Press release
Minister for Health announces commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023
From Department of Health
Published on
Last updated on
From Department of Health
Published on
Last updated on
Minister for Health Stephen Donnelly has today announced the commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides a legislative framework for a number of important patient safety issues, including the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to the patient and/or their family. The Act also provides for the mandatory external notification of those same events to the appropriate body. The Act contains a list of specified patient safety incidents resulting in the main, in death or serious injury, and also provides for the mandatory external notification of those same events to the appropriate body. The Act contains a provision by which the Minister can add to this list via regulation.
Minister Donnelly said:
"I am delighted to be commencing this important piece of patient safety legislation. It will serve an important role in progressing a cultural change in our health service whereby, together, we create space for openness and transparency in our everyday actions. Ireland has made another great stride forward in our suite of patient safety legislation and this will signal a new era for the health service."
The Act also provides for mandatory open disclosure requirements for completed individual patient requested reviews of their cancer screening by the Health Service Executive’s (HSE’s) National Screening Service in a dedicated part of the Act. It provides for an obligation for the Cancer Screening Services to inform patients of their right to request a review.
Under the Act, the remit of the Health Information and Quality Authority (HIQA) will be expanded into prescribed private health services and private hospitals. This will allow HIQA to set standards for the operation of prescribed private health services and private hospitals, to monitor compliance with them and to undertake inspections and investigations as required.
Prior to commencement of the Act, there were a number of preparatory steps required. These are now complete, and the majority of the Act is being commenced. Section 68, which provides that a new Section be inserted into the Health Act 2007 to provide the Chief Inspector with a discretionary power to carry out a review of a defined type of serious patient safety incident where some or all of the care of a patient was carried out in a nursing home, to include both public and private nursing homes, requires a minor technical amendment and will be commenced shortly.
The Act contains a provision mandating a review of the operation of the Act to be carried out two years from the date of commencement.
Minister Donnelly added:
"This is a landmark piece of patient safety legislation. It will play an important role in ensuring that patients and their families have access to comprehensive and timely information. This is achieved by the open disclosure mechanism in the Act which contributes to embedding a culture whereby clinicians, and the health service as a whole, engage openly, transparently and compassionately with patients and their families when things go wrong.
"Poor communication between patients and health practitioners has been at the heart of many patient safety issues. It is so important that when things go wrong, there is an understanding of what has happened and an assurance that it will not happen again."
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 which was signed by the President on 2nd May 2023 is an important piece of patient safety legislation. A key intention of the Patient Safety Act is to ensure that patients and their families have access to comprehensive and timely information. This is achieved by the open disclosure mechanism in the Act and contributes to embedding a culture whereby clinicians, and the health service as a whole, engage openly, transparently and compassionately with patients and their families when things go wrong.
The requirements of the Act apply to all healthcare bodies including:
The Patient Safety Act 2023 provides for the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to the patient and/or their family. The Act contains a provision by which the Minister can add to this list via regulation. Patients and their families must have access to comprehensive and timely information, including an apology where appropriate, in relation to serious patient safety incidents. It also provides for the mandatory external notification of those same events to the appropriate regulatory body (HIQA, the Chief Inspector within HIQA or Mental Health Commission as appropriate).
The Act contains measures, in a dedicated Part 5, to provide for mandatory open disclosure of completed individual patient requested reviews of their cancer screening by the HSE’s National Screening Service. Health services providers shall inform the patient of their right to a Part 5 review before or at the time the cancer screening is carried out and put in place procedures for the provision of further reminders.
The Act contains a clear, precise definition of clinical audit and provides additional protections for those processes which meet the definition.
The Act also makes a number of amendments to the Health Act 2007, including the provision for the expansion of HIQA’s remit into prescribed private health services and private hospitals. This will allow HIQA to set standards for the operation of prescribed private health services and private hospitals, to monitor compliance with them and to undertake inspections and investigations as required.
The Act also amends Section 9 of the Health Act 2007 which gives the Minister for Health and Minister for Children, Equality, Disability, Integration and Youth the power to direct HIQA to undertake an, to address serious ongoing risks to patient safety in Ireland's health and social services.
Prior to commencement of the Act, there were a number of preparatory steps required. As outlined above, the Act establishes a mandatory requirement for the notification of certain serious patient safety incidents. To facilitate this notification process, a new module to the existing National Incident Management System (NIMS) has been designed, built, tested and signed-off by key stakeholders, including the HSE, State Claims Agency, HIQA and the Mental Health Commission.
In addition, to facilitate commencement of the Act, the HSE developed a new open disclosure training policy and communications plan for all staff regarding the new disclosure and notification requirements under the Act. The HSE advise that the new open disclosure training module is now available to all staff.
Also, prior to commencement, the Department of Health needed to make a technical amendment to the Act to address a minor drafting error. This amendment was approved by government decision S180/20/10/2859, is technical in nature and does not alter the policy intention of the Act. The Bill which contains this amendment completed all stages in the Seanad on 9 July 2024 and was signed by the President on 15 July 2024. It commenced on 19 August 2024.
A further technical amendment needs to be made to Section 68 of the Act and this Section will be commenced as soon as this is complete.