I call on the Minister to make his opening contribution under Standing Order 45 and he has ten minutes.
Scoping Inquiry into the Cervical Check Screening Programme: Statements
Last week, I published the report of the scoping inquiry into the CervicalCheck programme and today I welcome the opportunity to speak about the issues at its very core. I want to acknowledge again on the record of this House the extraordinary contribution of Vicky Phelan as well as Stephen Teap and Lorraine Walsh and the other women and families impacted by the CervicalCheck audit.
Dr. Scally is clear that this crisis happened because of a failed attempt to disclose the results of a retrospective audit to women who had developed cervical cancer. There was significant public disquiet when it became clear that women themselves were not told about reviews of their own past screening history. The failure to disclose was absolutely wrong and I recognise the severe and real distress it caused to women and their families.
As is often the case with complex issues, some of the complexity was not fully reflected in the public discourse. I think it is fair to say there were people who believed women had not been told they had cancer - that assertion was made in this House - and people who believed that a diagnosis of cervical cancer in a woman who had been screened as negative was automatically negligence. Thanks to Dr Scally’s report, there is a greater understanding now of the complexities involved.
He has provided welcome reassurance on the quality of CervicalCheck laboratories. He has found no evidence of any cover-up - his words - and, most importantly, he has crystallised what this is about. It is about women and their families who did not get the information they should have got and the devastating impact that it had on them. It is about unreservedly recognising that people have a right to their own medical information. It is about ensuring that our systems work and acknowledging that they completely did not work in this case. It is also about the impact of this disease at a human level and the need to do all we can to prevent it. Collectively, we should endeavour to effectively eradicate cervical cancer.
The report is the culmination of intensive work by Dr. Scally and his team done quickly and under intense scrutiny, for which I thank him sincerely. It is robust and comprehensive and it will help ensure that women can trust that our cervical screening programme is safe, effective and patient-centred.
I particularly want to extend my gratitude to the women and families who engaged with Dr. Scally. I do not underestimate how difficult this must have been. I thank them for their courage and commitment in ensuring that our cervical screening programme is improved. I was struck by a comment that was said to me many times by many of the women who had been impacted, namely, that the one thing they wanted to come out of this was a better screening programme, that lessons would be learned and that they were doing it for their daughters, granddaughters and sisters to make sure we have a screening programme that is robust and saves lives. Their generosity in how they engaged is something for which we should all be extremely grateful.
Dr. Scally's reports sets out the enormous impact this situation has had on those affected. Through my own interactions with them, I have gained some sense of the distress and pain that has been caused. He has made a number of key recommendations in regard to disclosure, which I intend to implement in full.
I intend as a priority to establish a new independent patient safety council that will, as its first take, carry out a detailed review of the existing policy on open disclosure. The resulting policy will have legislative underpinning and will operate right across the whole health service.
The establishment of a statutory duty of candour is a further key requirement. The patient safety Bill is scheduled to undergo pre-legislative scrutiny on 26 September and I ask Deputies on all sides of the House to prioritise the scrutiny of this vital legislation because it provides a legislative framework for a number of important patient safety issues, including mandatory open disclosure of serious patient safety incidents.
While these are key steps, disclosure is also about core values such as openness and honesty, and trust and confidence in doctors. This report presents a challenge to the medical profession but I believe the majority of doctors and the profession in general holds these values very dear in the care they provide. I also believe the dedication and commitment of the entire range of health professions, including doctors, is one of the key assets of our health service. I want to see constructive engagement on the part of the medical profession with these issues. There were failings on behalf of their profession and they must be addressed by them.
I want to be clear that the Government is committed to the continuation of the CervicalCheck programme, as well as BreastCheck and BowelScreen. We know that screening saves lives, and Dr. Scally has emphasised this. Crucially, he found no reason the existing contracts for the laboratory services should not continue until the new HPV regime is introduced. He is satisfied with the quality management processes in the laboratories, contrary to some information put on the record of this House by others in the past, and the report presents no evidence that the rates of discordant smear reporting or the performance of the programme fell below what is expected. He emphasises the very substantial contribution that CervicalCheck has made to women’s health over the ten years of the programme, and I know that has been acknowledged by Deputy Alan Kelly and others in this House. A woman’s lifetime risk of developing cervical cancer has substantially reduced since the inception of the screening programme, from one in 96 in 2007, to a one in 135 in 2015.
Dr. Scally also considers that the work which has been carried out by staff in the programme to keep the screening service operating in the middle of what was a very intense controversy is worthy of recognition. I want to thank the staff for that as well.
I do not downplay in any way the very serious gaps that have been identified in the governance structures of our screening services, but I want to emphasise that Dr. Scally has stated in unequivocal terms that he had found no evidence of conspiracy, corruption or a cover-up - his words. This speaks to the integrity of our public and civil servants. Some of the things that were said in the heat of this controversy questioned the integrity of some of those public servants in leadership positions and, I think, after an independent report makes a finding on that, it is important we acknowledge the actual position on the record of this House, as outlined by the independent expert that we as an Oireachtas put in place to establish the facts.
The report examined the provision of briefing notes on screening audit and disclosure to my Department in 2016. These came into the public domain in May. I welcome the clarity provided - the inquiry considers that it would have been unreasonable to expect senior management in the HSE or, even more so, departmental officials to have intervened on foot of these notes. That is a finding of the inquiry. Subsequent problems were significantly associated with the failure to disclose, the report says, and it would have been difficult to predict this given the reassurance the briefing notes provided. As we have limited time, I will not quote from the report but they are there in the relevant sections.
Dr. Scally has based his findings on careful examination of contemporaneous records. He has had more than 12,800 records. I fully accept his conclusions in this regard and it clear that my officials and my Department acted entirely appropriately.
Dr. Scally has been clear that the problems he has uncovered are systematic and relevant to a whole system failure, and I believe a whole system failure requires a whole system response. I have already taken steps to re-establish a board for the HSE, appointing a chair designate yesterday. This provides a foundation for proper governance and accountability.
I intend to bring the Health Service Executive (Governance) Bill 2018, through the Houses of the Oireachtas during this session with a view to establishing the board this year. A priority issue for the new board will and must be the development and implementation of an effective performance management and accountability system in the HSE.
We are aware that screening alone is not enough to prevent all cervical cancers, but a well-organised screening programme, when combined with HPV vaccination for boys and girls, can bring us very close to eliminating this disease. That is the Government’s goal and that is the Oireachtas' goal. I do not intend to play party politics with this issue. It is supported by politicians from all political parties in this House. We now need to get on and do it. We have a vaccination that can save lives. It can prevent girls getting cancer and can prevent girls dying from cancer. We all need to support that unequivocally. I am very pleased that the House supported Deputy Kelly's motion to extend the HPV vaccination to boys. We need to extend the vaccination to boys once we receive the HIQA health technology assessment in the coming days. We should look to extend it next year.
I have given approval to a switch to HPV testing as the primary cervical screening test, and work is under way to progress this change. This is vital. We know that of 1,000 women who will be screened, 20 will have pre-cancerous cells. Screening today will pick up 15 of those 20 women but when we move to HPV testing it will pick up 18 of those 20. There will still be limitations to screening, but sadly there will always be limitations to screening. We can, however, have an even more accurate system and, along with a small number of other countries, Ireland can lead the way as we move to HPV testing.
I want to be very clear that the Government accepts in full all 50 recommendations in this report. I expect to return to Government in three months with a full implementation plan. In June I established the CervicalCheck steering committee, chaired by the Chief Medical Officer and the assistant secretary of acute care in my Department. Crucially, the committee includes representatives of the affected women and their families. I thank them for their generous and constructive contribution to that work. The committee meets weekly and we publish its minutes, its agendas and its weekly report on my Department's website. It will oversee and direct the implementation of all 50 recommendations, and my Department has established a working group to drive the work of those recommendations. I have written to each of the organisations mentioned in the report about preparations for implementation. Through the Chief Medical Officer, I have also commenced engagement with the leadership of the medical profession, which is very important. An initial meeting in this regard took place earlier today, and I intend to meet them shortly, along with the Medical Council.
The first step I wish to take, which I believe is the most appropriate, is to meet patients and their families, and I look forward to this happening next week. I will then engage with the Opposition on what needs further inquiry and what is the best modality in which to do that. I do not believe we should make knee-jerk decisions on this. I want to try to reach a consensus in this House, but most importantly with the patients also, on how best to move forward.
