Terms of Reference

The Health Information and Quality Authority (the Authority) will investigate the safety, quality and standards of services provided by the Health Service Executive (HSE) to patients, including pregnant women, at risk of clinical deterioration, including those provided in University Hospital Galway (UHG) and as reflected in, among other things, the care and treatment provided to Savita Halappanavar. The Investigation shall be carried out on the basis of the following terms:

1. The Authority will review the safety, quality and standards of services provided by the HSE at UHG to patients, including pregnant women, at risk of clinical deterioration and as reflected in the care and treatment provided to Savita Halappanavar. This will include the diagnosis and management of patients with sepsis. Assessment of the services will be made against the National Standards for Safer Better Healthcare and relevant national and international evidence of what is known to achieve best outcomes.

2. The Authority will review the arrangements that the HSE has in place to ensure that clinically deteriorating pregnant women, including those at risk of sepsis, receive care which is compliant with the National Standards for Safer Better Healthcare and relevant national and international evidence of what is known to achieve best outcomes.

3. The Authority will review the arrangements that the HSE has in place to assure the delivery of high quality, safe and reliable services. This will be limited to those aspects of safety, quality and standards that the Authority considers are relevant and material to the Investigation and will include those arrangements relating to the reporting and management of patient safety incidents and the implementation of the prompt identification and management of clinically deteriorating patients.

4. 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 the health or welfare of any person receiving similar services, the Investigation Team may recommend to the Authority and/or the Minister for Health, that these terms be extended to include further investigation or that a new investigation should be undertaken, as appropriate.

5. The Authority shall, in good faith, prepare a report of the findings of the investigation and make local and national recommendations as to the safety, quality and standards of services provided by the HSE, 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 health services for the benefit of the health and welfare of the public.

This Investigation will be carried out in accordance with Section 9(1) and other relevant provisions set out in the Health Act 2007, as the Authority believes that on reasonable grounds there is a serious risk to the health or welfare of persons receiving services following consideration of, amongst other things, information and correspondence received from the HSE.

The Investigation will be conducted by an Investigation Team appointed and authorised by the Authority in accordance with Part 9 of the Health Act 2007. The Team will carry out the Investigation and may exercise such powers as it has, pursuant to Part 9 of the Health Act 2007, including rights of entry, its rights to inspect premises, records and/or documents and its rights to conduct interviews and rights to require explanations in relation to documents, records or other information. In addition, the Authority (with appropriate Ministerial approval and in accordance with the Health Act 2007 where required) may engage such advisers as it considers necessary in the undertaking of this Investigation.

These Terms of Reference were approved by the Board of the Authority on 27 November 2012.