COMMITTEE OF PUBLIC ACCOUNTS debate -
Thursday, 5 Jul 2018

Implications of CervicalCheck Revelations (Resumed)

Mr. John Connaghan (Director General, Health Service Executive) and Mr. Jim Breslin (Secretary General, Department of Health) called and examined.

Chairman

For this session we are joined by the HSE director general, Mr. John Connaghan; Dr. Peter McKenna, acting clinical director of CervicalCheck; Mr. Ray Mitchell; and from the Department of Health, we are joined by Mr Jim Breslin, Secretary General and Ms Tracey Conroy, assistant secretary, acute hospitals division. I remind members, witness and those in the Public Gallery to switch off their mobile phones or put them into airplane mode as they interfere with the recording system when merely switched to silent.

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

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable. Members are reminded of the provision under Standing Orders that they shall refrain from inquiring into the merits or policies of a Government or a Minister of the Government or the merits of the objectives or such policies.

While we expect witnesses to answer questions put to them by the committee clearly and with candour, witnesses can and should expect to be treated fairly and with respect and considerations at all times in accordance with the witness protocol. We are allocating up to one hour for this session so there will be five minute slots. I think people will understand that the topic might come up again as part of the general discussion with the HSE over the course of the afternoon.

I will put one question to Mr. Connaghan before the clock starts for this hour. He got a request from us for information but I do not see the response. Perhaps he can point it out to me. We asked specifically for a note in advance of today's meeting regarding the three CervicalCheck laboratories and who signed off on the forms when they were returned to the HSE. We asked for details of whether the person or persons were administrative or medical staff with relevant medical qualifications and we asked for the HSE to provide a sample of such forms, redacted as appropriate, and to explain what sign-off process was involved. Can Mr. Connaghan tell us those details?

Mr. John Connaghan

I think we have sent in what the process is, including a flow chart, for the receipt and sign-off of samples that go to the collection point in Ireland and are then transmitted to the laboratories and what happens thereafter. It might be better if I ask Dr. McKenna to take the committee through that. The correspondence and flow chart that we gave the committee contain the answer to that question.

Chairman

Time is tight and I am being generous, so the hour will only start after I have finished my bit, in fairness to the other members. That flow chart, which is now up on the screen, does not answer the question. It starts talking about the GP surgery and the whole way along, the forms going out and coming back. All we want to know is when the laboratories that were contracted by the HSE to work for CervicalCheck sent results back to CervicalCheck and who signed off on them on behalf of CervicalCheck to confirm the HSE was happy with the work the contractors did. Can Mr. Connaghan show me the spot where that is shown on the flow chart?

He understands my simple and straightforward question.

Mr. John Connaghan

Yes, I understand the question.

Chairman

We do not need to know of the process before that.

Mr. John Connaghan

There might be a simple misunderstanding here. Once the samples are read and the reports are available, they are directly sent back by electronic means or by post to the doctor or clinician who requested them. That is detailed on the flowchart.

Dr. Peter McKenna

It is entirely possible that a smear could be taken and the report returned a medical practitioner having direct sight of it. Smears are read by laboratory technicians and may be taken by a practice nurse. If the reading is normal, the result is returned to the programme and the woman informed without any input from a medical practitioner. That is the system which is in place.

Chairman

That is exactly my point. For those who cannot see the chart, it details that women participating in cervical screening go to the general practitioner, GP, clinics and the laboratory has a collection system involving a pre-addressed envelope being sent to the laboratory for processing. The laboratory reports are then sent to the GPs or clinics. Are the witnesses saying that when the work comes back from the three laboratories, which are essentially contractors to the HSE, nobody in CervicalCheck looks at the results from a medical point of view? Do I understand that correctly?

Dr. Peter McKenna

If the results are normal, they would not, no.

Chairman

We are discussing the misdiagnoses which were marked as normal and in which cases the results do not correspond with the conclusion. Are the witnesses stating that smears went from a doctor to the laboratory and back and CervicalCheck had no medical involvement in the results?

Dr. Peter McKenna

If a result is normal, there might be no input from a medical practitioner between the taking of the smear and the result being filed.

Chairman

Why did the senior people in the HSE not have a quality assurance mechanism in place to verify from the point of view of the HSE and CervicalCheck that the work carried out by the contractors was valid? Nobody in a public organisation for which a contractor is doing a job accepts that the work is done satisfactorily on the basis of the contractor sending back a report. Rather, the results of the work are checked. I am putting it as simply as I can. The witnesses are stating that the contracted laboratories did the work but no check on that work was carried out by the HSE.

Dr. Peter McKenna

Quality assurance was built in at the start of the contract. As part of the contract, each laboratory has agreed in-built quality assurance mechanisms.

Chairman

Should CervicalCheck have a role in checking the results that come back from contracted laboratories?

Mr. John Connaghan

There is a set of quarterly metrics, although I do not have it to hand.

Chairman

I am asking about individual cases. I do not wish to waste time. The witnesses were asked a very specific question. I am dealing solely with a question asked on the previous occasion the witnesses were before the committee and also submitted in writing. The witnesses stated that it is possible that no medical staff may be involved in the process. The committee asked for the sample of forms sent back to CervicalCheck by the laboratory rather than a summary report on the number of tests carried out. Does CervicalCheck get a copy of results which are sent to doctors? Is the laboratory report for each patient sent to CervicalCheck? Does anybody in CervicalCheck review the forms sent back by the contracted laboratories from a medical point of view?

Dr. Peter McKenna

Almost certainly not. Some 250,000 tests came into CervicalCheck, the majority of which are reported as normal. As part of the quality assurance an agreed sample of, for example, one in 50 or 100 cases are sent to another laboratory, which would be sufficient.

Chairman

The patient results sent to CervicalCheck are not usually checked by a medical professional in the HSE, which writes the cheque for the work to be done on behalf of the individual patients. That is my understanding of the situation and it is part of the problem.

Mr. John Connaghan

The Chair is correct. However, there are accredited quality assurance checks in place on a quarterly basis which look at overall quality. The Chair is correct in regard to individual cases but such cases are sent back to the doctor or practising clinician who requested the samples in the first place.

Chairman

Okay. The hour to be spent on CervicalCheck will start now. The following speakers have indicated: Deputies Alan Kelly, David Cullinane and Catherine Murphy. Each Deputy will have a five-minute slot.

Deputy Alan Kelly

May I take the same amount of time as did the Chair?

Chairman

I was doing my work as Chairman on behalf of the committee in bringing up the request for information we sought but did not receive.

Deputy Alan Kelly

I was joking. The comment was in jest.

Chairman

Deputy Kelly's five minutes begins now.

Deputy Alan Kelly

The witnesses will be delighted to learn I will probably only have time to ask three questions in this round. As of 9 o'clock this morning, how many women have been identified as having been affected? That figure was at 209.

