The Health Information and Quality Authority today published the terms of reference for its independent investigation into the care provided to Rebecca O’Malley by the Health Service Executive. 

In addition to investigating the circumstances surrounding the care of Rebecca O’Malley in relation to her symptomatic breast disease, the investigation will also examine the provision of the pathology services provided by the Health Service Executive at Cork University Hospital and the symptomatic breast disease services provided by the Health Service Executive at the Mid Western Regional Hospital, Limerick. (see Editors Note 1 below for the full terms of reference).

Dr. Tracey Cooper, CEO of the Health Information and Quality Authority said; “the terms of reference will allow the investigation team to conduct a thorough and robust investigation into all aspects of the care received by Rebecca O’Malley. The investigation team includes experts from Ireland and the United Kingdom, as well as representatives of patient groups. In the interest of a fair and thorough investigation the Authority does not envisage making any further public comment until the investigation has concluded. The investigation report, and its recommendations, will be published following the completion of the investigation”.

The members of the investigation team are as follows:

• Dr Michael Durkin (investigation lead), Medical Director, South West Strategic Health Authority, UK
• Dr Gerard Boran, Dean of Faculty of Pathology, Royal College of Physicians of Ireland
• Professor Arnold Hill, Consultant Surgeon, Beaumont Hospital
• Christine Murphy-White, Chair of Europa Donna Ireland
• Dr Mairead Griffin, Consultant Histopathologist, St James's Hospital
• Dr Anne O'Doherty, Consultant Radiologist - Breastcheck – St. Vincent's Hospital
• Shelia O'Connor, Co-ordinator for Patient Focus and Board Member, the Health Information and Quality Authority
• Eddie Kinsella, Independent Consultant, Exemplar Consulting Limited, UK

The Health Information and Quality Authority is the new independent Authority which has been established to drive continuous improvements in the quality and safety of Ireland’s health care system. The Authority is independent of the HSE and has the powers to carry out investigations where there is a perceived risk to patients in Ireland’s health and social services

TERMS OF REFERENCE

1. Introduction

In accordance with Section 9 (1) of the Health Act 2007 the Health Information and Quality Authority (the Authority) will undertake an investigation into the circumstances surrounding the care of Rebecca O’Malley in relation to her symptomatic breast disease, and the provision of the symptomatic breast disease services provided by the Health Service Executive (the Executive) at the Mid Western Regional Hospital and pathology services provided by the Executive at Cork University Hospital.

Accordingly, the focus of the Investigation by the Authority will be on relevant aspects of the safety, quality and standards, including the governance arrangements, of symptomatic breast disease and pathology services provided by the Executive to Ms O’Malley and other patients, to ensure that best practice has been carried out and, if this is not the case, to ensure that where there may be serious risk to the health or welfare of a person receiving such services from the Executive, these risks shall be identified and recommendations can be made with a view to eliminating or ameliorating these risks for current and future patients. The Investigation shall be carried out within the following terms:

2. Terms

2.1. In respect of the period January 1st 2005 to 31st May 2007, the persons authorised to carry out the Investigation (“Investigation Team”) will:

• 2.1.1. Investigate the safety, quality and standards (including but not limited to the governance arrangements) of the services provided, and investigation undertaken, by the Executive to Rebecca O’Malley. The means of Investigation shall include (but not be limited to) inspection of medical records, imaging and slides.
• 2.1.2. Investigate the safety, quality and standards (including but not limited to the governance arrangements) of pathology services provided by the Executive at Cork University Hospital with a view to identifying any circumstances which may give rise to a serious risk to the health or welfare of any person receiving or having received such services and further to make such recommendations as the Investigation Team see fit in relation to this.
• 2.1.3. Investigate the safety, quality and standards (including but not limited to the governance arrangements) of symptomatic breast disease services provided by the Executive at (including but not limited to) the Mid-Western Regional Hospital, Limerick with a view to identifying any circumstances which may give rise to a serious risk to the health or welfare of any person receiving or having received such services and further to make such recommendations as the Investigation Team see fit in relation to this.

2.2. If necessary the Investigation Team will carry out an investigation into one or more of the matters mentioned at 1.1, 1.2 and 1.3 above for such other period that the Investigation Team deems necessary if this becomes apparent during the course of the Investigation.

2.3. The Investigation shall be carried out in whatever manner and with whatever methodology the Investigation team believes is the most appropriate, having regard, in particular, to the clinical judgment of the investigation team. The scope of the investigation will be limited to those patients and to those aspects of safety, quality, standards, and governance that the Investigation team considers are most relevant and material to the investigation.

2.4. The Investigation Team shall prepare a report outlining the Investigation, its findings, conclusions and any recommendations that the Investigation Team see fit to make

2.5. If, in the course of the Investigation, it becomes apparent that there are reasonable grounds to believe that there is a serious risk to the health or welfare of any person and that further investigation is necessary beyond the scope of these terms of reference, the Investigation Team may in the interests of investigating all relevant matters, and with the formal approval of the Authority, extend these terms to include such further investigation within their scope or recommend to the Authority that a new investigation should be commenced as appropriate.

Ends.

Further Information: 

Clare Manning, Account Director, MRPA KINMAN Communications 01 703 8616