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The course will provide participants with an in-depth knowledge and understanding of how to not only comply with the duty of candour and the Patient Safety Incident Response Framework (PSIRF), but to do so in an emotionally intelligent way, with empathy and compassion for all involved. Practical guidance on complying with the regulations and guidance The “grey areas” and what people most often get wrong Using emotional intelligence to understand the difficult emotions experienced by patients/those closest to them and staff following patient safety incidents What empathy and compassion mean in practice Handling difficult and emotive conversations well Making a meaningful apology How Duty of Candour and PSIRF work alongside other policies and procedures including complaints; litigation; Martha’s Rule and the soon to be introduced “Hillsborough Law” How the new “Harmed Patient Pathway” can help you get it right 7 How to ensure communication moves beyond compliance and frameworks but remains emotionally intelligent and personal Register hub members receive a 20% discount. Email [email protected] for discount code.

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].

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.

This course will explain and discuss the statutory duty of candour in principle, in practice, and in context, using real examples of good and poor practice. Openness, trust and good communication are at the core of the relationship between health and care professionals and their patients / families. But the duty of candour is widely misunderstood, and often misapplied, which can leave practitioners feeling exposed and patients / families feeling frustrated and, perhaps, push them towards other legal processes to get answers. This course will help attendees to understand the relationship between the statutory and professional duties of candour, in the wider context of the importance of good communication and the reasons why complaints and claims are made. We will look at each element of the legal test for a notifiable safety incident to trigger the duty of candour, and the next steps that are necessary, reflecting in particular on the importance of distinguishing fault and blame as irrelevant to the duty of candour. Examples will be given of regulatory consequences where the duty of candour has not been implemented appropriately and we will discuss the part of the duty of candour that requires an apology to be given, and consider the legal implications of this as well as good practice and examples to avoid where a poor apology has made things worse. WHO SHOULD ATTEND Health and social care professionals, front line practitioners and managers, including those dealing with complaints and claims. KEY LEARNING OBJECTIVES Understanding the importance of communication in a clinical context and the role of the duties of candour Appreciating the difference between the statutory and professional duties of candour The key elements of the statutory duty of candour for a notifiable safety incident, and the overarching duty to be open and transparent Understanding the process when the duty of candour is triggered Understanding the relationship between the duty of candour and fault / blame / liability The legal implications of an apology and what makes a good apology Register hub members receive a 20% discount. Email [email protected] for discount code.

Hi, my name is Andrew Payne. In October 2019, my late wife Janice was in the palliative stage of her cancer when she was a victim of a dispensing error. This was caused in large part by an intransigent pharmacist who refused me an emergency supply of medication for my wife a few days previously. Failures by the pharmacy branch and Janice's GP meant she had to endure the side effects of ingesting the medication of a patient with the same surname as her. She will have suffered pain, discomfort and harm. This much has been admitted by the private pharmacy company involved. I would like to share the series of events leading to my wife's death and after, and the actors involved and the questions that need to be answered. The pharmacy As much as the pharmacy involved said "we take this kind of circumstance very seriously", the truth is that they worked very hard to see the case closed. The pharmacy did not mention to me the failures of their staff to observe the Duty of Candour. They did not direct me to the industry regulator. Instead, I was advised that this case was being reviewed by their ‘customer complaint process’ and I was sent a ‘customer charter’. Their process gave the pharmacy a 20-day cushion for them to thoroughly investigate the error and in this time they batted away my questions and queries. Their own internal investigation found nothing untoward apart from the terrible human error of a lady behind the counter who served me as the pharmacist refused (against company and industry guidelines) to come out herself to see if my request for the emergency medication had merit or not. I made a complaint to the General Pharmaceutical Council (GPhC) and they found sufficient evidence to open an investigation. A pharmacy executive was unhappy about this and made efforts to assure the GPhC that this was a simple case of human error despite knowing that this was in fact more than a simple case of human error. The pharmacy executive went on to convince the GPhC investigators that they did not need to question the pharmacy staff that they had identified to take statements from, and, instead, this ‘non-involved’ executive became the single witness representing everyone. The insurers I was witness to the harmful influence of insurers, who indemnify healthcare professionals causing them to question their actions in an error circumstance. When the pharmacy company introduced me to their indemnity insurer, I conducted an internet search and found a piece of advice to their pharmacist members