Dr. Scally has reached a view on a commission of investigation and we should consider that view and explore it together over the next number of weeks. The Government’s priority is equally with the women and families as well as with ensuring that our cervical screening programme is as good as it can be. Dr. Scally has given us the framework to fix the very many flaws he has identified. Our focus must now be on implementation. If we want to learn the lessons and if we want to fulfil Vicky Phelan's request that some good comes from this awful tragedy, we need to deliver on these recommendations. I look forward to working with each and every Member to make that a reality.
On behalf of Fianna Fáil I welcome the comprehensive report by Dr. Scally. It is fair to say that it is a more comprehensive report than many of us thought it might be, including those of us who agreed the terms of reference. Dr. Scally and his team deserve huge credit for very robust and professional work done in a pretty short period.
This came about because of the bravery of some extraordinary people, including Vicky Phelan, Emma Mhic Mhathúna and Stephen Teap. The types of improvements we hope to see are entirely down to their bravery in standing up and in not being forced and bullied into signing non-disclosure agreements by third parties, so I acknowledge the work they did and the role they played. I am particularly happy to see that Dr. Scally recorded the testimonies of the women and their families. This is something there is not enough of and we need to reflect on the fact that testimony is vital. It is vital in areas such as institutional abuse, it was vital in this area on non-disclosure and we all heard some of the testimony. It brought to life the types of challenges these women and families have been dealing with.
Fianna Fáil supports all 50 recommendations. We will work as hard as we can with the Government to see those recommendations implemented as soon as possible. In doing so, however, we have to see a step change in how things are implemented in all aspects of CervicalCheck. In spite of the fact that the Government was briefed on this and told that it was going to blow up in public, it was still allowed to blow up in public, which created widespread fear.
The Government promised these women an awful lot of supports, some of which are still not in place. Huge frustration and struggle has been endured by these woman and their families because the supports were not put in place when they were told they would be. The women were told by the Taoiseach and by the Minister that they would never have to go back to court. I raised this in the House with the Tánaiste, and on the morning I raised it, Emma Mhic Mhathúna was back in court. Since the promise had been made, this was her fourth time in court. Even last week we saw it. I understood that the women and their families were promised they would be briefed before the report was published. I found that I and other Members of the House were being briefed and a very small number of the 221 affected women were briefed. The women and the families together should have been briefed by Dr. Scally before anyone in this House or the media and before publication, but this did not happen. I am not saying this to the Minister for Health, Deputy Harris, to score political points. I say it because I do not believe the implementation has been there. I have cited real examples of where I believe the Government has dropped the ball with regard to these women. We will work with the Government, and we want to work with it, but we have to start delivering on time and according to the promises that were made.
I will turn now to the commission of inquiry. We would like to see the women and the families listened to. This whole thing comes back to other people deciding what the women should or should not be told about their own health. Once given time to reflect on the recommendations in the report, let us listen to the women. I would like to see face-to-face briefings, for any of the women who want them, with Dr. Scally and his team. Let us listen to the questions they still have after reading the report. Let us talk about the different options for getting those answers. Whatever the women and their families want to do, let us do that, regardless of whether we think it is the right method. Let us for once do just what they want and put them at the centre of this.
The medical community needs to reflect on some of these issues, as do the Members. If we can implement these recommendations, not just for CervicalCheck but across the HSE, we would see a lot of improvements in governance, patient safety, patient voices and clinical voices in the future.
In the two and half years I have been in this House we have spent quite a lot of time discussing female gynaecological issues. I believe that the women of this State are fed up with the failures of our health system to serve their interests and needs. When this scandal broke there was widespread fear and panic across the country. Every woman who had been through the screening progress woke up that day wondering if her tests were okay and if she was okay. I rang the helpline but it was most unhelpful. The person to whom I spoke did not offer me any sort of consolation or direction. By the time I got through, I felt quite frustrated with the process.
It seems that our labs and our screening process are okay and up to good standards. What is not okay is that while going through the screening process, it is not clear that when one receives a result, it may not be accurate. We need to work on that. There was an adversarial approach taken towards women who went through this process. It is frightening to think that we almost did not know about this issue. We came very close to never learning about the withholding of information from these women and the difficulties in our processes.
We now need to restore confidence rapidly in the screening programme. The Minister's response at the outset was lacking. It was not a rapid or adequate response and it allowed the problem to get worse. The screening programme saves lives so we need to restore confidence in it. We need to educate people properly about what a screening programme entails and that if a woman has symptoms in between her smear tests, she must go to her GP. A woman may have received a result that said she was fine, and she thought she was fine, but may have ignored possible symptoms. We have to learn from this to ensure it does not happen again.
Fianna Fáil welcomes the final publication of the Scally report and urges the swift implementation of its 50 recommendations. The report is a truly shocking indictment of a key public health service.
Public confidence in the CervicalCheck system has been shaken. The trust thousands of women had placed in the system has been breached. From the perspective of a woman, mother, daughter and sister, I felt disappointed and let down by the system in which every other woman and I had put our trust. Thank God for Vicky Phelan, that courageous and amazing woman. Many thanks to Stephen Teap who lost his wife, the mother of his two boys. That family's life for the past few years must have been a nightmare. What about the bravery of Emma Mhic Mhathúna who is living with terminal cancer? Imagine her having to turn to her five children and asking where they would like to live after she dies. I cannot even imagine what that must have been like.
Patients cannot be left in the dark again. The priority is to listen to the women involved and see what their preferred choice is regarding a commission of investigation.
Some of the testimonies we heard about how a number of women were spoken to by their consultants were shocking. I hope no woman in Ireland will ever again be spoken to in that way. Imagine telling a woman who had just asked about how she would be informed to watch the news. It is disgusting.
Recently I read that it was a wonder that women did not spontaneously combust with rage on a regular basis. It sometimes feel like all we do is discover another failure by the State to take care of our health, children, right to equal pay, right to a fair pension and right to bodily autonomy. The voices expressed in the Scally report made me furious about how those women had been treated and kept in the dark by a paternalistic and misogynistic health system. I was furious about how many of them had been spoken to when the bad news was eventually broken to them. I was furious that the trust they had placed in the health system had been so grievously breached. A total of 206 women, with families and loved ones, missed out on earlier interventions. Lest we ever forget, 18 of those women have since died.
The report is a shocking indictment of the mismanagement of a public health system that is vital for women's health. It indicates that the system was doomed to failure and that the policy and practice of open disclosure were deeply inadequate. Are we ever going to listen to women's voices? If not for women like Vicky Phelan and her determination to bring this scandal to light, how many women would still be in the dark about a cancer diagnosis? How many men like Stephen Teap would not be facing life as a widowed father? It should be these women's voices who decide about the commission of inquiry. It is no longer acceptable for decisions to be made on their behalf, as they have lost their trust in the system. The report's recommendations must be implemented as quickly as possible and women must never again be left in the dark about their health. The Medical Council's code of ethics states patients are entitled to honest, open and prompt communication. We can only hope young women will not be failed as their mothers have been.
I will be sharing my time with Deputies Mary Lou McDonald and David Cullinane.
Agreed.
Despite what we are discussing, I urge women to engage with the screening programme and have smear tests. Without a doubt, screening saves lives. We must never lose an opportunity to remind women that, notwithstanding what they are reading in the press, they should engage with the service.
The events of the past few months in what we now call the CervicalCheck scandal form another difficult period in the history of women's health in this state. It has been a difficult time for the health service, as well as for those who work hard within it and try to do a good job. Sometimes, it must feel like they are trying to swim backwards against the tide, as they are working hard, but the system is letting them down.
There were many strands to the events that led to the Scally report. The report covers many of them in great detail. I the opportunity to thank Dr. Scally and his team. I join others in thanking those women who were affected and contributed to the report. Their evidence and testimony were invaluable to this process, as well as to the final report's conclusions.
The report outlines that the women affected wanted to see a screening programme that would deliver a patient-centred service and put the rights of women at its centre. Patient-centred care and the upholding of patients' rights are what we expect from health services. The women came back repeatedly to the issue of how their own medical histories had been withheld from them and that doctors knew information about them but did not tell them. Why was it withheld? Dr. Scally is clear, in that there was a degree of misogyny. I hope doctors will read that point and reflect on their role, as well as on the way in which they speak to women.
I have addressed in the House issues related to women's healthcare. I have spoken to the Minister many times about mesh implants and sodium valproate. We know that there are issues with the delivery of women's healthcare by the health service that must be addressed.
