Oireachtas Joint and Select Committees
Thursday, 5 July 2018
Public Accounts Committee
Implications of CervicalCheck Revelations (Resumed)
9:00 am
Seán Fleming (Laois, Fianna Fail)
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For this session we are joined by the HSE director general, Mr. John Connaghan; Dr. Peter McKenna, acting clinical director of CervicalCheck; Mr. Ray Mitchell; and from the Department of Health, we are joined by Mr Jim Breslin, Secretary General and Ms Tracey Conroy, assistant secretary, acute hospitals division. I remind members, witness and those in the Public Gallery to switch off their mobile phones or put them into airplane mode as they interfere with the recording system when merely switched to silent.
I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, they are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable.
Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable. Members are reminded of the provision under Standing Orders that they shall refrain from inquiring into the merits or policies of a Government or a Minister of the Government or the merits of the objectives or such policies.
While we expect witnesses to answer questions put to them by the committee clearly and with candour, witnesses can and should expect to be treated fairly and with respect and considerations at all times in accordance with the witness protocol. We are allocating up to one hour for this session so there will be five minute slots. I think people will understand that the topic might come up again as part of the general discussion with the HSE over the course of the afternoon.
I will put one question to Mr. Connaghan before the clock starts for this hour. He got a request from us for information but I do not see the response. Perhaps he can point it out to me. We asked specifically for a note in advance of today's meeting regarding the three CervicalCheck laboratories and who signed off on the forms when they were returned to the HSE. We asked for details of whether the person or persons were administrative or medical staff with relevant medical qualifications and we asked for the HSE to provide a sample of such forms, redacted as appropriate, and to explain what sign-off process was involved. Can Mr. Connaghan tell us those details?
Mr. John Connaghan:
I think we have sent in what the process is, including a flow chart, for the receipt and sign-off of samples that go to the collection point in Ireland and are then transmitted to the laboratories and what happens thereafter. It might be better if I ask Dr. McKenna to take the committee through that. The correspondence and flow chart that we gave the committee contain the answer to that question.
Seán Fleming (Laois, Fianna Fail)
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Time is tight and I am being generous, so the hour will only start after I have finished my bit, in fairness to the other members. That flow chart, which is now up on the screen, does not answer the question. It starts talking about the GP surgery and the whole way along, the forms going out and coming back. All we want to know is when the laboratories that were contracted by the HSE to work for CervicalCheck sent results back to CervicalCheck and who signed off on them on behalf of CervicalCheck to confirm the HSE was happy with the work the contractors did. Can Mr. Connaghan show me the spot where that is shown on the flow chart?
He understands my simple and straightforward question.
Seán Fleming (Laois, Fianna Fail)
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We do not need to know of the process before that.
Dr. Peter McKenna:
It is entirely possible that a smear could be taken and the report returned a medical practitioner having direct sight of it. Smears are read by laboratory technicians and may be taken by a practice nurse. If the reading is normal, the result is returned to the programme and the woman informed without any input from a medical practitioner. That is the system which is in place.
Seán Fleming (Laois, Fianna Fail)
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That is exactly my point. For those who cannot see the chart, it details that women participating in cervical screening go to the general practitioner, GP, clinics and the laboratory has a collection system involving a pre-addressed envelope being sent to the laboratory for processing. The laboratory reports are then sent to the GPs or clinics. Are the witnesses saying that when the work comes back from the three laboratories, which are essentially contractors to the HSE, nobody in CervicalCheck looks at the results from a medical point of view? Do I understand that correctly?
Seán Fleming (Laois, Fianna Fail)
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We are discussing the misdiagnoses which were marked as normal and in which cases the results do not correspond with the conclusion. Are the witnesses stating that smears went from a doctor to the laboratory and back and CervicalCheck had no medical involvement in the results?
Seán Fleming (Laois, Fianna Fail)
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Why did the senior people in the HSE not have a quality assurance mechanism in place to verify from the point of view of the HSE and CervicalCheck that the work carried out by the contractors was valid? Nobody in a public organisation for which a contractor is doing a job accepts that the work is done satisfactorily on the basis of the contractor sending back a report. Rather, the results of the work are checked. I am putting it as simply as I can. The witnesses are stating that the contracted laboratories did the work but no check on that work was carried out by the HSE.
Seán Fleming (Laois, Fianna Fail)
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Should CervicalCheck have a role in checking the results that come back from contracted laboratories?
Seán Fleming (Laois, Fianna Fail)
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I am asking about individual cases. I do not wish to waste time. The witnesses were asked a very specific question. I am dealing solely with a question asked on the previous occasion the witnesses were before the committee and also submitted in writing. The witnesses stated that it is possible that no medical staff may be involved in the process. The committee asked for the sample of forms sent back to CervicalCheck by the laboratory rather than a summary report on the number of tests carried out. Does CervicalCheck get a copy of results which are sent to doctors? Is the laboratory report for each patient sent to CervicalCheck? Does anybody in CervicalCheck review the forms sent back by the contracted laboratories from a medical point of view?
Seán Fleming (Laois, Fianna Fail)
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The patient results sent to CervicalCheck are not usually checked by a medical professional in the HSE, which writes the cheque for the work to be done on behalf of the individual patients. That is my understanding of the situation and it is part of the problem.
Mr. John Connaghan:
The Chair is correct. However, there are accredited quality assurance checks in place on a quarterly basis which look at overall quality. The Chair is correct in regard to individual cases but such cases are sent back to the doctor or practising clinician who requested the samples in the first place.
Seán Fleming (Laois, Fianna Fail)
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Okay. The hour to be spent on CervicalCheck will start now. The following speakers have indicated: Deputies Alan Kelly, David Cullinane and Catherine Murphy. Each Deputy will have a five-minute slot.
Alan Kelly (Tipperary, Labour)
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May I take the same amount of time as did the Chair?
Seán Fleming (Laois, Fianna Fail)
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I was doing my work as Chairman on behalf of the committee in bringing up the request for information we sought but did not receive.
Alan Kelly (Tipperary, Labour)
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I was joking. The comment was in jest.
Seán Fleming (Laois, Fianna Fail)
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Deputy Kelly's five minutes begins now.
Alan Kelly (Tipperary, Labour)
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The witnesses will be delighted to learn I will probably only have time to ask three questions in this round. As of 9 o'clock this morning, how many women have been identified as having been affected? That figure was at 209.
