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COMMITTEE OF PUBLIC ACCOUNTS debate -
Thursday, 14 Jun 2018

Implications of CervicalCheck Revelations (Resumed)

Mr. John Connaghan (Acting Director General, Health Service Executive) and Mr. Ciarán Breen (Director, State Claims Agency) called and examined.

We are joined today by the Comptroller and Auditor General, Mr. Seamus McCarthy.

We have restructured today’s engagement with Nursing Homes Ireland on the National Treatment Purchase Fund to deal with a matter arising out of correspondence following our meeting with the Health Service Executive and the State Claims Agency. We have asked representatives from the HSE and the State Claims Agency back to explain an apparent conflict in evidence and we will deal with this matter first. Following that, we will have a short engagement with Nursing Homes Ireland to inform our examination of the National Treatment Purchase Fund financial statements in the afternoon. We will take other business of the committee separately at an appropriate time during the meeting.

The first item on the agenda is matters relating to CervicalCheck and evidence given to the Committee of Public Accounts. We have invited representatives from the HSE and the State Claims Agency to provide clarification in respect of a contradiction in evidence given by the two bodies to the committee at our meeting of 17 May. As Chairman of the committee, and I know I speak for all of the members, I have to say that if information given to us is inaccurate or misleading, we regard it as a most serious matter. Witnesses do not give evidence just to the eight or ten people in the room but to the national Parliament on the public record while representing a State organisation. It is even more serious in this case as it relates to one of the most significant health issues we have experienced in many years. If we suspect that any witness has failed to provide accurate information to us, we will engage with him or her again until we are satisfied that we have obtained clear and correct information.

We are joined today from the HSE by Mr. John Connaghan, director general, Dr. Stephanie O'Keeffe, national director of strategic transformation and planning, Mr. John Gleeson, programme manager of CervicalCheck, Mr. Paul Connors, national director of communications, and Mr. Damien McCallion, national director of the national screening service. We are joined from the State Claims Agency by Mr. Ciarán Breen, director, Mr. Pat Kirwan, executive head of business development, Ms. Jenny Foley, solicitor and clinical claims manager, and Dr. Cathal O’Keeffe, head of clinical risk. We also have Ms Celeste O'Callaghan and Ms Mary Jackson from the Department of Health. We did ask the State Claims Agency for its legal representatives to be present but we received correspondence - No. 1376 - from Mr. Breen explaining why they are not here today. He might elaborate on this during the course of the meeting. I understand Mr. Breen is fully informed and in a position to answer all questions that would have been directed to the agency's legal representatives in any event.

I remind members, witnesses and those in the Public Gallery that all mobile phones must be completely switched off or placed on aeroplane mode.

I advise the witnesses 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 this committee. If they are directed by the committee to cease giving evidence in relation to 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 asked to respect the parliamentary practice to the effect that, where possible, they should not criticise nor 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 provisions of Standing Order 186, that the committee shall refrain from inquiring into the merits of a policy of the Government or a Minister of the Government or the merits of the objectives of such policies.

While we expect witnesses to answer questions put by the committee clearly and with candour, witnesses can and should expect to be treated fairly and with respect and consideration at all times, in accordance with the witness protocol.

The committee was given clear views at the previous meeting but the matter of clarification has been mentioned. If something on the record is not correct, we want the record corrected. Clarification, expansion, further explanations and more information are not the issue. If information on the public record is not exactly right, the record must be corrected. If inaccurate information has been placed on the record, the committee will require an apology because this is the record of the national Parliament. Talking around the issue or expanding on it will not deal with the inaccurate information on the public record. I make this point clearly because witnesses often believe that if they expand on statements made at a previous meeting, it will explain the context. However, if the record is not correct, it must be corrected and appropriate action must be taken by the relevant witnesses.

I will set out what happened regarding our previous meeting with representatives of the Health Service Executive. The committee received a letter from the State Claims Agency after the meeting stating Mr. Gleeson's assertion did not accord with the facts.

Is the Chairman reading from the letter of 22 May?

Yes, and that is the only sentence I will read from it. What is really troubling before we even start, and I say this to all public bodies, is that when the witnesses left the room they may have been in doubt about whether what was said was accurate. The HSE should have reverted to us with a statement setting out the exact position and clearing up any confusion that arose.

Representatives of the HSE would not even be here today if the State Claims Agency had not written to us. If it had not written to us, we would not know we had not been given fair evidence with full candour. If representatives of public bodies ever leave the committee room, go back to their offices and think that perhaps they did not explain a particular point, they should write to us and correct the record straight away rather than leaving us to pick it up from a third party. I think the witnesses understand that general principle. I say it to all representatives of public bodies who appear before the Committee of Pubic Accounts.

At the meeting of 17 May, Deputy Jonathan O'Brien asked questions about who in the HSE, CervicalCheck and the State Claims Agency attended various meetings or spoke with people. People watching proceedings will not remember that particular exchange. We will ask the communications unit to play an extract of the meeting on screen so people will remember the precise issue we are talking about.

Members viewed a video presentation.

That is a recording of the conversation we had at that meeting. The witnesses will understand that we left the room with a clear impression. We want the record corrected with regard to this matter. The public expects that when senior Department officials and officials from State agencies attend here there is a level of truthfulness and candour. We are entitled to believe it. We accept all the evidence we get in good faith. It is a source of major concern to us when we are alerted by somebody else that the evidence given may not have been accurate. That is why we have a duty, not only in this case but in cases involving all witnesses who come in here from week to week, to make sure evidence is accurate. If it is not accurate, witnesses should come back to us as quickly as possible and correct the record. That did not happen in this case. That is why we are here today. It adds to an issue involving delayed information and women not being informed when the national Parliament is not adequately informed. It gives a very bad impression of how the HSE is dealing with the issue. It is Mr. Connaghan's responsibility to take that forward.

At this stage, Mr. Connaghan wants to make a short statement, followed by Mr. Gleeson. Deputy O'Brien will then be the first speaker for ten minutes. We are doing ten-minute slots.

Mr. John Connaghan

Would it be acceptable, in the interest of time, - I know the committee has a busy day - to take my statement and that of Mr. Gleeson as read if they are on the record? Would that be okay? It would save about ten minutes.

It might be helpful if Mr. Connaghan sticks to the part of his statement containing the clarification. He should read the opening part announcing who is present at this meeting.

It would be useful for members of the public who are watching proceedings.

For the public.

It is more important for members of the public who are watching proceedings.

It is not for us. We have read the statement but people watching proceedings will not understand the context of the questioning if they do not hear the opening statement.

Mr. John Connaghan

I thank the Chairman and members of the committee-----

A large part of the issue is how Mr. Connaghan is dealing with Dr. Scally in the meantime. Will we deal with the clarification?

In the public interest, Mr. Connaghan has to read his statement into the record, as does Mr. Gleeson.

It is a matter of serious public interest. Mr. Connaghan should read it into the record.

Mr. John Connaghan

I will start again. I thank the committee for the invitation to attend the committee today. I am joined by my colleagues, Mr. Damien McCallion, Dr. Stephanie O'Keeffe, Mr. John Gleeson and Mr. Paul Connors. I will begin by setting out some points regarding the issues of concern about the evidence given by the HSE to the meeting of the Committee of Public Accounts held on 17 May and further concerns raised by the committee at its meeting of 31 May. I reassure members of the committee that as director general I fully understand the obligation placed on me to provide any information requested, to act with integrity and to be accountable, open, honest and transparent in evidence provided to this or another committee of the Oireachtas. My colleagues are also aware of these obligations and have and will fully comply with them.

Before I address the specific issue of the evidence given to the committee regarding the conference call with the State Claims Agency, I will briefly update the committee on the interim report on recommendations issued by Dr. Scally last Tuesday and to bring it up to speed on the actions we have taken since the last meeting of the committee, bearing in mind that members of this committee have previously raised issues on communication, transparency, management and governance.

On Dr. Scally’s interim report, we welcome the report and the recommendations. In the interests of transparency, it would be my intention to not only publish any recommendations on the HSE website but to also publish our progress tracker against each of the recommendations in the final report such that the public can observe and measure progress.

Since the commencement of the scoping exercise, the HSE has prioritised the provision of all relevant documents to Dr Scally in a manner that is both useful and timely. As previously advised to the committee, we have a special team in place to do this work in a manner that is both useful and timely. This remains an ongoing process. The HSE had a productive engagement with Dr Scally and his team yesterday morning, Wednesday, 13 June, with regard to how required documentation has been provided up to this point and how the HSE can guarantee the future management of documents to the satisfaction of Dr Scally. The HSE has provided to Dr Scally as many of the documents as possible that have been requested by him within the timescale required. Documents pertaining to contracting of the laboratory services have been prepared for release but in some instances require legal clearance and in others the consent of other parties prior to their release. This was discussed with Dr. Scally at yesterday’s meeting. We have been working intensively with our legal teams to release the laboratory contracts without compromising the terms of those contracts. We have made a breakthrough in the past number of hours on this matter. Consequently, we hope to be in a position to release the contracts to Dr. Scally shortly.

The HSE has provided the vast majority of documents to Dr. Scally’s team in electronic format. Due to certain technical issues, relating to software limitations in some locations, it has not been possible to provide some documents in a searchable format. However, a methodology is being agreed with Dr. Scally to overcome this problem in the future, which is designed to further enhance and sharpen the focus of the document searches. This involves more specific technological interventions. As director general of the HSE, I reiterate my intention to continue to fully co-operate with Dr. Scally in the most productive manner possible to ensure that he is properly assisted in his work.

Turning now to the actions we have taken thus far, we have strengthened the overall management of the programme with a national director, Mr. McCallion, reporting to me as director general. Mr. McCallion’s role is broad in scope and will not only cover the existing task of informing and supporting the women involved but will extend after the Scally review reports to ensure all recommendations are implemented fully. We have engaged external support as part of a records support team to ensure we fulfil the requirement to meet both legal requests and access requests for clinical records. I ask the committee to note that in the absence of a fully computerised electronic healthcare record, this entails a manual search for records dating back, in some cases, years and potentially over a number of sites. We are committed to meeting the standard of 30 days on access requests.

The committee previously voiced concern on risk management and oversight in screening. We are in the process of establishing a risk committee, which will be chaired independently by someone from outside the screening programme, enhanced with the appointment of a chief risk officer to support the work of that committee. The CervicalCheck programme has a quality assurance committee, which has an independent chair.

Since the establishment of the helpline, we have taken more than 24,000 calls with the vast majority of these now returned. Four support centres have been established, with 50 staff engaged to provide that support at various stages. I ask the committee to be aware that we continue to receive calls on a daily basis, although these are reducing significantly in number. With regard to practical support for the 209 women, each of these has an individual named person who is based in each community healthcare organisation. For those who want to access that support, it has so far covered the provision of medical cards, home support, physiotherapy, counselling, etc. Our job is to provide immediate support to the women affected and to ensure that is delivered with empathy and consideration.

We are supporting the international review panel, which is being commissioned by the Department of Health. We have provided matching data from the national cancer registry. We are transitioning from the CervicalCheck audit process to the audit process being developed by the Royal College of Obstetrics and Gynaecology. This will require a significant team to be put in place within the HSE to support this process. We understand the Department is concluding the contract for this work and the scope of work will include all women who were part of the CervicalCheck audit and those registered with the national cancer registry.

Turning to the substance of today’s meeting, at a meeting of the committee on 10 May 2018, the State Claims Agency, SCA, confirmed that it was told by CervicalCheck that all the women had been communicated with. The SCA, by letter dated 22 May 2018 to the committee, confirmed the basis for this initial evidence to be a teleconference held on 20 April 2018 in which the SCA legal team of four was provided with information by Mr. John Gleeson of CervicalCheck. This information, as carefully noted by the SCA legal team, was "that all women whose smear was part of the audit had now been informed or assumed that they had been informed by their treating clinicians". The committee will be aware from my letter of 30 May that I had asked the SCA and CervicalCheck to discuss why there were two apparently contradictory statements. My letter of 30 May accepted that the advice on the teleconference of 20 April that, "All women whose smear was part of the audit had now been informed or assumed that they had been informed by their treating clinicians", is correct and accepted by the SCA and CervicalCheck. In particular, Mr. Gleeson has advised me he does not dispute the note as recorded by the SCA on the legal file as it reflects his understanding of the position regarding communication with the women at that point in time - 20 April. With the Chairman's agreement, I will ask John Gleeson to make a short statement.

Before Mr. Gleeson makes his contribution, is the HSE in a position to give the names, addresses and telephone numbers of the 209 women affected to Dr. Scally?

Mr. Damien McCallion

Dr. Scally has requested that he would provide us with a letter, which he has done, and our advocacy unit will communicate to the women on his behalf. That is his preferred route. He has not formally requested the details. He wants to use the HSE advocacy unit to make contact with the meeting, to organise meetings and so on. We agreed this approach approximately a week ago. Dr. Scally wrote to me formally yesterday. I spoke to him yesterday and that process has commenced today.

Is Dr. Scally happy with that?

Mr. Damien McCallion

Yes.

I invite Mr. Gleeson to make a brief statement.

Mr. John Gleeson

With regard to requests for clarification that have arisen concerning responses provided by me to members' questions at the PAC meeting of 17 May, I am happy to provide this clarification.

At the meeting of May 17, my HSE colleagues and I were asked by Deputy Jonathan O'Brien who told the SCA that all women had been informed and whether this person was in the room. There was no reference to a particular meeting or exchange. As the transcript illustrates, Mr. Connors replied to the Deputy first before, as he can explain, under the impression that the person was not in the room. I, therefore, replied, "No" - first, because I thought there must have been another meeting between the HSE and the SCA at which I was not present and, second, because I would not have made such an unqualified statement. In subsequent explanation and questioning by Deputy O’Brien when he said that the person was a CervicalCheck person, I felt that he must in fact be referring to me. The recent exchanges I had had with the SCA, including telephone calls and teleconferences, concerned a specific court case. I did not recall the specifics of every question and answer during those exchanges but I sought to clarify on two occasions during the PAC meeting what would have been the substance of what I could have said. As the transcript shows, what I tried to say later was that I did not think anyone from CervicalCheck could have said that because it would never have been our understanding. Communications would have issued to the treating clinicians in respect of all women with cytology reviews and we would have believed that the clinician would have communicated with the women as appropriate.

In the letter provided to the PAC subsequent to that on 22 May, which I had sight of after that, the statement "All women whose smear was part of the audit had now been informed or assumed they had been informed by their treating clinicians" and reference to a legal note is, I believe, consistent with what I have said, with what I intended and with the understanding shared with the SCA of what was meant in our exchanges. I certainly did not intend to cause any confusion or lack of clarity or directness. If that was the case, I apologise for it.

I call Deputy Jonathan O'Brien who has ten minutes on this specific item.

I will come to Mr. Gleeson later. Mr. Connors said at that meeting that he had had a conversation with the SCA outside this room and that somebody from the agency had given him two names. Is that person present?

Dr. Paul Connors

Mr. Breen.

Did Mr. Breen give Mr. Connors outside this room two names of the individuals who told him that all the women had been informed?

Mr. Ciarán Breen

No. There was confusion by Mr. Connors on this particular point. I was referring, in fact, to a completely different meeting - nothing to do with the teleconference call. In fact it was a meeting that a person from my agency - a clinical risk adviser - had with CervicalCheck going back.

So Mr. Breen did not give any names to Mr. Connors at any stage outside this committee room.

Mr. Ciarán Breen

Just to clarify that so there will not be any confusion on that, I gave him the names of the two people in CervicalCheck that our clinical risk adviser met at a meeting, nothing to do with this matter about the teleconference call - completely separate meeting.

Just to be clear on the names Mr. Breen gave him, the evidence presented to this committee was that Mr. Breen gave him two names of individuals who told the State Claims Agency that all women had been informed. That is not the case.

Mr. Ciarán Breen

That is not the case. No.

Does Mr. Connors wish to comment?

Dr. Paul Connors

That is correct. We were talking about a completely different meeting, as Mr. Breen has just said.

In response to my question at that meeting when I asked who told the State Claims Agency that all women had been informed, Mr. Connors said that he had been given two names-----

Dr. Paul Connors

Correct.

----- who had actually said that. Does he accept that is now not the case?

Dr. Paul Connors

I accept that is not the case but I qualify that by saying that I had had the conversation with Mr. Breen. First, I was not aware of the teleconference on 20 April at that stage. I became aware of that subsequently. I made an assumption, which was incorrect, that the meeting that Mr. Breen had referred to was related to the question that the Deputy is asking.

In fairness, it was more than an assumption because I have the transcript to hand. I said: "Is the person who told the State Claims Agency that all women had been informed in this room?" Dr. Connors said: "Can I answer that? I think the answer is 'No.'"

Dr. Paul Connors

That was my belief at that stage.

Was Mr. Gleeson, in fact, the person who told the State Claims Agency that all women had been informed?

Mr. John Gleeson

No.

Mr. John Gleeson

I never told the State Claims Agency that all women had been informed, full stop. I told it that communications had issued in respect of all women, whose cytology reviews had completed, to their treating clinicians and we had assumed that the treating clinicians had informed the women, as the legal note from the teleconference. The meeting that has been referred to earlier, to which Mr. Breen and Mr. Connors refer, took place in March 2017. I was at it, as were a colleague of mine and a colleague of Mr. Breen's. We were not discussing communicating with women. We were discussing other matters.

However, Mr. Gleeson was part of that teleconference call on 20 April.

