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untilThe 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- Posted
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In healthcare, errors could have serious consequences for patients and staff. High-risk industries, such as aviation, have improved safety by taking a systems approach, known as safety management systems. Safety management systems are generally considered to have four key components: leadership commitment and safety policy; safety risk management; safety assurance; and safety culture. Safety management systems need to be context-specific to be effective. Evidence on the use of safety management systems in health care is therefore needed to inform policy decisions. A systematic review was undertaken to investigate the application of safety management systems to patient safety in terms of effectiveness, implementation and experience. The authors included evidence from Australia, Canada, Ireland, the Netherlands and New Zealand because their healthcare systems are similar to the United Kingdom’s. They included policy documents, research papers and accounts of patient and staff experiences. The study found that the Netherlands was the only country with a patient safety programme explicitly based on a safety management system approach. The programme was associated with improvement in some aspects of patient safety in hospitals but there was significant variation in its implementation and outcomes. The main components of a safety management system were also identified to some extent in the patient safety approaches of the other four countries, along with evidence of influence from high-risk industries and ‘safety science’ more widely. Across all five countries, there was a change in the patient safety discourse away from the narrow focus on reporting and learning from incidents. Without denying the importance of this element, the new approaches to patient safety adopted broader definitions of safety (e.g. including psychological and cultural safety) and harm (e.g. including harm resulting from social inequalities and structural oppression), and emphasised the importance of taking a systems perspective and involving everybody, especially patients and families, in the processes of assessing and creating safety, and learning from successful practice as well as failures. Although these new ideas were present in the policies of all countries, their translation into practice was not always clear, and robust evidence of their effectiveness was not available. Although there is a considerable overlap between the Dutch PSP and the NHS patient safety strategy in terms of specific components, one important difference is the role of leadership within individual healthcare organisations. While the role of leadership is also acknowledged in the NHS patient safety strategy, the responsibilities of the top management and the lines of accountability in relation to patient safety within a healthcare organisation are not always clearly defined. The responsibilities of local patient safety specialists are most clear but they may not have the authority or capacity to ensure patient safety throughout the organisation.- Posted
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A Learning Health System is not a technical project. It is the evolution of an existing health system into one capable of learning from every patient. This paper outlines a recently published framework intended to aid the understanding, design, development and evaluation of Learning Health Systems.- Posted
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The Learning Healthcare System: Workshop summary (2007)
Sam posted an article in Research, data and insight
The Learning Healthcare System is a summary of the Institute of Medicine (US) two-day workshop held in July 2006, convened to consider the broad range of issues important to reengineering clinical research and healthcare delivery so that evidence is available when it is needed, and applied in health care that is both more effective and more efficient than we have today. Embedded in these pages can be found discussions of the myriad issues that must be engaged if we are to transform the way evidence is generated and used to improve health and health care—issues such as the potential for new research methods to enhance the speed and reliability with which evidence is developed, the standards of evidence to be used in making clinical recommendations and decisions, overcoming the technical and regulatory barriers to broader use of clinical data for research insights, and effective communication to providers and the public about the dynamic nature of evidence and how it can be used.- Posted
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Internationally there is recognition that a holistic quality management system (QMS) approach will enable healthcare organisations to meet the needs of their populations and continuously improve the care and experience provided. In NHS Wales, the Duty of Quality was introduced in 2023 through the Health and Social Care (Quality and Engagement) (Wales) Act 20201 and requires Welsh NHS bodies to establish an effective QMS where appropriate focus is placed upon Quality Control, Quality Planning, Quality Improvement and Quality Assurance The 90-day cycle methodology was used to explore how high performing organisations manage for quality – identifying universal findings across all the organisations, a summary of what a QMS can achieve and the importance of the role of the Board. The findings informed the development of a QMS Framework for healthcare which has supported the development of the Duty of Quality and includes: A definition of quality: Continuously, reliably and sustainably meeting the needs of the population that we serve (aligned to the Duty of Quality). A definition of QMS for NHS Wales: An operating framework to continuously, reliably and sustainably meet the needs of the population we serve. Descriptions of the four aspects within a QMS: Quality Planning, Quality Improvement, Quality Control and Quality Assurance and examples of tools and resources that can be used to support their implementation. Descriptions of the organisation enablers for a QMS: leadership, workforce and culture; learning, improvement and research; whole system approach; and, information (aligned to the Duty of Quality Standards). A methodology to implement and embed a QMS: an adaptation of Quality as an Organisational Strategy (QOS) informed by the experience of piloting the approach at directorate and organisation level.- Posted
