Guidance on the professional duty of candour

The professional duty of candour

Every health and care professional must be open and honest with patients and people in their care when something that goes wrong with their treatment or care causes, or has the potential to cause, harm or distress¹. This means health and care professionals must:

• Tell the person (or, where appropriate, their advocate, carer or family) when something has gone wrong
• Apologise to the person (or, where appropriate, their advocate, carer or family)
• Offer an appropriate remedy or support to put matters right (if possible)
• Explain fully to the person (or, where appropriate, their advocate, carer or family) the short and long term effects of what has happened

Professionals must also be open and honest with colleagues, employers, relevant organisations, and their regulators. They must support and encourage each other to be open and honest, and not stop someone from raising concerns.

Being open and honest with patients

Discuss risks before beginning treatment or providing care

Patients must be fully informed^4,5 about their care. When discussing care options, you must discuss the risks as well as the benefits. You or an appropriate person⁶ must give the patient clear, accurate information about the risks of the proposed treatment or care, and the risks of any reasonable alternative options, and check that the patient understands. You should discuss risks that occur often, those that are serious even if very unlikely, and those that the patient is likely to think are important.

When do I need to apologise to the patient?

This guidance applies when something goes wrong with a patient's care and they suffer harm or distress as a result. It also applies in situations where a patient may yet suffer harm or distress as a result of something going wrong with their care.

When you realise that something has gone wrong, and after doing what you can to put matters right, you or someone from the healthcare team must speak to the patient⁹. Usually the most appropriate team member will be the lead or accountable clinician¹⁰. If this is not you, then you must follow the guidance in paragraph 6.

When should I speak to the patient and what do I need to say?

You should speak to the patient as soon as possible after you realise something has gone wrong with their care. There should be someone available to support them (for example a friend, relative or professional colleague). You do not have to wait until the outcome of an investigation to speak to the patient, but you should be clear about what has and has not yet been established.

You should share all you know and believe to be true about what went wrong and why, and what the consequences are likely to be. You should explain if anything is still uncertain and you must respond honestly to any questions¹¹. You should apologise to the patient (see paragraphs 14-20).

What if people don't want to know the details?

Patients will normally want to know more about what has gone wrong. But you should give them the option not to be given every detail. If the patient does not want more information, you should try to find out why. If after discussion, they don't change their mind, you should respect their wishes as far as possible¹², having explained the potential consequences. You must record the fact that the patient does not want this information and make it clear to them that they can change their mind and have more information at any time.

Saying sorry

Patients expect to be told three things as part of an apology:

1. What happened
2. What can be done to deal with any harm caused
3. What will be done to prevent someone else being harmed

Apologising to a patient does not mean that you are admitting legal liability¹³ for what has happened. This is set out in legislation in parts of the UK¹⁴ and NHS Resolution also advises that saying sorry is the right thing to do¹⁵. A fitness to practise panel may view an apology as evidence of insight^16,17.

We do not want to encourage a formulaic approach to apologising since an apology has value only if it is genuine. However, when apologising to a patient, you should consider:

• You must give patients the information they want or need to know in a way that they can understand¹⁸
• You should speak to patients in a place and at a time when they are best able to understand and retain information
• You should give information that the patient may find distressing in a considerate way, respecting their right to privacy and dignity
• Patients are likely to find it more meaningful if you offer a personalised apology – for example 'I am sorry...' – rather than a general expression of regret about the incident on the organisation's behalf. This doesn't mean that we expect you to take personal responsibility for system failures or other people's mistakes (see paragraph 16)
• You should make sure the patient knows who to contact in the healthcare team to ask any further questions or raise concerns. You should also give patients information about independent advocacy, counselling or other support services¹⁹ that can give them practical advice and emotional support
• You should record the details of your apology in the patient's clinical record^20,21. A verbal apology may need to be followed up by a written apology, depending on the patient's wishes and on your workplace policy²²

Speaking to those close to the patient

If something has gone wrong that causes a patient's death or such severe harm that the patient is unlikely to regain consciousness or capacity, you must be open and honest with those close to the patient^3,23. Take time to convey the information in a compassionate way, giving them the opportunity to ask questions at the time and afterwards²⁴.

