NHS England has published the new Patient Safety Incident Response Framework (PSIRF) which changes the way NHS trusts must respond to safety incidents affecting patients in their care. The PSIRF is supported by guidance, written with input from HSIB, which sets out new expectations for how NHS trusts engage with staff, patients and their families affected by patient safety incidents.The PSIRF replaces the Serious Incident Framework (SIF) and is intended to support the development of a new patient safety culture within the NHS. Key features of the PSIRF include ‘compassionate engagement’ with staff, patients and families, system (rather than blame) based approaches to learning and improvement, and proportionate responses which direct resources to where improvement is needed most. Acknowledging NHS trusts’ poor track record in patient safety investigations, the PSIRF includes guidance and processes to help the NHS develop a patient safety incident response system that prioritises compassionate engagement and involvement of those harmed or affected by patient safety incidents.What is the Patient Safety Incident Response Framework (PSIRF)?Patient safety incidents are healthcare events, failings or omissions that have harmed, or could have harmed, one or more patients. The PSIRF sets out how the NHS expects trusts and other NHS organisations to develop and maintain effective systems and processes for responding to these incidents, so that the NHS can learn from them and improve patient safety. The PSIRF is mandatory for all NHS services provided under the NHS Standard Contract, such as acute, maternity and ambulance services, and also applies to independent providers of NHS-funded care. It does not apply to GPs and other providers of primary care.The PSIRF requires NHS trusts to focus on understanding how incidents happen, rather than blaming someone, when something causes harm to a patient during NHS care. Patient safety incident responses will form part of a wider system of improvement leading to a patient safety culture within the NHS.Unlike the Serious Incident Framework, the PSIRF does not tell NHS trusts what to investigate, but requires them to understand their patient safety incident profile and their ongoing actions to improve patient safety. Based on that information, they must plan (and publish on their website) how they intend to respond to patient safety incidents, so that resources are used for improvement instead of repeated investigations into similar incidents. The plan should be updated regularly to adapt to the trust’s changing needs as learning and improvement takes place.Key aims of the PSIRF Compassionate engagement and meaningful involvement of patients, families, and staff affected by patient safety incidents is expected whenever an incident occurs, to prevent additional harm being caused by the handling of the investigation. The guidance says NHS organisations’ systems for engagement should be based on nine key principles, including:Meaningful apologies which demonstrate understanding of the impact of the incident on those involved, answer questions and concerns and communicate a sense of accountability (rather than liability) for the harm. Saying sorry is also an important part of the healthcare provider’s duty of candour.An individualised approach, with engagement and involvement that is flexible and adapts to individual and changing needs.Sensitive timing.Respectful and compassionate treatment of all who have been affected by the incident.Provision of clear guidance and information about the PSIRF process, communicated in a way that does not assume any prior understanding.Ensuring that all affected by a patient safety incident are heard.The investigation process must be collaborative and open, providing information and answers. The guidance recognises that the decision to litigate (claim compensation) is often difficult for injured patients but may be taken by those who struggle to obtain information and answers from the NHS about what went wrong.Recognition that everyone will experience the same incident in different ways, so patients, families, and healthcare staff should all be viewed as credible sources of information in response to a patient safety incident.Fairness and impartiality in choosing how to respond to an incident. Another key aim of the PSIRF is that NHS trusts provide considered and proportionate responses to patient safety incidents. This means that trusts can choose which incidents they investigate, to prioritise the use of resources on making improvements rather than responding to patient safety incidents arising from known safety issues, which are already being addressed and where any new learning would be limited. PSIRF suggests that examples of proportionate responses could include investigation of an individual incident where the contributing factors are not yet known or understood, or a thematic review of learning from past responses to help develop a safety improvement plan. Where a known safety risk is already being managed and contributory factors are being addressed, the trust does not have to respond to (investigate) similar incidents other than to engage with those affected and record that the incident occurred.Some types of patient safety incidents, such as Never Events or deaths which may have been caused by NHS care will usually need a patient safety incident investigation ( PSII) to help the NHS trust learn and improve. Other specific types of incident, such as complaints, serious maternity incidents, deaths requiring a coroner’s inquest, criminal activity or concerns about a clinician’s fitness to practice, may also require the NHS trust to refer or report the incident elsewhere. Where this occurs, the PSIRF response must be handled separately, and the trust must still engage with the patient and comply with its duty of candour.Other key aims of the PSIRF require NHS trusts to use system-based approaches which identify contributory factors to an incident rather than blaming an individual or identifying a single cause, and having NHS organisations work together to provide a governance structure which ensures effective NHS responses to patient safety incidents.What happens next?NHS organisations are now expected to begin a 12-month period of preparation before transitioning to PSIRF from the existing Serious Incident Framework. Guidance and HSIB training will be available to support NHS trusts in their preparation. Transition to PSIRF should be completed by Autumn 2023.Meanwhile further research will continue to evaluate the implementation and impact of PSIRF, and the guidance on engagement will also evaluated and kept under review. In addition, further work is being carried out to explore how the PSIRF can be applied to primary (including GP) care.Will PSIRF enable NHS trusts to learn from safety incidents in patient care? Rory Deighton, senior acute lead at the NHS Confederation, responded to the PSIRF by saying; "NHS leaders are always looking to improve patient safety and outcomes and welcome this new framework which will help streamline investigation processes. The framework will allow trusts operating in acute settings, mental health, ambulance services and community providers to focus resources on investigations which will have the greatest impact and to develop a greater understanding of why serious incidents occur rather than apportioning blame. As we approach what will be a very difficult winter and with the NHS under incredible strain, trusts will welcome the flexibility that has been built into the framework’s 12-month implementation process. However, they will also be concerned that acute workforce shortages will make implementation of these important changes very challenging.”The PSIRF is asking NHS organisations to do what the NHS has consistently shown it is incapable of doing – learning from mistakes to improve patient safety. Successful implementation of the PSIRF requires a significant shift in NHS culture, with committed trust leadership and time and training for competent staff. It also requires a leap of faith from injured patients and their families to trust hospitals to decide fairly which patient safety incidents should be investigated, when recent news reports have cast doubt on NHS England’s commitment to patient safety, and inquiries have highlighted the dangers of hospitals evading scrutiny by avoiding serious incident investigation and reporting. If NHS trusts fail to act in accordance with the principles of PSIRF’s patient safety culture, more patients will be forced to rely on the legal process to obtain honest and detailed answers about what went wrong during their care.Boyes Turner’s clinical negligence team welcome all genuine efforts to improve patient safety. With support from HSIB, the new Patient Safety Incident Response Framework (PSIRF) provides yet another opportunity for the NHS to learn. Whether it can rise to this challenge remains to be seen.If you have suffered serious injury as a result of medical negligence and would like to find out more about making a claim, you can talk to one of our experienced solicitors, free and confidentially, by contacting us here.