2016 Financial Statements of the HSE (Resumed)

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

Today we are returning to matters related to State claims, the management of legal costs, open disclosure, and the implications of CervicalCheck revelations. We are joined today by Mr. Jim Breslin and Dr. Tony Holohan from the Department of Health, and Mr. John Connaghan, Dr. Colm Henry, Dr. Jerome Coffey, Mr. Liam Woods, Ms Rosarii Mannion, Dr. Stephanie O'Keeffe, Mr. Damien McCallion, Dr. Peter McKenna and Mr. John Gleeson from the HSE. From the Medical Council, we are joined by Mr. William Prasifka and Dr. Audrey Dillon. From National Cancer Registry Ireland, we are joined by Professor Kerri Clough-Gorr. They are all very welcome to today's meeting.

We will be taking the opening statement and remarks from the Medical Council first because the representatives have another engagement. Everybody has agreed to this. When the representatives have their opening statement made, they will be free to attend their other meetings. If something arises during the course of the day that is relevant to the Medical Council, we can send a letter to the witnesses seeking a subsequent response in writing.

The witnesses at this meeting have all made themselves available at short notice. I am thankful for their assistance in this regard.

I remind everybody to turn off all mobile phones. That means turning them to airplane mode because merely putting them on silent is not enough; it will interfere with the recording of the proceedings.

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

Members are reminded of the provisions of Standing Order 186 indicating that the committee shall refrain from inquiring into the merits of a policy or policies of the Government or a Minister of the Government, or the merits of the objectives of such policies. While we expect witnesses to answer questions put by the committee members clearly and with candour, witnesses can and should expect to be treated fairly and with respect and consideration at all times in accordance with the witness protocol that has been circulated.

Viewers should note that since this controversy arose a number of weeks ago, on 2 May, this is the seventh meeting in the Oireachtas on the matter. The Joint Committee on Health held three meetings, on 2 May, 9 May and 16 May. The Committee of Public Accounts held meetings on 10 May and yesterday, 16 May, and it is holding one today, 17 May. The Joint Committee on Finance, Public Expenditure and Reform, and Taoiseach held a meeting on 8 May with the State Claims Agency. That amounts to seven meetings. In the course of those seven meetings, we have heard from seven people from the Department of Health, 15 from the HSE, including those at today's meeting, four people from the State Claims Agency, two from the Medical Council, and one from National Cancer Registry Ireland. Yesterday, we were joined by Ms Vicky Phelan, Mr. Stephen Teap, and Mr. Cian O'Carroll. Therefore, 32 people have been present at the seven meetings since 2 May. We know we put enormous pressure on the witnesses. Many people have had to attend multiple meetings and we recognise they have other work to do dealing with this issue, but the work of Oireachtas committees is very important to the public interest. People want to hear these matters spoken about and dealt with here. I acknowledge the discussions will move to another forum in due course but I wanted to put on record the number of meetings in case people were interested.

I ask Mr. Prasifka to make his opening statement. He will be free to attend his other meeting afterwards. If issues arise during the course of the meeting relevant to the Medical Council we can send any questions to it in writing for a response thereafter.

Mr. William Prasifka

I thank the Chairman very much for inviting us and for his consideration of our other commitments. It is the last meeting in the five-year term of the Medical Council. I will not read the opening statement but simply refer to a few highlights. The Medical Council was established under the Medical Practitioners Act. We operate under that legislation. We are the regulator of medical practitioners. That is our exclusive remit.

I want to touch on two of our particular statutory responsibilities that are relevant to the work of the committee. The first is that we are responsible for giving the practitioners professional guidance. The practice has been that each council, during its term, will revise and update the guide to professional conduct and ethics. This council fulfilled that responsibility two years ago by issuing the eighth edition of the guide. The guide deals specifically with the issue of open disclosure. The provisions on open disclosure were arrived at by the ethics committee. I am here with the chairman of that committee. The provisions on open disclosure were arrived at following a complete consultation with all relevant parties. It takes place in the context of an ethical guide that views medical care not as something delivered passively to a patient but as something in respect of which the patient is a full participant. The relationship is really a partnership between the patient and doctor. The particular provisions on open disclosure, which were significantly updated and expanded upon in the previous guide, are well worth noting. The ethics guide states:

Open disclosure is supported within a culture of candour. You have a duty to promote and support this culture and to support colleagues whose actions are investigated following an adverse event. If you are responsible for conducting such investigations, you should make sure they are carried out quickly, recognising that this is a stressful time for all concerned.

I simply refer the committee to our provisions on open disclosure.

We have another very important role, that is, to handle complaints that are made against doctors. There were certain questions that were put to us about how that is done. The Medical Practitioners Act is very explicit and sets out very precise procedures that must be followed when complaints are made. The practitioner who is subject to a complaint is entitled to full constitutional protections. There are very elaborate procedures put in place. All matters are put before the practitioner, who has a full opportunity to deal with whatever complaints are made. The investigation is a confidential investigation under the Act. The sanctions, at their most severe, can include an erasure and someone being taken off the register, and they can also include a suspension, whereby one is taken off the register for a period of time. There is also censure, admonishment and advice. Also, conditions can be put on a practitioner's ability to practice. These can include updating their skills, reporting to a mentor and engaging in supervised practice until the medical practitioner believes the problem has been remedied. What I must emphasise to the committee is that it is extremely important that we, as the regulator in this area, never prejudge any issue. We cannot come before the committee and say a doctor in a certain circumstance would receive a certain outcome. We cannot talk about individual cases but what we can do is expand upon the general principles that are in the ethics guide.

I thank the Chairman again for inviting us. I also thank him for recognising our particular circumstances today.

I thank Mr. Prasifka. He is joined by Dr. Audrey Dillon, chairperson of the ethics and professionalism committee and a member of the Medical Council. The two witnesses are free to leave because they have an important meeting pre-scheduled. They are very good to have made themselves available at short notice for this meeting this morning.

We shall now proceed. I just want to get clearance from the HSE and the Department of Health on the opening statements and the documentation submitted last night. Is it agreed to note and publish them? Agreed.

I invite Mr. Jim Breslin, Secretary General at the Department of Health, to make an opening statement.

I ask Mr. Jim Breslin, Secretary General of the Department of Health, to make an opening statement.

Mr. Jim Breslin

I thank members for the opportunity to meet with them this morning. I am joined by my colleague, Dr. Tony Holohan, chief medical officer.

I know the committee had the privilege of hearing at first hand from Ms Vicky Phelan and Mr. Stephen Teap last night. Their brave testimony over recent days, and that of other women and families, has raised profound questions for the way the national cervical screening programme, and the health service generally, engages with people. They have been willing to speak publicly about deeply personal matters. In doing so, they have drawn attention to their experience in the hope that this will lead to change. At the very heart of that change must be how the health service engages with individuals when things go wrong.

The CervicalCheck programme was established to help prevent cervical cancer. Before it was introduced we were not making any impact on cervical cancer but following its introduction we are seeing a steady reduction each year. However, every time a cervical cancer is not prevented it is a tragedy. That is compounded when women who have been diagnosed with cancer are not properly informed of the results of a subsequent audit. I would particularly like to acknowledge the powerful and deeply generous nature of the advice given when a woman who has such a painful experience encourages others to continue to participate in the programme in the interests of their health.

These powerful testimonies place on all of us a responsibility to act to address weaknesses while sustaining the national cervical cancer screening programme in the interests of current and future generations of Irish women. The Department is committed to discharging its particular responsibility to take the necessary steps, in association with the Health Service Executive, HSE, health professionals and others, to restore the trust of women in the CervicalCheck programme and, indeed, in our health service more generally.

Last week, the Government commissioned a leading UK expert, Dr. Gabriel Scally, to conduct an inquiry to establish the facts and to review all aspects of CervicalCheck. We are determined to do everything we can to assist Dr. Scally in his inquiries so that we can all find out what happened, and why it happened, to make sure that we have a robust cancer screening programme for women, and that lessons are learned for the future.

However, the focus needs to be on the women most affected as well as the CervicalCheck programme. On Friday last, the Government agreed a comprehensive package of health and social care measures to support the 209 women and their families who have been diagnosed with cervical cancer and whose audit result differed from their original smear test. The Government has committed to ensuring that these women and their families are supported to the fullest extent possible. The HSE nationally and locally is implementing these support arrangements and will be in a position to update the committee.

The health and social care measures include a discretionary medical card for each woman affected, or their next of kin in cases where the woman has sadly died, so that they can all avail of health services, including medicines provided under the medical card scheme, free of charge; out-of-pocket medical costs incurred, including the cost of any medicines which have been prescribed by their treating clinician; primary care supports, including counselling for the women affected and counselling for the immediate family members of these women, including bereavement counselling, where needed; and other health and social care supports, including travel costs and child-minding.