It has been reported that the independent review of the cases of 3,000 women will not be completed on schedule and is only commencing now. What is the reason for that? Why has it taken so long? If there were 300,000 slides per year and it takes five minutes to review each, a team of ten people could carry out the analysis in a few weeks even if each slide is surveyed twice and the women's slide history examined. Why was there a commitment to complete the review within a timeframe which has not been followed? Why was information on the delay not made public? Why is the review only starting now? It will not be possible for it to form part of the Scally review, which must be completed by the end of August. The Minister for Health, stated that the final Scally review must be completed by the end of August. However, these 3,000 slides will not be part of it because of the delay. Stephen Teap and Vicky Phelan, who gave evidence to the committee, are extremely disappointed and upset this morning that the review of the slides will not form part of the Scally review. Why was the review committed to on the basis of an unrealistic timeframe? When will it be completed? How in the name of God can we have a situation where Dr. Scally must report by the end of August to ensure credibility but this review will not form part of his report because of the delay? How will his review be complete without that information? How in the name of God did we end up in this situation? Who committed to those unrealistic timelines?
I have a third question which I had better ask before the Chair cuts me off. It relates to the legal cases, of which I understand there is a significant number. I remind the witnesses that the State Claims Agency, SCA, will appear before the committee next week. As I understand it, the HSE hired a legal firm, the identity of which I know, to draft a protocol for how cytology slides are given to the women affected. That protocol has been in use for several weeks. Solicitors for several affected women have gone to court to seek the release of the slides and in such cases the HSE has handed them over without the protocol being followed. These are urgent cases. All present know what that means: the women are in difficult health situations. Why is a protocol needed for the release of slides to which the women are entitled? Why is it taking so long? Why can the protocol be bypassed when a woman goes to court and takes on CervicalCheck and it or the SCA is so embarrassed that it hands over the slides? Some 80 to 90 women have sought their files from CervicalCheck and some have received access thereto.
When it comes to getting their slides they are being blocked by a protocol, which I doubt anyone has heard of up to now. Given what the Taoiseach and the Minister, Deputy Harris, said in the Dáil and the evidence given to this committee and the Joint Committee on Health, of which I am also a member, why is this protocol necessary? What is its purpose? If it can be bypassed in urgent cases why can it not be bypassed in this instance and these slides given to the women and their solicitors immediately? As I understand it, Quest Diagnostics is releasing the slides but Clinical Pathology Laboratories, CPL and MedLab Pathology Limited are in discussions in that regard in light of this protocol. According to the laboratories, the HSE, through the SCA, and this legal protocol, is holding up the provision of information to which these women are entitled.
Alan Kelly (Tipperary, Labour)
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As of now, there are 221 women affected.
Alan Kelly (Tipperary, Labour)
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Is that figure likely to increase?
Seán Fleming (Laois, Fianna Fail)
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I ask Deputy Kelly to allow Mr. Connaghan to respond as there are other members waiting to contribute.
Alan Kelly (Tipperary, Labour)
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I am just seeking clarification.
Ms Tracey Conroy:
The international clinical expert panel review is being carried out by the Royal College of Obstetricians and Gynaecologists, RCOG, with expertise also sourced through the British Society for Colposcopy and Cervical Pathology. There is ongoing daily engagement between the Department and RCOG on the details and complexities of this review. It was never intended that the RCOG review would be completed in advance of the Scally review. It was made clear from the outset, in terms of engagement with RCOG, that given the complexities of the review it could take four to six months to complete. We always knew that it would not be possible to complete it sooner and we were clear in this regard, including to Government.
Alan Kelly (Tipperary, Labour)
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It was not made clear to anyone else.
Ms Tracey Conroy:
The review is an independent clinical review. RCOG will review all of the diagnoses of cervical cancer since the programme was established in 2008, including the 1,482 cases that were notified to CervicalCheck since then and the further 1,630 registered by the National Cancer Registry which had not been notified to CervicalCheck. The review will examine the women within this cohort who were screened by the programme, which is approximately 1,856 women from within the total but that is subject to final validation within the review. The review will examine the cases of women who developed cancer and were screened by CervicalCheck. All of their screening histories will be examined. This involves reviewing all of the smears. The panel will have an algorithm for examining the smears and it will identify the number of cases in which there are discordant results. A report in each case will be provided to the women involved. The panel has its own quality assurance system and it wants to work systematically so that it can stand over this process. We have been engaging with RCOG on a daily basis since it agreed to come on board with this review.
Alan Kelly (Tipperary, Labour)
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This was not communicated----
Alan Kelly (Tipperary, Labour)
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This was not communicated outside of Government.
Ms Tracey Conroy:
We are very conscious of the need for good communications around this matter. Over the past number of weeks, RCOG has been working down through what will be involved in terms of examining the smears, files, cases histories and so on. It has been working with its own expertise in this regard while also engaging with the HSE and the Department on getting a handle on what is involved in terms of costs, timelines and so on. We are very close to finalising those matters. We have also engaged with RCOG on how best to communicate the review to all stakeholders but most importantly the patients involved. That is imminent.
Seán Fleming (Laois, Fianna Fail)
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I call Deputy Cullinane.
Alan Kelly (Tipperary, Labour)
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Excuse me, my third question has not been answered yet.
Seán Fleming (Laois, Fianna Fail)
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The Deputy had a five-minute slot and he spent it putting questions with no opportunity for answers. The five minutes allocated to each speaker is inclusive of questions and answers. I will allow a quick response to the third question.
Alan Kelly (Tipperary, Labour)
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This is ridiculous.
David Cullinane (Waterford, Sinn Fein)
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I do not mind waiting until the Deputy's third question has been answered.
Alan Kelly (Tipperary, Labour)
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I thank the Deputy.
Seán Fleming (Laois, Fianna Fail)
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I remind members that there is not five minutes allowed for questions and ten minutes for answers. We have only one hour on this topic.
Dr. Peter McKenna:
The third question concerned the return of the slides. It would be a new departure from practice that patients would look for their slides so it does not come as a surprise to me that a process would be instigated nor would it come as a surprise to me that if there are legal teams involved this process could be quite tortuous. As regards the specifics of what the process entails, I cannot tell the Deputy that but I will find out and revert to him.
Seán Fleming (Laois, Fianna Fail)
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I ask Dr. McKenna to revert to the committee on the matter before next week.
