2016 Financial Statements of the HSE

Mr. Jim Breslin (Secretary General, Department of Health), Mr. Tony O'Brien (Director General, Health Service Executive) and Mr. Ciarán Breen (Director, State Claims Agency) called and examined.

We are discussing matters related to the CervicalCheck revelations. In particular, we will examine the management of legal costs and the policy on open disclosure. These matters were included in the work programme of the Committee of Public Accounts to be considered in July, but as a result of the matters that have come to light, members agreed that they should be dealt with more urgently.

We are joined from the Department of Health by Mr. Jim Breslin, Secretary General and Accounting Officer for the HSE; Dr. Tony Holohan, chief medical officer, and Ms Mary Jackson, principal officer. From the HSE we are joined by Mr. Tony O’Brien, director general; Mr. Damian McCallion, national director, national screening service; Dr. Philip Crowley, national director, quality improvement division; Mr. Liam Woods, national director, acute hospital services; and Ms Maura Lennon, head of legal services. From the State Claims Agency we are joined by Mr. Ciarán Breen, director; Mr. Cathal O’Keefe, head of clinical risk; and Ms Ann Duffy, senior clinical risk manager. We also invited representatives of the National Cancer Registry. It was done at short notice earlier in the week, but its director is not available and it was not in a position to send anybody else.

The registry will be invited to join us again next week.

I welcome the witnesses. I remind members, witnesses and those in the Public Gallery that all mobile phones must be switched off. 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 the committee. However, if they are directed by it to cease giving evidence on a particular matter and they continue to do so, they are entitled thereafter only to 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 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 provisions of Standing Order 186 that the committee shall refrain from inquiring into the merits of a policy or policies 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 expect to be, should be and will be treated fairly and with respect and consideration at all times in line with the Oireachtas witness protocol. I will ensure that happens.

There were to be a number of opening statements from Mr. Breslin, Mr. Breen and Mr. O'Brien, but we will take those documents as read in order to save time.

Is there a statement from Mr. O'Brien?

I was just asking for the record.

The statements are only from Mr. Breslin and Mr. Breen. I have seen so much of Mr. O'Brien this week, I thought there was a statement. Is it agreed that we will take Mr. Breslin and Mr. Breen's statements as read? Agreed.

The director general of the HSE and Mr. McCallion will have to leave in an hour and a half, as the cervical cancer issues with which we are dealing are live ones and they must travel to Limerick. Now that the meeting has commenced, we will allow a round of questioning for the first hour and a half to the Deputies who are present. There is an order in which they will ask questions. They can ask questions of any of the witnesses, but they should be aware that Mr. O'Brien and Mr. McCallion will be gone in an hour and a half. The first two members will get seven minutes each. Thereafter, members will get five minutes each. Once the hour and a half is concluded, we will proceed to our normal routine of asking questions within the time slots normally afforded Deputies. The first batch of questions will come from Deputy MacSharry.

I welcome the witnesses and thank them for taking the time to attend. Did Mr. O'Brien listen to today's edition of "Morning Ireland"?

Mr. Tony O'Brien

I am afraid I was not in a position to listen to it. I will listen to it later on the RTÉ Radio Player.

I hope Mr. O'Brien does. I would ask him to do it as a matter of urgency. In my 16 years in the Oireachtas, it was the most harrowing interview that I have heard about any crisis. A lady we heard about yesterday naturally gave an emotional interview this morning where the presenter even became emotional. Any of us who listened would have been emotional. She stated: "I tried to do everything right, by, you know, breastfeeding, and being a full-time mum". She had got a clear result, but "now I'm dying [...] And I don't even know if my little baby is going to remember me."

In light of statements like that and the principle of accountability, does Mr. O'Brien not feel it is untenable for him not to resign his position?

Mr. Tony O'Brien

While I did not hear the interview-----

Mr. O'Brien can take it that I am quoting accurately.

Mr. Tony O'Brien

I am not disagreeing with the Deputy. I am just responding to his question. It is always very tragic when any young person receives a diagnosis of terminal cancer. That will always be the case. The Deputy's question is based on a presumption that there is some action that has been taken that has led to that diagnosis, but that is far from established. As has been explained in other forums, the reason we have a cervical screening programme, which is a screening rather than a diagnostic programme, is to limit the number of such cases, but it cannot eliminate them.

Mr. Tony O'Brien

The Deputy's question is based on a fundamental premise that this has arisen because of the CervicalCheck programme. I do not accept that that is a reality. There is a review process being established, which will be able to examine in a scoping exercise all of the relevant facts. It is wrong to jump to such conclusions in advance of the outcome of that process.

I fundamentally disagree with Mr. O'Brien. My question was based on accountability for taxpayers' money in the first instance. Irrespective of the outcome of scoping exercises and commissions of investigation, what we now know demands a level of accountability. Who is in charge of the health service?

Mr. Tony O'Brien

I am the director general of the HSE, as the Deputy knows.

Mr. O'Brien is in charge.

Mr. Tony O'Brien

Yes.

So Mr. O'Brien has no accountability.

Mr. Tony O'Brien

I did not say that. What I said-----

But when Mr. O'Brien-----

Mr. Tony O'Brien

-----was that the Deputy's question was based on a premise that was far from established.

No, it is not. Mr. O'Brien is in charge of the health service. What is crystal clear in advance of any scoping exercise is that we have had a systemic failure and a national health crisis that, to my mind at 44 years of age, is the worst in the history of the State. We know that now and Mr. O'Brien is in charge. How is his position tenable?

Mr. Tony O'Brien

Let me revert to where we started our short discussion. The cervical screening programme is designed to detect early cell changes, which can lead to further investigation. There is no-----

Mr. Tony O'Brien

The Deputy is not following the logic. There is no cervical screening programme or any population-based cancer screening programme in the world that can guarantee that there will not subsequently be a cancer. Neither can it guarantee that, in a test that is not fool-proof, there will be no abnormalities missed.

Let us use the analogy of the company that Mr. O'Brien has stepped back from as a non-executive director. If the contraceptives it manufactured were faulty, the matter was all over "60 Minutes" and he as a board member called on the CEO to attend a board meeting and explain the situation, could Mr. O'Brien see himself as a non-executive director of a commercial entity telling the CEO not to worry about it, that what was needed was a full investigation and that, at some stage down the road in the never-never when the share price was in the ground, the board may or may not feel that the CEO was responsible and needed to go? I put it to Mr. O'Brien that, in the private sector, he would have been gone months ago as soon as this issue emerged. Here we were this morning listening to a harrowing story on "Morning Ireland", a story that has every woman in the country - my sisters, my nieces, my neighbours, my friends and my work colleagues - terrified, but the only response from the person in command is nothing.

Mr. Tony O'Brien

No. The Deputy-----

The response yesterday was to decline respectfully the invitation to resign.

Mr. Tony O'Brien

Let me tell the Deputy something that he is unwilling to hear. Ten or 12 years ago when this country embarked on the process of introducing a cervical screening programme, it was known, because it was known everywhere, that that programme would not be infallible.

Say that again, please.

Mr. Tony O'Brien

Infallible. The choice was to have a screening programme, one that has since detected 50,000 high-grade abnormalities, leading to early treatment to the probable avoidance of hundreds of cervical cancers and, ultimately, deaths, or not to have it. If one wishes to hold population screening programmes to a test of infallibility, then no country in the world will do them.

Success has 1,000 fathers. We are talking about failures. An entire nation of women are terrified. We have heard the harrowing story of Ms Phelan. This morning we heard the harrowing story of this lady. She is 37 years of age and is afraid her baby will not remember her. Mr. O'Brien is implying that the HSE set up a system, that the system did a lot of good work and that there were some casualties. That is the implication of what he is saying-----

Mr. Tony O'Brien

No, that is what Deputy MacSharry is saying

-----and I put it to him that it is not acceptable. That is the implication.

Mr. Tony O'Brien

No. The Deputy needs to step back.

Mr. O'Brien needs to step back.

In fairness-----

Mr. Tony O'Brien

Deputy Cullinane's remark is a cheap shot.

No, it is not a cheap shot.

None of this is personal-----

Mr. Tony O'Brien

Actually, you know what?

-----but we do have to hold people to account. It seems there is zero accountability. Mr. O'Brien wants to claim credit for the successes, but when the wheels come off and people start dying, and when a nation of women are terrified this morning, he wants to say that the HSE has done a lot of good work and that we should have a scoping exercise.

Mr. Tony O'Brien

No.

When he is safely in some boardroom in the USA, as he was permitted to by the Minister, he will find out what really happened. It is not personal but today, in the here and now, Mr. O'Brien is in charge of a €13 billion budget and the reality is that we have had gross systemic failure and that people are dying and he is telling me that I am making these statements based on a false premise.

Mr. Tony O'Brien

Yes, I am.

Well he is wrong.

Mr. Tony O'Brien

Why do we not both wait until the outcome of the expert review and then the Deputy and I can reflect? At the moment he is causing hysteria.

Ms Mhic Mhathúna, who spoke on the radio this morning, does not have time to wait. She said she is too angry to worry about dying and we are in here kicking a football around about having an investigation and seeing what happened. Where is the accountability? As I said to Mr. O'Brien, when he enters the commercial world in a few months' time or a few weeks' time, whenever it may be, he will not last 20 minutes and he knows that.

Mr. Tony O'Brien

I could not disagree more with Deputy MacSharry.

Mr. Tony O'Brien

He is absolutely failing to take account of the reality of population-based screening. Perhaps it would be helpful-----

So is Mr. O'Brien saying that Ms Mhic Mhathúna's and Ms Phelan's situations are within the acceptable margin of error?

Mr. Tony O'Brien

I am not describing anything as acceptable. I am telling the Deputy that no population-based screening programme is perfect. We have a witness here who might be able to help the Deputy understand that.

If I want to talk to him I will do so later on. We will have time because he is going to be here later.

We will have to move on now.

No problem. I thank the Vice Chairman. I will come back in on the next round if I may.

I am certainly not here to deliver any cheap shots to Mr. O'Brien or to anybody else, but I do have a view on Mr. O'Brien's role as the Accounting Officer to this committee and as the director general of the HSE. I will get to that in a few moments. That is my job. Mr. O'Brien has a job to do as director general of the HSE. As public representatives it is our job to hold him to account. That is why we are here and that is what we will do. That is what I will do. I will do my job. My first question for Mr. O'Brien is; what is the difference between a false negative test result and an incorrect reading of a smear test?

Mr. Tony O'Brien

If there were a pathologist here, he or she would explain to the Deputy that it is possible for a test to appear normal and yet for there to subsequently be a finding of cancer leading to a review of that slide which can lead to a changed view. This is well understood in the literature of cervical cytology, which has a rate of accuracy well short of 100%.

Dr. Holohan has indicated that perhaps-----

I do not want to hear from Dr. Holohan. We have an hour and a half with Mr. O'Brien and we will then have time to put questions to Dr. Holohan. I am looking for Mr. O'Brien's interpretation.

Mr. Tony O'Brien

I will extend my time by as long as Dr. Holohan takes to speak.

That is fair enough.

Dr. Tony Holohan

I am not a pathologist either but perhaps, as a medical doctor, I am a little closer to the field. To explain, the process of smear taking involves a pathologist, or a technician in the first instance, who examines a sample through a microscope and makes a subjective judgment of subtle changes and abnormalities. The reality is that it is not a perfect science. That is part of the reason the organisation of any proper organised screening programme, such as the one we introduced in this country in 2008, builds in mechanisms to try to take account of the known limitations of the test. It builds in mechanisms to monitor the quality of the operation of that programme when it is in operation.

I am sorry, my question is quite distinct and I ask Dr. Holohan to also be distinct. I know it is a complex area but my question is a very simple one. Mr. O'Brien is telling us that this not a perfect science. We accept that. We accept that it is not infallible and that is not a diagnosis. We accept that there is approximately a 30% failure rate, which could include false negatives. However, there is a difference between misreading a smear result and something not being evident. What is the difference between an incorrect reading of a smear test and something which is simply not detectable, which I would imagine would be a false negative? Is there a difference between the two?

Dr. Tony Holohan

They are essentially one and the same thing in the sense that they are gradations. If one person were to look at a slide today and another person were to look at it in retrospect two years later, any differences they would report in their opinions would usually be very subtle. Frank differences such as somebody reporting a slide as completely normal and another reporting the same slide as completely abnormal-----

Was the difference in Vicky Phelan's case very subtle?

Dr. Tony Holohan

No, I am not saying that. I am answering the question in the abstract. I am not speaking about any individual case in answering the question. I am simply explaining the difference between false negatives and misses. It is about the gradation really. It is about judging that something was so frank and obvious that it should not have been missed.

I thank Dr. Holohan for that. I will come back to Mr. O'Brien because we are talking about individuals. We are talking about 208 women and I want to direct this question to Mr. O'Brien.

Dr. Tony Holohan

I am simply pointing out that in my answer I was not referring to any specific individual.

I appreciate that. When the serious incident management team did its review of the audit it established that there were 208 women who should have been communicated with and that 175 cases received an interpretation different from the original smear result. Based on the opinion of the review team, this would have led to a different clinical escalation. My problem with Mr. O'Brien is that he is putting up a straw man argument that this process in not infallible, a fact which we all accept. He is putting up a straw man argument that he cannot be held to account because of the actions of individuals in his organisation. He accused Deputy MacSharry of trying, in the case of Emma Mhic Mhathúna, to create the impression that the false diagnosis had some consequence on her being diagnosed with cervical cancer.

Mr. Tony O'Brien

If I can just be clear, it is important to note that I was not referring specifically to any individual case because I do not have the information to do so.

The issue here is that these 208 women were not told. That was a systemic decision taken by the HSE. Mr. O'Brien is responsible for systemic decisions taken within his organisation. The real scandal here was the response to that systemic failure and that women were not told. Mr. O'Brien has heard that Ms Mhic Mhathúna was on "Morning Ireland" this morning. It was very harrowing interview. This is a woman who had to tell her five children that she is going to die. Obviously she is very emotional. She told Teachta Mary Lou McDonald, who raised this issue in the Dáil yesterday, that she is more angry than she is worried about her death. It is a very personal tragedy for her.

Ms Mhic Mhathúna was told in 2013 that her smear test was normal. Three years later, following a routine smear test, she was diagnosed with cervical cancer. The audit of the 2013 result showed that, in Ms Mhic Mhathúna's case, the first indications of cancer were already there. She was never told. It was the same for Vicky Phelan and Irene Teap. We also heard from Stephen Teap. I would imagine it was the same for many more women. Ms Mhic Mhathúna, Ms Phelan and Mr. Teap have all asked Mr. O'Brien to resign because, unlike him, they understand accountability and that this was a systemic failure.

The reason Mr. O'Brien is paid the salary he is paid is because the buck stops with him. He is responsible for systemic failures. That is why he is in this position, why the post carries a heavy responsibility and why he is on the salary he is on. He is responsible for the actions of the corporate body of the HSE. I will say one more thing and then I will let Mr. O'Brien come back in.

Mr. O'Brien yesterday described the director general as the one person who must be personally accountable for every failure or mistake of 140,000 individuals who work in the health service and stated that that is not the basis for accountability. Nobody is asking Mr. O'Brien to be personally accountable for the actions of 140,000 individuals. We ask him to be accountable for a clear and systemic failure in the HSE not to communicate that information to 208 women who today are very angry. The failure to communicate is not the only matter that is causing hysteria. The hysteria has been caused by the systemic failures in Mr. O'Brien's organisation. The fact that, even today, Mr. O'Brien does not recognise that there were systemic failures and that he should take responsibility for that rings alarm bells for me. There is no doubt that Vicky Phelan, Emma Mhic Mhathúna and Stephen Teap are correct that Mr. O'Brien should step down. That would be the first step in he and the HSE taking accountability for systemic failures, although not responsibility for the actions of individuals.

Mr. Tony O'Brien

I thank Deputy Cullinane for correctly identifying that the central issue is the process of audit and the failure to communicate the outcomes of those audits to the individuals in whose cases it was found that, in retrospect, a different test result should have been given. I took issue with Deputy MacSharry because his line of questioning tended to suggest that there was something fundamentally wrong that a screening programme could not pick up all cancer, and it is by that that I was concerned.

I did not say that.

Was it a systemic failure?

I did not say that.

I ask Mr. O'Brien if it was a systemic failure.

Mr. Tony O'Brien

May I continue my answer?

I wish to firstly ask whether those 208 women not being informed was a systemic failure within the HSE.

Mr. Tony O'Brien

My principle------

Was it a systemic failure?

Mr. Tony O'Brien

My principle is to answer the question I am asked. When I have done so, I will be happy to deal with any follow-up questions the Deputy may have but I am not keen to------

Mr. O'Brien should deal with the first set of questions and then answer the follow-up question.

Mr. Tony O'Brien

Deputy Cullinane correctly identified that the key issue relates to the audit and the manner in which the communications process was undertaken. It is clear and in the public domain that there were differences of views between doctors about who should undertake the communication. We have clearly stated that the communication should have occurred and have identified that when the serious incident management team examined the 209 cases, only 48 had been informed prior to the establishment of that team. That was not a corporate decision within the HSE but, rather, related to a process managed by a relatively small group of staff in the CervicalCheck programme.

Those staff are accountable to the HSE.

Mr. Tony O'Brien

They are part of the HSE, absolutely.

Is it a systemic failure?

Mr. Tony O'Brien

It is not a systemic failure in the way that the Deputy means but it was a failure.

It was either a systemic failure or it was not. Mr. O'Brien is continually dancing on the head of a pin. Anybody with half a brain would know that it was a systemic failure. Mr. O'Brien does not want to accept it is a systemic failure because, if it was, he would have to step down.

Mr. Tony O'Brien

No. The reason I------

In February 2016, the women were not informed. Two years and two months later, only 46 of the 208 women had been informed. That was a decision taken within the HSE. It was, therefore, a systemic failure and the fact that Mr. O'Brien will not accept that speaks volumes about his understanding of failures and accountability.

Mr. Tony O'Brien

There is an important difference between system failure and systemic failure. Had I been party to any such decision------

I did not state that Mr. O'Brien was party to the decision.

Mr. Tony O'Brien

Had I been aware of any such decision and failed to act, I would take responsibility and accountability for it. However, I was not aware of it.

I wish to bring to the attention of Mr. O'Brien that in an interview on RTÉ Radio 1 this morning, Emma Mhic Mhathúna stated that her obstetrician, of whom she was very complimentary, told her that had the false negative been communicated at the time, it is likely that she would not be in the position in which she now finds herself. I acknowledge that Mr. O'Brien has not heard that very powerful interview. We can discuss these failures as though they are academic but the situations in which this woman and others find themselves is far from academic. It is a catastrophic failure for her and the Health Service Executive as a consequence.

I acknowledge the realities of population-based screening. We understand that screening gives indications. When one gets an indication of something that requires further scrutiny, one is referred on. The people who chose whether to communicate or not communicate the information made a decision not to do so. Those people, who are clinicians, were playing with people's lives in not so communicating. What has Mr. O'Brien done about that in terms of the chain of command?

Mr. Tony O'Brien

As I stated, I will listen to the interview when I have an opportunity to do so. An obstetrician or any treating clinician would be correct to say that had the test that was reported negative been reported positive at the time, there would have been a referral and earlier treatment and the outcome may have been very different. That does not relate to the failure to communicate and does not imply that the outcome would have been different but for that failure. The failure to communicate only arose after the diagnosis of cancer because it was that diagnosis which triggered the review that was subsequently not communicated.

I am advised by treating clinicians that receiving knowledge of a prior false negative after a person has been diagnosed and is in treatment would not change the course of that treatment. However, it is clear that had the screening programme picked up an individual's cancer three years earlier, the programme would have done what it is designed to do and has done in 50,000 other cases and brought the person into a treatment pathway which could have prevented cancer or further consequences from developing. What the obstetrician stated is correct.

Part of the reason for Mr. O'Brien being in attendance at the committee today is the issue of open disclosure, which is on the committee's work programme. We were considering it in a very cold way because we are looking at the contingent liabilities. However, we are examining those because they show the culture in an organisation. What we are being told about open disclosure and what is happening in practice are very different. According to the document provided by Mr. O'Brien, in January or February approximately 20,000 of the 140,000 HSE staff had been trained in open disclosure. Not all staff will directly impact on patients because there are many ancillary staff and sections 38 and 39 organisations and so on. Do we have open disclosure or not? What is Mr. O'Brien's viewpoint on voluntary, as opposed to mandatory, open disclosure?

