Oireachtas Joint and Select Committees
Thursday, 10 May 2018
Public Accounts Committee
State Claims, Management of Legal Costs and Policy on Open Disclosure
Implications of CervicalCheck Revelations
2016 Financial Statements of the State Claims Agency
2016 Financial Statements of the HSE
9:00 am
Alan Kelly (Tipperary, Labour)
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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.
Catherine Connolly (Galway West, Independent)
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Is there a statement from Mr. O'Brien?
Catherine Connolly (Galway West, Independent)
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I was just asking for the record.
Alan Kelly (Tipperary, Labour)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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"?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I asked-----
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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Mr. O'Brien is in charge.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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So Mr. O'Brien has no accountability.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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But when Mr. O'Brien-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We know that.
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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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The response yesterday was to decline respectfully the invitation to resign.
Catherine Connolly (Galway West, Independent)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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-----and I put it to him that it is not acceptable. That is the implication.
David Cullinane (Waterford, Sinn Fein)
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Mr. O'Brien needs to step back.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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In fairness-----
David Cullinane (Waterford, Sinn Fein)
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No, it is not a cheap shot.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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None of this is personal-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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-----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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Well he is wrong.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Clearly.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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So is Mr. O'Brien saying that Ms Mhic Mhathúna's and Ms Phelan's situations are within the acceptable margin of error?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Alan Kelly (Tipperary, Labour)
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We will have to move on now.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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No problem. I thank the Vice Chairman. I will come back in on the next round if I may.
David Cullinane (Waterford, Sinn Fein)
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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%.
Alan Kelly (Tipperary, Labour)
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Dr. Holohan has indicated that perhaps-----
David Cullinane (Waterford, Sinn Fein)
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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.
Alan Kelly (Tipperary, Labour)
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That is fair enough.
David Cullinane (Waterford, Sinn Fein)
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That is okay.
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.
David Cullinane (Waterford, Sinn Fein)
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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-----
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I did not say that.
David Cullinane (Waterford, Sinn Fein)
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Was it a systemic failure?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I did not say that.
David Cullinane (Waterford, Sinn Fein)
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I ask Mr. O'Brien if it was a systemic failure.
David Cullinane (Waterford, Sinn Fein)
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I wish to firstly ask whether those 208 women not being informed was a systemic failure within the HSE.
David Cullinane (Waterford, Sinn Fein)
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Was it a systemic failure?
Alan Kelly (Tipperary, Labour)
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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.
David Cullinane (Waterford, Sinn Fein)
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Those staff are accountable to the HSE.
David Cullinane (Waterford, Sinn Fein)
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Is it a systemic failure?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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I did not state that Mr. O'Brien was party to the decision.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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Doctors.
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.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien was unaware of any issue in relation to Vicky Phelan prior to hearing about it on RTÉ?
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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What was brought to Mr. O'Brien's attention in 2016 and when was it brought to his attention?
Catherine Connolly (Galway West, Independent)
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Okay. Therefore, in March-----
Catherine Connolly (Galway West, Independent)
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Just one moment.
Catherine Connolly (Galway West, Independent)
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Okay.
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien was told some time in 2016.
Catherine Connolly (Galway West, Independent)
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Is there a copy of the briefing note available?
Catherine Connolly (Galway West, Independent)
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Who gave the note to Mr. O'Brien?
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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May I put some plain English language around this, please?
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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What was the issue being communicated?
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien was aware at that point that something was wrong.
Catherine Connolly (Galway West, Independent)
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Yes.
Catherine Connolly (Galway West, Independent)
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Leaving aside the communications plan, what was the issue being communicated?
Catherine Connolly (Galway West, Independent)
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Yes and what had it found?
Catherine Connolly (Galway West, Independent)
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What had the audit found that was being brought to Mr. O'Brien's attention?
Catherine Connolly (Galway West, Independent)
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What would they be communicating to them?
Catherine Connolly (Galway West, Independent)
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Okay.
Alan Kelly (Tipperary, Labour)
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Please allow Mr. O'Brien to answer the question.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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Was Mr. O'Brien aware of how many women needed to be told?
Catherine Connolly (Galway West, Independent)
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Did Mr. O'Brien ask questions at that point? Did he ask anybody the extent of the problem?
Catherine Connolly (Galway West, Independent)
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I am not interested in a carefully planned spin programme or a carefully planned communication process-----
Catherine Connolly (Galway West, Independent)
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Let me finish.
Catherine Connolly (Galway West, Independent)
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I am interested in-----
Catherine Connolly (Galway West, Independent)
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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.
Alan Kelly (Tipperary, Labour)
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As a matter of interest, who sent the letter to Mr. O'Brien?
Alan Kelly (Tipperary, Labour)
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Perfect. Who held the position at the time?
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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I understand that. I ask Mr. O'Brien to listen to my question.
Catherine Connolly (Galway West, Independent)
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Are tests being carried out outside Ireland?
Catherine Connolly (Galway West, Independent)
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I asked a specific question.
Catherine Connolly (Galway West, Independent)
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Yes. Did Mr. O'Brien hear my question?
Catherine Connolly (Galway West, Independent)
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I asked if tests were being carried out in the laboratory in America.
Catherine Connolly (Galway West, Independent)
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MedLab carries out its work through a laboratory in Ireland. Will Mr. O'Brien clarify that?
Catherine Connolly (Galway West, Independent)
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Is there another company in America separate from MedLab that we are using?
Catherine Connolly (Galway West, Independent)
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What is the name of that company?
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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Are they going?
Catherine Connolly (Galway West, Independent)
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Yes.
Catherine Connolly (Galway West, Independent)
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Which laboratory?
Catherine Connolly (Galway West, Independent)
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When the HSE is encouraging women to go forward, some of those tests will go to the laboratories about which there are serious questions.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Mr. O'Brien was not aware that the circular left it to the discretion of consultants to inform women.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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No. I want to know what Mr. O'Brien takes responsibility for.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Who are those persons?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Who are those persons?
Alan Kelly (Tipperary, Labour)
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It depends on the circumstances.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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What action has Mr. O'Brien taken in respect of those individuals?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Doing what?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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No, we do not.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Any more.
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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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As the director general, Mr. O'Brien is responsible for systemic failures but not systems failure.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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It is a simple "Yes" or "No".
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Is Mr. O'Brien responsible for systemic failures but not systems failures?
David Cullinane (Waterford, Sinn Fein)
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Deputy O'Brien just outlined one to Mr. O'Brien over the past five minutes.
David Cullinane (Waterford, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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That is a systemic failure which Mr. O'Brien does not take responsibility for.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I asked Mr. O'Brien as simple question and he will not answer.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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?
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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?
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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Will the public be aware of this?
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Alan Kelly (Tipperary, Labour)
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I call Deputy Peter Burke.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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I just have two more questions. I only got to ask one. Will I get a second chance?
Alan Kelly (Tipperary, Labour)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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I will get in again.
Alan Kelly (Tipperary, Labour)
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We are going to try to get around again.
Peter Burke (Longford-Westmeath, Fine Gael)
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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. 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.
Peter Burke (Longford-Westmeath, Fine Gael)
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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?
Peter Burke (Longford-Westmeath, Fine Gael)
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I am asking if that is being done now.
Peter Burke (Longford-Westmeath, Fine Gael)
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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.
Peter Burke (Longford-Westmeath, Fine Gael)
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Of course there are differences in terms of demographics such as age-----
Peter Burke (Longford-Westmeath, Fine Gael)
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-----and types of people that they affect.
Peter Burke (Longford-Westmeath, Fine Gael)
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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.
Peter Burke (Longford-Westmeath, Fine Gael)
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Is there a two-way data exchange for BowelScreen?
Peter Burke (Longford-Westmeath, Fine Gael)
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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?
Peter Burke (Longford-Westmeath, Fine Gael)
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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.
Peter Burke (Longford-Westmeath, Fine Gael)
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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.
Peter Burke (Longford-Westmeath, Fine Gael)
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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.
Peter Burke (Longford-Westmeath, Fine Gael)
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How much money was saved to have the tests done in the United States rather than in Ireland?
Alan Kelly (Tipperary, Labour)
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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-----
Alan Kelly (Tipperary, Labour)
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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.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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I suggest that Mr. O'Brien turns around and gives his colleagues permission to supply us with the letter.
Alan Kelly (Tipperary, Labour)
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That would be helpful and I am sure all of my colleagues would appreciate that.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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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.
Alan Kelly (Tipperary, Labour)
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Did the memo refer to the volume of women involved, that is, the 209 women?
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.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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I appreciate that.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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Was there anything in the memo that rang alarm bells in any way, shape or form?
Alan Kelly (Tipperary, Labour)
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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.
Alan Kelly (Tipperary, Labour)
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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.
Alan Kelly (Tipperary, Labour)
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We will see the letter in a few minutes. Did the planned communication detail how this was going to happen?
Alan Kelly (Tipperary, Labour)
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Okay. Fair enough.
Alan Kelly (Tipperary, Labour)
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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.
Alan Kelly (Tipperary, Labour)
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But there were efforts.
Alan Kelly (Tipperary, Labour)
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Surely some efforts were made.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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That is 100% true. There is a reason there was an anomaly here.
Alan Kelly (Tipperary, Labour)
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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.
Alan Kelly (Tipperary, Labour)
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It is quite obvious that it is a priority for them in the current situation rather than down the road.
Alan Kelly (Tipperary, Labour)
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They need to have it done immediately.
Alan Kelly (Tipperary, Labour)
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We need accountability as to why that happened.
