Royal College of Obstetricians and Gynaecologists Independent Expert Panel Review into Cervical Screening: Discussion

The purpose of the meeting is to examine the findings and recommendations of the Royal College of Obstetricians and Gynaecologists, RCOG, independent expert panel review into cervical screening in cases of cervical cancer in Ireland between 2008 and 2018. On behalf of the committee, I welcome the expert panel lead assessors: Professor Henry Kitchener, lead assessor, and Dr. Patrick Walker, deputy lead assessor, ROCG.

Attending on behalf of the Department of Health are Dr. Tony Holohan, chief medical officer; Ms Tracey Conroy, assistant secretary with responsibility for acute hospitals; Dr. Ronan Glynn, deputy chief medical officer; and Ms Celeste O'Callaghan, principal officer on the CervicalCheck project team. I welcome from the HSE Mr. Damien McCallion, interim national director of the national screening service, Dr. Colm Henry, chief clinical officer, Ms Celine Fitzgerald, interim CEO of the national screening service, Dr. Lorraine Doherty, clinical director of CervicalCheck, and Dr. Peter McKenna, clinical director of the women and infant programme.

I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, they are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.

I call Professor Kitchener to make his opening statement.

Professor Henry Kitchener

I thank the joint committee for the invitation to appear today. I welcome the opportunity to engage with it on the findings of our review. I am joined today by Dr. Patrick Walker, deputy lead assessor of the RCOG review. We would like to take this opportunity to thank all of the women or their next of kin who consented to participate in this review. We would like to acknowledge the contribution of the cytology laboratory at University Hospital Monklands in Scotland and other consultant cytopathologists, the members of the expert panel, including our two lay representatives, and our project manager at the RCOG for assistance throughout this process.

After a complex and demanding exercise, the college had met the objectives defined in the terms of reference with the completion of 1,308 individual reports for women or next of kin by October 2019 and the publication of our aggregate report on December 3 2019. The timing of the final report was dictated by the requirement to ensure that all the women or next of kin had received their individual report prior to the aggregate report being published. At this point we wish to state how acutely aware we are of the impact that screening failures have had on the lives of affected women and their families. We would also like to recognise the 103 women in our review who have died, and will neither be able to read their individual reports nor the final RCOG report. We hope the individual reports will provide some service to next of kin.

The primary purpose of the individual reports was to provide consenting women or next of kin with a transparent and independent analysis of their CervicalCheck cytology slides prior to their diagnosis of cancer, along with an explanation of the findings and an independent conclusion regarding the clinical implications of any discordant result. Throughout this process, we felt it was of the utmost importance to obtain input from participating women with regard to the content, tone and style of letter that would convey their individual reports. In May 2019, we met a group of women and one next of kin to discuss our proposed style of letter. We received broad approval and suggestions, which we adopted. The group also conveyed a strong message that any women who so wish should have access to an appointment with a health professional to receive their reports. We were in full agreement and immediately conveyed this to the HSE.

The primary purpose of the final report was to aggregate the findings of the cytology slide review that directly compared the RCOG readings of 1,659 slides with those of CervicalCheck. By way of background, the slide review panel was comprised of screeners from the University Hospital Monklands cytology centre in Scotland as well as consultant staff actively working in the English NHS cervical screening programme. The role of the screeners was to identify those slides considered to be negative, that is, showing no abnormality. All slides considered to show any abnormal results were reviewed by a consultant. If there was disagreement with the CervicalCheck result, a second consultant read the slides. If there was disagreement between the first and second consultants, the slides would be viewed by a consensus panel over a multiheaded microscope to arrive at a final result.

With regard to process, those reading the slides were always blind to the CervicalCheck result. However, for reasons laid out in the report, seeding the slides blindly among routine day-to-day laboratory work would have been impracticable. We believe our methods were thorough and produced reliable results. In both the report and in explanatory notes to each participant, we have acknowledged that in a slide review of this type the detection of abnormalities will be enhanced. Our role was not to assess the performance of the CervicalCheck laboratories but to inform women whether or not the review had found that abnormal cells had been missed. In those cases where there was discordance between the CervicalCheck and the RCOG review, the college sought to determine whether this had impacted on the clinical outcome in terms of failure to prevent cancer or diagnose it at an earlier stage.

This was done by the expert panel determining the likely quantum of delay in the diagnosis of cancer engendered by missing abnormal cells, or undercalling cells in terms of grade, and applying this quantum to a set protocol of time intervals and stage diagnosis.

The RCOG expert panel felt the individual letters should include not only the results of the slide review but also the effect any discordant reading had on a delay in diagnosis. In the majority of cases, the expert panel considered there was no such effect but in half of the discordant cases the panel concluded there had been a missed opportunity to prevent or diagnose at an earlier stage. We applied scrutiny to those cases where prolonged colposcopy management was identified and found that in a quarter of such cases colposcopy management was suboptimal, sometimes further complicated by discordant cytology and sometimes not.

The slide review formed the basis of providing women with individual reports. The thoroughness and quality of the review combined with full disclosure of the findings means women can have confidence in their individual reports. The expert panel made it absolutely clear that these reports are not a judgment with respect to medical negligence and that such a matter would require others to determine. An explanatory note to this effect was included with the individual reports. This compilation of individual reports disclosing the findings and implications, together with an aggregate report based on a point in time slide review of more than 1,000 women diagnosed with cervical cancer, is, as far as the authors can determine, unique in scale and scope. It represents a transparent approach that others can reference and with which future comparison can be made.

We chose to compare our slide review findings with the English audit, which is the only other published large-scale slide review conducted as part of a national cervical screening protocol. Both involved slides of liquid-based cytology and both involved the slides being reviewed in the knowledge that cancer had been the outcome. The intention was to determine whether the findings of the RCOG review represented an outlier or was in line with what might be expected. In the event, it was the latter. The findings of the RCOG review were striking in the sense that a high proportion of discordant readings were found, many with significant implications. However, this was not unexpected, not only because similar discordant rates were found in the English NHS cervical cancer audit but also because the natural history of cervical cancer indicates that it is highly probable the cervix would have shed abnormal cells for a number of years prior to the diagnosis of cancer, whether it was screen detected or not.

Our review, therefore, illustrates the limitations of cervical cytology rather than pointing to a screening service that falls below what might be expected. Data published by National Cancer Registry Ireland shows falling incidence and deaths from cervical cancer since CervicalCheck was established in 2008. These endpoints are the cardinal signs of effective cervical screening. The findings of our review back this up, with a high proportion of early-stage cancer identified in the review cohort, which indicates that screening undoubtedly saved the lives of many women in the review.

To address concerns expressed regarding the verification process of finalising individual reports, we have submitted a detailed statement to the committee. When these concerns were initially raised with us in October, we offered to meet participants and patient representatives and came to Dublin to outline the process in detail and answer any questions. In a complex and demanding exercise involving more than 1,000 women and 20,000 individual data items, including 3,300 smear results, we acknowledge there is capacity for error. As we note in the statement, in a very small number of cases, totalling fewer than five, it has been necessary to issue supplementary reports because new information came to light, and in two of these cases the conclusion was updated. While these isolated incidents are regrettable they in no way impact the overall conclusions or recommendations laid out in our aggregate report.

We would be concerned if unfounded criticism of our evidence-based report undermined trust in our findings and confidence in the CervicalCheck programme. This could have the effect of diminishing coverage, which could only place more lives at risk. It is very important that the benefits of cervical screening in the existing programme are accurately portrayed in terms of public health. Vaccination against human papilloma virus was introduced in Ireland for early adolescent girls in 2010 and for adolescent boys this year. As already demonstrated in Australia and Scotland, where screening begins at 20, with high coverage this could reduce considerably the incidence of abnormal smears and, therefore, pre-cancer in young women and will result in a further reduction in deaths from cervical cancer.

We believe the RCOG review has provided all eligible women with open disclosure of their slide review and has provided an aggregate picture of the overall result. Our conclusion that the CervicalCheck programme is working in terms of effectiveness, cytology and colposcopy is supported by incidents in mortality data published by National Cancer Registry Ireland, which demonstrates year-on-year falls since 2010 following the establishment of the CervicalCheck programme. The premier objectives in cervical screening are being met and our report should restore trust in cervical screening in Ireland. With high coverage, the CervicalCheck programme, which will soon incorporate primary HPV testing, combined with the impact of high coverage vaccination, should ensure that cervical cancer prevention in Ireland will become as good as it can be and cervical cancer deaths should eventually decline to the point where they become a rarity.

We were privileged to have been tasked with undertaking this important piece of work, which we hope will have benefited the women who participated in the review.

The committee was disappointed we did not get Dr. Holohan's opening statement until 9 a.m. today.

Dr. Tony Holohan

My apologies for that. I thank the committee for the opportunity to address it this morning. I am pleased to update it on the outcome of the independent expert panel review of CervicalCheck, and we have just heard some of the details, which we established last year following the Government's decision of May, and the current position on the national screening programme as it pertains. I am joined by Ms Tracey Conroy, assistant secretary, Dr. Ronan Glynn, the deputy chief medical officer and Ms Celeste O'Callaghan, principal officer.

As we know, the failure to disclose the results of the CervicalCheck retrospective audit to women and families, which emerged in April last year, resulted in widespread concern about the programme. Since then, the Department's overriding priority has been to ensure the viability and sustainability of our national cervical screening programme so it can continue to save lives and improve outcomes for cervical cancer.

Neither screening nor HPV vaccination alone are enough and we need both to work together in tandem if we are to make cervical cancer a rare disease in Ireland, which is our policy objective. In pursuit of this goal, the Department has engaged very closely with the HSE and, in particular, the national screening service on the implementation of the various Government decisions and the range of very difficult strategic and operational issues faced by the programme.

It is important to recognise, however, that this work has involved multiple other stakeholders coming together and working collectively through the many challenges that arise, as well as those who continue to deliver the service in a hugely pressurised environment. This includes patient advocates, patient representatives and clinicians. I take this opportunity to acknowledge the commitment, input and expertise of each of them. Most particularly, I thank the Royal College of Obstetricians and Gynaecologists, which, at our request, agreed to undertake what has been an enormously complex and challenging task to give individual women in the first instance, or their next of kin, the opportunity to have the benefit of expert independent assurance with regard to their individual cases.

Over the past 18 months, we have moved from a period of crisis to an emerging more stable environment. The necessary laboratory capacity has been secured to ensure continuation of the programme following complex negotiations led by the HSE. Recruitment for key posts that will strengthen the governance of the screening service has been undertaken and investment is ongoing in the development of national laboratory capacity, colposcopy services and the introduction of HPV primary immunisation, to add to the introduction of HPV immunisation for boys during the course of 2019.

From the perspective of women and families involved in this issue, an ex gratia scheme to address the issue of non-disclosure was put in place as well as a package of health and social care supports.

In the past 18 months, we have had two independent reviews of the programme: the scoping inquiry initially led by Dr. Scally, which concluded earlier this year, and now the independent expert panel review led by RCOG, which concluded two weeks ago. Dr. Scally provided the final report in September of last year and a supplementary report in May of this year. He found no evidence of deficiencies in screening quality but he did identify a significant number of management and governance issues and made a total of 58 recommendations to address these. A comprehensive implementation plan was developed in late 2018 for these actions with approximately 170 actions across the Department of Health, the HSE and the National Cancer Registry of Ireland. Significant progress has been made overall with in excess of two thirds of these actions now completed. That is in the oversight of the CervicalCheck steering group. Quarterly progress reports on this are published on the website of the Department of Health.

Patient representatives make a significant contribution on an ongoing basis to the work of the Department, the HSE and health agencies, and the patient voice has been central to our work, not just in respect of CervicalCheck but all of our work in the past 18 months. Patient representatives have been active participants in the CervicalCheck steering committee chaired by the Department and contributed significant time also to working with the HSE in regard to the many operational issues arising over the past year and a half that the executive is grappling with.

Ms Lorraine Walsh resigned from her work on the steering committee and with individuals and committees in the HSE and CervicalCheck at the end of October. The Minister has thanked her for all of her work. Her significant input to the work of the steering committee since its inception was acknowledged at its November meeting. We have the opportunity now to acknowledge that and thank her for the work she has done with us during the course of that committee. The Department is examining how best to provide necessary structures that will allow for appropriate selection and compensation policies to be put in place to ensure that patient representatives are appropriately recognised and remunerated for their work and contribution to health service design and reform. International models of patient representation are being examined as part of this work, which is at an advanced stage.

On 3 December, the aggregate report of the international clinical panel review was published following the Government decision taken that day. The first key objective of the review was to provide women, or their next of kin, with independent clinical assurance about the timing of their diagnosis and treatment. In total, 1,038 women chose to participate in the review and this was a very welcome number, which allowed robust and comprehensive analysis of the programme. The process of communicating individual reports to women or their next of kin commenced in late September. All of those who wished to do so have now received a report at an individual level setting out the reports findings. We were keen to ensure that individuals in the first instance have the opportunity to hear from their individual clinician before any aggregate report could be published.

There is no doubt that this has been a difficult process for many women or their next of kin particularly where, sadly, a woman may have died. The Department has engaged closely through this process with the HSE in its planning for a communication process that is as sensitive and supportively delivered as possible. We recognise the significant work that has been undertaken by the HSE, including the clinical need for the national women and infants programme and the engagement of colposcopists in particular on whom we are enormously dependent to support this process around the country.

The second key objective of the review was to publish the aggregate report, which includes recommendations, where appropriate, that have the aim of improving care for women. In that context, the concern that first arose in April of last year was an important dimension of the work of the independent panel and adds to the work undertaken by the separate scoping inquiry reported on by Dr. Scally. Based on its overall findings the expert panel has stated, and it is important to reiterate, that it is not an understatement to say for many women who participated in this review screening undoubtedly has saved their lives; that there is no doubt that the programme has been successful and has worked effectively; that women can have confidence in the CervicalCheck programme; and that their findings at a population level are in line with those seen in the English cervical screening programme and should not be viewed as a cause for concern with respect to the population overall. We regard these conclusions as very welcome given the importance of cervical screening from a public health point of view. We know it saves lives and it is vital, therefore, that women have confidence in the programme. The public can be reassured that the programme is operating effectively now. As we know, the panel has made ten recommendations, which generally align with the work being undertaken in both organisations, the HSE, and the Department, including in regard to the recommendations of Dr. Scally. The Minister has written to the HSE and the National Cancer Registry in respect of the implementation of those recommendations. The independent panel's report also concluded that many of the women who participated in the review are alive today because of CervicalCheck. That conclusion underlines once again the crucial importance of ensuring a strong, viable and sustainable cervical screening programme while working to ensure that cervical cancer becomes a rare disease in Ireland, an objective we all share.

