The Statutory duty of candour came into force for NHS bodies on 27 November 2014.

On the same day the CQC published their guidance for NHS organisations which governs the duty of candour as well as the fit and proper persons test. In this update, we look in detail at the duty of candour guidance.

The CQC guidance is an interim document, to be updated in April 2015 to include their advice on implementing all of the fundamental standards under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.  

What does the guidance say?

‘To meet the requirements of Regulation 20 (duty of candour), an NHS body has to:

  • Make sure it acts in an open and transparent way with relevant persons in relation to care and treatment provided to people who use services in carrying on a regulated activity.
  • Tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable patient safety incident has occurred, and provide support to them in relation to the incident, including when giving the notification.
  • Provide an account of the incident, which to the best of the health service body’s knowledge is true, of all the facts the body knows about the incident as at the date of notification.
  • Advise the relevant person what further enquiries the health service body believes are appropriate.
  • Offer an apology.
  • Follow this up by giving the same information in writing, and providing an update on the enquiries.
  • Keep a written record of all communication with the relevant person.’

How is it monitored?

During the registration process the CQC will test with providers that they understand the requirements of the regulation and ask them what systems they have in place to ensure they can meet these requirements.

The inspection process will focus on identifying good quality care. Two of the CQC’s specific key lines of enquiry (KLOEs) under the ‘safe’ and ‘well-led’ questions are relevant to the duty of candour:

  • S2 criteria: Are lessons learned and improvements made when things go wrong?

 Prompt: Are people who use services told when they are affected by something that goes wrong, given an apology and informed of any actions taken as a result?’

  • W3 criteria: How does the leadership and culture reflect the vision and values, encourage openness and transparency and promote good quality care?

Prompt: Does the culture encourage candour, openness and honesty?’

The CQC say that if, on inspection, they find care that is not of good quality, they will assess whether the service requires improvement or is inadequate. They will also consider whether any regulation has been breached, taking this guidance into account when doing so.

They advise that where the duty is breached, they will assess the impact on people and decide whether or not to take regulatory action in accordance with their Judgement Framework and Enforcement Policy.

Specific guidance

There is no substitute for reading the document which includes the CQC’s comments on each aspect of Regulation 20. Some of the key requirements are as follows:

  1. There should be a board-level commitment to being open and transparent in relation to care and treatment.
  2. Candour, openness and honesty should be encouraged at all levels, as an integral part of a culture of safety that supports organisational and personal learning.
  3. Providers should take action to tackle bullying, harassment and undermining, and must investigate any instances where a member of staff may have obstructed another in exercising their duty of candour.
  4. Staff should receive appropriate training, and there should be arrangements in place to support staff who are involved in a notifiable patient safety incident.
  5. There is no formal deadline under the Regulation for notifiying the relevant person of an incident but the guidance refers to the NHS standard contract provision which requires notification within ten working days of the incident being reported, and sooner where possible.
  6.  Where the degree of harm is not yet clear but may fall within the criteria in the Regulation (death, severe harm, moderate harm or prolonged psychological harm) the relevant person must still be informed of the incident in line with the Regulations.
  7. Although there is a requirement to investigate incidents which ‘could result in’ harm as described above, the CQC state that there is no need to inform a person under the Regulation when a ‘near miss’ has occurred, resulting in no harm to that person.
  8. Where the incident relates to care delivered by another provider, the NHS body should work with others at that provider who will then be responsible for notifying the relevant person of the incident.
  9. There is guidance as to what constitutes ‘reasonable support’, e.g. third party emotional or advocacy support, arranging further treatment - where necessary by a different team or provider - and providing support to access its complaints procedure.
  10. Where, despite reasonable attempts, the relevant person cannot be contacted, or does not wish to communicate with the provider (including historic incidents) a written record should be kept of the attempts to contact or speak with them.