Alan Kelly (Tipperary, Labour)
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I accept that.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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Did the agency receive that in writing or orally?
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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Was it from senior people in CervicalCheck?
Alan Kelly (Tipperary, Labour)
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They said that everyone had been communicated to.
Alan Kelly (Tipperary, Labour)
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Would it be possible for Mr. Breen to come back to this committee to confirm the approximate time and date on which this happened-----
Alan Kelly (Tipperary, Labour)
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-----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.
Alan Kelly (Tipperary, Labour)
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Mr. Breen might do what I have asked so that we can join the dots and make sure everything is checked.
David Cullinane (Waterford, Sinn Fein)
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Would it be perjury?
Alan Kelly (Tipperary, Labour)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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No. I am giving Mr. O'Brien the hypothetical situation.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Okay.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Yes. I am asking about a commercial company. I think we all know what we are talking about.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Okay. I think Mr. O'Brien is dancing on the head of the pin about which he spoke earlier.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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The reality here is-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I would say-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Alan Kelly (Tipperary, Labour)
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I will move on to the other questioners.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Can the Department of Health confirm it?
David Cullinane (Waterford, Sinn Fein)
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Therefore, the witnesses do not know.
David Cullinane (Waterford, Sinn Fein)
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How could Mr. Breslin not know?
David Cullinane (Waterford, Sinn Fein)
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I will come to Mr. Breslin later.
On the circular that we discussed, does Mr. O'Brien believe individuals made mistakes in formulating it?
David Cullinane (Waterford, Sinn Fein)
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Who crafted the circular.
David Cullinane (Waterford, Sinn Fein)
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Was Mr. John Gleeson one of the people who had crafted the circular? He certainly had responsibility.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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No. It is not futile.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Not when we are trying to establish who was responsible for them.
David Cullinane (Waterford, Sinn Fein)
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It is central to this issue.
David Cullinane (Waterford, Sinn Fein)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Connolly (Galway West, Independent)
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How many cases are there? What is the update on the number of cases that have been taken?
Catherine Connolly (Galway West, Independent)
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It will follow that up later. That is 11 in total, to Mr. O'Brien knowledge.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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I am asking what Mr. O'Brien is aware of as head of the Health Service Executive.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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It was ad hoc and haphazard?
Catherine Connolly (Galway West, Independent)
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No, I am asking Mr. O'Brien.
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien cannot answer me, as head of the Health Service Executive, as to what criteria were used to notify those 48 women.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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I am asking Mr. O'Brien to answer that question as head of the Health Service Executive.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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It was escalated to Mr. O'Brien in early 2016.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien did say that. He said that he was not aware of the significance of it. What-----
Catherine Connolly (Galway West, Independent)
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The significance of the numbers.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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No, I am asking Mr. O'Brien now. He has re-read it lately.
Catherine Connolly (Galway West, Independent)
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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-----
Catherine Connolly (Galway West, Independent)
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Please let me finish.
Catherine Connolly (Galway West, Independent)
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I am talking about what I have read in the media.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien, listen to me-----
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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.
Alan Kelly (Tipperary, Labour)
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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.
Catherine Connolly (Galway West, Independent)
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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.
Alan Kelly (Tipperary, Labour)
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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.
David Cullinane (Waterford, Sinn Fein)
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The same sequence again.
Alan Kelly (Tipperary, Labour)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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We now know that that process did not happen.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Then tell me your opinion.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I am asking Mr. O'Brien whether it was a systems failure, yes or no?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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But Mr. O'Brien is not responsible for that.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Is Mr. O'Brien responsible for systems failures within the HSE, yes or no?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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That is not what I am asking Mr. O'Brien. I am asking if he is responsible for systems failure within the HSE?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Is Mr. O'Brien accountable for systems failures within the HSE?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Mr. O'Brien is the person who is to be held to account for those systems failures.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Kate O'Connell (Dublin Bay South, Fine Gael)
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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.
Kate O'Connell (Dublin Bay South, Fine Gael)
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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".
Kate O'Connell (Dublin Bay South, Fine Gael)
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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.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Was it reassuring in your view or that of the people who advised you?
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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-----
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I ask the Deputy to be quick.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We do not have the time to get into the detail of the entire tender process.
David Cullinane (Waterford, Sinn Fein)
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Can I make a small point?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Do it very briefly.
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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So nobody can speak on your behalf or on behalf of the entire organisation.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Of the people who remain from the HSE, is there anyone qualified to talk about service level agreements?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Are signed service level agreements in place with the laboratories in America?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Would there be service level agreements with those laboratories?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Can anyone present shed further light on that?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Including reporting and communication and so on.
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is anyone here familiar with the contract with the laboratories?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
David Cullinane (Waterford, Sinn Fein)
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Does Mr. Breen want to say something?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Section 219 in Part 15 of that Act specifies that the Minister should provide those regulations. Is that correct?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Has the Minister engaged with the State Claims Agency on that?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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When was that?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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What happened since?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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From the perspective of the agency, nothing has happened.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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In terms of the periodic payment orders which are provided for in the Civil Liability (Amendment) Bill, is the situation the same?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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None of that is happening now. Is that correct?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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That is in terms of the interest rate that would apply to periodic payment orders. Is that right?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Has Mr. Breen a view on what is holding this up?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I wish to ask Mr. Holohan if he has any view as to why these things are being held up.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Okay. What about the previous issue?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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What others?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Like who?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Okay. Anyone else?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Two and a half years' worth of work?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Where there is no admission-----
Catherine Murphy (Kildare North, Social Democrats)
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May I ask just one question?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Okay.
Catherine Murphy (Kildare North, Social Democrats)
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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.
David Cullinane (Waterford, Sinn Fein)
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The Deputy's time is up, but I will allow him five more minutes.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is that a "Yes" or a "No"?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Yes, it feeds back. Does it insist on retraining, monitoring or supervision of persons involved in an incident that costs the State money?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It does not.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
David Cullinane (Waterford, Sinn Fein)
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Mr. Breen wants to make a further comment. We will then go to the HSE, to be fair to the witness.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Okay.
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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
David Cullinane (Waterford, Sinn Fein)
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I will have to stop the Deputy.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I thank the Acting Chairman and apologise for taking up so much time.
David Cullinane (Waterford, Sinn Fein)
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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.
Alan Farrell (Dublin Fingal, Fine Gael)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Alan Farrell (Dublin Fingal, Fine Gael)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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?
David Cullinane (Waterford, Sinn Fein)
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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?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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No.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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In what year was that communication sent?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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No, I am not.
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.
David Cullinane (Waterford, Sinn Fein)
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It should not take a scoping inquiry for Mr. Breslin, as an Accounting Officer-----
David Cullinane (Waterford, Sinn Fein)
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-----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.
David Cullinane (Waterford, Sinn Fein)
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This is important. Who is Mr. Breslin's line manager? Who is he accountable to?
David Cullinane (Waterford, Sinn Fein)
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The Minister, exactly. Therefore, information that Mr. Breslin gets is information that is then shared with the Minister. Is that correct?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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Why was it inaccurate?
David Cullinane (Waterford, Sinn Fein)
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I understand that. Why was it inaccurate?
David Cullinane (Waterford, Sinn Fein)
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Who gave that false information?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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Mr. Breslin is the Accounting Officer. Does he find it acceptable that his reading about this in The Irish Timeswas the first time he became aware of it?
David Cullinane (Waterford, Sinn Fein)
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Who did not give Mr. Breslin sufficient information?
David Cullinane (Waterford, Sinn Fein)
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Only CervicalCheck? Has the HSE a duty to give Mr. Breslin the information?
David Cullinane (Waterford, Sinn Fein)
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Exactly. I do not draw a distinction but the director general certainly did this morning.
David Cullinane (Waterford, Sinn Fein)
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Let us say it is the corporate body that is the HSE.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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Is that a systemic failure?
David Cullinane (Waterford, Sinn Fein)
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Is it a systemic failure?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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Given what Mr. Breslin now knows, does he believe it was a systemic failure?
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Is that a "No" or a "Yes"?
David Cullinane (Waterford, Sinn Fein)
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More fudge-----
David Cullinane (Waterford, Sinn Fein)
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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-----
David Cullinane (Waterford, Sinn Fein)
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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-----
David Cullinane (Waterford, Sinn Fein)
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Yes but Mr. Breslin is hiding behind the scoping inquiry.
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Deputy Cullinane is out of time but I will give him a few more minutes to conclude.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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In that report, at 29.2-----
David Cullinane (Waterford, Sinn Fein)
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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".
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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What was the first case and in what year was that case?
David Cullinane (Waterford, Sinn Fein)
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Yes, the very first case.
David Cullinane (Waterford, Sinn Fein)
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When was the next one?
David Cullinane (Waterford, Sinn Fein)
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Yes, cases coming across Mr. Breen's desk.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Why not?
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.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Does Mr. McCarthy want to say something on this?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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When?
David Cullinane (Waterford, Sinn Fein)
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Did that set off any alarm bells?
David Cullinane (Waterford, Sinn Fein)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We need to move on. I ask Mr. Breen to give a quick answer to that.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Can he give us information on the communications-----
David Cullinane (Waterford, Sinn Fein)
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Can he furnish it to this committee?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Can you provide the communications themselves rather than just the dates of same?
David Cullinane (Waterford, Sinn Fein)
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Yes.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Not the dates of the interaction-----
David Cullinane (Waterford, Sinn Fein)
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The actual communications-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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The detail of the interactions as well as the dates.