The expert panel and Dr. Scally said that through a combination of screening and vaccination together with good uptake of both we can achieve this goal. The extension of the HPV vaccine to boys in September of this year and the introduction of HPV primary screening in quarter 1 next year are key steps towards that goal. Funding for both was provided in 2019. We will continue to engage closely with the HSE on its continued roll-out and implementation.

In addition, the focus remains on the continued implementation of the recommendations of the scoping inquiry and the implementation of the ten recommendations contained in the RCOG report. Through the combined effects of all these elements, we will have the opportunity to ensure that Ireland has a world class cervical cancer screening programme that will enable us to make cervical cancer a rare disease within a generation.

Mr. Damien McCallion

I thank the Chairman for the invitation to attend this meeting. I am joined by Dr. Colm Henry, chief clinical officer in the HSE, Dr. Lorraine Doherty, clinical director for CervicalCheck, Ms Celine Fitzgerald, interim CEO for the national screening service and Dr. Peter McKenna, the clinical director for the women and infants programme. We continue to address and manage all issues that have arisen in the programme since April 2018. The briefing submitted in advance of the meeting to the committee updates it on these key areas of priority.

Our information line and client services unit continues to provide information to women and their families. We also support women and their families in the provision of access to their records and ensuring women get their slides from laboratories where required for legal review. The client services unit continues to support this process and we have provided healthcare records to 665 women and slides to 388 women, families or their representatives. We continue to support the 221+ group through our community liaison officers who support women and their families with the provision of the support packages following the Government decision of May 2018. We also work closely with the 221+ patient representatives across a wide range of areas and are very grateful for their guidance and input to the screening programmes. It is helping to make a real difference. We have just completed a patient and public inclusion plan for screening services. This was developed in conjunction with our patient representatives and was recently launched. We are very grateful to the three lead patient representatives who are part of the team. Some key actions within the plan include appointment of a full-time patient inclusion officer, extension of the screening patient panel, patients on key committees and a model for patient inclusion. We also have patient representatives on the HSE steering group for screening, Stephen Teap and Lorraine Walsh, and would like to acknowledge the work of Lorraine Walsh, who recently stepped down from the HSE steering group. Despite her own difficult illness, Lorraine has been an invaluable and supportive patient advocate and has been key in making the changes necessary to sustain cervical screening in this country. The HSE would like to formally thank her and wish her well in the future.

The HSE has contributed significantly to the development of an implementation plan in collaboration with other State agencies in response to the Scally scoping inquiry recommendations. An oversight group was established in the HSE with a senior manager appointed to support and ensure continued implementation of the Scally report. At the end of November, a total of 95 actions have been completed by the HSE from a total of 116 within the overall plan with the remainder in progress. Examples of progress to date include key appointments, governance improvements in the national screening service and CervicalCheck, an organisational review of risk management structures has been completed and a report setting out a revised approach to risk management across the organisation has been approved by the HSE board. A review of the HSE's healthcare record management policy is also due to conclude shortly.

One of Dr. Scally’s recommendations included setting out the future approach to interval cancer audit. The HSE established an oversight group for this project with expert groups. The expert groups are independently chaired and comprise patients, patient advocates, patient ethicists, screening clinicians and international experts. The expert groups have considered international best practice as part of the scope and the work continues to be progressed with a target to complete early in 2020. The recommendations of the RCOG aggregate report in relation to interval cancer audit will now be incorporated in this work. An interim revision of the HSE open disclosure policy was published in June 2019 and the HSE remains committed to ensuring the operation of open disclosure throughout the organisation by continuing to roll out its national training programme through the national open disclosure office. An open disclosure governance steering group chaired by the national director for quality improvement continues to provide the governance and the oversight to the operation of open disclosure throughout the HSE. The governance framework in the group will provide leadership for the evaluation of the audit of compliance with the policy.

All recommendations for procurement have now been implemented and the HSE also continues to work with medical training bodies in developing an open disclosure in communication skills training programme.

Turnaround times for the reporting of results are now running at an average of six weeks. We hope to sustain the turnaround times at this level going forward. This will ensure that women and their GPs get their results in a reasonable time period, which is one of the key performance indicators for the programme.

The key risk to enable cervical screening to continue in Ireland was the extension of the laboratory contracts. The HSE reached agreement with both the Coombe and Quest to enable continuity of the programme. The development of the national cervical screening laboratory was included in our recent HSE capital plan and will enable a better balance between public and private laboratory capacity provision. A project steering group and team are now in place with building and workforce plans developed. Additional support has been procured to enable the project to be accelerated as much as possible. The new laboratory is already at the planning stage. While we are planning for a rapid build programme, it will still take a number of years to implement, primarily due to the challenge of retaining and recruiting suitably qualified staff. This challenge cannot be underestimated in our environment.

Hospital colposcopy services remain under pressure with increased referrals and the requirement for increased consultation time. The HSE women and infants programme has recently completed an impact assessment on hospital colposcopy services that identified some immediate resource requirements. Funding was included in the 2019 national service plan and this was rolled out to the clinics to support additional service sessions, to increase capacity and improve waiting times. We continue to work with the hospital colposcopy clinics and a joint working group between the national women and infants programme, acute hospitals and CervicalCheck has been established to support this process.

The programme, after a long search, has just appointed a national colposcopy adviser. While we have secured support from our hospital colposcopy services on particular projects, this has been a significant gap over the last year.

We are continuing to implement our plan to introduce HPV primary screening. A project team has been in place since last year and there are seven work streams involved in the project. We remain committed to implementing HPV primary screening, with the target for implementation in the first quarter of 2020.

Since we last appeared before the committee, we have reduced some of the major risks to the project through the reduction in the backlog and securing laboratory providers who can provide the testing service. The implementation project, however, remains complex, with a number of risks which we continue to actively manage including IT system changes, laboratory preparedness and to ensure sufficient availability of colposcopy services to address future demand from HPV primary screening.

The introduction of the HPV vaccine for boys in September 2019 combined with the existing uptake of the HPV vaccine by girls will help reduce incidences of cervical cancer and other cancers. Evidence from elsewhere in the world shows that this combination of HPV vaccine and HPV primary screening will have the impact of eliminating cervical cancer over the next two to three decades and in the shorter term, ensuring that women present with earlier disease and are much less likely to progress to cancer.

While recruitment and retention of staff remains a challenge for our screening services, we have made significant progress. We have completed a review of the organisational design of the national screening service and one of the key actions was the appointment of a permanent CEO. The permanent CEO position within the national screening service has been advertised and an interim CEO for screening services is in place while we recruit a permanent CEO for the service.

In addition, we have appointed a permanent quality and risk manager for screening services and have filled additional new posts in quality and risk management. A deputy laboratory co-ordinator is now in place to strengthen the laboratory capacity in the programme.

We have recently appointed a CervicalCheck programme manager and are concluding the recruitment of a deputy CervicalCheck programme manager. A CervicalCheck colposcopy adviser has just been appointed and we are continuing to progress the recruitment of a CervicalCheck primary care adviser and colposcopy nurse, which will further strengthen the clinical input to the programme. We have also recruited a permanent director of public health for the screening service and continue to make efforts in recruiting public health specialists to support the work of the director. This will strengthen the public health input to the programme. Posts in communications and HR have also been advertised, in addition to a number of other programme support roles. We will ensure that the recruitment of all posts from the service workforce plan continues to be prioritised.

The HSE provided support to the independent international expert panel review undertaken by the Royal College of Obstetrics and Gynaecology, RCOG, which was established by the Minister for Health, following a Government decision for women who were diagnosed with cervical cancer. The HSE supported the consent process, established a national help desk, developed an eligible data set with the national cancer registry, implemented a client management system to support RCOG, co-ordinating the release of slides and medical records to RCOG and supported the provision of individual reports to women.

The HSE put a verification process in place to ensure that an anonymised report went to the correct woman for whom the HSE held her name and address. This was an administrative process to ensure that the right report went to the right woman. All women, or their next of kin, who wished to do so have now received their individual report. Throughout the process of communicating individual reports, the HSE’s focus has been on ensuring this is done as appropriately and sensitively as possible.

The aggregate report was published following the Government meeting of Tuesday, 3 December and provided further assurance about the quality of the cervical screening programme. It contained ten recommendations which are being incorporated into our existing overall implementation plan. The report’s key findings included that there was as expected a high proportion of very early screen detected cancer, which has saved many lives and concluded that the CervicalCheck programme was working effectively.

The review did find for a number of women a discordance with their original CervicalCheck results and RCOG set out the reasons for this in their aggregate report. We are conscious of how difficult it has been for many women and their families who were part of the review. The HSE will continue to provide meetings where required and an information line for those women and families who were part of the review. We will continue to provide this support for people impacted by the review.

Overall, the conclusion of the RCOG review is another milestone for the programme. It completes a major programme of operational support and provides welcome assurance about screening quality as we continue to stabilise and strengthen our screening services. I want to assure members that the HSE is absolutely focused on ensuring these important public health programmes continue to save lives. All possible resources are being directed at this challenge.

That concludes the opening statements of our witnesses. Our first members to ask questions will be Deputies Kelly and O'Reilly and I ask them, because of time limitations, to stick to ten minutes.

I do not think that even our guests believe that will happen.

That is a target.

I will try my best.

I thank our guests for their opening statements. I have a lot to get through. I want to say to our guests from RCOG, the Department of Health and the HSE that we have a serious issue when the lady who commenced all of this, Vicky Phelan, says she has no confidence in this report. The two patient advocates who were before the committee last night also said they have no confidence in this report. That is their opinion and they aired it intensely and publicly and that is before all of the information that they have has been made public. Those people cannot put some of that information out into the public forum because there are individual cases involved etc., but that is deeply worrying.

The testimony of Lorraine Walsh yesterday was also deeply worrying. I will not get into it, but I would like the representatives of the Department of Health to reflect on what she said before the committee. I want to get the best for everyone out of this and am, and will continue to be, as big an advocate as anyone for improving our screening programme. The harrowing testimony we heard yesterday was upsetting. It is something I will reflect on, in whatever role I have, in the future.

Professor Kitchener referred to unfounded criticism in his opening statement and I thought that an unfortunate choice of phrase because the criticism that has been forthcoming, particularly from Ms Walsh, has been fully documented and sent to us. While Professor Kitchener may not believe that there are overt issues, there is certainly validity in, and direct evidence of, some of those criticisms. I have correspondence from Professor Kitchener in which he apologised for failings.

We only received Dr. Holohan's opening statement this morning. That is a tactic used by a number of individuals - not necessarily Dr. Holohan - of which I am getting tired. I was taken by the fact that Dr. Holohan's statement did not reflect that, although progress has been made and I have no doubt about that, we have also had major issues. I ask our guests to read the statement of Stephen Teap yesterday because, in about three paragraphs, he summed up all the issues. The Taoiseach has apologised on behalf of the people of Ireland for what happened.

Even Dr. Scally's recommendations have not all been implemented. It is not all rosy in the garden. Dr. Holohan's opening statement did not proportionately reflect that we still have a range of issues, which is of concern.

These are the terms of reference for RCOG. Terms of reference are very important. We are here to discuss RCOG. These were individual reports for all the women. We have had the first and second Scally reports. We know what we need to do and we know the recommendations. We needed an aggregated report statistically from RCOG, as is listed here - nothing more and nothing less. Some people have jumped to take certain findings out of that which were not part of this and I am not sure are helpful.

Professor Kitchener said today that some people have an issue with the credibility of the reporting. Let me say this straight: I agree with many people. I have no issue with RCOG's clinical analysis. My issues relate to the reporting and statistical management - how all those data have been managed. I also have an issue with the process by which data have been shared, the reporting mechanism and whether the crosschecking of databases has been accurate. Professor Kitchener said that among all these women there have been fewer than five supplementary reports and two cases where the conclusion has been updated.

Let us start at the beginning. On 21 November, Professor Kitchener said:

Following last Friday's alert regarding a partial report [I will get back to the phrase "partial report" in a while] we conducted an investigation to ensure all of the results had been uploaded on our database. I am writing to confirm there was no other valid slide result from batch 35 or indeed any other batch that has not been uploaded on to our database.

Therefore, there was one issue on 21 November. Following on from that Damien McCallion, who was complimented extensively by those who appeared yesterday evening, as was the HSE - I want to acknowledge that, wrote to Lorraine Walsh on 3 December and stated:

I want to make you aware that I know that RCOG have confirmed that no other women were affected by the issue which affected your initial report last Friday, which you have spoken about quite publicly and that that came in yesterday.

Therefore, we have confirmation again on 3 December.

Lorraine Walsh appeared on "Prime Time" on 3 December and an unsolicited email came into the programme. The unsolicited email was from Emma Gilgunn-Jones who is director of media and public relations for RCOG. It stated:

In order to ensure the correct letter was sent to the correct patient using the standard format ... For three women, supplementary reports were issued because new information came to light. In only one of these cases was the conclusion updated.

Therefore, we have now gone from one to three where only one case was updated. Today we have five supplementary reports and two cases where it was updated. The pattern is increasing all the time. Statistically I know the number of women involved. However, why was this information not available initially? Why has this been updated again today? It is a cause of concern.

I propose that we get some responses to those questions.

I have just one supplementary question. In the report regarding Lorraine Walsh's issue, which is public which is why we talk about it, it stated that as part of this process there was verification. We all know there was a whole range of reports done by RCOG which had to be sent by the HSE back to all the women. At one phase maybe 40% were sent through. All the databases were checked and in the case of Lorraine Walsh, her slide had been reviewed. If she had not come back - in fairness to Damien McCallion and others in the HSE - to this day we would not have got a second report. That is where the issue is here. It was only because she knew what she was talking about that the HSE was in a position to send two fantastic ladies down to her 24 hours later. It was only that she knew what she was talking about and she knew there had to be a problem. If it is in that case, how do we know it is not so in other cases? Today Professor Kitchener has told us there are five reviews and now there is a second case. That is my first question.

