by Katy Meade , Niamh O’Herlihy October-01-2024 in Healthcare Law
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (“The Act”) was enacted on 2 May 2023 and was commenced on 26 September 2024. It has introduced, for the first time in Irish law, mandatory open disclosure by health services providers of certain notifiable incidents which occurred during the provision to a person of a health service. It also places an obligation on the HSE’s cancer screening services to inform patients of their right to request a review of their screening.
The Act mandates that open disclosure is made to the patient concerned and/or relevant persons and provides detailed guidance on the process, to include the timing of the disclosure and the information to be provided. The Act contains sanctions in the event of non-compliance without reasonable cause but also provides for certain restrictions on the use of the information furnished in such disclosures and any apologies made.
The Act makes amendments to the Health Act 2007 to include the expansion of HIQA’s remit into prescribed private health services and private hospitals. These amendments will allow HIQA to set standards, monitor compliance and undertake investigations in private healthcare settings.
Health Service Providers and Notifiable Incidents
A health service provider is defined in Section 3 of the Act as a person, or a company that employs a health practitioner, enters into a contract for services with a health practitioner or enters into an arrangement with a health practitioner for the provision of a health service. The Act applies to both public and private hospitals together with private health and social care providers. Under the Act, a health practitioner includes doctors, dentists, pharmacists, nurses and midwives, amongst others.
The notifiable incidents which are now subject to open disclosure are set out in schedule 1 and include the following:
- 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 resulting in unintended and unanticipated death
- Unintended retention of a foreign object after surgery, resulting in unanticipated death
- Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia)
- Any unintended and unanticipated death that is directly related to any medical treatment
- Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated
- Patient death associated with medication error and the death was unintended and unanticipated
- An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy from any cause related to, or aggravated by, the management of the pregnancy, and which did not arise from, or was a consequence of the illness of the patient or an underlying condition of the patient
- An unanticipated stillborn child or perinatal death
- An unintended death where the cause is believed to be the suicide of a patient while being cared for in a health service setting
Schedule 1 Part 2 of the Act extends notifiable incidents to circumstances where a baby requires, or is referred for, therapeutic hypothermia or has been considered for, but did not undergo therapeutic hypothermia as such therapy was contraindicated due to the severity of the presenting condition.
Section 8 of the Act enables the Minister to define additional circumstances as “notifiable incidents” provided they meet certain criteria.
Open disclosure and notifications
Sections 5 and 6 of the Act provide where a notifiable incident has occurred, the health practitioner shall, as soon as practicable, inform the health service provider which is providing the health service to the patient. Once the health service provider is satisfied that a notifiable incident has occurred, it shall hold a notifiable incident disclosure meeting to make the open disclosure of that incident to the patient and/or relevant person.
Section 17 requires that the meeting shall be held in person, unless the patient or relevant person requests otherwise and section 18 provides detailed guidance on the information to be provided at the meeting and the written statement which must be furnished. This statement should specify the date on which open disclosure was made and that the meeting was held in compliance with section 5(1). The statement should also include the information provided to the family or relevant person, an apology if one was made and must be signed by the principal health practitioner or the health practitioner who made the open disclosure on behalf of the provider.
In addition to the disclosure meeting, section 27 of the Act requires that the health service provider notify the relevant external body within 7 days. The relevant external body involved will depend on the provider involved and will be HIQA, Chief Inspector of Social Services or the Mental Health Commission.
Of note, the Act provides for mandatory open disclosure of completed individual patient requested reviews of their cancer screening by the HSE’s National Screening Service. Under the Act, there is an obligation on the screening services to inform patients before or after their screening of their right to make a request for a Part 5 review.
Restrictions on the use of the information provided in disclosure meetings and apologies made.
Section 10 of the Act provides that information provided, and an apology where it is made, to a patient at a notifiable incident disclosure meeting shall not constitute an express or implied admission of fault or liability by the health service provider, shall not be admissible as evidence of fault in Court in a clinical negligence action or constitute an express or implied admission of fault in professional misconduct, fitness to practise or similar proceedings. Additionally, any information disclosed, or apology provided, does not invalidate any insurance or indemnity held by the health service provider or health practitioner.
Part 6 of the Act extends the above protections to information provided or data submitted as part of a clinical audit, provided that the data obtained from the clinical audit has been collected, analysed, published and used solely for the purpose of improving patient safety and quality improvement in healthcare of patients.
Consequences of non-compliance with the Act
Section 77 of the Act sets out the consequences for failure to disclose a notifiable incident. Where a health service provider fails to disclose a notifiable incident, without a reasonable excuse, they shall be guilty of an offence and shall be liable on summary conviction to a class A fine (up to €5,000). Section 77(8) provides that it shall be a defence to show that they made all reasonable efforts to ensure compliance with the provisions of the Act which are alleged to have been contravened.
Impact
The HSE, the Irish Medical Council and medical indemnifiers have had a long-standing commitment to the provision of open disclosure. Open disclosure was first put on a statutory footing under Part 4 of the Civil Liability (Amendment) Act 2017, but the 2017 Act provided for voluntary, rather than mandatory, disclosure. While this Act makes disclosure mandatory, health providers should be reassured that for sanctions to be imposed, it must be proven that there is no reasonable excuse for the failure to comply with the provisions of the Act which are alleged to have been contravened. The Act also includes similar protective provisions to those set out in the 2017 Act regarding information shared at open disclosure meetings. These provisions should help allay fears that such information could be interpreted as an admission of fault, professional misconduct or poor professional performance.
It is intended that the commencement of the Act will benefit both healthcare providers and patients by progressing the culture of openness and transparency in healthcare settings. The detailed guidance and protective provisions set out in the Act will help support health service providers in their engagement with patients or their families when a notifiable incident has occurred.
Back to Full News
Share this article:
About the Authors
Katy Meade
Katy is a partner in the Healthcare team at Hayes solicitors. Katy is dual qualified as a nurse and healthcare solicitor. She has over six years' healthcare litigation experience working in leading firms in both Ireland and the UK. Katy advises clinical practitioners and their indemnity bodies on the defence of medical negligence claims.
Niamh O’Herlihy
Niamh O'Herlihy is an associate solicitor in the Healthcare team at Hayes solicitors. Niamh practices in the defence of medical negligence claims on behalf of public and private healthcare providers.