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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.

Training to support the development of core understanding and application of systems-based patient safety incident response throughout the healthcare system - in line with NHS guidance, based upon national and internationally recognised good practice. This course covers the end-to-end systems-based patient safety incident response based upon the new NHS PSIRF and includes: purpose of patient safety incident response framework introduction to complex systems, system thinking and human factors restorative just and learning culture duty of candour involving staff in incident response involving patients, families and carers in incident response improvement science and developing system improvement plans general response techniques interviewing and asking questions conducting observations, understanding work as done systems frameworks response types patient safety investigation planning, analysis and report writing commissioning and oversight of an internal investigation a high-level overview of system-based response tools Who should attend: Lead investigators; Executives, commissioning, and service leads for investigations; Investigators supporting or overseeing patient safety incident investigations Facilitator: Jo Perruzza is a former mental health nurse and has been a clinician, a clinical leader and a senior manager in mental health provider organisations. With a passion for patient safety and an expert in psychological safety she brings experience of leading internal and external investigations. Register hub members receive a 20% discount. Email [email protected] for discount code.

Training to support the development of core understanding and application of systems-based patient safety incident response throughout the healthcare system - in line with NHS guidance, based upon national and internationally recognised good practice. This course covers the end-to-end systems-based patient safety incident response based upon the new NHS PSIRF and includes: purpose of patient safety incident response framework introduction to complex systems, system thinking and human factors restorative just and learning culture duty of candour involving staff in incident response involving patients, families and carers in incident response improvement science and developing system improvement plans general response techniques interviewing and asking questions conducting observations, understanding work as done systems frameworks response types patient safety investigation planning, analysis and report writing commissioning and oversight of an internal investigation a high-level overview of system-based response tools Who should attend: Lead investigators; Executives, commissioning, and service leads for investigations; Investigators supporting or overseeing patient safety incident investigations Facilitator: Jo Perruzza is a former mental health nurse and has been a clinician, a clinical leader and a senior manager in mental health provider organisations. With a passion for patient safety and an expert in psychological safety she brings experience of leading internal and external investigations. hub members receive a 20% discount. Email [email protected] for discount code.

Training to support the development of core understanding and application of systems-based patient safety incident response throughout the healthcare system - in line with NHS guidance, based upon national and internationally recognised good practice. This course covers the end-to-end systems-based patient safety incident response based upon the new NHS PSIRF and includes: purpose of patient safety incident response framework introduction to complex systems, system thinking and human factors restorative just and learning culture duty of candour involving staff in incident response involving patients, families and carers in incident response improvement science and developing system improvement plans general response techniques interviewing and asking questions conducting observations, understanding work as done systems frameworks response types patient safety investigation planning, analysis and report writing commissioning and oversight of an internal investigation a high-level overview of system-based response tools Who should attend: Lead investigators; Executives, commissioning, and service leads for investigations; Investigators supporting or overseeing patient safety incident investigations Facilitator: Jo Perruzza is a former mental health nurse and has been a clinician, a clinical leader and a senior manager in mental health provider organisations. With a passion for patient safety and an expert in psychological safety she brings experience of leading internal and external investigations. hub members receive a 20% discount. Email [email protected] for discount code.

Join this free webinar to learn how collaboration and support for HSSIB (Health Services Safety Investigations Body) will make a difference and will promote a culture of safety in your organisation. During the course the webinar will explore what meaningful recommendations look like and how these recommendations will directly impact individual patient care, policy and strategy. Additionally, we will take a look at how the views of patients and healthcare professionals feed into building a Safety Management System. The primary aim of this webinar is to strengthen the relationship of HSSIB with those who work in the medical profession to aid understanding and future collaboration. By attending the webinar, you will: Gain and build your understanding of HSSIB. Be able to consider how we can contribute and support investigations. Be able to consider how we can contribute and support the implementation of recommendations. Register