I call Dr. Holohan.

Dr. Tony Holohan

My initial response is-----

The question was more for Professor Kitchener.

Dr. Tony Holohan

Some questions were also addressed to me.

We will take Dr. Holohan and then Professor Kitchener.

Dr. Tony Holohan

I note what the Deputy said. I am aware that some people have expressed no confidence. I want to be clear that we, as the Department, in terms of how we received this report, how we have briefed Government, how we have briefed the Minister and how we have articulated in public, express full confidence in the findings and recommendations in the report and the processes. I want to be clear about that.

The Deputy referred to some of the evidence that was offered to the committee last night. We are aware of that and, of course, we will reflect on it. I want to make clear that we see as an organisation the role of patient representatives involving them in committees and processes as we do deliberately as a very important one that enhances all of the work and did so in this case. I pay tribute to the individuals who appeared last night and the other patients who have played an important role in ensuring that we have made progress on the implementation of as many recommendations as we have.

I do not wish to come across in any sense as suggesting that we are complacent or that we do not think that there is further work to be done. Even when we get to the point of full implementation of the recommendations from the Scally report, there will still be further work to be done and oversight needed to ensure that we continue to achieve progress in terms of incidence of mortality around cervical cancer. I want to be absolutely clear and unequivocal about that.

Professor Henry Kitchener

By way of qualification, in this morning's statement, I referred to fewer than five. I used that expression because the context here is that there are well over 1,000 letters. In fact, there have been three supplementary letters issued and in two cases conclusions altered again out of this very large number of responses.

I cannot comment on individual cases and I believe Deputy Kelly would not expect me to do so.

I do not expect Professor Kitchener to do so, in fairness.

Professor Henry Kitchener

However, with reference to having to correct an error, we would always review to confirm that a similar error had not occurred in any other case. We are absolutely confident that in the final analysis, every woman has received an accurate and open disclosure of her review.

On 18 April of this year, the RCOG report - it is public information because we do our research here - acknowledges that there are serious IT problems.

There is an urgent need to address the outdated IT systems that support cervical screening. The programme's IT infrastructure was deemed not fit for purpose by a 2011 Department of Health report and can hamper the quality of services. Since then little progress has been made.

Professor Henry Kitchener

When Deputy Kelly talks about IT, I believe he is referring to the cervical screening programme IT in England and not the RCOG.

I am just referring to the reporting system that you work with normally.

Dr. Patrick Walker

The RCOG IT system is not part of the National Health Service IT system. That appeared in the Deputy's remarks.

This is RCOG's own report. I am just referring to the process by which you manage your own data through your own organisation as regards your own work.

Professor Henry Kitchener

I am unaware of a public statement regarding the IT system of the RCOG in April of this year.

There was reference to the IT system of the cervical screening programme in the UK. That is an entirely separate matter and is not relevant to our report.

Professor Kitchener has no concerns about it.

Professor Henry Kitchener

I have no concerns in terms of establishing any sort of connection between what the Deputy is referring to and the production of our report.

That is good. I will move on to the mislabelling of slides. As Professor Kitchener will understand, there is grave concern about this. I have read the explanations and considered the validity of them. Lorraine Walsh is one of the two patient advocates who were part of the process themselves and, in fairness, she put herself forward as advocate. Vicky Phelan was the other person who was part of the process. Three sets of slides were mislabelled and two of them happened to belong to those two women. The third lady remains anonymous. Statistically, that is incredible and gives cause for public concern. We are to understand that in the case of Vicky and Lorraine, their labels were taken off and put on incorrectly, Vicky's on Lorraine's set and vice versa. How could that happen, statistically, to two of the three women, out of a total of 1,038 cases reviewed?

Professor Henry Kitchener

Again, I am not going to make a specific reference to individuals.

It is amazing that this should happen to the two people who are best known in this country in respect of this issue. It is phenomenal.

Professor Henry Kitchener

It would appear to be a remarkable coincidence. However, the key point is that the labelling issue, as the Deputy refers to it, took place following the completion of the review and, therefore, had no impact whatsoever on the actual conduct of the slide review. There can be no question-----

However, it is incredible. It is some coincidence.

Professor Henry Kitchener

It is a remarkable coincidence but, as I said, the incident took place following completion of the slide review and, therefore, there should be no confusion that any labelling issue complicated the thorough and safe conduct of the review.

I have three further questions, which I will put to Professor Kitchener in one go. He might take notes and then respond. I want his opinions on these three questions; I am not trying to catch him out. First, I do not understand how we did not have three categories of slides and, on reflection and having read the report, the panel really would have been better off if that had been the case. The idea that where slides were not available - reports were issued to women to say that they were concordant - is an error. The panel should reflect on that, and I say so genuinely. I can see why the reviewers did what they did, but there should have been three categories, namely, concordant, discordant and unknown or whatever other name the panel might wish to give it. When a slide is not available, one cannot give an assurance to women that it is concordant. Based on the date and information, that is the conclusion to which the reviewers came, but, in reality, the slide was not available. For future reference, and in this scenario, I am arguing that this was an error. I say that genuinely because several people have come to me and made that argument and a lot us who have reflected on the matter would agree with it. I am interested in Professor Kitchener's opinion in this regard.

I do not have the answers to my other questions. Again, I am seeking Professor Kitchener's opinions on these points. My second question relates to the cervical screening programme in Britain. The quality statement in respect of the 2018-2019 programme, which was published on 21 November 2019, states: "There is generally no accepted or expected level of false negative in the NHS Cervical Screening Programme." On page 11 of the RCOG report it is stated that a 30% false negative rate is an international standard. For the public watching and for confidence levels generally, how do we extrapolate and correlate those two statements? I am asking this question because it seems to be a real issue for people.

My final question is a follow-up to my second question. Ms Marie Culliton, a past president of the Academy of Clinical Science and Laboratory Medicine has stated her view that if some slides which are unavailable for review are classified as concordant, then the 30% rate for negative readings subsequently reclassified as showing high-grade changes has to be incorrect. In other words, the percentage is possibly higher. Does Professor Kitchener agree or disagree with Ms Culliton?

Professor Henry Kitchener

I ask Dr. Walker to address the first question.

Dr. Patrick Walker

The Deputy suggested that the slides should have been allocated to three categories. We all will be reflecting on what we have said and written. I see the logic behind Deputy Kelly's suggestion and, while considering these matters since the report, I have wondered about the categories. However, I have one or two points to make in this regard. The number of patients the Deputy is talking about amounts to fewer than 2% of the entire cohort.

It is still important to the people concerned.

Dr. Patrick Walker

Of course. They are very important as individuals. That is my point - that what we were doing was writing an individual letter to an individual woman about her individual circumstances. Those women who came under the partial report category do not form a homogeneous group. There were cases where a report was unavailable because it could not be shipped over. Some of those reports later became available, as we know. There were cases where the slides were missing and could not be located by the laboratories to be sent over. I would have to check the data but I think I am right in saying in three cases designated as partial, it was because the report was "inadequate" or smear-reporting category P1. This was not a homogeneous group where one could say that all the cases could be put in one basket. However, I take the Deputy's point.

With regard to the concordant issue, there may be a slight misunderstanding. Some women had multiple slides in the review. So, a woman could have an unavailable or missing slide and we would never make any comment on whether that slide was in agreement or disagreement. However, if she had another slide that reviewed as showing high-grade changes, that smear was concordant. In writing the individual letter to the woman, those terms were explained in the narrative, but there would not be a circumstance that an unavailable or missing slide was categorised as concordant or discordant. A letter would outline information in that regard if a concordant slide had been reported and was part of the patient's entire history. I understand the force of the Deputy's concern-----

Does Dr. Walker get my point that there should be a third category?

Dr. Patrick Walker

It is an interesting proposal but I would feel more comfortable if we were talking about a homogeneous group and could say that all the women have the same characteristics.

We knew that was not the case. We have two homogeneous groups, concordant and discordant, and another group. The women I am talking about should not have been assigned to one of the other two.

Dr. Patrick Walker

I hear the Deputy's point. I was trying to explain that it is not the missing, unlabelled or unavailable slide that we are talking about. it is another slide that was available within that patient's history which put her into the category of concordant or discordant, because that slide was either concordant or discordant.

However, that is not the full picture for each individual case.

Dr. Patrick Walker

We would need to see their reports to know that.

May we move on to Deputy Kelly's second question? Sorry, Dr. McKenna wishes to comment.

Dr. Peter McKenna

When a slide was missing, the reports state quite clearly that the designation of concordance or otherwise is based on the material available to the reviewer. They do not in any way make inferences from material they did not have.

Deputy Kelly's second question related to the level of false negatives.

Professor Henry Kitchener

It is important for us to distinguish between the 30% level of false negatives that was referred to and the limits of cervical screening in terms of preventing cervical cancer. The 30% figure is derived from a paper we cited in the British Medical Journal which compared women who had been screened with women who had not been screened. It is clear that screening affords a very high level of protection, and that level of protection happens to be a little higher in older women than in younger women. All in all, there is a figure of around 30% for where screening fails to prevent cancer.

The reference Deputy Kelly makes to the proportion of false negative smears that might be expected is a different question and a very difficult one to address, because to evaluate the proportion of false negative smears, one would have to undertake a thorough examination of a large number of women with varying smear results, colposcope them to establish the actual state of the cervix, and determine in what proportion the smears had been false negative. That would be perhaps an important figure to know but an extremely difficult figure to arrive at reliably.

It is important that the public does not conflate a 30% inability of cervical screening to prevent cervical cancer in a population and any suggestion of 30% false negatives in routine cervical screening.

I understand.

Professor Henry Kitchener

Deputy Kelly queried the 30%-----

In fairness, it was not my query. It was something I took from Ms Culliton and I thought was an interesting question.

Professor Henry Kitchener

It is. The Deputy also asked about the 30% that we reclassified, I think on behalf of someone, as high grade among our negatives. Among our negatives, just over half are reviewed as negative. That is very close to the figure that was identified in the English audit - just over 50%. Out of the remaining half, approximately one third were classified as low-grade abnormalities and two thirds as high-grade abnormalities. Therefore, the majority of non-negative smears on review were, in fact, high-grade and as a proportion of the total happen to be 30%, an entirely different 30% from the two sets of 30% we have just discussed.

I thank Professor Kitchener. We will now move on to Deputy O'Reilly.

I have a small procedural question. When did Dr. Holohan send his submission in to the committee?

Dr. Tony Holohan

This morning.

Dr. Holohan sent it this morning.

Dr. Tony Holohan

I apologised earlier to the Chair.

When did Dr. Holohan get the invitation to come to the committee?

Dr. Tony Holohan

I cannot remember the precise date.

We have already expressed our dissatisfaction with the late-----

I apologise if I missed that-----

Dr. Tony Holohan

I apologised.

-----but it is becoming par for the course. It makes it difficult for us to conduct our business.

Dr. Tony Holohan

I have apologised to the committee.

Apology accepted. I assume the officials from the Department all would have either read or watched the proceedings here yesterday with Ms Lorraine Walsh and Mr. Stephen Teap. Ms Walsh described being dismissed, ignored, bullied-----

We discussed this in private session earlier.

My apologies. I was late due to traffic.

We discussed that those comments, unfortunately, could identify officials within the Department and we said we would not discuss those comments at the meeting today.

Are those the verbal comments that are reported in the media, the stuff that was written, or both?

We were referring to the verbal comments that were made last evening.

One can only talk about it in a general way as regards the ethos of what was said rather than the specifics.

What was said was a fairly graphic description about a person who is known to all of us and about that person's treatment by the Department. There are so many campaigners on this who have given of their own time. As I stated yesterday, they gave up their time with their families to do that work. Has Dr. Holohan any comment as to why not all of the campaigners now have either confidence in this report or will continue with this process? Will that undermine the work that everyone here is trying to get done? It is unfortunate. I would be interested to hear Dr. Holohan's comments on that. It is a grave and serious matter and I wonder if Dr. Holohan shares those sentiments.

Dr. Tony Holohan

I am aware of the comments that were made. I heard them. I stated earlier that we regard the input and the role of patient representatives as important to the work that we do in the Department in particular relating to the work that we have done as part of this committee. I have seen the comments that have been made.

I am aware that people are not in a position to express confidence and they have said so publicly in relation to the findings. I do not want to discuss individual cases but if I was in a situation where two separate errors in respect of myself had been made in a review, if I am honest, I would find it difficult to express any level of confidence in that report as an individual and as it relates to me, and that is no criticism of the RCOG process. It is a different matter entirely for me to conclude then, or to advise Government or advise anybody, that the remainder of the report is something that I have a doubt about in terms of confidence, even if I can fully understand how that might feel for an individual who has been the subject of those errors. I have enormous sympathy for that. I took the opportunity earlier on to pay tribute to the individuals, who were with the committee last night and who gave evidence, for the work that they have done over the past 18 months with us and with the HSE to make the progress that we have made, and we are not all the way down the road that we want to be in terms of implementation of the findings of Scally, or indeed the other reports that we now have in front of us.

Following on from the proceedings here last night, is it Dr. Holohan's intention to act on the information that was presented or note what was said and move on?

Dr. Tony Holohan

We will act, as always, as we do in relation to any committee and any public hearing. With any issue that is raised that is a matter of either policy concern or other concern to us, we do our best as officials to support the Minister, and directly ourselves, to address those and we will do so in relation to this in no different way.

Might it, therefore, be possible for Dr. Holohan to provide us with an update on whatever actions are taken as a result?

Dr. Tony Holohan

In all the work that we have undertaken as part of CervicalCheck, whether it is through the screening committee or otherwise, and in all the fora where we have been asked, we have given account of what we have done. We have published minutes and agendas. We have supported the publication of statements in both Houses and the various committee rooms in which we have had to give account and we will continue to do that. We have no difficulty whatsoever in doing that.

I am specifically referring to anything Dr. Holohan might be doing differently on foot of what was said yesterday. We all know what we are talking about. I was quite shocked - I must be frank with Dr. Holohan - by some of the commentary. I am sure Dr. Holohan was as well. I am wondering, arising out of that, if there is any specific action Dr. Holohan will take or, as Dr. Holohan said, if it will be what he has been doing all along.