Alan Kelly (Tipperary, Labour)
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Eighty or 90 women are waiting eight weeks or more.
Seán Fleming (Laois, Fianna Fail)
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Will Dr. McKenna come back to us on the timescale?
David Cullinane (Waterford, Sinn Fein)
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I will be distinct with my questions. I am conscious in putting questions about process and cost that there is a human side to this issue and women who face a struggle every day, some in serious health difficulties. I want to send solidarity greetings to all of them. As a committee, we have a job to do. Our remit is to examine spend and value for money. If a mistake is made in the spending of State money, we have to follow up on it. That is the reason we focus on these issues but we are conscious of the human side of the matter as well.
Information we received from the National Treasury Management Agency, NTMA, on the national incident management system sets out the number of cases being taken under different categories. Under the heading, National Screening Service, it shows that there are 22 claims, 20 active, one closed and one potential claim. This information was provided a number of weeks ago. I am assuming that information has changed as Emma Mhic Mhathúna has since settled. Of the 22 claims listed, how many are still active?
David Cullinane (Waterford, Sinn Fein)
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I would rather Mr. Connaghan told me the correct figure rather than rely on what is stated in The Irish Times. Mr. Connaghan is the director general of the HSE. Will he come back to me with the exact figure before the meeting concludes?
David Cullinane (Waterford, Sinn Fein)
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I raise this issue because there are more women coming forward. We know from media coverage that in Emma Mhic Mhathúna's case the settlement was in two parts, against the laboratory, Quest Diagnostics, and the HSE. The media coverage states that the HSE accepted liability. Can Mr. Connaghan explain for what the HSE accepted liability and, also, is this the first time the HSE has accepted liability in court in any of these cases?
David Cullinane (Waterford, Sinn Fein)
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That is all I wanted to know.
Mr. John Connaghan:
That is in the case of Emma Mhic Mhathúna. The HSE also accepted responsibility for not communicating the results of the audit in the case of Vicky Phelan.
David Cullinane (Waterford, Sinn Fein)
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My understanding was that the settlement for Vicky Phelan came almost exclusively from the laboratory. Is Mr. Connaghan saying that there was a cost to the State in respect of Vicky Phelan's settlement?
David Cullinane (Waterford, Sinn Fein)
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In terms of Emma Mhic Mhathúna, it could be more substantial.
Mr. John Connaghan:
In the case of Emma Mhic Mhathúna, the total sum has yet to be apportioned between the HSE and the laboratory in question. This matter is still under discussion.
David Cullinane (Waterford, Sinn Fein)
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This is an important point. As for where this might leave us when this sorry saga is eventually complete and when every woman gets the justice she deserves, I note 28 cases are potentially before the courts and 209 women were not informed of the results. If it is the case that the HSE has accepted liability for not informing Ms Mhic Mhathúna of her incorrect smear test, as Dr. McKenna put it, does that admission of liability apply to all 209 women? As for those women who are not before the courts, how will they be compensated by the HSE? I am asking a straight question, that is, was the acceptance of liability only in the case of this individual or was it in respect of all the women? In answering that question, I want Dr. McKenna to bear in mind that when Mr. Gleeson, who was one of those people with responsibility for overseeing the process of informing or not informing the women, appeared before this committee, he did not and still to this day does not accept any mistake was made but yet in court, the HSE accepted liability that a mistake was made. There are two parts to my question. First, does the admission of liability apply only to this individual or does it apply to all 209 women? In the latter case, how will they be compensated given there is no class action opportunity in this State? Second, given that the individual who was responsible for the failure does not accept there was any failure, how will Mr. Connaghan, as the director general, deal with that problem?
Dr. Peter McKenna:
I am a little reluctant to speak about an individual case without having all the details, but my understanding is there may have been a clinical component outside of the smear programme that may have contributed to the HSE being involved.
David Cullinane (Waterford, Sinn Fein)
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That is fine but Mr. Connaghan said the admission of liability, certainly in part, was because of the failure to inform this particular individual. If that is the case, 209 women were not informed. Is the HSE accepting liability that it was a mistake, in respect of all 209 women, that they were not informed? If that is the case, how will they be compensated? Notwithstanding the other 209 cases, which Dr. McKenna can address shortly, there was an acceptance of liability in this case. The person with responsibility for this process in the HSE, however, is still to this day saying he does not accept any failure on his part, which means there was no failure on the part of the HSE. How does Mr. Connaghan square that with-----
Seán Fleming (Laois, Fianna Fail)
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I will ask Mr. Connaghan to answer that question and then I will call Deputy Catherine Murphy. If Deputy Cullinane is not happy with the answer he gets, he might have an opportunity to come back in at a later stage.
Mr. John Connaghan:
I will deal with Deputy Cullinane's question quickly. In regard to taking an opinion on one case, I would not like to venture an answer to his question without taking further legal advice on this. I do not think an individual settlement - without having legal advice on this - would tell me it applies to 209. Morally, I understand from where the Deputy is coming on this.
As regards responsibility and liability or accountability, the Scally review is currently under way and it will report by the end of August. We need to wait to see what it will state in regard to accountability.
Catherine Murphy (Kildare North, Social Democrats)
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This whole debacle started off about mandatory disclosure and women not being told their results. We are still at this point months later and people are not able to get their files. Why are they not able to get them? We have been constantly told that the HSE will give them their files. Why are we still hearing they are not able to get their files?
We now know the number of cases is 28. Is that from a cohort of 209 or 221, or are they made up from a different component?
The clinical review will require information to be transferred to be evaluated. Will that prove to be an impediment to others getting their files or are duplicates available? What issues will arise from the point of view of people getting the information that they own?
Mr. John Connaghan:
Generally, the evidence we have had, from a number of appearances before this committee on the provision of documentation, advises that this will be done against a 30-day standard for turnaround, and we are generally observing that. The last report the committee had on this indicated there is one case where we are outside that standard. I do not have an update on that as at the end of last week, but generally we are providing information that is required within a 30-day turnaround standard.
Catherine Murphy (Kildare North, Social Democrats)
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Is it true that at this stage 80 women, or their legal representatives, in that cohort of 209 women have not got their files?
Mr. John Connaghan:
We need to understand where we are against the 30-day cycle. If it involves original slides, I guess those might need to come from the laboratories, particularly if they are overseas. Regarding the provision of the documentation, the reports we have made to this committee, and the reports I have had, indicate that we are generally keeping within that 30-day standard, but we will certainly check out the detail.
