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Content ArticleThe World Health Organization (WHO) has published a new edition of this guidance on health technology assessment (HTA) for medical devices. Health technology assessment (HTA) is described as ‘a well-recognised and methodologically robust evidence-based priority-setting process used to provide information on the safety, efficacy, quality, appropriateness, and cost-effectiveness of health technologies’. This document ‘is intended to provide guidance to policy-makers, particularly those in low- and middle-income countries that are currently developing HTA capacity.’ The document describes ‘general concepts of HTA and points to best-practice resources to enable low- and middle-income countries to make consistent, transparent and informed decision-making on the adoption and use of medical devices to ensure clinical needs are met whilst delivering value to patients, healthcare providers, and the broader health system.’
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News Article
Physician associates to be renamed to stop them being mistaken for doctors
Patient Safety Learning posted a news article in News
Physician associates in the NHS will be renamed to stop patients mistaking them for doctors after a review found that their title caused widespread confusion. Thousands of physician associates who work in hospitals and GP surgeries across the UK take medical histories, examine patients and diagnose illnesses but are not doctors. However, Prof Gillian Leng, whose government-ordered review is looking into whether they pose a risk to patients’ safety, has concluded that they must be given a new name, so patients they treat are not misled into thinking they have seen a doctor, according to sources with knowledge of her thinking. Doctors who fear the term has created widespread confusion among the public and risks undermining trust in the medical profession will regard ditching it as a major victory. Wes Streeting, the health secretary, is expected to accept Leng’s recommendation and instigate the change, which could lead to physician associates being renamed “physician assistants” or “doctors’ assistants”. She will also specify in her final report, due later this month, that those who perform those roles must make clear to patients that they are assistants, not fully fledged medics. Physician associates have been implicated in several high-profile patient deaths. Earlier this year, a coroner found that in February 2024 a physician associate (PA) in the A&E at East Surrey hospital had misdiagnosed 77-year-old Pamela Marking as having a nosebleed when she had a small bowel obstruction and hernia that required emergency surgery. She returned to the hospital two days later but she died soon after. In her prevention of future deaths report the coroner, Karen Henderson, warned that the term “physician associate” was “misleading to the public” and that there was a “lack of public understanding of the role”. Read full story Source: The Guardian, 4 June 2025 Further reading on the hub: Physician associates: What are the patient safety issues? An interview with Asif Qasim Partha Kar: We need a pause to assess safety concerns surrounding Physician Associates -
News ArticleShould health systems tell patients when they’re using AI? UC San Diego Health says yes. The health system uses a generative AI tool from Epic that drafts MyChart patient portal messages for providers. But UC San Diego Health notifies patients when the responses are drafted by AI with the disclosure: “Part of this message was generated automatically and was reviewed and edited by [name of physician],” according to a May 9 NEJM AI article. Members of the organisation’s AI governance committee debated whether it was necessary, as providers use other documentation shortcuts and generative AI could elicit concern from patients, but ultimately came to the same conclusion. “Transparency is necessary, as AI-assisted replies may stand out to patients — especially if they differ from clinicians’ usual communication style,” wrote the authors, UC San Diego Health Chief Medical Information Officer Marlene Millen, MD, Professor Ming Tai-Seale, MD, and Chief Clinical and Innovation Officer Christopher Longhurst, MD. Lack of transparency “could lead to patients questioning the authenticity of the replies, potentially damaging the crucial doctor-patient trust,” the authors wrote. “With tens of thousands of physicians nationwide using AI to support patient communication, now is the time to begin transparent disclosure.” Read full story Source: Becker's Health IT, 12 May 2025
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Content ArticleExpectations of patient and family involvement in investigations of healthcare harm are becoming conventional. Nonetheless, how people should be involved, is less clear. Therefore, the “Learn Together” guidance was co-designed, aiming to provide practical and emotional support to investigators, patients and families. This study evaluated the use of the Learn Together guidance in practice—designed to support patient and family involvement in investigations of healthcare harm. Findings The guidance supported the systematic involvement of patients and families in investigations of healthcare harm and informed them how, why, and when to be involved across settings. However, within hospital Trusts, investigators often had to conduct “pre-investigations” to source appropriate details of people to contact, juggle ethical dilemmas of involving vs. re-traumatising, and work within contexts of unclear organisational processes and responsibilities. These issues were largely circumvented when investigations were conducted by an independent body, due to better established processes, infrastructure and resources, however independence did introduce challenge to the rebuilding of relationships between families and the hospital Trust. Across settings, the involvement of patients and families fluctuated over time and sharing a draft investigation report marked an important part of the process—perhaps symbolic of organizational ethos surrounding involvement. This was made particularly difficult within hospital Trusts, as investigators often had to navigate systemic barriers alone. Organisational learning was also a challenge across settings. Conclusions Investigations of healthcare harm are complex, relational processes that have the potential to either repair, or compound harm. The Learn Together guidance helped to support patient and family involvement and the evaluation led to further revisions, to better inform and support patients, families and investigators in ways that meet their needs (https://learn-together.org.uk). In particular, the five-stage process is designed to centre the needs of patients and families to be heard, and their experiences dignified, before moving to address organisational needs for learning and improvement. However, as a healthcare system, we call for more formal recognition, support and training for the complex challenges investigators face—beyond clinical skills, as well as the appropriate and flexible infrastructure to enable a receptive organisational culture and context for meaningful patient and family involvement. Related reading on the hub: The Learn Together programme (part A): co-designing an approach to support patient and family involvement and engagement in patient safety incident investigations
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Content ArticleThe General Medical Council (GMC) has submitted its response to Professor Gillian Leng’s independent review of the physician associate (PA) and anaesthesia associate (AA) professions in England. In its submission the regulator emphasised the importance of statutory regulation for PA and AAs because - as with any regulated healthcare profession - PAs and AAs undertake complex work that will pose some level of risk to the public, and regulation mitigates this risk. The submission also highlighted that, as the multi-professional regulator for doctors, PAs and AAs, the GMC is well placed to work with others across the health system to identify and address issues that concern all three professions. For example, the availability of supervisors and student training placements. The GMC also said that regulation is already beginning to raise standards of practice through ensuring that only those individuals with the right clinical knowledge and skills are entered onto the GMC’s registers.
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Content ArticleEpsom and St Helier Hospital have developed a SWARM guide and fictional example video, for use by those who wish to use the Swarm debrief learning response as part of their Patient Safety Incident Response Framework (PSIRF) work. Swarm is one of the four learning responses and can be used whenever there is something new to learn, and does not have to be initiated by a patient safety incident. Typically, a Swarm debrief happens within 48 hours after the event and includes the multiprofessional staff that were involved. The Swarm Guide suggests useful phrases and prompts across three distinct phases, starting with 'setting the scene'. This phase is important as it helps to create group psychological safety, where all participants can feel safe to speak up and share their perspectives, without fear of ridicule or reprimand. A Swarm debrief is informed by the Systems Engineering Initiative for Patient Safety SEIPS and Systems Thinking principles, that theorise most problems and possibilities for improvement belong to the work system. Therefore, the aim of a Swarm is to understand and explore important or relevant work system factors that helped or hindered event outcomes and crucially whether these system issues are present in our everyday work. You can spend most of the debrief 'exploring WSF & everyday work' as the questions and prompts within this phase support a curious approach. Finally, you can draw the debrief to a close in 'next steps', by thanking participants, summarising key learning and checking for understanding. Then informing participants of how you will document and escalate any important system issues or findings, so that these can inform ongoing or future improvement work.
