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The National Action Plan centres on four foundational and interdependent areas, prioritised as essential to create total systems safety, with 17 recommendations to advance patient safety. Culture, Leadership, and Governance 1. Ensure safety is a demonstrated core value. 2. Assess capabilities and commit resources to advance safety. 3. Widely share information about safety to promote transparency. 4. Implement competency-based governance and leadership. Patient and family engagement 5. Establish competencies for all healthcare professionals for the engagement of patients, families, and care partners. 6. Engage patients, families, and care partners in the co-production of care. 7. Include patients, families, and care partners in leadership, governance, and safety and improvement efforts. 8. Ensure equitable engagement for all patients, families, and care partners. 9. Promote a culture of trust and respect for patients, families, and care partners. Workforce safety 10. Implement a systems approach to workforce safety. 11. Assume accountability for physical and psychological safety and a healthy work environment that fosters the joy of the health care workforce. 12. Develop, resource, and execute on priority programmes that equitably foster workforce safety. Learning system 13. Facilitate both intra- and inter-organisational learning. 14. Accelerate the development of the best possible safety learning networks. 15. Initiate and develop systems to facilitate interprofessional education and training on safety. 16. Develop shared goals for safety across the continuum of care. 17. Expedite industry-wide coordination, collaboration, and cooperation on safety.

Allow me to start this essay with a real personal story: more than a decade ago, while I was doing my Transplant & Hepato-Biliary Surgery fellowship in the USA, I had to have elective orthopaedic surgery. The good news was the hospital where I was about to have the surgery was the number one in the US News Ranking for Orthopedics that year. The bad news was that I was literally ‘terrified’ while I was in the pre-op holding area, just before I was wheeled into the operating room! How could that be? Me: the surgeon, terrified of having a straightforward orthopaedic procedure in the number one orthopaedic surgery hospital in the US? The answer was yes. It was precisely for this reason – that I am a surgeon who knew what could go wrong in a clinical unit like the OR and that I was terrified of becoming just another casualty of a medical error! Back in 2016, in their book 'Safer Healthcare', Charles Vincent and Rene Amalberti beautifully articulated the safety levels in hospitals where they classified five levels of care: Level 1: The care envisaged by standards. Level 2: Compliance with standards / ordinary care with imperfections. Level 3: Unreliable care / poor quality, but the patient escapes harm. Level 4: Poor care with probable minor harm but overall benefits. Level 5: Care where harm undermines any benefit obtained. As a practicing healthcare professional (a surgeon), I can, unfortunately, say that the majority of clinical units in hospitals are performing around Level 3 (unreliable care / poor quality, but the patient escapes harm) with fluctuations towards Level 4 (poor care with probable minor harm but overall benefits) for below-average performers or Level 2 (compliance with standards / ordinary care with imperfections) for a very few leading medical centres... sometimes! Patient safety was defined as the absence of harm. I believe it is time to define patient safety using a patient-centric approach where patient safety can be defined as the absence of harm for each patient, by the right person(s), at the right time(s) and the right place(s). Such definition would help us think about a systemic and individual framework to safety, where safety is customised to every patient, all the time, in the backdrop of a safe clinical unit. Last year marked the 20th anniversary of the landmark paper 'To Err is Human'. Although the past 20 years have seen much progress in the understanding of the healthcare safety which helped bridge the knowledge gap in this significant field, we still have a significant implementation and structural gap, which continues to contribute to the ongoing inherently weak safety conditions for patients. The main reason for writing this essay is to say that 20 years after To Err is Human, the majority of hospitals are treading around Level 3 (mediocre patient safety conditions to use layman’s terms!). Such a situation is entirely unacceptable for high-reliability industries like aviation, nuclear, and oil and gas. Fifty to sixty years ago, these industries were not as safe as they are today but reached their watershed moments (tipping point) and had to transform their safety practices. This essay is a call for action to highlight the following: Healthcare continues to be structurally weak when it comes to the safety conditions. This lack of resilience leads to ongoing medical errors and harm to patients. There is an urgent need for us to have a paradigm shift in the way we think about patient safety and how we implement it while providing healthcare. As healthcare systems are complex adaptive systems, the only way to do that is to build resilience in the system. Here are my practical solutions: Adopting co-production principles: co-design, co-delivery and co-assessment. Introducing complementary checklists for both patients and healthcare professionals throughout the patient journey. Safety reconciliation: transition of care or any patient transfer carries potential patient harm – e.g., fall, tubes or IV dislodgement, communication failure with new staff members, such as radiology department technicians, etc. Hence, it is vital that a safety reconciliation is performed by both the patient/families and healthcare professionals (co-production) using checklists. Leveraging implementation science: by introducing safety principles into the day to day clinical practices at the bedside (undergraduate, postgraduate, and board-certified practitioners). Human Factors Engineering (HFE): introducing HFE principles into bedside clinical practice – e.g., effective communication, situational awareness, flat hierarchy and team-based simulated learning – will introduce resilience into the system and help reduce potential harm to patients.