Mr. John Gleeson

That was not alluded to in the transcript, but I recalled that-----

Hang on a second. The question I asked was not about any specific meeting or teleconference call because I would not have been aware of any meetings or teleconference calls. The question I asked was: "Is the person who told the State Claims Agency that all women had been informed in this room?" Mr. Gleeson said "No."

Mr. John Gleeson

That is correct.

However, that is not what we are being told now.

Mr. John Gleeson

We are being told that the person in the room said that all women whose smear was part of the audit had been informed or assumed they had been informed by their treating clinicians. I am reading from the letter of the State Claims Agency to the Committee of Public Accounts dated 22 May, which is the legal note of the teleconference and was the only time I could ever have been asked that question by somebody on the State Claims Agency.

So Mr. Gleeson told the State Claims Agency that all women had been informed or that their clinicians had informed them.

Mr. John Gleeson

Or assumed their clinicians had informed them.

Why did Mr. Gleeson not say that at the meeting?

Mr. John Gleeson

I tried to clarify. I said I was trying to remember which meeting. I said: "I do not think anyone from CervicalCheck could have said that because it would never have been our understanding..." The statement is there. It reads out and it was interrupted that we would have communicated with them. I went on to say we would have believed that communications in respect of all cytology reviews had issued to treating clinicians and assumed they were informing the women.

I think Mr. Gleeson is trying to play with words because the question was very clear on my behalf. I asked who informed the State Claims Agency. Mr. Gleeson informed the State Claims Agency that all women had been informed or their treating clinicians had informed them. The impression given to the State Claims Agency during that teleconference call on 20 April was that all women had been informed. Regardless of whether they were informed directly by CervicalCheck or their clinicians, the impression was that all women had been informed.

The Deputy has five minutes.

Mr. John Gleeson

I do not think that is the impression that the State Claims Agency received from the letter it issued to the Committee of Public Accounts.

Was it Mr. Breen's impression after that teleconference call that one way or another, all women had been informed?

Mr. Ciarán Breen

Certainly that was our assumption. Yes.

What would Mr. Breen say in relation to Mr. Gleeson who is now saying that could not have been the information he gave Mr. Breen because nobody from CervicalCheck would have been aware of that?

Mr. Ciarán Breen

I have personally examined the legal note and it is very clear. Senior counsel asked whether all of the women affected had been informed. The specific reply was that all women - I think I am on record to this committee in writing and saying this - whose smear was part of the audit had now been informed or assumed they had been informed by their treating clinicians. That is the exact reference in our note.

Mr. Gleeson is trying to tell me today that when I asked: "Is the person who told the State Claims Agency that all women had been informed in this room?", the reason he answered "No" was because he could not have told them that because he is now saying that the assumption was the clinicians had informed them.

Mr. John Gleeson

There were two reasons I said "No". One is that I thought I was not in the room because Mr. Connors had stated that in advance of me answering when the Deputy came to me to answer the question. Second, I do not believe I could have said that or made such an unqualified statement. I would never have made it. The record shows that I did not.

However, Mr. Gleeson just heard from the State Claims Agency that the information that it is saying it got from Mr. Gleeson was that all women had been informed.

Mr. John Gleeson

Or assumed to have been informed.

Mr. Gleeson is playing with words now. This is a very serious issue. When everyone left this room there was a clear assumption made and there was a clear narrative being put forward by Mr. Gleeson that neither he nor anybody else from CervicalCheck even had a conversation with the State Claims Agency about it being informed that all women were told. That was the narrative put forward at this committee. That was the understanding of all members when we left.

Mr. John Gleeson

I was not asked any question about whether I had had conversations with the State Claims Agency and I certainly would have said "Yes"; I have them all the time.

I asked Mr. Gleeson if he had informed the State Claims Agency that all women were informed and he said, "No".

Mr. John Gleeson

Then I went on to clarify I do not believe we could have ever stated that, thinking back on conversations that had happened. They were not specific; I had to recall on the spot what might have been my various exchanges with the State Claims Agency. I said clearly I did not think anybody from CervicalCheck - me or anyone else - could have said that.

Is that still Mr. Gleeson's position today?

Mr. John Gleeson

Yes.

Before I call the next speaker, I wish to clarify this assumption bit. I read from the letter of the State Claims Agency. In fact, did all the treating clinicians inform the women at that point?

Mr. John Gleeson

No. They did not.

How did Mr. Gleeson come to the assumption that they had done so? Just answer that question. Mr. Gleeson's entire answer here today is based on his assumption that they had. Everybody now knows that they were not so informed.

How did he arrive at that assumption, which we now know was not matched by reality? The assumption made by Mr. Gleeson is the issue here. He has used the word "assumption" several times. What was the basis for his assumption that all clinicians had informed the women involved, which we now know was not the case? Can he please explain why he thought that?

Mr. John Gleeson

We were issuing communications to treating clinicians under the open disclosure policy of the HSE, which applied throughout the organisation. We made the assumption that as we passed the information down the line the clinicians would pass it on. We alluded, in the previous meeting, to the fact that we did not check that they had done so, and that was an error in closing out the communication trail. We did, however, make the assumption that the policy was in operation and was working throughout the various sections of the organisation.

When did Mr. Gleeson first become aware that women had not been informed? We have seen correspondence from Limerick and from various meetings where there were issues about who was to inform the people affected, whether CervicalCheck, the GPs or the clinicians. When did Mr. Gleeson become aware of the issue of how the people affected were to be informed?

Mr. John Gleeson

Specifically, with specific clinicians, I first became aware when the Limerick case emerged. However, that had been resolved.

When did that happen?

Mr. John Gleeson

That happened in 2017.

The witness was aware in 2017 that there was an issue with informing the women affected.

Mr. John Gleeson

That is correct. When I was asked about the matter in April 2018 that had been resolved for many months, and I was not aware of any other issues, as the Chair has stated.

The witness accepts that his assumption was incorrect.

Mr. John Gleeson

It has obviously been proven incorrect.

The witness is appearing before the Committee of Public Accounts. I am addressing this point to Mr. Connaghan as well. Assumptions were made that somebody else had acted in a particular way, and we now know that was not a valid assumption. I do not deny that it was arrived at in good faith. However, the assumptions made are the reason the witnesses are here today, and the reason there has been such an outcry about women not being informed. When the witness was dealing with the Vicky Phelan case earlier this year he was operating in good faith at all stages, but-----

We do not all agree that the witnesses were acting in good faith. That is the personal view of the Chair.

That is my personal view. I said at the beginning that I expect that answers will be given in good faith. We are in no position to assume anything other than good faith at this point, and we have no basis for saying anything different. I am operating on the basis that what I have been told has been said in good faith. However, the assumption the witnesses arrived at was not valid. Does Mr. Gleeson accept it was not a valid assumption?

Mr. John Gleeson

Yes, not for all women.

This is the kernel of the issue. We are here because the witness is hanging on the assumption that all people were informed. Were they so informed at that point in time?

Mr. John Gleeson

No, we now know that they were not.

Was the assumption valid at that time?

I have a transcript here and I want to be helpful. The witness, on 20 April, said that he told the State Claims Agency that all women had been informed or it was his assumption that all women had been informed. However, he knew on 20 April that was not the case because he gave evidence to this committee stating that he became aware that it was not the case when the Vicky Phelan case became public knowledge. That is what Mr. Gleeson said. Therefore, when he had the conversation with the State Claims Agency he knew that all women had not been informed. He is now telling the committee that he told the State Claims Agency that was his belief.

Mr. John Gleeson

On 20 April, that was my assumption.

Mr. Gleeson gave evidence to this committee stating that he knew, on 20 April, that that was not a true assumption.

Mr. John Gleeson

The committee meeting was on 17 May, almost four weeks later. In the interim, it had been determined, on account, that many women had not been communicated with. It was not on 20 April.

Mr. Gleeson knew that was not the case on 20 April.

Mr. John Gleeson

I did not know that.

The witness knew it because he gave evidence to this committee to that effect, which I have here.

Mr. John Gleeson

That was on 17 May.

At the meeting in question I stated:

....women were not being informed through their clinicians until the Vicky Phelan case became public knowledge. Is that what I am being told by everyone in this room? If that is not the case, then somebody please tell me that is not true.

The witness replied: "I think that is [probably] a fair statement."

Mr. John Gleeson

On 17 May, it had been determined that the women had not been informed.

When did the Vicky Phelan case become public knowledge?

Mr. John Gleeson

I think it was 25 April, but I would have to check.

Mr. Gleeson mentioned the open disclosure policy in the HSE and he is hanging his assumption on that policy. Is that correct?

Mr. John Gleeson

That is correct.

This committee received letters from the HSE months earlier on the open disclosure policy. It is on file - I am sure the letters are here in front of me - that the HSE highlighted that the Civil Liability (Amendment) Act 2017 had not yet commenced and this was proving an obstacle to open disclosure. The witness had to know that the section on open disclosure has still not been commenced. The HSE put it in writing that the failure to commence Part 4 of the Civil Liability (Amendment) Act 2017 relating to open disclosure was an obstacle to open disclosure. Mr. Gleeson and all senior figures in the HSE must have known that open disclosure was not fully operational because the legislation to back it up and give people protection had not yet commenced at that point. It still has not commenced. That correspondence was sent months ago, in January or February this year, which means Mr. Gleeson must have known there was an issue with open disclosure. Part 4 of the Civil Liability (Amendment) Act 2017 was designed to facilitate open disclosure. The HSE knew Part 4 had not been implemented, yet Mr. Gleeson is hanging onto the view that open disclosure was occurring. What was the purpose of the legislation if Mr. Gleeson believes there was 100% open disclosure? He could not have believed that. While I accept that he was acting in good faith in making the assumption that the women affected had been informed, it was not a valid assumption to make based on the state of his knowledge of the issue of open disclosure. Does the witness accept that? I am trying to understand his assumption. I find it hard to believe that he validly arrived at that assumption.

Mr. John Gleeson

If I could explain, when someone says to me that all women have been informed, one understands that "all women" refers to all women for whom we have communicated cytology reviews. This is an historical issue, and there are many historical cases. We were aware that some women had sadly passed away and that some letters - it is a continuous process - might have gone out yesterday and appointments were being set up to talk to the women. I was not aware of the full extent of difficulties being expressed with the open disclosure policy, alluded to by the Chair. I am sure they came to me in time, but at the time I was not aware at that time that Part 4 of the Civil Liability (Amendment) Act 2017 was about to be enacted to remove one of the barriers to open disclosure. I am sure I would have learned that.

This exchange is not doing the HSE or Mr. Connaghan any good. That is not a finding but my personal observation. We should have been able to deal with this matter in a much more up-front manner and much more clearly. We find ourselves arguing about words and whether a fair assumption was made. There are women listening to this discussion which calls to mind the argument as to how many angels can dance on the head of a pin. It is not helpful to the women involved, the HSE or public confidence in the HSE's approach to this matter when there may some obfuscation involved in dealing with a particular issue. I do not believe the assumption made at the time was valid. Had the witness said that an hour ago it would have been helpful. I hope Mr. Connaghan, as the new director general, observes what is going on here and understands the public concern about how the HSE is handling this issue.

Mr. John Connaghan

The Chair has made a very good point. If there is something that a witness has provided in evidence which is unclear to the committee or where the witness subsequently realises that he or she has been talking at cross-purposes with a meeting that happened a year before, it is good practice that we are more proactive in terms of writing to the committee to explain matters.

It would be good practice to be more proactive in writing to the committee to explain things. That is something we need to take on board.

I will follow up. It is no clearer than the original scenario. That is the point. The Chairman is saying that we are arguing. We are not arguing. The statement in itself is enough. It speaks volumes.

I will move on to Deputy Murphy. I thought this was going to be a cleaner operation so that the women who are watching could get some confidence in the HSE's openness and transparency. I have not felt that today so far.

It is screaming off the page at me. I wish to make a comment to the acting director general of the Health Service Executive. One of the HSE's publications is entitled Building a high quality health service for a healthier Ireland. It refers to the values of care, compassion, trust and learning. I wonder if people watching today who have followed the CervicalCheck scandal feel that any of those boxes have been ticked.

Mr. Breen referred to legal correspondence that referred to an earlier meeting. When was that earlier meeting?

Mr. Ciarán Breen

It was not legal correspondence. I was speaking to Mr. Connors about a previous meeting. It was in March 2017.

What was that meeting about?

Mr. Ciarán Breen

It was a meeting between one of our clinical risk people and CervicalCheck concerning a range of issues to do with incident notification and various other matters.

Something would have been brought to the State Claims Agency's attention in March 2017 to say that there was a failure. We know there were memos around that time because these have been produced for the Committee of Public Accounts .

Mr. Ciarán Breen

Certainly nothing arose out of that meeting which raised any red flags or issues for us.

Very well, but why would the State Claims Agency have been engaged with?

Mr. Ciarán Breen

We do that as a matter of course. Our clinical risk advisers make frequent visits to hospitals, screening services and community health organisations as part of their brief to advise on risk matters.

There is, therefore, a risk matter here that the State Claims Agency was engaging with. Was it brought to the State Claims Agency's attention that there was a significant problem at that stage?

Mr. Ciarán Breen

No. It was a very open meeting at which our clinical risk adviser was chatting to them about various issues, including the cytology labs.

I am trying to get a timeline of a number of things. Around that time, there was knowledge that there had been a significant problem. There are different versions of memos being worked out, which Mr. Breen subsequently would have seen. Mr. Breen would not have been directly informed about that.

Mr. Ciarán Breen

No. There was certainly nothing that came out of that meeting that indicated a problem.

Not only would the State Claims Agency have known about the case concerning Vicky Phelan that went through the courts, it would have had engagement around it.

Mr. Ciarán Breen

Yes.

Did the State Claims Agency communicate that to the HSE?

Mr. Ciarán Breen

The critical dates are around 20 April, when the Vicky Phelan case was ongoing. As indicated to the committee, there was the teleconference call and then the case was settled by the laboratory.

What date was that?

Mr. Ciarán Breen

That was roughly around 22 or 23 April.

Once the State Claims Agency took responsibility for the case, the HSE would not have been informed that it was ongoing, would it? Did the State Claims Agency not look for records from the HSE? Did it have communication with the HSE?

Mr. Ciarán Breen

Yes, we had communication in the normal way. In fact, the teleconference call was part of the normal communication around a legal case.

Who would the State Claims Agency normally have dealt with on this?

Mr. Ciarán Breen

I am sure that our principal contact would have been with Mr. Gleeson as the programme manager. By the way, I should put on the record that he was always very helpful to us regarding the supply of documentation and anything that we needed.

That is quite interesting. I am pleased to hear that there is co-operation, but it is on the prosecuting side that this help would have taken place. That is to prosecute cases.

Mr. Ciarán Breen

What we look for is any information and records that we require to understand the case better, to manage the case, and to bring it to a conclusion. All of those issues are relevant.

The State Claims Agency's level of engagement would have been only at that level. It would not have been further up the ladder.

Mr. Ciarán Breen

No-----

I remember Mr. O'Brien saying to this committee that the first he heard of the Vicky Phelan case was on the day it was on the news, which I think came as a surprise.

Mr. Ciarán Breen

We definitely had not escalated it in that way. Given what we know now, it is an entirely different matter. The case was being settled by the laboratory, however, so we did not see, therefore, any necessity for escalation.

Were there other cases at the same time?

Mr. Ciarán Breen

Relating to?

Mr. Ciarán Breen

No. There were other cases in being, but there was no case at the stage of proceedings of heading either to court or to settlement.

Was the State Claims Agency in correspondence with or talking to the HSE about those other cases? It must have been.

Mr. Ciarán Breen

We were liaising with CervicalCheck on those cases, the reason being that we wanted to get the records and any other information we require from them.

Did the risk analysis change as a consequence of the Vicky Phelan case and the other cases?

Mr. Ciarán Breen

Afterwards, once we knew all the implications of the Vicky Phelan case around other women not being informed, that was a major issue, of course.

What did the State Claims Agency do? That is what I want to get to. What did it do, if anything, to make sure that everyone was informed? Was Mr. Breen satisfied or did he take it as a given that everyone was informed?

Mr. Ciarán Breen

At the time of the case, based on the teleconference call, we took the statement as it was that all the women had been informed or it was presumed they had been informed because their clinicians had been informed. We were going on the basis that all the women had been informed. When we knew they had not been informed, that was a-----

Mr. Ciarán Breen

We found that out in the general media after the Vicky Phelan case. I think I said this to the Committee on Finance, Public Expenditure and Reform, and Taoiseach when I appeared before it. That was the first time we knew that all the women had not been informed.

That was around 20 April.

Mr. Ciarán Breen

It was some time around 23 April or 24 April - the days following 20 April.

What engagement did the State Claims Agency then have with the HSE on the matter?

Mr. Ciarán Breen

We were engaging normally on the case-----

Did Mr. Breen talk to Mr. Gleeson at that stage about women not being informed?

Mr. Ciarán Breen

Not at that stage, because the HSE was reacting to it and handling that situation itself. It would not be normal for us to try to interfere with what the HSE would do to inform the women. We were assured that they were now engaged in a process with the women.

We would not have been here discussing that matter had there not been the controversy in advance of it, so it was well known at that point. The Vicky Phelan case had been in the public arena. There had been debates in the Dáil and there were meetings in other committees as well as this one. I say that in regard to timing and what Mr. Breen said at this committee.

I cannot figure out why Mr. Breen would have been so certain that all the women had been informed or would be informed by their clinicians. I cannot figure out why he would give us that information in the context of the meetings that we were having.

