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On Wednesday 15 October 2024, the Department of Health and Social Care announced an independent review of patient safety across the health and care landscape in England. This blog sets out Patient Safety Learning’s response to this announcement. Today the Government has published the terms of reference for a review of patient safety across the health and care landscape. This review will: “… assess whether the current range and combination of organisations delivers effective leadership, listening, learning (including investigations and their recommendations) and regulation to the health and care systems in relation to patient and user safety (and to what extent they focus on the other domains of quality).”[1] This follows on from the publication of Dr Penny Dash’s latest report highlighting significant failings at the Care Quality Commission (CQC), the independent regulator of care providers.[2] The main focus of the review will be on the following organisations: CQC – including the Maternity and Newborn Safety Investigations programme National Guardian’s Office Healthwatch England and the Local Healthwatch network Health Services Safety Investigation Body (HSSIB) Patient Safety Commissioner for England NHS Resolution (patient safety-related learning functions only, not clinical negligence functions). The review will focus on how these bodies work together, with the findings feeding into the government's 10-year plan for the NHS, expected to be published in the spring next year. Patient Safety Learning welcomes this announcement and sets out some initial reflections on this below. A fragmented landscape The landscape of organisations with patient safety roles and responsibilities is fragmented and lacks coordination. This makes it often ill-suited to tackling complex systemic challenges to patient safety. This is an issue we highlighted in our report last year, The elephant in the room: Patient safety and Integrated Care Systems.[3] Therefore, we welcome any steps to promote cross-organisational working and coordination between regulators, ultimately with the aim of reducing avoidable harm. Figure 1: Patient safety environment in England The need to review roles and remits of patient safety organisations in England is not a new issue. The CQC itself referred to this as early as 2018, in their report Opening the door to change: NHS safety culture and the need for transformation.[4] This was also highlighted in 2020 by the Independent Medicines and Medical Devices Safety (IMMDS) Review. Chaired by Baroness Julia Cumberlege, this looked at the harmful side effects of medicines and medical devices and how to respond to them more quickly and effectively in the future. It stated that: “We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.”[5] Again this was raised last year by the Parliamentary and Health Service Ombudsman. In their report, Broken trust: making patient safety more than just a promise, they stated that: “… political leaders have created a confusing landscape of organisations, often in knee-jerk rection to patient safety crisis points. HSIB, the Patient Safety Commissioner, PHSO, NHS England, NHS Resolution and more than a dozen different health and care regulators all play important roles in patient safety. But there are significant overlaps in functions, which create uncertainty about who is responsible for what. This means patient safety voice and leadership are fractured. This is not due to a lack of dedication and professionalism from those tasked with championing patient safety. The problem is structural.”[6] Patient perspective An overly complex system of regulation and oversight that cannot tackle underlying patient safety problems ultimately has a very real human cost. The persistence of avoidable harm, and every avoidable death and disability that accompanies this, is an unnecessary tragedy for patients, families and healthcare professionals. At Patient Safety Learning, we believe that patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account. We identify this as one of our six foundations of safer care in our report, A Blueprint for Action.[7] This is also one of the seven strategic objectives in the WHO Global Patient Safety Action Plan, which states that: “Patients, families and other informal caregivers bring insights from their experiences of care that cannot be substituted or replicated by clinicians, managers or researchers. This is especially so for those who have suffered harm.”[8] We would therefore stress the importance that this new review must feature a clear commitment to including and involving patients as part of the process. This should not be a top-down exercise without patient and public input. Safety culture We believe that we need a transformation in the health and care system’s approach to patient safety. Fundamental to this is patient safety not being seen as another priority, which in practice will be weighed (and inevitably traded-off) against other priorities, but as a core purpose of health and care. This will require a cultural shift in health and care in the UK. There remains a significant gap between what organisation leaders say about creating a patient safety culture in the NHS and what is done in practice. We see plentiful evidence of this in inquiries into unsafe care, whistleblower testimonies and staff survey results. This was an issue we examined in greater detail earlier this year in our report, We are not getting safer: Patient Safety and the NHS staff survey results.[9] In this context, we believe it would be beneficial if the review also considers the role of national leadership organisations in actively contributing and creating a just and fair culture in health and care. Safety Management System There is a growing debate in patient safety about the possible benefits that healthcare may gain from moving towards a Safety Management System (SMS) approach. SMSs are an organised approach to managing safety which are widely used in different industries. An SMS approach is used to: help enable proactive assessments of risks specify how risks should be managed set clear lines of accountability and responsibility in addressing risks. In considering the application of SMSs to UK healthcare, HSSIB in October 2023 published a report, Safety management system: an introduction for healthcare.[10] This identified the requirements for effective SMSs, how these are used in other safety critical industries and considers the potential of application of this approach in healthcare. A country-wide SMS would have the potential to provide a more structured and joined up approach to patient safety strategies, involving all the national bodies. Patient Safety Learning believes that integral to this is a standards-based framework to ensure safe, quality patient care is consistently delivered.[11] A patient safety standards framework helps organisations understand ‘what good looks like’ for patient safety, understand where more action is needed for improvement, with clearly defined safety aims and goals. Such a framework will enable organisations and regulators to demonstrate a risk-based approach to patient safety and evidence achievement, can provide assurance that patient safety sits at the organisation’s core, improves performance through increased effectiveness, and enables patients and families, staff, funders and communities to identify and differentiate good safety providers. This is an issue we believe requires serious consideration and we look forward to contributing as part of our submission to this review. References Department of Health and Social Car. Review of patient safety across the health and care landscape: terms of reference, 15 October 2024. Department of Health and Social Care. Independent report: Review into the operational effectiveness of the Care Quality Commission, 15 October 2024. Patent Safety Learning. The elephant in the room: Patient safety and integrated care systems, 11 July 2023. CQC. Opening the door to change: NHS safety culture and the need for transformation, December 2018. The IMMDS Review. First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. PHSO. Broken trust: making patient safety more than just a promise, 29 June 2023. Patient Safety Learning. The Patient-Safe Future: A Blueprint For Action, 2019. WHO. Global Patient Safety Action Plan 2021-2030, 3 August 2021. Patient Safety Learning. We are not getting safer: Patient safety and the NHS staff survey results, 26 March 2024. Health Services Safety Investigations Body. Safety management systems: an introduction for healthcare, 18 October 2024. Patient Safety Learning. Standards: What Good Looks Like, Last accessed 15 October 2024.