Mr. Tony O'Brien

I failed to address one part of Deputy Murphy's previous question but will do so now and then respond to her latter question. My understanding is that the decision in the CervicalCheck programme following the audit was that the results should be communicated. It is clear that the failure was one of not following through on that decision. Far too much time appears to have been taken up in discussions and possibly disputes about who should do the communicating. However, I have seen correspondence which does not involve arguments that people should not be told but, rather, discussion of who should tell. That is not an acceptable explanation for what happened.

In fairness to those involved, I have not seen evidence that there was a decision not to communicate, but certainly there was a failure to communicate.

Is it not the same?

Mr. Tony O'Brien

No. If somebody sets out on a course of action and the intention is to communicate results but he or she spends too much time figuring out how to do it or disagreeing about who should do it, that is one thing, but it is slightly different, in fact, fundamentally different, from a conscious decision not to communicate the results. What we have heard and seen in the past two weeks points to a failure to follow through on a decision to communicate, rather than an active decision not to communicate. That, of course, will also be looked at in the scoping review.

I find that very difficult to accept. If somebody is bouncing emails about whose decision it is, there is a decision being taken. The decision being taken is not to communicate if the decision is being postponed. I find it very difficult to accept Mr. O'Brien's explanation.

Mr. Tony O'Brien

I am not seeking to excuse anything. Given that the decision to communicate was made, that communication should have occurred. As I have said here and elsewhere, it appears that far too much time was spent on trying to resolve a dispute without bringing it to a final conclusion. Had it been brought to a final conclusion, clearly the results would have been communicated.

Let me make a quick point for the purposes of clarification. I do not think it is fair for the director general to leave it at that. In the circular discretion was given to GPs. They were given discretion to decide whether they should communicate the results; therefore, it is not correct to say the HSE, or the body, did not take a decision not to inform the women. Discretion was given to GPs, as Mr. O'Brien knows.

Mr. Tony O'Brien

To be fair, I do not think it was to GPs but to consultants.

Mr. Tony O'Brien

On the question of direct open disclosure, Dr. Crowley can talk about the process by which open disclosure training and so on is carried out. The open disclosure policy is pretty clear. It creates significant obligations, but in many jurisdictions throughout the world it is reported that in the absence of mandation or a legal duty of candour, policies will only get someone so far. I am on the record as saying and remain of the view that open disclosure-duty of candour should be on a statutory basis. Yesterday in this room the Minister gave an indication of his intention to do so.

Cuirim fáilte romhaibh. I do not think it is our role to be emotional or call for heads on a plate. It is our role to look at how this happened and ensure there is accountability in the spending of public money and so on. I have looked at Building A Better Health Service 2016, on page 16 of which it is stated the patient, the person, should be engaged, enabled and empowered to be at the centre of service delivery. It also references care, compassion, trust and learning. In that regard, will Mr. O'Brien explain how this matter was not brought to his attention? If I am incorrect that it was not brought to his attention, perhaps he might clarify how it was brought to his attention.

Mr. Tony O'Brien

I became aware of the case of Vicky Phelan and its settlement at the High Court once it had occurred and by way of the RTÉ news app.

Mr. O'Brien was unaware of any issue in relation to Vicky Phelan prior to hearing about it on RTÉ?

Mr. Tony O'Brien

That is correct.

Was it brought to Mr. O'Brien's attention that there were issues with the screening programme and arising from routine audits? I would like a "Yes" or a "No" answer to that question.

Mr. Tony O'Brien

Yes. I was aware from a briefing note in 2016 that audits had been completed. I was advised of the full process by which the results were to be communicated.

What was brought to Mr. O'Brien's attention in 2016 and when was it brought to his attention?

Mr. Tony O'Brien

I will have to come back to the Deputy on when it was brought to my attention, but I think it was in March or April 2016.

Okay. Therefore, in March-----

Mr. Tony O'Brien

May I answer the question?

Mr. Tony O'Brien

The Deputy asked me what I was told, as well as when I was told.

Mr. Tony O'Brien

I was provided with a briefing note that advised me that a communication process was about to ensue, by which the results of the audit would be communicated to patients.

Mr. O'Brien was told some time in 2016.

Mr. Tony O'Brien

Yes.

Is there a copy of the briefing note available?

Mr. Tony O'Brien

I do not have it with me, but it can be made available.

Who gave the note to Mr. O'Brien?

Mr. Tony O'Brien

It was provided for me by the person who at the time was national director with responsibility for health and well-being.

The national director with responsibility for health and well-being sent Mr. O'Brien a briefing note outlining issues that had arisen in this matter.

Mr. Tony O'Brien

No. She told me that the process of communication was about to commence and that there was a documented process. I asked if I could see that process.

May I put some plain English language around this, please?

Mr. Tony O'Brien

Certainly.

What issues were brought to Mr. O'Brien's attention with regard to the communication process? What was being said to him as director general of the Health Service Executive?

Mr. Tony O'Brien

I was provided with a document that set out a very clear communications plan. I was never-----

What was the issue being communicated?

Mr. Tony O'Brien

The communication of the outcome of the audit process.

Mr. O'Brien was aware at that point that something was wrong.

Mr. Tony O'Brien

No. I was not aware that there was anything wrong. I was aware that an audit had been carried out, which would have been good practice.

Mr. Tony O'Brien

I was aware of a detailed plan to communicate the results of that audit. I was never subsequently advised that anything had gone wrong with that communications plan.

Leaving aside the communications plan, what was the issue being communicated?

Mr. Tony O'Brien

As I said, the issue being communicated was that the programme had completed an audit.

Yes and what had it found?

Mr. Tony O'Brien

They told me that they would be communicating-----

What had the audit found that was being brought to Mr. O'Brien's attention?

Mr. Tony O'Brien

The fact that they would be communicating to patients-----

What would they be communicating to them?

Mr. Tony O'Brien

If the Deputy was to allow me to get beyond the word "communicate"-----

Mr. Tony O'Brien

-----I might tell her what they were going to communicate.

Please allow Mr. O'Brien to answer the question.

I will, but I want to know what was being communicated.

Mr. Tony O'Brien

Every time I get to the point where I tell the Deputy the answer, she repeats the question. If she pauses for one second, I will get through it quickly. What was to be communicated were the individual results of audits against notified cancers in persons who had previously availed of the screening programme.

Okay. Therefore, it was brought to Mr. O'Brien's attention that the audit had highlighted the fact that cancer had been detected when tests were reviewed and that the women concerned were to be told this.

Mr. Tony O'Brien

Yes.

Was Mr. O'Brien aware of how many women needed to be told?

Mr. Tony O'Brien

No. I was not given the numbers.

Did Mr. O'Brien ask questions at that point? Did he ask anybody the extent of the problem?

Mr. Tony O'Brien

I was advised that the audit had not thrown up significant issues of concern about the quality assurance of the programme but that there was to be a carefully planned process of communication. I was happy to hear that there was a carefully planned process of communication.

I am not interested in a carefully planned spin programme or a carefully planned communication process-----

Mr. Tony O'Brien

Excuse me-----

Mr. Tony O'Brien

I am sorry, but may I come in here?

Mr. Tony O'Brien

It is unfortunate when I give an answer which is factual, that the Deputy then tells me that she is not interested in the answer.

I am interested in-----

Mr. Tony O'Brien

The answer is conditioned by the question.

I am interested in everything Mr. O'Brien has to say. I wish I had a few hours to engage with him, but I do not; I only have a few minutes. In the time available to me I am trying to engage in plain English in order that I can understand what happened and take it back to the people who are asking me questions. Of what was Mr. O'Brien made aware in regard to the number of people affected? Did he ask questions to elicit more information? Did he escalate the process?

Mr. Tony O'Brien

I was advised that the audit had not thrown up any issue of concern. I was advised that the results of the audit would be communicated to the individuals who were the subjects of it. I was provided with quite some detail as to how it would be done. I was never subsequently told that any issue had arisen or that anything had happened to disrupt that plan.

As a matter of interest, who sent the letter to Mr. O'Brien?

Mr. Tony O'Brien

The national director of health and well-being. I will provide the committee with a copy of it.

Perfect. Who held the position at the time?

Mr. Tony O'Brien

Dr. Stephanie O'Keeffe.

The memo received by the Department of Health on the screening programme states that under current contractual arrangements with CervicalCheck, MedLab carries out its work through a laboratory in Ireland. Are all tests now being carried out in Ireland by the American company or are tests still being carried out outside the country?

Mr. Tony O'Brien

There are currently three laboratories, one of which-----

I understand that. I ask Mr. O'Brien to listen to my question.

Mr. Tony O'Brien

Okay.

Are tests being carried out outside Ireland?

Mr. Tony O'Brien

Yes. I was in the process of answering the Deputy's question. We have a pattern, whereby on the point of answering, the Deputy changes-----

I asked a specific question.

Mr. Tony O'Brien

There are three laboratories, two of which are in Ireland. The other is in the United States.

Yes. Did Mr. O'Brien hear my question?

Mr. Tony O'Brien

Yes.

I asked if tests were being carried out in the laboratory in America.

Mr. Tony O'Brien

Yes.

MedLab carries out its work through a laboratory in Ireland. Will Mr. O'Brien clarify that?

Mr. Tony O'Brien

That statement is correct.

Is there another company in America separate from MedLab that we are using?

Mr. Tony O'Brien

Yes.

What is the name of that company?

Mr. Tony O'Brien

It is Quest Diagnostics.

When we encourage women to come forward and have smear tests again, will those tests go to the laboratories of MedLab in Dublin and Quest Diagnostics in America?

Mr. Tony O'Brien

Each laboratory-----

Mr. Tony O'Brien

Can I answer the question in a reasonable way?

Mr. Tony O'Brien

Each laboratory has a particular catchment or service area so all the smears taken by particular smear takers go to just one laboratory.

Mr. Tony O'Brien

The one that relates to the area-----

When the HSE is encouraging women to go forward, some of those tests will go to the laboratories about which there are serious questions.

Mr. Tony O'Brien

The Deputy is reaching a conclusion that may not be substantiated.

Mr. O'Brien just stated that he knew there was a communication process about to commence. We now know that the communication process was through a circular. When did Mr. O'Brien first become aware of the circular? When did he first set eyes on that particular circular?

Mr. Tony O'Brien

After I heard about the settlement of the Vicky Phelan case.

Mr. O'Brien was not aware that the circular left it to the discretion of consultants to inform women.

Mr. Tony O'Brien

I was not. I was not aware of any aspect of the circular.

Mr. O'Brien stated the other day before the health committee that he does not take full responsibility but that he does accept some. What is Mr. O'Brien responsible for?

Mr. Tony O'Brien

Let me tell the Deputy why I do not take full responsibility.

No. I want to know what Mr. O'Brien takes responsibility for.

Mr. Tony O'Brien

I take responsibility for the fact that some persons in the organisation have failed in this communication process. The reason I do not take full responsibility is because-----

Who are those persons?

Mr. Tony O'Brien

-----that would be to absolve the other persons.

Who are those persons?

Mr. Tony O'Brien

I will not name persons here. There is a convention that one does not name persons who are not present, generally speaking. I think it was read out at the beginning.

It depends on the circumstances.

What action has Mr. O'Brien taken in respect of those individuals?

Mr. Tony O'Brien

At present, one of those individuals has, as the Deputy knows, resigned her position. The other individuals are centrally involved in the process of work of the serious incident management team.

Mr. Tony O'Brien

Helping with all the processes the serious incident management team needs them to do. What one does not do in the midst of a situation like this is remove all of the institutional knowledge relating to the factors one is trying to deal with.

So the people who were a part of the problem the first day are now the ones we are relying on, in part, to fix the problem.

Mr. Tony O'Brien

The part of the organisation that is in charge - Damien McCallion in now in charge of the cancer screening service having had no prior involvement, and the serious incident management team also consists of people who are not in the screening service - requires the information, knowledge, support and work of the people who were in the cancer screening service in order to ensure that all the processes that are under way can be got through. That is currently the focus.

Perhaps Mr. O'Brien can answer this question because he said there is a distance between a systemic failure and a systems failure. Will he very briefly point out the differences between a systemic failure and a systems failure?

Mr. Tony O'Brien

A systemic failure would tend to relate to the whole of the entity in question, meaning the whole wide HSE. In this instance, we are talking about a particular decision to communicate the results of an audit in the part of the organisation that is known as CervicalCheck where the decision was made but, as we now know, it did not result in the communication that was expected. There was not a loop in place to establish that the communication had occurred. At the time when the serious incident management team began its work, it was the expectation of those in CervicalCheck that every woman had been informed. Consequently, when we discovered it was only 48 out of 209, it came as a very significant-----

Is that not a systemic failure on foot of the fact that the decision was never taken to tell them? The decision was made to give discretion to consultants to inform them.

Mr. Tony O'Brien

We do not want to dance on the head of a pin.

Mr. Tony O'Brien

When-----

Mr. Tony O'Brien

I have not been dancing on the head of any pin, Deputy MacSharry. When Deputy O'Brien is asking me, as the head of the entire HSE, if I say it is systemic, I am saying that the same thing is replicated throughout the organisation. What I am actually saying to the Deputy is that we know there was a flawed system put in place around this communication. It was a flawed system.

As the director general, Mr. O'Brien is responsible for systemic failures but not systems failure.

Mr. Tony O'Brien

Again-----

It is a simple "Yes" or "No".

Mr. Tony O'Brien

I have a wide range of responsibility. The Deputy put to me at the start why I did not accept full responsibility. The reason is that if I do, it lets everybody else off the hook. I will not do that.

Is Mr. O'Brien responsible for systemic failures but not systems failures?

Mr. Tony O'Brien

The Deputy will have to give me a more concrete-----

Deputy O'Brien just outlined one to Mr. O'Brien over the past five minutes.

Mr. Tony O'Brien

Sorry.

The Deputy just gave Mr. O'Brien a system. Mr. O'Brien described a systems failure as opposed to the Deputy's description of a systemic failure. He just went through that for five minutes and Mr. O'Brien is messing around now.

It is a simple question. Is Mr. O'Brien, as the director general of the HSE, responsible for systemic failures? If it was a systemic failure, is it correct that Mr. O'Brien would resign?

Mr. Tony O'Brien

What I am saying is-----

If it was a systemic failure, would Mr. O'Brien take full responsibility for it and resign? As it is a systems failure, Mr. O'Brien refuses to take responsibility for it.

Mr. Tony O'Brien

I have not refused. The Deputy is putting words in my mouth. I will put it to the Deputy a slightly different way. Public organisations are one of the few places where all accountability passes upwards. I do not seek to run the organisation that way. The entire time I have been there, in accordance with Government policy, I have been trying to create accountability at the appropriate levels. I am not about to give everyone a get-out-of-jail-free card but I am accepting-----

That is fair enough, but I am not about to give Mr. O'Brien a get-out-of-jail card. I have one final question. I know other members want to come in.

To me, a systems failure would be if a decision was taken to inform the women and then that decision did not happen.

Mr. Tony O'Brien

We are agreed.

For me, a systemic failure is when the body decides it should tell people but decides to leave it to somebody else and at somebody else's discretion. That is a systemic failure because there was no firm decision taken to inform the women. That was in February 2016, through the circular. It was not until 30 April 2018 that the HSE changed that position and said that each hospital group was required to tell each of the 162 women. Up to that point, there was a discretion for consultants to tell the women. Is that a factual statement? Yes or no?

Mr. Tony O'Brien

The Deputy is referring to the decisions taken within CervicalCheck in the first instance and, second, to the decisions that the serious incident management team, which I put into CervicalCheck, took to ensure all those affected would be informed. In order to take out any ambiguity or doubt in a context where we wanted to be able to be clear that every woman had been told, we got into what is more typically regarded as a command and control-----

Up to 30 April, there was ambiguity around this issue on whether women should be told or who was responsible for telling them or whether it was at somebody's discretion to tell them. Yes or no?

Mr. Tony O'Brien

What we discovered was that whatever was intended and whatever the rule said, of 209 only 48 had been communicated with.

That is a systemic failure which Mr. O'Brien does not take responsibility for.

Mr. Tony O'Brien

The Deputy can use whatever language he likes.

I asked Mr. O'Brien as simple question and he will not answer.

Mr. Tony O'Brien

I have answered the Deputy.

Is Mr. O'Brien responsible for systemic failures within the HSE or not responsible for systems failures? Yes or no?

Mr. Tony O'Brien

This is not a systemic failure within the HSE as a whole. It is a systems failure in a decision that was made to communicate and was not communicated. This will all be part of the review.

Does Mr. O'Brien believe that the HSE, or part of the HSE, is dysfunctional in light of the fallout from what has happened and the disaster we have on our hands?

Mr. Tony O'Brien

In respect of this process, clearly CervicalCheck was dysfunctional.

We need to talk about dysfunction. Did the alarm bells not go off for Mr. O'Brien? He is admitting now there was dysfunction within the system. How come it took so long? It took Vicky Phelan to bring a case to court and to win. There were attempts to silence her during that case. I know it had nothing to do with the HSE but was due to a foreign company. Did no one within the entire HSE see that there was a dysfunction and step in to try to stop it? Is anyone, including Mr. O'Brien, responsible for what is going on?

Mr. Tony O'Brien

What I can tell the Deputy is that I was not made aware in the way that I should have been of this case. This case went into legal process, I believe, in January and was concluded in April. There would have been opportunities before and during that case for someone to recognise the seriousness of what was happening and to escalate it to me. They did not. In a different forum, many of the people who might have escalated it to me confirmed that they had not. They had nothing to gain by confirming that; in fact, they potentially had things to lose. They confirmed that they had not escalated it to me. Because it was not escalated to me, there was no potential for any alarm bell to ring in my head. Had I been aware of it, alarm bells would have rung. I said to a different committee yesterday, at which Deputy Kelly was present, that had I known that there were a significant number of women who had gone through the same audit process and who had not been made aware of their results, the first thing I would have done would have been to make sure they were aware of those results so that, by the time this did come into the public domain in the way it did, there would have been no cause or reason for other women to be concerned that they might be about to be told. That is one of the most regrettable aspects of this whole case.

Is Mr. O'Brien saying that there are people under his control who are culpable and responsible, who did not take action and who were dismissive in terms of what they did in their jobs? Has he identified these people and will there be consequences for them? This is important stuff. It is vital that the women of Ireland who are in crisis at the moment understand how both the HSE and the functions within it work.

Mr. Tony O'Brien

Once we declare a serious incident management event, the things the Deputy has identified are not the immediate focus. The immediate focus here has been as follows. First, to make sure we understood the totality of the nature of the audit and, as the Deputy is aware, we learned during the process issues to do with that. Second, to make sure there were effective processes in place to communicate with all of those who were the subject of the audit. We have got, I think, to 201 of 209. There is challenge establishing communication with others who may be out of the jurisdiction or on leave but we will pursue that continuously. Third, to deal with all of the persons who, as a result of concerns or worries, are making contact with the helpline. We are arranging for each of them to have a detailed, over-the-telephone medical consultation. That is taking quite some time. We are also carrying through a number of data check processes to ensure that we have a full picture on this. That has to be the priority at this time. Other things will follow in due course and we also now have the appointment by the Government of Dr. Scally to carry out the scoping exercise, with which we will co-operate with fully.

Just to clarify again, if people are found to be neglectful, will they be held accountable and will there be consequences for them within the HSE's system?

Mr. Tony O'Brien

Anyone who is found to have failed in his or her duty will, on the basis of an appropriate consideration of that evidence, following due process in accordance with a disciplinary procedure, be called to account, yes.

Will the public be aware of this?

Mr. Tony O'Brien

When the process is concluded, of course, yes.

Does Mr. O'Brien think that the services across the board in the HSE are professional and that they are rolled out in a proper manner? Are they fit for purpose in general?

Mr. Tony O'Brien

Overall, I think we have a health service that performs at a very high level against enormous challenges of demand which have already been well documented in the Government review of capacity and so on. We all know about the difficulty in getting access. Patient experience surveys carried out jointly by ourselves, HIQA and the Department of Health and published by HIQA show the way people feel about the services that they receive from the HSE. The biggest challenge of course is one of access. This situation aside, I believe that we are served very well by highly dedicated, professional and committed health service staff throughout the country. That also goes for the staff of CervicalCheck and the screening programmes, who are as devastated as anybody by the circumstances that have now unfolded.

