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The CQC strategy is built on four themes that together determine the changes they want to make. Running through each theme is CQC's ambition to improve people’s care by looking at how well health and care systems are working and how they’re acting to reduce inequalities. It is not enough to look at how one service operates in isolation. It is how services work together that has a real impact on people’s experiences and outcomes. The four themes in our draft strategy are: People and communities: CQC want their regulations to be driven by people’s experiences and what they expect and need from health and care services. They'll focus on what matters to the public, and to local communities, when they access, use, and move between services. Smarter regulation: CQC want their assessments to be more flexible and dynamic. They'll be updating ratings more often, so everybody has an up-to-date view of quality. Being smarter with data means our visits will be more targeted, with a sharper focus on what they need to look at. Safety through learning: CQC want all services to have stronger safety cultures. They’ll expect learning and improvement to be the primary response to all safety concerns in all types of service. When safety doesn’t improve, and services don’t learn lessons, CQC will take action to protect people. Accelerating improvement: CQC want to do more to make improvement happen. They’ll target the priority areas that need support the most. They want to see improvement within individual services, and in the way they work together as a system to make sure people get the care they need. You can read the full strategy in the link below where you will find an online form to respond. Responses by 5.00pm on Thursday 4 March 2021.

Last week the UK Government confirmed that it would accept one of the key recommendations in the First Do No Harm report, published earlier this year by the Independent Medicines and Medical Devices Safety Review (more commonly known as the Cumberlege Review). Nadine Dorries MP, Minister for Mental Health, Suicide Prevention and Patient Safety, was quoted as saying that this would be tabled as an amendment to the Medicines and Medical Devices Bill.[1] This announcement has been welcomed by the Review’s Chair, Baroness Julia Cumberlege, and members of the newly formed All-Party Parliamentary Group for First Do No Harm, which has recently been set up to raise awareness and build support for the implementation of the Review’s recommendations.[2] But what this role will look like in practice, and what impact will it have on patient safety? What was proposed by the Cumberlege Review? The Cumberlege Review examined how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices.[3] It focused on three specific medical interventions: Hormone pregnancy tests, Sodium valproate and Pelvic mesh implants. Its report, published in July this year, set out the shocking scale of avoidable harm that resulted from these three interventions over a period of decades. It made a series of recommendations and actions for improvement, the second of which was: “The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.”[3] The Review envisioned this role as sitting outside of the existing healthcare system with “a direct line of accountability to Parliament through the Health and Social Care Select Committee”.[3] It explained that the Commissioner should focus on two aims: Promoting and improving patient safety. Promoting the views and interests of patients and other members of the public in relation to the safety of medicines and medical devices. Independence, aims and resourcing The Cumberlege Review includes in an appendix with further information about how a Patient Safety Commissioner for England would work in practice, providing suggestions on its powers, appointment, accountability, and organisational structure. Until we see more details following the passing of the Medicines and Medical Devices Bill into law, the extent to which these suggestions will be adopted remains an unclear. Some elements that we think are essential are: 1) Independence The Patient Safety Commissioner must be independent of those funding and delivering healthcare and free to speak their mind without fear or favour. The Review suggests the Commissioner should be appointed by the Privy Council and funded by the Cabinet Office, maintaining a level of separation from the healthcare system. This is to be welcomed, especially as other Commissioners do not always that degree of independence. For example, this is not the case in the role that this proposal draws much inspiration from, the Children’s Commissioner, who is directly appointed by the Secretary of State for Education and funded by their Department. 2) Aims The First Do No Harm report states that the Patient Safety Commissioner should aim: “… to improve identification of systemic safety issues and to improve the system’s coordinated response. Through a renewed focus on patients’ needs and a drive for cooperation and coordination, the Commissioner will help to release the wider benefits for the healthcare system from individual organisations’ safety improvements.”[3] This is a welcome ambition, but is it achievable? The Commissioner’s main role is promoting the rights of patients. This must be more than just listening and promoting. The Commissioner should be able to recommend and/or lead inquiries and reviews. This is a recommendation that we believe is essential to turn words into action and we would strongly commend the Government to agree to this in its response. 3) Resourcing The healthcare system, or broader health and social care systems depending on the Commissioner’s final remit, is incredibly complex. The Commissioner’s Office will need to be properly resourced to enable it to: Listen to the many individual patients and patient groups who will want to raise their concerns. Engage with regulators, providers, commissioners, policy makers and the very many stakeholders in health and social care. Engage with and influence the media. Resources must be made available to the Commissioner to support their remit. This will prove to be instrumental as to whether they are able to achieve their objectives. 