It has been reported that the independent review of the cases of 3,000 women will not be completed on schedule and is only commencing now. What is the reason for that? Why has it taken so long? If there were 300,000 slides per year and it takes five minutes to review each, a team of ten people could carry out the analysis in a few weeks even if each slide is surveyed twice and the women's slide history examined. Why was there a commitment to complete the review within a timeframe which has not been followed? Why was information on the delay not made public? Why is the review only starting now? It will not be possible for it to form part of the Scally review, which must be completed by the end of August. The Minister for Health, stated that the final Scally review must be completed by the end of August. However, these 3,000 slides will not be part of it because of the delay. Stephen Teap and Vicky Phelan, who gave evidence to the committee, are extremely disappointed and upset this morning that the review of the slides will not form part of the Scally review. Why was the review committed to on the basis of an unrealistic timeframe? When will it be completed? How in the name of God can we have a situation where Dr. Scally must report by the end of August to ensure credibility but this review will not form part of his report because of the delay? How will his review be complete without that information? How in the name of God did we end up in this situation? Who committed to those unrealistic timelines?

I have a third question which I had better ask before the Chair cuts me off. It relates to the legal cases, of which I understand there is a significant number. I remind the witnesses that the State Claims Agency, SCA, will appear before the committee next week. As I understand it, the HSE hired a legal firm, the identity of which I know, to draft a protocol for how cytology slides are given to the women affected. That protocol has been in use for several weeks. Solicitors for several affected women have gone to court to seek the release of the slides and in such cases the HSE has handed them over without the protocol being followed. These are urgent cases. All present know what that means: the women are in difficult health situations. Why is a protocol needed for the release of slides to which the women are entitled? Why is it taking so long? Why can the protocol be bypassed when a woman goes to court and takes on CervicalCheck and it or the SCA is so embarrassed that it hands over the slides? Some 80 to 90 women have sought their files from CervicalCheck and some have received access thereto.

When it comes to getting their slides they are being blocked by a protocol, which I doubt anyone has heard of up to now. Given what the Taoiseach and the Minister, Deputy Harris, said in the Dáil and the evidence given to this committee and the Joint Committee on Health, of which I am also a member, why is this protocol necessary? What is its purpose? If it can be bypassed in urgent cases why can it not be bypassed in this instance and these slides given to the women and their solicitors immediately? As I understand it, Quest Diagnostics is releasing the slides but Clinical Pathology Laboratories, CPL and MedLab Pathology Limited are in discussions in that regard in light of this protocol. According to the laboratories, the HSE, through the SCA, and this legal protocol, is holding up the provision of information to which these women are entitled.

Mr. John Connaghan

On the first question, we advised the committee on the previous occasion that there were 209 women affected and that there could be a further 12 women affected. As of today, there are 221 women affected.

Deputy Alan Kelly

As of now, there are 221 women affected.

Mr. John Connaghan

Yes.

Deputy Alan Kelly

Is that figure likely to increase?

Chairman

I ask Deputy Kelly to allow Mr. Connaghan to respond as there are other members waiting to contribute.

Deputy Alan Kelly

I am just seeking clarification.

Mr. John Connaghan

As of today, there are 221 women affected. I will ask Ms Conroy to respond to the other questions.

Ms Tracey Conroy

The international clinical expert panel review is being carried out by the Royal College of Obstetricians and Gynaecologists, RCOG, with expertise also sourced through the British Society for Colposcopy and Cervical Pathology. There is ongoing daily engagement between the Department and RCOG on the details and complexities of this review. It was never intended that the RCOG review would be completed in advance of the Scally review. It was made clear from the outset, in terms of engagement with RCOG, that given the complexities of the review it could take four to six months to complete. We always knew that it would not be possible to complete it sooner and we were clear in this regard, including to Government.

Deputy Alan Kelly

It was not made clear to anyone else.

Ms Tracey Conroy

The review is an independent clinical review. RCOG will review all of the diagnoses of cervical cancer since the programme was established in 2008, including the 1,482 cases that were notified to CervicalCheck since then and the further 1,630 registered by the National Cancer Registry which had not been notified to CervicalCheck. The review will examine the women within this cohort who were screened by the programme, which is approximately 1,856 women from within the total but that is subject to final validation within the review. The review will examine the cases of women who developed cancer and were screened by CervicalCheck. All of their screening histories will be examined. This involves reviewing all of the smears. The panel will have an algorithm for examining the smears and it will identify the number of cases in which there are discordant results. A report in each case will be provided to the women involved. The panel has its own quality assurance system and it wants to work systematically so that it can stand over this process. We have been engaging with RCOG on a daily basis since it agreed to come on board with this review.

Deputy Alan Kelly

This was not communicated----

Ms Tracey Conroy

The work is progressing very well.

Deputy Alan Kelly

This was not communicated outside of Government.

Ms Tracey Conroy

We are very conscious of the need for good communications around this matter. Over the past number of weeks, RCOG has been working down through what will be involved in terms of examining the smears, files, cases histories and so on. It has been working with its own expertise in this regard while also engaging with the HSE and the Department on getting a handle on what is involved in terms of costs, timelines and so on. We are very close to finalising those matters. We have also engaged with RCOG on how best to communicate the review to all stakeholders but most importantly the patients involved. That is imminent.

Chairman

I call Deputy Cullinane.

Deputy Alan Kelly

Excuse me, my third question has not been answered yet.

Chairman

The Deputy had a five-minute slot and he spent it putting questions with no opportunity for answers. The five minutes allocated to each speaker is inclusive of questions and answers. I will allow a quick response to the third question.

Deputy Alan Kelly

This is ridiculous.

Deputy David Cullinane

I do not mind waiting until the Deputy's third question has been answered.

Deputy Alan Kelly

I thank the Deputy.

Chairman

I remind members that there is not five minutes allowed for questions and ten minutes for answers. We have only one hour on this topic.

Dr. Peter McKenna

The third question concerned the return of the slides. It would be a new departure from practice that patients would look for their slides so it does not come as a surprise to me that a process would be instigated nor would it come as a surprise to me that if there are legal teams involved this process could be quite tortuous. As regards the specifics of what the process entails, I cannot tell the Deputy that but I will find out and revert to him.

Chairman

I ask Dr. McKenna to revert to the committee on the matter before next week.

Dr. Peter McKenna

Yes. On the principle, if it is the woman's slide, it belongs to her and there is no disagreement from our point of view.

Deputy Alan Kelly

Eighty or 90 women are waiting eight weeks or more.

Dr. Peter McKenna

On the principle, there is no disagreement.

Chairman

Will Dr. McKenna come back to us on the timescale?

Dr. Peter McKenna

Yes.

Deputy David Cullinane

I will be distinct with my questions. I am conscious in putting questions about process and cost that there is a human side to this issue and women who face a struggle every day, some in serious health difficulties. I want to send solidarity greetings to all of them. As a committee, we have a job to do. Our remit is to examine spend and value for money. If a mistake is made in the spending of State money, we have to follow up on it. That is the reason we focus on these issues but we are conscious of the human side of the matter as well.

Information we received from the National Treasury Management Agency, NTMA, on the national incident management system sets out the number of cases being taken under different categories. Under the heading, National Screening Service, it shows that there are 22 claims, 20 active, one closed and one potential claim. This information was provided a number of weeks ago. I am assuming that information has changed as Emma Mhic Mhathúna has since settled. Of the 22 claims listed, how many are still active?

