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I love and support the NHS. But when things go wrong for patients and service users, the system is often too slow to change or respond effectively. I have been through complaints, the Ombudsman and Inquest processes around the poor end of life care of my late mother. Those processes took years and were almost as stressful as those last few days of my mother’s life. I would not do it again. At the time, I reported the incident in detail to the CQC (inspectors), to the CCG (commissioners), to Healthwatch (local and national), but I noted no evidence of change. In fact, the CQC continued for years to report similar failings at the same hospital. Too many other patients and service users say the same thing. I met many of these patients/users when I was part of the user/patient led group PHSOthefacts. Then, my elderly friend and neighbour asked me to be their advocate around their wishes for end of life care and unfortunately things were not perfect at all. I was able, through connections I had made from the previous experiences I mention above, to get a meeting with senior managers involved with her care. However, sadly I do not think much came of that either. I believe others could go through the same suffering my friend experienced. There are immense pressures on the NHS. Hospitals have budgets to operate within, reputations to manage and targets to meet, as well as keeping patients and staff safe. While the system is under huge pressure, and many of the known ‘complaint’ processes are not designed to improve patient safety, the good news is there is a growing awareness of the need to listen and learn from patients and service users, drawing on the best safety science and using independent experts. Safety improvement rather than simply complaining (often seen as an administrative process) is what so many patients and families most want to see so others do not suffer the same way as their loved one. Fortunately, via a convoluted route, I did discover the Patient Safety team of NHS England who was able to take one of my concerns about care very seriously. I also learned about the development of the Healthcare Safety Investigation Branch (HSIB). So the good news is that as well as traditional routes like Complaints, the Ombudsman (PHSO) and reporting to formal bodies (perceived as inadequate by too many patients/users who have been through this process), there are four developments to note of NHS dealing with events when patients suffer harm or potential harm: 1. New guidance is being developed by NHS England to help hospitals and health services address safety concerns and involve patients in this. 2. HSIB, who carry out up to 30 independent investigations a year, is developing an exemplar model of involving the patient and family perspective in these investigations. It offers an exciting, new, more change-focused, learning-focused and system-focused way of understanding and addressing many of the harmful incidents patients' experience, aligned with service users and families who wish to embark on a journey resulting in learning. Watch this HSIB video 'Why it's important that we learn from incidents'. 3. There is increasing recognition of the role of patients in all health decision-making, which is well covered in the Patients Associations' 'Shared decision making: a reality for everyone'. In fact, I recently wrote a blog for the hub on a particular patient harm issue: 'Please don't undermine my pain relief! A call for learning and respect for patients with long tern needs', which I then shared via ENGLAND.shareddecisionmaking@nhs.net and I was put in contact with a relevant Clinical Improvement Team in NHSE/I who were interested to learn more. 4. Finally, patients, service users and families can log issues on the NHS England NRLS reporting tool – although no one will get back to you personally, the information you share could be used to improve safety for future patients. However currently it is vastly under used (50 patient/family reports a year) compared to the general NHS complaints system (over 100,000 a year). In contrast, the system also logs and analyses nearly 2 million NHS staff-reported harm or potential harm incidents a year, examined by a team of NHS-employed independent patient safety experts. It may contribute to vital learning in the future and it is currently reviewed and upgraded, but to my mind the process is going too slow with regard to patient and family reporting. I think the patient, service user and family voice should be heard loud and strong. There should be a reporting option for where patients and users can go if they do not want to go through complaints, Ombudsmen, Inquest, legal or other processes (e.g. to CQC or CCG), or indeed want to do something alongside these processes and want to ensure independent health safety experts are made aware of concerning incidents. Please let me know if you are interested about developments in this latter area as there will be working groups wanting to hear the patient, service user and family experience, and I will be involved and want to ensure other harmed patient voices and their advocates are heard. The patient, service user, family and carer voice must be heard and acted on to improve patient safety at these difficult times.