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Content ArticleFamilies bereaved by state-related deaths and those affected by miscarriages of justice have issued a clear warning to Government following reports that the forthcoming Bill will fail to contain the key elements of Hillsborough Law. A new report published by INQUEST brings together the powerful voices of bereaved families, victims and survivors of some of the worst failings of public services and the legal system in the UK. This includes those affected by the Hillsborough disaster, Grenfell Tower fire, Post Office Horizon scandal, infected blood scandal and many others. These participants are united in their concerns about the Government’s plans for a Hillsborough Law, which was included in the 2024 King’s Speech. The testimony featured in this report reflects the emotional and financial toll of families forced to spend years, and in some cases decades, fighting for the truth despite cover-ups, denials and outright lies told by public and private organisations. The report also shows how the injustice experienced by the bereaved and survivors following the Hillsborough disaster is still a painful reality today. It is therefore critical, families told INQUEST, that a Hillsborough Law ensures a statutory duty of candour backed up by effective provisions to ensure compliance, and robust sanctions to ensure accountability. This would bring to an end the culture of denial and cover-ups following state failings which currently prevail. Another key demand of families is for the law to provide for public funding for their legal representation following state failures to ensure equality of arms with public bodies. Under the current system, families are often left without public funding and forced to crowd fund to cover their legal costs, whilst state bodies have legions of lawyers. Families see Hillsborough Law as a potential watershed moment, one that could redress the power of the state, fulfil the legacy project that Hillsborough families and survivors have fought for, and prevent future deaths and harm. However, the report makes clear that families and victims fear the Government will change or amend the 2017 Bill and, as such, are demanding that Hillsborough Law be “all or nothing”. Those involved in this report hope the Government heed their voices and resist attempts to dilute the bill, stressing that any compromise would undermine its vital purpose.
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Content ArticleIn November 2023 the British Medical Association (BMA) established a reporting portal for doctors and medical students to share concerns regarding the deployment of physician and anaesthesia associates in both primary and secondary care. This report includes all submissions received by February 2025 that concern patient safety. This report presents evidence of doctor substitution, doctors being coerced or pressured into signing prescriptions or ionising radiation requests for patients of whom they have no knowledge, examples of doctors losing out on basic skills training and situations where neither the public nor other healthcare staff know the role or competencies of physician and anaesthesia associates. It also highlights examples of where harm has come to patients, or been narrowly avoided only by subsequent intervention from a doctor.
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Content Article
These FAQs on the Duty of Candour were produced by the Patient Safety Management Network in collaboration with experts from the Care Quality Commission (CQC) and NHS Resolution, and address the most pressing concerns about Duty of Candour. Read more about how and why these FAQs were developed. These FAQs should be read in conjunction with the published CQC guidance Regulation 20: Duty of Candour and are accurate as of March 2025. Any updates to the CQC guidance beyond this date will not necessarily be reflected in these FAQs and the CQC guidance should be the primary source of guidance. You can download a pdf of the FAQs here: PSMN_Duty of Candour FAQs_040425.pdf The Professional Duty of Candour 1. What is the Professional Duty of Candour? The Professional Duty of Candour applies to individual healthcare professionals, requiring them to be honest with patients when something goes wrong with their care. This includes taking responsibility, apologising, explaining what happened and working to prevent future occurrences. It is enforced by professional regulatory bodies such as the General Medical Council (GMC) and the Nursing and Midwifery Council (NMC). The Statutory Duty of Candour – an outline 2. What is the Statutory Duty of Candour? The Statutory Duty of Candour applies to every health and social care provider that the Care Quality Commission (CQC) regulates. It is a legal obligation that requires registered providers and registered managers (known as ‘registered persons’) to act in an open and transparent way with people receiving care or treatment from them. 3. Who does the Statutory Duty of Candour apply to? The Statutory Duty of Candour applies to all health and social care providers regulated by CQC. This includes NHS and private healthcare organisations, care homes and other regulated services. 4. When must the Statutory Duty of Candour be applied? There are two parts of the Statutory Duty of Candour: The overarching duty to be open and transparent with people receiving care. This part applies at all times, in all cases. Notifiable Safety Incidents (NSI). Where an NSI has occurred, the regulation specifies exactly how the Duty of Candour must be applied. The Statutory Duty of Candour – What is a Notifiable Safety Incident (NSI)? 5. What is a NSI? A NSI is a specific term defined in the regulations and it should not be confused with other types of safety incidents or notifications. An NSI must meet all of three of the following criteria: It must have been unexpected or unintended It must have occurred during the provision of an activity regulated by CQC In the reasonable opinion of a healthcare professional, it already has, or might, result in death, or severe or moderate harm to the person receiving care. The levels of harm are defined differently depending on the type of provider, as set out in Table 1 below, but mean it is possible to trigger the harm threshold for NHS trust, but not for other service types, or vice versa. Table 1 6. What does the first criterion about unintended or unexpected mean? What does it mean in relation to known complications? The CQC guidance states: You should interpret "unexpected or unintended " in relation to an incident which arises in the course of the regulated activity, not to the outcome of the incident. By "regulated activity" we mean the care or treatment provided. By "outcome" we mean the harm that occurred or could have occurred. So, if the treatment or care provided went as intended, and as expected, an incident may not qualify as a Notifiable Safety Incident, even if harm occurred. This does not mean that known complications or side effects of treatment are always disqualified from being Notifiable Safety Incidents. In every case, the healthcare professionals involved must use their judgement to assess whether anything occurred during the provision of the care or treatment that was unexpected or unintended. Additionally, CQC guidance states that an NSI can still occur even if a patient consented to the procedure. Take these hypothetical scenarios, which illustrate the potential difference: Case A – A patient undergoes hip replacement surgery. A recognised complication is a venous thrombo-embolism (VTE) (blood clot). The consent process was followed and the risk was clearly explained. The patient received all appropriate chemical and mechanical prophylaxis and the surgery went as intended. However, the patient suffered a stroke. Case B – The circumstances are the same as Case A, however, this patient did not receive prescribed chemical prophylaxis. In Case A, although harm occurred, it occurred in relation to the outcome; that is, nothing unintended or unexpected happened in the care and treatment provided that contributed to that harm. In Case B, the same harm occurred but something unintended or unexpected happened in the care and treatment (prescribed prophylaxis was not given) that contributed to the harm. The provider would be required to act in an open and transparent way in both cases (the first part of the Statutory Duty of Candour), but Case B is also a Notifiable Safety Incident and therefore specific actions must be taken. 7. What does the second criterion about a regulated activity mean? Providers must register with CQC if they provide one or more of the Regulated Activities set out in Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. A description of each of the Regulated Activities is available in CQC’s Scope of Registration Guidance. 8. Is a patient receiving a regulated activity as soon as they call 999? Once the 999 call is transferred to the ambulance service then yes, this is captured under the Regulated Activity for Transport Services, Triage, and Medical Advice Provided Remotely. 