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Things can and do go wrong in health and social care. There is an expectation that when things do go wrong, HSC organisations treat those affected with respect, compassion and honesty. That they help members of the public understand what happened and they demonstrate that they have learned from the incident, to reduce the risk of it happening again. Recommendations arising from a number of Inquiries and Reviews have contributed to a clear and strong evidence base underpinning the need to redesign the current approach to learning following Adverse Incidents and SAIs. The Department of Health is therefore holding a public consultation on the redesign of the current Serious Adverse Incident (SAI) procedure in Northern Ireland. The SAI review process is intended to play an important role in securing improvements in the quality and safety of health and social care (HSC) services by ensuring that incidents are identified, reported and investigated as appropriate so that learning can be shared across the HSC system. Some of the key aims of the new draft Framework include: Providing a more streamlined and simplified process for reviewing Patient Safety Incidents, to ensure reviews are of a high quality; Place all those affected at the heart of the process; Focus on understanding how and why a Patient Safety Incident has occurred to identify system-wide learning leading to demonstrable and sustainable improvements in care. The proposed framework for Learning and Improvement from Patient Safety Incidents will form a key part of the HSC’s patient safety system and it is therefore crucially important that it is the right approach. The Department of Health would therefore like to hear directly from the public on these important proposals. The PCC is facilitating an online consultation event, to be led by Department of Health officials, on Thursday 15 May 2025, at 17:30. This event will also assist those intending to make a written response to the consultation. Register

In this blog, Patient Safety Learning highlights key issues included in its response to the Department of Health consultation on the draft ‘Being Open’ Framework and establishment of a Duty of Candour in Northern Ireland. In December 2024, the Department of Health launched a public consultation asking for views on its draft ‘Being Open’ Framework. Describing the proposed Framework, Health Minister Mike Nesbitt stated: “The ‘Being Open’ Framework aims to ensure that individuals within our health and social care system are fully empowered to exercise candour and openness, and that health and social care organisations have in place the necessary support and systems required to enable and nurture a truly open culture.”[1] The Framework aims to address some of the recommendations made in the 2018 report from the Inquiry into Hyponatraemia Related Deaths (IHRD) by Justice O’Hara KC.[2] This Inquiry was published following an extensive investigation into the deaths of five children in hospitals. The report’s recommendations included the introduction of a Duty of Candour in Northern Ireland. The purpose of the ‘Being Open’ Framework set out in the consultation document is as follows: To improve patient safety and the quality of services by developing an open, just and learning culture. To ensure that all people in contact with healthcare organisations (employees, patients, relatives and the public) can expect to be treated in an open, fair and compassionate way. That patients and those supporting them will be listened to, understood and treated with respect. That healthcare staff are entitled to visible, engaged and inclusive leadership. That senior leaders will listen to concerns and create safe spaces for learning. That learning will be promptly disseminated across the system.[3] Below we summarise the key points included in Patient Safety Learning’s response to this public consultation. Openness and culture The ‘Being Open’ Framework at its core places a strong emphasis on the principle of openness in the healthcare system. It looks at this on three levels: Routine openness: being honest in everyday care and communication. Learning from mistakes: reflecting on errors to improve and avoid repeating them. When things go wrong: clear communication and accountability when harm is caused. We welcome the Framework’s commitment to openness with patients and its focus on learning from mistakes. We stated this in our consultation response, while highlighting the need for proposed training and support for staff to be accompanied by a commitment by their organisation to support a culture of openness. We believe that this requires a clear leadership commitment to create a working environment for their staff where they feel psychologically safe to raise patient safety concerns. In our response, we also mentioned the importance of being open with patients and families following patient safety incidents and in the incident investigation process itself. To facilitate this, we set out that: It is important for staff to understand who is responsible for ensuring meaningful and compassionate engagement with patients and families. This needs to be accompanied by processes that enable organisations to evaluate how both to assess and meet the needs of patients and families in these processes. Having sufficient well-trained staff, with time for engagement, is essential if this is to be achieved. These issues around patient safety investigations is something we will come back to in more detail at a later date as part of our response to the new public consultation on the redesign of the current Serious Adverse Incident procedure for Northern Ireland.[4] Duty of Candour The consultation poses questions about the introduction of a Statutory Duty of Candour for organisations and individuals in Northern Ireland, a key recommendation of the IHRD. In our response, we state our support for this. Everyone working in healthcare must be open and honest in all their dealings with patients and the public. We also make clear that the introduction of Duty of Candour is a process that takes time and requires significant resources to embed. Highlighting the challenges of this, we pointed to the experience of introducing a Statutory Duty of Candour for health and care providers in England, first enshrined in law for all NHS Trusts in 2014. As results of last year’s call to evidence illustrate, even now there is still a significant gap between what is said and understood in regard to Duty of Candour, and what takes place in practice at many healthcare organisations.[5] Patient Safety Commissioner We also expressed our support for the potential introduction of a new role of Independent Patient Safety Commissioner in Northern Ireland. This is one of the options that the ‘Being Open’ Framework suggests exploring to help to monitor and scrutinise its implementation. This new post alone cannot improve openness and patient safety. However, with the right remit and responsibilities, we believe that it could play a potentially important role in supporting this and championing the voice of patients. In our response, we stressed that if such a role was introduced it was important to ensure that they had a clear remit, with the ability to advocate for systemic improvement and look at safety issues across health and care. The Patient Safety Commissioner for England currently has a remit that is restricted to medicines and medical devices, which in our view places an unnecessary limitation on the role. This can also create confusion for patients who want to highlight a clear patient safety issue that does not fall under the guise of medicines and medical devices. This can reinforce an inequity of treatment for patients affected by these issues, with there being no alternative pathway for them to raise such concerns outside the Commissioner’s scope. This is a problem that has been highlighted directly by the inaugural Patient Safety Commissioner for England, Professor Henrietta Hughes.