Dr. Tony Holohan

There are specific actions and I can go into them in some detail. We are at an advanced stage in considering a policy piece of work that we have been working on for some months on patient involvement to recognise both the time and financial effort that is involved for individuals to participate. As I have said, we regard the input of patients as being important in all of the work we do, not only in this but in the development of policy and the oversight of implementation of policy, and we want to support people better in doing that.

We had a management board discussion as an organisation on an advanced draft that we hope to be in a position in early 2020 to present to the Minister for approval and ultimately for publication following consideration by Government. We take that very seriously. That is a piece of work that will be fully informed by all that the committee heard here last night.

It is difficult to reconcile the statement that Dr. Holohan cares greatly with what we heard last night. I say that because I would find that a considerable challenge.

With regard to what the gentleman from RCOG referred to as the "remarkable coincidence", and it really is, would Dr. Holohan use that word? I will ask Mr. McCallion and Dr. Holohan if they would use that to describe what happened, in terms of the two most prominent campaigners happening to be the women where the error was made. The words "remarkable coincidence" was used. Would Dr. Holohan agree with those words?

Dr. Tony Holohan

I do not take issue with the description. It is surprising. Yes, of course, it is surprising. My understanding, although I will check with my colleagues in RCOG, is that the identity of any of the individuals as to who they were as individuals was not known to RCOG.

Professor Henry Kitchener

That is absolutely the case. We did not know the names of participants. Our only identification of them was the so-called CSP ID number.

Okay. Would Mr. McCallion agree with it being a remarkable coincidence?

Mr. Damien McCallion

We worked with RCOG and with the laboratory when the issue was raised. We then made contact with the women and explained the circumstances in letters to each of the three women affected. As the royal college has said, it did not know to whom the set of slides related. It is a very unfortunate set of circumstances. People in the HSE made contact with the people on the matter. The college has said that, thankfully, this did not have an impact on the individual's review, which was positive. It is certainly not something anyone wanted to happen.

Were the labels taken off every slide and then reapplied after they had been reviewed?

Mr. Damien McCallion

The process is set out in the explanatory letter. The circumstances are a little bit more complex. There are a number of labels involved. Temporary labels are applied to the slides and later removed. That was a factor. As the letter is a number of pages long, that is the short version. The college may wish to speak to the process. Some of the labs had permanent labels. That contributed to the confusion. When this was spotted and pointed out, it was then corrected.

Labels would have been removed from many slides.

Mr. Damien McCallion

Yes. These were temporary labels, which covered over aspects of the slide.

Will the witnesses describe very briefly how labels might have been taken off and put back on?

Professor Henry Kitchener

Following the completion of the review, after slides had been put into their boxes and sealed, a request was made to remove some of the material that had been used to anonymise the slides. It was in the process of removing this material that some of the original labels were removed. This labelling issue arose in respect of four slides. Again, it absolutely arose after the completion of the review.

Dr. Patrick Walker

May I make an observation? I have had something on my mind. I gave an answer to Deputy Kelly when we were talking about concordant and discordant slide reports. I said that we did not ascribe concordant or discordant if there was no slide result, such as cases designated unavailable or missing. I misspoke when I included the word "mislabelling" in that sentence. I used it because we had been talking about that issue. I emphasise that it was an error when I said it, because the mislabelling issue had nothing whatever to do with the reporting of the slides which had been completed or with any of our individual reports. If one was to read the sentence as I spoke it, it could be misleading. I would just like to correct that.

Any mislabelling occurred post the examination.

Dr. Patrick Walker

It occurred once the review had been completed and did not impact in any way on our decisions to ascribe concordance or discordance or on our decisions as to which slides we could comment on. This was nothing to do with mislabelling. That was a separate issue.

That is fair enough. We then have the remarkable coincidence of that happening to prominent campaigners. That is definitely a remarkable coincidence and even that is a massive understatement. Mr. McCallion referred to difficulties with recruiting and retaining staff. He said that this remains a challenge. We have had some discussion on this. Mr. McCallion will know my view, from this and other forums, with regard to the outsourcing. I have raised the issue consistently. Indeed, I raised it ten or 11 years ago. Obviously, some of those labs do not exist any more but I have been trying to get some kind of information about whether there is a quality issue with regard to some of the labs used. I have been told I can get it but it seems very difficult to do so, considering that Dr. Scally could not and that some of these labs have closed down.

I am firmly of the view that the best way to proceed is to do all of the testing on this island. That is my own view and the view of my party. I have expressed it on many occasions. I understand that moves are being made to repatriate this work. Notwithstanding the fact that recruitment remains a challenge - which is again a very nice way of putting it and I would say that it is extremely difficult to recruit and retain people - what work is being done to upskill people? One cannot just flick a switch and get qualified staff. They need to be in training now. I am not convinced there is a plan in place to repatriate this work but, if there is, students will be studying at the moment to take up these positions. Young people at home will be looking at their CAO forms with a view to taking up a new course or an additional course. What is the position in that regard? What consultation has the HSE had with colleges? What preparations have been made?

Mr. Damien McCallion

On the wider point, there is a commitment in the national service plan in respect of capital to develop a new national screening laboratory at the Coombe. That has gone to planning. It will comprise screening, research and education facilities. We have put up to ten positions in place in the Coombe. Many of these are still unfilled. There are challenges with regard to recruiting into that environment, as the Deputy has said.

How many of the positions are unfilled?

Mr. Damien McCallion

I cannot give the Deputy an exact number. A small number, two to three, are filled. I can confirm the exact numbers. Interviews have been held as recently as yesterday. Small numbers have come through. They are a combination of medical scientist posts. In growing the capacity of the Coombe, bearing in mind that capacity is very small, logistics, IT and so on are very important. It is much more than the building. In this instance, the building is the easier part. We have a joint steering group with the Coombe. There are a number of elements to that. It deals with workforce issues. There is a workforce plan as to what is needed and how to develop in the short and long terms.

With regard to recruiting medical scientists, which is one of the challenges, there has been a global shortage of cytologists. With the move to HPV testing, there are fewer career opportunities and people are less interested in doing it. That is one of the challenges that compounds our environmental factors. With regard to medical consultants, we have one permanent consultant. To grow the service to the extent we hope to, we will need to recruit into it. We have had interviews. We have had some success in attracting candidates to at least the interview stage. We will have to see, as it is with medical consultants, whether we can bring those home with the Coombe. We are more hopeful with regard to support roles such as laboratory aides and administrative staff. We can attract people for these roles but there are big challenges on the medical and medical scientist side. We have really struggled.

Retention of staff is equally important. We have to consider the age profile of the existing staff. It is a small team which works very hard and which has worked very hard over recent years, which have been difficult for the team due to the volume of work and targets to be met. The Coombe has an arrangement with an institute of technology. It provides basic undergraduate training for medical scientists to train them in cytopathology. We have managed to attract two people into the programme for next year. It has been quite difficult. There are attractive opportunities for medical scientists in both private and public environments. The Coombe has done work with the institutes of technology in that regard. We will be starting small. If we can get more people, we will seek to grow but it is quite challenging to attract people from the third level sector into that medical scientist area.

Separately, we are recruiting internationally. We are trying to attract people from the UK as its health service moves from cytology-based screening to HPV-based screening. There may be some people who would be prepared to relocate for various reasons. That is a market at which we are actively looking. My point is that, whether we recruit people or train people, this is going to take time. It will get a little bit easier as we move to the new testing model. There are also discussions with the likes of the National Virus Reference Laboratory with regard to collaboration on this new model. In summary, while the building is progressing to planning and a workforce plan is in place with regard to medical consultants - because we need consultants, of whom there are very few in this country - and medical scientists, we still face challenges. As I have said, the Coombe is working with third level colleges and we are still looking to recruit internationally. Posts have been approved this year through the Department and the service plan and these will roll forward into next year.

When does Mr. McCallion envisage this work being done? He has said it has gone to the planning stage. Are we talking about decades?

Mr. Damien McCallion

The building will be completed within a number of years. That is not really the challenge. The challenge is developing the capacity. We also have to consider resilience. There has to be a level of resilience in the model. Relative to other jurisdictions, we are a small country with regard to the volume for this programme. If we lose people in the future, backlogs may arise for women again, which none of us wants to happen.

We are also looking at opportunities around resilience and how we could do that with all the laboratories if issues arise. I am not talking about things like disaster recovery where a laboratory is flooded or something of that nature. It is more if they lose staff or if a laboratory gets a peak, as in the Jade Goody effect in the UK, the last thing we want in this country is to get back to the backlog situation. We are looking at those options as well. Obviously, we are still teasing it through legally and in other ways in terms of how we can develop it. It will take quite some time. I would not put a year on it. It would be madness to do that. We are committed to developing this. We have the funding available. The building will be available within a number of years. We will certainly try to grow it gradually through the human papillomavirus programme. We face significant challenges in attracting people.

When I said that people are not exactly confident in getting behind this, that is precisely what I mean. We have probably all been contacted by people who are in a situation where they are seeking an independent review. They have to go via the legal route to get an independent review. It is particularly costly apart from anything else. It is not really very fair. Women and their families want to know the truth. They have said that. For many people this will not be an issue. They are happy and it is a settled matter. They want to draw a line under it. However, for those who feel the real need for an independent review, the process is highly cumbersome and expensive. They have to go down the legal route simply to request their samples, as we have been told. Can anything be done for those people to make the whole process a little less adversarial and perhaps easier on them?

Dr. Tony Holohan

There is a submission with the Minister on that matter. He is considering it at the moment.

Do we have any timeline on that?

Dr. Tony Holohan

I am not going to commit to a timeline but I do not expect it will be very long.

When was the Minister given the submission? I imagine Dr. Holohan can tell us that.

Dr. Tony Holohan

It was within recent days but it has been the subject of ongoing discussion, as committee members know. The Minister has made his position on it clear in public. He has said he will keep the matter under review.

I know, but a number of positions have been made clear in public that have then been contradicted by subsequent actions.

Dr. Tony Holohan

That is not the case in respect of this issue.

Dr. Holohan reckons a resolution for this is imminent. Is that accurate? I am not trying to put words in his mouth. I am simply trying to get a handle on the timeline.

Dr. Tony Holohan

It is as I said. The Minister is giving it consideration.

I have had conversations with Dr. Holohan's colleagues where they described a number of years for this and a number of this and that. Dr. Holohan referred to a number of days.

Dr. Tony Holohan

The Minister is giving consideration to it at this moment.

In order of appearance this morning we will hear from Deputy Durkan, Senator Colm Burke, Deputy O'Connell and then Deputy Bríd Smith.

I thank our witnesses for coming before us this morning and for giving us all the information. Confidence has been mentioned on numerous occasions in recent years, including the lack of confidence in the system as expressed by patients and victims. We can do little about what has happened at this stage but we can affect what happens in future. Are the experts satisfied that the measures taken are sufficient to restore the confidence of patients and their families in the system? Are they sufficient to reassure the families and the bereaved that, in the event of something like this happening again, they are in safe hands? Can each of our experts address that question?

Professor Henry Kitchener

The issue of ongoing confidence is crucial. I believe unequivocally that women should have confidence. I believe that our report should provide the basis for women to have confidence in the programme ongoing and that the responses to the Scally report can provide a further layer of confidence. That is my unequivocal response.

Dr. Holohan wishes to respond.

Dr. Tony Holohan

It is a matter of significant concern, obviously, that confidence has been damaged substantially in an important programme that has worked in terms of reducing incidence. We know the programme is now feeding into a reduction in terms of mortality. All our efforts are to try to restore the service and then the confidence and trust that people can have in it. Confidence is easily damaged, perhaps, and challenging to rebuild and put back in place. We will not be complacent in saying that we believe this is done but we will continue to work to try to ensure that the confidence of people in the programme can be rebuilt.

It is also clear, not only in terms of the programme but in terms of what was at the centre of what happened with disclosure, that confidence in the medical profession was specifically talked about. Rebuilding trust and confidence on the part of patients is challenging and difficult. We will have to work together. The committee members heard testimony last night from patients, service providers, health professionals and policymakers. We need to try to ensure that collectively we do everything we can to try to rebuild confidence. We have hope. I will never say for certain that this will work, but we will continue to try to ensure that we build confidence. Anything we need to do to continue to improve that, we will do.

Dr. Colm Henry

I will add to that. All screening programmes are based on a foundation of confidence. We need a critical mass of the population to have confidence in the programmes and to partake in them. We know that despite all the events of last year, the uptake of the programme is remarkably high at 80%. We also know from some work we have done internally that the attitude of women who use the programme is positive towards the programme. There seems to be a high level of understanding of what the programme does and its limitations. It is important to us that women who have not yet entered the programme can have confidence in the programme and are not discouraged from taking part. There has been talk of reducing mortality. It is not only a question of reducing mortality but of detecting cancer or pre-cancer at an earlier stage, when intervention is far more effective and far less severe. That is a very important message for anyone watching this who may be wondering about the efficacy of the programme and what it may mean for them.

It goes without saying that those of us on this side of the room are equally keen to restore public confidence in the system as a matter of urgency. The measures that have been taken already and the experiences we have had point towards that. We need to see this from the point of view of the experiences of the patients, some of which were successful and some of which were not. That is where we have to deal with the extreme cases where things went wrong.

An issue arose some years ago with contamination in the blood bank. It took a long time and a major effort to restore public confidence in the system, but it was done. It was done because the system was corrected and double-checked in every which way to ensure that people could come forward and totally rely on the product. The same has to apply in this case.

Professor Kitchener said that neither screening nor HPV vaccination alone is enough. He said we need both public health programmes if we are to make cervical cancer a rare disease in Ireland. Will Professor Kitchener expand on that point a little?

Professor Henry Kitchener

The purpose of vaccination is to provide what one might term primary infection. In other words, we are preventing women from acquiring the very viral infection that is responsible for the disease. It is hoped a high level of coverage will be achieved. Primary vaccination does not cover, or is not capable of preventing, every case of cervical cancer. This is why there is still a need at the moment for what we might call secondary prevention. This is where HPV testing and cytology - at the moment it is cytology alone - comes in. This is the means of picking up abnormalities at an early stage such that they can be easily treated. The two public health measures are entirely complementary.

Dr. Tony Holohan

We have introduced HPV immunisation for boys this year.