Catherine Murphy (Kildare North, Social Democrats)
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Is there a difference between the HSE providing the women's files or the laboratory providing the information. Who has the information?
Dr. Peter McKenna:
Yes. There should be no difficulty in the HSE with respect to any person who requests their chart, or a copy of their data, to get it. That should be available either through the medical legal channel or freedom of information. If they are waiting for anything it is likely to be a physical slide - Deputy Kelly referred to this - there may be a difficulty in getting that material back from the laboratory.
Catherine Murphy (Kildare North, Social Democrats)
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With which the HSE has a contract.
Catherine Murphy (Kildare North, Social Democrats)
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Why would there be a difficulty with that?
Mr. John Connaghan:
Regarding Deputy Murphy's third question concerning impediments we may have, a clinical review of the documentation is under way. There should be no impediments in terms of physical documentation or physical records. I guess there could be an impediment if the Royal College of Obstetricians and Gynaecologists is looking at original slides and somebody has requested that information. There can only be one original slide, which I guess would be the impediment to which the Deputy referred.
Catherine Murphy (Kildare North, Social Democrats)
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Therefore, people could be waiting for months. Is that the case?
Ms Tracey Conroy:
We had a tripartite engagement with the Royal College of Obstetricians and Gynaecologists. The people in the HSE were involved in this process during the week and the HSE was very clear that it did not see any impediment in providing the smears within a timely fashion to the college.
Catherine Murphy (Kildare North, Social Democrats)
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However, there is an impediment. The HSE has a contract with these laboratories to carry out work. It is not that the laboratories own the slides afterwards. I cannot understand why there would be an issue with retrieving those slides or demanding that they be retrieved?
Catherine Murphy (Kildare North, Social Democrats)
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There is an issue in practice.
Mr. John Connaghan:
If there is an issue in practice, we have heard that perhaps between 80 and 90 women are waiting for physical slides to come back. If that is the case, we will check that out and report back in short order. We have already said that today. However, there should be no impediment in principle.
Catherine Murphy (Kildare North, Social Democrats)
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We hear there are 28 cases and that number is increasing, is that from a cohort of 209 or 221 women?
Mr. John Connaghan:
First, we need clarify that figure of 28. Even though we have press reports that this is the number, we still need to be able to provide clarify on that after checking that with the State Claims Agency. Once we do that we will also answer the Deputy's query on where the 28 lie against the 221 cohort.
Dr. Peter McKenna:
There is another confounding variable in the figure of 28. I do not know if that number refers to cases the State Claims Agency is aware of or that it is involved in, as they could be slightly different. If the laboratory has taken over the liability, then the State Claims Agency may not be a party to the settlement.
Seán Fleming (Laois, Fianna Fail)
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I will move on to the next speaker, Deputy Marc MacSharry, and I remind him these are short time slots.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Regarding CervicalCheck, have confidentiality agreements been abolished or abandoned?
Are we still seeking those in terms of any-----
Mr. John Connaghan:
Confidentiality agreements have not been deployed for several years. The briefing I have on this is that those confidentiality agreements have, by and large, been at the request of the plaintiff. The director of the State Claims Agency, Ciarán Breen, will appear before the committee next week and should be able to supply it with chapter and verse on that.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We will ask him about that but Mr. Connaghan is saying the HSE is not looking for them.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is that while mediation is ongoing?
Seán Fleming (Laois, Fianna Fail)
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That is just for people like Ciarán Brennan-----
Seán Fleming (Laois, Fianna Fail)
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-----next week when the State Claims Agency appears before us.
Mr. Jim Breslin:
Exactly. What would often happen in mediation would be that the process itself would be confidential so people could try to reach an agreement and offer positions that would allow that to happen. What can happen at the end of that, particularly where dependents are involved, is that the outcome would be registered in the court so the actual outcome would be a public outcome. The State Claims Agency, which has claims delegated to it and handles all the mediation and court processes, will be able to work this through with the committee next week in full detail.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We will ask it. However, the point is that we are not looking for-----
Mr. Jim Breslin:
Absolutely not. The confidentiality aspect of a plaintiff is really that the individual does not want his or her name out there but details of the settlement could be out there without divulging the person's identity. That is the person's right. It is not something the State would impose. The principle of open disclosure requires us not to push confidentiality agreements. I think the State Claims Agency has clarified that in recent days.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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With the audit happening, if a woman is unfortunate enough to be diagnosed, is there now a working protocol in place for informing that woman? Who is telling these women?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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If somebody is diagnosed now, is there a very clear protocol in place whereby the physician or CervicalCheck tells the patient? What is the protocol and is it working? Has a new one been put in place since this debacle?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is that a "No"?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is it fair to say that despite the debacle we have had, we are waiting until everything is over before we put a definite protocol in place?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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And no protocols have been put in place in the mean time.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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That did not really happen, as we know. What I am trying to establish is whether the HSE at management and director level has said that if this happens again, "You will do this and I will do that and this is how it will work out." Has that happened?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I think, as a recommendation, we could be pioneering, not to have to wait for the Scally review, apply basic common sense - I have no clinical training - and put a protocol in place notwithstanding the good recommendations of Scally or anybody else. At this point, has anyone in the HSE been held to account or is it the same answer in terms of waiting for Scally and other reviews? Are any disciplinary proceedings under way? Are there any issues being dealt with in that regard?
Mr. John Connaghan:
I have had some discussions on this very briefly with Dr. Scally. The HSE is currently considering a post-Scally review and how we will put in place a conduct investigation. We have a national protocol agreed with our staff representatives that generally applies to any conduct investigation. We must be very careful about how we observe that national protocol. We will wait until after the Scally review. These remarks are entirely neutral.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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The answer is-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It is possible, if not likely, or likely.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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That is all for now.
Catherine Connolly (Galway West, Independent)
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On the last occasion Mr. Connaghan was here, we talked about the general answering service and how it was overwhelmed. Is it still overwhelmed?
Catherine Connolly (Galway West, Independent)
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It is for general queries from women who are worried and are ringing in.