An international clinical expert review panel is also being established. The main purpose of the panel is to provide women with facts and independent expert assessment of those facts. The panel’s findings will also contribute to the overall independent assessment of the quality of the CervicalCheck programme.

The review will consider in depth all cases of invasive cervical cancer in Ireland since CervicalCheck was established. Women who developed cancer and who were screened by CervicalCheck will be identified and their screening histories will be examined. The expert panel will review the cases of those women who have had previous screening tests prior to their diagnosis and undertake a re-examination of cytology tests. Where the expert panel opinion of cytology results differs from the original results provided by CervicalCheck, the panel will endeavour to determine, wherever possible, any failures to prevent cancer or to intervene at an earlier stage. The panel will prepare individual reports for those affected, setting out the facts and their independent assessment.

The Government has also announced that the State Claims Agency is advancing a new initiative aimed at expediting resolution of the nine outstanding legal cases in a sensitive manner utilising mediation wherever possible.

In addition, last week, the Minister for Health received Government approval to provide in law for mandatory open disclosure, through the forthcoming patient safety Bill, in respect of serious patient safety incidents such as these. The Bill will also provide for mandatory reporting of these serious events to the appropriate regulatory authority, such as the Health Information and Quality Authority, HIQA. Policy on open disclosure has been informed by a number of elements, including the experiences of other comparable countries and the Report of the Commission on Patient Safety and Quality, the Madden report.

The open disclosure provisions brought forward last year were based on the principles set out in the Madden report. These proposals were also subject to pre-legislative scrutiny by the Joint Committee on Health. This legislation has since been enacted, following the passage of the Civil Liability (Amendment) Act 2017, and regulations flowing from it are due to be brought forward shortly. This approach is intended to help create a positive climate for open disclosure and to support the HSE’s national policy on open disclosure.

At no time has the Department of Health viewed open disclosure as something which clinicians or health service staff should regard as optional. It is quite clear that there is an expectation that patients should be told about any incidents regarding their care that may have occurred. This is clearly the standard expected in the HSE’s national policy on open disclosure and the requirements of the Medical Council for doctors, as we have just heard.

Like many health services internationally, we are seeking to achieve a health service where the relationship with patients is open, honest, listening and supportive. While progress in introducing such an approach has been made, this should be the everyday ethos of the health service. In this context, it is recognised that there are a number of very serious incidents where it is appropriate to introduce a requirement in law for mandatory open disclosure. That is why provisions for mandatory open disclosure will be incorporated into the forthcoming patient safety Bill, which will also provide for mandatory reporting of serious patient safety incidents to HIQA and others. The drafting of the patient safety Bill is being undertaken as a matter of priority within the Department.

The Department recognises the overriding importance of patient safety and quality in the delivery of health services and the need to ensure that all that can be done to prevent harm and error is done. The Department established the National Patient Safety Office 18 months ago and a range of important initiatives are under way on which we will be happy to provide further details. For example, the general scheme of the patient safety (licensing) Bill, which was approved by Government in December 2017 and referred to the Oireachtas, will ensure the need for all hospitals to have strong clinical governance and patient safety operating frameworks in place in order to be granted and maintain a licence to provide health services.

On Tuesday, the Department published records relating to the CervicalCheck clinical audit. The information submitted by the HSE in regard to this audit in 2016 provided the Department with an understanding that this was a retrospective clinical audit undertaken for quality assurance and learning purposes and that CervicalCheck had a clear objective to provide results to consultants in order to allow for direct communication with the women concerned. Both clinical audit and communication of the results of clinical audit to women were seen by the Department to be very worthy and valuable undertakings by the CervicalCheck programme. Clinical audit is an important means by which standards are maintained and advances made in healthcare.

I believe that a reasonable approach was taken by the Department at the time based upon the information available to it. There are two ways of looking at issues - based upon the information available at the time or with hindsight. Of course, had the subsequent widespread non-disclosure been escalated by CervicalCheck within the HSE and raised with the Department, this would have triggered a major concern and a much different attitude but based upon the information we had, we viewed the initiative taken to communicate audit findings to women in a positive light.

Let me be clear. The Department did not know about widespread non-disclosure of audit results. This has been confirmed by the HSE. Had we done so, that would have been escalated immediately. When we did become aware in April 2018, we immediately escalated the issue and worked with the HSE to put in place a serious incident management team to manage the response.

The widespread and still unfolding distress caused by the non-disclosure of the clinical audit results to the women concerned demands serious reflection. The Scally inquiry provides us with a mechanism to get an objective basis for introducing improvements where these can be identified. Those improvements will be introduced. However, some areas for improvement can already be recognised. As I set out last week, we will work with the HSE to review its open disclosure policy and the implementation of same in light of the experience to date. We will incorporate within the drafting of the patient safety Bill a mechanism to develop and introduce national standards for clinical audit. These standards will ensure that open disclosure, including roles and responsibilities for such disclosure, are fully addressed in advance of the commencement of an audit. As the CervicalCheck experience shows, it is important to anticipate the issues that will arise for the disclosure of clinical audit findings before commencing the process. The clinical audit standards to be introduced under the patient safety Bill should also entail a responsibility to record the fact that open disclosure has taken place.

I look forward to the recommendations produced by the Scally inquiry. The inquiry will produce an interim report at the start of June and a final report by the end of that month. The Department's role will be subject to detailed scrutiny by the inquiry. The committee can be assured that we will provide full support and co-operation and address any learning and recommendation as a matter of priority.

I thank Mr. Breslin. We will now take the opening statement of Mr. Connaghan, interim director general of the HSE. He is welcome to the meeting in his new role. It is his first time to make a presentation to us.

Mr. John Connaghan

Yes. I thank the committee for the invitation to attend this meeting with my colleagues.

At the Joint Committee on Health yesterday, I acknowledged and apologised for the confusion and alarm caused regarding the CervicalCheck programme as a result of the failure to communicate with the women affected. For the record of this committee, I wish to restate this acknowledgement and apology. The failures, particularly those related to the non-disclosure of essential information, have ultimately impacted on every female in Ireland as well as women's families, spouses and children. Irrespective of the original well-intentioned undertaking by the CervicalCheck programme to conduct an audit of invasive cervical cancers and communicate the results to the patients affected, the organisation - in that respect, I mean both the HSE and CervicalCheck - failed by any measure.

I have listened to the words of the many brave individuals who have spoken publicly about their situations over the past numbers of weeks, including Vicky Phelan and Stephen Teap at this committee yesterday. I reassure them that I am listening intently. Vicky Phelan commented yesterday that she was there to see change. I reassure her, the other families involved in this and the women of Ireland that I am determined that we will take on board all the lessons learned from this unacceptable chain of events. Together with my colleagues, we will work to bring about the changes with a view to ensuring that this does not happen again.

CervicalCheck is vital to women's health and we must clearly understand the mistakes that have been made and how we can learn from these and restore confidence in this life-saving public health programme. That will involve working closely with the Government and the Department of Health in order to put in place all necessary improvements in terms of governance and accountability. Many of these aspects were covered in the testimony of Vicky and Stephen last night.

In the short time that I have been interim director general, I have asked for a full record search and a full chronology of events to be compiled. That exercise in detail is now under way. It will involve conducting a forensic and extensive review of emails and is preparation, not just for the work of the inquiries made by Dr. Scally, but for any subsequent inquiry.

Last week, the HSE provided a number of briefing notes at short notice to the Committee of Public Accounts. We have submitted them again to this committee. Regrettably, there was not sufficient opportunity at last week's meeting to provide appropriate context and interpretation of these briefing notes. I have brought colleagues to this meeting who will be prepared to answer any question on the details of the notes. The notes were also discussed in some detail yesterday by the Joint Committee on Health. It is fair to say that the language in all the briefing notes is very functional and somewhat lacking in empathy for the women who were to be communicated to. At that time, the intent of the CervicalCheck programme was that all treating clinicians would be given individual audit findings for their patients so that these in turn could be communicated to the women concerned in line with the then guidelines.

A key element within the March 2016 briefing was the assurance it gave that there was no systemic quality issue of concern with the programme. This is the most important element of any audit from a cancer prevention and effectiveness perspective, namely, to provide assurance that there is nothing systematically happening in the screening programme and its operations that would lead to it operating outside of internationally acceptable quality parameters, for example, the European guidelines. However, this is an aspect that will be examined very closely by the Scally review and, indeed, informed by the work of the Royal College of Obstetricians and Gynaecologists.