You must show respect for, and respond sensitively to, the wishes and needs of bereaved people. You must take into account what you know of the patient's wishes about what should happen after their death, including their views about sharing information. You should be prepared to offer support and assistance to the bereaved – for example by explaining where they can get information about, and help with, administrative and practical tasks following a death; or by involving other members of the team, such as nursing, chaplaincy or bereavement care staff^25,26.

You should make sure, as far as possible, that those close to the patient have been offered appropriate support, and that they have a specific point of contact in case they have concerns or questions at a later date.

Being open and honest with patients about near misses

A 'near miss' is an adverse incident that had the potential to result in harm but did not do so²⁷. You must use your professional judgement when considering whether to tell patients about near misses. Sometimes there will be information that the patient needs to know or would want to know, and telling the patient about the near miss may even help their recovery. In these cases, you should talk to the patient about the near miss, following the guidance in paragraphs 11–17.

Sometimes failing to be open with a patient about a near miss could damage their trust and confidence in you and the healthcare team. However, in some circumstances, patients may not need to know about an adverse incident that has not caused (and will not cause) them harm, and to speak to them about it may distress or confuse them unnecessarily. If you are not sure whether to talk to a patient about a near miss, seek advice from your healthcare team or a senior colleague.

Encouraging a learning culture by reporting errors

When something goes wrong with patient care, it is crucial that it is reported at an early stage so that lessons can be learnt quickly and patients can be protected from harm in the future.

All health and care organisations have a duty to support their staff to report adverse incidents. Health and care organisations should have a policy for reporting adverse incidents and near misses, and you must follow your organisation's policy.

A number of reporting systems and schemes exist around the UK for reporting adverse incidents and near misses. Patient safety incidents in England and Wales are reported to the National Reporting and Learning System, or its replacement, the Learn from patient safety events (LFPSE) service^29,30. You must use the UK-wide Yellow Card scheme³¹ to inform the Medicines and Healthcare products Regulatory Agency (MHRA) about serious suspected adverse reactions to a medicine and any suspected adverse reactions to products marked with a Black Triangle symbol (▼)³². Adverse incidents involving medical devices must be reported to the medical device safety lead in your organisation (if there is one) and the relevant national body³³.

In addition to contributing to these systems, you should comply with any system for reporting adverse incidents that put patient safety at risk within your organisation. If your organisation does not have such a system in place, you should speak to your manager and – if necessary – raise a concern in line with our guidance^36,37. Your organisation has a duty to support you to report adverse incidents and near misses routinely. If you do not feel supported to report, and if you are discouraged or prevented from reporting, you should raise a concern in line with our guidance^36,37.

You must not try to prevent colleagues or former colleagues from raising concerns about patient safety³⁸. If you are in a management role, you must make sure that individuals who raise concerns are protected from unfair criticism or action, including any detriment or dismissal.

You must take part in regular reviews and audits^39,40 of the standards and performance of any team you work in, taking steps to resolve any problems. You should also discuss adverse incidents and near misses at your appraisal^41,42.

Additional duties for doctors, nurses and midwives with management responsibilities

Senior clinicians have a responsibility to set an example and encourage openness and honesty in reporting adverse incidents and near misses. Clinical leaders should actively foster a culture of learning and improvement.

If you have a management role or responsibility, you must make sure that systems are in place to give early warning of any failure, or potential failure, in the clinical performance of individuals or teams. These should include systems for conducting audits and considering patient feedback. You must make sure that any concerns about the performance of an individual or team are investigated and, if appropriate, addressed quickly and effectively.

If you are managing or leading a team, you should make sure that systems, including auditing and benchmarking, are in place to monitor, review and improve the quality of the team's work. You must work with others to collect and share information on patient experience and outcomes. You should make sure that teams you manage are appropriately trained in patient safety and supported to openly report adverse incidents. You should make sure that systems or processes are in place so that lessons are learnt from analysing adverse incidents and near misses, lessons are shared with the healthcare team, concrete action follows on from learning, and practice is changed where needed.