Like many countries, we experienced a dip in the uptake of that vaccine for a variety of reasons, many relating to concerns that were expressed around vaccination. This has been one of the few countries that have been able to turn around some of the experience in terms of uptake of immunisation for girls, so that is good. The anecdotal evidence we have is that the uptake among boys is as good as the uptake currently is among girls. We will not know that for sure until we have hard data at the end of quarter 1 and we will be happy to come back and share it with the committee.

Dr. Peter McKenna

Deputy Durkan referenced the product. I do not think the public did lose confidence in the product. The reason I say that is because more women than ever before came forward for screening last year. If people lose confidence in something like vaccination, they stay away. We experienced the contrary point of view last year.

What instigated this, and what appears in the first line of the Scally report, is the difficulty that we had in communicating to patients the results of what we were doing. We are in a position to reassure Deputy Durkan that we have learned that lesson. We have taken it on board and are working very hard to ensure that that particular element, which started all of this off in the first place, will not happen again.

One of the things that created a problem was the imprecise nature of the cervical smear test. We discussed it last evening on the basis that nobody really knows if we have accuracy, or at least we do not. I speak for myself. A range between 70% and 100% allows for a wide margin of error. It is a bit like an opinion poll which has a margin of error. Are the witnesses satisfied, given the margin of error, that vague and nebulous area, that we can go forward with absolute confidence in the system, that it will work in the future and that we will not have to revisit this particular issue?

Dr. Colm Henry

It is an interesting question. Every screening programme balances the risk between false negatives, on which much of the discussion has been focused, but there is less focus on the false positives, which can be very harmful too. Over-referral of patients for interventional investigation can be harmful too. We know that not just from the cervical screening programme but from other screening programmes. In the breast screening programme, for example, the aim is to keep the recall rate below 7%. Otherwise, they are over-referring patients who are otherwise healthy, coming in to a screening programme, volunteering their time to partake in a screening programme for interventions and investigations which may be harmful. Every screening programme calibrates between the need to pick up as many precancerous changes or early cancer changes in the case of breast cancer against the risk of over referring people. In the case of the cervical screening programme, for every 1,000 women screened, there are 20 abnormal findings of which the liquid-based cytology picks up 15, but once we move to HPV screening, that will improve to 18, as it is a much more sensitive screening test than cervical cytology. We expect to see an improvement in the sensitivity without the expense of over-investigating and subjecting people to unnecessary harmful investigations.

My understanding is that in the United States where some of the screening tests were processed, they have a more frequent screening system. In this country we use a less frequent system. Ours is every three years compared to a one and a half year screening in the United States. The question that arises immediately is which of those systems we go for now.

Dr. Lorraine Doherty

I will clarify exactly what happens in the United States, they do not have a population screening programme. What it has is a test that practitioners can offer on an annual basis to women in their practice, so it is slightly different in terms of how the programme is organised. There is not a screening programme, as such. What we have in Ireland, Northern Ireland, the UK and in other European countries is a population screening programme that is offered at regular intervals.

Does the test that they have in the United States work? Are there pitfalls similar to the ones that we have experienced here, and do they happen to a greater or lesser extent? From our point of view in trying to establish confidence in the system, I believe that is the way we have to go. We have to know how well we can rely on whichever system is being used. Professor Kitchener has already said that we need the two systems. That is good. We know already one of them is imprecise in its determination. Let us compare that with the United States and see which works best. Could the witnesses indicate which we should do?

Dr. Lorraine Doherty

There are differences in how the programme is delivered but the test is the same. They also use cytology and HPV testing, so the same issues arise in terms of false negatives and false positives.

Have they had a similar experience to the one that we have had here in this country?

Dr. Lorraine Doherty

In what context?

Have they had a major crisis such as we have had here on this issue?

Dr. Tony Holohan

There are some issues, as Dr. Doherty has rightly pointed out, that mean the system that pertains in the United States is not comparable to what happens here. Testing is offered through laboratories, but it is at the individual level. In this country what we have is an organised population-based programme where people are invited proactively on the basis of their age. In effect, what our programme is saying to people is that if a woman participates in the organised programme from the age of 25 to the age of 60, at different intervals depending on one's age, over one's lifetime it will reduce the risk of mortality from cervical cancer. They do not make that offering in the United States because they do not offer a population-based programme.

As part of our programme, we were then able to have in the quality-assurance arrangements a retrospective audit, which does not exist in the United States. The non-disclosure of those findings of retrospective audit, which happened here, is not part of the design at all of what happens in the United States, so there is no comparable circumstance that could have arisen regarding what happened here.

As I said previously to this committee, the quality assurance arrangements and the retrospective clinical audit that was in place for CervicalCheck made us one of the very few programmes in the world that offered that. The United States is quite a substantial way from that, and it does not have any of the features of an organised population-based screening.

It is rather unfortunate from our point of view that we send slides to the United States for testing, where they have a different system that we do not know about and where one cannot compare one with the other.

Dr. Tony Holohan

What we were not procuring from the United States was the population service. It was the cytological service, in other words, the laboratory processing of the smears.

Yes, but the slides sent from here to those laboratories were processed there as well. Somebody, somehow, somewhere must be able to tell us what the Irish experience is in the last 150, 200 or 5,000 tests that were done, and the result was X, Y or Z, positive or negative. What is the difference? There has to be a comparison somewhere.

Mr. Damien McCallion

I will make two points in response. One relates to the timing and whether it is one year, two years or three years. That would have been looked at initially by a clinical expert group to determine what is the appropriate timing in terms of interval between screening and there are balances, as has been described by colleagues, in relation to false negatives and false positives, in other words, over screening versus getting that balance right. There would have been recommendations around that. Going forward, with the advent of the new national screening committee, that will also help in terms of looking at that for future testing or major changes to existing programmes. The timing would have been evidence-based in terms of whether one does three years and then how one deals with individual cases. Some people may require a more frequent smear and others can move to a longer smear cycle. That is all determined by experts in terms of the timing.

As Dr. Holohan said, the laboratories provide a service simply around cytology and HPV. That is quality assured and examined through a whole series of measures. My colleague, Dr. Doherty, can speak to that if need be. That is purely the laboratory element of it, but in terms of the timing on whether it is one year, two years or three years, that is determined by a group of medical experts that would have determined that three years was appropriate for most people. Some people will have more frequent recalls where that is determined by their own clinical status.

Dr. Tony Holohan

In relation to the population performance of some of the kinds of issues Deputy Durkan raises, we now have information from the report completed by the Royal College of Obstetricians and Gynaecologists.

Dr. Lorraine Doherty

I want to clarify the issue concerning the laboratories we use in the United States.

We know exactly now which laboratories are processing the work that is coming from the Irish screening programme. There are five laboratories involved, and the headquarters are in Teterboro, New Jersey. As recently as November, a team from the HSE visited those laboratories on a formal quality assurance visit, and the reason I raise this issue is that I want to reassure women who are coming for screenings that they are getting a quality screening from this laboratory. The laboratory has made a number of vast improvements in the quality of service it delivers. It has worked very closely with us on aligning our testing processes and in complying with our quality assurance guidelines. It has expertly trained staff who are participating in formal education and CPD programmes. It has standardised quality measures right across the five laboratories that provide the service for us. It has meetings with us on a weekly basis by teleconference and we have face to face meetings four times a year. We have a very good working relationship with it around the quality of the service, and we are content with the quality of the service being provided to the women in the programme from these laboratories at this time.

Chairman, that is the information that I was looking for. This is reassuring, and this is where confidence can grow from. Without that we will waste our time. I appreciate that information. It is very useful and it can be used to good effect in the future to restore that vital confidence in the system. Once we have that, the women who have tests in this country will certainly have confidence in the system. We are very sorry about the kind of pressure that the system had to work under over the last few years. It is difficult to be under the microscope all the time, and to be criticised all the time. It is difficult to restore any confidence in the system while that scrutiny is going on. It is also difficult to retain staff in that system. The confrontational nature of the business and the politics surrounding it is such that it puts pressure on a lot of people, in an area that can have its own sensitive pressures at the same time. We recognise that, but we also recognise the things that we have to do to address the issues. I refer to the weakness in the system and where the system went wrong and failed to deliver, reassure, and inform women. This goes back to full and frank information and full disclosure. This is hugely important, Chairman. If we are to learn one lesson, that has to be about the need for full disclosure and the need to apply it across the board.

I have to go to the Chamber in a few minutes, but I would like to ask a question before I call Senator Burke. It arose out of evidence that we received last night, but it is something that has been on our minds as we have assessed this over the past 18 months. I refer to the balance of risk in relation to screening programmes. We understand that there is an inherent high rate of missing early changes of cervical cancer, pre-cancerous changes, and we understand that this is a problem with most screening programmes. As Dr. Henry said, 15 out of 20 will be picked up, but five will not. When one goes through the balancing of risk of a screening programme, there are instances where one looks at a slide and there is no evidence of pre-cancerous changes, even though there may be but they have not been picked up on the slide, there are instances where changes are not picked up but are evident and there are instances where major changes are not picked up.

As one moves through that gradiation, is there now a rebalancing of the risk? The witnesses last night felt that there are inherent deficiencies in screening, but CervicalCheck was outside those inherent risks. In other words, the programme was deficient. Is that rebalancing down to the limitations of screening, and ensuring that the programme is not adding a greater risk because it is in some way deficient? Is that being rebalanced at the moment? Is the programme now running at a rate efficient to the maximum of the limitations of screening?

When we invite healthy people in to have a service, for instance, screening, should there not be a no-fault compensation scheme for people damaged by the failures of the system? Might that encourage more people to come forward, because 20% of women are not being screened, for whatever reason. It may not be because they do not have confidence in the screening but rather because they just do not engage. If there was a no-fault compensation scheme in place, would that alleviate a lot of the anxiety that has developed over the last 18 months? Perhaps the three main witnesses this could comment on that.

Dr. Tony Holohan

I will address the first part of the Chairman's question. The RCOG review gives substantial insight and evidence into the answer to the question that the Chairman is asking. The limitations of screening was spoken about last night and there are many and varied reasons that explain the screening programme not identifying, failing to pick up on and, in about 30% of cases, failing to prevent cancers. The reasons for that can be very different, and the Chairman will be aware of this. They can be everything from the chain in terms of the issuing of call and recalls, and there could be errors there even before one gets to screening, the adequacy of the smear itself, the mounting on slides, and then ultimately, the cytology. We have heard a lot about the cytology all the way through to colposcopic diagnosis and so on.

It is true to say that where one sets the balance of risk and benefit ultimately determines the levels, broadly speaking, regarding false positives and false negatives. For most types of medical tests, not just screening, there is always a balance between the two. As Dr. Henry said, we can set the balance at a certain level which means we are over-diagnosing, we are over-treating, and exposing people to genuine harm, because over-treating means unnecessary drugs, unnecessary surgery, unnecessary time in hospital, exposure to infection and so on. All of those things have to be calibrated, and that constant calibration is an issue for all forms of medical test, but we have the best evidence that we have had in relation to the operation of our screening programme through what RCOG has done for us. On a dynamic basis, the programme would have to have its own quality assurance ranges into the future that continue to provide that assurance, but I will defer to colleagues who wish to supplement what I have said in relation to that.

On the specific issue of no-fault compensation, the committee will be aware that the Department is soon to receive the final report of Mr. Justice Meenan, who is giving consideration to the whole question of compensation. He was asked specifically how it might be applied in relation to vaccination. The point that the Chairman makes is a fair one. As part of the overall consideration of whatever recommendations Mr. Justice Meehan will make, it may form one of the considerations as to how that might operate, how that might facilitate the objectives of a population-based programme in the same way as it might in relation to something like immunisation.

Is Dr. Holohan saying that the balancing of risk is a dynamic assessment that is changing all the time, and that we should be looking at the programme and improving it as it progresses? For instance, we are going to move from cytology to HPV testing, which reduces the risk of missed cases. Is Dr. Holohan saying that there is a constant review of the balance of risk?

Dr. Tony Holohan

Yes. In broad terms for screening programmes, and as a point of principle, that has two dimensions to it. One is what the evidence says, in general terms, around the performance of tests, but then there is also the question of the risks and benefits that arise in a particular country or a particular setting. Ultimately, the costs and expenditures that accrue here will be difficult, so the cost and benefit of a screening programme, even if the technology is the same, can be different in different populations.

Professor Kitchener, do you have any comments?

Professor Henry Kitchener

The Chairman made reference to three things. The inherent limits of sensitivity that cytology screening has is the reason women are invited every three years. We know that - to use Dr. Henry's figure that one quarter of the abnormalities are not picked up in one screen - because the natural history of cancer of the cervix endures over a number of years, the hope is that they will be picked up in a subsequent screen. Repeated screening, and compliance with or adherence to repeated screening, is an important way of trying to raise the overall sensitivity of cervical screening. It is quite clear that HPV testing will reset the risk, because there will be an increased detection of underlying pre-cancerous lesions, and that will happen.

It is also the case that because women who are HPV negative are at such low risk, not just at that moment of time but in the short term, that screening intervals could increase. Regarding no-fault compensation, we do not have that in the UK and this is a matter for Irish policy-makers to consider.

Would any of the witnesses like to comment?

Dr. Peter McKenna

Looking towards the future, when HPV is introduced, an algorithm is already in place for frequency of testing. This is not a static document and it will be reviewed in the light of best international evidence and our experience here. Nothing is carved in stone as to how the programme will function in future. All we can do is to take the experience of what other countries are doing, modify it and then look to see how that works here. To say that it is an inflexible forever document would give the wrong impression. It will be modified with time.

I thank Dr. McKenna. I have to leave now and Deputy O'Reilly will take the Chair for the next half an hour anyway.

Deputy Louise O'Reilly took the Chair.

I thank the witnesses for their presentations and the work they have done on this issue. Some people have been involved from the start and some people came in at a later stage. I thank them for the detailed information provided to us. I will start with Professor Kitchener. His report states reviews were carried out of 1,000 women. It is not easy to do a review. It is a complex process and involves many people. Professor Kitchener has given that explanation, but in his report he has stated there were 20,000 data items. He might outline what those data items are, because I understood that around 3,500 smear results were reviewed. How is that total of 20,000 data items made up?

