Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

Introduction

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (the “Act”) was commenced last month on 26 September 2024 by the Minister for Health.

The Act provides a legislative framework for a number of important patient safety issues such as the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to the patient and/or their family by healthcare professionals. The goal is to create a culture of open disclosure as opposed to solely following mandatory disclosures.

Under the Act, the remit of the Health Information and Quality Authority (HIQA) is to be expanded into prescribed private health services and private hospitals, allowing them to set standards for the operation of prescribed services and to monitor compliance with them and to undertake inspections and investigations as required.

A key intention of the Act is to ensure that patients and their families have access to comprehensive and timely information which is to be achieved by the open disclosure mechanism in the Act in the aim of establishing a culture whereby the health service engage transparently and compassionately with patients and their families when things go wrong.

Who does the Act apply to?

The Act applies to both public and private health service providers.

Who is Notified?

An open disclosure of a Notifiable Incident can be made to the relevant patient or a “relevant person” where the patient has died, is lacking in capacity, or has they have requested that disclosures be made to the relevant person.

A relevant person can include those appointed under the Assisted Decision Making (Capacity) Act 2015, those with enduring power of attorney in respect of the patient, someone nominated by the patient in writing, as well as a parent or guardian.

The Act also provides for the mandatory external notification of those same events to the appropriate body.

What is a Notifiable Incident

The Notifiable Incidents that are currently outlined by the Act under Schedule 1 of the Act include inter alia:

• A death following surgery performed on the wrong patient;
• A death following surgery performed on the wrong site;
• A death following the wrong procedure being performed on a patient;
• A death following the unintended retention of a foreign object in a patient after surgery;
• The death of an otherwise healthy patient undergoing an elective procedure where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia)
• Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service that is directly related to any medical treatment where the death did not arise from an underlying condition or illness of the patient;
• A death due to the transfusion of incompatible blood or blood components;
• A death arising from a medication error where the death did not arise from an underlying condition or illness of the patient; and
• An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy related to the management of the pregnancy as opposed to an underlying condition or illness of the patient.

With the exception of incidents involving a newborn, the Notifiable Incidents, as they are currently set out in the Act, all relate to the death of an individual patient under the health service provider’s care.

Consequences of Non-Disclosure

Section 77 of the Act sets out that where a Notifiable Incident is not disclosed, the persons liable will be guilty of an offence and liable on summary convention to a Class A fine (up to €5,000). It must be proven that there is no reasonable explanation for the failure to disclose a Notifiable Incident.

Conclusion

The majority of the Act is to be commenced with the exception of 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 a serious patient safety incident where the patient was cared for in a nursing home (to include both public and private nursing homes).

Healthcare Practitioners should be aware that the disclosure of any Notifiable Incident cannot be taken as any admission of liability in potential future clinical negligence claims or any other regulatory complaint.

The key aim of the Act is to encourage and facilitate open and honest disclosure between patients, relevant persons and health services providers.

The Act can be viewed in full here: here.