Regulation 20: Duty of Candour

The start of this month saw the implementation of Regulation 20: Duty of Candour, as part of the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015. This important new regulation was introduced in response to the Francis Report 2013, which recommended a statutory duty of candour be introduced for all health and care providers. Read on to learn more about the report and the steps you should take to ensure you comply with the Regulation 20: Duty of Candour.

The report defined 3 key areas that apply to all providers and which the Care Quality Commission (CQC) has adopted as part of its approach to this regulation:

  1. Openness: enabling concerns and complaints to be raised freely and questions asked to be answered.
  2. Transparency: allowing information about the truth concerning performance and outcomes to be shared with staff, service users, the public and regulators.
  3. Candour: any service user harmed by the provision of a service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made, or a question asked about it.

From April 1st, the CQC will expect all providers to meet this regulation both during inspection and at the point of registration. Any breach of the regulation will lead to an assessment of the impact on service users and the risk of regulatory action. Guidance from the CQC on the Duty of Candour states that, to meet the requirements of Regulation 20, a registered provider has to:

  • Make sure it acts in an open and transparent way with relevant persons, in relation to the care and treatment provided to people who use services carrying out a regulated activity.
  • Tell the relevant person, face to face, as soon as reasonably practicable after becoming aware that a notifiable 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 provider’s knowledge, is true of all the facts the person knows about the incident, as at the date of the notification.
  • Advise the relevant person what further enquiries the provider believes are appropriate.
  • Offer an apology.
  • Follow up the apology 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.

5 Essential Steps for Duty of Candour Compliance

    1. Communication. Communicate to all staff, irrespective of seniority, the importance of understanding their role in being open and transparent about any incidents or concerns and in sharing information with other relevant persons when things go wrong.
    2. Policies. Ensure that your policies are updated to encourage a culture of openness, honesty and transparency and that staff trust that they will be implemented in practice. Pay particular attention to protecting whistleblowers and take action against anyone who obstructs an individual from exercising their duty of candour.
    3. Reporting. Regulation 20 sets out ‘harm thresholds’, to indicate what constitutes a notifiable safety incident. These are broadly in line with existing thresholds for the notification of deaths and serious injuries and include any incident which appears to have resulted in:
      1. 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.
      2. An impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days.
      3. Changes to the structure of the service user’s body.
      4. The service user experiencing prolonged pain or prolonged psychological harm.
      5. The shortening of the life expectancy of the service user.
  1. Professional regulation. Staff such as nurses who are professionally registered are subject to a duty of candour under their own code of conduct. If found to be in breach of this duty, you should be aware that you may need to refer the case to the relevant professional regulatory body.
  2. Further information. For full details of this new regulation, including examples of reportable incidents, read the full guidance document entitled Regulation 20: Duty of candour – Information for all providers: NHS bodies, adult social care, primary medical and dental care and independent healthcare, available from the CQC website.

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