The doctors operated a hands-off policy. The literature pointed out that screening was not 100% effective and they knew that figure. They just did not bother to tell the women.
Dr. Scally has done a good job. As the Minister stated, he has given us a framework. However, the work is not finished, as Dr. Scally acknowledged when we spoke to him. Many more questions remain. If we need a commission of investigation to get to the bottom of them, we should have one. Women are still being dragged through the courts and let down. Information is still being leaked to the media. All of the things we said could not and should not happen are still happening. This has to stop. The only way to stop it is with accountability.
Táim buíoch as an deis labhairt ar an ábhar tábhachtach seo um thráthnóna. I welcome the publication of the Scally report. We would all like to know who leaked it. The Minister might shed some light on that matter.
I would like to know, too.
Screening saves lives. In the course of this debacle, our debate and everything that flows from them, let us be clear - any woman listening who is concerned should have a smear test. It may well save her life; it has saved others.
It is welcome that the Minister has accepted all of the recommendations made. He shares a view about having them implemented. We look forward to working with him in that regard.
The report makes difficult reading, not least because it is empathetic in reflecting the views and experiences of women, including the gross disrespect shown to them. The Minister has made the point that no evidence of a cover-up or conspiracy was unveiled, but he will agree that a finding of institutional misogyny is a damning reflection on the system-----
Yes.
-----and may, in and of itself, beg for further investigation and a commission.
The default position of the State apparatus when it became clear that problems had arisen in a screening system that was, of course, not 100% effective - there are very few 100% figures in life - was to deny, obfuscate and leave women in the dark. I commend Vicky Phelan, Emma Mhic Mhathúna, Ruth Morrissey, Lorraine Walsh and Stephen Teap. They are victims. More to the point, they are an inspiration for us all.
Dr. Scally has made an open and shut case for the necessity to provide for mandatory open disclosure. That debate is over. For anyone who doubted it, the report puts the matter to bed.
Dr. Scally has made positive soundings which we must welcome about quality assurance.
He points to the 80% positive predictive value in the laboratories. He makes the point that it is not stellar but it is more than within acceptable boundaries. He also raises very worrying insights into quality assurance, with the theme in the report of cost efficiency outstripping other considerations. He criticised the efficacy of quality assurance visits, which were very thin on the ground. I am struck by the fact that even though the contract between the screening service and the laboratories allowed for a number of mechanisms where difficulties arose, including a Health Information and Quality Authority, HIQA, type investigation on quality matters, that never happened. I am not raising the issue of quality to cause distress and certainly not to cause panic or to dissuade anyone from availing of the service and having a smear. I want to place on record that while we have a general reassurance in the report about issues of quality, these beg further investigation in order that we will learn from them. Ultimately, open disclosure and treating women as autonomous adult individuals entitled to our medical information is an absolute must. So too is robust quality assurance.
Many questions arise in this report. I know the Joint Committee on Health and other committees will address this. I hope the Minister has a keen eye for that and may even consider a HIQA intervention for the inspection of those laboratories. That would be worthy of his consideration.
I welcome the publication of the Scally report. There is universal acceptance that Dr. Scally has done a good job in the timeframe given to him and with the terms of reference that governed his work. He admits that he was unable to establish the full facts and the truth in many areas because of a lack of time, access to information and so on. An awful lot more work needs to be done to establish the full facts and the truth. If that means a commission of investigation, that should happen. Let there be no doubt about that.
What Dr. Scally uncovered has raised serious questions about the Department of Health, the HSE and CervicalCheck with regard to systems, practices and procedure failures. We know from the report that one of the company laboratories, CPL, outsourced part of its work to four laboratories that were not accredited or certified to the standards demanded by CervicalCheck. The problem is that Dr. Scally says in his report that CervicalCheck knew of that, yet did not take the appropriate action. Dr. Scally asks a number of questions on page 56 of his report. He asks what volume of CervicalCheck tests was performed in each of these four laboratories, what their compliance with quality and standards was, if CPL informed CervicalCheck of workload being transferred to other sites and whether such transfers were approved. He asks questions that he cannot answer in his report. It is incredible that that is the case. On outsourcing of contracts, there were questions about rolling over of tenders and procurement which I am sure the Committee of Public Accounts will examine.
Dr. Scally was damning about the non-disclosure issue. That is important because we cannot explain all of this away as simple systems failures. Some of this happened by design with individuals taking decisions to withhold information from women. I am not about witch-hunts or looking for people's heads for the sake of it but surely people must be held to account for this. We have had this far too often and seen it in many areas, not just health but across the public service. When failures occur, the wagons are circled and they are explained away as simple systems failures when individuals made very bad decisions and need to be held to account. One way to do that is through a commission of investigation. I hope the Minister will be able to say that it is still on the table and something the Government could and will support.
I will not be able to cover one quarter of the issues I want to talk about in ten minutes. We could have written the first page of the Scally report. It refers to systemic system failure. We all knew that. I am a member of the Joint Committee on Health and the Committee of Public Accounts. Systemic system failures happen because people either make or do not make decisions. Human enterprise is involved. This is not something that happens from on high and we have to find out why it happened. Who made or did not make decisions and who acted in certain ways such that we ended up where we are today? If not for the bravery of Vicky Phelan, we would not be talking about this today. It is incredible and I want to acknowledge her, Stephen Teap, Lorraine Walsh and everyone else. I have spoken to many people on this, many of whom do not want to be named.
I welcome the Scally report and having spoken to Dr. Scally on a number of occasions since its publication, I welcome his frankness. This was a scoping inquiry, not a full report. It is nowhere near being one because the issues are too large and it is not of that scale. It is limited but it is excellent in its findings. The 50 recommendations of the report are the priority for all of us in this House. Everything else is secondary. The 50 recommendations have to be implemented. The move to the HPV vaccine is a priority. The Minister needs to resource the laboratories and the personnel to be able to implement that. He must also implement the resolution that I and my Labour Party colleagues passed in the Dáil to extend vaccination to boys to create herd immunity.
Non-disclosure will be dealt with and has to be a priority. Loss of trust between clinicians and their patients has been spoken about an awful lot. I do not want to dwell on it except to say it was enlightening. It is something on which the medical profession and many different medical representative bodies need to reflect, not just in this area but in a number of other areas too. Many of these clinicians met during this process. This was not known to the public until we pulled out the minutes of colposcopists' meetings that took place in the middle of this crisis. That needs to be investigated. Clinicians were aware that there was a serious issue but there was no urgency. We need to find out why that was the case.
There are structural issues with the HSE. As I stated, this happened because people made or did not make decisions. It has gone beyond a matter of debate that we will have some form of inquiry or investigation. Any investigation should be short, must not get in the way of recommendations and should have tight terms of reference. We need to find out who did what, when, where, why and how with regard to the HSE CervicalCheck and possibly the Minister's Department.
There is a jigsaw for where we are going with regard to cervical cancer. The priorities are the recommendations, HPV, and herd immunity and extending vaccination to boys. That is one component. The second is the review of the slides by the Royal College of Obstetricians and Gynaecologists, which is critical. The third relates to Mr. Justice Meenan's work. I hold the Taoiseach, not the Minister, accountable for this. On more than one occasion, the Taoiseach did not know what he was talking about. He did not know what he was talking about on "Six One News" when he said that the women affected would not have to go through the courts, the laboratories would be chased and they would settle with the women. He was wrong and I knew the second he spoke that he was wrong. He subsequently met Vicky Phelan.
Mr. Justice Meenan's work has two components. The broader component is due in a number of months but his first findings will be in a couple of weeks. I do not believe the judge can achieve a great deal other than making recommendations, which means the Taoiseach has overpromised a second time. I find it almost impossible to envisage a scenario in which women will not end up in the courts again and that is disgraceful. Please bring that message back to the Taoiseach.
The fourth component of the jigsaw is what we need to discuss in the coming weeks as regards investigating who did what, when, where and how in the HSE and other organisations, the issues related to a forum to deal with what clinicians did or did not do and, in particular, the manner in which they behaved. In addition, there are elements related to how contracts were managed with the laboratories.
I am delighted with what Dr. Scally said about the laboratories. I dare say it helps the Minister and all of us in this country in ensuring we have a screening programme. We must all behave responsibly in the future in order to have a screening programme. I welcome that, but we need to ensure there will be an investigation into how the contracts were managed, or not. I will come back to that point.
