Minister Harris said: “This important new legislation will for the first time provide in law for mandatory open disclosure in respect of serious patient safety incidents. The proposals being brought forward are in line with the UK Duty of Candour and will complement the legal protections for clinicians engaging in open disclosure that were introduced through the Civil Liability (Amendment) Act 2017.
“The Patient Safety Bill will also provide for mandatory reporting of serious events to the appropriate regulatory authority, such as HIQA or the Mental Health Commission. In addition it will empower the Minister for Health to issue guidance with regard to the undertaking of clinical audit.
“I strongly believe that creating a culture of mandatory open disclosure and learning from things that go wrong is the bedrock of making services safer.
“The Bill, which will now be sent to the Health Committee, is part of the broader programme of legislative changes and policy initiatives being taken by the Government to improve the ability of the health service to anticipate, identify, respond to and manage patient safety issues.
“The Civil Liability (Amendment) Act, passed last year, provides the legal framework to support voluntary open disclosure. It provides for an open and consistent approach to communicating with patients and their families and providing an apology, as appropriate, when things go wrong in healthcare. The Minister has now signed the commencement order for this legislation and the regulations to accompany the Act have been finalised.
“The Patient Safety Bill also addresses another key patient safety issue around the lack of regulation in the private sector by extending the powers and responsibilities that HIQA currently exercises in relation to public hospitals to private hospitals as well. This will allow HIQA to set standards for the operation of private hospitals, to monitor compliance with them and to undertake inspections and investigations as required.
Ministerial regulations will be used to prescribe serious patient safety incidents that are subject to mandatory open disclosure. Examples of serious patient safety incidents would include wrong site surgery, patient death or serious disability associated with a medication or diagnostic error, serious errors that emerge in screening programmes and maternal deaths.
Reacting to the approval of the Bill, Dr Rob Hendry, Medical Director at the Medical Protection Society (MPS) said: “All healthcare professionals have a professional duty to promote an open, learning culture and we continue to share our expertise on tackling barriers to open disclosure. Open communication can improve the dynamics in a multi-disciplinary team, build trust between patients and healthcare professionals and create an environment where mistakes are learnt from.
<br /> “We have long advised our members that a meaningful apology is not an admission of liability; rather, it is an acknowledgment that something has gone wrong and a way of expressing empathy. We recognise however, that this can be challenging for healthcare professionals as they remain fearful of blame or personal recrimination.
<br /> “MPS has always been of the view that while you can mandate open disclosure through legislation, it may not result in real behavioural change, and may even result in a ‘tick-box’ process when something goes wrong. This could mean that patients do not get the sincere apology and explanation they deserve.
“A cultural shift is needed. Clinicians need to feel confident to admit errors, apologise and learn from mistakes. They also need to feel supported at an organisational level, by leaders equally committed to the principles of open disclosure.”