The Professional Standards Authority for Health and Social Care (PSA) is an independent body which oversees the ten statutory bodies that regulate healthcare professionals in the United Kingdom and social care in England. Its aim is to protect the public by improving the regulation and registration of people who work in health and social care.[1] In its new report, Safer care for all – solutions from professional regulation and beyond, the PSA set out their view of the main unresolved challenges which impact the quality and safety of health and social care.[2] This is structured around four main themes: Tackling inequalities – considering the persistence of unequal and unfair outcomes for protected groups in aspects of professional regulation. Regulation for new risks – noting the need to adapt to both the risks and opportunities posed by rapidly developing and increasingly accessible new technologies and approaches in health and care. Facing up to the workforce crisis – considering the impact of workforce shortages on patient safety and the capacity of healthcare professionals. Accountability, fear and public safety – looking at the balance that needs to be struck between making individual accountability work in a system that is safe for patients and fair to healthcare professionals. The report also highlights a sector-wide issue which it describes as “structural flaws in the safety framework”.[2] This concerns the fragmentation and complexity of our current system-wide approach to safety in health and social care. The report highlights that no one organisation currently takes an overarching view of this, noting that instead this is only looked at through individual organisational remits. In this blog, we will consider the four main themes highlighted in this report from a patient safety perspective and reflect on the sector-wide issue of structural flaws in the safety framework. Tackling inequalities Health inequalities pose a serious threat to patient safety, with poorer outcomes for specific patient groups presenting themselves in a variety of different ways.[3] This report highlights some specific examples of this, such as abuse and neglect of people with learning disabilities, highlighted by reviews such as the Muckamore Abbey Hospital Public Inquiry, and people from specific ethnic and racial backgrounds being disproportionately affected by certain types of patient safety incidents.[4] [5] The PSA make a number of recommendations in this area, emphasising the importance of collecting appropriate health and social care data relating to people with protected characteristics, reducing barriers to raising complaints and identifying issues that disproportionately impact particular groups. We welcome the proposals set out in the report and also what appears to be a growing acknowledgement more broadly of the patient safety concerns raised by health inequalities, as evidenced by the recently announced Government call for evidence on the potential racial and gender bias of medical devices.[6] However, much more work is needed to ensure this becomes a key focus for all health and care organisations. To date, the most thorough work in this area has often been carried out either by tenacious patient campaigning groups, such as FIVEXMORE on disparities in maternal outcomes for Black women, or very specifically tasked bodies, such as the NHS Race and Health Observatory. Regulation for new risks The second key theme this report focuses on changes to how health and care is funded and delivered, including the use of new technologies. The PSA stresses the importance of the Government and regulators being ahead of the curve on such changes, ensuring they identify emerging risks and protect the public. We agree with this view and believe it is vital that we ensure that patient safety considerations are at the heart of new healthcare innovations and technologies, from the point of development through to their deployment. We also need to ensure there is a direct role for patients in the development and implementation of new innovations, and consistent use of Patient Reported Outcome Measures (PROMS) and Patient Reported Experience Measures (PREMS) to monitor their safety in use. Facing up to the workforce crisis There is a wide body of research highlighting the negative impacts on patient outcomes as a result of insufficient staffing levels.[7] [8] In addition, reports into major patient safety scandals, such as the Francis report on the Mid-Staffordshire NHS Foundation Trust, have made clear the link between patient safety incidents and safe staffing levels.[9] It is about having the right numbers of staff, with the right skills, in the right place at the right time.