David Cullinane (Waterford, Sinn Fein)
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No, not the nature but the actual communications. Let us be clear about this.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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If it is emails or letters-----
David Cullinane (Waterford, Sinn Fein)
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Can Mr. Breen provide the emails or letters?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It should be easy enough to print that off for the committee. Is that right?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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Is it imminent?
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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Right-----
Alan Kelly (Tipperary, Labour)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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Is there an audit in the hospitals that looked at particular files?
Catherine Murphy (Kildare North, Social Democrats)
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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.
Alan Kelly (Tipperary, Labour)
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We have to move on.
Catherine Murphy (Kildare North, Social Democrats)
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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.
Catherine Murphy (Kildare North, Social Democrats)
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Would that be the same for breast screening and bowel screening?
Catherine Murphy (Kildare North, Social Democrats)
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Would there be any cases-----
Catherine Murphy (Kildare North, Social Democrats)
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Are there cases relating to those that have come-----
Catherine Connolly (Galway West, Independent)
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Earlier this morning, I asked for the memo and it still has not come. Why is there a delay with that memo?
Alan Kelly (Tipperary, Labour)
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I spoke with-----
Catherine Connolly (Galway West, Independent)
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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.
Alan Kelly (Tipperary, Labour)
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Does anyone from the HSE wish to respond to that?
Catherine Connolly (Galway West, Independent)
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It is just a memo. It should have been here.
Alan Kelly (Tipperary, Labour)
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It has been three and a half hours now.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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Have I misread that in the newspapers? Is my statement incorrect?
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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No, my question is-----
Alan Kelly (Tipperary, Labour)
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Allow the witness to speak, please.
Catherine Connolly (Galway West, Independent)
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Please, my question was on mandatory-----
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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Does Dr. Holohan regard what has happened with cervical smears as a serious incident?
Catherine Connolly (Galway West, Independent)
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Dr. Holohan is on record as saying he believed this was an isolated incident with Vicky Phelan.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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The Vicky Phelan case.
Catherine Connolly (Galway West, Independent)
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No. I have only-----
Catherine Connolly (Galway West, Independent)
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Listen, I am not going into the difficulties-----
Catherine Connolly (Galway West, Independent)
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-----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.
Catherine Connolly (Galway West, Independent)
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How did the Department become-----
Catherine Connolly (Galway West, Independent)
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I will. How did the Department become aware of the situation?
Alan Kelly (Tipperary, Labour)
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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-----
Catherine Connolly (Galway West, Independent)
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No, please.
Catherine Connolly (Galway West, Independent)
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No. You can explain-----
Alan Kelly (Tipperary, Labour)
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I am sorry, Deputy-----
Catherine Connolly (Galway West, Independent)
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Just one second.
Alan Kelly (Tipperary, Labour)
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Deputy, I am the Chair. Let him answer the question.
Catherine Connolly (Galway West, Independent)
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I will, but just let me point-----
Catherine Connolly (Galway West, Independent)
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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-----
Alan Kelly (Tipperary, Labour)
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It will not be long, but we will judge it.
Catherine Connolly (Galway West, Independent)
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I thank the Vice Chairman.
Alan Kelly (Tipperary, Labour)
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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.
Catherine Connolly (Galway West, Independent)
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Dr. Holohan-----
Catherine Connolly (Galway West, Independent)
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Yes.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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When did Dr. Holohan become aware it was an issue?
Catherine Connolly (Galway West, Independent)
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That is when Dr. Holohan first became aware of it.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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No. I am not using the term "false negatives".
Alan Kelly (Tipperary, Labour)
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Deputy, please.
Catherine Connolly (Galway West, Independent)
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I am using simple, plain English.
Catherine Connolly (Galway West, Independent)
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It was news to the women who were being treated for-----
Alan Kelly (Tipperary, Labour)
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The Deputy might continue.
Catherine Connolly (Galway West, Independent)
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When did Dr. Holohan become aware of it?
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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Neither of you was on the risk assessment committee.
Catherine Connolly (Galway West, Independent)
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Mr. O'Brien is on the list of directorate members as of 31 December 2016. Was Dr. Holohan a member of the directorate?
Catherine Connolly (Galway West, Independent)
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Was this issue brought to your attention at directorate level?
Catherine Connolly (Galway West, Independent)
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You were on it in 2016, though.
Catherine Connolly (Galway West, Independent)
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It was never brought to you nor discussed at this level.
Catherine Connolly (Galway West, Independent)
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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.
Catherine Connolly (Galway West, Independent)
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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?
Catherine Connolly (Galway West, Independent)
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There are 11 in total.
Catherine Connolly (Galway West, Independent)
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So when I read in the paper that there are 21 cases at different stages, it is incorrect.
Catherine Connolly (Galway West, Independent)
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Which laboratory?
Catherine Connolly (Galway West, Independent)
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It is a matter of public record if there are proceedings.
Catherine Connolly (Galway West, Independent)
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They are the subject of legal proceedings.
Catherine Connolly (Galway West, Independent)
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There are two so far.
Catherine Connolly (Galway West, Independent)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Prior to that there was nothing specific.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Do we have any information relating to the third screening programme, for bowel cancer?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Has an audit been done, or is one being done, of BreastCheck? We have four cases with the State Claims Agency at the moment.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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When did the HSE become aware there are ten cases with regard to CervicalCheck?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Alan Kelly (Tipperary, Labour)
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We requested that.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Alan Kelly (Tipperary, Labour)
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There should be a comprehensive list of people at a different level in the HSE, along with the National Cancer Registry.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Mr. Breen does not have that information off-hand.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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. 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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Do we have the memo?
Alan Kelly (Tipperary, Labour)
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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.
David Cullinane (Waterford, Sinn Fein)
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Will that be in electronic format or hard copy?
Alan Kelly (Tipperary, Labour)
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It will be hard copy for us to read it but we will get it electronically as well.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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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.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I might come in again later.
Alan Kelly (Tipperary, Labour)
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Deputy MacSharry is next but he is not here so I call on Deputy Cullinane.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Yes.
David Cullinane (Waterford, Sinn Fein)
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No, not what Mr. Breslin knows now but in terms of what they knew at that time.
David Cullinane (Waterford, Sinn Fein)
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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-----
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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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-------
David Cullinane (Waterford, Sinn Fein)
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Is that what Dr. Holohan would tell Emma Mhic Mhathúna and Vicky Phelan?
David Cullinane (Waterford, Sinn Fein)
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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------
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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With respect, through that response Dr. Holohan is giving comfort to those who failed to communicate the information.
David Cullinane (Waterford, Sinn Fein)
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Dr. Holohan is giving comfort to those people.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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However, Mr. Breslin is not making such decisions. With respect, he is almost excusing away-----
David Cullinane (Waterford, Sinn Fein)
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-----why he was not given the information.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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And Ms Lennon.
David Cullinane (Waterford, Sinn Fein)
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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.
David Cullinane (Waterford, Sinn Fein)
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And Mr. Woods.
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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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?
David Cullinane (Waterford, Sinn Fein)
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Was it enforced? Was it used in this instance?
David Cullinane (Waterford, Sinn Fein)
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It failed.
David Cullinane (Waterford, Sinn Fein)
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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------
David Cullinane (Waterford, Sinn Fein)
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No, that is not the case because open disclosure means there is no discretion. Open disclosure is that one does------
Alan Kelly (Tipperary, Labour)
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We will conclude this line of questioning because we must address the next matter.
David Cullinane (Waterford, Sinn Fein)
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I might come back on the memo in a few minutes if there is time to do so.
Alan Kelly (Tipperary, Labour)
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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.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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That is March 2016, for clarity.
Alan Kelly (Tipperary, Labour)
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No, July 2016, is it not? The first one on members' lists-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is the one he got.
Alan Kelly (Tipperary, Labour)
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------is the one he got. I presume the other two were drafts. Is that what we are told?
Alan Kelly (Tipperary, Labour)
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I ask Mr. Mitchell to speak up.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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It concludes that the first memo of July 2016 is the one to which the director general referred today.
Catherine Connolly (Galway West, Independent)
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I beg your pardon.
Alan Kelly (Tipperary, Labour)
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I have not finished.
Catherine Connolly (Galway West, Independent)
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He did not refer to it today; he referred to it earlier in the year, in March.
Alan Kelly (Tipperary, Labour)
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I know, but he could have got it wrong.
Catherine Connolly (Galway West, Independent)
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No, there was another one, in March.
Alan Kelly (Tipperary, Labour)
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I know, but in fairness to him, he said he was not sure of the date. We will have to accept his word.
Catherine Connolly (Galway West, Independent)
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We do not.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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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.
Alan Kelly (Tipperary, Labour)
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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?
Alan Kelly (Tipperary, Labour)
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Were they sent to Mr. O'Brien?
Alan Kelly (Tipperary, Labour)
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We know that the final version was sent to him.
Alan Kelly (Tipperary, Labour)
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Would members like five minutes to read the memo?
Catherine Connolly (Galway West, Independent)
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I suggest we complete what we are doing and come back to this issue. There are a number of us waiting to put questions, particularly about the State Claims Agency. We can come back to this issue which is new.
Alan Kelly (Tipperary, Labour)
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I suggest we take five minutes to read the memo. We can finish this round of questions quickly and then ask questions about this issue.
Catherine Connolly (Galway West, Independent)
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Okay.
Alan Kelly (Tipperary, Labour)
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Will Deputy Marc MacSharry be asking questions related to this memo or in the current round of questions?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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If it gives others an opportunity to read it, I can proceed on a different line.
Catherine Connolly (Galway West, Independent)
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I want to come back in on the memo as soon as I have read it, but I also want to put questions in this round. However, I think Deputy Catherine Murphy is next.