4) Collaboration with patient safety groups and networks While the role of the Patient Safety Commissioner will be a new one, there are already a diverse range of groups outside of the NHS that can provide a helpful source of knowledge, insight, information, and support. By bringing these organisations into a network, the Commissioner could amplify the voices of many already actively promoting patient safety. By no means an exhaustive list, but this could include: AvMA, The Patients Association, Healthwatch, Care Opinion, patient campaigning groups and of course, Patient Safety Learning. Our free knowledge sharing platform for patient safety, the hub, could provide valuable resources and a community forum for listening to patients’ voices. The need for system-wide change We believe that a well-resourced Patient Safety Commissioner could play a vital part in improving patient safety in England. The Commissioner must have the resources and powers to influence change. It will not be sufficient for the Commissioner to raise patients’ concerns if the healthcare system is not compelled to listen and respond. We consider that the Commissioner alone will not be able to bring about the fundamental change that is required to tackle unsafe care and empower patients. What is required is a step change in how we support and engage patients in patient safety and how the health care system transforms itself to put patient safety at its core. Many of these changes are needed throughout the health and social care system, from the bottom up. We describe the action that is needed in our report A Blueprint for Action and highlight 6 foundations for safer care that are urgently needed.[4] Another one of the recommendations of the Cumberlege Review was to establish a task force to implement its findings. If we are to make the wide-ranging changes needed for safe care, we believe that any such task force needs to look at patient safety issues beyond this report. Such a task force should include recommendations made by other major patient safety reports, such as: Recent reports by the Care Quality Commission, including Opening the door to change: NHS safety culture and the need for transformation, Out of sight – who cares? Restraint, segregation and seclusion review and CQC Inspections and regulation of Whorlton Hall: second independent report.[5] [6] [7] Report of the independent Inquiry into the issues raised by Paterson.[8] Ockenden Report: Emerging Findings and Recommendations from the Independent Review of Maternity Services at the Shrewsbury and Telford Hospital NHS Trust.[9] The Life and Death of Elizabeth Dixon: A Catalyst for Change.[10] Implications for devolved health and social care One final notable issue posed by the commitment of the Government to establish a Patient Safety Commissioner for England is how this will work within the devolved health and social care system across the UK. The Scottish Government announced in September that they would be seeking to establish such as role, confirming this in a subsequent parliamentary debate.[11] [12] However at this time it is unclear whether these arrangements will be replicated across each of the four nations. In Wales, the Government is yet to issue a formal response on the Cumberlege Review’s recommendations, indicating in a recent response to a parliamentary question that they were still considering this.[13] Meanwhile in Northern Ireland, at the end of November the Minister for Health Robin Swann MLA stated in a Assembly debate that this was one of a number of issues being considered by a working group looking at the Cumberlege Review’s recommendations.[14] This was not an issue for the Cumberlege Review to consider, with its remit specifically concerning England. However, thought needs to be given as to how multiple Patient Safety Commissioners may interact and work together, or how this might work in practice if some parts of the UK are covered by such a Commissioner and others are not. There would be likely be significant common ground between the different Commissioners, resulting from similarities in healthcare provision across the UK. If significant patient safety issues who identified by one nation, there would be a value in ensuring a significant degree of coordination is in place to ensure that similar issues are not missed in other parts of the country. References Health Service Journal, Government finally accepts need for ‘independent’ national patient safety commissioner, 17 December 2020. APPG for First Do No Harm, Homepage, Last Accessed 21 December 2020. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. Care Quality Commission, Opening the door to change: NHS safety culture and the need for transformation, December 2018. Care Quality Commission, Out of sight – who cares? A review of restraint, seclusion and segregation for autistic people, and people with a learning disability and/or mental health condition, October 2020. Care Quality Commission, CQC Inspections and regulation of Whorlton Hall: second independent report, 15 December 2020. The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Emerging findings and recommendations form the independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, 10 December 2020. Dr Bill Kirkup CBE, The Life and Death of Elizabeth Dixon: A Catalyst for Change, November 2020. The Life and Death of Elizabeth Dixon: A Catalyst for Change - November 2020 (publishing.service.gov.uk) Scottish Government, Protecting Scotland, Renewing Scotland: The Government’s Programme for Scotland 2020-2021, 1 September 2020. Scottish Parliament, Official Report: Meeting of the Parliament, Session 5, 8 September 2020. Senedd Cymru – Welsh Parliament, Written Question 81592, 26 November 2020. Northern Ireland Assembly, Official Report, 30 November 2020.

