1. Direction of Minister to undertake a Section 9 investigation

Following communication with the Minister and the Department of Health, the Authority has been directed by the Minister (pursuant to the Minister’s power to do so under Section 9(2) of the Act) to undertake an investigation (the “Investigation”) under Section 9(1) of the Act. The Minister outlined that he has reasonable grounds to believe there is a particular patient safety risk in relation to the provision of surgical services outside of core working hours and the readiness of the National Maternity Hospital to effectively respond to major emergencies regarding obstetric or gynecological surgical intervention.

2. Scope of Investigation specified by the Minister

In particular the Minister directed the Authority, cognisant of the report entitled (Maternal Death Investigation Report Review — HSE, August 2017), to provide in its investigation an assessment of the National Maternity Hospital;

• The implementation of early warning systems for the clinical management and recognition of a deteriorating patient
• Practice of surgery outside of core working hours
• The seniority of on-site clinical staff outside of core working hours
• The on-call arrangements for senior staff outside of core working hours
• The readiness of the hospital to respond to major emergencies which require surgical intervention

3. Specific Terms of Reference of the Investigation

In conducting this Investigation, the Authority will investigate and assess against nationally mandated standards and evidence based practice arrangements the National Maternity Hospital has in place to effectively manage obstetric major emergencies and out of hours obstetric and gynecological surgery.

The Investigation will be carried out on the basis of the following Terms of Reference:

 a) To investigate, determine and evaluate the appropriateness of measures employed at the National Maternity Hospital to manage risk and ensure safety in the conduct of obstetric or gynecological surgery outside of core working hours
 b) In doing so, to take particular account of the presence of required senior medical clinical decision makers during the conduct of surgical procedures outside of core working hours
 c) To investigate and assess the wider overarching governance arrangements at the hospital to ensure safe surgical services outside of core working hours
 d) To investigate and assess the readiness of the hospital to respond to major emergencies related to obstetric or gynecological surgical intervention outside of core working hours.

It should be noted that this investigation will extend:

• To the provision of all required medical expertise, including but not limited to the specialisms of Obstetrics, Gynecology, Anesthetics and Vascular Surgery
• Senior clinical decision makers are defined as qualified Consultants, or Registrars who have completed relevant training/passed membership examinations, and have been appropriately assessed as competent to work independently
• Consultants employed post 2008 will be registered on the relevant Medical Council specialist register
• The investigation will also take into account, as relevant, the availability of other required patient safety inputs, including but not limited to required workforce, diagnostic and laboratory availability outside of core working hours.

4. Recommendations and Reporting

If, in the course of the Investigation, it becomes apparent that there are reasonable grounds to believe that there are further or other serious risks to any persons receiving services, the Investigation Team may recommend to the Authority and/or the Minister that these terms be extended to include further investigation or that a new investigation should be undertaken, as appropriate.

The Authority shall consider the findings of this investigation, prepare a report on the findings of the Investigation and make national recommendations pertaining to the National Maternity Hospital and all public acute hospitals in Ireland on the management of obstetrics and gynaecology surgeries outside of core working hours, to the extent that the Authority considers appropriate.

The report will be submitted to the Board of the Authority for approval. This report will be published in order to promote safety and quality in the provision of these services for the benefit and welfare of the public.

5. Monitoring under Section 8 (1) (c) of the Act

Aligned to and informed by the investigation - the Authority will conduct a wider monitoring programme against the National Standards for Safer Better Maternity Services with a focus on management of obstetric emergencies, including out of hours emergencies, across all statutory and voluntary maternity hospitals.

6. Legislative Framework

In conducting this Investigation, the Authority will investigate and assess against nationally mandated standards and evidence based practice arrangements the National Maternity Hospital has in place to effectively manage obstetric major emergencies and out of hours obstetric and gynecological surgery.

This Investigation will be carried out in accordance with Section 9 and all other relevant provisions set out in the Act. The Investigation will be conducted by an Investigation Team appointed and authorised by the Authority in accordance with Part 9 of the Act.

The Team will carry out the Investigation and may exercise all of the powers available to it or its personnel under the Act, particularly those powers set out in Part 9 of the Act, including but not limited the rights of entry, rights to inspect premises, records and/or documents and its rights to conduct interviews and require explanations in relation to documents, records or other information.

In addition, the Authority (with appropriate Ministerial approval and in accordance with the Act, where required) may engage advisors as it considers necessary in the undertaking of this Investigation.

This Investigation will take account of existing information available to the Authority arising from its monitoring function under Section 8(1) (c) of the Act.

These Terms of Reference were approved by the Board of the Authority on 18 December 2017