Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was signed into law in May 2023 and comes into effect from 26 September 2024.

Overview of the Act

The Act seeks to strengthen openness and transparency throughout the Irish health care system. It applies to public and private health services and must be followed by all staff. A key focus of the Act is on open disclosure.

Open disclosure is defined as an open, honest, compassionate and timely approach to communicating with patients and, where appropriate their relevant person, following patient safety incidents. The Act introduces a legal requirement to disclose a list of specific incidents called notifiable incidents. The notifiable incidents are described in the Act.

The Act requires health services providers to be open and transparent with patients, their families, or both depending on the patient's wishes. For most of the notifiable incidents the patient has sadly died.

The Act outlines a process for open disclosure, ensuring that patients, their families, or both, receive truthful and timely information in any healthcare setting when a notifiable incident happens. The Act also requires mandatory notification of the notifiable incidents to the appropriate regulatory body.

Summary of the Act

The Act provides a legal framework for:

mandating a health services provider to disclose notifiable incidents when providing a health service to a patient. There are currently 13 notifiable incidents but the Minister of Health may add to this list in the future - Notifiable incidents 1.10 and 1.11, which relate to incidents in maternity and neonatal care, use terminology that has been defined by regulation. This regulation has now been published as ‘Statutory Instrument 501/2024’ and is available on the Patient Safety (Notifiable Incidents and Open Disclosure) Regulations 2024 - irishstatutebook.ie
mandating health services providers to communicate reviews of cancer screenings they have carried out at the patient's request (breast, bowel and cervical screening)
information shared, as well as an apology made, as part of an open disclosure of a notifiable incident and communication of patient-requested cancer screening reviews, cannot be used for certain legal or regulatory purposes
procedures for clinical audits and protections for the data gathered
a health services provider must inform the relevant regulator (Mental Health Commission, Chief Inspector of Social Services, and the Health Information and Quality Authority) of a notifiable incident within 7 calendar days using the National Incident Management System (NIMS). It is important to note that reporting notifiable incidents through NIMS does not remove the need to report such incidents through other reporting channels
the law outlines the requirement of the designated person, who is a support person for the patient or their relevant person and is an employee of the health services provider. The designated person is essential for open disclosure
the Act specifies what should be discussed at the open disclosure meeting and cancer review meetings, in the written follow-up, and how important it is to keep accurate records
open disclosure is recognised as a process, and the Act specifies what must be covered at an open disclosure meeting, written follow-up of such meetings, the need for additional open disclosure meetings, as well as how a patient or their representative can seek clarification on what was discussed
once the incident has been logged on NIMS, in line with local governance processes, the health services provider (HSE or S38) can notify the relevant regulator on this digital platform. Private providers and independent practitioners will report a notifiable incident through a portal on the regulator's website
the Act amends Part 4 of the Civil Liability (Amendment) Act 2017 to align the process with that of the Patient Safety Act. It applies to all patient safety incidents but is not mandated in law. It is an option for staff to use it if they would like similar protections that apply to the Patient Safety Act for all other patient safety incidents
amendments to the Health Act 2007 that modify the threshold for HIQA to carry out statutory investigations and expansion of monitoring into private hospitals
the Chief Inspector of Social Services' discretionary power to carry out a review of specified incidents that may have resulted in death or serious injury where some or all of the care was delivered in a designated centre, such as a nursing home. This part of the Act is not commencing on 26 September 2024. It will commence once an essential technical update has been made to the Act. Commencement of this part of the Act will be communicated by the Department of Health in due course

There are 2 circumstances recognised in the Act where open disclosure may not happen:

if the patient or their relevant person declines open disclosure. In this scenario, they must be provided with the information on how to contact the health services at any time within the next 5 years to request open disclosure
when the patient or their relevant person cannot be contacted despite reasonable attempts to do so

Who does the Act apply to?

The Act applies to public and private health services providers.

Health services providers can be fined up to €5000, if without valid reason, they do not:

hold an open disclosure or review of cancer screening meeting (including situations where the patient or their relevant person declines at first but later requests it, or when they are at first unreachable but later return to our service)
report a notifiable incident to the relevant authority (such as HIQA, Chief Inspector, Mental Health Commission)

Clinical audit

The Act and clinical audit protections

The Act encourages staff to carry out clinical audits to continuously improve our patient care standards.

The Act offers significant legal protections to clinicians undertaking clinical audit . Information created during a clinical audit cannot be used as:

admission of fault by a healthcare professional or organisation
evidence in legal cases (civil proceedings) against healthcare professionals or healthcare organisations
evidence to cancel a healthcare professionals’ indemnity insurance
evidence of fault, professional misconduct, poor professional performance or any other failure or omission
evidence in disciplinary or fitness to practice procedures against healthcare professionals

HSE National Centre for Clinical Audit - A Practical Guide 2023 (PDF, 5 MB, 64 pages)

Support materials on how to conduct a clinical audit - resources for staff and organisations

Sharing the results of cancer screening reviews

Part 5 of the Act allows patients to request a review of their cancer screening results. It requires the HSE National Screening Service to describe how the review will be carried out, including the requirements and conditions that will be followed. The screening programmes must communicate the results of the review during a meeting and provide a written summary within 5 days.