Alan Kelly (Tipperary, Labour)
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No, the Deputy is.
Alan Kelly (Tipperary, Labour)
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Thank you, Mr. Mitchell.
Catherine Connolly (Galway West, Independent)
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I have read the State Claims Agency's documentation which is very good. I have also read the chapter in 2012 by the Comptroller and Auditor General. What impresses me is that the State Claims Agency is thorough in theory and carries out an investigation. According to the chapter, only 40% of the claims which the agency came across had been previously reported as adverse clinical incidents. Is that right?
Catherine Connolly (Galway West, Independent)
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Even though there was an obligation on the various health organisations to report a clinical incident, only 40% had been reported. Given that that was in 2012, has the figure changed? Given all of the training and the importance of disclosure, what is the current figure for the number of adverse clinical incidents reported?
Mr. Cathal O'Keeffe:
We now measure in a slightly different way. The figure to which the Deputy referred was the number of claims that previously had been reported as incidents. It was reasonable that some claims had not previously been reported as incidents because it might not have been known at the time of the incident that there had been an adverse outcome and that a subsequent claim would arise. Looking specifically at claims previously reported as incidents is not terribly helpful. This year we have revised the process. When a claim comes in, we can make an assessment of whether it should previously have been reported as an incident. What we are trying to look at is the difference between the number which should have been reported and the number that were actually reported. Looking at the figure quoted by the Deputy in isolation is not that helpful.
Catherine Connolly (Galway West, Independent)
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Mr. O'Keeffe will note how difficult it is to bring accountability into a process.
Catherine Connolly (Galway West, Independent)
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Enterprises covered by the clinical indemnity scheme have a statutory obligation to report adverse clinical events to the State Claims Agency.
Catherine Connolly (Galway West, Independent)
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While it is likely that only a small proportion of adverse clinical events will lead to a claim, nevertheless there is still a statutory obligation to report them. In that regard, the figure in 2012 was 40%. What was the percentage reported in 2013, 2014, 2015 and 2016?
Catherine Connolly (Galway West, Independent)
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Does Mr. O'Keeffe know if the percentage has improved?
Catherine Connolly (Galway West, Independent)
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It was at that point.
Catherine Connolly (Galway West, Independent)
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In the case of Galway University Hospital, how many adverse clinical events were notified in 2016?
Catherine Connolly (Galway West, Independent)
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Is the information available publicly and will Mr. Breen forward a note on the matter to the committee?
Catherine Connolly (Galway West, Independent)
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What I am trying to find out is how one improves the system. Moving away from the very specific issue at which we have looked today, generally, how can the system be improved? Under the system in place in 2012, the figure was 40%, but Mr. Breen does not have any of the details. He is now telling me that he has changed the system because it was not a very reliable indicator.
Catherine Connolly (Galway West, Independent)
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I just want to know if the system has improved sufficiently that more than 40% of serious clinical incidents are being reported? I refer to Galway University Hospital and the publicity surrounding the inappropriate procedure carried out by a surgeon. It is all public knowledge. Was it reported as a major clinical event?
Mr. Ciarán Breen:
In terms of improvement, in the past three years we have gone from 130,000 incidents reported on an annual basis to 170,000. As my colleague said, we are in the process of moving to use of the new indicator. We are writing to every hospital and community health office about incident notification.
Alan Kelly (Tipperary, Labour)
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Time is up, Deputy.
Catherine Connolly (Galway West, Independent)
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I would like to finish my questioning. On the memo, this incident was not regarded as serious. The memo states it was not a patient safety incident but rather a reflection of the known limitations to the current screening test. Does the agency still hold to that view or has it changed its mind?
The national screening programme has assured the Department that no quality issues have arisen with the US laboratory which performed the testing in 2011. We now know that two laboratories are being sued in 11 cases about which we know, yet there are no quality issues with those laboratories. The solicitors for them gave an expert opinion. I have run out of time, but perhaps Mr. Breen might respond on the two issues I have mentioned.
Alan Kelly (Tipperary, Labour)
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I call Deputy Marc MacSharry.
Catherine Connolly (Galway West, Independent)
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I would like to receive responses to my questions.
Catherine Connolly (Galway West, Independent)
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I thank Mr. Breslin. Will he respond on the laboratories and quality issues?
Catherine Connolly (Galway West, Independent)
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I understand. In the meantime, the tests will continue to be carried out at the laboratories.
Alan Kelly (Tipperary, Labour)
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I call Deputy Marc MacSharry.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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How much time do I have?
Alan Kelly (Tipperary, Labour)
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We are trying to keep to six to eight minutes per person.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I will be quicker than that. I have a couple of preliminary questions before I get to the memo.
The following question was asked today in the Dáil but not answered. As I appreciate that Mr. O'Brien has left, I am addressing it to Mr. Breslin as Secretary General of the Department.
Is he, his Department or the Minister aware and, if not, can he find out because it has been suggested in the Dáil-----
Alan Kelly (Tipperary, Labour)
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Deputy Connolly asked a question. What was it?
Catherine Connolly (Galway West, Independent)
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I asked if the Vice Chairman could clarify who is doing-----
Alan Kelly (Tipperary, Labour)
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We might ask the recorders to find out. After Deputy MacSharry concludes, the next speakers will be Deputies Cullinane, Murphy and Connolly in that order.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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To recap, in the Dáil today Deputy Michael McGrath asked the Minister a question which he did not answer. It is important that we place the question on record, even though I do not like asking it. Does the director general of the Health Service Executive, Mr. Tony O'Brien, who held a different role during the period in question, have any connection to any of the laboratories in the United States, either through family association, investment, family investment or otherwise?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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If that question had been brought to my attention, I would have put it to Mr. O'Brien in person. It is important in the interests of comprehensiveness that we have that information.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We could help Dr. Scally in advance of his scoping exercise by getting an answer to the question. I ask Mr. Breslin to get an answer if he can.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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On the State Claims Agency, last week, my local newspaper, The Sligo Champion, covered the case of the Carpenter family. A settlement was made in the case after ten weeks of mediation and this was celebrated and trumpeted as the way forward. Will the State Claims Agency outline how many years elapsed between receipt by the agency of the legal letter and the beginning of the mediation process?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I understand it may have been five years. Does that seem likely?
Mr. Ciarán Breen:
It would seem very unlikely to me that we would have a case lasting five years from a letter of claim to resolution unless there were special features. Sometimes we get a delay between the date of birth of an infant with a catastrophic injury and the making of the claim. That is just a delay over time while the child is going through various tests, assessing the level of disability, for example, before the claim is made.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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The State Claims Agency issued a defence in 2017 before mediation took place. Is that right?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Would the statement of claim have been made in 2015?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Would it not be in everyone's interests to sit down on day 1?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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What would prevent that being done in this type of case?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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The blame is with process and consultants as opposed to legal positioning.
Mr. Ciarán Breen:
No, as I stated earlier, if we had a pre-action protocol where there would be no need to issue proceedings and where the claim could be set out and responded to within a protocol, the more adversarial elements that we are talking about here would not be taking place and it would be smoother.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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We established earlier that it is the role of the Minister for Justice and Equality, Deputy Charles Flanagan, to take protocols forward and he has done so. The relevant Bill was passed and signed into law by the President on 30 December 2015. It is now 2018 and nothing has happened, although Mr. Breen suggested it is a complex scenario. I suggest the matter has not been given the level of priority it requires. Does the Secretary General have a view on what is holding up pre-action protocols, other than the word "complexity"?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I have read the memorandum. May I refer to it?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I was most interested in the first version of March 2016, which the director general had. Having read it, I am shocked and it is not manufactured shock. This reads like a letter of containment. It states that screening "is not 100% accurate" and that CervicalCheck "cannot give a 'yes' or 'no' answer". I have a problem with the statement that there is, "always a risk that in communicating individual case reports to clinicians of an individual patient reacting by contacting the media if they feel that 'screening did not diagnose my cancer'." The memorandum continues: "Most importantly during the course of the clinical audit to date no systematic quality problem of concern has been identified." That is a concern.
The document subsequently states: "One of the cytology laboratory providers has sought legal advice into the right of the programme to communicate audit outcomes." The laboratories obviously had an issue with anyone being told the truth.
The memorandum continues:
The programme is liaising with legal team. This is not an impediment to moving forward with formal communication of audit outcomes.
It then sets out the next steps - this is frightening stuff - which are as follows: "await advice of solicitors"; "Decide on the order and volume of dispatch to mitigate any potential risks"; and - here we go - "Continue to prepare reactive communications response for a media headline that 'screening did not diagnose my cancer'." CervicalCheck was concerned about media reaction rather than individuals who had been falsely informed they were healthy when they could have taken remedial steps such as those we have heard about in recent weeks. The director general stated earlier he found the memorandum reassuring. If that is reassuring, it is the clearest indictment the committee and perhaps the House more generally has heard of the culture of containment, bury, suppress and protect ourselves at all costs.
I did not bother to read the two follow-up memorandums but I scanned them. The memorandum issued in March 2016 and, according to his own testimony, the director general did nothing about it from that date until he heard about it on the news. The policy of continuing "to prepare reactive communications response for a media headline that 'screening did not diagnose my cancer'" was very successful for two years because everybody, including the media, were kept in the dark for two years until the director general heard it on the news. Frankly, this is an indictment of the Minister, the Taoiseach, the Secretary General, the HSE director general and everyone else associated with this issue and are taking wages paid by the income tax from the people. The absence of humanity, compassion and accountability is a disgrace and I hope Mr. O'Brien, wherever he is en route to meetings in Limerick today, hears loud and clear that he should resign and allow us to reflect on whether the Minister, the Secretary General, I am afraid to say, and others also have to go. This memorandum, which has been in circulation for two years, indicts many more people than its author. I am disgusted. I have no further questions because what we need now are actions from so-called leaders who, in reality, are nothing more than commentators.
