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At the beginning of 2025 we launched our video interview series Speaking up for patient safety. The series is hosted by Peter Duffy, NHS whistleblower and Chair of the Healthcare Working Group at WhistleblowersUK, and Helen Hughes, Patient Safety Learning’s Chief Executive.  In each interview we hear from someone who has raised concerns about patient safety in healthcare, often at great cost to their own career and personal life. They share their story and their reflections on what needs to be done to improve organisational cultures so that when staff raise patient safety issues, their concerns are responded to appropriately and not dismissed because they are inconvenient to address. Alongside the thread of bravery and tenacity that runs through each contributor, a number of common themes come up time and again as people share their experiences. In this blog, Helen and Peter look at some of these themes and outline their implications for people who speak up or whistleblow. We are now three months into the series, which seems like a good time to stop and reflect on what we have learned so far. Our introductory blog about ‘Speaking up for patient safety’ explains why we launched the series and what we hope it will achieve. It also explains in more detail what we mean when we talk about speaking up and whistleblowing. Briefly, speaking up in healthcare is when a member of staff raises concerns about something that is worrying them to a manager or someone else within, or outside of, their organisation. In some cases—but not all—when someone speaks up, it is also defined as ‘whistleblowing’. Whistleblowing always involves a concern that is in the public interest and might relate to a criminal offence, health and safety risks, failures to carry out legal obligations, a miscarriage of justice, or an attempt to conceal and cover up any of these things. Three key themes from the interviews so far These are the top three recurring themes we have noticed coming up in the interviews so far. Other issues we have noticed include the lack of clarity about who should take responsibility for whistleblowing and the reality of threats and bullying, and we will continue to explore these issues going forward. 1. “I didn’t realise I was speaking up, I was just doing my job!” Perhaps the comment we have heard most frequently is that people didn’t realise they were formally speaking up or whistleblowing—they just thought they were doing their job. Every healthcare profession has a set of professional standards which all practitioners are expected to keep to. For example, the General Medical Council (GMC) states that all doctors have a duty to take action by raising concerns if they believe patient care or safety are at risk.[1] In addition, each healthcare organisation has a code of conduct, which will include requirements for staff to be honest, open and accountable for their work. For the interviewees we spoke to, to not raise their concerns would be a failure to fulfil their duty to both their patients and their organisation. When people speak up, they often find themselves in the middle of a process that they had no idea they were entering. This can be very disorientating and leave them unprepared for the path ahead of them. At the end of this blog, we share some advice from our interviewees about what to do if you find yourself in this position. 2. There is a whistleblowing ‘playbook’ Most organisations have policies and support in place to listen to staff members who raise concerns, including access to a Freedom to Speak Up Guardian. We have interviewed Jayne Chidgey-Clark, the National Guardian, who described the good practice that many are developing. However, we are hearing about several common tactics that some organisations use when dealing with people who speak up or blow the whistle. The experiences of our interviewees suggest that these approaches may be deliberately designed to disadvantage the individual throughout the process—from investigation through to employment tribunals. Some of the key activities we have heard about include: Organisations not responding—or responding at the very last minute—to communications from the staff member. Interviewees said they received emails with key information at 5pm on a Friday, which left them with no opportunity to ask questions or respond until the next working week. They expressed their belief that this may be a deliberate tactic to exert pressure on the individual speaking up, which amounts to emotional bullying. The use of occupational health as a way to cast doubt on the mental state of the person. Occupational health providers are often very supportive, but we are concerned that organisations are fishing for reasons to question the believability and motives of staff who speak up. Over-focus on HR issues, rather than focusing on the patient safety issues someone has raised. Mandated isolation from colleagues while investigations take place. This can have a very damaging effect on the person’s mental health as well as restricting their ability to source evidence from other staff in support of the concerns they have raised. We have heard examples of colleagues agreeing to provide supportive testimony, but then feeling pressurised to withdraw this support. Retaliatory referrals against the person speaking up to professional regulators, such as the General Medical Council and Nursing and Midwifery Council, which can have a detrimental effect on a healthcare professional’s reputation and career. Regulators are aware of how such referrals can be used to intimidate whistleblowers and discourage them from raising concerns. Some have approaches to ensure that fitness to practice concerns are appropriately addressed without unfairly impacting doctors who have raised whistleblowing concerns. We believe it is important to identify and call out these tactics so that people raising concerns are aware of them and can seek support and advice. Organisational leaders need to look at their own practice and recognise the ethics of their approaches and whether their actions match their stated organisational values. They need to be aware of the significant damage these tactics cause to people who raise concerns and the chilling impact it might have on their organisational culture, effectively preventing others’ raising concerns. 3. Employment tribunals are unfit, unfair and imbalanced Every person we spoke to who had attempted to pursue justice at an employment tribunal commented that the process was unfit for purpose and not the right place for whistleblowing cases to be heard. Employment tribunals take no interest in the safety issues being raised. The main issue we keep hearing is that the tribunal system is weighted in favour of whichever side has the most financial resources—which will almost always be the employer. A single individual who has lost their employment can rarely succeed against the millions of pounds that organisations are willing to spend on highly specialised lawyers who have tried and tested ways of winning. The playbook we identified above also runs into employment tribunals, with whistleblowers reporting: The employer and their legal advisers withholding key documents, and emails, minutes, notes and other vital information going missing. Key witnesses, often in senior leadership positions, being unable to recall events. Receiving last minute threats from their former employer to come after them for costs and often being given a limited time to consider signing a non-disclosure (NDA) to settle a case. If rejected, often the NHS organisation will seek the full costs from the whistleblower, including expensive external legal costs and internal staff costs, which can amount to thousands of pounds—few whistleblowers can afford to take this financial risk, even if they and their advisers think they have a strong case. Advice from our interviewees if you find yourself speaking up Reflecting on their experiences, our contributors have made some observations about how you can protect yourself when speaking up, should the issue escalate. Try to resolve issues locally first. This is not always possible, but if a concern can be raised and dealt with within a team or with a manager, in some cases this will prevent the situation from escalating to a formal process. Keep a record of concerns and events as they happen. This means you will have some facts and clear observations to refer back to, if the situation does escalate. Don’t go to meetings alone. Take a trusted colleague with you so that every conversation is witnessed. Get your union involved if you are called to meetings about your concerns or receive counter-complaints or accusations. Regulation of NHS managers Some of the interviewees highlighted that regulating NHS managers may be a potential means of tackling some of these issues. The Department of Health and Social Care recently held a public consultation on proposals that could see managers who use misconduct to silence whistleblowers barred from working in the NHS. Patient Safety Learning has formally responded to the consultation, stating that there is a clear case for the regulation of NHS managers, for the protection and benefit of both staff and patients. Everyone in healthcare should be honest and transparent when something goes wrong. Patient Safety Learning’s response expressed support for a professional register of NHS managers and the requirement for individuals in NHS leadership to have a professional duty of candour. These measures would be a positive step in increasing accountability for healthcare organisations in how they respond to staff raising patient safety concerns. But this is only one part of a much wider set of changes needed—significant cultural change also needs to take place in tandem with these reforms. Staff across many organisations are still afraid to speak up, as indicated by the most recent NHS staff survey results. Thank you to our contributors, and an invitation to get involved We’d like to take this opportunity to express our gratitude again to each person who has been willing to share their experiences and insights with us—it can be very difficult to retell traumatic events that have changed the course of your life. We are also aware that there are many other individuals who have experienced unjust treatment because they have spoken up for safety. If that’s you, thank you for your commitment to standing up for safe, ethical care. We invite everyone with experience in this area to contribute to this vital conversation. We would particularly like to hear from: Allied health professionals. Staff from Black and minority ethnic backgrounds Staff in non-clinical roles such as administration. If you would like to share your story, you can: Contribute to our community conversation (you’ll need to sign up first). Comment on any hub post (you’ll need to sign up first). You can find information about organisations that offer support and guidance for staff about speaking up and whistleblowing on the hub. Watch the interviews Helené Donnelly Martyn Pitman Jayne Chidgey-Clark Gordon Caldwell Bernie Rochford Beatrice Fraenkel References General Medical Council. Professional Standards: Raising and acting on concerns about patient safety, 13 December 2024

