Oireachtas Joint and Select Committees
Wednesday, 2 May 2018
Joint Oireachtas Committee on Health
National Cervical Screening Programme: Department of Health, HSE, CervicalCheck and the National Cancer Control Programme
9:00 am
Michael Harty (Clare, Independent)
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I remind witnesses and members to turn off their mobile phones or put them on airplane mode, as they can affect the recording of the meeting.
We are meeting officials from the Department of Health and representatives from the HSE, the national cancer control programme and CervicalCheck in order to discuss the controversial issues surrounding the CervicalCheck programme. On behalf of the committee, I welcome Dr. Tony Holohan, chief medical officer at the Department of Health, Dr. Kathleen MacLellan, director of the National Patient Safety Office at the Department, and Ms Tracey Conroy, assistant secretary of the Department's acute care division. From the HSE, I welcome Mr. Tony O'Brien, director general; Dr. Colm Henry, chief clinical officer; Dr. Jerome Coffey, national director of the national cancer control programme and screening service; Dr. Peter McKenna, clinical director of the national women and infants programme; Ms Angela Fitzgerald, deputy national director of acute services; Mr. John Gleeson, programme manager of CervicalCheck; and Mr. Patrick Lynch, national director of quality assurance and verification and chair of the serious incident management team. I thank everyone for attending.
I wish to draw witnesses' attention to the fact that, by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses 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 a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and 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. Any opening statement they make to the committee may be published on the committee's website after this meeting.
Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official either by name or in such a way as to make him or her identifiable.
I invite Dr. Holohan to make his opening statement.
Dr. Tony Holohan:
I thank the committee for the opportunity to address it. I will start by acknowledging the important role that Vicky Phelan has played in highlighting a number of major weaknesses in how people have experienced our national cervical screening programme, CervicalCheck. The Minister has publicly commented on his swift action so far to address these issues. He has also expressed his gratitude in public to Vicky Phelan, which I will do here again, for her courage in bringing forward these issues. Without her, we would not have the opportunity to learn the lessons that I am confident we will learn from this circumstance. Without attempting to set out a comprehensive roll call, she adds her name to a range of other patients to whom we are grateful who had to come forward in similar circumstances to raise issues of public concern, leading to improvements in the system. Not least of these are Susie Long, Rebecca O'Malley, Róisín and Mark Molly and Shauna Keyes, but there are many others. Our challenge will be to derive what value and learning we can from Vicky Phelan's experience, which she courageously brought forward, and use them to improve the system.
Vicky Phelan was diagnosed with cervical cancer in July 2014 and, sadly, was informed in 2017 that her cancer was incurable. In 2014, CervicalCheck's clinical audit of Ms Phelan's 2011 smear test result, which was reported at the time as normal, identified a query squamous cell carcinoma. However, Ms Phelan was not made aware of this finding until September 2017. This delay has raised serious concerns about the processes for providing information to patients and clinicians.
Subsequent to the controversy that arose surrounding her case, the HSE initially advised that, between 2008 and early 2018, 1,482 cervical cancer cases were notified to CervicalCheck. The majority were women who had already been referred for further investigation or for treatment by CervicalCheck. As part of the clinical audit process, these notified cases were re-examined and a number were flagged for further cytology review. In 208 of these cases, the cytology review recommendations differed from the original results.
Last Friday, 27 April, the HSE established a serious incident management team, SIMT, to oversee and direct the management of this incident. The SIMT has reported that approximately 162 of the 208 women involved have now been informed of the outcome of the audit process. Communication with these women is ongoing. We have further details, which we would be happy to share with members. I regret to say that 17 of the 208 patients are deceased. Like the Minister, we express our sympathies to the families of those patients.
Arising from the work of the SIMT, and as outlined by the Minister last night on the floor of the Dáil, the number of cases of cervical cancer notified to CervicalCheck - 1,482 - does not represent all of the cases of cervical cancer occurring in Ireland since the establishment of the programme in September 2008. I regret to say that I do not at this point have the necessary information to confirm how many additional cases this might represent, but work has started on ascertaining what that number is. We will detail that work. The Minister has directed that immediate steps be taken so that information from the national cancer registry on any additional case of cervical cancer that occurred during that period is provided to the CervicalCheck programme. Any screening history that those additional cases may have - not all will necessarily have been screened - will be established. If any of these women was screened through the CervicalCheck programme, her case will be reviewed in further detail, with cytology review where necessary. A helpline has been in operation at the national cancer screening service since Friday and clinical staff are following up with women on their specific clinical questions.
Since 2008, some 3 million smears have been carried out by CervicalCheck. It is important to note that the cervical screening test is not a diagnostic test, only a screening test, that is, a test to indicate the possibility of pre-cancerous or cancerous lesions, thereby identifying women who need to be referred for further investigation or follow-up. Smear tests can produce false positive and false negative results.
Therefore, cervical cancer may well develop in the time interval between a negative screening test and the next scheduled screening in any cervical screening programme. The current primary screening test used by CervicalCheck is a cytology test which is known to have low sensitivity, that is, it produces a not insignificant number of false negative results. Naturally, many women are now concerned about their own health following the publicity surrounding CervicalCheck. It is certainly our intention, if we may, to use the committee and its indulgence to reassure people about the performance of the programme in relation to those people. In order to provide assurance, CervicalCheck will make the necessary arrangements to enable any woman who has had a CervicalCheck smear test to have a consultation with her GP, in order to help her determine whether she wishes to have a further test without charge. These arrangements are currently being worked through and will be confirmed this week. We will hear further detail of this over the course of the afternoon.
In addition, in February 2018, the Minister approved the introduction of primary HPV screening for cervical smear samples, and I can confirm that this will be introduced later this year. A Health Information and Quality Authority, HIQA, health technology assessment has found that HPV screening would benefit women by making the screening process much more clinically effective as well as reducing unnecessary tests, and greatly elongating the interval between tests for individuals.
I would now like to turn to the steps that are being taken to ensure the integrity of the CervicalCheck screening programme. Non-disclosure of information to affected patients has raised concerns for users within the health service. Patients have an absolute right to be provided with honest, open and prompt communication about any adverse event that may have caused them harm. This is underpinned in the medical practitioner's code of conduct and the HSE open disclosure policy. The Civil Liability (Amendment) Act 2017, which includes provisions that support open disclosure, became law last year. These provisions were drafted to create a safe space for professionals to be open and transparent with patients in order that they would be given as much information as possible, as early as possible, including an apology where appropriate. By doing this, we have taken away any fears that doctors may have in being open and apologising to patients, specifically, fears of creating legal liabilities for themselves. There is no longer room for excuses. The patient has a right to know and should be told.
The next step is to further strengthen and protect open and honest communications between patients and the health service by bringing forward proposals for mandatory open disclosure for serious reportable events. A stand-alone patient safety Bill goes to Government next week to expedite this. The Minister’s intention is to have an independent statutory investigation to examine the CervicalCheck screening programme. This investigation will have all the necessary powers to investigate the issues highlighted by Ms Phelan and will place particular focus on the quality assurance systems, clinical audit processes and communications with patients within the cervical screening programme.
As part of this, a comprehensive examination of the cervical screening programme in Ireland against international best practice and standards will be undertaken. The investigation will also identify, within its terms of reference, any implications that may apply to other cancer screening programmes. In addition to this statutory investigation, we are now working on putting in place, as a matter of urgency, an international clinical expert process to provide the women concerned with an individual clinical review. This panel will also produce an overall report to inform the statutory investigation and the work of the international peer review group. We are mindful of the need to provide support to these women and a liaison nurse specialist will co-ordinate the work of the expert group. We intend to include patient advocates as part of that process also.
Cervical cancer is the second most common cause of death due to cancer in women aged between 25 and 39 years. Every year in Ireland approximately 270 women are diagnosed with cervical cancer and just under 100 deaths occur from it. Cervical cells change slowly and take time to develop into cancer cells, making cervical cancer a preventable disease. Even with the inherent challenges in screening, having regular smear tests can pick up early cell changes or pre-cancerous growths and reduce the risk of cervical cancer. This is the scientific basis of screening. I must emphasise how important it is that women continue to have their smears and take this test, which can and will continue to save lives.
It is our intention to take these necessary steps in order to ensure the integrity of the cervical screening programme while at the same time disseminating any learning to all cancer screening programmes. These programmes are an important component of the progress that we have made over the past ten years in cancer survivorship for people in this country. The Department is fully committed to the further development of our cancer services and to delivering the ambitious roadmap set out for these services as outlined in the national cancer strategy which was launched last year. We will be happy to take any questions from the committee members.
Mr. Tony O'Brien:
I thank the Chair and the members of the committee for the invitation to attend the meeting to discuss the current issues surrounding the CervicalCheck Programme. I am joined today by my colleagues Dr. Colm Henry, recently appointed as the HSE chief clinical officer; Dr. Jerome Coffey, national director of the national cancer control programme; Dr. Peter McKenna, clinical director of the national women and infants programme; Ms Angela Fitzgerald, deputy national director of acute services; Mr. John Gleeson, programme manager of CervicalCheck; and Mr. Patrick Lynch, national director for quality assurance and verification and chair of the serious incident management team, SIMT.
I would like to begin by reiterating on behalf of the HSE my sincere apologies to all those women who have been affected and families involved in the CervicalCheck controversy, and others who although not directly involved have experienced any distress by what they have heard and read in recent days. I also wish to state that I did contact Ms Vicky Phelan to apologise to her for the delay in telling her that her test results had been a false negative and I want to sincerely make that apology to her and her family again here today.
At the centre of this issue was our failure to communicate to the women that were the subject of the audit. Those women should have been informed and that is something that will happen from now on. It is essential that we re-establish confidence in our cervical screening programme, which is a critical public health initiative.
CervicalCheck, the HSE’s national cervical screening programme, has provided a population-based cervical screening programme to the women of Ireland since 2008. It is important to be clear and to understand that cervical screening is not a test for cancer, but a means of preventing it. Cervical screening works by looking for changes in the cells of the cervix, the neck of the womb, using a smear test and cervical cytology. The earlier abnormal cell changes are found, the easier they are to treat and the treatment of these changes in the cells of the cervix means that the risk of developing cervical cancer is reduced. Screening is internationally accepted as a preventative health measure. While it is recognised that no screening test is 100% accurate, cervical screening is the most effective method of reducing a woman’s risk of developing cervical cancer. By achieving and maintaining the targeted coverage rate of 80% as it currently does, CervicalCheck has the potential to reduce the incidence and mortality of cervical cancer significantly.
Since 2008, women in Ireland have been attending in increasing numbers. CervicalCheck has achieved an 80% coverage rate among eligible women, a figure that is among the highest in EU countries. Latest figures from National Cancer Registry Ireland, NCRI, show that the incidence of cervical cancer in Ireland has reduced by around 7% per annum since the period from 2010 to 2015. This means that fewer women will develop cervical cancer and there will be fewer deaths.
To date, CervicalCheck has provided 3 million cervical screenings to more than 1.1 million women. It has detected more than 50,000 high grade pre-cancerous changes in women, reducing their risk of cervical cancer by 90%. These were women without any symptoms who, without screening, would not have known they had pre-cancerous changes. Furthermore the programme has detected more than 35,000 cases of low-grade cell changes and more than 1,200 cancers.
There are 15 clinics across the country which provide colposcopy services as part of the CervicalCheck programme. Continued successful collaboration between the programme and colposcopy clinics nationwide has led to sustained improvements to colposcopy services and eliminated waiting lists. The high standard of colposcopy has ensured that women who require a colposcopy are guaranteed timely access to a standardised level of quality-assured care.
In 2009 CervicalCheck participated in an external international peer review of the CervicalCheck quality assurance, QA, standards.
The international peer review panel consisted of those named on the printed version of the statement and I will not read the list out, subject to the agreement of the committee. They are, however, a credible international set of experts. It has been asserted that, in some way, the screening programme in this country is substandard to the US as it is asserted that the US screens every year. However, the HIQA report of October 2009 on the evaluation of the use of resources in the national population-based cancer screening programmes and associated services presented the recommended screening interval internationally. In the case of the USA, recommended intervals are initially two smears, one year apart, then every three years. It is also important to note that much of the US system involves a self-select process, an opt-in which, in effect, is a voluntary presentation and not a calling or invitation system as in Ireland. It is not an organised programme in that sense.
HIQA goes on to say in that 2009 report:
A systematic review of the existing evidence base for the optimal age-range and screening interval for cervical screening was undertaken in order to determine if the current age-range (25-60 years) could be narrowed or the screening intervals increased. Based on the literature review, the current age range and screening interval adopted in the CervicalCheck programme in Ireland would appear to be consistent with the international evidence base.
The HIQA report also noted that CervicalCheck administration has achieved the ISO 9001-2000 quality certification and maintains this standard through regular internal and external audit. A comprehensive smear taker training prospectus has also been developed and underpins a smear taking training programme developed and delivered in partnership with the Royal College of Surgeons in Ireland, RCSI, the National University of Ireland Galway, and the Irish College of General Practitioners, ICGP.
There has been much commentary on the outsourced CervicalCheck laboratory services. In that regard, I would like to make the following comments. A procurement process for the provision of cytology laboratory services was undertaken in December 2007 with the publication of a notice in the Official Journal of the European Union in line with public procurement regulations. The requirement of the NCSS was that each potential contractor would need to meet certain criteria, including that they must hold third party accreditation from a recognised accreditation body to international standard ISO 15189; have capacity to screen a minimum of 25,000 cervical smear samples per year; have capacity and ability to process smears within a ten-day turnaround in order to facilitate the delivery of results to women within four weeks of their smear test; and hold independent quality accreditation of the service.
On completion of the procurement process, a private sector provider of laboratory services, Quest Diagnostics Inc., was appointed for the provision of cytology laboratory services. In addition to the criteria above, each slide analysed by the laboratory is examined twice by two separate cytologists. CervicalCheck, in line with public procurement guidelines, re-tendered for laboratory services in 2009 and again in 2012. Following the 2009 procurement process, Medlab Pathology Limited was appointed along with the previous incumbent Quest Diagnostics Inc. In 2012, a further tendering process took place and the two laboratories mentioned above were appointed under a HSE framework agreement. This framework agreement is still active today and both Quest Diagnostics and Medlab Pathology are still providing cytology and HPV laboratory services, under contract, on behalf of CervicalCheck.
I now want to address the findings of the serious incident management team, SIMT, report. I have submitted the full report, which is also available at hse.ie, to the committee with the opening statement so I will highlight some of the key issues here. Over the past week there has been considerable public focus on, and concern about, the cervical screening service. Much of this concern stems from an audit of 1,482 cases of cervical cancer reported to the programme in the period between 2008 and 2018. The CervicalCheck clinical audit process examines the screening history of all notified cases of cervical cancer, with a date of diagnosis since the programme commenced in September 2008. The cases covered by the audit were those cases of cervical cancer notified to the programme and not the larger number of cases notified to the National Cancer Registry for the same period. The programme advised Department of Health officials on Friday evening that the figures were based on the cancer registry figures and it was on this basis that the Minister was briefed. It was subsequently determined by the SIMT that this was incorrect.
The audit process is an opportunity to see if any aspect of a programme could be improved. The process can also provide more detailed information to women on the reasons their cancer was not prevented, as well as information on the effectiveness and limitations of screening. Of the 1,482 cases notified and logged to date, 442 cases, 29%, were flagged for review of one or more elements of the cervical screening pathway, which includes programme operation, screening, cytopathology and HPV testing, colposcopy or histopathology. Cases are reviewed by an internal review group, with the support of an independent pathologist. The most common review type, as expected in a cervical screening programme, is of cytology, that is, the smear test, due to its inherent limitations as a screening test. Cytology reviews are performed internally by the original reporting laboratory, and by independent laboratories if a further opinion is required.
In February 2016, the programme commenced formally communicating review outcomes of historical notified cervical cancer cases where prior cytology had been reviewed to the consultant doctor looking after an individual woman diagnosed with cervical cancer. All historical reviews were communicated to treating doctors by October 2016 and the programme has been communicating current cases since that date. While the audit process established by CervicalCheck is seen as good practice and has the potential to make an important contribution to improving the quality of the programme, there was some evidence that the women whose cytology smear test had been reviewed as part of the audit process had not been informed either of the review or the outcome as it pertained to them. The women whose cases were reviewed already had a diagnosis of cancer so the outcome of the review of their cytology smear test would not have changed their diagnosis or treatment. They were entitled, however, to know that their case was reviewed and the outcome of that review. This was particularly important where the review team drew conclusions that were different from the original interpretation of the smear result.
The SIMT established that there were 208 women who should have been communicated with in relation to the review process. These were women where the CervicalCheck review team interpretation of their smear result was different from the original smear interpretation. Of these, 175 cases reviewed had an interpretation that was different from the original smear result and, based on the opinion of the review team, this would have led to a different clinical escalation, namely, a referral for biopsy or colposcopy. Of the total, 33 cases reviewed had an interpretation that was different from the original smear result but, based on the opinion of the review team, they would not have recommended different clinical management other than an earlier repeat smear.
On 30 April 2018, following the review of patient charts over the weekend, it was established that of the 208 women concerned, 46 women have already been communicated with and 162 women had not been told. Each hospital group was then required to ensure that each of the 162 women who had not been told of the review outcome would be phoned on Monday, 30 April and Tuesday, 1 May 2018. They would be offered an appointment to meet the appropriate senior clinician during the week ending Saturday, 5 May 2018. There were 17 women in this cohort who have died. It has been established that two of these women had the results of their review communicated to them before their death. It is acknowledged that, in addition to a diagnosis of cancer, finding out at this stage that they were the subject of a review will be distressing. The SIMT is confident that the clinicians meeting with these women or their next of kin will be very sensitive to the context of this information.
While the women who were the primary focus and concern of the work of the SIMT had all received a diagnosis of cancer at the time of their review and the review would not have changed the outcome, they were all entitled to know the review had been conducted and its outcome as it related to them. This openness and transparency should lie at the heart of a caring and compassionate health care system. Many women may be worried because of the recent coverage, and there is useful information available on .
During the course of its work, it became evident to the SIMT that the number of cases audited by the screening programme varied from the number of cases of cervical cancer reported to the National Cancer Registry over the same period. The SIMT immediately took action, escalating this matter to me. This, as the chief medical officer has already referenced, will result in the National Cancer Registry being mandated to share its data with the programme, the lists being reconciled, and an immediate audit of these remaining cases being undertaken.
I would like to conclude by saying that I welcome the announcement by the Minister that he is establishing a statutory investigation, which will be carried out by HIQA. I also welcome the appointment of an international clinical expert panel to provide the women concerned with an individual clinical review. The HSE will fully co-operate with both processes to ensure we establish all of the facts surrounding what has occurred and, above all, so we can learn from what has happened and ensure it does not occur again.
Given that I started my career in the public service in BreastCheck, the recent events are indeed a personal blow to me. I do not have many more weeks in my role. Indeed, I have only a few months because, as members know, I announced some time ago I would not be remaining beyond the term of my current contract, and consequently I intend to devote the greater part of those weeks to addressing these issues. In that regard, as I believe the Taoiseach confirmed earlier, I have appointed Mr. Damien McCallion, one of our senior national directors, currently responsible for emergency management, among other duties, to take charge of the national cancer screening service from tomorrow so all the issues that need to be worked through as we deal with this can be managed by him. He will report directly to me. I will be taking a very close personal interest in every aspect of this process. The SIMT will continue its work also.
That concludes my opening statement. Together with my colleagues, we will endeavour to answer any questions members may have.
Michael Harty (Clare, Independent)
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I thank Mr. O'Brien. As this may be a prolonged meeting, witnesses and members may take a break after two hours, if they wish. It is very important for the members and witnesses to note that the women at the centre of this controversy should remain our main focus. The setting up of an inquiry that will seek the truth on this issue should concern us. We should concentrate on that and not take political issues into account. The issues that arise this evening relate to trust. There has been a breakdown of trust. There has been a loss of trust in the CervicalCheck programme. There have been a breakdown in and failure of open disclosure. There has been a destruction of confidence in the CervicalCheck programme. That needs to be restored as quickly as possible. Full disclosure might not have affected treatment but it certainly would have altered women's ability to respond to the information. It might have afforded an opportunity to seek redress elsewhere, as Ms Vicky Phelan did. Therefore, non-disclosure had a significant effect. It raises issues regarding governance, accountability and the cultural change required in the HSE and the Department.
I have three questions to start the meeting. The first is for Mr. John Gleeson. How could open disclosure not be part of the CervicalCheck programme? It seems quite difficult to understand. The cervical cancer registry and the CervicalCheck database did not match. How could that possibly be and how could there have been such a breakdown in communication? My third question is for Mr. O'Brien. Is it now possible to say we know all the information in regard to this issue? Have we identified each person who requires a smear case audit but who has not had one thus far? Has the total number of patients been identified? Perhaps these questions could be addressed first.
Members will have ten minutes each for questions and answers. Witnesses are advised to keep their answers as concise as possible, just as I hope members will keep their questions as concise as possible, to allow every member to engage. Perhaps Mr. Gleeson might address the two questions addressed to him.
Mr. John Gleeson:
On the Chairman's first question, on open disclosure, we started the process of cancer audit in 2010 with a view to ensuring quality assurance and continual improvement and through 2014 decided to review it and then commence, in line with the published HSE open disclosure policy of 2013, an evaluation of what that meant in screening terms, mostly in terms of defining serious incidents. It did not make specific reference to screening, which is different. One is dealing with people who do not have symptoms. It is not like people in hospitals; it is a different cohort of the population. Without trying to not do open disclosure, we went about trying to figure out how best to do it in respect of women we were concerned about because, after all, they had been diagnosed with cervical cancer. We were looking at something before that point in time and how to communicate it but we did develop the process. It took a considerable amount of time, for which I apologise, but the intent was always to let the women know. We looked to practices in England and elsewhere to determine how that might best be done. It was always felt that the treating clinician of the woman at that time was the best channel through which to communicate with her. We would not know the context surrounding her current care and treatment at whatever stage she was at in her plan to address the diagnosis. We did develop and implement the open disclosure and communication policy in respect of treating clinicians. Admittedly there were certainly gaps, for which we apologise, in terms of making sure the information actually got to the women but our intention was always that information we had that related to a woman should be made accessible to her.
