Department of Health and CQC publish finalised Duty of Candour regulations

The Department of Health has published the outcome of its consultation period on the Duty of Candour. As part of the publication, the Department also clarified what penalties would be put in place for providers that breach new fundamental standards of care, and finalised its fit and proper persons regulations for directors. This is all part of a post-Francis push to ensure that health providers are held accountable for failures in care that occur on their watch.

The responsibility to implement the Duty will be on providers, who are expected the implement it across their organisations. The harm threshold is classified as moderate or severe, or where “prolonged psychological harm” (psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days) has arisen will give rise to a Duty of Candour to the service user. The Duty will also apply in death. “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 cause of the service user’s illness or underlying condition”.

“moderate harm” means harm that requires a moderate increase in treatment, which is stated as:

“an unplanned returned to surgery, an unplanned 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”.

Where a person is under 16, deceased, or lacks mental capacity providers will be required to notify a person lawfully acting on the service users behalf. The notification from the provider must include an apology. If the harmed individual cannot be contacted, then providers must keep a copy of all correspondence.

The Duty of Candour will apply to NHS bodies from October 1st, and all healthcare providers from April 2015.