on the National Pharmacy Association website on how to react in a dispensing error circumstance. In my opinion this advice was written by a legal executive and I suggest it is an invitation to their members to breach their professional duties to their patient. When I discovered this, I advised the pharmacy company that their branch team had followed this advice almost to the letter. This triggered unseemly actions by both the pharmacy and the insurer. I had many exchanges with them in which I invited them to remove this terrible advice from their website, but was told this is typical advice, and of course it is, but this comes in the form of ‘deny liability’ and represents a threat to all NHS patients. The National Pharmacy Association did eventually removed this when the Chief Pharmaceutical Officer for England at the time became involved. I was unable to convince the GPhC that their investigation was corrupted and, therefore, invalidated. The regulator The GPhC took 18 months to take statements from the pharmacy executive and myself, consider the factors and make their decision. I called their investigation ‘a parody’. I was beside myself with astonishment and despair to see that they did not include the breaches in the Duty of Candour in their investigation. I received an unsigned letter from the ‘outsourced’ solicitor company investigators. I was advised that they had found the pharmacy company to have acted positively to the error and that there were no grounds for further action. I wrote a strong letter of discontent, in which I reminded the CEO of the regulator that he was a signatory to the joint statement on the Duty of Candour in 2014. To his credit, he commissioned an outsourced review of the handling of the case. Unfortunately for the cause of finding the truth, learning lessons and doing the right thing, this review was poor. There were aspects of the review that the CEO did not agree with and he ordered that the case should be reviewed again. Seven months of ‘investigations' later, it came to the same conclusions as the first investigation, albeit with a more wordy outcome letter. Janice and I, as the ‘public being protected’ by this regulator, had been failed on a monumental scale. Putting patients in harm's way I have looked behind these fine words and promises to protect the public to find a different set of interests being placed before the public. I have seen the betrayal, not just of the GPhC but also of other regulators. I have seen the flaws in the authority tasked with overseeing these healthcare regulators and I have seen the depth of failure. I was forced by the GPhC to use the Freedom of Information Act to learn otherwise undisclosed details of my case. I found this Act a crucial mechanism as I was able to ask questions of the regulators. I have used the Act to ask the same questions to NHS Trusts and I have compared the results to see how much safer the public are when they are being cared for by the NHS. That is to say, if an error occurs and this happens within a facility operated by the NHS, are there are better systems in place. I am very fearful to see community services operating from NHS facilities. I see this as exposing patients to harm. I am committed to seeing changes introduced that will see the public made as safe as it is possible to be. Difficult questions asked I finish this story with the difficult questions I have asked. All of these queries resulting from one case. Why is it possible for two healthcare professionals working in the same NHS facility to be regulated differently when it comes to the Duty of Candour? For example, a nurse working in the NHS facility will be regulated by the Nurses and Midwives Council (NMC) and thus governed by the professional Duty of Candour. If a nurse breaches the Duty of Candour they will be investigated by the NMC and the Care Quality Commission (CQC) will be responsible for investigating the NHS facility as the organisation is responsible for its staff to adhere to the Duty of Candour. However, community pharmacies operating within the NHS facility are not regulated in the same way. The GPhC (and other regulators) are not mandated to ask whether the pharmacist under investigation was supported or trained by their employers. Why are there better systems in place for patients when their NHS services are provided by the NHS rather than by a private company? In the NHS the employers have a marked responsibility to ensure that their staff are updated, informed and observe their professional duties. This is because the CQC are policing a statutory duty and a breach in this duty is a breach in law. Why aren’t private companies providing NHS services, such as pharmacies, required to meet NHS standards? Why aren’t private companies regulated for the part of their business which provides NHS services to NHS patients? Why aren’t standard operational procedures standardised across the private companies providing NHS services to NHS patients? When ‘something goes wrong’ with an NHS patient receiving an NHS service from the private sector, why is it the NHS picks up the costs of ‘harm done’? Why are insurers allowed to undermine the integrity of professionals in the conduct of their duties? It is inevitable that when an error has occurred, a professional's thoughts turn to the possible impact on their future, and so it is not surprising that a call to an insurer is made before following employer standard operating procedures and professional guides. In our case, the GP failed to alert the coroner of the dispensing error and only did so following a call to his indemnity insurer. Why are unregistered professionals working in healthcare exempt from sanction? Why are regulators allowed to make false claims of ensuring public safety? Janice Payne needs to be the last NHS patient failed by needless neglect. We need to act now in the name of public safety. Further reading on the hub: How to make a complaint How do I make a complaint: Sources of help and advice