Dr. Peter McKenna:
The short answer is that there were 14,500 phone calls, the vast majority of which have now been returned as of the end of last week. I think there were only about 200 phone calls outstanding. We expect that these will be dealt with this week. There are a further 50 calls that are not call backs. They are clinical consultations. These clinical consultations are much more detailed and involve a lengthy conversation with a consultant. These will take a bit of time to get through but the call back for the generality has been addressed.
Catherine Connolly (Galway West, Independent)
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With regard to the suspended audit, there is no ongoing audit at the moment. Is that right?
Catherine Connolly (Galway West, Independent)
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This arose as a result of the Vicky Phelan case following an audit, the results of which were not communicated. Is that not right?
Catherine Connolly (Galway West, Independent)
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There was an ongoing audit. Results came forward, there was then the debacle about who should tell the women and nobody told the women. Is that correct?
Catherine Connolly (Galway West, Independent)
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That is it in a nutshell.
Catherine Connolly (Galway West, Independent)
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At the moment, nobody is reviewing smear tests. The results are coming back from the lab and CervicalCheck is just accepting those. Is that right?
Catherine Connolly (Galway West, Independent)
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No, just listen to my question. We know all of that. When CervicalCheck carried out its audit, it found things that were wrong. There is no audit at the moment so who is finding out what things are wrong at the moment?
Catherine Connolly (Galway West, Independent)
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CervicalCheck discovered matters from the audit. There is no audit at the moment so what quality assurance is in place? How is CervicalCheck finding out whether something is wrong?
Catherine Connolly (Galway West, Independent)
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I understand that. As a result of the retrospective audit, we have these cases. How many women are affected?
Catherine Connolly (Galway West, Independent)
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At the moment, could there be another 221 cases if another retrospective audit was done?
Dr. Peter McKenna:
What will inevitably happen is that each month, there will be some women who will be diagnosed with an interval cancer. They will have been screened, the screening will have failed and they will be diagnosed with an interval cancer. They should be looked at and they should be informed. That will be done outside of the screening programme. How that is doing within the screening programme will await direction from Scally, which should report on that matter shortly.
Catherine Connolly (Galway West, Independent)
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That is worrying. The audit is suspended so nobody is checking.
Catherine Connolly (Galway West, Independent)
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But when the diagnosis is wrong, as was the case in 221 cases, that was discovered by a retrospective audit.
Catherine Connolly (Galway West, Independent)
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Sorry, I beg your pardon - the retrospective audit identified that the analysis was wrong.
Catherine Connolly (Galway West, Independent)
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That is not happening now.
Catherine Connolly (Galway West, Independent)
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So let us go back to quality assurance, which was teased out earlier on. When the results come back from the labs with which CervicalCheck has the contracts, it simply accepts them because they have their own quality assurance. Is that right?
Catherine Connolly (Galway West, Independent)
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Where does it get that from?
Catherine Connolly (Galway West, Independent)
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I understand all that and we get that every week - that all the processes are in place. What happened though was that 221 women did not benefit from that. It was quite the opposite. What I am trying to get here is that the system accepted the results of the smear tests coming from the labs and now there is a serious question over the quality assurance and the checking of that. Is that right? There has to be a serious question on quality control with 221 women affected and more going to come to light. Am I using the wrong language?
Catherine Connolly (Galway West, Independent)
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No, Mr. Connaghan, I have only five minutes and we have been through that a thousand times. We are talking about the women affected. Despite everything Mr. Connaghan talked about and despite the quarterly reports, something has happened here that this has failed. That was not picked up by CervicalCheck nor by the HSE. It came to our attention as a result of Ms Vicky Phelan speaking out and more women then coming forward. Is that not right? The internal mechanisms have not worked.
Catherine Connolly (Galway West, Independent)
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That was part of the failure but it came from the retrospective audit.
Dr. Peter McKenna:
I think the difficulty is in distinguishing what is considered "an acceptable rate of failure" from what is an unacceptable rate of failure. Where women are being compensated, on the look-back it is considered that, possibly, there was no reason this should not have been noted or the number of times in which it was overlooked was unacceptable.
Catherine Connolly (Galway West, Independent)
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On the confidentiality agreements, and this is my last question, it was said that they have not been used in the last number of years. Is that in every case and not just in cervical smear tests? I understand, first of all, that Ms Vicky Phelan said that she was asked to have a confidentiality clause. Is Mr. Connaghan saying, openly, that the HSE has not used confidentiality clauses for years?
Seán Fleming (Laois, Fianna Fail)
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Would the involvement of the laboratory have been an issue?
Mr. Jim Breslin:
That is the core of the Ms Vicky Phelan case. The laboratory insisted or put forward a confidentiality clause but the State Claims Agency did not and argued against that. Ms Phelan - and we all owe her great credit - stuck by her guns and insisted that there would be no confidentiality clause. The State Claims Agency did not seek that clause and I think it will confirm that when it is before the committee next week.
Seán Fleming (Laois, Fianna Fail)
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I call Deputy Jonathan O'Brien.
Seán Fleming (Laois, Fianna Fail)
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I thank Mr. Connaghan.
Seán Fleming (Laois, Fianna Fail)
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I thank Mr. Connaghan and I call Deputy O'Brien.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I have two questions. The first one is on human papillomavirus vaccine, HPV, testing. The proposed roll-out date we were looking at was in October. Will Mr. Connaghan give us some information on whether we are still working towards that timeline?
Mr. John Connaghan:
There are three or four elements on the critical path for that roll-out. The first is the service specification, the second is the preparation of tender documentation and the third part is, after tender, mobilisation. Those are three things on the critical path. I am not able at this stage to tell Deputy O'Brien the time elements of each of those. There are some things in play which we are going to try to deploy to speed things up. Regarding tendering, there is a possibility that we can go for a negotiated contract which would truncate the tendering process. We are considering that right now.
We need to tidy up the service specification and the tender documentation needs high level clinical input, so we need to have a clinical director for the CervicalCheck part. We are working on that and we might have some news next week. If that is the case, once we get that clinical input, authority, accountability and responsibility, it will allow us swiftly to close off the position in the service specification and to tender. If we can go to a negotiated contract, then that might be the best way forward in getting HPV testing in place quickly. There is also an element here of the capacity of each of the labs. On what we want in respect of resilience, I have already given advice in response to a question raised by Deputy Catherine Connolly earlier. My view is that we should have at least three or four.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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There are a number of things in play, we are still working towards the October roll-out, but that is based on progress over the next couple of months. Is that right?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I just want to check something Mr. Connaghan said earlier about the original 209 women. I think my colleague, Deputy David Cullinane, asked if the HSE had accepted liability for any part or role in respect of those 209 women, outside of Ms Vicky Phelan and Ms Emma Mhic Mhathúna. Mr. Connaghan said that is correct to the best of his knowledge. Is that right?