Mr. John Connaghan

As of today, there are 28 cases but I will need to check that with my SCA colleagues. According to The Irish Times today, there are 28.

Deputy David Cullinane

I would rather Mr. Connaghan told me the correct figure rather than rely on what is stated in The Irish Times. Mr. Connaghan is the director general of the HSE. Will he come back to me with the exact figure before the meeting concludes?

Mr. John Connaghan

I will.

Deputy David Cullinane

I raise this issue because there are more women coming forward. We know from media coverage that in Emma Mhic Mhathúna's case the settlement was in two parts, against the laboratory, Quest Diagnostics, and the HSE. The media coverage states that the HSE accepted liability. Can Mr. Connaghan explain for what the HSE accepted liability and, also, is this the first time the HSE has accepted liability in court in any of these cases?

Mr. John Connaghan

The HSE has accepted liability for not communicating the results of the audit.

Deputy David Cullinane

That is all I wanted to know.

Mr. John Connaghan

That is in the case of Emma Mhic Mhathúna. The HSE also accepted responsibility for not communicating the results of the audit in the case of Vicky Phelan.

Deputy David Cullinane

My understanding was that the settlement for Vicky Phelan came almost exclusively from the laboratory. Is Mr. Connaghan saying that there was a cost to the State in respect of Vicky Phelan's settlement?

Mr. John Connaghan

No.

Dr. Peter McKenna

There was a modest contribution by the State of, I think, €25,000.

Deputy David Cullinane

In terms of Emma Mhic Mhathúna, it could be more substantial.

Mr. John Connaghan

In the case of Emma Mhic Mhathúna, the total sum has yet to be apportioned between the HSE and the laboratory in question. This matter is still under discussion.

Deputy David Cullinane

This is an important point. As for where this might leave us when this sorry saga is eventually complete and when every woman gets the justice she deserves, I note 28 cases are potentially before the courts and 209 women were not informed of the results. If it is the case that the HSE has accepted liability for not informing Ms Mhic Mhathúna of her incorrect smear test, as Dr. McKenna put it, does that admission of liability apply to all 209 women? As for those women who are not before the courts, how will they be compensated by the HSE? I am asking a straight question, that is, was the acceptance of liability only in the case of this individual or was it in respect of all the women? In answering that question, I want Dr. McKenna to bear in mind that when Mr. Gleeson, who was one of those people with responsibility for overseeing the process of informing or not informing the women, appeared before this committee, he did not and still to this day does not accept any mistake was made but yet in court, the HSE accepted liability that a mistake was made. There are two parts to my question. First, does the admission of liability apply only to this individual or does it apply to all 209 women? In the latter case, how will they be compensated given there is no class action opportunity in this State? Second, given that the individual who was responsible for the failure does not accept there was any failure, how will Mr. Connaghan, as the director general, deal with that problem?

Dr. Peter McKenna

I am a little reluctant to speak about an individual case without having all the details, but my understanding is there may have been a clinical component outside of the smear programme that may have contributed to the HSE being involved.

Deputy David Cullinane

That is fine but Mr. Connaghan said the admission of liability, certainly in part, was because of the failure to inform this particular individual. If that is the case, 209 women were not informed. Is the HSE accepting liability that it was a mistake, in respect of all 209 women, that they were not informed? If that is the case, how will they be compensated? Notwithstanding the other 209 cases, which Dr. McKenna can address shortly, there was an acceptance of liability in this case. The person with responsibility for this process in the HSE, however, is still to this day saying he does not accept any failure on his part, which means there was no failure on the part of the HSE. How does Mr. Connaghan square that with-----

Chairman

I will ask Mr. Connaghan to answer that question and then I will call Deputy Catherine Murphy. If Deputy Cullinane is not happy with the answer he gets, he might have an opportunity to come back in at a later stage.

Mr. John Connaghan

I will deal with Deputy Cullinane's question quickly. In regard to taking an opinion on one case, I would not like to venture an answer to his question without taking further legal advice on this. I do not think an individual settlement - without having legal advice on this - would tell me it applies to 209. Morally, I understand from where the Deputy is coming on this.

As regards responsibility and liability or accountability, the Scally review is currently under way and it will report by the end of August. We need to wait to see what it will state in regard to accountability.

Deputy Catherine Murphy

This whole debacle started off about mandatory disclosure and women not being told their results. We are still at this point months later and people are not able to get their files. Why are they not able to get them? We have been constantly told that the HSE will give them their files. Why are we still hearing they are not able to get their files?

We now know the number of cases is 28. Is that from a cohort of 209 or 221, or are they made up from a different component?

The clinical review will require information to be transferred to be evaluated. Will that prove to be an impediment to others getting their files or are duplicates available? What issues will arise from the point of view of people getting the information that they own?

Mr. John Connaghan

Generally, the evidence we have had, from a number of appearances before this committee on the provision of documentation, advises that this will be done against a 30-day standard for turnaround, and we are generally observing that. The last report the committee had on this indicated there is one case where we are outside that standard. I do not have an update on that as at the end of last week, but generally we are providing information that is required within a 30-day turnaround standard.

Deputy Catherine Murphy

Is it true that at this stage 80 women, or their legal representatives, in that cohort of 209 women have not got their files?

Mr. John Connaghan

We need to understand where we are against the 30-day cycle. If it involves original slides, I guess those might need to come from the laboratories, particularly if they are overseas. Regarding the provision of the documentation, the reports we have made to this committee, and the reports I have had, indicate that we are generally keeping within that 30-day standard, but we will certainly check out the detail.

Deputy Catherine Murphy

Is there a difference between the HSE providing the women's files or the laboratory providing the information. Who has the information?

Mr. John Connaghan

In the case of original smear slides, these are held by the laboratory.

Dr. Peter McKenna

Yes. There should be no difficulty in the HSE with respect to any person who requests their chart, or a copy of their data, to get it. That should be available either through the medical legal channel or freedom of information. If they are waiting for anything it is likely to be a physical slide - Deputy Kelly referred to this - there may be a difficulty in getting that material back from the laboratory.

Deputy Catherine Murphy

With which the HSE has a contract.

Dr. Peter McKenna

That is right.

Deputy Catherine Murphy

Why would there be a difficulty with that?

Dr. Peter McKenna

I am not sure if that was covered in the contract. I genuinely do not know that but I think it is being worked out. We said we would see what the problem was and that we would revert to Deputy Kelly on this.

Mr. John Connaghan

Regarding Deputy Murphy's third question concerning impediments we may have, a clinical review of the documentation is under way. There should be no impediments in terms of physical documentation or physical records. I guess there could be an impediment if the Royal College of Obstetricians and Gynaecologists is looking at original slides and somebody has requested that information. There can only be one original slide, which I guess would be the impediment to which the Deputy referred.

Deputy Catherine Murphy

Therefore, people could be waiting for months. Is that the case?

Mr. John Connaghan

The Royal College of Obstetricians and Gynaecologists has not yet started this.

Ms Tracey Conroy

We had a tripartite engagement with the Royal College of Obstetricians and Gynaecologists. The people in the HSE were involved in this process during the week and the HSE was very clear that it did not see any impediment in providing the smears within a timely fashion to the college.

