Mr. Tony O'Brien:

I thank the Chair and the members of the committee for the invitation to attend the meeting to discuss the current issues surrounding the CervicalCheck Programme. I am joined today by my colleagues Dr. Colm Henry, recently appointed as the HSE chief clinical officer; Dr. Jerome Coffey, national director of the national cancer control programme; Dr. Peter McKenna, clinical director of the national women and infants programme; Ms Angela Fitzgerald, deputy national director of acute services; Mr. John Gleeson, programme manager of CervicalCheck; and Mr. Patrick Lynch, national director for quality assurance and verification and chair of the serious incident management team, SIMT.

I would like to begin by reiterating on behalf of the HSE my sincere apologies to all those women who have been affected and families involved in the CervicalCheck controversy, and others who although not directly involved have experienced any distress by what they have heard and read in recent days. I also wish to state that I did contact Ms Vicky Phelan to apologise to her for the delay in telling her that her test results had been a false negative and I want to sincerely make that apology to her and her family again here today.

At the centre of this issue was our failure to communicate to the women that were the subject of the audit. Those women should have been informed and that is something that will happen from now on. It is essential that we re-establish confidence in our cervical screening programme, which is a critical public health initiative.

CervicalCheck, the HSE’s national cervical screening programme, has provided a population-based cervical screening programme to the women of Ireland since 2008. It is important to be clear and to understand that cervical screening is not a test for cancer, but a means of preventing it. Cervical screening works by looking for changes in the cells of the cervix, the neck of the womb, using a smear test and cervical cytology. The earlier abnormal cell changes are found, the easier they are to treat and the treatment of these changes in the cells of the cervix means that the risk of developing cervical cancer is reduced. Screening is internationally accepted as a preventative health measure. While it is recognised that no screening test is 100% accurate, cervical screening is the most effective method of reducing a woman’s risk of developing cervical cancer. By achieving and maintaining the targeted coverage rate of 80% as it currently does, CervicalCheck has the potential to reduce the incidence and mortality of cervical cancer significantly.

Since 2008, women in Ireland have been attending in increasing numbers. CervicalCheck has achieved an 80% coverage rate among eligible women, a figure that is among the highest in EU countries. Latest figures from National Cancer Registry Ireland, NCRI, show that the incidence of cervical cancer in Ireland has reduced by around 7% per annum since the period from 2010 to 2015. This means that fewer women will develop cervical cancer and there will be fewer deaths.

To date, CervicalCheck has provided 3 million cervical screenings to more than 1.1 million women. It has detected more than 50,000 high grade pre-cancerous changes in women, reducing their risk of cervical cancer by 90%. These were women without any symptoms who, without screening, would not have known they had pre-cancerous changes. Furthermore the programme has detected more than 35,000 cases of low-grade cell changes and more than 1,200 cancers.

There are 15 clinics across the country which provide colposcopy services as part of the CervicalCheck programme. Continued successful collaboration between the programme and colposcopy clinics nationwide has led to sustained improvements to colposcopy services and eliminated waiting lists. The high standard of colposcopy has ensured that women who require a colposcopy are guaranteed timely access to a standardised level of quality-assured care.

In 2009 CervicalCheck participated in an external international peer review of the CervicalCheck quality assurance, QA, standards.

The international peer review panel consisted of those named on the printed version of the statement and I will not read the list out, subject to the agreement of the committee. They are, however, a credible international set of experts. It has been asserted that, in some way, the screening programme in this country is substandard to the US as it is asserted that the US screens every year. However, the HIQA report of October 2009 on the evaluation of the use of resources in the national population-based cancer screening programmes and associated services presented the recommended screening interval internationally. In the case of the USA, recommended intervals are initially two smears, one year apart, then every three years. It is also important to note that much of the US system involves a self-select process, an opt-in which, in effect, is a voluntary presentation and not a calling or invitation system as in Ireland. It is not an organised programme in that sense.

HIQA goes on to say in that 2009 report:

A systematic review of the existing evidence base for the optimal age-range and screening interval for cervical screening was undertaken in order to determine if the current age-range (25-60 years) could be narrowed or the screening intervals increased. Based on the literature review, the current age range and screening interval adopted in the CervicalCheck programme in Ireland would appear to be consistent with the international evidence base.

The HIQA report also noted that CervicalCheck administration has achieved the ISO 9001-2000 quality certification and maintains this standard through regular internal and external audit. A comprehensive smear taker training prospectus has also been developed and underpins a smear taking training programme developed and delivered in partnership with the Royal College of Surgeons in Ireland, RCSI, the National University of Ireland Galway, and the Irish College of General Practitioners, ICGP.

There has been much commentary on the outsourced CervicalCheck laboratory services. In that regard, I would like to make the following comments. A procurement process for the provision of cytology laboratory services was undertaken in December 2007 with the publication of a notice in the Official Journal of the European Union in line with public procurement regulations. The requirement of the NCSS was that each potential contractor would need to meet certain criteria, including that they must hold third party accreditation from a recognised accreditation body to international standard ISO 15189; have capacity to screen a minimum of 25,000 cervical smear samples per year; have capacity and ability to process smears within a ten-day turnaround in order to facilitate the delivery of results to women within four weeks of their smear test; and hold independent quality accreditation of the service.

On completion of the procurement process, a private sector provider of laboratory services, Quest Diagnostics Inc., was appointed for the provision of cytology laboratory services. In addition to the criteria above, each slide analysed by the laboratory is examined twice by two separate cytologists. CervicalCheck, in line with public procurement guidelines, re-tendered for laboratory services in 2009 and again in 2012. Following the 2009 procurement process, Medlab Pathology Limited was appointed along with the previous incumbent Quest Diagnostics Inc. In 2012, a further tendering process took place and the two laboratories mentioned above were appointed under a HSE framework agreement. This framework agreement is still active today and both Quest Diagnostics and Medlab Pathology are still providing cytology and HPV laboratory services, under contract, on behalf of CervicalCheck.