Could the Chairman repeat the second question?
Michael Harty (Clare, Independent)
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The second question was on the incompatibility of the National Cancer Registry and CervicalCheck.
Mr. John Gleeson:
The National Cancer Registry is a different statutory body. It is not part of the HSE so there are data protection issues in terms of the exchange of data. When we ask women whether they would like to participate in the screening programme, they give consent to share their information with the National Cancer Registry. It does not operate the other way, however. If the National Cancer Registry is registering a cancer — in our case, cervical cancer — it does not go the other way. The National Cancer Registry was given access to the cervical screening register in order to be able to report, in an aggregate way, on the programme. It is a question of whether, over time, we can reduce the incidence and whether the detection of cancer will start to move to an earlier stage to give a better prognosis. The national screening service measure was under way to implement a data-sharing agreement in line with the forthcoming GDPR to make that communication two-way. We also felt in the early years, however, that most of the women would not have engaged in cervical screening. There are roughly 1.2 million women between 25 and 60, and about-----
Mr. Tony O'Brien:
To come to the wider question, on whether we know everything yet, the SIMT process has not reached its conclusion. This is a very important issue that the Chairman raises because there is concern or a feeling – I acknowledge where that feeling is coming from – about a drip-drip flow of information. Therefore, what we wanted to do as the SIMT progressed was bring as much information and clarity into the public domain as we could. That has had the effect that we had been sharing information before we had complete information.
We gave a media briefing and provided the written briefing the members have on Monday based on the best information the serious incident management team had at that point. It was only after that that what we have told the committee today about the National Cancer Registry information not being the same cohort of women became clear. We have shared all the information we have. However, the data matching exercise has not been completed, and we do not yet know the total number of women who participated in CervicalCheck. That work is currently under way.
Mr. Patrick Lynch:
The real priority for the serious incident management team, SIMT, when it was established at about half five on Friday evening was, having discovered there were a large number of women who had not been communicated with, to ensure that contact was made with them over the weekend. That involved finding out who had been told and who had not been told. We did not know, when were started on Friday evening, whether the majority had been told or not. We discovered that in the cohort of 208 women only 48 had been communicated with. The other 162 women had not. Regardless of the other issues that had to be dealt with, the priority for myself and senior colleagues who stayed in all over the weekend was to inform these women. Clinicians went into hospitals to pull files and identify the women. Our objective was that from Monday everybody on that list had to be contacted and offered an appointment so that they could be told that a review had taken place which they should have been told about, and to make sure they had information on the outcome of that review as it pertained to each individual. The first focus was on the women concerned, and as the process has progressed other issues have been identified which the SIMT will focus on. We did not want to be deflected from the core purpose in the first few days. We could have got caught up in the data issues and not done what we were set up to do in the first place.
Mr. Tony O'Brien:
As the chief medical officer outlined, in relation to the additional cases which came to light yesterday and which the Minister reported to the Dáil, the screening history will be established, and if any of these women was screened through CervicalCheck their cases will be reviewed in further detail, with cytology review where necessary. We cannot give a number for those cases; the work is ongoing.
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the witnesses for their time. I want to start with the number of women who are affected. Of the 208 women identified, how many have been told at this stage?
Mr. Patrick Lynch:
Someone was instructed to check with each of the hospitals, and as of just prior to this meeting we know that 172 women have now been contacted. In some cases - and I do not have the exact number - the woman has died, but their next of kin has been contacted. All of them have been offered an appointment this week. Some of the women have chosen not to take appointments this week because they have scheduled appointments and do not want to come in for a second time. The objective was that all of those women would be contacted and offered an appointment this week. Of the 36 who remain, at our press conference on Monday we were aware of 14 who were outside of the public hospital system. There has been difficulty in determining where they are and how contact can be made with them.
Attempts have been made to try to contact everybody, but there have been some difficulties in reaching people. Some people are out of the country and some have just been difficult to contact. We have moved from a situation at the beginning of the week where only 46 women were contacted to the current position, with 172 women contacted.
Stephen Donnelly (Wicklow, Fianna Fail)
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Mr. O'Brien has said that we do not know exactly how many people are involved in this new group. To give the public some sense of the scale we are talking about, a back of the envelope calculation would suggest 250 to 300 new cases a year for ten to ten and a half years would represent approximately 3,000 women. Just under 1,500 have already been identified to CervicalCheck. Are we talking about an additional 1,500 women? Are the witnesses in a position to broadly confirm that?
Stephen Donnelly (Wicklow, Fianna Fail)
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Is this group as a population likely to be different from the 1,400 to 1,500 from CervicalCheck? Is it a randomised group? Should we assume that approximately 200 women from this group may also have an existing diagnosis of cervical cancer but have not been told about a previous error or false negative?
Stephen Donnelly (Wicklow, Fianna Fail)
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Many women in Ireland will be worried until we have answers to these questions. When is the HSE likely to be able to identify exactly how many women in this additional group are in the same situation as the 208 who are being contacted at the moment?
Dr. Colm Henry:
The first stage is reconciliation of the list from CervicalCheck with the list from the national registry. The next stage, in addition to identifying names, addresses and phone numbers, is identifying those patients who had cervical smears. We will then ensure that those patients are audited in a similar way to the original audit.
Stephen Donnelly (Wicklow, Fianna Fail)
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The public will want to know when the additional women likely to be affected are likely to be contacted. Are we talking about a matter of days or weeks? Will it take two or three months?
Dr. Colm Henry:
I am not in a position to say. We will work as fast as we can, along with the National Cancer Registry, to identify who these women are. The first stage is to reconcile the two lists, and then we will move quickly to identify which of those patients partook in the CervicalCheck programme. We will then subject those patients to an audit.
Stephen Donnelly (Wicklow, Fianna Fail)
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If Dr. Henry cannot confirm whether we are talking about a matter of weeks or months, is it the case that it could be a matter of months before these women are informed?
Stephen Donnelly (Wicklow, Fianna Fail)
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Are we talking about a number of weeks?
Mr. Tony O'Brien:
Every resource available will be applied to ensure this is completed in the shortest time possible. Assuming the data matching happens within the next couple of days, it will then be a matter of pulling the slides and having them reviewed separately. We will have to make a decision, which we will do in consultation with the Department, as to whether we should inform women that the reviews are about to take place or carry out the reviews and then inform the women they have taken place.
Stephen Donnelly (Wicklow, Fianna Fail)
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Are we talking about a week or two?
Dr. Peter McKenna:
It is my opinion that the two groups - the 1,482 and the speculative 1,500 - are not similar. I believe there will be less than 208 in the second 1,500. I base that on the fact that the women in the second cohort are more likely to be older and not have gone through the screening programme and will have presented directly to their general practitioners or gynaecological services with bleeding.
Stephen Donnelly (Wicklow, Fianna Fail)
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Dr. McKenna has provided a useful segue into the next question, which many people have been asking since the Minister made his statement last night. If there are approximately 3,000 women known to have been diagnosed with cervical cancer, why has the national screening service only been engaging in audits on less than 1,500 of those? Why were the other 1,500 not under the remit of CervicalCheck?
Dr. Jerome Coffey:
The issue here is really the data source and how we ascertain the case number.
The audit was performed and continues on the cases notified to the screening programme, generally from the colposcopy service directly, GPs or individuals registering their case of cancer diagnosis with the programme. This is with regard to the 25 to 60 year old age group. There may be people who presented from the 20% of the population who never engage with the screening programme. That is a big part of the gap between the number we are speaking about and the potential for other cases above and beyond the 1,482.
Stephen Donnelly (Wicklow, Fianna Fail)
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In light of what has happened over recent days, does Dr. Coffey think, with the benefit of hindsight, it is a major oversight on the part of CervicalCheck not to have proactively engaged with the full population diagnosed?
Dr. Jerome Coffey:
It is worth saying the programme has a responsibility and duty of care to the patients on the programme, and it fulfils those obligations notwithstanding the comments made about disclosing information and review. To my mind, the best long-term outcome from what we are learning here is that we have an integrated data programme and, with respect to legislation and regulation, we have full access to all data on all cancer patients.
Stephen Donnelly (Wicklow, Fianna Fail)
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With regard to the helpline, I want to read out a post that went up today on social media, but there are many throughout the country. The writer states that as a young woman she is second guessing the accuracy of her results as, she assumes, are most women at this point. Regarding the HSE number, which is the 1,800 number, she states the line is impossible to get through to and those lucky enough to make contact with somebody have had their details taken and been dismissed quickly only to be told they will get a callback. There is an awful lot of anger, but she states it is fair to say there is real fear, and it would appear the steps that have been put in place do not adequately service the demand and fear that is out there. I ask, as a matter of urgency, what is being done to make sure there is an adequate patient and public support response to this.
Dr. Colm Henry:
There has been a large volume of calls over the weekend and the serious incident management team became aware of it very quickly. In addition to the 15 trained nurses in place this morning, we have provided an additional 40 to 50 public health nurse staff, between doctors and nurses, who are being made available today to answer messages that have been left and those who have requested callbacks. They are being provided with brief training and information to provide to patients or concerned members of the public the most accurate information, and encourage them to continue to partake in the screening programme. These calls may take some time, perhaps 25 minutes apiece, so at the same time we need to get the message out there, and today on the websites of CervicalCheck and the HSE we have provided information for the public, including a video message by Dr. McKenna of the national women and infants health programme, who is with us today. In addition, today we have engaged with primary care and we have sent information on frequently asked questions and frequent scenarios to all general practitioners, circulated through the Irish College of General Practitioners, the Irish Medical Organisation and the National Association of General Practitioners. In addition, we have printed and sent this to all smear takers in our service. This information explains the background to the service and provides a framework of advice to GPs to provide to any concerned patients.
Stephen Donnelly (Wicklow, Fianna Fail)
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Thousands of women throughout Ireland are scared and they cannot get through to anybody. They need to talk to somebody. Dr. Coffey has listed the various steps. The question I am asking is when can women in Ireland expect to pick up the phone, dial that number and talk to someone with whom they can have an initial conversation about the circumstances.,
Dr. Colm Henry:
We have provided additional staff today, not just to answer calls but to provide additional information. Might I suggest also it is equally if not more important that we get information out there for general practitioners in primary care and those engaged in the smear taking programme to allay any fears or anxieties people may have, rather than taking recourse to phoning the number.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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As a follow on from the last question, it might be advisable to get that information out to GPs as soon as possible because the women who cannot get through to the helpline are trying to get through to their GPs and they are being advised that the GPs have absolutely no knowledge of what they should be doing. That is just by way of comment.
My first question is for Mr. O'Brien. He stated at the press conference that he found out about what he describes as a failure to communicate - and perhaps he might want to revisit that description of what we are discussing today - in the media. I am interested in trying to get to the bottom of this. A circular issued in 2016 is at the heart of the failure to communicate, as Mr. O'Brien describes it. It advised clinicians simply to add a copy of the audit to the file and use their clinical judgment on whether to tell a woman something about her own health and, in a case where the poor unfortunate patient had died, to stick a note on the file. When that circular was being drafted, and I understand it was signed by someone who was a member of the senior management team, senior clinicians and senior people in the HSE presumably were involved in drafting a circular of this nature. It stretches credibility a bit for me that these people, members of Mr. O'Brien's senior team, would not have communicated to him on an issue as serious as this. If we want to talk about open disclosure and being full and frank, I hope we can get away from what we have had in recent days, which is an endless round of people - mostly men as it goes and no disrespect intended to men - describing to women what it is like to have a smear test and how important it is. I do not need any of that advice. I have been having smear tests for 22 years, since I had my daughter. I understand how important it is. I also know it is not a diagnostic test and I understand it is a screening test. It would probably be helpful if we could dispense with having to repeat that.
Will Mr. O'Brien give me some information as to who would have been involved in compiling that circular, because to me it seems that it came from a very senior level? It strikes me as odd that it did not come across Mr. O'Brien's desk, but he is telling us the first he knew about it was in the media. Perhaps he can talk to us about who was involved in compiling that circular.
Mr. John Gleeson:
I was involved with the then clinical director of the screening programme in compiling it. On the particular point the Deputy mentioned, and the reference to whether a woman was deceased, we conducted this review long after the diagnosis of cancer and when we were notified the woman may have been deceased. Our understanding of data protection legislation is that it was her information and it was not to be told to anyone else. In other words, putting it on the file would make it legally accessible to anyone granted legal access to the file. This may have been a wrong interpretation. We did allow for clinical judgment as we did not feel we were in that position. We did not know what the particular circumstances of a woman were when a letter was written. We did, by phone, text and email, consult among various members of the team to try to get it right.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Mr. Gleeson might just name them or the grade they were at, if he does not mind.
Mr. John Gleeson:
It was the then head of the screening service, who is no longer with us and left some time ago. We would have shown it to the colposcopists and typically consultant gynaecologists received it and were asked what they thought of it in a draft and then we stated it was just to assist in the process. That is how it came about.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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How many meetings took place before the circular was drafted?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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The people involved in drafting the circular.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It took a month or two for it to be drafted by senior people.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Did nobody think at any stage to tell the director general? Maybe they did not think it was serious. Surely they must have known that it was serious.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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But nobody thought it was important to bring it to the director general's attention.
With regard to the cases that have been identified, the 208 and rising, how many of them are beyond the statistical rate? My understanding of Vicky Phelan's case, and I am not a doctor, is it was not within the normal range of statistical error and, in fact, when they went to look back it was not that she had had a missed diagnosis and that test had missed the early stages of cancer but, in fact, by the time she had her first test her cancer was far advanced.
I ask Mr. Gleeson to correct me if I am wrong in that regard. Will he also advise me on the margin of error? Are the figures within the margin of error or outside it? If the latter is the case, are the figures at the higher end of normal?
Dr. Peter McKenna:
I am not aware of the details of the unfortunate person at the centre of this case. However, if one had a clinical cancer, the chances of finding abnormal cells on the smear are less than if for a pre-cancer, the reason being that a clinical cancer may be ulcerated and one will have lots of blood cells, white cells. The smear programme is not designed to pick up cancers but to pick up pre-cancers. I am not in a position to draw any statistical significance from the lessons from one person.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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What about lessons from 208 cases?
Dr. Peter McKenna:
Part of the problem is we are looking at 208 case out of either 3 million or 3 million minus whatever we add to the 208 figure from the other 1,500 cases. Even if the figures are approximately the same, I think, although I am not absolutely accurate, that is probably within the acceptable range.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It is within the acceptable range.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Does Dr. McKenna think so or does he know so?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It would have been handy for the joint committee to have this important information.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I understand we do not know the figures as yet.
Mr. Tony O'Brien:
For clarity, I wish to ensure members are aware that Dr. McKenna has stepped in to provide clinical governance only in the past 24 hours. Members will be aware that previous clinical governance arrangements are no longer in place and that, therefore, the level of detail Dr. McKenna can give in respect of clinical questions is limited by the length of time he has been involved in the programme.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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That is unfortunate.
I return to how this matter came about and how it came into the public domain. The memorandum sent to the Minister states: "The Department is in consultation with the HSE in regard to their preparation of a press statement on the matter." Presumably, this was before the bombshell hit Mr. O'Brien. The HSE was clearly involved and I would like to know which personnel were involved. I watched what appeared to be old footage on an RTÉ news programme the other night - it appeared to be snowing - showing Mr. O'Brien and the HSE's head of communications, Dr. Paul Connors, leaving an RTÉ building. Mr. O'Brien rarely appears before a committee without his director of communications. Was Dr. Connors involved in drafting this press statement? If so, I am curious to find out why he did not inform Mr. O'Brien.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I thought it was snow.
Mr. Tony O'Brien:
From discussion with colleagues in the Department, the term "HSE" is used to refer to any part of the entire organisation. In this instance, the dialogue was with CervicalCheck and the national screening service. The screening service has two communications persons attached to it, as in people who do the advertising and so on, and my understanding is that is the level at which the dialogue took place.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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To whom do the two individuals in question report?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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They report solely to the screening service and are not part of the HSE's internal communications structure.
Dr. Jerome Coffey:
It is worth noting that my role dates back a full eight weeks in terms of responsibility and direct involvement with the screening programme. I think the point the Deputy is getting at is that, as this case at hand came before the courts under the management of the State Claims Agency, we became aware of it without knowledge of what was going to happen next. We communicate internally to prepare for any potential outcome.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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They are not part of the HSE.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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As I stated, it stretches credibility beyond breaking point, if one will, that Mr. O'Brien was not aware of this. Dr. Coffey, in his memorandum to the Minister, stated he did not consider this to be a patient safety incident. I am sure he will understand the reason any woman reading the document would consider it to be very much a patient safety incident. At that stage, was Dr. Coffey aware that there was one case and possibly other legal cases in train? How many cases would there have to be to constitute a patient safety incident? Is it a matter of numbers or severity? The woman at the centre of this case is gravely and seriously ill. It struck me as odd that the case was not considered a patient safety incident. I wonder what would qualify as a patient safety incident.
Dr. Jerome Coffey:
What those words were trying to express was the fact that this particular patient had a diagnosis and had previously had a screening history that we were aware of. The screening look-back, the retrospective nature, is what I was referring to. It does not mean this was not a broader issue or that the ongoing cancer audit was not important and it was not referring to any disclosure issues. Specifically on that point, the patient at that time and what we knew to be the case, I would have to say that much additional knowledge about the broader programme and the disclosure issues became evident subsequent to that communication.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I have one last point on that matter-----
Michael Harty (Clare, Independent)
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The Deputy can contribute again later.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It very much is a patient safety matter. I find the statement outrageous.
Alan Kelly (Tipperary, Labour)
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I welcome all witnesses. There is nothing personal in this. We are trying to get accountability and find out what happened. The political sideshow needs to move on because the women in question and public confidence are the most important issues here. With all due respect to Dr. Coffey, from what I have heard at this meeting, his comments on the letter do not stand up because given what has happened, this clearly is a patient safety issue.
Alan Kelly (Tipperary, Labour)
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Incident or issue, this is mammoth. If, during my years as a Minister, I had received that note and the events we are discussing had transpired subsequently, I would have felt misled. That is my honest opinion, not that of the Minister for Health, Deputy Harris, although I am not sure if his opinion differs much from mine. Regardless of whether we like it, in the opinion of the public this is either a massive cover-up - the witnesses can shake their heads - or one of the largest examples of collective incompetence in the history of Irish health care management. It is one or the other because the issues here are so significant and they are frightening many people across the country, as all of us accept.
My first question is to the Department of Health. As of today, 2 May 2018, how many cases similar to Ms Vicky Phelan's have been taken against a diagnostic company and-or the HSE?
Ms Tracey Conroy:
We have been in contact with the State Claims Agency which has advised that the Vicky Phelan case is the first case that has been settled in relation to CervicalCheck. Legal proceedings have commenced in six cases involving CervicalCheck and the audit process. In the case of three of these six cases, indemnities have been received from the laboratories involved.
Alan Kelly (Tipperary, Labour)
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I ask the witness to speak up.
Kate O'Connell (Dublin Bay South, Fine Gael)
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There is an issue with the sound.
Alan Kelly (Tipperary, Labour)
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I am aware of that. It is just the simple facts because we met yesterday for an hour and 20 minutes. Between yesterday and today, how many cases in total are there which are similar where there is a claim against one of the companies and, or, the HSE? Please provide certainty on this question.
Alan Kelly (Tipperary, Labour)
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There are six in total at various stages. I will direct my question to the HSE in a minute.
Alan Kelly (Tipperary, Labour)
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I direct the same question to the HSE.
Mr. Tony O'Brien:
Based on an inquiry we have made, we have received data from the State Claims Agency today on the clinical indemnity scheme which is operated by that agency. This does not break down in quite the same way as the Department asked the questions. We asked slightly different questions. Our question was on the number of active claims. Active claims could be ones in which proceedings have issued, inquiries have been received from solicitors or a level of inquiry exists which leads the agency to believe a matter should be treated as an active claim. It is a different question. The answer is "ten". We are also aware of media reports today on another case which is not included here and in which the State Claims Agency was not involved. Media reports relate to a prior case which it is reported was settled by one of the laboratories with a plaintiff.
Alan Kelly (Tipperary, Labour)
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That was in 2013.
Alan Kelly (Tipperary, Labour)
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I stand corrected.
Alan Kelly (Tipperary, Labour)
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I want to clarify this for the public because this is all new information. I am aware of that case. The Department of Health says there are six cases in train, for want of a better phrase, of which it is aware from the State Claims Agency. Is that correct?
Alan Kelly (Tipperary, Labour)
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The HSE says there are ten active claims.
Alan Kelly (Tipperary, Labour)
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Potentially, there will be ten active cases.
Alan Kelly (Tipperary, Labour)
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I am trying to get at whether the witnesses are aligned as to the fact that there are six active and four potential cases.
Alan Kelly (Tipperary, Labour)
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There are ten cases, six of which are active and four of which are potential, and there is one historic case on which we do not have the full details.
Mr. Tony O'Brien:
No. There is one that is historic that is reported in the media, that did not involve the State Claims Agency and we do not have details. There are ten on this list that I can see in front of me, but I cannot share it with the committee because it is a State Claims Agency list. Ten cases are listed as active which means, in essence, that they are either in legal proceedings or they are in pre-legal proceedings and there is a further one which is described as "potential".
Alan Kelly (Tipperary, Labour)
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We have one historic, ten which are divided, six and four, respectively, as active and potentially active, and one other. That is the executive summary. On the historic case, is either the HSE or the Department of Health aware of the case? If so, are they aware that a non-disclosure agreement was signed in the case?
Alan Kelly (Tipperary, Labour)
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At all. What about the Department of Health?
