06


• Define/ Discuss


I


N the wake of Robert Francis QC’s report on the failings at the Mid Staffordshire Foundation Trust in 2013, there has been intense focus on the so-called duty of candour when delivering healthcare. Recognising when care has fallen below standard and reporting this to patients and those in charge promptly is seen as integral to avoiding the unfortunate events that have taken place in Mid Staffordshire and


elsewhere in recent years. Francis summarises this duty of candour in the following terms: any


patient harmed by the provision of a healthcare service should be informed of the fact and an appropriate remedy offered, regardless of


2015. This is still under consideration by the Scottish Government, but it appears likely that some form of statutory requirement will be passed. Although these statutory provisions relate to organisations rather than individuals, there is of course a clear expectation that individual doctors working for these organisations will co-operate fully with notification requirements so that the organisation complies with the law. There has been much debate over the need for a statutory duty of


candour, with some critics describing it as a “crude tickbox approach” while others predict that legislation will not improve openness and could even “undermine professionalism”. Supporters, on the other hand,


MDDUS medical adviser Dr Barry Parker highlights what doctors need to know about the duty of candour


OPEN AND H whether a complaint has been made or a question asked about it.


Recent changes in the law All doctors have an ethical requirement to be honest when dealing with patients. This is hardly contentious, being one of the basic principles underpinning the practice of medicine, ensuring trust between patients and doctors. In addition to this ethical requirement, all NHS organisations in England whose services have been commissioned under a post-April 2013 standard NHS contract, with the exception of primary care services, have a contractual duty of candour. This relates to incidents that occur during the provision of care that lead to moderate harm, severe harm (as defined by the National Patient Safety Agency) or death. These must be reported to patients or carers as soon as possible, and at most within 10 days of the incident being reported to local risk management systems. The most significant change, however, occurred in England in


November 2014, when a statutory duty of candour was introduced under the provisions of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 20 initially gave legal force to the duty of candour for NHS bodies as organisations, but not including primary care services. From April 2015, primary care services have also been included. In Scotland, following a consultation process, similar provisions have been included in the Health (Tobacco, Nicotine etc and Care) (Scotland) Bill which was introduced by the Cabinet Secretary for Health in June


believe the legislation is long overdue and will play an important role in safeguarding patient safety. In its information document on Regulation 20, the Care Quality


Commission states: “The introduction of a statutory duty of candour is an important step towards ensuring the open, honest and transparent culture that was lacking at Mid Staffordshire NHS Foundation Trust. The failures at Winterbourne View Hospital revealed that there were no levers in the system to hold the ‘controlling mind’ of organisations to account.


“It is essential that CQC uses this new power to encourage a culture of openness and to hold providers and directors to account.”


When to disclose In relation to primary care services, a notifiable safety incident under the statutory duty of candour means any unintended or unexpected incident that occurred in respect of a service user during the provision of care that, in the reasonable opinion of a healthcare professional:


(a) appears to have resulted in— i.


the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition


ii. an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days


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