Deputy Catherine Murphy

However, there is an impediment. The HSE has a contract with these laboratories to carry out work. It is not that the laboratories own the slides afterwards. I cannot understand why there would be an issue with retrieving those slides or demanding that they be retrieved?

Mr. John Connaghan

There is no issue in principle.

Deputy Catherine Murphy

There is an issue in practice.

Mr. John Connaghan

If there is an issue in practice, we have heard that perhaps between 80 and 90 women are waiting for physical slides to come back. If that is the case, we will check that out and report back in short order. We have already said that today. However, there should be no impediment in principle.

Deputy Catherine Murphy

We hear there are 28 cases and that number is increasing, is that from a cohort of 209 or 221 women?

Mr. John Connaghan

First, we need clarify that figure of 28. Even though we have press reports that this is the number, we still need to be able to provide clarify on that after checking that with the State Claims Agency. Once we do that we will also answer the Deputy's query on where the 28 lie against the 221 cohort.

Dr. Peter McKenna

There is another confounding variable in the figure of 28. I do not know if that number refers to cases the State Claims Agency is aware of or that it is involved in, as they could be slightly different. If the laboratory has taken over the liability, then the State Claims Agency may not be a party to the settlement.

Chairman

I will move on to the next speaker, Deputy Marc MacSharry, and I remind him these are short time slots.

Deputy Marc MacSharry

Regarding CervicalCheck, have confidentiality agreements been abolished or abandoned?

Are we still seeking those in terms of any-----

Mr. John Connaghan

Confidentiality agreements have not been deployed for several years. The briefing I have on this is that those confidentiality agreements have, by and large, been at the request of the plaintiff. The director of the State Claims Agency, Ciarán Breen, will appear before the committee next week and should be able to supply it with chapter and verse on that.

Deputy Marc MacSharry

We will ask him about that but Mr. Connaghan is saying the HSE is not looking for them.

Dr. Peter McKenna

I also understand that it is standard practice in mediation that confidentiality would be sought. I do not know how this translates into an individual case but I understand that it is a general principle of mediation that there is confidentiality.

Deputy Marc MacSharry

Is that while mediation is ongoing?

Dr. Peter McKenna

No, I think it is meant to be part of the standard agreement.

Mr. Jim Breslin

I think Ciarán Breen will walk all the way through this with the committee. What would often happen in mediation is that-----

Chairman

That is just for people like Ciarán Brennan-----

Mr. Jim Breslin

Ciarán Breen.

Chairman

-----next week when the State Claims Agency appears before us.

Mr. Jim Breslin

Exactly. What would often happen in mediation would be that the process itself would be confidential so people could try to reach an agreement and offer positions that would allow that to happen. What can happen at the end of that, particularly where dependents are involved, is that the outcome would be registered in the court so the actual outcome would be a public outcome. The State Claims Agency, which has claims delegated to it and handles all the mediation and court processes, will be able to work this through with the committee next week in full detail.

Deputy Marc MacSharry

We will ask it. However, the point is that we are not looking for-----

Mr. Jim Breslin

Absolutely not. The confidentiality aspect of a plaintiff is really that the individual does not want his or her name out there but details of the settlement could be out there without divulging the person's identity. That is the person's right. It is not something the State would impose. The principle of open disclosure requires us not to push confidentiality agreements. I think the State Claims Agency has clarified that in recent days.

Deputy Marc MacSharry

With the audit happening, if a woman is unfortunate enough to be diagnosed, is there now a working protocol in place for informing that woman? Who is telling these women?

Dr. Peter McKenna

I think the audit has been suspended pending the outcome of the Scally review.

Deputy Marc MacSharry

If somebody is diagnosed now, is there a very clear protocol in place whereby the physician or CervicalCheck tells the patient? What is the protocol and is it working? Has a new one been put in place since this debacle?

Dr. Peter McKenna

An audit process is not in place so if someone is diagnosed and previously had a smear, that smear would not be subject to an audit process at the moment.

Deputy Marc MacSharry

Is that a "No"?

Dr. Peter McKenna

On an individual basis, the clinician may request it, which would not be unusual. It would then be up to the clinician to inform-----

Deputy Marc MacSharry

Is it fair to say that despite the debacle we have had, we are waiting until everything is over before we put a definite protocol in place?

Dr. Peter McKenna

It would be fair to say that the audit has ceased.

Deputy Marc MacSharry

And no protocols have been put in place in the mean time.

Dr. Peter McKenna

Good clinical practice would say that if one has an interval cancer, one would request the results to be looked at and then inform the patient. That would be good clinical practice.

Deputy Marc MacSharry

That did not really happen, as we know. What I am trying to establish is whether the HSE at management and director level has said that if this happens again, "You will do this and I will do that and this is how it will work out." Has that happened?

Dr. Peter McKenna

No, it is awaiting the Scally review.

Deputy Marc MacSharry

I think, as a recommendation, we could be pioneering, not to have to wait for the Scally review, apply basic common sense - I have no clinical training - and put a protocol in place notwithstanding the good recommendations of Scally or anybody else. At this point, has anyone in the HSE been held to account or is it the same answer in terms of waiting for Scally and other reviews? Are any disciplinary proceedings under way? Are there any issues being dealt with in that regard?

Mr. John Connaghan

I have had some discussions on this very briefly with Dr. Scally. The HSE is currently considering a post-Scally review and how we will put in place a conduct investigation. We have a national protocol agreed with our staff representatives that generally applies to any conduct investigation. We must be very careful about how we observe that national protocol. We will wait until after the Scally review. These remarks are entirely neutral.

Deputy Marc MacSharry

The answer is-----

Mr. John Connaghan

After Scally.

Deputy Marc MacSharry

It is possible, if not likely, or likely.

Mr. John Connaghan

Likely.

Deputy Marc MacSharry

That is all for now.

Deputy Catherine Connolly

On the last occasion Mr. Connaghan was here, we talked about the general answering service and how it was overwhelmed. Is it still overwhelmed?

Mr. John Connaghan

Is that the answering service for women?

Deputy Catherine Connolly

It is for general queries from women who are worried and are ringing in.

Dr. Peter McKenna

The short answer is that there were 14,500 phone calls, the vast majority of which have now been returned as of the end of last week. I think there were only about 200 phone calls outstanding. We expect that these will be dealt with this week. There are a further 50 calls that are not call backs. They are clinical consultations. These clinical consultations are much more detailed and involve a lengthy conversation with a consultant. These will take a bit of time to get through but the call back for the generality has been addressed.

Deputy Catherine Connolly

With regard to the suspended audit, there is no ongoing audit at the moment. Is that right?

Dr. Peter McKenna

Correct.

Deputy Catherine Connolly

This arose as a result of the Vicky Phelan case following an audit, the results of which were not communicated. Is that not right?

Dr. Peter McKenna

Correct.

Deputy Catherine Connolly

There was an ongoing audit. Results came forward, there was then the debacle about who should tell the women and nobody told the women. Is that correct?

Dr. Peter McKenna

That is correct.

