A renewed focus on patient safety

Yesterday (6 December 2023) the Department of Health and Social Care announced a review into the statutory duty of candour for health and social care providers in England.

Believe it or not it has been in place for nearly 10 years!

As readers will know, the statutory duty of candour is about people’s right to openness and transparency from their health or social care providers. It provides that when something does go wrong patients and their families have a right to receive explanations for what happened as soon as possible and a meaningful apology.

The duty applies to all health and social care providers that the Care Quality Commission regulates. CQC regulates compliance with the duty and failure to comply with the duty can result in enforcement action ranging from warning or requirement notices to criminal prosecution. The “most recent” CQC enforcement action was taken in October 2021 when West Suffolk NHS Foundation Trust was fined for failures in complying with duty of candour regulation – so that’s over two years ago now.

The duty is set out in regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 20 puts a legal duty on health and social care providers to be open and transparent with people using services and their families and sets out actions that providers must take when a ‘notifiable safety incident’ happens.

Notifiable safety incidents:

  1. are unintended or unexpected
  2. happen during the provision of an activity the CQC regulates
  3. are incidents that - in the reasonable opinion of a healthcare professional - could, or already appear to have, resulted in death or severe or moderate harm to the person receiving care

Where a notifiable safety incident has been identified, organisations must act promptly and are expected to:

  • tell the relevant person, face-to-face, that a notifiable safety incident has taken place
  • say sorry
  • provide a true account of what happened, explaining what is known at that point
  • explain what further enquiries or investigations will take place
  • follow up by providing this information and the apology in writing, and giving an update on any enquiries
  • keep a secure written record of all meetings and communications with the relevant person

The review will focus on:

  1. To what extent the policy and its design are appropriate for the health and care system in England
  1. To what extent the policy is honoured, monitored, and enforced
  1. To what extent the policy has met its objectives

The output of the review is due to be published in spring 2024.

To be clear the review will not consider the professional duty of candour.

Commenting on the DHSC’s review, Parliamentary and Health Service Ombudsman, Rob Behrens CBE said:

“Despite [the duty of candour] being a statutory duty to be open and honest when things go wrong with a patient’s care, I know from the cases we investigate that this doesn’t always happen. Patients and their families deserve better.”

The Ombudsman’s recent report, Broken trust: making patient safety more than just a promise called for the DHSC to assess the lack of compliance with the duty.

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