The process involved sending audit results to treating clinicians in order that these results could be communicated to the women concerned in line with the relevant guidelines. The CervicalCheck programme had commenced sending letters to treating clinicians in February 2016. All individuals briefed on it expected that the women affected would be receiving information from their treating clinicians on the result of the audit findings pertinent to their cases.

The subject matter of the March 2016 briefing was to provide a snapshot of the process to date and to escalate a particular issue at hand. The issue concerned one laboratory - Quest Diagnostics - that challenged the CervicalCheck programme's communications process with treating clinicians and, as part of its contract, invoked a dispute resolution process. CervicalCheck and the National Screening Service requested support to resolve it. I have been advised in my new role that this is why "Pause all letters" was listed as a next step in the briefing. At that point, it was believed to be imperative that CervicalCheck and the National Screening Service resolve this issue so as to ensure the former had solid legal footing to continue with its work in sending audit findings to treating clinicians for onward disclosure to the women concerned, within the guidelines set out. If CervicalCheck had continued sending letters without the assurance that it had legal cover to do so, it could have created subsequent legal issues for the operation of the programme, in addition to any potential risk for any woman seeking redress, where the laboratory could claim its legal rights and entitlements had been infringed by the process. This is why "Await advice of solicitors" was one of the next steps outlined in the briefing note from March 2016.

CervicalCheck was supported in resolving the dispute with Quest Diagnostics and the process of issuing letters to treating clinicians recommenced in June 2016. During the time it took to resolve the dispute, CervicalCheck was preparing individual letters for each patient case history to send to treating clinicians. The briefing note of March 2016 reads: "The specific issue is that there is now a batch/accumulation of clinical audit case reports that have been completed." It was understood by those who were briefed that these case reports needed to be converted into individual letters in respect of each patient concerned. Correspondence demonstrates that this work was happening at the time. This correspondence will be made available to the scoping inquiry in full detail.

CervicalCheck explained in the briefings how the audit and communications process was complex, multilayered and resource intensive. They made clear to those being briefed that each communication needed to be specific to the individual and checked and rechecked for accuracy relating to the specifics of each patient, and the logistics of sending these communications needed to be carefully thought through so as to mitigate any risk relating to the manner, mode, content and logistics of that communication. This is why "Decide on the order and volume of dispatch to mitigate any potential risks" was set out as a next step in the briefing note. It is important to note that CervicalCheck issued the majority of the correspondence - approximately 200 letters - during July and August 2016.

We need to be realistic in an assessment of the communication process. The CervicalCheck programme did not effectively close out the issues that were subsequently encountered regarding the breakdown in the process of treating clinicians discussing audit findings with their patients. Indeed, it is not clear to me that the staff within the programme were aware of the scale of the difficulty in terms of the proportion of women who had not been communicated with.

It is also important in our consideration of the programme that we look at some key facts. Most women's smear test results are accurately reported. Every year, some 270,000 smears are undertaken. For women who have received a normal result, the chance of going on to have cancer by their next smear test three years later is less than 1%.

Since 2008, the programme has provided 3 million cervical screenings to more than 1 million women, and has detected in excess of 50,000 high grade precancerous changes in women, reducing their risk of cervical cancer by 90%. These were women without any symptoms who, without the screening programme, would not have known that they had precancerous changes. Latest figures, which are very welcome, show that the incidence of cancer in Ireland has reduced by 7% in the period 2010 to 2015. This means that fewer women have developed cancer and hundreds of lives have been saved.

Can I take the opportunity, in moving towards closure, to say a few words in support of our national audit programme? The process of clinical audit is about measuring the quality of care against relevant standards and best professional practice. It encompasses the requirement to identify any factors causing suboptimal delivery of care, either at an individual patient level or more widely, and allows the necessary remedial actions to be identified and taken. In light of the controversy over the CervicalCheck audit, we must ensure that healthcare professionals are not discouraged from taking part in clinical audit. We need to foster an open culture which supports clinicians and encourages learning, and that must be part of our ethos.

At this point it might also be useful for me to say a word or two about accountability. To me, personally, accountability is the obligation for an organisation or individual to account for its, his or her activities, to accept responsibility for them, and to disclose the results in a transparent manner. As interim director general, it might be useful to outline how I see myself discharging these duties against the obligation to be accountable to the Minister and more generally. As part of the Health Service Executive (Governance) Act 2013, which established the directorate as the governing body of the HSE, the directorate is accountable to the Minister for the performance of its functions and those of the HSE. As the interim director general, I account to the Minister, on behalf of the directorate, through the Secretary General of the Department of Health. It is important that we foster a culture of openness and transparency and of personal and organisational accountability in doing so.

The process and procedures for how the CervicalCheck programme intended to communicate the results of the audit to patients was developed at that time with the best of intentions and with a view to ensuring that women would receive the results of the audit, consistent with policy and best practice as set out in the 2015 open disclosure national policy and informed by wider best practice for the disclosure of cancer screening audit results. The failure, and it is a collective failure, was on ensuring effective follow-through with these good intentions. In common parlance, we did not adequately close the loop. While the results of the audit were communicated to the relevant clinicians, the arrangements thereafter appear to have broken down. The outcome was that a large proportion of women were not told about either the audit itself or the results for them as individuals. The impact of this failure, as I have said, has been profound both for every single woman affected and their families. This caused significant levels of fear and anxiety for the wider population of women living in Ireland and it has, sadly, undermined public confidence in the CervicalCheck programme.

I would like to conclude my opening statement with the following pledges. First and number one, we will move swiftly and with compassion to provide effective support packages to the women and families who require that support. We will do that with the minimum of fuss and bureaucracy and with empathy. Contact started yesterday with those affected, and we will conclude that in the next few days. We will provide, through each community healthcare organisation, a single point of contact to make access as easy as possible for those affected.

Second, we will fully, transparently and openly co-operate with the Scally inquiry, the international expert panel review and any subsequent inquiries. Third, I am aware of the testimony given by both Vicky Phelan and Stephen Teap yesterday to this committee. If there is a requirement to hold individuals to account on a personal basis, we will do so. In that respect, the Scally inquiry and subsequent inquiries will be important for the independence of their views and to allow due process and fair procedures to be followed. We will learn lessons from recent weeks, not least the ability to say sorry.

Before I call the various speakers, I wish to raise one issue with Mr. Breslin concerning his opening statement and the one topic of open disclosure. Mr. Breslin mentioned open disclosure quite a bit in his opening statement. As we stand, what does he see as one of the main barriers to open disclosure?

Mr. Jim Breslin

Out in the health system?

Mr. Jim Breslin

Implementation. Across the board, all countries are moving increasingly towards the type of relationship that Bill Prasifka outlined as the model that we want to implement. Change does take some time to embed within a professional organisation. The policy that has been there since 2013, and evidence was given last week on some audits about how well it has been implemented, has made significant difference to how doctors and clinicians approach patients, but we have not got it 100% there and there is a lot of work still to do. The work that was done in last year's civil liability Bill was to create the type of supportive environment for everybody involved in that disclosure to feel that they could do it without a consequence for doing it, to be able to admit, say what went wrong and deal with the consequence of that, but without the very act of telling somebody being used against them. That was an important thing to address what is a fear among the medical profession in different countries, which is a medico-legal fear that something will subsequently come against them in terms of their professional legal standing. We dealt with that last year.

The next bit that we are going to deal with is in respect of serious events, because there are a range of issues that arise within the health services which are routine, which do not involve harm, but which are sufficient in terms of being an incident to require attention for the future. In respect of serious incidents, we will now have a position in place where it is mandatory and it is required under law that that happen. That will be a further step forward in making sure that, in cases such as this, it does happen.

I cannot accept that answer as I do not think it is adequate. Mr. Breslin specifically said, in relation to open disclosure, that the matter was dealt with last year by way of the Civil Liability (Amendment) Act 2017, to which I am sure he was referring. This committee has been dealing with this issue and the State Claims Agency for quite a considerable period. I will display on the screen the letter that we received from the HSE on 8 February 2018 specifically dealing with open disclosure. I will read one paragraph from the letter because I do not believe that the matter has been dealt with at all by the Department. I refer to PAC No. 1075B, dated 8 February 2018. There was a substantial document from the HSE about open disclosure with which Mr. Breslin will be familiar. Let us look at near the end of the last page of the letter from the HSE that deals with legislation. The letter was written to the committee on 8 February of this year. The letter reads, "One of the main barriers to open disclosure identified in the independent evaluation of the national programme is fear of litigation." Mr. Breslin has just said that and he said that he had dealt with that. The letter continues:

This is a barrier which is identified in many international studies. This has now been addressed in part 4 of the Civil Liability Amendment Act 2017 which provides protective provisions for staff when they engage in open disclosure in that the disclosure and any apology provided cannot be used as an admission of liability in a court of law. This will have a significant impact when commenced [I emphasise that the last two words are "when commenced".] in relation to increasing the confidence of staff when engaging in open disclosure discussions with patients/service users.