Professor Kitchener also referred to the comparison with the UK. The Irish results were similar to the UK. Regarding audits undertaken in the UK, what has been the experience regarding releasing information back to the patients? Is that process in place? I understand that in some European countries information from an audit it not released. It is retained because the whole idea of an audit is to ensure the system is working, first of all, and then that any glitches are addressed. Will Professor Kitchener deal with those issues?

I turn now to the issue of staffing and the challenges staff have faced over the past 18 months. I refer in particular to comments made by Dr. Nóirín Russell, who is based in Cork and Kerry, which set out clearly that staff have faced major challenges in some centres. I understand that in some centres there have been resignations and people have been difficult to replace. Has any mechanism been put in place to support staff who had to deal with this defensive work daily during the past 18 months? In fairness, all the staff have been doing their best to provide the best possible service. The public perception was different, however. If staff are facing challenges, it is important that they have the necessary support. The last time I raised this issue was when someone from the Medical Council was in here. I am referring to a situation where there is an adverse outcome regarding work done within the HSE or by medical staff and the lack of support available. Have we identified how we can support and retain staff?

Also on staffing, the number of consultants in this area is very small. The total number of consultants in obstetrics and gynaecology is about 135, and it is smaller again in this particular area. Have we set out how many people are due to retire in the next five years, how many people are in training and how many people we need to encourage to go into training in this area? What work is being done on that issue? I ask that because I see major challenges. For example, I have heard of two people who have dropped out of the area of obstetrics and gynaecology. One person was in training for nine years, but then decided to go back to do GP training. The second person had done six years of training in obstetrics and gynaecology before dropping out, again to do GP training. It is the same in this particular area. What supports are we putting in place? How can we now help retain those staff and ensure we have the necessary numbers of staff in place to deal with requirements and provide an adequate service for the patients? They are entitled to the best quality service and to do that it is necessary to have the staff. Those are my opening questions.

Professor Henry Kitchener

I will deal with one of Senator Colm Burke's questions and refer the other to Dr. Walker. The Senator asked about the policy of disclosure in England. That policy was developed some years ago by policy-makers who felt it was important that there was transparency in the system. That was what it was all about. It was a measure taken to try to increase public confidence in the cervical screening programme. Senator Burke is correct that in a number of countries with high standards of cervical screening that the results of slide audits are not disclosed to individual women. I have recently been in contact with the director of the world-renowned cervical screening programme in British Columbia. He informed me that the programme has not been doing that, but they are examining the resources put in place in England for that purpose. The Senator is correct about other countries with good programmes in Europe. We have this policy of disclosure and we think it is a good policy.

As for the response women have to this situation, a significant proportion when asked do not want to know the result of the slide review because they are content that they have been diagnosed. They may regret and be upset, of course, that cancer intervened, but having been treated they do not necessarily want rake over all of that again. Other women do want to know and when some find out they are prepared to accept the results in the context of the limitations of screening. Some women may also wish to use the results as a basis for pursuing litigation. The policy is there and the interaction women have with that policy of disclosure is a matter of individual preference. I will hand over to Dr. Walker now, if I may, to answer the question concerning the size of the data.

Dr. Patrick Walker

I have in my mind now the spread across as we were working on the letters. There were 1,038 women, but 1,659 slides. As we worked across the database, therefore, we had the CSPID to identify the case.

There is a slide number to identify the slide. There is the CervicalCheck result, classified as negative, low-grade or high-grade, and the P number, which is from one to nine. There are sometimes more than one P number. Then comes the review result, the review result P number, the final diagnosis from the cytology group, and the P number result - P 2 from the screener. Where the slide went to a first consultant, there is that consultant's opinion and a P number. Where there was a second consultant, there is another opinion and P number. Then there is consensus, if there was a consensus, and the subjective comments, if made. The date of attendance at colposcopy had to be tabulated against the date of diagnosis of cancer to identify the subgroup that needed to be seen. Then there is the comparison of the CervicalCheck result with the review result in terms whether it is concordant or discordant. Then there is the issue of whether a letter has been drawn up or not, or whether the letter has been completed or not, and other matters relating to stage. All these items did not come down in the dropped merged mail. They all had to be put up there and extracted. For each individual letter, there are approximately seven items to be drawn down, manually or otherwise. We sent the committee a copy of the draft letter. The point that was being made in the sentence was that this was a complex task.

Mr. Damien McCallion

Colleagues may also want to contribute on colposcopy. I acknowledge the work doctors, nurses and support staff have done in the 15 colposcopy units around the country. Undoubtedly during the crisis they would have been the front-line point of contact for women who were understandably anxious and concerned. The staff have provided extra sessions and done a huge volume of work to try to bring about some stability. They are still challenged in the service. What has been put in place is a working group involving the acute hospitals, the women and infants programme, Dr. McKenna and CervicalCheck, under Dr. Doherty. There is a team in place to examine a number of issues, one being investment. As I stated, €2 million was allocated this year to try to support the service in regard to both staffing and equipment. A second aspect involves looking at the clinical pathways in the utilisation of the service. The third aspect involves GP education and guidance on referrals to the colposcopy service. In addition, it is a matter of considering alternative pathways for certain categories of patients in terms of ambulatory gynaecology clinics. Colleagues could speak about this. Finally, there is a focus on planning over the next few years as we move to HPV. As we have mentioned, there is a higher impact over a number of years as one moves through HPV screening in colposcopy. Alongside that, there is a workforce piece examining some of the issues referred to in terms of planning, including medically and in the areas of nursing and other models that would have been developed. An impact assessment was done. Dr. McKenna might speak about that first before tackling the wider point. Each unit was visited last year to consider the issues and what the solutions might be. They vary around the country based on the nature and shape of the units. Dr. McKenna might speak to that first and then talk about support.

Dr. Peter McKenna

I very much welcome the Senator's observations on the staff. There are two important features to retaining staff in colposcopy. They must have the facilities to treat the patients coming to them. They have been under a lot of pressure owing to clinical referrals. One of our objectives is to take the clinical referrals out of the colposcopy clinics in order that they can focus on the patients who are best seen in them.

The Senator mentioned trainees dropping out. This has always been a concern in the specialty of obstetrics and gynaecology. It is not something that is suitable for everybody, for a variety of reasons, but, in fairness, colposcopy is not a reason for trainees not continuing in the specialty. It may be a very cogent reason for those becoming consultants not taking up that particular part of the profession.

The Department has allocated funding to make the conditions for the patients and the staff in the colposcopy units better but it would be remiss of me not to say the biggest difficulty the staff have in the colposcopy units is the fact that they felt they have been pilloried and demonised over the past 18 months. They are very sensitive about the negative information about them in the public domain. When that ceases, it will go a long way towards making recruitment into this area less difficult.

What backup support was provided to staff? Everyone knew they were under pressure.

Dr. Peter McKenna

A colleague and I visited every unit to know what backup support was appropriate. We went through their needs in terms of equipment, staffing and infrastructure. This is what we are trying to address in the current allocation.

Is the Senator referring to emotional support?

I am talking about emotional support because it is challenging.

There may have been a misunderstanding.

It covers both.

Dr. McKenna was describing physical supports. I suppose anything beyond the employee assistance programme is open to everybody.

Dr. Colm Henry

I welcome the Senator's comments on colposcopy staff. It is important to recognise the screening programmes are primarily about the women engaged in them. They will only be successful, however, if they have happy, engaged and supported staff, including not only colposcopists but also administrative staff. I visited the staff in Limerick on Monday. I pay tribute to them for their great resilience and for sticking with the programme over the past 18 months. The unit proved quite successful at holding on to staff in a period of markedly increased demand, not only in terms of the number of inquiries but also in terms of the nature of the interactions with the public. The Senator is quite right. To refer to what Dr. McKenna said, when we consider the needs of colposcopists and the sources of pressure on clinicians, the primary objective is to ascertain the supports they need to address the demand in their clinics. The past year has seen a remarkable increase in demand, not just through the screening service but also through direct referrals from GPs. With the support of Dr. McKenna and his colleagues, we have been seeking and securing funding for alternative pathways to ensure women can go to the right clinic for the first time and preserve the integrity of those clinics in respect of what their set-up is supposed to be.

I am not sure that addresses the question directly.

Mr. Damien McCallion

The supports for people on the ground were highlighted by Dr. Russell. The colposcopy units are under the management of the acute hospitals. The hospitals run the colposcopy clinics and the programme then funds and has a contract with the colposcopy clinics. I spoke to Dr. Russell myself. All the hospitals have asked us to ensure the necessary supports are in place in terms of employee assistance and so on. There may have been variation between hospitals in this regard over the past year but we are going to make sure that whatever is needed is provided. As we have all said and agreed, the service has been through a very difficult 18 months and continues to be under pressure. It is a bit like the laboratories in that we have to try to retain and stabilise the service and then deal with future demand. That is the purpose of the group I mentioned in terms of considering how to utilise the funding provided by the Department under the service plan and the changes to which Dr. McKenna referred.

The concern I have is that she had to go public to highlight the issue. I have not spoken to her directly about this but this indicated that she felt the level of support required for staff was not in place. I do not know what Mr. McCallion's view on that is.

Mr. Damien McCallion

In response to it, I have spoken to her myself. I do not want to personalise it, in fairness to her. She is just representing a general view. The hospital groups are being contacted to make sure that if what should be in place for them is not in place, it will be put in place. They ultimately have responsibility for managing the service from day to day. From a screening perspective, Dr. Doherty has secured a colposcopy adviser. There was a gap in this regard, and we have talked about it here. I am referring to someone within the programme to interface with the units on a day-to-day operational basis. We have just appointed someone in the past week after a long search to recruit someone. That will help from a screening perspective. Ultimately, the units work within the hospitals and we need to make sure the supports are available for them in the hospitals. There are practical aspects, which we have discussed, but there are also elements in terms of the personal impact on the staff of working in a service that is stretched and under pressure.

Dr. Peter McKenna

On the practical support we have offered, the RCOG report had to be disclosed to patients who wanted a meeting.

In the past, the units were written to and they were told to get on with it. On this occasion, we engaged with the units. We offered support and training as to how to do it and what was likely to lead to the best outcome for the patients and, indirectly, for the staff. Where the staff felt that they were unable to do it we provided a central team that would go to their unit and deliver these results. This is a quite significant difference from how the programme would have interacted with the individual colposcopy units in the past. More than 200 of these visits and meetings with the women have taken place to date, many of them with the local units, most with the central support team. The fact that we have not heard more about them - I am not saying that they are all going absolutely smoothly - says something for the effort that the HSE put into preparing for this event.

Mr. Damien McCallion

I do not think any of us is saying that there is not more work to be done with the colposcopy service. I mentioned the units were all visited last year. The intention in January, through the women and infants programme, is to visit the units again. This is in order to understand the issues at a practical level, because each unit does not necessarily have the same issues in relation to how it is functioning, how it is supported and so on. That repeat visit of each individual site will also help to identify issues for each unit that can be addressed either locally or with support from the centre.

Dr. Peter McKenna

In terms of whether the units need more support, the answer is yes. It is a question of how we can best provide that.

Has there been an assessment done of what we need to do over the next three to four years to plan for people who are retiring?

Dr. Peter McKenna

That is not something that centrally we have been engaged in. It is left to the individual hospitals and their groups to recruit people, but that has been brought to our attention and we will be engaging with the institute, which is the training body as to how best to ensure that this does not happen. The Senator is absolutely correct that this is a real risk.

Can I ask one final question?

The Senator may ask one quick question.

It is about the positive outcomes in cervical screening and the progress that has been made over the past ten to 15 years. I am not sure if enough information is out there in the public domain. For instance, the National Office of Clinical Audit published figures recently on the reduction in the number of people dying in hospitals due to heart attack, stroke or pneumonia. I do not know whether we have got enough information on the changes that have occurred over the past ten years in CervicalCheck. A lot of progress has been made and I am wondering if something can be done to get out the positive information because it has been very much a defensive role that the HSE and the Department have played over the past 18 months. I am wondering if something could be done to get that information out as well.

Dr. Colm Henry

One of the positive outcomes from the royal college review is that an independent outside body confirmed that this programme is working effectively. It is not just a question of us communicating figures such as the reduced mortality or the earlier detection of precancerous changes. It is the summary view of the royal college that the CervicalCheck programme is working effectively. That is a strong message of reassurance to our population, not just to those who are engaged in the programme now, but to women who are coming up to the starting age for the programme. They should have confidence that this programme works, and is effective, as benchmarked by an external, independent body.

It would be helpful if the indications in terms of numbers going back ten years ago, and the numbers now------

Senator, we have to wrap up there.

I am wondering if if that could be done as well to outline the changes that have occurred over the past ten years.

I call on Dr. Doherty to reply briefly as I am conscious of time.

Dr. Lorraine Doherty

I thank the Senator for his question. We do monitor the outcomes from the screening programme on the incidence of cervical cancer. As the Senator will know, before the programme was introduced cervical cancer was rising by a rate of around 4% a year. What we know from our most recent data is it is decreasing by approximately 5% to 5.5% year on year now. The most recent data we have on that is from 2016.

It is not generally out in the public domain-----

I apologise to the Senator, but we are up against it for time. I know that some of our guests have to leave. I call Deputy O'Connell.

I wish to follow on from Senator Burke's comments about the impact of screening on the population's health. Perhaps it is not Dr. Doherty's area, but my understanding is that before the start of the cervical screening programme ten years ago we had the highest rate of cervical cancer in Europe, and we had done nothing to try to impact on that. I think Dr. Walker said at the private briefing that it has gone down 7% year on year; that is what I wrote down that day. It may be 5.5% as Dr. Doherty said, but at least it is in the right direction. There was a comment passed here yesterday, and I am not sure if I misinterpreted it, asking if there was a material impact. It is very important that somebody with a medical background, who is qualified to say it, can say categorically here today that we used to have an increasing rate of 4% and now it is between 5.5% and 7% in the downward direction. The net impact of that is lives saved, but also that early intervention has had positive outcomes for the population for women who might have had their fertility or their personal lives affected.

It is not just about mortality. One of the witnesses said earlier on that it is about having the least impact on people's lives. Reference was also made earlier to the consequences of over-diagnosis, or dealing with false positives, and that one does not start zapping everybody with radiation if they have a small cellular change, that that has a net impact on the rest of their cells. If it was as easy as just assuming everybody had a certain low level we could zap everybody, but that is not the way it is done. One has to deal with the data in front of one on the slides-----

I apologise to the Deputy, but Dr. Holohan is indicating that he wants to respond directly to her.