Deputy Catherine Connolly

That is it in a nutshell.

Dr. Peter McKenna

Yes.

Deputy Catherine Connolly

At the moment, nobody is reviewing smear tests. The results are coming back from the lab and CervicalCheck is just accepting those. Is that right?

Dr. Peter McKenna

The generality of smear tests are negative.

Deputy Catherine Connolly

No, just listen to my question. We know all of that. When CervicalCheck carried out its audit, it found things that were wrong. There is no audit at the moment so who is finding out what things are wrong at the moment?

Dr. Peter McKenna

In other words, if a patient develops a cancer-----

Deputy Catherine Connolly

CervicalCheck discovered matters from the audit. There is no audit at the moment so what quality assurance is in place? How is CervicalCheck finding out whether something is wrong?

Mr. Jim Breslin

There are two things. One is the quality assurance programme while the other is a retrospective audit by-----

Dr. Peter McKenna

The retrospective audit has ceased and will-----

Deputy Catherine Connolly

I understand that. As a result of the retrospective audit, we have these cases. How many women are affected?

Dr. Peter McKenna

A total of 221 women are affected.

Deputy Catherine Connolly

At the moment, could there be another 221 cases if another retrospective audit was done?

Dr. Peter McKenna

What will inevitably happen is that each month, there will be some women who will be diagnosed with an interval cancer. They will have been screened, the screening will have failed and they will be diagnosed with an interval cancer. They should be looked at and they should be informed. That will be done outside of the screening programme. How that is doing within the screening programme will await direction from Scally, which should report on that matter shortly.

Deputy Catherine Connolly

That is worrying. The audit is suspended so nobody is checking.

Dr. Peter McKenna

It is not that there is nobody checking. The diagnosis has been made.

Deputy Catherine Connolly

But when the diagnosis is wrong, as was the case in 221 cases, that was discovered by a retrospective audit.

Dr. Peter McKenna

No, the diagnosis of cancer was not-----

Deputy Catherine Connolly

Sorry, I beg your pardon - the retrospective audit identified that the analysis was wrong.

Dr. Peter McKenna

It identified that the smears had mis-called the problem - correct.

Deputy Catherine Connolly

That is not happening now.

Dr. Peter McKenna

It is not happening with the screening service.

Deputy Catherine Connolly

So let us go back to quality assurance, which was teased out earlier on. When the results come back from the labs with which CervicalCheck has the contracts, it simply accepts them because they have their own quality assurance. Is that right?

Dr. Peter McKenna

Their quality assurance gets external validation.

Deputy Catherine Connolly

Where does it get that from?

Dr. Peter McKenna

From the organisations in their country that validate them.

It would be the equivalent of our ISO.

Mr. John Connaghan

These are picked up in the quarterly monitoring reports for each laboratory to ensure it accords with what was expected in respect of the standards of detection.

Deputy Catherine Connolly

I understand all that and we get that every week - that all the processes are in place. What happened though was that 221 women did not benefit from that. It was quite the opposite. What I am trying to get here is that the system accepted the results of the smear tests coming from the labs and now there is a serious question over the quality assurance and the checking of that. Is that right? There has to be a serious question on quality control with 221 women affected and more going to come to light. Am I using the wrong language?

Mr. John Connaghan

I wonder if we are mixing up a couple of things. Perhaps I can explain this better from a clinical point of view. In any screening programme, there will always be a question about false positives and false negatives-----

Deputy Catherine Connolly

No, Mr. Connaghan, I have only five minutes and we have been through that a thousand times. We are talking about the women affected. Despite everything Mr. Connaghan talked about and despite the quarterly reports, something has happened here that this has failed. That was not picked up by CervicalCheck nor by the HSE. It came to our attention as a result of Ms Vicky Phelan speaking out and more women then coming forward. Is that not right? The internal mechanisms have not worked.

Dr. Peter McKenna

What failed was not telling the patients, not communicating that their previous smears had been misread - that was the failure.

Deputy Catherine Connolly

That was part of the failure but it came from the retrospective audit.

Dr. Peter McKenna

I think the difficulty is in distinguishing what is considered "an acceptable rate of failure" from what is an unacceptable rate of failure. Where women are being compensated, on the look-back it is considered that, possibly, there was no reason this should not have been noted or the number of times in which it was overlooked was unacceptable.

Deputy Catherine Connolly

On the confidentiality agreements, and this is my last question, it was said that they have not been used in the last number of years. Is that in every case and not just in cervical smear tests? I understand, first of all, that Ms Vicky Phelan said that she was asked to have a confidentiality clause. Is Mr. Connaghan saying, openly, that the HSE has not used confidentiality clauses for years?

Mr. John Connaghan

I think the State Claims Agency will tell the Deputy exactly where we are in respect of the chapter and verse on that. My understanding is that confidentiality clauses have not been used for a few years.

Chairman

Would the involvement of the laboratory have been an issue?

Mr. Jim Breslin

That is the core of the Ms Vicky Phelan case. The laboratory insisted or put forward a confidentiality clause but the State Claims Agency did not and argued against that. Ms Phelan - and we all owe her great credit - stuck by her guns and insisted that there would be no confidentiality clause. The State Claims Agency did not seek that clause and I think it will confirm that when it is before the committee next week.

Chairman

I call Deputy Jonathan O'Brien.

Mr. John Connaghan

I am sorry, I have some information. It is just as well that we do not rely totally on the popular press for information.

Chairman

I thank Mr. Connaghan.

Mr. John Connaghan

The position on claims is that three have been settled, 35 are active-----

Deputy Alan Kelly

How many?

Mr. John Connaghan

Three have been settled, 35 are active and there are two potential cases.

Chairman

I thank Mr. Connaghan and I call Deputy O'Brien.

Deputy Jonathan O'Brien

I have two questions. The first one is on human papillomavirus vaccine, HPV, testing. The proposed roll-out date we were looking at was in October. Will Mr. Connaghan give us some information on whether we are still working towards that timeline?

Mr. John Connaghan

There are three or four elements on the critical path for that roll-out. The first is the service specification, the second is the preparation of tender documentation and the third part is, after tender, mobilisation. Those are three things on the critical path. I am not able at this stage to tell Deputy O'Brien the time elements of each of those. There are some things in play which we are going to try to deploy to speed things up. Regarding tendering, there is a possibility that we can go for a negotiated contract which would truncate the tendering process. We are considering that right now.

We need to tidy up the service specification and the tender documentation needs high level clinical input, so we need to have a clinical director for the CervicalCheck part. We are working on that and we might have some news next week. If that is the case, once we get that clinical input, authority, accountability and responsibility, it will allow us swiftly to close off the position in the service specification and to tender. If we can go to a negotiated contract, then that might be the best way forward in getting HPV testing in place quickly. There is also an element here of the capacity of each of the labs. On what we want in respect of resilience, I have already given advice in response to a question raised by Deputy Catherine Connolly earlier. My view is that we should have at least three or four.

Deputy Jonathan O'Brien

There are a number of things in play, we are still working towards the October roll-out, but that is based on progress over the next couple of months. Is that right?