Is Mr. O'Brien confident that there is no other section within the HSE, besides the cervical screening programme, in which there is a problem that we will hear about next year or in three or six months' time? Is this making the HSE alert to other parts of the service? Are both the system and the roll-out of services fit for purpose? Is Mr. O'Brien happy that this is a once-off and that there is not something else happening that we are not aware of and, perhaps, that he is not aware of? Is there a system in place now to check all the services that are-----

Mr. Tony O'Brien

Through the review that the Minister has announced, there will be a cross-look at other screening programmes to ensure that they are operating in accordance with best international standards. We are carrying out a specific case management review in this instance to ensure that the warning bells that did not sound in relation to this case will sound in the future. We will be working closely with our colleagues in the State Claims Agency in relation to that. All of those who are in charge of hospital groups and community health organisations are very much aware of the need to ensure that every step is being taken to assure the quality of services, recognising that the biggest challenge to the quality of our services actually is getting access to them, not the quality of care once a person is in.

I call Deputy Peter Burke.

I just have two more questions. I only got to ask one. Will I get a second chance?

Yes, we are going to go around again. The Deputy was not here at the beginning when I explained to everyone that there is a different system working today because we have a shorter period.

I will get in again.

We are going to try to get around again.

I thank the witnesses for appearing. Obviously it has been a very difficult two weeks for the health service. On the national screening programme, from the HSE accounts, if we look at CervicalCheck, it seems to be operating in isolation. It has its own website and its own register for all the details, the patients, etc. When I look at the accounts for the HSE, I cannot see what the costs of outsourcing to laboratories are or what the cost of running the programme is. That goes for the other screening programmes. Are they all bulked into one area or what way is that derived from the accounts?

Mr. Tony O'Brien

I will ask Mr. McCallion to answer the Deputy's question.

Mr. Damien McCallion

The national screening service has an overall budget of €77.8 million. That is split up across the four programmes and there are some common elements to that. One of the things that undoubtedly will be looked at, either through myself or through the other review process, will be whether there are opportunities for the programmes to perhaps work together more closely. There is a common piece. Approximately €5 million of that is the national screening service as a whole and then each of the programmes has a budget underneath that. The laboratory costs are in the order of about €6.9 million per year spread across the different laboratories that provide the services. At the moment, there is an overall national screening programme and there are four programmes underneath that. Each of those has a budget but there is an overall budget of €77.8 million.

Obviously, we have been made aware of the ten cases where legal action is ongoing in respect of the lab in the US. However, my concern is that identifying risks in accounts is very difficult when we cannot see the figures. The problem here is that for the different screening programmes, it is very hard for the reader to assess what is happening or to get a clear picture when we are not given the detail. I think that does need to change in the future.

In terms of all the screening programmes that are under way in the health service, it was very strange to see the Minister for Health being handed information just before coming into the Dáil to state that the National Cancer Registry had not liaised or reconciled with the CervicalCheck register in terms of having cases reviewed. That showed huge concern at that stage. Can Mr. O'Brien tell me if there have there been cross-checks done with the other screening programmes? If there is another screening programme and someone does develop cancer, is there a cross-check done to check that those original tests are being held to the highest accountability and to ensure that they are being carried out correctly?

Mr. Damien McCallion

Basically, part of the review is going to look at that across the cancer programmes from an initial-----

I am asking if that is being done now.

Mr. Damien McCallion

In terms of the audit processes, the programmes are different in that there does not appear to be a comparable formal audit process within the other programmes.

There is not an audit process. What about the other screening programmes?

Mr. Damien McCallion

Sorry, Deputy, all programmes have an assurance process around it and each of those are set out. I am just saying that in terms of the contrast I believe the Deputy made between the cervical programme and the other programmes, there are differences in how they are approached. Clearly, the review is going to look at that to give us assurance that there are no issues in terms of the wider programmes.

Of course there are differences in terms of demographics such as age-----

Mr. Damien McCallion

And nature.

-----and types of people that they affect.

Mr. Damien McCallion

Yes.

In terms of having confidence in the programme, CervicalCheck seemed to be working in isolation. I seek a stronger assurance that robust procedures are in place to detect anomalies in other screening programmes. I do not feel confident having listened to what has been said.

Mr. Tony O'Brien

I can clarify definitively that there is a two-way data exchange in relation to BreastCheck. The issue with CervicalCheck was that the data exchange was in one direction only. CervicalCheck data was going to the registry but registry data was not coming back.

Is there a two-way data exchange for BowelScreen?

Mr. Tony O'Brien

I believe so. The BowelScreen programme is at a sufficiently young age whereby this is not as significant an issue, because it relates to the progress in respect of screening rounds when this become particularly relevant.

The HSE is a large organisation. Why were there no indicators to show there was no two-way check for the CervicalCheck programme? Why would such a situation not come to the forefront? Clearly, there was two-way data exchange for BreastCheck. Why was the same system not put in place for CervicalCheck?

Mr. Tony O'Brien

Again, the individuals concerned would need to flag their concern upwards for the organisation at a higher level to be aware of an issue there, and that had not been escalated as an issue.

I am sure that the HSE applies risk assessment procedures on a regular basis. If one has two separate lists or two cohorts of patients, one of which has those who developed cancer but had gone through screening, then the original tests should be checked again for anomalies. That is a basic thing that should happen with screening.

Mr. Tony O'Brien

There is a quality assurance committee with significant international representation in respect of the CervicalCheck programme that has reviewed programme data but has not raised flags of concerns about the fundamentals of the programme. As I said earlier, I think Deputy Cullinane was correct to identify and distinguish between the known shortcomings of all screening programmes which, unfortunately, will lead to a later diagnosis of cancer for patients who have not been detected in the screening programme, on the one hand, versus this failure to communicate in the aftermath of an audit process, which is really what this issue is actually about.

It was also a failure of the system not to pick up that there was no audit process under way. Screening programmes should be risk assessed. When the programme commenced a decade ago, it was groundbreaking for Irish people in that the scheme could prevent or save people from developing cancer.

Mr. Tony O'Brien

There was-----

I find it hard to understand why checks and audits were not a fundamental part of the programme and why, for the people who developed cancer, that their original tests were not audited and checked. It is a fundamental core issue that should be happening within the system.

Mr. Tony O'Brien

The issue here was that the audits they had done were in relation to cases notified from places of treatment. The reason the issue arose in respect of the Dáil, as the Deputy referenced - the difficulty with which the Minister was faced - was that in the white heat of the process of the serious incident management team, what was communicated to the serious incident management team was that the audit had related to all cancers in that period, rather than that they had only related to cases notified in a particular way. That is what led to the Minister, myself and colleagues in the Department believing that the audit was about a wider group of patients than it actually was. We will get to the bottom of why that was communicated in that way. There could be a number of reasons for it but clearly that was a significant issue for us giving rise to a difficulty for the Minister in having confidence in the information he was being given. That was corrected as soon as the serious incident management team identified the problem on Tuesday afternoon and that very day, he clarified the matter in the Dáil Chamber.

How much money was saved to have the tests done in the United States rather than in Ireland?

Mr. Damien McCallion

I must respond to that. I do not have the actual cost per test but we can, I am sure, dig that out.

I thank Mr. McCallion. We will have another round of questions but I have a couple of quick questions myself.

Mr. O'Brien mentioned a letter dated March or April 2016-----

Mr. Tony O'Brien

It was a memo.

The memo came from the director of well-being. Mr. O'Brien has said that the person was the director of well-being. Is the person still the director of well-being?

Mr. Tony O'Brien

No. We do not have quite that process anymore. The cervical cancer screening service moved back into the cancer control programme earlier this year. We gave the person a different role. Even were that person to be in the same role, the director would not continue to have this responsibility.

I thank Mr. O'Brien for his clarification. Can he ask his colleagues seated behind to supply the committee a copy of the letter for our perusal? Mr. O'Brien may be gone by the time we get it. Can he ask his colleagues to supply a copy because it would help formulate some of our questions later on?

Mr. Tony O'Brien

I can do that once I am not talking to the Vice Chairman.

I suggest that Mr. O'Brien turns around and gives his colleagues permission to supply us with the letter.

Mr. Tony O'Brien

We will make steps to supply the memo to the committee before we finish today.

That would be helpful and I am sure all of my colleagues would appreciate that.

Mr. Tony O'Brien

Yes.

In terms of the letter dated March or April - I do not hold Mr. O'Brien to the exact date - obviously he was made aware, as he said, that an audit had been conducted and there was a communication process in place. I do not want to misquote him but, broadly speaking, there was nothing to be alarmed about. Is that correct?

Mr. Tony O'Brien

Yes.

Did the memo refer to anything else?

Mr. Tony O'Brien

No. It described the whole process by which communications was obviously alerting me to the fact that there was always a possibility that, as individuals were informed, it could lead to public debate, discussion and so on. It was really a simple process alerting me to the fact that there was a communication process to follow and that they were prepared for it. On re-reading it recently I found it was as reassuring now as it had been then, except that I know that it did not actually follow the way it was supposed to.

Did the memo refer to the volume of women involved, that is, the 209 women?

Mr. Tony O'Brien

I would have to check and see whether it mentioned that number. I would not want to mislead the committee now-----

Mr. Tony O'Brien

-----without having it in front of me. That number, in the context of 3 million cervical smear tests and 1.12 million women participating in the programme, based on what we know of the reliability and efficacy of population-based screening and as difficult and as harrowing as it is for all of the individuals concerned, is not a number that would raise fundamental concerns about the screening programme.

The audit covered approximately 1,400 women, the memo may have referenced the number of 209 and Mr. O'Brien will check. Is that correct?

Mr. Tony O'Brien

Yes.

Mr. O'Brien has been fairly open about how he felt in light of reading the letter now versus back then. Does he feel the letter was appropriate, comprehensive enough and detailed enough for him to get a better judgment on what was going on?

Mr. Tony O'Brien

What I can say to the Vice Chairman is that if everything that had been set out in that memo had happened, we would not be here today.

Does Mr. O'Brien feel that anything else could have been added to the memo? Does he feel it was comprehensive enough? Does he feel he was misled in any way?

Mr. Tony O'Brien

No, because it could not, at that time, have told me what subsequently transpired, which we now know about.

I appreciate that.

Mr. Tony O'Brien

It would be wrong to look at what we know now, that happened subsequent to that memo, and say that that memo should have told me about it because the person writing did not know that these things would happen.

I understand and appreciate that. I want to refer to the detail in the memo that Mr. O'Brien received about this matter. I appreciate that he has broken down the figures and, given the scale of screening, that the figure would not be unusual in terms of international standards. Is that, effectively, what he said?

Mr. Tony O'Brien

Yes.

Was there anything in the memo that rang alarm bells in any way, shape or form?

Mr. Tony O'Brien

No. Having re-read it recently, not in the last couple of days but recently, I remembered it as a reassuring memo.

Mr. Tony O'Brien

I read it as a reassuring memo when I re-read it. Clearly, what it could not tell me, because it was not known at the time, was what would subsequently unfold.

To be balanced, looking back on the memo, is it fair to say now that the biggest issue, as a result of this matter, was the fact that the memo stated there was a defined communications process in place for these women who were affected, that is, the 209 women? Obviously we now know that there was a huge and disgraceful failure in the way in which that was conducted. In the memo it said there was a process in place. We now know that that process failed.

Mr. Tony O'Brien

Exactly.

Is that fair enough?

Mr. Tony O'Brien

Yes, and it has always been my view that the central issue here, apart from the obviously tragic situation that individual women face when they go on to experience a diagnosis of cervical cancer, which is a very adverse diagnosis, was the failure to follow through on a plan to communicate results with women. That was the central failure in the programme.

We will see the letter in a few minutes. Did the planned communication detail how this was going to happen?

Mr. Tony O'Brien

How about I give the letter to the Vice Chairman and he can reach that conclusion for himself?

Okay. Fair enough.

Mr. Tony O'Brien

I am not reading it here.

Grand. That is fair. We will get the letter and we will go through it. I would like to ask a quick question about the issue referred to by Deputy Burke. As colleagues will know, I have discussed this matter with Mr. O'Brien at two committees - this committee and the health committee. I have gone through it in the finance committee with the State Claims Agency and there have been debates in the Dáil. I have classified as a "bombshell" the fact that there was a difference between the cancer registry figures and the CervicalCheck figures. The issue in relation to those two sets of figures - the fact that they relate to completely different catchments of women - has been detailed. As part of the review by the Royal College of Obstetricians and Gynaecologists, we will get details of what has transpired in respect of this other cohort of women. Over a number of years, CervicalCheck attempted to ensure these figures were consistent and correlated. Obviously, it failed. In what aspect did it fail? It is possible that the failure was not on its part. In what aspect did those figures fail to come together? I understand that similar issues do not exist across other screening programmes. Can Mr. O'Brien confirm that?

Mr. Tony O'Brien

As I said to Deputy Burke, there is a two-way exchange of data with the cancer registry in relation to the BreastCheck programme. In the case of the diabetic retinopathy screening programme, there is no relationship with the cancer registry so there is no requirement for exchange. BowelScreen will operate in a similar way to BreastCheck. There is no immediate issue there because it is at an early stage and because of the way cancer data is collected. I do not want to comment on the efforts that were or were not made to resolve the issue of two-way data exchange over various periods of time because I am not sure of the details at this stage.

But there were efforts.

Mr. Tony O'Brien

I am saying that I am not going to comment on it because I do not have the information.

Surely some efforts were made.

Mr. Tony O'Brien

That is a reasonable assumption, but I cannot confirm it because I have not gone looking for the information at this point. In the heat of a situation like this, the focus of a serious incident management team is on managing the incident itself.

Is it not true that from a public confidence point of view, we have to confirm that other screening programmes are not in a similar position?

Mr. Tony O'Brien

That is true.

That is 100% true. There is a reason there was an anomaly here.

Mr. Tony O'Brien

Yes. The priority here was to ensure the data was exchanged, rather than to get into the whys and wheres and who did what and when in relation to previous non-exchange of data. It is clear that there are issues of-----

Mr. O'Brien's assistant said at the health committee yesterday that there is a process going on at the moment. He said that they expect to conclude the data reconciliation process over the coming days.

Mr. Tony O'Brien

Yes, that is what I am-----

It is quite obvious that it is a priority for them in the current situation rather than down the road.

Mr. Tony O'Brien

Yes.

They need to have it done immediately.

Mr. Tony O'Brien

Yes, that is what I am saying. The focus of the serious incident management team is to do that reconciliation now, rather than to inquire into what did or did not happen five or six years ago.

We need accountability as to why that happened.

Mr. Tony O'Brien

Yes, but that is not what is done-----

I accept that.

Mr. Tony O'Brien

-----in this particular phase.

I have a final question for Mr. Breen. I am asking it now because I will not get another chance. The State Claims Agency was told by CervicalCheck that all the women had been communicated with. Is that not right?

Mr. Ciarán Breen

That is correct.

Did the agency receive that in writing or orally?

Mr. Ciarán Breen

We received it orally towards the end of the Vicky Phelan trial.

I have noted Vicky Phelan actually saying this - asking this question. It is the reason I am asking it, actually. She brought it to my attention. The agency did not receive it in writing. It received it orally. From whom did the agency receive it orally?

Mr. Ciarán Breen

From CervicalCheck.

Was it from senior people in CervicalCheck?

Mr. Ciarán Breen

Yes.

They said that everyone had been communicated to.

Mr. Ciarán Breen

Yes.

Would it be possible for Mr. Breen to come back to this committee to confirm the approximate time and date on which this happened-----

Mr. Ciarán Breen

Yes.

-----and from whom the agency received this assurance? Obviously, it would be very useful to Vicky Phelan to know that. It would also be potentially useful to other women as well. Mr. Breen might come back with that detail.

Mr. Ciarán Breen

My understanding is that it may have been given in evidence to the court that all the women were told.

Mr. Ciarán Breen

It would be in the transcript.

Mr. Breen might do what I have asked so that we can join the dots and make sure everything is checked.

Would it be perjury?

We are not going there. As we have some extra time, there are approximately 30 minutes left. I will limit everyone to two quick questions. That is the way. We will do a full round when the two lads have left.

If Dr. Crowley came to Mr. O'Brien to say he had been asked to sit on the board of AbbVie laboratories as a non-executive director, what would Mr. O'Brien say?

Mr. Tony O'Brien

I have no idea because he has not asked me.

No. I am giving Mr. O'Brien the hypothetical situation.

Mr. Tony O'Brien

I would imagine that we are doing significant business with AbbVie laboratories, and therefore it would be inappropriate.

Mr. Tony O'Brien

I am almost certain-----

What if it was a company with which the HSE is not doing any business?

Mr. Tony O'Brien

I think I have given sanction for various HSE personnel to sit on various external boards of voluntary bodies, charities and all sorts of entities.

Yes. I am asking about a commercial company. I think we all know what we are talking about.

Mr. Tony O'Brien

It is a hypothetical question. I would have to look at it in detail.

Does Mr. O'Brien think it would be a good use of taxpayers' money if he were to allow one of his senior team to sit on an external commercial board, thereby dividing that person's time at least somewhat from the focus of the job for which he or she is paid?

Mr. Tony O'Brien

Provided there was no conflict of interest and it was made clear that the person in question had to undertake whatever he or she was going to undertake entirely in his or her own time and with no expense to the organisation, I might well give such consent. It is a hypothetical-----

So Mr. O'Brien thinks it is good practice in the taxpayer's money to allow paid personnel of the State in major executive positions, with a turnover of €13 billion, to take up positions with other commercial entities.

Mr. Tony O'Brien

Obviously, each case would have to be examined on its merits.

Okay. I think Mr. O'Brien is dancing on the head of the pin about which he spoke earlier.

Mr. Tony O'Brien

No.

The reality here is-----

Mr. Tony O'Brien

The Deputy is not asking me-----

I would say-----

Mr. Tony O'Brien

-----questions that he wants me to answer.

No, Mr. O'Brien has given his answer. If one of his senior team came to him to say he wanted to be a director of X, I would say his answer would be "No". Frankly, I think the Minister showed an appalling lack of judgment in giving his permission. Since this crisis began, how many HSE staff have been disciplined, suspended or put on notice of verbal or written warnings?

Mr. Tony O'Brien

In the last two weeks in relation to this matter, none.

None. Okay. Nobody is being held accountable. This is a problem for me. I will finish on this thread if I can. I want to put on the record a communication that was received by Dr. Keith Swanick, who is also a Member of the Oireachtas, from one of his colleagues. It reads:

How can you and your colleagues stand over the cervical controversy. We are inundated with requests for smears with no formal guidance even how to process them, how to claim remuneration. We cannot offer any form of reassurance to any patient so all smears need to be repeated. Can we trust the results of repeat smears? What's the lab they will be sent to?

I think this captures for me the reality here. Mr. O'Brien has taken no action against any member of staff. He has admitted he was not told things when he should have been. We know there were system failures. In calling for Mr. O'Brien's resignation, I have to say it may well go to Ministers, taoisigh and the head of the State Claims Agency for further calls of resignation. Mr. O'Brien and the Ministers are commentators on a national crisis. We have no leaders. That is crystal clear. Mr. O'Brien has admitted that no action has been taken against anybody. There is nobody accountable. Three weeks into the crisis, Mr. O'Brien is not even in a position to tell us who was supposed to tell him but did not do so. There is a policy of sitting back and letting everything take its course. The people and accountability come last.

The problem is that all of those here, most of the political establishment and it seems the Government served the system, not the people. That is why I again appeal to Mr. O'Brien, in the interests of the women in Ireland, to show them what their taxes have purchased - accountability on their behalf.

I will move on to the other questioners.

On the memorandum to which Mr. O'Brien referred and which he said would be published or furnished to the committee, was it passed to the Department of Health and, if so, when?

Mr. Tony O'Brien

I think it was a copy of something that would have been shared with the Department at the time, although I cannot confirm that.

Can the Department of Health confirm it?

Mr. Jim Breslin

I can confirm that we are in the process of checking all records.

Therefore, the witnesses do not know.

Mr. Jim Breslin

At this stage, I cannot be definitive. We do not have evidence in that regard.

How could Mr. Breslin not know?

Mr. Jim Breslin

Because we are doing a lot of record checking over a very extended period and until we complete that process, I will not be definitive. Whereas I think we may not have something, I will not be definitive until we get to the end of that process.

I will come to Mr. Breslin later.

On the circular that we discussed, does Mr. O'Brien believe individuals made mistakes in formulating it?