The organisational duty of candour

All health and care organisations have a duty to support staff to be open and honest with patients if something goes wrong with their care. Each of the four UK governments has considered ways to implement the organisational duty of candour, with some writing it into law (see appendix 2).

Appendix 1: Extracts from GMC and NMC standards and guidance

From Good medical practice

45. You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you must follow our guidance on Openness and honesty when things go wrong: the professional duty of candour, and you should:

• Put matters right, if possible
• Apologise (apologising does not, of itself, mean that you are admitting legal liability for what has happened)
• Explain fully and promptly what has happened and the likely short-term and long-term effects
• Report the incident in line with your organisation's policy so it can be reviewed or investigated as appropriate – and lessons can be learnt and patients protected from harm in the future

73. To help keep patients safe you must:

• Contribute to confidential inquiries
• Contribute to adverse event recognition
• Report adverse incidents involving medical devices (including software, diagnostic tests, and digital tools) that put the safety of a patient or another person at risk, or have the potential to do so
• Contribute to incident reviews and/or investigations
• Report suspected adverse drug reactions
• Respond to requests from organisations monitoring public health

76. If you have a formal leadership or management role, you must take active steps to create an environment in which people can talk about errors and concerns safely. This includes making sure that any concerns raised with you are dealt with promptly and adequately, in line with your workplace policy and our more detailed guidance on Raising and acting on concerns about patient safety.

From Raising and acting on concerns about patient safety

13. Wherever possible, you should first raise your concern with your manager or an appropriate officer of the organisation you have a contract with or which employs you – such as the consultant in charge of the team, the clinical or medical director or a practice partner. If your concern is about a partner, it may be appropriate to raise it outside the practice – for example, with the medical director or clinical governance lead responsible for your organisation.

Medical professionals with extra responsibilities

21. If you are responsible for clinical governance or have wider management responsibilities in your organisation, you have a duty to help people report their concerns and to enable people to act on concerns that are raised with them.

22. If you have a management role or responsibility, you must make sure that:

• There are systems and policies in place to allow concerns to be raised and for incidents, concerns and complaints to be investigated promptly and fully
• You do not try to prevent employees or former employees raising concerns about patient safety – for example, you must not propose or condone contracts or agreements that seek to restrict or remove the contractor's freedom to disclose information relevant to their concerns
• Clinical staff understand their duty to be open and honest about incidents or complaints with both patients and managers
• All other staff are encouraged to raise concerns they may have about the safety of patients, including any risks that may be posed by colleagues or teams
• Staff who raise a concern are protected from unfair criticism or action, including any detriment or dismissal

From Leadership and management

24. Early identification of problems or issues with the performance of individuals, teams or services is essential to help protect patients.

From Decision making and consent

87. We use the term 'overall benefit' to describe the ethical basis on which decisions are made about treatment and care for adult patients who lack capacity to decide for themselves. This involves weighing up the risks of harm and potential benefits for the individual patient of each of the available options, including the option of taking no action. The concept of overall benefit is consistent with the legal requirements to consider whether treatment 'benefits' a patient (Scotland), or is in the patient's 'best interests' (England, Wales and Northern Ireland).

From Treatment and care towards the end of life

84. Death and bereavement affect different people in different ways, and an individual's response will be influenced by factors such as their beliefs, culture, religion and values. You must show respect for and respond sensitively to the wishes and needs of the bereaved, taking into account what you know of the patient's wishes about what should happen after their death, including their views about sharing information.

From The Code: Professional standards of practice and behaviour for nurses, midwives and nursing associates

Preserve safety – You make sure that patient and public safety is not affected. You work within the limits of your competence, exercising your professional 'duty of candour' and raising concerns immediately whenever you come across situations that put patients or public safety at risk. You take necessary action to deal with any concerns where appropriate.