It does not make any sense. How can we trust any information we get from the HSE when this circle cannot be squared?

Mr. John Gleeson

It was subsequent to the case that Mr. Breen has alluded to, towards the end of April. The HSE then instituted a procedure to check whether all women had been informed, discovered that many had not, and immediately set about ensuring those women were informed. That happened from the end of April into May and we met on 17 May-----

I refer to Mr. Gleeson's earlier statement, "What I tried to say later was I did not think anyone from CervicalCheck could have said that because it would never have been our understanding", that communications with all women had been made.

Mr. John Gleeson

As I alluded to, on 17 May we were discussing 209 women and 72 women. Those numbers had been ascertained between the end of April and the meeting on 17 May. Those women were diagnosed with invasive cervical cancer from 1 September 2008. Our knowledge was that, sadly, some of them had passed away and others were in the process. When Deputy Murphy refers to "all women"-----

Mr. Gleeson did not qualify what he meant by "all women". We were discussing what we understood to be 208 women, which subsequently transpired to be 209 women. That was the group about which we were talking; we were not talking about another group. That is the group to which we were told Mr. Gleeson was referring in his statement; it was not another group.

Mr. John Gleeson

I did not say that all women had------

Deputy Murphy has one minute left.

I wish to move on to the retrieval of records as mentioned in the opening statement and the video presentation. At the meeting on 17 May, we were told that women would be facilitated in getting their records in the context of the experience of a person going to Limerick and not being able to get her records having been raised. We are now being told that in the absence of fully computerised electronic healthcare records, the retrieval process entails a manual search for records going back many years in some cases and potentially over a number of sites and that, although the HSE is committed to meeting the 30-day target, that does not always happen. We understand that records may go back for a significant period and that people may wish to access their full health records but the scope of this issue is relatively narrow. People will not look for their records because they had a broken toe when they were aged five. Specific records are being sought. We were given an assurance at that meeting that there would be no obstacles to the retrieval of such records but it now appears that issues are arising because the HSE does not keep records in a certain way. Is there an obstacle to women getting their records within the 30-day timeframe? We are being made aware of issues in that regard.

Mr. Damien McCallion

I will clarify that. At that meeting I committed to putting someone in charge of that process and bringing in all necessary resources. A number of critical cases involved people who were terminally ill and we committed to prioritising those cases such that the information would be provided in order that court deadlines could be met. The request for access to records may come directly from women or from their solicitor, which may be by means of a freedom of information, FOI, or data access request. All those requests are currently being met. I am aware of one case in which an extra day will be needed and that was agreed yesterday with the woman concerned. We are currently providing access to records in accordance with the deadline. An issue which initially caused some problems was the volume of legal correspondence received which meant that we could not concentrate on getting the records out but, rather, had to try to deal with that correspondence in terms of acknowledgements and so on. We have now put extra resources in place such that legal letters are acknowledged in a timely manner. With the exception of the case that arose yesterday to which I referred and which was clarified this morning with the lady involved, we are meeting the targets for access to records. For access requests the current target is 30 days, while for legal requests, it is meeting the deadlines for pending court cases.

Several steps are needed to provide the records, including the hospital records regarding the woman's cancer treatment and so on, the screening records and the associated correspondence between the hospital and the screening system. Although some of the records are automated, all of those elements must be gathered. We are currently achieving the deadlines for access requests and we will continue to put in whatever resources we need to achieve that. We have put a full team in place. We have three full-time legal people and an administrative team to which we have appointed a manager.

I presume that everything to do with the screening programme is in a digital format.

Mr. Damien McCallion

No, not all correspondence. Some correspondence might still be issued via letter and that must also be provided. The search for records could extend to a woman's hospital, which may be her colposcopy clinic, her treating hospital - those may be different institutions - the CervicalCheck screening centre in Limerick and the national screening service offices in Dublin. That is the process through which we work and we then link with the SCA regard to legal cases to ensure that all records are provided as requested.

I call Deputy Cullinane. Members have indicated in the following sequence: Deputy Cullinane, Deputy Kelly, Deputy Connolly and Deputy MacSharry.

The letter sent to the committee by Mr. Connaghan on 30 May 2018 stated that a meeting took place at the request of the HSE, which was attended by officials from the SCA and the HSE, who would have been CervicalCheck representatives. At the request of whom in the HSE did the meeting take place?

Mr. John Connaghan

At my request.

Why did Mr. Connaghan make that request?

Mr. John Connaghan

I referred to that in my opening statement. We had two contradictory statements which Deputies have explored this morning: one that all women had been contacted and the other contradicting that. I wanted to clarify the correct version of events with the SCAy and CervicalCheck. Members will see in my response of 30 May that it lines up exactly for the most part with the letter from the SCA------

Who was at the meeting?

Mr. John Connaghan

Who was at the meeting?

Mr. Damien McCallion

Myself, Mr. John Gleeson, and Mr. Breen and another representative of the State Claims Agency. It was originally a conference call, if I am correct.

Was a note or minute of the meeting taken?

Mr. Damien McCallion

We agreed to agree the position in regard to having reviewed what was there and this was the output of the meeting.

I will return to what Mr. McCallion has just said. Were notes taken of the meeting?

Mr. Damien McCallion

No. We just wanted to clarify the position.

No minute was taken.

Mr. Damien McCallion

The output from the meeting was the correspondence from the director general-------

I know what the output was. No formal minutes were taken.

Mr. Damien McCallion

No. The output from the meeting was a letter.

I understand that the output was a letter. I asked whether formal minutes were taken.

Mr. Damien McCallion

No.

I know that a letter was issued. However, no minute or note was taken.

Mr. Damien McCallion

No. The correspondence was the output from the meeting.

Mr. McCallion stated that a position had to be agreed.

Mr. Damien McCallion

No. We wanted to clarify the position and see if there was an issue or not, as Mr. Connaghan stated.

Was it a case of aligning positions?

Mr. Damien McCallion

Not at all. I went into the meeting with an open mind on what the position was, as did others. We went back through Mr. Breen's letter and Mr. Gleeson's position, and Mr. Connaghan's letter then clarified that in terms of------

There were two contradictory positions, as Mr. Connaghan stated. It is unusual that the HSE would bring officials from both sides together and a letter would emerge to state that the two sides did not contradict each other and a mutual understanding had conveniently been reached. That is how it appears to some members and Mr. McCallion and the other witnesses are here because we want to test that. We have done so and there are cracks in it.

Mr. Breen earlier stated that it was still his understanding that because of the information given to him by Mr. Gleeson he was of the view that all women had not been informed. Mr. Gleeson stated that he said that in the context of an assumption that all women would be informed by their clinicians. Is it correct that this was the understanding of the SCA?

Mr. Ciarán Breen

Yes, that was our understanding. I read exactly from our note.

Mr. Breen was clear. It was crystal clear from the note that all women had not been informed, one way or another.

Mr. Ciarán Breen

That was our assumption.

Mr. Ciarán Breen

No.

Even when the word "assumed" was used, was any clarity sought? Why assume? Either they were informed or not informed. Mr. Breen is certain now and says he knew they were informed. If the word "assume" was there, did anyone question why an assumption was made? Either it was known or not known.

Mr. Ciarán Breen

I was not at that meeting so I am reading exactly from the particular question which was put by senior counsel and that was the reply. He was satisfied with that reply, as was the legal team, that all the women had been informed.

So we do not know what clarifications there were. I assume a legal person, when somebody uses the word "assume", would want to know more because there is no certainty then. I imagine some clarification might have been given.

Mr. Ciarán Breen

It was not followed up in that way.

It would be clumsy on the side of the legal representatives there if they accepted the word "assume", would it not?

Mr. Ciarán Breen

Not necessarily. The phrase was that all the women had been informed. It says they had been informed or it was assumed they had been informed by their treating clinicians.

Mr. Gleeson is saying to this committee that he was informing the State Claims Agency that, in his view at that time, his assumption was that all women would have been informed, primarily through their clinicians. That was essentially Mr. Gleeson's view at that time. Is that correct?

Mr. John Gleeson

My confirmation would have been that communications had gone to all the treating clinicians-----

Mr. John Gleeson

-----and our assumption was that the treating clinicians had informed the women.

Yes. Mr. Gleeson is saying that, at that time in 2018 when he was part of this conference call, he was very clear to the State Claims Agency that one way or another, but mainly through their clinicians, all women had been informed. Mr. Gleeson would have had no concern that women were not being informed.

Mr. John Gleeson

It would have been only through their clinicians.

I accept that. It was only through their clinicians. We are clear that all women would have been informed through the clinicians. Mr. Gleeson would have had no concern that women were not informed.

Mr. John Gleeson

I did not have a concern and I answered the question as noted.

That does not stack up at all. Who wrote the memo that was given to clinicians?

Mr. John Gleeson

Is the Deputy referring to the information for health professionals?

The memo that was given to clinicians to inform them as to how they should deal with informing the women. Who wrote that memo?

Mr. John Gleeson

A number of parties.

Mr. Gleeson was one of them.

Mr. John Gleeson

I was. I think the Deputy is referring to 2016.

Bear with me. Mr. Gleeson is telling this committee that he was making an assumption on the basis that clinicians would have informed women. I am saying that is not tenable because, in 2016, Mr. Gleeson wrote the memo or was part of writing a memo that gave discretion to clinicians and if the woman had passed on, the next of kin would not be informed and it would simply be noted on her file. Mr. Gleeson's position is absolutely inconsistent because he was part of a number of people who wrote that memo that developed a strategy that women would not be informed or, at least, that they would limit the number of women who would be informed.

Mr. John Gleeson

The intention was the opposite, to make sure that women were informed where possible. It was done in the context of the HSE open disclosure policy, which states that clinical judgment should be taken into account. I was complying with the policy-----

Mr. Gleeson was not.

Mr. John Gleeson

-----and that is with the notes in the information for health professionals. With regard to women who are deceased, it is in the guidance from the Medical Council on disclosure.

Mr. Gleeson was not consistent with the guidelines.

Has the Deputy a reference for that document?

This a memo that was given to the Committee of Public Accounts on 25 May 2018.

Is there a number on the top of it so we can get it?

It is PA 32 1891. It is the context of the guidelines the HSE would have to comply with with regard to full disclosure. It says only in exceptional circumstances based on the clinical interest of a service user, it is likely that the service user will not benefit from open disclosure, and it goes on to give reasons. What Mr. Gleeson had in the circular that was given to clinicians was that, as a general rule of thumb, the outcome should be communicated to women.

Mr. John Gleeson

That is our wording for alluding to that section. Only in exceptional circumstances should one not disclose and there would be specific reasons.

With respect, that was not put in the memo or circulars to consultants.

Mr. John Gleeson

We referred to the policy for open disclosure.

No. What Mr. Gleeson said in his opening statement today was "we would have believed that the clinician would have communicated with the women as appropriate". The words "as appropriate" are important in this context. If we go back to the letter that we got from Mr. Connaghan, which clarifies, after the meeting that took place between the officials: "Mr Gleeson's understanding was consistent with the record of the call. Mr Gleeson's understanding of the communication with the women was that at the time he assumed the women had been informed by their treating physicians." In his opening statement, he says "we would have believed that the clinician would have communicated with the women as appropriate". The words "as appropriate" do not appear in this and that is key. Mr. Gleeson knew that not all of them would have been informed by their treating clinicians. I want to put this to Mr. Breen. Given that, while I do not know whether he picked that up with regard to Mr. Gleeson's opening statement-----

The Deputy is out of time. He can come back.

-----it is Mr. Breen's version of it and the integrity of his organisation that is also on the line, because he is telling us, from this letter, that it has been clarified because Mr. Gleeson assumed the women had been informed by their treating physicians. In his opening statement, he says "as appropriate". That is a very healthy caveat that is not in that letter.

Mr. Ciarán Breen

We can only take the statement that was made at the time of the teleconference call. That is what we went on and understood.

I have two final questions. Does Mr. Gleeson believe that his position is tenable as programme manager for CervicalCheck?

Mr. John Gleeson

I certainly would like to think that the contribution I have made to date in developing the programme and bringing it to where it is could be continued, and addressing any issues that arise with it out of reviews and inquiries, which we are more than happy to facilitate.

Does Mr. Gleeson believe the 209 women and the women who appeared before this committee, to whom we gave time and commitments that we would ask hard questions, would have confidence in Mr. Gleeson as programme manager?

Mr. John Gleeson

I think they will see the evidence that, in future, there will not be any delay in disclosing clinical audit findings.

Mr. John Gleeson

I do not believe they will find that there will be any evidence of future delays in communicating clinical audit findings to women.

My question, while I will not give my personal opinion because I can give that outside this chamber, is if Mr. Gleeson believes his position is tenable as programme manager for CervicalCheck. It is either a yes or a no. He either believes his position is tenable or not. Does he believe his position is tenable?

Mr. John Gleeson

Yes.

Does Mr. Connaghan believe that Mr. Gleeson's position is tenable?

Mr. John Connaghan

I have no reason to doubt at this stage that his position is untenable.

We are moving on to Deputy Kelly. There will be a further opportunity if needs be. The sequence is Deputies Kelly, Connolly, MacSharry and O'Connell. There are ten minute slots and Deputies can come back a second time.

I have to go to Leaders' Questions about this issue.

What time does Deputy Kelly have to leave at?

Less than an hour. We have been round the houses again. We all know and are fairly familiar with this at this stage. I will not go into the nitty-gritty of who said what or when. I find it strange that the State Claims Agency, SCA, and the HSE met following the SCA's letter. I am not sure of the appropriateness of it. From another angle, and Mr. Connaghan might listen, part of the confusion which ended up with us here was Dr. Connors's contribution. Does he accept that?

Dr. Paul Connors

I do.

Does he accept that he totally and utterly confused this committee with his evidence?

According to the story we are being told, two meetings were mixed up. I appreciate Mr. Connor's directness on that. To be fair to my colleague, Deputy Jonathan O'Brien, he is the one who pursued this matter. What worries me is that we are left with this ram-jam of a story and we will have to make a decision on what we believe happened. We must take the word of witnesses that there was no disagreement at the meeting between the State Claims Agency and HSE. However, neither organisation should have intercepted something that would obviously come back before the Committee of Public Accounts once the letter had been written to the SCA. Having been before the committee before the State Claims Agency wrote to the committee, surely Mr. Connaghan was aware that there was a problem with this evidence? Soon after the meeting it became clear that the information given at the meeting was incorrect. Given that this is glaringly obvious to everyone following proceedings and everyone present, why did Mr. Connaghan choose to do and say nothing? The only reason the committee is addressing this issue again is that the State Claims Agency wrote to us about it. Mr. Connaghan needs to reflect on that deeply.

In layman's language, this was a case of the HSE believing the committee had not noticed this and the HSE had, therefore, got away with it and would say nothing. However, when Mr. Breen and his colleagues wrote to the committee, the HSE had to deal with the issue. If ever a series of events symbolises my view of arse covering in the HSE, it is this. We are being told a story and we have to take people's word for it. The committee took their word last time and it has since transpired that there were inaccuracies. That is fine. We will take the word of the HSE again today and it may stand up. The committee will have to make a judgment on that but it is not a court of law.

However, the bigger issue is why the HSE did not deal with the issue once it became clear there was a problem. In fairness to Deputy Jonathan O'Brien, that became obvious when he raised the matter. While I acknowledge Mr. Connaghan's statement that there is a lesson to be learned from this, it is not damn well good enough. We represent the public and the whole country is following these meetings, as are HSE management and staff. The impact of the performances of HSE witnesses at this committee and other committees has had a serious and negative impact on its staff. The administrative work creeping up on the HSE is multiplying as a result of those performances. HSE staff did not like what they saw, namely, multiple instances of arse covering. As a result, many people in the organisation believe they must push everything up the line, rather than assume personal responsibility in case their managers land them in it. I have outlined one such example and the events that transpired following a meeting of this committee. While the problem that has arisen may have been accidental, the fact that it was not dealt is emblematic of the HSE. If Mr. Connaghan cannot see what is glaringly obvious, I do not know where we are going. He may respond if he wishes.

Mr. John Connaghan

I have already responded on the reason I asked the HSE and State Claims Agency to look at the facts. It was to satisfy my own curiosity as to why there were two contradictory statements. It is entirely reasonable that I would ask for a version of events and for the truth on the matter. That is why, in the letter of 30 May, the committee got that response. It was entirely reasonable that the committee asked for some clarification.

To be honest, Mr. Connaghan's response did not add anything. I will do a quick fire round of questions because we all have limited time.

I have a habit of drifting through committee meetings and I attended a meeting of the finance committee when representatives of the State Claims Agency appeared before it. I accept the agency's hands are tied in many cases by the legislative basis on which it operates, for example, tort law. Considerable time has passed. What proposals has the State Claims Agency put to the Department of the Taoiseach or the Department of Finance on how it can change the current position? The Taoiseach told the Dáil he had instructed the State Claims Agency to use mediation in all of these cases. We now know that if the laboratories do not disentangle themselves from the HSE, the agency will be locked into a certain position. Will Mr. Breen set out in detail the engagement between the State Claims Agency and the Government? I presume they have engaged in days and weeks of intensive negotiations and discussions involving legislative proposals and whatever else may be needed. How many meetings have taken place?

Mr. Ciarán Breen

We have had numerous meetings with ministerial officials and we had a meeting, for example, with the Minister for Health. We had meetings with the Attorney General and his office.