[10] PSA rightly identifies the serious workforce shortages we currently face in both health and social care in the UK as a key challenge to the quality and safety of care. We welcome their recommendation that the four UK governments should work together to develop a coherent strategy for the regulation of professionals, to support delivery of the national workforce strategies. Accountability, fear and public safety The fourth theme of this report is focused on striking the balance between making individual accountability work in a system that is safe for patients and fair to healthcare professionals. The PSA emphasise the importance of ensuring that workplace cultures do not unfairly punish healthcare professionals for mistakes when things go wrong whilst also retaining the importance of individual accountability. At Patient Safety Learning we believe it is vital that we create an environment in health and social care organisations with an open and fair culture that enables patient safety issues to be raised, discussed and resolved, ensuring incidents of avoidable harm are responded to with empathy, respect, rigour and action for improvement. To achieve this, patient safety incidents must be reported consistently, and staff and patients feel safe and supported in doing so. Related to this, we would agree with the PSA’s recommendation that professional regulators are seen to be fair and transparent, with clear explanations of how and why decisions are taken. This section of the report also considers the issue of ‘safe space’ principles in patient safety investigations by the Healthcare Safety Investigation Branch. This is where, as part of safety investigations, material such as transcripts, witness statements from staff and patients involved in the incident, notes written by investigators, electronic recordings of interviews and other information generated by the investigation are non-disclosable and inadmissible, except on the order of the High Court. The report raises concerns that this approach may run counter to the professional duty of candour that requires professionals to be open and honest when things have gone wrong. They suggest that: “The UK Government should ensure that the ‘safe spaces’ investigation approach being implemented in England does not cut across the duty of candour or otherwise negatively impact on transparency or accountability.”[2] Structural flaws in the safety framework Considering the health and social care landscape more broadly, the PSA highlights that the current approach to safety across health and social care is too complex and fragmented. It points out that while many individual organisations take a view on safety, they all do so only through the lens of their own remit, with no one taking an overarching overview. They also note this occurs in the case of public inquiries too, which can often vary considerably and are not necessarily looked at in a joined-up way. In response to this, the report makes a core recommendation that: “Each UK country has a Health and Social Care Safety Commissioner, or equivalent function, with broad responsibility for identifying, monitoring, reporting, and advising on ways of addressing patient and service user risks. The commissioners should sit above all other health and care organisations, spanning public as well as private provision. They would also be independent of Governments, and transparent in both their approach and outputs.”[2] We agree with the PSA’s diagnosis of this issue. In our recent report, Mind the implementation gap, we highlighted that part of the difficulty in implementing improvements in patient safety in the UK lies in absence of a systematic and joined-up approach to these issues and unclear leadership at a system level.[11] This is not a new problem, previously identified in a 2018 report by the Care Quality Commission, Opening the door to change, which stated: “Arm’s-length bodies, including CQC, royal colleges and professional regulators, have a substantial role to play within patient safety, but the current system is confused and complex, with no clear understanding of how it is organised and who is responsible for what.”[12] The PSA’s proposals for independent commissioners have significant merit and are worth further exploration as part of an effective Safety Management System. However, the introduction of a Health and Social Care Safety Commissioner, while potentially bringing significant benefits of coordination and oversight at a system level for patient safety, will not alone bring about a significant improvement in patient safety. In our view, any such change must be part of a wider transformation in our approach to patient safety, placing this at the heart of our healthcare system. This cannot just be limited to the most senior levels of health and social care, we need everyone – politicians, policymakers, patients, families and communities, clinicians, managers, system and professional regulators, researchers and academics, and health and social care system leaders – involved in this effort. References PSA., Who we are. Last Accessed, 6 September 2022. PSA. Safer care for all – solutions from professional regulation and beyond. 6 September 2022. Patient Safety Learning., Health inequalities and patient safety. 15 December 2021. Muckamore Abbey Inquiry. About the inquiry. Last Accessed 7 September 2022. Chauhan A, et al. The safety of health care for ethnic minority patients: a systematic review. Int J Equity Health 2020: 8;19(1):118. Department of Health and Social Care. Equity in medical devices: independent review call for evidence. 11 August 2022. Rafferty AM. Research proves we need safe staffing. RCN Bulletin, 23 July 2019. National Institute for Health and Care Excellence. Safe staffing for nursing in inpatient mental health settings. Last Accessed 22 August 2020. Robert Francis QC. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. February 2013. Royal College of Nursing. Safe and Effective Staffing: Nursing Against the Odds. 2017. Patient Safety Learning. Mind of the implementation gap: The persistence of avoidable harm in the NHS. 7 April 2022. CQC. Opening the door to change: NHS safety culture and the need for transformation. 2018.

