The Care Quality Commission (CQC) has updated its guidance for providers on Regulation 20: The Duty of Candour, here, making it clear that an apology, required to fulfil this statutory duty, does not mean accepting liability and will not affect a provider’s indemnity cover regardless of the health or social care, public or private sector involved.
The message, that the risk of legal action should never prevent an apology, is so important that the organisation which manages clinical negligence claims against the NHS, the NHS Resolution, has published advice, Saying Sorry, here, where Chief Executive Helen Vernon states openly: “We have never, and will never, refuse cover on a claim because an apology has been given.”
In fact, both organisations say delayed or poor communication, or the lack of a timely apology, makes it more likely that a patient and/or their family will seek information in a different way such as complaining or taking legal action.
The Duty of Candour is ultimately a way of ensuring providers face up to mistakes, so they can learn from them when there are notifiable safety incidents. It requires all health and social care providers, including NHS trusts, to be open and transparent with the people who use their services and their families, in relation to their treatment and care.
The CQC updated its guidance in March 2021 to support all health and social care providers to fully understand this legal duty, to clarify the circumstances in which it must be applied, and to know what they have to do to carry it out.
Beyond learning lessons and limiting legal action, the guidance is very clear that saying sorry is “always the right thing to do”, it “acknowledges that something could have gone better” and, as well as being what families and carers expect morally, they have a right to expect it. So, to fulfil the duty, providers must apologise for the harm caused, “regardless of fault, as well as being open and transparent about what has happened”.
The reason for a statutory Duty of Candour
A public inquiry led by Sir Robert Francis QC into events at Mid-Staffordshire NHS Foundation Trust uncovered appalling patient care compounded by systemic failings, poor leadership and a lack of openness, transparency and candour, which allowed maltreatment to carry on and exposed limitations in professional regulation. It was the report, published in December 2013, here, that first recommended the introduction of a statutory duty of candour. This also followed a campaign by the parents of Robbie Powell who died in 1990 and whose case highlighted the need to legislate for this new duty.
The Government’s response to the report was published in January 2014, Hard Truths: The Journey to Putting Patients First, here, which made a pledge to introduce the new statutory duty for all CQC registered health and care providers.
To address the evidence of a system guilty of “cover-ups” in the face of failings, Regulation 20: Duty of Candour of the Health and Social Care Act 2008 (Regulated Activities) 2014 became the first legislation of its kind in the world. It applied to health service providers from October 2014 and to adult social care providers from April 2015.
Overseen by the CQC, it compliments and strengthens the existing professional and contractual duty of candour requirements, overseen by bodies such as the General Medical Council (GMC), Nursing and Midwifery Council (NMC) and the General Dental Council (GDC), but in addition is enforceable by law.
From 1 April 2019, NHS Resolution asked to be informed of “notifiable patient safety incidents” which have or may have resulted in severe harm as soon as possible and no later than one month after becoming aware of the incident. New requirements issued April 2021, for when and how to report an incident, are available here.
The statutory duty includes specific requirements for certain situations known as “notifiable safety incidents”, which are incidents categorised as death, moderate harm, severe harm or prolonged psychological harm. A notifiable safety incident must meet all three of the following criteria.
It must have been unintended or unexpected.
It must have occurred during the provision of an activity that the CQC regulates.
In the reasonable opinion of a healthcare professional, already has, or might, result in death, or severe or moderate harm to the person receiving care (this varies slightly depending on the type of provider).
The CQC has provided information about identifying a “notifiable safety incident”, and its definitions of “harm” are here.
How to apologise
The person representing the provider must:
tell the relevant person about the incident face-to-face as soon as possible
give an account of the known facts
offer appropriate support
notify the CQC.
Where the incident has led to the death of a patient, the Duty of Candour applies to the patient’s family members or carers.
The person representing the provider must also:
advise family members or carers about any more enquiries that are planned
what will be done to find out more
apologise on behalf of the provider
tell patient and family that they will be kept informed.
The CQC says the apology means “that the provider is admitting fault and expressing regret for harm caused but is not the same as admitting liability.”
NHS Resolution’s leaflet, Saying Sorry, here, says everyone can say sorry but they may need to be supported to do so.
NHS Resolution advises that an apology should show “sincere regret” that something has gone wrong. It should be confidential, tailored to the individual patient’s needs, in person where possible as well as in writing, involve the right members of the healthcare team, and should be “heartfelt” and “sincere”.
It is important to avoid acronyms and jargon in all communications. NHS Resolution lists clear “dos and don’ts” for the wording of a compassionate apology, in its leaflet, here.
Failure to comply with regulation 20 can lead to CQC issuing requirement notices or taking enforcement action.
CQC advice and support
The CQC’s, Nigel’s Surgery 32: Duty of Candour and General Practice (regulation 20), here, provides information about the processes the CQC will follow when checking that providers comply with the Duty of Candour regulation, including the specific key lines of enquiry (KLOEs) and illustrative examples for General Practice that trigger the thresholds for the duty.
The CQC’s spotlight on learning, candour and accountability
A year after a review commissioned by NHS England uncovered failings at Southern Health NHS Foundation Trust spanning from April 2011 to March 2015, the CQC launched its own inquiry into the way NHS trusts review and investigate the deaths of patients in England. It was prompted by very low numbers of investigations or reviews of deaths at the Trust, especially in its learning disability services and mental health services for older people.
The CQC’s report, Learning, Candour and Accountability, here, published in December 2016, concluded that many carers and families did not experience the NHS as being open and transparent, that they were not consistently treated as equals with kindness, compassion, respect and honesty, and that families were not always informed or kept up to date about investigations, ”something that often causes further distress and undermines trust in investigations”.
One of the observations was that barriers to learning were "most notable where care is provided outside of hospital settings and where multiple providers are involved”.
Recommendations included for leaders of national oversight bodies and Royal Colleges to work together with families to develop a new single framework on learning from deaths. This would include the provision of guidance on the expectation that “the involvement of lawyers should be limited” but, where they are involved, there should be “a focus on advising in the context of NHS values, the Duty of Candour, and the principles of patient partnership/involvement”.
It also said NHS Improvement and NHS England, with support from the CQC, should lead work to define what families and carers can expect from healthcare providers when they are involved in an investigation process.
This wasn’t the end of the issue for the CQC. In 2018 CQC Chief Inspection of Hospitals Ted Baker reinforced the regulator’s commitment to ensuring a robust and consistent assessment of the Duty of Candour at registration, on inspection and through its ongoing monitoring activity. He said: “We recognise there is more we can do to improve and as part of this we are currently reviewing our approach to assessing compliance with the Duty of Candour regulation across all sectors to identify where our regulatory processes may be strengthened further.”
He said this year, "good progress” has been made by many providers but more needs to be done “to ensure that the culture of openness is fully embedded”.