Mary Harney (Dublin Mid West, Progressive Democrats)
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I believe all Members are at one in expressing their sincere sympathy for all the women affected by these failings of the Midland Regional Hospital radiology services. As Minister for Health and Children, I offer an unreserved apology to the women who have been caused needless anxiety since August and, most especially, to the women who been given false results and whose treatment has been delayed. We are at one in this House in our resolve that they are now to receive the best possible care and treatment, as they should always have done. As Minister, I am also determined that every possible action is taken to minimise the risk of this happening again.

Today is a day for patients first. It is a day when patient safety should come before hospitals, constituencies and the professions and also before cynicism and defeatism about achieving top class quality-assured health services. It is a day for facts and to let facts about ensuring patient safety speak for themselves. It is time to face facts about the changes patient safety demands so that no more patients have to face appalling facts about their own health and treatment.

I wish to set out the facts, therefore, as I know them today. The report of Professor Niall O'Higgins, Development of Services for Symptomatic Breast Disease Services, was published in 2001 and €60 million was made available by the Government to implement it. The report stated that the population of the midland region marginally supported a single breast unit. The report specifically recommended that there was a case to be made for locating the breast unit in Tullamore because of its geographical location in the health board area and because this would fit in with the previous decisions regarding the organisation of oncology and pathology services. The Midland Health Board debated this report, with arguments about the allocation of services between Mullingar, Tullamore and Portlaoise. In 2001, the Midland Health Board decided to locate thebreast service in Portlaoise and other cancer services at Tullamore.

By summer 2005, breast radiology services were being provided by two locum consultant radiologists. On 5 July 2005, a consultant surgeon at the Midland Regional Hospital, Portlaoise, Mr. Peter Naughton, wrote to me at the Department of Health and Children outlining his concerns in relation to the breast services at the hospital. His letter went beyond general policy comment, although it did not raise specific cases or mention specific clinical staff. It clearly required attention of HSE and clinical management, and this is what was done on my behalf. Mr Naughton gave his view, for example, that "radiological services were being provided by people who have no expertise in this area".

My officials replied on my behalf on 15 August 2005, advising that his letter had been brought to the HSE national hospitals office for urgent examination and appropriate attention. It was also brought to the attention of Professor Donal Hollywood, consultant radiation oncologist who was then regional director of cancer services in the midland region and was involved in the discussions around this issue in that capacity with hospital management and Mr. Naughton. Essentially, since August 2005 a new permanent consultant post was filled and strong efforts were made to fill another. The details are as follows.

Portlaoise hospital had one permanent consultant radiologist appointed in June 2004. In addition, a recruitment process managed by the Public Appointments Service was under way to make another permanent appointment of a consultant radiologist at the hospital. One person applied for the post, the doctor who had been a locum beforehand, was offered the position, and took it up on 1 November 2005.

A third consultant radiologist position was advertised in July 2005, interviewed for in December 2005, with an offer being made to the preferred candidate in February 2006 which was ultimately turned down by that individual in July 2006. This post was re-advertised on 30 November 2006, with shortlisting taking place in March 2007. No candidate was deemed suitable for interview. In 2006, a pathologist with a special interest in cytology was appointed to Mullingar with sessions in Portlaoise. Since November 2005, breast radiology services have been provided at Portlaoise by a combination of two permanent post holders and at least two locum radiologists.

The review under way at present covers mammogram readings by the two permanent post holders and any locums that provided services at the time. I understand from the HSE that medical and nursing staff within Portlaoise expressed concern about the mammography reporting of one of the radiologists in question. The main concern was that there was potential over-diagnosis of serious disease. They believed radiological assessment and diagnosis of possible breast cancer symptoms may not have routinely followed best practice. If the consultant's report was at odds with clinical opinion, medical staff requested repeat mammograms in another hospital, St. Vincent's in Dublin. This was happening by December 2006. This referral process confirmed their concerns.

Their concerns were formally notified to the network manager by letter dated 15 August 2007 which caused the full suspension of breast radiology services. I understand the director of nursing at the hospital took a lead role in raising these concerns and I commend her particularly for her courage and commitment to patient safety in so doing.

The consultant radiologists wrote to the hospital management about equipment and those points were followed up by the HSE. The HSE has said that "the latest independent routine inspection report on the machine dated May 18th last indicated that the machine was satisfactory and did not include any identifiable faults".

The most pertinent fact about the equipment is that the review being undertaken at the moment is based on the images taken by that equipment, and the mistaken diagnoses are evident to the expert eye reading those images. Three consultant radiologists have been involved in reading the same 3,000 images and have found diagnoses of cancer on them. I have the utmost confidence that if the images were defective arising from machine defects, this would have been evident and would have already been brought to our attention. I await the full report in this regard.

On 29 August last, the HSE informed my Department, and I was informed personally, that following concerns raised in a letter of 15 August by staff in the breast service concerning approximately ten false positive mammograms, the HSE had ceased the provision of breast radiology services at Portlaoise, placed the consultant radiologist concerned on administrative leave and set up a review of all breast radiology diagnoses at the Midland Regional Hospital in Portlaoise in the period from November 2003 to August 2007.

