Supplementary Report of the Scoping Inquiry into the CervicalCheck Screening Programme: Statements

Last week, I published the Supplementary Report of the Scoping Inquiry into the CervicalCheck Screening Programme following a Cabinet meeting and today I welcome the opportunity to discuss the report's findings and speak about the issues at its core. At the outset, I would like to place on the record of this House my sincere gratitude to Dr. Gabriel Scally and his team for not only the comprehensive work undertaken over the past number of months but the way in which he has gone about robustly establishing the truth and the facts and putting in place a comprehensive implementation plan. This work is crucial to our aim of providing a world-class cervical screening programme that inspires trust and confidence among the women of this country. Government has accepted this report, and, indeed, Dr. Scally's previous reports, and my focus now is on ensuring the full implementation of all his recommendations. Considerable work is already ongoing in the HSE, National Cancer Registry Ireland and my Department on these recommendations and in his supplementary report Dr. Scally acknowledged the significant progress that is being made.

On completion of the final report of the scoping inquiry last September, Members will be aware that I requested Dr. Scally to do further work to address some outstanding issues relating to the laboratories which had been referenced in that report. This supplementary report confirms that the number of laboratories involved in CervicalCheck's work was greater than originally thought or than was known to CervicalCheck. We now know the number of laboratories that provided screening for the Irish programme was 16. We also know that the use of many of the additional laboratories was not approved in advance by CervicalCheck. Clearly, this situation should not have arisen, and the implementation of all of Dr. Scally's recommendations is vital to ensure this does not arise in the future. However, the core question is whether the use of these additional laboratories resulted in a quality problem. Dr. Scally says there is no evidence to suggest deficiencies in screening quality in any laboratory. This is a crucial and important message that we all must communicate to women in this country who are rightly looking for assurance and information. I hope that this will reassure women that they can trust the results they receive from the CervicalCheck programme and that they should continue to attend for their scheduled screenings. Indeed, we see already that women are attending in large numbers for screening.

It is worth noting that in this report Dr. Scally has also points to an important safeguard, which is that double reading of all Irish slides takes place, including on slides screened in the US. This is different to the general US practice where slides are examined by a single screener. Furthermore, Dr. Scally is very clear that the two major accreditation standards in use, that is the ISO standard and the CAP standard, are comparable. He says they do not create any cause for concern in terms of the quality of laboratory services provided. All but one laboratory had the appropriate accreditation at the time they were providing screening services to the HSE. Dr. Scally has found that all of the laboratories used in the US were accredited but expressed concern about accreditation in relation to one laboratory in Salford, in the UK. This is ancillary to the main MedLab facility in Dublin.

Accreditation is an important process in providing assurance about quality, of course, but the question remains was there any deficiency in screening. Dr. Scally states that there is no evidence of any such deficiency. He indicates that it is reassuring that the performance data for the screeners based in this ancillary laboratory were part of that reviewed by the scoping inquiry in mid-2018. At that time, the inquiry concluded there was no reason, on quality grounds, the existing contracts for laboratory services should not continue. The HSE has said this concurs with its own ongoing performance monitoring in regard to MedLab Pathology. While he has been clear there is no evidence of deficiency in screening quality, Dr. Scally is also clear on the need to have the right quality assurance systems in place. This is being addressed now as part of the implementation of Dr Scally's recommendations.

CervicalCheck now has a national laboratory quality assurance, QA, lead in place which is a key and important step, and work is continuing to strengthen governance, quality assurance and management in the CervicalCheck programme and the wider National Screening Service. We have already seen these improvements in the work done by the HSE to quality assure the additional laboratories in the US prior to entering into a new contract with these for additional screening capacity, and this has been acknowledged by Dr. Scally. I asked him if he is he satisfied with those new arrangements and he stated that he is.

Dr. Scally has made two further recommendations in his supplementary report. Actions to implement these will be incorporated in the approved implementation plan which has been in place since last December. There are more than 160 actions in the plan and 48 of these had been implemented by the end of the first quarter of this year.

I am pleased to state that Dr. Scally has acknowledged the substantial and important progress that has been made to date in implementing the recommendations of his first and final reports.

We are now at a point where we have made important progress in a number of areas: we will begin the tribunal legislation recommended by Mr. Justice Meenan in this House next week; the ex gratia scheme has been established; the Royal College of Obstetricians and Gynaecologists review is well under way; the HSE has secured additional capacity to support our screening programme and the backlog is quickly and substantially shrinking; preparations are ongoing within the HSE for the switch to HPV primary testing; and the vaccine for boys will be introduced in September.

We must have a strong and sustainable screening programme in which women can have full confidence. Since CervicalCheck was set up in 2008, cervical cancer rates decreased from approximately 14 cases per 100,000 women in the years 2009 to 2011 to ten cases per 100,000 women in the years 2013 to 2015. A well organised screening programme, when combined with HPV vaccination for boys and girls - with all of us in this House supporting that vaccination programme - can bring us very close to eliminating cervical cancer. Our national goal is to effectively eradicate cervical cancer. My priority now is ensuring that Dr. Scally’s recommendations are fully implemented because this will make that goal a reality.

I want to start by thanking Dr. Scally. He has completed what was a very arduous but necessary follow-up report and I want to acknowledge his work over the past year in shining a light on such an important issue. This is a supplementary report, following his inquiry last September, and we have had an additional report into the implementation of his recommendations. I want to recognise that there has been much progress regarding those recommendations.

When Dr. Scally first began the scoping inquiry last year, we all understood that there were six laboratories involved. It subsequently emerged that work had been contracted out to other laboratories around the world. By last September, some 11 laboratories were involved. Another four were then discovered and just last week another laboratory was found. That gives a grand total of 16 laboratories, with two located in Ireland, two in the UK and 12 in the US. The increase in the number of laboratories from six to 16 is deeply worrying. Rightly or wrongly, it paints a picture of secrecy and confusion which Dr. Scally appropriately described as entirely unacceptable. It is not too much for women availing of the cervical screening service to be able to discover where their tests are going. It is certainly not too much to ask - indeed it is essential - that the HSE and CervicalCheck, which is part of the executive, know where those tests are going and have been. It was almost impossible for Dr. Scally to discover all of this information. He claims that information about the other laboratories was as much of a shock to CervicalCheck and the HSE as it was to him. We know that the HSE and CervicalCheck were not told. The contracts specified that they should have been told but they were not.