Alan Kelly (Tipperary, Labour)
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I am due to speak next but I will ask Deputy Cullinane to contribute now to allow me to take a note of some questions I wish to ask. He will be followed by Deputies Connolly, Murphy and O'Brien in that order.
David Cullinane (Waterford, Sinn Fein)
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Members have just received the memorandum and are still going through it. We need time to read the full detail and reflect on its content before calling for resignations. However, I share Teachta MacSharry's view that the memorandum crafted in 2016 was a letter of containment.
It was a policy of containment. It strikes me that if I were one of the women reading the memo prepared for the director general and read by him, I would be absolutely livid. What jumps from the pages is that the authors of the memo were basically saying to the director general that he needed to be concerned about the media reaction; not about patients or the women, but about the media reaction. Even in terms of the next steps, nowhere does it say all women should be informed, nowhere does it say anything about open disclosure, and nowhere does it express concern for the welfare of women and patients. Next steps include to pause all letters, await advice from solicitors and decide on the order and volume of dispatch to mitigate any potential risks. I imagine, given the next line, that the potential risks are not risks to individuals but risks to the corporate body which is the HSE. The next step is to continue to prepare a reactive communications response for a media headline that "screening did not diagnose my cancer". It is profoundly shocking that this was the issue which was uppermost in the minds of the people who wrote that memo. Is there anyone from the HSE here - Dr. Crowley, Ms Lennon or Mr. Woods - who can give any response on behalf of the HSE to this memo?
David Cullinane (Waterford, Sinn Fein)
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Who prepared the memo?
Alan Kelly (Tipperary, Labour)
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It was Stephanie O'Keeffe and John Gleeson. John Gleeson prepared it on behalf of Stephanie O'Keeffe. To be fair, John Gleeson's title is CervicalCheck programme manager, national screening service, health and wellbeing division, and he prepared this on behalf of Stephanie O'Keeffe, national director, health and wellbeing. That is just so that everyone knows who we are talking about.
David Cullinane (Waterford, Sinn Fein)
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On three occasions, I have called for John Gleeson to appear before this committee. I hope very much that he will be before the committee next week. He should have been here today. My understanding is that John Gleeson was one of those who was central to the circular we had a lot of discussion on, which was then sent to consultants. He is also central to drafting this memo. We have gone beyond expressing outrage at this point. I do not think when I look across at some of the people here that they really understand why we are outraged and concerned. I get blank responses when I look across. I will finish on this because I do not really have anything more to say; if I were any of the women who suffered because of this scandal and who are shocked, fearful and angry, I would be absolutely disgusted by the mindset within the HSE. Writing this memo was about containment and concern about the media reaction rather than for the welfare of the women. Shame on those who did that. Absolute shame on them.
Alan Kelly (Tipperary, Labour)
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I will jump in with a few questions here. I will not be long. I appreciate that HSE colleagues here have only just seen this and we do not know if the Department of Health had a copy of this at the time, albeit we will find out in the coming days. There are three versions. Without putting words in his mouth, the Secretary General said it was likely it was sent on. What jumps out most to me from what we have just read is on page 2 of the memo. It continued on the previous version. It refers, using inverted commas, to "a communications protocol" prepared for consulting clinicians to address their questions. It says the spokesman on matters related to this audit was Dr. Gráinne Flannelly, clinical director of the CervicalCheck programme, who we know has now moved on.
Unless I was chairing a different meeting, I understood earlier from the director general of the HSE that the communications he took to be in the memo and the programme of communications work was obviously with the patients first through the clinicians. This is not how that reads. Anybody reading that can see it does not use the word "patient" anywhere. It says a communications protocol has been prepared for consultant clinicians to address their questions. What about the questions of the women?
The spokesperson on matters related to the audit was named as Dr. Gráinne Flannelly, clinical director of the CervicalCheck programme. I say to all of those here that this should not give comfort that there is a communications process in place with the people that matter the most, namely, the women. It does not. It says, more or less, that there will be a protocol in place to ensure the clinicians are being told.
This is almost as if within the politics of health, it was intended to ensure that there was a protocol to tell the clinicians what was going on here and to name the spokesperson. If that is the memo written by John Gleeson on behalf of Stephanie O'Keeffe and sent to the director general, is it any wonder that the women affected were not told for years in some cases? Is it any wonder? This memo has nothing to do with communications to the patients. It only goes down as far as the clinicians. That is the most devastating part of this. It actualises what we have all been thinking and talking about for the last week and a half. That one paragraph is a communications process being put in place from the HSE through the screening programme for clinicians, not the affected women. It sums up where we are today. That is at the bedrock of where this issue lies.
The women were not being thought of. Nowhere in this memo does it say it is necessary to put in place a programme to communicate with all of the women and to ensure that they are all communicated with properly and dealt with in a compassionate way. It does not say that. It says there is a protocol in place for consulting clinicians and it names the spokesperson. Does that not say a great deal about the politics of health in Ireland and the way in which the ultimate end users, the patients affected and the women whose lives have been destroyed, were treated? It is a devastating paragraph in the letter and it is not a paragraph anybody could read to give comfort that the communications process down to the patients was going to happen.
On page 1, it states that all international screening programmes will have encountered a media headline that "screening did not diagnose my cancer". It states that the CervicalCheck programme has prepared communications material to ensure transparent, effective and robust communications processes are in place to provide clear information for the media and the public, where appropriate, on the CervicalCheck clinical audit process and results. A small issue jumps out again; the patient. It says "all international screening programmes will have encountered a media headline that "screening did not diagnose my cancer". It says the CervicalCheck programme has prepared communications material to ensure transparent, effective and robust communications processes are in place to provide clear information. To whom? Not the women affected, but to the media and the public. Transparent, effective and robust communications processes are referred to, not for the women affected but for the media and the public.
That says it all and it is quite damning. It is not what I was expecting to read given the evidence I heard this morning.
David Cullinane (Waterford, Sinn Fein)
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Hear, hear.
Alan Kelly (Tipperary, Labour)
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This is the complete opposite of what I heard this morning. From what I heard this morning, I would have been under the impression that a communications strategy was put in place to communicate with the people most affected - the women. This is a strategy to ensure that the HSE and the corporate brand is protected and to ensure that there were communications processes with clinicians in place within the political health family.
David Cullinane (Waterford, Sinn Fein)
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It does not trust women.
Alan Kelly (Tipperary, Labour)
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It forgets that they all only exist for the betterment of people's health, including that of the end users, namely, these women. This is a devastating document because of the tone used and manner in which it is written and in light of what it focuses on from a communications point of view. I rest my case.
Catherine Murphy (Kildare North, Social Democrats)
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I echo the Vice Chairman's point. This is not what I expected to read. When Mr. O'Brien was talking to us this morning, he was very much focused on the communications strategy and how it was not carried out. He went further, however, and said that when he reread it, it did not cause him any serious concern. He also talked about the requirement to manage the situation when something like this occurs in order to ensure that widespread concerns about something like the cervical screening programme are not exacerbated, which is exactly what has happened. Given the notice on this matter, which he must have read, it is very difficult to figure out why a different type of action was not taken.
The final four bullet points on the last page of the first memo include the phrase "Pause all letters", which is the converse of what we have been told in respect of the communications strategy. Obviously, legal advice was then sought. Was that legal advice received? What was that legal advice? Was that legal advice to the effect that people should not be told? Can Ms Lennon confirm that? The memo also includes the phrase "Decide on the order and volume of dispatch to mitigate any potential risks". I presume that refers to the order and volume of the letters that were to be sent to clinicians in respect of making contact with the patients who had received false negatives. It is, therefore, about who would be told first and in what order people would be told in order to mitigate risk to the organisation and the programme. On what is termed the "reactive communications response", I presume there is correspondence or a body of documentation in respect of that response. It would be useful for us to see that because clearly it will have been worked through. The witnesses might tell us what kind of working through would have been done and who it would have been done with.
I would particularly like to know what constitutes a patient safety issue? That kept jumping out at me as it was being said over the past week or so. People said that it was not a patient safety issue. I am certain the patients do not feel that reflects their experience. Will the witnesses tell us how that is defined and where the judgment call is made in that regard? There are a number of questions there. Some are addressed to Ms Lennon, others may be more appropriate for Dr. Holohan.
Ms Maura Lennon:
The position on the legal advice is that I have not seen this memo before now. At the time it was prepared in March 2016, I was not in my present position as acting head of legal services. Unfortunately, I am not aware of the legal advice which was sought or which may have been provided so I regret that I cannot assist the Deputy with any more detail on that particular point.
Catherine Murphy (Kildare North, Social Democrats)
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Can Ms Lennon come back to us on that point?
Catherine Murphy (Kildare North, Social Democrats)
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I ask her to do so as soon as possible. We will be revisiting this issue next week and it would be very helpful if we had the information in advance of our meeting. I do not know who would deal with the communications strategy. There would have been a communications strategy and it would be quite useful for us to see it because it would seem to be at variance with the information in the public arena about there being a strategy to communicate with the individual clinicians who, in turn, would communicate with the patients.
