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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.

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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The objectives of the Medication Errors Group are aligned with and expand on WHO Medication Safety Objectives as follows: To create opportunities for those researching and investigating medication errors to network in a friendly and mutually supportive environment and disseminate their research using good quality outlets. To support healthcare professionals and/or organizations with scientific evaluation of medication errors and how to prevent them. To promote and develop teaching and education about all aspects of medication errors including their mitigation as part of pharmacovigilance, patient safety and pharmacology curricula. To support regulatory authorities with medication errors guidance evaluation and acting as a neutral bridge with the wider pharmaceutical and healthcare sectors. To organise and/or support training and tutorials to pharmacovigilance centres to further enable their role in detecting medication errors through Individual Case Safety Reports (ICSRs) by using specific methods and tools. Insights from this enhanced detection could lead to signal detection and which may inform on new and/or targeted prevention strategies to reduce medication errors. To provide a neutral and impartial forum for all stakeholders including patients to ask questions related to medication errors and obtain answers within a reasonable timeline. To communicate current activities and provide a forum for discussion and generation of new research and ideas leveraging social media and/or other communication platforms. To interact with the pharmaceutical sector and suggest evidence based solutions that can help prevent medication errors, especially in the case of look-alike and sound-alike medications. Evaluate and where appropriate recommend the need for meetings, education and/or affordable training, such as encouraging abstracts for the Annual Meeting and inputting into ISoP and chapter training meetings.

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.

Definition The authors of this paper have developed a definition, including both a short-form and a long-form definition. Here is the short-form and the long-form can be found in the full paper: Patient and family* engagement in the ICU is an active partnership between health professionals and patients and families working at every level of the healthcare system to improve health and the quality, safety, and delivery of healthcare. Arenas for such engagement include but are not limited to participation in direct care, communication of patient values and goals, and transformation of care processes to promote and protect individual respect and dignity. PFE comprises five core concepts: Collaboration, Respect and Dignity, Activation and Participation, Information Sharing, and Decision Making. Brief summaries of the core concepts are presented in Table 1 and depicted visually in Figure 1. *Family is broadly defined to include all the individuals whom the patient wants involved in his/her care, regardless of whether they are related biologically, legally, or otherwise; if the patient is noncommunicative, health professionals will make their best effort to identify and include the individuals whom the patient would want involved in his/her care.