What do we know? The report suggests that there is no concern about the standards of the laboratories involved, which is a relief, but is obviously not how business should be conducted. We need to know ahead of time that the laboratories are safe and not have to satisfy ourselves afterwards that it turns out that they were. The phraseology that Dr. Scally uses is very important. He stated that he did not find evidence of deficiency. I imagine he chose those words carefully. It is not the same as saying that there were no deficiencies and that everything was up to scratch at all times. We, and Dr. Scally, do not know that. All he could say is that he could not find evidence of deficiencies, which is welcome, but is not a categoric assurance and he is not able to provide that. We know that some of these laboratories are no longer in operation. Unless there are extraordinary records of these closed laboratories - failing time travel - we may never know the detail on a lot of these issues. Had there been problems with those laboratories, neither CervicalCheck nor the HSE would have been in a position to do anything because they did not know about it. We need to ensure that CervicalCheck has the resources needed for contract enforcement and for developing the standards to which Dr. Scally refers.

Perhaps the Minister is aware of this but my understanding is that CervicalCheck was run on a shoestring budget by a very small number of people doing their very best. The clinical lead, Dr. Flannelly, was trying to run this entire programme - one of the best programmes of its kind in the world - on two or two and a half days each week. I will be very pleasantly surprised if there were highly proficient legal and contract enforcement people in the background who could have enforced these contracts. It is something that we must ensure is there in the future.

The big question is where does this leave the women? The HSE says this supplementary report provides further reassurance to Irish women about the cervical screening programme, notwithstanding the issues raised and we must focus on that. The CervicalCheck screening programme, in spite of the failures of disclosure, has been one of the most successful screening programmes of its kind run anywhere in the world from a medical perspective. Some 50,000 women have been identified with high-grade abnormalities. Cervical cancer rates have fallen 7% per year. The programme is an incredible success. It is incumbent upon us all to support the clinicians, the administrators, the GPs, and everyone involved in ensuring that they have everything they need to continue with the medical success of the programme, while obviously getting much tighter on governance and contract enforcement and the ability to ensure there is a global quality standard for all tests.

I will start by thanking Dr. Scally and his team for the work they undertook. The reports are comprehensive pieces of work and we know they were delivered under very difficult circumstances. There was much shock expressed on the benches here and in the media at the fact that information had to be wrestled from the Department in certain instances, which is not good enough. We know, notwithstanding trying circumstances, that he still managed to produce a report that is comprehensive.

The report seeks to genuinely reinforce and restore confidence in the CervicalCheck programme. The programme has limitations, which we have discussed. It is invaluable, it does and will continue to save lives. I say this as somebody who, like many other women, uses the service and who wants and deserves to have the fullest confidence in that service.

There are many sections of the report that jumped out at me when I first read them. However, nothing jumped out at me more than the chapter on procurement of laboratory services. This section raises a number of questions, most notably as to why the HSE and the CervicalCheck programme reduced the weighting for quality assurance and capacity in the tender process for laboratories to conduct this testing. When I spoke with Dr. Scally, he stated that it was unable to give an answer as to why this was the case. When he had attempted to investigate the contracts and the procurement process, documents and vital information were either missing, destroyed or could not be found. When one looks at the reduction in the weighting for quality and the increase in the weighting for fees, the reduction in the weighting for capacity and the consequent increase in the weighting for fees, we can see that there was an attempt made to get screening services on the cheap. That is certainly what it looks like. They were willing to sacrifice quality and capacity for the right fee. That is wrong and it should not be the guiding principle for any service at all. Clinicians should have been involved. We need to know why there was reduction in emphasis on quality assurance and capacity while there was an increase in the weighting for fees and we need and deserve to have this explained in full.

The report also raises many questions in respect of contracted laboratories using other laboratories without the knowledge of the CervicalCheck programme. I say this as someone whose own test was possibly on its holidays somewhere and I would not have known that.

I would have believed it when I asked my doctor and was told that the outsourcing was to a laboratory in the US. I did not realise then that it could have bounced on to a second and a third laboratory, and possibly then on to another one again. That is not right. Doctors should have confidence when talking to patients. At the outset of the scoping inquiry in May 2018, it was believed that six laboratories had been used. The figure increased to 11 in the middle of the process and we now know it was actually 16. Dr. Scally has not received any evidence from Quest CPL or Medlab that they had notified CervicalCheck in advance in writing in respect of the use of additional laboratories outside those contracted. Nor was he able to provide any evidence that anyone in CervicalCheck, the HSE or the Department actually asked those questions. All we see is a reduction in the emphasis on quality, an increase in the emphasis on price and everybody running around with their fingers in their ears and their eyes closed trying not to ask any important questions about this really vital and important service. While Dr. Scally outlined in the report that the additional laboratories did not result in a reduction in the quality of the screening provided in his opinion, there is no evidence to suggest that deficiencies in screening quality in any laboratory were there because he could not find any. What happened is still not right. Dr. Scally said he could not find any evidence but he did not say that no evidence exists. This was something of an opaque process. The relationships between the contractors and the person conducting the service should have been built on trust yet it appears there was a certain amount of deception. I would say again that those questions were not asked.

Sinn Féin opposed the outsourcing in 2008 when the Fianna Fáil-Progressive Democrats Government introduced it. We did so for good reason and our view has been vindicated. What we see in the Scally report is the loss of control and a loss of oversight. It was a political decision as the clinicians will tell us. We hope that in due course the testing will be repatriated. It will be good for our universities, for jobs and, ultimately, for the health service. It is something clinicians have looked at. We have not had an examination of the results from each of the laboratories and that is extremely regrettable. I do not know how many times I have asked for this and others have as well. We now hear the clinicians saying there is a possibility of what they call cluster errors. That needs to be examined because we are still using an outsourced service. We need to get some answers.

With the permission of Deputies Kelly and Bríd Smith, I call on Deputy Connolly now as she is to take over the Chair next.

I would like to start by thanking the brave women who brought this matter to our attention, for the courage they showed, particularly the woman who did not sign the confidentiality agreement. Clearly, the existing provisions would not have brought anything to our attention. All of this is retrospective. Certainly our appreciation is due to Dr. Scally but it is to the women that I give my respect and gratitude. Without them, we would not be aware of any of this.