Before I speak about the laboratories, I wish to deal with one other matter, namely, the commentary over the summer on the purpose of some of the work being done by many of those affected in this country. It almost amounted to revisionism. The view was that their pursuit of justice and their legal rights was, in some way, damaging the future of screening. That insinuation was wrong and affected people who had ensured the matter became public in the first place. As far as I am concerned, such revisionism should be avoided. I know Vicky Phelan, Stephen Teap and Lorraine Walsh and their number one priority is not self-interest. They have families or, in the case of Lorraine, she does not because of what happened. Their number one priority is ensuring screening is available for future generations, my children and everyone else's.
I welcome what the Scally report states about the laboratories, but I have some questions. I am concerned about the manner in which the contracts were managed by the HSE. The laissez-faire manner in which the contracts were managed by the HSE must be investigated. We know of 221 cases. There are accepted errors in some cases. We all know that negligence must be proved, but in some cases we know what happened. Has CervicalCheck or the HSE investigated what happened in these cases? It is such a simple question, but it is so obvious that it does not occur to people. We know of cases, as they are public. As of today, have they been investigated? In any scenario where a public body has such issues, surely it looks at its contracts and investigates what happened in each and every case? Surely, it looks for patterns and examines every detail. I deliberately raise these questions with the Minister.
The new information provided in the Scally report on CPL and outsourcing to other laboratories across the United States is very welcome. No provision was made for this. How did the HSE or CervicalCheck not know it? Who was monitoring the position? Who was not doing his or her job? That is not acceptable. We have had scenarios where the CervicalCheck service was in operation, contracts were in place and we now know outsourcing took place about which CervicalCheck did not know. We now know that there were errors and issuing about how women were dealt with. I am still not sure who in the HSE has been investigating that matter, who has gone through the contracts and whose job it was to look at the contracts and ensure there was quality assurance because there was not. That is a component of an investigation, with who did what, where and when in the HSE, in addition to the other issues I identified. We will need some inquiry to be agreed to. It should be agreed to in the next two weeks consequent on the Minister, me and others meeting patient advocates and those who have been the victims, to whom reference has been made.
I wish to share time with Deputy Ruth Coppinger.
Is that agreed? Agreed.
I wish to start by stating something obvious. I am not being smart, but I hope it is obvious that I am a woman, that I have access to CervicalCheck services and that I support the screening programme. I have received a lot of criticism for scaremongering. I am not scaremongering; rather, I am querying why the outsourcing issue has not been properly addressed. Privatisation and outsourcing are at the core of the crisis women face in this country.
Yesterday I attended a protest outside the gates of Leinster House with a busload of women from Cork whose organisation was called Women's Lives Matter. A number of women in the group had been misdiagnosed and had false negatives returned. They were very upset that they had not been told properly by the clinicians. They were also very upset at the scandal concerning disclosure, but most of all they were extremely upset that their lives and future ability to have children had been jeopardised by outsourcing. They demand the repatriation of the service.
The Scally report shows that there was a deep problem with outsourcing, even though Dr. Scally himself said to me that he did not have a problem with the continued outsourcing of the test to the US laboratories. He said that if he was a woman, he would have faith in Quest Diagnostics. I refer to his report to indicate why I believe it shows that there was always a problem with outsourcing. First, the US laboratories were not ISO accredited. I tabled two parliamentary questions to the Minister for Health in May and he said they were accredited. It may be the case that they were ISO accredited in May 2018, but they were not ISO accredited when the contracts were awarded and renewed from 2008 onwards. That is a fact.
There are different standards in the US laboratories than there are in ISO accredited laboratories. US laboratories perform 100 screens a day, whereas generally the accepted norm and standard in Irish public laboratories is 60 a day. There is a big difference already, one that could jeopardise the scrutiny of the tests. Irish laboratories have screeners who are educated to degree level and often go on to undertake postgraduate studies in cervical screening. They are overseen by clinical pathologists, which is not the case in the US laboratories. According to Dr. Scally, the cost of the service in the tender from the State to the US laboratories was overemphasised. The Irish laboratories scored very highly when they tendered, except for costs. They were not as cheap as the US laboratories. CPL, the company that settled with Vicky Phelan, was found to have problems on the site in 2011 that were not adequately addressed, yet we still awarded it another contract in 2012. We may never know why and how that happened because we discovered from Dr. Scally’s report that the tender documents had been destroyed in 2017. Will the Minister, please, explain why that would happen? I worked in the public sector, in the library service, and we had to keep a record for years and years of every penny that came into or went out of the library, even though libraries do not normally handle money. Why would the tender documents have been destroyed?
Outsourcing is at the heart of the issue. I have asked the Minister twice about it. I asked Mr. Tony O'Brien when he was in situ as director of the HSE. I asked the Tánaiste here one day and the Minister for Finance who had replaced the Tánaiste one day during Leaders' Questions if he could, please, tell us the laboratories from which the 221 false negatives had come. I was assured I would receive the information. I asked the clinical professionals if it was difficult to find out. They replied absolutely not because each slide had its own identity and as soon as a problem was triggered, the first thing that would have to happen was an audit at the point where the slide had originally been tested. The audit has to happen in the laboratory from where the slide came. Could we, please, get a simple answer to the question of from where the 221 false negative slides came? I believe that is at the heart of the matter.
The definition of outsourcing and the privatisation of women's health are at the core of this problem. The reason I raise the issue is the Minister is about to sign off on, if he has not already done so, the continued outsourcing of the service to Quest Diagnostics and MedLab Pathology, a subsidiary of CPL.
Is that not the definition of insanity - doing the same thing over and over again but expecting a different result?
It is a recommendation of the Scally report.
I ask the Minister to address that issue, please, because I am worried about the future of the service as well as its past.
Many people found it highly ironic that at a time when the country was voting in the referendum on the eighth amendment and many Members were campaigning to put women at the centre of their own lives and healthcare, the Government was ensnared in a scandal which involved women's health and views being utterly diminished. It has been confirmed in the report that paternalism ran and runs through women's medical care. Medical misogyny is a term that has been used in that regard. Doing medicine on the cheap is another term I would use because the Minister has stated that he is satisfied with the quality management of the labs and that that was confirmed by the report.
That is what the report states.
That is not confirmed by the report.
It is.
The central issue is the testing service that led to the errors in the first place. It is not true that the labs were given a clean bill of health.
I wish to mention a group which came up from Cork yesterday, Women's Lives Matter. It had a petition with 1,200 signatures and its members wanted to meet the Minister. I know that is not always possible but they were disappointed that they could not do so having travelled from Cork. They asked if the Minister will meet them. Those women have been affected by this scandal and I think the Minister should agree to meet them because their ultimate request is that the testing not be outsourced to companies in other time zones but rather be conducted in the not-for-profit public health system in this country where multidisciplinary teams can confer on issues.
Ten minutes' speaking time per group is not enough to discuss this issue properly. It is unfortunate and very frustrating. Having read the report, there are many points I wish to make but will not have time to do so.
The allocation of time was not my decision.
More time should have been allocated. This is the biggest issue of recent months.
Agreed.
I will have to cut my contribution short but there are important issues that need to be thrashed out. I wish to mention Vicky, Stephen, Emma, Lorraine, Ruth and many others who never wanted to be household names but now are for all the wrong reasons. They have made a great difference and I acknowledge that.
On the laboratories, chapter 6 of the report outlines that the US-based labs, Quest Diagnostics and Clinical Pathological Laboratories, CPL, never held the required international accreditation. There were two levels of accreditation and many of the labs did not hold the international standard. CPL, which is owned by Sonic Healthcare, examined 300,000 Irish samples, but one third of those were outsourced to other labs, with the tests being carried out in places such as Honolulu, Las Vegas, Victoria and San Antonio, without the knowledge of CervicalCheck. How can the Minister claim that everything is hunky-dory in the labs?
I did not say that.
In the report, Dr. Scally also examines the nature of the testing, how many tests were carried out and the compliance of the labs with quality and regulatory standards. This is of current relevance because Sonic Healthcare is the mother company of MedLab Pathology, which is proposing the outsourcing of testing of Irish samples to Australia. In terms of quality assurance and the visits that were made, it is true that Dr. Scally states that the labs met the standards for the country or region in which they were located but they were not up to international standard. The local standards varied depending on location. CPL was asked about its standards in 2011, but Dr. Scally states that there is no record of what happened when errors were identified in regard to the under-reporting of low-level cervical cancers, which is very dangerous because those cancers might develop further. Consistent error by a pathologist responsible for training others was identified but nothing was done. No consideration was given to the wider impact of that on the training of other staff.
