Posted: 19/03/2024
The duty of candour is the general duty upon healthcare providers to be open and transparent with patients when treatment or care goes wrong. There is both a professional and statutory duty which together mandate transparency, requiring practitioners to candidly acknowledge errors, communicate truthfully and offer timely apologies.
The professional duty is a responsibility to be open and honest with patients and their families when things go wrong. Where care or treatment causes harm or distress, there is a duty to say sorry and take action to ensure things are put right where possible. However, this is recognised as the right thing to do, rather than an admission of liability. This duty is overseen by the regulators of the specific healthcare profession and a failure to comply can lead to disciplinary action.
In practice, the duty requires that professionals speak to the patient, or their family, when they realise something has gone wrong. The healthcare professional has a duty to say sorry and apologise for the harm caused, regardless of the severity of the situation or implications of harm. An accurate and factual account of what has happened should be provided and the patient or their family should be given the opportunity to ask questions. A single point of contact should also be established and this person’s details provided.
Until 2014 there was no legal duty on healthcare providers to share information with patients or their families who had suffered harm. The Francis Inquiry in 2013 put forward recommendations for a statutory duty, in addition to the professional duty that existed at that time within standard NHS contracts.
The legislation governing the statutory duty is Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This provides an overarching legal duty on health and social care providers to be open and transparent, overseen by the Care Quality Commission (CQC). Whilst Regulation 20 is an overarching duty, it also encompasses specific action that must be taken, where a notifiable safety incident occurs.
Under the legislation, a notifiable safety incident refers to:
‘Any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a healthcare professional, could result in, or appears to have resulted in
Severe harm refers to a permanent injury which has resulted in the lessening of bodily, sensory, motor, physiologic or intellectual functions. For example, this could include instances where there has been removal of the wrong limb, organ or brain damage.
Moderate harm is defined as causing significant, but not permanent, harm where there may be an increase in treatment required. This could include extended or further surgery, un-planned re-admission to hospital, cancelling of treatment or transfer to another treatment area. Prolonged psychological harm is defined as harm that continues for a period of at least 28 days.
When such harm occurs, CQC expects organisations to act promptly. It also expects the promotion of a safe culture by senior managers where staff feel able to speak up and feel supported to fulfil their duty. It is an offence to fail to comply with this duty, with enforcement ranging from warnings and notices, up to criminal prosecution. Patients suggest that where the duty of candour is carried out well, they have received a heartfelt apology and that there has been a sense of honestly from the outset of treatment.
HSSIB is the investigative body of the Department of Health and Social Care that came into operation on 1 October 2023. As a fully independent body, it investigates patient safety concerns across the NHS in England as well as in private care. Its investigations seek to understand why patients may have been harmed, or are at risk of harm, with the aim of minimising the occurrence of patient safety incidents.
HSSIB completes multiple investigations annually and shares its findings in patient safety investigation reports. These reports also make safety recommendations, observations and suggestions for local learning and HSSIB then checks that the organisation under investigation has met its duty of candour obligations.
However, findings from HSSIB’s reports are safeguarded by special protections and typically do not qualify as admissible evidence in legal proceedings. The provision of a ‘safe space’ for HSSIB’s investigations is to ensure participants in the investigation can speak openly, without fear of repercussions. This aligns with the purpose of HSSIB investigations; not to assess or apportion responsibility, but rather identify opportunities for learning and highlight areas where systemic improvements are needed. To this end, HSSIB also suggests this gives staff greater scope to discuss concerns not directly connected to a specific patient safety incident, with a view to addressing the overall systemic issues impacting patient safety.
Despite the ‘safe space’ element provided by HSSIB’s investigations, there are a limited set of circumstances where HSSIB may be forced to disclose protected information, which include:
It is important to note that HSSIB has replaced the former healthcare watchdog, the Healthcare Safety Investigations Branch (HSIB), which was also an independent body running safety investigations into NHS-funded care. Alongside the national investigations programme (which now comes under HSSIB), there was a specific HSIB maternity investigations programme, which is now hosted by the Care Quality Commission and is known as the Maternity and Newborn Safety Investigations programme (MNSI).
The main differences between HSIB and HSSIB are that:
The approach of the court to the disclosure of material obtained during healthcare investigations was considered in the recent case of Turner v Sheffield Teaching Hospitals NHS Foundation Trust, in which the claimants succeeded in their application for specific disclosure of recordings of midwifery interviews, taken during the course of HSIB’s investigation. In his judgment, Master Brown explained the safe space principle underlying the work of HSIB and noted that:
‘It is plainly intended to ensure that employees can make complaints against their employers, or against their colleagues, or their superiors, or others, in a safe space with some degree of confidence that their employers should not have the right to demand any document generated in the process.’
However, Master Brown concluded that, whilst the safe space principle is a meaningful one that should be respected, one of HSIB’s principal concerns against disclosure in that case, that any order made in the claimant’s favour would undermine the work of HSIB, was not borne out. Significantly, he determined that, on the basis that the claimant was severely injured, a trial was anticipated, and the contents of the midwifery interviews were central to the issues to be decided, there should be disclosure.
The duty of candour means that healthcare providers should be open and transparent with patients when treatment or care goes wrong. The professional and statutory duty mandate transparency, requiring practitioners to candidly acknowledge errors, communicate truthfully and offer timely apologies.
The provision of a ‘safe space’ as part of an investigation carried out by HSSIB will limit a patient’s ability to access information collated during that investigation, but the case of Turner v Sheffield demonstrates that the court will order disclosure where it is deemed necessary to balance the interests of the claimant, the public and any independent bodies in preserving confidentiality.
This article was co-written with Ellen Banks, trainee solicitor.
© 2024 Penningtons Manches Cooper LLP.
All rights reserved.
Website design by Frontmedia / Dynamic Pear
Penningtons Manches Cooper LLP is a limited liability partnership registered in England and Wales with registered number OC311575 and is authorised and regulated by the Solicitors Regulation Authority under number 419867.
Return to news headlines 