Alan Kelly (Tipperary, Labour)
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We now have new information that there are ten to 11 other cases which are similar in some way to Vicky Phelan's. That is new information today. When did the Department become aware of these cases? Is it only in the past 24 hours?
Alan Kelly (Tipperary, Labour)
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Why did the Department not ask before?
Alan Kelly (Tipperary, Labour)
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I am asking a question.
Alan Kelly (Tipperary, Labour)
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I presume that the question was asked following our meeting yesterday.
Alan Kelly (Tipperary, Labour)
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When did Mr. O'Brien become aware of these cases? Has he been continually aware of these issues?
Alan Kelly (Tipperary, Labour)
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Mr. O'Brien was not aware before today.
Alan Kelly (Tipperary, Labour)
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Before today.
Alan Kelly (Tipperary, Labour)
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It is extraordinary. While it is a subjective question, I found it amazing, albeit I believe him completely, that Mr. O'Brien found out about Vicky Phelan's case and the issues around it from the RTÉ website. The Minister for Health was aware of it before Mr. O'Brien. How did that make Mr. O'Brien feel?
Alan Kelly (Tipperary, Labour)
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Did Mr. O'Brien feel undermined?
Mr. Tony O'Brien:
I do not feel undermined by the fact that the Department was made aware and the Minister was aware. I feel let down by the fact that I was not aware. There is very significant contact and communication at many different levels between the HSE and the Department. Different divisions and different parts of the HSE are in constant dialogue. I have no concern that the Department was aware. The concern is that I was not aware.
Alan Kelly (Tipperary, Labour)
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In the last 24 hours, the Taoiseach has said that since this commenced in 2008, there have been double eyes on every smear. That gives a sense of comfort. Obviously, two sets of people are looking at it. Are we completely sure that has been the case since 2008?
Ruth Coppinger (Dublin West, Solidarity)
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I cannot hear.
Mr. Tony O'Brien:
I do not know what is wrong with the system today. The question relates to the reading in a laboratory of the slide on which the material from the cervical smear test has been applied. In other words, it is the examination of that through a microscope. In the first three years of the programme, there were two full and complete reads by two separate people. On the basis of an international evaluation panel recommendation, there are still two reviews, but the second is what is known as a "rapid review".
Alan Kelly (Tipperary, Labour)
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The reason I ask is that the 2009 quality assurance document from CervicalCheck sets out at paragraph 5.2.2.2 the conditions under which there is a second check. It is long and I will not read it out in full. However, I ask Mr. O'Brien to refer to it. It does not say they are all checked. I presume that changed subsequently. It lists the conditions and sampling under which they should be checked. We do not have time here, but I ask Mr. O'Brien to look at that and come back.
Alan Kelly (Tipperary, Labour)
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Will Mr. O'Brien cross reference and make sure?
Michael Harty (Clare, Independent)
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We have to move on.
Alan Kelly (Tipperary, Labour)
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I know that. This is my last question. The last question relates to the bombshell, as I described it in the Dáil yesterday, when the Minister came in. He was obviously not aware of the new information regarding the approximately 1,500 women who have not been audited.
For me and the public, it is incomprehensible that we had a national cancer control programme with its layers of management - whom I presume are all very good people - we have a process to compile and maintain a registry of national cancer statistics, and we have CervicalCheck. Even though we had layers of people, management, processes and pathways not one person over the years noticed that only half of the tests were being audited. Collectively, for our health system, how does that make the witnesses feel? It is absolutely mind-boggling that only half of tests have been audited since 2008. Frankly, that is just not good enough and it is wrong. There was panic in the Dáil Chamber last night as a result. I do not think it is credible to claim that nobody in the whole place knew about this. Somebody must have known. I am shocked by the fact that the matter was found out and then told inside in Dáil Éireann.
Michael Harty (Clare, Independent)
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I thank Deputy Kelly.
Alan Kelly (Tipperary, Labour)
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I would like somebody to answer my question.
Michael Harty (Clare, Independent)
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I suggest that we move on to taking comments from Deputy O'Connell and we may get an answer in the next session. I call Deputy O'Connell.
Alan Kelly (Tipperary, Labour)
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Can I have an answer to my question? I asked a question and all I want is a quick answer.
Michael Harty (Clare, Independent)
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The ten minutes allocated to the Deputy have expired and I call Deputy O'Connell.
Kate O'Connell (Dublin Bay South, Fine Gael)
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I thank the witnesses for their attendance. Mr. O'Brien, initially there was a two-year contract for the outsourcing of cervical smears, which took place under his watch in 2008. Was the two-year contract renewed or was it audited in order for the State to continue the contract? Mr. O'Brien was in charge at the time. In 2008, the decision was made by the then Minister to send the smears to America. Mr. O'Brien outlined the procurement procedure involved and stated that serious concerns were raised in various quarters. It would seem obvious to me that if domestic concerns had been expressed about the process then two years into it Mr. O'Brien, as the person in charge, should have reviewed the outcomes. Perhaps I missed something in the opening statement. Under the heading, the procurement of cytology laboratory services, in his opening statement he referred to capacity of a laboratory and the turnaround time. I am reading his statement and can see mention of "international standards". His statement seemed to dwell on speed of turnaround rather than on quality. There is not much reference to quality. Perhaps he did not elaborate on quality in his opening statement.
Kate O'Connell (Dublin Bay South, Fine Gael)
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No, I am not finished. Mr. O'Brien said at the end of his statement that this matter was a personal blow to him. I would like to make it very clear to you, Mr. O'Brien, that this is not about you. You are the last person that this is about. It is about the women of Ireland who have, yet again, been let down by the health service and by you because you are at the top and you are in charge.
Can anyone tell me who owns the slides, the slides that have bits of my cervix on them in America? Who owns them? If we end the contract can we retrieve the slides for audit purposes?
When a company pays €2.5 million without contesting it then it is obvious that the company has calculated the sum in advance and multiplied 2.5 million people by 208. Does Mr. O'Brien think that handing over €2.5 million to 208 people could indicate, without an inquiry, that the laboratory knew that it was not up to scratch?
Can Dr. Coffey explain his job to us now, if he does not mind?
Michael Harty (Clare, Independent)
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Is the Deputy finished asking questions for the moment?
Kate O'Connell (Dublin Bay South, Fine Gael)
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I would say I have plenty of time.
Michael Harty (Clare, Independent)
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Yes. I call Mr. O'Brien first.
Kate O'Connell (Dublin Bay South, Fine Gael)
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No. I would like to hear from Dr. Coffey first and then Mr. O'Brien, if the Chairman does not mind.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Dr. Coffey, as the director of the national cancer control programme, what does he see as top of his list? Is it to reduce cancers and improve outcomes?
Kate O'Connell (Dublin Bay South, Fine Gael)
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Does Dr. Coffey think he has done that job?
Dr. Jerome Coffey:
If one looks at the cancer registry data for survival outcomes in this country one will see that outcomes have improved significantly over the past decade and beyond. Every time a five-year survival date is looked at one will see that we have done better than the previous five-year period in this country and the data support that claim.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Does Dr. Coffey think that result is down to him and the programme or lifestyle and education? Clearly, in this case, outcomes could have been better for women.
Kate O'Connell (Dublin Bay South, Fine Gael)
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I ask Mr. Gleeson to explain his job.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Does Mr. Gleeson think that he has done his job right?
Kate O'Connell (Dublin Bay South, Fine Gael)
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I know. I ask Mr. O'Brien to answer my questions, if he does not mind.
Mr. Tony O'Brien:
Certainly, Deputy. In referring to international standards, I was referring to international quality standards, of course. I will come back to the bigger question. The only reason there was a reference to a ten-day turnaround, and why that was important, was because prior to that it had not been possible to indicate to women who availed of the pilot programme in the mid-west when, against a very long timeframe, they might expect to get their results. A big priority, in order to encourage uptake of a screening programme, is that at the point that a smear test is taken there is some certainty about when the result will be provided. That was the rationale behind that issue.
Before the tendering process took place, guidelines for quality assurance on cervical screening with reference to the EU guidelines were developed in 2007 to 2008, and they were part and parcel of tendering process. There was also an external international peer review of those guidelines, which was referenced earlier. Quality metrics were in place, and still are in place, for any laboratory under the contract, which relate to pathologist workload and reporting profiles, screeners' workload, primary screening sensitivity, the reporting protocol-----
Kate O'Connell (Dublin Bay South, Fine Gael)
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Sorry, Mr. O'Brien, the answer should be simple enough. Before the tender was awarded for the second time-----
Kate O'Connell (Dublin Bay South, Fine Gael)
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-----was the effectiveness of the programme comprehensively evaluated?
Kate O'Connell (Dublin Bay South, Fine Gael)
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Can I have answers to the rest of my questions? Does Mr. O'Brien admit that this matter is not about him but the women?
Mr. Tony O'Brien:
I never said that this matter was about me. I think it would be odd if I did not have a personal sense of how important this matter is, particularly given my past role in screening programmes. Of course, it is not about me. When one comes in here and makes an opening statement it is pretty much expected that one expresses one's own views on these matters.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Mr. O'Brien said the following in his opening statement: "While it is recognised that no screening test is 100% accurate, cervical screening is the most effective method of reducing a woman's risk of developing cervical cancer." I have to hand a couple of studies from recent years that suggest cervical screening is an effective method to reduce the incidence of such cancer but Mr. O'Brien has claimed that cervical screening is the most effective method. Is that a true statement?
Kate O'Connell (Dublin Bay South, Fine Gael)
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That is not what Mr. O'Brien said in his opening statement.
Kate O'Connell (Dublin Bay South, Fine Gael)
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It is ten years since the cervical screening programme commenced, and Mr. O'Brien was there at the start, before moving to his role in the HSE.
Can Mr. O'Brien assure me, the committee members and the wider public that he, as the head of the national cancer screening service and on his subsequent appointment as chief executive of the HSE was re-evaluating the CervicalCheck programme, auditing it on an annual or biannual basis, making sure that the results of the checks that were done were comparable with the results in other European countries and in the wider global arena? Is he confident that in his role then and now that the laboratory was up to scratch for the job that it was paid to do?
Kate O'Connell (Dublin Bay South, Fine Gael)
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Deputy Louise O'Reilly mentioned the discrepancy in Ms Vicky Phelan's smear. I believe that Ms Phelan's solicitor outlined on the media last night that it was not a case that a second set of eyes missed the abnormalities. My understanding from the media reports, and I am sure a solicitor would not say the incorrect thing on national media, was that the difference between the smear where her diagnosis was and the re-audited smear where it had been missed was very obvious.
Michael Harty (Clare, Independent)
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The Deputy has one minute.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Does Mr. O'Brien think that he should continue to work for the remainder of his contract?
Kate O'Connell (Dublin Bay South, Fine Gael)
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With respect, it is a pity that he did not focus on it before now.
Michael Harty (Clare, Independent)
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I thank Deputy O'Connell and call Deputy Margaret Murphy O'Mahony.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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I thank the Chairman. I thank the witnesses for coming before us. First, I wish to praise Ms Vicky Phelan, the lady at the centre of this who brought this debacle to life. She is very courageous and brave and I send her the best wishes of all the members here today.
As the only female Member of the Oireachtas from Cork, I have been inundated with calls from women all over Cork in the past few days. There has been a significant loss of confidence in the health system and in smear testing. There have been major blunders, one after the other. What steps will be taken to restore confidence in the system so that the women of Ireland can have confidence in it?
Dr. Peter McKenna:
We have not been very good at getting the story out that the screening programme at the centre of this crisis is saving lives and if people stick to it, it will continue to save lives on an annual basis. We are behind the curve in getting that message out.
To return to a point that Deputy O'Reilly raised about how good the programme is, let us say that we add another 100 to the 200 cases of false negatives we are taking, that would be 300 false negatives out of 3 million tests, that is one in 10,000. That is a very acceptable rate of false negative screening. The programme is effective. It would be terrible if people were scared from using it and scared of using other methods of having their cervix checked because only by enrolling in the programme can one continue to have the umbrella of being sent for a check and having the screening quality checked.
I fully accept that we have not done well in defusing the confusion and getting our good story out.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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It needs improvement.
Dr. Tony Holohan:
It is important to say that we still have substantial confidence in the performance of the programme for the reasons that Dr. McKenna has outlined - sufficient to enable us to give full reassurance that the programme operates to the highest quality assurance standard still. I know that much has been said on the issue of public confidence. I am not suggesting in any sense that the Deputy is taking us back in comparison, but it is worth pointing out that before the programme was established in 2008 - and this is a ballpark figure - we were doing somewhere in the region of 300,000 smears a year. We were sending the smear tests to small laboratories, where we were getting poor quality assurance, QA and we had no QA to tell us what the performance was. Some of the women being screened were being screened far too frequently and others were not being screened at all. We were having no impact on mortality. I can remember testimony by clinicians, particularly from those who came back to work in this country around that time about the late stage of presentation of young women with young children with cervical cancer. That situation has not changed completely, but it is changing substantially. We have had since 2010 a substantial reduction in the mortality associated with the programme and a range of other factors that allow us to say that people are being identified.
We heard earlier about the 50,000 or so women who have been identified with early stage changes that could be dealt with definitively. If we continue with the performance parameters that we are seeing with our programme, we can be confident that we will continue to drive down that mortality. When we supplement that with what we are doing in terms of HPV screening, which will start later year, we can be confident in the screening performance of that. We have substantial reason to continue to express high confidence as leaders in the health care system. All of our health care practitioners should be in a position to continue on the basis of the data that we have available to us. I can make available to the committee an article that was published in the European Journal of Cancer Careabout three years ago, based on a side by side comparison, questionnaire based. This analysis of cervical cancer screening programmes around Europe confirmed that we have one of the most organised, highest performing and most quality assured programmes anywhere in Europe. Many of the features we are talking about here today are exhibited by very few organised programmes. Many well-known countries, First World countries as it were, do not have that type of organised programmes. The basis for us to continue to reassure people that they can have confidence in the programme, confidence in the results of their tests on the basis of its performance remains. That has not been changed by any of the unfortunate experiences that some of the people of whom we have talked about have had.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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The issue is public confidence.
Michael Harty (Clare, Independent)
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I call Dr. Coffey.
Dr. Jerome Coffey:
I wish to make one brief comment in response to the question on public confidence. It came through very clearly in conversations I had directly yesterday and today with the Irish Cancer Society, the Marie Keating Foundation and this morning with the Irish Patients' Association. What needs to happen in cancer services in general and in screening in today's context is bringing patients and patient groups into the programme to be part of the redesign and service development so that they know and understand the process from the inside, have all the information and contribute to it. I made that commitment yesterday and today.
Michael Harty (Clare, Independent)
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I thank Dr. Coffey.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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I will combine two questions because my time could run out. We all know that the volume of calls to the helpline are significant. We are now being advised that calls are being prioritised. How can that be done? If the three lady members present were ringing the helpline at the same time, who decides which of us would be a priority and who decides on the criteria for priority?
The advice from the HSE is that women who are worried about their screening results should go to their GP. I am aware that the GPs in west Cork are inundated already with large numbers in the waiting room. One must wait a few days, unless it is an emergency, to get an appointment to see the GP before this crisis happened at all. How can a GP, take on this workload on top of everything else?
Dr. Peter McKenna:
The message we are trying to get out is that for the majority of women who have negative smears there is no need for them to do anything other than to attend for their next scheduled programme appointment. If there are exceptional circumstances in one's personal case, then attend one's GP and in discussion with one's general practitioner, decide whether another smear test would be necessary or indeed advantageous. For the majority of people who have had negative reports, the message we would like to get out is to stick with the programme and attend for the next scheduled smear.
Mr. Patrick Lynch:
In regard to the helpline, when the serious incident management team met over the weekend, the programme had set up the helpline. We were concerned by the volume of calls that were coming in. The helpline is the initial contact point, but the most important element of the service is the callback.
It is experienced qualified people who are in a position to call back and talk to women about the questions that they have. There were very serious challenges. We understand that as of this afternoon, from the programme, there will now be 72 qualified people taking those calls. Most of them are clinical staff, doctors, nurses and people who have been trained. We have had very good support from others as well. There will also be people from the Irish Cancer Society and from the Marie Keating Foundation, who have agreed to support this.
There is a distinction to be made in respect of the issue of prioritisation. It is not prioritisation, it is that different types of questions have been raised. Some can be answered by a particular type of clinician, some may have to be answered by a doctor. In terms of streaming the calls and the questions, they will be streamed to particular members of the overall team.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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Would I get an answer if I rang and I had three or four questions that had to be streamed in different directions?
Mr. Patrick Lynch:
No, it will be a single person who will call people back. The HSE issued an apology on Saturday and on Monday morning, where there were technical difficulties with the volume of calls and there were definitely long waiting times for people, and people had to call multiple times. My understanding from assurances that have been given to the serious incident management team, SIMT, today is that has improved. We were then concerned by the length of time it was taking to return calls to women; one does not want to phone on a given day and feel that one has to wait a week for a call back. We have been given assurances this morning, as I have already mentioned, that all of those elements have been put in place. I would be surprised and disappointed if we find tomorrow, when we look at the statistics, that things have not improved significantly today.
That is in addition to the wider communication through the clinical community, through GPs and the Irish Nurses and Widwives Organisation, who have also been very supportive and want to ensure that the confidence in this programme is not lost. There has been a general goodwill by everybody to get this fixed and make sure that we respond appropriately.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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I cannot emphasise enough the importance of this helpline working, because women who are really worried and really down about this, this will be their first point of contact to allow them to try to move on with their lives.
Can I also ask what resources will be put in place to ensure that all women who request another check will receive it without delay?
Mr. Tony O'Brien:
There are two layers to that question. Some women may seek to have a repeat smear test, and the Minister has offered that opportunity. That will obviously depend on the availability of an appointment with a smear taker. Women will already know who their smear taker is and how to access a different one, from the CervicalCheck website.
It may be that for those women who may wish to do that, that they might alternatively think of requesting that the original slide, which will still exist could be re-checked, rather than having to have a fresh smear test. In general, as Dr. McKenna has said, that is not what is being actively advised.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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Is it up to the lady herself which option to choose?
Mr. Tony O'Brien:
We would advise that she discusses this with her GP, and although there was a delay, which led to expressions of concern from GPs - partly because of the complexity of what is being dealt with in the last two days - this morning, through the relevant bodies, appropriate guidance and information has now been distributed to every general practitioner.
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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Is it possible to request both, if someone is really uneasy?
Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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What if one goes the other way around first?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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There is a point, to find out if the test was-----
Michael Harty (Clare, Independent)
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Thank you, Deputy. Deputy Murphy O'Mahony, I understand the question, will it be set up that a woman can request a slide?
Mr. Tony O'Brien:
At this point in time the focus, as we have discussed, is on the first actions the SIMT has been taking forward. There is a discussion that will happen with the Department and clear guidance will be issued in relation to a process for this. The helpline is in operation. There have been a lot of calls and we have drafted in very significant additional resources, which Mr. Lynch has described. It is anticipated, however, that each callback is likely to generate a conversation that is likely to continue for up to half an hour. Even with that number of staff, with the number of calls, it is going to take a number of days for everyone to have that full detailed conversation. I am sorry that that is the case, but it is important that those conversations take place with the right, appropriately qualified personnel, as I know the committee will appreciate.
Michael Harty (Clare, Independent)
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Before we bring in Senator Burke, Deputy O'Connell did ask a question in relation to the ownership of the slide.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Which is what?
Michael Harty (Clare, Independent)
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Thank you very much for that clarification. I now call Senator Burke.
Colm Burke (Fine Gael)
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Thank you very much to all of the witnesses for coming in here today.
Can I go straight into the issue of open disclosure and the failure to provide that open disclosure? When the information became available that there were inconsistencies in the results, at what stage was there a decision taken not to share that information? Was legal advice sought by either the HSE or CervicalCheck, on that?
The second question I have relates to when the first legal letter came in on this matter and who it came to. There would have been an exchange of legal correspondence before proceedings started. Who did it come in to and why did that not set off alarm bells at that stage about notifying the other people who were involved? Why has it been the case that we have had to wait for it to go all of the way to court before we have now decided to notify all of the other people involved? Can these matters be clarified? When did the letter come in? Why were alarm bells not set off immediately that this is an issue that was going to come to the fore at some stage, if not in this case, then in other cases?
The other issue I want to move on to - and I am aware that Mr. O'Brien has spoken about reassuring people - is that the problem out there now is that people do not feel reassured. There is going to be huge increase in the number of people looking for repeat smears. What system has been set up to deal with the increased volume of repeat smears that are going to be taken and analysed? Has any process been looked at at this stage in relation to that area as regards ensuring that, if there is an increase in volume, that they can be dealt with in an expeditious manner?
Finally, my understanding is that there are 15 clinics. Some of those clinics had raised concerns with the people directly at the top of the organisation over the last number of years. Can it be clarified whether there were regular meetings with the principal people involved in these 15 clinics, or was it all by email and by telephone? I have received information to the effect that some people in the clinics based around the country had expressed concerns about issues as they arose but found that their concerns were not being taken on board. Was there a mechanism where regular meetings occurred on an overall basis between the 15 clinics and the people who were in charge of the entire programme?
Dr. Jerome Coffey:
First, I will deal with the questions in sequence, I will then hand over to Mr. Gleeson for certain points.
The first point about disclosure which is critical and central here, a decision not to share is the reverse of my reading of the process in this situation. There was a clinical audit ongoing. There was a very protracted discussion both nationally and internationally about models of disclosure, concerning how and when to disclose. That is where the debate was; it was not designed not to disclose.
What has evolved, apart from the reference earlier to the information being sent to the clinicians, was a patient information leaflet for patients telling them, where appropriate, that a review had taken place, and a very simple mechanism to trigger an appointment with a clinician to discuss all elements of the review.
The second point I will leave to Mr. Gleeson, regarding the current case and when correspondence started.
The third point is that we anticipate an increased volume of smears, but it is very hard to quantify. Our actions this morning were to make sure there was the capacity, where clinically appropriate, to enable women to have smears without delay. That is open-ended. We do not know how long the interest and anxiety will last for, but we are prepared to keep the enhanced resourcing until everybody has had their questions answered to their satisfaction and, where appropriate, additional smears will be taken. That process will continue for as long as it takes.
