A new statutory duty of candour, which was introduced last year for NHS bodies in England following the Mid Staffordshire public inquiry, will now apply from April to all other healthcareproviders registered with the Care Quality Commission.
This new statutory obligation requires organisations to disclose information where they believe poor care has resulted in death or harm to a patient.
Moore Blatch clinical negligence partner, Sarah Stanton comments: “Organisations will need to inform and educate staff on the implications of these changes. For patients and their representatives, it will be essential that the care provider you are engaging with has complied with its duty from the outset and provided you with the information that you are entitled to.
“Organisation that do not comply with this new duty and are then forced to apologise later down the line could face serious consequences, including a fine for the organisation, reputational damage and for individuals, possible referrals to their professional regulatory bodies.
The key principles of the new obligations, which are contained in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, are:
- Healthcare organisations will be under a general duty to act in an open and transparent way when providing care to patients – this means that an open and honest culture must exist throughout the organisation.
- The new statutory duty applies to organisations, not individuals, but there is an expectation on staff to cooperate and ensure that organisations can meet the requirements of the duty.
- After a notifiable patient safety incident occurs, the organisation must as soon as is reasonable tell the patient (or their representative) about it in person.
- The organisation must give the patient a full explanation of what is known at the time, including what further enquiries will be carried out. Organisations must also provide an apology and keep a written record of the notification to the patient.
- There is a statutory duty to provide reasonable support to the patient, which could include providing an interpreter to ensure discussions are understood, or putting in place emotional support to the patient following a notifiable patient safety incident.
- Once the patient has been told in person about the notifiable patient safety incident, the organisation must provide a written note of the discussion to the patient, and copies of correspondence must be retained.
A notifiable patient safety incident, which has a specific definition, applies where a patient has suffered, or could suffer, unintended harm that results in death, severe harm, moderate harm or prolonged psychological harm.
Doctors will especially need to be informed of the changes, as they are often involved in candid discussions with patients and are most likely to be the organisation’s representative under the statutory duty. It is recommended they cooperate with the organisation’s policies and procedures, including the requirement to alert the organisation when a notifiable patient safety incident occurs.