I now want to address the findings of the serious incident management team, SIMT, report. I have submitted the full report, which is also available at hse.ie, to the committee with the opening statement so I will highlight some of the key issues here. Over the past week there has been considerable public focus on, and concern about, the cervical screening service. Much of this concern stems from an audit of 1,482 cases of cervical cancer reported to the programme in the period between 2008 and 2018. The CervicalCheck clinical audit process examines the screening history of all notified cases of cervical cancer, with a date of diagnosis since the programme commenced in September 2008. The cases covered by the audit were those cases of cervical cancer notified to the programme and not the larger number of cases notified to the National Cancer Registry for the same period. The programme advised Department of Health officials on Friday evening that the figures were based on the cancer registry figures and it was on this basis that the Minister was briefed. It was subsequently determined by the SIMT that this was incorrect.

The audit process is an opportunity to see if any aspect of a programme could be improved. The process can also provide more detailed information to women on the reasons their cancer was not prevented, as well as information on the effectiveness and limitations of screening. Of the 1,482 cases notified and logged to date, 442 cases, 29%, were flagged for review of one or more elements of the cervical screening pathway, which includes programme operation, screening, cytopathology and HPV testing, colposcopy or histopathology. Cases are reviewed by an internal review group, with the support of an independent pathologist. The most common review type, as expected in a cervical screening programme, is of cytology, that is, the smear test, due to its inherent limitations as a screening test. Cytology reviews are performed internally by the original reporting laboratory, and by independent laboratories if a further opinion is required.

In February 2016, the programme commenced formally communicating review outcomes of historical notified cervical cancer cases where prior cytology had been reviewed to the consultant doctor looking after an individual woman diagnosed with cervical cancer. All historical reviews were communicated to treating doctors by October 2016 and the programme has been communicating current cases since that date. While the audit process established by CervicalCheck is seen as good practice and has the potential to make an important contribution to improving the quality of the programme, there was some evidence that the women whose cytology smear test had been reviewed as part of the audit process had not been informed either of the review or the outcome as it pertained to them. The women whose cases were reviewed already had a diagnosis of cancer so the outcome of the review of their cytology smear test would not have changed their diagnosis or treatment. They were entitled, however, to know that their case was reviewed and the outcome of that review. This was particularly important where the review team drew conclusions that were different from the original interpretation of the smear result.

The SIMT established that there were 208 women who should have been communicated with in relation to the review process. These were women where the CervicalCheck review team interpretation of their smear result was different from the original smear interpretation. Of these, 175 cases reviewed had an interpretation that was different from the original smear result and, based on the opinion of the review team, this would have led to a different clinical escalation, namely, a referral for biopsy or colposcopy. Of the total, 33 cases reviewed had an interpretation that was different from the original smear result but, based on the opinion of the review team, they would not have recommended different clinical management other than an earlier repeat smear.

On 30 April 2018, following the review of patient charts over the weekend, it was established that of the 208 women concerned, 46 women have already been communicated with and 162 women had not been told. Each hospital group was then required to ensure that each of the 162 women who had not been told of the review outcome would be phoned on Monday, 30 April and Tuesday, 1 May 2018. They would be offered an appointment to meet the appropriate senior clinician during the week ending Saturday, 5 May 2018. There were 17 women in this cohort who have died. It has been established that two of these women had the results of their review communicated to them before their death. It is acknowledged that, in addition to a diagnosis of cancer, finding out at this stage that they were the subject of a review will be distressing. The SIMT is confident that the clinicians meeting with these women or their next of kin will be very sensitive to the context of this information.

While the women who were the primary focus and concern of the work of the SIMT had all received a diagnosis of cancer at the time of their review and the review would not have changed the outcome, they were all entitled to know the review had been conducted and its outcome as it related to them. This openness and transparency should lie at the heart of a caring and compassionate health care system. Many women may be worried because of the recent coverage, and there is useful information available on .

During the course of its work, it became evident to the SIMT that the number of cases audited by the screening programme varied from the number of cases of cervical cancer reported to the National Cancer Registry over the same period. The SIMT immediately took action, escalating this matter to me. This, as the chief medical officer has already referenced, will result in the National Cancer Registry being mandated to share its data with the programme, the lists being reconciled, and an immediate audit of these remaining cases being undertaken.

I would like to conclude by saying that I welcome the announcement by the Minister that he is establishing a statutory investigation, which will be carried out by HIQA. I also welcome the appointment of an international clinical expert panel to provide the women concerned with an individual clinical review. The HSE will fully co-operate with both processes to ensure we establish all of the facts surrounding what has occurred and, above all, so we can learn from what has happened and ensure it does not occur again.

Given that I started my career in the public service in BreastCheck, the recent events are indeed a personal blow to me. I do not have many more weeks in my role. Indeed, I have only a few months because, as members know, I announced some time ago I would not be remaining beyond the term of my current contract, and consequently I intend to devote the greater part of those weeks to addressing these issues. In that regard, as I believe the Taoiseach confirmed earlier, I have appointed Mr. Damien McCallion, one of our senior national directors, currently responsible for emergency management, among other duties, to take charge of the national cancer screening service from tomorrow so all the issues that need to be worked through as we deal with this can be managed by him. He will report directly to me. I will be taking a very close personal interest in every aspect of this process. The SIMT will continue its work also.

That concludes my opening statement. Together with my colleagues, we will endeavour to answer any questions members may have.