The Health Information and Quality Authority today announced the terms of reference and investigation team that will undertake an independent investigation of pathology services at University College Hospital Galway (UCHG). The investigation is being undertaken following the mis-diagnosis of cancer in a private patient receiving care in the mid-west. 

The investigation is being undertaken to ascertain what happened in this case and it will also review as many additional cases as are required, in order to reassure women with symptomatic breast disease whose pathology specimens were examined in UCHG over the relevant time period that they have been correctly diagnosed. The Authority will be working closely with UCHG to ensure that other women whose cases are being reviewed are communicated with promptly and appropriately.

The investigation team will be led by Dr Mike Durkin, Medical Director of the South West Strategic Health Authority, England. Terms of reference are attached and the membership of the investigation team is as follows:

• Dr Ann O’Doherty – Consultant Radiologist at St Vincent’s University Hospital, Dublin and Clinical Director BreastCheck
• Professor Arnold Hill - Professor of surgery at Beaumont Hospital, Dublin
• Mrs Sheila O’Connor – Patient Focus
• Dr Gerard Boran – Faculty of Pathology of Ireland
• Dr Mairead Griffin – Consultant Cytopathologist
• Dr Michael Jeffers – Consultant Histo/Cytopathologist
• Dr Clive Wells – Consultant Cytopathologist, St Bartholomews Hospital, London, UK

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.

Terms of Reference Investigation into the pathology and symptomatic breast disease services provided to Ms A and other patients by University College Hospital Galway

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 (the Investigation) into the provision of services to Ms A by the Health Service Executive (the Executive) at University College Hospital Galway (the Hospital) in relation to her symptomatic breast disease, and the provision of pathology and symptomatic breast disease services by the Executive at the 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 the pathology and symptomatic breast disease services provided to Ms A and other patients by the Executive at the Hospital. The Investigation will seek to ensure that acceptable practice has been carried out and, if this is not the case, to ensure that where there may be serious risks to the health or welfare of a person receiving such services from the Executive, these 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 by the Executive at the Hospital, in respect of Ms A.
• 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 the 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. The means of Investigation may include (but not be limited to) inspection of medical records, imaging and slides.
• 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 the 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 sees 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 sees 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: 

Marty Whelan, Head of Communications and Stakeholder Engagement

01 6041785 / 086 2447623 mwhelan@hiqa.ie