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The report “To Err is Human: Building a Safer Health System” is often considered a turning point in the history of patient safety, raising alarm both about the volume of “preventable” medical errors, and the state of safety management in healthcare relative to other industries. The report called for the adoption of a wide range of practices from other industries, in particular aviation, ranging through incident reporting and investigation policies, team training methods, management systems, and structured risk assessment methodologies. ‘To Err is Human’ exemplifies a phenomenon that to me is quite remarkable. Healthcare – one the best educated, professionalised skeptical and evidence-based domains – is willing to set aside its usual standards of critical thinking when adopting practices from other industries. In this talk, Dr Drew Rae makes the argument, illustrated with examples from projects across a range of industries, that to a certain extent safety problems are universal, with patterns repeating across domains. However, he will also present some reasons to believe that the problems are exacerbated rather than improved by the uncritical adoption of safety ‘solutions’ between industries. Register

On the 13 February 2025, the Health Services Safety Investigations Body (HSSIB) published a report exploring how patient safety is managed across different organisational boundaries. This forms part of a series of reports looking at Safety Management System principles and their application to health and care. In this blog, Patient Safety Learning sets out its reflections on the findings of this investigation. HSSIB investigates patient safety concerns across the NHS in England, and in independent healthcare settings where safety learning could also help to improve NHS care. Their latest report looks at patient safety issues across organisational boundaries, by exploring the safety management activities of Integrated Care Boards (ICBs).[1] An ICB is a statutory NHS organisation responsible for bringing NHS and other partners together to plan and deliver services in an Integrated Care System (ICS). ICSs are partnerships that bring together organisations in specific geographical areas—there are currently 42 across England.[2] This HSSIB investigation focuses on the experiences of Ros and her husband and carer Norman, using their case to demonstrate the gaps in patient safety management when patients’ care is managed across multiple providers in an ICS. Reflecting on the findings of this report, in this blog we focus on four key subject areas: safety management systems reporting and learning from patient safety incidents ICBs and ICSs patients still having to join the dots of patient safety. Safety management systems The HSSIB report forms part of a series looking at the application of a safety management systems (SMSs) approach to health and care. HSSIB define this as: “A safety management system (SMS) is a proactive approach to managing safety that is used in other industries. It sets out the necessary organisational structures and accountabilities to manage safety risks. It requires safety management to be integrated into an organisation’s day-to-day activities.” There is a growing debate about the potential benefits of moving towards a SMS approach in healthcare, which is widely used to manage safety in different industries. HSSIB states that such an approach has four key components: Safety policy—establishes senior management's commitment to improve safety and outlines responsibilities; defining the way the organisation needs to be structured to meet safety goals. Safety risk management—which includes the identification of hazards (things that could cause harm) and risks (the likelihood of a hazard causing harm) and the assessment and mitigation of risks. Safety assurance—which involves the monitoring and measuring of safety performance (e.g., how effectively an organisation is managing risks), the continuous improvement of the SMS and evaluating the continued effectiveness of implemented risk controls. Safety promotion—which includes training, communication and other actions to support a positive safety culture within all levels of the workforce.