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Yesterday the government made a commitment to introduce a statutory duty of candour. This is something the Health Foundation has been calling for and we are pleased that the government has now taken action.

There is a clear moral imperative to tell those affected when something has gone wrong - but like many moral values, the devil is in the detail: what constitutes harm and how should the patient be told?

The first difficulty is defining ‘when things go wrong’. The NHS standard contract for 2013/14 states the providers must ‘notify the Relevant Person that a Reportable Patient Safety Incident has occurred or is suspected to have occurred’. It defines a reportable patient safety incident as one that involves moderate harm or severe harm (as defined in the NPSA’s Seven Steps to Patient Safety: a full reference guide) or death of the service user.

The immediate problem is how to interpret moderate or severe harm. Healthcare professionals inevitably have a different frame of reference from patients or their families and therefore it is almost inevitable that agreeing the level of harm will be the first source of confusion. If staff grade the harm as insignificant or minor, some patients are likely to find this distressing and feel that their suffering as a result of avoidable error has not been recognised, which can impede a positive discussion. For example, if a nurse gives an antibiotic one hour later than prescribed, is this a serious error? The nurses may have had to prioritise between this and giving a dying patient analgesia, taking a patient with cancer to theatre for surgery and giving a patient with Parkinson’s disease their drugs. The nurse may have decided that the delay in the antibiotic would lead to the least serious harm but the patient and their family may consider this to be a serious failing. Even if the patient goes on to experience an intractable infection, how easy would it be to link this delay (or even omission) to the harm?

The next dilemma is how to inform the patient. The NHS standard contract requires that the notification ‘be accompanied by the offer of a written notification; and be recorded in writing for audit purposes’. This will potentially increase the administrative load of busy clinical staff. When the harm is associated with lack of staff, this can create an additional hazard for patient safety. Together with the ambiguity about which harms to be notified, there is a danger that organisations will introduce a defensive bureaucracy to ensure that they are not liable for prosecution. For this reason, individuals, as well as organisations, need to be accountable for any acts or omissions within their control.

The real challenge, however, is not administrative but cultural – for both patients and staff. Patients who have suffered avoidable harm need psychological as well as physical support from healthcare staff, in addition to notification and explanation of why it happened. This can only happen when the staff comfortable about doing so.

While harms are occasionally caused by negligence (for which individuals do need to be held to account), they are more often caused by human factors and under-resourcing which are beyond the control of the individual practitioner. This does not mean that the harms should not be recognised, and the patient informed, but it also makes clear that staff will also need to be supported psychologically. If staff perceive that their disclosure will lead to conflict with the patient or to sanctions from their peers and employers, they may chose not to report, and in some cases to conceal, the harm. A duty of candour therefore needs to be supported by a positive attitude to reporting errors and it is this which the government needs to consider in more detail when considering how to introduce a statutory duty.

A positive climate has other advantages too. The BBC Horizon programme 'How to avoid mistakes in surgery' reported fascinating research that showed how those people with a positive attitude to acknowledging their mistakes learn more quickly and are less likely to repeat the same error.

At the Health Foundation, we support a duty of candour as it is clearly the right thing to do. We believe it should apply to all healthcare providers, whether NHS or private, and to sub-contractors including cleaning services. But we also believe that there are some potential pitfalls. Careful planning and preparation will be needed to avoid them and to create an open, learning culture which will both help individual patients who have been harmed and inform the design of service to improve safety for future patients. The effort required to implement the duty of candour effectively will be more than recompensed by the results.

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