14. Be open and candid with all service users about all aspects of care and treatment, including when any mistakes or harm have taken place

• 14.1 Act immediately to put right the situation if someone has suffered actual harm for any reason or an incident has happened which had the potential for harm
• 14.2 Explain fully and promptly what has happened, including the likely effects, and apologise to the person affected and, where appropriate, their advocate, family or carers
• 14.3 Document all these events formally and take further action (escalate) if appropriate so they can be dealt with quickly

16. Act without delay if you believe that there is a risk to patient safety or public protection

• 16.1 Raise and, if necessary, escalate any concerns you may have about patient or public safety, or the level of care people are receiving in your workplace or any other health and care setting and use the channels available to you in line with our guidance and your local working practices
• 16.2 Raise your concerns immediately if you are being asked to practise beyond your role, experience and training
• 16.3 Tell someone in authority at the first reasonable opportunity if you experience problems that may prevent you working within the Code or other national standards, taking prompt action to tackle the causes of concern if you can
• 16.4 Acknowledge and act on all concerns raised to you, investigating, escalating or dealing with those concerns where it is appropriate for you to do so
• 16.5 Not obstruct, intimidate, victimise or in any way hinder a colleague, member of staff, person you care for or member of the public who wants to raise a concern
• 16.6 Protect anyone you have management responsibility for from any harm, detriment, victimisation or unwarranted treatment after a concern is raised

Appendix 2: The statutory duty of candour for care organisations across the UK

England

Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 sets out a duty of candour. It requires all health and social care providers registered with the Care Quality Commission (CQC) to be open and transparent with people using services, and their families, in relation to their treatment and care. The regulation also sets out specific actions that providers must take when a 'notifiable safety incident' occurs. This includes informing people about the incident, providing reasonable support and providing truthful information and a timely apology. The CQC can prosecute for a breach of parts 20(2)a and 20(3) of this regulation.

Northern Ireland

In April 2021 the Department of Health (Northern Ireland) launched a consultation on Duty of Candour Policy proposals and a 'Being Open Framework'. The consultation outlined three policy proposals relating to a statutory duty of candour. The consultation followed recommendations for a statutory duty of candour made by the Inquiry into Hyponatraemia-Related Deaths, which reported in January 2018. This examined the circumstances relating to the deaths of five children in Northern Ireland hospitals.

Scotland

The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 and The Duty of Candour Procedure (Scotland) Regulations 2018 set out an organisational duty of candour on health, care and social work services in Scotland. The duty came into effect on 1 April 2018. The overall purpose of the duty is to ensure that organisations are open, honest and supportive when there is an unexpected or unintended incident resulting in harm or death, as defined by the Act.

Organisations are required to follow a duty of candour procedure which includes notifying the person affected, apologising and offering a meeting to give an account of what happened. The duty also requires the organisation to review each incident and consider the support available to those affected (this includes both those who deliver and receive care and support services).

Organisations are also required to publish an annual report on when the duty has been applied. This includes the number of incidents, how the organisation has implemented the duty and what learning and improvements have been put in place.

Alongside the legal requirements set by the Act, the Scottish Government has also published guidance on the implementation of duty of candour for all organisations that provide health services, care services or social work services in Scotland.

Wales

The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 place a number of duties on responsible bodies providing NHS care. This includes a duty to be open when harm may have occurred.

The Welsh Government's Health and Care Standards Framework includes a standard called 'listening and learning from feedback'. In meeting this standard, the framework advises that 'health services are open and honest with people when something goes wrong with their care and treatment'. The standards provide a framework for how services are organised, managed and delivered on a day-to-day basis.

On 1 June 2020, The Health and Social Care (Quality and Engagement) (Wales) Act 2000 became law and came into force on 1 April 2023. The Welsh government also issued The Duty of Candour Statutory Guidance 2023 on 1 April 2023 to support the implementation of the duty of candour.

The Act established an organisational duty of candour on providers of NHS services, requiring them to be open and honest with patients and service users when things go wrong. The legislation places a duty of candour on providers of NHS services (NHS bodies and primary care). The duty requires NHS providers to follow a process – to be set out in Regulations – when a service user suffers an adverse outcome which has or could result in unexpected or unintended harm that is more than minimal and the provision of health care was or may have been a factor.

The Act also requires NHS providers to report annually about when the duty has come into effect. The Welsh government also issued The Duty of Candour Statutory Guidance 2023 on 1 April 2023 to support the implementation of the duty of candour.