Working together to achieve safer care for all There are some big challenges ahead that need us all to work together to solve them. In our new report, 'Safer Care for All: solutions from professional regulation and beyond', we set out four key challenges for patient and service user safety: Tackling inequalities. Keeping pace with changes to technology and the delivery of care. Facing up to the workforce crisis. Addressing issues of accountability, fear and public safety. We suggest possible solutions as well as one major overarching recommendation: that each UK nation should have a Health and Social Care Safety Commissioner. These Commissioners would have broad responsibility for identifying, monitoring and advising on ways of addressing patient and service user risks. Tackling inequalities in health and care professional regulation Inequalities in the health and care sector affect both patients and registrants (healthcare professionals). For patients, this can result in significantly worse outcomes, such as black women being four times more likely to die in childbirth than white women in the UK.[1] For registrants, inequalities affect career attainment and experiences of disciplinary processes. In England, amongst NHS staff as a whole, black, Asian and minority ethnic (BAME) staff are more likely to enter local disciplinary processes and, according to General Medical Council (GMC) research, are twice as likely to be referred to the GMC by employers compared to white doctors; and international medical graduates face an increased likelihood of receiving a serious sanction.[2] This is echoed in the findings of other regulators, which indicate that BAME professionals are overrepresented at all stages of the fitness to practise process. Regulators and employers need to work together to tackle this issue. There is also a lot we still do not know about how inequalities affect all-important complaints mechanisms when care has gone wrong, which is crucial to addressing health inequalities for patients and service users. We recommend a range of actions to help tackle inequalities, and for our part have committed to ensuring that our equality, diversity and inclusion (EDI) standards for regulators are stretching and stimulate continuous improvement. Keeping pace with changes in how care is delivered and funded Health and care is changing, with more care being delivered by the private sector and online. Technology is being used increasingly to diagnose and treat conditions, presenting both opportunities and risks to patient care. Regulation can be slow to adapt; instead it needs to keep pace and be agile enough to adapt quickly to new delivery models and emerging risks to patient care. Some of the issues we examine in the report are the interplay between profit and the best interests of patients and staff, individual conflicts of interest, online care provision and new technologies. We recommend a cross-sector review of arrangements to address financial conflicts of interest among healthcare professionals and that regulators do more to tackle any business practices that fail to put patients first. We also highlight the opportunity to give regulators greater agility to address new and developing risks through the Government’s reform programme for professional regulation. Facing up to the workforce crisis It is estimated that the UK needs over a million extra health and care workers in the next decade. But it takes time to train healthcare professionals and we fear it will be too little too late without some radical change. We consider what might be done differently to grow the workforce and adapt to new ways of working, and how professional regulation might help. Our recommendations include considering whether regulated professionals can be trained faster. We believe that the risks posed by the lack of staff is now so severe that a new approach is required. This means regulators, educators and professional bodies exploring whether there are opportunities for accelerating training safely. We also recommend that better and smarter use be made of unregulated roles. We propose a new strategy for the regulation of health and care professionals to be developed by the four UK Governments to support delivery of their national health and social care workforce strategies. Accountability, fear and public safety The report considers how to make individual accountability work in a system that learns from mistakes, is safe for patients and service users, and fair to professionals. We ask whether professional regulation can do more to explain its role in keeping people safe so that professionals are not practising in fear of unfair sanctions. We raise questions about how to ensure that the ‘safe spaces’ approach to safety investigations doesn’t cut across the professional duty of candour and individual accountability mechanisms. Regulators may have to investigate and take action relating to individuals involved in a safety incident, and individual accountability plays a key part in keeping people safe in health and care. Further, and understandably, when care has gone wrong, victims and families typically want the truth about what happened. Candour and transparency are key to this. In order to ensure that ‘safe spaces’ approaches address more risks than they create, we recommend that the UK Government should build in a review of the policy and assess how compatible it is with the professional duty of candour. The way forward There have been improvements in health and care regulation, but the patient safety landscape is still fragmented and complex. Concerns often fall between organisations or are left unaddressed due to jurisdiction issues or insufficient powers. Large-scale failures of care still occur frequently, as repeated inquiries testify. That’s why we think a new role is needed to oversee patient safety. The Health and Social Care Safety Commissioners would help to identify current, emerging and potential risks across the whole health and social care system, and bring about the necessary action across organisations. They would also coordinate public inquiries and reviews, and monitor how recommendations are addressed. In the meantime, there is action we, the regulators and registers we oversee, the four UK Governments, workforce bodies, employers, registrant organisations, health and social care services, and education bodies, can take to help make the system safer and more coherent. However, it is essential this is done hand in hand with patients, service users and organisations like Patient Safety Learning. I hope you will read the report and join us in working together towards safer care for all. References NHS Race and Health Observatory. Ethnic Inequalities in Healthcare: A Rapid Evidence Review. February 2022. Atewologun D, Kline R, Ochieng M. Fair to refer? Reducing disproportionality in fitness to practise concerns reported to the GMC. 2019.

With general practice in crisis due to workforce shortages, an increasingly complex workload, rising public expectations, and further pressures caused by the Covid-19 pandemic, The King's Fund are providing the time and space for you to reflect, think differently, share and learn. Join peers and experts from The King’s Fund to explore: what the future of general practice looks like how the experience for patients and staff can be improved how to ensure those actions are building blocks towards the future. This event is for GPs, commissioners, nurses, practice managers, allied health professionals, Additional Roles Reimbursement Scheme (ARRS)-funded roles, and other professionals working in multidisciplinary general practice teams and those responsible for general practice at place or neighbourhood level. Register