Training to support the development of expertise involving patients, families, carers and staff when things go wrong, in line with NHS guidance, based upon national and internationally recognised good practice. To include the duty of candour and ‘being open’ principles. This course covers the end-to-end systems-based patient safety incident response based upon the new NHS PSIRF and includes: Duty of candour regulations Being open and apologising when things go wrong Challenges/complexities associated with cases where there is more than one investigation Effective communication, including dealing with conflict and difficult conversations Effective involvement of those affected by a patient safety incident throughout the incident response process to ensure a thorough and richer investigation Sharing findings Signposting and support: including loss, trauma and stress Who should attend: Lead investigators conducting patient safety incident investigations Executive and service lead for duty of candour Executive and service lead for patient safety Executive and service lead for the supporting response to patient safety incidents Investigators supporting patient safety incident investigations Facilitator: Jo Perruzza is a former mental health nurse and has been a clinician, a clinical leader and a senior manager in mental health provider organisations. With a passion for patient safety and an expert in psychological safety she brings experience of leading internal and external investigations. hub members receive a 20% discount. Email [email protected] for discount code.

This course will explain and discuss the statutory duty of candour in principle, in practice, and in context, using real examples of good and poor practice. Openness, trust and good communication are at the core of the relationship between health and care professionals and their patients / families. But the duty of candour is widely misunderstood, and often misapplied, which can leave practitioners feeling exposed and patients / families feeling frustrated and, perhaps, push them towards other legal processes to get answers. This course will help attendees to understand the relationship between the statutory and professional duties of candour, in the wider context of the importance of good communication and the reasons why complaints and claims are made. We will look at each element of the legal test for a notifiable safety incident to trigger the duty of candour, and the next steps that are necessary, reflecting in particular on the importance of distinguishing fault and blame as irrelevant to the duty of candour. Examples will be given of regulatory consequences where the duty of candour has not been implemented appropriately and we will discuss the part of the duty of candour that requires an apology to be given, and consider the legal implications of this as well as good practice and examples to avoid where a poor apology has made things worse. Who should attend Health and social care professionals, front line practitioners and managers, including those dealing with complaints and claims. Key learning objectives Understanding the importance of communication in a clinical context and the role of the duties of candour. Appreciating the difference between the statutory and professional duties of candour. The key elements of the statutory duty of candour for a notifiable safety incident, and the overarching duty to be open and transparent. Understanding the process when the duty of candour is triggered. Understanding the relationship between the duty of candour and fault / blame / liability. The legal implications of an apology and what makes a good apology. Register hub members receive a 20% discount. Email [email protected] for discount code.

This course will explain and discuss the statutory duty of candour in principle, in practice, and in context, using real examples of good and poor practice. Openness, trust and good communication are at the core of the relationship between health and care professionals and their patients / families. But the duty of candour is widely misunderstood, and often misapplied, which can leave practitioners feeling exposed and patients / families feeling frustrated and, perhaps, push them towards other legal processes to get answers. This course will help attendees to understand the relationship between the statutory and professional duties of candour, in the wider context of the importance of good communication and the reasons why complaints and claims are made. We will look at each element of the legal test for a notifiable safety incident to trigger the duty of candour, and the next steps that are necessary, reflecting in particular on the importance of distinguishing fault and blame as irrelevant to the duty of candour. Examples will be given of regulatory consequences where the duty of candour has not been implemented appropriately and we will discuss the part of the duty of candour that requires an apology to be given, and consider the legal implications of this as well as good practice and examples to avoid where a poor apology has made things worse. WHO SHOULD ATTEND Health and social care professionals, front line practitioners and managers, including those dealing with complaints and claims. KEY LEARNING OBJECTIVES Understanding the importance of communication in a clinical context and the role of the duties of candour. Appreciating the difference between the statutory and professional duties of candour. The key elements of the statutory duty of candour for a notifiable safety incident, and the overarching duty to be open and transparent. Understanding the process when the duty of candour is triggered. Understanding the relationship between the duty of candour and fault / blame / liability. The legal implications of an apology and what makes a good apology. Register hub members receive a 20% discount. Email [email protected] for discount code.