I believe the actions of key nursing, medical and administrative staff at Portlaoise and the decision to end mammography services have removed this identified clinical risk to women in the midland region. The HSE has assured me that arrangements are in place to ensure appropriate follow-up and treatment of the women affected.

The review is being led by Dr. Ann O'Doherty, consultant radiologist, St. Vincent's University Hospital and BreastCheck. I have great confidence in the clinical standard and integrity of this review and I believe it will be of considerable assurance to women. The HSE has advised that 3,026 mammograms have now been reviewed, representing the total number involved. This led to 234 women having their diagnostic status and clinical notes reviewed following which 54 women were recalled to clinics at St. Vincent's University Hospital. Of the 54 women recalled to date, seven have been identified as having a diagnosis of cancer. All seven women have been offered appropriate treatment and counselling. The HSE has apologised to these women for the delay in diagnosis.

At the beginning of this week, 19 women were still to be reviewed. Of these 19 women, 13 are clear of cancer. Six have been referred to the special clinic at St. Vincent's University Hospital, four attended last Monday, 5 November, and two are scheduled to attend tomorrow.

The review phase will be completed this week and a full report will be published by the end of November. The consultant radiologist whose practice gave rise to this review remains on administrative leave. A helpline is in operation at the hospital for people who may need further information. I have requested an urgent report from Professor Drumm on the circumstances which led to the decision to suspend the service, place the consultant radiologist on leave and initiate the review. This will help us to identify any lessons which can be learned from these particular circumstances. However, it is most important that we move forward now as rapidly as possible to implement the national cancer control programme. It is absolutely clear that the highest quality, safe specialist cancer services will only be delivered where there are large numbers of consultants working together on large numbers of cases, with continuing competence assurance and audit.

Dr John Hillery, the former President of the Irish Medical Council and chairman of the International Association of Medical Regulatory Authorities, wrote this week in The Irish Times that large centres were essential to ensure that both formal competence assurance processes and informal processes between doctors worked best for patient care in specialised areas. To accept political responsibility must surely mean to act on this consensus of evidence and advice. Therefore, the Government is supporting, and will continue to support, the organisation of cancer and other services that puts patients first. Our commitment to the people is that we will organise and support safe, quality-assured services, as close to people's homes and communities as can safely be provided. In some instances this will mean services not being delivered in hospitals — large or small — but in community-based and primary care settings. In others, it will mean services being delivered in regional hospitals or centralised services. In the most rare cases, it will mean a national centre only.

We use the phrase, "centres of excellence", as if that were a rare and exceptional standard. I want to emphasise two things: there is excellence already in many hospitals and among many clinical services in cancer services and other areas. Of the 2,000 women a year who are diagnosed with breast cancer, the vast majority receive quality care and treatment. Relative survival rates for breast cancer in Ireland have improved from 72.9%, for people diagnosed between 1994 and 1997, to 78.2%, for those diagnosed between 1998 and 2001. We have now ended breast cancer surgery at 13 locations which, between them, were carrying out fewer than 56 surgeries per year. This is far below any safe level. Every form of health care can and should reach a standard of excellence, be it home care, general practitioner services or the work of local, regional and national hospitals. Excellence and patient safety apply to all medical locations and centres.

We simply must act upon the fact that not every location can deliver excellence in every specialist service, no matter what the level of resources, staffing or equipment for local hospitals. This is why we are also committed to recruiting many more consultants on a new contract rather than relying on locums and non-consultant hospital doctors, thinly dispersed across many locations where competence assurance cannot be reliably and systematically maintained. Let this be a day for determination to follow through on doing the right thing now and in the future for female and male cancer patients.

The international radiology standard, and that in Ireland, as covered by the O'Higgins report, is not that two radiologists should read a mammogram, as Deputy Kenny stated in good faith. This is only recommended if there is a very low volume of mammograms, that is, well under 500, which would be the case in exceptional circumstances. It is not recommended by the guidelines that every mammogram should be read by two radiologists.

On triple assessment, money was provided to the HSE, midland area, and elsewhere. There were surgeons, pathologists and radiologists at the Midland Hospital. Generally, where there is a suspicion of cancer, the case should be subjected to triple assessment, whereby the opinions of the pathologist, surgeon and radiologist would be sought. Clearly, in the case in question the seven women were given the all-clear and were not suspected of having cancer by the radiologists reading their mammograms, and therefore the issue of triple assessment did not arise.

Unfortunately, many issues are being raised because we do not have the report. The fact is that three different consultants in Dublin, led by Dr. Ann O'Doherty, each read approximately 1,000 mammograms. I believe there were 3,028 in total. The consultants found seven cancers in the same mammograms that were given the all-clear in Portlaoise. They were using the exact same mammograms delivered by the machinery now being questioned.