Maintaining the statutory duty of candour

The requirement for openness and honesty of those in the health and social care sector about the care provided to service users, particularly when things have gone wrong (referred to as the duty of candour), is a key duty that has been at the forefront of the media recently.

Both providers of health and social care services and individual professionals are subject to the “duty of candour” and the duty can take many forms, including statutory, contractual and professional.

The statutory duty of candour applies to all care providers registered with the Care Quality Commission and has applied to NHS providers since October 2014. The duty is set out in section 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and requires providers to:

• Act in an open and transparent way in relation to care and treatment provided to service users;
• As soon as reasonably practicable after becoming aware of a notifiable safety incident, providers must notify the service user and/or their representative that the incident has occurred;

The notification should be given in person (unless you have been unable to – in this instance providers should keep written records of attempts to contact the relevant person), provide an account of all the facts that are known as at the date the account is given, advise what further enquiries are believed to be appropriate and include an apology.

• Follow up any notification in writing and keep a secure written record of the notification and incident. Written notifications should include the above referenced information along with details of any enquiries to be undertaken and the results of any further enquiries into the incident;
• Provide reasonable support to the relevant person in relation to the incident.

For health service bodies the term “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of any service user during the provision of a regulated activity that, in the reasonable opinion of a healthcare professional, could result in or appears to have resulted in (a) the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition, or (b) severe harm, moderate harm or prolonged psychological harm to the service user.

CQC guidance on the duty of candour confirms that where the degree of harm is not yet clear but may fall into the above categories in future, the relevant person must be informed of the incident in line with the regulation.

Compliance with the statutory duty of candour is a legal requirement and the CQC is able to take enforcement action where relevant breaches are identified. If a provider commits a regulation 20 offence the maximum penalty is £2,500. It should be recognised that the statutory duty of candour applies to organisations, not individuals.

Therefore, if individuals within an organisation do not act in accordance with the requirements placed on providers under the statutory duty, this will be an internal matter to be resolved by the provider themselves. Providers should be doing all they can to ensure their staff are aware of the obligation and take appropriate action where required.

Reflections on errors

There have been a number of matters in the news lately that link to the duty of candour, most notably the proceedings relating to Hadiza Bawa-Garba. In this case Dr Bawa-Garba made a mistake which led to the death of a six year old boy. As a result of the mistake, she was convicted of manslaughter by gross negligence and subsequently the General Medical Council successfully argued that she should be struck off the medical register.

Mr Hunt has called for a rapid review into the application of gross negligence manslaughter in healthcare

Following the court decision in favour of the GMC, it has been suggested that doctors may be dissuaded from being candid about their reflections on errors which could also impact on potential learning in relation to mistakes thus having an impact on the quality of medical care and treatment.

Health and social care secretary Jeremy Hunt has expressed concern about the Bawa-Garba case, in particular in relation to the concern that doctors who want the freedom to learn from their mistakes might not have a voice.

As a result of the case, Mr Hunt has called for a rapid review into the application of gross negligence manslaughter in healthcare. The review will look at how to ensure that reflective learning continues and mistakes are not covered up as well as any lessons to be learned by the GMC.

He stated the review needs to consider “How we ensure clarity in where the line is drawn between gross negligence manslaughter and ordinary human error in medical practice so that doctors and other health professionals know where they stand in respect to criminal liability and professional misconduct.” The review is expected to be completed by the end of April 2018.

The case is a clear reflection of what could go wrong and how professionals and organisations may be dissuaded from complying with the duty of candour, whether statutory or professional, as a result of the potential additional action that could be taken as a result of owning up to and apologising for mistakes.

How to comply with the duty of candour

To ensure compliance with the statutory duty of candour providers need systems and procedures in place that promote openness and transparency with service users and/or their representatives. In particular, the development of appropriate policies and systems, including staff training on such systems, may be required to ensure that staff can identify and report harm appropriately.

The CQC requires providers to be taking steps to ensure that there is good organisational management and leadership in place to encourage and support staff to be open with service users and to drive a culture change towards more openness and transparency. Operating with an open and honest learning culture in which staff feel empowered to admit mistakes and raise concerns is key to ensuring the duty of candour is complied with.

In light of the continued budget deficit within the NHS, the maintenance of positive cultures continues to be one of the biggest challenges facing the healthcare system.