The Care Quality Commission (CQC) has updated its guidance to healthcare providers about when they must notify and apologise to patients under the duty of candour after things go wrong. The new guidance uses specific explanations and examples of the type of safety incidents that must be communicated to the patient under the duty of candour. It also makes clear that an apology given under the duty of candour is not a legal admission of liability and does not affect the healthcare provider’s indemnity (claims insurance) cover. What is the duty of candour?The CQC is responsible for regulating and inspecting health and social care services in England.The duty of candour was introduced into its regulations in 2014, following recommendations made by the Francis Report into multiple failings in care at Mid Staffordshire NHS Foundation Trust. Since 2014, all providers of health and social care that are regulated by the CQC have been legally required to comply with the duty of candour by being open and honest with patients after things go wrong during their care.Healthcare professionals, such as doctors, midwives and dentists, also have a professional duty to be open and transparent with the people they are treating. Their professional duty of candour is overseen by the professional regulators for their particular qualification or area of specialism, such as the General Medical Council (GMC) for doctors, the Nursing and Midwifery Council (NMC), and the General Dental Council (GDC). In addition to each individual’s own professional duty, the CQC regulates all registered health and social care organisations’ legal (statutory) duty to be open and transparent with patients about their care.Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 imposes a statutory duty on health care providers to notify patients (and in some cases their families) as soon as the healthcare provider becomes aware that something has gone wrong with their care or treatment. Regulation 20 ( the statutory duty of candour) sets out specific actions that the healthcare provider must take after healthcare or treatment goes wrong, including:informing the patient about the incident; providing reasonable support,providing truthful information about what has happened;giving an apology. How does the duty of candour help patients when things go wrong?The CQC’s updated guidance on the duty of candour now makes it clear what the CQC expects healthcare providers to do as soon as reasonably possible after they become aware of a ‘notifiable safety incident’ in the ‘service user’s’ care.Regulation 20 contains very specific definitions, but put simply, the duty of candour relates to any unintended or unexpected incident suffered during a patient’s care which could or did lead directly to their death, severe or moderate harm, or prolonged psychological injury.When this occurs, the healthcare provider’s duty of candour includes:notifying the patient that the incident has occurred:in person by one or more of the healthcare provider’s representatives;giving a truthful account of all the facts that the provider knows about the incident at that time;advising what further enquiries into the incident are appropriate;including an apology;recording the notification in a written record kept securely by the care provider;keeping a written record of all attempts to contact the patient if they cannot be contacted or decline contact;providing reasonable support to the patient;following up by sending the patient a written notification, which contains:the information previously given about the incident;details of any enquiries to be undertaken;the results of any further enquiries they have carried out;an apology.This information must be given to someone who is lawfully acting on the patient’s behalf:where the patient died; where the patient is under 16 and is not competent to make decisions about their care or treatment;where the patient is 16 or over but lacks mental capacity.What does it mean when a doctor says sorry? The CQC says that the apology that must be given under the duty of candour is ‘an expression of sorrow or regret in respect of a notifiable safety incident’. CQC tells healthcare providers that to fulfil their duty of candour they must apologise for the harm caused, regardless of fault, as well as being open and transparent about what has happened.NHS Resolution, the NHS defence organisation which manages and defends medical negligence claims made against the NHS, also reiterates that an apology should be made to the patient when something goes wrong during their care. In their 2017 guidance leaflet to NHS staff, Saying Sorry, NHS Resolution advised NHS staff that saying sorry:is always the right thing to do;acknowledges that something could have gone better;is the first step towards learning from what happened and preventing it from recurring.Both CQC and NHS Resolution make clear that an apology must be given but it is not an admission of fault or liability. They also reassure healthcare practitioners that their indemnity (covering claims against them) insurance will not be affected by them apologising to a patient. NHS Resolution states in its Saying Sorry guidance, “We have never, and will never, refuse cover on a claim because an apology has been given.” Given that reassurance, there is no excuse for failing to apologise to a patient after something has gone wrong.What happens if a healthcare professional or organisation fails to comply with duty of candour?Where a healthcare provider fails to comply with the statutory duty of candour after a patient suffers harm as a result of a notifiable safety incident, the CQC can prosecute the non-compliant healthcare provider or take other regulatory action.Does the duty of candour give an injured patient a right to compensation?Making an apology and acknowledging when things have gone wrong can sometimes be the first step towards making amends for an injured patient. It does not entitle the patient to compensation.If you believe that you, or a member of your family has suffered serious injury as a result of medical negligence you should seek advice from solicitors who specialise in medical negligence claims for patients, to discuss your entitlement to compensation.If you are offered compensation directly by NHS Resolution after you or your child has suffered a severe injury, it is essential that you seek independent legal advice before accepting any offer. You may be at risk of settling your claim irrevocably for significantly less than it is worth. In these circumstances, we advise you to contact us straight away. If you have suffered serious injury as a result of medical negligence and would like to find out more about making a claim, contact us by email at email@example.com.