Another issue is the fiddling of figures by Quest in 2014. Some 1,224 false negatives were identified. I will have to rush through these figures as I am running out of time. Quest claimed an error rate of 3.19% but the Scally report identified the rate as 17.6%. This may be explained by labs in different countries with differing testing and definitions of abnormality being used.
Cost is another major issue. Why did costs become an increasingly relevant consideration in contracts being awarded? In 2008, it made up 20% of the criteria but by 2010 it was 35% and by 2012 it was 40%. The country was in a bailout programme, things had to be cut and cost became far more important. Does the Minister claim that that would not impact on the testing of women's samples? In 2016, there were mini-competitions in which cost accounted for 80% of the criteria. This is doing medicine on the cheap.
Quest Diagnostics has generated profits of €7.7 billion and Sonic Healthcare had net revenue of €3.5 billion. The testing should be carried out in the public health system in this country. It is not fair or right to say that there is no issue arising from the report.
I did not say that.
Further investigation of these issues is needed.
I welcome the opportunity to participate in this debate. I echo the comments that the time allocated to it is very short. I have read all 170 pages of the report and it would be helpful if Members had more time to go into its details.
I welcome the comprehensive report and the blunt, clear language of Dr. Scally. He overstepped his brief, however, when he said we do not need a commission of inquiry. That was not for him to say. I checked the terms of reference and do not think he was asked to give an opinion on that. That was one mistake. He was asked to scope the issues and the questions that arise from this scandal.
I am not a Member of this Dáil to reassure women that they should have cervical smear tests or any other test. That is not my job. My job is to ensure that we have an open and accountable system which instills confidence in women and allows them to make up their own minds. That is what was and is sorely lacking in this matter. It is the responsibility of this House to ensure that confidence is engendered by having open and accountable systems rather than on the reassurance of Members. I will leave it to women to decide what they wish to do based on the information available to them in an open and accountable manner.
The report raises serious issues. As has every speaker, I thank Vicky Phelan, without whom we would not be discussing this today. I also thank Dr. Scally and his team for meeting women affected by the scandal throughout the country and abroad. He met 67 women and their supporters in my city, Galway, 130 in Dublin and 60 in Cork. He examined more than 12,500 documents. On occasion, he had to apply pressure to access those documents and needed an extension of time.
He has carried out a scoping exercise. I fully agreed with the scoping exercise when it was proposed by the Taoiseach. I thought it the best and wisest way to go prior to any investigation to establish the issues. Dr. Scally has repeatedly pointed out throughout the report that there are other issues regarding the outsourcing of samples from American labs to Honolulu in Hawaii and many other cities and that, apparently, CervicalCheck and the Health Service Executive knew nothing about that. He wants more time to examine that issue among others. He also highlights an absence of documentation in one of the laboratories and also in Ireland following the procurement because it has been destroyed. As such, he can only reach limited conclusions.
I reiterate the comments by Deputies that outsourcing is a major problem, notwithstanding that the report contains some positive comments in that regard in terms of the standards being good, based on Dr. Scally's observations. The contract stated that the labs should have the IPL accreditation but they did not. No one seemed to think that was a problem. The labs had accreditation under the American system and met those specifications but that is not what was specified in the contract. They did not have what was specified in the contract. The contract also seems to have been loose enough for the tests to be sent to Honolulu and for the labs not to inform CervicalCheck, the national screening service, Mr. Tony O'Brien or whoever was in charge.
This scandal involves a whole systems failure to which I will return because I am not happy that some person, organisation or government allowed it to happen. I will address it now in case I run out of time.
The comment was made by the women that, when we rolled out CervicalCheck in 2008, we also guaranteed the banks in the same month. As we pulled back on resources, staff and money for cervical smear tests, we had no problem rolling out money for the bank guarantee. Notwithstanding that, they struggled on gallantly to provide a screening service as an independent entity, reporting to an independent board with an independent chair that had oversight and outside monitoring. Subsequent Governments of Fine Gael, the Labour Party and Fianna Fáil in their wisdom saw the need to change and allow the Health Service Executive to change its structure, with the resulting consequence that there was less accountability and no independent board to which to report. In fact, before the board was abolished, we had directors of services talking to civil servants in the health sector. There was no accountability whatsoever. We have not had a single accountable person in CervicalCheck for the past number of years. I ask the Minister where the responsibility lies for that. We have also had a number of vacancies.
We then had an open disclosure policy that was really a close policy. It was a case of do not tell, or only tell if it we have to, and only after all of this correspondence between CervicalCheck and the consultants and general practitioners, and we will not tell the women. It was a case that we had a policy of open disclosure but that it really meant that we do not tell at all because there might be screaming headlines and difficult issues we have to cope with and, in true Irish fashion, on a certain level we will not cope with anything like that. It was a case that we will pretend it is not happening and if the person is dead, just put it on their medical notes. That is what is reported throughout this report.
Those of us in the Dáil asked for mandatory disclosure. The Minister saw fit not to support us and now we will have to bring it in by way of legislation and force the situation.
There were serious governance gaps at every level. There were serious problems with a risk register and what was put on a risk register. A systemic failure was not identified as something that should go on a risk register. Can the Minister imagine that?
There was an absence or a limited amount of public health medicine and a limited amount of input from public health physicians. Parallel with the bank guarantee, the withdrawal of the money for the service and the outsourcing at the lowest cost, which I will come back to, we were getting less and less accountability.
I sat on a health forum for ten years. I became a member when it was set up and spent ten years of my life on it. In my first year on the forum we were under pressure from the people working in the laboratory in Galway and elsewhere not to outsource this service. They said not to outsource, that they were in the process of building up their expertise, and that this should remain in Ireland or else they would envisage serious problems. Notwithstanding that, it was outsourced. Now, Dr. Scally, who is very cautious and gives positive results to the laboratories on what his limited time allowed him to do, confirms that one of the firms, the Australian one, Sonic Healthcare, has been in the process of repatriating the system to Dublin with one of its companies because it sees it is far easier to have it based in the country rather than going to New York, for example, with Quest Diagnostics, where there are delays of two or three days and so on. If we read Dr. Scally's report we see that even the private companies are coming back to Dublin. I cannot recall the actual name of it. The CPL one is gone. It is the sister company that is now back in Dublin.
A Deputy
MedLab Pathology.
I thank the Deputy. I have many questions but little time. The audit was suspended. Will the Minister tell me the position on that and the implications of the suspension of that audit?
Regarding the foreword addressed to the Minister in the form of a letter, Dr. Scally asks for an independent monitoring of his 50 recommendations. I do not see the Minister addressing that. He talked about implementing them. He gives specific timeframes of three months and six months. I would like the Minister to confirm that is precisely what he will do because we have been down this road before where Kevin Toland and his team offered to monitor independently the implementation of the recommendations in respect of the Department of Justice and Equality and he was not taken up on it.
According to Dr. Scally, the cost of the cervical screening test is €23.9 million. That is all. There is an extra sum in respect of the hospitals. Will the Minister tell me now what is the cost so far of the consequences of the failure to give information to the women? What are the legal costs and the awards to date in terms of the number of women who have managed to get through the labyrinth of the Courts Service? What does the Minister believe the final cost will be compared with €23.9 million to roll out a service? Would it not have been much cheaper to have complied with the open disclosure policy and ensured it was in place at every level? Will the Minister confirm for me the audit and in regard to the recommendations?
What system is used for sending out these samples to the various companies, including the Coombe Hospital? Is there a public private distinction? Is there a public private patient distinction or a public private hospital distinction? How is it decided which hospital or which laboratory is chosen?
I am sharing my time with Deputy Mattie McGrath. I thank the Minister for taking this debate. There are a number of issues regarding this report and the first and most important concerns open disclosure. Mandatory open disclosure will now be part of the patient safety Bill, which will come before the Committee on Health for pre-legislative scrutiny next Wednesday. That will be a very important meeting in terms of defining open disclosure.
