The Patient Safety (Notifiable Incident and Open Disclosure) Act 2023 as it relates to Open Disclosure

Lorraine Schwanberg
Lorraine Schwanberg

The legislation was enacted in May 2023 and the Department of Health is aiming for commencement (when it officially starts to take effect) this summer, writes Lorraine Schwanberg, Assistant National Director, HSE National Quality and Patient Safety Incident Management.

The fundamental aim of the Patient Safety Act 2023 is to further embed openness and transparency across the Irish healthcare system as it applies to private and public healthcare.

In part, the Patient Safety Act 2023 sets out the legal requirement for open disclosure when one of a list of 13 Notifiable Incidents occurs. Notifiable Incidents are defined and itemized in the Patient Safety Act 2023 and predominantly describe events where the patient or service user sadly died. They incorporate incidents such as medication related incidents, surgery/surgical intervention related incidents, maternity related incidents, mental health related incidents and more. The list can be accessed here.

Open disclosure is not new of course in the HSE and has been policy since 2013. This Act builds on current policy. When things go wrong, there has always been a requirement for open, transparent, compassionate and empathetic communication, which should be reinforced with good documentation. Throughout the open disclosure process, patient/service users and staff must be supported.

The HSE Open Disclosure Policy is currently being updated to further align with the Patient Safety Act 2023. Whilst the HSE is working towards standardising requirements to make it as seamless and straightforward as possible for staff to implement the Patient Safety Act 2023, there are some elements specific to open disclosure as described in the Patient Safety Act 2023:

  • The legal requirement for open disclosure applies to one of 13 Notifiable Incidents only. The HSE Open Disclosure Policy applies to all patient safety incidents.
  • The health services provider must notify the relevant regulator (HIQA, the Chief Inspector or the Mental Health Commission) within seven calendar days from when one of the Notifiable Incidents is identified. This will be in addition to other regulatory reporting requirements, for example reporting a Serious Reportable Event to the regulator. Where the Notifiable Incident is also a Serious Reportable Event then it needs to be reported via NIMS as a Notifiable Incident and as an SRE via the current reporting mechanisms (e.g. via the Comprehensive Information System (CIS) to the Mental Health Commission).
  • Reporting a Notifiable Incident to the regulator must be via the National Incident Management System (NIMS). For users of the system, such as HSE staff, they must access the NIMS incident record and complete a form on the incident record page and submit that electronically to the regulator. This function is currently being built and will be ready for June 2024. For private providers, an electronic portal is being purpose built to enable Notifiable Incident reporting. The portal will be accessible through the relevant regulators website pages.
  • The Patient Safety Act 2023 makes it a legal requirement to assign a designated person to support the patient or their relevant person throughout the open disclosure process of a Notifiable Incident. This is in line with current policy and adds weight to the importance of this role. A designated person is not only desirable but essential.
  • The Act is specific as to what must be covered at an open disclosure meeting and within the written follow-up. This is being aligned in the HSE Open Disclosure Policy. The Patient Safety Act 2023, requires that the written record following an open disclosure meeting is shared with the patient or their relevant person within five calendar days of the meeting.
  • There are offences and penalties that apply to non-compliance with the Patient Safety Act 2023, specifically when the regulator is not notified or an open disclosure meeting is not held as set out in the Patient Safety Act 2023. Importantly, not undertaking open disclosure is detrimental in any situation, in particular where a patient or service user was harmed and may lead to compounded harm. It could be reputationally damaging for an organisation and lead to mistrust in the health services provider by the patient/service user and their relevant person.

HSE Sepsis Summit

03rd September 2024, Dublin Castle

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