Mr. Tony O'Brien

Given that the circular did not have the intended effect - the communication of results to all of the women - yes, but certainly it was a full process.

Who crafted the circular.

Mr. Tony O'Brien

I do not know at this point. As I said-----

Was Mr. John Gleeson one of the people who had crafted the circular? He certainly had responsibility.

Mr. Tony O'Brien

Yes. At a previous meeting of the Joint Committee on Health Mr. Gleeson indicated that he had participated in the process of drafting the circular.

Did he make mistakes?

Mr. Tony O'Brien

I am not in a position to assign responsibility or culpability to any individual, unless I go through due process. If the Deputy will bear with me, I wish to make one point and will not try to use up his time. At this point our focus has been on dealing with the issues that need to be dealt with in the interests of all those women who needed to be informed of the outcome of the audit and all those who are being provided with telephone consultations and other issues that need to be dealt with in the here and now.

Mr. O'Brien does know that Vicky Phelan's legal team has accused the HSE of a cover-up. One reason is this circular which, as we said, gave discretion to GPs. At no point, at the time the circular was issued, did the HSE as a corporate body decide that all patients must or should be informed. It is amazing that even today, as Mr. O'Brien sits here, he is not in a position to tell me exactly who drafted the circular and who the individuals were because I suspect that they are the same people to whom he referred in answer to Deputy Jonathan O'Brien's question. They are still working in organisation and, furthermore, now central to the examination being carried out and the solutions being put in place.

Mr. Tony O'Brien

I say to the Deputy, honestly and candidly, that if I were to go down the road some people would wish me to take - effectively, summary suspension, dismissal or whatever else of a whole bunch of a small number of staff who have the corporate knowledge that enables us to deal with what we are dealing with - I would not serve the public interest at all.

Mr. O'Brien allowed him to answer this question at the health committee. Mr. Gleeson said, "I was involved with the then clinical director of the screening programme in compiling it,"; therefore, he was responsible. The circular gave three instructions. I want Mr. O'Brien to take this in for one moment, as I am sure he has already. The first instruction was that a copy of the audit be added to the patient's file; to use clinical judgement in deciding whether patients should be informed and that if the patient had died, a note was to be added to the file. That was a decision taken by the corporate body that is the HSE. Imagine, that if somebody had died, a note was simply to be added to the file. That is the systemic failure Mr. O'Brien is not prepared to accept. He is not prepared to accept that that instruction clearly given and the circular represented a systemic failure. How can it not be a systemic failure?

Mr. Tony O'Brien

I do not want to go back and rehearse the difference between a systems failure and a systemic failure because it is a futile discussion.

No. It is not futile.

Not when we are trying to establish who was responsible for them.

It is central to this issue.

Mr. Tony O'Brien

This is not the place where the Deputies will find out who was responsible. The Government has established a scoping review, to which this issue is central. We will find out very quickly through that review which will look at a wide range of issues.

I do not think that it is acceptable and will explain why. Mr. O'Brien has come to the committee weeks after the scandal frightened the women of Ireland and days after a number of the women affected have asked him to stand down from his position. From today, we know that Mr. O'Brien believes a number of individuals made mistakes, but he is not prepared to say who they are. Even when it is pointed out to him who one of the individuals is, he is still not prepared to accept it, nor is he prepared to accept that a circular sent by the HSE, I imagine on HSE-headed paper, bearing the brand of the HSE, was sent by the organisation, not by individuals as individuals. He is still sitting here not able to answer straight questions or to accept any accountability - whatever about responsibility, Mr. O'Brien is accountable - and not even prepared to accept that the issuing of the circular and the instructions given represented a systemic failure.

I may never have another chance to see Mr. O'Brien before the Committee of Public Accounts or in any forum. I do not believe, given all his years of public service, all the years he has worked in the HSE, he does not understand it is a systemic failure. Frankly, I do not believe he does not believe it was a systemic failure.

Returning to the 2016 memo, when Mr. O'Brien looked at it, it was within the range that would not have caused him particular concerns? The communications strategy was to communicate with people who would be told that there had been a false negative in the past. There was a catastrophic piece of communications work to be done. Two separate things are happening in this case. One is looking at the overall system and the level of error, while the communications strategy was only about communicating with people who would be told something very significant. We know that one person, Vicky Phelan, went through the courts system - I understand there were more - and was not subject to a confidentiality agreement. Where is the process between the HSE and the States Claims Agency in that regard? I do not see it. It is as if there are two parallel universes. The fact that Vicky Phelan did not sign a confidentiality agreement has led to the issue being brought into the public arena. How will Mr. O'Brien deal with the fact that he only learned from the news headlines that something as significant as this case was going through the courts?

Mr. Tony O'Brien

To reiterate, no party acting for the State sought a confidentiality agreement. That was said, but I want to be clear in the context of the Deputy's question. It is also evident that the case proceeded quickly and that the judge commended all parties involved for their humanity. Notwithstanding that, clearly there are lessons to be learned from the way the HSE participated in the process because matters that were in the public domain as a result of the legal process of discovery, had they been analysed more effectively in terms of the issues drawn from them within the HSE, they could have provided an additional route by which alarm bells would have rung and might have been escalated to me. I have initiated a case review of the way in which the particular case was handled from beginning to end in order that we can improve the process. I will ask the HSE's internal audit division to map out all of the steps and opportunities a different process might create for a speedier escalation and identification of issues at an earlier stage.

Is that when a case is initiated?

Mr. Tony O'Brien

There are a number of steps here, a number of stages, but clearly a lot of the information that is now in the public domain came from different parts of the HSE. They were joined together by a discovery process. The joining together of those pieces of information ought to have flagged the nature of the concerns that are now in the public domain. That process did not do that. It did not happen and I am intent on finding out how we can close that off. While the ideal situation, of course, is that things do should not have to go to court, but at least when they do, the information is being assembled for that purpose ought to be interrogated to find out what are the wider issues that could be identified, and that is a process that we are engaged in.

How many cases are there? What is the update on the number of cases that have been taken?

Mr. Tony O'Brien

As of last Wednesday, the State Claims Agency advised us that there were ten active cases and one potential case. The State Claims Agency-----

It will follow that up later. That is 11 in total, to Mr. O'Brien knowledge.

Mr. Tony O'Brien

That is the information provided by the State Claims Agency.

Is Mr. O'Brien aware of who is being sued in those cases? Are all of the laboratories being sued, or just one laboratory along with the Health Service Executive? Can Mr. O'Brien confirm that for me at this point?

Mr. Tony O'Brien

I would leave that to the State Claims Agency.

I am asking what Mr. O'Brien is aware of as head of the Health Service Executive.

Mr. Tony O'Brien

I am not aware to a sufficient level to provide the Deputy with any meaningful answer.

In relation to the 48 cases of women who were initially notified, what criteria were used for notifying those women, as opposed to the rest of the women out of the 209?

Mr. Tony O'Brien

I do not believe there were different criteria. I think it was down to individual practice by individual clinicians.

It was ad hoc and haphazard?

Mr. Tony O'Brien

There must have been some criteria, but they were not-----

No, I am asking Mr. O'Brien.

Mr. Tony O'Brien

I cannot answer that.

Mr. O'Brien cannot answer me, as head of the Health Service Executive, as to what criteria were used to notify those 48 women.

Mr. Tony O'Brien

No, I cannot and the reason I cannot is that this was done in the context of clinical interaction between clinicians and their patients, and I am not in that space.

Mr. O'Brien is in this space as head of an organisation, responsible for holding everything to account. If Vicky Phelan had not come forward, what would have happened within the system of which Mr. O'Brien is the head? What changes would have occurred, if any, if she had not come forward and this had not come to light?

Mr. Tony O'Brien

I cannot answer that question.

I am asking Mr. O'Brien to answer that question as head of the Health Service Executive.

Mr. Tony O'Brien

I cannot. It is such a hypothetical question that anything I could give the Deputy would be pure speculation.

No, it is not hypothetical. I have read the whole annual account. I have looked at it. There are systems in place. How was someone not alerted at some level in all of these? There is a risk assessment committee, there is a directorate that Mr. O'Brien reports to, and Mr. O'Brien also reports to the Minister. In answer to a previous question I asked him, Mr. O'Brien said he was informed early in 2016 in a memo he was given, and he was going to give the committee a copy of that.

Mr. Tony O'Brien

Yes.

How did it not go further at that point? I think the word is "escalate". How was it not recognised at that point, given all of these systems?

Mr. Tony O'Brien

The issue is that subsequent to that, the process that was to have communicated with the individual women did not function. That malfunction, failure to deliver or failure to complete was never escalated to me.

It was escalated to Mr. O'Brien in early 2016.

Mr. Tony O'Brien

There was nothing to escalate. This had not happened then.

Sorry. Mr. O'Brien was made aware in early 2016 that results of an audit confirmed that previous smear tests given a negative result were positive. Mr. O'Brien was aware of that.

Mr. Tony O'Brien

Yes, of course. I have said that.

Mr. O'Brien did say that. He said that he was not aware of the significance of it. What-----

Mr. Tony O'Brien

No, I have not said that at all.

The significance of the numbers.

Mr. Tony O'Brien

No, I have not said that.

I beg the witness's pardon. Correct me, please.

Mr. Tony O'Brien

What I have said is that had the process of communication that was laid out in that memo been followed through, had it been brought to conclusion, then we would never have got to a position where there were women who did not know the outcome of their audits. That is actually what I said.

I do not know what is true. What I am asking the witness is this. He was made aware in a memo. With how many women was he made aware that there was a problem?

Mr. Tony O'Brien

I am going to share the memo with the committee.

No, I am asking Mr. O'Brien now. He has re-read it lately.

Mr. Tony O'Brien

The Chair has already accepted that the appropriate course of action is for me to provide the committee with the memo. I am not going to begin the process of partially telling the Deputy what I remember from a memo that is not in front of me. That would be wrong.

Let me say that I find this unacceptable. I prefaced my remarks by saying I do not think it is the role of this committee to call for heads. That is not part of my role. It is my role to ask Mr. O'Brien a question, and I asked him earlier when he was made aware. I read in the newspaper that he was made aware by the media. It looks like he was made aware in-----

Mr. Tony O'Brien

No.

Please let me finish.

Mr. Tony O'Brien

No, I have to stop the Deputy, because she is conflating two different things.

I am talking about what I have read in the media.

Mr. Tony O'Brien

Yes.

Mr. O'Brien can correct me in a minute . Today he has told me he was made aware early in 2016 of issues that arose from the audit.

Mr. Tony O'Brien

No. I was not made aware of issues that arose from the audit. Let me be very clear, if I can, so that there is not a subsequent misunderstanding about what I am saying. First of all, I had no knowledge of the case initiated by Vicky Phelan or the failure to communicate-----

Mr. O'Brien, listen to me-----

Mr. Tony O'Brien

The Deputy has to let me answer.

I will, but I want to clarify something. I have only a limited time. That is not what I asked. I asked what Mr. O'Brien was made aware of in the memo. Earlier, he said it was not significant. I am asking Mr. O'Brien what he was made aware of. He responded to me by saying that he did not have the memo in front of him. He should have the memo, and he read it recently. He said he re-read it recently.

Mr. Tony O'Brien

I did.

Good. So what was in the memo? What was communicated to him?

Mr. Tony O'Brien

The Chair agreed on a simple process. I will give the committee a copy of the memo. Deputy Connolly can read the memo. I do not have the memo in front of me. I am not going to begin paraphrasing, and possibly getting what is in the memo wrong. I have been down this road with the Committee of Public Accounts before - where I have attempted to give it information and it has been partially wrong. I told the committee before, with respect, that I am not going to do that again.

Will Mr. O'Brien give an answer to the question as outlined?

Mr. Tony O'Brien

Yes. Let me be clear. I was made aware by a memo, which I will provide to the committee, of the fact that an audit had been concluded, and that there was a plan in place to communicate the results of that audit. The memo itself provided reassurance to me that there was an effective plan in place. I was never subsequently informed that anything had gone wrong in the process of communication. The first I knew that this was the case was when I heard media reports relating to the Vicky Phelan case.

I just want to finish on that. My question was in relation to accountability and what Mr. O'Brien was made aware of. He is repeating and repeating. The question is, as director general of the Health Service Executive, what alarm bells rang for Mr. O'Brien at that point, if any, and what did he do? I have got repetition in response. I have run out of time.

Mr. Tony O'Brien

I will answer that, if I may, because I answered it before. There was nothing in the memo that rang alarm bells.

I have to go to the Chamber so I will ask Deputy MacSharry to take the Chair. There will be three short slots of two or three minutes each for Deputies O'Brien, O'Connell and Aylward. I would appreciate it if the witnesses stayed for them. That will be a short segment. Once Mr. O'Brien and Mr. McCallion are gone, we will begin our normal process of questioning for 20 minutes or 15 minutes.

The same sequence again.

The same sequence. As Deputy MacSharry is one of the questioners, I would ask one of my colleagues to take the chair while he is asking his questions. Maybe Deputy Cullinane or Deputy Murphy would do so.

Deputy Marc MacSharry took the Chair.

I know Mr. O'Brien needs to get away to Limerick, so I will be very brief. He said that the central issue, apart from the trauma for the women involved, was the failure to follow through on the planned communication to inform the women. He said that if the process had been carried through, there would be no women who were not informed. Is that is correct?

Mr. Tony O'Brien

That is right, yes.

We now know that that process did not happen.

Mr. Tony O'Brien

Correct.

We will come back to this again. In my opinion, that is a systemic failure. In Mr. O'Brien's opinion, it is a systems failure. Is that correct?

Mr. Tony O'Brien

I think we have established that our opinions-----

No, I am asking if that is correct. In Mr. O'Brien's opinion, it is a systems failure, but in my opinion it is a systemic failure. Is that accurate?

Mr. Tony O'Brien

I can only answer for my opinion, not the Deputy's.

Then tell me your opinion.

Mr. Tony O'Brien

The Deputy has just confirmed to me that my opinion is that it was a system failure.

I am asking Mr. O'Brien whether it was a systems failure, yes or no?

Mr. Tony O'Brien

Yes.

But Mr. O'Brien is not responsible for that.

Mr. Tony O'Brien

I think we answered this question.

Is Mr. O'Brien responsible for systems failures within the HSE, yes or no?

Mr. Tony O'Brien

If I were aware of it and had failed to act on it-----

That is not what I am asking Mr. O'Brien. I am asking if he is responsible for systems failure within the HSE?

Mr. Tony O'Brien

The Deputy has asked me this question many times. I do not think there is any value in me continuing to answer it.

Mr. O'Brien has not yet answered the question of whether he is responsible for systems failures within the HSE. It is a "yes" or "no" answer.

Mr. Tony O'Brien

I take partial responsibility, as I said last week before the health committee. I cannot be personally responsible for the actions of others of which I am not made aware.

Is Mr. O'Brien accountable for systems failures within the HSE?

Mr. Tony O'Brien

Yes, indeed.

As the person who is accountable for systems failures within the HSE, does he not think it is appropriate that he takes responsibility for them?

Mr. Tony O'Brien

The Deputy is just going round in circles.

That is because Mr. O'Brien will not answer the question, which is very simple. Is he responsible for systems failures as director general of the HSE, yes or no?

Mr. Tony O'Brien

I had no responsibility for this system failure. Had it been escalated to me I would have been able to intervene.

It is Mr. O'Brien who is going round in circles now. I am asking him a simple question. Is he responsible for systems failure? Is he the person who is to be held to account for systems failures as director general of the HSE?

Mr. Tony O'Brien

Accountability, yes.

Mr. O'Brien is the person who is to be held to account for those systems failures.

Mr. Tony O'Brien

Yes, and I have to answer the Deputy's question on the subject. I did this earlier and I gave him my analysis of what happened, notwithstanding the fact that there is a further process to undergo.

Do we know how many of the 209 women have terminal cancer?

Mr. Damien McCallion

No. There are 201 women who have been contacted and there are four people whose appointments have been scheduled in the next ten days. One lady is in Russia and we are trying to work through the Russian Embassy to make contact with her. There are three people in respect of whom multiple hospitals were involved and we are trying to close those out. We would need to go back to the consultants for the numbers with terminal cancer as it is a clinical judgment and all these situations are very difficult. We would have to assess whether it would be an appropriate course of action to go back but perhaps we can reflect on it. Each of the consultants has met the women and their families, some on a number of occasions. It is a medical judgment but we can certainly look at that, if that is what is required.

Mr. O'Brien referred to the memo as "reassuring" and said the figure of 209, out of 1,400 plus, would not alert. What is that based on? Is it based on clinical knowledge? Without knowing what the actual rate should be, how can he read a memo in his position and make that assumption?

In the data reconciliation process, the two-way data does not seem to have been transferred from the National Cancer Registry, in this case to the CervicalCheck people. It seems that when the audit process started, for the first two years the audit data were used for education and training purposes and they were only used for patient purposes subsequently. There is a definite swing to a focus on academia, education and data, rather than the patient. We spoke last week on this. There is an issue when one does not have clinicians in positions of management. If a clinician was in charge, I firmly believe patients' needs would have been to the fore.

Mr. O'Brien talked about there not being a joined-up process when the systems kicked in. That is a very serious admission to make because it says that the process did not work when it kicked off. If Mr. O'Brien is admitting that the HSE cannot even communicate in a joined-up way to serve a population the equivalent to that of Manchester, he is admitting that it is not fit for purpose. Mr. O'Brien also spoke about the corporate knowledge of the team. I agree that just firing everybody who was in charge would get us nowhere but the way the corporate management team did its business does not seem to be the gold standard. I am not sure how much value its corporate knowledge is; can Mr. O'Brien elaborate on this?

It is extremely strange that it is not as simple as putting a reference number into a sheet and pulling up a memo or a circular. If the memo is not to hand, it appears as though no one can get it for Mr. O'Brien. As for Mr. Breslin not knowing whether he got the memo, how does the Department get memos? Where does it put them? Does it put them in a box in a corner? What way is it to run a business when it is not known how to find a memo or who definitively crafted a circular? Surely, if someone writes a circular there is a reference number showing who did it. I cannot understand this.

One reason for not having a statutory inquiry immediately was to avoid a pause in delving into things but Mr. O'Brien told me on a couple of occasions that a matter was for the scoping inquiry. That, however, is exactly what this committee, as well as members of Opposition parties who met the Minister, did not want. We did not want the answer to be that you could not talk about it because there was going to be a scoping inquiry or a statutory inquiry.

I ask Mr. O'Brien to say how he deemed himself qualified to read a memo and make an assessment that it was reassuring and did not raise alarm bells.

Mr. Tony O'Brien

The memo was the product of work that was done in the CervicalCheck programme, which has an external quality assurance, QA, committee, with significant international representation. I have to base my judgments on the advice given to me and the issues that are raised. It is not that I deem myself qualified to make these judgments.

Did you get advice on the memo or did you just read it and decide? The impression you gave was of reading it and thinking "This is grand".

Mr. Tony O'Brien

I was brought through the issues and I then asked to read the memo. The memo is self-explanatory.

It does not really answer my question. Did Mr. O'Brien sit down with statisticians and quality assurance people and did they tell him there was nothing to worry about?

Mr. Tony O'Brien

The memo is the product of that process. If I were to go through a full-blown investigation into every memo I receive, given the scale and complexity of the organisation I would do nothing but that. The memos sent to me are to advise me of the outcome of processes that involve all the types of people to whom the Deputy referred. A range of people report to me and they will flag something to me if there are concerns. This was a reassuring memo.

Was it reassuring in your view or that of the people who advised you?

Mr. Tony O'Brien

Both.

I do not accept Mr. O'Brien's opinion that his appointment to a board while still a senior public servant, as director general of the HSE-----

Mr. Tony O'Brien

I was not asked about that, with respect.

I am asking you now. I cannot believe that the Minister for Health, Deputy Harris, or the Government sanctioned it. As head of the HSE, Mr. O'Brien has an onerous job. If he retired, which he will shortly, I would see no conflict but he has a job of great consequence in this country yet he has been allowed to take a directorship of a board in America. I understand he will have to go there once a month.

Mr. Tony O'Brien

I will be happy to tell the Deputy about it.

Let me finish first. That is acceptable to Mr. O'Brien and to the system here in Ireland. That is not good. I do not believe it is good practice that a senior public servant such as Mr. O'Brien, given the responsibility he has, should be allowed to sit on another board in a foreign country. It should not have been allowed. As I said, if he is retired there is no problem, but I cannot believe the Government sanctioned it while he is still active.

