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This masterclass will focus on developing your role as a SIRO (Senior Information Risk Owner) in health and social care. Key Learning Objectives Understanding the role of the Senior Information Risk Owner Identifying Information Risks across the organisation Working with others to mitigate the risk to patients, staff and organization. Confidence that all reasonable technical and organisation measure are in place Giving assurance to the Board that risks have been considered, mitigated or owned Understand the requirements of external confidence that policies, procedures are in place to deal with Data Breaches Register hub members receive a 20% discount. Email [email protected] for discount code.

To support the implementation of the National Patient Safety Plan of the Republic of North Macedonia, this handbook provides a structured framework using the Plan-Do-Check-Act (PDCA) cycle and focuses on six core intervention areas, including infection prevention, medication safety, surgical safety, safe birth practices, capacity strengthening, and error-reduction strategies. It emphasises stakeholder engagement, monitoring and evaluation, risk management, and sustainability planning. By providing a clear roadmap, this initiative aims to foster a culture of patient safety and improve health-care quality in North Macedonia.

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.

This masterclass will focus on developing your role as a SIRO (Senior Information Risk Owner) in health and social care. Key Learning Objectives Understanding the role of the Senior Information Risk Owner Identifying Information Risks across the organisation Working with others to mitigate the risk to patients, staff and organization. Confidence that all reasonable technical and organisation measure are in place Giving assurance to the Board that risks have been considered, mitigated or owned Understand the requirements of external confidence that policies, procedures are in place to deal with Data Breaches Register hub members receive a 20% discount. Email [email protected] for discount code.

Join a conversation with industry experts on cyber risk, response and claims. With increasing and high profile cyber-attacks on both health and care organisations we discuss the issues that organisations face, what can be done prevent and minimise attacks, what to do if your organisation falls victim to an attack and the steps that should be taken to minimise the impact on your organisation which can far ranging in terms of patient safety, work force, and finance. Your panel of expert speakers: Richard Hearn - Divisional Director, Howden Dave Allen - CEO, Cysiam Vicki Bowles - Partner, Bevan Brittan Julie Charlton - Partner, Bevan Brittan Register

Blood clots, particularly deep vein thrombosis (DVT) and pulmonary embolism (PE), together venous thromboembolism (VTE), pose a significant health threat to patients. These potentially life-threatening conditions can manifest silently and without warning, making vigilance and knowledge crucial. In this Top picks, we’ve pulled together resources, blogs and reports from the hub for patients and healthcare professionals, which focus on how to recognise venous thromboembolism and how to improve patient safety. 1. Deep vein thrombosis: understanding and managing your risk In this blog, Jo Jerrome, CEO of Thrombosis UK, explains the dangers of DVT and why it is important for patients and staff to be aware of the risk factors. Jo offers advice on how we can all manage our risk of DVT. 2. HSIB - Clinical decision making: diagnosis of pulmonary embolism in emergency departments This investigation by the Healthcare Safety Investigation Branch (HSIB) explores the timely recognition and treatment of suspected pulmonary embolism in emergency departments. 3. Jenny, and why we must learn from her misdiagnosis of pulmonary embolism Jenny Edwards died in February 2022 from pulmonary embolism, following misdiagnosis. In this blog, her son Tim introduces us to Jenny, illustrating the deep loss felt following her premature passing. He talks about the care she received and argues that there were multiple points at which pulmonary embolism should have been suspected. 4. Venous thromboembolism (VTE): deep vein thrombosis and pulmonary embolism VTE is a significant cause of mortality, long-term disability and long-lasting ill-health problems – many of which are avoidable. 1 in 20 people will have a VTE at some time in their life and the risk increases with age. This NHS Resolution guide provides more information about the risks of VTE and how to spot the common signs and symptoms. 5. HSIB - The assessment of venous thromboembolism risks associated with pregnancy and the postnatal period final report This investigation by the HSIB explores the issues associated with the assessment of risk factors for venous thrombosis in pregnancy and the first six weeks after birth. 6. NHS Resolution: Working to prevent avoidable venous thromboembolism VTE is an international patient safety issue and a clinical priority for the NHS. Around half of all cases of VTE are associated with hospitalisation, with many events occurring up to 90 days after admission. It is a leading and preventable cause of death in an estimated 25,000 of hospitalised patients each year. This information leaflet highlights the cost of VTE claims and what you can do in your organisation to prevent VTE. 7. Pulmonary embolism misdiagnosis – a systemic problem Tim Edwards is a risk management expert and son of Jenny, who passed away in February 2022 from pulmonary embolism, following a misdiagnosis. Frustrated by the quality of the initial investigation that followed her death and the lack of assurance that learning would take place, Tim conducted an independent review. In this opinion piece, Tim draws on his research to highlight the key patient safety issues, and to encourage further dialogue around the topic. 8. Let's Talk Clots! Help reduce your risk of DVT and PE in hospital with this simple app Download the free Let’s Talk Clots patient information app from Thrombosis UK, and help reduce your risk of DVT and pulmonary embolism in hospital. 9. Patient Safety Spotlight Interview with Beverley Hunt, Professor of Thrombosis and Haemostasis and founder of Thrombosis UK In this interview, Beverley Hunt talks about setting up Thrombosis UK and how it has grown to have a national impact on patient safety in hospitals. She also describes the value of combining policy work with seeing patients face-to-face, and explores the need to find new ways of working to deal with the pressures facing the healthcare system. 10. Risk assessment models for venous thromboembolism in medical inpatients This cohort study in JAMA Network Open aimed to determine the prognostic performance of the simplified Geneva score and other validated risk assessment models (RAMs) to predict VTE in medical inpatients. The study provided a head-to-head comparison of validated RAMs among 1352 medical inpatients. It found that sensitivity of RAMs to predict 90-day VTE ranged from 39.3% to 82.1% and specificity of RAMs ranged from 34.3% to 70.4%. The authors concluded that the clinical usefulness of existing RAMs is questionable, highlighting the need for more accurate VTE prediction strategies. 11. HSIB: Investigation into management of venous thromboembolism risk in patients following thrombolysis for an acute stroke This HSIB investigation focused on the management of VTE risk in inpatients following thrombolysis for an acute stroke detection of medical problems (that impact on VTE risk) occurring in inpatients following thrombolysis for an acute stroke. Do you have a resource or story to share? We’d love to hear about it - leave a comment below or join the hub to share your own post.