The final point was about correspondence and colposcopy clinics. I am afraid I will have to leave it to my colleague.
Mr. John Gleeson:
First, I will corroborate what Dr. Coffey said that there was never a decision or a consideration not to disclose, it was a question of how to disclose. We will disclose, but it is a question of how best to do it.
We communicated with the 15 colposcopy clinics which tend to be the centre for most of the diagnoses and invited their views. We have an annual colposcopy forum where we gather and to which we invite all of the doctors and nurses who work in colposcopy clinics to discuss issues. We brought in a consultant doctor from England who was involved in having to engage in open disclosure on cases to provide for some learning and a stimulated discussion on how best to do it. Individual consultant doctors did engage, more or less, with us in saying no, this way or that way. It is an evolving process and getting better. We met them a couple of times last year. We have communicated suggested changes to them, some by email and some by face-to-face meetings. It has been a process for over two and a half years and it is still evolving.
Colm Burke (Fine Gael)
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In fairness, is two and a half years not a long period of time in which essential information was not being provided for patients?
Mr. John Gleeson:
I am sorry, I should correct what I said. The process has been evolving for two and a half years. The decision to disclose was taken. It was to go back to every diagnosis made since 1 September 2008 when the CervicalCheck programme started. They commenced in February 2016. There was a backlog because we were going back to 2008, but we got all of them out by around September 2016 and as cases have been reviewed since. We have modified this approach slightly to make it better to make sure it gets to whom it is intended. The process is still evolving and obviously we are trying to get better at it.
Colm Burke (Fine Gael)
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In the particular case there was a detailed exchange of correspondence between Mr. Hickey in Limerick and the head of CervicalCheck which, as I understand it, went on for over a period of 18 months. Surely to God, someone can come to a decision one way or the other, rather than having dragged on correspondence.
Mr. Tony O'Brien:
Let me express a corporate view based on what we now know, particularly what we now know from the exercise in which the SIMT has engaged to establish how many patients actually were told. Clearly, it was a flawed process. Clearly, too much time was spent in trying to resolve disagreements. Had the matter been escalated, as it ought to have been much sooner, at a corporate level we would clearly have intervened to make sure the objective which was communication to patients would have happened. A key lesson is that there was probably too much time spent in trying to come up with a "perfect methodology". As time passed, that pursuit should have ended and the process of communication should have started.
Colm Burke (Fine Gael)
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When the legal letter came in, surely it must have set off alarm bells at that stage. The question is to whom did the legal letter come? Was it to CervicalCheck or the HSE? Everyone is hiding behind the State Claims Agency, but am I correct in stating it initially came to the HSE or CervicalCheck?
Mr. Tony O'Brien:
I cannot speak to this - maybe Mr. Gleeson can - but what typically happens is the individual service will receive correspondence, either from a patient or legal representation, seeking access to file-based information. In some cases, that provision is made and the thing does not proceed further. In some cases, it proceeds further. Then either the service or the official headquarters of the HSE receives correspondence. There is much such correspondence which, by statute, is passed to the State Claims Agency. In this particular case Mr. Gleeson may be able to tell us the sequence of events.
Colm Burke (Fine Gael)
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I want to find out when the letter came in and who received it. Surely it must have set alarm bells ringing about the need for disclosure to everyone else also?
Mr. John Gleeson:
To my knowledge, the letter was received in late January or early February. The judge in the case has acknowledged that it was an incredibly short timeframe. A letter from a legal representative was received on my desk related to the service in which I was involved asking for the disclosure of all records related to a named woman, to which we responded.
Colm Burke (Fine Gael)
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In January of what year?
Colm Burke (Fine Gael)
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Did it not set off alarm bells because we are now going through a legal process on the need to look at the process in place for disclosure. The person obviously had concerns that a disclosure had not been made. Surely when a letter like that comes in - it is like any organisation getting a legal letter - the immediate response is if that is what is happening in the particular case, maybe we should now look at the other cases also.
Mr. John Gleeson:
To clarify, the allegation was that the disclosure had been delayed, not that it had not been made. In the records we provided in response to the request for all records was a copy of the disclosure from 2016 because it had not gone out. It was then when the woman was informed, but this did not trigger, "Oh, we have got to disclose" or in other cases which had already been done with. It was an access to records request.
Colm Burke (Fine Gael)
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Surely where errors had been identified and there was a need to disclose information the letter received in January should have set off a process to make sure something was put in place at that stage, rather than having to deal with it now in the public domain.
Mr. Tony O'Brien:
In addition to everything else at which we are looking, there is to be a case management review. It is clearly the case, given that this was never escalated to me prior to my hearing about it on the RTE app, that the significance of all of this was recognised and identified to a sufficient extent. The Senator is right to identify that there was an event which should have triggered an analysis, an assessment and possibly a series of actions. We do need, as part of the totality of what we are doing - this will not be for the SIMT - to look at how such initiations of proceedings are used to inform our understanding of risk and issues and the success or otherwise of the processes that have gone before. I am actually agreeing with the Senator's point.
Michael Harty (Clare, Independent)
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Thank you very much, Mr. O'Brien.
Bernard Durkan (Kildare North, Fine Gael)
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To continue the theme of my colleague, what alert system is in place within the health service in the event that something occurs within the system which should set off alarm bells? Is there such a trigger mechanism and, if not, why not? What happened in the particular case we have discussed in the past couple of weeks? Was the emphasis on defending the case in court, or was it on reaching out to the victim, the patient, and alerting other patients to what might be happening? To what extent do the delegates believe public confidence in the system has been damaged? By the system I mean the health service.
Mr. Tony O'Brien:
I will take two of the questions and ask Mr. Lynch to respond to the third.
This case was not defended by the State. There was no defence. To use the technical term, the case was struck out and a settlement was reached with the laboratory, not the State. As I understand it, the efforts of the State Claims Agency were very much aimed at facilitating a settlement.
Since the question has been asked, not by the Deputy but in the wider public debate, I can confirm that at no point did the State Claims Agency seek a confidentiality agreement on this matter. On its behalf, I want to put that into the public space because it is important.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Could Mr. O'Brien repeat that?
Mr. Tony O'Brien:
At no point in time did the State Claims Agency seek a confidentiality agreement on this matter. It has been very clear that this was not something it was involved in. It is important as a matter of public confidence.
Has public confidence been shaken? Yes, of course it has. That is the most tragic thing in this circumstance because, unless the CervicalCheck programme continues to receive the active participation and support of the 80% of those eligible who have supported it up to now, we will be in danger of seeing a reversal in the trend for cervical cancer.
I have explained — some people have taken issue with my explanation — that what is at the heart of why we are here now is that a decision to carry out reviews or audits and then to communicate the results to the individuals concerned fell apart at the implementation stage. That is kind of what brings us to where we are now. As Dr. McKenna has outlined, even in extremisbased on the estimates we have heard and even if all of the cases were missed opportunities for diagnosis, they fall, in total, within the parameters of a successful screening programme because screening programmes are not 100% effective. The benefit of this screening programme is that 50,000 women have had a diagnosis of high-grade cell changes resulting in early treatment, resulting in their being able to avoid developing cancer. Consequently, the numbers of cancers have fallen and the number of deaths has fallen. These are really important health benefits in respect of which we must collectively try to do our best not to lose because it would be to the detriment of everyone if the trend went backwards. In addition to putting matters to right for the women who were not given the information they should have been given, one of our greatest focuses and one that has been our immediate priority is restoring public confidence. Without it, we will pay a huge public health price. That is why I am focusing on this now to the extent that I am and why I have taken the steps with the movement of Mr. Damien McCallion to take personal charge of the national cancer screening service.
I ask Mr. Patrick Lynch to speak about how alarm bells should be treated.
Mr. Patrick Lynch:
A range of things happen anywhere in the health service on any given day. Therefore, when one asks about alerts, one should note there is a whole range of alerts and different levels of severity. Certainly, where patient safety is any way concerned, we have incident-reporting systems and risk-management systems, all of which should ensure the people who need to know do know. That is not just for information purposes because very often some action has to be taken.
In the context of the serious incident management team, our objective, as I said at the beginning, related to the women concerned. We did not know last Friday about the 208 women and how many had been told and how many had not. At the end of the weekend exercise, we were surprised by the number who had not been told. That, for us, was very concerning in terms of openness to the women. We have not got to the why, who and what at this stage but I believe there was an important lesson to be learned. It might not have appeared on an incident system but there are opportunities for any part of our service now to know that there are certain things that have got to be escalated, not just to notify people but very often with a view to taking action, and something has got to change as a result. The work we have done in the past week will help in addressing this.
Bernard Durkan (Kildare North, Fine Gael)
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Was this deemed to be a public patient health risk?
Mr. Patrick Lynch:
When we examined this, we noted the primary issue was that these women, who already had a smear and went through the review process, were entitled to any new information we had about their original smear. They were entitled to know that information. These were women already diagnosed with cancer but they were entitled to know. In 175 cases, when the review team reviewed the smears its clinical interpretation was different and it would have recommended a different escalation of clinical management. Yes, they should have known. The process was in place to achieve this. It fell down somewhere.
Bernard Durkan (Kildare North, Fine Gael)
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Why did it fall down? In the interim, has the HSE had an opportunity to test the system to find out where the weakness was given the potential threat to the health and, eventually, the lives of a quite substantial number of women throughout the country?
Mr. Patrick Lynch:
The review itself was not a threat; it was the information contained in the review on what had happened previously that was important for the women to know. The focus for us this week has primarily been on making sure the women who had a review were made aware of the fact that a review was undertaken and the outcome in their cases. That is just a basic requirement in respect of the openness of the health system and the responsibility to the women of those of us working in it. The second priority was to a very large cohort of women and their families right across Ireland who were concerned about cervical screening and their own health.
There will be time. All of these things will be looked at because we want to improve the system and ensure we learn from what happened so it will not happen again.
Bernard Durkan (Kildare North, Fine Gael)
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Did anybody warn that this might happen given that tests are carried out every three years here and every year in the United States? Did anyone anticipate what could happen in a situation like that given the scientific knowledge available to the health services?
Mr. Tony O'Brien:
It is absolutely inevitable that there will be women who will get a "no abnormality detected" smear test result and subsequently develop cervical cancer and in respect of whom, on the basis of a review of their slides, once it is known that they have had cervical cancer, a reviewer will suggest a different result ought to have been given. That is because this form of testing is internationally understood to be 70% accurate. It is a screening test and not a diagnostic test. It was always inevitable that the screening programme, as with all population screening programmes, would not provide a pathway to diagnosis for every woman who might have been able to benefit from it. At the outset, based on all the public health information available, and in any country that has decided to have a screening programme for any population-based cancer, the decision is made to have the screening programme based on the benefit it can deliver as opposed to the benefits it will not deliver. That benefit, as I characterised earlier, is a 7% reduction in the incidence of cervical cancer. The detection of high-grade cervical cell abnormalities among 50,000 patients, enabling them to have treatment, means they will not go on to develop cervical cancer. There have been 1,200 women diagnosed with cervical cancer through the programme, the result being that they could start their treatment pathway earlier than otherwise.
The issue to which the Deputy is referring is the relationship or suggestion that the decision to provide the cervical cytology testing through laboratories outside Ireland is in some way connected with this. There was always going to be a certain number of cases like this, unfortunately. There was always going to be a need to review, and there was always going to be a need to communicate, but the performance of the laboratories is in line with international expectations and has not contributed to a situation where there are more such events than would be likely to occur in any event.
Bernard Durkan (Kildare North, Fine Gael)
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Are all the laboratories-----
Michael Harty (Clare, Independent)
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The Deputy has just one minute.
Bernard Durkan (Kildare North, Fine Gael)
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These are my final questions. Are all the laboratories - those in the United States and those here - equally efficient in their ability to determine and alert to the existence of the disease? How does the HSE propose to set in place a procedure that will quickly alert both the system and patients as to what to be aware of? Who alerts whom from there on? How are the relevant sections of the HSE and the Department of Health alerted? Are they alerted at the same time? Is all the information collated and referred in such a way as to ensure that the necessary information is available to everyone within the system?
Michael Harty (Clare, Independent)
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A brief answer, if possible.
Bernard Durkan (Kildare North, Fine Gael)
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Accuracy as well.
Mr. Tony O'Brien:
Yes, in accuracy as well, particularly as the test is not 100% accurate. The laboratories are all operating within the norms one would expect, and this is monitored closely.
Regarding the alert system, the first thing to note is that the CervicalCheck programme will be fully data-linked with the National Cancer Registry. The triggering of a review will be based either on a notification from the registry or, where that notification becomes known to the programme more quickly, as a result of presentation at one of the colposcopy clinics. Each individual review will be undertaken expeditiously and the information communicated at speed to the treating clinician. The treating clinician will be the one to convey that information to each individual patient. We will go through a specific learning exercise and a review of what happened in this particular case to ensure that we cover and block off the gaps. There will, of course, be continuous sharing of information at appropriate times with the Department of Health, just as there was in this instance but perhaps in a different way, more efficiently and more transparently. Of course, what we will not allow to happen again is the kind of confusion and communication that arose in respect of this cohort, the numbers of women who had assessments carried out versus the National Cancer Registry data, which I discussed in my opening statement.
Michael Harty (Clare, Independent)
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I am obliged to offer Mr. O'Brien the opportunity to take a break for five minutes if he so wishes. Is he happy to continue?
Michael Harty (Clare, Independent)
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I thank Mr. O'Brien. I will now bring in some Deputies who are not members of the committee. The arrangement we had come to prior to the meeting was that non-members would have five minutes to ask questions. Deputy Coppinger is first, followed by Deputy Bríd Smith.
Ruth Coppinger (Dublin West, Solidarity)
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The HSE opening statement reads, "The current primary screening test used by CervicalCheck is a cytology test known to have low sensitivity, that is, it produces a not insignificant number of false negative results." Why would we use a system with low sensitivity in a country that has the highest cervical cancer rate of all EU member states? I wish to ask about the claim Mr. O'Brien has just made to the effect that 70% is the average accuracy of the test. That is not the figure that was cited on the Dáil record in 2008. What is a not insignificant number? I will group my questions, if the Chairman does not mind, because I have only half the time of the committee members. Why is the accuracy so low when, in 2008, Irish labs had a 95% accuracy rate, according to Senator James Reilly, who went on to become Minister for Health and who is a doctor. I assume he was not telling a lie. Why would we move to a system that, according to other experts at the time, had an 85% accuracy rate? I refer to the US system. I am not just blaming the witnesses. These were political decisions that were taken. The witnesses are managers. I put it to them that this was testing on the cheap. At the time, Mr. O'Brien, in an article in The Irish Timespublished on 9 May 2008, said he was satisfied Quest Diagnostics could provide the required quality of testing. However, the emphasis in his opening statement today seemed to be on getting 25,000 smear samples done a year with a high turnaround to get the results back in people's hands by a certain amount of time. This seems to sacrifice quality for quantity and a fast turnaround regardless of the results.
I wish to take the following issue up with Mr. O'Brien. He has said, or has given the impression to another Deputy, that two people were looking at every slide in the American labs. Is he satisfied that this was the case? He will be well aware that Dr. Gibbons, who was high up in the HSE and the cervical programme, took issue at the time with this and said this would not be the case. Also, with the difference in the way they test - once every three years there with two pairs of eyes, whereas we tested once a year with one pair-----
Michael Harty (Clare, Independent)
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Deputy Coppinger has five minutes and has used up three.
Ruth Coppinger (Dublin West, Solidarity)
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I will put my other questions then. Why has Ireland never reached the 1.8% average high-grade detection rate that other countries reached, particularly as this incidence of cancer here is higher than anywhere else in Europe? Will the witnesses explain the other screening programmes? MedLab Pathology claims, in its own propaganda and publicity material, that it has the contract for the bowel screening programme. Will Mr. O'Brien or anyone else from the HSE clarify if this is the case? Will the witnesses also clarify how outsourcing to a foreign company could be considered best practice when it is not then possible to have multidisciplinary team meetings?
Finally, regarding the calls to the helpline, it was stated that 4,876 women are awaiting callbacks. Obviously, this could take a huge amount of time because they will require significant conversations. Is Mr. O'Brien saying that these women could also have had inaccurate results and that if they require callbacks, the scale of this could be much higher? Given what we have learned, will the HSE give a commitment not to outsource this testing ever again and to bring it back under public, nationalised control here in Ireland? In other words, to be carried out close by to the hospital where a woman would be receiving treatment?
Michael Harty (Clare, Independent)
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Some of Deputy Coppinger's questions have already been answered so-----
Ruth Coppinger (Dublin West, Solidarity)
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I do not think I asked anything that has already been answered.
Dr. Tony Holohan:
It is not that we have a choice available to us of using a better test; that is the extent of the benefit, the limitations of that technology internationally. Nowhere else was able to get a better performance or a better or alternative type of test until a new technology called human papillomavirus, HPV, testing recently became available. Ireland will be one of the first countries in the world to introduce HPV testing as part of its cervical screening programme later this year.
Ruth Coppinger (Dublin West, Solidarity)
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I was referring to the fact that over the ten years we never reached the 1.8% average rate that other countries did yet we have a higher instance of cervical cancer. If we are getting lower detection rates back but getting a higher number of actual diagnoses, did Dr. Holohan not flag a problem over the ten years?
Ruth Coppinger (Dublin West, Solidarity)
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Why did we not reach the average other countries reached?
Dr. Tony Holohan:
We have hit all the quality assurance parameters for each of the stages of the programme. The quality assurance, QA, guidelines we have and the publication of QA audits in this regard demonstrate that. A side-by-side comparison makes that clear. We have had a substantial impact on mortality as a consequence in this country and we know we have had a significant impact on indicators such as the stage of presentation of cervical cancer. We are confident, therefore, that the QA data and the actual outcome experience of our population demonstrate that we have had significant public health value. The, in my view, erroneous assumption that was being made that in some way this was falling short by the order of a third in terms of the standard in comparison to other countries is simply not correct.
Ruth Coppinger (Dublin West, Solidarity)
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That was only in one year. That was the first year. However, while it did go up in subsequent years and hovered around a rate of 1.4%, it never went up to a rate of 1.8%. That is a significant difference in average from other countries that do the test differently. I refer to our nearest neighbour, the National Health Service, NHS, for example.
Mr. Tony O'Brien:
In relation to high grade, the 2015-16 CervicalCheck annual report listed all the different categories of high-grade detection. Added together, they come to 1.66%. That is perfectly within what one would expect. I wish to correct any belief the Deputy might have that the decision to outsource was cost driven. It was not. While every competitive tendering process must take account of cost in order not to be a hostage to overpricing, 80% of the criteria in the tendering process were quality orientated. The volume requirement of 25,000 was because, as in many things, there can be a correlation between volume and quality. We did not want to have very small providers doing things such as were happening in Ireland at the time. The Deputy used the interesting phrase "reading the slides close to the hospital". In some cases, that meant on the kitchen table at home. Ten years ago, Deputy Coppinger's constituents might have waited up to a year for their results. The ten-day turnaround is because that is what is required to be able to offer a credible cervical screening programme - or any screening programme. We can not say come have a test and wait forever for the result.
Ruth Coppinger (Dublin West, Solidarity)
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Some women waited seven years for the results.
Michael Harty (Clare, Independent)
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I am sorry. To manage the time, I am going to have to move on.
Ruth Coppinger (Dublin West, Solidarity)
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Would Mr. O'Brien just answer the question as to whether every slide is looked at by two technicians.
Ruth Coppinger (Dublin West, Solidarity)
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The witness is satisfied every single slide is?
Michael Harty (Clare, Independent)
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Deputy Coppinger can come in again later. We are going to stay as long as we have to. I call Deputy Bríd Smith, who has five minutes for questions and answers.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Mr. O'Brien was asked on the "Today with Sean O'Rourke" programme about the concerns raised in 2008 by Dr. David Gibbons and Dr. Sam Coulter-Smith. Dr. Gibbons and other scientists subsequently resigned because their concerns were ignored and dismissed. When that was put to Mr. O'Brien, he said that he had addressed those concerns in the final contract before it was awarded to Quest Diagnostics. Will the witness describe how he addressed those concerns? What was written into the contract? If Mr. O'Brien was prepared to address those concerns, why was that not indicated to the scientists at the time, instead of forcing their resignation?
He subsequently said he was happy with the standards applied by Quest Diagnostics. Mr. O'Brien must have been happy with the standards applied by CPL in Austin, Texas, as well, because he awarded it the contract. However, CPL is the company that was successfully sued by Ms Vicky Phelan. It settled with her for €2.5 million. Why would the company have settled with her if there was not a difficulty? I would like a brief answer.
I have read the press release from the Academy of Clinical Science and Laboratory Medicine on cervical screening. It has called on the Minister for Health to publish the results of the 2014 audit. When I asked the Minister in the Dáil last night to do that, he said there were no results of the audit - there were just individual reports for individual women. I spoke to a friend of mine who is a scientist about this today. She said that would be extraordinary because every audit has to have at least an introduction, the basis on which the audit was carried out, why it was carried out, what triggered it and what the terms of reference were. That is the very least. An audit will not just have Margaret's results, Ruth's results and Bríd's results and a description of how they have been looked at. There has to be a description and a report back. We are looking for that to be published. I echo the call by the academy for the 2014 audit to be published. I would like Mr. O'Brien to comment.
When the State Claims Agency, and I think it was Mr. Gleeson, was alerted that there was a claim made by Ms Vicky Phelan, Mr. O'Brien said he did not know anything about it until last Friday. I do not believe him. I do not believe that the Minister did not know. Other people might believe Mr. O'Brien but I doubt it. I think there are thousands of people out there who do not believe Mr. O'Brien. There may not be a paper trail or a smoking gun, an email or anything else but there could have been a conversation. Did Mr. Gleeson keep this to himself as a secret or did he discuss it verbally with anybody else? Would Mr. Gleeson get information like that, in a position of responsibility, and keep it all to himself? If Mr. O'Brien, as the head of the HSE, did not know until last Friday, he must be hopping mad. He must be looking for heads to roll over this. If he is not, I wonder why. I think anybody else would. I have one more quick question.