The report is supplementary to the main report of last September. I ask the Minister to go back and read it rather than taking a selected number of points from it.

I have read it.

Then let me just highlight some. Two recommendations follow on 50 and we will come back to them during the questions. The reason for the supplemental report was that there were issues about which Dr. Scally was worried in respect of tendering, contracting and the operation of laboratories. There were not six laboratories but 16, as my colleagues have said. The use of the laboratories was not approved in advance. One laboratory in England was retrospectively accredited and the system in place for responding to errors in Ireland to the screening is inadequate to the task. That is pretty damning. I would like to go through the findings in detail in respect of the three companies involved but my time is limited. I will go straight to the key statements of Dr. Scally. "It is profoundly disappointing that the Scoping Inquiry only learnt about the additional laboratories as a result of our extensive and intensive probing." That was in addition to people coming forward and alerting the inquiry about possibilities of laboratories in other areas including Mexico and India. I hope I will have time to come back to that. Dr. Scally says it is disappointing that not one of the bodies involved retained complete records for a period of time over the last decade. No knowledge of the laboratories on the part of the screening service and the HSE meant that the national cancer screening service had no means of assessing the accreditation, quality standards, governance or other critical features regarding the suitability of these laboratories to undertake cervical check work. Dr. Scally says:

The most benign interpretation [I certainly would not agree with him. I would give a different interpretation] of these events is that neither party [imagine that] appears to have understood, or articulated, the importance of the role of the NCSS in monitoring the quality and safety of the laboratories and the importance of documenting how and where the work was being done, how it was monitored, and by whom.

Dr. Scally says, "it is disappointing that it took Quest more than six months (from the time of the Scoping Inquiry’s first engagement with the company) to disclose the involvement of these four laboratories." It is extraordinary that Dr. Scally goes on to take their word later in respect of there being no laboratories in India or Mexico. They have not proved it and had not complied with their word prior to that. Dr. Scally says that "the lack of transparency by the major private sector laboratory companies about the precise locations of their screening services provided to CervicalCheck, and therefore to Irish women, is entirely unsatisfactory." He states that "the tendering process appeared to move over time to place an increasing emphasis on price rather than quality." I would have thought that might be something the Minister would have focused on. The report states that, "the use of additional laboratories, without express authorisation, lay outside the bounds of the contracts and [...] the introduction of additional laboratories with no previous experience of CervicalCheck did introduce a potential risk." Most importantly, it states that, "the reasons for requiring prior written permission to use additional laboratories were to ensure accreditation and quality of service, to enable CervicalCheck to monitor and gauge risks, and to maintain overall transparency within the screening programme." If the organisation responsible for looking after women's health is not in a position to carry out quality assurance because it does not know the laboratories exist, we have a serious problem. Is that not right?

That arises from the fatal decision in 2008 to outsource to Quest and the other companies and to go forward with outsourcing to America, to a company based in Australia, and all the laboratories from Honolulu to Texas. The Minister might elaborate on how quality assurance can be carried out across laboratories with five hours' time difference and 4,000 miles between them. Do teams of Irish experts go out and examine each laboratory, the ones they know about? Can the Minister imagine that for a system? The Minister gave a four-page speech here with no reference to any of those issues or how we might learn from this. How are we going to stop the outsourcing? Ironically, one of the companies has come back to the idea that it should be located in Ireland and should have never moved from here in the first place. The Minister would agree with that. It has gone right back to Dublin because it was much more efficient and effective to do so. I appeal to the Minister to tell us what plan the Government has to stop the outsourcing. What capacity have we now and when will we have the capacity to provide a proper screening service to the women of Ireland, who deserve it?

I have only five minutes and look forward to the six minutes of questions more than to these five minutes. I want to commence by asking the Minister to do something. Yesterday in the Dáil, the Taoiseach stated - I know what I am talking about here - that representatives of Ruth Morrissey were aware of the decision to appeal the case. They were not.

The Taoiseach has been communicated with and has been told the facts and while the Minister and I can speak and hold a debate in this House, the people outside of these Houses do not have the capacity to defend themselves in here. I ask that the Minister go to the Taoiseach to deal with that matter on the floor of the Dáil Chamber, to correct the record and to get to the facts of what happened. Ruth Morrissey's representatives were not told beforehand. I ask that the Minister would please do that.

I will begin my statement by acknowledging the people who got us to this point: Vicky Phelan in particular, without whom we would not be here; Emma Mhic Mhathúna - may she rest in peace; and Ruth Morrissey, whose case was in the High Court for 36 days. It is a national disgrace. After what the Taoiseach said on RTÉ's "Six One", it is a national disgrace and I will never forget it. It is the Minister's decision and I do not agree with the Minister's decision or the Government's decision on where this is going. According to this decision, Ireland is looking for a lesser standard of testing than is found in the UK.

This lady who has fought so hard for these women - and whose legacy this is - should not be left in this situation for the next months. It will take a significant amount of time for the case to get into the Supreme Court. It is not necessary. The future will tell us. The manner in which communication was done with Ms Morrissey and her representatives and the manner in which she found out that the Government would appeal the High Court decision is something we should all regret.

I have many questions with regard to the Scally report. Dr. Scally will come before the Oireachtas Joint Committee on Health in July, which I welcome. I take a lot of what Dr. Scally had brought out in his first report as being absolutely essential, including the 50 recommendations. I always had a serious issue with quality assurance in respect of the laboratories and the Minister is aware that I have pursued this issue for a long time. I was disappointed that it took nine months. I do not know why it took nine months to get to the bottom of this. I will have serious questions to ask at the committee. On the floor of the Chamber tonight, however, I want to ask the Minister something else on behalf of the women, their families and the patient representatives such as Lorraine Walsh and Stephen Teap, who the Minister knows well. Through the Minister and the Government, we need to give them a full apology. I put it to colleagues that we now know the extent of what has happened. They need a full apology based on Dr. Scally completing his report.

The HSE has also said it would look into its own organisation, its processes and what happened. A commitment was made on this by the former interim director general at the HSE, John Connaghan. Will the new director general do that? Will the Minister confirm whether he has asked him to do that?

