On 1 April 2015, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 extended a new duty of candour, which was introduced in November last year for NHS bodies, to all service providers of regulated activities. This means that care providers need to put measures in place to ensure they can comply with the new duty.

What is the duty?

The duty of candour requires care providers to act in an open and transparent way in relation to care and treatment provided to service users. This duty applies to their dealings with the service user themselves, or, in limited circumstances, a person acting on their behalf. 

The new duty means that, as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, the provider must notify the relevant person that the incident has occurred, and provide reasonable support to them in relation to the incident. This notification must satisfy a number of requirements:

  • be delivered in person by one or more representatives of the provider;
  • provide an account, which to the best of the provider’s knowledge is true, of all the facts which the provider knows about the incident at that time;
  • advise what further enquiries into the incident the provider believes are appropriate;
  • include an apology;
  • be recorded in a written record which is kept securely; and
  • be followed up in writing including the information given verbally, details of any further enquiries to be undertaken and their results and an apology.

If the provider is unable to contact the service user or representative in person, or they decline to speak to the provider, a written record must be kept of attempts to make contact.

What is a notifiable safety incident?

A notifiable safety incident is defined as any unintended or unexpected incident that occurs in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, appears to have resulted in:

  • 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;
  • 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;
  • changes to the structure of the service user’s body;
  • the service user experiencing prolonged pain or prolonged psychological harm;
  • the shortening of the life expectancy of the service user; or
  • the requirement for treatment by a health care professional to prevent the service user’s death or any injury which would lead to one of the above outcomes if left untreated.

A similar definition is in place for health service bodies. 

Action points for care providers

It is important for care providers to ensure that when implementing procedures to ensure compliance with this new duty, they consider how this fits with their other reporting requirements. Where an incident occurs in the course of delivering care, there are a number of potential reports and notifications which may need to be made, including to the Care Quality Commission, the local safeguarding board and the Health and Safety Executive. 

Care providers will already have systems in place to ensure that notifications are provided to these organisations where necessary. The introduction of the new duty means where an incident occurs, care providers now need to take the additional step of assessing whether this falls within the definition of a notifiable safety incident, and therefore whether this new duty will apply. In addition to this, although many providers will already have policies in place to deal with notifying service users and their representatives where incidents have occurred, these will need to be looked at again to ensure that they meet the rigorous requirements of the new duty.