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In May 2019, the World Health Assembly recognised patient safety as a key health priority, acknowledging the need to “take concerted action to reduce patient harm in healthcare settings”.[1] They asked the World Health Organization (WHO) to formulate an action plan to help improve patient safety, resulting in the first draft Global Patient Safety Action Plan 2021-2030, published for consultation in August 2020.[2] Patient Safety Learning is pleased to have contributed to the development of this global initiative, with our Chief Executive, Helen Hughes, having attended the initial consultation sessions earlier this year.[3] [4] At the end of September, we responded to the WHO with our feedback on the first draft. Here is a summary of that feedback. The WHO Global Patient Safety Action Plan Patient safety is an issue which impacts all countries, with the WHO estimating that unsafe care is one of the 10 leading causes of death and disability worldwide.[5] In high income countries, as many as one in 10 patients are harmed while receiving hospital care.[5] In low- and middle-income countries, the impact is even greater, with poor quality care estimated at accounting for 10-15% of total deaths, some 2.6 million deaths annually.[6] We welcome, therefore, the WHO’s focus on patient safety as a global priority, along with its vision of a “world in which no patient is harmed in health care, and everyone receives safe and respectful care, every time, everywhere”.[2] It sets out its goal as achieving the maximum possible reduction in avoidable harm as a result of unsafe care.[2] To help achieve this goal, the Action Plan outlines a set of guiding principles: Treat patients and families as partners in safe care. Achieve results through collaborative working. Analyse data and experiences to generate learning. Translate evidence into measurable improvement. Base policies and action on the nature of the care setting. Use both scientific expertise and stories of care to educate and advocate. These principles closely align with our six foundations for safe care that are needed to progress towards a patient-safe future, as we argue in our evidence-based report A Blueprint for Action.[7] The Action Plan subsequently goes on to outline seven strategic objectives which provide a framework for achieving its goal. Each objective is underpinned by specific strategies with accompanying actions for the WHO, governments, healthcare organisations and key stakeholders. Tackling the implementation gap and sharing learning A key issue that the Action Plan identifies as a barrier to making patient safety improvements is what it describes as the “knowing-doing” gap, known elsewhere as the “implementation gap”.[8] There are many examples where a team, organisation or even country may be implementing patient safety solutions, but this good practice or successful measure is siloed within that team, organisation, or country. Patients will then continue to experience harm from problems, despite successful solutions already in existence elsewhere. At Patient Safety Learning, we see the shared learning for patient safety as a vital means of tackling this ‘knowing-doing’ gap. We feel that the Action Plan could place a stronger emphasis on shared learning more widely, both by the WHO and between member states, stressing the importance of disseminating good practice and patient safety knowledge. As an example, where the WHO proposes that governments should publish an independently audited annual report on patient safety performance, we believe an additional action is needed, specifically that the WHO should collate these national reports and share their findings on annual basis. There would be huge value in seeing what progress member states are making and this would support active networking and collaboration. We are helping to tackle the knowing-doing gap with the hub, our platform to share learning for patient safety. We would be happy to share our experience and collaborate with the WHO in sharing learning to improve patient safety. Building high reliability health systems and organisations The Action Plan notes that a key safety success factor in other high-risk industries is “the emphasis placed on preventing accidents, harm and mistakes that have serious consequences”.[2] Related to this it sets a strategic objective focused on the creation of High Reliability Organisations in health, that are able to operate in complex circumstances where there are significant risks without serious accidents or catastrophic failures.