9. Under criterion 3, what is considered ‘reasonable’ in determining harm levels? The ‘reasonableness’ is about whether, given the same information, another healthcare professional would come to the same conclusion. 10. Should ambulance services contact receiving hospitals to confirm the level of harm? It would not be reasonable to expect a service to routinely commission advice from an external healthcare provider in order to answer this question in every case (although there may some incidents where this is done). It is possible that a receiving provider may be of the opinion that something in the ambulance service’s care and treatment contributed to harm, in which case they should follow the CQC Guidance: NSI occurred in a different provider: “If you discover a notifiable safety incident that occurred in a different provider, you should inform the previous provider. You must also be open and transparent with the person receiving care about whatever you have discovered. But you do not need to carry out the specific procedures relating to notifiable safety incidents. The provider where the incident happened must carry out the notifiable safety incidents procedures.” 11. Are incidents that trigger professional Duty of Candour always NSIs? No. An incident must meet all three NSI criteria to qualify. Some incidents may require professional openness without meeting NSI thresholds. The Statutory Duty of Candour – What to do if an NSI occurs 12. What actions are required if an NSI has occurred? If a NSI has occurred, the provider must, as soon as reasonably practicable: Tell the relevant person (the service user who was harmed or someone acting lawfully on their behalf), in person, that an NSI has occurred. Apologise for what happened. Provide a true account of what happened, explaining what you know at that point. Explain to the relevant person what further enquiries or investigations you believe to be appropriate. Follow up by providing this information, and the apology, in writing, and provide an update on any enquiries. Keep a secure written record of all meetings and communications with the relevant person. Duty of Candour is complete once all the above steps have been followed. Any new information that comes to light at a later date may require further communication with the relevant person. If the relevant person cannot, or refuses to, be contacted, then you may not be able to carry out the actions outlined above, but you must keep a written record of all attempts to make contact. Throughout this process you must give reasonable support to the relevant person, both in relation to the incident itself and when communicating with them about the incident. This will vary with every situation but could include, for example: Environmental adjustments for someone who has a physical disability. An interpreter for someone who does not speak English well. Information in accessible formats. Signposting to mental health services. The support of an advocate. Drawing their attention to other sources of independent help and advice. 13. What does ‘as soon as reasonably practicable’ mean? Why are there no defined timescales? Providers are expected to act promptly as soon as an NSI has been discovered. No defined timescales are given as each NSI, and the circumstances of the relevant person who has been affected, will be different. For example, the relevant person may not be contactable for a period of time. 14. Does the apology for a NSI have to be given face-to-face? The legislation states that the apology must be given in person and the CQC guidance interprets this as face-to-face; so that should be the case where possible, if it best meets the needs of the service user. However, if face-to-face is not possible or not in the best interest of the service user, it may be given in person another way, such as by telephone or virtually. The key principle is ensuring openness and transparency. 15. Is an apology an admission of liability? No, an apology under the Duty of Candour is not an admission of legal liability. In many cases it is the lack of a timely apology that pushes people to take legal action. NHS Resolution’s ‘Saying Sorry’ leaflet confirms that apologising will not affect indemnity cover. 16. Can NHS Resolution’s 'Being Open' be used instead of Duty of Candour to simplify compliance? No. The statutory Duty of Candour has two parts: A general duty to be open and transparent at all times. A specific process that must be followed if an NSI occurs. Being Open aligns with part one but does not replace statutory obligations in relation to NSI. The Statutory Duty of Candour – Illustrative examples 17. Whose responsibility is it to enact Duty of Candour when ambulances are delayed because of waits in other providers, and there is no learning for the ambulance services to share? Duty of Candour is primarily about being open and transparent with service users, which may involve an element of sharing learning, but that is not the primary driver and therefore ‘not having any learning’ does not mean that the duty is not triggered. The specifics of the regulation still need to be carried out if it is an NSI. In this scenario, the requirement to tell the relevant person about the appropriate enquiries or investigations might, for example, include work being done across the system to reduce waits. 18. How does Duty of Candour apply to delays in diagnosis or treatment? In terms of the unexpected or unintended criterion, there is the need to consider whether the delay contributed to the harm experienced. If the delay did not affect the patient outcome, then it is unlikely to meet this criterion. 19. Should a follow-up letter be sent if a porter apologises for accidentally injuring a patient by catching their arm? A letter is only required if the incident is a NSI. It seems unlikely that the harm levels would be met in this scenario, but if they are (and the other criterion are also met) then it would be a NSI and all actions, including following up the face-to-face notification with a written letter, must be carried out. 20. Who is responsible for informing a patient’s family if an incorrect ambulance referral results in death? In this scenario, the receiving provider should inform the referring provider that they believe an NSI has occurred (see question 10). The referring provider can assess whether the incident is an NSI and it is they who should carry out the specifics of the regulation as required. The Statutory Duty of Candour – the role of CQC 21. How is the Statutory Duty of Candour enforced? The ultimate responsibility for ensuring the Statutory Duty of Candour is carried out rests with the registered provider or manager. Where CQC believe that it is not happening, they can use powers of enforcement, including action plan requests, warning notices, imposition of conditions and criminal prosecution. Any decisions will follow CQC’s Enforcement Policy and Decision Tree. Regulatory bodies such as the CQC in England, Healthcare Improvement Scotland, Healthcare Inspectorate Wales, and the Regulation and Quality Improvement Authority (RQIA) in Northern Ireland monitor compliance. The Statutory Duty of Candour – interactions with the Patient Safety Incident Response Framework (PSIRF) 22. If an incident is not a NSI, should the patient still be involved in the investigation? Yes. PSIRF promotes compassionate engagement. Patients should be given an informed choice about their level of involvement in a learning response, as set out in the ‘Engaging and involving patients, families and staff following a patient safety incident’ guidance. 23. How does Duty of Candour, PSIRF and compassionate engagement align? Duty of Candour ensures openness and transparency, requiring healthcare providers to inform, apologise, and support patients and families after a NSI. PSIRF shifts focus from blame to learning and improvement, ensuring proportionate responses to patient safety incidents rather than automatic investigations. Compassionate engagement is central to both, ensuring empathetic, meaningful involvement of patients, families and staff in the response process. Together, these principles promote trust, learning and system-wide safety improvements. The Statutory Duty of Candour – other issues 24. What has happened with the review into the Duty of Candour? Were the consultation figures low? A review into the statutory Duty of Candour was announced in the Government's response to the Hillsborough disaster report in December 2023. A call for evidence closed in May 2024, with the findings of the call for evidence published in November 2024. The published findings state there were 261 responses, which is a small response rate given its wide applicability. A final response to the review has not yet been published by the Department of Health and Social Care (DHSC). 25. Why is there little focus in the guidance on applying statutory Duty of Candour in mental health services? The statutory duty applies to any provider registered by CQC. While there is a mental health example in CQC’s guidance it is about a medication error that has occurred in a mental health setting. Once the situation regarding the DHSC review of the duty is clearer, CQC will look to strengthen the guidance and provide further examples for this sector. 26. Should there be a Duty of Candour towards staff? Any legislative changes to create a statutory Duty of Candour for staff would require action from the DHSC. However, CQC’s assessment framework emphasises: A culture where staff can raise concerns without fear. Workforce wellbeing, ensuring staff feel supported and valued. You can download a pdf of the FAQs here: PSMN_Duty of Candour FAQs_040425.pdf Last updated 4 April 2025.- Posted
