New Bill provides for mandatory open disclosure

The Government has given approval for the Patient Safety Bill, which for the first time will provide in law for mandatory open disclosure in respect of serious patient safety incidents and extend HIQA’s powers to the private sector.

Health Minister, Simon Harris said the proposals being brought forward were in line with the UK Duty of Candour and would complement the legal protections for clinicians engaging in open disclosure that were introduced through the Civil Liability (Amendment) Act 2017.
He said, “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,” he said.
“The Bill 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.

“I would also like to take this opportunity to recall the commitment of the staff of our health service, including the many doctors and nurses who do engage in open disclosure on a daily basis. I want to work with them also as we look to move our health service into a new phase.”

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.

The Patient Safety Bill is being progressed by the National Patient Safety Office (NPSO), which was established by the Minister for Health in December 2016. The NPSO is charged with delivering a programme of policy and legislative changes to improve the ability of the health service to anticipate, identify, respond to and manage patient safety issues.
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