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The new Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, (“2023 Act”) marks a significant shift in Ireland’s healthcare landscape. The legislation introduces mandatory disclosure requirements for healthcare providers in the event of certain serious safety incidents, aiming to instigate cultural change, enhance learning and embed openness and transparency across the healthcare system in Ireland, which is a very welcome development.
Background
Before the 2023 Act, voluntary disclosure was governed by Part 4 of the Civil Liability (Amendment) Act 2017, which came into effect on September 22, 2018. The 2017 Act, building upon the groundwork laid by the Health Service Executive’s (“HSE”) Open Disclosure Policy 2013, established the initial framework for open disclosure in the Irish health service.
Key Amendments
The following important amendments to the 2017 Act were introduced at Committee and Report Stages in the Dáil:
Review of Act Mechanism
Section 80 stipulates a mandatory review of the Act by the Minister within two years of its commencement. This timeframe allows for the integration of the Act’s provisions within the health sector and enables the assimilation of initial learnings from various organisations implementing its protocols.
The amendment empowers the Minister to conduct a comprehensive review, engaging with any individual, body or organisation having regard to their work or functions.
Patient Screening Review
An amendment flagged by the Minister during the Committee Stage of the Bill introduces mandatory open disclosure for completed individual patient-requested reviews of cancer screening conducted by the HSE’s National Screening Service.
This amendment ensures that patients receive legally mandated full disclosure of the results of their screening reviews.
Nursing Home Incident Review
The 2023 Act grants the Health Information and Quality Authority’s (“HIQA”) Chief Inspector of Social Services discretionary power to conduct a review of specific serious patient safety incidents occurring in nursing homes during healthcare provision.
This discretionary power complements the responsibility of nursing home services to address raised concerns, providing a structured pathway for addressing concerns raised by patients and families.
Notifiable Incidents
Schedule 1: Schedule 1 of the 2023 Act outlines a comprehensive list of notifiable incidents that are now subject to mandatory open disclosure. These incidents encompass a range of scenarios, including surgical errors, unintended deaths, medication errors and specific cases related to pregnancy and childbirth.
Open Disclosure and Liability
Section 5: The Act mandates health service providers to convene a notifiable incident disclosure meeting when they are satisfied that a notifiable incident has occurred. This facilitates the open disclosure of the incident to the patient or relevant person.
Section 10: This section provides an important clarification for healthcare providers and their insurers by explicitly stating that information and apologies made during a notifiable incident disclosure meeting do not constitute an express or implied admission of fault or liability. Importantly, this information is not admissible as evidence in proceedings against the health service provider.
Non-Compliance
Section 77: Failure to comply with open disclosure of a notifiable incident, without a reasonable excuse, is deemed a criminal offence under this section.
Conclusion
The introduction of the 2023 Act and the incorporation of mandatory disclosure requirements signals a positive shift in both patient care and the healthcare provider’s approach. The legislation’s broader objectives are meaningful in seeking to transform the prevailing culture, foster transparent communication about serious incidents and ensure better accountability in the Irish healthcare sector.
For those interested in a comprehensive understanding, the complete text of the new Patient Safety (Notifiable Incident and Open Disclosure) Act 2023 is available here. This document outlines the legal framework that underpins the evolving landscape of patient safety in Ireland.
Further Information
For further information on making a claim for spinal injury in Ireland, please contact Avril Scally, Head of our award-winning Medical Negligence & Personal Injury Team.
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This article was first published in the Winter 2023 edition of the Spinal Injuries Ireland Magazine.