Mr. John Connaghan

That is correct.

Deputy Jonathan O'Brien

I just want to check something Mr. Connaghan said earlier about the original 209 women. I think my colleague, Deputy David Cullinane, asked if the HSE had accepted liability for any part or role in respect of those 209 women, outside of Ms Vicky Phelan and Ms Emma Mhic Mhathúna. Mr. Connaghan said that is correct to the best of his knowledge. Is that right?

Mr. John Connaghan

Yes. My advice to Deputy Cullinane was that I know that the HSE has accepted liability for not providing the audit results. Dr. McKenna has got further advice that there may be a clinical element to that and I would need to study all of the judgments to be able to give Deputy O'Brien a proper answer to that question.

Deputy Jonathan O'Brien

As far as Mr. Connaghan is aware, did one of those 209 women settle a case in March 2017?

Mr. John Connaghan

I am not aware of that.

Deputy Jonathan O'Brien

I suggest that we should look at those 209 women because the information I have is that at least one of those women settled a case against the HSE in March 2017. It was not against the labs, it was against the failings of the HSE in not referring her to a gynaecologist-----

Mr. John Connaghan

Was that in respect of CervicalCheck?

Deputy Jonathan O'Brien

Yes, it was in respect of smear tests. She was also asked to sign a confidentiality agreement. That was in March 2017. One person I have met personally has told me that. It is my information that there are a number of other women in similar situations. I have yet to meet them but I am in the process of meeting with them. If we are giving out information then we need to be 100% sure that it is accurate because I am sure Deputy Alan Kelly also has information that some of those 209 women have settled previously, before Ms Vicky Phelan's case became public knowledge, and have also been asked to sign confidentiality agreements.

I know that at least in one instance, the woman that I met, a case has been taken against the HSE for failings in CervicalCheck in not being referred to a gynaecologist and then developing cancer. She is now, thankfully, in remission but she took a case, settled in March 2017 and signed a confidentiality agreement. Perhaps the witnesses could come back with some additional information on those 209 women as regards exactly how many of them have taken cases against the HSE previously and been awarded settlements? Those are the only questions I have at the moment.

Chairman

We are finished at this stage but we have a quick five minute slot for Deputy Kelly and Deputy Cullinane, and then Deputy Catherine Murphy as well. It is a strict five minutes because the time is up.

Deputy Alan Kelly

I have a couple of comments. I find it unbelievable that the witnesses cannot provide the information relating to this protocol today.

Why is the protocol being pushed legally, particularly when it is preventing women from getting their slides? Why can some solicitors representing women go into court and get the slides, thereby bypassing this protocol? I do not understand how Mr. Connaghan cannot provide that information.

I understand what Ms Conroy is saying regarding the review of the 3,000 cases. That is fine. These are the words of Vicky Phelan and Stephen Teap this morning. They are surprised and disappointed and they were not aware of this. It is not me or any other member of the committee saying this. Whatever is going on, it had been expected that this would be completed by the end of May and would form part of the Scally inquiry. It was not completed by the end of May. When will it commence? We now know that it is not part of the Scally inquiry. Scally is already incomplete and a large chunk of the inquiry will be irrelevant.

On the previous occasion he was here, Mr. Connaghan said that he had to catch up with and meet Dr. Scally. I presume he has done so on numerous occasions. Has he visited Limerick? Will Mr. Connaghan confirm that when Dr. Scally reports, he will not say that one reason he could not complete his report - which he will not be able to do - is because he was not provided some information by the HSE? I want Mr. Connaghan to guarantee that Dr. Scally's review will not be able to say that at the end of August and that the HSE will have provided everything.

On the admission of liability in respect of non-disclosure of information, we know from Emma Nic Mhathúna's case that this has been admitted. Will that be the standard for all other cases?

Given what was said by a previous speaker, my next question is very important. The State Claims Agency's clinical risk advisers met CervicalCheck in March 2017. Why did the HSE not reveal the risk of this audit at that point?

Mr. John Connaghan

On the provision of information, there is no intention to hold anything back. Everything we have in our remit or within the HSE will be provided to the Scally inquiry. The Deputy may not be aware that we sought and received agreement from the Minister that we will deploy section 40(c) of an Act, the name of which I have forgotten at this moment, that will allow us to send everything to Dr. Scally on an unredacted basis, save matters covered by patient confidentiality. I have recently advised Dr. Scally of that. The answer to the first question is that we will not hold anything back.

Will the Deputy remind me of the second question?

Deputy Alan Kelly

I asked for clarification on meetings with Dr. Scally and with the lads in Limerick.

Mr. John Connaghan

We met, and have been in regular communication with, Dr. Scally in recent weeks.

Deputy Alan Kelly

My other questions relates to the protocol on the slides and the issue of the review of the 3,000 cases, which, I presume, Ms Conroy will answer. The third question relates to the meeting in March 2017 regarding clinical risk and admission of liability.

Mr. John Connaghan

I am not aware of the March 2017 meeting. I will need to look at that.

Deputy Alan Kelly

That is not what I asked. The State Claims Agency and the clinical risk advisers met with CervicalCheck in March 2017. Why did the HSE not tell them that there was a risk?

Mr. John Connaghan

I am not aware of that meeting. I will have to look at the detail of it.

Deputy Alan Kelly

It is public knowledge.

Chairman

Mr. Connaghan will need to check that out because it has been mentioned extensively here in the past. Mr. Connaghan will need to come back with a written response to that in the next week.

Deputy Alan Kelly

I am sorry, Mr. Connaghan should know this information.

Ms Tracey Conroy

On the RCOG communications-----

Deputy Alan Kelly

Ms Conroy might explain what RCOG means.

Ms Tracey Conroy

I am referring to the international review being conducted by the Royal College of Obstetricians and Gynaecologists-----

Chairman

In the UK, it is not the Irish royal college.

Ms Tracey Conroy

Yes. We fully accept the need for clear communications with patients and all stakeholders. We have been working through, with the RCOG, the detailed processes, costs and timelines. Its finalisation is imminent. We have been engaging with the RCOG on the need for clear communications and for it to work on that. It includes a narrative that explains exactly what the review is, its scope, what it will involve, its timelines-----

Deputy Alan Kelly

Will it refer to Vicky Phelan and Stephen Teap?

Ms Tracey Conroy

Absolutely. We expect to be in a position to do that.

Deputy Alan Kelly

How is it that the two people who have inspired this most - who appeared before this committee and sat where Ms Conroy is sitting - came to believe that this would be completed by the end of May? How can Ms Conroy think that Departmental or HSE communications are working?

Ms Tracey Conroy

We are genuinely cognisant of the need for communications.

Deputy Alan Kelly

It is not working.

Ms Tracey Conroy

One thing is that we need to finalise the exact timelines with RCOG and then we can communicate that.

Deputy Alan Kelly

My other questions relates to admission of liability and protocol.

Chairman

Those are the Deputy's final questions.

Deputy Alan Kelly

I presume Mr. Connaghan will respond to the question on admission of liability and the protocol. I asked how he does not know about the protocol when I know about it? Why is it necessary? Is admission of liability standard for non-disclosure of information in all cases of this nature. Those were my specific questions.

