By | 15 February, 2018

Few healthcare professionals would argue with the sentiments of the Duty of Candour: being open and honest with patients and their families when things go wrong. After all, it is contained in the Nursing and Midwifery Council ‘Professional Code’ (2015) and the General Medical Council ‘Good Medical Practice’ guidance (2013). NHS organisations have also been subject to a contractual duty to be open and honest under the NHS standard Contract. But what impact does this have on organisations, now that it is law?

Definitions and Thresholds

The first consideration is the threshold of harm that triggers the statutory duty, bearing in mind that any breach could mean a financial penalty for the organisation and the potential for criminal sanctions.

Initially it was thought that the Duty of Candour would be restricted to patient safety incidents resulting in death or severe disability. The charity Action Against Medical Accidents (AvMA) had been campaigning for a Duty of Candour, or something similar, for over two decades and were vigorous in their opinion that it should cover ‘significant harm’.

Following the publication of the Francis Inquiry, the Secretary of State for Health asked Sir David Dalton Chief Executive of Salford Royal NHS Foundation Trust and Professor Norman Williams, President of the Royal College of Surgeons to consider the threshold.

Their recommendation, following consultation, was that the duty should include ‘Any unintended or unexpected incident that could result in, or appears to have resulted in, death of a service user or severe harm, moderate harm or prolonged psychological harm (more than 28 days continuous)’. These all come under a single heading of ‘significant harm’.

The issue of harm can be complex and raises uncertainties, including the difference between harm and complications. Moderate harm is described as ‘Harm that requires a moderate increase in treatment and significant but not permanent harm’. It could be argued that a recognised complication such as bleeding following anticoagulation therapy, requiring a hospital admission, meets the threshold of moderate harm. However many clinicians may not consider this a patient safety incident, particularly if all care had been taken and risks and benefits considered.

It is challenging to interpret the duty consistently when there are grey areas such as this. Investment in education and training across an organisation is paramount for staff to understand their responsibilities, provide consistency, and feel confident in triggering and applying the Duty of Candour.


The duty requires that any patient harmed, or their family, should receive a verbal apology and this should be followed up in writing. Details of any enquiries should be communicated, and when complete, should be made available to the person.

This creates an additional administrative obligation, which in most organisations will fall upon the governance/risk departments to fulfil.  Even from the point of reporting a patient safety incident and applying a harm threshold there needs to be clear documented evidence of the decision making process.

It could be argued that all of this should have been in place before the Duty of Candour was put on a legal footing, and there is value in that argument, but nevertheless it has become a greater bureaucratic burden and this needs to be considered and supported appropriately, starting by identifying who at the organisation will facilitate the Duty of Candour process.

The Care Quality Commission (CQC) is responsible for monitoring the application of the Duty of Candour. Organisations will need to be able to evidence their compliance and this requires that they have clear documentation, easily retrievable if required.

Fear of Litigation

When the Duty of Candour was put on a legal standing, many clinicians voiced concerns of increased litigation, despite their professional responsibility to be open and honest with patients. There does not appear to be much evidence to support this view, although data is limited. On the contrary, there is a belief that it may even reduce clinical negligence claims as the Duty of Candour seeks to improve healthcare by acknowledging when things go wrong and creating an open and honest culture where lessons can be learnt.

In his evidence to the Francis Inquiry the Chief Executive of AvMA made the point that ‘people felt driven to take legal action, not by the original medical accident, but by what they regarded as unreasonable denial or dishonesty’.  This is another view that would support the belief that negligence claims may reduce.

The NHS Litigation Authority (NHSLA) has been clear in their response to these concerns and in their guidance on candour advises that candour is all about sharing accurate information with patients and should be encouraged. The NHSLA ‘Saying Sorry’ advice adds ‘ Saying sorry is not an admission of legal liability; it’s the right thing to do’.

Education and Training

To facilitate the implementation of Duty of Candour, organisations need to invest in education and training and have systems in place to support staff with this process. Understanding the principles and statutory requirements is paramount for staff, but importantly staff should feel confident to have difficult conversations with patients and/or their families.

Saying sorry sounds easy, but can be very challenging. An educational programme should include the principles of ‘Being Open’ and be part of a wider focus upon patient safety and service improvements. Ensuring staff have access to high quality training is essential. For those who lack confidence a blended learning approach including role play that focuses on communication skills can be extremely helpful, as can the provision of counselling services to support staff faced with difficult conversations.

This is the third in a three-part weekly blog series by Elaine Spencer on the topic of Duty of Candour and the requirement for openness in the NHS. Subscribe for future blog posts by entering your email address above.

Relias released its Duty of Candour e-learning course on 1st February 2018. To experience the course, and discover how it can help your healthcare staff, simply fill out the form below. 

Elaine Spencer

Governing Body Equality and Diversity Lead, Safety & Quality Team at Brighton and Sussex University Hospital Trust

Elaine took up her post as a Governing Body Member at Dorset CCG in August 2016 with a focus on quality. She also fulfills the role of the Freedom to Speak up Guardian and is the Governing Body Equality and Diversity Lead. Elaine has most recently been working within the Safety & Quality Team at Brighton and Sussex University Hospital Trust investigating serious incidents and leading on the introduction and monitoring of the statutory Duty of Candour. Elaine has previously worked as a Consultant Nurse in Cardiology at Guys and St Thomas NHS Foundation Trust introducing and evaluating nurse-led services and as a Clinical Director of S&C Healthcare providing clinical and management services to the NHS. She has been involved in, designing, delivering and commissioning innovative services, including complex care pathways. Elaine has shared her knowledge and expertise widely as a public speaker, a lecturer and is widely published.


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