Regarding CervicalCheck, and I am not in any way trying to explain what happened, there is a difference between organisational open disclosure and individual open disclosure. In terms of what happened in CervicalCheck, the lines of responsibility on disclosure were blurred. They should have been clarified and quickly identified. The failure to identify the lack of open disclosure in CervicalCheck was because there was no independent oversight of the scheme and there were no patient advocates on the structures of CervicalCheck who would have spotted that difficulty very early on, because when one openly discloses an incident, it is usually contemporaneous. Something happens and, within a few days, it has been identified that there has been a problem and one openly discloses. CervicalCheck, however, referred to historical events that had happened several years ago. It failed to identify the difficulties that would pose and who was to be the responsible person regarding disclosure. That has led to this failure.
The difficulty was in respect of disclosing to women but also the communication gaps that developed within CervicalCheck regarding where the lines of responsibility lay and the appalling shortcomings in the manner in which disclosure was eventually made when the scandal broke. It was rushed, ham-fisted, amateurish and did not reflect very well on the medical profession.
The second point is that Dr. Scally identified CervicalCheck as a dysfunctional organisation that lacked governance and accountability, that there was no clear responsibility among the various sectors in CervicalCheck and no clear job description. There was a lack of clarity in the way people should function within the system, in particular, how information was transmitted up and down the line. Dr. Scally identified a whole systems failure, and he was restrained in identifying particular individuals. If particular individuals are to be found wanting, I have no problem with that, but the blurring of lines in terms of the organisation, governance and accountability of CervicalCheck make that very difficult. There was nobody in charge. There was an absence of governance and poor oversight by the HSE.
There is an absolute urgency in reinstating the HSE board. I note that the Health Service Executive (Governance) Bill will also come before the Dáil very soon. It is absolutely essential that we have a reorganised, slimmed down, very clear governance structure within the HSE, not just in respect of its board but going right down through the organisation. It is a substantial part of the Sláintecare report that there has to be huge governance reform within the HSE. As we have spoken about that on many occasions I will not go into it again.
There is a necessity for no-fault compensation in respect of what happened. To have women go through the adversarial court system, as we have seen Vicky Phelan, Emma Mhic Mhathúna and others do, is not fair. We are talking about dealing with people who have offered themselves voluntarily, who are perfectly healthy when they go for screening, in the same way that when children present for vaccination they are perfectly healthy children. If they suffer an injury, whatever the case may be, there should be no-fault compensation. They should not have to go through the adversarial system. Mr. Justice Charles Meenan is to report on alternative methods. We have to look at how we deal with people who are injured by our health system. They should not have to go through the adversarial system. Gabriel Scally identifies that.
Another aspect of the report is data sharing. There was a breakdown in data sharing in that the National Cancer Registry and cervical screening service had different lists of people who had cervical cancer and they were not sharing that information with each other. Even the gathering of data was a problem in respect of CervicalCheck and the gathering of data is a big problem in the health service in general. We discussed that briefly at our health committee meeting this morning. Data is king. Without data, we cannot plan a health service. That was a deficiency within CervicalCheck.
I refer to a journalist who wrote about this during the week. He wrote that the shortcomings of CervicalCheck indicate a whole-of-system failure, a wider failure within the health service, where the welfare of patients got lost in the political and bureaucratic manoeuvres operating in a cocoon of detachment. That summarises what happened here. There was no outside vigilance on what was happening within cervical screening. People got locked into a bubble and were not thinking properly or putting the patient at the centre of the service. It is so important, whatever service we provide, that we put the patient at the centre. That is why it is important that we have two patient advocates on the HSE board. We should have two patient advocates on every board at local, regional and national level to make sure this does not happen again.
I am happy to make a few remarks on this very important issue this afternoon. The Scally report has laid bare a scandalous catalogue of failures right across some of the most sensitive areas of health care in this country. The women and the families who have been affected and, in some cases, utterly devastated by these failures are the true heroes of this entire sorry saga and their bravery cannot be commended enough.
The report indicates that we have reached a tipping point in the level of dysfunction that afflicts the HSE. We have all known that for a long time and the Minister must know it after two years in office. When will he do something about it? Dr. Scally observed how apparent it is that there are serious gaps in the governance structures of the screening services. In the specific case of CervicalCheck, there was a demonstrable deficit of clear governance and reporting lines between it, the National Screening Service and the higher management structures of the HSE. This confusion, according to Dr. Scally, complicated the reporting of issues and multiplied the risks. We need to let that sink in. Here we have a so-called healthcare service that actually multiplied the risks to women and their families. They were going in there for checks in their own interest. As the Deputy from Galway stated earlier, she is not here to tell people to go for checks; it is up to people themselves but they must have confidence. To think that this is where they ended up - how can we have confidence?
Dr. Scally also noted that there were serious gaps in the range of expertise in the professional and managerial staff directly engaged in the operation of CervicalCheck. In one of his recommendations, Dr. Scally says the Department of Health and the HSE should revise their policies in respect of document management. The implication here is that HSE document management at present is not reliable and does not ensure accountability. I honestly feel that is a deliberate act at this stage, so that there cannot be any accountability. Indeed, Dr. Scally says the view was expressed to the scoping inquiry by some working within National Screening Service that screening was downgraded after being absorbed into the HSE and that they felt they had little influence within the HSE as a whole. That is a common practice. We have seen that no matter what service is absorbed into this monstrosity, it just gets lost. There are lots of good people who have been absorbed into the HSE but it is such an unaccountable and unwieldy organisation now that it must disbanded.
Among other findings, the report noted that there continues to be a somewhat negative relationship and clear disconnect described by the programs between themselves and the HSE chain of command. Issues of isolation, suspicion, lack of trust or support and poor or non-existent communications were cited. We are going to continue with this. The Minister walked into Cashel hospital one day with Deputy Healy, myself and others and he was shocked to see it lying idle. There are so many instances and the Minister has done absolutely nothing about it - an abject failure. Then there was the selective leaking of the report. I am not blaming the Minister but it was only a handful of people who had it. That was despicable as well. It is a case of covering backsides all the time and allowing the HSE senior management and the Department to cover themselves and then wheel in the barristers in court if anything happens. It is despicable, degrading and disgusting. The Minister is presiding over that. I have called on him several times to resign and if he had any moral compass he would do so.
To clarify, there are 26 minutes left and the Order of the House gives the Minister 20 minutes. With his approval, I do not want to deprive the Green Party or Social Democrats Deputies. If it is agreeable to him, the Minister will have 16 minutes rather than 20.
That is fine.
Agreed.
I welcome the Scally report. It is excellent and extremely comprehensive. It has established many of the facts and truths of the CervicalCheck issue. I believe it has gone a very long way to answering many of the questions we have all had over recent months. The most important thing about the report is that it puts women and families front and centre in respect of this entire matter. Most importantly, Dr. Scally met with the women and families concerned. He listened to them and recorded their views and feelings. He really gave them a very strong voice in this whole process. Their experiences as recorded by Dr. Scally are undoubtedly a disgrace and raise many important issues for us.
The most significant finding and one of the most significant recommendations is the need for early legislation for mandatory open disclosure. It is extremely regrettable that, at the end of last year, the Government and Fianna Fáil conspired to delete the provision for mandatory open disclosure and, instead, as a result of a strong lobby, went with a voluntary disclosure regime. The shortcomings of that have been shown up very starkly.
I welcome the heads of the patient safety Bill. It provides legal liability in respect of disclosing basic information to patients. It is very important that we get clarification from the Minister that the legal liability will actually apply to individual clinicians and not to healthcare providers. That, I think, is the obvious interpretation of the heads of the Bill as they stand at the moment but it is not good enough. The Minister has to go much further than that.
This legislation is absolutely critical in changing the culture that Dr. Scally discovered. He has lifted the lid on a highly paternalistic culture which, as he said himself, was bordering on misogynist, in respect of many of the 30 consultants who were involved in this.
Stephen Teap referred to the God complex that was a factor in this matter. We are all too familiar with the God complex that some members of the profession display. Not only did these doctors fail to disclose key medical information to their patients but when, thanks to Vicky Phelan, this issue came out into the open, the attitude and approach of those consultants were disgraceful. There must be early follow through in respect of those clinicians engaging with and apologising to the women and families concerned, as recommended by Dr. Scally.
Dr. Scally found major shortcomings in CervicalCheck relating to governance, quality assurance, risk assessment, understaffing and accountability. This was only a microcosm of the HSE. Dr. Scally said that everywhere he went within the HSE, there were problems. Many of these issues have been addressed in the Sláintecare report but we need to ensure we take the steps recommended by Dr. Scally with the principal one being the reinstatement of the independent oversight board. It is important to point out that 88 Members of this House voted to abolish that independent oversight board five years ago. There must, therefore, be accountability in here as well in other places. The political mishandling of this issue needs attention. There was certainly competitive outrage and many of the comments and much of the behaviour of Members of this House, including members of the Government, did little to help the situation.