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ICBs ‘detached’ from patient safety risks
Patient Safety Learning posted a news article in News
A new reporting system has left integrated care boards “detached” from patient safety incidents, a watchdog has found. The Health Service Safety Investigations Body (HSSIB) said some ICBs first heard of an incident when they were asked to provide a media statement. In a report published today it highlighted views that a new reporting framework had “eroded assurance activities and patient safety oversight.” The NHS has largely moved from the serious incident framework – where incidents were investigated locally but ICBs played a key role – to the patient safety incident response framework (PSIRF), which is less prescriptive about how trusts need to react to incidents and is not based on the level of harm involved. But the HSSIB report revealed widespread dissatisfaction among ICBs about the new model, with commissioners saying many PSIRF responses did not trigger a report, leading to them having less visibility of risks from incidents. This was a particular concern when risks arose when patients moved between providers. ICBs were also often uncertain how risks were being mitigated and what providers had done as a result of incidents. The safety body was also critical of the Learn from Patient Safety Events database, highlighting problems with “the useability and utility of the data”, with one ICB saying it had “3,000 incidents downloaded but no way of understanding them.” Multiple ICBs had escalated issues with this to NHSE as the data was not useful for identifying hazards and risks. Helen Hughes, chief executive of the charity Patient Safety Learning, said issues with database were “not simply a technical problem 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,” she said. “With greater clarity around the roles, ICBs and ICSs have the potential to drive systemic improvements in patient safety. However, to do so effectively, they require enhanced tools, capacity, and a more integrated approach to digital solutions, such as LfPSE, that support patient safety.” Read full story (paywalled) Source: HSJ, 13 February 2025 You can read Patient Safety Learning’s response to this report here.- Posted
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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.- Posted
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This is one of a series of Health Services Safety Investigations Body (HSSIB) investigations exploring safety management and whether the principles adopted in other industries may assist in the management of safety in health and care. The aim of the investigations is to help improve patient safety in relation to the management of patient safety risks across organisational boundaries. This has been explored through an understanding of the pathways of care for patients whose care involves engaging with providers in primary, secondary and community care and with integrated care systems (ICSs). This report makes reference to processes which exist within the health and care system relating to the management of safety. You can read Patient Safety Learning’s response to this report here. This investigation explored the experiences of Ros, and her husband and carer Norman, to demonstrate the gaps in patient safety management when patients’ care is managed across multiple providers in an ICS. The investigation engaged with patient safety and quality teams within Integrated Care Boards (ICBs) to understand how patient safety risks were managed at this level of the health and care system. The investigation also engaged with NHS England regional and national teams to understand the risks that were escalated to them and how they were managed. Findings 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. 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. National organisations’ expectations of how ICBs manage patient safety are not in line with what ICBs can currently achieve due to challenges with resourcing and the usability of safety data. Patient safety risks may be escalated from the regional to the national level but there is variability in how these risks are managed at a national level and how responses to escalations are fed back. Cross-organisational safety risks are not always being escalated to ICBs and there may be limited resources and capability to identify, define and investigate such risks. Learn from Patient Safety Events (LFPSE) is the national learning service for the NHS; however, challenges in the usability of LFPSE data means that system level risks may not be visible to ICBs and the wider health and care system. Existing informal ‘good relationships’ between individual providers and an ICB facilitate the effective sharing and management of risks. Where these ‘good relationships’ do not exist or change, formal governance processes do not always ensure information sharing continues. 