Mr. Jim Breslin:
I very much agree with the Deputy. I have only read the July memo because that is where I got stuck, but there is a reference to a communications protocol having been prepared. Seeing that communications protocol would also be very useful. The memo says that the protocol was for consulting clinicians in order to address their questions. What is not to the fore here, as the Vice Chairman said, is the women. If, in the communications protocol, people had put themselves in the women's shoes and asked the questions they would ask their clinicians, it might be helpful to see.
Catherine Murphy (Kildare North, Social Democrats)
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Yes, that would be helpful. There are two communications issues here. The first is most definitely that protocol and the second is that there is a communications strategy in respect of the media. It is important for us to see what that strategy was. There may have been other strategies in respect of follow-on care and the reassurance that people might receive - reassurance which, I believe, is still absent - in respect of the CervicalCheck programme. I am certainly being asked to ask certain questions in emails and in telephone calls to my office. That is the kind of thing I am getting. I am sure it is the same for other Members. If a strategy had been worked out in respect of the questions that people who are fearful would be prompted to ask, surely we would also see that. There will probably be three different types of strategy involved. We might see what the HSE has with regard to all three. I would like the witnesses to tell us if they do not exist. On the issue of patient safety, how is it defined?
Dr. Tony Holohan:
On the issue of patient safety, in a broad sense we categorise cases in different levels. When we find out about something the first objective we set for ourselves is to determine whether anything about the incident represents a risk for people who have yet to use the service. I am not talking about screening, I am just talking in a general sense. We ask who would be at risk if the service was to continue on the same basis without something happening. Such cases are the first group. The next group relates to instances where there is reason to believe something about the use a group of people made of a service placed them at risk or harmed them and where there is a need to look back to identify such people and to put in place some service to address whatever has been identified. The next would be individual incidents which are very significant but which might not have either of the first two ramifications I have identified.
Catherine Murphy (Kildare North, Social Democrats)
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In looking at the correspondence, does Dr. Holohan believe it is an accurate reflection to say that this was not a patient safety issue?
Catherine Murphy (Kildare North, Social Democrats)
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The people who have had a false negative result have to be considered in the context of this as well. Is that not considered a patient safety issue?
Catherine Murphy (Kildare North, Social Democrats)
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Would the witness read that in both respects, or would he only read it in the context of the cervical screening service?
Dr. Tony Holohan:
That is a fair question. Clearly it applies to people who are the subject of the audit, in particular with the finding that the disclosure of information to them did not happen. It is a significant patient safety issue, which can clearly be seen now. It is not apparent from the note that that was evident at the time. I have not had a chance to read the full note.
Catherine Murphy (Kildare North, Social Democrats)
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The witness might read the four bullet points on the last page, which are pretty damning. That is all he needs to read. One of the bullet points says that all letters should be paused. That is the opposite of open disclosure.
Alan Kelly (Tipperary, Labour)
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What would the National Patient Safety Office have to say about all of this? I hope it is watching this.
Alan Kelly (Tipperary, Labour)
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It is incredible.
Dr. Tony Holohan:
I am seeing this now. My general understanding about the audit and the arrangements in place for feedback to clinicians and so on, is that I knew that those features were part of the screening service arrangements and I saw them as positive developments. What has come to light in the past two weeks, that in fact the screening programme was not operating the policy of open disclosure it purported to, changes that.
Catherine Murphy (Kildare North, Social Democrats)
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Is the witness shocked by the four bullet points suggesting the next steps?
Alan Kelly (Tipperary, Labour)
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We will have to find out. The last document is not signed. We need to find out who wrote it, the context in which it was written and who the writer was reporting to. Is it by the same people who wrote the other two memos? We do not know and cannot say, and to be fair to those people we have to find that out. It is quite damning if the proposed next steps are as outlined in this memo. It is also quite damning that the Department of Health is saying that it is quite damning.
Catherine Murphy (Kildare North, Social Democrats)
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Can I clarify that the piece of information I sought will be forthcoming?
Alan Kelly (Tipperary, Labour)
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Is that okay?
Catherine Connolly (Galway West, Independent)
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I want to go back to basics. I asked Mr. O'Brien when he found out about this and he clearly said early 2016. We then get a memo from March 2016. He knew as far back as March 2016. There is no date or signature on that memo, which is extraordinary. Was the Department aware of this memo or the other two memos?
Catherine Connolly (Galway West, Independent)
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I heard him say that he got a memo. I did not hear anything else.
Catherine Connolly (Galway West, Independent)
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The Department was possibly aware of this March memo. Does that mean that Dr. Holohan and Mr. Breslin were possibly aware of it?
Dr. Tony Holohan:
I honestly do not know. I am not going to say that I was not. I do not want to delay the Deputy but I want her to understand the arrangements we had in place for the engagements with the screening programme. There is a means for us, on a monthly basis, to sit down with the cancer control programme as part of the screening service. There is an ongoing dialogue about issues as part of those types of engagements.
Catherine Connolly (Galway West, Independent)
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Will the witness listen to me?
Catherine Connolly (Galway West, Independent)
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This matter has come to light because brave women have come forward. I have tried to stay away from emotions. It has taken a number of deaths, several committees and until now today to establish the existence of these memos. As the head doctor in the Department, was the witness aware of any of these memos? The answer is yes or no.
Catherine Connolly (Galway West, Independent)
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Was Mr. Breslin aware?
Catherine Connolly (Galway West, Independent)
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The memo we have seen is from March 2016. It is undated and unsigned. Did Dr. Holohan stand over it? It says that there was a risk - not to the lives of the women or their health - that in communicating individual case reports to clinicians the patients would go forward to the media and there would be headlines such as, "Screening did not diagnose my cancer". This was the risk that this memo was zoning in on. It is not focused on the risk to lives or health. Does the witness stand over that?
Catherine Connolly (Galway West, Independent)
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Does the witness know whether he was aware of this and thought that it was okay or not at this point?
Catherine Connolly (Galway West, Independent)
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The contents are shocking. I believe we would all agree with that. Was the witness aware of this memo? Did he stand over the content of this, as the chief medical doctor?
Dr. Tony Holohan:
I cannot honestly tell the Deputy whether I saw this specific memo or not. The general information it includes is not, in broad terms, new information to me. Given my understanding of screening programmes, and if I am in a position to do so, I can outline and explain why that is the case.
Catherine Connolly (Galway West, Independent)
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The witness may do that with the Chair's time afterwards, perhaps, but I-----
Catherine Connolly (Galway West, Independent)
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-----have repeatedly heard that there is a problem with communication. I have heard that it was a communications issue, an isolated case and that nobody knew. We all know now. I am saying to the witness, as the chief doctor, that the message in this memo has nothing to do with difficulties with cervical smears. It concerns controlling the message and anticipating screaming headlines. That is the risk that is being discussed here.
Dr. Tony Holohan:
I can point out, if it is helpful, that the people who were charged, in both policy and operational delivery terms, with the operation of screening programmes are genuinely concerned about the way, manner and means of communications of false negatives, when they do occur, and their impact on the reputations of programmes. It is an international phenomenon, and these people have genuine concerns about it. The literature is full of that type of concern. I am not suggesting it. There is nothing different in that.
Catherine Connolly (Galway West, Independent)
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I have tried to avoid making conclusions all day and to listen with an open mind. At this point I am finding it extremely difficult. I have read the three memos very quickly. It is clear that containment of the problem is being attempted here. Would the witness agree with that?
Catherine Connolly (Galway West, Independent)
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The witness disagrees.
Dr. Tony Holohan:
I outlined the reasons why I disagree earlier and I am happy to say it again. My understanding of screening programmes at a European level - and I understand this from my own knowledge - is that open disclosure policies, regrettably, are not well developed. We have evidence that our screening programme was attempting to put an arrangement in place to look back at areas of the programmes where audit was not standard and to feed back that information. We know that it did not work.
Catherine Connolly (Galway West, Independent)
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What we know is that an undated, unsigned memo was sent to Mr. O'Brien in March 2016. We know that the witness, the chief doctor in the Department, is not sure whether he saw this memo and that he is not telling us whether he disagrees with the message contained in the memo which states that the message to the media must be controlled. There are no alarm bells about the women.
Catherine Connolly (Galway West, Independent)
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What did the witness say?
Dr. Tony Holohan:
I am very sensitive about any sense that messages are being controlled. I am saying that the memo, in language I would not use, appears to advert to what is a known international phenomenon of general concern for the reputation and uptake of screening programmes when harms that arise come to public prominence.
Catherine Connolly (Galway West, Independent)
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There are serious concerns for reputation as opposed to women's lives and women's health.
There are two other memos from July. No specific date is given for either. There are contradictions between the two memos. For example, one memo refers to over 1,200 cases and the other mentioned 1,100.
In relation to letters, to date a total of 86 letters went out with 200 more to go. According to the other July note, 56 letters have gone out. I do not know why there are two similar notes. Was Dr. Holohan aware of those?
Catherine Connolly (Galway West, Independent)
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We are looking at these. At this point, would Dr. Holohan have serious concerns about these notes and the nature of the content of them? Would Dr. Holohan, as the Chief Medical Officer, have serious concerns about the content of these three memos?
Catherine Connolly (Galway West, Independent)
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Okay, that is fine.
Dr. Tony Holohan:
What I would say to the Deputy in relation to this is it is not giving me new information that gives me a concern on the basis of what it is saying about the standard and performance of the screening programme at that time. It is giving me, in language that I would not use - when I look back now and see the language and how it might be interpreted I can see exactly what the Deputy is saying and I understand exactly why the Deputy is saying it - the arrangements that were put in train in relation to clinical audit and the arrangements that were put in place in relation to feeding information back to patients I saw at that time as developments that were ahead of most other countries in relation to screening and that is how I am interpreting it.
