In this blog post, Elizabeth Boulden and Megan Griffiths discuss the duty of candour in response to the news that the University Hospitals Plymouth NHS Trust is the first to have been prosecuted and convicted for breaching the statutory duty of candour.
The Care Quality Commission (CQC) recently brought a successful prosecution against the University Hospitals Plymouth NHS Trust for breaching the statutory duty of candour, following the death of 91-year-old Elsie Woodfield . It was the first prosecution of its kind and resulted in a conviction, with a fine of £1,600, a victim surcharge of £120 and court costs of £10,845.43.
Mrs Woodfield had undergone an endoscopy at Derriford Hospital in December 2017. During the procedure, she suffered a perforated oesophagus, and, accordingly, the procedure was abandoned. Mrs Woodfield was transferred to the ward for observations, where she collapsed and sadly later died. The CQC then brought the prosecution after finding out that the Trust had not been open or transparent with Mrs Woodfield’s family about what had happened or given an apology in good time.
In light of this news, we shall look at the duty of candour in more detail: what it is, where it originates from, and what it means in practice.
What is the duty of candour?
The duty of candour is often something that does not get much discussion when considering the legal aspects of clinical negligence cases. However, such a duty is fixed in English law, by virtue of Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014/2936 (“the Regulations”), as modified by the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015/64. The Regulations have effect until 31 March 2022 . In Wales, a statutory duty of candour is due to be introduced by Part 3 of the Health and Social Care (Quality and Engagement) (Wales) Act 2020, which is not yet in force.
Regulation 20(1) states: “Registered persons must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity”.
Regulation 2(1) defines a “registered person” as the service provider or registered manager in respect of a regulated activity. Such identities are further explained within regulation 2(1) and broadly amount to registered health or social care providers. According to regulation 20(7), a relevant person is the patient/service user, or, alternatively, the person acting lawfully on their behalf if the patient/service user a) has died, b) is over 16 and lacks capacity, or c) is under 16 and not competent to make a decision about their care or treatment. The meaning of “regulated activity” is elaborated in regulation 3(1), regulation 8 and Schedule 1 of the Regulations, and encompasses almost all types of medical and nursing treatment that would occur in a hospital setting. There are exceptions to regulated activities set out in Schedule 2 to the Regulations; however, it is submitted that it is good practice for all medical professionals to take heed of and adhere to the duty of candour.
The duty of openness and transparency referred to in regulation 20 relates not only to information provided to patients (or their representatives or advocates), but also to the culture within organisations. Such a duty encourages staff to be open and honest with their colleagues and employers, as well as with investigations and reviews, regulatory bodies, and the public. This is not to say that such openness and transparency does not already happen within many healthcare organisations; it is simply that there is a legal framework to enforce and support this requirement.
The formation of the duty of candour arose from the recommendations of the Francis report, a report setting out the findings of the Mid Staffordshire NHS Foundation Trust Public Inquiry chaired by Robert Francis QC (“the inquiry”). The inquiry looked into serious failings at the Trust regarding “conditions of appalling care” between 2005 and 2008. It discovered failures in the system which meant that legitimate concerns were not addressed and that there was “[t]oo great a degree of tolerance of poor standards and of risk to patients”. It also noted failures in “a system which ought to have picked up and dealt with a deficiency of this scale”. The inquiry identified negative aspects of the organisation’s culture, including defensiveness in response to criticism and a lack of openness with patients, with the public and with external agencies.
Accordingly, one of the aims of the inquiry’s recommendations was to “[e]nsure openness, transparency and candour throughout the system about matters of concern”. Indeed, the inquiry’s findings included the recommendation of a statutory obligation on “healthcare providers, registered medical and nursing practitioners to observe the duty of candour” and on “directors of healthcare organisations to be truthful in any information given to a regulator or commissioner”. There was also a recommendation for it to be a criminal offence for various organisations and healthcare professionals to “obstruct the performance of these duties or dishonestly or recklessly to make an untruthful statement to a regulator”.
The Francis report gave a definition of the duty of candour as follows :
“For a common culture to be shared throughout the system, these three characteristics are required:
- Openness: enabling concerns to be raised and disclosed freely without fear, and for questions to be answered;
- Transparency: allowing true information about performance and outcomes to be shared with staff, patients and the public;
- Candour: ensuring that patients harmed by a healthcare service are informed of the fact and that an appropriate remedy is offered, whether or not a complaint has been made or a question asked about it.”
The report’s summary further elaborated that all organisations and those working in them should be “honest, open and truthful in all their dealings with patients and the public” and that organisations and their leaders should be “completely truthful when making statements to regulators, and they must not be misleading by omission” and that “[p]ublic statements must also be truthful and not misleading” .
What does the duty of candour require healthcare professionals to do?
