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New legislation, commenced on 26 September 2024, aims to ensure openness and transparency within the Irish health care system by establishing a legal framework which directs the mandatory open disclosure of specific "notifiable incidents" to a patient and/or their family and relevant external authorities. The legislation further expands the remit of the regulatory body, the Health Information and Quality Authority ("HIQA") into certain private health services and private hospitals.
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (the "Act"), commenced on 26 September 2024. The Act establishes a legislative framework which directs the mandatory open disclosure of specified serious patient safety incidents that must be disclosed to the patient and/or their family along with the appropriate external governing authority. The Act also amends the Health Act 2007 to extend the scope of the Health Information and Quality Authority ("HIQA") to private health services and private hospitals. These changes enable HIQA to set standards, monitor compliance, and undertake investigations within the private healthcare sector.
Who does the Act apply to?
The Act applies to all public and private health service providers and individual practitioners such as GPs, dentists, pharmacists, nurses and midwives.
What is a Notifiable Incident?
Schedule 1 of the Act specifies a list of thirteen "Notifiable Incidents" that require mandatory open disclosure, primarily relating to unintended or unanticipated death and incidents in relation to neonatal care. The Minister for Health has the legislative authority to expand this list.
Open Disclosure of the Notifiable Incident
When a Notifiable Incident occurs, Section 5 and 6 of that Act stipulates that the health practitioner must promptly notify the health service provider responsible for the patient's care. Once a Notifiable Incident is confirmed, the health service provider must arrange a Notifiable Incident Disclosure Meeting, informing the incident to the patient and/or the relevant person. The Health Services Provider must determine the timing for this meeting, considering the accessible information and the circumstances of the patient. This meeting should be held in person unless the patient or the relevant person requests an alternative arrangement.
What information must be disclosed?
- The names of the persons present at the Notifiable Incident Disclosure meeting.
- A description of the Notifiable Incident.
- The date the Notifiable Incident occurred and the date that the Notifiable Incident came to the notice of the health services provider.
- The manner in which the Notifiable Incident came to the notice of the health services provider.
- Where the health services provider believes that physical or psychological effects stemming from the notifiable incident are existing or have emerged by the time the Notifiable Incident Disclosure Meeting takes place, information regarding those consequences must be provided.
- Information on the potential physical or psychological consequences of the Notifiable Incident that may emerge because of the incident.
- If any physical or psychological effects have emerged and the patient is currently receiving clinical care from the health services provider, the provider must inform the patient about the treatment and clinical care being offered (or planned) to manage those effects.
- Where a health services provider believes that no physical or psychological consequences are likely to develop from the Notifiable Incident, a statement confirming this.
- Having considered the Notifiable Incident, the health services must confirm: (i) the actions they have taken, or propose to take, and (ii) procedures or process to be implemented in order to address the knowledge the provider has obtained from its consideration of the Notifiable Incident and the circumstances giving rise to it.
- If a health services provider decides that an apology should be made for the Notifiable Incident, such apology may be made to the patient and/or the relevant person at the meeting.
External Notification Requirements
Section 27 of the Act mandates that a health service provider must inform HIQA as soon as practicable but not later than 7 days from the day on which the provider was satisfied the incident had occurred. A health service provider carrying on the business of a nursing home or services to children, persons with a disability, or other dependents, must notify the Chief Inspector of Social Services within the same timeframe. A registered mental health services provider must notify the Mental Health Commission.
Right to Review of Cancer Screening Results
The Act introduces a new right for a patient to request in writing, a review of their cancer screening results. Patients must be informed of this right before, or at the time, the initial cancer screening is carried out. Upon receipt of a request for review, a health services provider must carry out the review, communicate the results of the review at an Notifiable Incident Disclosure Meeting with the patient and deliver a written statement within five days of the Notifiable Incident Disclosure Meeting.
Non-Compliance with the Act
If the provisions of the Act are not complied with, an individual will be liable on summary conviction to a Class A fine of up to €5,000. It shall be a defence for a person against whom such proceedings are brought to show that the person made all reasonable efforts to ensure compliance with the Act. Where a company fails to disclose a Notifiable Incident and it is demonstrated that the offence was carried out with the consent or involvement of a member, director, manager, secretary, or other officer of the company, that person shall, as well as the company be guilty of the above-mentioned offence.
Conclusion
The introduction of the Act represents a significant step in fostering transparency and timely communication between patients, health practitioners and health service providers. Health Service Providers and practitioners will need to implement policies and procedures and conduct staff training to ensure compliance with the Act.
