The regulations implementing a new statutory duty of candour come into force today.  For those responsible for managing NHS services, what is going to change?  In short, this is the first time a clearly defined standard has been applied across the NHS.  This is also the first time that NHS trusts which are not open with patients in the aftermath of harmful incidents face the possibility of criminal proceedings.  These carefully drafted regulations set out a series of very specific requirements:

  • Inform the patient or their representative as soon as reasonably practicable after any incident which has, or may have, resulted in moderate or severe harm, death or prolonged psychological harm. This includes:
    • An account of what is known about the incident at that date;
    • An explanation of further enquiries which are appropriate; and
    • An apology.
  • Provide reasonable support to the patient or their representative;

The duty will be enforced by the Care Quality Commission (CQC).  Along with the creation of a criminal offence, compliance with the duty of candour forms an essential element of the CQC’s inspection regime and failure to have systems and processes may affect the CQC rating of the trust.

Therefore, the very first priority for NHS managers must be to ensure that the trust’s existing policies on being open with patients are both clear and clearly communicated to all those working within the organisation.  The specific incidents which are must be disclosed to patients under the regulations are carefully defined:

“any unintended or unexpected incident that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in the death of a service user or severe harm, moderate harm, or prolonged psychological harm."

Critically, the regulations also require disclosure of incidents which could cause harm, thereby encompassing possible future harm arising from an incident. However, NHS managers must know about all incidents in which a patient has been or may have been harmed, no matter how serious the harm.

And once aware of such an incident, the first thought of the manager responsible must be when and how the patient or their representative will be informed.  The legislation requires notification to take place “as soon as reasonably practicable after becoming aware of an incident.”  Investigations into incidents causing death or moderate to serious harm are likely to take weeks or months rather than days.  The regulations only require the NHS trust to provide an account of the facts known to the trust at the time.  However, this clearly must be given at the beginning rather than the end of any investigation, along with an explanation of the investigation process.

Unnecessary confusion and concern will inevitably follow unclear communication.  The relevant NHS manager will therefore need to make sure that the patient or their representative understands both the knowns and the unknowns at the time of notification and are kept updated throughout the investigation process.  I suggest that written updates are important, but the value of an initial meeting for both representatives of the trust and the patient or their representative to discuss the incident and its implications should not be underestimated.

The regulations require support to be provided to the patient or representative upon notification and given the inevitable element of uncertainty in this process, this makes sense.  Such support should be provided by a single individual within the trust who the patient or representative is able to contact with queries and who will provide regular updates.

Finally, an apology must given.  Although a definition has been provided (“an expression of sorrow or regret”), I believe that NHS managers can safely rely upon common sense and their own empathy with the patient in providing such an apology.  As the investigation unfolds and final conclusions reached, an initial apology based upon the known facts at the time should be revisited.

Whilst this statutory duty is carefully defined, any organisation which remains committed to the principles of being open with patients should be considering informing patients of each and every occasion in which any harm was, or may have been, caused.  Although legislators have drawn a line below which the duty of candour will not be enforced through criminal prosecution, adherence to the principle of candour is essential to bringing about a culture of openness.