Mr. John Connaghan:
Yes. My advice to Deputy Cullinane was that I know that the HSE has accepted liability for not providing the audit results. Dr. McKenna has got further advice that there may be a clinical element to that and I would need to study all of the judgments to be able to give Deputy O'Brien a proper answer to that question.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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As far as Mr. Connaghan is aware, did one of those 209 women settle a case in March 2017?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I suggest that we should look at those 209 women because the information I have is that at least one of those women settled a case against the HSE in March 2017. It was not against the labs, it was against the failings of the HSE in not referring her to a gynaecologist-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Yes, it was in respect of smear tests. She was also asked to sign a confidentiality agreement. That was in March 2017. One person I have met personally has told me that. It is my information that there are a number of other women in similar situations. I have yet to meet them but I am in the process of meeting with them. If we are giving out information then we need to be 100% sure that it is accurate because I am sure Deputy Alan Kelly also has information that some of those 209 women have settled previously, before Ms Vicky Phelan's case became public knowledge, and have also been asked to sign confidentiality agreements.
I know that at least in one instance, the woman that I met, a case has been taken against the HSE for failings in CervicalCheck in not being referred to a gynaecologist and then developing cancer. She is now, thankfully, in remission but she took a case, settled in March 2017 and signed a confidentiality agreement. Perhaps the witnesses could come back with some additional information on those 209 women as regards exactly how many of them have taken cases against the HSE previously and been awarded settlements? Those are the only questions I have at the moment.
Seán Fleming (Laois, Fianna Fail)
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We are finished at this stage but we have a quick five minute slot for Deputy Kelly and Deputy Cullinane, and then Deputy Catherine Murphy as well. It is a strict five minutes because the time is up.
Alan Kelly (Tipperary, Labour)
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I have a couple of comments. I find it unbelievable that the witnesses cannot provide the information relating to this protocol today.
Why is the protocol being pushed legally, particularly when it is preventing women from getting their slides? Why can some solicitors representing women go into court and get the slides, thereby bypassing this protocol? I do not understand how Mr. Connaghan cannot provide that information.
I understand what Ms Conroy is saying regarding the review of the 3,000 cases. That is fine. These are the words of Vicky Phelan and Stephen Teap this morning. They are surprised and disappointed and they were not aware of this. It is not me or any other member of the committee saying this. Whatever is going on, it had been expected that this would be completed by the end of May and would form part of the Scally inquiry. It was not completed by the end of May. When will it commence? We now know that it is not part of the Scally inquiry. Scally is already incomplete and a large chunk of the inquiry will be irrelevant.
On the previous occasion he was here, Mr. Connaghan said that he had to catch up with and meet Dr. Scally. I presume he has done so on numerous occasions. Has he visited Limerick? Will Mr. Connaghan confirm that when Dr. Scally reports, he will not say that one reason he could not complete his report - which he will not be able to do - is because he was not provided some information by the HSE? I want Mr. Connaghan to guarantee that Dr. Scally's review will not be able to say that at the end of August and that the HSE will have provided everything.
On the admission of liability in respect of non-disclosure of information, we know from Emma Nic Mhathúna's case that this has been admitted. Will that be the standard for all other cases?
Given what was said by a previous speaker, my next question is very important. The State Claims Agency's clinical risk advisers met CervicalCheck in March 2017. Why did the HSE not reveal the risk of this audit at that point?
Mr. John Connaghan:
On the provision of information, there is no intention to hold anything back. Everything we have in our remit or within the HSE will be provided to the Scally inquiry. The Deputy may not be aware that we sought and received agreement from the Minister that we will deploy section 40(c) of an Act, the name of which I have forgotten at this moment, that will allow us to send everything to Dr. Scally on an unredacted basis, save matters covered by patient confidentiality. I have recently advised Dr. Scally of that. The answer to the first question is that we will not hold anything back.
Will the Deputy remind me of the second question?
Alan Kelly (Tipperary, Labour)
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I asked for clarification on meetings with Dr. Scally and with the lads in Limerick.
Alan Kelly (Tipperary, Labour)
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My other questions relates to the protocol on the slides and the issue of the review of the 3,000 cases, which, I presume, Ms Conroy will answer. The third question relates to the meeting in March 2017 regarding clinical risk and admission of liability.
Alan Kelly (Tipperary, Labour)
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That is not what I asked. The State Claims Agency and the clinical risk advisers met with CervicalCheck in March 2017. Why did the HSE not tell them that there was a risk?
Alan Kelly (Tipperary, Labour)
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It is public knowledge.
Seán Fleming (Laois, Fianna Fail)
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Mr. Connaghan will need to check that out because it has been mentioned extensively here in the past. Mr. Connaghan will need to come back with a written response to that in the next week.
Alan Kelly (Tipperary, Labour)
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I am sorry, Mr. Connaghan should know this information.
Alan Kelly (Tipperary, Labour)
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Ms Conroy might explain what RCOG means.
Seán Fleming (Laois, Fianna Fail)
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In the UK, it is not the Irish royal college.
Ms Tracey Conroy:
Yes. We fully accept the need for clear communications with patients and all stakeholders. We have been working through, with the RCOG, the detailed processes, costs and timelines. Its finalisation is imminent. We have been engaging with the RCOG on the need for clear communications and for it to work on that. It includes a narrative that explains exactly what the review is, its scope, what it will involve, its timelines-----
Alan Kelly (Tipperary, Labour)
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Will it refer to Vicky Phelan and Stephen Teap?
Alan Kelly (Tipperary, Labour)
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How is it that the two people who have inspired this most - who appeared before this committee and sat where Ms Conroy is sitting - came to believe that this would be completed by the end of May? How can Ms Conroy think that Departmental or HSE communications are working?
Alan Kelly (Tipperary, Labour)
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It is not working.
Alan Kelly (Tipperary, Labour)
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My other questions relates to admission of liability and protocol.
Seán Fleming (Laois, Fianna Fail)
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Those are the Deputy's final questions.
