The Parliamentary and Health Ombudsman (PHSO) recently reported that individuals who complain to the NHS are not getting the answers that they need, with the result that they are often forced to bring their complaints to the PHSO to get those answers. The PHSO report includes a snapshot of unresolved complaints brought to the PHSO for investigation, including complaints made against NHS England where family members have not been given answers explaining why their relatives have died. According to the PHSO mistakes have not been admitted, resulting in much needed improvements to services being delayed.
As a concept, the duty of candour is not entirely new. NHS bodies were already subject to a contractual duty of candour under the NHS Standard Contract and adult social care providers work within in a well established framework of statutory reporting and practice arrangements including adult safeguarding procedures, Care Quality Commission (CQC) inspection and notification requirements, reporting requirements in relation to the Health and Safety Executive, and contract monitoring.
The report of the Mid-Staffordshire NHS Foundation Trust Public Inquiry led by Robert Francis QC (Francis inquiry report) emphasised that the receipt of and processing of complaints from patients, their families, carers and other representatives is, or should be, at the heart of any system for ensuring that appropriate standards of care are maintained. A health service that does not listen to complaints is unlikely to reflect its patients’ needs. Conversely one that does will be more likely to detect the early warning signs that something requires correction, enabling it to address those issues and to protect others from harmful treatment.
From an adult social care perspective, the duty of candour forms part of the Care Act 2014’s (CA 2014) safeguarding statutory framework, along with the provisions in sections 42-47 (safeguarding adults at risk of abuse or neglect) and section 92 (offence for health and care providers to supply, publish or otherwise make available information that is false or misleading) of the CA 2014. The Pan London Adult Safeguarding Policy and Procedures has recently been updated to reflect the new statutory framework in the CA 2014 for adult safeguarding (see Legal update, New Pan London Adult Safeguarding Policy and Procedures launched).
Background to the duty of candour
Francis inquiry report
Part 2 of the CA 2014 deals with care standards and was introduced to address aspects of the government’s response to the Francis inquiry report, the Report of the Mid-Staffordshire NHS Foundation Trust Public Inquiry. The duty of candour was introduced in direct response to recommendation 181 of the Francis inquiry report that a statutory obligation to observe a duty of candour should be imposed on:
- Healthcare providers who believe or suspect that treatment or care provided by it to a patient has caused death or serious injury to the patient, to inform that patient or other duly authorised person as soon as is practicable of that fact and thereafter to provide such information and explanation as the patient or relative may reasonably request.
- Registered medical practitioners, registered nurses and other registered professionals who believe or suspect that treatment or care provided to a patient by or on behalf of any healthcare provider by which they are employed has caused death or serious injury to the patient.
Section 81 of the CA 2014 inserted a new sub-section 5A, into section 20 of the Health and Social Care Act 2008 requiring regulations to be made that impose a duty on health and social care providers to provide specified information to relevant persons when a notifiable safety incident has occurred.
The duty of candour is set out in regulation 20 of the Health and Social Care 2008 (Regulated Activities) Regulations 2014 (2014 regulations), amended by the Health and Social Care Act 2008 (Regulated Activities)(Amendment) Regulations 2015 (2015 regulations).
Regulation 20(1) requires that a registered person 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 20(2) provides that as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, a registered person must:
- Notify relevant the person, (regulation 20(1)(a)). The notification must include an apology.
- Provide reasonable support to the relevant person in relation to the incident including when giving the notification.
Who does the duty apply to?
The duty of candour applies to all provider organisations that are registered with the CQC.
The duty was first introduced for health service bodies, (NHS trusts, NHS foundation trusts and Special Health Authorities) from 27 November 2014. The 2015 regulations extended the duty to all service providers, including providers of adult social care services, primary medical and dental care, and independent healthcare with effect from 1 April 2015.
(Regulation 10 of the 2015 regulations made a number of amendments to regulation 20 of the 2014 regulations, including that the duty of candour now applies to “registered persons” rather than just health service bodies. A registered person is defined in regulation 2 of the 2014 regulations as a person who is the service provider or registered manager of a regulated activity.)
The duty of candour requires registered persons to act in an open and transparent way with relevant persons. A “relevant person” for the purposes of regulation 20 is:
- The service user.
- A person lawfully acting behalf of the service user:
- on the death of the service user;
- where the service user under 16 and is not competent to make a decision in relation to their care or treatment; or
- where the service user is 16 or over and lacks capacity.
What is a notifiable safety incident?
Registered persons are required to take specified steps as soon as reasonable practicable after becoming aware that a “notifiable safety incident” has occurred. A notifiable safety incident is defined in regulation (7) of the 2014 regulations (as amended). The nature of the incident depends upon whether it is in relation to a health service body or a registered person.