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Content Article
The Patient Safety Management Network (PSMN) recently held two insightful and collaborative sessions focused on the Duty of Candour—the legal requirement for healthcare organisations to be open and transparent with those receiving care and treatment. The session brought together a diverse group of experts from the Care Quality Commission (CQC), NHS Resolution and the PSMN members to explore common challenges and seek clarity on key aspects of this essential duty. Through the joint effort between members of the PSMN and the invited experts a Frequently Asked Questions (FAQs) resource was produced that addresses the most pressing concerns about Duty of Candour. This collaborative approach ensured that the FAQ tool reflects the insights and expertise of those actively engaged in the regulation, implementation and oversight of candour practices. By pooling their knowledge, the team was able to provide clarity on a subject that often presents nuanced challenges to healthcare providers. Understanding the Duty of Candour The PSMN sessions delved into both the statutory and professional Duty of Candour, highlighting their distinct but complementary roles: Statutory Duty of Candour Regulated by the CQC, this duty comprises two key elements: Being open and transparent with patients at all times, regardless of whether an incident occurs. Responding to notifiable safety incidents (NSIs) by following a defined process. Professional Duty of Candour This duty, overseen by professional regulatory bodies, encourages individual healthcare professionals to act with honesty and openness when something goes wrong. Defining Notifiable Safety Incidents A NSI is defined by three criteria: The incident must be unintended or unexpected. It should occur during the provision of a regulated activity (14 regulated activities are listed by the CQC). In the reasonable opinion of a healthcare professional, the incident has resulted in, or might result in, death or severe or moderate harm. Defining and identifying NSIs remains a challenge, particularly because harm thresholds differ between healthcare bodies and other providers. Discussions also highlighted how understanding ’unintended or unexpected‘ is tied to the incident not the outcome, which adds another layer of complexity. CQC’s role in assessing Duty of Candour While the CQC does not investigate every NSI, it assesses compliance with the Duty of Candour by focusing on organisational culture. Ensuring that openness and transparency are embedded in day-to-day practices is key to meeting regulatory expectations. Guidance on saying sorry NHS Resolution provided valuable guidance on “saying sorry”, reinforcing that an apology is not an admission of liability but an essential step in acknowledging that something could have been done better. This simple but powerful act can build trust and contribute to a culture of transparency. A commitment to clarity and improvement These PSMN sessions underscored the importance of continuous learning and collaboration in addressing complex safety issues. By bringing together regulators, safety experts and healthcare professionals, the PSMN has taken a significant step toward ensuring that the Duty of Candour is consistently understood and applied across all healthcare settings. The creation of the FAQs page is not just a resource, it’s a testament to the power of collaboration in driving positive change and enhancing patient safety. “Openness and transparency are not just regulatory requirements—they are the foundations of a culture that puts patients first.” The Duty of Candour FAQs can be read here or downloaded from the attached pdf below. PSMN_Duty of Candour FAQs_24032025.pdf How to join the Patient Safety Management Network You can join by signing up to the hub today. When putting in your details, please tick Patient Safety Management Network in the ‘Join a private group’ section. If you are already a member of the hub, please email [email protected]. -
Content Article
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In this blog, Patient Safety Learning highlights key issues included in its response to the Department of Health consultation on the draft ‘Being Open’ Framework and establishment of a Duty of Candour in Northern Ireland. In December 2024, the Department of Health launched a public consultation asking for views on its draft ‘Being Open’ Framework. Describing the proposed Framework, Health Minister Mike Nesbitt stated: “The ‘Being Open’ Framework aims to ensure that individuals within our health and social care system are fully empowered to exercise candour and openness, and that health and social care organisations have in place the necessary support and systems required to enable and nurture a truly open culture.”[1] The Framework aims to address some of the recommendations made in the 2018 report from the Inquiry into Hyponatraemia Related Deaths (IHRD) by Justice O’Hara KC.[2] This Inquiry was published following an extensive investigation into the deaths of five children in hospitals. The report’s recommendations included the introduction of a Duty of Candour in Northern Ireland. The purpose of the ‘Being Open’ Framework set out in the consultation document is as follows: To improve patient safety and the quality of services by developing an open, just and learning culture. To ensure that all people in contact with healthcare organisations (employees, patients, relatives and the public) can expect to be treated in an open, fair and compassionate way. That patients and those supporting them will be listened to, understood and treated with respect. That healthcare staff are entitled to visible, engaged and inclusive leadership. That senior leaders will listen to concerns and create safe spaces for learning. That learning will be promptly disseminated across the system.[3] Below we summarise the key points included in Patient Safety Learning’s response to this public consultation. Openness and culture The ‘Being Open’ Framework at its core places a strong emphasis on the principle of openness in the healthcare system. It looks at this on three levels: Routine openness: being honest in everyday care and communication. Learning from mistakes: reflecting on errors to improve and avoid repeating them. When things go wrong: clear communication and accountability when harm is caused. We welcome the Framework’s commitment to openness with patients and its focus on learning from mistakes. We stated this in our consultation response, while highlighting the need for proposed training and support for staff to be accompanied by a commitment by their organisation to support a culture of openness. We believe that this requires a clear leadership commitment to create a working environment for their staff where they feel psychologically safe to raise patient safety concerns. In our response, we also mentioned the importance of being open with patients and families following patient safety incidents and in the incident investigation process itself. To facilitate this, we set out that: It is important for staff to understand who is responsible for ensuring meaningful and compassionate engagement with patients and families. This needs to be accompanied by processes that enable organisations to evaluate how both to assess and meet the needs of patients and families in these processes. Having sufficient well-trained staff, with time for engagement, is essential if this is to be achieved. These issues around patient safety investigations is something we will come back to in more detail at a later date as part of our response to the new public consultation on the redesign of the current Serious Adverse Incident procedure for Northern Ireland.[4] Duty of Candour The consultation poses questions about the introduction of a Statutory Duty of Candour for organisations and individuals in Northern Ireland, a key recommendation of the IHRD. In our response, we state our support for this. Everyone working in healthcare must be open and honest in all their dealings with patients and the public. We also make clear that the introduction of Duty of Candour is a process that takes time and requires significant resources to embed. Highlighting the challenges of this, we pointed to the experience of introducing a Statutory Duty of Candour for health and care providers in England, first enshrined in law for all NHS Trusts in 2014. As results of last year’s call to evidence illustrate, even now there is still a significant gap between what is said and understood in regard to Duty of Candour, and what takes place in practice at many healthcare organisations.