Alan Kelly (Tipperary, Labour)
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I presume Mr. Connaghan will respond to the question on admission of liability and the protocol. I asked how he does not know about the protocol when I know about it? Why is it necessary? Is admission of liability standard for non-disclosure of information in all cases of this nature. Those were my specific questions.
Alan Kelly (Tipperary, Labour)
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No. As the chief executive of the HSE, Mr. Connaghan, when asked to come before the committee to discuss this matter, cannot say "I will get back to you". That is not acceptable to the public or to the women affected and their families. He is not doing his job if he cannot at least give basic answers to these questions.
Alan Kelly (Tipperary, Labour)
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What about the admission of liability?
Dr. Peter McKenna:
The HSE has apologised to the patients who did not get the disclosure, and for the delay. It is a different thing to issue an apology and attach a monetary value to that.
Alan Kelly (Tipperary, Labour)
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I am not asking that; I am asking whether it is standard practice in order that people will know whether this is the case. A precedent has already been set. I presume that the answer is "Yes", but I just want clarification.
Seán Fleming (Laois, Fianna Fail)
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It will be clarified before the day is out.
David Cullinane (Waterford, Sinn Fein)
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We have our job to do. I understand that much of this information is changing constantly. There are court cases that are quite complex, with different nuances in individual cases. I accept that. Nevertheless, we are trying to establish the facts at any given time.
I return to the number of claims. The Irish Times reported a figure, which was accurate at that time, to the effect that there were 28 active cases, two potential cases and one that was settled, so a total of 31. When Mr. Connaghan helpfully provided clarification to the committee earlier, he said that he has since had an update and that there are now 35 active cases, two potential cases and three have been settled, which is 40 in total. Am I correct in assuming that the number of new cases is increasing quite rapidly with each passing week?
David Cullinane (Waterford, Sinn Fein)
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It has gone up by nine cases in this instance.
David Cullinane (Waterford, Sinn Fein)
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Has the figure of for the women affected increased?
David Cullinane (Waterford, Sinn Fein)
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Earlier, when I put the question of admission of liability, Mr. Connaghan said that he understood the moral thinking behind the question. That is fine but we are not here to discuss either his moral thinking or mine for that matter. We are here to discuss process failures which led to potential liability and what the cost might be to the State. I understand that he might not have the full details of each case. In the case of Emma Nic Mhathúna, however, Mr. Connaghan clarified and accepted that there is liability on the part of the HSE and that an element of what happened was due, perhaps, to medical negligence - he does not have full details in that regard - and that another aspect involved her not being informed of the result of her smear test on foot of non-disclosure. A monetary value was attributed in respect of the latter in court. How many of the other 221 women were not informed of the results of their smear tests?
David Cullinane (Waterford, Sinn Fein)
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Will Mr. Connaghan give it to us again?
David Cullinane (Waterford, Sinn Fein)
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No, prior to this.
David Cullinane (Waterford, Sinn Fein)
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Dr. McKenna has stated the HSE is not in a position at this point to put a monetary value on it. However, in at least one of the court cases a monetary value was put on the individual not being informed of her smear test results. Logic dictates that, for all of the women among the 220 plus who were not informed, a monetary value will attach at some point. Forty cases have been or are before the courts. What about the women who are not before them? How will they be compensated?
David Cullinane (Waterford, Sinn Fein)
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I am sorry, but will Dr. McKenna say that again?
David Cullinane (Waterford, Sinn Fein)
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I find it extraordinary that no one in the Department or the HSE-----
David Cullinane (Waterford, Sinn Fein)
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Mr. Breslin might be of assistance.
Mr. Jim Breslin:
I can tell the committee what I know as of last week about the case in question. However, I do not want to go too far into just one case. My briefing by the State Claims Agency is that from the start it conceded liability for the non-disclosure of the clinical audit. To try in the particular circumstances of the case to reach a settlement as quickly as possible, the State Claims Agency and the laboratory agreed to reach an overall settlement with the plaintiff to allow the case to be closed.
David Cullinane (Waterford, Sinn Fein)
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I understand it was an overall settlement. I do not want to go into the details of the figures for an individual-----
David Cullinane (Waterford, Sinn Fein)
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Will a monetary value be put on the admission of liability for not informing the individual?
David Cullinane (Waterford, Sinn Fein)
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If the answer is "Yes," why would it not apply to the cases of all 220 women?
Mr. Jim Breslin:
Dr. McKenna has also stated there may be features. We do not go into this level of detail of clinical and personal issues in individual cases, but there may be an issue above and beyond the non-disclosure in terms of clinical management, of which I was not aware. The Deputy is quite right, that there is a sequence, but we need to be careful not to get to the end before we work through all of the issues with the State Claims Agency. We have one case and it was last week. We have to stand back, consider and assess it and then come to conclusions. Doing it in the rapid way that might across the floor here could lead to us ending up in a place where none of us would want to be.
David Cullinane (Waterford, Sinn Fein)
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I am sorry, but if-----
David Cullinane (Waterford, Sinn Fein)
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I accept that. I have a further question on this matter and I will then finish. I have no difficulty in stepping back, evaluating and learning from the court judgment in this case, but the committee has to consider the potential cost of an accepted failure by the HSE. Can a note be given to the committee to help us understand it? My question is valid and obvious. If a monetary value is attached to non-disclosure in at least one case, it may also be attached in others. That is my point.
I have a question for Mr. Breslin-----
Mr. Jim Breslin:
May I say something about that matter? The legitimacy of the Deputy's question is plain to me. The only risk is in doing it in real time. Being fully apprised of the matter, having a clear understanding of the liabilities and where they fall between the laboratory and the State - the State Claims Agency will be part of it - and then accounting to the committee is the right thing to do. However, if we do it in real time, we risk misstepping.
Seán Fleming (Laois, Fianna Fail)
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We will ask the State Claims Agency to address this matter in advance of next week's meeting. As we are running out of time, I will ask our final two speakers, Deputies Catherine Murphy and Catherine Connolly, to put their questions one after the other and the witnesses to take them together in their final answers. There will be a further opportunity in the afternoon.
Catherine Murphy (Kildare North, Social Democrats)
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It might not be that easy to do.
