Reporting Notifiable Incidents to the MHC under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 has now commenced. This new legislation will result in a range of changes for service providers. In addition to the requirements to disclose certain information to patients, there will be new legal requirements for notifying the Mental Health Commission and the Health Information and Quality Authority (HIQA) about patient safety incidents. It is the responsibility of service providers to familiarise themselves with these new requirements.
The MHC is obliged to change its processes and align them with the provisions of the 2023 Act. The MHC has updated its guidance on quality and safety notifications which you can find by clicking on the link Guidance on Quality and Safety Notifications (QSNs). The MHC has developed the regulatory guidance that can be accessed by clicking on the link Regulatory Guidance for Approved Centres on the Patient Safety Act 2023. These changes are relevant to both HSE-run services and private entities alike.
Under the 2023 Act approved centres will be required to notify certain incidents to the MHC through the new functionality of the National Incident Management System (NIMS). The existing reporting requirements for approved centres under CIS remain unchanged. This means that in addition to the notifications submitted through CIS, some incidents will also have to be notified through NIMS to ensure service providers fulfil their legal obligations under the 2023 Act.
Where a registered proprietor is satisfied that a notifiable incident under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, has occurred in the course of the provision of a health service to a patient, it shall notify the MHC as soon as practicable, and not later than seven days from the day on which the registered proprietor was satisfied the incident had occurred. The registered proprietor shall make the notification by means of the National Treasury Management Agency incident management system (NIMS) if the approved centre is operated by the HSE or the Patient Safety Notifiable Incident Portal if the approved centre is operated by entity other than by the HSE.
Regulatory guidance from the MHC in relation to notifiable incidents is available at the link Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 Regulatory Guidance for Approved Centres.
Notifications outside of the scope of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, should be submitted to the MHC as normal using the MHC's Comprehensive Information System (CIS).
Submission Requirements
The requirements of the 2023 Act are in addition to existing MHC notification requirements as set out in the MHC’s Guidance on Quality and Safety Notifications. Therefore, notifiable incidents that occur within an approved centre are also required to be submitted as usual via the Comprehensive Information System (CIS). This means that two notifications for incidents that take places in an approved centre may be required in order to satisfy the requirements of both the 2023 Act and the 2001 Act.
Note: The only notifiable incidents that are notifiable to the MHC under the 2023 Act are those that occur in an approved centre. All notifiable incidents taking place in Community Mental Health Services should be reported to HIQA and not to the MHC. This includes death notifications of individuals who have been in care of HSE community mental health teams. Death notifications relating to individuals in Community Mental Health Services are no longer required to be made via the Comprehensive Information System (CIS) operated by MHC.
Approved Centres operated by non-HSE services
All non-HSE health service providers that carry out the business of an approved centre as defined in the Mental Health Act 2001-2018 are also required to submit notifiable incidents that take place in those approved centres. This means that all approved centres that are not operated by the HSE should use the Patient Safety Notifiable Incident Portal to notify the MHC that a notifiable incident has occurred.
Guidance on using the portal can be accessed at the link Portal Guidance.
Approved Centres operated by the HSE
All HSE approved centres should use the NIMS system to notify the MHC that a notifiable incident has occurred.
The HSE have information about the Patient Safety (Notifiable Incidents) Act 2023 at the webpage link Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 - Corporate (hse.ie)
The HSE have resources for HSE staff and HSE organisations at the webpage link Resources for staff and organisations - Corporate (hse.ie)
Please note that HSE staff should already have access to NIMS. The MHC cannot provide access to or support for NIMS. Additional information from the HSE relating to NIMS is available at the webpage link National Incident Management System (NIMS).
Queries
Queries regarding the submission of Notifiable Incidents to the MHC can be sent to the email address standards@mhcirl.ie.
Queries regarding the submission of Notifiable Incidents to HIQA can be sent to the email address patientsafetyactincidents@hiqa.ie.
Notifiable Incident Types
What incidents should be notified to the MHC under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023?
1.6 Unintended, unanticipated death directly related to any medical treatment
1.6 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 and the death did not arise from or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
1.8 Patient death associated with a medication error
1.8 Patient death associated with a medication error and the death was unintended and unanticipated as it did not arise from or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
1.9 Unanticipated death while pregnant or within 42 days of the end of pregnancy
1.9 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 (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
1.10 An unanticipated and unintended stillborn child
1.10 An unanticipated and unintended stillborn child where the child was born without a fatal foetal abnormality and with a prescribed birthweight or has achieved a prescribed gestational age and who shows no sign of life at birth, from any cause related to or aggravated by the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the child.
1.12 An unintended death of a patient where the cause is believed to be suicide
1.12 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 whether or not the death was anticipated or arose from, or was wholly or partially attributable to, the illness or underlying condition of the patient.
Types 1.1, 1.2, 1.3, 1.4, 1.5, 1.7, 1.11, 2.1 (a), 2.1(b)
Notifiable Incident Types 1.1, 1.2, 1.3, 1.4, 1.5, 1.7, 1.11, 2.1 (a) and 2.1(b) are related to surgical procedures, blood transfusions and deaths related to babies and are not relevant to notifications made to MHC.