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. Recommendations, observations and suggestions HSSIB makes the following safety recommendation: Safety recommendation R/2025/057: 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. HSSIB makes the following safety observations: Safety observation O/2025/061: 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. Safety observation O/2025/062: Health and care organisations can improve patient safety by having clear lines of safety accountability and assurance of risk management processes. Currently patient safety risks are not managed in line with established UK government risk management principles. HSSIB makes the following safety suggestions: Safety learning for Integrated Care Boards ICB/2025/011: HSSIB suggests that integrated care boards seek assurance of how health and care providers will work together when commissioning services, so that patient safety can be managed across health and care providers. This is to help support the visibility and management of patient safety risks across an integrated care system. Safety learning for Integrated Care Boards ICB/2025/012: HSSIB suggests that integrated care boards develop their patient safety capability and expertise to ensure they can effectively analyse safety data and intelligence about patient safety risks. This would help to identify and understand patient safety risks that exist across multiple providers in order to proactively investigate and manage these risks.- Posted
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untilTraining 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.- Posted
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untilTraining 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.- Posted
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untilTraining 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.- Posted
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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.- Posted
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This is the terms of reference for an independent review of patient safety across the health and care landscape in England. The review will map the broad range of organisations that impact on quality and focus on six key organisations overseen by the Department of Health and Social Care, which have a significant impact on patient safety. The primary task of this review is to 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). Based on this assessment, the review will make recommendations on whether greater value could be achieved through a different approach or delivery model. The review will also set out the wider landscape of quality, looking at health and social care. The mapping work will provide context for the review of the specific organisations named below. This work will also be used to more widely inform the 10-year health plan. The main focus of the review will be on the following organisations: Care Quality Commission (CQC) - including the Maternity and Newborn Safety Investigations programme National Guardian’s Office (NGO) – NGO is hosted by CQC and its work on staff experience should inform improvements in patient safety Healthwatch England (HWE) and the Local Healthwatch (LHW) network – HWE is also hosted by CQC. Its work, alongside LHW, on patient experience should inform improvements in safety Health Services Safety Investigation Body Patient Safety Commissioner for England NHS Resolution (patient safety-related learning functions only, not clinical negligence functions)- Posted
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For many years, standardisation has been regarded as the cornerstone of improving healthcare safety by increasing reliability and reducing variation. Yet, variation in the delivery of healthcare remains high and there are questions around the extent to which unquestioning application of standards supports safe care. Safety II theory views healthcare as a complex system with safety being regarded as the ability to succeed in varying conditions. At the heart of this theory lies the assumption that variation is not inherently risky, and that complex systems actually rely on adaptations in response to varying conditions to work effectively. This PhD from Deborah Clark aims to understand how and in what circumstance a flexible approach to safety management supports safety.- Posted
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untilJoin 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- Posted
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Better use of data for medication safety in hospitals
Kenny Fraser posted a topic in Medicine management
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NHS hospital staff spend countless hours capturing data in electronic prescribing and medicines administration systems. Yet that data remains difficult to access and use to support patient care. This is a tremendous opportunity to improve patient safety, drive efficiencies and save time for frontline staff. I have just published a post about this challenge and Triscribe's solution. I would love to hear any comments or feedback on the topic... How could we use this information better? What are hospitals already doing? Where are the gaps? Thanks- Posted
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In this report, Patient Safety Learning considers the roles and responsibilities of Integrated Care Systems (ICSs) in relation to patient safety, and how this fits in with the wider patient safety landscape in England. This article contains a summary of the report, which can be read in full here or from downloading the attachment below. Action is needed to ensure that ICSs are not ‘patient safety free zones’, says Patient Safety Learning. A year on from ICSs being placed on a statutory footing, a new report, The elephant in the room: Patient Safety and Integrated Care Systems, argues that there needs to be a greater focus on the role that they play in patient safety. The report sets out what we mean by avoidable harm in healthcare, outlining the scale of this problem and the need for a transformation in approach to improving patient safety. It also looks at the landscape of different coordinating groups and organisations in England that have roles and responsibilities to improve patient safety and reduce avoidable harm. What is revealed is a complex and fragmented environment, lacking strong measures for cross-organisational thinking and coordination to address complex systemic threats to patient safety. Considering the creation and