How advanced are proposals to unlock the issue we discussed?

Mr. Ciarán Breen

We have all set about ensuring that we are in line with the Government commitments on these cases, namely, to prevent, wherever possible, women having to go to court and that we get to mediation in the earliest possible time.

I do not wish to be rude but I am caught for time. When Mr. Breen says the State Claims Agency is in line with Government commitments, that is fine and dandy, but we all know there has to be change. We had an extensive discussion on this issue. I read through the transcripts of the meeting last night.

Mr. Ciarán Breen

Yes. If I may, I will explain some of the changes because the changes that we have brought about are very precise. Traditionally, if we were dealing with a medical negligence case where there is a plaintiff and a defendant, and we are obviously always for the defendant, we would engage a series of expert reports, have the person examined and engage other experts in relation to quantum. We are not doing any of that. We are immediately, in our defences which we are required to put in, we are admitting breach of duty in relation to the non-disclosure point, and we are asking the plaintiffs in the cases if they would share their reports with us immediately so that we can get to mediation as quickly as we possibly can. I need to explain this to the Deputy. He is asking me what changes are there and I need to explain them to him. By doing it in this particular way, we are short-circuiting these cases by an incredibly shortened time.

I will make a suggestion which will save us all time. Will Mr. Breen write to the committee to explain how this has all changed? That would be useful and would save us time.

That is a request to issue a written response to the committee.

I have some more quick questions. I first have a question for Mr. Gleeson. I do not live far from his offices, although it is in a different county which beat Tipperary in hurling this year. I also know some of the people who work with him and I have met and spoken to people who work with him and people who work in CervicalCheck. There are some very good, impressive people working in that organisation. There are, however, serious issues with CervicalCheck.

On the provision of information, we all know that approximately 4,000 documents were provided on a USB key or CD-ROM or in some electronically scanned document. Yesterday, the Minister for Health said he had issues and used the word "pathetic". I do not know if that is correct but that is the word he used. Why has Dr. Scally not been given direct access to all the files which all the staff have? Why is he not being given remote or direct access to all those files? Did the HSE ever propose that he have such access and, if so, why has it not been provided?

The Deputy's first ten minute slot has concluded. He will get back in.

I will not get back in.

Mr. John Gleeson

We did raise it as a possibility of a means of access to all the records, documents and so on that we have. The response was that it would be preferable to have electronic files provided in searchable PDF format.

Who said that?

Mr. John Gleeson

The liaison under Mr. McCallion.

Mr. Damien McCallion

A senior manager appointed in the HSE, Mr. Gerry O'Neill, is heading that up with legal support to ensure the documentation and links with the Scally inquiry-----

Let me get this straight because it is important. Mr. Gleeson or someone with him proposed to give Dr. Scally the same full access that the relevant HSE staff had. However, that was shot down in preference for taking the electronic files, putting them on a device - be it a USB device or a CD - and giving that to Dr. Scally, which he has gone ballistic over and which the Minister has called "pathetic". As a result of this, the Taoiseach had to stand up in the Dáil yesterday and say that he was instructing the HSE to do otherwise. Why did the HSE not give Dr. Scally full access from day one? The Taoiseach and Minister for Health are on the same page as me about this.

Mr. Damien McCallion

I will have to confirm that with Dr. Scally. He has a team that works on the document side. It agreed a process with our team to make sure that-----

I am not a big fan of the first report the HSE produced. In fact, it is not what was agreed in the Dáil. However, that is not the issue. Dr. Scally was clear in that he was furious about the documentation. Everyone present knows that. We have now revealed that the people in Limerick just wanted to give him full access. As usual, though, when it went up the food chain, a decision was taken somewhere in the HSE that it would have to edit that documentation in some way. Why can we not give him full access?

Mr. Damien McCallion

My understanding is that the process was agreed with Dr. Scally's team, but we can confirm that for the Chair. I have not spoken to Dr. Scally on this specific issue, so I do not want to say something-----

If that is the case, it is amazing. The Minister for Health has had discussions with Dr. Scally since then and I have had communications with the Minister for Health. There is a contradiction in this somewhere. Either Dr. Scally is not telling us that he was offered an opportunity or it was refused to him by someone in the HSE.

Mr. Damien McCallion

May we confirm that? I do not want to mislead the Deputy about it.

No, I want confirmation now. The HSE should not be able to attend our meetings only to always say that it will have to revert to us. I want confirmation now. I have to walk into the Dáil. The idea of kicking to touch and reverting to us after an answer is agreed is not acceptable. That is why we are back here today.

Mr. Damien McCallion

I appreciate that, but I do not want to give an answer to the committee that is not correct. We might make a call to Mr. O'Neill to clarify what was offered with Dr. Scally's team.

Can someone do that while----

Now.

As to my final question, how many-----

I will help the Deputy by clarifying that. Has the HSE a problem with providing all of the personal confidential information of patients to someone who does not have statutory authority to examine those files without the patients' consent?

Mr. Damien McCallion

I spoke to Dr. Scally on this issue in terms of contact with the women affected. Dr. Scally's preference was not to get the individual information of the women. He did not feel that was appropriate. That is why, when answering the Chairman's question on sending correspondence to the women on behalf of Dr. Scally-----

Okay, but there is a way-----

Mr. Damien McCallion

May I clarify this point, because it is important? Our head of advocacy is linking with Dr. Scally directly to ensure that the letter he wants to go out and any other contact he needs to make in respect of meetings and so on are scheduled. That was his choice.

I do not have an issue with the data protection question.

I need Mr. McCallion to be present for my final question. Has Dr. Scally ever-----

(Interruptions).

Mr. McCallion-----

Mr. Damien McCallion

Sorry.

Has Dr. Scally been to Limerick and met the staff? If he has not, it would be insane. Are there doctors present in Limerick to deal with the serious requests from women who have been affected, particularly those who have cancer, in some cases terminal cancer? I am hearing that there are no doctors there in a capacity to ring the women back. Is that not right, Mr. Connaghan? What is the total number of women affected? Is it still 209 and does the HSE expect that number to rise?

Mr. Damien McCallion

I will take a couple of those questions. The first was on medical supports.

No. It was on whether Dr. Scally had been-----

Mr. Damien McCallion

Dr. Scally has plans to meet the CervicalCheck team. To the best of my knowledge, he has not done so yet but he has clarified with me that doing so is in his plans.

That is unbelievable.

Has he met Mr. Gleeson?

Mr. John Gleeson

No.

Mr. Damien McCallion

Not yet.

Has he requested to meet Mr. Gleeson?

Mr. Damien McCallion

I will be helpful. In my discussion with Dr. Scally, he clarified that it is his intention to do so. He will meet the CervicalCheck team and all of the people who have been involved in this. That is my understanding, but he can confirm that himself.

There is medical cover. There are consultants working in Dublin to deal with those medical calls.

Regarding the 209, there is the potential for more. We are notified on an ongoing basis of audits and cancers. If audits conclude, we will immediately make full disclosures to women. Once the Royal College of Obstetricians and Gynaecologists commences the international panel, that will assume responsibility for all future audits.

Mr. McCallion is not answering two of my questions. Has the 209 figure increased and, if so, by how much? Does the HSE expect it to increase even further? Are there cases where women ring in but there is no doctor to ring them back?

Mr. Damien McCallion

I will take the first question. I expect the figure to increase before the royal college's review concludes. As we are informed of any change in interpretation from an audit, we will inform the women first. That is the first priority. We are not going to repeat-----

What is the number now?

Mr. Damien McCallion

The number is still 209, but that will be added to. People are being added to it at the moment as the audit progresses. Of the 1,482 women who were part of the cervical cancer audit, 46 audits are still in progress and 12 are concluding. Once those are concluded, the women will be contacted about those audits. From that point forward and once the royal college process commences, any future audit will run through. To be clear, there are 12 women in the current audits and 46 in the ongoing audits. Those women will be contacted as the results are disclosed to them. I anticipate that, as the royal college process commences, which will happen in the coming weeks, we will cease all audits on the basis that we do not want two audit processes to be running at the same time.

Regarding the Deputy's question on medical cover, I am sorry, but I thought I had clarified that. There are medical consultants available to any of the call centres. We have medical consultants in Dublin to take those calls. Those calls are listed, co-ordinated and allocated to medical consultants. There is not necessarily a doctor in Limerick, but there is access from Limerick to medical consultant cover in Dublin.

Given that Limerick is the epicentre of this, may I make a suggestion to Mr. McCallion? It is one that his own staff are telling him and of which he was probably made aware in the past 24 hours when he visited Limerick yesterday and returned with Mr. Gleeson to prepare for today. There should be a doctor there. The staff in Limerick need a doctor who can deal with these cases.

Mr. Damien McCallion

I might add to what I said to give some assurance to the Deputy. Mr. Connaghan flagged this from Limerick and I called the staff again to confirm that the medical cover in Dublin will address-----

Mr. Damien McCallion

One final point, Deputy. I am sorry. If there are complex cases remaining from the calls, it is our intention with the interim clinical director to ensure that they are allocated directly to hospitals. To recap, the call centre model involves a call centre in Cork that effectively takes the first line of calls and provides advice to women. That amounted to approximately 14,000 calls. The second level was general nursing and the third was oncology or colposcopy nursing, for example, the team in Limerick, which has done phenomenal work in a short time. The final level is the medical piece. That is either dealt with directly by a consultant or referred to a hospital.

I will call Deputy Connolly. Deputy Kelly will take the Chair. I have to step out for 20 minutes.

I will be gone in 20 minutes. I can do it for that time, though.

If I am not back, then one of the Deputies who has already spoken might cover until I return.

I will be back in 20 minutes or so.

Please do. I have to go.

Deputy Alan Kelly took the chair.

I have a practical question before asking about this specific issue. People are contacting the call line. I heard yesterday that someone had called more than two weeks ago and was told to put her query about her smear test in an email. She did so but has heard nothing since. Weeks have passed. Will Mr. McCallion please clarify this practical issue?

Mr. Damien McCallion

Sure. If there is an individual case, I would be happy to take it separately-----

Mr. Damien McCallion

-----but, in general-----

I am not raising this individual case to get an answer.

I am raising it because that was the person's experience. Is that an indication of what is going on? Is the HSE snowed in and lacking in staff? Lovely language is being used, spoken with lovely voices but the reality is that when people ask for the position in writing they are told they will be contacted but then there is nothing. HSE officials have said they will contact those affected but one week later they have heard nothing. Is that an exception?

Mr. Damien McCallion

Maybe I can clarify that.

Is that an exception?

Mr. Damien McCallion

I would hope so. I wish to clarify this. It has been a complex process. I am not going to say it has been easy. There have been more than 25,000 calls. At the point when the help desk was established we had a backlog of several thousand. Earlier, I described the model of four tiers of calls. We have more than 50 staff in each area.

That is okay. My heart goes out to the people who are answering the calls in the system - I have no difficulty with that. However, the reality is that telephones are not being answered and messages are not coming back. Obviously, the system is swamped. Is that the case?

Mr. Damien McCallion

We would have been swamped. In fairness, I do not believe some people got the response they needed as quickly as they needed it. We have 400 calls left of the 25,000, although that number grows every day. Extraordinary work has gone in. The delays for some women in getting call-backs have been excessive, more than we would have wanted – there is no question about that.

My next question is for Mr. Connaghan. I was at the meeting in May. Then, I was missing for the 17 May meeting. I came back. We were in Africa with the Committee of Public Accounts, so we were not missing in action. Then, I saw Mr. Connaghan's response. I am on record as saying that I was shocked at Mr. Connaghan's response on the inconsistency between the HSE and the State Claims Agency. The agency wrote to us indicating that a scoping exercise was in being with a view to a commission of inquiry or whatever inquiry would be settled on. Mr. Connaghan, as the new person, decided not to attend that meeting. Is that right?

Mr. John Connaghan

Which meeting is this?

The meeting where Mr. Connaghan called heads together to sort this out. The letter refers to Mr. Connaghan writing to the agency on 13 May at the request of the health executive. Mr. Connaghan said State Claims Agency officials met officials of the health executive. Was Mr. Connaghan at that meeting?

Mr. John Connaghan

No, I was not.

Mr. John Connaghan

It was because I delegated that to Mr. McCallion.

What did Mr. Connaghan delegate to him? What did Mr. Connaghan tell him to sort out?

Mr. John Connaghan

I asked him to find out why there was a difference between the two accounts.

What did Mr. Connaghan think of the difference?

Mr. John Connaghan

At the end of the day there is no difference.

What did Mr. Connaghan think when he saw the difference, when he saw the letter the State Claims Agency wrote to the Committee of Public Accounts?

Mr. John Connaghan

The State Claims Agency wrote to the committee on 22 May, as I recall it.

The letter says that on 22 May the agency noted that John Gleeson, during his evidence, indicated that all of the women who were the subject matter of this had been informed of the audit. It goes on to say that Mr. Gleeson's assertion does not accord with the facts. The agency reiterated its advices and so on. Mr. Connaghan has read that letter. Is that correct?

Mr. John Connaghan

Yes, I have read that.

I wish to assure Mr. Gleeson that I am not here to personalise anything. I am talking to the head of the Health Service Executive. He is the new person with a new vision and approach. Mr. Connaghan read this letter from the State Claims Agency which said that account was not accurate. What was Mr. Connaghan's response to that?

Mr. John Connaghan

My response to that was to ask both parties to reconcile the inaccuracies. I believe it is entirely reasonable for me to ask both parties to come together to explain their versions of events and to explain the alternative version of events and why there was a difference. At the end of the day, that difference did not exist because we agreed with the latter part of the letter of 22 May.

It is my purpose to ask questions. We are here to oversee governance and procedures. We are not here to ask people whether their job is tenable. That is not our role. Our role is to see whether procedures are in place. I am not reassured by Mr. Connaghan's approach on procedures. The State Claims Agency has said certain matters were not recorded in the way suggested. Mr. Connaghan saw fit to call the relevant people together. Mr. Connaghan did not attend the meeting. There are no minutes of the meeting. That does not represent good governance or accountability for someone who is in charge, does it?

Mr. John Connaghan

Does Deputy Connolly not think it represents good governance that I would ask both parties for their version of events?

They had given their version of events to the Committee of Public Accounts in a public venue. That is exactly what happened. Mr. Connaghan is the new director. The previous director has been before the committee and we extracted the fact that three memorandums exist. I am going to come back to them. Mistakes happen and to err is human, but not to learn is unforgivable. I do not think this is good governance. On reflection, does Mr. Connaghan think it was good governance?

Mr. John Connaghan

I still think it was good governance and I will explain why. We have two contradictory statements. How could I provide an answer to the committee without asking the other party about that party's version of events?

I think Mr. Connaghan is missing the point. The other party gave evidence.

Mr. John Connaghan

That may well be the case.

I accept that Mr. Connaghan is arguing back to me and I respect that, but the evidence had been given. That is the problem - it had been given. That will be looked at in future, presumably by the scoping inquiry. Forgive me if I am wrong, but this looks like Mr. Connaghan decided to get the one story. That added to the insult.

I will leave that for today. I will leave it for the inquiry but I appeal to Mr. Connaghan to reflect on it. Did Mr. Connaghan read all the briefing documents that were produced to us eventually by Mr. O'Brien? I will be specific. I am referring to the three memorandums.

Mr. John Connaghan

Yes, I did and the subsequent memorandums. I do not have them with me.

It is okay. I am not going to go into them in detail. They are for another day. The memorandums are from March, April and July. They were produced but it was like pulling bad teeth. I apologise for comments like that because this is far too serious – I will take that back.

I will come to Dr. Stephanie O'Keeffe. Is she the same person as Dr. O'Keeffe?. She is down as national director of health and well-being.

Dr. Stephanie O'Keeffe

That was my role pre-January of this year.

I am not querying any of that. Her name appeared on all the briefing notes. She has now changed position. Is that correct?

Dr. Stephanie O'Keeffe

I have.

Was that a promotion?

Dr. Stephanie O'Keeffe

No, it was reorganisation as part of the overall reconfiguration instituted by the former director general.

Dr. O'Keeffe is now in charge of planning and transformation. Is that correct?

Dr. Stephanie O'Keeffe

I am responsible for planning.

Mr. Connaghan read all the documents I have before me. Yet he still thought it was okay to call a meeting and get those involved to sort out their recollections, having read these memorandums. Is that accurate?

Mr. John Connaghan

They are the memorandums from 2016 and 2017. Is that correct?

That is right. They raise major issues of communications strategies and warnings in advance that there might be screaming headlines. Clearly, a strategy was in place on the basis of these memorandums. Is that not right? Did Mr. Connaghan read them?

Mr. John Connaghan

I did read them.

Good. They are signed by Simon Murtagh, acting head of the National Screening Service, on behalf of Dr. Stephanie O'Keeffe, national director. The issues coming up relate to the results of the audit coming through with problematic findings and communications to women. What comes through from them is a strategy to address controlling the issue and the screaming headlines.

Dr. Stephanie O'Keeffe

Can I answer that?

Dr. Stephanie O'Keeffe

It is important. Deputy Connolly was not at the last meeting of the Committee of Public Accounts that she referenced. The transcript of that meeting and the previous meeting of the Joint Committee on Health addressed all those issues in full. The purpose of the briefings requested and shared with the director general and the Department was to explain the matter to those people. They would have received a verbal briefing in advance, at the same time as they received a written briefing, to the effect that the CervicalCheck programme was conducting the audit and that those responsible had come to the point where they wished to communicate the findings to women.