In a three-part series of blogs for the hub, Norman Macleod explores how systems behave and how the actions of humans and organisations increase risk.  He argues that, to measure safety, we need to understand the creation of risk. In this first blog, Norman looks at the problems of measuring safety, using an example from aviation to illustrate his points. In the final paragraph of his seminal 2005 paper, 'Evaluating the Quality of Medical Care',[1] Donabedian suggests that instead of asking "What is wrong: and how can we make it better?" we should, more often, ask "What goes on here?" The author identifies three areas of enquiry: process, outcomes and structure. He also recognises that care episodes are not discrete: instead, they form chains of events involving multiple actors. The issues raised in the paper apply equally to the problem of measuring safety. Vincent, Burnett and Carthey[2] offer a definition of patient safety as: "The avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare." The authors also suggest that quality deals with the intended results of the healthcare system whereas safety looks at the ways the system can fail to function. Leveson, though, observes that, in engineering, reliability is not the same as safety: and we could substitute quality for reliability.[3] Safety has been described as a "dynamic non-event" (Weick) in that it is "an ongoing condition in which problems are momentarily under control […]".[4] Implicit in this position is that the absence of failure does not mean that an entity is safe. Another view is that safety is the "freedom from [a level of] risk which is not tolerable".[5] These approaches shift the focus from outcomes to the domain of structure and how it shapes processes. This suggests that measures of safety should address the issue of ‘control’ in the workplace. We particularly want to understand the distribution of risk and how it becomes ‘intolerable.’ Understanding ‘What goes on here?’ A patient entering the healthcare system experiences episodes of care, each of which is intended to remediate the patient’s condition in some way. Despite being highly proceduralised, the inherent variability in each patient requires treatment to be adaptive because, in short, no two patients are the same. Equally, the condition of the healthcare worker introduces variability. As a result, there are multiple pathways that can lead to the same safe outcome. The range of different ways an episode can unfold can be described as ‘buffering’: the system has the capacity to cope with variability and still function as intended. Unfortunately, each variation in the delivery of a specific episode carries with it a degree of risk, which is often not apparent unless something goes wrong. Occasionally activity will exceed the system’s buffering capacity. We can hypothesis a point where a process transitions from safe to unsafe: the resources available to restore the process to a safe state have been exhausted. We are particularly interested in how systems behave in these boundary states. Finally, we want to know how a system fails. Is the outcome inconsequential, recoverable but with additional intervention, or catastrophic? A system’s response to failure can be described as its tolerance. These concepts are illustrated using output from an aircraft’s digital flight data recorder (DFDR): Figure 1: Li L. CityU, Hong Kong. Personal communication. The graph depicts an aircraft during the final approach.[6] Approaching the runway, the pilot lifts the nose to stop the rate of descent. Power is reduced, the aircraft settles on the runway and the nose is lowered again. This change in attitude is recorded in flight data as the pitch angle. The graph shows the pitch angle of 300 aircraft during the final mile of the approach to touchdown and then shows the aircraft on the runway and slowing down. The dark blue band shows the central 50% of data points, those closest to the planned approach path, with the outer, lighter bands showing 20% either side (some data is lost in the processing). All these approaches were successful and the data shows the range of solutions to the problem of attitude control on final approach: the buffering. Airline safety management systems are required to track parameters out of tolerance and the chart shows the angle that would trigger a Flight Data Monitoring (FDM) alert. We can see the gap between ‘normal’ and what would trigger a safety alert. Put another way, it shows how close the system is operating to a safety trigger but without knowing it. The graph reveals the ‘what goes on here’ that would normally be invisible. The red line on the graph is the data for a specific flight that did result in an investigation. The outcome was a ‘hard landing’. Hard landings can trigger a mandatory maintenance inspection (lost productivity while the aircraft is being checked), damage to the aircraft structure and even a collapsed undercarriage. These are the outcomes that could arise from the same initial problem. The result, in this case benign, illustrates the tolerance in the system. Conclusion To measure safety we, first, need to understand performance variability (buffering), behaviour at the boundaries (opportunities to recover) and tolerance (how failure propagates). Having said that measures of outcome are not useful indicators of safety, the first problem we face is that safety reflects performance in a space that is not easily open to inspection. If that is the case, then we need to look for surrogates that can reliably stand in for direct measures of safety. In part 2 of this blog, I will look at how error may offer insight into system’s behaviour. I would love to hear your feedback on this blog and how you 'measure safety'. Please add your comments below (you will need to be a hub member and signed into the hub to comment). References Donabedian A. Evaluating the Quality of Medical Care. The Milbank Quarterly 2005; 83 (4):691-729. Vincent C, Burnett S, Carthey J. The Measure and Monitoring of Safety. The Health Foundation Spotlight, 2013. Leveson N. Engineering a Safer World. MIT Press. 2011. DOI: https://doi.org/10.7551/mitpress/8179.001.0001 Weick KE. Organizational culture as a source of high reliability. California Management Review 1987: 29 (2): 112-128. Li L. CityU, Hong Kong. Personal communication. Read part two and part three of Norman's blogs. Further blogs from Norman: What is a ‘safety management system’? Error isn’t a problem – the problem is the word ‘error’