Mr. John Connaghan

I said that I would return to those.

Deputy Alan Kelly

No. As the chief executive of the HSE, Mr. Connaghan, when asked to come before the committee to discuss this matter, cannot say "I will get back to you". That is not acceptable to the public or to the women affected and their families. He is not doing his job if he cannot at least give basic answers to these questions.

Mr. John Connaghan

We should be able to get answers on the protocol to the Deputy today. If he will allow me a little time to do the research-----

Deputy Alan Kelly

What about the admission of liability?

Dr. Peter McKenna

The HSE has apologised to the patients who did not get the disclosure, and for the delay. It is a different thing to issue an apology and attach a monetary value to that.

Deputy Alan Kelly

I am not asking that; I am asking whether it is standard practice in order that people will know whether this is the case. A precedent has already been set. I presume that the answer is "Yes", but I just want clarification.

Chairman

It will be clarified before the day is out.

Mr. John Connaghan

We will clarify it before the day is out.

Deputy David Cullinane

We have our job to do. I understand that much of this information is changing constantly. There are court cases that are quite complex, with different nuances in individual cases. I accept that. Nevertheless, we are trying to establish the facts at any given time.

I return to the number of claims. The Irish Times reported a figure, which was accurate at that time, to the effect that there were 28 active cases, two potential cases and one that was settled, so a total of 31. When Mr. Connaghan helpfully provided clarification to the committee earlier, he said that he has since had an update and that there are now 35 active cases, two potential cases and three have been settled, which is 40 in total. Am I correct in assuming that the number of new cases is increasing quite rapidly with each passing week?

Mr. John Connaghan

It is increasing. I do not know how rapidly, but it is certainly going up.

Deputy David Cullinane

It has gone up by nine cases in this instance.

Mr. John Connaghan

Yes.

Deputy David Cullinane

Has the figure of for the women affected increased?

Mr. John Connaghan

I clarified that already. There were 209 plus another 12 cases, which is 221.

Deputy David Cullinane

Earlier, when I put the question of admission of liability, Mr. Connaghan said that he understood the moral thinking behind the question. That is fine but we are not here to discuss either his moral thinking or mine for that matter. We are here to discuss process failures which led to potential liability and what the cost might be to the State. I understand that he might not have the full details of each case. In the case of Emma Nic Mhathúna, however, Mr. Connaghan clarified and accepted that there is liability on the part of the HSE and that an element of what happened was due, perhaps, to medical negligence - he does not have full details in that regard - and that another aspect involved her not being informed of the result of her smear test on foot of non-disclosure. A monetary value was attributed in respect of the latter in court. How many of the other 221 women were not informed of the results of their smear tests?

Mr. John Connaghan

I think that information has been given to the Committee of Public Accounts already.

Deputy David Cullinane

Will Mr. Connaghan give it to us again?

Mr. John Connaghan

The women involved in the 12 cases which came out of the most recent audit have all been informed.

Deputy David Cullinane

No, prior to this.

Mr. John Connaghan

It was 46.

Deputy David Cullinane

What Mr. Connaghan and Dr. McKenna have said in the course of this discussion is that a mistake was made in not informing the women concerned.

Mr. John Connaghan

Correct and we have apologised profusely for it.

Deputy David Cullinane

Dr. McKenna has stated the HSE is not in a position at this point to put a monetary value on it. However, in at least one of the court cases a monetary value was put on the individual not being informed of her smear test results. Logic dictates that, for all of the women among the 220 plus who were not informed, a monetary value will attach at some point. Forty cases have been or are before the courts. What about the women who are not before them? How will they be compensated?

Dr. Peter McKenna

I am unaware of the components that comprise the settlement. I am unaware of whether the failure to inform formed part of the monetary compensation. I do not know that for sure.

Deputy David Cullinane

I am sorry, but will Dr. McKenna say that again?

Dr. Peter McKenna

I do not know whether the failure to inform was assigned a monetary value in court.

Deputy David Cullinane

I find it extraordinary that no one in the Department or the HSE-----

Mr. Jim Breslin

No-----

Deputy David Cullinane

Mr. Breslin might be of assistance.

Mr. Jim Breslin

I can tell the committee what I know as of last week about the case in question. However, I do not want to go too far into just one case. My briefing by the State Claims Agency is that from the start it conceded liability for the non-disclosure of the clinical audit. To try in the particular circumstances of the case to reach a settlement as quickly as possible, the State Claims Agency and the laboratory agreed to reach an overall settlement with the plaintiff to allow the case to be closed.

Deputy David Cullinane

I understand it was an overall settlement. I do not want to go into the details of the figures for an individual-----

Mr. Jim Breslin

No, but, as of last week, the actual apportionment had not been negotiated between the two. The State Claims Agency will obviously be relying on the indemnity clause in respect of the laboratory's actions, but it will require some monetisation of the non-disclosure.

Deputy David Cullinane

Will a monetary value be put on the admission of liability for not informing the individual?

Mr. Jim Breslin

I think so.

Deputy David Cullinane

If the answer is "Yes," why would it not apply to the cases of all 220 women?

Mr. Jim Breslin

Dr. McKenna has also stated there may be features. We do not go into this level of detail of clinical and personal issues in individual cases, but there may be an issue above and beyond the non-disclosure in terms of clinical management, of which I was not aware. The Deputy is quite right, that there is a sequence, but we need to be careful not to get to the end before we work through all of the issues with the State Claims Agency. We have one case and it was last week. We have to stand back, consider and assess it and then come to conclusions. Doing it in the rapid way that might across the floor here could lead to us ending up in a place where none of us would want to be.

Deputy David Cullinane

I am sorry, but if-----

Mr. Jim Breslin

We want to see good recompense for all persons who have had harm done to them. We always want to see the laboratories, if there are issues for which they are responsible, paying out fully for same.

Deputy David Cullinane

I accept that. I have a further question on this matter and I will then finish. I have no difficulty in stepping back, evaluating and learning from the court judgment in this case, but the committee has to consider the potential cost of an accepted failure by the HSE. Can a note be given to the committee to help us understand it? My question is valid and obvious. If a monetary value is attached to non-disclosure in at least one case, it may also be attached in others. That is my point.

I have a question for Mr. Breslin-----

Mr. Jim Breslin

May I say something about that matter? The legitimacy of the Deputy's question is plain to me. The only risk is in doing it in real time. Being fully apprised of the matter, having a clear understanding of the liabilities and where they fall between the laboratory and the State - the State Claims Agency will be part of it - and then accounting to the committee is the right thing to do. However, if we do it in real time, we risk misstepping.

Chairman

We will ask the State Claims Agency to address this matter in advance of next week's meeting. As we are running out of time, I will ask our final two speakers, Deputies Catherine Murphy and Catherine Connolly, to put their questions one after the other and the witnesses to take them together in their final answers. There will be a further opportunity in the afternoon.

Deputy Catherine Murphy

It might not be that easy to do.

Chairman

Okay.

