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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.

Content includes: Patient Safety: We’ve Come a Long Way National Patient Safety Consortium: Learning from Large-Scale CollaborationPatient Engagement in a Large-Scale Change Initiative: “As Safe as Possible, as Soon as Possible” Commentary: Three Ideas About “Post-Vention” Patient Safety Never Events: Cross-Canada Checkup Empowering Patients: 5 Questions to Ask About Your Medications Accelerating Post-Surgical Best Practices Using Enhanced Recovery After Surgery Patient Safety Culture Bundle for CEOs and Senior Leaders Commentary: We Must Look at Multiple Perspectives Homecare Safety Virtual Quality Improvement Collaboratives Commentary: Patient Safety in the Home Measuring and Monitoring Healthcare-Associated Infections: A Canadian Collaboration to Better Understand the Magnitude of the Problem Patient Safety: Patient Involvement Matters.

In our recent blog Analysing the Cumberlege Review; Who should join the dots for patient safety? we identified a number of key patient safety issues which were reflected in the Review’s findings. One theme running throughout the Review was a lack of support for patients after incidents of unsafe care, particularly around patient complaints. Why are complaints important for patient safety? Complaint processes are often viewed in a negative light, with patients and families not being recognised as playing a ‘primary source of learning for safety’.[1] Too often, processes are variable in their quality and are insensitive and adversarial, frustrating patients further and causing additional harm. Review findings The Review reflects on the complexity of the complaints system in health acting as a significant barrier to patients raising concerns, highlighting issues around: 1) Difficulties navigating the system – the Review notes that they have heard from many patients who “have expressed their frustration at the lack of a clear pathway for them to make a complaint or raise concerns about aspects of their care”.[2] They note that the length of time this can take, all while patients are living with complications from their original complaint, results in some patients describing themselves as being “broken” by this experience.[3] 2) Failure to listen – another issue cited was dissatisfaction with the complaints system itself. The Review notes that complainants feel that they are being treated unfairly during the process. It expressed concerns that this could discourage patients from making complaints again, reinforcing a “culture of denial and resistance to acknowledging mistakes”.[4] 3) Time limits – the Review raises the issue that “where there is a pattern of complaints relating to an individual doctor that spans years, these restrictions mean older complaints are not investigated by the GMC”.[5] Investigations into clinical matters by the GMC are limited to the event taking place within five years of the allegation. The Review notes that this may risk prevent exposing “a pattern of poor practice” where complaints relating to an individual doctor may span a number of years.[6] There is a significant amount of literature on complaints in healthcare. Earlier this year, Healthwatch published a report looking at complaints processes in the NHS, finding inconsistent local reporting and a focus on counting complaints rather than demonstrating learning.[7] The Paterson Inquiry in February also highlighted concerns about this, noting that “while there were differences in the way patients complained in the NHS and the independent sector and how they escalated their complaints, the response was inadequate in both sectors”.[8] What needs to be done to improve complaints processes? The Cumberlege Review suggests some specific recommendations around complaints processes, including: Patients across the NHS and private sector must have a clear, well-publicised route to raise their concerns about aspects of their experiences in the healthcare system.[9] All organisations who take complaints from the public should designate a non-executive member of the board to oversee the complaint-handling processes and outcomes, and ensure that appropriate action is taken.[10] The Parliamentary and Health Service Ombudsman (PHSO) are currently working to develop a Complaints Standards Framework to provide a “shared vision for NHS complaint handling”.[11] In their proposals for public consultation, they suggest an effective complaint handling system is one that: promotes a learning and improvement culture positively seeks feedback is thorough and fair gives a fair and accountable decision [12]. At Patient Safety Learning, we concur with these points and think it is vital that we have systems where harm is properly investigated and where learning is applied to prevent future harm. Further to the PHSO’s suggestions, we believe that it is important that learning from complaints processes is shared widely and feeds directly into the actions taken. Organisations should be able to demonstrate how complaints have been acted on, and resulted in, improvements. What are your thoughts on this issue? Are you a patient or member of staff who has had a negative or positive experience of the complaints process. Do you have examples of good practice that we can share? Let us know in the comments below. References 1. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. https://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=20190701143409 2. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf 3. Ibid. 4. Ibid. 5. Ibid. 6. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf 7. Healthwatch, Shifting the mindset: A closer look at hospital complaints, January 2020. https://www.healthwatch.co.uk/sites/healthwatch.co.uk/files/20191126%20-%20Shifting%20the%20mindset%20-%20NHS%20complaints%20.pdf 8. The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf 9. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf 10. Ibid. 11. PHSO, Have your say in shaping the future of NHS complaint handing, Last Accessed 17 July 2020. https://www.ombudsman.org.uk/csf 12. PHSO, Complaint Standards Framework: Summary of core expectations for NHS organisations and staff, Last Accessed 17 July 2020. https://www.ombudsman.org.uk/sites/default/files/Complaint_Standards_Framework-Summary_of_core_expectations%20.pdf