Catherine Connolly (Galway West, Independent)
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I am not allowing Dr. Holohan at this point to go down the route of telling me how good the service is. That is not for here. What is for here is accountability.
Catherine Connolly (Galway West, Independent)
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And whether he can stand over it.
Catherine Connolly (Galway West, Independent)
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Is Mr. Breslin standing over these three memos?
Catherine Connolly (Galway West, Independent)
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I am asking Mr. Breslin-----
Catherine Connolly (Galway West, Independent)
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No, I am asking Mr. Breslin.
Catherine Connolly (Galway West, Independent)
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I am asking Mr. Breslin now. I asked Dr. Holohan the same question. Is Mr. Breslin standing over the content of these three memos?
Catherine Connolly (Galway West, Independent)
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Good.
Catherine Connolly (Galway West, Independent)
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Sweet Jesus. Honestly, at this point, I have really tried. I think they have no concept of the damage that has been done. Leave that aside, you have no concept of accountability. We have three memos with no dates. We have one memo with no signature. We have a memo addressed to somebody who was on the directorship of the health board. Dr. Crowley is on the directorship, is that correct?
Catherine Connolly (Galway West, Independent)
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Dr. Crowley was on the directorship, and Mr. Woods. Am I correct that the person to whom this note was addressed is also on the directorship? This states:
On behalf of
Dr. Stephanie O’Keeffe
National Director, Health and Wellbeing
She was also on the directorate. Was this raised at the directorate?
David Cullinane (Waterford, Sinn Fein)
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They are for different points in time. We have got them from the dates on them.
Alan Kelly (Tipperary, Labour)
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In fairness, we asked for the memo today and we can only work on what we have here today. If there was a final, final, final memo, it should have been provided. What we are working off today is all we can work off. We cannot deal in hypotheses.
Catherine Connolly (Galway West, Independent)
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Chairman-----
Alan Kelly (Tipperary, Labour)
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No, sorry. Deputy O'Brien has been waiting for some time.
Catherine Connolly (Galway West, Independent)
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I was in the middle of a sentence. Briefly, I asked the question, not about a memo. I asked when did Mr. O'Brien become aware of the situation. This was Mr. O'Brien's answer. He said, "A memo." It turns out to be three memos. In that context, I am asking Mr. Breslin the question.
My final question relates to the laboratories. There was obviously a discussion with the laboratories which said, "had difficulties that the women would be communicated with". Has Mr. Breslin seen that in the memos?
Catherine Connolly (Galway West, Independent)
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The laboratories interests were of the utmost concern to whoever wrote this memo.
Alan Kelly (Tipperary, Labour)
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Deputy O'Brien is next. Deputy Cullinane is taking the Chair.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Where even to start? I do not want to say something which is inaccurate. I want to try and get the timeline in my own head. Maybe Mr. Breslin can agree or, if it is wrong, he or whoever can correct me.
In relation to the timeline, an audit was carried out. That was the first step. There was then a decision taken that the results of that audit should be communicated. We can say that whether it should have been communicated with the clinicians or with the women is a matter of opinion right now, based on the memos we have just got.
I presume there was a decision then to relay that decision to the laboratories, so somebody must have picked up the phone to the laboratories and said that he or she was going to relay the outcome of the audit to either the clinicians or the women as part of the HSE's open disclosure policy. The laboratories objected to that. They issued legal letters in relation to that outlining their opposition to the results of the audits being communicated - I will not say being made public - to clinicians or women. Is that correct?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Yes. It is clear from this.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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A memo states they "have reacted with concern in some instances to the ... Programme communicating cytology review findings to [not even women] treating clinicians and there has been legal correspondence in previous months." I would presume the correspondence is in relation to the decision to relay that information to clinicians.
Mr. Jim Breslin:
I am also looking at the March memo, the last page of which states:
One of the cytology laboratory providers has sought legal advice into the right of the programme to communicate audit outcomes. The programme is liaising with legal team on this.
I just mentioned a moment ago, it is also important that it goes on to say, "This is not an impediment to moving forward with formal communication of audit outcomes." The Deputy is definitely correct. Somebody was saying, "What are you doing there?"
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I accept that. The July memo states that the national screening service "met with one of the laboratories in May 2016 and legal correspondence has ceased since that meeting." The question I would have to ask is, what was said at that meeting to reassure the laboratories? I am presuming and I do not want to be presuming. That is why I am asking the question. There must have been something said at that meeting between the national screening service and the laboratories in May 2016 which allayed their fears and the laboratory in question then decided not to pursue any further legal correspondence. That is one question and I do not know whether anyone in this room has the answer to it. What was said at that meeting? Were assurances given to the laboratories? Was the open disclosure protocol or policy which was to be rolled out, that we discussed earlier, relayed to the laboratories? I do not know the answer to that and maybe somebody here might.
The other point I want to clarify is the numbers. The two July memos or briefing notes that we got contain two different figures. That may be because one dates from the start of July and the other dates from the end of July. We do not know because they are not dated. It only states "July". One is for 256 and the other is for 286. I am just looking for some information on this. We now are dealing with 209 women. What happened to the other letters? Who were they being sent to? If the HSE is saying we have 209 women who needed to be informed, either through their clinician or directly, where are the figures of 286 and 256 coming from and how did we get from those figures down to 209? That is my second question.
My third question relates to a paragraph in the July memo on the amount of correspondence which will have to be sent out.
It says that from September 2016, letters communicating the cytology review findings are likely to issue at a rate of four to six per month. There was either 256 or 286 letters, but in both memos it says there are approximately 200 letters left to be issued, at a rate of four to six per month. Even if the higher figure of six is taken, it would take two years and seven months.
Mr. Seamus McCarthy:
I have had a chance to look at some of the anomalies in the numbers. My interpretation of the July figures is that one relates to an eight year period of data or notifications whereas the other one relates to a seven and a half year period. I would say the difference between the 256 and the 286 or 288 is a seven and a half year period and an eight year period. My interpretation on the volume of correspondence is that they were recognising a backlog that had to be cleared in July-August 2016 and that once it was through that it would be in a steady-state of notifying four to six women per month, into the future, as false negative cases would have arisen. I think that is what explains those figures.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I appreciate that. On the memo that was sent in March, which is the one Mr. Tony O'Brien said he saw, I want to quote what the director general said this morning. He said that the memo outlined that a communication process was going to be put in place. When pressed, he said that if the process had been carried through there would be no woman who was not informed. I do not know how that can be taken from that memo because nowhere in the memo does it say it will inform women. It says it will inform clinicians. The memo says the volume of letters increases the risk of an individual reacting to the content if or when shared by the attending clinician. It is not even clear from this that the attending clinician would share the information as it says "if" or "when".
Dr. Tony Holohan:
Can I make some points of general clarification on the numbers and not so much around the precision? The number that is here is the number that is flagged for review. The 209 that is circulating at the moment relates to those that have been reviewed in terms of their cytology and what is called a discordance - in other words, the difference in what we say now looking backwards and what was said then has been identified. That is what that number of 209 relates to and it relates to the cohort of years. It is not just the eight years but it is all the way up to the end of last year, in effect, because there were effectively two more years worth of the screening programme operating and contributing to that number. Those numbers get done by starting with all of the incident cases it knows about. We now know it did not know about the ones the registry had or did not include those. It worked those down. The question it is effectively asking is where a person who has cervical cancer, was there some failure in the chain of screening that failed to take the opportunity to prevent this cancer from occurring? That could be because an appointment was not sent out. It could be because the person did not respond to an appointment. It could be the screening. It could be the GP service not taking an adequate smear. It could the cytology or colposcopy service after the full chain is looked at. Only those where there is a reasonable suspicion that it is the smear that needs to be looked at are flagged for review and then a subset of those are identified where there is that discordance or difference between what it said back then in the report and what it now appears to be saying. I wanted to explain that.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I refer to what the Comptroller and Auditor General said in respect of 286 as opposed to 209, which is the number that is out there. Can someone explain the difference?
Mr. Seamus McCarthy:
The Deputy wants to know where I got the figure of 288. I was working off the 1,200 cases in the latest figures for eight years. The point is made that approximately 30% of the total notified cases have been flagged for a review. The figure of 30% of 1,200 is 288 by my reckoning. That is where a figure of about 288 comes from.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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That letter would have been to inform the clinician-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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The 20% is in relation to missed appointments or-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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That is where we get the figure. What was the nature of the letters that were sent out?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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We can go over the figures but it does not change the fact-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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-----that nowhere in the memo the director general saw does it state that a communication process is under way to inform the women.
Mr. Jim Breslin:
The only thing I think that is worth digging further on, and I hope it will be available to the committee, is that it says a communication protocol has been prepared for consulting clinicians to address their questions. If we saw that and if it detailed the questions women would have as this result is communicated to them and it set out all the thinking on that-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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The circular was the communication process.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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In regard to the communication process the director general spoke about today, was that the circular which was issued?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Does anyone know? What was the communication process?
David Cullinane (Waterford, Sinn Fein)
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Can I pause an Teachta O'Brien for a second? I want bring in Mr. Mitchell if he is able to help us. The problem we have here is that we are discussing three memos or briefing notes, depending on how they are viewed and the director general of the HSE is not here or there is nobody senior from the HSE here who can answer the questions we have. We are asking the Department to answer questions on behalf of the people who wrote this. We will have them in next week. There are genuine concerns on the status of these three documents we have before us. I think Mr. Mitchell said that the director general certainly had sight of all three documents.