There are women, some of whom I have named, who probably will never know where their test slides were misread. Some of the laboratories do not exist any longer or, as Dr. Scally has acknowledged, he may never find some laboratories. Only that the report was extended for an extra four months, I doubt Dr. Scally would have found some of the information he did. We need to understand that.

I have much to say on this matter but I will make one final point and then come back to questions. Given that the HSE had the contracts in place, given that the laboratories did not get agreement from the HSE and given that we are going through a huge volume of court cases, were these laboratories not in breach of contract? Dr. Scally's report goes as far as bringing it up to the point of saying it. There may be legal reasons why he did not say it. Surely the laboratories were in breach of contract. Outside of the disgraceful situation in which it left the women and their families, surely it also means there are issues to be considered from a liability perspective and breach of contract.

I thank the women and their families for their courage and determination in the face of such adversity. I also acknowledge their representatives who have done some great work on this. When Dr. Scally last reported to the Dáil, he said that he supported the outsourcing of the CervicalCheck screening. Dr. Scally defended the standards and practices in the laboratories that he had visited, which were operating the screening services. Dr. Scally also told the Oireachtas that he defended the HSE reaction to his report and its speed at implementing his recommendations. Dr. Scally more or less defended the entire screening process. When I read this supplementary report, however, I see - by my interpretation - a condemnation of the laboratories and their standards and therefore, logically, a huge question mark over the decision to outsource and rely on private labs outside Ireland to provide the service.

At the time, tender competitions were weighted overwhelmingly in favour of low cost and turnaround times above health standards. In an ironic twist, in 2008 the Irish public laboratory at the Coombe hospital was excluded from the tendering competition because it had not yet received an ISO accreditation, which it was to receive later that year. We found out with the Scally report that CPL, which was awarded that and subsequent tendered contracts, had no ISO accreditation. There were other outsourced subcontracted laboratories that we did not know about.

There appears to be a determination by the HSE and the Minister to spin these reports in a way that takes the light away from the original decision and subsequent decisions to continue with the privatisation of a huge aspect of women's health services. Those of us who raise questions about the decision to privatise the service, about the difference in standards between the service in private or public hands, are often met with criticism and condemnation. We are told we are undermining the health service and jeopardising women availing of it. I will take no lectures from anyone about women’s health services or my attempts to shine a light on those errors. I understand that sometimes cancers may be missed for entirely genuine and reasonable reasons in any screening service regardless of who is conducting that service. It was not non-disclosure or a series of unfortunate events that resulted in tragedy for these women. It was gross and negligent error in the laboratories that should never have happened. That is not normal or understandable.

The questioning of outsourcing and the continued reliance on private for-profit laboratories when we had the choice to operate a service in Ireland in a properly resourced, high standard service in the public sector does not undermine screening. It is questioning how the private outsourced service has failed women, with catastrophic results.

On reading Dr. Scally's report I believe that serious questions remain to be answered about the continued reliance on the private laboratories. I find it astonishing that a year after this issue erupted, the State has still not fully investigated any of cases that have come to court where large settlements have been arrived at, when it is clear there was a catastrophic failure in a laboratory, and that the HSE, the Minister and the State are not interested in investigating the causes and outcomes of that failure. It is akin to a plane crashing at Dublin Airport and the State deciding that the deaths and injuries are within the norm of aviation figures and, therefore, there is no point investigating.

On the decision of the State to appeal the Ruth Morrissey High Court decision, I would like the Minister and Dr. Scally to stop misrepresenting the judgment and the term “absolute certainty”. It is outrageous that the Minister and the medical colleges are appealing this judgment. It does not mean that all laboratories must be “absolutely certain” that every screening is either positive or negative; it means that the test must be done to a correct standard and that the gross failures and negligence we have seen would not be repeated and cannot be put down to everyday errors and limitations in the screening process.

I will now turn to the issue of the tribunal. If the Minister wants this tribunal to be taken up by the myriad women who are suffering or who have suffered, and if the Minister wants to settle with the women and their families who seek justice, will the Minister give an undertaking here and now to those who are affected that if they settle their claim with the tribunal, they can revisit the case if there is a reoccurrence of their cancer? This is important. Were the Minister to give that undertaking now, it might encourage a huge number of women and their representatives to take the tribunal very seriously.

In other words, if the cancer recurs they will not be blocked from re-submitting. This is important to me because of the frustration I feel about it and I am sure it is important to women outside this House. For a whole year I have been repeatedly asking the Minister, the Taoiseach and whoever was in the Minister's seat to tell us from which laboratories the 221 misread slides come and I have been told it is coming, I will be told, it will be in the Scally report, it will be in this and that. The latest was that it would be in the Royal College of Gynaecologists report. There is still no answer but I know that the HSE and the Department have the answer. I have seen paperwork but until I get the answer here I will continue to suspect that the Minister does not want to give it to me because it will show that the bulk and a disproportionate number of gross errors have been a result of the privatisation and the outsourcing and that they will be shown to have come from one particular laboratory in the United States. I may be proved wrong, but I would like to have that answer.

It is with a heavy heart that I stand here to comment on this. I compliment Dr. Scally on doing this work and coming forward with this supplementary report and the scoping inquiry into the CervicalCheck screening programme which was just a fiasco. We now know that the latest Scally report identified that the number of laboratories involved in CervicalCheck was greater than originally believed. Initially it was believed that there were six laboratories which increased to 11 but this supplementary report established that at least 16 laboratories spread across Ireland, England and the USA were used.

The report also shows that requirements for written permission from the HSE needed before outsourcing were not met and that a laboratory used in Salford, UK, was of particular concern. What is so systemically and fundamentally wrong with the HSE, which the Minister presides over, that basic principles of good governance are blatantly ignored? The report has established that there were at least 16 laboratories and that they needed written permission from the HSE. Who in the HSE is going to be held accountable, where, when or how? The lack of accountability and of respect for people's quality of life and health beggars belief.

It also found that the right systems were not in place, or only technically in place. They were not being operated properly or did not have the expertise needed. This would not happen in a roads project - it would not be accepted - never mind talking about women’s health. Women have got life sentences. Women have died. It is unbelievable and it gets worse and worse. The Minister is still in his position, I do not mean anything personal against him but Fianna Fáil continues to vote confidence in him. I cannot believe it. Then they come in and do a double dance, giving out about him. It just does not wash.