This committee received the letter on 8 February. I tabled a parliamentary question to the Minister for Health immediately after we received the letter, on 27 February, asking when section 4 of the Civil Liability (Amendment) Act 2017 would be commenced, and if the Minister would make a statement on the matter. Part 4 of the Act is headed "Open Disclosure of Patient Safety Incidents". Therefore, we are talking about Part 4 of the Act. The reply to my parliamentary question reads as follows:

Part 4 of the Civil Liability (Amendment ) Act 2017 which provides for the voluntary open disclosure of patient safety incidents was signed into law in November 2017.

Work has commenced on the drafting of Regulations to accompany Part 4 of the Act. Consultation with the various stakeholders including the Health Service Executive, HIQA and the Regulators is underway. It is intended to commence Part 4 in the near future.

More than three months ago, we were told it was intended to commence Part 4 in the near future. Those provisions on open disclosure that the Secretary General referred to in the Act, passed by the Oireachtas on 22 November 2017, have not commenced. This week, the Minister stated in the Dáil during the debate on this topic, “The legislation to provide for a voluntary approach to open disclosure has been enacted following the passage of the Civil Liability (Amendment) Act 2017 and regulations flowing from it are due to be brought forward shortly.” The Secretary General's said here today, “This legislation has since been enacted, following the passage of the Civil Liability (Amendment) Act 2017, and regulations flowing from it are due to be brought forward shortly.” Six months after legislation was passed, the Department of Health has not brought forward the regulations to commence the legislation which was passed by the Oireachtas on 22 November 2017.

Will the Department take me through the steps of who is working on this and at what stage of preparation are these regulations? Without these regulations, we have no open disclosure. The HSE has my sympathy being caught in this bind. It has had a national policy of open disclosure from 2013 but it cannot implement it because the Department has not given it the legislative framework to do so. The Secretary General stated today that is why provisions for mandatory open disclosure will be incorporated into the forthcoming patient safety Bill. How about implementing the legislation we passed six months ago? The Department should not talk to us about what it is going to do in the future when it is sitting on legislation for six months which it has not yet implemented. The HSE and the clinicians are in a bind and are no better off with the passage of this legislation. Why has there been a delay? As Chairman of this committee, I have been on this case with letters, parliamentary questions, opening statements and Minister's statements. They say it is all going to be done in the near future and shortly. Who in the Department has been working actively on these regulations to allow open disclosure to have any effect? How close is the Department to having this matter concluded? It is wishful thinking to be talking about the next batch of legislation when Department has not implemented the last.

Mr. Jim Breslin

We are going to do both. We are going to do the regulations next month, if not before that. We are close to finalising the regulations. Significant work has gone into that which I will ask Dr. Tony Holohan to outline.

If the impression was taken that I was trying to say something in my opening statement other than the factual position, that is not what I intended. I did say that the regulations flowing from it are due to be brought forward shortly. I appreciate the Chairman's point but it was not, however, that I was trying to say that the legislation in and of itself would be sufficient to do that. There is that piece of work which the Chairman identified.

The Secretary General told me verbally before that the matter was dealt with last year. I am saying it was not. This is May and seven committee meetings on from when this controversy arose. Those regulations are still not in place. The clinicians and people involved in the HSE are as fearful of open disclosure as they were before the passage of the legislation because the Department has not provided the legal cover.

This is not a HSE matter. This is a Department of Health matter. We will come on to the Department's future plans about the patient safety Bill. We need, however, to put into operation the legislation the Oireachtas passed last year, imperfect and all as it may have been.

Dr. Tony Holohan

The process under way for the past several months informing the regulations is setting out the standards which will apply to the definition of “apology”, as well as describing the requirements in detail around the disclosure and how it should happen. This will ensure it is done in the right way and it is not just a tick-box disclosure. Consultation has been under way involving the bodies relevant in informing that. It will include the Department of Health, the HSE, HIQA, as the regulator, and other bodies.

Who are the other bodies?

Dr. Tony Holohan

They will be professional bodies and the Medical Council.

The context regarding doctors is still clear as it stands. We heard reference earlier to the 2016 guidelines. The obligation on each individual medical practitioner is set out clearly and unambiguously and makes it clear their absolute obligation regarding open disclosure. What we are seeking to do is to reinforce both the implementation of that and the open disclosure policy of the HSE with something we know will tackle the pervasive culture which exists internationally in terms of fear of litigation. This will help to support the creation of the right kind of space. We want to ensure that when things go wrong, rather than retreating from patients, doctors will support patients actively through that without fear that an apology and engaging with patients will create risks for them.

Our experience has been of patient safety incidents. These have been written up and described by us in the Department. We found that at that very moment of harm, doctors, sometimes through fear, step away from patients at the very moment they need help and support. Accordingly, trust and confidence in the service and practitioner is lost. The purpose of this is to create and maintain that safe space. Open disclosure is not the ticking of a box or the filling of a form. It is supporting a patient through a journey of beginning to understand what happened, maintenance of confidence in that service and beginning to adjust to what in some situations could be life-altering or life-limiting findings. It cannot be just a tick-box culture.

I understand that is the process involved. How close are the regulations to completion? Has the Department circulated to the bodies involved and received responses from them? Are they still outstanding? Has the second draft been agreed? We all understand it is good and necessary. It is a policy that all doctors engage with open disclosure. The Department, however, has not given them the legal framework to do so without fear of litigation. Will the Department talk me through the mechanics of what is involved? If we asked for the current copy of the draft, could we receive that today?

Dr. Tony Holohan

I will undertake to give the committee a full and written briefing precisely on all of the details. The team working on it is based in the national patient safety office, which is part of my division in the Department. I am not directly involved in it on a day-to-day basis. The Secretary General has given the committee the assurance that we expect that work to be completed in the coming weeks and, for certain, those regulations to be signed by the Minister and commenced next month.

In June.

Dr. Tony Holohan

Yes.

Has the Department got formal responses back from the HSE? Is the HSE satisfied that the draft it has seen will be signed by the Minister?

Mr. John Connaghan

I hope the Chairman will understand that I have only been three days in the job.

I understand that but is there somebody here in the HSE delegation who can answer that question?

Mr. John Connaghan

We can get that information before the committee breaks.

Dr. Tony Holohan

Some of the people the HSE would have engaging with us are not in the room today.

How about HIQA? Has it responded? The Secretary General has come in here with a full page about open disclosure. We had debates in the Dáil on this topic this week and responses from the Minister. I want to talk to the Secretary General about open disclosure and he is telling me there is nobody in the room who knows the details of where this process is at.

Mr. Jim Breslin

The bit we are lacking is on the HSE side. I will undertake to get a note, not just for the committee-----

We want to see something today. I do not want to be back months later.

Mr. Jim Breslin

I am pretty confident I can get a message to the individuals working on the draft and a cover of their engagements with the HSE and other bodies. I can have that with the committee before the meeting adjourns.

Yes, over the lunch break. We need to see that. We have all this talk, and when we want to pursue a question, we need this information.

I mentioned that this is the seventh Oireachtas meeting and we need to be getting some answers to the specifics before we move on. It is understandable that people are seriously concerned. I did not get to follow all the deliberations of the other Oireachtas committees. Did I hear right that these audits and so on would not be categorised as a patient safety incident? Was that mentioned somewhere?

Dr. Jerome Coffey

Yes.

It was mentioned that the CervicalCheck issue would not be defined as a patient safety incident.

Dr. Jerome Coffey

In one piece of correspondence from me, as this case was coming through, I stated that I did not feel this was a patient safety issue. Knowing now what I should have known then about the audit, the findings and the disclosure issues, it becomes a much more complex issue. My answer at that point was specifically on the fact of a single cervical smear taken in 2011.

When did Dr. Coffey give that answer?

Dr. Jerome Coffey

I do not have a precise date.

Was it at one of the Oireachtas committee meetings?

It was in correspondence, in the memos that were given.

It was in the memo Dr. Coffey wrote to the Minister on 16 April, just a few weeks ago. Is it possible to bring that up on the screen? Some of the content is blacked out. Essentially Dr. Coffey is saying on 16 April 2018 that this would not fit in with the definition of a patient safety incident.

Dr. Jerome Coffey

That was based very narrowly on the patient's case. It was a smear test from 2011.

