Mary Harney (Dublin Mid West, Progressive Democrats)

I addressed the House on the issue of cancer services on 12 March, following the publication of the reports on the misdiagnosis of nine women in the Midland Regional Hospital, Portlaoise. On that occasion I expressed my deep regret to the women and their families. Once again I reiterate this regret and offer sincere apologies to all those women and their families who are the subjects of the various reports we are discussing today.

We must never forget that our health system must have the treatment and welfare of the patient as its central focus. Health service staff must at all times strive to deliver quality driven, patient-centred care. In turn, staff must be supported by management in an environment where the highest standards of care are fostered, where there is teamwork and where roles and responsibilities are clear.

Of course, in the context of cancer care a prerequisite to a quality driven service is the multidisciplinary team providing initial diagnosis and treatment. Evidence has shown that where women are treated for breast cancer in a multidisciplinary quality environment survival rates can improve by as much as 20%. In each of the cases reviewed multidisciplinary teams were not present.

The key findings of the reports in Portlaoise were as follows. There were no multidisciplinary team meetings other than in oncology and consultant medical staff were not represented at the meeting that decided to suspend breast radiology services. There was confusion regarding roles and responsibilities in the hospital and there were gaps in decision-making processes. There was a fundamental weakness in the management and governance of the review process because no authoritative co-ordination role was established for the process as a whole. Decision-making was fragmented, communications were inconsistent and there were too many individuals involved, which led to confusion about the status of the overall review process.

Since that date two other reports have been published. The review of the clinical care of patients who presented to the symptomatic breast disease service at Barringtons Hospital, Limerick, was published on 1 April, and the independent investigation by the Health Information and Quality Authority, HIQA, into the care provided by the Health Service Executive, HSE, to Rebecca O'Malley at the Cork University Hospital and the Mid-Western Regional Hospital, Limerick, was published on 2 April.

I received a report from the HSE on 31 July 2007 relating to the misdiagnosis of breast cancer in a woman who resides in the mid-western region. The patient, Ms A, had presented to Barringtons Hospital, Limerick, initially in 2005 and again in 2007. The HSE's specific concern related to two pathology tests performed on behalf of Ms A that were carried out on behalf of Barringtons Hospital in University College Hospital, Galway.

On 7 August 2007, HIQA announced that it would undertake a review of pathology services at University College Hospital, Galway, which would include establishing the facts about this aspect of the patient's care. It is anticipated that this review will conclude shortly. On 9 August, HIQA informed my Department's chief medical officer about concerns relating to the adequacy of the management and care of ten women who attended the breast disease services at Barringtons Hospital within the past four years. On 10 August, the chief medical officer and deputy chief medical officer of my Department, on my behalf, met Barringtons Hospital and requested it to suspend the delivery of breast services, and it agreed to do so.

It was agreed by the hospital that an independent clinical review was required into the clinical care of patients who presented at the symptomatic breast disease service at Barringtons Hospital between September 2003 and August 2007. The review team was chaired by Dr. Henrietta Campbell, a former chief medical officer in Northern Ireland. As I said, the report was published on 1 April.

The report found that hospital records identified 331 patients falling within the remit of the review. Of these, 285 patients consented to the review. Following assessment of all available records, the review team concluded that in its opinion, the diagnosis and treatment of 139 patients was entirely appropriate and there was no need for further assessment. In a further 118 cases, it was the clinical and professional judgment of the review team that the level of clinical care was not always what it considered appropriate. However, in none of these cases was a diagnosis of cancer missed or delayed and in no case was a diagnosis of cancer wrongly given.

The report concludes:

whilst it is not considered that any of these patients have come to lasting harm, the review team is of the opinion that many of these patients could have been managed differently. In some women with benign disease, operative intervention would not have been required if appropriate investigations had been undertaken prior to surgery. In other cases where cancer was present, definitive surgery should have been undertaken as one procedure rather than in two stages.

In two patients, a diagnosis of cancer was delayed for a significant period from initial presentation, potentially causing serious harm. In 26 cases it was concluded that these patients should be referred for further investigations to exclude the possibility of breast cancer. In most of these cases the referral was regarded as a precautionary measure.

The report emphasises the importance of triple assessment, that is, a joint assessment carried out on a multidisciplinary basis by a pathologist, a radiologist and a surgeon. Triple assessment was not available in Barringtons Hospital and as a result some patients may have undergone unnecessary surgery while others did not receive definitive surgery based on the results of normally expected pre-operative diagnosis.

The findings of HIQA's first investigation into the care provided for Rebecca O'Malley by the HSE were published on 2 April. The main finding of the report is that the interpretive error made by a consultant pathologist that led to the initial misdiagnosis was a single mistake of human error. However, the report notes the absence of a triple assessment review in the centre, which led to missed opportunities to correct the error. The report is also critical of the HSE on governance, management and communications and the way in which Rebecca O'Malley was informed of matters relevant to her care. In total, the report contains 15 recommendations, including matters relating to clinical practice and management.

One of the most important things about any review is that we learn from the exercise and apply that learning throughout the service. All reports highlight the need for swift implementation of the national quality assurance standards for symptomatic breast disease services, which I approved last year under the Health Act 2007. The implementation of the standards will ensure that every woman in Ireland who develops breast cancer has an equal opportunity to be managed in a centre that is capable of delivering the best possible results. The standards need to be applied to all hospitals, both public and private, that provide symptomatic breast disease services. I strongly believe that symptomatic breast services should be provided only in hospitals that meet these standards in full.

