causes’.  In their place will be a more flexible, system-focused approach, with improvement and engagement with patients/families/staff taking centre stage.  This new system aims to channel resources where they will have most impact, rather than going through the motions of churning out incident investigation reports in every case.

The PSIRF applies to all services provided under the NHS standard contract (except for primary care currently), including NHS-funded services in the independent sector.

Organisations are required under the PSIRF to develop a patient safety incident response policy and a patient safety incident response plan, which must be based on a thorough understanding of the organisation’s patient safety incident profile and improvement priorities.  Both the policy and plan must be made publicly available on the organisation’s website.

Whereas the Serious Incident Framework requires providers to grapple with whether or not the ‘serious incident’ threshold for investigation is met, the PSIRF does not prescribe what to investigate (with a few important exceptions - see below) and there are no prescribed timelines for investigations, with these to be agreed on a case-by-case basis (although learning responses should usually be completed within 1- 3 months, with a long-stop of 6 months).

Plenty of detail about how the PSIRF should work in practice has been provided in a series of accompanying guidance documents, including: engaging with patients/families/staff; responding proportionately to patient safety incidents; oversight roles and responsibilities; and patient safety incident response standards.  Templates for patient safety incident response policies and plans, plus a template patient safety incident investigation report, have also been provided.

What key differences will we see under the PSIRF compared with the current system?

• Flexibility of approach

Under the PSIRF, carrying out an investigation following a patient safety incident is no longer the default position.  Instead, a patient safety incident investigation is just one type of learning response envisaged in the PSIRF, which promotes a range of system-based approaches (excluding root cause analysis, which is being moved away from) and encourages providers to refer to the national ‘learning response toolkit’ for support. Alternatives to an incident investigation mentioned in the PSIRF guidance include: ‘swarm huddles’, MDT reviews, after-action reviews, thematic reviews and horizon scans.

In terms of when a patient safety incident investigation (PSII) should take place, the PSIRF leaves this up to organisations to decide for themselves, depending on the circumstances and factors such as their patient safety profile - for example, a PSII may be indicated where contributory factors to an individual incident are not well understood. However, there are some categories of incident where carrying out a PSII is mandatory. These are set out in the accompanying guidance on responding proportionately to patient safety incidents and include: patient deaths thought more likely than not to be due to problems in care under the ‘learning from deaths’ criteria; deaths of patients detained under the Mental Health Act; and incidents that meet the ‘never events’ criteria (or its replacement).         

Importantly, if an organisation and its ICB are satisfied that risks are already being appropriately managed and/or improvement work is ongoing to address known contributory factors in relation to an identified type of patient safety incident, it is acceptable under the PSIRF not to undertake an individual response to an incident (other than to engage with those affected and record that the incident occurred).  This aspect of the PSIRF is likely to take some getting used to, not least for patients and their families.

It is also worth underlining that, whilst flexibility of approach is key to this new system, providers must comply with the standards for patient safety incident responses (also set out in one of the accompanying guidance documents), including the requirements around competencies/levels of training for those involved in delivering and leading on this.  CQC teams will apply these PSIRF standards as part of their assessment of an organisation’s systems for responding to patient safety incidents.

• Engagement

Ensuring that patients, their families and clinical staff are directly involved in the incident response process is very much at the heart of the PSIRF, with ‘compassionate engagement’ being top of the list of the PSIRF’s stated aims. 

Details on how to do this are set out in the accompanying guidance document: ‘Engaging and involving patients, families and staff following a patient safety incident’, which replaces ‘Being Open’ as the national standard for engaging those affected by a patient safety incident. It includes detailed practical advice on how to engage/involve patients, families and clinical staff right from the start and throughout the incident response process and covers matters such as sharing draft PSII reports, which ‘may feel daunting’, but needs to happen - ‘The PSII report must be shared in draft form before it is finalised, and those affected given a realistic opportunity to influence the content before it is finalised’. 

• Improvement focus

Another key pillar of the new system relates to supportive oversight which focuses on improvements in the safety of care, and not simply on the quality of investigation reports, with the PSIRF requiring regulators and ICBs to consider the strength and effectiveness of providers’ incident response processes. Although providers will not need to seek ICB sign-off of individual incident response reports under the PSIRF, their incident response policies and plans will have to be approved by their ICB. Collaboration across systems is also an important feature, with ICBs expected to facilitate collaborative working on the NHS response to patient safety incidents, at both place and system level.

How to get ready

What do you need to do now to prepare for the transition to the PSIRF?

In terms of timeframes, organisations have 12 months - until autumn 2023 - to complete the transition from the Serious Incident Framework to PSIRF.  Exactly how and when this happens within that 12 month period will vary, but one option might be for all organisations within each ICS to be supported to enter PSIRF at the same time.

There is a lot of support available to help achieve this, including a preparation guide, which breaks PSIRF preparation into 6 phases and provides detailed information about the steps to be taken within each phase, with one of the key starting points in that process being to put together a core PSIRF implementation team, including those with expertise in patient safety, patient safety incident response, QI, human factors, risk management and clinical and quality governance.

Seventeen NHS Trusts are ahead of the game on this as ‘early adopters’ of the new system.  Examples of their experience and tips so far are included in a number of videos available on the PSIRF webpage.

Potential impact

• Welcome focus on improvements in patient safety rather than producing endless incident reports which often do not result in meaningful change
• There will be challenges around changing culture in safety and learning and working with so much flexibility and supporting those involved in implementing the PSIRF on the ground
• Engaging positively with the various stakeholders including patients, their families, coroners, regulators and claimant solicitors will be vital and getting “buy in” now that not all serious incidents will necessarily be the subject of an investigation report
• Disclosure issues, including around draft investigation reports, depending on the particular circumstances
• Evidential issues around outcome of learning responses other than actual incident investigations (e.g. ‘swarms’, after-action reviews, thematic reviews etc) and the documenting of those outcomes
• There should be an awareness that patient safety response plans will inevitably be scrutinised by the regulators and therefore should be as accurate and achievable as possible

How we can help

Our national teams of regulatory and clinical risk lawyers have extensive experience of supporting healthcare providers on a wide range of matters relating to patient safety and incident responses, including:

• Clinical governance scrutiny to assess the effectiveness of incident investigations, organisational learning and board leadership/culture on learning;
• Duty of Candour requirements;
• Reviewing draft patient safety incident investigation reports and improvement plans;
• Representation and support in relation to further investigations which may be linked to incidents, including inquests and CQC or police investigations.