You can find out more about the Conquer Silence campaign and download a Communications Toolkit for Healthcare Providers and Leaders via the link below.

Topics include: reasonable adjustments for people with learning difficulties and autism when they come into hospital hospital gowns and how it may make some people feel patient engagement online support groups.

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.

The report suggests that it’s time for a fresh look at how we evaluate and capture patient experience. While there is no shortage of measures of ‘patient experience’, they tend to measure the performance of the system. Few truly start from the patient’s perspective and illuminate what being a patient is like. Nor are they reliable drivers of improvement in the health and care system. Being A Patient investigated possible new approaches to capturing patient experience, which go beyond the traditional model of evaluating the experience of receiving care, and instead consider the experience of living with a health or care need. So far we have suggestions for possible new factors to consider, including the nature of a person’s illness and its impact on their life. This report completes the first stage of the patient experience programme.

“After he died, the little plastic ID band that was around his tiny wrist should have been slipped onto mine. There was nothing more that could have been done for him, but there was plenty that needed to be done for me. I needed an infusion of truth and compassion. And the nurses and doctors who took care of him, they needed it too." Leilani Schweitzer[1] When someone is hurt, it is reasonable to expect the healthcare system to provide care to alleviate symptoms or to cure. It is also reasonable to expect those providing the care to be adequately trained and supported to do so. Yet, when harm is caused by healthcare, the spectrum of harm suffered is not well understood, care needs are not fully recognised and, therefore, the care needed to facilitate optimum recovery is not being provided.[2] In fact, with outrageous frequency, at a time when exceptional care is so desperately needed, those hurting describe how they are further harmed from ‘uncaring’ careless and injurious responses. Healthcare harm is a ‘double whammy’ for patients Healthcare harm is a ‘double whammy’. There’s the primary harm itself – to the patient and/or to those left bereaved – but there is also the separate emotional harm caused specifically by being let down by the healthcare professionals/system in which trust had to be placed.[3] This additional emotional harm has been described as being the damage caused to the trust, confidence and hope of the patient and/or their family.[4] Trust – you rely on professionals to take responsibility for what you cannot do yourself. Confidence - you believe that the system will protect you from harm. Hope – you have the conviction that things will turn out well. Anderson-Wallace and Shale[4] For the patient and family to be able to heal from healthcare harm, appropriate care must be provided not only for the primary injury and any fall out from this, but also this additional emotional injury (being let down by healthcare) and any fall out from that. For example, a parent who loses a child as a result of failures in care will need help to cope with the loss of their child and all of the processes that occur as a result. But they will also need support to cope with having had to hand over responsibility for their child’s safety to healthcare professionals, only to be let down, and all the feelings and processes associated with that. Much needs to happen to restore that parent’s trust, confidence and hope in our healthcare system and the staff within it. This is different to the parent of a child who has passed away from an incurable illness despite exemplary healthcare. A parent let down by healthcare has specific additional care and support needs that need to be met to help them cope and work towards recovery. Healthcare harm also causes emotional harm to the staff involved In 2000, Albert Wu introduced the phrase ‘second victim’ in an attempt to highlight the emotional effects for staff involved in a medical error and the need for emotional support to help their recovery.[5] The term has recently been criticised, since families should be considered the second victim,[6] and the word victim is believed “incompatible with the safety of patients and the accountability that patients and families expect from healthcare providers.”[7] While the term itself may be antagonistic, or misrepresentative, the sentiment – that staff involved in incidents need support to cope with what has happened, and to give them the confidence to do what is needed to help the patient/family heal – certainly stands. When staff are involved in an incident of patient harm, they may lose trust in their own ability and the systems they work in to keep patients safe, and they may worry about their future.