Wait one second. I have only ten minutes. I have before me the transcript of the meeting that I missed. I have read it in detail. I was present and asked a question on the memorandums given to us at 3 p.m. that afternoon. I was present for the questioning on the memorandums. I could not possibly accept the language in the memorandums on the strategy being communicated. Again, I am leaving it for the commission and the scoping exercise. I have read them. The officials are taking another position now. The three documents I have before me show me that there was a strategy in place to contain the message. I am asking Mr. Connaghan whether, when he read all those documents, he still thought it was appropriate to contain the message.

Mr. John Connaghan

I will outline my reading of those documents. I do not have them in front of me but it did not immediately read to me that this was a containment strategy. There was clearly a strategy to make the audit results available to women. That is why all the treating clinicians had a letter asking them to pass on the results in question. I did not immediately read that interpretation into it. This is the subject of copious evidence given over seven hours at the previous meeting of the Committee of Public Accounts.

No. What jumps out of the documents is the strategy to contain. Anyway, I am leaving it.

I would say to Dr. O'Keeffe that I think the language was wrong. I think it was totally unacceptable. When a new person joined the HSE, the organisation should have reviewed the matter. In my opinion, the action was not good governance.

I have a few questions for Mr. Breen about the State Claims Agency. I have attempted to find out how many cases are pending, in whatever form, such as a warning letter or proceedings settled. How many cases are there in terms of the cervical smear programme?

Mr. Ciarán Breen

I have those figures here.

Mr. Ciarán Breen

Deputy, just before I give them, can I comment on why we, the State Claims Agency, at the request of the HSE attended that meeting, and I know that Deputy Kelly referred to the matter as well?

Mr. Ciarán Breen

We did so in a very bona fides way to assist the committee on to the differences that were between us. In fact, I felt that there was a duty, certainly on our part, that if there was a difference between us to communicate that with the HSE and to see how that could be resolved for this committee. I can assure the Deputy that that was the only reason that we had that.

It should be done in an open manner with minutes and an agenda.

Mr. Ciarán Breen

Yes. We recorded it, ultimately.

Is Mr. Breen saying that what he told us in his letter has not changed?

Mr. Ciarán Breen

Exactly, I quite agree.

Is Mr. Breen saying that what he told us in his letter has not changed?

Mr. Ciarán Breen

I absolutely agree. To just emphasise the point, it was the unease of this committee that it did that.

The only thing that has changed is that Mr. Gleeson has said that the words "assumed" and "assumption" were used.

Mr. Ciarán Breen

Yes.

I am going to leave the matter because my colleagues have gone into it and I do not have the time.

Mr. Ciarán Breen

On the case numbers as of today-----

Mr. Ciarán Breen

-----we have one closed case-----

Mr. Ciarán Breen

-----which is the case that we know of. We have 28 cases where there are legal proceedings or there are letters of claim, and we have two potential claims.

Is that one closed case and 28 cases where there are legal proceedings either from a letter-----

Mr. Ciarán Breen

Or a letter of claim, yes.

Mr. Ciarán Breen

Then there are two potential cases.

Are they part of the CervicalCheck programme?

Mr. Ciarán Breen

Absolutely, yes.

Sorry, Deputy Connolly, but I will give you back time. Has the State Claims Agency the numbers for the other screening programmes?

Mr. Ciarán Breen

Yes, we do.

Such information would help us to close that out.

Mr. Ciarán Breen

Yes, on BreastCheck, we have five cases in total. One is settled and we have four active.

What about the other screening programmes?

Mr. Ciarán Breen

Yes, I have other figures. On cervical cancer misdiagnosis-----

Mr. Breen told us there are 28 cases, two potential claims and one closed case.

Mr. Ciarán Breen

Yes.

What are the figures for BreastCheck?

Mr. Ciarán Breen

On the non-national screening services, we have 12 active claims, four closed claim and one potential claim.

For clarity, and after this Deputy Connolly can resume, we have 28 cases, plus two potential cases and one closed case in terms of CervicalCheck.

Mr. Ciarán Breen

Correct.

.

Vice Chairman: We have five cases, four active cases and one settled case in terms of BreastCheck. In the other screening programmes, there are 12 cases, four closed and one potential case. Is that correct?

Mr. Ciarán Breen

These are non-screening services. These are ones that would come from hospitals, which is in regard to cervical cancer and misdiagnosis.

Are they non-screening services?

Mr. Ciarán Breen

They are non-screening.

Are they related to cervical cancer?

Mr. Ciarán Breen

Yes.

Is that the last reference to 12, four and one claim?

Mr. Ciarán Breen

Yes.

For total clarity, are there more cases in terms of the other screening programmes?

Mr. Ciarán Breen

No. I will go through those figures again.

Mr. Ciarán Breen

On bowel cancer misdiagnosis, there are none under the national screening service. As part of the non-national screening service we have 18 active claims, four closed claims and three potential claims.

Is that in addition to the 209 cases?

Mr. Ciarán Breen

I referred to bowel cases.

How many cases?

Mr. Ciarán Breen

The numbers are 18, four and three.

Are there 18 active claims, four closed claims-----

Mr. Ciarán Breen

Sorry, the numbers are 18, five and three.

In terms of the cervical cases, do the figures all relate to the 209 cases or people within the 209 cases?

Mr. Ciarán Breen

Yes, we believe that they are in the 209.

I will clarify the numbers in order to prevent confusion. The last figures relate to bowel cases.

Mr. Ciarán Breen

Yes.

Are there 18 active claims, five closed claims and three potential claims?

Mr. Ciarán Breen

Yes.

Are those cases outside of the actual screening?

Mr. Ciarán Breen

Yes, absolutely.

Does Mr. Breen have more figures?

Mr. Ciarán Breen

On breast cancer misdiagnosis outside of the national screening services, we have 23 active claims, 18 closed claims and we have two potential claims.

I have asked about the bowel screening programme and was told that there were no outstanding claims.

Mr. Ciarán Breen

That is right but that is for the bowel screening service. I gave the figures for bowel cancer misdiagnosis outside of the screening process.

Are the figures for outside of the screening process?

Mr. Ciarán Breen

Yes.

In fairness, Mr. Breen has given figures for inside and outside the screening programmes.

Mr. Ciarán Breen

Yes.

That is fine. I thank Mr. Breen.

Is that it?

Mr. Ciarán Breen

That is it.

I call Deputy Connolly.

Mr. Ciarán Breen

Sorry, there is retina and we have none. We have one public liability claim, which is not related to-----

I ask Mr. Breen to forward his tabular statement with the date to the committee so that we can distribute it.

Mr. Ciarán Breen

Yes.

I apologise to Deputy Connolly for interrupting her questions but I believe that last exchange has been useful.

Yes. I wish to raise two issues and one is for Mr. Connaghan. There is one case that brought all of this matter to our attention yet there was no escalation in procedures by the State Claims Agency, in terms of this area. Is that right? Mr. Breen has said so on more than one occasion here.

Mr. Ciarán Breen

Yes, and I can explain why. We had a case, which arose from a screening service.

Mr. Ciarán Breen

It was where there was a liability on the part of a laboratory. It was one case that we were dealing with - a very tragic case - and it was dealt with within ten weeks. There was nothing about it, at that point in time, that had the appearance of what later emerged from that.

Was the State Claims Agency aware of the memos that we, subsequently, became aware of?

Mr. Ciarán Breen

No, we were not aware of them.

Was the State Claims Agency ever alerted, by any agency, about what was going on in terms of these memos and matters being highlighted?

Mr. Ciarán Breen

No.

Was the State Claims alerted?

Mr. Ciarán Breen

No.

Mr. Ciarán Breen

In so far as I am aware there was nobody in our organisation who knew of those.

I am afraid that I will run out of time. My last question is for Mr. Connaghan. I have read what Dr. Gabriel Scally has said and I have read the two reports. Can I presume that Mr. Connaghan has read them too?

Mr. John Connaghan

Yes, I did.

Is Mr. Connaghan comfortable that it takes an interim report, on 11 June, for Dr. Scally to tell us that it is disappointing and unclear? Why do we need a report to tell us and the HSE that?

Mr. John Connaghan

The Deputy has asked if I am disappointed. I am disappointed as well.

I did not ask Mr. Connaghan whether he was disappointed. Why has it come to this that it takes a progress report to set out that Dr. Scally is disappointed and unclear?

Mr. John Connaghan

We do not just have progress reports. We have got regular liaison between the two teams.

What happened? Why was this matter not sorted out? Why did Dr. Scally have to highlight the matter in written form in a report?

Mr. John Connaghan

That is something that the Deputy needs to ask Dr. Scally.

No. I ask Mr. Connaghan what happened with the process, procedures and communication with an independent scoping exercise that forced Dr. Scally to say he was disappointed not to get the documentation.

Mr. John Connaghan

So we have a letter from Dr. Scally dated 18 May, which was received in my office on 22 May. Information was starting to be provided between 24 May, to Dr. Scally, up to 7 June to close out that information request.

I think where Dr. Scally's disappointment lies is the fact that the information provided to him was not totally in an immediately searchable format. We are looking at the technical reasons to try and readjust that right now so that he can search all documents. I mirror his disappointment but there is no question of full co-operation with the HSE. All of the staff understand that.

Why did the HSE not take up Mr. Gleeson's request?

Mr. John Connaghan

It is not a bad suggestion from Mr. Gleeson. I would like to think of it.

Look Mr. Connaghan, Dr. Scally did not personalise the matter. He said: "It is disappointing and unclear why documents that would originally have been prepared in electronic format" and so on. Why was it unclear on 11 June after so much pain and difficulties?

Mr. John Connaghan

I think that is because at that point in time we had finished supplying the documentation to Mr. Scally's inquiry on 7 June. So obviously he looked at that and discovered some things that he did not like, in terms of the transmission of those documents. We are working to sort that right now, okay.

There are two points on which I seek clarification from Mr. McCallion and Mr. Connaghan. Mr. Connaghan said he would like to consider Mr. Gleeson's offer of access. How, in the name of God, did he not know about it before today? This is the biggest health scandal in decades and Dr. Scally has come out and criticised the HSE about access. Surely, it was fed up the line that the programme manager had given an open disclosure access policy, perhaps with limitations, yet Mr. Connaghan is only becoming aware of it today.

Mr. John Connaghan

Yes, indeed. Something occurs to me and it is that I have only met Dr. Scally once and that was at the outset. It is important to make sure I have oversight of where Dr. Scally's review is going, that we are supportive of it and that we can provide the required information. I will probably need to set something up. I will be doing so this afternoon in order to have regular contact with Dr. Scally to make sure we iron out any issue. I thank Mr. Gleeson for making the suggestion. It is something I need to consider.

For the public, the witnesses are all on the same team and Mr. Connaghan is thanking Mr. Gleeson in front of the whole country for a suggestion that seems glaringly obvious to most of us - giving access to information. Yesterday the Minister for Health called the witnesses "pathetic", but Mr. Connaghan was not even told that this had been offered. He really needs to sit down and have a chat with people because it is embarrassing. I cannot go any further.

I request clarification on one thing Mr. McCallion said. We know that the number of women affected will increase. He talked about a further 12 audits and 46 ongoing audits. Will he clarify if that means that there are potentially a further 58 cases?

Mr. Damien McCallion

What I was differentiating was that there were 46 cases remaining in the audit process, 12 of which were being concluded. What I was saying was that when the audits were concluded, the first thing that would be done in all cases was disclosing to the women concerned. That is the priority.

The maximum number is 48. There are 12 in process. Is that so?

Mr. Damien McCallion

There are 46 in process, but, to be clear, in the overall review the Royal College will look at a much wider group of women.

I know that; it concerns the 1,500 found up the line.

Mr. Damien McCallion

It involves the 1,600 records from the National Cancer Registry, in the region of 1,000 of which were never screened, The balance will form part of the review by the Royal College. There may well be others within it.

I understand that because I was the person who raised the issue on day one. For the purposes of clarity, there are ongoing audits of 46 women, 12 of which are nearing conclusion-----

Mr. Damien McCallion

Twelve are close to conclusion in terms of disclosure. The women concerned will be disclosed to first, if there is a difference of interpretation. With the Royal College about to commence, the balance may then be paused and moved into the review because we do not want to have two audits running in parallel because they will run at the-----

That is fine. I understand that, but they will be prioritised if they are at the top of the queue.

Mr. Damien McCallion

Yes, we will write to the Royal College for a full debrief on the original audit and-----

A total of 48 cases-----

Mr. Damien McCallion

There were 46 remaining.

Twelve have been reviewed-----

Mr. Damien McCallion

Concluded.

-----and the findings will be disclosed. On top of that, we will have the follow-on from the 1,600-----

Mr. Damien McCallion

The additional 1,600 records. For the purposes of clarity, because this is important for the women with cervical cancer who are listening, there were 1,482 cases which were part of the original audit, 1,600 cases have been advised by the National Cancer Registry and the Royal College will look at the totality-----

We have been through all of that.

Mr. Damien McCallion

It is really important in not causing further anxiety for those who were in that group and will wonder where they sit. The Royal College process will look at all of them and respond. I understand from the Department that it is close to commencement.

To follow on, I refer to the 46 cases that were pulled from the total of 1,482 that are in process. There are 58 in total, of which 12 are nearly finished-----

Mr. Damien McCallion

There are 46 in total.

The figure of 46 includes the 12 cases mentioned?

Mr. Damien McCallion

Yes.

Were they randomly picked from the 1,482 or did the women concerned have an active cancer diagnosis?

Mr. Damien McCallion

The 1,482 cases came from CervicalCheck, the screening programme, which had received a notification from a hospital of a woman having cervical cancer. That was how this all started and led to the initiation of the audit.

I understand that. I want to clarify that the 46 cases-----

Mr. Damien McCallion

They are part of the total. They are a more recent group of women who have come through. The audit process has run. It was not a one-off audit process; it ran over a period.

Deputy Kate O'Connell's question is from where did the 46 cases come.

Yes, how do we-----

They are not part of the total of 1,600 cases. From where did they come?

Mr. Damien McCallion

No, they are part of the total of 1,482 cases.

We called them group A before we found a secret group B, of which the Minister was informed on the Monday or Tuesday.

Mr. Damien McCallion

The National Cancer Registry.

These 46 cases-----

Mr. Damien McCallion

They are part of the total of 1,482 cases and part of an ongoing audit.

The 46 cases have been pulled from the total of 1,482. The women in question have an active cancer diagnosis, which is why we are looking back.

Mr. Damien McCallion

The audit was concluding, which is why I was explaining-----

The 1,482 cases were not randomly audited.

Mr. Damien McCallion

No, it was a structured-----

In order to be audited, a woman had to have cancer?

Mr. Damien McCallion

That is right.

Deputy Sean Fleming resumed the Chair.

To get back to where I was, the scanning of documents-----

Mr. Damien McCallion

I apologise to the Deputy; I was providing clarification on request.

It does not make sense to me. I am not accusing anybody of telling lies or giving misinformation or whatever nice version one wants to use about lying. As we all heard, Professor Scally has a history of dealing with stuff like this in other organisations. It does not make sense that it would be acceptable to somebody at his level to receive scanned documents on a disk or a USB stick. Neither he nor anyone at his level would think it was practical to go through documents in that manner. It is not believable and I find it incompetent that scanned documents would be given in a format that was not searchable, as Mr. Connaghan said. It is a needle in a haystack job. It is not the way to go about it. That it took until 11 June to find out that this was the format in which he had been given the information does not add up.

Many of us on the Committee of Public Accounts and the Joint Committee on Health, including me, believe we are constantly met with resistance, avoidance of disclosure and every barricade that can be put in our way in our engagement with the HSE. For the public looking in, I estimate the combined salaries of the witnesses present per year to be in the region of €2.5 million, leaving the rest of us out of it. I have said here before and at the Joint Committee on Health that we are dealing with a population the size of that of Manchester. For normal people looking in, this is madness. It is a dysfunctional system that is rotten to the core and not fit for purpose. We have all of the witnesses, many of whom do great work, but committee members are like a court of law. Deputy Jonathan O'Brien has to read transcripts and we then start dancing on the head of a pin with words such as "assurances" and "assumptions". The last time we had the word "feelings" from Dr. O'Keeffe. All of this language does not give us answers and, to my mind, it is a complete waste of time. Somebody needs to take control. I thought Mr. Connaghan was in control, but the fact that he has admitted that he has only met Dr. Scally once, which was at the outset, seems mad. It seems reasonable on something of this magnitude that he would be meeting Dr. Scally on a weekly basis to be updated. To have to sit here on a such beautiful day land listen to Mr. Gleeson talk about things he had "assumed" is disrespectful to us and the public.

I do not buy the notion that somebody thought that giving scanned, unsearchable documents was the way forward. It seems to be a deliberate attempt to stop information from being received. I do not buy either the notion of not having statutory authority because I have often inquired of the primary care reimbursement service, PCRS, and it seems people with no medical qualifications have access to medical records. The issue can be dealt with. Many people go to doctor A for treatment and doctor B gets to see their files and there is no confidentiality issue. It is just another barricade put in our way in trying to get the answers.

I just wonder what the point of all the witnesses is at this stage. They are not able to answer us. Who is to blame? Is it the labs, the audit process, the system, politics or something else? We are still here. I do not know what is the point of this meeting. It must be the tenth or 12th meeting with the witnesses I have attended and we are no further along. There is no point to the witnesses being here because they are not giving us answers. If this is - I am trying to think of a word that does not include bad language - the mess we are in, they clearly cannot manage things.