The Civil Liability (Amendment) Act to give protection for open disclosure has not yet been commenced and the regulations might be out next month. Even they were in place, however, according to Dr. Coffey they would not cover this issue because he would not categorise it as a patient safety issue. The memo states that the National Cancer Screening Service and Dr. Jerome Coffey, head of the national cancer control programme, have advised the Department in writing that they do not consider this to be a patient safety incident but rather a reflection of the known limitations of the current screening test. That memo was sent to the Minister on 16 April, only a few short weeks ago. We have had all this discussion on open disclosure, yet when the provisions are enacted, we are going to see that the National Cancer Screening Service will have advised that it would not consider this a patient safety issue and it will not even be covered.

Mr. Jim Breslin

I can state categorically that this will fall within the regulations. The Minister has also said to the House that it will fall within the mandatory open disclosure approach we are going to take in the patient safety Bill.

The director of the national cancer control programme was not categorising this as a patient safety incident in his memo to the Minister on 16 April. Mr. Breslin is now saying that because of the public controversy and thanks to Vicky Phelan and others, the issue is going to be escalated not just to a patient safety issue but a serious patient safety issue that will require mandatory disclosure. If Vicky Phelan has achieved anything, she has achieved that much. I have made my point. None of these issues has been dealt with at all. This was not intended to be covered by the regulations before this incident blew up. That was Dr. Coffey's view to the Minister. Now we are finding that it will be covered and we acknowledge that progress. It should not have had to take Vicky Phelan to bring about this change.

Mr. Jim Breslin

In fairness to Dr. Coffey, he was not commenting on the work that was under way in the Department when he made that statement.

We understand that, but the witnesses can understand the point we are making as well. The following speakers have indicated: Deputies Cullinane, Kelly, Catherine Murphy, MacSharry and Jonathan O'Brien. We will take some other names. I am starting with slots of 20, 15 and 10 minutes. People will get a second and third opportunity but I am not letting people go on for 20 or 30 minutes. Everyone will get all the time they want, but in segments.

I welcome the witnesses. We hear an awful lot about duty of candour in respect of whether women and patients should be given information through full disclosure. There is another issue in respect of duty of candour, namely, people like the witnesses giving information to committees like this one. For a lot of people in this room the witnesses have failed in that duty. Some of the information we did not get and stuff that was not said last week at the meeting of the Committee of Public Accounts shows a clear lack of duty of candour. I will put all my questions very respectfully, but I am very angry at some people in this room. I am sure most of them will have seen the hearing yesterday when we heard from Vicky and Stephen. We heard from Vicky's legal representative as well. He talked about a co-ordinated, premeditated, orchestrated strategy to minimise the volume of women who would be informed of the results of their smear. That is what happened, in my view.

When I heard the two Accounting Officers read their opening statements today, I heard a lot of hollow words from both of them. Mr. Connaghan said that if there is a requirement to hold people to account on the basis of their individual performances, this will be done. There is such a requirement and some of those people are in this room. We will put those questions to them today. There are people in this room who have questions to answer, who have failed those women, and we have a duty to put the questions to them. We will do so robustly and fairly but we do so with anger as well. We are representing those women and also the husbands and partners of women who passed away because of this scandal.

In terms of duty of candour, we also requested information which was delivered to the committee late last night. These were answers to questions that were submitted by Deputies to prepare us for this meeting. An Teachta Kelly, I and others submitted questions. We received the information about an hour before the meeting was due to commence and we had to suspend the meeting for an hour before we could proceed because of that. I want to register my disappointment at that. It is a practice that happened before Mr. Connaghan's time. We have always expressed our frustration and hoped the practice would stop. I respectfully request that in future we get the information as quickly as possible to allow us to do our job.

Part of the correspondence we got was a minute of a meeting of the CervicalCheck lead colposcopists group on 1 September 2017. Have the witnesses got that minute in front of them? Mr Connaghan has. This was a meeting of what I imagine is the steering group of the CervicalCheck programme. There were a lot of clinicians there and Dr. Gráinne Flannelly was there too. There was a very lengthy discussion about whether women should know. The minutes state that there was a general consensus that CervicalCheck should let women know prospectively about the process around the time of diagnosis. It talked about a perception that putting the onus on the clinicians to initiate the conversation was not correct and caused a deal of concern and negative feeling towards the programme on the part of clinicians. One of the clinicians who was there was Dr. Kevin Hickey, a consultant to Vicky Phelan. He had previously raised concerns with Dr. Gráinne Flannelly about informing the patients in cases he had dealt with. He had been told he should inform only three of the ten patients. When he asked Dr. Flannelly about this, she said a balance needed to be struck in deciding who needs a formal communication of the outcome of the audit and that the possibility of resultant harm was crucial. This is what angers and frustrates me. The response from Dr. Flannelly and the decision that was made at this meeting were astounding.

Dr. Flannelly spoke about producing an information leaflet. That was the response. An information leaflet was to be the big solution. When it got to decision time at that meeting, it was decided "to work up the leaflet(s) and changes to the process and discuss at a follow up meeting". Was the leaflet ever produced and can the committee have a copy of it? What changes were made to the process and why do we not have the information? What follow-up meetings were held and can the committee have the minutes for them?

I asked for those documents and the minutes for all of the meetings. There were further meetings, but we have not been supplied with that information.

We need the information. We are referring to September 2017, a few weeks before Vicky Phelan's case was made public, and no decision had still been taken to inform the women. There was still a strategy of containment.

Will Mr. Breslin explain why the Minister for Health was not informed of these issues before he learned about them in the media, or wherever he learned about them? Why were the Taoiseach and the Minister for Health not informed when they should have been?

Mr. Jim Breslin

There are two elements to it and they have become conflated, including in some of the coverage of yesterday's meeting. The first element-----

Will Mr. Breslin, please, just respond to the opening part of the questioning about the time it took to get the information on the HSE to us, about which criticism has been expressed?

Mr. Jim Breslin

I can do that.

We would like to get that issue out of the way because we received documentation very late. Perhaps Mr. Breslin might explain it from his perspective.

Mr. Jim Breslin

I have just reviewed the log in my office at the Department of Health. We received the request for information at 3.30 p.m. on Monday afternoon, with two questions. They were questions we had covered here last Thursday, but their specific nature was received on Tuesday at 3.30 p.m. Last night at 7.52 p.m., I signed off on the responses to the committee to both questions. I did this having spent the day here with some of the members but at a different committee. When I got back to the office, I had a number of things to do, including clearing the responses. I made some changes and got them to the committee last night at 7.52 p.m. I would have liked to have got the information to the committee earlier, but it was pretty much as fast as I was humanly able to do it.

My question was about information that had been given to the Minister for Health. I will be more specific for Mr. Breslin before he comes back in.

Last week we had a very lengthy discussion on what information the Department had. While I put my points robustly, fairly and respectfully, I am very angry with the Chief Medical Officer about the fact that we sat here for one and a half hours last week when we had a very lengthy discussion with Mr. Breslin on what information the Department knew about the memos. There were three memos. It is not just the memos that were known to the Chief Medical Officer and the Department; there were also seven meetings at which the Department had been represented and not once did the Chief Medical Officer inform this committee that he was aware of the memos or that he had sat in at those meetings. This was in dereliction of his duty. I will return to the issue of the Chief Medical Officer shortly, but Mr. Breslin was obviously not made aware either. Not only was the Minister not made aware, Mr. Breslin was also not made aware. The memo, referred to in the opening statement, reads:

Pause all letters.

Await the advice of solicitors.

[I imagine that was with regard to the dispute with the laboratory]

Decide on the order and volume of dispatch to mitigate any potential risks.

[The risks to the HSE]

Continue to prepare reactive communications response for a media headline that ‘screening did not diagnose my cancer’.

That was the context and there were subsequent memos and meetings. The Chief Medical Officer and others in the Department knew about this or were central to it and did not tell Mr. Breslin or the Minister. I want to know, from Mr. Breslin's perspective, why that was the case.

Mr. Jim Breslin

As I explained at the last meeting, I have a significant trawl under way of the entire-----

That is not what I asked Mr. Breslin.