[6] We also stated the need to ensure that a new Patient Safety Commissioner in Northern Ireland would have clear operational independence. They should feel able to ‘speak truth to power’ and represent the best interests of patients and the wider public. To support this aim, we believe that this role would need to be independent from those funding and delivering healthcare. Finally, we noted that it would be useful for the new postholder to establish a strong working relationship with the Patient Safety Commissioner for England and, when appointed, the Patient Safety Commissioner for Scotland. This would enable them to coordinate in the future on emerging patient safety concerns and share examples of good practice. Engaging with patients and the Patient and Client Council One area where we felt that the ‘Being Open’ Framework could be strengthened was in relation to patient engagement and involvement. While further changes may emerge in this area from feedback to the consultation itself, we also highlighted in our response the value of giving greater consideration to the role the Patient and Client Council (PCC) can play in the delivery of this. The PCC is a statutory body in Northern Ireland that provides a powerful and independent voice for patients, clients, carers and communities on health and social care issues through: Representing the interests of the public. Promoting the involvement of the public. Assisting people in making, or intending to make, a complaint. Promoting the provision by health and social care bodies of advice and information to the public about the design, commissioning and delivery of services. Undertaking research into the best methods and practices for consulting and engaging the public.[7] We believe that these functions of the PCC align with the core aims of the ‘Being Open’ Framework, and their existing knowledge and experience could help to support the implementation of this. Commenting on specific aspects of this, we noted the following points: In potentially creating a new Patient Safety Commissioner role, consideration would need to be given as to how its remit and responsibilities relate to and complement the existing role of the PCC. When discussing “Openness with a focus on learning” and “Openness when things go wrong”, the Framework talks about organisations having patient safety incident investigations that involve patients. The PCC’s work involving patients and communities in the design, delivery and evaluation of services could support embedding these principles in practice. Training and education We also welcome proposals in the ‘Being Open’ Framework to provide training and support to staff to properly understand and exercise their responsibilities to be open routinely and focused on learning and when things go wrong. In our consultation response we also placed particular emphasis on the need to consider how this applies to those in leadership positions. At Patient Safety Learning we believe that good leadership can drive patient safety performance, supporting learning from unsafe care and putting in place clear governance processes to enable this. In our Patient Safety Standards we identify the need for Board members (Executives and Non Executives) and governors to be provided with training and support in relation to compliance with Duty of Candour and being open as a key requirement for healthcare organisations.[8] We believe there would be value in also reflecting that in the ‘Being Open’ Framework. Concluding comments We strongly support the introduction of the ‘Being Open’ Framework in Northern Ireland. We also welcome that it directly acknowledges the importance of having a clear implementation plan to take this work forward. Importantly, it also recognises that neither legislation nor policy alone will necessarily inspire the behaviours that are intrinsic to an open organisation, emphasising the importance of taking action needed to promote behaviours and beliefs that enable this. In our concluding comments to the consultation, we highlighted further consideration how the implementation of the Framework could potentially form part of a wider application of a safety management system approach to health and social care in Northern Ireland. A safety management system 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.[9] References Department of Health. Consultation on ‘Being Open’ Framework and Duty of Candour launched, 10 December 2024. IHRD. Report of the Inquiry into Hyponatraemia related Deaths, 31 January 2018. Department of Health. Draft Regional being Open Framework for the HSC, 10 December 2024. Department of Health. Framework for Learning and Improvement from Patient Safety Incidents Consultation, 11 March 2025. Department of Health and Social Care. Findings of the call for evidence on the statutory duty of candour, 26 November 2024. Emily Townsend. Safety watchdog urges Streeting to expand her role. HSJ, 24 October 2024. PCC. Who we are and what we do. Last accessed 28 March 2025. Patient Safety Learning. Why Standards? Last Accessed 24 March 2025. HSSIB. Safety management systems: accountability across organisational boundaries, 13 February 2025.

The Professional Standards Authority (PSA) and the Patient and Client Council (PCC) have complementary organisational objectives of public protection and representing the interests of the public in health and social care. This event will focus on how we can improve patient safety by embracing the public as assets and developing workplace culture. This event builds on ongoing conversations across the system, including those hosted by PCC at NICON and we consider that it will have significant relevance for a number of key focus areas across Health and Social Care (HSC) in Northern Ireland, including the Department of Health’s openness work, the duty of candour and emerging issues from public inquiries. The event is aimed at leaders across the HSC, healthcare regulators, the voluntary and community sectors, representative bodies and members of the public. It will take the format of two panel discussions following on from presentations by our speakers, with opportunities for Q&A from participants. Confirmed speakers include: Sarah Castell, Chief Executive of Involve and Co-Author of the Citizens White Paper Helen Hughes, Chief Executive of Patient Safety Learning Jim Wilkinson, Deputy Secretary, Healthcare Policy Group, Department of Health Patricia Donnelly OBE, Chair of the Assurance Group for the Department of Health Northern Ireland, Independent Inquiries Programme Management Board Paula Bradley, PCC Council Member Matthew Redford, Chief Executive of the General Osteopathic Council Dr Nazia Latif, Regulatory Quality and Improvement Authority Professor Owen Barr, Professor of Nursing and Intellectual Disabilities, Ulster University Paul Whiteing, Chief Executive, Action Against Medial Accidents Peter McBride, Independent Consultant. Register