Mr. Tony O'Brien

To be clear, I have not been to the United States at all in connection with this process. Despite some very strange media reports the actual time commitment is in the range of one to two hours per month in this phase, although currently I am taking a leave of absence from that.

I am aware of that, but the witness is taking the leave of absence because of the circumstances. He had not intended to take the leave of absence until the storm he is dealing with now blew up.

Mr. Tony O'Brien

That is correct. My intention was to be on leave this week and to be in that country. As it happens, I have never been to that location, and it will wait for another day. I followed a procedure set out in my contract of employment. I applied appropriately and I was given consent appropriately. The organisation in question has no products on the market. There is absolutely no conflict of interest, and the amount of time absorbed in a non-executive director role at this stage in the life of that process is minimal. For the Deputy's information, I spend far more time leaving my house in the late hours of the night to respond to 999 calls than I ever did with regard to that company at this stage. There has absolutely been no impediment to my functioning as director general. Some of this wild reporting that I spend five hours per week on it is complete nonsense. Like so much in the media today, it is just made up.

Does the witness think it should be normal for this to happen in the future and for other directors general in this country to go onto a board? Does he think it would be normal and good practice?

Mr. Tony O'Brien

I have no idea whether it will be normal or not. Each judgment is made on a case-by-case basis. The standard contract of employment for chief executives of State agencies such as this provides for a process where one can apply for the consent of the Minister if there is a remuneration involved. I have two consents from two different Ministers. One relates to a pro bono teaching commitment I have to a health sector-related higher level course in a third level institution in this country in respect of which I give approximately 15 hours per year and for which there is no remuneration. The second relates to this issue, of which the Deputy is aware. I followed absolutely the correct procedure in this regard.

I understand the cervical screening programme was originally rolled out in 2008. Was the witness part of setting up the original screening programme?

Mr. Tony O'Brien

Yes, I was. In 2007, having previously been director of BreastCheck, I became the first chief executive of the National Cancer Screening Service board. That board was created to continue with BreastCheck, to seek to roll out what had been a fledgling, regionally-based Irish cervical cancer screening programme from about 1996, which had not rolled out at that point, and to begin the investigative process around the development of BowelScreen. At the time I was very pleased to be given that opportunity because as early as 1993, when I was chief executive of the Irish Family Planning Association, I had participated in a lobbying exercise to seek to win Government policy. I hope I played some small part in the development of the pilot programme in Limerick. That programme in Limerick, 12 years on, had not achieved all that it could. We were having as many smear tests taken in this country without a cervical programme, probably more than we do now with an organised programme, and it had made absolutely no difference to the incidence of cervical cancer. Women were waiting up to a year in some instances for results. One could not roll out a screening programme on that basis. Some of those tests were being done on kitchen tables at home on overtime in non-quality assured circumstances.

The priority was to ensure that this country got a cervical screening programme to minimise the incidence of, and reduce deaths from, cervical cancer. This programme has brought down the incidence by 7% per year. There have been 50,000 high grade detections of cervical intraepithelial neoplasia, CIN, which is a pre-cancerous abnormality of the cervix, and I am absolutely certain that one of the best day's work I ever did was to ensure that this county had a national cervical screening programme that is currently called CervicalCheck. I know that it has saved many lives, and I am very pleased it has. I thank the Deputy for the opportunity to say that today.

That is all very honourable, and fair play to Mr. O'Brien. I accept that. I have a question about outsourcing the contract to America. This is the last question and it is the same subject. Why was this laboratory in America picked when outsourcing the contract? I am told there are other laboratories in Ireland that were capable of doing this.

I ask the Deputy to be quick.

Why did we not go to Great Britain, Germany or France? Why did it go so far away to America? Some of the misdiagnosis results are mostly from this American laboratory.

Mr. Tony O'Brien

I would slow down with that if I was the Deputy.

It is not an accusation. It is what I read in the newspapers.

Mr. Tony O'Brien

I would wait for the scoping review for some hard information on that, to be fair. An open competitive tendering process was carried out in 2008, which followed quite a significant public debate, including a debate in the Houses. There was a debate on this in the Dáil at the time. Some of the members of the committee might have been there; I am not sure. The process was carried out in accordance with European standard procurement. The requirements were that the laboratories had to be accredited to the relevant ISO standard - I cannot remember the exact number of it now but it was ISO 15 something or other - and that they had to have a volume of 25,000 tests per annum.

We do not have the time to get into the detail of the entire tender process.

Can I make a small point?

It was outrageously disingenuous of Mr. O'Brien to make such sweeping comments about the media. It is an outrageous comment given that his organisation has not been very quick to give good journalists information when they have sought it. It is not very good about giving information to the public. To make sweeping generalisations about the work of the media speaks volumes about Mr. O'Brien as an individual.

Mr. Tony O'Brien

The Deputy is not too shy about making sweeping generalisations himself.

The Punch and Judy can stop. Thank you for your time this morning. Can I ask for a clarification for the second session? Who is your deputy to whom we can pose questions and who can answer authoritatively on behalf of the organisation?

Mr. Tony O'Brien

I am not leaving a deputy. We were originally asked to provide people who could speak on the relationship with the State Claims Agency and the general broad issue of open disclosure. There are two people here who can do that, but I am not leaving a deputy. I was not asked to leave a deputy.

So nobody can speak on your behalf or on behalf of the entire organisation.

Mr. Tony O'Brien

No.

Thank you for your time today. I hope you will reflect throughout the day on the contributions that were made. They were not personal but at the same time were very valid. I also thank Mr. McCallion. We will suspend the meeting for a convenience break.

Sitting suspended at 11.50 a.m. and resumed at noon.
Deputy David Cullinane took the Chair.

I have temporarily taken the Chair to allow Deputy MacSharry to ask questions. I remind members that we are joined by the Comptroller and Auditor General and Ms Ruth Foley from his office. There are three organisations before us, including the Department of Health, represented by Mr. Jim Breslin, Secretary General and Accounting Officer, Mr. Tony Holohan, chief medical officer and Ms Mary Jackson, principal officer. While Mr. Tony O'Brien and Mr. McCallion have left, we still have representatives from the HSE, namely, Dr. Philip Crowley, national director, quality improvement division, Mr. Liam Woods, national director, acute hospital services, and Ms Maura Lennon, head of legal services. From the State Claims Agency, we have Mr. Ciarán Breen, director, Mr. Cathal O'Keeffe, head of clinical risk, and Ms Ann Duffy, senior clinical risk manager. As there are three groups of witnesses, it would be helpful if members would name the organisation to which they are directing the questions they ask. Deputy MacSharry has 20 minutes.

Of the people who remain from the HSE, is there anyone qualified to talk about service level agreements?

Mr. Liam Woods

I can address that in some areas.

Are signed service level agreements in place with the laboratories in America?

Mr. Liam Woods

I apologise. I thought the Deputy meant service level agreements with voluntary bodies which we fund under sections 38 and 39, not contracts. I am not familiar with the contracts to which the Deputy refers.

Would there be service level agreements with those laboratories?

Mr. Liam Woods

I am not sure. I cannot comment. I imagine there is a contract under a tender, but I am not familiar with it.

Can anyone present shed further light on that?

Mr. Seamus McCarthy

An observation I would make is that I would expect a service level agreement to be between public bodies. In this context with a private company, all of the terms of the service to be provided, costs and so on should be contained in the contract governing it.

Including reporting and communication and so on.

Mr. Seamus McCarthy

Any provision that was a condition of the contract should be specified.

I note at this point that even though the director general is no longer here, the next person in charge should be here. It is unacceptable that questions may be put which will not be answered because people still here are not in senior positions or are not responsible. The HSE is responsible for that, that is, in not ensuring that people who can answer questions are here. While the director general has left, there are people apart from him who can answer questions but who are not here. That should be noted.

Is anyone here familiar with the contract with the laboratories?

Mr. Ciarán Breen

I might be able to help.

I have a list of questions for Mr. Breen on that matter, but I am asking if there is anyone from the HSE who is familiar with the contract.

Does Mr. Breen want to say something?

I have specific questions for Mr. Breen on the same issue. I attended the finance committee as a guest and had the benefit of questioning Mr. Breen on this. I asked at that meeting, albeit it was unorthodox, that he would familiarise himself with the service level agreement which I assumed was in place, but I appreciate people are saying it might be a contract. Did Mr. Breen have an opportunity to examine that in the meantime?

Mr. Ciarán Breen

Yes. We contacted CervicalCheck and established that there is no service level agreement, as the Comptroller and Auditor General has said. It is a contract which sets out a whole series of things to include the indemnity clauses, which were the purpose of our particular detail.

I appreciate that this is not Mr. Breen's end of the spectrum, but did the contract detail, as a service level agreement under section 38 or 39 would, a specific contact person in the HSE, CervicalCheck or whichever body the first party to the contract was?

Mr. Ciarán Breen

I did not read it in that detail. I looked at it for all of the various clauses setting out, for example, who the contract was between, the duration of the contract and the ordinary terms of the contract in relation to the duties and obligations on the parties arising from it to include insurance, indemnities and so on.

Is there anybody here from the HSE with authority over CervicalCheck? I ask those senior personnel who remain from the HSE make contact with CervicalCheck and ask that the contract be made available to the Committee of Public Accounts, if necessary on a confidential basis, but ideally on a public basis, so that we can examine a number of issues related to value for money, reporting, communication and so on which may or may not have been reflected in it.

I asked Mr. Breen specifically at the finance committee the other day if there were any terms in the contract that would give recourse to the State for what are unknown but likely to be very substantial costs relating to this crisis, including the cost of investigations, scoping, a commission of investigation, redress and so on. Is there anything in the contract which provides recourse for the Irish State in that regard?

Mr. Ciarán Breen

I could not in my perusal of it find anything of that length beyond the ordinary indemnity which would extend in respect of the services the contractor was providing to CervicalCheck. It would be the normal ones in relation to those particular services and, for example, any legal proceedings that might arise, or claim in respect of a failure of those services which are more generally described within the contract. Beyond that, I could not find anything necessarily which would give recourse. I should caution that I had only very limited time to examine the contract.

It would be indemnity in terms of the individual patient but not to the State in the way I have outlined. Is that Mr. Breen's reading of it so far?

Mr. Ciarán Breen

That is certainly my reading of it so far.

In the absence of that, in his legal opinion in his role in the State Claims Agency, does Mr. Breen consider that we have any recourse regardless of whether it was mentioned to recover the costs of this crisis from this laboratory or these laboratories?

Mr. Ciarán Breen

I simply could not answer that at this stage, unfortunately. I was looking at it entirely from what was recoverable by the State in terms of the indemnity clauses and the insurance available but I would have to look more broadly at the issue before I could answer that.

Could the witness give us a note on that?

Mr. Ciarán Breen

We certainly could look at it but I would have thought that it would be the kind of legal opinion that HSE might get, for example, in regard to whether there is any recourse.

Given that we are all on the one team, perhaps we could conspire together to come up with a view on whether there is recourse, whether it is the HSE, the State Claims Agency, CervicalCheck, all of the above or whoever. If the witness could give us a note on it between now and the next meeting, that would be fantastic.

At the meeting the other day, we were talking about the Legal Services Regulation Act 2015 and we also discussed the Civil Liability (Amendment) Act 2017. It is clear from recent days that parts of those Acts have not been commenced, which has affected the State Claims Agency's ability to do its work as Mr. Breen expressed at the meeting of the finance committee the other day. I will quote Mr. Breen. He said:

I personally sat on the medical negligence working group in 2010. We advocated PPOs, periodic payment orders, legislation. We advocated pre-action protocol. If we had the pre-action protocol tomorrow, I know that myself and my colleague [Jenny, who was with Mr. Breen at the time] would say it would transform the behaviour and way we would handle these cases. It has been in the UK for a very long time and what it does is it stops the adversarial element. People do not have to issue proceedings, simply a letter of claim. We then issue a letter in response to that and the idea is that you narrow down the issues to the issues that are real between you and that you mediate them.

I can tell the Chairman that I have advocated this position for a very long time. Despite the fact the Legal Services Regulation Act has brought that into place, subject to the making of the regulations, we do not have it even now. It would be of considerable assistance to us if we had it tomorrow. We still do not have it because that section of the Act has not been commenced or implemented. Is that correct?

Mr. Ciarán Breen

It is actually the regulations that have not been made. Once the regulations are made, it will give force to the bringing in of the pre-action protocol.

Section 219 in Part 15 of that Act specifies that the Minister should provide those regulations. Is that correct?

Mr. Ciarán Breen

That is the Minister for Justice and Equality, yes.

It also says that the Minister for Justice and Equality could liaise with the State Claims Agency in drawing up those regulations. Is that correct?

Mr. Ciarán Breen

Yes.

Has the Minister engaged with the State Claims Agency on that?

Mr. Ciarán Breen

Yes. We provided advice to the Minister's Department in respect of the protocols.

Mr. Ciarán Breen

That would have been a number of months ago.

What happened since?

Mr. Ciarán Breen

We are waiting for the regulations to be made.

From the perspective of the agency, nothing has happened.

Mr. Ciarán Breen

We do not have a pre-action protocol.

In terms of the periodic payment orders which are provided for in the Civil Liability (Amendment) Bill, is the situation the same?

Mr. Ciarán Breen

Yes. The Civil Liability (Amendment) Act gives power to have compensation paid by way of period payment orders rather than lump sums in catastrophic injury cases. The Act has not actually been commenced.

Would there be communications from the State Claims Agency to the relevant Government Department and Minister that it requires more haste with this, that the delay is affecting outcomes, costs and processes?

Mr. Ciarán Breen

We in the State Claims Agency are on record that it is a considerable frustration to us that we do not have the periodic payment order legislation. At the moment, we are obliged simply to get an order of the court made for an interim payment for a defined period with a returnable date to court for the renewal of that order for another period. In a PPO legislative environment, we would simply have the making of a periodic payment order and, each year thereafter on an annual basis on a defined date, we would send the relevant cheque to the injured party's carers and family who would then have the exact amount for the care and aids and appliances for that year.

None of that is happening now. Is that correct?

Mr. Ciarán Breen

That is correct.

Has the agency sent any direct communications to the Secretary General of the Department or the Minister asking about the hold-up and stating that it really needs this?

Mr. Ciarán Breen

From time to time, we have made contact with the Department and we have been told that considerable work is under way on it, particularly, as I understand it, in respect of the appropriate index to be used.

That is in terms of the interest rate that would apply to periodic payment orders. Is that right?

Mr. Ciarán Breen

Correct.

On pre-action protocols, could I ask that Mr. Breen do a quick trawl of his communications with the Secretary General or the Minister directly and provide to the committee any correspondence since the passage of the relevant Acts expressing his view that this was a matter of urgency? Can he say authoritatively that in their absence, it has cost the State more money and has in effect caused more distress to claimants?

Mr. Ciarán Breen

There is no doubt that the fact that we require a return to court on a defined date on the expiry of the interim payment order, which is made for a defined period, involves costs for us and for the plaintiff. We are paying both sets of costs and certainly that is an additional cost that would not exist if we had the statutory scheme.

Has Mr. Breen a view on what is holding this up?

Mr. Ciarán Breen

I do not. I am not sure. The Department of Justice and Equality is dealing with it. I understand there has been some work at that end in respect of indexation in particular.

I wish to ask Mr. Holohan if he has any view as to why these things are being held up.

Mr. Jim Breslin

Maybe I could respond. The provision in respect of periodic payment orders, in which we also have an interest, was on foot of the 2017 Act and I am told that it will be finalised in the coming weeks.

Okay. What about the previous issue?

Mr. Jim Breslin

The pre-action protocol has been more complex and has taken longer to do. There has been a great deal of consultation, including with the State Claims Agency and others. I am told that will be finalised before the summer recess.

Mr. Jim Breslin

Other people who would have an expertise or interest in this.

Mr. Jim Breslin

The Courts Service, I presume.

Okay. Anyone else?

Mr. Jim Breslin

I do not know the detail around the consultations but I was told that part of the process has been significant consultations undertaken.

Has Mr. Breslin any view on what has frustrated the process in terms of timing?

Mr. Jim Breslin

I am passing on information rather than having my own view on it. As I understand it, the Legal Services Regulation Act is quite high level. It is an enabling clause and there is quite a deal of complexity to set out the actual rules around pre-action protocols. Some Acts are very clearly set out and the regulation is to commence them. In this case, a lot of work has to be done post the Act to set out the detail of how it will operate.

Two and a half years' worth of work?

Mr. Jim Breslin

That is the information I have been given.

I would suggest that it is unacceptable that nothing has happened, given that it was celebrated as being a game changer by the then Minister for Justice and Equality. In the current crisis, I cannot let the timing of the promise to have it in the next number of weeks pass. It is very unfortunate. We have no doubt based our legislation on a similar 2008 Act in the UK. They have a very clear system. We often take a lead or guidance from what is working in other jurisdictions. That should be done as a matter of urgency.

It is costing the State more money, but much more than that, its absence has led to the incredible distress caused to patients affected by the crisis.

My next question is for Mr. Breen. Of the 98% of claims settled - he had a flyer that he gave to us today and at our last meeting - how many are settled without an admission of liability?

Mr. Ciarán Breen

It is difficult to give a very precise statistic for the number settled without-----

To the nearest 10%.

Mr. Ciarán Breen

In the cases we settle there are two issues that arise. There is a breach of duty which we concede on a lot of occasions, as well as a breach of causation. I do not mean to be over technical, but the breach of duty may not, in fact, have caused the damage. That might be a point of real issue between medical experts in cases. Without an admission of liability is, in fact, only one component of cases in terms of there being a double breach. I am guessing that it would probably be somewhere in the order of between 30% and 50% of cases in which there would be no admission of liability.

Where there is no admission-----

May I ask just one question?

There is a breach of duty and a breach of causation. Will Mr. Breen, please, define them?

Mr. Ciarán Breen

Let me give an example. A doctor may not have properly sought the consent of a patient; that is a breach of duty, but with regard to the injury that actually occurred, a court could find the patient would have had the surgery in any event and that the complication - a known complication - might have occurred even if the doctor had obtained the consent of the patient. We had such a case a number of years ago which went the whole way to the Supreme Court which found exactly that point, that although there had been a breach of duty, it had not led to the actual damage caused - natural damage that had occurred as a result of the procedure. It is a legal concept which is based almost entirely on medical expert evidence.

The Deputy's time is up, but I will allow him five more minutes.

I thank the Acting Chairman. There are only three of us here at the moment.

When there is a settlement without an admission of liability, does the State Claims Agency impress on the HSE the need for monitoring, retraining or supervision of the persons involved in the incident?

Mr. Ciarán Breen

We have a clinical risk unit in the State Claims Agency which, for example, looks at adverse incident notifications from hospitals and carries out analysis of closed claims. It feeds back into the system the lessons learned from particular trends and clusters or behavioural issues that are emerging. It is a constant process between us and the HSE and has been quite effective over a period of time.

Is that a "Yes" or a "No"?

Mr. Ciarán Breen

In what way does the Deputy mean? Yes, we feed back-----

Yes, it feeds back. Does it insist on retraining, monitoring or supervision of persons involved in an incident that costs the State money?

Mr. Ciarán Breen

No, we do not.

Mr. Ciarán Breen

We in the State Claims Agency do not.

Frankly, it is scandalous that the State Claims Agency does not do so because it has a duty of care to the taxpayer, like any of us. When there is an instance, particularly if there is ambiguity between a breach of duty or the other issues mentioned, it is vitally important that whatever consultant, administrator, doctor, nurse or orderly is involved be monitored in order that there is a cultural awareness that this happened in an institution and need never happen again. I ask the HSE the same question. Who among the witnesses is best placed to answer it? If an incident takes place as a result of which the State pays out without an admission of liability, what retraining, monitoring and supervision take place?

Mr. Breen wants to make a further comment. We will then go to the HSE, to be fair to the witness.

Mr. Ciarán Breen

Our relationship is entirely advisory. We do not have a sanction in the Act for anything to do with clinical risk management and it would never be for us to engage in any retraining. We can only feed back into the system the lessons learned. It would be a matter for the HSE in any individual case or cases to take whatever action is required by way of retraining or upskilling.