Mr. Jim Breslin

It is in answer to the Deputy's question. There is a significant trawl under way of the entirety of the records of the Department on the full gamut of the issues raised. The trawl is very significant and being undertaken in parallel with the response to the incident. There are people with expertise and knowledge in this area in the Department who have been working absolutely flat out since the issue arose. The senior incident management team is putting in place all of the necessary responses. The memos were not sitting on people's desks. They are from 2016. They would have come to light in the comprehensive trawl process I have under way. When I sat in at the committee-----

I will have to stop Mr. Breslin because I am getting very angry. He knows the question I am putting to him and I am not going to listen to waffle from any Accounting Officer, given how angry committee members and I feel. We are not talking about trawls of emails and what was sitting on people's desks; we are talking about information of which the Chief Medical Officer had sight and had knowledge. We are referring to the March memo, the two July memos and the fact that he sat in at high level meetings between the Department, CervicalCheck and the HSE with full knowledge of the strategy to reduce the volume of women to whom information would be given on the outcomes for them. Mr. Breslin is talking nonsense. When the Chief Medical Officer and others in the Department knew that information, why was it not given to Mr. Breslin or the Minister?

Mr. Jim Breslin

The memos-----

I am looking for the reason. Perhaps Mr. Breslin might answer the question.

Mr. Jim Breslin

The memos were from 2016.

Mr. Jim Breslin

They were related to the objective of the programme to inform the women, not widespread non-disclosure of the results to the women. The knowledge was within the Department that there had been a clinical audit programme undertaken in CervicalCheck with the intention of informing the women. That is set out in the memos. We did not have the specific memos in our documentation that we had pulled together at that stage. The explanation is the absolute commitment that has been under way on the part of all of the officials in the Department to trying to respond to the immediate issues. I have put in place a separate process, one that does not involve those officials, to go through the emails within the Department to establish exactly what we knew. When I sat in at the previous committee meeting, I gave an immediate undertaking because the director general of the HSE had referred to a specific memo from March 2016 that the director general indicated had gone to the Department. I double checked to see where that memo would have come into the Department. I was told by the HSE about it. By that evening I had issued a press statement confirming that the Department had the memos. I then followed them and how they had been handled within the Department. I briefed the Minister and published all of the documentation last Tuesday.

With respect to Mr. Breslin - m apologies to the Chairman - I am seething with anger. I am trying to get answers to questions. We are trying to drag information out of the HSE and the Department, minute by minute, day by day and meeting by meeting. There is a drip feed of information and Mr. Breslin is telling me what he did last week. I am asking what was done in 2016 and subsequently, when there was not just knowledge of the memos but meetings were being held to discuss the strategy to be put in place to give discretion to consultants to reduce the "volume" of dispatch. The memo also stated: "Decide on the order and volume of dispatch to mitigate any potential risks". They were concerned that some of the women would go to the media. When Mr. Breslin was before the Oireachtas Joint Committee on Health last week, he said, "...the judgment made was that it was not, within the gamut of issues being managed across the health service, of sufficient scale." Despite this, the memo referred to concern about the scale and volumes involved. It strikes me that Mr. Breslin is explaining away. It is quite obvious to me that the scale should have been notified to the Minister. I will ask Mr. Breslin to answer one question. The same memo referred to the HSE putting in place a communications strategy because of concerns about media headlines and that some women might go to the media. If that did happen, who would have had to go out and answer questions about the screening programme? Which person would have had to go out to do so?

Mr. Jim Breslin

The CervicalCheck programme.

Politically, who would have had to go out? If there was a concern within the HSE and CervicalCheck that a media strategy had to be put in place because of the risks to the organisation and the programme and that some of the women might go to the media and the programme would be compromised, who would have had to go out and defend it politically?

Mr. Jim Breslin

That is a really important question. It will recur if we do not have this clarified. There is a conflation of two issues. My comments yesterday were about an approach that was being taken proactively by CervicalCheck to inform women of their results.

It was not about the subsequent, widespread non-disclosure of those results. The Department was not aware of that and the HSE has confirmed that.

That is fine. I am asking Mr. Breslin now about the March 2016 memo and the July memos which talk about putting a media strategy in place and about fears and risk in terms of the programme. I am asking - if that did happen - who would have been the person who would have had to answer questions on that in a political sense?

Mr. Jim Breslin

The Minister.

Mr. Jim Breslin

What we would have done-----

I am going to stop Mr. Breslin there, the Minister-----

Mr. Jim Breslin

What we would have done for the Minister in that situation was that we had a plan from CervicalCheck, which was a very well intentioned plan, to inform the women. We were keeping in touch with it as to how it was progressing.

Mr. Breslin and his colleagues were not-----

Mr. Jim Breslin

Yes we were.

-----as he and his colleagues were not aware of it. The Minister was not-----

Mr. Jim Breslin

Officials were-----

Officials were down the chain.

Mr. Jim Breslin

-----and that is absolutely correct. That is where-----

No, it is not correct.

Mr. Jim Breslin

That is where issues should get managed. There was a potential risk that there could be adverse publicity arising from that and in a situation where that were to develop into a real, present issue, the early warning approach between the Department and CervicalCheck, would have allowed for that to come to the surface and for us all to be advised of what the response would be on that. There are countless risks within a health service the size of the one we have that may or may not come to pass. There are strategies put in place to manage those and early warnings to see if they come to fruition. It is at that point, as a risk actually becomes present, that the response has to be escalated. We cannot-----

It was not a plan to inform all women. It was a plan not to inform all women. Bear with me. It was a plan to inform some women, where we give consultants discretion. We know then from the meeting, about which we talked earlier, in September 2017 that clinicians had a concern that they were being asked to do it. We know only one in four women was told. We then know that of those women who came forward that they were asked to sign confidentiality agreements and if they did not, it would be dragged out through the courts. That was the strategy. That is what was known within the organisation at the highest level. It is very clear from all the information we now have. When all of that was going on, nobody thought of telling the Minister. I put it to Mr. Breslin that the reason they did not want to tell the Minister was that they wanted to talk this up as a small problem and not a big problem because if it was a big problem, action would have to be taken. That is why the Minister was not informed.

Mr. Jim Breslin

There are people here who can talk to the plan and we will have the time to do so but I ask the following question. If the plan was not to inform women, why were reports generated and letters issued? I do not believe the plan was not to inform women.

I did not say that, so please do not put words in my mouth. I said the plan was not to inform all women. There was a plan put in place to inform some women. Listen to what I am saying. What I said earlier was that the strategy was to reduce the volume of women who would know. It is very clear when the plan said to decide on the order and volume of dispatch to mitigate any potential risks. We are intelligent enough to know what happened. There was a concern that were hundreds of women and if they were all informed at the same time, it would get out so a containment plan should be put in place and the Minister should not be informed. The Minister was not informed. That is the point I am making, and Mr. Breslin knows it.

The Deputy has two minutes.

Mr. Jim Breslin

The documentation shows that hundreds of letters did issue.

I am very disappointed with Mr. Breslin's response but I will put questions now to Dr. Holohan. I said earlier that I was very angry with him and I am. Last week when I put very specific questions to Mr. Breslin about the knowledge of the memos to the Department, Dr. Holohan tried in a brazen way to try to help us understand-----

That is how I saw it.

I am cutting in here. I said at the beginning that we had a good, respectful meeting yesterday and I want the same level of respect to be shown to the people here today. Before Deputy Cullinane spoke, I said that we wanted candour from the witnesses but that they would be treated with respect. The Deputy can have strong views but I will make sure this meeting is conducted with respect to everybody like it was yesterday. The witnesses are entitled to the same respect as the people who were here yesterday, but we expect them to answer the questions.

With respect to the Cathaoirleach, I have respect for everybody here but I believe the witnesses performance last week and the fact that they did not give us that information was absolutely unacceptable. I ask Dr. Holohan why he did not volunteer that information to us last week.

Dr. Tony Holohan

What I said honestly to Deputy Cullinane and the committee last week was what I understood those memos to mean. I had not seen that memo in two years. I was seeing it for the first time in two years in the same way as the Deputy was seeing it when it was brought to the committee. What those memos show over that time period, as the Secretary General has set out, was the progression of the issuing of letters over a period of time, with the clear intention of that information being shared with patients. I would have understood that in the following way. That was a clinical audit arrangement. Clinical audit as part of cervical screening only happens in a minority of countries in Europe. The only other country we have been able to identify that has an expressed policy of openly disclosing those findings to patients is England. I would have been able to see and understand, with my knowledge and background, from a professional point of view, that these were developments and enhancements that placed our screening programme well ahead of other screening programmes in the world. That was the knowledge we had at the time.

I accept that but let me make this point-----

Dr. Tony Holohan

What has come to light since and there is nothing in those memos-----

-----because I am tight on time.

Dr. Tony Holohan

I understand.

It was not just the March memo. I was two memos in July. There were a lot of meetings which Dr. Holohan attended and it is not good enough for him to say he had a memory blank because it was two years ago.

Dr. Tony Holohan

No.

It is inconceivable that he would not have known about all the memos and meetings. I ask Dr. Holohan a direct question. How many women were directly contacted by CervicalCheck on their misdiagnoses?