Put simply, those providing medical treatment to a patient must be open and transparent about the treatment given when talking to the patient and their family. The NMC and GMC have issued helpful guidance about what the duty of candour entails. In particular, the guidance on the NMC website  sets out, inter alia, the following:
- Patients should be fully informed about their care
- When discussing care options with patients, both risks and benefits should be discussed
- The patient should be given clear, accurate information about the risks of the proposed care or treatment plan, as well as the risks of any reasonable alternative treatment options
- Practitioners should check that the patient understands
- The risks that should be discussed are those that occur often, those that are serious even if very unlikely, and those that the patient is likely to consider to be important
When something goes wrong with a patient’s care 
- After doing what they can to put things right, healthcare professionals should speak to the patient as soon as possible (which, most appropriately, would be done by the lead or accountable clinician)
- The patient should have someone available to support them
- The clinician informing the patient should share all they know to be true about what went wrong and why, and what the consequences are likely to be, and should make clear what has and what has not been established so far
- The clinician should be honest in response to any questions and should apologise to the patient
- The patient should be given the option of not knowing every detail, but, if this is the case, clinicians should try to find out why, and, if the patient does not change their mind, this should be recorded and the patient’s wishes respected, with the patient being offered the option of being given more information at another time
- If the patient has died, or is unlikely to regain consciousness or capacity, then those close to the patient should be informed in lieu of informing the patient
Encouraging a learning culture 
- When things go wrong with a patient’s care, reporting should occur at an early stage so lessons can be learnt rapidly and future harm be prevented
- Professionals should follow their organisation’s policy on reporting adverse incidents and near misses
- There are also national reporting schemes for various types of incidents, which professionals should adhere to
- If a professional’s organisation does not have a reporting system, the professional should report this to their manager, and, if necessary, raise a concern in line with the guidance
- Professionals should not try to prevent colleagues or former colleagues from raising concerns.
- Equally, professionals should be supported by their organisation in routinely reporting adverse incidents and near misses, and, if professionals are discouraged or prevented from reporting, concerns should be raised in line with the guidance
- Professionals must participate in regular reviews and audits of their team’s standards and performance
Senior/high-profile clinicians or those with management responsibilities 
- Senior clinicians should set an example and encourage a culture of openness and honesty in reporting adverse incidents and near misses, and should actively foster a culture of learning and improvement
- Those with management responsibilities should ensure that systems are in place to give early warnings of failures or potential failures in clinical performance by individuals or teams
- Such systems should include those for conducting audits and systems for patient feedback to be considered
- Any concerns about individuals or teams should be investigated, and, if appropriate, addressed, quickly and effectively
- There should be systems in place to review, monitor and improve the quality of a team’s work
- Those with management responsibilities should ensure that the teams they manage are appropriately trained in patient safety and supported to openly report adverse incidents
Near misses 
- Professionals should use their professional judgement when considering whether to tell patients about near misses
- Sometimes there will be information that the patient needs to/would want to know and sometimes the information could aid the patient’s recovery
- Also, sometimes not being open with a patient about a near miss could damage their trust and confidence in the healthcare team
- However, in some circumstances, patients might not need to know and speaking to them about it may distress or confuse them unnecessarily
- Near misses do not include adverse incidents which may result in harm but have not yet done so – on these occasions patients must be told and these incidents must be reported in line with the guidance
What do the Regulations require when things go wrong?
When aspects of a patient’s care do go wrong, there is explanation in the Regulations as to what, in law, needs to be done by healthcare professionals/the healthcare provider. Regulations 20(2) to 20(6) set out the mandatory steps that must be taken if a notifiable safety incident has occurred.
A “notifiable safety incident” is defined in regulations 20(7)-(9) as 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/appears to have resulted in death, or one of a number of listed types of harm. For a health service body, that harm is severe harm, moderate harm, or prolonged psychological harm, such terms being defined in regulation 20(7). For other registered persons, that harm is i) 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, (ii) changes to the structure of the service user’s body, (iii) the service user experiencing prolonged pain or prolonged psychological harm (as per the definitions in regulation 20(7)), (iv) the shortening of the life expectancy of the service user, or (v) a need for treatment by a healthcare professional in order to prevent death or any injury to the service user which, if left untreated, would lead to death or one or more of (i)-(iv) above.
The mandatory steps listed in regulations 20(2)-(6) must be taken as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, and include:
- As per regulation 20(2)(a), the registered person’s representative(s) notifying the relevant person that a notifiable safety incident has occurred
- Providing reasonable support to the relevant person regarding the incident, including when being notified of the incident (regulation 20(2)(b))
- When notifying the relevant person of the incident, doing so in person (regulation 20(3)(a)), providing an account of all the facts known by the registered person at the time which must be true to the best of the registered person’s knowledge (regulation 20(3)(b)), as well as providing advice as to what further enquiries into the incident the registered person believes are appropriate (regulation 20(3)(c))
- Providing an apology when notifying the relevant person of the incident (regulation 20(3)(d))
- Keeping a written record of the notification to the relevant person of the incident, which must be kept securely by the registered person (as per regulation 20(3)(e))
- Providing a written notification as a follow-up to the initial notification (either written or sent to the relevant person), which contains the account of all the facts known by the registered person at the time (which must be true to the best of the registered person’s knowledge), details of any enquiries into the incident the registered person believes are appropriate, the results of any further enquiries into the incident, and an apology (regulation 20(4))
- The registered person keeping a copy of all correspondence with the relevant person made under regulation 20(4) (regulation 20(6))
If the relevant person cannot be contacted or refuses to be contacted, a record must be kept of the attempts made to communicate with them (regulation 20(5)).