Michael Harty (Clare, Independent)
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The Deputy is eating into the time for the answers.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I know. Is the screening carried out in Sandyford or do they just dispatch and export the screens off to America? It has been said that the tests are dealt with in Sandyford but are they are carried out there? I am wondering because I am trying to track what is happening. I was talking to my doctor three weeks ago and I am wondering how the decision is made to send a smear to America, to Sandyford or the Coombe?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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In Sandyford?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Sandyford does the work?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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They are not sent off?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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On the other question, did Mr. Gleeson keep that secret?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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What does up the line mean? Who did Mr. Gleeson send it to?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Did the witness report it to Mr. Tony O'Brien or anybody in the Department?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Does Mr. Gleeson not find that extraordinary? Does Mr. O'Brien not find it extraordinary?
Mr. John Gleeson:
We work through a channel of communications. We get in cases. There was an element relating to the HSE. There was an element in respect of the reading the test. I was informed by the State Claims Agency we had co-defendants, a named laboratory. The element against the HSE, which was subsequently struck out, was how long it took us to disclose and not that we did not disclose. We have acknowledged there was a delay in the outcome of a review we conducted-----
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Who did the witness send it to up the line? That is what I would like to know.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Mr. Gleeson said he sent it to the head of screening. It would be helpful if he could associate a name with that.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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What is the title?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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What is the title of the office and the time when he or she occupied it?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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It is probably a he. It is extraordinary that we are sitting here talking about women's bodies in front of nearly all men. I am used to going to committee's on climate change or something where it nearly all men. Could the witness tell us the role of the person that he reported to?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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The head of the national screening service.
Ruth Coppinger (Dublin West, Solidarity)
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We will hear about it ourselves then.
Dr. Jerome Coffey:
I have a point of information that may help the discussion. I became aware of this in the run-in to the case. At that point, there was an opportunity for mediation. Unfortunately, that was unsuccessful and it went to court. Then followed the sequence of events that Mr. Gleeson described. As said earlier, it was an accelerated process facilitated by everyone in view of the clinical condition that the patient is unfortunately in.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Dr. Coffey told nobody else above him about it?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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The witnesses got the word in January.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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There was a legal case coming up.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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When was it known that it was turning into a procedure in the court?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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The witness could have still talked to someone above him.
Michael Harty (Clare, Independent)
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I am going to move on now. I call Senator Rose Conway-Walsh, who has five minutes for questions and answers.
Rose Conway Walsh (Sinn Fein)
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Does Mr. O'Brien accept that the buck stops with him in all of this?
Mr. Tony O'Brien:
Inevitably, I have an absolute responsibility for all 140,000 personnel in the HSE. It is my responsibility now to address this issue. I do not know whether the Senator was here for my opening statement.
Rose Conway Walsh (Sinn Fein)
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No, I was at the domestic violence Bill debate but I have the opening statement here. I want to clarify, in terms of accountability and the setup of this in 2008, in spite of all the advice that was given to the witness and the experts that resigned and all that, he made the decision to outsource this screening to America. Is that the case?
Mr. Tony O'Brien:
I think the Senator ascribes a bit too much total power to me. In fact, there were other experts who supported that process. There was a national cancer screening service board. There was a debate in the Oireachtas and there was ministerial approval but I certainly supported the decision. Contrary to what was said earlier, nobody was forced to resign and there were a number of steps taken. The issues that were raised at that time did not relate to this process, they related to an earlier process. A total of 1,000 slides had been outsourced as part of a catch-up programme in 2006 to 2007 by the HSE which I did not work for at that time. I worked for another organisation. Certain conclusions were being drawn based on that. Those were addressed in a number of ways.
Rose Conway Walsh (Sinn Fein)
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I am just trying to get to who did the final sign off on this to make the decision, in spite of all the information and the expertise that was being given in terms of the negative externalities which we have talked about in many other cases around the HSE. Who made the final decision on this? Normally somebody signs off on it. Was it made by the HSE in the screening process or was it made by Government?
Mr. Tony O'Brien:
The actual signing of the contract was authorised by the National Cancer Screening Service Board, which was a State agency, it was not part of the HSE. In fact the original Irish cervical screening programmes set up in the Mid-Western Health Board was part of the HSE and the Government decision was made, I presume it was a Government decision, to transfer it out of the HSE and into a new board which subsumed it and the-----
Rose Conway Walsh (Sinn Fein)
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This is the real crux of the problem. There is layer after layer but there is nobody who will stand up and say this was his or her decision or there is no group of people that will say they made this decision.
Rose Conway Walsh (Sinn Fein)
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Does Mr. O'Brien still believe today that the decision to outsource to America was correct?
Mr. Tony O'Brien:
Yes and I will tell the Senator why. At the time, there was no potential to provide a national cervical screening programme based on the laboratory system that was in place in Ireland at that time. The labs were not accredited. Women were waiting for up to a year for their results. Some of those slides were being read on kitchen tables. That is not a place-----
Rose Conway Walsh (Sinn Fein)
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What would it have taken to make those accredited and fit for purpose instead of outsourcing it to America? Was it investment that it required? What did it require?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Were many of the laboratories here applying for accreditation when the outsourcing was done?
Michael Harty (Clare, Independent)
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Sorry Deputy Smith.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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That is true. Many of them were already applying.
Rose Conway Walsh (Sinn Fein)
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That is what we are trying to get at because it seems to me that regarding the solution and the service that could have been provided here, investment was not made in it. It was run to an extent that there would be no alternative, which happens so many times, so it would be outsourced to America. I know I am very limited in time. When I had my smear, why did somebody not tell me there is a 30% chance that this is not going to work or I will not get the correct information? There is a 30% chance so this is what I need to do, that was not communicated to me or to other women.
Mr. Tony O'Brien:
My reading of the information that goes out by CervicalCheck, then and now, makes it very clear that there are both false negatives and false positives associated with cervical cytology. It is not 100% effective. In the public discourse we have heard a lot of talk about people being given the "all clear". I understand that is a shorthand approach but it conveys a certain meaning. The result is "no abnormality detected". It is not an "all clear".
Rose Conway Walsh (Sinn Fein)
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When the witness is talking to ordinary people, to busy women-----
Michael Harty (Clare, Independent)
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One minute Senator.
Rose Conway Walsh (Sinn Fein)
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I am not sure how much the communications budget within the HSE is but nobody talks to people and says there is a 30% chance this will not work for them. I need to ask Mr. O'Brien - this may have been covered, I apologise if it was - if he is going to publish all of the information around the audit and all of that now, so that we have full information on what is happening now.
Mr. Tony O'Brien:
Our absolute intention through the serious incident management team, SIMT process is to continually bring all our findings into the public domain. There will also be a Health Information and Quality Authority, HIQA, review. I understand there are discussions about another review. Clearly we will fully co-operate with that. The decisions about what will be published will be made on a conjoint basis in discussions with the Department and in a way that will not disrupt any review. We not do anything that disrupts the review.
Rose Conway Walsh (Sinn Fein)
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The witness is trying to hide behind a review that has not even happened yet, God help us all when we go into a commission and there is a completely closed door on it. We need to see the information now and we need to see what communications have taken place between Mr. O'Brien, the Minister and all of the people involved in this. Women are really concerned about what is happening. The GPs are not getting information, to read-----
Michael Harty (Clare, Independent)
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I am sorry Senator.
Rose Conway Walsh (Sinn Fein)
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There is a debacle here to which we have not got any answers.
Michael Harty (Clare, Independent)
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I understand. Mr. O'Brien answered this question earlier.
Rose Conway Walsh (Sinn Fein)
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As Oireachtas Members we need that information here because people are ringing us all of the time. We need to know what has been given to the GPs, what information is out there. We need to know who will pay for these and all of that. I ask the witness to give the committee a full copy of all that.
Dr. Colm Henry:
To reiterate, we have sent information following engagement with the Irish College of General Practitioners, ICGP, the Irish Medical Organisation, IMO and the National Association of General Practitioners. We sent information to all GPs to equip them to give women the best information.
Rose Conway Walsh (Sinn Fein)
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What time today?
Michael Harty (Clare, Independent)
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Deputy Donnelly we are coming back to you again.
Ruth Coppinger (Dublin West, Solidarity)
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This is a really important point of order. Mr. O'Brien has said that the cervical screening is only 70% accurate, that is really serious. When I checked the website it says there is a small risk.
Michael Harty (Clare, Independent)
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Sorry it is not a point of order.
Ruth Coppinger (Dublin West, Solidarity)
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Sorry it is extremely important for that to be clarified Chair because there is a 30% risk that a test does not mean anything. That is not accurate, the witness is trying to backpedal.
Michael Harty (Clare, Independent)
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Deputy Donnelly.
Ruth Coppinger (Dublin West, Solidarity)
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The website said there is a small risk, not a 30% risk.
Rose Conway Walsh (Sinn Fein)
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That is what women go on the assumption of, that there is a small risk.
Ruth Coppinger (Dublin West, Solidarity)
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Can the witness clarify what the detection rate of this screening is?
Michael Harty (Clare, Independent)
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It has been clarified already.
Ruth Coppinger (Dublin West, Solidarity)
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No it has not Chair.
Michael Harty (Clare, Independent)
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I call Deputy Donnelly.
Ruth Coppinger (Dublin West, Solidarity)
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It is 70%.
Ruth Coppinger (Dublin West, Solidarity)
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That is not 30% which the witness said earlier.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I am sorry Chair, this actually is important. Here is the leaflet, what does the leaflet say? It says the result-----
Ruth Coppinger (Dublin West, Solidarity)
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-----may not be accurate.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Yes, may not be 100% accurate.
Ruth Coppinger (Dublin West, Solidarity)
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It does not say 70%.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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The witness has given a figure that he would give to a woman and of course not every woman is going to see Dr. McKenna is she? No she is not. This was shambolic before we came in here. I imagine Mr. O'Brien came in here with his large assembled team to do some form of damage limitation exercise. With respect, he has made it worse. There is not one solitary woman outside of here who will be comforted by what he is saying. The error rate could be 30%, it could be less than that, it might not be 100%.
Michael Harty (Clare, Independent)
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Deputy O'Reilly.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I am sorry Chair but this is outrageous.
Michael Harty (Clare, Independent)
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We have made our arrangements in how we would conduct this meeting today and we will stick to them.
Ruth Coppinger (Dublin West, Solidarity)
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Something important has just come up that the Chair should be concerned about in his capacity as Chair of the process.
Michael Harty (Clare, Independent)
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We are going to be here as long as it takes. We are going to go around the room as many times as is needed for people to ask questions. We did come to an arrangement before we started-----
Ruth Coppinger (Dublin West, Solidarity)
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Yes.
Michael Harty (Clare, Independent)
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-----and we are going to stick to it.
Ruth Coppinger (Dublin West, Solidarity)
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Can I suggest that we should get the answer on that?
Michael Harty (Clare, Independent)
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I call Deputy Donnelly.
Stephen Donnelly (Wicklow, Fianna Fail)
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I am up next, I am willing to swap time with Deputy O'Reilly. If she would like to keep going on this issue I am happy to cede my time and I will go after Deputy O'Reilly.
Michael Harty (Clare, Independent)
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Does that work for the Deputy?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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That is fair enough yes. Can one of the witnesses give me an answer as to what exactly the accuracy rates are? Is there a difference between whether or not it is tested in Ireland or America? Is there a difference between who takes it? Is there standard advice that is given to people? Is there any kind of standardised process at all?
Dr. McKenna said what he would say to women, but clearly he does not see all women. That is what he would say, and something different is said to someone else. I will repeat what I said. If the witnesses came in here to do a damage limitation exercise I strongly suggest they put down the shovel and start answering some questions because this is not acceptable.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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So Dr. McKenna would not have confidence in the literature that is issued.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Dr. McKenna would not have confidence in it.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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If Dr. McKenna would change it then he is not confident in what goes out.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Which is what?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Which is what?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Then I ask Mr. O'Brien where he got the figure of 30%, and I would prefer if he did not defer to one of his colleagues and just answer the question directly.
Ruth Coppinger (Dublin West, Solidarity)
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Is that in America or here?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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To be honest, as I have said, this is-----
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I want to know where Mr. O'Brien got his figure from as the former head. I want to ask him a direct question. As the former head of the service where did he get his figure from?
Dr. Tony Holohan:
What I will point out to the committee is that the statistics here are difficult to understand. There are many different statistics that appear to be in conflict with each other but they are not. When we talk about sensitivity and specificity of a test, it means a different thing when we talk about false positive and false negative. They are technically different things. It is a different thing again in terms of a yield and how likely it is, and how positive one can be that the result that is negative is in fact negative. They are different measures and they are being used interchangeably.
It is important we are given time to be able to set this out for the committee in a way it can understand. I am not suggesting Deputy O'Reilly is doing this, but the way in which various statistics are being used is creating an impression that there is a conflict that is not in fact there. If I can give an example, and I am not going to quote in terms of the screening programme and its figures because we can calculate those figures off the performance of our own programme, but if we are talking about something that is 80% sensitive this means there is an 80% chance that if a disease is there a test will find it, and there is a 20% chance that if the disease is there it will not find it. This is what the 80% means.
Whether or not we can rely on the test being negative when we get a negative result depends not only on the sensitivity but also on the incidence of the disease in the background population. I appreciate this is a technical epidemiological point I am making. If a disease has a frequency of 1% and a test is applied that has a sensitivity of 80%, there is a different likelihood of it being positive or negative than if the disease had a frequency of one in 10,000. All of these factors bear.
The statements that are being made about the performance of the test, and its sensitivity and specificity being low, at in and around 70% in relation to sensitivity, is correct. It is broadly in line with the performance of the test in international hands. Statements have been made about negative predictive value, in other words, if I get a negative test how likely is it that the disease is not present. This is a very small figure. It is a percentage figure that probably for the performance or test might even be much lower than the figure that has been given, and I am not in any sense disputing the figure my clinical colleague has given. He may be referring to a different patient population where a higher incidence of the disease might exist.
It is important that we do not get confused and create a sense in which figures that are really important in terms of people's ability to be able to rely on the test and rely on the information they are getting in terms of predictive value, in some way appear on the part of the programme to be confused. I take the point that in general terms the programme should, on a continuing basis like any source of information, continue to improve its communication. This is not in any sense to say that erroneous information is being transmitted to patients. It is really important that we get this point across.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Dr. McKenna said he would change the leaflet. I want to ask Dr. Holohan, Dr. McKenna and Dr. Coffey what they would put on the leaflet to indicate the likelihood of there being a false negative result. It states it may not be 100% accurate. Would they put it at 99%, at 70% as Mr. O'Brien has done, or at 85%? What would they put it at?
Dr. Jerome Coffey:
I will make a general point, and I do not have the expertise to give a specific number or tight range. I will not put anything forward on that. What I will say is that a point I made earlier is it is probably appropriate to state that in any redesign or review of any of the patient information material, it is important that we get the patient's voice and the patient representative's voice in the room when it is being drafted. I cannot say what-----
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Were they in the room when this was drafted?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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They were in the room when it was being outsourced.
Dr. Jerome Coffey:
The level of information and the type of information need to be reviewed. Every couple of years more clinical science data is available. We need to be continuously updated. I cannot remember the data on the current version, but for future versions there will probably be a changed approach.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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This is the seventh revision and it is the most up-to-date version. Perhaps Mr. O'Brien can advise us how many times it was updated when he was in charge of it. Dr. McKenna might also advise on what he would like to see on it instead of it stating that it may not be 100%.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It would not have been revised during Mr. O'Brien's tenure.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Mr. O'Brien might have looked that up before he came in.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I thank Dr. McKenna.
Ruth Coppinger (Dublin West, Solidarity)
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Do the three laboratories have the same results or are they different?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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That is a question I asked. Is there a difference between the levels depending upon to which laboratory the results are sent?
Mr. John Gleeson:
All of the laboratories we have ever engaged have positive predictive values. If a test states the person has high grade abnormal cells and she then goes on to colposcopy and a biopsy, which is a diagnostic test, a disease that is pre-cancer or cancer is confirmed in the range of 70% to 90% of the time, which is the international rate if we look at screening programmes in England, Scotland, Wales and Ireland. We monitor this, and it is true for all programme laboratories that have worked with us or are working with us.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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As part of the monitoring, is there any distinction between where the samples are sent to be reviewed? Would the witnesses know whether there was a discrepancy-----
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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-----to be checked. If a test is carried out in America versus Dublin 8 versus Sandyford, is there a variation in the rate of false negatives between each laboratory?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Sorry, yes. Is there a variation in the true positive rate between the laboratories?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Which laboratories perform best?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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What would be really helpful is if Mr. Gleeson would point me in the direction of the place where all of this information is published because this is very important information. I was going to ask a question with regard to the audits, and perhaps Mr. Gleeson would give us a link to the website where we can review all of this audit information because it is extremely important information. The witnesses came in here to talk to us about transparency and accountability, and they might just point us in the direction of where we can get this important information because people want to know.
Ruth Coppinger (Dublin West, Solidarity)
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The witnesses must have the results for the three laboratories in detecting high grade-----
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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But not for the laboratories.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Is the information available per each laboratory? It may not be published. Will the HSE publish it?
Michael Harty (Clare, Independent)
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Could Mr. Gleeson provide the committee with the information whenever it is available to him?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I am sorry, Chairman. How soon can that be done?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Okay, so we could get it tomorrow. That would be very helpful.
Michael Harty (Clare, Independent)
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The Deputy has one more minute.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I know we will have another opportunity to ask questions. I want to home in if I can on who knew what, at what stage. I am reading from a letter that was copied to Dr. Henry and Mr. McKenna from a consultant gynaecologist and it is dated 22 August 2017. It states: "What has happened is totally inappropriate." That is referring to withholding of information from women. What I want to know is, given that Dr. Henry, who is here, and Dr. McKenna who is also here, were aware that there were serious concerns, was any of this kicked up the line, and at what point? Mr. Gleeson has already indicated that stuff got kicked up the line. I am not quite sure what that means. We might get a chance to go back to that. Was any of this kicked up the line? I find it absolutely extraordinary that Mr. O'Brien would not have been informed of a senior clinician who had serious issues with regard to the conduct of sharing information with women about themselves, which is material. The consultant said: "It is because I feel that the women deserve to know the results of the audit process." My God, if only other people shared that desire to share the information with women about their own health and well-being. Was Mr. O’Brien, as the head of the HSE, unaware of this? Those are very senior people.
Michael Harty (Clare, Independent)
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Deputy O’Reilly's minute has come to an end.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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My apologies, Chairman, but a significant amount of time was taken up with a very long and detailed explanation for which we are very grateful to Dr. Holohan, but it did use up a considerable amount of time. Could I have Mr. O'Brien’s and Mr. McKenna's view on that?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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That serious issues were raised with senior members of Mr. O'Brien's organisation, and he expects us to believe that they chose not to tell him and that he was not informed. Does Mr. O'Brien consider that important information, which we are now all here talking about, was withheld from him, or would it be routine and he simply did not ask? I am curious to know because, as previously discussed, the buck stops with him, but he does not seem to be taking any responsibility for it.
Mr. Tony O'Brien:
Well, if I can answer the question as opposed to the comment. Was I aware of the correspondence Deputy O'Reilly referenced? The answer is "No". Would I have asked if such correspondence existed? I would not have had any reason to. I have to rely on the layers of senior experts and those who report to me to bring things to me that I should know about.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Is this not something Mr. O'Brien thinks he should have known about?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I am sorry about this, Chairman. When Mr. O'Brien found out on the television, as he has told us - I said that stretches credibility - did he then start asking questions? Is he aware of this correspondence now? Where did he go when he started to look for this information?
Mr. Tony O'Brien:
What I found out on the television - it was not actually on the television it was on a NewsFlash app, was about the settlement of the case - the Vicky Phelan case - and at that point I asked to be advised of all the circumstances in relation to that case, which led to the establishment of the serious incident management team last Friday.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Since this correspondence refers directly to that case, and the withholding of information and all that goes along with it, could I have Mr. O'Brien’s view on it now?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Is Mr. O'Brien not going to express a view on something of this nature? I would have thought this would have formed part of it. It is a very senior clinician expressing some very serious views about the withholding of information from women, but Mr. O'Brien does not want to comment on it. When people say they do not have confidence in Mr. O'Brien-----
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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-----it is when he gives answers like this that causes people to say that.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It is an important piece of correspondence and Mr. O'Brien is telling me he has not seen it. I find that quite unbelievable because it is very material to what we are discussing here today. I am sorry, Chairman, I am way over my time.
Michael Harty (Clare, Independent)
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I thank Deputy O'Reilly and call Deputy Donnelly.
Stephen Donnelly (Wicklow, Fianna Fail)
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At the heart of this issue is non-disclosure. I have the HSE’s non-disclosure policy document here.
Stephen Donnelly (Wicklow, Fianna Fail)
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I beg Mr. O’Brien's pardon.
Stephen Donnelly (Wicklow, Fianna Fail)
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The open disclosure policy. I thank Mr. O'Brien. I would like to read out what the HSE defines as open disclosure, which is at the heart of all of this.
An open, consistent approach to communicating with service users when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the service user informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event.
So, the question at hand is whether Vicky Phelan was afforded open disclosure, and whether many other women, and possibly men, within the national screening service have been afforded open disclosure, and indeed there is a wider question now across the HSE, due to this. From what I have seen in the past week, there is a conspiracy of silence within the healthcare system when it came to Vicky Phelan's case and when it came to several hundred other women who were not informed of false negatives. Senior people within the national screening service knew the details of Vicky Phelan's case and they knew that hundreds of other women had not been communicated with. Senior management within the HSE knew those things as well, and the doctors knew those things - maybe not in the hundreds but they knew that their own patients had not been communicated with. People at the very highest levels within the HSE, at the level of direct reporting to Mr. O'Brien, at a senior level within the national screening service and senior consultants, all knew for years that the false negatives had occurred and as of today all of the women still have not been told.
