When the statutory duty of candour was introduced, there was some confusion about how it would operate. While that initial confusion has subsided, we do still receive a number of queries from our clients about it. Here, Gill Stoll and Sally Lock review some of the most common questions, and consider what the future may hold for this organisational duty. In addition to the statutory obligations placed on organisations, individual practitioners have a professional duty to adopt a duty of candour.

Background to the duty

During the Mid Staffordshire inquiry Sir Robert Francis QC called for openness and transparency within the healthcare industry. As part of this, he advocated a statutory duty of candour, to ensure that patients harmed by a healthcare service were informed that this had happened, and that an appropriate remedy would be offered, whether or not a complaint had been made. This was by no means a new concept for the NHS, as there had been a contractual duty of candour since 1 April 2013 under the NHS Standard Contract. However the new duty placed matters on a statutory footing as one of the 12 new ‘fundamental standards’ of safety and quality below which care should never fall, introduced by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The duty of candour is an organisational duty and failure to comply can attract a fine.

The statutory duty has applied to all NHS bodies since 27 November 2014, and was extended to all other CQC registered providers on 1 April 2015. Prisoners are entitled to the same standard of healthcare and treatment as those in the wider community (Zinzuwadia –v- Home Office [2001] EWCA Civ 842). The rules apply to them in exactly the same way as they do to the wider population.

What is the duty?

As well as a general duty under regulation 20(1) to act in an open and transparent way with relevant persons in relation to the service user’s care and treatment, there is also a specific duty under regulation 20(2) which requires that:

‘As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must (a) notify the relevant person that the incident has occurred and (b) provide reasonable support to the relevant person in relation to the incident.’

Is the duty being implemented?

We have engaged with a number of trusts and other healthcare organisations to gauge the impact of the new duty, speaking with individuals at a range of levels from senior managers through to front line staff. Our resounding impression is that very real efforts are being made to generate a culture of candour and to ensure that this is embedded within the very heart of the organisations we have worked with. This is encouraging. In our view, achieving buy in from staff at all levels really is the key to ensuring that the duty is implemented.

Practical points

Whilst useful guidance has been provided by the CQC and jointly between the GMC/NMC, below is a reminder of some of the relevant points:

What is a notifiable patient safety incident (NPSI)?

A NPSI is any unintended or unexpected incident that has occurred during the provision of care or treatment, which has or could result in one of the four harm thresholds: death, serious harm, moderate harm and/or prolonged psychological harm (for a period of over 28 days).

Identifying moderate harm

Moderate harm is:

  1. a moderate increase in treatment, which might include an unplanned return to surgery or re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, the cancellation of treatment or transfer to another treatment area; and
  2. significant, but not permanent, harm.

How quickly is ‘as soon as reasonably practicable’?

Notifications to patients/the relevant person should be made ‘as soon as is reasonable practicable’. This should be as soon as possible and in any event within 10 working days. If, after 10 days, there is little information known, it would be appropriate to acknowledge the incident, confirm that further investigations will be conducted and set out what those further investigations will look like.

Who is the ‘relevant person’?

Where the patient has died, lacks capacity or is under 16 and is not competent to make treatment decisions, this can be anyone lawfully entitled to act on their behalf. In the prison setting, it is likely to be the person identified by the prisoner to be contacted on their behalf. If no such person exists and/or the patient had identified that they would not wish anyone else to be contacted, this should be clearly documented.

How can an apology be made?

The statute provides that an apology must be given. This should not amount to an admission of liability, but an expression of ‘sorrow or regret’ for the harm that has arisen. The discussion should be in person, with careful consideration given to who would be best placed to undertake it. This will often be the clinician or nurse with overall care of the patient, but not necessarily. If, for example, the relationship with the patient has broken down it might be better to involve a neutral party.

How can we keep an audit trail?

It is crucial that a written record is made confirming that the verbal discussion has taken place and that this is kept securely. A note in the medical records is sufficient, often supplemented by an incident reporting programme. There is also a requirement to provide written notification to the relevant person containing the detail of the verbal notification, the outcome or results of any further investigations, and a written apology. If the relevant person cannot be contacted or declines to speak with you, a written record should be kept of any attempts to engage with them. This is the only way you can show that the duty is being properly implemented and is therefore a vital element of the process which must not be overlooked.

What should we do if we identify an incident involving another provider?

You should not speak on behalf of another provider, but it is important to notify them that you have identified an issue and ask them to make enquiries and to comply with their statutory duty.

The future

The duty of candour is consistent with a whole host of other patient safety initiatives aimed at highlighting and learning from errors, to improve patient outcomes.

At three to four years after the implementation of the statutory duty of candour, in our view organisations should be ready to show the CQC that members of staff are truly familiar with the duty. This includes demonstrating that staff have been appropriately trained and supported and that local policies have been properly updated. There should also be a readily accessible system to evidence incident reporting and patient notification, but most importantly of all that a ‘culture of candour’ exists and is being actively nurtured.