Health service bodies
For health service bodies, a notifiable incident means 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 health professional could result in, or appears to have resulted in:
- The death of the service user, where the death relates directly to the incident rather than to the natural cause of the service user’s illness or underlying condition.
- Severe harm, moderate harm or prolonged psychological harm to the service user.
Severe harm means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user’s illness or underlying condition (regulation 20(7), 2014 regulations).
Moderate harm means harm that requires a moderate increase in treatment and significant but not permanent harm. Moderate increase in treatment is defined in regulation 20(7), and will include situations where the harm results in an unplanned return to surgery or re-admission , a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment or transfer to another treatment area such as intensive care.
Any other registered person
For any other registered person, such as those responsible for providing adult social care services (for example, domiciliary care providers, care and nursing homes), a notifiable safety incident means 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 health care professional, either:
- Appears to have resulted in:
- 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;
- 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;
- changes to the structure of the service user’s body;
- the service user experiencing prolonged pain or prolonged psychological harm; or
- the shortening of the life expectancy of the service user.
- Requires treatment by a health care professional in order to prevent:
- the death of the service user; or
- any injury to the service user which, if left untreated, would lead to 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) or 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.
Regulation 20(3)-(5) of the 2014 regulations prescribes the way that the notification must be given. The notification must:
- Be given in person by one or more representatives of the registered body.
- Provide an account, which to the best of the registered person’s knowledge is true, of all the facts they know about the incident as at the date of the notification.
- Advise the relevant person as to what further enquiries into the incident the registered person believes are appropriate.
- Include an apology. “Apology” is defined in regulation 20(7) and means an expression of sorrow or regret in respect of a notifiable safety incident.
- Be recorded in a written record which is kept securely by the health service body
The notification must be followed with a written notification to the relevant person containing all of the information referred to above. It must also include the results of any further enquiries into the incident.
Sanctions for failure to comply with the duty
It is an offence for a registered person to fail to comply with the:
- Requirement to notify the relevant person in regulation 20(2)(a).
- Way in which the notification must be given, as set out in regulation 20(3).
These offences are prescribed as fixed penalty offences, the monetary amount for which is £1,250 (Schedule 5, 2014 regulations).
Role of the Care Quality Commission
The CQC is responsible for ensuring that providers comply with the duty of candour, and it has published guidance on how to meet the requirements set out in the regulations. Providers must demonstrate that they are meeting the requirements of regulation 20, in order to register with the CQC and to be able to continue to deliver regulated services.
If a provider applying to be registered with the CQC cannot demonstrate that it will meet the requirements of regulation 20 from its first day of business, the CQC may refuse its application for registration or impose conditions of registration.
As part of its enforcement action, the CQC can bring prosecutions for breach of the provisions in regulation 20(2)(a) and 20(3) of the regulations.
Will the duty of candour ultimately affect the number of complaints or volume of litigation?
The duty of candour is, in certain respects similar to the process for dealing with complaints, in that both processes involve dealing with situations where things have gone wrong, investigating reported problems, offering redress where that is appropriate and ensuring that lessons are learned so that the same problems do not re-occur in the future. The duty of candour does not affect an individual’s right to make a complaint, and in situations where the duty does not apply because the criteria in regulation 20(3) is not met, service users and their families will still have recourse to the complaints process. Similarly providers must ensure that they are alive to the fact that the duty of candour is an explicit obligation that can be triggered through a specific incident, but also through complaints and claims.
As to whether the duty could lead to a reduction in complaints and litigation over time remains to be seen. In a paper published by the national partnership Think Local Act Personal (TLAP), TLAP’s Quality Forum observed that candour could actually reassure service users since it gives them a right to the information they seek, and even more so if there is confirmation that lessons have been learnt as a result. This reassurance may decrease the likelihood of legal action.
There are however concerns that compliance with the duty could actually encourage litigation claims. It is worth noting that the Francis Inquiry report stated that provision of information in compliance with the duty should not of itself be evidence or an admission of any civil or criminal liability, but non-compliance with the statutory duty should entitle the patient to a remedy. Guidance on the duty published by NHS Litigation Authority also informs health providers to not assume that apologising to patients amounts to an admission in relation to a subsequent civil claim.
The duty is still in its infancy and it therefore remains to be seen whether it will lead to a reduction in complaints and litigation against health and social care providers. However, the new Learning from mistakes league launched this month by Monitor and the NHS Trust Development Authority to encourage openness and transparency in the NHS appears to demonstrate that this issue is high on the NHS’s agenda.