Catherine Murphy (Kildare North, Social Democrats)
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I want to discuss the point I pursued with the witnesses previously regarding the slides. They separated two elements, telling us that the medical files were one matter, while the slides were another. I have examined the contracts with Quest Diagnostics and MedLab Pathology. They are similar, if not identical. Under the heading of "Storage and Disaster Recovery" on page 12, the contractor shall at the request of the national screening service forward eligible samples stored by the contractor or on the contractor's behalf to the national screening service or any third party specified by the service in a manner prescribed by it within three working days. It seems clear from this that the national screening service is in control and ownership of the slides. Why is there any question of a delay when the contract is clear about the contractors' obligations and the service's rights?
On radio in the past half hour, the solicitor for Vicky Phelan stated the HSE was holding up the protocol to agree to the release of slides and that, until this occurred, they could not be reviewed by clinical cytologists. Is the HSE holding it up and, if so, why?
Someone made reference to an apology, but an apology is hollow if it is not followed through with actions that will give it meaning. We are being given the runaround on some of our questions. The contract is clear, but we are not being given clear answers about the protocol. If it is being held up, any claim about dealing sincerely with people who may have been harmed by the State is hollow. Will the witnesses answer my question on the protocol?
Seán Fleming (Laois, Fianna Fail)
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I will call Deputy Catherine Connolly afterwards.
Mr. John Connaghan:
If there is a requirement to provide slides within a timely period, we should do so. I am not aware of the individual circumstances of the case outlined by the Deputy in terms of a hold-up. That should not be the case. I advised previously that, in respect of the 80 to 90 cases that may be in train, we would look at that issue immediately.
Catherine Murphy (Kildare North, Social Democrats)
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Does the HSE talk to the laboratories? Does it tell them that it wants the slides to be made available within three days as per the terms of the contract?
Catherine Murphy (Kildare North, Social Democrats)
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Yes.
Catherine Murphy (Kildare North, Social Democrats)
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Has the HSE done that?
Catherine Murphy (Kildare North, Social Democrats)
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Therefore, CervicalCheck is separate from the HSE. To whom am I speaking about responsibility today?
Mr. John Connaghan:
No, CervicalCheck is a part of the HSE. What I am saying is that local managers would request the slides directly from the laboratories for provision for the patients.
Catherine Murphy (Kildare North, Social Democrats)
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Have they done that?
Seán Fleming (Laois, Fianna Fail)
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Will Dr. McKenna help? He is the acting clinical director.
Alan Kelly (Tipperary, Labour)
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Why was a separate legal firm hired to do this?
Seán Fleming (Laois, Fianna Fail)
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Will Dr. McKenna do his best to get an answer for us during the course of the meeting?
Seán Fleming (Laois, Fianna Fail)
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We expect Dr. McKenna to make some inquiries-----
Catherine Murphy (Kildare North, Social Democrats)
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About the protocol.
Seán Fleming (Laois, Fianna Fail)
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-----after the break.
Alan Kelly (Tipperary, Labour)
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He has already said he will revert to us. I have asked for it twice.
Seán Fleming (Laois, Fianna Fail)
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During the course of the day. We will have time to revert to this matter. Deputy Catherine Connolly can make a final comment.
Catherine Connolly (Galway West, Independent)
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I have a comment and a question. As a process, we dragged out the three memorandums that existed. Thanks to Ms Vicky Phelan and the other brave women who came forward, things are emerging. Now we are quoting a solicitor. It does not build confidence. When Mr. Connaghan was before us a few weeks ago, I made this point to him. It is not helpful. Moreover, Dr. Scally had to come forward publicly and state he was not getting co-operation and he was not getting the information. Bit by bit is the way this is proceeding.
My specific question is on the audit. I am trying to tease this out. Is the audit process now suspended?
Catherine Connolly (Galway West, Independent)
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It was the audit process retrospectively that discovered the mistakes.
Catherine Connolly (Galway West, Independent)
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If there is no audit process, there is no discovering of mistakes.
Catherine Connolly (Galway West, Independent)
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We wait for the cancer to develop.
Catherine Connolly (Galway West, Independent)
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Dr. McKenna waits for the cancer to be caught?
Catherine Connolly (Galway West, Independent)
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There is a misunderstanding here on my part. The cases that are increasing all of the time, which in number are now up at 221, have come to light as a result of the audit process.
Catherine Connolly (Galway West, Independent)
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Okay. That audit process has now been suspended.
Catherine Connolly (Galway West, Independent)
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Why has it been suspended?
Dr. Peter McKenna:
It has been suspended because the process of the audit has come in for a huge amount of criticism, in that at the start of the audit process it did not have built into it full disclosure to the patient. When the process started, it did not engage with the clinicians who were subsequently delegated to inform the patient that her previous slide had been re-categorised.
Catherine Connolly (Galway West, Independent)
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We saw all that from the memorandums.
Catherine Connolly (Galway West, Independent)
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It was all outlined in the memorandums. It was more concerned about the communication process-----
Catherine Connolly (Galway West, Independent)
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-----and avoiding screaming headlines. Notwithstanding those difficulties, those memorandums are totally unacceptable. At the time, I asked Mr. Connaghan had he read them.
I will stick with the audit. Is it correct that the HSE is suspending an audit process that discovered problems because the protocol around who should talk to the patients has not been agreed?
Catherine Connolly (Galway West, Independent)
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As happened, smear test results might come back saying "All clear" but that was not the position. They were not all clear. There was cancer but the result of the smear test said it was clear.
Catherine Connolly (Galway West, Independent)
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Until the audit was done.
Dr. Peter McKenna:
No. There may be a misunderstanding here. Perhaps I have not made myself clear. The patient would be diagnosed with cancer clinically and then there would be a look-back and it would be seen that the smears could be re-categorised into a more severe level of abnormality. But the patient is diagnosed with cancer.
Catherine Connolly (Galway West, Independent)
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On the cases that the audit was done.
Catherine Connolly (Galway West, Independent)
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In looking back, it was discovered then that they were not informed in time.
Catherine Connolly (Galway West, Independent)
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That whole process has been suspended now, pending sorting all of this out.
Catherine Connolly (Galway West, Independent)
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I thank Dr. McKenna.
Seán Fleming (Laois, Fianna Fail)
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At this stage, we will move on to the main item of business. I understand it might require some change of witnesses. It is 10.45 a.m. The intention is to proceed until the Dáil voting session. I propose we suspend for ten minutes because we cannot go from 9 a.m. to 1 p.m. without some break. Is that agreed? Agreed.