The Duty of Candour, introduced in 2014, requires healthcare professionals to be honest with patients when things go wrong. They must also be open with colleagues, employers, and relevant organisations and participate in reviews and investigations when requested. Our training developed with industry experts - Peter Walsh, the ex-Chief Executive of AvMA, who is well known for his pioneering work on the Duty of Candour, and Carolyn Cleveland, who specialises in training professionals in dealing with difficult emotions and conversations and doing so with empathy, understanding perspectives. The training focuses on empathy and compassion and equips you to navigate the Duty of Candour effectively. The training will cover the following areas: Overview of the Duty of Candour Legislation Requirements and expectations of the Care Quality Commission (CQC) The importance of empathy and compassion in implementing the Duty of Candour Balancing compliance with the human side of the duty Empowering and supporting individuals responsible for the Duty of Candour Understanding the emotional component behind the duty Providing evidence of compliance with the legislation Impact of meaningful interactions on patients, families, and colleagues Avoiding harm when providing an apology Price: £245 + VAT per person Discounted rate for bookings of 3 or more: £220 + VAT per person Event details and booking page Discount Code – Early bird 10% discount code valid until 2 April Hub discount code: DoC-Hub-10 Alternatively, the training can be delivered in-house at your organisation, either in person or online. Please enquire for details by emailing [email protected]

This popular training day covers the must-dos and the grey areas around the statutory Duty of Candour, with a strong emphasis on going beyond mere compliance and delivering the duty of candour in a meaningful way for patients and families and for the staff involved and the organisation. It has been updated to directly support the successful implementation of the PSIRF guidance and the ‘Harmed Patient Pathway’. The training is delivered by Peter Walsh, the ex-Chief Executive of AvMA, who is well known for his pioneering work on the Duty of Candour, and Carolyn Cleveland, who specialises in training professionals in dealing with difficult emotions and conversations and doing so with empathy, understanding perspectives. Prices: £245 (plus vat) per person. Discounted rate for bookings of 3 or more: £220 (plus vat) per person AvMA is offering a 10% discount for delegates referred via the hub. Use code: DoC-Hub-10 Register for the training Training can also be delivered in-house at your organisation, either in person or online. Please enquire for details by emailing [email protected]

Derek Richford’s grandson Harry died in November 2017 at just a week old. Since Harry’s death, Derek has worked tirelessly to uncover the truth about what happened at East Kent Hospitals University Foundation Trust (EKHUFT) to cause Harry’s death. His efforts resulted in a three-week Article 2 inquest that found that Harry had died from neglect. In addition, the Care Quality Commission (CQC) successfully prosecuted the Trust for unsafe care and treatment and Derek’s work has contributed to a review into maternity and neonatal care services at EKHUFT. In this interview, we speak to Derek about how EKHUFT and other agencies engaged with his family following Harry’s death. As well as outlining how a culture of denial at the Trust affected his family, he talks about individuals and organisations that acted with respect and transparency. He highlights what still needs to be done to make sure bereaved families are treated with openness and dignity when a loved one dies due to avoidable harm. Hi Derek, thank you for speaking to me today. Firstly, can you describe the attitude of managers and senior clinicians at the Trust towards your family after Harry’s death? Leaders and staff at EKHUFT were closed off to us from the beginning. At every step, it very much felt like they were saying, “There’s nothing to see here.” Looking back, I realised very soon after Harry’s birth that we needed to start documenting what was happening because the Trust was not being honest. When I arrived at the hospital, we asked a nurse for the name of the doctor who had overseen my daughter-in-law Sarah’s care, and who my son Tom had expressed concerns about. The nurse told us, “You can’t have that information, it’s confidential.” At that point I started photographing Sarah’s notes as I wanted to make sure we had a record. Once the Trust’s internal investigation into Harry’s death started, they told us they couldn’t talk to us while it was ongoing. When we said that we wanted to contribute, we were totally shut out. It was upsetting that the investigation was used as a reason to avoid engaging with us, but we allowed them to get on with it for four months until they released the root cause analysis report into Harry’s death. We were offered a meeting at the Trust in March 2018, so we requested to see the report beforehand. After initially saying they would just show us the report at the meeting, they eventually agreed to send us a hard copy by post, saying they couldn’t send it by email. When we finally got to read it, the report was full of errors and just didn’t add up. At the meeting, it