The public and the medical people are becoming more annoyed because we are now undoing all the good that was done through the screening process in this country over ten years. We will probably reverse our 7% reduction in cervical cancer rates. The whole negativity around this is bad for public health, which, as far as I am concerned, it is supposed to be the witnesses' job to protect. I am a Government Deputy and I just think the whole lot of them should be sent packing and we should get new people to do this. It is the middle of June. This has been going on for weeks now and we are none the wiser. We are looking at people who are paid with taxpayers' money and who are supposed to be accountable to us telling us "Well, maybe", "Oh, I assumed this" and "I felt this". I just do not have any time for it because I do not buy it. It reminds me of when I used to try to get away with things with my parents when I was a teenager and I tried to baffle them with my various versions of the story so they would not know where I was. That is what the witnesses have managed to do today. We do not know who is in charge, who is accountable or what qualifications people have. I looked at the organisational structure of the HSE and it has changed in the past two days. The HSE has been shifting the deck-chairs around on the Titanic as well. It is just insulting. The witnesses' continuous behaviour at these meetings is insulting to the elected Members of this House and to the public. It is a waste of our time.

Does the Deputy have a question?

I have a question somewhere. A previous speaker - Deputy Kelly, I think - asked Mr. Breen about mediation and he did not get to finish. What is happening? Is the HSE offering mediation to people? If so, in what way is it being offered? How is the mediation initiated? When it is decided that the HSE wants to contact person X, is a letter written?

Mr. Ciarán Breen

Yes.

I am not being smart now.

Mr. Ciarán Breen

Absolutely.

Is an email sent? How is somebody contacted and offered mediation?

Mr. Ciarán Breen

If I may explain to the Deputy, it is done very simply. We write to the woman's solicitor, we say we would like to attend mediation with the solicitor and his or her client and we ask for suitable dates and the solicitor's reports to assist us.

How many did Mr. Breen say have been offered mediation?

Mr. Ciarán Breen

It has been offered in four cases. They are the four most urgent cases. They are the ones the court is managing on the basis that the women are gravely ill.

What is the total number, leaving urgency out of it, that Mr. Breen would consider eligible for mediation?

Mr. Ciarán Breen

All cases, potentially, are amenable to mediation.

We are looking at four out of how many? In what number of cases has the HSE sought to offer mediation?

Mr. Ciarán Breen

We only have nine cases in respect of which there are legal proceedings. In other words, where they have gone to court and they have set out their pleadings. As I said, out of those nine, the four which are the most important and urgent have been offered mediation, and we will continue to do that as we work through the cases.

I know this is hard to quantify, but how is that going? Are people up for it? Are these four engaging?

Mr. Ciarán Breen

They are. The first of them will take place on Sunday, 24 June. The second will be on Monday, 25 June. They will flow on like that.

The letters have been sent and have been accepted, but there has not actually been formal engagement on a one-to-one basis yet, so the-----

Mr. Ciarán Breen

No. If the Deputy can imagine, they are getting their own reports anyway. They have to get their reports as to what the size of their claim is and to calculate all that. We have to wait for them to do that and to present it. Then a mediator is appointed, a date for mediation is set and the parties enter into mediation.

Does Mr. Breen think this will work out? Does he think it is a process that-----

Mr. Ciarán Breen

I do. I see no reason why it would not work. The very idea of mediation is to have a calmer, less adversarial environment where people can engage one another in a very honest way without having all that trauma of having to give evidence, undergo cross-examination and so on. It is therefore an ideal solution, particularly to cases such as these.

The Deputy is at ten minutes.

Deputy Catherine Murphy had indicated she wished to contribute a second time.

Going back to the Scally report and Mr. Connaghan's opening statement, the Opposition groups met the Minister for Health. It was agreed that a scoping inquiry, as opposed to a commission of investigation, would be the best way to proceed - there is likely to be a commission of investigation afterwards - to identify the issues. The inquiry was given until the end of June. This was publicly known. It would have been known to the witnesses that the end of June was the target date for completion of that work. Was Mr. Connaghan consulted before the Cabinet met about whether or not there was a capacity issue with doing it within that timeline? Was there any engagement in that regard?

Mr. John Connaghan

Personally, I have had no engagement in that regard, but I would need to check the record to know whether or not the previous director general had.

Was the end of June realistic?

Mr. John Connaghan

Dr. Scally is probably looking at the exercises now, and I think he has replied that he is looking at the end of summer.

I am not asking about what is in the public domain. In Mr. Connaghan's opinion, was it realistic in light of what he knows about records and where they are? Did he flag anything about that being unrealistic?

Mr. John Connaghan

No, we did not flag anything about it being unrealistic.

Regarding the information Dr. Scally sought, would it have occurred to people that it was not just about the information, it was also about how that information was to be used? If one looks for something, one does not look just for the documents; one looks to see what use those documents will be put to. That the documents had been digitally generated but then scanned and sent in a format that cannot be searched would certainly underscore the point that Vicky Phelan made that she believed it was stonewalling. She said that whereas Dr. Scally did not say that, she felt more at liberty to say it. Would Mr. Connaghan accept there was a degree of stonewalling in respect of the method of transfer of that information?

Mr. John Connaghan

Certainly not.

Was this a very junior person?

Mr. John Connaghan

No. We have a very senior team working on this.

They would have known that there was a deadline on this. They would have known that it was hoped to have this done by the end of June - a scoping inquiry, not a detailed inquiry, as the Royal College of Obstetricians and Gynaecologists is doing in respect of its review. They would have understood that.

Mr. John Connaghan

Yes, they would have understood that.

Does Mr. Connaghan find the way in which the documents were transferred acceptable, particularly in view of the fact that most of them were digitally generated?

Mr. John Connaghan

They were not all digitally generated. We need to consider that some of these documents might have been spreadsheets, which are not capable of being searched without being reformatted. There is a technical side to this that I will probably need to get some further briefing on. Generally, however, in answer to the Deputy's question, on reflection, almost a five-week period from inception - I am starting from the point at which I get a letter on my desk requesting this information - to completion by about the middle to the end of June is an incredibly short timescale.

Does Mr. Connaghan then think the Taoiseach, in hindsight, was wrong to give such a tight timeframe?

Mr. John Connaghan

With respect, Chairman, the answer to that is above my pay grade.

We know Mr. Connaghan is on a high pay grade but he is probably safer not going there.

If I could move on, I will talk about the modules that are being gone through. I am sure CervicalCheck will want to reassure people and it will want women to continue to engage with the screening process, as I would myself, and it will want to give every assurance to people that they can have confidence in the screening programme. It seems to me that in order to give that confidence the very first thing that should have been provided and worked on was the labs and their reliability and if one lab was better than the other so that Dr. Scally could come to a judgment on that. There was a breakthrough yesterday on the contractual obligations relating to that.

Mr. John Connaghan

Yes.

That would not have been one of the first items dealt with. How quickly can that information be given? Can we rest assured that sufficient information is going to be given in respect of this so that Dr. Scally can deal with this particular aspect in as timely a fashion as possible, not just for the 209 women and their families but to ensure confidence in the CervicalCheck programme?

Mr. John Connaghan

I think the question is how quickly that information can be available. To put on the record, at 4.15 p.m. yesterday we got the breakthrough, as the Deputy described, after working behind the scenes to make sure there were no further legal barriers. There will be some caveats to that, because there always are in legal terms. I will turn to Mr. McCallion to respond on how quickly we can now begin to turn that around.

Mr. Damien McCallion

In fairness to the Deputy, there are two things. One of Dr. Scally's objectives is to provide assurance in respect of the laboratories, particularly in the context of the importance of the screening programmes. The Deputy is right. One woman is diagnosed with cervical cancer through screening every two days and that is the key point on which, hopefully, Dr. Scally will give assurance.

In terms of the laboratory performance-----

Did Mr. McCallion say they are diagnosed through screening? Is it diagnostic?

Mr. Damien McCallion

Yes. The screening programme will identify people. Approximately 50,000 people have been diagnosed with pre-cancerous cells through the programme's lifetime but every year approximately 190 people are diagnosed with cervical cancer through the programme.

Through the screening programme.

Mr. Damien McCallion

Yes.

It is not diagnostic.

I understand. There is much confusion.

Mr. Damien McCallion

What I am saying is that people go through screening and then up in a diagnostic process. The reference to 50,000 is a wider number. I am sorry. I was only trying to reflect the importance of the testing, which was the Deputy's point.

In terms of the performance of the laboratories, all of that information has been available and will be made available. The committee had sought copies of the contracts as well so we had to go through a process to ensure that we did not in any way undermine some of the terms and indemnities contained in the contracts that could, in effect, impact on the State. We have got an agreement with the laboratories to release those contracts, as Mr. Connaghan said, with some provisos. We will be going through that with Dr. Scally and also writing to the Chair of the committee in terms of the release of those contracts.

Does the breakthrough include providing the Committee of Public Accounts with copies of the contracts?

Mr. Damien McCallion

Yes. We took both of those.

When are we likely to see them?

Mr. Damien McCallion

There are some provisos in place. The legal people are working through that today. I hope to have that achieved and sorted within the next week at the latest.

We know we are moving to a different type of screening process. Earlier, Mr. Connaghan stated, "This will require a significant team to be put in place within the HSE to support this process." He went on to say something else and the word "understand" jumped out at me. He said, "We understand the Department is concluding the contract for this work and the scope of work will include all women who were part of the CervicalCheck audit". Is it the HSE or the Department of Health? That jumps out at me as being odd. If the HSE is running the programme I would have thought it would also be involved in the contractual obligation around the process. What is going on in relation to that?

Mr. Damien McCallion

To clarify, there are two different things. The HPV roll-out is a separate project. I think what Mr. Connaghan is referring to in the opening statement is the Royal College of Obstetricians and Gynaecologists' review, which is of the 3,100 women I mentioned earlier who have been diagnosed with cervical cancer.

Mr. Damien McCallion

They were grouped through the programme. While the Department is leading on that - it is independent, rightly so, of the HSE - we have been working very closely with it in terms of the numbers to ensure that the Royal College of Obstetricians and Gynaecologists is clear on the total numbers and the size of the task it is taking on. I think what was being referred to in the opening statement was the international expert panel, which is effectively being undertaken by the Royal College of Obstetricians and Gynaecologists and the faculty of pathology in the UK. It is separate to the HPV project and the Scally review.

Will it require a significant team to be put in place?

Mr. Damien McCallion

That is correct, yes.

Is that team in place?

Mr. Damien McCallion

We are recruiting. We are currently trying to get a project manager assigned because we will not have time to recruit and we are also looking at both recruitment where we need specialist skills like medical laboratory scientists and so on to support the work of the Royal College of Obstetricians and Gynaecologists' review.

I had understood that it would commence the review within a short period?

Mr. Damien McCallion

I think it is imminent. My understanding from talking to colleagues in the Department is that it is imminent.

What timeline is involved?

Mr. Damien McCallion

I do not have an exact timeline on it in terms of the timeframe it will take them to work through. The college will need to determine its approach. It will be independent of the HSE but we will work very closely with it on the review.

I will come back to one particular point regarding the State Claims Agency. We had a meeting last year at which it was talked about generally. I cannot recall the specific date.

Mr. Ciarán Breen

Does the Deputy mean the 20 April teleconference or the previous meeting?

The risk meeting.

Mr. Ciarán Breen

That was in March 2017.

It is clear from the memos what was known at that stage. Deputy Connolly referred to some of those matters such as concern in the HSE about screaming headlines and potentially undermining the screening programme. It was well known in the HSE and there was talk about how it would communicate, but then it did not communicate and held back letters. We know the body of memos that are there. I think there were four of them. The State Claims Agency takes responsibility for any court actions and it has to do an assessment of what is likely to happen. The sum of €2 billion is provided for contingent liability.

It is €2.6 billion.

Pardon me for overlooking €600 million here or there.

It is a big issue.

It is a very large amount of money. Would that not have jumped out as something being wrong in terms of risk assessment? Was it not considered to be a very serious risk and that the risk assessment needed to be upscaled? Did that arise? I cannot get my head around the fact that it is only when one is almost at the end game that the State Claims Agency gets involved. The agency is going to go through a mediated process and have open disclosure.

Mr. Ciarán Breen

If I could just explain, we have two separate sections, one is a clinical risk management section and then we have our claims section. There is a great deal of interaction between both, so there is an awful lot of learning that arises from the claims side that is fed back through our risk management side on closed claims analysis, for example, across the range of health services. To put the particular meeting in context for the Deputy, it was very much a preliminary meeting with the screening service. It was not something we had worries about. A lot of claims occur in hospitals due to medical negligence so they were our priority. This was a very introductory-type meeting. Mr. Gleeson was at the meeting and he might speak about it as well. It covered a range of things.

Was Mr. Breen surprised subsequently with what they knew and what information was brought to his attention?

Mr. Ciarán Breen

I can tell the Deputy that there was nothing at all that came to our attention at the meeting that gave us any-----

Mr. Ciarán Breen

Looking at it now, in the context of women not being told, that is the kind of thing that we might have been told, for example, but nothing arose with regard to those issues at that meeting.

I have a couple of brief questions on the labs.

I do not know whether it is still the case that all the cases which are before the courts, or are potentially coming before the courts, relate to the American laboratories.

Mr. Ciarán Breen

Yes, the two laboratories involved are MedLab Pathology and Quest Diagnostics.

So it is just those two laboratories and there are no Irish-----

Mr. John Gleeson

May I clarify the matter?

Mr. John Gleeson

They are not both American. One is American and is not the American laboratory in the case - Ms Phelan's case - that was in the public domain.

Mr. John Gleeson

The other one is a laboratory operating in Ireland.

Okay. The reports coming from the laboratories that enable people to see whether there are discrepancies between the various laboratories have been requested previously. Having checked with Deputy O'Connell, I believe the health committee requested that information a number of weeks ago. It was subsequently requested by this committee. Are we any closer to getting that information?

Mr. Damien McCallion

I can clarify that for the Deputy. My understanding is that the information was supplied to a committee - I will have to recall which committee it was - regarding the period between 2013-2014 and 2015-2016. The request-----

If I may, it was only three years. I asked-----

Mr. Damien McCallion

No.

Excuse me now. I am not sure whether it was this committee or the health committee. I cannot remember. Why did we get those years? As I understand it, they were not part of the audit. Maybe they were.

Mr. Damien McCallion

They were.

It seemed wrong that we were given those years and not all of the years we asked for ages ago.

Mr. Damien McCallion

Yes. I will clarify the matter. We have someone working on the historical stuff. It is more complex to draw out the historical data. The other issue we have is that the same people - it is a very small team - are working on the archive process, on finishing the audits and on other work. We have to try to prioritise some of that. I am assured that this work will be finished within the next week. We will get the full results to both committees then.

Dr. Scally will want that information as well.

Mr. Damien McCallion

Yes, I am sure he will look for more detailed information as part of his audit.

I understand that when a laboratory has been accredited, Cervical Check conducts quality assurance visits each year. Is that correct?

Mr. John Gleeson

No. If a laboratory is to achieve accreditation, it must be certified annually by an independent certification body. The relevant body for those who are operating laboratories in Ireland is the Irish National Accreditation Board. There is an equivalent authorised certifying body in every country for laboratories that operate there. Laboratories are audited against an international standard every year.

I ask Mr. Gleeson to clarify something he said in response to a question posed by Deputy Burke at the meeting of this committee on 17 May last. When Deputy Burke said, "Just to clarify, we are exclusively relying upon these laboratories. At that time, we did not do any independent checking. Once the laboratories were accredited and quality assured, that was it from the HSE's point of view. Is that correct?", Mr. Gleeson replied by saying "We do quality assurance visits."

Mr. John Gleeson

Yes, we have done periodic quality assurance visits.

So it was true to say "We do quality assurance visits."

Mr. John Gleeson

We have done such visits in the past.

Mr. John Gleeson

We have noted the days to people.

Mr. Gleeson also said at the 17 May meeting that CervicalCheck gets "annual reporting rates" from the laboratories and they are "discussed at committee meetings". Is that correct?

Mr. John Gleeson

They are presented to management.

Mr. Gleeson would have had sight of those documents. They would have been discussed at committee meetings. From his reading of them, did he see any variation between any of the laboratories? The only information we have is from 2014 to 2015. I presume Mr. Gleeson has seen information for all of the years.

Mr. John Gleeson

I have seen variation between all laboratories as I would expect. I would not expect them to be identical. I have not seen variation outside what we would expect to see among laboratories operating correctly.

So the variation would be within acceptable limits.

Mr. John Gleeson

Yes.

Okay. That is fair enough. My next question relates to the information that Mr. McCallion's colleague was asked to get. I do not know his name but I note that he has returned to the room. I wonder whether he has an update.

Mr. Damien McCallion

I will let the official in question, Mr. Ray Mitchell, respond to the Deputy.

Mr. Ray Mitchell

I have texted and rang the person who would be able to give us that information, but unfortunately they have not got back to me yet.

Mr. Ray Mitchell

As soon as they do, I will try to make sure the committee gets it. Otherwise, I will email in the response.

Okay. I appreciate that.

Mr. Ray Mitchell

Maybe I will get it before this meeting concludes. I am watching to see if it comes in. I do not want to do anything that disrupts the meeting.

Just in case Mr. Mitchell's remarks were not picked up by the microphones, Mr. McCallion might summarise what he has said.

Mr. Damien McCallion

We are still waiting to make contact with the person in question. If we do not make contact, we will email it in-----

The person in question has been contacted. Mr. Mitchell is waiting for them to come back.