Is the HSE going out of its way to make this situation worse than it already is? Has it learned nothing in terms of transparency and accountability? We know it has not because it gets worse by the hour. We also know that a review is being conducted by the Royal College of Obstetricians in the UK. The review aims to be an independent examination of the screening history and results and to identify if there were failures by the national cervical screening programme to detect underlying abnormal cells that could have led to cancer or to intervene at an earlier stage in the development of the patient's cancer. Where is that review now? Do we have any sense that it will be completed in the timeframe laid out in its terms of reference? How can the Minister have confidence when there is unmitigated disaster after disaster? People have died, such as Vicky Phelan, and there is the Ruth Morrissey case now where after spending so many days in court the Government is now going to appeal the judgment. It beggars belief that the Minister would force that on any family again.

I have no faith whatsoever in a tribunal. We have seen tribunals all the way back to the beef tribunal. There were acres and acres of print and millions upon millions of euro spent on barristers' fees and nothing has come out of it. What will we get out of this tribunal? I do not know, more fat cats getting fatter and more massive expenses for the State with a huge avoidance of any prosecutions of anybody, or any intention to prosecute, and no semblance of fairness or justice for the victims and their families. I have no faith in any tribunal because we have had one bad experience after another with tribunals over the past three decades. When are we going to learn? The Taoiseach brought us to a briefing recently about the Irish Bank Resolution Corporation, IBRC, one. One module has gone years over the deadline and millions of euro beyond what it should have cost. I have no faith in this gravy train. I want honesty, decency and respect for the women and their families.

The Deputy referred inadvertently to Mrs. Phelan as not being with us any more. I do not think he meant it but he might like to correct the record.

I did not mean it. I am very sorry.

As there is nobody else to speak we will move on to questions and answers. I call Deputy O'Loughlin.

Why did CPL not consult CervicalCheck in writing before proceeding with the outsourcing of tests?

I cannot second guess why a laboratory did or did not do anything. All I and this House can rely on are the findings of the Scally report which showed very serious shortcomings in respect of governance and procurement but not in respect of deficiencies. I am satisfied that Dr. Scally has established the truth in that regard. I am also satisfied that the new standards that we have in place will ensure that this will not happen again.

We need to know why they did not consult and that measures have been put in place to ensure better communication.

What other medical testing is being outsourced to laboratories outside Ireland?

I would have to check that with the HSE but I will provide the Deputy and perhaps Deputy Donnelly with a written record on that. I would not have that available to me.

I would appreciate if the Minister would let us know. What oversights of future contracts can be introduced to ensure that there is no repeat of outsourcing without permission?

That is the key question. I am very pleased that when I had a chance to meet Dr. Scally before the publication of this report I asked him was he satisfied that the new arrangements in place for quality assurance of the new contract are appropriate and meet what I refer to as the "Scally standard" and he said that he was. I am satisfied that the implementation of Dr. Scally's recommendations will ensure that this cannot happen again whereby laboratories that were not approved for use, although they may have been accredited in their country, were being used.

What can be done to prevent women having to endure the trauma and distress of court appearances when they seek compensation?

That is a very important question. We are trying to find as many alternative pathways as possible. This week I got approval from the Cabinet for the publication of the full tribunal Bill. I heard Deputy Mattie McGrath refer to it as a different sort of tribunal. The idea here is that this would be an adjudicative tribunal and an alternative to court. I intend to introduce that Bill on Second Stage in this House next week and, with the co-operation of Deputies on all sides of the House - the Deputy's party has been co-operative - I believe we can pass that legislation before these Houses rise for the summer recess and we can put this tribunal in place by the autumn which will provide women with an alternative pathway. The ex gratia scheme we have put in place is another pathway. I acknowledge that is only for the non-disclosure element. The independent assessment panel yesterday decided on the amount to be paid out for non-disclosure by the ex gratia scheme and I expect those payments to issue in the coming weeks.

When will the women within the 221 group receive reimbursement for the costs involved in them having to carry out their own independent slide reviews?

This is something I am considering at the moment. I am talking to the patient representatives, namely, Stephen Teap and Lorraine Walsh, about how this matter will be dealt with. We have an independent review of slides available for everybody to avail of through the Royal College of Obstetricians and Gynaecologists process. The last day for participating in same was 7 June. That is also due to report this autumn. Some of the patient representatives have asked me to consider reimbursement of the cost of private reading of smears and I am considering same at the moment.

I mentioned earlier that better communication is needed between laboratories and the HSE in the future. What measures will be taken to ensure there will be better communication?

The implementation of Dr. Scally's recommendations will bring that about. That is not all that needs to be brought in. A quality assurance lead must also be put in place within CervicalCheck. I heard the Fianna Fáil spokesperson, Deputy Donnelly, rightly acknowledge earlier that while in the past our CervicalCheck programme has been a great success in terms of outcomes and the decrease in cervical cancers in Ireland, it seemed to be run almost as a silo from the general health service. I agree with him and clearly that cannot continue. Dr. Scally's recommendations, the more stringent requirements that he puts in place and the implementation of same are key. I have not asked the HSE or my Department to oversee implementation, but Dr. Scally. That will prevent this from happening again in the future.

Why did the laboratories not inform the inquiry of all testing locations at the first opportunity and at the initial stage?

I am no spokesperson for the laboratories. They failed to do so, it was entirely inappropriate and I share Dr. Scally's frustration with that situation. Dr. Scally kept me informed throughout the process and I am pleased that he seems to have got to the bottom of matters and established many facts. The idea that people could not or would not co-operate is entirely unacceptable to me, to the Government and to this House.

I will make a final comment as opposed to asking a question. I thank the Minister for responding to my questions and I know that he will have to come back to me on some of them. It is so important that women have confidence in the system and have confidence that the recommendations of this report are met. In particular, every woman needs to know exactly where her smear test is being screened. Every single smear should be screened in a laboratory with a quality assurance that is developed and implemented by CervicalCheck and the HPV test should be rolled out as soon as possible.

The Minister has just said that the non-co-operation that happened is not acceptable. He was very definitive in saying that it is not acceptable to him or to the Government. We know that a lot of people did not co-operate and we know that some of those people are in the Department, some are in the HSE and some are in CervicalCheck. What was done about those people? If the same people are in the same positions we will keep getting the same results.