became clear that we knew more about their report than the consultants in the room did. They were totally in denial that Harry’s death could have been avoided and were told that there was no way it needed to be referred to the Coroner. I couldn’t put my finger on exactly what was going on, but I just knew something was wrong with the way Harry’s death was being treated. I began to suspect that what happened to us had happened to many, many families before us—the Trust had avoided taking responsibility and failed to make referrals to the Coroner for years, saying that baby deaths were ‘expected’. Their argument that Harry’s death was expected was that they didn’t have to factor in anything that happened more than 24 hours before they withdrew life support. Later we found that, on their internal notes, Harry’s death was described as an unexpected outcome. It is undoubted that there had been a cover up in the maternity department for many years and I don’t think anyone would deny that now. To quote the Kirkup report, “This pattern of behaviour by the Trust, clearly evident in this case, recurred in many others that we examined. It included denying that anything had gone amiss, minimising adverse features, finding reasons to treat deaths and other catastrophic outcomes as expected, and omitting key details in accounts given to families as well as to official bodies. Although we did not find evidence that there was a conscious conspiracy, the effect of these behaviours was to cover up the truth.” When it came to Harry’s inquest, the Trust didn’t expect or want it to happen and were obstructive throughout the process. When the Coroner suggested that it should be an Article 2 inquest, the Trust disputed it, arguing that it didn’t even come close to the criteria, which was obviously untrue. If the hospital had been upfront with us about what had happened in Harry’s case right at the beginning, we would have been able to forgive the staff and move on. But they didn’t do that. Instead, it felt like a battle from day one and I had to force myself into areas they did not want me to look. At times, I have been painted by Trust staff as a trouble maker. The Trust’s Chief Executive had to apologise to me after writing to our local MP Sir Roger Gale that I was trying to “undermine the reputation of the entire hospital.” This was in response to a letter Roger wrote to the Trust when I raised concerns that they were rating their maternity department 10/10. When NHS Resolution finally investigated, they found that the Trust was actually only scoring 6/10, and the Trust had to repay the large rebate the maternity department had been awarded for their self-audited high score. How were you able to keep pushing for answers in the face of the Trust’s attitude to your family? As Harry’s grandfather, I was one step removed from the situation. That enabled me to stand back and look at what was going on, to ask questions and raise issues that newly bereaved parents would struggle to raise. I call it ‘the grandparent effect’, and it made a huge difference in this case. I was able to be an advocate for Harry’s parents Sarah and Tom, who were obviously severely affected by losing their baby. I looked into the various reviews and audits the maternity unit had been through, and kept uncovering more evidence. The Trust was lacking in so many areas—I dug and dug and with every layer of the onion I took off, I found more rot beneath. I feel it’s so important to share what we’ve been through and what we managed to achieve by not backing down. Once the inquest was over, I learned how to set a website up and published Harry’s Story. I wanted to collect all the information and evidence we had gathered in one, accessible place. I’m still working with EKHUFT now, trying to help them make improvements and deliver Bill Kirkup’s Reading the Signals report, but there’s still such a long way to go. How easy was it to find out which organisations you could refer your concerns about Harry's care to? The Trust left us to our own devices, so I took any route I could to try and find out the truth about what happened to Harry. I went to many organisations such as AvMA and kept being told, “Yes, we hear of these things happening, have you tried X organisation?” We were being sent from pillar to post, but kept trying to find out how we could take it further. I happened to have a relative working for an unrelated department of the Care Quality Commission (CQC) and she recommended that I make a report to the CQC. It was an uphill struggle to be heard by them and I initially found that they really didn’t want to engage with me. They eventually, after 10 months, got back to me saying there was nothing for them to investigate, and at that point I replied by copying in Professor Ted Baker, then Chief Inspector at the CQC. At that point, things started to change! Although the CQC eventually started to engage with us, I’m struck by how we were expected to go to them. We were invited to a meeting in London—we paid our own train fares and Tom had to take a day off work, which is difficult as a teacher. Were there individuals who engaged with you and your family well? What was it about their response that was positive? The individuals who engaged well with us were honest and listened to what we had to say. The Director of Maternity