Newsletters Professional Discipline 11th Oct 2022

Gavin Irwin comments on the new Patient Safety Incident Response Framework

On 14 September 2022, NHS England (‘NHSE’) published the New Patient Safety Incident Response Framework (‘PSIRF’), “set[ting] out the NHS’s approach to developing and maintaining effective systems and processes for responding to patient safety incidents for the purpose of learning and improving patient safety”.[1]

Patient Safety Incidents (‘PSIs’) are defined as, “unintended or unexpected events (including omissions) in healthcare that could have or did harm one or more patients”.[2]

The need for a new framework

A number of reports (Public Administration Select Committee, Parliamentary and Health Service Ombudsman, Care Quality Commission), had identified shortcomings in the way PSIs were investigated and learned from and in 2018 NHSE began a consultation to determine what action should be taken.  The PSIRF emerges from feedback received through that consultation and has been trialled by a group of ‘early adopters’ since May.

The PSIRF replaces the Serious Incident Framework (2015) and organisations are expected to complete the transition by Autumn 2023.

Aidan Fowler, NHSE’s National Director of Patient Safety, has stated that, “[t]he introduction of this framework represents a significant shift in the way the NHS responds to patient safety incidents, increasing focus on understanding how incidents happen – including the factors which contribute to them”.

To whom does it apply?

The PSIRF is a contractual requirement under the NHS Standard Contract and is therefore mandatory for services provided under that contract, including acute, ambulance, mental health, and community healthcare providers (includes maternity and all specialised services).

Primary care providers may adopt the framework but are not required to do so.

Organisations that provide NHS-funded secondary care under the NHS Standard Contract but are not NHS trusts or foundation trusts (e.g. independent provider organisations) are required to adopt the framework for all aspects of NHS-funded care and may apply this approach to their other services for consistency. Such organisations may not need to undertake the full analysis required for patient safety incident response planning but are required to engage in processes such as stakeholder engagement.

Significant / “fundamental” shifts

The PSIRF makes no distinction between PSIs and ‘Serious Incidents’ – it removes the Serious Incidents classification and instead promotes a proportionate approach to responding to PSIs by ensuring resources allocated to learning are balanced with those needed to deliver improvement.

Unlike the SIF, the PSIRF is not an investigation framework that prescribes what and how to investigate, instead it: advocates a co-ordinated and data-driven approach to patient safety incident response that prioritises compassionate engagement with those affected by patient safety incidents; and, embeds patient safety incident response within a wider system of improvement and prompts a significant cultural shift towards systematic patient safety management.

A new Incident Response Toolkit is provided.[3]

Key take aways

  1. Compassionate engagement and involvement of those affected by patient safety incidents

That means, “working with those affected by patient safety incidents to understand and answer any questions they have in relation to the incident and signpost them to support as required” through, “meaningful involvement”.

Organisations must have policies to support this to happen.  Detailed guidance and standards have been published.[4]

  1. Application of a range of system-based approaches to learning from patient safety incidents

Denotes a move away from, “methods that assume simplistic, linear identification of a single cause … to explore the contributory factors to a patient safety incident or cluster of incidents, and to inform improvement”.

Detailed requirements have been published.[5]

  1. Considered and proportionate responses to patient safety incidents

Recognising that organisations have finite resources for PSI responses, the PSIRF “supports organisations to use resources … to maximise improvement, rather than repeatedly responding to patient safety incidents based on subjective thresholds and definitions of harm”.  While some PSIs, such as ‘Never Events’ and deaths thought more likely than not due to problems in care continue to require a PSI investigation, where not mandatory, responses must be proportionate – there are no additional thresholds and, in certain circumstances, it is acceptable not to undertake an individual response to an incident.

Guidance has been published.[6]

  1. Supportive oversight focused on strengthening response system functioning and improvement

Since all healthcare organisations providing and overseeing NHS-funded care must work collaboratively to provide an effective governance structure, the PSIRF expects Integrated Care Boards (‘ICB’ – the replacement for CCGs) to facilitate collaboration at both place and local system level.   Providers are not required to seek sign off for PSI response reports from their ICB, however, they must be open with information relating to PSIs and findings from incident responses, including formal reports.

Guidance has been published.[7]

In Conclusion

Dr Rosie Benneyworth, Interim Chief Investigator at the Healthcare Safety Investigation Branch (HSIB) has stated that the, “PSIRF reflects the key principle that guides our national patient safety investigations – a focus on understanding how incidents happen rather than attributing blame or liability – and applies this to local investigations”.

The PSIRF does not represent a change in tone or change by degree, it is a new system and will not be able to be adopted and deployed through amending existing policies and procedures – a fresh pair of eyes and meaningful engagement, will be required.

In the short term, achieving compliance is likely to be resource intensive but for NHS contracted health care providers any shift away from a culture attributing blame or liability is likely to be welcome and, ultimately, a focus on fair and proportionate engagement with staff and with patients at least permits an element of autonomy in deploying such resources in the longer term.


Gavin Irwin









Categories: Newsletters