Key points A robust safety culture is the combination of attitudes and behaviours that best manages the inevitable dangers created when humans work in complex environments. Great leaders know how to wield attitudinal and behavioural norms to best protect against these risks. These include: psychological safety – that is, an environment where no one is hesitant to voice a concern and caregivers know that they will be treated with respect when they do) organisational fairness – where caregivers know that they are accountable for being capable, conscientious and not engaging in unsafe behaviour, but are not held accountable for system failures a learning system in which engaged leaders hear patients and front-line caregivers’ concerns regarding defects that interfere with the delivery of safe care, and promote improvement to increase safety and reduce waste. Leaders are the keepers and guardians of these attitudinal norms and the learning system.

Yesterday, Health Service Journal (HSJ) reported that the London Ambulance Service (LAS) NHS Trust is now looking into alternative defibrillators after receiving two warnings from Coroners Prevention of Future Deaths (PFD) reports due to problems with their existing machines.[1] PFD reports are issued when, in the coroner’s opinion, the case they are reviewing requires action to be taken in order to prevent future deaths.[2] Delays in defibrillation The reports in question relate to the deaths of Najeeb Katende in 2016 and Mitica Marin in 2019.[3] In both cases, an issue had occurred when using the LP15 defibrillator, which had been started in ‘manual’ rather than ‘automatic’ mode. This resulted in the paramedic not initially realising the patient had a shockable heart rhythm and led to a delay before the first shock was administered. If the defibrillator had initially been in ‘automatic’ mode it would have detected a rhythm and prompted the paramedic to shock the patient. In the coroner’s report into the death of Mitica Marin, it was noted that LAS had carried out a review of cases of delayed defibrillation with the LP15 and recognised that this specific machine “defaults to manual mode requiring the user to switch to automatic mode before use”.[4] Garrett Emmerson, LAS Chief Executive, noted that they were now taking a series of actions to address this, “including putting warning stickers on the defibrillators and staff refresher training on how to use the machines”.[1] Preventing future deaths While this case focuses a specific safety in use issue concerning the LP15 defibrillator, it also serves to highlight the broader issue we have previously raised at Patient Safety Learning; failure to harness learning from PFD reports. We believe that by learning from PFD reports, patient safety can be improved and the reports can achieve their aim of preventing future deaths.[5] One of our concerns in this regard is that learnings from PFD reports may be applicable beyond the organisation, however at present there appears to be no clear system of sharing learning more widely. We are pleased that LAS has identified this safety issue, however it is vital that this information is now widely shared so others can also take action to manage the risks to patients. If the concerns identified in PFD reports remain in silos, there is a danger that this could reoccur in a different trust. At Patient Safety Learning, we believe there are a number of actions which could be taken to help address the current gaps in the system. Please refer to our previous blog on Learning from PFD reports to see these actions in detail. References 1. HSJ, Patient deaths prompt ambulance chiefs to look for alternative defibrillators, 10 August 2020. 2. The Coroners (Investigations) Regulations 2013, SI 2013/1629. 3. Edwin Buckett, Prevention of Future Deaths Report – Najeeb Katende, 21 April 2017. 4. Graeme Irvin, Prevention of Future Deaths Report – Mitica Marin, 12 March 2020. 5. Patient Safety Learning, Learning from Prevention of Future Deaths reports, 25 February 2020.