That is an important point. I am open to correction but from my engagements with Dr. Scally and from my reading of any of Dr. Scally's reports, I do not believe that he has suggested that my Department did not co-operate. I have had conversations with my Secretary General from day 1 about the importance of my Department co-operating in full. The Deputy is correct that at the start of his original report, Dr. Scally highlighted difficulties in accessing documents in the HSE, and I intervened to get on top of that. Dr. Scally said to me when I met with him that the CervicalCheck programme is under new management. There is a new clinical director, there is a new lead for the programme in Mr. Damien McCallion, who will be familiar to Members. Both have the trust and confidence of the patient representatives and they have my full confidence and by extension I would hope the women of Ireland would also have confidence in them. Deputy Kelly asked about this earlier and he may return to it but there is a HR review ongoing on who knew what or maybe who did not do what in the HSE at the appropriate time. That review was established by Mr. John Connaghan, and Mr. Paul Reid, as the new director general, has assured me he will see it through.

I appreciate the Minister cannot answer for everything that has gone wrong here and I do not expect him to do so but can he give me a view on why the emphasis on quality was reduced as part of the tendering process from 2010 to 2012? The Minister can see on pages 34 to 36 of the Scally report that there was a consistent reduction in the emphasis on quality and an increase in the emphasis on price. It was screening on the cheap and I do not make any apologies for saying that. How can we be sure that will not happen again? What specifically has changed in the procurement process?

I appreciate that the Deputy is being reasonable. I cannot answer for things that happened, not just before I was Minister for Health, but before I was a Member of this House in 2010. It is a cause of concern and Dr. Scally pointed out that it was a cause of concern that the ratio seemed to change quite significantly. He did not say that the safety of the screening was altered by that. I know the Deputy is not suggesting that he said that and he did not find that. He even said in his most recent report that he found no evidence of deficiencies when it came to safety. What I want to do, however, and I do not want to guess Deputy Bríd Smith's questions later, is for us to do more here in our country. I want us to see us build a national laboratory service in the Coombe Women and Infants University Hospital so we can do more here in Ireland. As we continue to outsource our services, I want to make sure that what I call the Scally standard is applied. I am satisfied that Dr. Scally is satisfied that is the case today.

The Minister has anticipated one of my questions. What exactly is he doing to ensure the slides and the testing will be repatriated? It is one thing to want it. That is fine and maybe we all want that but people want to see what concrete steps are being taken. I have said before that the decision to outsource was a political decision, not a clinical one. The decision on how to proceed should be informed by clinicians and not by political expediency.

I know the Deputy is aware of this but I want to assure her that when the HSE tried to identify additional capacity for the programme this time around, it searched everywhere, including in Ireland, to see if additional capacity could be found. The Deputy will accept that there is no additional capacity today. The Deputy is correct that there may have been at a point in the past but today there is not.

There was in 2008.

I have asked the HSE to draw up plans on how we can significantly increase the size of the facility in the Coombe Women and Infants University Hospital. That hospital is carrying out about 10% of our tests today and there is no reason, particularly with the move to HPV testing, that it could not be doing an awful lot more, coupled with investment. I am told, however, and I am awaiting more details on this, which I will share with the Deputy when I have them, that even if this process was begun today, there is probably a two or three-year lead-in time. I expect that within two or three years we could be doing an awful lot more here in our country.

If we are not training the people to carry out the tests we will not be. If the Minister is not talking to the universities then this definitely will not happen in three years. On the laboratory-by-laboratory result, this is something I asked about on the first day I raised this matter here. It is a laboratory-by-laboratory result to check for things such as cluster errors. I am not a clinician, I am using the words that clinicians use. Has that been done and can the result of that be shared with us? I and others have asked for that on countless occasions and every time we ask we are told it is not a problem, yet here we are and we still do not have it.

That point is more than fair. This has been going on for too long at this stage. My understanding is that there is a draft report on this. I am being careful with my words because I want to check this but my understanding is it has been shared with the patient representatives. They have certainly seen it and had a chance to have an input to it. I will put it on the record of the House that I want it to be made available to Deputies in this House in the next number of weeks. I will come back to all of the Deputies present here with a specific date for when it will be made available to them. There is no great mystery to this. My understanding is that, roughly speaking, the proportion tallies with the volume of work done but I will make that report available as soon as I have it.

That will be welcome. Can the Minister give a commitment that, for the future and for as long as we are outsourcing to laboratories abroad, on which my views are well known and I do not need to rehearse those, slides will not be read in a laboratory where people have not been physically present to investigate and to carry out that quality assurance? Clearly, quality assurance by phone or by whatever means was being used, was not working.

I can give that assurance because it is a recommendation from Dr. Scally and on top of that I want to give the assurance that there will continue to be a double reading of all Irish slides being read in US laboratories. That is not normal US practice but any Irish slide being read in a US laboratory will be double read. As I said, this is different to normal US practice where slides are examined by a single screener.

Why did the secondary report take such a long period of time when it was meant to be completed much more quickly? It took nine months.

The Deputy has asked me this question before and I asked Dr. Scally about this when I met him as I was conscious that the Deputy may ask me this question again. The Deputy will have a chance to ask him directly and I am sure he will do so. My understanding is that it took Dr. Scally that period of time to get to the bottom of the various questions he wanted answered.

As the Deputy will know, he is a thorough individual. As he continued to poke and prod at the issue, he found more laboratories but his report makes clear he did not receive early co-operation from a number of laboratories.

On 12 February, in a reply to a parliamentary question I tabled, the Minister stated he could confirm that Dr. Scally had indicated to him on 31 January that in the course of his work, he identified further laboratories. The Minister went on to state he was awaiting Dr. Scally's report, which was expected soon. The following day, at a meeting of the Committee on Health, when I asked the Secretary General of the Minister's Department when the report would be published, he replied it was imminent. I understood him to mean it would be the same week. It turned out Dr. Scally was in Dublin, for a meeting or something else, and he was at the Department, according to the Minister's diary, the following day - 14 February. I believe Mr. Jim Breslin, Secretary General, and that what he told me was correct, namely, that the report was imminent. If it was imminent, if the Minister believed on 12 February that it was coming soon, if on 13 February, the Secretary General believed that it was imminent, and if on 14 February, Dr. Scally was at the Department, what changed to make it four months? Was there some large revelation or did new information appear at that juncture?