Regulation 22(3) states that failure by a registered person to comply with regulation 20(2)(a) or regulation 20(3) is an offence. However, regulation 22(4) indicates that it is a defence for a registered person to prove that they took all reasonable steps and exercised all due diligence to prevent the breach of any of those regulations that has occurred.
Apologising when things go wrong
One of the most crucial aspects of the duty of candour is the apology. This is defined in regulation 20(7) of the Regulations as “an expression of sorrow or regret in respect of a notifiable safety incident”.
There is further helpful guidance on the NMC website, which states, inter alia, that :
- As part of an apology, patients normally expect to be told what happened, what can be done to deal with any harm caused, and what will be done to prevent harm to others
- The apology should occur at a time and place where the patient is best able to understand and retain information, and the information should be given in a way that they can understand
- An apology only has value if it is genuine, hence a formulaic approach to apologising should not be encouraged
- An apology is not an admission of legal liability
- The NHS Litigation Authority (currently NHS Resolution) advises that apologising is the right thing to do, and fitness to practise panels might view apologies as a sign of insight
- There is no need for professionals to take personal responsibility for things that were not their fault
- Professionals should ensure that the patient knows who to contact if they have any further questions of if they wish to raise concerns
- Professionals should also give patients information regarding independent advocacy, counselling or other support services
It is important to reiterate that an apology would not amount to an admission of liability for the purposes of Part 14 of the CPR. In particular, the NMC guidance referred to above contains a link to the Compensation Act 2006. Section 2 of the Compensation Act 2006, entitled “Apologies, offers of treatment or other redress”, states that “[a]n apology, an offer of treatment or other redress, shall not of itself amount to an admission of negligence or breach of statutory duty.”
Unfortunately, things do sometimes go wrong in a healthcare setting. At this point it is crucial for healthcare professionals to have open discussions with patients and/or their families about what has happened.
For patients and their families, one of the issues of key importance is understanding what went wrong and why. Often there is difficulty in getting information, which sometimes only starts to materialise following pursuit of a civil claim or during the process of an inquest (if the patient has died). This, unsurprisingly, feels unsatisfactory to those involved, who can feel that they are intentionally being left “in the dark” about what happened.
From the perspective of healthcare organisations and healthcare professionals, there is concern that apologies or comments by members of staff can be taken as admissions, or that such might prejudice subsequent legal proceedings. This is not the intention of the duty of candour, and it is worth reiterating that an apology or discussion of what happened would not, in and of itself, amount to an admission of civil liability. It is also sometimes the case that there is difficulty in providing full information due to investigations being incomplete; in these instances, it is suggested that the situation is explained to the patient and their family, with what has been established so far being imparted.
In the context of civil claims, swift clarification of what happened and what went wrong can aid early narrowing of the issues. Indeed, paragraph 2.2(a) of the Pre-Action Protocol for the Resolution of Clinical Disputes encourages openness, transparency and early communication of the perceived problem between patients and healthcare providers. Such communication and clarification can further assist in enabling claims to be concluded at an earlier stage: from the patient’s (or family’s) perspective, this prevents prolongation of stressful legal proceedings; from the healthcare provider’s perspective, swift resolution of claims can avoid legal costs continuing to accrue over several months or years.
In general, an early apology and discussion of what went wrong can assist in maintaining trust and communication between healthcare professionals and patients, or their families and representatives. Not only does this promote continuation of the relationship, which is beneficial if there is still ongoing treatment with the same provider, but also it should serve to reduce the level of stress of any ensuing litigation. Finally, on a more pragmatic note, timeous investigation and discussion of an incident enables early collation and preservation of evidence, which thereby avoids the risk of memories having faded when matters are inevitably revisited at a later date.
 Regulation 1(6) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014/2936
 supra at page 7 paragraph 1
 supra at page 4
 supra at page 4
 supra at page 4
 supra at page 75 paragraph 1.181
 supra at page 75 paragraph 1.181
 supra at page 75 paragraph 1.176
 supra at page 75 paragraph 1.177
 supra at page 75 paragraph 1.178
 supra at page 75 paragraph 1.178
 supra at paragraphs 6-7
 supra at paragraphs 8-12
 supra at paragraphs 22-28
 supra at paragraphs 29-31
 supra at paragraphs 20-21
 supra at paragraphs 13-16