[5] Patient Safety Commissioner We also expressed our support for the potential introduction of a new role of Independent Patient Safety Commissioner in Northern Ireland. This is one of the options that the ‘Being Open’ Framework suggests exploring to help to monitor and scrutinise its implementation. This new post alone cannot improve openness and patient safety. However, with the right remit and responsibilities, we believe that it could play a potentially important role in supporting this and championing the voice of patients. In our response, we stressed that if such a role was introduced it was important to ensure that they had a clear remit, with the ability to advocate for systemic improvement and look at safety issues across health and care. The Patient Safety Commissioner for England currently has a remit that is restricted to medicines and medical devices, which in our view places an unnecessary limitation on the role. This can also create confusion for patients who want to highlight a clear patient safety issue that does not fall under the guise of medicines and medical devices. This can reinforce an inequity of treatment for patients affected by these issues, with there being no alternative pathway for them to raise such concerns outside the Commissioner’s scope. This is a problem that has been highlighted directly by the inaugural Patient Safety Commissioner for England, Professor Henrietta Hughes.[6] We also stated the need to ensure that a new Patient Safety Commissioner in Northern Ireland would have clear operational independence. They should feel able to ‘speak truth to power’ and represent the best interests of patients and the wider public. To support this aim, we believe that this role would need to be independent from those funding and delivering healthcare. Finally, we noted that it would be useful for the new postholder to establish a strong working relationship with the Patient Safety Commissioner for England and, when appointed, the Patient Safety Commissioner for Scotland. This would enable them to coordinate in the future on emerging patient safety concerns and share examples of good practice. Engaging with patients and the Patient and Client Council One area where we felt that the ‘Being Open’ Framework could be strengthened was in relation to patient engagement and involvement. While further changes may emerge in this area from feedback to the consultation itself, we also highlighted in our response the value of giving greater consideration to the role the Patient and Client Council (PCC) can play in the delivery of this. The PCC is a statutory body in Northern Ireland that provides a powerful and independent voice for patients, clients, carers and communities on health and social care issues through: Representing the interests of the public. Promoting the involvement of the public. Assisting people in making, or intending to make, a complaint. Promoting the provision by health and social care bodies of advice and information to the public about the design, commissioning and delivery of services. Undertaking research into the best methods and practices for consulting and engaging the public.[7] We believe that these functions of the PCC align with the core aims of the ‘Being Open’ Framework, and their existing knowledge and experience could help to support the implementation of this. Commenting on specific aspects of this, we noted the following points: In potentially creating a new Patient Safety Commissioner role, consideration would need to be given as to how its remit and responsibilities relate to and complement the existing role of the PCC. When discussing “Openness with a focus on learning” and “Openness when things go wrong”, the Framework talks about organisations having patient safety incident investigations that involve patients. The PCC’s work involving patients and communities in the design, delivery and evaluation of services could support embedding these principles in practice. Training and education We also welcome proposals in the ‘Being Open’ Framework to provide training and support to staff to properly understand and exercise their responsibilities to be open routinely and focused on learning and when things go wrong. In our consultation response we also placed particular emphasis on the need to consider how this applies to those in leadership positions. At Patient Safety Learning we believe that good leadership can drive patient safety performance, supporting learning from unsafe care and putting in place clear governance processes to enable this. In our Patient Safety Standards we identify the need for Board members (Executives and Non Executives) and governors to be provided with training and support in relation to compliance with Duty of Candour and being open as a key requirement for healthcare organisations.[8] We believe there would be value in also reflecting that in the ‘Being Open’ Framework. Concluding comments We strongly support the introduction of the ‘Being Open’ Framework in Northern Ireland. We also welcome that it directly acknowledges the importance of having a clear implementation plan to take this work forward. Importantly, it also recognises that neither legislation nor policy alone will necessarily inspire the behaviours that are intrinsic to an open organisation, emphasising the importance of taking action needed to promote behaviours and beliefs that enable this. In our concluding comments to the consultation, we highlighted further consideration how the implementation of the Framework could potentially form part of a wider application of a safety management system approach to health and social care in Northern Ireland. A safety management system is a proactive approach to managing safety that is used in other industries. It sets out the necessary organisational structures and accountabilities to manage safety risks. It requires safety management to be integrated into an organisation’s day-to-day activities.[9] References Department of Health. Consultation on ‘Being Open’ Framework and Duty of Candour launched, 10 December 2024. IHRD. Report of the Inquiry into Hyponatraemia related Deaths, 31 January 2018. Department of Health. Draft Regional being Open Framework for the HSC, 10 December 2024. Department of Health. Framework for Learning and Improvement from Patient Safety Incidents Consultation, 11 March 2025. Department of Health and Social Care. Findings of the call for evidence on the statutory duty of candour, 26 November 2024. Emily Townsend. Safety watchdog urges Streeting to expand her role. HSJ, 24 October 2024. PCC. Who we are and what we do. Last accessed 28 March 2025. Patient Safety Learning. Why Standards? Last Accessed 24 March 2025. HSSIB. Safety management systems: accountability across organisational boundaries, 13 February 2025. -
News Article
Baby deaths trust claimed £2m 'good care' payments
Patient Safety Learning posted a news article in News
An NHS trust criticised over the avoidable death of a newborn baby was paid £2m for providing good maternity care, the BBC can reveal. A senior coroner ruled on Friday that University Hospitals of Morecambe Bay (UHMB) NHS trust contributed to Ida Lock's death and had failed to learn lessons from previous maternity failures. Despite this, the trust claimed it had met all 10 standards under an NHS scheme aimed at promoting safe treatment. Ida's mother Sarah Robinson said it was "another kick in the teeth" while her father Ryan Lock labelled it "disgusting". The trust, which has previously apologised for its failings in Ida's care, declined to comment about the NHS payment scheme. Senior coroner for Lancashire James Adeley concluded that Ida had died due to the gross failure of three midwives to provide basic medical care. Ida, who was born at the Royal Lancaster Infirmary (RLI) on 9 November 2019, died a week later after suffering a serious brain injury due to a lack of oxygen. Dr Adeley ruled her death had been caused by the midwives' failure to deliver the infant "urgently when it was apparent she was in distress" and contributed to by the lead midwife's "wholly incompetent failure to provide basic neonatal resuscitation". He said eight opportunities had been missed "to alter Ida's clinical course". Read full story Source: BBC News, 26 March 2025 -