The issue is how the Government and Minister respond to these 50 recommendations. The Minister needs to tell us what mechanism he will put in place to ensure those recommendations are implemented swiftly and we keep the focus on this issue until they are implemented in full.
I want to focus on one important political point that has not received much attention. There is a clear recognition that a mistake was made in 2011 when the HSE board was abolished. That mistake must be rectified and Dr. Scally puts that front and centre. I say this because to a certain extent, we must be careful that in our work we do not always view the public service as bad or believe that structures relating to it will inevitably be bad. At the time, the then Minister for Health, Senator James Reilly, said he would take all the responsibility, that he was sweeping away all those structures and that he would be the great single-handed orchestrator of everything. We must be careful in the political system and we must work with our public servants to make sure we deliver the services our people need.
This colours my second comment, which is that the Scally report has done the country a great service because it highlights a problem in our public service relating to the nature of communications between doctor and patient, particularly, as has been said on several occasions here, between male doctors and female patients in terms of the sharing of information. It concerns attitude. It is very hard to define that, to regulate for it and to be scientific about what empathy is, how one listens and how one fulfils the Hippocratic Oath in sharing information that belongs to a patient with him or her. There is a huge amount of learning here because how we share data in the modern world is of increasing importance, as is the ownership of data. The ability to get access to one's data, particularly health data, should be enshrined after this crisis - this terrible disaster for those patients. Hopefully, we will get one good thing out of it, namely, a system under which patients have full transparency and access to data. Where the State makes a mistake, and in some instances the mistake will be unavoidable because there will be screenings that are inaccurate, we must develop a mechanism whereby the State can share information about those failings without it becoming a legal wrangle and where it is not doing down the State or the public service to admit mistakes. I hope this is at least one positive outcome of what has been a terribly trying process for the more than 250 women involved.
The way in which the report was written, with the women and their comments being put centre stage, was correct. It indicates the general approach we should take in terms of the medical profession, the sharing of data and how the public administrative system works. Dr. Scally has done us a great service, as have those women who did an incredibly difficult thing in speaking publicly about their tragedies. They have done us a service, as has Dr. Scally. We should live up to that in the work we do from now on.
It is important to commend the bravery and determination of Vicky Phelan and the other women involved. Without their courage, we would probably be blissfully ignorant of this scandal. I welcome the Scally report and its 50 recommendations and hope those recommendations will be implemented immediately. I also welcome the certainty of mandatory open disclosure.
Dr. Scally rightly highlights the outrageous treatment of women by their doctors and correctly states that the doctors involved should apologise to the women involved. That must happen. We also need accountability for this debacle. I have no doubt that we need a full public inquiry that can compel witnesses and documentation. Without such an inquiry, senior management, Ministers, Secretaries General and chief medical officers will be able to avoid having to take responsibility for what has happened. Without such an inquiry, having to make fundamental changes to the health governance model can also be avoided. I believe this model is at the root of this scandal. It would also mean that there would be no investigation of the highly problematic outsourcing of these tests, which is a very important point. Without such an inquiry, similar outrages and scandals will happen in the future. Such an inquiry is necessary and should be set up forthwith.
We have 15 minutes left. A number of questions were raised. The Minister will take three minutes to respond to those as best he can. I then have indications from Deputies Donnelly, Bríd Smith, O'Reilly, Kelly and Shortall that they may wish to raise questions.
I will be as quick as I can so we can have as many questions as possible. In response to Deputy Healy's point about ministerial responsibility, the Scally report is very clear that I did not know so while I did not cause this problem, I have a responsibility in the office I hold to fix it and to make sure the recommendations are implemented in full. That is what I want to do.
This is a scandal about women not being told and about what Dr. Scally called a laudable audit in terms of its objectives being botched in terms of its execution and the pain it caused. I take Deputy Connolly's point about it not being the job of Members of the Oireachtas to promote screening but there were Members of the Oireachtas - not Deputy Connolly - who allowed the perception that laboratories were not safe to seep out. I do not know about the Deputy but the largest number of queries I received in my office and from women in my own life involved queries about how safe their smear tests would be in terms of the labs to which they were going. Dr. Scally, who we asked to do a job, said they are safe, which is a really important point for us to make.
All Members focused on implementation, which is key to this. I was asked what the implementation structure will be. Dr. Scally has offered to continue to work for the next 12 months on the delivery of the recommendations and to oversee their delivery from an external point of view. I have taken him up on that offer and intend to meet him in the next week or so to finalise how best to do that. Patients will be involved. I would suggest that he attend the Oireachtas Committee on Health. He has already been invited by the Chairman and I know Dr. Scally would be very willing to attend. I suggest that, through that committee, the Oireachtas could play an oversight role in making sure we are making progress and sending reports. I intend to keep to the timeline, as envisaged by Dr. Scally's report in which he asks me to publish a full implementation plan for all 50 recommendations within three months, which is December. That is the timeline to which I am working.
I do not like being adversarial about this but Deputy Bríd Smith said that outsourcing is at the heart of this issue. It is not.
We cannot have our own facts. The Deputy can and has every right to believe we should insource screening. She can and does believe we should do it here in Ireland. That is a perfectly legitimate view to hold.
We have not got the ability to do so.
I, too, would like to build capacity in Ireland, but outsourcing is not at the heart of this scandal. We cannot say that and allow it to hang there such that women would have a doubt. Dr. Scally who, frankly, knows a hell of a lot more than the Deputy or I do reviewed 12,800 documents. He and his team visited the laboratories and interviewed all of the key people. They - four doctors, a senior counsel and a barrister - have said the laboratories today are safe.
Today.
Yes. Therefore, outsourcing is not at the heart of this scandal. We can have ideological debates all day long about outsourcing, but the source of the scandal is non-disclosure of personal information - women's information - that was withheld from them. Let us be clear that that is the scandal.
On open disclosure, yes, we need legal changes. Deputy Róisín Shortall is entirely correct and I will work with her and anyone else in this House to ensure it will apply to individuals. They did not do this in the United Kingdom where they watered it down. We need it to apply to individuals and, I believe, institutions. That is my intention and it is Dr. Scally's recommendation. I will work with the Deputy and others to make sure it will happen.
As we have all said, we do not just need legal change, we also need cultural change. While it might not have had legal underpinning, clearly the policy of open disclosure was not implemented and was contradictory. I do not buy into the narrative that we blame all doctors and that all doctors are bad. We have many dedicated healthcare professionals. However, the ones who said what we read in the report and the ones who said what Deputy Joe O'Reilly illustrated to me on the issue affecting women who used transvaginal mesh - those who speak to women like that - have let us all and their profession down. We need a cultural change.
Let me be clear that there will be a further investigation because Dr. Scally is clear on it. While I do not have it in front of me, from memory, there are at least three places where he calls for a further inquiry. The CPL laboratory is not used today and we cannot let anyone suggest it is. That is one issue.
On the issue of procurement in general, Dr. Scally is not suggesting anything was illegal, but, clearly, more work needs to be done on the issue of procurement and contracts. He also makes the point about having a common data set in order that we can see the same data about all of the laboratories in a transparent way.
Deputy Mary Lou McDonald asked about the issue of leaking. Let me say whoever leaked it was absolutely cruel. While I do not speak for the patient advocates, like many in the House, I have got to know them extraordinarily well. Obviously, the report was not leaked, but someone who knew something about some element of it leaked it. It was suggested that was the report. It caused huge upset and was absolutely cruel to do it.
On governance, I agree with the points made about the HSE board and that there is a need to have two patient representatives on it. We need to use the report as momentum in delivering in that regard.
Deputies Catherine Connolly and Alan Kelly asked about the continuance of the audit. Dr. Scally said the idea of an audit was laudable and we all get that, given that we know the way that it was done was so poor. There were two key recommendations on the issue of an audit among his 50 recommendations, recommendations Nos. 26 and 27. They state, effectively, that patients must be at the heart of developing and designing audits. We will work to deliver this before an audit recommences. It is very important that the audit be correct and that we do not see a repeat of the mistakes made.
