For NHS providers (NHS trusts and FTs) the statutory duty of candour goes live on 27 November 2014 (for independent healthcare and adult social care providers the duty will not take effect until April 2015).

CQC have now issued guidance for NHS bodies on how to comply with the statutory duty. The guidance does not differ dramatically from the draft Guidance consulted upon but does provide some further clarification of how CQC expect the duty to be implemented:

When is the duty of candour triggered?

For NHS bodies the definition of a 'notifiable safety incident' which will trigger the duty of candour is one which, in the reasonable opinion of a healthcare professional, could result in, or appears to have resulted in, death, severe harm, moderate harm, or "prolonged psychological harm".  The definitions of "moderate" and "severe" harm are consistent with those used within the NHS for reporting under the National Reporting and Learning System and the existing contractual duty under the NHS Standard Contract.  However, the inclusion of "prolonged psychological harm" means that candour notifications will need to be made when a service user has experienced, or is likely to experience, psychological harm as a result of an incident, for a continuous period of at least 28 days.

The latest CQC guidance states that the duty to make a candour notification will also be triggered where the degree of harm resulting from an incident is not yet clear "but may fall into the above categories". This wording reflects the definition, in the Regulations, of a 'notifiable safety incident' as including incidents which "could result in" the requisite level of harm. In the light of CQC's Guidance, therefore, it appears that when considering incidents which might result in latent, or delayed onset, harm, providers should err on the side of caution and not only treat the duty of candour as triggered if the requisite level of harm is a possible outcome.

How to comply with the duty?

The Regulations require the provider to give the initial notification "as soon as reasonably practicable" after becoming aware of a 'notifiable safety incident'.  CQC's Guidance states that this must be "within at most 10 working days of the incident being reported to local systems, and sooner where possible".  In imposing this time limit, the CQC Guidance again seeks to align the statutory duty with the existing contractual duty.

CQC's Guidance sets out a number of points in terms of the mechanisms of making notifications to patients/relatives and generally supporting an open and transparent culture.  However, a significant component involves complying with the existing NPSA 'Being Open' guidance  .

Scrutiny and enforcement

CQC's Guidance makes it clear that the extent to which providers create open and transparent cultures and comply with the specific duties of candour around notifiable safety incidents will feed into its quality ratings under the domains of both 'Safe?' and 'Well-led?'.  However, failure to comply with the duty of candour is also an offence under the Regulations and the Guidance states that when CQC identifies a breach of the regulation, it will assess the impact on patients in deciding whether or not to exercise its enforcement powers, which could include prosecution or the issuing of a Penalty Notice.

Other issues

CQC's Guidance follows hot in the heels of the joint launch, by the GMC and the NMC, of their draft guidance on the professional duty of candour for doctors, nurses and midwives.  It appears that CQC have sought to reflect this, and their own Guidance states that providers "should have a system in place to identify and deal with possible breaches of the professional duty of candour". Given that the professional duty of candour arises in relation to low harm incidents (and, indeed, 'near misses'), this appears to place an additional burden on providers; it may be considered unreasonable if CQC is expecting providers to effectively police the observance of professional duty of candour by healthcare staff in circumstances where the organisation's own statutory and contractual duties of candour do not arise.

Conclusion

As can be seen, therefore, although, in many respects, the Guidance is helpful, there is a concern about the extent of the burden this places on providers. CQC do make the point, however, that they are still in a learning phase and that the Guidance on duty of candour will be updated as part of the forthcoming guidance on meeting all the Fundamental Standards to be issued before 1 April 2015.

Suggested course of action

Provider organisations should review their policies, procedures, and systems in place around compliance with the duty of candour alongside CQC's Guidance and the 'Being Open' framework. Steps to take might include:

  • Create or review and strengthen local policies identifying how to communicate with patients where "notifiable safety incidents" have occurred; and ensure these policies are embedded with the organisation's wider risk management processes
  • Ensure clarity around processed for classifying incidents as low, moderate and severe harm
  • Board should make public commitments to implementing a policy of candour
  • Providers should have named executive and non-executive leads responsible for candour
  • Publicise the new policy with staff and provide advice and training for staff on managing patient safety incidents
  • Publicise information on the support systems currently available for staff distressed by patient safety incidents.

Providers should also ensure they apply the recent NHSLA guidance 'Saying Sorry' on the making of apologies and the distinction from admissions of legal liability.

How can Bevan Brittan help?

We can provide assistance and support on a wide range of issues relating to candour including:

  • Investigations and response to specific incidents
  • Advice on issues of compliance with the duties of candour
  • Drafting and reviewing candour and related quality governance policies and procedures
  • Training throughout organisations (from boards and Executive Teams to front-line staff)