The statutory duty of candour
Following the mid-Staffordshire inquiry, which considered the poor care and high mortality rates of patients at the Stafford Hospital, Sir Robert Francis recommended the implementation of a statutory duty of candour.
On 27 November 2014, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 brought this into force through Regulation 20. The Regulation states at (1) "A health service body 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". According to the consultation outcome from the Department of Health, the new duty requires all NHS trusts, foundation trusts and special health authorities to comply with it. It is envisaged that this duty will be further implemented for all other healthcare providers from April 2015.
The Care Quality Commission ["CQC"] guidance accompanying the new duty of candour prescribes how the terms "openness", "transparency" and "candour" are to be interpreted, following the definitions as set out by Sir Robert Francis. According to the guidance and in order to meet the requirements, an NHS body has to:
- Make sure it acts in an open and transparent way with relevant persons in relation to care and treatment provided to people who use services in carrying on a regulated activity;
- Tell the relevant person as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, and provide support to them in relation to the incident, including when giving the notification;
- Provide an account of the incident which, to the best of the health service body’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification;
- Advise the relevant person what further enquiries the health service body believes are appropriate;
- Offer an apology;
- Follow this up by giving the same information in writing, and providing an update on the enquiries; and
- Keep a written record of all communication with the relevant person.
During the consultation, there was concern that the requirement to apologise might be taken in some circumstances as an admission of legal liability. The CQC addressed this in their guidance, stating that "The NHS Litigation Authority has produced guidance on making an apology, which states that saying sorry is not an admission of legal liability".
The duty of candour does not extend to individual healthcare professionals. However, the professional regulators, namely the General Chiropractic Council, General Dental Council, General Medical Council, General Optical Council, General Osteopathic Council, General Pharmaceutical Council, Nursing and Midwifery Council and the Pharmaceutical Society NI, have issued a joint statement confirming that they will promote the duty of candour to their registrants, students and patients. The Joint Statement sets out, in line with the statutory duty incumbent on providers, that every healthcare professional must also "be open and honest with patients when something goes wrong with their treatment or care which causes, or has the potential to cause, harm or distress". The statement further lists the ways in which this objective can be achieved, including; by telling the patient, their family or advocate when something has gone wrong, apologising for this, offering an appropriate remedy or support and explaining fully the long and short-term effects of what has happened.
It is worth noting that, in reality, this is not an entirely innovative breakthrough in the scope of healthcare provider duties. Of course, as the CQC guidance states that most NHS bodies are already subject to a contractual duty of candour under the NHS Standard Contract, Condition 25. Furthermore, the CQC are also implementing their new regime of inspections, which will look specifically at how providers react when things go wrong and will consider the extent of the provider's candour. However, because the duty of candour has now become enshrined in statute, there is now scope for offences to be prosecuted and for offenders to be fined (regulation 22(3) and regulation 23(6)).