Mr. Damien McCallion

We have contacted them, yes. We are waiting for them to come back. If we do not hear from them before the end of the meeting, we will email the committee with the details that were sought in the original question.

That is fine. I asked Mr. McCallion to repeat what Mr. Mitchell said in case his remarks were not picked up by the microphone.

I want to be fair to everyone. We now know information which we did not know previously, particularly in relation to women being informed. It was assumed that women were being informed through their clinicians. Unfortunately, we now know that was not the case. That is what has caused a lot of controversy in this committee and a lot of trauma and hurt for the women themselves. I presume lessons have been learned in that regard. Is it the case that we are not relying on clinicians now? Are we still relying on clinicians to inform women into the future? Is the process changing? Can someone explain what happens now? At the meeting of 17 May, I made the point that because of the failure to put in place a check at the end point, we did not close the loop. I asked Mr. Gleeson who was responsible for ensuring the loop was closed. I was told it was not possible at the time to state who was responsible. Mr. Gleeson said it may or may not have been his responsibility. I asked him whether he would go away and reflect on whether it should have been his responsibility. Somebody needs to be held accountable. I am genuinely not looking for a head on a plate. Somebody needs to put their hand up and say "I was the person responsible for ensuring the loop was closed, but it did not happen and I apologise for it". Nobody has done that yet. I think somebody should do it. I want to give the people in the room an opportunity to take responsibility for the loop not being closed. If they can take responsibility for it now, and if they want to comment on it, the floor is open to them. I think it is important. Much of the stuff that is out there at the moment relates to the fact that the women who have been affected by this issue feel that nobody is being held accountable and nobody is taking responsibility. That, outside of everything else they are going through, is causing hurt to these women. They see a lot of officials and politicians coming in and having a ding-dong back and forth without anybody putting up their hand and saying "I was responsible, I apologise, this will not happen again". Do we now know who was responsible for closing that loop? If that person is here, would he or she like to make a comment?

Mr. John Connaghan

Maybe I can start with some kind of answer to that. I am relatively new in the role of director general and in my understanding of the full scope of responsibilities and accountabilities in that role. From my perspective and in my role, I need to be accountable and responsible for the performance of the system. I understand the committee had a discussion at a past meeting about whether the previous director general was accountable and responsible for the actions of every single person inside the system. The answer at that point was that it was going to be pretty hard to have such accountability and responsibility, given that people sometimes step out of the system. The role of the director general and the board of the HSE, when it is established, is to make sure that a proper set of system controls and procedures is in place, that there is a safe system of working and that all of this is regularly monitored with good procedures. I fully accept that my responsibility lies at that level.

I appreciate that because the person who held the position before Mr. Connaghan did not accept that. I have always said that this is a systems failure. Mr. Connaghan is now admitting that it was a systems failure. If he is not admitting that, maybe I am reading into it incorrectly.

Mr. John Connaghan

The Deputy has used the word "admitting", but I have never denied it, if I can put it like that.

Okay. The person who previously held Mr. Connaghan's position said it was not a systems failure. I appreciate the fact that Mr. Connaghan is now taking responsibility for that. Given everything we now know about information and assumptions, does Mr. Breen have full confidence that all the information the State Claims Agency is getting on CervicalCheck is factual and correct and that no more assumptions are being made?

Mr. Ciarán Breen

Yes. The information we are principally seeking now is in respect of the ongoing claims and ensuring that we have all of the relevant records and documentation we require. We are getting those and getting them in a way that meets our needs. We do not have any doubts about the quality of the information or the rapidity with which we are receiving it.

I want to give Mr. Gleeson an opportunity to comment. He was the person responsible for ensuring that loop was closed initially. It was not closed, for whatever reason. As already stated, at our previous meeting he was uncertain whether it was his responsibility. If Mr. Gleeson would like to comment, he should feel to do so because I think it is important that women hear that someone is taking full responsibility. I know Mr. Connaghan has done that from the HSE point of view. If Mr. Gleeson has a comment, it would be important for CervicalCheck.

Mr. John Gleeson

It is clear from Mr. Connaghan's statement that there was a failure to continue the communication from the treating clinician to the woman. The failure was not to have any responsibility assigned. That was the failing in the system. It did not continue the loop. Had I assumed or been assigned responsibility for it, then it could have been done. I have already apologised for that link not being made. I reiterate that apology now. We have to learn from this process and make sure that final step is taken and if it is assigned to me I will be more than happy to ensure it happens.

To whom has it been assigned? Who is responsible for ensuring that loop remains closed into the future?

We are expecting that the numbers will increase. It is not over yet.

Mr. Damien McCallion

To clarify the process going forward for the Deputy, a central team has now been set up. It links directly with the hospitals. I will take the 209 women as an example. Disclosure was made in the case of 42 of those women but not in respect of the balance. A central team linked directly with the hospitals ensures that the loop is closed in respect of the supports for those women. We maintain a database that keeps an up-to-date picture of exactly where each of those cases stands at any point in order that the loop is closed. The serious incident management team set up in respect of this has the directors of hospitals and all of the other relevant directors on it to make sure that all of those loops are closed. We track all of the contacts made with each of the women. That is not just in respect of informing them but also in trying to keep track of all the different requirements they have.

That is in respect of the 209 women.

Mr. Damien McCallion

Yes, and-----

Mr. Damien McCallion

-----that same process applies to those that I mentioned earlier that are incomplete. There will be a central rigorous process to make sure that happens. We have learned from what happened before and that cannot reoccur.

It is the responsibility of that team from now on.

Mr. Damien McCallion

Yes, it is.

Who is the head of that team?

Mr. Damien McCallion

It comes under me. It is a small team based in the health service.

If there is a failing in future, will it be on Mr. McCallion's head?

Mr. Damien McCallion

Yes. I have responsibility for making sure that the team makes contact with the women involved.

Mr. Connaghan may have answered this earlier. On page 12 of his report, Dr. Gabriel Scally recommends that a process be commenced as soon as possible for structured conversations all of the women. Where do matters stand in the context of that recommendation and whose responsibility is it? Dr. Scally mentioned Mr. Justice Quirke's commission as an example.

Mr. John Connaghan

Let me get the recommendation. I have the report here. Is it paragraph seven?

It is the final recommendation on page 12.

Mr. John Connaghan

I am on page 10 of the wrong report. I am sorry. That is Dr. Scally's responsibility. As Mr. McCallion has explained, Dr. Scally wishes to engage personally with each of the women.

That is fine. I just want to know whose responsibility it is. It was not clear to me whether it is that of Dr. Scally or of the HSE. I refer again to the recommendation of a process being commenced as soon as possible for structured conversations with every woman so that it be documented. Does Mr. Connaghan understand that to be Dr. Scally's responsibility?

Mr. John Connaghan

We are engaging with Dr. Scally on that.

Mr. Damien McCallion

To differentiate for Deputy Connolly, there are two things. One is in respect of contact with women. Dr. Scally wants to put a process in place where he can communicate directly with them.

I would like clarification just on that recommendation.

Mr. Damien McCallion

My understanding is that is a recommendation from Dr. Scally that will be undertaken by Dr. Scally himself.

It would be Dr. Scally's team.

Mr. Damien McCallion

That is my understanding.

Will Mr. McCallion confirm that?

Mr. Damien McCallion

We will.

Mr. Damien McCallion

I do not want to speak on his behalf.

I just want that confirmed.

The people from the Department of Health wish to comment.

Ms Celeste O'Callaghan

I can confirm that the Minister for Health has asked Dr. Scally to identify the arrangements to put that structured process in place.

It is a little difficult that we do not know. Perhaps, inadvertently, it lies with Dr. Scally, but it should be crystal clear as to who is responsible. Here we go again. I have a few minutes and I am trying to establish who is responsible. Perhaps it is Dr. Scally that is at fault on this particular occasion. I do not know. It should, however, be crystal clear.

Mr. John Connaghan

In the time available last night, the management team dealing with this in the HSE had a meeting to look at the recommendations and to attempt to assign responsibilities for each of them. That it why I recognised that recommendation and why at the meeting last night we came to the conclusion that it was Dr. Scally's. I wish to reassure Deputy Connolly, as I said in my opening statement, that we are going to be putting up on our website the recommendation and who is responsible-----

Mr. Connaghan can tell the Chair that afterwards. I want to use my time effectively. I do not want reassurance, I want to see procedures in governance so that we do not end up back here again. There is a scoping exercise and a commission in place because it failed. Reassurance is too late now.

Mr. John Connaghan

I am describing the process.

Mr. Connaghan can tell the Chair in his time. I would be delighted to hear it in his time but I want clarification on who is implementing that recommendation.

The Minister has sought that so, by definition-----

Ms Celeste O'Callaghan

He has asked Dr. Scally-----

-----Deputy Connolly is saying it is not clear?

Deputy Connolly would not have sought that clarification if it was crystal clear. We will wait to see that.

I address Mr. Breen again on the 31 cases. One case has been closed, 28 are proceeding and there are two potential cases.

Mr. Ciarán Breen

Yes, that is correct.

That is 31 cases. Is that right?

Mr. Ciarán Breen

Yes, that is correct.

There may be more. Do all of those cases post-date that of Vicky Phelan?

Mr. Ciarán Breen

No, not all of them.

Please clarify that for me.

Mr. Ciarán Breen

We had 11 at the time of Vicky Phelan's case.

There were 11 cases preceding that of Ms Vicky Phelan?

Mr. Ciarán Breen

That included her case.

It has increased since then. My colleague on my right asked about the laboratories. Who is being sued in these 31 cases?

Mr. Ciarán Breen

It is the HSE.

Is that in each of them?

Mr. Ciarán Breen

There are only nine at the moment where there are proceedings-----

Mr. Ciarán Breen

It would be the relevant laboratory or laboratories, because sometimes both are involved, and the HSE.

What is the breakdown of the laboratories? I want to be clear about the laboratories. One is American but operates in Ireland. Is that correct?

Mr. Ciarán Breen

They are broken down pretty evenly. Roughly half of them are one lab and half of them are the other lab and then in some cases they are intermixed.

Is that Quest Diagnostics in half of these 31 cases?

Mr. Ciarán Breen

Yes, that is correct. It is Quest Diagnostics and MedLab.

Is MedLab the one with the operation in Ireland?

Mr. Ciarán Breen

Yes, that is correct.

The HSE is also being sued. In all of the letters then, is it either one or both of these labs plus the HSE that is being sued?

Mr. Ciarán Breen

Yes, that is correct. A hospital is also sometimes involved when an issue may have arisen after a smear in respect of a colposcopy. That is very few however.

Is it correct that the HSE has adopted a new approach and that a paper will be sent in to the committee to clarify that?

Mr. Ciarán Breen

Yes. If Deputy Connolly recalls, I explained it to Deputy Kelly earlier.

Yes, I do. Is Mr. Breen at liberty to tell us where the State Claims Agency stands with these cases in the context of hat new process?

Mr. Ciarán Breen

I indicated earlier that mediation has been offered in the four cases and we are proceeding towards that. As I indicated, we are not commissioning any reports as we would normally.

We are asking for those reports to be shared with us. We are trying to get dates for the mediation so that in advance of their case management in any event by the court we are trying to get the cases set down for the mediation process. I hope they can be resolved at mediation.

The State Claims Agency is, in effect, acting as an agent for the laboratories.

Mr. Ciarán Breen

Not really. The Deputy should remember there is an issue for the State in some of these cases where there is material non-disclosure and a woman will want to raise that and so on. To that extent, there is an allegation against the State. The primary liability, if it is a smear test issue, is a matter for the laboratory.

The agency will rely on its indemnities.

Mr. Ciarán Breen

Yes.

There are contracts with these laboratories. What contracts are in place in terms of time?

Mr. John Connaghan

Is that the timing? The contracts run until the autumn.

What about Quest Diagnostics?

Mr. John Connaghan

It is October or November. It will be some time in the autumn. We could be precise about the date.

The witnesses can come back with the precise date. Will the contract with Quest be up this year?

Mr. John Gleeson

The term of the current contract is due to end in either October or November.

That is this year.

Mr. John Gleeson

Yes.

What about MedLab Pathology?

Mr. John Gleeson

It is the same.

What are the plans for those contracts?

Mr. John Gleeson

It is linked with the planned introduction or change in the primary test to HPV testing. Therefore, the termination of laboratory services is required to operate the programme going forward.

The new system being put in place will determine the type of lab to be sought.

Mr. John Gleeson

Correct.

Will it be outside the country? Have the witnesses assessed the capacity within the country for the new system?

Mr. John Gleeson

We are in that process.

When will that assessment be ready?

Mr. John Gleeson

It is quite imminent. I am not involved directly in procurement.

It is an extremely important question in terms of value for money. I sat on the health forum years ago and watched this debacle emerge when all the experts told us not to outsource. Quest was mentioned in particular at the time. I am not blaming the witnesses for that but I certainly put blame on the establishment of the time and the type of philosophy that existed. We watched this happen and now it will cost an absolute fortune. That may be a bad choice of words given the suffering of many women so I am not making it in that context but in the context of actual cost. We had an excellent laboratory in Galway that was doing a brilliant job but it was all outsourced. Here is a golden opportunity so is the HSE looking at insourcing the tests?

Mr. John Connaghan

I will give our preference and some thoughts in that regard. Mr. Gleeson is right in that there is a technical process under way. It is slightly hampered by the fact we do not at this stage have a clinical lead for CervicalCheck. We are attempting to work around that.

There is no clinical lead.

Mr. John Connaghan

There is no clinical lead after the resignation of the last clinical lead. We need a clinical lead to be able to close out the process. The Deputy asked what is the preference and I can answer from my perspective as director general. No matter what is the service, I have always had the preference to attempt to do as much insourcing as possible. However, that needs to measured in terms of resilience of the supply chain, value for money, quality etc. There are some caveats.

They are major issues, as value for money is relevant to this committee.

Mr. John Connaghan

Last but not least, we need to consider the use of the word "resilience", which is very important. We need to ensure there is more than just one supplier. The Deputy can understand issues that might arise if one lab goes down. Having had discussions with some of the clinical staff, my preference is to seek three separate providers.

If we are giving preferences, I would like to see the service provided in our public hospitals. Is there an update on the risk register? Why was there not one before? Did I understand correctly that there were quality assurance visits to the various companies? What did that entail or highlight? What is the record of those visits?

Mr. John Connaghan

I cannot indicate what happened before with respect to not having a risk committee.

Is that with respect to CervicalCheck?

Mr. John Connaghan

It is for screening. A board was established in 2010 and it may well be that there was a risk committee before that. It seems that with the risk around this general provision, it is good management practice to have a risk committee. It will be chaired by somebody who is independent and it will be across screening.

When will that be?

Mr. John Connaghan

I would prefer not to venture a date now that is unrealistic. We need to put all the stuff in place appropriately.

Is there an estimate?

Mr. John Connaghan

It should be imminent.

What about the quality assurance visits?

Mr. John Gleeson

The visits were done under the auspices of the programme and screening service management and the quality assurance committee. They were organised as a team. The nature and scope of them was led by an independent pathologist and they made site visits to whatever lab was operating with us at the time. They occurred in 2011 and 2014 but I would have to confirm the dates.

Was it part of the contract that there would be site visits to go over?

Mr. John Gleeson

It is allowed within the contract.

There would be a record of that visit, what was discussed and what was found out.

Mr. John Gleeson

Yes.

It is freely available somewhere.

Mr. John Gleeson

I do not know.

Who has it or where is that?

Mr. John Gleeson

It would be within the CervicalCheck quality assurance committee and management team.

Could we get a copy?

Mr. John Connaghan

Sure.

We have been sitting here for over three hours and we have a rule that witnesses are entitled to a break. If we continue longer than a couple of minutes to wrap it up we must take a break.

Do the witnesses want to have a break?

Mr. John Connaghan

I think we can keep ourselves together for another short period.

I ask people to be brief with questions and answers.

I have a question on the process of cases taken by individuals in the State that are contested by the HSE and often settled without an admission of guilt. I am sure the witnesses can understand from the perspective of a patient and the public that this is an horrific experience for the individuals in question. There is not a week that goes by when the courts are sitting that there are newspaper articles or television coverage of victims of wrongdoing being forced to go through the process of having to defend and vindicate their rights. From a policy perspective, why does the HSE do this time and again to individuals who suffered wrongdoing at the hands of the HSE?

Mr. John Connaghan

There was some previous correspondence about the nature of the engagement we have in the legal system. It was either to the Committee of Public Accounts or the health committee but I am not sure. I will ask Mr. Breen to comment on the nature of the engagement and the policy perspective.

Mr. Ciarán Breen

The management of all clinical negligence cases taken against public hospitals is managed by us on behalf of the Health Service Executive. Having regard to the delegated function, the HSE does not dictate policy in settling or defending those cases and so on. It is a matter entirely for the State Claims Agency.

The Deputy said that sometimes people feel very hurt and traumatised by a process.

I meant victimised.

Mr. Ciarán Breen

The cases are sometimes very complex-----

Mr. Ciarán Breen

-----and there are practitioners' reputations involved. Very often when we settle without an admission of liability it is because we have a very strong expert report which would say that an individual practitioner in the circumstances is not liable yet there is very often damage to the person and for good reason we settle without the case admission of liability. Only 3% of all of our cases end up in the courts, which means 97% of our cases do not go to a full trial.