Join the Patients Association for a candid conversation with Sir Julian Hartley, Chief Executive of the Care Quality Commission (CQC), as he shares his vision for rebuilding a trusted approach to regulation. Sir Julian will reflect on the challenges ahead and the opportunity for change and to restore confidence. Hosted by Rachel Power, Chief Executive of the Patients Association, this webinar offers a unique chance to hear directly from Sir Julian about his approach to leadership, transparency, and driving improvement. It takes place ahead of our Patient Partnership Week (30th June - 4th July 2025), a week dedicated to highlighting the importance of shared decision-making and championing patient power and agency. Whether you're a healthcare provider, patient advocate, policymaker or someone who uses care services, book your free place. Register

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.

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].

The Professional Standards Authority for Health and Social Care and the Welsh Government invite you to their joint eighth annual Regulatory developments and the Welsh context seminar. The event will bring together those with an interest in health and care professional regulation across Wales and beyond. The theme for this year’s event is: How professional regulation can promote a safety culture Sue Tranka, Chief Nursing Officer for Wales and Nurse Director of NHS Wales, will deliver the keynote address. Key issues that will be considered on the day include: How can regulators, employers and professional groups collaborate to improve safety? How can education and training promote a safety culture? How can data be used to improve safety and how can we best engage the public with data? Register