I will start with Dr. Henry. We know that he was made aware of this issue, not just Vicky Phelan's case, but the wider issue of women not being afforded open disclosure, why did he not inform Mr. O'Brien as the head of the HSE, and why did he not act to begin to put in place the measures which are now being put in place, in an emergency response - because this has gone public? Why, when he was told about this, did he not act to ensure that all of these women were afforded open disclosure, as is clearly required under HSE policy?
Dr. Colm Henry:
In my then role as clinical adviser I was informed by the clinical director of a hospital group of his concerns over who was responsible for disclosure of this information, so I immediately consulted with the women and infants health programme and contacted the medical director of cervical screening asking her opinion and her response to the concerns raised by the clinical director in the hospital group. The reply I received from the cervical screening programme was that it was the responsibility of the caring clinicians to provide this information. There was an exchange of correspondence and meetings on advice I received from other relevant clinical leads which culminated in a meeting between the lead colposcopists, that is the clinicians, and the medical director of the screening programme on 1 September, three months later - the first correspondence I received was on 11 July. I received correspondence the following week from the medical director of the screening programme saying that they had changed the policy regarding communication and that further meetings were planned with the colposcopists so there would be consensus as to how they were going to communicate with patients, who was going to take responsibility and when this would happen.
Stephen Donnelly (Wicklow, Fianna Fail)
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Okay, perhaps Dr. Henry was trying to answer the question but I did not hear an answer. My question is that Dr. Henry was made aware of a very serious breach of open disclosure, it would appear that when he was made aware, actions were not taken to ensure that the women were informed. Why?
Dr. Colm Henry:
At that time I was working as a clinical adviser and what I did was I engaged with the people, including the medical director of cervical screening, and the hospital group clinical directors and relevant clinical leads to facilitate a discussion that would lead towards that. That was the role I played there. I received assurances subsequently that that meeting had taken place, that the communication policy had changed, and that there was agreement as to how communication would take place.
Stephen Donnelly (Wicklow, Fianna Fail)
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Given the national public anger and fear, did it not occur to Dr. Henry that the matter warranted escalation to Mr. O'Brien?
Dr. Colm Henry:
Rather than escalating a problem I usually try to engage directly with the problem myself, which is exactly what I did. I consulted with the relevant clinical leads, the clinical director of the hospital group, the clinician concerned and the medical director of CervicalCheck on a number of occasions. After those meetings those people dealt directly with the clinicians, after which I was told that a consensus had been achieved.
Stephen Donnelly (Wicklow, Fianna Fail)
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We now know that no action occurred. We know that three in four women were not told. We know that there were open disputes, which Dr. Henry was brought into, between a clinician and the service. Dr. Henry has just stated to the committee that as far as he is concerned he initiated the process, took the appropriate action, and was led to believe that things were happening. Does he, bearing in mind what we now know, believe he was misinformed by other parts of the HSE? It seems he was led to believe things were happening that clearly were not happening.
Stephen Donnelly (Wicklow, Fianna Fail)
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Is the witness saying that of course he believes he was mislead?
Stephen Donnelly (Wicklow, Fianna Fail)
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Mr. Gleeson stated earlier that a decision was never taken not to disclose, specifically-----
Stephen Donnelly (Wicklow, Fianna Fail)
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-----in the case of Vicky Phelan and the others.
Stephen Donnelly (Wicklow, Fianna Fail)
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I want to challenge that statement for several reasons. We have a circular from CervicalCheck, saying to doctors that in instances where the woman is still alive they should use their judgement, and that in instances where the woman is deceased it should be noted on the file. We also have a letter from Dr. Hickey, Vicky Phelan's consultant, to CervicalCheck, addressed to Dr. Gráinne Flannelly. It stated that on further reviewing the letter CervicalCheck sent down to Dr. Hickey with respect to an audit of the cervical smears on cancer patients, CervicalCheck highlighted just three it felt should be considered for recall on discussion. Dr. Hickey wrote there were a number of others that looked as though there were significant discrepancies, and he was somewhat uncomfortable about just recalling the three that CervicalCheck had highlighted. Dr. Hickey had ten patients. This was active correspondence from a consultant saying this matter was affecting ten of his patients. Doctors have been told to use their discretion, but clearly Dr. Hickey was being told by CervicalCheck that only three of the ten needed to be told. Given that information, and given what was in the circular, does Mr. Gleeson stand over the statement that there was never a decision not to disclose? If so, how does he stand over it?
Mr. John Gleeson:
The Deputy is referring to ten cases. The process was under discussion between two senior clinical people - consultant doctors - about how to disclose. We had already sent the information to the receiving clinician. There is an assumption that the other nine cases were identical to the one that has appeared in court. I doubt if any two cases are the same, so I believe caution should be exercised. I am certainly not going to reveal the details of those cases.
We had disclosed. We had sent it on and asked that it be taken further. The commentary around that - and I will not speak for Dr. Flannelly, who is still here - was that this consultant sought assistance in reviewing patient notes. That was done collaboratively, and it was decided who should immediately be told. One does not know whether one of those reviews had changed anything or not.
Stephen Donnelly (Wicklow, Fianna Fail)
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We will move on.
Stephen Donnelly (Wicklow, Fianna Fail)
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We have documentary evidence showing that the active advice from CervicalCheck was to tell just three in ten patients, and I do not need a response, but my view is that that represents a decision not to disclose.
Turning to Mr. O'Brien, in 2013 the open disclosure policy came into effect. In 2014 there was an audit. In 2015 a decision was taken to share the results with the women; two years after open disclosure came in. In 2016 the information was shared with the doctors. In 2017 Vicky Phelan got the information on her smears. Given that timeline, does Mr. O'Brien believe the HSE has failed in its duty of open disclosure and in its duty to these 208 women?
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the witness. How did so many people in the HSE, including clinicians and managers, stay quiet in what clearly was an egregious breach of open disclosure?
Mr. Tony O'Brien:
I do not know that they stayed quiet, because there does seem to have been quite a lot of discussion and debate, which appears to have been intended to bring a resolution to the matter. I said in response to a question earlier - I believe the Deputy was out of the room - that at an earlier stage it would have been appropriate for someone to put their hand up to say that the process was taking too long and that the fact that there was an ongoing discussion about how to do it rather than doing it needed more significant intervention. It should have been escalated, if necessary, all the way to myself, although I would have hoped it would not have had to get that far. The fact that that escalation did not occur is a source of concern.
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the witness.
Stephen Donnelly (Wicklow, Fianna Fail)
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I was here for that.
The principles of open disclosure in the HSE are: acknowledgement; truthfulness, timeliness and clarity of communication; apology-expression of regret, recognising the expectations of service users, that they may reasonably expect to be fully informed of the facts and consequences in relation to an adverse event; and clinical governance. Does Mr. O'Brien believe that the case of Vicky Phelan and the subsequent cases constitutes a failure of clinical and managerial governance within the HSE?
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the witness. When was the screening job last tendered? Was it 2012 or was there a subsequent tendering?
Stephen Donnelly (Wicklow, Fianna Fail)
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The witness's opening statement references 2012, but it does not say whether or not that is the most recent tender process.
Mr. Tony O'Brien:
From 2012 we entered into a framework agreement. Under a framework agreement, as the Deputy probably knows, the arrangement is that the service is not fully tendered, in the way it would be in the absence of a framework agreement. Mr. Gleeson can update us on how that framework agreement has proceeded.
Stephen Donnelly (Wicklow, Fianna Fail)
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Before we turn to Mr. Gleeson, Mr. O'Brien might answer one further short question. I thank the Chair for his indulgence. This is off topic but it was raised in the Dáil today, and while Mr. O'Brien is here I want to raise the issue. It concerns his board membership of Evofem Biosciences.
Michael Harty (Clare, Independent)
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That is not the subject of the committee meeting today so I cannot allow that question.
Stephen Donnelly (Wicklow, Fianna Fail)
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It is not out of order; it is a very quick question.
Michael Harty (Clare, Independent)
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It is not the subject of our meeting.
Stephen Donnelly (Wicklow, Fianna Fail)
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We had a three-hour meeting earlier today, which was supposed to be about specialist registers, and many other topics were discussed. This is one question in the course of a 20-minute discussion. I beg the Chair's indulgence.
Michael Harty (Clare, Independent)
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No. I am sorry. I am going to move on to Deputy O'Connell.
Stephen Donnelly (Wicklow, Fianna Fail)
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We were moving to Mr. Gleeson to get an answer to a question that the Chair was ruling in order.
Stephen Donnelly (Wicklow, Fianna Fail)
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I asked when the screening service was last tendered.
Stephen Donnelly (Wicklow, Fianna Fail)
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The last time the decision was made to use services based in the United States was 2016. Is that right?
Kate O'Connell (Dublin Bay South, Fine Gael)
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One of the witnesses spoke about the four laboratories in the United States being comparable within certain parameters. Many members have asked questions, so I just want to be clear.
Is Mr. O'Brien telling us that he is happy with the standards of the three or four labs being used - it does not matter to me how many - both American and Irish? As head of the HSE, does he think, not in his personal opinion but from evidence, that they are up to scratch for the provision of this service to the women of Ireland?
I have a second question. Before the 2014 audit that led to the recent findings, I am led to believe that there were two years of audit that were used for education and training purposes. Might Mr O'Brien explain why that happened? When the real audit of real people's data happened in 2014 and this rate of false negatives was identified, did the HSE compare the rates of false negatives and false positives of the four individual labs? That is the first batch of questions. I am sure Mr. Gleeson and Mr. O'Brien can answer those.
Mr. John Gleeson:
I think I need to clarify. People are talking, I do not know why, about a 2014 audit. In the court case that has been subject of much discussion, the diagnosis was made in 2014 and that triggered the review. The audit process is that if there is a diagnosis of cancer, a review starts. We look at the previous screening history prior to-----
Kate O'Connell (Dublin Bay South, Fine Gael)
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I understand that.
Kate O'Connell (Dublin Bay South, Fine Gael)
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During the time since auditing started, at any point did the HSE draw a line in the sand and compare the outcomes from the four individual labs? There is lab A, lab B, lab C and lab D. Did the HSE look at each lab's smears and the resultant false negatives? I think it is a "yes" or "no" answer.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Sorry?
Mr. John Gleeson:
Laboratories examine 30,000, 40,000, 50,000 or 100,000 samples per annum. Three false negatives might emerge three years later when we go back and look at them. Meanwhile, we are monitoring the period in question, and the positive predictive value is correct for their quarterly measure. It is complex. We are monitoring all the time. The false negative rate can only be determined against what, all the other positives? There could be 70,000 negatives, and three that might be false negatives when one looks back three years later under review conditions. It is minuscule.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Are those Irish figures?
Kate O'Connell (Dublin Bay South, Fine Gael)
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No, I understand. There is no comprehension issue here. Mr. Gleeson is referring to the Irish cohort of women. However, the lab is obviously doing American smears too. Obviously, they would not be minuscule figures. Has the HSE looked at all of the work being done by a lab?
Kate O'Connell (Dublin Bay South, Fine Gael)
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That is insignificant, is that what Mr. Gleeson is saying?
Kate O'Connell (Dublin Bay South, Fine Gael)
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Very well. I have a question for Mr. O'Brien. How can Irish clinicians conduct multi-disciplinary teamwork with people in different time zones, who use different nomenclature and perhaps different terminology regarding cervical cytology? That is the first question. Second, from the time the cervical screening programme was introduced, and we did not have the capacity in Ireland because there was a backlog, was any attempt made by the HSE to increase the capacity in the Irish system? When the backlog was dealt with abroad, was the HSE working to ramp up capacity in the Irish system, based on the concerns of clinicians in Ireland in 2008? Doing the job in the United States was a third of the price of what it was here. Did that ring any alarm bells when it came to quality analysis? I have come upon the McGoogan report from 2004, which laid out what we should be doing before we had the screening programme. Here is recommendation 1.7 on how it should be conducted:
"A management structure with clear governance arrangements is required to ensure that the legal obligations to eligible women, health care professionals and staff participating in the Programme including Phase One are met."
Another recommendation: "The establishment of effective governance arrangements with immediate effect is necessary in order to provide overall leadership and direction in terms of policy development", and so on.Recommendation 1.12: "A quality assurance (QA) programme should continue to be given priority in the ICSP." The report further recommends that:
"Structures must be put in place to allow review or revision of quality standards by a National ICSP Quality Assurance Committee which should include representation from the Professional bodies, other key stakeholders such as the Cancer Registry, the Cancer Society and other cancer screening programmes".
It seems that much of what was recommended did not actually happen. Then I found the women's charter. This is addressed to the women: "All members of CervicalCheck staff will respect your privacy, dignity, religion, race and cultural beliefs." It makes a commitment that women would always have the opportunity to make their views known and to have them taken into account. Women are assured that their smear tests will be screened in an accredited quality-assured lab. CervicalCheck also committed that a woman's result and any treatment recommendations would be provided to her and her nominated smear taker by the programme within four weeks. In regard to that last point of the women's charter, I do not think Vicky Phelan got what it said on the tin. Would Mr. O'Brien agree?
Mr. Tony O'Brien:
Clearly in relation to being communicated with around the outcome of the review, no. On the point in the charter about four weeks, this is intended to refer to the initial smear test. The fact that this is what the charter is referring to does not take way from the fact that Vicky Phelan should have had open disclosure in relation to the outcome of the review into her particular case that was carried out.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Mr. O'Brien was in charge. At the initiation of this process, was there any standard operating procedure for crisis management in case of something like this? It does not look like one was followed. The response seems to have been ad hoc. People were trying to get messages up the line to wherever. I think this is a yes or no question.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Specifically to deal with systems failures such as this?
Kate O'Connell (Dublin Bay South, Fine Gael)
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Mr. O'Brien said earlier that the decision to go to the US was correct at the time. Does he think it is still the right decision for those smears to be done there now, ten years on?
Kate O'Connell (Dublin Bay South, Fine Gael)
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Individually performing, not collectively.
Mr. Tony O'Brien:
Individually performing. There is a QA programme of the type described by Dr. McGoogan in the report that Deputy O'Connell referenced. Mr. Gleeson is in charge of that overall. I am aware that there is now a debate in which some people are saying that it would be better if we created cervical cytology capability in Ireland.
Kate O'Connell (Dublin Bay South, Fine Gael)
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That was said back in 2008.
Mr. Tony O'Brien:
They are also saying it now. What I would say is that wherever the screening takes place, there is no point in recreating cervical cytology experience, because by the end of this year that test will be obsolete. The screening programme will move to human papillomavirus, HPV, testing, which will deal with many of the vagaries that we have discussed today. Wherever the testing is to take place, there is no merit whatsoever in beginning to create-----
Kate O'Connell (Dublin Bay South, Fine Gael)
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That seems logical.
Kate O'Connell (Dublin Bay South, Fine Gael)
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The population of Ireland is similar to the population of Manchester. There seem to be a lot of people involved and a lot of people moving around the organisational structure, being in one place and going to another place. It is very hard to track who was in what job when, and who was responsible.
Does Mr. O'Brien accept at this point that the organisational structure of the HSE is not fit for purpose because it does not actually have anything to do with organisation? To my mind, it is to do with diminishing pathways to accountability or somehow making it more confusing for people like me. Mr. O'Brien is head of the HSE. Given that we are dealing with a subset of population the size of a major city in the UK and have made such a hames of the situation, I do not know how he thinks his position is tenable at this stage.
Kate O'Connell (Dublin Bay South, Fine Gael)
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Please.
Mr. Tony O'Brien:
I was appointed to this role. Rather, I was invited to take up the role on the basis of a set of Government policies which were about the abolition of the HSE and the introduction of universal health insurance. So I did the job in a particular way, in the context of that, for close to three years, expecting to be winding down the organisation and moving it into a collection of different types of service providers, hospital groups on a statutory basis and community health organisations. As the Deputy knows, that did not happen. I had discussions with the relevant Ministers. What we have actually been doing is seeking to prepare the HSE for the type of future envisaged in the Sláintecare report as a result of which Government sanctioned: the appointment of a chief operations officer so that there is very clear accountability for the operating system; the appointment of a strategy and planning head in order that we have much more focus on planning to population need, as they do in other countries; and, just recently, for the first time ever in the Irish healthcare system, the appointment of a chief clinical officer. So what I have been attempting to do in the second three years, and it has been extraordinarily slow because of the approvals processes one must go through, is come to a much more streamlined system of governance. That is the only reason people have moved around in this context. In an organisation the size of the HSE, people move around. They have opportunities to apply for different jobs, posts become vacant and other people come in. Yes, it is complicated. An organisation the scale of the HSE is inherently complex. I have long maintained that the structures of the HSE are in fact not fit for purpose. I have been saying that throughout my time. I have now got to a point where I think, subject to the implementation plan for Sláintecare, that there is a much coherent organisation of functions at the top level which is useful and valid. It is extraordinary that, for the very first time, the Irish health system has a chief clinical officer - appointed within the past four or five weeks. I am very glad to have been the one who brought that about.
Colm Burke (Fine Gael)
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I will follow up on the point Deputy Donnelly raised with Dr. Henry regarding the decision-making process and how it seemed to go around in circles. I am sorry for coming back on this. Did it not occur to Dr. Henry that, in the context of the delay in making the decision about getting the information out, someone should have sought legal advice about whether we could run into difficulties about not disclosing this information and the delay in making the disclosure? Did it concern Dr. Henry that there might be a legal problem caused by not making the disclosure in a timely manner? The next issue is the time it takes to make a decision. We are going over a period where no decision was made. Did that not concern Dr. Henry? He was the clinical officer. Will this be the process in the future regarding any decisions that are to be made? Will it go around the house and back again to the same place where it was two years previously? Did that occur to Dr. Henry at the time? I know he was not clinical director but surely it must have occurred to him that this delay was not acceptable.
My second question concerns the role of clinical director. The clinical director was in situfor quite a period. I know we are going back to 2008 when this process was set up. The masters of the Coombe, Holles Street and the Rotunda have seven-year contracts. In fairness, any of these roles are extremely demanding. The person is dealing with a huge number of people and a number of different units throughout the country. Likewise, a master of one of the maternity hospitals faces a huge number of demands. Does Dr. McKenna not think the way forward might be to stipulate a defined period for the director's job? The director can reapply when the job comes up for review but that process would be there. I am just looking at the way forward.
What kind of timescale would be involved if we decided tomorrow morning that we wanted all smear tests to be dealt with here? I know the Coombe is carrying out some analysis in this area in the sense that it is providing a service. My understanding is that the Royal College of Surgeons in Ireland had a laboratory but that this service has now gone out to private enterprise. I stand open to correction on that. The process is being provided in Ireland. How long would it take to put in place the requisite number of people with the skills necessary to deal with all of the smear tests that are done here? Would it take two, three or four years? What kind of period would it take us to build up those skills? It is important to look at that. Given that we have been sending tests out and using US companies for over ten years, surely we should be looking at trying to keep all of this work within the Irish jurisdiction.
Dr. Colm Henry:
As I outlined before, I first became aware of this on 11 July 2017. It was presented to me by our clinical director in seeking advice in my then role as a clinical adviser. I facilitated and engaged directly with the medical director of CervicalCheck, the clinical director and the appropriate clinical leads in the hope that rather than have recourse to legal advice, they would come to a consensus themselves. I was assured of the same after their meeting on 1 September. At the time, I did not-----
Colm Burke (Fine Gael)
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Did Dr. Henry not set a timeline with them for when a decision had to be made?
Colm Burke (Fine Gael)
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Did Dr. Henry suggest it?
Colm Burke (Fine Gael)
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Dr. Henry must have become concerned when the issue was still dragging on quite a number of months after he first discussed it? He must have raised concerns. Did he raise those concerns in writing?
Dr. Colm Henry:
I did. I wrote to CervicalCheck on two occasions and engaged directly with it. I wrote to the clinical director who first raised issues with me and held a number of meetings with relevant clinical leads to address this issue. As I said, this led to a direct meeting and engagement between the clinicians involved with the service and CervicalCheck, after which I came to believe that they had come to a resolution between them.
Colm Burke (Fine Gael)
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Dr. Henry came to a conclusion that they had come to a resolution of the problem.
Colm Burke (Fine Gael)
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Was Dr. Henry then surprised to find that this did not happen?
Colm Burke (Fine Gael)
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Was it confirmed to him in writing whether it was going to happen?
Colm Burke (Fine Gael)
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In the context of saying that there would be communication, there was no decision. Dr. Henry was not advised of the decision to inform the patients or not.
Colm Burke (Fine Gael)
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So Dr. Henry was never told at any stage, either in writing or verbally, that communication was occurring and all people were being communicated with.
Colm Burke (Fine Gael)
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Did that not concern Dr. Henry?
Colm Burke (Fine Gael)
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If Dr. Henry was unhappy with the response he was getting from the director of CervicalCheck, did he not then communicate with somebody else in the HSE about his concerns?
Dr. Peter McKenna:
The Senator asked a question about the length of time it is suitable for a director to be in place and cited the seven years which masters of the Dublin maternity hospitals spend in their positions. That is probably at the upper end of what is acceptable for a clinical director. After that period one could be replaced or reconsidered but a term exceeding seven years is probably too long. Was that the Senator's question?
Colm Burke (Fine Gael)
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If Dr. McKenna was making a recommendation into the future, would he say that a person should be appointed for a specific period of time rather than ad infinitumor until he or she retires?
Colm Burke (Fine Gael)
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Yes, that is right.
Dr. Peter McKenna:
Once a person has done seven years and given his or her best, that is it. A shorter period of time might allow for the possibility of a person being reappointed for another three, four or five years if that person was doing the job well and if everyone agreed. Seven years does not allow for a reappointment. It is too long. I certainly agree that appointing a person for a set period of time is far more appropriate than appointing someone until retirement.