On the issue of political mishandling, Deputy Róisín Shortall makes a fair point. I include myself in that regard. Mistakes were made by everyone, including me. I think many of us made mistakes in trying to do the right thing, but there are serious lessons to be learned by all of us, on all sides of this House, and elements of the media in how we deal with an issue in a calm, rational manner and establish the facts, which is what the people affected always want to happen.
Deputy Stephen S. Donnelly
I would like to come back to the women involved and the briefing. My understanding was that they would be briefed before the report was published and that this was the commitment the Minister had made to them, but it has not happened, except in a very few specific circumstances. Will the Minister liaise with the women involved and their families as a matter of urgency to offer a briefing directly with Dr. Scally? We were briefed by him and it was very useful to be able to ask him directly about various parts and get his thoughts on things that one would not necessarily write in a report. Is anything under way and when can the women involved and their families expect to receive a briefing directly from Dr. Scally and be able to engage with him and his team?
I have heard the Deputy make this point a number of times and accept that he makes it from the point of view of wanting to achieve good and stand by the people who have been impacted on. My understanding is that Dr. Scally first made the decision about how best to brief those who had been impacted on, as was appropriate, given that it was an independent process. He took the view, which I share, that the best way was to brief Vicky Phelan, without whom we would not have had the report, and the two patient representatives on the CervicalCheck screening committee, Lorraine Walsh and Stephen Teap. Dr. Scally wrote - it was circulated via email - to all of the women for whom he had contact details or their next of kin, providing them with a view on the report and also a copy of it. The advocacy group which is independent but funded by my Department through the Irish Cancer Society and the Marie Keating Foundation held a meeting in Athlone on Sunday at which those who had been impacted on had an opportunity to discuss the report. I am absolutely open to providing for a further briefing, as I am sure Dr. Scally is, although I cannot speak for him. What I suggest is that I ask the advocacy group which seems to be the best representative forum whether it would like that to happen. If it would, there would be no issue in arranging it.
I am glad that the Minister has qualified that the laboratories are safe "today". It is an historical question and there is a need for an investigation into outsourcing. I again ask the Minister, probably for the sixth time, if he will give the Oireachtas the information on from which laboratories the 221 false negative test results came. I am told by reliable scientists that it would be very simple to find out. I, therefore, ask him the question again.
I welcome the Minister's statement that he would like to see the repatriation of the service. I further ask him whether he would consider investing in laboratories and the training of clinical scientists in our colleges since we let go hundreds of them ten years ago.
My priority is the continuance of the service. Some of the comments made in this House make that harder. The laboratories we are using today are safe.
The Minister keeps saying "today".
I would appreciate it if the Deputy said that the next time she speaks. The laboratories we are using today are safe. That is what Dr. Scally found. On what happened pre-2012, he did not find that they were not safe but said he would like to do more work. Whether, contractually, they had the right to use that laboratory, he believes not. He should and will investigate that matter.
What about before today?
Order, please.
Deputy Bríd Smith is very interested in this issue. She has read the report and seen what Dr. Scally said about the laboratories we have used in the past, yet she is trying to create a cloud of doubt for an ideological reason.
He said they were not ISO accredited. There are different standards.
The Deputy is correct that they are not. He did say that. I was misinformed in the past. However, there are women watching this debate. He is not suggesting those laboratories are in any way inferior from a safety or quality point of view. That is what the report states and that is what he said. If the Deputy had met him, that is what he would have said to her.
As we move to HPV testing which I expect to happen in 2019, it will provide an opportunity and an obligation to retender and reconfigure our use of laboratories. We need to look at capacity in this country. If it is possible to do more here, of course, we should do more here. However, the continuance of screening which is saving lives has to be the priority. I do not have the data the Deputy is seeking. It is not as simple as referring to 221 tests because many of the women would have had multiple smears sent to multiple locations.
I do not believe that.
What is the Minister doing about the leak? He said it was cruel, with which we all agree.
On quality assurance, it is not enough and is a little paternalistic, if the Minister will forgive me saying so, to say the laboratories are safe. We need to have it demonstrated. They are not ISO accredited. From where are they receiving accreditation? How is the Minister satisfied that they are safe? Will he agree that HIQA has an oversight role? We all need to put people's minds at rest and get rid of the paternalistic attitude.
I have never been accused of having a paternalistic attitude just because I am a man. I am the Minister for Health and have a duty to tell people who rely on me the fact that the laboratories are safe today.
With regard to the leak, the Taoiseach has said he is going to investigate it and I hope he will do so. As the Deputy knows, it is often not possible to find out how these things are. A number of people had it, both in and outside government. The report was not leaked, but I take the point that it was cruel that an element of it was leaked.
As regards HIQA, I think the suggestion made by Deputy Louise O'Reilly and her party leader is very constructive. I am not going to make a knee-jerk announcement on the floor of the Dáil, but I will consider it and will engage with them on it.
What about accreditation?
Dr. Scally has said there are different accreditations but that it is still safe in terms of quality. He has made a very important recommendation on accreditation but also on the use of data. He suggested we make an English HTA, health technology assessment, in order that we can measure them. That is what we will do.
That is not what he said.
It is what he said.
I have asked the following question before, but I would like an update on it. When will the audit recommence? There are ongoing issues if it is not continued. We will all be responsible if it does not recommence because it could potentially result in other issues being delayed because it is not happening. Can we have some urgency in that regard, given that carrying out the audit is good practice?
While this does not relate to any specific case, obviously, there have been legal cases and liability and errors have been admitted.
I have great confidence, having heard Dr. Scally say the laboratories are safe. I read the report and questioned him on it. I agree wholeheartedly with the Minister that it is very important that everyone here acknowledge that. However, I presume that in the individual cases where errors were found and admitted, the HSE has been in contact with the laboratories, flown over and investigated what has gone on. That would be normal practice in every other scenario.
In relation to the audit, I appreciate what Deputy Kelly has said. Audit is a good thing. Dr. Scally found that. No one wants the outcome of this to be that people in the clinical community are less likely to audit. In fact, while the CervicalCheck audit was completely botched and I do not defend it in any way, had it conformed to the concept behind it, it would have been in line with one of the best forms of intended open disclosure. Not every country does that. I do not have a timeline for recommencement as Dr. Scally has made two key recommendations. However, this will be prioritised and we will come back with a timeline for the implementation plan. I do not know the answer to the Deputy's second question and I am not going to guess. Presumably, the laboratories produced expert reports, but I will find out. There is a benefit in the process under Mr. Justice Meenan. I agree with the Deputy that under the Constitution no one can tell a person not to go to court, but we must provide people with other avenues of redress. That is with what Mr. Justice Meenan has been charged.
What is the timeline for the Health Service Executive (Governance) Bill? I welcome the confirmation by the Minister that there will be two patient advocates on the HSE board. My other question is on the mechanism to implement the 50 recommendations and looking at issues outside those. What does the Minister envisage in terms of Dr. Scally's involvement continuing until all of the issues are resolved?
The plan is to have the Health Service Executive (Governance) Bill passed during this session. I would like to see the HSE board take office at the start of 2019. While the Bill must go through the normal process, including before the health committee, that is why I put forward a chair designate yesterday to get the ball rolling. Regarding implementation, I assume the Deputy is getting at the point that Dr. Scally has a major role to play. He has the confidence of those who were impacted and of all parties and groupings in the House. Crucially, he has the confidence of the public, an important clinical record and vast experience. I would like him to remain involved until we implement the recommendations. He has said he would be happy to remain involved for the next 12 months and I would like his reporting mechanism not only to link with me but also to include going before the health committee on a regular basis.
I welcome the offer by Dr. Scally of his services for the next 12 months and that the Minister has taken him up on it. What is the timeline for the implementation of the 50 recommendations? Will it be within 12 months? Is the HPV test on track to be rolled out in October or did I mishear the Minister say it would be in 2019?
The Deputy did not mishear. It will be 2019. A great deal of work has been going on, including liaising with other countries which have introduced this and rolled it out. It is the major priority with the continuance of laboratories in order that we can keep our screening programme going in the interim. The report asks that I come back with a full implementation plan within three months. As such, we will have identified timelines, actions and identified owners against each action within three months. Crucially, the voices of patient representatives will be included in the development of the implementation plan. I hope some of those who have worked so constructively with us will continue to be involved. I would also like Dr. Scally to be involved and to be satisfied that the implementation plan is robust. Within three months, we will have a published and detailed implementation plan.
I thank all contributors for their co-operation. That concludes statements on the scoping inquiry into the CervicalCheck screening programme.