New regulations of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, come into force today designed to fundamentally change the way that NHS bodies act after a notifiable safety incident (NSI).  Implemented following a Francis Inquiry recommendation, the new duty of candour is central to the government’s vision of a new NHS culture of openness, support and a commitment to learn from mistakes.

What is the new duty, what should doctors be doing to ensure compliance and how should the new duty be interpreted alongside similar provisions in Good Medical Practice, the new joint statement issued by the health and social care regulators and the GMC draft guidance on candour?

NHS bodies: a new statutory duty

The Care Quality Commission (CQC) is now responsible for ensuring that providers of regulated healthcare services (at present comprising NHS Trusts, Foundation Trusts and Special Health Authorities) implement the new duty of candour provision (Regulation 20).  Whilst the legal obligation does not fall on doctors personally, NHS employers will expect compliance with published guidance on what do to following an NSI; failure of an organisation to comply with the new directive is a criminal offence and any breach is likely to affect their new CQC rating.  Any shortcomings on behalf of a doctor could become a disciplinary matter.

NHS bodies must now act ‘as soon as reasonably practicable’ after a NSI and notify the relevant persons, providing a truthful account of the event and details of the next steps of the investigation, along with an apology.  This is undoubtedly a huge step forward in moving towards a culture where mistakes are discussed openly, without blame, in order that lessons can be learnt and those affected, patients and doctors alike, are properly supported.

A notifiable safety incident (NSI) as defined as:

…any unintended or unexpected incident…that, in the reasonable opinion of a [doctor], could result in, or appears to have resulted in…the death of a service user or severe harm, moderate harm, or prolonged psychological harm.

Follow local guidance…

If you work in the NHS and are involved in, or witness, a NSI (where actual harm has resulted), you must follow the steps set out in the guidance published by your employer.  The guidance should detail who you should inform, how and when.  If you have not yet been provided with training on what to do, it would be worthwhile asking if this can be arranged.  Under the new regulations, the duty falls on the NHS employer, not individual doctors, to inform the relevant person (service user or person lawfully acting on their behalf); the manner in which this should be done will vary from organisation to organisation and doctors should study the guidance carefully in order to be fully conversant with is required of them.

Ensure compliance with GMP

What about professional compliance with Good Medical Practice?  Doctors are already required, personally, to let patients know when something has gone wrong, whether they work in the NHS or in private practice.  Doctors must also contribute to confidential inquiries and adverse event recognition. (Paragraphs 21-30 GMP).  Compliance with GMP is mandatory and failure to comply may result in action being taken by the General Medical Council, action which may put a doctor’s registration at risk.

You must be open and honest with patients if things go wrong.  If a patient under your care has suffered harm or distress, you should:

  • put matters right (if that is possible)
  • offer an apology
  • explain fully and promptly what has happened and the likely short-term and long-term effects

Good Medical Practice, paragraph 55

This requirement is supported by both the joint statement recently issued by the healthcare regulators and the joint GMC and NMC draft guidance on candour,  which reminds doctors of their personal obligation to be candid with patients when things go wrong.  The GMC expects candour following an untoward event whether harm ensues or not.  This obligation is wider that the new statutory obligation and means that, when something goes wrong in the care of a patient, doctors must navigate their way through the two differing regimes.

Whose duty is it?

Doctors working in the NHS may well ask whose duty is it – should doctors speak directly to the patient or let their employer take the lead?  The GMC is clear; doctors must speak with the patient, unless they are sure that another member of the healthcare team is taking on that responsibility” (Ibid).  Following a NSI, a doctor must report in accordance with internal guidance and if that does not result in a report being made to the patient, when the doctor reasonably believes that such a report is warranted, they must make the report themselves. It is always wise to discuss your intentions with your manager before you embark upon this route and you must consider the terms of the up to date guidance issued by the GMC.

The new statutory obligation on NHS bodies will add yet another layer of requirements on doctors, already struggling to understand the piecemeal approach that has been taken to this issue to date.  NHS bodies should now have guidance in place to assist doctors navigate their way through the new regulations and if they do not, doctors are encouraged by the GMC to raise this with their managers or seniors (Ibid, paragraph 30).  The landscape will change again in March 2015 when the new GMC guidance will be published.