initial development of ICSs, the report highlights how there has been little mention of their role in, or impact on, patient safety. It illustrates that although patient safety has not been set as explicit priority for ICSs, the delivery of safe care runs implicitly through each of their main aims. It goes on to consider the potential role that ICSs can potentially play in helping to embed and improve patient safety. Recommendations Considering the steps that could be taken to address the current gap that exists between patient safety and ICSs, and the wider fragmentation of the patient safety landscape in which they operate within, the report makes the following recommendations: The Department of Health and Social Care and NHS England should consider introducing a fifth aim for ICSs making explicit their role in helping to improve patient safety and reduce avoidable harm. NHS England should update the NHS Patient Safety Strategy to account for ICSs being placed on a statutory footing in July 2022 and set out their roles and responsibilities in relation to this. The Department of Health and Social Care and NHS England should consider revising the remit of the National Patient Safety Committee to take on a greater role in coordinating and joining-up the existing patient safety landscape in England. The National Patient Safety Committee should regularly publish agendas, papers and the minutes of its meetings to help inform all bodies that may be impacted by this, such as ICSs and individual healthcare providers, and also patients and the wider public. Patient Safety Learning comment: Patient Safety Learning Chief Executive Helen Hughes said: “ICSs present a significant opportunity to drive improvements in patient safety in local health systems across the NHS. However, we think patient safety remains the ‘elephant in the room’ in the development of ICS roles and responsibilities. Currently there is not clear guidance or support to ensure that ICSs treat patient safety as a core purpose of healthcare. We believe they need to have specific aims for reducing avoidable harm and improving patient safety. There also needs to be clarity on where the patient safety role of ICSs fits into the wider healthcare system. The landscape of organisations with patient safety roles and responsibilities in England is fragmented and lacks coordination, often ill-suited to tackling complex systemic challenges to patient safety. We believe that the Department of Health and Social Care and NHS England need to consider how to better join-up this system, to promote cross-organisational working, coordination and ultimately reduce avoidable harm.”- Posted
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NHS England: The National Patient Safety Committee
Mark Hughes posted an article in NHS England
This is an overview of the role and responsibilities of the National Patient Safety Committee. This was established in 2021 to bring key national healthcare organisations together to address complex patient safety issues that require cross-organisation effort and input to make care safer within the NHS. The National Patient Safety Committee is intended to play strategic role in considering the existing landscape of national patient safety planning, response and improvement and consistently share insight and thinking about how, as a national healthcare system, there can be improvements made to effectiveness of these patient safety functions. It is accountable to the National Quality Board. The Committee will make strategic decisions on how issues for which there is no existing system or approach, or inconsistent systems, should be operationally managed. This may include: where identified national patient safety risks or national patient safety issues do not appear to fit within the existing remit of an Arm’s Length Body (ALB) or other national body or; where there may be a need to have a coordinated approach across multiple ALBs due to the complex nature of the national patient safety issue. Scope The committee’s main focus is on the most significant patient safety challenges in terms of scale of harm and where issues benefit most from national organisations working together with a coordinated approach. Alongside this it may have workstreams related to specific safety processes needing an aligned approach. It currently has three such workstreams: overseeing a pilot of oversight of delivery of the Healthcare Safety Investigation Branch recommendations a nationally agreed operational process to improve cross-national organisation working for urgent special patient safety circumstances and to review its operation overseeing the accreditation of organisations issuing national patient safety alerts and ensuring alerts meet the required common standards for effectiveness (this function has been taken over from the now disbanded National Patient Safety Alerting Committee). Core membership Academy of Medical Royal Colleges Allied Health Professionals Care Quality Commission Chief Medical Office Chief Pharmaceutical Officer Department of Health and Social Care Emergency Preparedness, Resilience and Response Health Education England Medicines and Healthcare products Regulatory Agency National Institute for Health and Care Excellence NHS England and NHS Improvement: Patient Safety NHS England and NHS Improvement: Estates and Facilities NHS England and NHS Improvement: Nursing NHS Digital NHSX UK Health Security Agency Terms of reference You can find the full terms of reference for the Committee here.- Posted
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In this blog Aiden Fowler, the National Director of Patient Safety in England and a Deputy Chief Medical Officer at the Department of Health and Social Care, reflects on progress made in implementing the NHS Patient Safety Strategy, four years on from its publication. He outlines some of the main programmes of work associated with this and considers their impact on avoidable harm in the NHS.- Posted
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Can you measure safety? Part 1