for Healthcare Safety Investigation Branch (HSIB), Sandy Lewis, was so helpful. She would call me with regular updates and communicate how much Harry’s case mattered to her. I could sense her commitment to seeing change. HSIB in general were exceptionally helpful, but there were hurdles to overcome there too. Harry was born in November 2017, but HSIB only had the remit to investigate cases from April 2018. I spoke with various individuals at the organisation including the medical director, who was keen to take on Harry’s case as he recognised its seriousness. They eventually found a way to take it on, by carrying out a learning investigation rather than a maternity investigation. The coroner’s officer was also fantastic—she listened and was so encouraging. I was constantly emailing new evidence over and in every email I would apologise for the extra reading, but she was so affirming and would say, “Send me whatever you want, I’ll make sure the Coroner sees everything.” The Coroner was also very respectful and told me what a difference I was making; after Harry’s inquest, he said to me, “You’ve done a good thing. Without you this wouldn’t have come before me Mr Richford.” I get very emotional thinking about it even now. You and your family suffered a terrible loss. How did the responses of the Trust following Harry's death affect your family further? We’ve discussed this as a family before. The loss of Harry was on one level, but the denial and the way we were treated by the Trust was almost worse—I would say it added at least 50% to the trauma. The approach taken by the Trust was to deny, delay and defend, and the damage that has caused us as a bereaved family is immense. Have you seen any positive change in how bereaved families are treated by the system? One positive move is that I was recently involved in the panel to appoint the new Chief Midwife for England. It was a privilege to be part of the process, and it felt like being told, “You are welcome at this table.” So maybe we are making a difference, but progress is far too slow. For patients and families, the cost of engaging is far more than it should be, both emotionally and financially, as I mentioned earlier. It’s only because I run my own business that I was able to do what I did. I spent hours and hours investigating Harry’s death. We need the NHS to actively help make it easier for people to engage, and to overcome barriers such as financial cost and working hours. During our first meeting with the CQC, I realised that we had access to information that they didn’t—for example, they weren’t aware of a Royal College of Gynaecologists (RCOG) report about EKHUFT that was referenced in the Trust’s board papers. I had done the legwork to draw all the evidence together, which none of the statutory organisations had done. Eventually the CQC agreed to prosecute the Trust for unsafe care and treatment. The prosecution was successful, and the evidence we had collected contributed significantly to that. Lots of families whose babies have died due to harm in or after labour get in touch with me, and their experiences tell me that bereaved families are still being treated with suspicion and a lack of care. I recently discovered that some of the families who took part in the EKHUFT Kirkup investigation—and whose cases featured in the final report—are having to go through a whole new investigation process to claim compensation through NHS Resolution. That means reopening case notes and revisiting yet again the harrowing events that led to the deaths of their babies. The level of trauma this will cause for parents who had hoped the inquiry would bring the justice they need is huge. It is yet another example of how the system is not designed to support victims of harm, and how it fails to place compassion and dignity for patients and their families at the centre of pathways and processes. What do we still need to see change in how organisations respond to families when a loved one dies due to avoidable harm? We need people like me (but not me!) at the top of the NHS—‘real-life’ people who can represent the patient perspective at local board level and right up to the top of the NHS. Most of the people who are currently in leadership have only ever worked for the NHS or have worked there for years, and they don't know any other way of working. There’s an extent to which NHS leaders are institutionalised—they accept the foibles of the system as normal. In the face of serious patient safety concerns many seem to simply say, “No, that’s not what goes on here.” We need leaders who are upfront and honest and will say, “We made a mighty mistake and we’re sorry. We’ll do something about it.” We also need to see trust leaders being held to account. During our experience, we heard the phrase, “the Trust has done this,” a lot, with no individuals taking ownership of actions and decisions. Ultimately, people in leadership were responsible for so many of the lies we were told, but they never had to answer for that. In any other business, people would be held to account, but I am concerned that NHS leaders are allowed to do whatever they want. If this doesn’t change then very little else will. You can read more about the investigations into Harry’s death and Derek’s work to improve the safety of maternity care on the Harry’s Story website.