The commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 that was signed into law by the President in May 2023, has now been in effect since 26^th September 2024.

The Act outlines a process for open disclosure, ensuring that patients and their families receive truthful and timely information in any healthcare setting when a notifiable incident occurs. The Act requires mandatory notification of the notifiable incidents to the appropriate regulatory body and also includes guidance around the timing of the disclosure and the information to be provided.

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 the service); or
• report a notifiable incident to the relevant authority (such as HIQA, Chief Inspector, Mental Health Commission)

What is a notifiable incident?

The legislation is not drafted to provide for a mandatory approach to every incident that occurs. Instead, the Act includes a schedule containing a list of very serious, primarily death related incidents, that will be subject to mandatory open disclosure and notification. These are called ‘notifiable incidents’. The current list of notifiable incidents are as follows:-

• Surgery performed on the wrong patient resulting in unintended and unanticipated death;
• Surgery performed on the wrong site resulting in unintended and unanticipated death;
• Wrong surgical procedure performed on a patient resulting in an unintended and unanticipated death;
• Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death;
• Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery;
• 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;
• Patient death due to transfusion of ABO incompatible blood or blood components;
• Patient death associated with a medication error;
• An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy;
• An unanticipated and unintended stillborn child where the child was born without a fatal foetal abnormality and with a prescribed birthweight;
• An unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care in labour;
• An unintended death where the cause is believed to be the suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service; and
• A baby who in the clinical judgment of the treating health practitioner requires, or is referred for, therapeutic hypothermia, or has been considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition.

Further notifiable incidents in the future?

There are currently 13 notifiable incidents as highlighted above, however, Section 8 of the Act gives the Minister a wide scope to prescribe further patient safety incidents as notifiable incidents, bearing in mind the learning from incidents that have occurred in the Irish health service or internationally, as well as learnings from advances in clinical practice. Furthermore, the Act provides that all cancer screening services (CervicalCheck, BreastCheck and Bowel Screen), will be subject to mandatory open disclosure ensuring access to comprehensive and timely information.

Procedure prior to making an open disclosure

Before disclosure is made to a patient or a relevant person, the principal health practitioner must:

• Consider the timing of such a disclosure, taking into consideration the circumstances of the patient and the nature and consequences of the notifiable incident;

• Determine if disclosure is to be made to the patient the relevant person or both;

• Determine, based on the nature of the incident if an apology is appropriate;

• Take all steps to present the information relating to the incident as clearly as possible; and

• Designate a liaison person.

A ‘Designated Person’ is someone who has been assigned to act as a liaison between the

health services provider and the patient or relevant person (or both of them) in relation to

the open disclosure of the notifiable incident. Section 15 (e) of the Act provides that the designation of such a person must happen before making an open disclosure of a notifiable incident.

To whom should the open disclosure be made?

Under Section 7 of the Act, open disclosure of a notifiable incident must be made to:-

• The patient concerned;
• A relevant person where (the patient is unable to participate in open disclosure; the patient has died; or the patient has requested open disclosure to be made to a nominated person); and
• Both the patient and the relevant person, where the patient requests the relevant person to assist the patient.

A health services provider must also 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

Finally, there are two 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; or
• when the patient or their relevant person cannot be contacted despite reasonable attempts to do so.

Conclusion

Mandatory open disclosure of serious patient safety incidents has now been enshrined into law in Ireland. The HSE has also provided guidance for all medical practitioners to ensure that they are in compliance with the Act. Commenting on the commencement of the Act, Mr Stephan Donnelly, Minister for Health, has said: “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.. 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.”

If you have any queries in relation to this, please do not hesitate to contact Alan Martin or another member of the Healthcare team at Carson McDowell LLP.

*This information is for guidance purposes only and does not constitute, nor should be regarded, as a substitute for taking legal advice that is tailored to your circumstances.