Content ArticleOn 9 November 2019, a woman who was pregnant with Ida, attended the Royal Lancaster Infirmary Labour Ward in early labour. Ida was a normal child whose death was caused by a lack of oxygen during her delivery. This occurred due to the gross failure of the three midwives attending her to provide basic medical care to deliver Ida urgently when it was apparent she was in distress and contributed to by the lead midwife‘s wholly incompetent failure to provide basic neonatal resuscitation for Ida during the first 3 1/2 minutes of her life that further contributed to Ida’s brain damage. Ida died on 16 November 2019 at the Royal Preston Hospital neonatal intensive care unit. The inquest was one in which Article 2 was fully engaged as a result of the Trust’s clinical governance arrangements, inadequate investigations, a lack of transparency and openness, a failure to respond to a detailed complaint letter, a failure to comply with the Duty of Candour, disputing the findings of the Secretary of State for Health’s independent review panel (HSIB now MNSI), failing to notify external monitoring bodies and failing to comply with internal protocols. The Trust’s lack of compliance with clinical governance requirements in the investigation into Ida’s death had significant similarities with the criticisms made in 2015 of the Trust as set out in The Report of the Morecambe Bay Investigation, otherwise known as the Kirkup Report. [REDACTED] who gave evidence at the inquest, expressed the view that there was a deep seated and endemic culture of defensiveness in respect of maternity incidents at the Trust. [REDACTED] also said that the investigation showed elements of failing to identify significant care issues, brevity, defensiveness and was conducted by unskilled investigators. Matters of Concern A: Culture of Candour [Trust, ICB and DHSC] 1. I am concerned that there is not a culture of candour within University Hospitals of Morecambe Bay NHS Foundation Trust (Trust) and the impact that this has on safety, learning and implementing required changes to prevent deaths. Urgent action is required by the Trust to meaningfully embed the Dury of Candour. 2. [REDACTED]’s evidence to the inquest was that a deep-seated and endemic culture within the Trust leads to denial and a failure to learn. [REDACTED]’s Investigation report was published in 2015, the Trust is ten years on and still issues and themes identified in 2015 were very much in issue in 2019 and still exist at the Trust as identified by Ida’s inquest. 3. The Trust’s approach to the inquest has been one of a lack of transparency and openness, failure to provide relevant information and a failure to identify with candour the defective clinical governance processes that have operated at the Trust from 2019 to present day. 4. The Trust did not disclose that they had failed to notify the external bodies namely the CQC and the then CCG [ICB] via STEIS and the Trust’s internal Serious Incidents Reporting Investigation panel, none of which was noted by the Trust’s Patient Safety Summits .The matter was reported to the Coroner a year after Ida’s death by the family after the Trust took no action to do so, despite being on notice of failures in treatment from the HSIB report Ida’s harm was at no point categorised by the Trust as a harm event that caused “death”. 5. Trust figures to the Board provided in 2025 stated that there were no complaints over 6 months old when the Trust at the time of the inquest have not responded to [REDACTED] and [REDACTED]’s 1 June 2020 complaint. Together with the Trust’s failure to categorise Ida’s death as only “Moderate Harm” (see point 4 above) cause me also to have concern about the reliability of Trust’s data. B: Clinical Governance and Maternity Governance [Trust, ICB and DHSC] 6. I consider the clinical governance arrangements at the Trust require urgent review to ensure the appropriate personnel are in place, with the necessary training and skills to deliver robust clinical governance to ensure patient safety in maternity care. 7. As a result of the Trust’s deficient processes, the Trust did not undertake any examination of its own clinical governance processes, which were a principle area of concern and which was identified to the Trust five months before the inquest commenced. The Trust’s clinical governance arrangements were extracted piecemeal during the course of the inquest. The deficiencies included lack of version control and audit of documents, untrained staff, chaotic clinical governance arrangements, defensive attitudes and inappropriate self- congratulation. The clinicians’ reports to the inquest only answered the questions they were asked rather than trying to assist with a holistic view of the evidence, did not provide relevant information until it was extracted from the witness in testimony, that resulted in rolling disclosure of documents and additional witness evidence. This approach caused additional distress to the family who had to sit through an extended court hearing to address these issues 8. [REDACTED] is now Head of Compliance and Assurance at the Trust but that there has been no investigation into her role in respect of reneging on the Trust’s acceptance of the HSIB report at senior management level and with the family as was indicated by her approval of the July 2021 position statement. Similarly, [REDACTED] is now Head of Midwifery at the Trust and there has been no investigation in respect of her disputing the HSIB findings and submission of challenge to the HSIB report in Ida’s case. 9. All investigations conducted by the Trust to date in respect of Ida’s death have been unskilled, superficial, brief, failed to identify issues and left the family without answers and were all features identified by the 2015 Kirkup Report. In view of the continuing culture at the Trust, this cause a significant concern that issues of safety and safeguarding are not properly considered, transparently engaged with and then addressed formally in respect of a child fatality and serious injury by the Trust. 10. The Trust’s clinical governance capability has been the subject of repeated and often severe criticism in the Flynn Review 2009, Fielding Report 2010, Central Manchester Hospital Report 2011, Price Waterhouse Cooper 2012 and Kirkup Report 2015. [REDACTED] in his evidence to the inquest said that the Trust focus on process, which means that you can comply with the process requirements and still produce an inadequate investigation, rather than focussing on outcome, which measures the quality of the investigation and the patient experience. [REDACTED] noted that the Trusts culture impeded transparent and open investigation. I am told that the Trust now uses the PSIRF model and is to appoint 3 whole time equivalent Response Leads by 30 September 2025. However, I remain concerned that the Trust has not fully engaged with the duty of candour such that I am not satisfied that the work on PSIRF to date has truly addressed the issues in respect of Trust’s investigations. C. Mandatory Training, expired training and remedial training [Trust and ICB] 11. The Band 5 midwife supporting [REDACTED] in Labour had not undertaken her required mandatory training and this fact had not been provided and was only revealed at the inquest as part of the evidence of the Head of Midwifery in March 2025. I was also concerned to learn that in 2025 non-completion of mandatory training was still an issue as [REDACTED] had not completed her mandatory training. 12. It concerns me that the Trust do not have robust systems in place to ensure that any midwife who has not completed her mandatory training is subject to immediate action to ensure that all mandatory training is completed and is in date. 13. There was no remedial training was put in place for either the midwives involved in Ida’s delivery and resuscitation or for the paediatric SHO after Ida’s death. This raises a significant concern that the Trust do not operate a system of remedial training when this inquest has identified remedial training was required for [REDACTED], [REDACTED], [REDACTED] and [REDACTED]. D. Grading of harm for incident reporting: Babies who have sustained hypoxic brain injury and undergo cooling [Trust, ICB, DHSC, NHSE, [REDACTED]] 14. The Trust graded Ida’s level of harm as “moderate”, even after her death. This grading should have been adjusted to “severe” by the Trust before Ida was transferred to Royal Preston Hospital as the consultant paediatrician identified that she had sustained a severe hypoxic ischaemic encephalopathy due to fetal bradycardia. 15. The 2024 NHSE Learn from patient safety events (LFPSE) guidance that replaced the National Reporting and Learning System (NRLS) confirms that the recording and analysis of patient safety events that occur in healthcare support the NHS to improve learning from patient safety events to help make care safer. There is a significant risk that if reporting is graded on harm alone, clinical care that resulted in hypoxic brain damage during delivery and which was prevented by therapeutic cooling, will not adequately identify the problems that caused the harm during the delivery. 16. [REDACTED] confirmed that nationally there is inconsistency in categorisation of harm for babies who sustain a hypoxic injury due to fetal bradycardia in labour and who require cooling and clarification guidance would assist prevent further maternity deaths and ensure full and proper investigation of hypoxic injuries sustained in labour. E: Funding for MSNI [DHSC and [REDACTED], NHSE and ICB] 17. But for the HSIB investigation report into Ida’s death [REDACTED] admitted that Ida’s death due to failures by the Trust would never have come to light or resulted in an inquest. 18. The MSNI is now hosted by the CQC with funding secured for the next two years but no certainty as to ongoing funding after this date. These independent investigations by specialist skilled investigators into the most serious of events is an essential safeguard to the lives of mothers and unborn children. 19. Without an assurance that funding will continue beyond 2027 I am concerned that significant harm events to mothers and babies and deaths such as Ida’s will go unrecorded and lessons that should be learned to prevent future maternal and baby deaths will go unnoticed, and there will be a risk of future maternity deaths.
