The Government accepted a recommendation from the Francis Report (2013) for a statutory organisational duty of candour to encourage openness and transparency in health services to prevent a repeat of the deliberate concealment of poor care and negligence found in the Mid Staffordshire Hospital scandal (Department of Health (DH), 2014).
The Government went further and argued that, unless health professionals were also professionally obliged to report poor practice and admit mistakes, then a culture of openness would not develop (DH, 2014).
There are two forms of the duty that now apply to nurses in England: an organisational duty that is imposed on the employing trust and a professional duty imposed by the Nursing and Midwifery Council (NMC). These duties have been in place since the spring of 2015 and cases are beginning to emerge where action has been taken against nurses and their employers in cases when there has been a failure to discharge a duty of candour.
Statutory Organisational Duty of Candour
The organisational duty of candour is imposed on healthcare providers in England under the provisions of the Health and Social Care Act 2008 and the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It applies to all health service bodies regulated by the Care Quality Commission (CQC), the statutory regulator for health services in England. Nursing services have been subject to these regulations since 1 April 2015.
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, regulation 20, requires nursing services to act in an open and transparent way with patients in relation to their care and treatment. It imposes a general duty to be candid with patients, whether or not there has been a complaint, and seeks to encourage an open, honest culture. In practice, the organisational duty of candour requires nurses to tell the patient or their representative about a notifiable patient safety incident as soon as is reasonably practicable after the incident.
There is currently no equivalent statutory organisational duty of candour with the legal force of England's in place in the other devolved health services, but there are general duties in Wales and Scotland for those services to be open and raise concerns.
In Wales, the National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 place a duty on the health boards providing NHS care to be open when harm may have occurred. The Scottish Government imposes a statutory duty of candour in its devolved health services through the Health (Tobacco, Nicotine etc and Care) (Scotland) Act 2016, Part 2.
Northern Ireland is currently considering the introduction a statutory duty of candour in health and social care following a recommendation of the Inquiry into Hyponatraemia-Related deaths (The report of the inquiry into hyponatraemia-related deaths 2018).
Notifiable Patient Safety Incident
A notifiable safety incident is defined as one where a patient suffered or could suffer unintended harm resulting in:
Duty to Give an Explanation and Apology
Once a notifiable patient safety incident has arisen, a full explanation of what is currently known and details of any further inquiry to be carried out must be given to the patient or their representative in a timely manner. The patient must also receive an apology. Both the explanation and apology must be made in person. The duty to explain and apologise incudes a requirement to support the patient during this process. This might include the provision of an interpreter to ensure the patient understands the explanation and is able to ask questions of the nurse. It also includes the need to give emotional support to the patient.
Once the patient has received an explanation and apology, the district nursing service is required to provide the patient with a written note of the discussion and must ensure that a written notice of the incident and copies of correspondence are kept for later inspection by the CQC.
The CQC used its enforcement powers to issued its first fine for a breach of the statutory duty of candour in 2019 when an NHS foundation trust had to pay £1250 for failing to give a timely apology to the family of a baby who had died as a result of a delay in diagnosis and missed opportunities to admit the baby to hospital. The trust did record it as a notifiable safety incident, but did not issue an apology to the family for some 3 months (Knight, 2019).
More recently, the CQC brought its first prosecution for failing to discharge the requirements of the statutory duty of candour. An NHS trust pleaded guilty in court of not being open with a patient's family about the circumstances of her death and for not apologising in a timely way. A district judge fined the NHS trust £12 565 and restated the importance of honesty and transparency in health care. The judge held that the family had not only had to come to terms with the death of a loved one, but also with the additional upset caused by the NHS trust's lack of candour (Morris, 2020).
Professional Duty of Candour
In its response to the Francis report (2013) the Government made clear that a statutory organisational duty of candour alone was not enough to promote openness and honesty in the NHS. In the Government's view, it was critical to ensure that registered health professionals also had an individual duty of candour imposed on them. A professional duty also ensures that those who seek to obstruct others in raising concerns will be in breach of their professional code and guilty of professional misconduct.
The NMC has introduced a professional duty of candour as Standard 14 of its revised Code in the spring of 2015 (updated in 2018). The standard requires that nurses must:
‘Be open and candid with all service users about all aspects of care and treatment, including when any mistakes or harm have taken place.’
The Code imposes not only a requirement to be open and candid, but also further requirements not to obstruct the raising of a concern and a duty to protect those who have raised a concern (Standard 16) (NMC, 2018:14). Nurses who fail to discharge their professional duty of candour can have their fitness to practice questioned for a breach of the standards of The Code (2015). Cases of professional misconduct in relation to a breach of the duty of candour have recently been concluded by the NMC.
A nurse was struck off when she gave a patient the wrong medication and then tried to cover up her mistake. The error occurred when the nurse administered the medicine to a patient who shared a first name with another patient. She failed to check the full details needed to properly identify the patient. The NMC fitnessto-practice panel found the nurse had breached her professional duty of candour and found her actions dishonest and worthy of having her name removed from the register (Brown, 2020).
A mental health nurse was suspended by the NMC when a fitness-to-practice panel found that a patient's death could have been prevented had the nurse completed an adequate mental health assessment, and found that she had given incorrect information to the coroner at the inquest. The fitness-to-practice panel held that the nurse had deliberately breached her professional duty of candour to cover up her error.
Guidance on the Duty of Candour
The NMC and the General Medical Council (2015) have issued joint guidance on the implementation of their professional duty of candour. The guidance makes clear that:
Nurses should apologise to the patient who will expect to be told three things as part of that apology: what happened, what can be done to deal with any harm caused, and what will be done to prevent someone else being harmed
Conclusion
Nurses are subject to a professional duty of candour that imposes an obligation to be open and honest with patients about errors that may cause them harm or distress. Failing to discharge that duty can result in a nurse's fitness to practice being questioned and has resulted in a nurse being removed from the register.
Health and care providers in England are subject to a further organisational duty of candour imposed under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, regulation 20, that requires nursing services to give an explanation a timely apology to a patient following a notifiable patient safety incident. Failure to discharge this duty has resulted in NHS trusts being fined or prosecuted by the CQC.
The NMC and GMC (2015) have issued joint guidance on how to discharge the professional duty of candour to ensure openness in nursing that protects patients and improves public confidence in nursing.