That is the problem. That is what we have learned today. We are so far into the crisis and nobody is on a verbal warning or a written warning, subject to suspension or anything else because nobody seems to have any sanction available. Not even the public, it seems, has a sanction. That is the crux of the problem. I ask the witness present from the HSE who is in a position to answer if the State pays out in a case involving medical negligence or a clinical issue without an admission of liability, is there retraining, monitoring or supervision to ensure the person or persons involved do not mess up again?

Mr. Liam Woods

I will take it from a hospital's point of view. Colleagues may wish to add additional comments.

I am sorry, but from whose point of view?

Mr. Liam Woods

From a hospital's point of view. That is where I am working and many of the claims made are in the acute hospital space. There are processes in terms of risk assessment and training. There are many occasions on which evidence of the requirement for training is addressed through recommendations, whether in the context of an incident or a report or as part of the normal process between a clinical director and clinicians or other parties in a hospital. There is a process of learning. There is a piece that is conscious of the point the Deputy is making.

Therefore, is it fair to say there is a process of learning but no sanction.

Mr. Liam Woods

No. I was addressing the piece related to whether there was training. The sanction process in the HSE is the disciplinary procedure which is set out in our HR policy and guidance.

I am sorry; I know that I am taking up the time of others, but I want to tease out this issue. If a physician or a person in whatever role he or she has is associated with a case in which there is no admission of liability, is that person monitored and supervised for a period to ensure everything is correct?

Mr. Liam Woods

To a large extent, it would depend on the individual circumstances, but there are a couple-----

Let us take a case as an example. There was the case of Dr. A which was being pursued. I am sure Mr. Woods is familiar with it as it was all over the media at the time. I think it involved the hospital in Clonmel. I have reason to believe Dr. A may have been involved in other cases previously without an admission of liability. Before he moved from the particular hospital to the one where the issue arose, was there any supervision, monitoring, retraining, sanction or otherwise?

Mr. Liam Woods

I am not familiar with the individual case, but, without going into more detail, from a professional regulation point of view, clearly for HSE and voluntary hospital staff who are clinical doctors and nurses, there is guidance and there are requirements related to regulation. The Medical Council and the nursing board have roles to play.

Will Mr. Woods provide for the Committee of Public Accounts the process followed - I hope there is one - when the State Claims Agency rings the HSE to state it has paid out in a case without an admission of liability. Will he outline the process in order that we can consider it? What would be even more helpful - if he feels the needs to take out the names, so be it - is if he could cite as an example physician A, orderly B or whomever else who was associated with incident X as a result of which the State Claims Agency had paid out without an admission of liability and the way in which that person was retrained, monitored and supervised to ensure we had learned demonstratively from the incident and put procedures in place to ensure the individual was up to speed.

I will have to stop the Deputy.

I thank the Acting Chairman and apologise for taking up so much time.

I will come to Teachta Alan Farrell, even though I am next to speak. He wants to come in as he has somewhere to go.

To follow on, Mr. Woods stated there was a disciplinary procedure in place in the HSE which was overseen by HR. Teachta Marc MacSharry asked what sanction was in place. The sanction is a procedure.

Can Mr. Woods or another HSE official numbers - not names - of how many people were sanctioned as a consequence of disciplinary procedures within the HSE going back over a three or four years to give us an indication of whether people are held to account and sanctioned? If he cannot do that, he might ask the person who can to furnish the committee with that information.

Mr. Liam Woods

I will ask our HR colleagues how has there been such data.

Deputy Marc MacSharry took the Chair.

I have two questions, although Deputy MacSharry did a good job of covering the territory I wanted to examine, specifically in respect of medical negligence cases where a procedure has to be followed, which I was not aware of and which has been in so far as I can ascertain based on my research involving a number of parliamentary questions over the past few years that have not yielded an answer as far as I can determine. The main issue is that there does not appear to be a process within the HSE, or one that Oireachtas Members have been made aware of through the various avenues open to us, including parliamentary questions, to determine whether there is some form of sanction, retraining or at least awareness building in respect of these issues within the medical profession, including for doctors, nurses and care staff. Deputy MacSharry and the Acting Chairman have hit the nail on the head regarding the provision of information. Should the committee consider writing to the Medical Council to seek a direct example of the processes it goes through to deal with medical personnel who are the subject to medical negligence cases and an outline of its role and follow-up activity with them? It might be worthwhile for us to entertain sending such a letter.

My other query is more about the nuts and bolts of whether the SCA has seen an adjustment following the amendment to the book of quantum in recent years, which the former Minister for Business, Enterprise and Innovation, Deputy Mitchell O'Connor, brought the Houses and whether that resulted in marked savings during the most recent budgetary cycle for the State.

Mr. Ciarán Breen

The application of the book of quantum relates more to personal injuries, which are standard personal injuries that result from motor accidents, employer liability accidents and public liability accidents. It is not framed for medical negligence injuries. For example, a fistula created following a surgical repair will not be found in the book of quantum. Its application to medical negligence is limited, if at all.

With regard to Deputy Farrell's proposal, will we invite a member of the Medical Council as part of the grouping to be invited in on either Tuesday or Thursday of next week?

Yes. I will not be present because I will be travelling with a delegation from the committee but the Acting Chairman might take this up on my behalf.

Given that we have asked for Mr. Gleeson and a number of others from the HSE to attend next week, perhaps the head of HR with the executive should be invited as well.

We will add the head of HR and a representative from the Medical Council in that regard.

Mr. Seamus McCarthy

May I ask the committee to note that one of the aspects of the estimated liability which is recorded in the SCA's figures for 2016 is the impact of a Supreme Court decision in respect of estimating the quantity that will be paid in cases in the future and there was quite a significant increase. Between 2015 and 2016, there was a €400 million increase in the amount that was provisioned, €300 million of which was to do with the discount rate that was applied to estimate the payout to be made in individual cases. To a certain extent, it is not exactly the book of quantum issue but it is an expectation because of lower returns on investments that a bigger sum will have to be paid out to ensure that somebody who is expected to live for whatever period is actuarially determined to have sufficient. It is quite a complicated issue but it is one of the reasons the amount that is provisioned or disclosed is increasing.

In his report in 2012, the Comptroller and Auditor General suggested that the SCA cease the practice of allowing a 20% comfort in payments. Why has the agency not done that? Was he wrong?

Mr. Ciarán Breen

No, we would never say that the Comptroller and Auditor General was wrong.

I know that but the agency has still not done as he asked.

Mr. Ciarán Breen

What happened was we sat down with our actuaries who advise us in respect of the general indemnity and clinical indemnity schemes and we looked at what medical defence organisations and insurers do. We felt that the provisioning system we use in estimating the contingent liability is the best system we can use to do that. We also got advices from our actuaries which indicated that our provisioning was good when we looked at outcomes in settled cases. Is the Comptroller and Auditor General happy with that?

Mr. Seamus McCarthy

Yes. At the point we were looking at it, we felt there needed to be a better statistical base for it. We are satisfied with the process that is in place now and that it is properly founded.

Earlier, I put questions to Mr. O'Brien about the memorandum the committee will now be furnished with and he was not in a position to talk about it without having it in front of him? Has the committee received it yet?

My first question is for Mr. Breslin. I asked whether a copy of the memorandum had been sent to the Department. Mr. O'Brien was not sure whether it was sent but he had a sense that there was some communication. Is that a correct interpretation of what he said?

Mr. Jim Breslin

That is my recollection of what he said.

Then I asked Mr. Breslin to what the phrase "some communication" referred and he said the Department was doing a trawl and he was not in a position to say whether something - whatever that is - was sent. Is that correct?

Mr. Jim Breslin

We are in the process of a full trawl, which was extended over recent days to the full period.

In what year was that communication sent?

Mr. Jim Breslin

Mr. O'Brien was referring to 2016 so we will try to zero on that.

I find it incredible that we are weeks into this scandal and we are only going back two years. That is not a massive period to cover in terms of doing a trawl of emails, letters and so on, but the Department and the HSE have different versions of what happened. Mr. Breslin is not a position to tell me whether his Department received any information regarding the memorandum. He is not even in a position to tell me whether he received any information regarding the memorandum Mr. O'Brien had sight of.

Mr. Jim Breslin

In respect of the trawl, we are going back to at least 2008.

The Department does not need to go back to 2008. The specific question relates to the memorandum. It was not around in 2008 and, therefore, I am not interested in what happened in 2008 and what the Department is trawling through. With regard to this memorandum, how in God's name does it take this long to get this type of information? We had this issue with the Department of Justice and Equality when there was a difficulty trawling through and finding emails. What is going on in the public service that we cannot be told whether the HSE gave information to the Department? The HSE director general is saying one thing while Mr. Breslin is telling me that the Department is still trawling through emails and he is still not in a position to confirm whether he received anything. Can he understand how frustrating that is for those of us whose job is to hold him and Mr. O'Brien to account?

Mr. Jim Breslin

But the Deputy is seeking to hold me to account on the entirety of the issue.

Mr. Jim Breslin

I am not talking to the Deputy personally; I am talking about the process. That is absolutely correct. The scoping inquiry pertains to the entirety of the process, commencing with the establishment of the programme and the contracting of the laboratories. I have put in place arrangements to seek to bring together all the records that will need to be used for the various questions that will be asked on this.

It should not take a scoping inquiry for Mr. Breslin, as an Accounting Officer-----

Mr. Jim Breslin

It did not.

-----to be able to confirm to me today whether some form of communication was sent from the HSE because this would have come from the director general's office. He cannot sit there in all seriousness and tell me that is something that cannot be easily established given that this would come from the most senior person in the HSE to the Department. Even today, he is not in a position to answer that question. That means one of two things. Either it is in the system and Mr. Breslin cannot find it, which is his problem, or it was never sent, which is a problem of the director general of the HSE. I do not know which it is, even today, weeks into the discussion on this in the Dáil and outside it.

Mr. Jim Breslin

I believe we are talking about two different things. A range of questions have been put to the Department over different periods. The first question put to the Department, which was the most obvious, was to establish our awareness of the Vicky Phelan case. From then on, we have had a series of other questions, all of them really important. I am absolutely committed to getting to the bottom of everything in regard to them.

This is important. Who is Mr. Breslin's line manager? Who is he accountable to?

Mr. Jim Breslin

I am accountable to the Minister.

The Minister, exactly. Therefore, information that Mr. Breslin gets is information that is then shared with the Minister. Is that correct?

Mr. Jim Breslin

It depends on the information.

In terms of this issue, it certainly would be shared. Is it not the case that it was only 20 minutes before the Minister, Deputy Harris, took to his feet to give a very important speech to the Dáil on this issue that he found out that not all the patients who developed cancer were subject to the audit? It was only at that point that he was made aware of it.

Mr. Jim Breslin

We are talking about different things. If the Deputy is asking me about 2016, the question is one of clinical audit. Actually, clinical audit is a good thing. It is not something one would look at and say, "Good gosh, somebody is doing clinical audit." It is a good thing. What happened last week was that information we had provided that had been sourced from CervicalCheck was inaccurate. It was inaccurate within about five days of being provided to us.

Why was it inaccurate?

Mr. Jim Breslin

The information provided to us first was that all cases were got from-----

I understand that. Why was it inaccurate?

Mr. Jim Breslin

Within about five days, or certainly four or five, we were told that was not where the cases were taken from. They were not taken from the National Cancer Screening Registry; they were taken from other sources.

Who gave that false information?

Mr. Jim Breslin

The CervicalCheck programme.

The CervicalCheck programme, yet the HSE director general said at a meeting of the health committee that it was commonly known within the HSE that that was the case.

Mr. Jim Breslin

I think he said it would have been known within the CervicalCheck programme but he and the serious incident management team were subject to the same inaccurate briefing as us over those days.

It is quite incredible, however, that it was so widely known within CervicalCheck while, it seems, not so widely known within the HSE, and not known to the Department, which is the body that reports to the Minister. At the end of the day, the Minister is accountable to the Dáil and the people. If the Minister is not being given pertinent and important information, that is a problem. Therefore, there was a failure in communication-----

Mr. Jim Breslin

But the parameters of a clinical audit in a particular part of the health service comprise a very defined issue. It is not necessarily a matter with which one would have an issue contemporaneously, although we now have an issue with it. Clinical audit is not pervasive across our health service. It is part of our health service. Some people are subject to clinical audit but many patients, probably the majority, come all the way through the health service and they are not subject to clinical audit. In and of itself, the information being held somewhere would not have been of sufficient import to get to me or a Minister contemporaneously. It became an issue when, within five days of us being told one version, it was immediately retracted and the opposite was told. Unfortunately, within the five-day period, the briefing had gone out. The director general had referred to it. We had briefed the Minister. We had briefed the Government in regard to that. I considered it a serious issue, as did the Minister, and he put it into the House as soon as he learned of it. That was the context for that.

When did Mr. Breslin become aware of the circular that was subject to a lot of discussion this morning? I refer to the one given to consultants giving discretion in regard to whether patients should be told.

Mr. Jim Breslin

I believe I first read that there was an issue of non-disclosure in The Irish Times on the Friday after the case. I do not know if it referred to the circular.

Is it acceptable? Mr. Breslin is actually the Accounting Officer for all health expenditure. The director general of the HSE, I understand, is an accountable officer.

Mr. Jim Breslin

That is correct.

Mr. Breslin is the Accounting Officer. Does he find it acceptable that his reading about this in The Irish Times was the first time he became aware of it?

Mr. Jim Breslin

What I see in hindsight is that when we were given information on the Vicky Phelan case, we were not given sufficient information to understand the wider implications.

Who did not give Mr. Breslin sufficient information?

Mr. Jim Breslin

CervicalCheck.

Only CervicalCheck? Has the HSE a duty to give Mr. Breslin the information?

Mr. Jim Breslin

CervicalCheck is the HSE. I do not draw a distinction.

Exactly. I do not draw a distinction but the director general certainly did this morning.

Mr. Jim Breslin

When I refer to CervicalCheck, I am referring to the part of the HSE.

Let us say it is the corporate body that is the HSE.

Mr. Jim Breslin

The part of the HSE.

It is the HSE. The HSE has a responsibility to give Mr. Breslin information that is pertinent so he may use that information and his judgment to decide whether it should be given to the Minister.

Mr. Jim Breslin

That is right.

Mr. Breslin, as Accounting Officer for all expenditure in the health service, including, I would imagine, HSE expenditure, because the director general is only an accountable officer, read about the matter in The Irish Times.

Mr. Jim Breslin

And all the significance of the non-disclosure, which was not apparent in the briefing on the Vicky Phelan case.

Is that a systemic failure?

Mr. Jim Breslin

It is a serious difficulty in terms of the information that has been exchanged.

Is it a systemic failure?

Mr. Jim Breslin

It is an instance of a failure. There needs to be a pattern for it to be systemic.

There was a pattern. It dates back to 2014, when the audit was first done, and when the circular was issued. At no point was the Department ever informed of any of that. Therefore, there was a pattern. What I am saying is that Mr. Breslin found out only when this became public. He found out not only when it became public but when it was a crisis for the HSE.

Mr. Jim Breslin

That is right.

Exactly. Therefore, it has to be systemic. Like the director general, I am really frustrated with the public service because all of us here are dealing with and watching women in a very distressed state. Reference was made earlier to the poor woman on "Morning Ireland" this morning and to how harrowing her story was. We are here to ask questions on the women's behalf. These women were not given information that they should have been given.

I discussed earlier with Dr. Holohan the difference between a false negative and a misreading of the smear test. He said they are one and the same. I do not accept that. For many of the women, it was a misreading of their smear tests. They were not given the information. There was a strategy put in place not to give it to them. That is what was in the instruction given to consultants. Mr. Breslin was not made aware of it. The Minister was not made aware of it. The director general says he was not made aware of it.

Mr. Jim Breslin

I am equally asking questions on behalf of the public. I am a public servant. Part of my job is to try to establish what has gone on here. I am absolutely committed to doing that. I am not going to be put in a position of excusing things I have a difficulty with. I do not excuse it.

I expect Mr. Breslin, as a public servant, to be in a position to say this was a systemic failure. Everybody outside this place believes it was a systemic failure. It is an open-and-shut case. There is nobody in the real world who believes this was not a systemic failure, except Accounting Officers who are not prepared to use the words. I cannot understand why Mr. Breslin, as an Accounting Officer for the Department of Health, cannot accept that what happened from the beginning to the end was as I describe. He, like the director general, is still not in a position today to give us some information indicating that this was a systemic failure. I refer to women not being informed of a misdiagnosis, false readings or bad readings.

Mr. Jim Breslin

I am very happy to follow this absolutely to where the conclusions take us. I am also happy — very happy — that somebody is going to look at it independently-----

Given what Mr. Breslin now knows, does he believe it was a systemic failure?

Mr. Jim Breslin

-----and categorise what has gone on here. I am absolutely committed to that, and it is the least that everybody in this deserves.

I am going to press Mr. Breslin on this because I believe people watching and the women who are affected deserve an answer. Does Mr. Breslin believe it was a systemic failure?

Mr. Jim Breslin

I just told the Deputy I am absolutely committed to establishing all the facts on this and having what has occurred categorised independently.

Is that a "No" or a "Yes"?

Mr. Jim Breslin

That is where we are going to end up and we are going to try to get there as quickly as we possibly can.

Mr. Jim Breslin

That is not fudge

It is fudge, with respect. Mr. Breslin should be in a position to say, as would anyone with half a brain cell, that this was a systemic failure. However, for reasons which are very obvious, he is not in a position to say it. I find that deeply disturbing given what we are talking about here and given that we are dealing with grieving women who are very upset and who were let down by the State. To have Accounting Officers coming before this committee, hiding behind words, dancing on the head of a pin-----

Mr. Jim Breslin

I am not hiding behind words.

I think that Mr. Breslin is hiding behind words.

Mr. Jim Breslin

I am not; I am absolutely committed to the truth being established in relation to this. The Department will make all of its records available to establish that truth and to have that independently determined. I am absolutely committed to that. That is what we are all interested in-----

Yes but Mr. Breslin is hiding behind the scoping inquiry.

Mr. Jim Breslin

I am not hiding behind anything-----

That is what the civil servants are doing here.

Mr. Jim Breslin

As soon as we have records, we will be able to make them available. I am not hiding behind anything. As was referred to earlier, the discussion between the Minister and the other political parties in the Oireachtas was aimed at putting something in place that would get us there as quickly as possible, in a matter of weeks. The aim was not to go down a road where everything closed down for two or three years and only at the end of that process would things begin to emerge.

Deputy Cullinane is out of time but I will give him a few more minutes to conclude.

I wish to put on the record my appreciation to Mr. Breen, one of the few Accounting Officers who has been exemplary in giving information and answering questions. If the same level of candour was shown by other Accounting Officers it would be very good for the public service. I very rarely say that about Accounting Officers when they come before this committee. Our job is to hold them all to account. I watched Mr. Breen's appearance before the Oireachtas committee on finance where he took the same approach.

I have a number of questions for Mr. Breen but before I pose them, I wish to ask the Comptroller and Auditor General a question. In 2012, the Comptroller and Auditor General's office compiled a special report which contained a chapter examining the issue of clinical indemnity schemes.

Mr. Seamus McCarthy

That is correct.

In that report, at 29.2-----

Mr. Seamus McCarthy

I am sorry, what was the reference?

The reference is 29.2 which deals with the principal objectives of the State Claims Agency, the second of which is to "implement risk work programmes, including risk advisory services in State authorities with the aim of reducing the costs of future litigation against the State".

Mr. Seamus McCarthy

That is correct.

What does the term "risk advisory services" mean?

Mr. Seamus McCarthy

We outline in the chapter the process of information feedback and my understanding is that it would be a key tool for dealing with issues that arise. On the one hand there would be an expectation that, in this case, the HSE would inform the State Claims Agency of incidents when they occur so that the agency would be in a position to identify patterns and then to feed back that information to the HSE, advising it, as Mr. Breen mentioned, on steps that might need to be taken to prevent future claims.

That would be my understanding too. In that context, I ask Mr. Breen to tell the committee how many cases are before the courts that are related to the misdiagnosis or misreading of these tests.

Mr. Ciarán Breen

Including the Vicky Phelan case, there are ten in total.

What was the first case and in what year was that case?

Mr. Ciarán Breen

Does the Deputy mean since when we set it up?

Yes, the very first case.

Mr. Ciarán Breen

Our first was in 2014.

When was the next one?

Mr. Ciarán Breen

It was in 2016. Is this in terms of us getting either a formal letter from a solicitor or proceedings being issued?

Yes, cases coming across Mr. Breen's desk.

Mr. Ciarán Breen

They were in 2014, 2016, 2017 and 2018.