Dr. Tony Holohan

CervicalCheck will have to answer that specific question.

No, I am asking about Dr. Holohan. Does he know? Can someone answer that question?

Dr. Tony Holohan

I do not have a precise number.

Can somebody answer that question? How many women were informed directly by CervicalCheck about their false smear results?

Dr. Stephanie O'Keeffe

I certainly know that when women reached out to CervicalCheck, the clinical director at the time made herself available to meet with women. My understanding from the February and March memos was that that was the case. I do not know how many women Professor Flannelly would have actually spoken to. Mr. John Gleeson might have an appreciation of that.

Does Mr. Gleeson have that number?

Mr. John Gleeson

I do not.

He does not have that number. Nobody here knows how many people were-----

Mr. John Connaghan

I covered part of this in my opening statement. I have been advised that the correspondence during July and August 2016 amounted to approximately 200 letters - according to the July 2016 briefing notes.

Did they go the clinicians or to the patients?

Dr. Stephanie O'Keeffe

Deputy Cullinane's question is about-----

Yes, and that is why I am trying to be respectful. I am asking very direct questions. I did not ask about the number of clinicians or consultants because we know they were given discretion. I am asking how many patients were informed directly by CervicalCheck about their smear results.

Dr. Stephanie O'Keeffe

I can confirm that was not their plan. When they had looked at-----

So what is the answer to "how many"?

Dr. Stephanie O'Keeffe

We are missing a person here today and that is Professor Flannelly.

Mr. Damien McCallion

I might be able to provide some further-----

Dr. Holohan has indicated as well.

Mr. Damien McCallion

From the process of working through the 209 women impacted, it would appear that around 40 people were contacted by clinicians at the time. The letters were sent from CervicalCheck to the clinicians, as I understand it and around 40 would have made contact at that time.

That is 20%.

Again that is not the question asked because we know that some of those clinicians took the decision to inform patients and some did not. I am asking how many were informed directly by CervicalCheck.

Mr. Damien McCallion

The answer that was given was that the letters went from CervicalCheck to the clinicians.

"None" is the answer then.

Mr. Damien McCallion

Not from CervicalCheck.

Yes, exactly. That is all I wanted to know.

Mr. Damien McCallion

Just to close the-----

Dr. Stephanie O'Keeffe

"None" is not the answer. My understanding is that there were women who would reach out directly to the CervicalCheck programme. The Deputy will see in a couple of the memos that when diagnosed with invasive cervical cancer, some women reach out to the CervicalCheck programme before the audit has even commenced and the programme will tell them that this audit will be conducted and the information can be given. That is within the briefing notes at the time. I cannot tell Deputy Cullinane exactly how many women Professor Flannelly spoke to because she is not here to give that evidence.

I call Deputy Kelly. We will be able to come back to Deputy Cullinane.

I have so many questions. This is like a big jigsaw with the amount of information coming through. This will be a very difficult day for all the witnesses. It will probably be one of the most difficult days in their careers, and certainly the most difficult day they will spend here. I think we will be here for many hours. I have so many questions and I will not leave here until I have asked them all. I ask the witnesses to be conscious that their own management across the country and the Minister for Health are watching them. I expect that we will get answers that are direct, straight and honest. I agree with the opening sentiments of my colleague, Deputy Cullinane, on information not being provided previously and on the manner in which information was provided to us today.

Vicky Phelan has just tweeted about the drip drip of information, "This has been the gameplan since the #CervicalCheckScandal broke. Drip feed inflammatory documents fo try to water down the effect of the cover up." These are Vicky Phelan's words at 9.38 a.m. this morning. She says to me to "Please take them to task on this and demand answers". She says that the documents are to try to water down the effect of the cover up. I thought that should be read into the record.

I want to start by saying something to the acting director general. I thought yesterday that we had found somebody who would act in a manner of candour and in a certain way to get information. I genuinely did but I am concerned about his statement today and how it differentiates from the statement yesterday. I will tell him why. At the end of the first document, in point 3, he says "If there is a requirement to hold individuals to account on a personal basis we will do so. In that respect the Scally Inquiry and subsequent inquiries will be important". It changes today and starts adding in the information relating to Vicky, Stephen and so on. I would have thought the testimony Mr. Connaghan heard yesterday would have elevated this. He is aware of the testimony. Being aware of it is not good enough for me. This is a live issue. There are people in Mr. Connaghan's organisation who are responsible for this. Some of them may sit among us. When Stephen sat in either Mr. Connaghan's or Mr. McCallion's seat yesterday, he said he did not understand how they were still in place and how they were not stood down because of the impact their management and decision-making had on women in this country. I think Mr. Connaghan has an opportunity. We are public representatives but I have gone beyond the politics of this.

I will never forget yesterday's testimony for the rest of my life. I cried through it. She said she would not stop over her dead body. They want and need accountability. Stephen was very clear on this. They represent society. They do not just represent themselves but society. They go beyond. They are better representatives than us. The Irish political system has let these people down. It is a stain on all our houses. It is a stain on my party, on Fine Gael, Fianna Fáil, Sinn Féin, the Independents and Social Democrats. It does not matter who one is - it is a stain on us all. There will be the Scally inquiry and I am entirely behind that. There will be a commission of investigation, as I have said all along. This is a live issue and there is a huge amount of pressure and responsibility on Mr. Connaghan's shoulders to deal with this issue in an ongoing way. He will have to make decisions based on the evidence he has heard and the knowledge he has.

I know what is going on in the HSE. Across the HSE are phone calls, meetings, people going in for cover, verifications of documents, verifications of whether people replied or not. In the last three or four weeks, most people in this room and many outside of it have been doing all the work except this. This has been it for the HSE - arse-covering. That is what is happening. The responsibility is with Mr. Connaghan. Our faith has to be with him to deal with this as a live issue. Bear in mind what Stephen and Vicky said last night, not what we are saying. We will have questions and will pull out more information. Please do that because I have not seen it yet. The Minister for Health, Deputy Simon Harris, is watching this as well and I would ask Simon, who is a very good person, to bear in mind what I just said. I asked witnesses here yesterday why Mr. Liam Woods and Mr. Patrick Lynch were not able to come. In fairness to Mr. Woods, he is here. Mr. Patrick Lynch, on the organisational chart, is the national director for quality assurance and verification. That is risk and quality assurance. He was working on Monday. Why is he not here?

Mr. John Connaghan

Mr. Lynch has a long-standing personal commitment. I was in touch with him last night. He regrets that he is not here today. I am grateful to Mr. Woods, who has interrupted a family holiday. He did not step on that plane and came in to the committee today. The committee can decide what to do with this. If it dispenses with any evidence from Mr. Woods as early as possible, I am sure he would be grateful to resume his family holiday. Having spoken to Mr. Lynch last night about his position on this, he advised me of the following. When he was asked to take charge of the serious incident management team, SIMT, that was not a responsibility that included any investigation of the events.

I did not ask that. I will get into that.

Explain what the SIMT is.

Will all due respect, Chairman, I will get into that. We might not have to. We are all caught for time and I will be back here three or four times. Why is he not here? When was his leave signed off?

Mr. John Connaghan

I did not personally sign his leave off. That would have been done by the previous director general. I can get Deputy Kelly that answer.

Do. Let me get into this since we are caught for time. Yesterday, Dr. O'Keeffe told us that he was obviously aware of these issues on 4 March 2016.

Dr. Stephanie O'Keeffe

February.

February. That is better still. We have also seen from other minutes that we have been provided that he was made aware of correspondence on 4 March and 27 April 2016. Who in the directorate management team were aware of the issues relating to CervicalCheck all the way along? We look at Vicky Phelan's case, since she has been extremely open with us and we had long conversations with her yesterday and afterwards. When Dr. Kevin Hickey was dealing with this issue and it had not been communicated to her, was there not correspondence to a number of people at the directorate level in the HSE from University Hospital Limerick telling them about this issue? In July 2017, as I said yesterday, who on the national directorate was told about it? We already know that Dr. Colm Henry was made aware of it. What did they all do? When they received that correspondence, what did they do? I am asking Mr. Connaghan.

Mr. John Connaghan

Can I refer to the people who were in post at that time and dealt with that correspondence?

I will look at Dr. Henry and Stephanie O'Keeffe on this. Does Dr. Henry want to go first?

I am asking Mr. Connaghan. He is aware of this. I told him about it.

Mr. John Connaghan

The Deputy told me about this. I am aware of that. I have had an account from Dr. Henry on this, but I would rather refer to him because he was there at the time.

A precis please, because we do not have time. Will Dr. Henry remind us to whom he reported at the time and tell us what his role was, for his own benefit as much as mine?