Colm Burke (Fine Gael)
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Will the witnesses address the issue of trying to build up the skills base to deal with all of the-----
Mr. Tony O'Brien:
I will answer that. Later this year there will be a change away from cytology to the HPV test for primary screening. This will have the effect that the cytology capacity required by the programme will fall from approximately 280,000 cases per annum to 50,000 to 70,000 per annum. This is because if the HPV test is negative, the patient or client will simply return to routine HPV testing. If it is positive, that is, if HPV is detected, it will be followed up by cytology. The expectation is that will be in the range of 50,000 to 70,000 cases, which is less than the number of cytology tests currently being conducted onshore.
Colm Burke (Fine Gael)
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Could what Mr. O'Brien is talking about rolling out in October now be rolled out at an earlier date? I know many plans have to be put in place, but could it be rolled out at an earlier date? Is it the case that all of the work involved in that will be dealt with in Ireland or will we still need resources or assistance from outside?
Mr. John Gleeson:
We have been planning for some time. This might accelerate it a bit, but we will be required to comply with procurement legislation and timeframes if we need to tender for the service. Nobody in procurement in the HSE would specify a country in which it was to be located unless we were directed otherwise. It is a considerable undertaking even to put in place the structures to change the operation of the screening programme and to convert it to HPV testing, that is, looking for the presence of infection with certain types of HPV which are associated with cervical cancer rather than looking down a microscope for the presence of abnormal cells on a slide. It will have to inform what we-----
Colm Burke (Fine Gael)
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Do we have a target date for HPV testing?
Colm Burke (Fine Gael)
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Does Mr. Gleeson believe it can be delivered by October?
Michael Harty (Clare, Independent)
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I thank Mr. Gleeson. Our next contributor is Deputy Durkan. We are getting tired, so can we really concentrate on the issue at hand, which is the women involved in this, for want of a better word, scandal?
Bernard Durkan (Kildare North, Fine Gael)
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I will do my best not to falter in the course of my contribution. I want to mention two or three things which have come to my mind. The statement provided to the committee by Dr. Holohan states:
Patients have a right to be provided with honest, open and prompt communication about any adverse event that may have caused them harm. This is underpinned in the Medical Practitioners Code of Conduct and the HSE Open Disclosure Policy. The Civil Liability (Amendment) Act ... These provisions were drafted to create a safe space for staff to be open and transparent with patients.
How does that sit with current events? It is very laudable but it does not seem to have been part and parcel of the daily exercise of the HSE in all its workings. That is one question. The other thing I notice is that in 2009 HIQA conducted a survey which concluded that the system warranted an ISO 9001 accreditation.
Bernard Durkan (Kildare North, Fine Gael)
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That was a major positive element in its assessment.
Bernard Durkan (Kildare North, Fine Gael)
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It was not suggesting that the service was up to that standard.
Bernard Durkan (Kildare North, Fine Gael)
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In hindsight does Mr. O'Brien think it was up to that standard?
Mr. Tony O'Brien:
In terms of the things which that accreditation covers, yes. It would not cover the process we are talking about. Against the original quote, which came from the chief medical officer's opening statement, had the experience of the patients involved lived up to that standard, we would not be here today, so clearly it did not.
Bernard Durkan (Kildare North, Fine Gael)
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A new system is anticipated with greater sensitivity and greater accuracy in the determination of the positive existence of the disease. I presume that is a very new system.
Mr. John Gleeson:
Dr. Holohan might know more about this, but the HPV test being recommended for use is considered to have a higher sensitivity to the disease, meaning that if one gets a negative result, the negative predictive value is better than that achieved through cytology. There is less risk of a false negative or that a person will develop cervical cancer within the next appreciable interval to the next test.
Bernard Durkan (Kildare North, Fine Gael)
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Its accuracy will be somewhat-----
Bernard Durkan (Kildare North, Fine Gael)
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Recognising that the cervical test is just a test or screening and not a diagnosis, how close together can screening and diagnosis be brought? Will they converge? Are we bringing the screening nearer to the diagnosis? Will the witnesses tell me more?
Dr. Peter McKenna:
The diagnosis is not made until a sample is looked at under a microscope histologically. That requires a biopsy to be taken. Only then can what is until then a well-informed impression which is likely to be correct be confirmed. The ultimate arbiter is a pathologist looking at a sample under a microscope. Only then can a definitive diagnosis be given.
Bernard Durkan (Kildare North, Fine Gael)
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It is said that any system is only as good as its weakest point. Would any of the witnesses like to comment on what might be the weakest point in the issue which has led us to where we are?
Dr. Peter McKenna:
That is a very perceptive question. There are many places in which a screening service can fall down. In the first place, one has to get the patient to the doctor or practice nurse. One has to get the practice nurse to take the sample correctly. One then has to get the sample to the laboratory where it must be processed correctly and then one has to get the information which the laboratory generates back to the referring doctor and to the patient. Clearly, in this process, where the system has broken down is beyond the steps which I have laid out. It broke down where a quality assurance programme was instituted, which was found to have failed. In its failure, that information was not passed on.
The steps I have pointed out have worked pretty well, but it is the step beyond that, which is the conveying of wrong information to the patient, is the reason we are here.
Bernard Durkan (Kildare North, Fine Gael)
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Has the witness identified precisely the weakest point or points, in the event of there being more than one which obviously there are?
Dr. Peter McKenna:
One must start off with the first point, which is that one must get the right people to enter into the service. Traditionally with cervical screening, certainly up until instituting national screening, it was the well informed and well off woman who had availed of the benefits of screening. When one introduces a population-based screening such as this, one eliminates that as much as one can and one includes the entire population. However, it remains a challenge to get everybody in the target population to avail of the service. That is one weakness any screening service will have. The concern will be that the debacle surrounding this, as it was referred to, will make it more difficult to make inroads into the number of women who will not be availing of the service. Getting the right woman to avail of the service is the first step. Ideally, the service should be trying to get to nearly 100% but no service achieves that for a variety of reasons, some of which are very valid.
Bernard Durkan (Kildare North, Fine Gael)
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Is the witness satisfied that he has the correct amount of information available to him to address that issue in its varied forms to the best of his ability?
Dr. Peter McKenna:
I am happy that most of the steps I pointed out are being dealt with very well. What we are talking about today is how to make what is a satisfactory service better and more comprehensive, in that it will make sure the patient will be informed not only if the result is positive at the time, which is usually considered to be the challenge, but also that if it subsequently turns out to be positive and one looks back and it was negative that will also be included as part of the process. That is where the system has fallen down on this occasion.
Bernard Durkan (Kildare North, Fine Gael)
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Mr. O'Brien will recall that I have been a critic of the structure of the HSE for a long time. I never agreed with it and I never will. I believe it is the wrong structure to deliver services here, although I am not asking anybody to comment on that at this stage. However, I am raising whether a different structure might have been more alert and responsive, whereby the alarm bells about what might have happened might have gone off at an earlier stage and generated a reaction to it. If the witness was to make recommendations, apart from the ones he just mentioned, relating to the structures of delivering the services to the population of this country, what would they be?
Dr. Peter McKenna:
My involvement with the cervical screening programme has been fairly limited. We are talking about days. I believe it would benefit from being part of a bigger structure. It appears to have been working in a relative silo so the values may have gone relatively unchallenged, whereas if one broadens out the base of participation these values will be challenged and, hopefully, be more comprehensive and fit in with the values we are hearing reflected today.
Mr. Tony O'Brien:
I wish to offer a slightly alternative perspective, having been chief executive of the national cancer screening service when it was a stand-alone agency. This does not fundamentally disagree with what Dr. McKenna is saying because he is talking about the present day context. I spent a number of years doing my best to try to prevent the national cancer screening service board ending up as part of the HSE - it is ironic that I am now the director general of the HSE, although not for too much longer - and I believe that had governance with a non-executive board remained closer to the screening programmes red flags would have been raised more quickly, more locally and more effectively in that structure.
Michael Harty (Clare, Independent)
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Deputy Coppinger has five minutes.
Ruth Coppinger (Dublin West, Solidarity)
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I am sure the witnesses are tired but the issue regarding the testing system that emerged earlier is very important. We all know the mistakes were made with disclosure. I believe a very paternalistic attitude towards women pervades the Irish health service, and it is probably reflected in what happened. However, I wish to focus on the testing because my concern is that once one turns the health service to a profit motive one gets these mistakes. The witnesses are at pains to assure us that is not the case, but they have not been able to provide the results from the different laboratories which might go some way to reassuring us.
Ruth Coppinger (Dublin West, Solidarity)
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Yes, but I cannot judge and this is the only chance I have to ask questions. To be honest, that information should be at the top as the witnesses knew this issue had emerged in the press. The witness made some disparaging remarks about tests being done on the kitchen table. That is at odds with what Dr. Sam Coulter-Smith said. He is not an insignificant person as a former master of the Rotunda Hospital and he called the service it ran accredited and world class.
One cannot dismiss the fact that this was predicted by people ten years ago. In addition, they said it would be ten years before these problems would emerge. Some €20 per test multiplied by 3 million, which is €60 million, was paid to a private company which makes massive profits and has connections with Goldman Sachs. These people are in it for a reason, and it is not for patients. That was not purely the HSE's decision. The witness is correct that the Dáil voted for that, despite counter arguments at the time. The majority of parties, even if they ranted about it at the time, did not challenge it when they came into power. It is the issue of public services being starved of resources and then being privatised.
I have a question about the rate of testing. My understanding, and I am open to correction, is that the NHS guidelines are that 50 tests per day is the recommended best practice level. Quest Diagnostics was doing 90 to 100. I tried to calculate the figures by dividing 25,000 by 365, but presumably laboratories do not operate for 365 days a year. They might take weekends off, but I do not know. However, the rate in Quest Diagnostics must have been nearly twice what the NHS recommends.
A screener is only supposed to carry out a maximum of 5,000 per year. If there is pressure to make profit by getting as many tests carried out as possible these things are absolutely inevitable. Corners were cut in women's health at a time when the economy was going into recession. Again, political parties took that decision. Why did CervicalCheck downgrade, as I have read, from two deep checks to one deep check and one rapid check in 2011?
Dr. Tony Holohan:
I wish to make a general point and not to take issue with many of the specifics Deputy Coppinger has raised or, indeed, the legitimacy of questions about laboratories and contracts being raised.
I have been doing some calculations and I can give some general figures for the purpose of illustration. What I am trying to address here is a sense that we have evidence of a substantial failure of the cytology service that people here depend on for the reliability of the tests. We have to try to reassure people about that because they are genuinely worried and concerned.
We carry out approximately 250,000 smears per year. The abnormal rate that is reported, between high grades and low grades, is approximately 8,000. I will call that 10,000 for the purpose of simplicity. That is 240,000 negative test results per year. We know we have approximately 300 incident cases of cervical cancer in this country per year.
We believe the test performs at the rate of about 70% sensitivity. That means it misses about 30% of cancers that are present at the time of testing. For simplicity, we will say that works out to be somewhere in the region of 100 false negatives. That gives a false negative rate of substantially less than 1%, therefore, when the accuracy figure of 99% set out in the figures is quoted, it is based on statistics like that. That is a back of the envelope calculation. What I am trying to illustrate is that the general assertion - I do not suggest Deputy Coppinger is making this particular assertion - is that there is some evidence here of a substantial failure in the cytology service being used to give people reassurance. We simply do not have evidence of that. There have been substantial failures. There has been clear admission in regard to them, particularly in terms of unacceptable failures of communication to patients, but that cannot be equated with a statement or review. I have to make that point about the cytology service and the evidence we have in terms of performance. The point has been made by the director general that the differential performance, about which again there is a legitimate question, can be provided by way of response to the committee. That may well help to satisfy some of the questions that have been asked.
Michael Harty (Clare, Independent)
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I am going to extend Dr. Holohan's time. I have a question on that. In a case of a false negative, and the frequency of testing is every three years, the rate of growth of cervical cancer is slow. If someone has a false negative and she comes back in three years' time, is there an estimation of how advanced that cancer would have progressed in those three years? The benefit of screening is that women are screened every three years in order that a profile of the patient is being built up. If there is a false negative on one smear, how much of a change would be expected in a three-year period?
Dr. Peter McKenna:
I could hazard offering an answer on that. Once a woman has a visible, invasive cervical cancer, she will probably live without treatment for about 18 to 24 months. However, we know, and this is one of the best studied areas of screening in any part of the body, that to get to that stage there is a pre-invasive stage that may take as long as 12 or 15 years, which starts off as a mild abnormality and usually progresses at a reasonable rate to a severe abnormality and then to cancer. At any of those stages it can revert back to being normal, but the nearer one gets to having an invasive cervical cancer, the more likely it is to progress into being an invasive cancer. The premise of the Chairman's question is whether one has several opportunities to catch it before it becomes invasive. The answer is one has many opportunities. This test, which has a high false negative rate, works because one has several attempts at it over the ten or 12-year period before it turns into an invasive cancer. If it progressed more rapidly and the test was as good as it is now, it would not work but because it progresses so slowly, this test, which has error built into it, works.
Mr. Tony O'Brien:
To go back to the Deputy's question about the prediction Dr. David Gibbons made, I heard him saying that what is happening now is what he predicted. What is happening now is not what he predicted. What he predicted was that there would be a very high incidence of missed cancers. The chief medical officer has just taken us through an explanation of why that is not what we are experiencing. Dr. Gibbons did not predict that there would be a review process that would go so terribly wrong in terms of its communication to patients. That review process going terribly wrong has got nothing to do with where the slides were read. Such a review process would have had to occur wherever those slides were processed, including here, and there were such misses when the programme was based in Ireland in terms of its cytology process. If the same flawed process of communication had occurred, we would still be here having this discussion because it is fundamentally not about an excessive level of miss, taking into account the limitations of this test. Clearly, any miss is highly regrettable. While we have this programme, the whole purpose is to prevent cervical cancer. We do not take some satisfaction from the fact that the miss rate here is simply that which would normally be expected. We would wish we had a better test, and we will move to a better test, but what Dr. Gibbons predicted is not what we are experiencing. What we are experiencing does not vindicate the arguments he made ten years ago, however valid. This does not prove that he was right.
Ruth Coppinger (Dublin West, Solidarity)
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To conclude on that, we asked earlier for the results from the private for-profit laboratories to compare them, for example, with the public laboratories. I cannot actually gauge what Mr. O'Brien is saying and whether it is true.
Ruth Coppinger (Dublin West, Solidarity)
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Does Mr. O'Brien not believe he should have had that information? Dr. Gibbons has been in the news for days, and we raised this in the Dáil last night.
Mr. Tony O'Brien:
When one comes before a committee like this, one of the challenges is that one is not quite sure exactly what one will be asked. It is often the case that we need to revert with additional information. There has never been an issue between us and the committee doing that, and we are happy to do that.
Michael Harty (Clare, Independent)
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I thank Mr. O'Brien. I call Deputy Bríd Smith.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I want to follow on quickly from that. There were 208 false negatives. That is all over the news and Mr. O'Brien does not know the laboratories from which they came. He cannot tell us that, and it was raised in the Dáil yesterday and elsewhere the day before. Hello.
Ruth Coppinger (Dublin West, Solidarity)
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Do the witnesses know the laboratory from which those 208 false negatives came?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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From where did the 208 missed diagnoses come?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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From different laboratories.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Can Mr. Gleeson not say how many of them came from the United States, Sandyford and the Coombe? I would imagine that figure is in his head somewhere and that he knows it. If he does not, he is not doing a proper job. That is a fundamental question in terms of what was said in 2008. Mr. O'Brien misrepresented Dr. Gibbons and the obstetrician when he said that that is not what they predicted. They predicted that in about ten years' time we would see the results of poor-quality testing that had been outsourced to America. That is what Dr. Gibbons argued at the time. We are seeing that now but what we are also seeing is an attempt to cover it up. That is why we want to know what was reported to whom on which I have a few questions to ask.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Yes, but I do have questions. Can I ask them after Mr. O'Brien responds?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I am not clear on that.
Mr. Tony O'Brien:
The chief medical officer has been quite clear in terms of the incidence of false negatives resulting in later diagnosis of cancer. We are not seeing something that is out of line with what might reasonably be expected in a screening programme based on this technology. However, with the Chairman's agreement, we will provide full written information on the questions that have just been asked because it is far better done by giving it to the Deputy in writing than seeking to give her that kind of information verbally.
Michael Harty (Clare, Independent)
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Thank you.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Mr. O'Brien will tell us the exact number of false negatives and the laboratories from which they came. Are we clear about that?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Why would Mr. Gleeson not name them?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Mr. O'Brien will name them.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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He will not refer to them as laboratory A, B or C.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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He will name them and we will be able to clearly see whether what Dr. Gibbons said in 2008 was correct, namely, that outsourcing would lead to an increased number of false negative results in ten years' time. If that is not the case, why did CPL settle the case with Vicky Phelan for €2.5 million? Why would it do that? Why would it say, "here is €2.5 million but there is no issue here with us having poor quality testing"? Our contention is that the outsourcing has delivered poor-quality services in cervical screening for women.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I do not want to get into that yet as I will lose my time and I want to ask the chief medical officer a question. At any stage did the chief medical officer have a discussion with the Minister for Health, Deputy Simon Harris, be it a conversation over a cup of coffee or in a corridor, about the Vicky Phelan case in advance of the Minister being formally told through the note he read out in the Dáil last night? Mr. Gleeson kicked it up the line. Who did Mr. Gleeson kick it up the line to? There are two heads of screening; one is the head of the national cervical screening programme, Dr. Gráinne Flannelly, and the other is the national head of screening overall, Charles O' Hanlon. To whom was this kicked up the line and what did they do with the information? Did they at any stage kick it further up the line to the chief medical officer and did he tell the Minister? If he did not, why did he not?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Dr. Holohan knew about it.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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But Dr. Holohan did not tell him at any stage.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Before the briefing note, was there any indication about it in private conversation? Anything at all?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Never. I know there were no emails and no smoking gun but was it never mentioned to him?
Michael Harty (Clare, Independent)
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The Deputy has one minute.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I put this question to Mr. Gleeson. Who did he kick it up the line to?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Was that Charles O'Hanlon or Dr. Gráinne Flannelly?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Who was it?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I just named them both.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Will Mr. Gleeson give me the title again please?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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So it was Charles O'Hanlon to whom Mr. Gleeson kicked the issue. Does the chief medical officer know if he kicked it up any further?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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Did Charles O'Hanlon kick it up further?
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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By Charles O'Hanlon.
Michael Harty (Clare, Independent)
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Deputy Smith I am sorry-----
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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I am going to shut up but I find it so incredible-----
Michael Harty (Clare, Independent)
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The Deputy has breached the privilege of naming somebody here.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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We got his title.
Ruth Coppinger (Dublin West, Solidarity)
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The Chairman names people all the time.
Bríd Smith (Dublin South Central, People Before Profit Alliance)
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As my mother used to say, "All you have to do is ask Dougal." We just have to Google it and we will find out who it is.
Rose Conway Walsh (Sinn Fein)
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I know it is getting late. I want to home in on the relationship between the HSE, the State Claims Agency and the processes involved there. Mr. O'Brien has said he had no knowledge of it but perhaps he can explain what contact the HSE has with the State Claims Agency.
Mr. Patrick Lynch:
There are multiple contacts between the HSE and the State Claims Agency. On one side of the house they are the indemnifier for the health service-----
Rose Conway Walsh (Sinn Fein)
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Maybe we will narrow it down a small bit. What would the process be around the State Claims Agency with regard to Vicky Phelan's case?
Rose Conway Walsh (Sinn Fein)
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Does the State Claims Agency seek advice? Would the agency come to the cervical screening board to seek advice on whether or not the agency should go ahead with the case?
Dr. Jerome Coffey:
I stand to be corrected by my colleague here but I understand the agency managed this case. As it was approaching, mediation efforts were made by the cervical screening programme to discuss the particulars with the State Claims Agency - the direction of the request was from CervicalCheck to the State Claims Agency. I cannot remember how successful that effort was.
Mr. John Gleeson:
Yes. Proceedings were made against naming the HSE and another entity, which happened to be a laboratory. We were informed of that and the State Claims Agency asked if the contract indemnified the HSE in respect of the reading of a test with regard to a co-defendant. We went to work on that and found that it does. The plaintiff's legal team was asked if it would drop the case and make it just against the co-defendant, and they said "No". The legal team said it had an issue around the delay in informing the affected woman. That element of the case was struck out; it was not that we did not tell the patient, it was noted that the information was late and took a long time. That was the basis. After that, any engagement largely centred on legal teams and we were asked if a settlement was proposed during mediation prior to a court appearance. The State Claims Agency advised that we should be supportive of any such moves. We took the agency's advice and said "Yes".
Mr. Patrick Lynch:
In discussions I had with the State Claims Agency it wanted to make very clear that the public reporting about a confidentiality agreement did not originate with the State Claims Agency and the HSE put on the record at the time its objection to it. That was a specific requirement of the other defendant, which was the laboratory. It would never be a case - that I am aware of - that we would seek to enter into something like that, or that the State Claims Agency would. The agency was very clear that it would like that message to be known more broadly.
Rose Conway Walsh (Sinn Fein)
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So the HSE would never seek a person to sign a confidentiality agreement?
Mr. Patrick Lynch:
I have no evidence that has ever been the case. Certainly, in my discussions with the State Claims Agency it has said it would not be a view it would take. I cannot answer for all the cases they have held, but in talking to the head of the State Claims Agency it is very clear that this is not something it would-----
Rose Conway Walsh (Sinn Fein)
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Generally the HSE does not require or seek confidentiality clauses or agreements?
Rose Conway Walsh (Sinn Fein)
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Perhaps Mr. O' Brien could answer that.
Mr. Tony O'Brien:
The HSE certainly does not. The legal strategy is directed by the State Claims Agency and I understand it does not do that. The HSE would never be in a position of leading or directing the legal strategy in any case. Under the relevant legislation it is the State Claims Agency that takes the lead on all such cases.