They were all within that four-year period. At what point did the State Claims Agency understand that there might be a pattern here and that maybe it needed to send a note to the HSE to alert it to the fact that there might be a problem?

Mr. Ciarán Breen

We did not actually identify a pattern in them-----

Mr. Ciarán Breen

When we looked at them in terms of the periods of time that they cover, from 2014 up to 2018, there were different years involved. In a cervical smear situation, one would expect to see some claims arise from misdiagnosis. That is something one would expect and certainly looking at the numbers, we did not see a pattern here.

Is it that the agency did not see a pattern because enough women did not come forward and take cases? There certainly was a pattern, as we can now see. Is it the case that there were not enough women at that point who had submitted claims? Is that why the agency did not see a pattern?

Mr. Ciarán Breen

If one looks at the number of claims that were made - and we were looking at it on that basis - in the context of the total number of smear tests that were carried out, this did not look like an adverse pattern.

Does Mr. McCarthy want to say something on this?

Mr. Seamus McCarthy

The point that must also be made is that an agency represented by the State Claims Agency has an obligation to report to the latter if it identifies incidents that could give rise to a claim. There are actually two strings to it.

Did that happen? Did the HSE do that?

Mr. Ciarán Breen

Yes. The HSE notified incidents to us through our national incident management system, NIMS.

Mr. Ciarán Breen

The majority of them were in 2016.

Did that set off any alarm bells?

Mr. Ciarán Breen

No because there were references to different years. They were not referable to a single year. They did not all come in as one particular notification. In looking at them and looking at our claims, we did not think that there was a pattern.

I find that incredible, given that this is a two-way process. The HSE gives the State Claims Agency information and the agency then reports back to the HSE. It seems that both organisations are telling us that at no point did they see a pattern. In fact, the HSE did see a pattern because it issued a circular in 2016 which showed clearly that it did so. It strikes me that either the HSE saw a pattern and did not report that to the State Claims Agency - which is a problem - or the State Claims Agency itself missed the pattern. In that area of the relationship between the HSE and the agency something was missed somewhere, either intentionally or unintentionally.

We need to move on. I ask Mr. Breen to give a quick answer to that.

Mr. Ciarán Breen

To respond quickly to Deputy Cullinane, the incidents are notified to us by the agency involved. It clearly has that information and needs to notify it to us. In terms of timing and so on, the agency involved is the one that has the knowledge about what is happening.

Is Mr. Breen in a position to provide the committee with details of whatever communication there was going back to 2016? He said that there was some information given by the HSE. Can he furnish the committee with copies of that?

Mr. Ciarán Breen

I can tell the committee the dates of notification-----

Can he give us information on the communications-----

Mr. Ciarán Breen

Yes.

Can he furnish it to this committee?

Mr. Ciarán Breen

Yes.

Can you provide the communications themselves rather than just the dates of same?

Mr. Ciarán Breen

Do the Deputies mean our interaction with cervical screening?

Mr. Ciarán Breen

Yes, we will be able to give the committee the dates of our interaction-----

Not the dates of the interaction-----

The actual communications-----

The detail of the interactions as well as the dates.

Mr. Ciarán Breen

The nature of the interactions-----

No, not the nature but the actual communications. Let us be clear about this.

If it is emails or letters-----

Can Mr. Breen provide the emails or letters?

Mr. Ciarán Breen

All of this is notified on NIMS. That is how it comes into us. We see the incidents on our system.

It should be easy enough to print that off for the committee. Is that right?

Mr. Ciarán Breen

Yes.

Okay, that is great.

Voting is about to begin in the Dáil so we will adjourn until 2 p.m., in the hope that voting is finished by then. Deputy Catherine Murphy will have the floor when we resume.

Sitting suspended at 1 p.m. and resumed at 2 p.m.
Deputy Alan Kelly resumed to the Chair.

Before we resume, a copy of the memorandum that was sent to the director general, Mr Tony O'Brien, in early 2016 was requested before we resumed after lunch. Is that available?

Mr. Liam Woods

I spoke to Mr. Ray Mitchell, who is outside. He is waiting receipt of the memorandum. He will come back in when he has it.

Is it imminent?

Mr. Liam Woods

I believe so.

When we put the subject of contingent liability and open disclosure on the committee’s work plan earlier in the year, it was viewed in a more academic way than how it is unfolded now. It has unfolded because of system and process failures which have impacted people in a very personal way.

There have been 10,000 phone calls to the helpline, some of which have been replied to. From what I am hearing, some general information would be enormously helpful as to what women should do and what advice doctors should give them. I am hearing that there is a general confusion about this matter. That confusion could be allayed by some general statements of advice. If that advice is out there, it may not be as prominent as it should be. Women have asked me who they should talk to and if they should have another smear test. It is basic information that certainly is not getting across. Whatever platforms it is put out on, it should reach as wide an audience as possible.

I am aware contingent liability is dealt with on a pay-as-you-go basis. How does the State Claims Agency assess the HSE’s €2.2 billion contingent liability? Is it by examining cases, such as the recent one in question, going through the courts? Is an actuarial assessment done of others who might find themselves in such a situation? Is it estimated on the number of catastrophic failures during delivery of a baby? What system is used to calculate this?

Mr. Ciarán Breen

We do it within the State Claims Agency. We manage these cases on behalf of the HSE. We do this quite independently of it.

In the clinical indemnity scheme, when we get a case and we understand what it entails, we immediately set contingent liability against it. This is based on our knowledge of what that particular case involves, whether there are issues regarding liability, for example, and what we think is the most likely outcome in the case. Sometimes in any individual case, it can be an incremental process. In other words, as we gather more information and we get more expert reports, it then might become clearer to us as to what the injuries and losses are. One problem we sometimes face is that when we are well developed in a case, on the day before trial we might be furnished with a schedule of special damages in respect of something we did not anticipate. That can happen from time to time.

Going back to our earlier discussion, to which the Comptroller and Auditor General referred, we always have prudent margins in our reserve setting in order to meet contingencies as best we can.

We need people to be taken care of if there is a failure. We all accept it is how it happens. The open disclosure experience in other countries tends to show it can be beneficial in that one can save on the legal side and not take shortcuts in the actual care and treatment required by people.

Mr. Breslin's submission stated:

As the committee will be aware, in 2017 a total of €283 million was paid by the health service towards the cost of ongoing cases and settlement of claims. Speeding up the process and moving to a less adversarial approach has the potential, not just to reduce the legal costs for both the plaintiff and the State, but to avoid unnecessary anxiety for those who have already suffered injury.

This suggests we would like to move to open disclosure as it has benefits. Earlier this year on 8 February, we got a submission from the HSE about moving towards open disclosure, which referred to pilot programmes, the Mater Hospital and Cork University Hospital in 2010 and 2013. In the Dáil, the Taoiseach spoke about open disclosure regarding regulation by the Medical Council. The HSE’s document referred to 20,000 of the 140,000 health service staff requiring training in this regard. We do not know what degree of training will be required.

If open disclosure is so beneficial, why is it taking so long?

Mr. Jim Breslin

I can clarify, and I think it is indicated by the placement of the paragraph there. That paragraph, which refers to the €283 million, is following a number of other points that are made about the scope for further reform of the legal system around this. In the next paragraph, I move to open disclosure. Specifically, in that sentence I am referring to further reform of how we legally approach claims. The Minister has indicated that we are going to work with the Minister for Justice and Equality to try to identify further reforms, building on the Quirke working group report to try to do that.

I recall a matter that is not relevant to the health service; it is more one for the State Claims Agency. Perhaps ten years ago, we had case after case involving parents who went to the courts because they could not get appropriate education for their children. In response to a parliamentary question, I was advised that over a period of three years €20 million was spent on legal fees, effectively fighting parents in the courts. Systems were subsequently put in place to make provision in schools for education, whether it was mainstream, special needs or whatever. At that point, we stopped seeing so many cases going through the courts. There was some degree of learning, albeit after parents had gone through quite a torrid time.

Every week now, we see people coming out of court. Parents make the point that although the money will look after the child for the rest of his or her life, nothing will repair the damage. It strikes me that the lack of services - not just open disclosure - prompts some of the cases because people feel that the services will not provide for their needs. Has any evaluation done as to what might be the best outcome for people in circumstances where a failure occurs?

Mr. Ciarán Breen

I might answer in the context of the litigation we have. I agree with the Deputy. I say at the outset, quite genuinely, that we do not pursue anybody through the courts. We try, wherever possible, to settle these cases by way of mediation to avoid that court process. Going back to the pre-action protocol, it would be a considerable advantage if we had that to avoid all of this.

To come back to a catastrophically injured victim, whether it is a child or adult, there is little doubt that when we are evaluating the overall cost of that, the largest item is the cost of future care - for example, aids, appliances, assistive technology and things like that. The allegation that will always be made by the plaintiffs in those actions is that the current level of services will not support the kind of care that they need. We have had some very fruitful discussions - they are ongoing - with the HSE on this particular issue about catastrophic injury cases and putting in place some kind of care packages more quickly outside the litigation process, which would be of assistance.

Sorry, Dr. Crowley wishes to answer the question.

Dr. Philip Crowley

I thank the Deputy for the question on why it has taken so long. It is a reasonable question. The policy that was produced in 2013 was based on the pilot in the two hospitals, Cork University Hospital and the Mater. The idea was that when bringing something new in, there would be some resistance to it. Potentially, people would have to change their practices. We want people to openly disclose. We have evidence that it was not happening. The pilots were to prove to people that we could do it, that there was no threat in it and that it was something which people involved welcomed once they had done it.

We based the policy on that experience. We then disseminated the policy and guidelines widely, once they were written, in 2013. So they were then available. However, because this is such an important policy, we committed, with the State Claims Agency - because we did this work together - to undertake a training programme as extensive as we had the resources to do. The reason it took so long was because of the initial format of the training. The training is very high quality and has been assessed by external evaluators and by the participants. It is very much welcomed and people find it effective. The people involved - the one or two individuals doing the training - were training everybody. So, taking into account the basis of the Deputy's question, we moved from training everybody to training trainers who would, in turn, train other people so that we could at least multiply it. Our next stage now is to develop an e-learning module so that everybody can train on it.

When can we expect to see training complete and open disclosure fully operational within in the HSE in order that we might see a change in the culture?

Dr. Philip Crowley

That is a very difficult question to answer with exactitude, but I will answer it. There will always be instances where individuals under stress, feeling ashamed of what has happened, feeling stress or whatever, fail to do what we would want them to do which is to openly disclose. What we do is put policy out there. We train people on it. We try to de-stress it. We try to ensure management supports people in something because one has to support staff when things go wrong as well; otherwise they will not necessarily do the right thing. I do not think one can ever guarantee that in every instance of an adverse event. I cannot say, hand on heart and with absolute certitude, that in every instance open disclosure will happen. What we want to do is make sure it does.

We do not just do the training and see what happens. One of the things we have done is that we did an audit of four hospitals and looked at charts in those hospitals. In those charts we found 33 events that should be disclosed and in those hospitals disclosure happened. I think it is starting to happen and if we continue training the trainers and maintaining the lead roles around the hospital groups and the community healthcare organisations, I think one will see the culture continue to change.

Is there an audit in the hospitals that looked at particular files?

Dr. Philip Crowley

We did an audit.

Is an audit carried out across the hospital system?

Dr. Philip Crowley

We had the resources to do an audit in four hospitals. One of the things we would like to do - perhaps the State Claims Agency could comment on this - is try to build into the incident management system that clarity is achieved and that if an incident occurs open disclosure happens so it is actually recorded.

We have to move on.

Dr. Philip Crowley

Then we will update it.

I wish to ask about the incident that is very current at the moment, namely, that relating to cervical smear tests. Within that €2.2 billion, would the State Claims Agency have captured an amount that would be part of a contingent liability specifically relating to the failure that we are seeing at the moment?

Mr. Ciarán Breen

Yes. Given that we have to include the now concluded Vicky Phelan case, we have ten cases. Then we have the one extra case that we think could come along. They would be in the contingent liability. We would have a liability set aside for those which would match what we feel is our liability.

Would that be the same for breast screening and bowel screening?

Mr. Ciarán Breen

Yes, any cancer screening-----

Would there be any cases-----

Mr. Ciarán Breen

----- and any claims that arise from that.

Are there cases relating to those that have come-----

Mr. Ciarán Breen

We have four claims arising from breast cancer screening.

Earlier this morning, I asked for the memo and it still has not come. Why is there a delay with that memo?

I spoke with-----

Let me finish my question. Why is there a delay with it? I would like to be reassured that it is not because the organisation is seeking legal advice.

Does anyone from the HSE wish to respond to that?

Mr. Liam Woods

Unfortunately, I cannot help. I am not aware of that. I believe Ray Mitchell is upstairs awaiting receipt of it.

It is just a memo. It should have been here.

It has been three and a half hours now.

Mr. Liam Woods

I would not contest that at all.

The Department is not too far away and there is no reason why it could not be here. This begs the question as to what other memos exist, if any, of which the committee should be made aware.

This memo arose by accident this morning or as a result by a question put by me. Are there other memos of which we should be aware that we are not? I do not like this type of question. It is like a fishing expedition. I am not comfortable asking it, but it has emerged that there is a memo that Mr. O'Brien was given in March or April 2016. What other memos are there relating to this matter?

Mr. Jim Breslin

I do not speak for the HSE but, speaking on behalf of the Department, we are in the midst of a full search. Insofar as that information is not personally sensitive to women - I am not referring to other parties - we will release it. I understand that, due to the reference this morning to the 2016 memo, a search is under way with a specific target around that period. If we are in a position to identify something there, we will release it to the committee. The other point to note is that all of those records will be given over to Dr. Gabriel Scally.

I am delighted. I am one of those who believes the scoping exercise is a good idea. However, I have repeatedly said that, if we got answers to our questions, we would not need all of this.

Mr. Jim Breslin

Yes. Dr. Holohan might wish to comment on the-----

One second, please. There have been cases involving Áras Attracta, Grace, Savita Halappanavar and Galway, to which I will revert with the State Claims Agency in terms of what remains outstanding, and reviews are under way regarding the carrying out of inappropriate procedures, including on a member of my family. There are the cervical smear, Portiuncula Hospital and Portlaoise hospital situations. All of this is from a quick search I did this morning. There are serious failures in accountability. When memos are unavailable, it is difficult.

Dr. Holohan is on record as saying he is not for mandatory disclosure and that he prefers open disclosure on a voluntary basis. Is that correct?

Dr. Tony Holohan

Not precisely.

Have I misread that in the newspapers? Is my statement incorrect?

Dr. Tony Holohan

There is not a full representation in the newspapers of the advice I have given to various Ministers.

Would it be fair to say that Dr. Holohan was in favour of voluntary disclosure with the significant encouragement of staff to disclose?

Dr. Tony Holohan

I will explain, although it will take me a little time to do so. Last week, I was asked by the Joint Committee on Health to make available the advice. Arrangements are being made to give it, so I have no problem with outlining and explaining it.

I want to be clear about any impression that has been given. We do not regard open disclosure as something that is optional. It should happen in every circumstance.

No, my question is-----

Dr. Tony Holohan

I understand the Deputy's question.

Allow the witness to speak, please.

Please, my question was on mandatory-----

Dr. Tony Holohan

I do not want to give the impression-----

No. Was Dr. Holohan in favour of making disclosure mandatory?

Dr. Tony Holohan

I am not in favour of mandatory open disclosure in every circumstance where error occurs. There is not a country in the world where that is the standard. There is a duty of candour arrangement in the UK that is often cited. It does not apply to physicians, only to organisations. The arrangements we are making, confirmed by the Government's approval on Tuesday to draft legislation based on proposals that we have had in train for some time, are to make mandatory a list of what are called serious reportable events. They are less frequent, but they are serious in terms of their potential. A list is already in operation in the HSE in administrative terms. It reports on that each month. This is in line with the UK's duty of candour arrangement. That is what I am in favour of.

Does Dr. Holohan regard what has happened with cervical smears as a serious incident?

Dr. Tony Holohan

A very serious incident.

Dr. Holohan is on record as saying he believed this was an isolated incident with Vicky Phelan.

Dr. Tony Holohan

No, I do not believe I ever used those terms.

Am I incorrect? I checked what was reported in the newspapers before I attended the meeting. Is that reporting not accurate either? Dr. Holohan did not believe this to be an isolated incident.

Dr. Tony Holohan

Just to be clear, when the Deputy says "this", to what is she referring?

The Vicky Phelan case.

Dr. Tony Holohan

I would not have believed that to be an isolated incident where there would be a discordance in reporting in respect of a case of cervical cancer in retrospect. That is a feature of cervical screening programmes around the world-----

No. I have only-----

Dr. Tony Holohan

-----and that is why I would have known it was not an isolated incident.

Listen, I am not going into the difficulties-----

Dr. Tony Holohan

I understand.

-----inherent in the system. That is not for me to do, but for the experts. What is for me to determine is what happened after the audit. We have been told this morning and at various other times that the smear testing and analysis are not a perfect science. I am not going down that route. Rather, I am asking about what happened when the Department became aware. I am trying to establish whether the process worked.

Dr. Tony Holohan

I will clarify what we understood to be the situation in 2016 and why we understood it to be so-----

How did the Department become-----

Dr. Tony Holohan

-----if the Deputy will allow me the chance to explain it.

I will. How did the Department become aware of the situation?

Allow Dr. Holohan to answer.

Dr. Tony Holohan

The Department would have been aware from a general briefing from the HSE. I do not at this point remember the precision. That is part of the purpose of the scoping exercise, but I would have had a general awareness of the features of all of our screening programmes. That is not to say every single detail, though. The fact that we were doing a clinical audit in 2016 and that there was knowledge of that was a good thing in retrospect. I say that because, when we look across Europe-----

Dr. Tony Holohan

No, I need to explain.

No. You can explain-----

I am sorry, Deputy-----

Deputy, I am the Chair. Let him answer the question.

I will, but just let me point-----

I am not stopping him. I will let him answer, but there must be a little discretion. If the answer is too long, it has to be-----

It will not be long, but we will judge it.

I thank the Vice Chairman.

Mr. Jim Breslin

To clarify, we do not have a time limit. I certainly do not.

Mr. Ciarán Breen

Ditto. The committee can take all the time it needs.

Dr. Holohan should proceed.

Dr. Tony Holohan

I would have contextualised that from my general knowledge of screening. I would have known that this country was one of a large minority that had an organised screening programme in the first instance. It is still the case that the majority of screening programmes across Europe do not have organised clinical audits. Of those that do, the only one where there is an ongoing discussion around open disclosure of facts identified - false negatives - is in the UK. It is not the standard throughout Europe, but we introduced that standard in 2016. We purported through our screening programme to give that information to patients, but the health system did not do that effectively. That is what is at issue in this case.

Clinical audit is a good thing. It would have generated information that should have been fed back to patients. We believed that was happening, as we were told it was. We heard that evidence this morning. The people who were telling us also believed that to be the situation.

Dr. Tony Holohan

I am giving the Deputy my general understanding.

Dr. Tony Holohan

I am trying to be helpful and to give the Deputy a sense of what we understood in policy terms in 2016.

I do not find it helpful. As the man in charge in the Department and as the clinical expert, when did Dr. Holohan become aware of the issue of false negatives and women being given the all clear when their tests were not all clear?

Dr. Tony Holohan

I would have been aware continually that was a feature of the screening programme.

When did Dr. Holohan become aware it was an issue?

Dr. Tony Holohan

I became aware of the issue of information not being fed back to patients when it became a matter of public knowledge on this day two weeks ago.

That is when Dr. Holohan first became aware of it.

Dr. Tony Holohan

I did not know there was what we now can see was a widespread practice of non-disclosure of that information to patients until that day.

Let me get this clear. In 2014, there was an audit of the smear tests of women who had subsequently developed cancer. Is that correct?

Dr. Tony Holohan

Yes.

Then it was discovered that a substantial number of women had smear tests and had been given the all clear when they should not have been. Is that not correct?

Dr. Tony Holohan

There were false negatives as part of the programme. That is correct.

No. I am not using the term "false negatives".

Deputy, please.

I am using simple, plain English.

Dr. Tony Holohan

To me, that would not have been news.

It was news to the women who were being treated for-----

Dr. Tony Holohan

Of course it is news to each individual, but the fact of there being a group of false negatives was not news.

The Deputy might continue.

When did Dr. Holohan become aware of it?

