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Patient Safety Bill 2018: Mandatory Open Disclosure in Serious Clinical Incidents

The need for a professional duty of candour, or open disclosure in healthcare has been much publicised in recent times especially as a result of the cervical check controversy. In 2016 in our newsletter, entitled ‘The Verdict’ ‘Patient Safety: A New Dawn? http://www.sellors.ie/sellors-the-verdict-1-year-on/, we discussed whether the introduction of a number of patient safety reforms such as mandatory reporting of adverse medical incidents and a concept of open disclosure would represent a significant landmark for patient safety in the Irish healthcare system. Regrettably, many of those proposed reforms were never introduced by Government.


Unfortunately, it has taken the tragic plight of Vicky Phelan, Emma Mhic Mhathuna and many other women, who were incorrectly told their smear test results were clear, to put pressure on the Government to introduce and approve a new Patient Safety Bill, which may finally mark a major milestone for patient safety in Ireland.


The Bill provides for mandatory open disclosure in respect of serious patient safety incidents, and notification of reportable incidents. The Bill facilitates a consistent approach to communicating with patients and their families when things go wrong in healthcare and it restates the legal protections for healthcare professionals who engage in open disclosure. The new Bill goes further than the duty of candour that currently operates in the UK.


The Bill aims to close the current loophole which did not include private hospitals under the regulatory remit of the Health Information and Quality Authority (HIQA). This means patients in both the public and private sectors will benefit equally in terms of ongoing monitoring and standard-setting. If passed, the type of incidents covered by the new legislation will include wrong site surgery, patient deaths, a serious disability resulting from a medication or diagnostic error and errors with screening and maternal deaths.


It is proposed that health service providers will have to notify the State Claims Agency and either HIQA or the Mental Health Commission of any serious patient safety incidents. Any such incidents shall be reported as soon as the body becomes aware of the incident and, in any event, not later than 7 days after becoming so aware.


The registered health service shall be guilty of an offence if the provider fails to make a mandatory disclosure of a serious reportable incident and penalties on conviction are fines or imprisonment. Sanctions can also apply to individual doctors who are found to have failed to comply with open disclosure.


Ronan Hynes, Partner and Patient Safety Expert commented on the new Patient & Safety Bill that: “The new Patient Safety Bill is long overdue and over time I hope it will create a culture of change and learning within the HSE when things go wrong. More importantly, it will provide patients and their families with access to vital information and eliminate unacceptable delays in seeking answers and redress where necessary.”


Should you require any further information, please contact Ronan Hynes, Partner in the Medical Negligence Department of Keating Connolly Sellors at 061 432 348 or by email at [email protected].



Published On: July 17, 2018

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