[9] Such organisations “cultivate resilience by relentlessly prioritising safety over other performance pressures”.[9] We strongly agree with this approach, which aligns with our belief that patient safety should not simply be another priority but part of the purpose of health and social care. In our feedback, we noted that it is vital to also account for the role of Health IT (HIT) systems in making patient safety core to health and social care. Failure to do so can, under certain conditions, lead to patient harm. In the design, development and use of new technologies, patient safety should be embedded into all stages of the process, helping to reduce errors in healthcare and ultimately saving lives. We made the case in our feedback that the Action Plan should include guidance around the use of healthcare technology assessment and safety risk management when making decisions about the use of new IT systems.[10] This guidance would need to include steps to ensure that organisations have specific safety guidelines and tools for the use of HIT, and publicly available examples of HIT safety cases. Included in these steps should be the assessment of patient safety risks when introducing any changes, whether technology, operational or process changes. Working with partners to bring about change The Action Plan rightly emphasises the importance of working with stakeholders - beyond those charged with the delivery of health and social care - to improve patient safety and staff safety. We believe the following groups should also be considered as essential partners: Trade Unions - bodies that represent health workers have a key role to play if we are to ensure that patient safety considerations are at the core of healthcare. Ensuring the safety of health workers is intrinsically linked to making improvements to patient safety.[11] Human Factors/Ergonomics professionals - collaboration with these individuals will be particularly important in making the changes needed, as set out in the Action Plan’s Strategic Objective 2, to build high reliability health systems. Included in this group should be both experts in this area working in healthcare and those from other industries who are able to contribute their experiences and expertise. International Development organisations - the relationship between international development and patent safety is an underexplored area, worthy of further work. As such, we believe that Non-Governmental Organisations involved in development work should also be included on the stakeholders list. How do we create a global patient safety movement? Much of the focus of the Action Plan understandably centres on work that can be done by governments, healthcare organisations and the WHO to improve patient safety. To achieve the scale of change needed, however, Patient Safety Learning believes we also need to develop and support a social movement for patient safety. In early initial discussions about the Action Plan, Sir Liam Donaldson, WHO Envoy for Patient Safety, noted this, emphasising the value and impact of mobilising public pressure to deliver change. He also deemed it essential that we learn from past campaigns that have succeeded.[3] How do we start such a social movement? It is a difficult question, but we believe a key consideration is the democratisation of healthcare systems and the role of co-production with patients. This will mean overcoming some of the fears that exist around working in equal partnership with patients and avoiding the trap where patients can become ‘insiders’. Patients, families and carers need to be an effective independent voice for change. References 1. WHO, World Health Assembly Update, 25 May 2019. 2. WHO, Global Patient Safety Action Plan 2021-2030, 28 August 2020. 3. Patient Safety Learning, Developing the next Global Patient Safety Action Plan - Part 1, 6 March 2020. 4. Patient Safety Learning, Developing the next Global Patient Safety Action Plan - Part 2, 16 March 2020. 5. WHO, Patient Safety Fact File, September 2019. 6. National Academies of Sciences, Engineering and Medicine, Crossing the Global Quality Chasm: Improving Health Care Worldwide, 2018. 7. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. 8. Suzette Woodward, Patient safety: closing the implementation gap, 30 August 2016. 9. Agency for Healthcare Research and Quality - Patient Safety Network, High Reliability, 7 September 2019. 10. Health technology assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making. WHO, Medical devices: Healthcare technology assessment, Last Accessed 13 October 2020. 11. Patient Safety Learning, Why is staff safety a patient safety issue?, 3 September 2020.

