The CQC has recently fined an NHS Trust for not complying with the Duty of Candour by virtue of a delay in providing an apology to the family as required by regulation 20 (3)(d) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“the Regulations”). It provides a timely reminder of the CQC’s focus on enforcement and an opportunity for providers to review their compliance with the Duty of Candour.

First things first, don’t forget there are two distinct duties of candour

The Regulations are clear—providers have a duty to act in an open and transparent way with people in relation to the care and treatment provided to them. There is no ‘harm threshold’ for this and it applies to all care and treatment provided. Equally, there is no prescribed manner in which to discharge this duty; it is common sense.

In addition to this generic duty of candour, a separate duty of candour applies in all cases where there has been a ‘Notifiable Safety Incident’. We will refer to this as the ‘specific duty of candour’. It is this duty which requires a face to face discussion with the user of the service (or their lawful representative), followed up with a letter.

What is a ‘Notifiable Safety Incident’?

The first, and arguably most difficult, step is to determine whether an incident is a ‘Notifiable Safety Incident’ and therefore whether the specific duty applies at all. If in doubt about what constitutes a ‘Notifiable Safety Incident’ for the purposes of deciding if the specific duty of candour applies, then there is no substitute for considering the wording of the Regulations themselves. The regulations also make it clear that the definition of ‘Notifiable Safety Incident’ is different for ‘health service bodies’ than for other registered providers of care.

There is potential for confusion here due to the plethora of terminology used in connection with incidents and which is frequently referred to in policies and guidance alike. This is especially so within the NHS so we have referred to the most common terms below and explained how these relate to the specific duty of candour placed on NHS providers:

• Serious Incidents: as per the Serious Incident Framework, all Serious Incidents are to be reported via STEIS within 2 working days of being discovered. All serious incidents involving the provision of care to patients as defined in the SI Framework will also be Notifiable Safety Incidents and will therefore trigger the specific duty of candour, except near misses.
• Near misses: can be a ‘serious incident’ but will not be caught by the specific duty of candour due to the lack of harm occurring.
• Patient Safety Incident: defined in the SI Framework as ‘any unintended or unexpected incident that could have led or did lead to harm for one or more patients receiving NHS-funded healthcare’. Patient Safety Incidents will be reported by NHS Trusts via the NRLS. Those patient safety incidents leading to death, serious or moderate harm or prolonged psychological harm will also be ‘Notifiable Safety Incidents’ and therefore trigger the specific duty of candour. ‘No harm’ or ‘low harm’ incidents will not be ‘Notifiable Safety Incidents’ and will not trigger the specific duty of candour.

Avoiding prosecution

A breach of certain requirements of the Regulations constitutes a criminal offence.  We are seeing the CQC using its criminal enforcement powers to pursue these breaches either by way of issuing fixed penalty notices of up to £1,250 or by prosecuting through the Courts with a view to securing fines of up to £2,500 per breach.

It is important to be clear on the various components of the specific duty of candour to avoid the risk of a criminal prosecution for breach of the Regulations. A failure to comply with any of the following elements of the proper discharge of the specific duty of candour will constitute a criminal offence:

• Notification ‘as soon as reasonably practicable’ after becoming aware that a Notifiable Safety Incident has occurred. Unreasonable delay in carrying out the notification will expose the provider to the risk of prosecution.
• The notification needs to be given ‘in person’ by a representative of the Trust
• Provision of an account of all the facts of the incident known at that time
• Advice as to what further enquiries into the incident will be undertaken
• An apology
• A written record of the notification must be kept securely by the Trust

Providers should ask themselves how they would provide evidence that each of the above requirements has been met in any given case. For example, where is the written record of the notification kept? Is it clear from the written record that each and every one of the requirements has been complied with and by whom? Do all staff who are involved in candour discussions with patients and their families have sufficient training to discharge the specific duty of candour and meet all of the above requirements?

Other requirements

The Regulations contain other important requirements regarding the specific duty of candour, but a breach of these will not constitute a criminal offence—for example, following up the verbal notification with a written notification (also to include an apology). Breaches of these elements are likely to lead to regulatory action by the CQC in the form of adverse findings at inspection, poor ratings and/or the issuing of Requirement Notices, Warning Notices or Conditions, but cannot lead to a criminal prosecution.