The NHS defines patient safety incidents as “unintended or unexpected events (including omissions) in healthcare that could have or did harm one or more patients.”
This protocol is designed to help providers and organizations learn from such incidents while ultimately improving patient safety. Unlike the previous framework, which mandated a prescribed investigatory process for specific incidents designated as serious, this new framework encourages organizations to view patient safety through a holistic, systemic, and compassionate lens.
By recognizing that each organization has an individual patient safety incident profile, the NHS in England is promoting a flexible approach to identifying, investigating, and remediating patient safety incidents. Processes adopted by organizations must support both involved practitioners and patients with a goal of understanding the systemic issues behind the patient safety incident and preventing similar incidents from occurring in the future.
Healthcare providers, MPL insurers, and MPL stakeholders can learn much from understanding how and why the NHS has pivoted in terms of how it handles patient safety incidents. The NHS is one of the world’s largest employers with 1.2 million full-time equivalent staff members in England. The organization had a yearly budget of $223.8 billion in 2019-2020, with more than 1 million patients attending GP appointments daily.
New Framework Overview
The PSIRF seeks to move away from a focus on current thresholds that define serious incidents. There is also a shift towards proportionate identification of systemic issues, with a requirement to increase support for those affected by patient safety incidents.
Organizations are required to develop a thorough understanding of their patient safety incident profile, ongoing safety actions, and established improvement programs. The PSIRF supports the development and maintenance of a patient safety incident response system that has four key aims:
1. Compassionate engagement and involvement of those affected by patient safety incidents: There is a focus on the need to engage both patients and staff. Organizations must put in place policies addressing the engagement of people affected by incidents. This should focus on apologies, timing, openness, and listening.
2. Application of a range of system-based approaches to learning from patient safety incidents: There is a move away from identification of simplistic causes of incident that brings a systemic rather than individualistic-focused approach. Organizations should support the implementation of these new approaches with published tools and guides.
3. Considered and proportionate responses to patient safety incidents: Except for a few specific remaining categories, such as “never events,” there are no longer thresholds for which incidents require investigation. Because the NHS has finite resources, the onus will be on service providers to identify themselves whether risks are being appropriately managed. Organizations may also decide to investigate incidents that would not previously have met the criteria for mandatory investigation. This could include incidents previously classified as “near miss” incidents.
4. Supportive oversight focused on strengthening response system functioning and improvement: Service providers must be open with information relating to patient safety incidents and findings. There is an expectation of collaboration with regulators and Integrated Care Boards (ICBs).
In July 2019, NHS England published a patient safety strategy, announcing the intention to implement a new protocol, known as the Patient Safety Incident Response Framework (PSIRF) to replace the Serious Incident Framework (SIF). The SIF was first introduced in 2015. The NHS attributed the need for change to compelling evidence that NHS organizations were struggling to deliver the SIF.
The new PSIRF was initially published on August 16, 2018. Covered organizations are required to implement this new framework in full by September 2023, 12 months after this announcement.
Implementation of the PSIRF is a contractual requirement for organizations considered as service providers under the NHS Standard Contract. This includes acute, ambulance, mental health, and community healthcare providers as well as maternity and specialized services.
Organizations that are not NHS Trusts that provide NHS-funded secondary care under the NHS Standard Contract, such as independent provider organizations, are required to adopt the framework for all aspects of NHS-funded care. Implementation is optional for primary care providers such as GPs.
NHS England has published a detailed national preparation guide, supported by additional guidance documents, tools, and templates. This preparation guide is informed by insights from 17 early adopters. These early adopters include West Suffolk NHS Foundation Trust, Norfolk and Suffolk NHS Foundation Trust, and NHS Derby and Derbyshire Clinical Commissioning Group.
The preparation guide provides a detailed month-by-month guide on what service providers should aim to achieve during the 12-month transition period between SIF and PSIRF. This includes guidance about engagement, program management, and implementation.
The PSIRF does not represent a different version of the current investigation format, but rather a completely different system altogether. Implementation by NHS service providers will not be achieved by a change in policy alone. There is a need to design a whole new set of systems and processes.
Clearly, implementation will be a significant undertaking. NHS organizations may be concerned about how they can put the framework into effect within 12 months.
Although implementation will be challenging, once in place, the framework should be welcomed as an opportunity. That’s because NHS service providers will have more flexibility and autonomy over what they investigate and how they ensure effective learning in a way that best fits with their own organization’s specific service provision and challenges. The focus on engagement with patients and staff should also help with the advancement of a fair and open culture.
1 “Patient Safety Incident Response Framework,” U.K. National Health Service, August, 2022, https://www.england.nhs.uk/patient-safety/ incident-response-framework/
2 “Patient Safety Incident Response Framework,” U.K. National Health Service, August, 2022, https://www.england.nhs.uk/wp-content/uploads/ 2022/08/B1465-1.-PSIRF-v1-FINAL.pdf
3 “Patient Safety Incident Response Framework,” U.K. National Health Service, August, 2022, https://www. england.nhs.uk/wp-content/uploads/2022/08/B1465- 1.-PSIRF-v1-FINAL.pdf
4 “Patient Safety Incident Response Framework,” U.K. National Health Service, August, 2022, https://www. england.nhs.uk/wp-content/uploads/2022/08/B1465- 1.-PSIRF-v1-FINAL.pdf
5 “Patient Safety Incident Response Framework,” U.K. National Health Service, August, 2022, https://www. england.nhs.uk/wp-content/uploads/2022/08/B1465- 1.-PSIRF-v1-FINAL.pdf
6 “Key Facts and Figures About the NHS,” King’s Fund, Jan. 13, 2022, https://www.kingsfund.org.uk/audio-video/key-facts-figures-nhs
7 “Key Facts and Figures About the NHS,” King’s Fund, Jan. 13, 2022, https://www.kingsfund.org.uk/audio-video/key-facts-figures-nhs
8 “Engaging and Involving Patients, Families and Staff Following a Patient Safety Incident,” National Health Service England, August 2022, “Patient Safety Incident Response Framework,” U.K. National Health Service, August, 2022, https://www.england.nhs.uk/wp-content/ uploads/2022/08/B1465-1.-PSIRF-v1-FINAL.pdf
9 “The NHS Patient Safety Strategy,” National Health Service England, July 2019, https://www.england. nhs.uk/wp-content/uploads/2020/08/190708_ Patient_Safety_Strategy_for_website_v4.pdf
10 “Serious Incident Framework,” National Health Service England, March 27, 2015, https://www.england.nhs.uk/wp-content/uploads/2015/04/serious-incidnt-framwrk-upd.pdf
11 “Patient Safety Incident Response Framework Preparation Guide, National Health Service, England, August 2022, https://www.england.nhs.uk/wp-content/uploads/2022/08/B1465-6.-PSIRF-Prep-Guide-v1-FINAL.pdf
12 “Patient Safety Incident Response Framework Supporting Guidance,” National Health Service England, August 2022, https://www.england.nhs. uk/wp-content/uploads/2022/08/B1465-3.-Guideto-responding-proportionately-to-patient-safety-incidents-v1-FINAL.pdf
13 “Early Adopters Share Their Experiences, National Health Service England, August 2022, https://www.england.nhs.uk/patient-safety/incident