IN 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 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 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, 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
iii. changes to the structure of the service user’s body
iv. the service user experiencing prolonged pain or prolonged psychological harm, (continuous period of 28 days)
v. the shortening of the life expectancy of the service user; or
(b) requires treatment by a healthcare professional in order to prevent—
i. the death of the service user, or
ii. any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in (a) above.
This mirrors the CQC reporting requirements for GP practices in England. NHS bodies have slightly different disclosure requirements under the regulation, which include incidents which could result in, or appear to have resulted in the harms specified. This difference has been the subject of some debate.
Examples of notifiable GP cases are provided by the CQC in a “mythbuster” article on their website.
Ultimately, doctors must exercise judgement in terms of when to disclose a particular matter in the light of these requirements.
The GMC has been issuing specific guidance in relation to being open and honest with patients when things go wrong since 1998, so there is no fundamental change in the regulatory position. However, expanded guidance has recently been produced which provides more detail on expected behaviours and the steps doctors should take to honour their professional duty of candour.
These include telling the patient (or where appropriate the patient’s advocate, carer or family) when something has gone wrong; apologising to the patient; offering an appropriate remedy or support to put matters right, if possible, and explaining fully to the patient the short- and long-term effects of what has happened.
In summary, for doctors who have already been complying with GMC guidance on what to do when things go wrong, there is little that has changed. The statutory duty placed on a general practice at an organisational level perhaps brings some clarity to the types of incidents that must be notified, but there remains an element of individual judgement that must be exercised depending on the circumstances of each case. The GMC guidance is more general than the statutory requirements, and simply emphasises that if something has gone wrong, the doctor has a duty to explain and apologise. It also includes guidance on reporting ‘near misses’ and encouraging a learning culture by reporting errors.
It can only be hoped that this new duty of candour brings positive changes for patient care and that doctors, as the GMC states, receive the support of an “open and honest working environment where they are able to learn from mistakes and feel comfortable reporting incidents that have led to harm.”
Dr Barry Parker is a medical adviser at MDDUS