Dr. Tony Holohan

I am entirely in agreement that there have been a range of improvements at a population level since the programme was commenced, not just in relation to mortality. A total of 50,000 high grade lesions have been picked up and so on over the period, and the incidence impact that we have heard about, just under 7% in the years from 2010 to 2015, is now beginning to feed into mortality. I want to take the opportunity to pick up on the point that Senator Burke was making. I refer to the importance of us being able to get into a situation where we can on a positive and a proactive basis communicate the full range of information. That has been a challenging space for the HSE, and for the Department, and for the professional colleges who would normally be in that space over the course of the past 12 to 18 months. It is something that proactively we need to get back into in the coming year, and that is something that we will be doing for sure.

It is important that that message is gotten out there in terms of how aggressive cervical cancer is, the population it affects, that it has life-changing impacts and that despite the best efforts, somehow we still have a system that is fit for purpose.

Dr. Tony Holohan

A number of us were around when the programme was commenced, and we did not have a programme in 2008, unlike our colleagues in England, and in the UK. I can recall the role that was played by the original CervicalCheck clinical director Dr. Gráinne Flannelly, in her engagements with the Department, and in public, in making strongly the case for the introduction of a screening programme. She talked in very clear and passionate terms about her gynaecological practice in the UK, where she had trained, and seeing young women presenting with late-stage cervical cancer, and lives being lost with young children. She was instrumental in making the case in public and political terms, for investment in the development of a new programme at a time, in 2008, when the overall expenditure on the health system was being reduced. There is no question that that played an important role in establishing a programme that has had the positive impacts we have seen over the past ten years.

It is worth noting as well the ethical challenges she faced at the time and the different space we were in as a country. There was a lot of resistance to funding for this area, and there was a lot of hearsay and all sorts of carry-on that was very hard to battle. I know that Senator James Reilly was instrumental in bringing the truth of the situation to the fore as well. To go back to today's job, I have been meeting all the witnesses at the Committee of Public Accounts and this committee for a while now and for 18 months with regard to this matter.

The words "blame" and "truth" have come up a lot. I would level the blame for this on the audit and, in particular, whoever it was who decided that it was a good idea to audit without considering the impact of the audit results. Something that was imprecise, with a 70% detection rate, was being audited so naturally the results would not be easy to read if someone fell into the other 30% all the time and had cancer. The main lesson that needs to be learned is that in the context of everything that is done by the Department and the HSE, the patient must be to the fore. The impact all the way down to the person whose slide is involved must be considered.

Another lesson from what happened involves the lack of leadership and governance. It was very clear to me and to other members of the committees that no one seemed to be in charge. There was a vacuum and this left space for falsehoods or for incomplete information to get out. A lie is halfway around the world before the truth is putting its boots on. That is really what happened in this case to some extent. I am grateful for the report and I believe in its independence. However, it is very difficult to explain to people that despite the questionable quality assurance that was in play when we were going over to see the labs, despite not noticing that slides were being sent to other labs in clear breach of contract, despite the guy in Salford operating without approval and despite all the things we discovered, it appears that our gross population data, as per the report, is not too different from that of the UK. I believe that but it is very difficult to communicate it to the public and to say that, despite all that has happened over the past 18 months, "Nothing to worry about girls, it has all been fine." That is a very hard message to get across to people and they do question it.

In terms of the labelling of slides, I can understand the complexities involved. I would like to clarify something which emerged yesterday and about which I am unhappy. Where there was a slide that was concordant with the result, it was categorised as concordant. Where a slide was discordant with the CervicalCheck result, it was discordant. Dr. Walker spoke about the non-homogenous group, namely, the third group of people. I agree with him, particularly in the context of trying to just force everybody into that group. On the basis of what he stated, they were not a homogenous group and they could have had no smears. I just want to clarify that where there was an assumption or a decision made that a slide was concordant, there was actually a physical slide present.

Dr. Patrick Walker

Absolutely, 100%.

There was no default position of concordance. That is something that came out of yesterday's meeting. I do not really know why, but it left me uncomfortable and last night I was wondering if the results are as I read them initially.

In terms of the labelling issues, there is continuous reference to the idea that a person would be as likely to win the Euromillions as to have this happen to her, which is just ridiculous because the sum is not right. In terms of looking at people's smears, there was no indication given to slide readers or operatives of who the slides belonged to. Is that not true? The process was totally anonymous. The slide readers knew that the person had cancer, because that was obviously the trigger, but they did not know it was my smear, Deputy Bríd Smith's smear or whatever. They did not know who it was. It is unfair for people to suggest that particular people were being looked at through a different lens. I think there is some element of that going on.

Professor Henry Kitchener

Yes, that needs to be refuted absolutely.

I just want to make sure because certain things are coming that are not being discussed fully and then assumptions are being made publicly. All of this damages the screening programme. I thought the whole point was to have an adequate screening programme. Lorraine Walsh spoke yesterday about oncofertility and lymphedema These are the side-effects of surviving a devastating illness. There appear to be inadequate services for people who are diagnosed and treated and then have to deal with the issues that come from surviving such a devastating illness. I understand that there are recruitment and financial issues. W are trying to get over this hump, as it were, but what work is being done with the Irish Cancer Society in terms of referral pathways for women who maybe at 32 or 34 years of age find themselves with this devastating diagnosis? They might not have anybody in their lives they can turn to. They might not be able to have children. What about freezing eggs or any of the advice that is out there? In terms of dealing with women who have an early diagnosis and treatment and the pathways for them, as cancer survivors, is there anything in train?

Dr. Colm Henry

With regard to lymphedema, I would like to acknowledge the work of Lorraine Walsh in advocating for this service. It is somewhat of an orphan speciality in that it does not lend itself readily to one particular specialty. We will be interviewing this Friday for a lymphedema lead. Working with the Department, we have secured funding to start up a service in the Mater Hospital and one of the community healthcare organisations. That service will address the needs and will be core to the needs. One of the core issues for some of the survivors of cervical cancer and indeed other types of cancer is lymphedema and the difficulty they have in accessing a single specialist who can signpost them. We are making progress on that and will be working with Lorraine and others in pushing it and with the Department in securing funding.

On the broader issue of cancer survival and the ten-year strategy of the NCP, part of that strategy focuses on post-cancer care which has been somewhat neglected in recent years with all the focus we have on consolidating care in our eight cancer centres and all the improved outcomes we see in that. As we see greater success with cancer survivorship, there needs to be greater focus on the needs of people who have survived cancer, which until now have not been as well addressed as they should have been. I acknowledge that.

With respect, Deputy O'Connell's question was about what is being done. There is acknowledgement that there is not a range of supports in place for - this is not a medical term - the fallout or aftermath of surviving cervical cancer in particular. There were a number of issues raised regarding the type of support and-or intervention that a woman might need. If I am understanding her correctly, that is the issue Deputy O'Connell wanted addressed. It is not so much an acknowledgement of it, which is grand, but more what plans are in place to deal specifically with the fallout.

There is this interview on Friday. There is somebody interviewing for a post.

Dr. Colm Henry

For the post of lymphedema lead. We have funding secured for lymphedema services.

In terms of fertility treatment or matters of that nature, is there even the genesis of a plan?

Dr. Peter McKenna

It is probably more than just a plan. The person who has kept me most aware of this is Professor Donal Brennan in the Mater, who has obtained funding from the Irish Cancer Society with a view to improving survivorship. The team is not medically based. It is multidisciplinary, including dietetics, physiotherapy, psychological counselling and that sort of thing. He will be looking for co-funding from the HSE in order that this pilot project can be rolled out long-term and for other units as well. It has gone beyond a plan. I would not be aware of this only for the tenacity of Professor Brennan in keeping me informed and looking for funding.

It is people like Donal Brennan who are interfacing with the patients who have survived and who have, perhaps, had their life plans altered. A bit like engaging with patient groups, we have to talk to the people it affects. I imagine that people in the Department and, from our perspective, in here can be very removed from the process.

One has to interface with patients in order to hear what they are saying.

Ms Conroy has indicated she wants to respond to Deputy O'Connell.

Ms Tracey Conroy

We have been talking about survival and as has been mentioned, survival rates for Irish cancer patients continue to improve. Survivorship is a key theme of the national cancer strategy that was approved by Government and launched in 2017 by the Minister for Health, Deputy Harris. The statistics show that in 2016 there were 173,000 people alive in Ireland who have had a cancer diagnosis. That is almost 4% of the population. In developing the cancer strategy, which was done in consultation with cancer patients, we were keen to ensure a focus on this area generally. In August, the Minister launched the National Cancer Survivorship Needs Assessment: Living With and Beyond Cancer in Ireland. That report establishes a baseline assessment of the services available to cancer survivors and it recommends models of care for future development and actions to develop cancer survivorship care across the full spectrum of care required. We are very focused on that. Under the auspices of the cancer strategy, a cancer patient advisory committee has been established. That builds on the work of the cancer forum that developed the strategy. We have 15 members selected to sit on that committee and it meets actively to work on those issues, including survivorship. The Department is strongly focused on the ongoing need for funding of these services, particularly survivorship services across the spectrum of care. There is a lot of work still to be done on that.

Dr. Tony Holohan

While I do not want to take further from Deputy O'Connell's time, I should point out that the Minister will shortly bring proposals to Cabinet for consideration on assisted human reproduction and on the development of a model of care. We have worked with the HSE in the development of same. This is for the full range of assisted human reproduction services to sit alongside the drafting of the legislation. Members will be aware of this as they completed pre-legislative scrutiny of that legislation in July. We will be considering the committee's recommendations as part of the drafting. We hope to have the Bill drafted by the end of quarter 1 and to be in a position to move on the development of the services.

I am fully aware of that through my work on this committee. People often get a quick and unexpected cancer diagnosis. They often then fall foul of interventions such as having their eggs frozen in short order and money is taken from them in a frenzied situation where there is a lack of information. If cancer patients are being supported in this way, it has be structured with clear evidence coming from qualified clinicians as opposed to people who want to make a few euro out of people at their lowest moment.

On the laboratories, we have five laboratories now which are subject to quality assurance visits. It is, therefore, a different picture from what we saw a year or 18 months ago. Is it a completely different picture with regard to custody over slides and governance? I imagine it is far more robust now and it will be much easier to audit if we ever have to audit again. We are no longer trying to find laboratories in Salford, Honolulu or wherever. We know where the laboratories are, that the slides will stay in them and be available to be looked at, and that the quality assurance is up to scratch. Is that fair to say?

Dr. Lorraine Doherty

That is fair to say. We know where all the laboratories are. They are all on the eastern seaboard of the United States. They are all linked in to a common system in Quest Diagnostics. As I alluded to earlier, they have good quality assurance measures in place. Most importantly, we have a close working relationship with them now, including regular meetings, and they are working closely with us every week.

Lorraine Walsh told the committee yesterday that she wants to stop looking back and instead look forward and she wants us to work together. This has been a testing time for many of us on the committee. Our job is to interrogate what went wrong. I know it has been difficult for many of the witnesses and many staff working in the system. I ask them, however, to understand where we are coming from. It is very difficult to explain to the public that the test being provided to women was only 70% accurate. Some women do not think about having a smear test but most do not look forward to it. It is something they do because they have bought into the system. It was very difficult to meet women or families who had lost people. In the information vacuum we had in the immediate aftermath of this crisis, the medical people at the top of the Department - I have the height of respect for Dr. Holohan and Dr. McKenna - should have taken hold of the reins. There are lessons for all of us in this. I am not saying I am blameless either but there should have been better leadership at the top, especially when so much was at stake. We had the roll-out of a large population-based screening programme involving an invasive test for a cancer that is personal to people and has affected many families. It was such a basket case of a situation 18 months ago. I genuinely believe the position has improved, although we could not possibly have gone any further backwards, and we will learn from this experience.

Stephen Teap spoke at our meeting yesterday about the lack of organisation and leadership. The medical person, Dr. Gráinne Flannelly, who has arguably saved more lives than anyone in this room, was the first person to get the chop. Lessons have to be applied from what we have learned today. If I have the privilege of being a Member of these Houses in the next term, I will be disappointed if we ever again come across such a lack of organisation or top-down accountability in the HSE or the Department. It is regrettable for population health that we have ended up where we are today. It is testament to the work of all the witnesses, the laboratories and the patient advocates that we can, as a result of the report from RCOG, say that despite all that has happened, the screening programme has not been pointless or a waste of time and money because women have lived who would ordinarily have died and women have had better outcomes than they would have had if there had not been a screening programme. I thank all the witnesses for their time.

I thank the Deputy. There was no question there so unless the witnesses want-----

There does not have to a question.

I am alerting our witnesses to the fact that they do not have to respond unless they wish to.

Dr. Tony Holohan

I feel tempted to respond to the question on whether we could have done a better job in the leadership of all of this. That is probably true. All I will say, and this is a personal reflection, is that it was a difficult time for everybody. That is not any form of excuse. In the public engagements in the early days of this, there was a concerted effort to do exactly what Deputy O'Connell is reasonably suggesting, namely, to establish and provide clear communications. Good work was done in that regard between the colleges, the HSE and others. It got to a point where communicating in public and doing our jobs in public in the normal way became almost impossible. I am not reflecting on that in terms of us doing our jobs alone, but it impeded our ability to be able to provide the assurance to people who were using the services. That is where the regret is. However, we are a long way down the road, as the Deputy has said, in learning the lessons that come from this. The Minister and many others have made clear publicly that mistakes were made and there are lessons to be learned. Everybody across the board is committed to ensuring the lessons that have been set out for us in the Dr. Scally report and elsewhere will be fully implemented.

It would be remiss of us at this point not to acknowledge that, notwithstanding the difficulties faced by people in this room and in the employment of the service, extreme difficulties were faced by the women affected and their families. We should also acknowledge that. Our last speaker is Deputy Bríd Smith. I am conscious of time because two of the witnesses have to leave to catch a flight.

I thank the witnesses for their contributions. As they will know, the committee heard from Stephen Teap and Lorraine Walsh yesterday. I was particularly struck by Ms Walsh's lack of confidence in the RCOG report. We have had a lot of discussion about the need for confidence in the screening system.