I do not have anything further to add. From my recollection, although I will check and revert to the Deputy tomorrow, Dr. Scally may have written to me to say he would take some more time. Certainly, as my reply to the Deputy's parliamentary question correctly stated, I met Dr. Scally on the same day I met the 221+ group at the Department. He updated me on his work in that regard and believed that his work would be finished imminently. My Department did not receive the report until 4 June and I was not briefed on the report by Dr. Scally until 7 June.

I will recap to be helpful. On 12 February, the Minister stated the report was due. On 13 February, the Secretary General said it was imminent. On 14 February, there was a meeting with Dr. Scally and, on 15 February, he wrote to the Minister with the updated timeline. That was the Minister's final meeting with Dr. Scally until the report was published, according to the Minister's records.

There were regular meetings until 14 February, after which there was a large gap until the report came in. Did Dr. Scally give the Minister any other versions of the report before it was published?

No. While I am sticking to the advice of my official, I have no knowledge of any other version of the report.

I have raised the issue with the Minister on a number of occasions because I believe the Secretary General of the Department when he said the report was imminent. Obviously, something has changed that made it not imminent and we will have to get to the bottom of what that was.

On the Manchester laboratory, I asked Dr. Scally last week when he found out it was not accredited. He told me he would revert to me because he could not remember the date. What date was it?

I do not have to hand the date of when Dr. Scally found that out.

The Minister might ask Dr. Scally. I have asked him but he has not reverted to me. I need to know what date he found out about the non-accreditation. I know the dates he found out about the four extra laboratories but I want to know when he found out that the Manchester laboratory was not accredited.

I will certainly ask that. As the Deputy helpfully pointed out, Dr. Scally will appear before the health committee but I will certainly ask him-----

I have asked him.

I will certainly ask Dr. Scally to provide the Deputy to provide him with that information.

I want some assurance from the Minister. Dr. Scally said it was surprising and disturbing that the Manchester laboratory was not accredited. I want to know when he found out, how the Irish National Accreditation Board, INAB, was informed, and who informed it, given that it inspected the laboratory on 17 April? The INAB gave a three-year retrospective accreditation without any baseline. On behalf of the more than 91,000 women, which is the figure for those affected between 2016 and 2018, although there have been more women since, will the Minister seek a clinical assurance statement from the HSE that it is okay that the Manchester laboratory was used for all the slides and that there is no issue? The laboratory was not accredited and had no baseline for accreditation. I know the history of how it was set up.

Yes, I will certainly ask the HSE to do that. For the patient representatives, I asked that the HSE issue a statement in that regard. That was done but the Deputy is asking for a clinical view in that regard-----

A clinical statement.

I will certainly ask for that. I do not mind saying the idea of a retrospective accreditation does not sit well with me. It sounds a bit like an oxymoron. Nevertheless, I am satisfied Dr. Scally was clear there was not a safety deficiency.

I will group my final questions. Were there any changes to the governance structure in the HSE in respect of the screening programme in the months leading up to the report, or changes to personnel? When will the audit begin again? When will the Minister issue the apology to which he committed? Will he consider instructing the HSE to examine potential breaches of contract to save the taxpayer money in ongoing court cases?

On the governance structure, I am not aware of any changes but I will have to ask the director general of the HSE, which I undertake to do.

On the audit, my understanding is we will establish, as per Dr. Scally's report, a national screening committee later this year. It will interact with patients to decide how to audit appropriately, as opposed to what happened in this debacle.

On making an apology, I have done so directly to the 221 women. Nevertheless, I believe there needs to be a robust apology on behalf of the State. The Taoiseach is also very willing for that to happen and has indicated he wants to work with the patient representatives to determine how appropriately to do that. I had some initial contact with them today in that regard.

I had contact with them in the past hour.

I would like it to happen and the representatives would like it to happen. I want it to happen in a manner that is acceptable and appropriate to them. I fully apologise as Minister for Health.

On the final question, I will certainly ask the HSE to examine breaches of contract.

The Minister indicated that the tests from Ireland will now be read twice. Will we pay twice? If they are read twice, will we pay double?

I do not have access to that contractual information but whatever we pay will be to ensure there is an appropriate safety standard that meets Dr. Scally's standards.

Will the Minister find that out?

I refer to whether the State will have to pay the laboratories time and again for certainty, to be sure to be sure.

I will seek that answer for the Deputy.

In the case of the Morrissey judgment, will the Minister confirm that the award made to her will not be affected by the appeal the State is making against the judgment? There seems to be some confusion in that regard between the Minister and the Taoiseach.

There is certainly no confusion between me and the Taoiseach. In fact, I welcome the opportunity to give an assurance on the record of the House. Yesterday, a letter of assurance issued from the Chief State Solicitor's office to Ms Morrissey's legal team. While I do not like discussing individuals and do not wish to cause them distress in any way, a legal assurance was given yesterday in a letter. I now give a political assurance, on the record of the House, to go alongside that. The award given by the High Court to Ms Morrissey will be honoured, irrespective of the outcome of an appeal.

I asked the Minister the following question earlier but he might be able to answer it now. For women to find the tribunal adequate, attractive or suitable, will he give them an assurance that if they make an application to the tribunal, and they then go through chemotherapy or other forms of therapy and enter respite, they can re-enter a case to the tribunal if their cancer recurs?

I would like to be in a position to give that reassurance, although I cannot currently do so, simply because I do not have the legislation in front of me. We will debate the legislation next week on Second Stage, which will be followed by Committee Stage. I will work with the Deputy to try to provide that assurance. My initial gut reaction is that if the facts or circumstances change, it would be a new case or opportunity to explore.

It may be the same cancer, however.

I will take on board the Deputy's comments, examine the legislation and revert to her.

It is very important and I request that the assurance be given to women. The Minister may believe that it is a different case but if the same cancer occurs as a consequence of what they faced, it is not a different issue and they should be able to return to the tribunal.

If the Minister cannot give that guarantee, will he agree with me there might be a lower uptake for the tribunal?