[3] However, as the findings of their report highlight, we are currently a long way removed from such an approach in our health and care system. Emphasising this, it states: “There are no overarching principles that all healthcare providers and ICBs can use which enable a consistent and collaborative approach to the management of patient safety.” The report notes a particular gap around the role of ICBs, referencing the NHS Oversight Framework, which describes how oversight of NHS trusts, foundation trusts and ICBs operates. It highlights that this does not specify the day-to-day patient safety management activities to be undertaken by ICBs. The report’s key recommendation in this area is as follows: “HSSIB recommends that the Department of Health and Social Care, working with NHS England, uses the findings of this report to inform the development of the 10 Year Health Plan and NHS Quality Strategy. The intent of this recommendation is to encourage further exploration of how the safety management principles described in this report might be applied in health and care settings to improve patient safety.” Patient Safety Learning supports this recommendation. We think that 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. We believe that integral to this is a standards-based framework to ensure safety, quality patient care, consistently delivered.[4] A patient safety standards framework helps organisations understand ‘what good looks like’ for patient safety and 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. It 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 a point we recently highlighted in our submission to the independent review of patient safety across the health and care landscape being led by Dr Penny Dash.[5] Reporting and learning from patient safety incidents In the last couple of years, the NHS has been transitioning to a new system for recording and analysing patient safety incidents. The former National Reporting and Learning System (NRLS) has been gradually phased out, with organisations moving onto the new Learn from Patient Safety Events (LfPSE) service.[6] This HSSIB investigation highlights a number of concerning issues relating to how effectively the LfPSE service supports the identification and management of patient safety risks across organisational boundaries. The report notes difficulties accessing and using data from the system with less analysis tools available compared to the previous NRLS. Worryingly, it states: “ICBs suggested that they needed to be building a picture of ICS risks, including those which involved cross-organisational boundaries, but they could not currently do this because of the usability of the LFPSE service and data.” The report does note that in response to these concerns some ICBs have developed local adaptations to compensate for this lack of visibility of patient safety risks within providers. It also says that NHS England has indicated it is developing a new Recorded Data Dashboard for LfPSE that will allow for greater analysis of incident records than was possible with NRLS. Considering these concerns, HSSIB makes the following safety observation: “Health and care organisations can improve patient safety by working together to identify the challenges with the practical use of the Learn from Patient Safety Events service to enable the identification of risks that span multiple providers. This is intended to identify the requirements and support needed to improve risk management.” On these issues, we feel more robust action is required. Sharing learning from patient safety incidents is a fundamental component of improving patient safety and delivering safe care. That LfPSE is not currently providing the means to analyse and share cross-organisational learning represents a significant missed opportunity. As the findings of the report demonstrate, local fixes, which may not be applied consistently across the NHS, are now required because of ICBs lack of visibility of patient safety risks within providers. At Patient Safety Learning we also have related concerns about the availability of LfPSE data beyond ICBs. Currently, individual trusts can see reports of their own data but not system-wide information to help them assess risk or engage with others. This can create a siloed approach where individual trusts or departments may benefit from their data but fail to contribute to a wider culture of safety improvement. We are also troubled that the outputs of local learning responses and safety incident investigations under the new Patient Safety Incident Response Framework (PSIRF) are not widely shared either within or across ICBs. We understand that the new initiatives, PSIRF and LfPSE, are intended to align so that there is a comprehensive and system-wide analysis with reports on the causes and contributory factors of avoidable harm and action needed to make improvement. However, this alignment is not currently reflected in practice. This is not an acceptable situation. The existing gaps in the LfPSE service are not simply a technical issue with a new digital service. They will result in missed opportunities to identify patient safety risks, learn from them and ultimately prevent avoidable harm to patients. We believe the Department of Health and Social Care and NHS England must now prioritise the development and improvement of LfPSE and its integration with PSIRF. Integrated Care Boards and Integrated Care Systems A theme that runs throughout the HSSIB report is the lack of clarity around the roles of ICBs and ICSs in patient safety. Its key findings highlight this, noting: “There is a difference in the perception of how patient safety is managed between ICBs and national health and care stakeholders, including the lines of safety accountability.” This lack of clarity can also be seen in a number of other examples in the report: Inconsistency in how ICBs have reported processes and responses when escalating safety risks to NHS England. If these do not fall within existing programmes of work, responses were described as “hit and miss”. Uncertainty about whether ICBs have oversight of provider collaboratives in relation to patient safety. This was described by an NHS England respondent as a “big black hole”. Varying approaches to safety management activities by ICBs. The report notes that while some undertake assurance visits, “these are limited by capacity and ICBs described a reliance on more reactive activities such as responding to incidents which had already occurred”. In a further example of this lack of clarity, at one point the report notes: “… a senior manager at NHS England told the investigation that while there is an expectation that ICBs will manage cross-organisational safety risks, NHS England “have not told ICBs they have to” do this or “flagged this” in planning or operational guidance. The investigation acknowledges that PSIRF guidance refers to management of cross-organisational safety risks. However, this does not direct how cross-organisational safety risks should be managed more generally outside of PSIRF.” Patient Safety Learning believes action is required to create clarity about the role of ICBs and ICSs in patient safety. We set this out previously in in our report, The elephant in the room: Patient safety and Integrated Care Systems.[7] One means of addressing this gap could be through implementing a SMS approach in health and care, with ICBs and ICSs tasked with a clear leadership role for system safety. This is another point we recently highlighted in our submission to the independent review of patient safety across the health and care landscape.[5] We believe that there is potential at an ICS level to develop an integrated and coordinated approach to safety, reflecting patient care pathways across systems and ensuring consistency and collaboration. Patients still having to join the dots of patient safety 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.[8] The importance of patient feedback is reflected in the HSSIB report, which notes that: “Patients and carers are an important source of feedback to ICBs about patient safety risks across organisational boundaries. However, this can create inequities as some people are more able than others to make their voice heard.” There is no doubt that insights and feedback from patients and carers can provide ICBs with valuable information on patient safety risks, within organisations and across organisational boundaries. However, this must be accompanied by a structured and resourced framework for gathering these insights otherwise the visibility of these insights are likely to favour those patients and carers who are more adept and confident at making their voices heard. As noted by Norman in his own reflections on his carer role for Ros: "Norman told the investigation that he was getting the care Ros needed through his actions and that he was aware of other patients whose families did not have as strong an advocate as him. He said this affected their ability to get the care they needed, and that 'there are a lot of us out here trying to look after patients'.” While points around safety management systems, LfPSE and ICB/ICS roles and responsibilities can appear detached from day-to-day care, ultimately their impact comes back to the patient. As noted by the First Do No Harm report of the Independent Medicines and Medical Devices Safety Review, patients impacted by avoidable harm and unsafe care often have to ‘join the dots of patient safety’ in response to systemic failures.[9] If we fail to address these systemic failures, they will result in patient safety risks that come with a very real human cost. References HSSIB. Safety management systems: accountability across organisational boundaries, 13 February 2025. NHS England. What are integrated care systems? Last accessed 10 February 2025. HSSIB. Safety management systems: an introduction for healthcare, 18 October 2023. Patient Safety Learning, Standards: What Good Looks Like, Last accessed 10 February 2025. Department of Health and Social Care, Review of patient safety across the health and care landscape: terms of reference, 15 October 2024. NHS England. Learn from patient safety events (LFPSE) service, Last accessed 10 February 2025. Patent Safety Learning. The elephant in the room: Patient safety and integrated care systems, 11 July 2023. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020.

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.

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.