David Cullinane (Waterford, Sinn Fein)
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My understanding-----
David Cullinane (Waterford, Sinn Fein)
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Maybe Mr. Mitchell can take a seat for a second.
David Cullinane (Waterford, Sinn Fein)
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I know that.
David Cullinane (Waterford, Sinn Fein)
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You clarified that he had sight of all three.
David Cullinane (Waterford, Sinn Fein)
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The obvious question then is, when did he have sight of each of the individual documents? There was the March 2016 briefing note. I imagine that was a briefing note that was contemporaneous in terms of what was being given to the director general at that time. We then have an updated one in July 2016 and a further one in July 2016, two separate ones, is that correct?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Can Mr. Mitchell clarify which of the two notes in July is the earlier one?
David Cullinane (Waterford, Sinn Fein)
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Which one is the latest one of the two July documents? My question to Mr. Mitchell is, are these three separate briefing documents that were given to the director general at different times or did he receive all three documents, all three iterations of briefing notes, at once?
David Cullinane (Waterford, Sinn Fein)
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That would be my reading of it.
David Cullinane (Waterford, Sinn Fein)
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That would be my reading of it as well but is it not absolutely-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is Mr. Breslin saying that the start of July 2016 and 1,200 case one is the second of the three?
David Cullinane (Waterford, Sinn Fein)
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Is it not amazing that we have got three of these documents? First of all, we sought a memo. There is no cover note to say in what context and all of us here are trying to guess. I find this extraordinary.
David Cullinane (Waterford, Sinn Fein)
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I am not blaming Mr. Mitchell-----
David Cullinane (Waterford, Sinn Fein)
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What the committee sought was a copy of the memo. What we got was three different documents. We now have members who are more confused than they were before they got the documents, because we are trying to figure out between us which was which. Were they all sent at the same time, or were they sent to the director general at the time that they were crafted, which was March and two in July documents? We are still guessing.
David Cullinane (Waterford, Sinn Fein)
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It is referred to but it does not tell us-----
David Cullinane (Waterford, Sinn Fein)
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That is obvious, but it does not tell us, basically, the context of each of them.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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The difficulty I have, and I will wrap up on this, is that we were told this morning by the director general that the memo he received indicated to him that a communication process was under way to inform the women. That is what was said. When he was pressed, he said that if the process had been carried through, there would have been no woman who was not informed. Nowhere in any of these three documents does it state that the women must be informed. One memo says "if" or "when" they are informed. The other ones talk about a communications process to the clinicians. I do not understand how the director general can say that he was under the impression that women were going to be informed. He has admitted this morning that is a systems failure. He is the person accountable for that systems failure, but he will not take responsibility for it.
David Cullinane (Waterford, Sinn Fein)
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I am not going to allow anyone to speak for the director general because he should speak for himself but cannot speak for himself. A lot of people are making excuses for people who are not here. When Teachta MacSharry is finished, I will come to the witnesses we hope to have in next week, who will shed more light on this because there are a lot of outstanding questions for individuals. Could the Deputy be as brief as possible, please?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I appreciate there are not too many off here at the moment, but it may well be necessary to re-invite Mr. O'Brien as part of that grouping, whether it is next Tuesday or Thursday - I know he had other commitments today - should he still be in the post.
I wish to ask Mr. Breslin if the Department received these memos.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Pending the clarification, these documents may possibly have been circulated to the Department of Health. Is it reasonable to assume that the Minister would be informed of these things?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Who was Minister for Health in 2016?
David Cullinane (Waterford, Sinn Fein)
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Are they all the same? Is it that hard to-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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In May 2016, there was a change between-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I am just trying to remind Mr. Breslin because we are all trying to concentrate on a number of different issues.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Before that it was the Taoiseach, Deputy Varadkar?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It may have gone to Dr. Holohan. Has he any recollection of these memos going to him?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It would be very useful then-----
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It is surprising to me.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I appreciate a trawl is being done but, as quickly as humanly possible, we need to know was the document received and who was it shared with. Was the Minister or other Ministers informed? Did the document go to Cabinet?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Is that not a communications failure in itself?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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If something as important as that came in, is that not Secretary General level stuff as opposed to the post room?
Mr. Jim Breslin:
I am going to have to establish this. What I am very clear about is that it could not have gone to Government because I would have known it. In the normal course, I would not see it as an item for Government. We will do the search and we will see where it was within the Department, if it came in, and what was done with it.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Was it passed to ministerial level?
David Cullinane (Waterford, Sinn Fein)
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When Mr. Breslin spoke about doing a search, what exactly will be searched?
Mr. Jim Breslin:
The process we have under way at the moment is of the paper files and electronically. We are using various key words that are likely to generate material in relation to this. They will also generate material which is not related to this, and we then go through that to see what are the relevant records that relate to this
David Cullinane (Waterford, Sinn Fein)
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Has Mr. Breslin been looking for this for a couple of weeks?
David Cullinane (Waterford, Sinn Fein)
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How long has Mr. Breslin been searching for the communication Mr. O'Brien was talking about?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Ms Lennon is the head of legal affairs for the HSE.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Was Ms Lennon in post during this period in 2016?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Was the witness in the legal department at this time?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does she recall legal advice referred to in the March memo?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It states: "await advice of solicitors". Would that be Ms Lennon's department or-----
Ms Maura Lennon:
No. The system that applied was that there was a very small in-house legal department in the HSE system. The vast majority of the legal advice and legal services have been outsourced to private law firms which are contracted following a tender process.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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What does the legal department do?
Ms Maura Lennon:
Our function is to largely oversee the management of the law firms which provide us with legal advice and to assist generally within the HSE system, occasionally for requests for legal advice.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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I am talking about the March memo where it states "pause all letters". Does this mean any letters going to patients?
David Cullinane (Waterford, Sinn Fein)
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Can I ask the Deputy to finish quickly here, please?
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Yes, I am nearly finished.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Following on from what Deputy O'Brien said, and I will conclude on that, it is not even implicit never mind explicit in any of these three copies that the patients, the women, were to be told.
They refer to clinicians and that is a matter for them because, as we know, we do not have open disclosure.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Yes.
Dr. Tony Holohan:
On page 1 of the first memorandum, the third paragraph after the heading "Current Status" in the middle of the page states, "... the Programme commenced the formal step of communicating cytology review findings arising from the clinical audit to the treating clinicians looking after individual women diagnosed with cervical cancer." I would not have concluded from that the patients would not hear. I would have concluded the opposite. I know there has been a dispute among clinicians which we would not have been aware of at the time. I would have understood this to have been something like radiology so radiologists would give findings back to a clinician who is looking after a patient and it is explained to a patient in the context of their care.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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As Deputy O'Brien stated, there is already a circular in play stating that this is at the discretion of the clinician.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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It is at the clinician's discretion.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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Given the next steps defined in the first memorandum about reactive communications and the preparation of responses for media headlines, it is certainly well within the bounds of possibility that any communication - we would love to see copies of the communications that went out - might have suggested that although the decision was at the discretion of clinicians, they should be careful about doing more damage than good.
Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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That is a concern. I thank the Acting Chairman for allowing me to contribute again.
David Cullinane (Waterford, Sinn Fein)
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Before we conclude, it is important to review what we have agreed for next week. Before I do that, I believe I can speak on behalf of all members on this issue. Today started for me with the "Morning Ireland" interview with Emma Mhic Mhathúna. Since then, I have spent hours at this meeting and I have found this to be one of the most depressing exchanges the committee has had because of the absolute lack of information forthcoming. There is still serious confusion and nobody wants to take responsibility for anything. This is a source of great irritation to me and I am deeply shocked.
I will make a final point on the first briefing note of March 2016 and the statement in that note that there "is always the risk that in communicating individual case reports to clinicians of an individual patient reacting by contacting the media". The concern was that the women might go to the media and that women should not be trusted. That is the message I get from the briefing note. This is beyond shocking when one considers how this day started for most of the people in the room.
To take up the point made by Teachta MacSharry, it is important that the director general of the HSE appears before the committee again next week. Dr. Holohan tried to do his best to interpret elements of these briefing notes but we have only an interpretation. We need to hear from the people who wrote the notes and the HSE director general who is responsible for overseeing all of this. The correct course of action, therefore, would be to invite Mr. O'Brien to appear again and if he cannot attend, the person who is next in charge, whoever that may be. Mr. O'Brien should, however, make himself available. The Department also needs to be represented and I hope Mr. Breslin, when he returns next week, will have found the correspondence he indicated he started to look for today. It would be great if he had that material next week in order that members could discuss it. He can send it on to the committee at any time. If he does not have it, that would indicate to me that it was never sent. We will find out next week.
The other witnesses we hope to have before the committee next week are Mr. John Gleeson, Dr. Stephanie O'Keeffe, representatives of the National Cancer Registry who, I understand, have confirmed they will attend, the national director of human resources in the HSE and a representative of the Medical Council. All the relevant invitations will issue.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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A representative from the National Cancer Screening Service should also attend.
David Cullinane (Waterford, Sinn Fein)
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Yes. My understanding is that our meeting with representatives from the National Treatment Purchase Fund and nursing homes to discuss the 2016 financial statements will proceed. As a result, there will be two elements to next week's meeting. While it is a matter for the Chairman and clerk to sort out times, I expect the more lengthy of the two sessions will be the follow-up discussion with the HSE. I hope the individuals to whom I referred will be able to make the meeting. It would also be useful to have Mr. Breslin attend.
David Cullinane (Waterford, Sinn Fein)
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While I am aware that this has been a long day for witnesses and that many of the questions have been robust, they will understand that members have a job to do and must put questions. I thank them for their attendance.