The terms of reference for an inquiry into the breast cancer pathology services at University College Hospital Galway (UCHG) have been published today.
The inquiry follows the mis-diagnosis of cancer in a private patient - identified as 'Ms A' - receiving care at Barringtons Hospital in Limerick. Her tests were handled by UCHG.
At the request of the Minister for Health, Barringtons Hospital has since suspended its breast cancer treatment service and a large number of breast cancer cases are to be reviewed.
The independent Health Information and Quality Authority (HIQA) announced the terms of reference for the investigation.
HIQA said the investigation is being undertaken to ascertain what happened in this case.
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.
It said the focus of the investigation 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 UCHG.
"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 authority said it will work 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.
Other members of the team are: Dr Gerard Boran, Faculty of Pathology of Ireland; Dr Mairead Griffin, consultant cytopathologist; Professor Arnold Hill, Professor of surgery at Beaumont Hospital, Dublin; Dr Michael Jeffers, consultant histo/cytopathologist; Sheila O'Connor, Patient Focus; Dr Ann O'Doherty, consultant radiologist at St Vincent's University Hospital, Dublin and clinical director BreastCheck and Dr Clive Wells, Consultant Cytopathologist, St Bartholomew's Hospital, London.
"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 statement added.