I would not like to say anything that could in any way be accidentally misleading. I would like to look at the tribunal legislation, as drafted. It is only legislation and we will get a chance to debate it in the House and people can put forward amendments. I will revert to the Deputy directly on that. I take on board the point she is making. I want as many people as possible to see this as a viable alternative to the court process, and I hope many people will take up that opportunity.

On the 221 results and the laboratories from whence they came, can the Minister give me some idea when we will get the answer to that question? Is it coming from the Royal College of Obstetricians and Gynaecologists or in some other way?

I said to Deputy Kelly that the audit would be re-established by the national screening service. In the interests of clarity, I should have said an internal expert group on cancers is looking at that. I want to correct the record in that regard.

In response to Deputy Bríd Smith, that has been done by clinical experts. I do not believe it has been done by the Royal College of Obstetricians and Gynaecologists, as it is a separate process. There is a draft report. The patient representatives have had an opportunity to see that, which is important. I expect it to be published in the next few weeks and I will make sure it is published before this House rises for the summer recess.

Will the Minister give us the answers to the questions before it is published or will its publication be our answer?

I hope and expect its publication will answer the Deputies' questions.

On the repatriation of the service to Ireland, is it the Minister's intention to reopen on a significant scale training courses in universities and institutes of technology to train clinical laboratory technicians to meet what we hope will be a native-based service with full standards going forward?

It is my intention, once the HSE and the CervicalCheck programme have done their work in regard to what a new laboratory in the Coombe Hospital would look like, that we will put in place the entire project plan to make that happen. That will obviously have a staffing element and we will have to provide training for such staff.

In regard to the ongoing review by the Royal College of Obstetricians and Gynaecologists, the Minister said it is under way and ongoing. What is the completion date?

My understanding is that the final date for taking part in the review by the Royal College of Obstetricians and Gynaecologists was 7 June. My understanding is that it is due to be completed by the autumn. While I do not have a specific date for completion, I would expect it to be by the month of September.

Will it be published and available by the month of September?

Not to be technical about it, the first thing we will be doing is making sure individual women are communicated with. I expect that is likely to happen in the month of September. My understanding is that the Royal College of Obstetricians and Gynaecologists also will produce a composite report, which will be published. The first thing will be appropriate disclosure, unlike what has happened in the past, to the women impacted. I expect that is likely to happen in the month of September.

I ask the Minister to come back with more precise times. I presume there were terms of reference and there was a time for beginning and another time for completion. It is particularly important because this was a scoping exercise by Dr. Scally, with a supplementary scoping exercise and then the review by the Royal College of Obstetricians and Gynaecologists, all with a view to seeing whether we needed an inquiry. The Minister might recall that this was the purpose. We never decided on that because it has been an ongoing process.

To be clear, it is the intention that disclosure will start taking place to individual women in early September and a group of stakeholders, including doctors, nurses and patient representatives, has already been put in place to prepare for that. In early September, disclosure to individual women will start.

In regard to outsourcing, who makes the decision and how is it made? Which results are sent to which laboratories and from what part of the country? Is there any differentiation between public and private patients? Can the Minister clarify this?

I do not believe there is. It is an operational matter for the HSE, although that is not to shirk the question. To be truthful, as we know only 10% of slides are read in the Coombe Hospital here in Ireland, and 90%-----

I understand that. My question is, who makes the decision as to which laboratory the tests go?

I will have to ask the HSE to provide that information.

It is an important question. I would appreciate it if the Minister would come back to me to clarify how the decision is made and what differentiation there is.

In regard to outsourcing, and while I hope I am not misinterpreting him, I welcome the Minister's comments that he would like to see the service reinstated in Ireland and that he has been in consultation with the HSE in regard to doing that. Will he clarify that? What consultation has there been? What has the HSE been asked to do and what is the time span?

My view is that the Coombe Hospital has an ability, subject to appropriate investment and expansion, to do an awful lot more. Particularly as we move to HPV testing, this will provide an opportunity to look at the entire configuration of our screening programme. The HSE has undertaken to look at what the creation of a national laboratory at the Coombe would look like and the resources and staffing that would be required. I expect that very shortly, certainly in the coming months, we will receive what one might call a project plan.

That is reassuring. In regard to Dr. Scally accepting what Quest and the different companies told him, in regard to rumours that laboratories in Mexico and India were used and bearing in mind he was reassured by the companies there were only a certain number of laboratories and it turned out that was incorrect, why has he taken their reassurance that no other laboratories were being used? I have a question as to how he can be reassured. It seems somewhat naive, I would think, after his experience in regard to what he was told and not told. It would seem there are other sources of information in regard to what laboratories were used because, from reading this report, it is clear that when a report comes back to the GP or consultant, it is written on it which laboratory was used, because that is the regulation in America. How many doctors have been consulted to look at their records to see what other laboratories, if any, have been used?

That is a good question but I suggest it may be a question for Dr. Scally when he appears before the health committee. Although Deputy Connolly certainly did not say this, I do not believe Dr. Scally to be in any way naive. I believe him to be one of the most robust people we can possibly have to do this job. When he gets the bit between his teeth, he keeps on pursuing, and we saw that with the progress he has made. All I can take is his satisfaction that he got to the bottom of this in terms of the number of laboratories.

I certainly do not want to be making a comment on Dr. Scally, who has produced a good report. However, I would not be taking reassurance. It seems to me he specifically set out that it was as a result of his persistence and that of his team, and their intense questioning, that more information came out. This begs the question that if he continues his intrusive, intensive questioning, more information might come out. When would that process start?

How many claims are there to date? What is the total cost to date of running the screening service? We were given a figure in the Committee of Public Accounts but, given the payments and given the fact quality assurance involves teams travelling, presumably, to Honolulu and Orlando and to those laboratories that are still functioning, what is the cost of the service at the moment and what is the likely cost as we move on?

We do not have an accurate number for the Deputy in regard to the number of current claims but we can certainly get that to her tomorrow as it is readily available.

I might provide her with another figure which she did not ask for but which I know she will be interested in, namely, what is the backlog today in terms of the number of women waiting for their smears. The Deputy will remember that was up at over 80,000. As the latest figure given to me today is 49,130, I expect that backlog to be cleared by the end of the summer. It might be useful to put that on the record of the House.

I will come back to the Deputy tomorrow with a direct number in regard to claims. I believe it is above 90 but I do not wish to put a figure that is wrong on the record of the House.