It has been a month since the publication of the Cumberlege Report, which detailed the harm that has happened to tens of thousands of patients over many years. Following a 2-year period of gathering evidence, listening to views and deliberation, the report made several important recommendations. Since then, it has generated only modest headlines and within healthcare circles little debate. Has there ever been such an important report that has generated such little discussion and debate following publication? It would be easy and obvious to cite Covid as the reason for this, but surely the current pandemic is all the more reason for the importance of patient safety to be integral to our planning and priorities as we restart and reset services and look to the future. The report made several key recommendations across a number of devices, procedures and drugs. The main themes were to: involve patients more in their care and to listen and take their views seriously move away from a culture of blame so that staff could speak up and voice concerns improve data collection and incident reporting to aid learning provide more support to patients after things have gone wrong better address health inequalities improve leadership and regulation. It is one of several reports in the last 20 years that has considered patient safety scandals and sought to address this persistent and fundamental problem within healthcare. It is not just a UK problem, the OECD estimates 15% of healthcare budgets are spent on harm, much of it entirely preventable, and the remainder on rectifying or compensating for the problems created. Within the Cumberlege report was this quote: "I have to say 20 years later it is very frustrating how little progress we have made. It’s clear to me that we still have not got the leadership and culture around patient safety right. As long as you have that culture of people trying to hide things - then we are not going to win this." Professor Ted Baker, Chief Inspector of Hospitals, CQC At this time of unprecedented change, with an acceleration of acceptance and adoption of innovation and technologies like never before, surely now is the time to bring patient safety to the fore of the debate about how our healthcare services should be run and managed. If it is not deemed important now will it ever truly be important? Or will it remain forever in the camp of “too difficult” to solve? To ensure the safety of patients we should also recognise the need for people and organisations to share learning when they respond to incidents of harm, and when they develop good practice for making care safer. Patient Safety Learning’s the hub plays an important part in this, providing a platform to share resources, stories and good practice for anyone who wants to make care safer for patients. At PEP Health (Patient Experience Platform), we have one of the largest databases of patient comments tracking back to Jan 2018. It covers every hospital in the UK and includes every comment made by patients across social media platforms and online review sites. Our analysis of these comments demonstrates that what patients say matters and that patients provide remarkable insight and perspective. It also highlights that patient experience and patient safety are not two discrete components of “quality” but are closely interwoven and linked. For example, we hear patients commenting on issues such as repeated medicine errors, an inability to access essential services and being provided with either poor or confusing information So, in the spirit of starting some discussion following the Cumberlege report, here are my recommendations and thoughts: Without better, faster data to support change nothing will happen. This data needs to be a balance of quantitative and qualitative data that brings together patient safety, patient experience and the patient voice. A patient safety commissioner can provide leadership but they cannot change the culture alone. After so long trying internally without success, we should now publicise results and be more transparent than ever before. Organisations should be benchmarked and compared against their peers. Greater celebration and promotion should be made of successes. Best practice and learning is too slow to take hold. Teams should not only be encouraged to adopt change but be empowered to make change locally. The patient voice must be taken much more seriously by organisations and clinicians so that in 20 years’ time we are still not publishing reports following scandals with little change to celebrate and few lessons learnt.

This version of the Framework is for: All NHS staff, including all clinical and non-clinical staff and senior leaders, to: provide a clear vision of how to approach feedback and complaints effectively set out how they should approach learning from complaints to improve services. Everyone who provides feedback or makes a complaint about the NHS, and the people who support, advise or advocate for them. It sets out what they can expect to see and experience when doing so. NHS staff who are being complained about. It will make sure they are supported and that the complaint is seen as a learning opportunity rather than a finger-pointing exercise. The Framework is built on the following four principles: Promoting and learning and improvement culture. Positively seeking feedback. Being thorough and fair. Giving fair and accountable decisions.

The Healthcare Safety Investigation Branch (HSIB) published ‘Summary of themes arising from the Healthcare Safety Investigation Branch maternity programme (April 2018-December 2019)’ in February 2020. This described eight themes for further exploration in order to highlight opportunities for system-wide learning; one of these themes was group B streptococcus (GBS). This report, Severe brain injury, early neonatal death and intrapartum stillbirth associated with group B streptococcus infection, highlights a number of patient safety concerns and recommends that maternity care providers should consider the findings and make necessary changes to their local systems to ensure that mothers and babies receive care in line with national guidance. The Healthcare Safety Investigation Branch will keep the theme of group B streptococcus under review and consider a future national investigation to explore this subject further.

Vincent et al. believe that the skillset of patient safety and quality improvement personnel is essential for the successful implementation of the changes required to achieve the desired outcomes. An understanding of systems theory and the complexity of healthcare systems, human factors and reliability theories, and change methodologies is key to the success of any transformation programme. In their paper in the International Journal for Quality in Healthcare, they propose a five-step strategy and actions through which PS and QI staff can meaningfully contribute during a pandemic by employing their core skills to support patients, staff and organisations.