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Patient Safety 35. We affirm that patient safety is a global health priority that deserves urgent attention and concerted action, particularly in the context of the additional strains on health systems as a result of the COVID-19 pandemic. We recognise patient safety as one of the significant cornerstones for achieving UHC and SDGs. The principle of "first do no harm" is a fundamental element to providing quality healthcare and services. We are committed to strengthening the international coordination of initiatives and platforms to improve patient safety through quality of care and people-centered strategies that empower individuals and healthcare professionals, expand the frame of primary healthcare and the role of patients in improving care and engage communities. We are also committed to advancing research to demonstrate the benefits of investing in patient safety interventions that can be implemented in an appropriate and sustainable way. Patient Safety should be emphasized in all types of health care delivery, including the use of digitalization in health services. We are committed to increase patient safety culture awareness with continuous training for all healthcare providers, particularly in primary healthcare. 36. We recognize that patient safety will reinforce the efforts to address health disparities, in particular, promoting the safety of patients in positions of vulnerability, such as mothers, newborns, children, adolescents, elderly patients, persons with disabilities, and those facing emergencies and extreme adversities. 37. With the aim to support the implementation of the resolution adopted by the 72nd World Health Assembly in May 2019, "Global Action on Patient Safety," (WHA 72.6) and the Jeddah and Tokyo Declarations on patient safety, we welcome the establishment of a Global Patient Safety Leaders Group. The purpose of this Group is to bridge implementation gaps through system-level solutions, global shared platforms for reducing patient safety risk and increasing learning, and locally applicable innovative solutions. This can be done by adapting evidence-based practices from high-reliability industries (e.g. aviation, nuclear, gas and oil) and human factors engineering to improve patient experience and engagement as well as enhance workforce training and education in patient safety. Patient safety actions will also support efforts in relation to COVID-19 outbreak and other emerging health care threats, such as addressing risks of nosocomial transmission and unwarranted medication, need for infection prevention and control measures, and protecting healthcare workers from infection, and gearing up for healthcare facilities to provide for healthcare worker safety and meet the required minimum standards for hygiene and infection prevention and control (i.e. UNICEF WASH/ Health program). Accordingly, the Group will promote global advocacy for patient safety. 38. The Group will produce a progress report for the member states and relevant International Organizations. It is comprised of patient safety experts nominated by member and non-member countries, on a voluntary basis. The Group will also have representatives from high-reliability industries and relevant International Organizations. 39. The Group will have one eminent Chairperson who has been a leading voice in the global patient safety agenda and two deputy chairs: one from the World Health Organization and another from the Kingdom of Saudi Arabia. The Group's initial term will be five years with the possibility of renewal based on consensus and recommendations from the members, and, beyond the current year, will continue as an independently

Take home messages and a call for action Over the course of two days debate many issues were raised and important messages sent out. These included the following: WHO Chief Scientist Soumya Swaminathan and the International Federation of Pharmaceutical Manufactures (a non-State Actor in Official Relationship with WHO) reassured patients that all WHO Member States and all of the pharmaceutical industry are cooperating and sharing knowledge and resources as never before. Strengthening health systems, especially primary health is a priority to lead the effort to vaccinate 8 billion people over a short time span. Patient engagement is vitally important here to address both the infodemic and vaccine hesitation, and help ensure vulnerable patients are vaccinated quickly When effective vaccines come on stream regulators such as the FDA and EMA must maintain their strong stance on patient engagement and co-creation of guidelines and the African Medicines Agency should adopt the same approach The World Health Organization’s Global Action on Patients Safety and the WHO Flagship Decade of Patient safety 20200-30 be integrated into all covid-19 control systems and the full spectrum of healthcare Patient engagement and co creation in health systems must be formalised by legal and policy means.