NMacLeod posted an article in Improving patient safety
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’- Posted
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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’? 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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.- Posted
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Those who work in health and care are keenly aware of the need to identify and manage risks to protect patients from harm. But we are not the only industry that must take safety seriously. This video from the Healthcare Services Safety Investigation Branch (HSSIB) we compare notes with other safety-conscious industries – oil and gas, shipping, aviation, rail, road, nuclear and NASA – to understand their approach to safety management. In these fields, systems for organising and coordinating safety are often called Safety Management Systems (SMSs). See also HSSIB's report: Safety management systems: an introduction for healthcare.- Posted
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Safety Management Systems (SMSs) are an organised approach to managing safety which are widely used in different industries. In this report, the Health Services Safety Investigations Body (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. It makes safety recommendations for NHS England and the Care Quality Commission in relation to this. See also HSSIB's video Introduction to safety management systems. The purpose of an SMS is to ensure that an industry achieves its business and operational objectives in a safe way and complies with the safety obligations that apply to it. HSSIB note that there are four recognised areas associated with SMS frameworks: 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. Findings Exploring this topic, the report identifies three opportunities for an organised approach to safety management in healthcare: 1. SMS development in healthcare There is an opportunity to improve safety activities in healthcare to increase proactivity and coordination across and within organisations. In other safety-critical industries an SMS is mandated in regulation, but healthcare organisations are not required to have all four areas of an SMS. There is an opportunity to improve standardisation in the coordination of safety activities within and between different organisations across healthcare, in terms of how risks are escalated and managed. An effective safety system and culture requires a shared understanding of safety management principles. There is variability in the current language and definitions that describe the safety activities, functions and processes already common across healthcare. 2. Safety accountability frameworks across healthcare For effective safety management, clear lines of accountability and responsibility are needed. Within an SMS, everyone has some measure of responsibility, such as reporting unsafe conditions. Accountability takes responsibility to another level. When someone is accountable, they are responsible for systems and processes that assure safety. If there is no co-ordinated approach in place, accountability and responsibility can become misaligned, leading to gaps in the oversight of safety management. While there are clear accountabilities for safety at provider level through the Care Quality Commission regulation, there is no multi-level framework that specifies who should be accountable for the management of safety risks across the healthcare system. There is consensus within other safety-critical industries that effective safety management is only possible when there is a clear accountability framework that underpins the process. 3. Safety maturity assessments across healthcare The term safety maturity is used to describe how far an organisation has developed and embedded its SMS. Existing maturity frameworks in healthcare do not promote the principles of SMSs, do not define the key components of a healthcare SMS, and do not provide organisations with a road map for incremental development of their safety activities. Future work and recommendations Considering what would be needed to explore applying the SMS approach to healthcare, HSSIB suggest that this could involve: Mapping current safety management activities in healthcare to SMS principles and identifying opportunities for improvement. Determining if planned and ongoing changes to the way safety is managed in healthcare would be usefully guided by SMS principles. Further understanding how an accountability framework could support an SMS approach in healthcare. Understanding how safety issues and risks for inclusion health groups are identified and then managed through an SMS approach. It makes the following safety recommendations: HSSIB recommends that NHS England explores, and if appropriate, supports the development and implementation of safety management systems (SMSs) through an SMS co-ordination group. This should be in collaboration with regulators, relevant arm’s length bodies and national organisations, academics, patient representatives and safety leaders from other safety-critical industries. HSSIB recommends that the Care Quality Commission is responsible for ensuring that its regulatory assessment approach effectively assesses safety management activities. It also makes the following safety observation: The oversight of safety management can be improved if relevant bodies, such as providers, commissioners and regulators, adopt a multi-level safety accountability framework. Related reading Five Cornerstones to an Effective Safety Management System (Andrew Ottaway, 2 August 2021) The involvement of patients and families in a healthcare safety management system: In conversation with Jono Broad (21 February 2023) What is a ‘safety management system’? A blog by Norman MacLeod (3 October 2023) Why healthcare needs to operate as a safety management system: In conversation with Keith Conradi (24 October 2022)- Posted
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