This blog provides an overview of a Patient Safety Management Network (PSMN) meeting discussion on 27 October 2023. At this meeting, members of the network were joined by Dr Ted Baker, Chair of the Health Services Safety Investigations Body (HSSIB). The PSMN, created in June 2021, is an innovative voluntary network for patient safety managers and everyone working in patient safety. It provides a weekly drop-in session with guests to talk through issues of importance to patient safety managers, providing information, peer support and safe space for discussion. Find out more about the Network. HSSIB investigates patient safety concerns across the NHS in England and in independent healthcare settings. It initially started its life in 2017 as the Healthcare Safety Investigations Branch (HSIB), subsequently undergoing a period of transformation following new legislation in the Health and Care Act 2022 to become HSSIB on the 1 October 2023.[1] Dr Ted Baker joins HSSIB as its first Chair. He was previously Chief Inspector of Hospitals at the Care Quality Commission and prior to this spent most of his career working in clinical practice for 35 years. Dr Baker welcomed the invitation to the PSMN and commended the value of the forum both for its members and for the wider healthcare community. Role and duties of HSSIB Opening the meeting, Dr Ted Baker set out his background prior to becoming Chair of HSSIB and talked about the origins of the organisation. He explained that this was established as an arm’s length body of the Department of Health and Social Care to: Carry out independent investigations in health services. Not to apportion blame or liability. Focus on system-level (policy and regulatory) change. Professionalise the patient safety investigator role. He noted that HSSIB will conduct investigations in what is commonly referred as a ‘safe space’ to ensure people feel able to speak up about safety concerns. This prohibits, on a legal basis, the unauthorised disclosure of protected material and applies to all HSSIB employees and anyone they provide information with as part of an investigation. Approach to investigations Dr Baker advised that the areas of investigation that HSSIB will focus on will be subject to a forthcoming strategic review to form their initial priorities. However, before this takes place, he highlighted that there are already several factors that influence how they approach investigations. This included the need to avoid incidents where their work would simply replicate already effective local investigations, and to focus on those cases that are likely to have widespread implications where they believe their approach can add value. He outlined four key aspects of the HSSIB approach to investigations: Wide-ranging expertise from safety-critical industries. Multidisciplinary and inclusive teams; patient and family involvement. Focus on learning not blame to reduce risk of harm. Transparent and collaborative to support learning. He outlined that HSSIB would be consulting widely on the criteria for investigation, and that he would welcomes input from the PSMN and its members. Safety Management Systems Dr Baker went on to speak about the first investigation report formally published by HSSIB, which considers the potential application of Safety Management Systems (SMSs) as an approach to managing safety in healthcare.[2] In this report, HSSIB identifies 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. He emphasised the importance of different parts of the system working more collaboratively to achieve this and showed a brief video explaining more about this, which can be viewed below. Network discussion Discussing potential themes and areas that HSSIB could consider as part of its forthcoming strategic review, the following points were made by Network members: Importance of considering how the themes that emerge from individual organisation’s Patient Safety Incident Framework (PSIRF) plans may help inform HSSIB’s future priorities, particularly where these are not issues specific to a locality. Dr Baker emphasised that PSIRF is a significant opportunity for organisations, and there will be significant value from the insights gained in learning responses. A possible future area/theme to investigate may be why organisations struggle to collaborate with each other on patient safety issues, connected with the need for a wider SMS. Potential to look in detail at learning from near misses. Considering IT risks and their impact on patient safety. Looking at how resources are allocated in regard to safety. Particularly in cases where there are new safety innovations and initiatives that could be implemented, potentially saving lives, but are not prioritised. Procurement and its impact on patient safety. How findings and recommendations from patient safety reports actually translate into change, a key issue highlighted in Patient Safety Learning’s report Mind the implementation gap. There were also some issues raised by Network members about HSSIB’s role more broadly, including: Whether the scope of HSSIB investigations would extend into social care. Dr Baker noted that while their role is explicitly focused on healthcare, it may be that there are issues regarding health care services that fall within a social setting that need future investigation. How HSSIB will approach patient engagement, both working with patients directly and also how they take on board the wider patient/public view of what they should be prioritising. A question about the oversight arrangements for HSSIB, with Dr Baker noting that this is provided by Parliament. Discussion around the role of leadership in improving patient safety and what more needs to be done to ensure this is a core purpose for organisations. That HSSIB is supporting an international network of patient safety organisations from 17 different countries for shared learning. How to get involved in the Patient Safety Management Network Do you work in patient safety and are interested in joining the Patient Safety Management Network? You can join by signing up to the hub today. If you are already a member of the hub, please email [email protected]. And if you would like to discuss setting up other networks, we’d love to hear from you and support you. References HSSIB, HSIB legacy, Last Accessed 29 October 2023. HSSIB, Safety management systems: an introduction for healthcare, 18 October 2023.

The annual Healthcare Safety Investigation Branch (HSIB) conference agenda will cover: A focus on patient and family engagement. Sharing learning from HSIB national investigations – what has been learnt and how it can help support and improve local investigation practice. HSIB's maternity investigation programme work with families and trusts. This includes how HSIB implements learning from investigations and where the opportunities are to influence change. HSIB's work on Safety Management Systems. How HSIB's education programme is sharing learning to develop and improve local safety investigations. • An overview of HSIB's international work. Breakout sessions to share knowledge. You will also hear how the HSIB will form into the Health Services Safety Investigations Body and the Maternity and Newborn Safety Investigations (MNSI) function and how this may impact you. Register

The provision of safe and quality care is the most fundamental principle to consider for patients in perioperative practice. Alongside this commitment, is the safety and welfare of all staff and visitors within the setting. Risk assessment, staffing ratios, competency and skill are crucial to ensuring that the intended outcome for patients is achieved as far as is reasonably practicable. The discussion will outline how this can be achieved utilising the recommendations by the Association for Perioperative Practice (AfPP). Learning outcomes: Understanding risk and the process of risk assessment in perioperative practice. The components of a safe perioperative environment. How to calculate a safe staffing model for your environment based on the AfPP standard. Register

Start time: 6pm GMT or 1pm ET. A panel discussion with: Karen Wolk Feinstein, PhD, President and CEO of the Pittsburgh Regional Health Initiative Ken Segel, CEO of Value Capture Moderated by Mark Graban, Value Capture Register here