“There's no such thing as the unknown—only things temporarily hidden, temporarily not understood.” James T. Kirk, Captain, Starship Enterprise. Star Trek, Season 1: The Corbomite Maneuver. Leading a large enterprise isn’t easy. Vision, compassion, humility, curiosity and adaptability are required attributes for those in charge to keep moving forward during times of relative calm or uncertainty. The stress and tragedy that accompanies catastrophic events can reduce the resolve and effectiveness of even the most accomplished leaders. Unprecedented large-scale situations, such as the Hurricane Katrina landfall or the September 11th terrorist attacks, reveal gaps in understanding that may not have been apparent before the disaster. These blind spots can dismantle the reserve of a leader and their team to culminate in poor decisions, inaction and organisational dysfunction. The COVID-19 pandemic is such an event. Rules are being mindfully adjusted to respond to the litany of process, clinical, financial and political disruptions healthcare workers must grapple with as they face the uncertain conditions of their patients, communities and themselves. It is incumbent on leaders to create stability by addressing these unknowns. Leaders within hospitals, social care organisations and within the public health spectra need to make immediate process adjustments to optimise effort, realise opportunities for improvement and learn to be resilient. They need to arrive at understanding while simultaneously managing challenges that emerge from the strained system to keep their enterprise on track. They need to do this by paying attention to safety culture, transformation and innovation, and will need tools and resources to do so. Leadership must build a culture to keep patients and workers safe. Leader’s communications and actions are core to the implementation of safe working conditions to provide the best care possible during a crisis. Yet, a Gallup poll of US healthcare workers found a lack of understanding of their organisation’s COVID-19 plan and lack of belief that safety policies in place will support their safe return to work. To address this gap, experts recommend leaders three steps to a better safety culture: use formal and informal mechanisms to explicitly communicate what the organisation is doing to keep staff informed and safe during the pandemic enlist their managers to implement policies, create opportunities to align the work of management and hold managers accountable to implement and sustain current practice and procedure talk to their people. Keeping an open dialogue through the use of established mechanisms such as ‘rounding’ can solicit insights and raise concerns to enhance the safety of teams and patients. Leadership must see opportunities to transform systems: COVID-19 has presented leaders with immense responsibility to act, adjust quickly as required and use those process changes to improve the overall system of care post-pandemic in preparation for the next unprecedented challenge. Geisinger Health System leaders in their article, 'How one health system is transforming in response to Covid-19' share the experience of designing their emerging COVID response to reliably innovate rather than only react. Leaders examined core system business concerns such as pharmacy and information technology by bringing together multidisciplinary groups that dismantled silos. Teams worked together using scenario planning to fully consider how restoring care processes, entering new work phases, preparing for the second wave and restoring financial viability would affect patients and employees. Leadership must use evidence and collective knowledge to adapt: The Journal of Public Health and Management Practice shares recommendations for leaders to meet COVID-19 stressors successfully. The article suggests leaders communicate well, be decisive, lead without hierarchy, remain proactive and take care of themselves to protect others. For example, to lead across a system seek expertise from a variety of organisational and environmental elements. Working with government officials, staff and peers can form collaborations, solidify shared purpose and distribute responsibility to serve a community well in crisis. Public health is a core partner in understanding how to guide, motivate and inspire change to enhance a collective response to COVID-19 and upcoming health threats. Clinicians in patient-facing leadership roles also exhibit these behaviours as their roles shift to manage crisis. The perspective of a New York cardiologist leading a COVID-19 infections disease service illustrates how the transfer of tacit knowledge around deliberate leadership observed daily while coordinating the service shaped his views on leadership and his ability to lead. Being emotionally available was a core characteristic that helped to express grief, exhibit vulnerability and openly share concerns, giving the experience the humanness it needed. This was important not only in his ability to mature as a leader but to demonstrate the empathy needed to get his team through the challenges at hand. James T Kirk knew how to lead. He sought consensus, learned from mistakes, yet acted as necessary to keep his crew safe, engaged and aligned with the organisational mission. He sought partners across the federation as needed. Kirk could be firm, decisive, yet empathetic. Have health leaders done similarly to protect staff, patients and the community, while gaining experience during COVID-19 to apply over time to enrich the care system at large and boldly go to a better, safer future?

Practical guidance on the application of human factors in the investigation process is presented. Nine principles for incorporating human factors into learning investigations are identified: 1. Be prepared to accept a broad range of types and standards of evidence. 2. Seek opportunities for learning beyond actual loss events. 3. Avoid searching for blame. 4. Adopt a systems approach. 5. Identify and understand both the situational and contextual factors associated with the event. 6. Recognise the potential for difference between the way work is imagined and the way work is actually done. 7. Accept that learning means changing. 8. Understand that learning will only be enduring if change is embedded in a culture of learning and continuous improvement. 9. Do not confuse recommendations with solutions.