I accept that 97% of medical negligence cases handled by the agency are settled prior to going to court or, perhaps, dates being set. In my experience, it is the setting of a date that prompts the settlement. In terms of the 3% and the horrific cases we read about and the families involved in those cases, would it not be more appropriate for the State to deal with these matters more directly and with the admission of liability rather than expending hundreds of thousands, if not millions, of euro on an annual business saving face for individuals? It may be that there is a report stating that individuals did not do anything wrong in accordance with procedure and medical practice, but ultimately the State is still coughing up large sums of money to compensate patients. Where in this equation, from a taxpayers' money perspective or a patient care perspective, is it worthy of the State to pursue individuals through the courts and then finally settle on the steps of the court without admitting liability, which is often what happens? To me, it seems horrific to do this to people. I understand these are complex cases but, putting it mildly, this practice has to stop. There must be a process of mediation before cases get to the courts so that these families do not have to go through that experience, not to mention the public moneys being expended in that process.

Mr. Ciarán Breen

I agree. The agency in no way wants to bring people to the steps of the courts or into the courts unless it is compelled to do so. By way of example, the other day we were facing a case with a demand for €3.9 million. After a day in court, the case settled for €75,000. This is an inevitable situation in which we find ourselves at times. Where settlement demands are so significant and beyond our professional estimate of what should be given we are compelled to go to court. We do so because we have a duty to the taxpayer. The 3% of cases that go to trial are cases where there would be a very fundamental liability point. I will give another example. Two weeks ago, we had a case which we requested be discontinued, based on our expert report prior to the trial. We were willing to provide our expert report on why the case did not have merit yet the case progressed and was withdrawn after one day. There are inevitable situations where this happens.

In cases of catastrophic injuries to infants, many are settled before court but they require to be ruled on by a court and, therefore, it appears that we are bringing a family into court but we are not. We are required to do this under ordinary rules.

I understand the legal process.

Mr. Ciarán Breen

It is a complex answer but I do want to reassure the Deputy that we do not as a matter of policy ever want to do that. Where possible, we advocate mediation in practically all of our medical negligence cases.

Does the State Claims Agency maintain a book of quantum on medical negligence cases and, if so, is it publicly available?

Mr. Ciarán Breen

No. We do not have a book of quantum like, for example, injuriesboard.ie.

Does the agency have an internal document?

Mr. Ciarán Breen

No. We do not have a document which would say that, for example, a perforated hernia is worth a certain amount of money, the reason being that cases by and large are not about a single factor. They tend to be much more complex, the reason being it is very difficult to say that one case has a value of €30,000 and another has a value of €50,000 yet the range of injuries might be relatively non-variable. The issue is how they impact on the person, the age of the person, the sex of the person and so on. There are many qualitative differences that lie in these issues.

I thank Mr. Breen.

Mr. Connaghan referenced searchable data and spreadsheets and the technicalities of searching same. I do not think he is correct because an electronic spreadsheet is easily searchable. It is possible to convert documents to searchable format. I do not buy the idea that there is some complexity involved in searching documents. As far as I am concerned the issue here is that somebody made a decision that Dr. Scally was to be given scanned PDF documents rather than electronic hard copies. In other words, rather than give Dr. Scally a desk, computer and password in the HSE to enable him to access the documents somebody made the decision to give him scanned documents, which he has made very clear is not appropriate. I do not think Mr. Connaghan is correct in saying data searching is a complex process. Perhaps, I misinterpreted him. We all do it every day. If we receive documents in PDF format we convert them. I do not understand what the technical issue is and so perhaps Mr. Connaghan would elaborate.

Mr. John Connaghan

I think I made that point in my opening statement and I referenced a spreadsheet as an example, but I am open to correction on whether that is an appropriate example. I also said that I needed to understand the technical barriers to our not being able to do this and what we now need to do to correct it.

I would argue that the barrier was a human barrier rather than a technical one. On the laboratory data, Mr. McCallion said that drawing out historical data is a complex process. Deputy Jonathan O'Brien asked Mr. McCallion about the results from the laboratories for 2013-2014, 2014-2015 and 2015-2016. I have a photograph of the results on my phone which is dated 9 May. I do not know on what date the committee received them but I got them on that date from the witnesses. We were able to get them on 9 May, which is a month ago. What is so complicated about getting the results for previous years? Do the witnesses expect us to believe that there is not a similar data available for other years? The data we have comprises four columns detailing the names of the laboratories, the form of screening that took place, the number of inappropriate smears, the number of negative results and various other percentages. How is it that it was easy to get the results for that period when today we are being told it is complex to draw out historical data? Are we back to technicalities with searching the spreadsheet or there is another reason?

Mr. Damien McCallion

I think I said there were two reasons, including that some of the laboratories are no longer under contract with us. The other issue I flagged which is probably-----

Mr. McCallion said that the State no longer has a contract with some of the laboratories. Am I correct that what he is saying that the State employed a laboratory from which data was not received and collected and installed on our own systems, scanned or otherwise?

Mr. Damien McCallion

The second issue I flagged, which is more fundamental, is there is only a small group of people who can do this. These are the same people we are using for the Royal College of Surgeons review and for other work. In terms of priority, what they-----

I do not believe what Mr. McCallion is saying because we already have data detailing in simple format the percentage accuracy of the laboratories over three years. To my mind, there should be similar data available for other years.

Mr. Damien McCallion

I have committed that we will get information to the committee by the end of next week at the latest. We have to prioritise what we are doing. The Royal College review is the first priority but we will provide the information being requested by the Deputy.

In respect of the three years for which we were given data, who decided they were the years for which we should be given data?

Why do we get those three years?

Mr. Damien McCallion

They were the easiest to come off at that time, but subsequently-----

What does "easy" mean? Did the service have them or were they in the laboratory? What does Mr. McCallion mean by "easy"?

Mr. Damien McCallion

It was in terms of the people using the information. The core issue we have at the moment is that we have a very small team and, as the Deputy will appreciate in the current environment-----

I cannot appreciate it. I actually cannot appreciate it.

Mr. Damien McCallion

Well, maybe-----

Sorry. If Mr. McCallion would not mind.

Mr. Damien McCallion

Sure.

I cannot appreciate it because it seems the most basic thing to have in this set-up would be the total number of smears, or slides, that went to labs A, B and C for every year and the percentage. It seems like the most basic thing the service would have.

Mr. Damien McCallion

All I am explaining to the Deputy is that there is a very small group of people working on this who are also the same people who are working on all the other aspects, including the Royal College review, the audits and the other pieces.

It is just not acceptable.

Mr. Damien McCallion

I have committed to get the information for the Deputy within the next week.

Let us say, for example, that in one of the particular years that are missing there was a dodgy machine and lots of things were missed. The screening service would not know because if one does not have it, one will never know. It is only when people started to drop dead that the service would cop on.

Mr. Damien McCallion

No. The QA process goes beyond that. It was described earlier and the document may have been circulated setting out the entire QA process around the laboratory for the programme.

I am getting to that. I think Mr. McCallion is moving away from my point, namely what would happen if there was a huge outlier. I use the machine, I totally get QA and I am a QP myself. So, I get it.

Mr. Damien McCallion

Sure.

If there was an outlier, the screening service would never know because it did not have the data. It could be for whatever reasons; perhaps someone looking at slides lost the sight in one eye, the machine broke or a window was left open. The service would never know because, if it does not have it, how would it?

Mr. Damien McCallion

The data is there, to be clear.

It is there in a secret place.

Mr. Damien McCallion

Through the process, which I can ask Mr. Gleeson to talk through the detail of in a second, there is a detailed QA document which looks at a whole range of things about the laboratory on an ongoing basis.

I know what this is. I am not talking about the temperature of the room, the competency of the operator or the competency of the machine. I am talking about the number of slides in, false negatives, negatives and borderlines. It is the table we got but which I do not have a copy of with me.

Mr. Damien McCallion

I know the table.

I do not buy that the screening service does not have that table for every year and that it does not have it handy. I cannot understand how we got three years on 9 May whereas there is some historical barrier regarding the rest of it.

Mr. Damien McCallion

All I am saying is that I have committed to getting the balance and the small group involved in this have had huge pressures in their workload and simply have had to prioritise some of the other pieces around the Royal College and other work. We have committed to getting that to the Deputy no later than the end of next week.

Mr. McCallion also said there was agreement with the laboratories to release the document. Mr. Gleeson then said the contracts were due to expire in November this year. How often were the contracts reviewed? Was it every two years or is this the first time? How often are the contracts for the laboratories reviewed and reassessed?

Mr. John Connaghan

I think the Deputy is asking how long does the contract last.

Yes. It is a rolling contract. If a laboratory got a contract in 2009, when was it re-evaluated? Was it every year or every two years?

Mr. John Gleeson

For contracting purposes or for performance or quality-----

For renewal of the contracts.

CervicalCheck is spending taxpayers' money to pay a laboratory and it does not matter if it is in Tullamore or San Francisco. How often are the contracts reviewed or did someone sign a contract for ten years and say "We will suck it up for ten years and then have a look at it"? Is it being looked at every 18 months?

Mr. John Gleeson

Contracts were awarded following a public procurement process in 2008.

I know this. How often are they reviewed?

Mr. John Gleeson

We went back to the market for money in 2010 and we awarded contracts from then on. It has been documented in a list. I am doing this from memory here.

I am asking Mr. Gleeson to verbalise it.

Mr. John Gleeson

It was reviewed again in 2012, 2014 and 2016-----

So, every two years.

Mr. John Gleeson

-----under procurement terms. Then last year, in 2017, we reviewed it to see if we would go to the market again or extend for a period while planning the introduction or changeover of the test stage.

I find it interesting that every two years when the contract was looked at, nothing seemed to stand out. Maybe there was nothing to see, but it seems a bit odd. I turn to the QA matter. This is back to the regulation and we are dealing with Brexit. Every country or area has its QA people who come in to ensure the machine is working properly, that the guy checking is qualified and that the QP is right and all that. However, would that QA process have involved any examination of the tables I have been speaking about to Mr. McCallion? I see those as two separate things. QA is about machinery and skilled operators but it seems to be conflated here today. QA is a question of whether the laboratory is working, ensuring there are no rats in the corner, that the temperature is right and that people sign in so the right people are in the room and nothing is compromised. Am I right in saying that?

Mr. John Gleeson

We need to separate those.

Mr. John Gleeson

The accreditation by national certification bodies that I referred to states that a laboratory can operate to do whatever it has declared. The body tests the laboratory for that whether it is blood testing or whatever. Second, we have published quality assurance guidelines on our website. If one works within the programme as a laboratory, these are what must be met. Having been awarded a contract, one will have to be accredited and meet these standards. Third, we do quality monitoring against those quality standards. The national certification body will do its annual audits for the accreditation and we will do ongoing monitoring against the standards set in our QA guidelines.

Is that why the service was going over for visits?

Mr. John Gleeson

We do the visits as allowed for in the contract on a periodic basis to check various things. That is one element of quality assurance.

For a particular laboratory, there is the QA of the particular country, be it America or Ireland, to ensure it is working within the right parameters from a lab point of view. We then have people going over periodically on site visits. Somebody committed to providing us with the detail of those visits and what happened. Did Mr. Gleeson say an oncologist went on the site visits?

Mr. John Gleeson

A pathologist.

Sorry. I did not hear that right. In any event, it was a medical person who went over. He or she hardly went over to check the temperature of the room. It is more than likely that as a pathologist went over, it was to look at slides or the level of accuracy of readings. That would have been the focus of a pathologist.

Mr. John Gleeson

The person would have looked at a number of practices.

I think Deputy Murphy or Connolly asked about this. It is very important for this investigation to determine what happened when the pathologist went to the laboratory. Was it for tea and coffee or was it to look at proper data outcomes for Irish patients?

A commitment was given in the Dáil by the Taoiseach on the women or their families in the cohort of 209 women in relation to legal cases. The Taoiseach made a commitment - and I am paraphrasing - that the objective was for the women not to have to take legal cases but that the State would take the cases. As such, the women would not have to do it directly themselves. What engagement would there have been before that commitment was made? Is that possible when a statement of claim has already issued and proceedings have already commenced? Is there anything new that has come in to mediate following that statement?

Mr. Ciarán Breen

Typically, any plaintiff in a complex case will want to get his or her proceedings out. In other words, he or she will want to put his or her case before the courts in terms of the legal documents required such as a personal injuries summons and so on for the purposes of laying out what the claim is about and where there have been failures by the defendant.

In these particular cases the women are anxious to do this to get their proceedings out in any event because they want to make sure they are within the Statute of Limitations. That is an important issue for them. They will also rely on an expert report and will want to paraphrase some of its content in their pleadings. In the hopefully unlikely situation where mediation fails, many of the women will want to fall back on the court. In any event the women, some of whom are gravely ill, would want the court to lay out set timelines. That is a choice for the women to go to court to set these matters out for their protection.

The process that we are engaged in respect of the mediation effectively runs parallel to that process. The judge keeps an eye on the case on a case management basis to make sure the parties are doing what they should do because the women are gravely ill. At our end, we are going as fast as we can to mediation, which is exactly what the Taoiseach had said.

That is what he said, yet within a week or two, Ms Emma Mhic Mhathúna was in and out of the High Court. It almost jarred with the commitment that was made.

Mr. Ciarán Breen

The reason that happened and the reason any woman would do that - I am not just picking out Emma Mhic Mhathúna - would be that they are going into the court to give it periodic updates about how things are happening, whether they are getting discovery and whether things are moving on for them, and maybe if there is a particular issue asking the court to make an order about it. This is why they are going back to court, understandably. It is to ask the court to be a guardian of the process to make sure that things are happening. That is why, unfortunately, we see these applications. We would prefer not to see them. Where we want to get to, in line with what the Taoiseach has said, is that these women will be going to mediation and not having to go to court.

Has the SCA the capacity to mediate with the number of people involved in a timely way?

Mr. Ciarán Breen

Yes, absolutely.

Deputy Cullinane is next. I ask him to be as brief as possible. If somebody needs a breath of fresh air, they should feel free to walk out for five minutes and come back in. We could be here for another then minutes.

I will be as brief as everybody else if that is of any help.

The HSE obtained data from the laboratories for 2013-2014, 2014-2015 and 2015-2016. Data have been requested for the years going back to 2008, yet that has not been published. A letter was sent to the committee stating the reason it has not been sent to us is the time it would take to do it, which is extraordinary. Can Mr. Connaghan, not Mr. McCallion, explain that?

For the Deputy's information, Deputy O'Connell teased that exact point out at length a few minutes ago.

I can do so again.

We are not into repetition in this committee. The Deputy will get his answer now.

Mr. Damien McCallion

There were two points. One was the data and the other issue I flagged in reply to Deputy O'Connell was that a small group produced that data. It has been working on the Royal College process, the audits and the other pieces. What I committed to the Deputy is that the work is concluding and we will have that no later than the end of next week for the Deputies.

What size is a small team? Is it four or five people, or ten or 15?

Mr. Damien McCallion

Typically one or two people. It is small.

People would understand if it is one or two people and they are doing the other work as well. A small team in the HSE could be 15.

Mr. Damien McCallion

Apologies. It is one or two people. To be clear, the CervicalCheck team is just over 30 people. There are people in the other programmes. With all of the other pieces, we have had to prioritise the work on the audits and the Royal College review but we will get the Deputy that information.

It will be next week.

Mr. Damien McCallion

Yes.

I thank Deputy O'Connell for that.

We are almost concluded. The Department of Health officials were asked why the scoping inquiry is taking longer than expected. They need not give an answer now but I want detailed notes from the Department on the work that went into preparing the timescale, not the terms of reference. The Department came up with a timescale and the Minister announced it would be in place by the end of June. We want to know how that timescale was arrived at, what consideration went into the work required and why somebody felt it that could be completed in that time, and whether it encompassed adequately what was requested in the terms of reference. I always knew it was an impossible timetable based on what was being asked. I would like to see what notes the Department had on it and whether it was a realistic timetable to begin with.

At the end of all this, does Mr. Connaghan believe the clinicians should have communicated with the women as appropriate? Is that where responsibility rests?

Mr. John Connaghan

The straight answer is "Yes".

He does. So it is the clinicians' fault?

Mr. John Connaghan

The Chairman asked me if I believed the clinicians should communicate directly with their patients and the answer is "Yes".

That is a direct question and a direct answer, which I appreciate. Mr. Connaghan can understand this from point of view of the committee. We have had a debate based on the letters as to whether people had been informed or it was assumed they had been informed. If we have had this lengthy a debate about that in public, I shudder to think what went on in private. If we can have this level of debate about a word, as to who should have done what or who believed what, and it has taken two hours to get through this in public, I would hope in private that the witnesses would move much more quickly in trying get to the bottom of issues like this. I would be fearful that if the witnesses were not in the public eye, a debate like that would go on interminably. That is a worry.

Mr. John Connaghan

I gave the Chairman a straight answer to a straight question. However, we should have fail-safes behind that. We all realise that other things wrap around the system to make sure we have a feedback loop and we close that loop. It is not just clinicians. We need to have wider things around there to make sure the system itself does not fail.

I thank the witnesses. The session went longer than expected. I propose that we suspend in advance of our next sessions on Nursing Homes Ireland and the National Treatment Purchase Fund. I hope we will not have the same witnesses from the HSE and the Department of Health before us for that, for their own sakes. We will recommence with committee business at 2.30 p.m. for 15 minutes.

The witnesses withdrew.
Sitting suspended at 12.50 p.m. and resumed at 2.30 p.m.
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