Deputy Catherine Murphy

I want to discuss the point I pursued with the witnesses previously regarding the slides. They separated two elements, telling us that the medical files were one matter, while the slides were another. I have examined the contracts with Quest Diagnostics and MedLab Pathology. They are similar, if not identical. Under the heading of "Storage and Disaster Recovery" on page 12, the contractor shall at the request of the national screening service forward eligible samples stored by the contractor or on the contractor's behalf to the national screening service or any third party specified by the service in a manner prescribed by it within three working days. It seems clear from this that the national screening service is in control and ownership of the slides. Why is there any question of a delay when the contract is clear about the contractors' obligations and the service's rights?

On radio in the past half hour, the solicitor for Vicky Phelan stated the HSE was holding up the protocol to agree to the release of slides and that, until this occurred, they could not be reviewed by clinical cytologists. Is the HSE holding it up and, if so, why?

Someone made reference to an apology, but an apology is hollow if it is not followed through with actions that will give it meaning. We are being given the runaround on some of our questions. The contract is clear, but we are not being given clear answers about the protocol. If it is being held up, any claim about dealing sincerely with people who may have been harmed by the State is hollow. Will the witnesses answer my question on the protocol?

Chairman

I will call Deputy Catherine Connolly afterwards.

Mr. John Connaghan

If there is a requirement to provide slides within a timely period, we should do so. I am not aware of the individual circumstances of the case outlined by the Deputy in terms of a hold-up. That should not be the case. I advised previously that, in respect of the 80 to 90 cases that may be in train, we would look at that issue immediately.

Deputy Catherine Murphy

Does the HSE talk to the laboratories? Does it tell them that it wants the slides to be made available within three days as per the terms of the contract?

Mr. John Connaghan

Does the Deputy mean provision of the original slides?

Deputy Catherine Murphy

Yes.

Mr. John Connaghan

If that is included in the contract and we are requesting the original slides, we expect to get them back.

Deputy Catherine Murphy

Has the HSE done that?

Mr. John Connaghan

It would have been done via CervicalCheck management asking for the provision of slides.

Deputy Catherine Murphy

Therefore, CervicalCheck is separate from the HSE. To whom am I speaking about responsibility today?

Mr. John Connaghan

No, CervicalCheck is a part of the HSE. What I am saying is that local managers would request the slides directly from the laboratories for provision for the patients.

Deputy Catherine Murphy

Have they done that?

Chairman

Will Dr. McKenna help? He is the acting clinical director.

Deputy Alan Kelly

Why was a separate legal firm hired to do this?

Dr. Peter McKenna

We will inquire immediately as to why there is a delay and why the legal team is perceived as holding up the process and try to expedite it.

Chairman

Will Dr. McKenna do his best to get an answer for us during the course of the meeting?

Dr. Peter McKenna

Yes.

Chairman

We expect Dr. McKenna to make some inquiries-----

Deputy Catherine Murphy

About the protocol.

Chairman

-----after the break.

Deputy Alan Kelly

He has already said he will revert to us. I have asked for it twice.

Chairman

During the course of the day. We will have time to revert to this matter. Deputy Catherine Connolly can make a final comment.

Deputy Catherine Connolly

I have a comment and a question. As a process, we dragged out the three memorandums that existed. Thanks to Ms Vicky Phelan and the other brave women who came forward, things are emerging. Now we are quoting a solicitor. It does not build confidence. When Mr. Connaghan was before us a few weeks ago, I made this point to him. It is not helpful. Moreover, Dr. Scally had to come forward publicly and state he was not getting co-operation and he was not getting the information. Bit by bit is the way this is proceeding.

My specific question is on the audit. I am trying to tease this out. Is the audit process now suspended?

Dr. Peter McKenna

Yes.

Deputy Catherine Connolly

It was the audit process retrospectively that discovered the mistakes.

Dr. Peter McKenna

Correct.

Deputy Catherine Connolly

If there is no audit process, there is no discovering of mistakes.

Dr. Peter McKenna

Not necessarily, no. In an individual clinical case, if an integral cancer develops, it would be appropriate for the clinician, or indeed, the patient, to request that these would be looked at. Then, if they have been misread, that should be communicated.

Deputy Catherine Connolly

We wait for the cancer to develop.

Dr. Peter McKenna

Pardon?

Deputy Catherine Connolly

Dr. McKenna waits for the cancer to be caught?

Dr. Peter McKenna

No, no, I am sorry.

Deputy Catherine Connolly

There is a misunderstanding here on my part. The cases that are increasing all of the time, which in number are now up at 221, have come to light as a result of the audit process.

Dr. Peter McKenna

That is correct.

Deputy Catherine Connolly

Okay. That audit process has now been suspended.

Dr. Peter McKenna

Correct.

Deputy Catherine Connolly

Why has it been suspended?

Dr. Peter McKenna

It has been suspended because the process of the audit has come in for a huge amount of criticism, in that at the start of the audit process it did not have built into it full disclosure to the patient. When the process started, it did not engage with the clinicians who were subsequently delegated to inform the patient that her previous slide had been re-categorised.

Deputy Catherine Connolly

We saw all that from the memorandums.

Dr. Peter McKenna

Correct.

Deputy Catherine Connolly

It was all outlined in the memorandums. It was more concerned about the communication process-----

Dr. Peter McKenna

Yes.

Deputy Catherine Connolly

-----and avoiding screaming headlines. Notwithstanding those difficulties, those memorandums are totally unacceptable. At the time, I asked Mr. Connaghan had he read them.

I will stick with the audit. Is it correct that the HSE is suspending an audit process that discovered problems because the protocol around who should talk to the patients has not been agreed?

Dr. Peter McKenna

Nobody's treatment is being delayed by stalling the audit process. The patients in whom the cancer has been diagnosed are getting their treatment in any event.

Deputy Catherine Connolly

As happened, smear test results might come back saying "All clear" but that was not the position. They were not all clear. There was cancer but the result of the smear test said it was clear.

Dr. Peter McKenna

But that would not be apparent until-----

Deputy Catherine Connolly

Until the audit was done.

Dr. Peter McKenna

No. There may be a misunderstanding here. Perhaps I have not made myself clear. The patient would be diagnosed with cancer clinically and then there would be a look-back and it would be seen that the smears could be re-categorised into a more severe level of abnormality. But the patient is diagnosed with cancer.

Deputy Catherine Connolly

On the cases that the audit was done.

Dr. Peter McKenna

Yes, correct.

Deputy Catherine Connolly

In looking back, it was discovered then that they were not informed in time.

Dr. Peter McKenna

In looking back, it was found that their smears should have been re-categorised and that is what they were not told about.

Deputy Catherine Connolly

That whole process has been suspended now, pending sorting all of this out.

Dr. Peter McKenna

Correct.

Deputy Catherine Connolly

I thank Dr. McKenna.

Chairman

At this stage, we will move on to the main item of business. I understand it might require some change of witnesses. It is 10.45 a.m. The intention is to proceed until the Dáil voting session. I propose we suspend for ten minutes because we cannot go from 9 a.m. to 1 p.m. without some break. Is that agreed? Agreed.

The witnesses withdrew.

Sitting suspended at 10.44 a.m. and resumed at 11.03 a.m.