The statutory duty of candour was first recommended by Sir Robert Francis as a result of the Mid-Staffs inquiry, and was intended to apply to both healthcare organisations and professionals. The statutory duty currently applies to NHS Trusts, Foundation Trusts and Special Health Authorities, but is expected to be extended to all care providers in April 2015. While the statutory duty does not apply to individual healthcare professionals, the professional regulators have made a joint voluntary agreement to apply a similar duty of candour to their registrants.
Health services bodies are under a continuing obligation to act in an open and transparent way in relation to care and treatment provided to patients. They also have further obligations to a patient if they are involved in a "notifiable safety incident", i.e. when an unintended incident occurs during their care that results in moderate or severe harm, or prolonged psychological harm. If this occurs, the provider will be required to hold a face-to-face meeting with the patient, explaining what has happened and what further enquiries the provider intends to make, and must include an apology. This must be followed up by a written notification setting out the same information, as well as any progress since the meeting.
During the consultation on the duty of candour there was some concern about the requirement to make an apology to patients, including whether an apology should be given where the provider believed there had been an "honest error". However, the CQC guidance accompanying the duty addresses the concerns by making very clear that, according to the NHS Litigation Authority (and the Compensation Act 2006), an apology is not necessarily an admission of legal liability.
While this new duty appears to break new ground, it is in reality an extension of several non-statutory requirements that already apply to healthcare bodies. For instance, the NHS Standard Contract already uses the same concepts of harm and requires the provider to inform the patient of what has happened; this form of a duty of candour was introduced in the 2013/14 version of the Standard Contract. In addition, the CQC's new inspection approach, which is currently being rolled out, also considers how providers react when things go wrong. If concerns were raised about a provider's candour, this would inform the CQC's assessment of whether a service requires improvement or is inadequate. However, the statutory duty means these existing requirements are now backed up by offences which can be prosecuted by the CQC and lead to fines of up to £2,500. It will be interesting to see whether the CQC does indeed bring prosecutions and what exactly will be required to trigger sanctions.