The Statutory Duty of Candour has been in force since November 2014 (for NHS providers) and 1 April 2015 (for independent health care and adult social care providers). The introduction of the Statutory Duty followed Sir Robert Francis QC's recommendations in the Mid Staffs Inquiry and, in the period between the Inquiry reporting in February 2013 and the Duty taking affect, has been the subject of considerable discussion including:
- the Government's initial response to the Inquiry ('Patients First and Foremost'),
- The Government's final response ('Hard Truths');
- Sir David Dalton and Professor Norman Williams' review 'Building a Culture of Candour'" (March 2014);
- Department of Health consultation ('Introducing the Statutory Duty of Candour') (March 2014).
- The Think Local Act Personal Review ('Duty of Candour – An Adult Social Care Perspective') (March 2014);
- CQC's guidance on the Duty of Candour for NHS providers (November 2014);
- CQC's guidance on the Duty of Candour for all providers (March 2015);
- CQC's subsequent publication "Regulation 20: Duty of Candour – Information for All Providers" (March 2015)* ("the Information Document").
However, despite the various consultations and guidance, a number of uncertainties about the Duty remain. In particular, there are uncertainties around precisely what constitutes a "notifiable safety incident" which triggers the need for formal verbal and written notification of the incident to the patient in accordance with regulation 20(3) and (4) of the Regulations, and how the organisational duty (policed by CQC) interfaces with the professional duties of candour on health care workers. These are important issues for providers given that, in addition to impacting on their quality ratings, failures to comply with the Duty of Candour can result in prosecutions, fines and reputational damage. It is therefore all the more concerning that, as a result of a number of recent events, the uncertainties remain. There are three main areas of concern:-
Is the duty limited to 'mistakes'?Much of the discussion regarding the Duty of Candour in the Mid Staffs Inquiry and subsequently focused on the importance of the duty to ensure that healthcare organisations are open about, and take steps to learn from, 'errors'. However, the CQC Information Document issued in March 2015 indicated (albeit subtly by way of some of the examples quoted in an Appendix) that the need for formal verbal and written notification will also be triggered by the eventuation of recognised (and consented) complications of procedures. But, at the same time, CQC's Press Release announcing the extension of the Duty of Candour to the independent sector described it as a requirement for providers "on being open about mistakes when they happen".
Interface with professional duties -On 29 June 2015 the GMC and NMC published their joint guidance** to assist doctors, nurses and midwives to comply with their professional duties of candour. The professional duties apply to all levels of harm (and 'near misses') and there is much useful practical guidance contained within the joint GMC/NMC document. However, the accompanying GMC Case Study*** suggests that where patients have moved to a new provider on a pathway by the time an incident is identified, it may be most appropriate for the 'candour notification' to be made by professionals currently caring for the patient (even though the incident occurred when the patient was under the care of another provider). Whilst this may be sufficient to discharge the professional duties of candour, it does seem to be at odds with the statutory duty to notify which would sit with the first provider under the Regulations. There are, therefore, potential dangers for providers who may be exposed to poor ratings and findings of non-compliance (and potentially prosecution) in some circumstances despite their staff complying with their professional obligations.
Further extension of the threshold for independent health care and adult social care providers? -The HSJ has reported that the Department of Health is now planning a further consultation on changes to the Duty of Candour following a threat of judicial review proceedings brought by AvMA. Apparently, the concern raised by AvMA is that the incidents which trigger verbal and written notifications in independent health care (including GP) and adult social care settings need to be extended to match those which apply to NHS providers. As currently drafted, although for independent health care and adult social care providers, the Regulations require notification to be given of incidents which "appear to have resulted in" the requisite level of harm, in the NHS the requirement is extended to incidents which have not yet, but "could result in" such harm.
Particularly bearing in mind the potential consequences of failing to have appropriate procedures around the duty of candour, providers should keep a close eye on the outcome of further consultations from the Department of Health and any further clarification from CQC, regarding the application of the duty.