[5],[8] They need care and support in order to recover themselves and, crucially, so that they feel psychologically safe and are fully supported to be open and honest about what has happened. They need to feel able to do this without fearing personal detrimental consequences for being honest, such as unfair blame or a risk to their career. This is essential to the injured patient/family receiving the full and truthful explanations and apologies they need in order to regain trust, confidence and hope, and, ultimately, to heal as best they can. So, in addition to patients and families there should be a ‘care pathway’ for staff involved in incidents of harm. A google search on ‘second victim’ reveals a wealth of research on the emotional effects of medical error for staff involved and the best ways to provide support for this, and this is resulting in the emergence of staff support provision to aid recovery.[9] In contrast, very little research has been done into the emotional effects and support needs of families and patients. How is ‘care’ for emotional harm given? The ‘treatment’ of the emotional harm has been described as ‘making amends’ – by restoring trust, confidence and hope.[4] Once a patient has been harmed by healthcare, every interaction (physical, verbal or written) they have with healthcare after that will either serve to help them heal or to compound the emotional harm already suffered. Trew et al.[10] describe harm from healthcare as a “significant loss” and conclude that “coping after harm in healthcare is a form of grieving and coping with loss”. In their model, harmed patients and families proceed through a ‘trajectory of grief’ before reaching a state of normalisation. Some can move further into a deeper stage of grief and seemingly become stuck in what is referred to as complicated grief. They can display signs of psychiatric conditions "if there are substantial unresolved issues, or where there is unsupportive action on the part of individuals associated with the healthcare system and the harm experience”. At the point of the harmful event, the patient/family experiences losses, including a drop in psychological wellbeing. From this point on, healthcare staff and organisations have opportunities to respond. If the response is supportive it may be helpful for the patient/family in coping with the losses. If the response is not supportive, this may cause ‘second harm’ complicating the healing process, leaving the patient/family with unresolved questions, emotions, anger and trust issues. The patient’s psychological wellbeing and ability to return to normal functioning are severely affected. “Most healthcare organizations have proved, in the past at least, extraordinarily bad at dealing with injured patients, resorting at times, particularly during litigation, to deeply unpleasant tactics of delay and manipulation which seriously compounded the initial problems. My phrase ‘second trauma’ is not just a linguistic device, but an accurate description of what some patients experience.” Charles Vincent[11] There is no shortage of individuals who have suffered extensive ‘second harm’ sharing their experiences in the hope this will lead to better experiences for others and some help for themselves to recover. Many are, wrongly, being ‘written off’ as historical cases that can no longer be looked at. This cannot be right – when these people are suffering and need appropriate responses to heal their wounds. The extent of suffering that exists now, in people who have been affected by both primary trauma and then second harm from uncaring defensive responses, or responses that have not taken into account the information patients and families themselves have, or relevant questions they ask, is no doubt nothing short of scandalous. There is a pressing urgency for the NHS to stop causing secondary trauma to affected patients and families. ‘Patient safety’ has to start applying to the harmed patient and their family members’ safety after an adverse event, and not just focus on preventing a repeat of the event in the future. Yes, future occurrences must be prevented, learning is crucial, but so is holistically ‘looking after’ all those affected by this incident. If they are not looked after, their safety is at risk as their ability to heal is severely compromised; in fact they are in danger of further psychological trauma. These same principles apply to affected staff. Avoiding second harm: what happens now and what is needed? This series of blogs will highlight that every interaction a harmed patient or family member has with staff in healthcare organisations (not just clinical staff) after a safety incident should be considered as ‘delivery of care’. With this view, the ‘care interaction’ should be carried out by someone trained and skilled and supported to do so, with