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Care Quality Commission issues first 'duty of candour' breach fine


The Care Quality Commission (CQC) has issued its first fine to an NHS trust for failing to comply with its 'duty of candour', which requires healthcare providers to be open and honest with patients or their families if there is an incident in which they suffer harm.

The health sector regulator issued a fixed penalty notice of £1,250 to Bradford Teaching Hospitals NHS Foundation Trust ('Bradford') over the incident, after finding it had not apologised to the family of a baby boy within a reasonable period of time.

The baby was admitted to Bradford Royal Infirmary in July 2016, but the CQC heard that there were delays in diagnosing his condition and admitting him to hospital. Bradford recorded these delays as a 'notifiable safety incident' under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, but did not inform the boy's family. The family did not receive an apology until October 2016.

Under the 2014 regulations, regulated health and social care providers must "act in an open and transparent way" and notify service users, or their representatives, as soon as possible after becoming aware that a 'notifiable safety incident' has occurred. The regulations go on to define a notifiable safety incident as any unintended or unexpected incident affecting a service user that "could result in, or appears to have resulted in [either] the death of that service user ... or severe harm, moderate harm or prolonged psychological harm".

CQC inspector Professor Ted Baker explained that the fine did not relate to the care provided to the baby, but "to the fact that the trust was slow to inform the family that there had been delays and missed opportunities in the treatment of their child".

"Under the duty of candour, all providers are required to be open with patients or their families when something goes wrong that appears to have caused significant harm … Patients or their families are entitled to the truth and to an apology as soon as practical after the incident – which didn't happen in this case," he said.

The Health and Social Care Act gives the CQC the power to serve a penalty notice against a registered person who has failed to comply with certain requirements in the Act, or in the 2014 regulations. In this case, it felt that a fixed penalty notice was a proportionate alternative to full criminal prosecution.

In an interview last year, CQC chief executive Ian Trenholm said that he was "keen to do more enforcement".

"Although the fine is small, the conviction brings reputational damage to the trust," said healthcare regulatory expert Sean Elson of Pinsent Masons, the law firm behind Out-Law.com.

"The case is a reminder that the duty of candour is something that duty holders have to have in mind when deciding how to respond to negative events, and that it interacts with other duties and responsibilities," he said.

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