Rose Conway Walsh (Sinn Fein)
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I completely understand that but I am trying to establish if the State Claims Agency seeks advice from the HSE about if a case is winnable or should it go ahead with a case. I find it absolutely disgusting the way that Vicky Phelan and many others are dragged through the courts. Who is the State Claims Agency accountable to? Who does it seek advice from on whether or not a claim is winnable and whether or not it should go ahead with a case?
Rose Conway Walsh (Sinn Fein)
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Does Mr. O' Brien know how many legal cases are being taken against the HSE currently?
Rose Conway Walsh (Sinn Fein)
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It is my question.
Rose Conway Walsh (Sinn Fein)
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I look forward to the answer.
Michael Harty (Clare, Independent)
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Deputy Boyd Barrett is aware there are five minutes for questions and answers.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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On foot of comments made by Deputy Donnelly yesterday, I want to clarify a point about the 1,482 women. As well as the additional 1,500 women who had cancer diagnoses - and the pretty frightening implications given that 208 women's false negative results missed their cancer - of the original 1,482 only some 400 of those women were included in the audit. Is this correct?
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Will the witness be as brief as possible because I have a very short time.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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What flags?
Dr. Jerome Coffey:
Flags with regard to any element on the pathway, from being invited for a smear, attending for a smear, results, revisits, every single issue. Only one component of that was examined in the pathway, namely, cytology, where a smear would be flagged with a view to a look-back being required.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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To put it another way, what about the other 1,082?
Mr. John Gleeson:
With the diagnosis of cervical cancer, one would get the record, match it with the screening register, and look at the history. The woman was invited for a screening test, had the test, had an abnormal result, was referred for a colposcopy, had a biopsy and a diagnosis of cancer. The screening detected that and there would be nothing to review because the system would have worked. There would be no further review in those cases and it would not be flagged. If one wants one of the 29% mentioned by Dr. Coffey which was flagged for further review, the easiest example -----
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Given the time, if Mr. Gleeson allows me to hone my question, is there no possibility that those 1,082 cases not included in the review had false negatives and were victims of the same errors as the 400?
Dr. Peter McKenna:
My understanding is that the vast majority of the 1,482 cases were found appropriately by cytology and referred for colposcopy and the diagnosis was made in that way. The number was narrowed down to the 400 figure which the Deputy mentioned, and out of those the other concerns were removed, as we have heard. In the remaining 208 cases, cytology was the remaining issue. It was those 208 cases where there a possibility of false negative cytology.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I will have to study the witness's answer afterwards because it contained a lot of detail.
I now return to the testing and warnings. When Dr. David Gibbons, Dr. Sam Coulter-Smith and others made their warnings and indicated their fears on the consequences of outsourcing, it was not mere speculation. They had evidence, namely, that the positive rate coming from US laboratories, because of a different methodology or system, was 1.2 rather than 1.8 in Ireland. Were they correct at that time? Was that true then? Is that evidence correct?
Mr. Tony O'Brien:
That requires more than a "Yes" or "No" answer, but I will be very brief. They were basing that on a sample of 1,000 slides which had been outsourced from the St. Luke's laboratory and which were not subject to the same requirements as the contract in place from 2008 under CervicalCheck. While they were correct in what they said, what they referred to was not what CervicalCheck does.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Mr. O'Brien is saying that the detection rate improved with the new contract. Can he say that definitively?
Mr. Tony O'Brien:
They referenced about a 1.8 return rate of high grade, which they normally experienced, versus a 1.2 return rate from the 1,000 slides. That is their data and I have no reason to question it. Currently, the return rate of high grade is at 1.66. A number of things were different. We have discussed the double reading and the fact that the laboratories in question know they are dealing with a population in Ireland that is screened on a three-year cycle. They have dedicated cohorts of readers who are screening Irish-originated slides. None of that was the case with those 1,000 slides.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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One factor suggested for the inferior detection rate and the quality of the screening was that readers in the United States were reading 80 to 90 tests daily, whereas the NHS had a maximum of 50 that readers were allowed to examine. Here in Ireland the figure was more like 30 to 35 slides. I would have thought that if a reader is looking at 90 slides each day, the possibility of making mistakes is considerably higher than if he or she is doing 30 to 35 or a maximum of 50. That was one of their concerns. Will the witnesses tell us if that continued to be the case after the contract for the screening programme was established?
Is the 1.66 rate that the witnesses mentioned, which is still lower than 1.8, across the results from both the Irish and American tests? We were told that 50% are still being done in Ireland and 50% are being done in the US. When the witnesses give the figure of 1.66, is that the aggregate of both the Irish and American tests? If it is, that does not tell us specifically what detection rate is coming from the American laboratories.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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What about the readers and the number of readings being done?
Mr. John Gleeson:
I cannot remember for the original contract that was awarded in 2008, but by 2010, and here in our quality assurance guidelines and at the quality assurance committee, the number of screens that a screener can do in one day and the number of hours in which he or she can spend in front of the microscope is the same for all laboratories. They are very consistent with what is in England and Europe.
Michael Harty (Clare, Independent)
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I thank Mr. Gleeson. I thank the witnesses for staying for the duration of the meeting. I call Deputy Donnelley.
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the witnesses. The meeting is in its fifth hour and their presence is appreciated.
I will start with the Department. I seek two pieces of information for the committee. One is referred to in the memorandum to the Minister, namely, the national screening services advice that Vicky Phelan's case did not concern patient safety. I understand this was an email sent on 11 April 2018. Will the committee get that?
Stephen Donnelly (Wicklow, Fianna Fail)
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I do not know if Dr. Holohan was the chief medical officer at the time, but the Taoiseach referred to chief medical officer advice on disclosure. Will the committee get that written advice? The advice, as I understand it having been relayed from the Taoiseach, was that, counter-intuitively, mandatory disclosure would lead to less disclosure. I am not asking for the witnesses to relay that information now, but will the witnesses provide that to the committee?
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank Dr. Holohan. I now return to the case of Vicky Phelan and the Department's response. Is it reasonable to say that no action was taken to prepare for the publicity and its effects as it began to unfold from late Wednesday?
Stephen Donnelly (Wicklow, Fianna Fail)
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To clarify the question, I appreciate that action was taken when it became an issue of public concern. The Minister had been told about it ten days before it became a matter for public concern, and the Department knew about it ten days before that. It is fair to say that the system was caught completely off guard. Did the Department do anything to prepare for the potential publicity and public reaction which has ensued before it became public?
Dr. Tony Holohan:
We had no way of foreseeing it because we did not have information that this was related to anything other than the case. I do not want to take up the Deputy's time in giving a long-winded answer but the information we received gave us no reason to believe that there were concerns that went beyond the individual case. That has manifestly proved not to be the case and the public information that came out on the Thursday of that week made that very clear for everyone.
Stephen Donnelly (Wicklow, Fianna Fail)
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In the conversations between the Department and the national screening service was the Department given any indication that there could be other cases like this?
Dr. Tony Holohan:
No. There was no indication. We had no reason to believe that this was anything other than an isolated case. Again, I do not wish to be long-winded. We receive notifications, formal and otherwise, from lots of sources about individual cases. They come to the Minister; they come through the media; they come from the HSE and many other sources. Our initial focus is to try to determine first and foremost if there is a reason to believe that this leads to a concern about a service and a potential risk to people who are not yet using that service, in other words that the service is not safe. That is our primary line of questioning. That is the basis on which we would interact.
Our next issue to try to satisfy is whether we have any evidence that there is a group of people who have been harmed as a result of contact with the service who now have to be identified and a lookback or something of that nature required. If we can satisfy both of those questions in the negative on the basis of the information, we would take the view that that is an issue that does not have wider patient-safety concerns. That is not in any way to take away from a view that the individual case and the case for an individual might be something of great significance.
Stephen Donnelly (Wicklow, Fianna Fail)
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Given that that is the Department's remit, should officials not have asked if there are other cases and wider implications?
Stephen Donnelly (Wicklow, Fianna Fail)
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I am referring to cases like Vicky Phelan's or false negatives.
Stephen Donnelly (Wicklow, Fianna Fail)
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We all know that. However, if the Department's role is to determine potential adverse future use of screening services, which is exactly what has happened, should officials not have asked the national screening service when it said: "This is Vicky Phelan's case. This is what is coming. There is an issue of a false negative. Actually it is more serious than that. It is a missed screening of cancer. The State Claims Agency say in their view there is going to be publicity around that."? I know hindsight is a wonderful thing. Should officials not have asked the national screening service if this was an isolated case or if there were other issues? Officials gave the Minister a note and therefore knew about it. The court case from the State's perspective centred on non-disclosure. Where there is potential liability to the State and it goes to the confidence of the screening service, would officials not regularly ask if it is an isolated case or if there are more? Should that question not be asked?
Dr. Tony Holohan:
In retrospect I would like if I was able to say that we had asked that question. That question was not asked as part of the interrogation. As the Deputy said, we are speaking with the benefit of hindsight. I gave him a sense of the primary purpose of the assurances we would give to a Minister in that situation and the role of that. I can go through that in more detail. On our index of suspicion, so to speak, regarding what has now come to pass that there was a widespread - I will not say systemic - practice whereby discordant smear test results were not being fully fed back to patients, there was nothing in that note that could reasonably be said on the basis of what it said at the time to give any reasonable index of suspicion that that was the case - that that would be a reasonable line of questioning.
Stephen Donnelly (Wicklow, Fianna Fail)
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Does Dr. Holohan believe that the national screening service should have informed the Department because it knew this was a wider issue?
Dr. Tony Holohan:
The Deputy can ask the national screening service this. I do not know if the national screening service, itself, had a significant suspicion that this issue of open disclosure and the thing that the Deputy referenced in the note were likely to a substantial concern - that it had a substantial concern about that practice - because it did not know about it either. Events of recent days have shown that. The extent of that has only come to light through our investigations once we became aware.
Stephen Donnelly (Wicklow, Fianna Fail)
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I know Dr. Holohan is speaking in good faith, but we have letters from the clinical director of CervicalCheck saying:"Sure, you only need to tell three of your ten patients about this." CervicalCheck not only knew this it was a wider issue, but it was actively involved in the wider issue.
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank Dr. Holohan.
I turn to Dr. Henry. This is a very worrying illustration of a culture of silence. I presume he is doing a lot of thinking about this issue. Why are clinicians not disclosing information to patients, which is clearly in contravention of the HSE's open disclosure policy?
Dr. Colm Henry:
I have no doubt in my mind that clinicians should be aware of their duty for open disclosure and their duty to tell patients in the timeliest manner possible. It should be ingrained in their clinical practice when they are relaying good and indeed bad news every day of their lives. It should be ingrained in their training.
In this case, my reading of this looking back is that there was an audit designed for quality assurance and learning, and that the linkage between that learning and quality assurance audit to the clinicians who are treating the cervical cancer patients was never closed.
Stephen Donnelly (Wicklow, Fianna Fail)
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When CervicalCheck finally acted, it informed the clinicians in 2016. We know that in 13 hospitals and in three out of every four patient cases, the doctors did not relay on the information. That is nothing to do with training and what one understands the purpose of an audit to be. The doctors were told of these serious incidents. They were presumably aware of the HSE's open disclosure policy. Furthermore, even if they are only acting in enlightened self-interest, the Taoiseach in the Dáil yesterday and again today, and the Medical Council representatives before this committee this morning, stated that the level of non-disclosure involved in these cases - I am not talking about any individual clinicians - could lead to a clinician being struck off.
Given it being so contrary to a culture or at least a stated policy of open disclosure and given that it could lead to them being struck off - these are people who have dedicated their lives to saving men and women - why do they choose to put themselves at such risk and act contrary to open disclosure? What is going on?
Dr. Peter McKenna:
I offer this by way of explanation rather than by way of excuse. In these particular circumstances, there was a dispute as to who had the responsibility to disclose this information to the patients. Did the duty lie with the programme that had collected the information about the audit or did it lie with the clinicians? That degree of disagreement can be seen coming through the correspondence the Deputy has. It was not that there was a decision not to tell. Unfortunately the discussion centred on who should tell and this was the subject of the disagreement.
Stephen Donnelly (Wicklow, Fianna Fail)
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While I understand that, it still does not answer the question. Clearly if there was no issue; there would not have been that. The clinicians would have got the results and if they felt safe and ethically bound to tell their patient, they would have just told their patient. However, they did not do that. Clearly something is stopping the clinicians from sharing the information. It is really important that we try to understand what that is. Until we understand what that is and name it and do something about it, one of the adverse outcomes of this saga is that patients will no longer believe as a matter of default that their doctor is being fully open with them. I know I am asking the witnesses to hypothesise and speculate, but what is causing the doctors to put their patients and indeed themselves in this situation?
Michael Harty (Clare, Independent)
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I might get Dr. Holohan to answer the question.
Dr. Tony Holohan:
I will give an answer to this. There will be an investigation into those facts and how they might have played out in these cases that might help to elucidate the specifics. That goes to the heart of the question he asked earlier about the advice I gave the previous Minister for Health and now Taoiseach and gave to the current Minister which seems to be counterintuitive. The reality is that it is complex. In the minds of many medical practitioners, what plays into their decisions are fears over creating medical legal risk for themselves. This may not be the reality in terms of genuine risk, but there is a perception there. All too often when harm occurs, instead of embracing the opportunity to sit with patients and explain, sometimes the temptation on the part of practitioners is to circle the wagons, close ranks and not share information. I could give a long list of cases where that has been at the very heart of those practices.
Without going into detail, the purpose ultimately of what is in the Civil Liability (Amendment) Act is to essentially offer protections to doctors and standards on open disclosure, effectively saying that if they do it in the right way, these protections will be offered to them. That allows us to give them reassurance and say that it is a safe and worthwhile thing to do and to encourage it. There is a judgment at the heart of my advice around which is likely to be more effective, because we want to see disclosure happening in every case.
We want to encourage people to do the right thing rather than require them to do something they are unwilling to do. We want doctors to do the right thing. That is a very shortened version of complex advice.
Stephen Donnelly (Wicklow, Fianna Fail)
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I thank Dr. Holohan.
Stephen Donnelly (Wicklow, Fianna Fail)
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I will ask my question first, which may be on the same issue. I appreciate that the chief medical officer has provided the perspective of the Department, which is very welcome, but it would be useful to get the viewpoint of the HSE on that matter Dr. Holohan has expressed his view on why this culture of non-disclosure developed and is clearly extant in the HSE. What is the view of the HSE witnesses in this regard? Mr. O'Brien may have another point to make.
Dr. Colm Henry:
The duty of open disclosure should supersede all other concerns. Medical practitioners have historically feared the consequences of full open disclosure, as has been outlined. The more protection that is afforded, the easier it will be to create an environment where doctors can discuss all outcomes, including adverse outcomes, directly and confidentially with patients, which is what we want to have in every clinical scenario in this country.
Stephen Donnelly (Wicklow, Fianna Fail)
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Legal liability is a concern for doctors.
Mr. Tony O'Brien:
To be fair to the clinicians involved and for the avoidance of any doubt, fault for the failure or bad news that was communicated could not have been attributed to the clinicians who were asked to communicate it because it did not relate to anything they or their practice had done, but rather to a cytology issue.
Stephen Donnelly (Wicklow, Fianna Fail)
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That makes it even more surprising that they did not pass on the information.
Michael Harty (Clare, Independent)
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I thank Deputy Donnelly. I call Deputy O'Reilly, who will be the last member called as we have now been here for-------
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Quite some time.
Michael Harty (Clare, Independent)
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-----almost five hours.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Time flies when one is having fun. It feels like we have been here for 20 hours. I thank all the witnesses for remaining with us this evening. The committee members are aware that the meeting has been prolonged but we have questions which must be answered.
Two people in this room - Dr. McKenna and Dr. Henry - received the letter from Vicky Phelan's consultant. I do not understand what happened after they received the letter, nor why it was not brought to the attention of senior management. What did they do when they read it? Its content, with which I am sure they are familiar, is astonishing.
Dr. Peter McKenna:
I spoke to some of the clinicians and understood that a resolution as to who would inform the patient had been found at a meeting with the cytology service . I regret that I did not follow up to check on who that would be or, more importantly, that it was being done. I was led to believe that the matter had been resolved.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Led to believe by whom?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It is quite late in the evening and I would prefer if Dr. McKenna were not vague in his answers. How high up did this go? He is a very senior person in the HSE structure and was such when he received the letter. Did he feel the need to give it to a more senior person? Did he speak to people on the same level as himself? Did he inform the Department? Were any other letters of that nature in circulation? This type of letter would cause me alarm and prompt me to take action. I do not think I would be happy to walk away and assume everything would be okay, given that the purpose of the letter was to advise that everybody in the equation was assuming that somebody else was taking action. Nobody was doing so. In the intervening time, information was being withheld from women, as per the circular that was issued. Notwithstanding that, did Dr. McKenna or Dr. Henry feel obliged to take action? With whom did Dr. Henry discuss the letter and what action did he take?
Dr. Colm Henry:
My approach was not to escalate the matter automatically, but rather to ensure that those concerned resolved it such that patients would be informed. I regret that that outcome was not achieved. At the time, I believed no further actions were required by me as a clinical adviser once the clinicians had met the lead of the cervical screening programme and I had been assured that that caused a change in the communication policy and there would be further engagement on a consensus approach which would lead to patients being informed. If I had known the patients were not going to be informed, I would not have been happy.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Is Mr. O'Brien satisfied that the appropriate action was taken at the time?
Mr. Tony O'Brien:
Given the roles of Dr. McKenna and Dr. Henry at the time and in light of my discussions with Dr. Henry since, my understanding is that he was asked to intervene and facilitate a resolution to what he understood to be the core problem of a disagreement on who should tell patients. I am not critical of Dr. Henry for thinking that he had done what was asked of him, which was to facilitate a resolution, as he was advised that had been resolved, although that proved not to be the case. He is not accountable for that resolution not being followed through to delivery. Those who said they had resolved it but did not deliver must be accountable for that.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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While we are discussing accountability, who does Mr. O'Brien consider should be held accountable?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It is late in the evening. Is Mr. O'Brien going to say it is the fault of those who did not do their job but fail to identify those people? I am on the record as stating that the buck stops with Mr. O'Brien.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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That answer has caused even more confusion. I suspect that might have been its intention. Has Dr. McKenna or Dr. Henry been promoted since then?
Mr. Tony O'Brien:
Dr. Henry is no longer is an adviser. He is now the first chief clinical officer of the HSE, albeit on an interim basis. That means he has considerably more authority than he did at that time.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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These are the people who did not follow up but have subsequently------
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It is clear that they did not take action.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Their action was to assume that somebody else was going to take action.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I have not done so.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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What assurances were received? Was anything written down? Was there a meeting? Was it done over the phone? Did they stop someone in the corridor and go for a cup of coffee with him or her?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Who sent that letter?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Which member of the programme sent it? Was it sent by the head of the programme?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Will Dr. Henry provide a copy of the letter to the committee?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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It would be very helpful if he did so as soon as possible. The Taoiseach described what happened as a cock-up. Would Mr. O'Brien use that phrase to describe it?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Mr O'Brien takes full responsibility for that cock-up.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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He does not take any responsibility for it.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Does he take some responsibility for it?
Mr. Tony O'Brien:
As the head of the HSE, I must recognise that those who cocked-up, to use the Taoiseach's phrase, were in the organisation but I did not personally make that cock-up so I cannot take full responsibility for it.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Mr. O'Brien does not take full responsibility but he does take some.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I have two more very quick questions. Does Mr. O'Brien think he is doing a good job?
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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He does and rates his work highly. I am sure it is not news to him that there are people inside and outside this establishment who do not think so.
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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They hold opinions for very good reasons. Mr. O'Brien has advised us, notwithstanding the opinion we may or may not have on how good he is at doing his job, that he intends to devote himself and the time remaining to him to tackling this issue, let us say the latest scandal-----
Louise O'Reilly (Dublin Fingal, Sinn Fein)
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-----before he moves on at the end of his contract. Does it extend to him being here on Tuesday or will he be in San Diego at the annual meeting of Evofem?
Michael Harty (Clare, Independent)
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That is not an appropriate question. This meeting was set up at very short notice. I thank the clerk for organising it and arranging for the delegates to come.
Dr. Tony Holohan:
I do not want to cut across the Chairman as he is bringing the meeting to a close, but I believe we have not had an opportunity to set out in broad terms some of the things we think are going to happen in the next few days. I would like to give a little more detail of what the Taoiseach was talking about this morning, although in the circumstances, I do not want to spend a long time in describing it. If we call the total 3,000 people for the purposes of discussion, whether they are part of the original 1,482 or the cohort that has to be identified, each case is to be looked at through an international process we are to establish. We have taken steps to begin to mobilise some of that expertise. It will require us to gain access to some of the slide materials from some of the laboratories. It will require us to do the data matching that was described. Any discordance, in the 208 cases we know about or any other one we might identify, will be subject to a full clinical review which will involve assessment by an international panel of experts capable of making it. It will include a review of charts and a meeting with each of the individual patients. Each individual woman who finds herself in this situation will have the question addressed as to the likelihood it has had an impact on either her treatment at the time of diagnosis or the eventual outcome. In very tragic cases where people are no longer alive, for the next of kin who will such information, it will help to address some of the questions for them.
We also see some of the information in the findings of that process which will bring it to one report which will be published being made available to feed into ongoing consideration of the redress process that the Taoiseach this morning indicated that he was open to considering and to which the Government will give consideration. We are also giving further consideration - I know that the Minister has taken steps today to engage with other parties to - to the question as to what will be the most effective investigative vehicle to bring closure to some of the items of information, in particular some of the additional items that came into the public domain last evening. With the Minister amd as the director general said, we will receive receive daily reports from the head of the serious incident management team, SIMT, and Mr. Damien McCallion who will have operational responsibility. We will receive a daily report from the director general on progress in the management of everything that has been described.
Michael Harty (Clare, Independent)
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Thank you., Dr. Holohan. I also thank the secretariat and the clerk for organising the meeting and the delegates for coming at such short notice.