Dr. Tony Holohan

I would be aware from my general medical knowledge that false negatives in those numbers were a feature of the programme. I would not have known about any individual until it became a matter-----

As the Department's chief medical officer, did Dr. Holohan see fit to decide that this was very important and the women needed to be told quickly that they had, for whatever reason, been given wrong information?

Dr. Tony Holohan

We would have a general-----

When did Dr. Holohan make that decision?

Dr. Tony Holohan

I cannot honestly recall, but I would have known for some time, certainly as far back as 2016, that there was an audit practice in the programme that also fed that information back to patients. That was the information and understanding we had. I regarded that then, as I do now, as a good standard of practice, but it clearly did not happen.

Does Dr. Holohan see this report, entitled "Building a Better Health Service"? It contains beautiful language about empowering people and the patient, putting the patient at the centre of services and strengthening the system of responsibility. It refers to a risk assessment committee and a directorate.

I believe Mr. Woods and Mr. Crowley are on the risk assessment committee. Is that correct? Do they have membership of the directorate?

Mr. Liam Woods

I was a member of the directorate at that time. We were not on the risk committee.

Neither of you was on the risk assessment committee.

Mr. Liam Woods

No.

Mr. O'Brien is on the list of directorate members as of 31 December 2016. Was Dr. Holohan a member of the directorate?

Dr. Tony Holohan

No. I work in the Department of Health.

Was this issue brought to your attention at directorate level?

Mr. Liam Woods

I am not on the directorate now.

You were on it in 2016, though.

Mr. Liam Woods

I have no recollection of it at that time.

It was never brought to you nor discussed at this level.

Mr. Liam Woods

Not to my recollection.

I welcome the candour of Mr. Breslin this morning, his directness and honesty and his willingness to give all information. However, this was not reflected in his opening statement. He said health services can be made much safer but that it is inevitable that things will sometimes go wrong. I do not think that is a great statement and I think his role is to come here and explain how things went wrong and how systems did not work, allowing this to happen.

Mr. Jim Breslin

I agree with that but I stand over the statement, which is meant to be a general position. It is meant to reflect that we need to educate the public and talk to them more about the risk within our health services, and that balanced judgments are always needed. We have to have a partnership with people in making judgments and the patriarchical healthcare system, where it is left to the doctor to make all the decisions and where information is not shared, is part of the problem we are trying to get away from.

In respect of the State Claims Agency, how many cases were there and which laboratories are being sued? I understand the agency has to act in an ethical manner and that it has to carry out a full investigation when a claim comes its way. It gets a statement from the person on the other side setting out his or her version of events. Was that done in all of these cases? How many cases are there? Who is being sued? What investigation has been carried out?

Mr. Ciarán Breen

We have to include the now-concluded Vicky Phelan case. We have ten cases where we have received solicitor's correspondence or proceedings. We have one other case where we believe a claim is likely to arise.

There are 11 in total.

Mr. Ciarán Breen

Yes.

So when I read in the paper that there are 21 cases at different stages, it is incorrect.

Mr. Ciarán Breen

We have 11 relating to the national cervical cancer screening service. In three of them, we have been given an indemnity by the laboratory concerned.

Mr. Ciarán Breen

There are a number of laboratories.

It is a matter of public record if there are proceedings.

Mr. Ciarán Breen

Quest and Clinical Pathology Laboratories are the two which are concerned.

They are the subject of legal proceedings.

Mr. Ciarán Breen

Yes.

There are two so far.

Mr. Ciarán Breen

Yes. They have offered an indemnity to the State relating to the action against them.

What is the position regarding investigations?

Mr. Ciarán Breen

We get involved only when we receive either a letter of claim or a personal injury summons. In those cases, if it is a misread smear we immediately seek an indemnity from the laboratory, as we would in any case where we believe another party has a liability. When there is a contractual document in place between the screening service and the laboratory concerned, as was referred to this morning, CervicalCheck does that as a matter of course. It is set out in the contractual documentation that they need to know immediately if a claim is being made.

My first question relates to open disclosure. We were taken through the process of where we are and what has happened as regards the pilot projects. We have a letter dated 8 February which states that, moving forward, a number of initiatives will take place. One is the roll-out of the programme to GPs and practice staff and another is the development of guidelines for national screening services. Can I take it that no guidelines for open disclosure are in place at the moment as they relate to national screening services?

Ms Ann Duffy

I work in the open disclosure area in the State Claims Agency. There are no specific guidelines relating to the screening services but I and my colleague in the HSE, Ms Angela Tysell, met with the screening services in February this year and offered our services to help them around this area and to develop a process with them.

As Dr. Holohan said, there is a policy of open disclosure within the national screening services but no written guidelines on how it is to be implemented. Is that correct?

Ms Ann Duffy

That is correct.

The only thing on paper of which we have been told relates to the circular of 2014, which stated that anyone who is affected by the audit should be told. Is there anything else, in the Department or the HSE or anywhere, which goes through how open disclosure should work in the national screening services?

Ms Ann Duffy

In February this year, we were asked to look at the incident management policy around the whole area of open disclosure. Open disclosure should be integrated into many policies and procedures and should be part and parcel of our everyday business. Following the review of the document, we made amendments to include open disclosure, to make it more visible and to look at the processes involved. We gave it back to the clinical cervical services in March this year.

Prior to that there was nothing specific.

Ms Ann Duffy

There was nothing specific to cervical services.

I might come back to this issue later.

There are 11 cases relating to cervical care. Mr. Breen said there were four claims relating to the breast cancer screening programme.

Mr. Ciarán Breen

Yes.

Do we have any information relating to the third screening programme, for bowel cancer?

Mr. Ciarán Breen

No.

Can Mr. Breen say if the four screening services have similar results to those of cervical checks, in terms of false negatives or misdiagnosis etc?

Mr. Ciarán Breen

There are misdiagnoses of cancer cases but they are at different stages and we are gathering expert evidence to establish whether there is a liability. The most I can say is that they allege misdiagnosis and we are in the process of handling them and getting expert evidence to establish the factual situation.

Has an audit been done, or is one being done, of BreastCheck? We have four cases with the State Claims Agency at the moment.

Dr. Philip Crowley

I am not aware of any more. I am not over that area so I do not know the answer.

Can we find out the answer? It is important to find out whether an audit process is under way, given that there are four cases with the State Claims Agency.

Of the 11 cases, one is finalised and in another one there is a letter of intent, so we have nine cases. There are quarterly meetings with the HSE executive on cases. I know the answer to this question because we were told on Tuesday but for the purpose of this meeting, were those nine cases relayed to the HSE executive? Is that correct?

Mr. Ciarán Breen

They were advised, like all of these cases were advised, as notifications in the first instance by HSE CervicalCheck. They were aware of them first. They were notified to us and became claims.

When did the HSE become aware there are ten cases with regard to CervicalCheck?

Dr. Philip Crowley

It is not my area. Damien McCallion left this morning.

I appreciate it is not Dr. Crowley's area but it is one of the reasons why there should have been a deputy who can answer these questions.

We requested that.

We requested it because there is now a situation where we have questions that cannot be answered. It is unfortunate. I am not pointing the finger at any of the individuals who are left here.

There should be a comprehensive list of people at a different level in the HSE, along with the National Cancer Registry.

There is nobody in here who can tell me - maybe somebody in the Department may know this - when the HSE was made aware of these ten cases through those quarterly meetings. In one of them, the Vicky Phelan case, which is now concluded, the State Claims Agency was only made aware of it on 12 February 2018. I am trying to get some information on when the HSE was made aware of the other cases. Was it last year? Was it in recent months? Can anyone in the room give me a general timeframe on it?

Mr. Liam Woods

With a view to being helpful, while it is not my direct role, Mr. Breen has already said he could provide copies of the reports on the national incident management system, NIMS, which would identify - and some guidance on this from Mr. Breen would be helpful - the date on which the incidents were put on the system and hopefully also the date on which the incidents arose. That information has already been offered to the committee.

Mr. Breen does not have that information off-hand.

Mr. Ciarán Breen

No.

On risk management, one of the objectives of the State Claims Agency is to advise and assist healthcare enterprises on measures to be taken to prevent the occurrence or to reduce the incidence of adverse clinical events which could result in medical negligence claims. Given we now have 11 cases, has the State Claims Agency given or will it be giving any advice to the HSE on measures to be taken to prevent this occurrence given we now know that all of the cases the State Claims Agency is dealing with are related to American labs?

Mr. Ciarán Breen

I will ask my colleague, Mr. O'Keeffe, who heads up the clinical risk side to respond to the Deputy.

Mr. Cathal O'Keeffe

There are probably two issues there. The first issue relates to the misdiagnoses in the first place. The second issue relates to the disclosing of that information. With regard to the misdiagnoses in the first place, we probably need to await more information from the scoping exercise to see exactly what issues lay behind those misdiagnoses. I am not sure we are in a position at the moment to make a comment on that. We need to learn what happened first before we are in a position to give any advice about it. That is the first thing to say.

With regard to the open disclosure issue, there has been a failure in open disclosure as my colleague, Ms Ann Duffy, has already said. We have already been in contact with the screening services and in view of what has happened, we will be redoubling our efforts and engaging with them on an ongoing basis to make sure the issue around open disclosure is properly managed going into the future. That is something we will be doing in partnership with the HSE.

Do we have the memo?

We will have the memo - for the information of the probably 20,000 journalists watching - by 3 p.m. With the agreement of the committee we will share it among members and will publish it.

Will that be in electronic format or hard copy?

It will be hard copy for us to read it but we will get it electronically as well.

I have a final question. I want to go back to the screening programme. When did the Department become aware of the four cases of BreastCheck that are with the State Claims Agency at the moment? Was it aware of them?

Mr. Jim Breslin

I met the State Claims Agency last Friday and we went through a range of claims it might be dealing with, obviously with a focus on the current controversy. We started with CervicalCheck and we went through the number of claims Mr. Breen has referred to. We went through BreastCheck. They confirmed there were no claims with regard to BowelScreen. It was Friday evening for me.

I might come in again later.

Deputy MacSharry is next but he is not here so I call on Deputy Cullinane.

I want to return to a number of questions when Mr. Breslin is ready. It is good to see the HSE and the Department is interacting.

Mr. Jim Breslin

People say in public it is the opposite.

My question is in that space. We had a very robust exchange earlier on information flow from the HSE to the Department. How important is it that there is good communication between the HSE, whatever part of the HSE it is, and Mr. Breslin's office specifically, as Secretary General?

Mr. Jim Breslin

At my office it is important, but it is important at other levels within both organisations. While the director general and I keep in touch on matters and have meetings, including formal meetings, there is also iterative engagement between the different policy areas of the Department and the HSE in respect of both policy and issues as they arise in the health service.

In February 2016, when the HSE was formulating a response to the high number of cases where there had been a mis-reading or a false negative in terms of the testing, there was a communications strategy put in place. Does Mr. Breslin believe that, in or around that time period, his office should have been informed?

Mr. Jim Breslin

It depends on the significance the people working on the issue were attaching to it. One of the lessons of this whole process is-----

The problem is if it is left to the discretion of those individuals - we can see already and the director general has said it - that their understanding of its magnitude is different from his.

Mr. Jim Breslin

I agree.

I am not asking Mr. Breslin to put himself in their shoes. I am asking, from his perspective, does he believe he should have been informed?

Mr. Jim Breslin

In the light of where we are now.

Mr. Jim Breslin

If we had known the significance-----

No, not what Mr. Breslin knows now but in terms of what they knew at that time.

Mr. Jim Breslin

It is conjecture as to what they knew at the time. It is not obvious to me-----

It is not, with respect. I will go a bit further to make it a bit easier for Mr. Breslin. At the time the circular was issued, the circular that was sent to consultants pertained to, as we now know, 209 women. At that point only a small number of them had been informed. Discretion was given to consultants as to whether they should tell the patients. They knew the scale of it at that point. Mr. Breslin is telling me he is not sure whether his office was informed at that point. When that circular was drafted, agreed and then sent to consultants, Mr. Breslin is not sure whether his office actually received any communication.

Mr. Jim Breslin

The setting up of a clinical audit process, in and of itself, is not something that would have merited the type of escalation to which the Deputy is referring. The weaknesses in the approach to it, which included the fact that the clinical audit was under way and people had not worked out what they were going to do with the information when they got it-----

I do not think Mr. Breslin understands the point I am making.

There was a court case in 2014 which was settled. At that point, did people in the HSE know about Vicky Phelan's situation?

Mr. Jim Breslin

I do not know.

My point is that certain people in the HSE knew that there had been false readings or worse in the cases of 209 women and a conscious decision was taken that discretion should be given to consultants and a circular was sent out in that regard. Surely, it would have been important for the Department also to have been made aware of that?

Dr. Tony Holohan

To be helpful, on the point of discretion and what it means in this particular context, I do not recall seeing the circular and we would not be copied on something like that or the individual communications between the screening programme and the clinicians who were to tell the patients and so on. However, discretion in that context means sometimes there is information - that would not necessarily be appropriate - that the screening programme has and passes to the clinician. The clinician is then in a situation where he or she can assess whether it is appropriate to pass on that information-------

Is that what Dr. Holohan would tell Emma Mhic Mhathúna and Vicky Phelan?

Dr. Tony Holohan

Of course not.

Why would he not tell them that?

Dr. Tony Holohan

I will give the Deputy an example of such a situation. I do not wish to overindulge. As the Secretary General stated, we are happy to stay for as long as it takes to give members whatever information we can. Technically, there are two types of cervical cancer. One causes 90% of------

I understand that there are two types of cervical cancer. We have been through this.

Dr. Tony Holohan

I must make the point for general understanding that screening is focussed on the type responsible for 90% of cases. In a case where a person goes on to have an invasive cancer of the other type, previous knowledge of the screening history has no value and a decision may be made at that point that there would be no need to pass that information. That is a matter on which an individual clinician can make a decision.

With respect, through that response Dr. Holohan is giving comfort to those who failed to communicate the information.

Dr. Tony Holohan

No. I have very clearly stated on the public record------

Dr. Holohan is giving comfort to those people.

Dr. Tony Holohan

-----on many occasions and am happy to again state today that the non-disclosure of that information was wrong and should not have happened.

I will stop Dr. Holohan there because that is what I am focused on: that the non-disclosure of that information was wrong. The non-disclosure of the information was partly due to the circular that was issued. We all agree that the non-disclosure was wrong. A conscious decision was made, for whatever reason, to give consultants discretion not to inform all of the patients and it is clear that everybody now accepts that was wrong. Surely, Mr. Breslin would be of the view that his Department should have been made aware at that point.

Mr. Jim Breslin

I genuinely think that would have required the people who did not approach this in the thorough way that was required to have understood the consequences of that lack of thoroughness. Further inquiry will have to be made but I do not believe people necessarily set off to create the problem that has arisen.

The Comptroller and Auditor General previously appeared before the committee in regard to issues relating to An Garda Síochána and information not being given. The Comptroller and Auditor General was clear that the information should be given to him as a matter of course and he would make the decision on its importance. Mr. Breslin is essentially stating that those within the HSE who were dealing with this matter should be allowed to make that judgment call. Surely, there should be good communications between the HSE and the Department and then Mr. Breslin, as the person who has to brief the Minister, can decide whether something is of importance.

Mr. Jim Breslin

Yes, but up to------

However, Mr. Breslin is not making such decisions. With respect, he is almost excusing away-----

Mr. Jim Breslin

No, I am not.

-----why he was not given the information.

Mr. Jim Breslin

I am not because we are absolutely disappointed that we-----

I remind Dr. Holohan that I am putting questions to Mr. Breslin and would appreciate if he did not shake his head.

Mr. Jim Breslin

We are very disappointed by how this issue emerged and the relevant information which was not made apparent to us. The only point I am making is that the national incident management system, NIMS, database runs to hundreds of thousands of incidents, so discretion is required to decide which of those incidents are the signal ones, which are the absolutely most important ones that need to come all the way into a small Department that sits on top of a huge organisation.

I move on to Dr. Crowley. I do not mean this in a flippant way but, rather, a genuinely inquisitorial one. What is the purpose of Dr. Crowley appearing before the committee today? On which area is he here to answer questions?

Dr. Philip Crowley

Open disclosure.

Ms Maura Lennon

I am the acting head of legal in the HSE.

What type of questions was it anticipated that she would answer? On what issue is she here to answer questions?

Ms Maura Lennon

I am here to address questions on the types of legal cases the HSE manages itself and those managed by the State Claims Agency.

Mr. Liam Woods

I am here because I have some awareness of the background relationship with the State Claims Agency. I have a background in finance which relates to some of the issues under discussion and my current role is in hospitals.

Which of those three witnesses is qualified to answer questions on the circular that was drafted and sent to hospital consultants and which gave them discretion?

Mr. Liam Woods

I have no awareness of it.

Ms Maura Lennon

Likewise.

Is that not the point? The director general comes in for an hour and a half and then leaves but the critical issue pertains to decisions that were made by certain individuals and yet none of these witnesses are in a position to answer questions in that regard. I find that extraordinary and all the more reason why those central to those decisions should be brought before us next week.

Perhaps Dr. Crowley will be able to answer my next question. We heard earlier from Deputy Jonathan O'Brien in regard to the legal services paper, which states guidelines for national screening services should be developed. One of the witnesses from the State Claims Agency stated there are no specific guidelines for open disclosure in terms of screening but, rather, a more general policy. Why is there no such policy for screening services?

Dr. Philip Crowley

In the first instance, the general policy applies to screening services. The general policy applies to all services.

Was it enforced? Was it used in this instance?

Dr. Philip Crowley

It failed.

Dr. Philip Crowley

If it was used, disclosure did not happen in spite of that.

Was the circular that was sent and which gave discretion to consultants as to whether they should inform the patients a breach of the guidelines?

Dr. Philip Crowley

That is a difficult question for me to answer and while I will tell the Deputy why, I still will try to answer it. The Deputy asked if I understand what is meant by discretion and in what specific clinical circumstances that discretion might apply. I do not. That is a technical area where a gynaecologist and a cytologist might------

No, that is not the case because open disclosure means there is no discretion. Open disclosure is that one does------

We will conclude this line of questioning because we must address the next matter.

Dr. Philip Crowley

Our policy is that if an adverse event occurs, disclosure should be made.

I might come back on the memo in a few minutes if there is time to do so.

We are moving on to the next issue. For clarity, the memo that was sent to Mr. O'Brien has been delivered to us. It will be available on the Committee of Public Accounts section of the Oireachtas website at 3 p.m. We have been given three iterations of the memo, namely, an earlier version from March 2016 and two versions from July 2016. We have been told that the first memo on members' lists is that which was sent to Mr. O'Brien and to which he referred to in his evidence today.

That is March 2016, for clarity.

No, July 2016, is it not? The first one on members' lists-----

Is the one he got.

------is the one he got. I presume the other two were drafts. Is that what we are told?

Mr. Ray Mitchell

All three iterations------

I ask Mr. Mitchell to speak up.

Mr. Ray Mitchell

All three follow each other in the------

Okay, but the first two were drafts and were not sent. For clarity, these are three iterations of the same memo: one from March and two from July. We must do right by Mr. O'Brien in terms of accuracy in this regard. The last memo is the one that was sent to him. Is that correct?

Mr. Ray Mitchell

The memo states, "The briefing memo prepared by John Gleeeson, [sic] CervicalCheck Programme Manager is the most up to date memo and as such is the memo referred to by the Director General at the meeting today."

It concludes that the first memo of July 2016 is the one to which the director general referred today.

I beg your pardon.

I have not finished.

He did not refer to it today; he referred to it earlier in the year, in March.

I know, but he could have got it wrong.

No, there was another one, in March.

I know, but in fairness to him, he said he was not sure of the date. We will have to accept his word.

If my memory is correct, he said in his testimony that it had been sent to him by Dr. Stephanie O'Keeffe. That would not tally with the Vice Chairman saying it was the one from Mr. Gleeson.

To be fair, it does because it was from Dr. Stephanie O'Keeffe and Mr. John Gleeson. For the purposes of clarity, were the other two versions of the memo sent or were they just drafts?

Mr. Ray Mitchell

To whom were they sent?

Were they sent to Mr. O'Brien?

Mr. Ray Mitchell

I will check.

We know that the final version was sent to him.

Mr. Ray Mitchell

Yes, that is the one to which he referred.

Would members like five minutes to read the memo?

I suggest we complete what we are doing and come back to this issue. There are a numbe