My Department wrote to the Independent Hospital Association of Ireland and the private health insurers, on my behalf, last August, enclosing a copy of the standards, and I subsequently had discussions with them relating to these matters. The standards will clearly have implications for some private facilities. Some have already ceased providing symptomatic breast services. I continue to encourage hospitals in the independent sector to take the necessary steps to ensure that their breast cancer services comply with the standards.

The HSE has designated eight centres for symptomatic breast disease services. The HSE National Hospitals Office will shortly transfer full responsibility for symptomatic breast services to the national cancer control programme, which is being overseen by Professor Tom Keane. The programme recently completed a detailed review of resource requirements to create capacity for the progressive transfer of all symptomatic breast cancer services to the eight designated centres with the objective of completing 60% of the transfer by the end of this year and 90% by the end of 2009. Funding of €5.8 million has been allocated across the eight centres from the programme to support additional staff, including consultant, radiography, nursing and clerical posts. Funding has also been allocated for some necessary additional equipment.

Two other reports have yet to be published. One is the investigation by HIQA into pathology services at University College Hospital, Galway, which commenced in September 2007. While it is difficult to predict precisely at this stage when the work will be completed, it is hoped that the investigation will be concluded shortly and the report will be published as soon as possible thereafter. The other is the pathology review in Cork University Hospital, which is completed. A report is being finalised by the HSE in that regard.

Following the discovery of a small number of errors in the reading of X-rays, the HSE invited a panel of experts from the UK to assess the need for a review of the radiology services in Our Lady of Lourdes Hospital, Drogheda, and Our Lady's Hospital, Navan. The panel recommended a review and work is progressing in identifying its full scope. It will be carried out in accordance with the HSE's recently adopted policy on serious incident management.

If the recent reports and reviews have taught us anything, it is that we must fully support the establishment of the national cancer control programme and ensure it is established by the HSE without delay. The HSE has designated four managed cancer control networks. For the first time in Ireland, we have a national leader in cancer control. I have full faith in Professor Keane in delivering on this programme.

The decisions of the HSE to designate four managed cancer control networks and eight cancer centres will be implemented on a managed and phased basis. The HSE plans to have completed 50% of the transition of services to cancer centres by end 2008 and 80% to 90% by end 2009. Professor Keane is in discussions with the HSE to take control of all new cancer developments and progressively all existing cancer services and related funding and staffing.

The designation of cancer centres aims to ensure patients receive the highest quality care while allowing local access to services, where appropriate. Where diagnosis and treatment planning is directed and managed by multidisciplinary teams based at the cancer centres, much of the treatment, other than surgery, can be delivered in local hospitals. In this context, chemotherapy and support services will continue to be delivered locally. Cancer day-care units will continue to have an important role in delivering services to patients as close to home as possible.

Significant progress has been made on the implementation of the programme, including the appointment on a part-time basis of national clinical leaders in surgical, medical and radiation oncology; cessation of breast cancer surgery in 16 hospitals with low volumes; agreement with the surgical leads in the eight designated breast cancer centres on a transparent and evidence-based resourcing mechanism, benchmarked to best practice; the move to a common referral process, supported by the Irish College of General Practitioners, which will allow urgent patients to be seen within two weeks; the elimination of unnecessary follow-up of previously treated asymptomatic patients; agreement with the Irish Cancer Society on the administration of a grants programme to enable patients to be transported to designated cancer centres.

A new era of patient safety has begun in health care. We have started out on a path from which there is no return, the path of setting and implementing objective standards of care. It is a long road ahead, with many milestones yet to pass. It will involve all health care settings; the organisation of services between hospitals as well as within hospitals. We have taken some of the most important steps, that is, the first steps in the journey.

Three key milestones in legislation have already been passed. A statutory body responsible for standard setting and monitoring, the Health Information and Quality Authority, HIQA, has been established. A year ago, we enacted the first major overhaul in 30 years of the law regulating the medical profession through the Medical Council. A new Pharmacy Act has been enacted to regulate the pharmacy profession. All legislation has been driven by patient safety and the public interest.

The journey also involves honestly describing where mistakes and failures have occurred or do occur and to learn and improve from them. That requires a blame-free reporting and management culture. I am determined that we operate in an open way, that we implement improvements from mistakes and that the hue and cry of a search for blame does not undermine what really needs to be done in patients' interests.

Patient safety and standards setting are powerful drivers of reform and improvement in services for patients. These are at least as powerful drivers of change as finance, staffing levels and working time issues. We are making patient safety — the best possible diagnosis and best possible outcomes — drive our decisions in cancer care. We shall see the results of this clearly. The patient safety agenda will be implemented without distinction between public and private patients. My concern as Minister for Health and Children is for all patients in all settings.

The Government is aware of the significant issues relating to patient safety and is treating the matter as a priority. We are committed to ensuring the delivery of the best quality health service possible, doing so effectively and efficiently.

Some time ago I established the Commission on Patient Safety and Quality Assurance. Membership of the commission is made up of medical and nursing representatives, management and, importantly, two representatives of patients and carers. The commission is chaired by Dr. Deirdre Madden BL, a leading expert on medical law and ethics. The commission is due to report to me in the summer. Among the issues it will address will be the need for a licensing regime for health provision. Short of such a regime, we will not be in a position to enforce the standards on a mandatory or legislative basis in the private sector.

I have set out the broad policy framework that I want to put in place and the main findings resulting from the recent reports on cancer. Professor Keane has set himself ambitious targets for his two-year tenure as director of the national cancer control programme. He has quickly set about realigning cancer services to ensure a person can be assured of the highest quality service. He is receiving buy-in to the plan from clinicians across the country. The emerging clinical leadership will be the greatest guarantee that the plan will be implemented without delay.

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