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Content ArticleWhilst patients and families can and do support patient safety in several ways, empirical evidence for the specific impact of involvement in patient safety incident investigations and their outcomes, has been limited, with little information about how to undertake involvement meaningfully. The authors of this paper aimed to (i) develop a set of common principles to guide involvement of patients and families in patient safety incident investigations; (ii) develop a working programme theory for how these might be enacted; (iii) co-design guidance to support the meaningful involvement of patients and families in patient safety incident investigations. They developed ten ‘common principles” and a working programme theory for an approach that might support meaningful patient and family involvement in incidents investigations. Based on these principles and the programme theory, they co-designed guidance to be used within NHS Trust and national investigations of harm that follow patient safety incidents. The guidance includes information, resources and tools to enable better understanding and practice, from the perspective of patients, families, investigators and staff, on how to be meaningfully involved. Related reading on the hub: The Learn Together programme (part B): evaluating co-designed guidance to support patient and family involvement in patient safety incident investigations
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Content ArticleComplete and accurate patient history is essential for patient safety. Medical and surgical information is typically reported by the patient using a checklist to indicate medical and surgical history and current medications and supplements. This method has been shown to be generally successful in obtaining an accurate history in most healthcare settings. However, there are instances when patients may withhold information. Patients may hesitate to disclose information when they fear a procedure may be cancelled, when a topic is sensitive, or when they don’t understand that a particular detail is important to their care. Examples of sensitive topics may include pain management, abortion care, weight loss, gender-affirming care, and medical marijuana use. Recent event reports submitted to the Pennsylvania Patient Safety Reporting System (PA-PSRS) included patient safety events that involved patients withholding relevant medical information for fear of a procedure being cancelled. Some event reports described patients who underwent a surgical procedure and experienced complications, which necessitated transfer to a higher level of care. After a discussion between the facilities’ patient safety officers and Patient Safety Authority advisors, it was discovered that these patients had a known medical condition but did not disclose this on their medical history form because they were worried that their procedure might be cancelled. In these cases, these preexisting conditions would not have necessitated cancellation, but their course of treatment would have been modified to prevent the complication and, in turn, the transfer to a higher level of care. Other event report submissions describe procedure cancellations due to an active infection, which the patient did not initially disclose to avoid the cancellation. Each case involved sensitive topics and procedures, which may have led to patients withholding information.
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News ArticleThe abrupt withdrawal of Dr David Weldon’s nomination to lead the Centers for Disease Control and Prevention (CDC) highlights the ongoing political and financial entanglements that shape public health policy. Weldon, a former congressman and internist, was informed just twelve hours before his scheduled Senate confirmation hearing on 13 March that his nomination was being pulled due to insufficient support. The decision, reportedly made by the White House after realising they lacked the votes, raises critical questions about the rigidity of political gatekeeping in public health leadership. Weldon’s nomination was doomed by concerns over his past inquiries into vaccine safety. As he explained in his statement, he was repeatedly accused of being ‘anti-vax,’ despite never claiming that vaccines cause autism. In today’s political climate, however, even a small, measured scepticism about certain vaccines is enough to disqualify someone from holding public office. The issue of whether vaccines cause autism is considered settled by the medical establishment. As Senator Bill Cassidy stated during Jay Bhattacharya’s confirmation hearing, conducting further studies on the matter would be “wasting” resources on research that already confirms what we know. While this argument has some merit (since research funding is finite and often squandered), Bhattacharya countered with a crucial point: vaccines are a public health intervention, and the public must have confidence in them. If people do not trust the data, then the government has a responsibility to present more evidence to convince them. Refusing to engage in further study only fuels scepticism and deepens public distrust. Read full story Source: Maryanne Demasi, 14 March 2025
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Content ArticleThe regulation of NHS managers must drive real change by addressing root causes, prioritising patient safety, and ensuring accountability without repeating past failures, writes Roger Kline in this HSJ article. Principles a code might adopt should include: Make safety the prime litmus test for all initiatives and “stop the line” (from board to ward and community setting) when it is not. Make speaking truth to power a precondition of effective leadership. Prioritise the duty of care all staff owe. Expect and support managers (and staff) to always behave respectfully to each other (and to patients) and to relentlessly seek to create a culture of psychological safety, civility and inclusion, not least by leaders and managers modelling the behaviours they should expect of all staff; Cease performative measures to tackle toxic cultures. Employer legal proceedings involving staff who have raised concerns should also be regarded as a “never event” and all costs disclosed. Employers must review at pace (with independent support) all cases of staff who have left or been dismissed after raising concerns with a view to helping them gain NHS employment; Appointment and appraisal decisions. Openness and transparency. Duty of candour. Specifically regarding as a breach of the Code “never events”.
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EventMedical errors remain a significant challenge in healthcare systems across Europe, affecting patient safety and trust. Despite advancements in medical practices, barriers to effective error reporting persist, limiting opportunities for learning and improvement. To address these critical issues, the European Patient Safety Foundation (EUPSF) together with the World Patients Alliance (WPA) are hosting a webinar. This session will bring together experts, policymakers, and patient representatives to discuss the current landscape of medical errors, explore solutions for improving reporting mechanisms, and foster a culture of transparency and learning within healthcare systems. Join us as we work toward building safer and more accountable healthcare for all. Register
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Content ArticleThis article, co-authored by IHI President Emeritus and Senior Fellow Don Berwick, highlights how healthcare in the US is failing patients and presents a vision of a system that better supports the nation’s needs.