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’

It was recently reported that NHS Finance Directors were ‘incensed’ that the Health Services Safety Investigations Body (HSSIB) should think that they could be working more closely with patient safety chiefs. Whereas medical staff and clinicians represent the sharp end of healthcare delivery, the administrative functions, including finance, are the blunt end. Removed in space and time from the action, it can be hard to see how their behaviour can directly influence workplace outcomes. To understand the issue, Norman MacLeod reflects on how systems behave and the decision-making hierarchy within healthcare organisations. Most discussion of ‘systems’ revolves around assemblages of artefacts: tools, processes, people and spaces. However, the late Jens Rasmussen described a system as a set of nested decision-making processes.[1] Leveson, at MIT, adds that systems are hierarchical, with control being exercised by higher tiers over the lower levels. She adds that control is exercised through communication and feedback.[2] From this perspective, a ‘system’ comprises actors engaged in different types of decision making. The hierarchy of decision making At the lowest level, we have the individual in the workplace. At any moment, our behaviour is directed at a specific goal and our probability of success is shaped by such factors as stress and fatigue, competence, expertise and motivation. Control is represented by direct action and feedback is in the form of observed outcomes. Because of the complexity of work, individuals form teams to get work done and this is the next level in the system. Teams make decisions about allocation of work, priorities, coordinating effort, problem solving. When an individual joins a team they surrender a degree of autonomy: you are no longer a free agent. Control is exercised through briefings, instructions and procedures, and feedback is manifested in behaviour meeting expectations, through raising queries, declaring problems, etc. Teams can be both real and virtual. Real teams are typically those assigned to a task, working in close proximity. Virtual teams comprise agents that collaborate for a specific purpose and are usually remotely located. Virtual teams often work asynchronously: a request is submitted and the response follows after a lag. Virtual teams require additional skills as they typically involve working across organisational boundaries. Individuals and teams are where direct action occurs. The next level in the system is the organisation. At this level, decisions are made in relation to the specific goals the organisation has been set up to achieve and cover configuring assets, allocating resources, command and control. The organisation exercises control over teams and individuals through contracts of employment, codes of conduct, policies, etc. Feedback is typically through audit and compliance, event reporting, tracking of resource utilisation. Of course, the ‘organisation’ is also made up of individuals and teams: the model is recursive. What differentiates each level is the nature of the decisions it makes. The next, and possibly, highest level in the hierarchy are those entities that facilitate the functioning of the system but do not, in themselves, get directly involved. Here we see government departments, regulatory bodies, accrediting bodies. Actors at this level set strategic goals, allocate resources at the macro level and grant permissions. The components outlined here all exist in a broader environment. By convention, the environment describes attributes that exert influence on the actors in the system but is not influenced, in turn, by those actors. For example, the public health profile in a geographic area will shape the strategic goals set for the organisation and will influence the healthcare capabilities that need to be provided in that area. However, the action of an individual healthcare organisation will not necessarily shape the public health profile of its hinterland. Emergence and cross-scale effect So, where do finance directors fit into all of this? Obviously, as actors at the level of the organisation their decisions relate to the allocation of financial resource. As such, they shape decision making by others in the system responsible for spending on specific functions. But we now need to look at some other properties of systems: emergence and cross-scale effect. Emergence describes behaviours that cannot be explained simply based on the functioning of the parts of the system. Cross-scale effects captures how actions at one level in the system can have unintended consequences at another level. If we start with emergence, ‘safety’ is an emergent property at the level of the individual. Only individuals can act in a manner that bolsters safety or, conversely, it is the actions of individuals that create unsafe states. ‘Culture’ is an emergent property at the level of the team, while at the level of the organisation we see morale as a key emergent. Patient safety activities compete for resources in a landscape where other demands can be seen to have a more direct influence on outcomes. In financial terms, patient safety can be seen as a discretionary spend. This attitude to a legitimate demand can shape morale. Cross-scale effects are akin to Reason’s Latent Factors.[3] Their presence is often only revealed when something goes wrong. We can see cross-scale effects at work in the case of staff recruitment. For example, to save money posts are often ‘gapped’: a post is not advertised until after the incumbent has left. While the post remains unfilled, the burden of work is borne by others or simply not done. Where workload is increased, outcomes can include increased fatigue, staff turnover, sickness/absence or risk of error. So, a simple, rational decision at one level can have multiple consequences elsewhere. The example given here – gapping posts – is typically a response to financial constraints. My intention here is not to portray finance directors as villains: they simply have their hands on some powerful levers of control. But their protestations do possibly support the need for a more sophisticated attempt to understand how systems work. References Rasmussen J, Svedung I. Proactive Risk Management in a Dynamic Society. Swedish Rescue Services Agency, Karlstad, Sweden; 2000. Leveson N. Engineering a Safer World. MIT Press; 2012. Reason J. Human Error. Cambridge University Press; 1991. Other blogs from Norman MacLeod: 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.