I for one am an advocate of screening. I have taken part in it all my life and I would never undermine the need for it and the recognition that it saves lives. To ask questions is not a mortal sin and, in some ways, the statements that the questioning by others is leading to a lack of confidence are really over-exaggerated. I understand that RCOG has stated that unfounded criticism of its evidence-based report could undermine trust in its findings. The witnesses should probably tell us where that unfounded criticism is coming from. The one critic that I heard here yesterday was Ms Lorraine Walsh. Some people in this room think it is no big deal that in the two most high-profile cases, hers and Vicky Phelan's, the slides were confused-----

Who is Deputy Smith referring to?

I am referring to Deputy O'Connell.

If a charge is going to be made-----

Nobody is making a charge. Hold on for one moment.

Can we de-anonymise the charges please?

We have already discussed this issue, Deputy Smith. The Deputy knows that it is not appropriate for her to make charges against any person who is here. If the Deputy has a charge to make, she should not make it anonymously.

I am not making it anonymously. I am saying that Deputy O'Connell has said that it is not like a lottery that the two slides got mixed up. To say that it is an exaggeration.

That is what Deputy O'Connell said, not what Deputy Smith had inferred.

To intimate that-----

I will allow Deputy O'Connell to respond to that.

We are short on time. To intimate that-----

I am not short on time.

I am sorry, our witnesses are short on time. Could Deputy O'Connell respond and keep it exceptionally brief? I do not think we do anyone any service by continuing this.

I do not think I will dignify it with a response.

Fair enough. I ask Deputy Smith to resume.

I believe that is an extraordinary coincidence that they were mixed up. So does Lorraine Walsh. She has lost confidence in the RCOG report. She also said that she felt that women were not being listened to and she felt bullied by the Department.

We had a session beforehand and agreed that, given the nature of the evidence that was given to us yesterday, we are not going to go down the road of directly addressing the comments that were made because it may identify a person. I have fallen foul of this myself because I missed the earlier session but was briefed by the Chair before I sat in here. As the Deputy knows, it is read out at the beginning of every session that we do not do that at these committees. I ask the Deputy to refrain from mentioning those.

Okay. I will park that. Deputy O'Connell also referred to her colleague, Senator Reilly, who advocated for the introduction of a national screening programme. At the time, he stated:

I understand several laboratories are now accredited, including Beaumont/Rotunda, RCSI, St. James's Hospital through its connection with Antrim and Altnagelvin Hospital, which has looked after the needs of Donegal, Sligo and Leitrim. St. Luke's is also mid-way through the process.

Having pointed out all that, he said: "This call for action obviously fell on deaf ears". He continues to say that instead of addressing this issue and ensuring that our laboratories would be in a position to tender for and successfully provide cytology, there was a rushed and ill-considered decision that has serious consequences for our health service and for the health of our women and further begs the question as to why we sought out partners in the USA. At the time, the unions, professionals, academics and many politicians advocated against the outsourcing of our health service to the USA. Why do all the bodies here think this is not an issue, when they have settlements for several millions in several high-profile cases from laboratories in the USA? Are the bodies here happy with the way those laboratories were run when we knew they were not ISO-accredited, they were processing 100 slides per day compared with an average of 30 to 60 in Irish laboratories, that the standards were lower and all the evidence from Dr. Scally? Why is there not something to look at? The NHS has a document in which it advises on the guidance of applying duty of candour and disclosure for audit results. It states "sometimes it can be hard for screening services to know how to distinguish between a false negative/false positive that has occurred because of the limitations of screening and a false negative/false positive that has occurred because something has gone wrong". I note "something has gone wrong" is written in italics. Something went wrong in the cases of the women with whom the laboratories settled for millions. More cases are coming up. Cases have fallen outside the audit and outside the RCOG report that are now coming to light too. That will go to court and cannot go through this non-adversarial process. Nobody has actually looked at what went wrong. This is a problem and it is very disappointing that RCOG was not able to look at it either. Something has to have gone wrong when one hears evidence that states that Dr. Scally told us that he could not look at the particulars in Lorraine Walsh's case because the laboratory told him it did not have the records.

An answer to a parliamentary question about the missing slides stated that more than 1,700 slides were transferred for the RCOG report. The HSE reported that during the process, a total of 35 slides of women or their next of kin who had consented were not located by the laboratories at the closing date for the slides to be transferred on 7 June. Does that inspire confidence? I am not trying to undermine the process, the screening or the need for it, but does that inspire confidence in laboratories that tell Dr. Scally that they cannot investigate the particulars of very serious and high-profile cases because the evidence is missing and that somehow cannot find 35 slides that should have been part of the RCOG report? As it happens, many of those 35 slides had serious misreadings. My final question to RCOG is, if it had those slides and they had serious misreadings, would that change the outcome of its judgment that what happened here in Ireland is broadly in line with the audit of what happened in Britain? I do not believe it reflects it. I think it would change it and the headline here is that we are broadly in line, in our audit, with what happened under the NHS.

Professor Henry Kitchener

As to whether the fact that 35 slides were missing would have made a material difference to our-----

If they were included.

Professor Henry Kitchener

I do not believe that would have made a material difference. I do not think that those slides as a sample would be qualitatively different from the very large sample that we reviewed. In other words, the ratio of concordant and discordant findings would not have been any different. The Deputy suggested that given all of the cancers that have developed following involvement in the CervicalCheck programme, that is surely a sign that all is not well. I refer back to the fact that, as has been said on multiple occasions today, cervical screening will simply not prevent every case. Each and every one of these cases is of major consequence to the lives of women. In this cohort, a very large proportion of women were caught at a very early stage which, as Deputy O'Connell has indicated, means that women can avoid some of the more unpleasant consequences of, for example, radical treatment. Despite all of that, that does not mean that the programme is not working. Those two matters are not-----

I understand that. Why does the report state that in 159 of these cases, the difference was judged by RCOG to have been a difference that could have represented an opportunity to prevent cancer or to provide a diagnosis at an earlier stage?

Professor Henry Kitchener

We said that because we identified abnormal cells that had not been originally detected either because high-grade cells were found as opposed to low-grade findings in the slide, or the original slide was negative and we found abnormal cells.

We were able to come to the determination that depending on the length of delay that was engendered by the original result, as opposed to what would have happened with the review result, in a specific number of cases it had exerted an impact and that had the RCOG result been available at the time of the original result, a different course of action would probably have taken place, which might have prevented the disease or led to its diagnosis at an earlier stage.

Deputy Michael Harty resumed the Chair.

Does Professor Kitchener agree that the fact the slides were missing from the overall results given could have changed that percentage level, in line with the NHS?

Professor Henry Kitchener

I do not believe that would be the case because=====

Could it have been the case if many of them were found to be discordant?

Professor Henry Kitchener

My initial comment was that there is no reason to believe that the missing slides would be materially different in nature to the large number of slides that were found. I would expect to see similar proportions with discordant results and similar proportions with concordant results. I do not think it would have affected the result. We would have liked every single slide to have been available for review but the fact that some were not would not, I think, have altered our conclusions.

Professor Kitchener's position is that he does not "think" it would have altered the result but he cannot be sure.

Professor Henry Kitchener

I am certain that those missing slides would not have materially affected our conclusions.

Professor Kitchener is certain of that-----

Professor Henry Kitchener

I am.

-----despite that many of them could be seriously discordant.

Professor Henry Kitchener

What I am certain about is that it would not have altered the conclusions of our aggregate report. It may have altered the detailed content of individual letters because it may have allowed us to include that slide in our determination. Would Dr. Walker like to add anything further?

Dr. Patrick Walker

I think Professor Kitchener has summarised it very well.

Does everybody present today - the representatives of the HSE, the Department and RCOG - believe that there have been seriously high settlements in the courts for women who have been failed by these tests, particularly on the part of the US laboratories?

Mr. Damien McCallion

In terms of court settlements, they are obviously outside of our domain. As discussed earlier, we know there is a false negative rate in terms of cervical screening. The issue of negligence and so on is a matter for the courts. We do not get involved in that area. Earlier Dr. Doherty described well the focus there is now on the quality assurance around both laboratories, the Coombe and Quest. We visit both laboratories and we monitor both and we work closely, operationally, with them. There is increased operational management, as well as quality assurance in the laboratories to try to strengthen them going forward. This will continue through to the HPV primary screening.

Would any of the witnesses like to comment on my assertion that nobody is looking into "the something" that went wrong, which is in the guidelines issued by the NHS, which are regularly quoted. Has anybody looked into the "something" that went wrong? I accept the points regarding the limitations of screening, false negatives and false positives but when "something" goes wrong, should not there be an investigation?

Mr. Damien McCallion

Quality assurance will try to identify that in regard to the overall programme in terms of laboratories, not only at laboratory level but at individual screener level in terms of improvement, learning and education. That is part of any good screening programme. The original audit was constructed to examined education and learning opportunities also. In regard to the expert group that we have set up around interval cancers, that is one of the aspects on which it will come back with recommendations. That will be incorporated into the recommendations for implementation going forward. There are a series of steps that are examining quality at a much lower level, including, as I said, at individual screener laboratory in the Coombe and in Quest, which are the two current providers.

I understand Dr. Doherty recently visited the US laboratories. As of now, how many slides per day are reviewed by each cytologist?

Dr. Lorraine Doherty


Currently, as opposed to in the past.

Dr. Lorraine Doherty

The workload is concentrated into five laboratories. The volume of work that comes through each laboratory varies on a daily basis and so I cannot tell the Deputy how many exactly are being reviewed today.

Can Dr. Doherty give me the average number reviewed per day?

Dr. Lorraine Doherty

It is less than 80 per day. We have a list of all of the cytoscreeners involved in the programme. We know exactly what days they were working and we know who is dedicated to Irish work. For example, when we visited the laboratories, we noted that they have established dedicated teams who only screen Irish work and have specific requirements to meet in terms of that work. In the Quest laboratories, there is now great attention to the quality of service it is delivering for the Irish programme.

Is Dr. Doherty happy that they are reviewing the average rather than-----

I apologise for interrupting Deputy Bríd Smith, but I am conscious that Professor Kitchener and Dr. Walker need to leave now to catch a flight back to the UK. I thank them for attending the committee two weeks ago to brief us the report and for being here today to give evidence to the committee, which was very valuable.

Dr. Patrick Walker

We mean no discourtesy to Deputy Smith. I am sorry not to be able to remain until the end of the meeting.

If there are no further questions we will conclude at this point.

May I put a question to Dr. Holohan, please?

We were told yesterday that when one of the women involved in the high profile cases asked Dr. Scally what had happened in the CPL laboratory with regard to her slide, his response was that the laboratory told him that the records had been destroyed and as such, it was not possible to tell her exactly what had happened in her case. Does Dr. Holohan find that shocking? Does it inspire confidence in the laboratories?

Dr. Tony Holohan

I am not aware of the conversation to which the Deputy refers or what exchange of information took place.

I am told I cannot identify people but I am speaking about the woman who appeared before the committee yesterday.

Dr. Tony Holohan

In regard to the laboratories and the findings, I am familiar with Dr. Scally's views as set out in his report. I am not familiar with the conversation to which the Deputy refers.

Does Dr. Scally say in his report that the laboratories refused to, or could not, co-operate?

Dr. Tony Holohan

I cannot recall a part of the report in which he said exactly that. I will have check the report. Is there something specific the Deputy can direct me to?

No. I do not recall him having said that in the report-----

Dr. Tony Holohan

I do not either.

-----but I heard the woman say that he told her that the laboratory could not provide details of her history.

Dr. Tony Holohan

I am not in a position to make any observation on that matter.

Would Dr. Holohan be shocked if that was the case and it was mentioned in Dr. Scally's report?

Dr. Tony Holohan

I will not be drawn one way or the other on what my reaction would be to a conversation I know nothing about.

I was surprised to hear that was the case, in particular as it was not mentioned in Dr. Scally's report.

If the Deputy wishes to do so, she can provide the details of the case and we can forward them to the Department.

It is on record in regard to the committee's meeting yesterday.

We can follow up on a specific case, if the Deputy has details.

The RCOG witnesses have left. There was an assumption that all of the missing slides were discordant but Professor Kitchener stated in one of his responses that it is not known if they were discordant because they are missing. As he is not here to clarify that point, perhaps Dr. Henry would do so. Am I correct that the point he was making is that inclusion of the missing slides would not have had a material effect on the overall aggregate data. I would not like to hear that on the news this evening as fact.

My understanding is that they are not missing, they just were not submitted to RCOG in time for its review.

Dr. Colm Henry

My understanding of what Professor Kitchener said is that he had no reason to believe there would be any difference in the relative proportion of concordant and discordant slides that were missing and, as such, he was certain they would not have made any substantial difference to the aggregate report.

I thank Dr. Henry.

Dr. Tony Holohan

Professor Kitchener made it clear in earlier evidence that it was not a homogeneous group.

Some were missing and some were not submitted. There is a series of different reasons in each of the cases to account for-----

He clarified that the default position was not concordant.

Dr. Tony Holohan

He clarified that, yes.

Confidence is an important issue that we have to look at from two perspectives. The confidence of patients, victims and their families has been seriously dented, which is absolutely understandable. If it had not been affected, it would not be a normal reaction at all. We have to take on board what we have been told after thorough investigation, particularly in view of all the medical expertise that is available to us. Do the HSE and Department of Health have confidence in the RCOG report?

Dr. Tony Holohan


Dr. Peter McKenna

I do not think it is illogical or incompatible to be able to express the deepest possible sympathy to the patients who have concerns about the report but at the same time to also be able to express very deep confidence in the report of the RCOG that has been submitted. In the future, the RCOG report will be regarded as a milestone. It will be referenced for many years to come. It is direct and very helpful. I hope it will be part of the epitaph of what has been a very cathartic situation for the screening service.

I thank Dr. McKenna. On behalf of the committee, I thank our guests, Dr. Glynn, Dr. Holohan, Ms Conroy and Ms O'Callaghan from the Department of Health and Mr. McCallion, Dr. Henry, Ms Fitzgerald, Dr. Doherty and, last but not least, Dr. McKenna from the HSE. I wish everyone a happy Christmas and a healthy new year.

The joint committee adjourned at 1.12 p.m. until 9 a.m. on Wednesday, 22 January 2019.