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News Article
‘After my baby died, NHS colleagues mocked me’
Patient Safety Learning posted a news article in News
Jack Hawkins used to love his job as a doctor at the Nottingham University Hospitals NHS Trust. It was where he met his wife, Sarah, a senior physiotherapist. It was where, seven years later, the couple planned she would give birth to their first child, a daughter they would call Harriet. They trusted their colleagues to take care of them. Their colleagues failed, horrifically. Harriet was stillborn after a catalogue of errors by midwives and doctors in 2016. After a lengthy legal battle, the couple received £2.8 million in compensation in 2021 and have since been at the forefront of efforts to expose the NHS’s largest maternity scandal. Some 2,500 cases are now being examined. Almost nine years after Harriet’s death, her parents continue to learn new and horrific details about what happened to her. It can now be revealed that the hospital allowed her body to decompose so badly in the months after her death that she had to be “triple-bagged” when placed into a coffin for her funeral. Her parents only discovered the horrific failure last summer after forcing the trust to release a cache of internal emails. A few months later they learnt that staff recorded a 2017 phone call made by Jack, a former medical consultant at the trust, without his consent, and played it at a meeting of senior midwives months later. In this meeting they allegedly “mocked” the grieving father. Jack said the revelations made him feel sick. “It is an abuse,” he said. “This encapsulates the failures in values, behaviours and quality of care that has caused so much harm and death in Nottingham.” Sarah added: “They couldn’t even look after Harriet when she was dead. How much more can they put us through? It’s never ending.” Anthony May, a former chief executive at Nottingham county council, who was appointed to lead the trust and its response to the maternity scandal in 2022, said: “There are many examples of where we have compounded the harm experienced by Jack and Sarah through the way in which we have communicated with them and dealt with their inquiries and concerns. I am committed to improving the way in which we engage with Jack and Sarah, and the wider group of affected families.” Read full story (paywalled) Source: The Times, 2 March 2025 -
Content Article
In this podcast interview series, NHS whistleblower Peter Duffy and Patient Safety Learning’s Chief Executive Helen Hughes explore how the healthcare system responds when its staff raise concerns about patient safety. In each episode, Helen and Peter interview someone who has spoken up about patient safety issues in healthcare organisations, or who works to help staff raise concerns where they see unsafe care. In this episode, Peter and Helen speak to consultant endocrinologist Gordon Caldwell, who retired early from the NHS after speaking up about patient safety concerns in his hospital. Gordon shares his experience of raising concerns about unsafe staffing levels while working as a clinical lead and how this led to extreme stress and the decision to retire years before he had planned to. They discuss the importance of transparency, team work and clear record-keeping processes to ensure patients are kept safe and Gordon outlines how lack of accessible patient health records hinders decision-making and can lead to avoidable harm. They also look at how target-led approaches and financial incentives have led to cultural changes in healthcare organisations over the past few decades. Subscribe to our YouTube podcast to keep up to date with the latest episodes. View a transcript of this interview Read a blog from Peter and Helen about the interview series -
News ArticleThe Care Quality Commission has been criticised by the High Court for failing to follow its own conflict of interest policy, after a legal challenge by a mental health provider. Cygnet, the private inpatient mental health provider, instigated the judicial review against the regulator, accusing it of failing to follow its conflict of interest policies in its choice of inspector. The CQC will now have to review its report into one of the Cygnet-run sites, the Acer Hospital in Chesterfield. It was given an “inadequate” rating, an unusual outcome for a focused inspection, and put into special measures over risks to patients and poor staffing. The inspector at the centre of the case – who cannot be named because of reporting restrictions – had previously been detained in two hospitals run by Cygnet in 2012-13 – and had complained about his care and treatment. The former mental health nurse went on to become a CQC inspector and started to inspect facilities run by Cygnet in 2019. At a court hearing, Cygnet argued seven inspection reports on five of its sites, and enforcement action taken against one of them, were affected by the inspector’s apparent bias. The CQC had previously refused to review these reports and enforcement action, the provider said. Read full story (paywalled) Source: HSJ, 24 February 2025
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News Article
CDC scientific report resumes publication after unprecedented pause
Patient Safety Learning posted a news article in News
The Centers for Disease Control and Prevention (CDC) resumed publishing its weekly scientific report Thursday after an unprecedented pause, but information about the bird flu virus that was supposed to appear remained on hold even as the outbreak spreads. Three studies about the H5N1 bird flu virus were scheduled to be released in the weekly Morbidity and Mortality Weekly Report on 23 January according to multiple CDC officials who spoke on the condition of anonymity out of fear of retaliation. But release of the results was abruptly halted when the Trump administration instructed federal health agencies to pause all external communications on 21 January. The weekly document is the agency’s primary vehicle for disseminating public health information and recommendations. Health officials, clinicians and researchers are among those who rely on the studies for vital guidance. Until last month, the MMWR has been published without interruption since 1952, even during government shutdowns. “Although I’m encouraged that the MMWR is being published again, I’m surprised and concerned that it doesn’t contain any reports on bird flu spreading in animals and people, the new strain of mpox spreading or other emerging health threats,” said Tom Frieden, a former CDC director for the Obama administration. “If political decisions determine which health threats to highlight, we’ll all be less safe,” Frieden said. “I hope the new Administration will see the value in CDC publishing information on health threats every week, without political interference.” Read full story (paywalled) Source: Washington Post, 6 February 2025 -
Content ArticleMedical misinformation can have a profound impact on perioperative patient safety. With users numbering in the billions, platforms such as Facebook, Instagram, TikTok, X (formerly Twitter), Snapchat, Pinterest, Reddit, Messenger and YouTube command an ever-increasing share of the public’s time, attention, and dependence. Consequently, they have also become primary sources of information for politics, sports, general knowledge, and news for the general public. Statistics published by Pew Research in 2022 show that adults under the age of 30 actually trust information from social media almost as much as national news outlets, and in 2023, half of US adults get news at least some of the time from social media. The relationship between medical care and information on the internet has been fraught since the early days of the internet, predating the more recent increase of medical misinformation. According to the United States Office of the Surgeon General, medical misinformation is “information that is false, inaccurate, or misleading according to the best available evidence at the time. Misinformation can affect understanding of public health concerns, as was seen in the recent Covid pandemic when concerns were expressed regarding social distancing, mask mandates, and vaccination. Perioperative medicine is no less affected, as highlighted in this blog in the Anaesthesia Patient Safety Foundation (APSF) newsletter.
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Content ArticleCare Quality Commission (CQC) guidance on the Duty of Candour, including: The duty of candour: guidance for providers Background to the duty of candour Notifiable safety incidents Examples of notifiable safety incidents What you must do when you discover a notifiable safety incident How we regulate the duty of candour Regulation 20 in full.
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