the genuine intention of meeting the patient/families’ needs and aiding the patient/family to recover and heal (restore trust, hope and confidence). The interaction / response must not cause further harm. Stress or suffering, and the content of the interaction, for example a letter, should not have been compromised, as often occurs, by competing priorities of the organisation to the detriment of the patient/family. Thus, these blogs will look at: The processes that occur after an incident of harm (Duty of Candour, incident investigation, complaint, inquest) with the aforementioned focus. The care the patient and family need and the obligation (that ought to exist) to meet that need. Processes that are core to the package of ‘care’ to be provided to the harmed or bereaved and to be delivered by skilled and supported ‘care providers’. The blog series will seek to show that meaningful patient engagement in all of these processes is crucial for restoring trust, confidence and hope; therefore, aiding healing of all groups in the aftermath of harm. “It is important to respect and support the active involvement of patients and their families in seeking explanations and deciding how best they can be helped. Indeed at a time which is often characterised by a breakdown of trust between clinician and patient, the principle of actively involving patients and families becomes even more important.” Vincent and Coulter, 2002[3] It will also consider the additional care and support needs that might need to be met alongside these processes in a holistic package of care, such as peer support, specialist medical harm psychological support and good quality specialist advice and advocacy. It will describe what is currently available and what more is needed if healthcare is to provide adequate care for those affected by medical error in order to give them the best chance of recovery. Alongside this, the needs of the staff involved will also be considered. We welcome opinion and comments from patients, relatives, staff, researchers and patient safety experts on what should be considered when designing three harmed patient care pathways: for patients, families and staff. What is the right approach? What actions should be taken? How can these actions be implemented? What more needs to be done? Join in the discussion and give us your feedback so we can inform the work to design a harmed patient care pathway that, when implemented, will reduce the extra suffering currently (and avoidably) experienced by so many. Comment on this blog below, email us your feedback or start a conversation in the Community. References 1. Leilani Schweitzer. Transparency, compassion, and truth in medical errors. TEDxUniversityofNevada. 12 Feb 2013. 2. Bell SK, Etchegaray JM, Gaufberg E, et al. A multi-stakeholder consensus-driven research agenda for better understanding and supporting the emotional impact of harmful events on patients and families. J Comm J Qual Patient Saf 2018;44(7):424-435. 3. Vincent CA, Coulter A. Patient safety: what about the patient? BMJ Qual Saf 2002;11(1):76-80. 4. Anderson-Wallace M, Shale S. Restoring trust: What is ‘quality’ in the aftermath of healthcare harm? Clin Risk 2014;20(1-2):16-18. 5. Wu AW. Medical error: the second victim: The doctor who makes the mistake needs help too. BMJ 2000;320(7237):726-727. 6. Shorrock S. The real second victims. Humanistic Systems website. 7. Clarkson M, Haskell H, Hemmelgarn C, Skolnik PJ. Editorial: Abandon the term “second victim”. BMJ 2019; 364:l1233. 8. Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care 2009;18(5):325-330. 9. Second victim support for managers website. Yorkshire Quality and Safety Research Group and the Improvement Academy. 10. Trew M, Nettleton S, Flemons W. Harm to Healing – Partnering with Patients Who Have Been Harmed. Canadian Patient Safety Institute 2012. 11. Vincent C. Patient Safety. Second Edition. BMJ Books 2010.

Myths of pain: Myth 1: Pain meds compromise the abdominal exam. Myth 2: Treatment of pain will compromise a patient’s decision making capacity. Myth 3: Opiophobia: The fear of addiction Myth 4: She's not in pain! I just saw her sleeping! How can we improve? First: Stop saying that it’s not you. It is you! You suck at managing pain. Perhaps not in everyone, but you’re definitely mistreating someone. Once we accept this fact, we may become cognizant and then able to improve our practices. Second: Educate thyself. Tintinalli’s actually has a whole chapter on acute pain management. Studies show that short training sessions led providers to give more analgesia with improvement in patient satisfaction (5). Third: Simply ask. Ask your patients if they have pain and ask them if they want pain medication. Fourth: Don’t get caught up by stupid myths. Your patient is in pain, treat him! Last: Do not give in to the Great Opiophobia! We are emergency physicians and we aren’t afraid of anything!