Dr. Colm Henry

I was a clinical advisEr to acute hospitals at that time.

To whom was Dr. Henry's direct reporting line?

Dr. Colm Henry

I reported to the national director of acute hospitals, Mr. Liam Woods.

For future reference, witnesses should mention names as much as titles so that we can attach people.

Dr. Colm Henry

Does the Deputy want me to go on?

Dr. Colm Henry

On 11 July, I was communicated with by the lead clinical director of University of Limerick Hospital Group. He sent a letter to his group-----

Mr. Paul Burke.

Dr. Colm Henry

Correct. He sent a letter to his CEO, Colette Cowan, and copied the letter to me but cited me in the letter also asking my advice. The issue he had was that one of the consultants in his hospital was unhappy that he had been asked to convey the results of information from this audit-----

Dr. Colm Henry

-----to his patients. He did not name patients. He conveyed this message to his group CEO and copied the letter to me asking for my advice. What followed then, as I outlined a couple of weeks ago, was that I consulted with the clinical director of the women and infants health programme, Dr. Peter McKenna, who is here beside me and correspondence ensued. To save time for the committee, I will not go through it in detail, but there was correspondence between Professor Flannelly and me on two occasions and back to Dr. Hickey and Dr. Burke to seek clarification over what the programme was doing.

How long did all of this correspondence take?

Dr. Colm Henry

It went on until 8 September, which was the date of the last communication I got from Professor Flannelly.

Amazingly enough, that is around the time the first colposcopists meeting was called, to which many did not turn up, which is why I requested it in the first place. No one had decided at this point that Vicky Phelan should be told about this.

Dr. Colm Henry

At no stage during the correspondence and my communication with Professor Flannelly did she make clear or did anybody make clear that women were not being told. The issue that was brought to my attention was that a consultant in Limerick was not happy that he had been asked to convey this to patients. He copied me in a letter in August to say-----

Did Dr. Henry not feel that, whoever the patient or patients were, they should be told?

Dr. Colm Henry

Absolutely.

Did Dr. Henry convey that?

Dr. Colm Henry

At no time in that correspondence was it said to me. I quote from what Professor Flannelly said to me in one letter, "If doubt exists that a lady's disease might have been detected at an earlier time or if she had required more intensive treatment than she otherwise might have needed, it is our view that women should be made aware of this rather than simply filing a note". Later on in that letter to me, she described where she herself had informed women and said it was a very difficult process. Dr. Hickey later wrote to her, copying me in, saying he was dissatisfied with the process but he decided himself to proceed and tell women. At no stage was it stated that women were not being told. The issue was that a consultant was unhappy that individual clinicians were being asked to do this.

Was Dr. Henry not concerned that so much time had passed and that the woman in this case had not been told?

Dr. Colm Henry

Of course, I was concerned and I persisted with the communication conveying back the dissatisfaction of the clinician in Limerick and his clinical director to Professor Flannelly.

Who else was on this email list? Who else was told?

Dr. Colm Henry

At that stage, I was being asked for advice as a clinical adviser and I consulted with Dr. McKenna.

We are caught for time. Who else was told?

Dr. Colm Henry

Professor Burke would have known, Colette Cowan and my correspondence otherwise was directed to Professor Flannelly who was providing me with assurances.

As such, Dr. Henry had no email correspondence at that time with Mr. Woods or Mr. Lynch.

Dr. Colm Henry

No, I did not.

Mr. Liam Woods

To complete that, I would have received an email from the CEO of the UL group on 13 July.

What did Mr. Woods do with that?

Mr. Liam Woods

The content of that email related to an issue the CEO had identified which is reflecting the same subject the Deputy has been referring to.

-----have just been told because she had not been copied on the 26 June notifications as Ms O'Keeffe had told us yesterday.

Mr. Liam Woods

Sorry, I am not sure-----

I will come back to it as we do not have time.

Mr. Liam Woods

That note was suggesting that there was an issue of concern and in fact the note to me was saying that the CEO was dealing with that issue. What I did with the note that came in on-----

The CEO was dealing with that issue.

Mr. Liam Woods

Yes. That was the content of the-----

I recommend to Mr. Connaghan that, with the permission of Vicky Phelan, all of this is published - every single email and all correspondence. I would say he will get that permission.

The Deputy has one minute left in the first round.

Mr. Liam Woods

I referred that email on to the women and infants programme, which resulted in the dialogue to which Dr. Henry has referred briefly but also was concluded in the meeting of colposcopists on 1 September. The Deputy made one comment earlier on which I wanted to come back. We understand there may have been another meeting of colposcopists on 26 October, but we do not see minutes of that meeting. That is something we still look for.

Professor Burke was copied on this. I ask Mr. Connaghan if he replied. Did Mr. Woods reply to the email he received?

Mr. Liam Woods

I responded. My action was to refer the matter on to the women and infants programme.

How did Mr. Woods do that?

Mr. Liam Woods

By email through my office.

Did Professor Burke respond?

Mr. John Connaghan

I am not aware of Professor Burke responding.

So, he did not.

Mr. John Connaghan

I cannot say he did not. I can just say that I am not aware of it.

I understand that he did not. He was aware in February, March and April 2016 of issues in relation to the whole thing, specifically in relation to these elevated issues in July 2017. Mr. Breslin said the SIMT was put in place to investigate what was going on. "Investigate" might not be the right word, but that is the word I am using. The guy who was doing it was actually privy to a lot of the information. He is part of the investigation. What I come back to here is the following. One has all of these people, a number of whom will actually be supplying information to the Scally inquiry. Does Mr. Connaghan not think they will cover their backsides? Not all of them, but some of these people remain in position while co-operating. Does Mr. Connaghan not think the process will be tarnished? Can he not see the obvious here? Can he not see what Vicky Phelan and Stephen Teap said yesterday?

Mr. John Connaghan

I have two responses to that. It is important to recognise that the SIMT was not charged with any responsibility to investigate events. It was set up for the specific purpose of ensuring that we had good contact tracing at that point in time. The other advice or, really, information to give the committee is as follows. On 10 May, there was a meeting between Mr. McCallion and Mr. Lynch.

In May of what year?

Mr. John Connaghan

This year, 2018. The notes from Mr. Lynch came in last night. He said he agreed with Mr. McCallion that as he has been assigned responsibility as national director for leading the screening services, it would now be appropriate for him to chair the SIMT. That handover of responsibility took place on Friday, 11 May.

That does not change anything.

I will move on to Deputy Murphy. Deputy Kelly will come back several times.

I have 22 or 23 more questions.

That is fine. The Deputy will be back in again.

Last week, I looked for particular information, including the communications strategy. We got a lot of stuff overnight. I had been watching for it all week. We have received some correspondence overnight but I cannot see the communications strategy included in that. There was a commitment to give us that documentation. Why have we not received it? Before that question is answered, I have some other questions to pose on the laboratories. Who has responsibility for the laboratory contracts?

Mr. John Connaghan

Can the Deputy rephrase that question?

Which one of the witnesses has responsibility for the contracts the HSE has with the laboratories?

Mr. John Connaghan

That would be CervicalCheck.

Mr. John Connaghan

Direct line management responsibility lies with Mr. John Gleeson.

Mr. John Gleeson

That would be me.

I will address some of my questions to Mr. Gleeson. In reading the memos last week and in reading some of the other material, it was obvious that what was being looked at was a kind of statistical analysis and whether it was within the expected range in circumstances in which, we have been told, screening is not 100% accurate in identifying what have been described as false negatives.

One of the points that was made last night by Mr. Cian O'Carroll was that within that there were some failures that were of a magnitude that should have been picked up. He expressed a concern that there may have been a closed mind because they were in the statistical range one would expect to see. Were those in the HSE of a closed mind when they saw the result? Did they look at individual results? Vicky Phelan spoke about the failure being identified in two previous smear tests she had.

Mr. John Connaghan

I wonder if I could direct part of the answer to this question to one of our clinical colleagues who can give some of the additional material the Deputy seeks.

Mr. John Connaghan

I will suggest that I also direct some of the answer to the question the Deputy has just asked to one of my clinical colleagues, Dr. Peter McKenna, who can also give some of the information the Deputy needs.

Failure at that level is critically important. We are told two sets of eyes look at these. In Vicky Phelan's case, there were two separate smear tests. That is a failure rate of 400%. Will the witnesses comment on whether or not there was a closed mind, by simply looking at this from a statistical perspective rather than delving deeper? There seems to have been a difference between one lab and some of the others with regard to the extent of the failures. Will the witnesses comment on that first?

Dr. Peter McKenna

On a monitoring basis, the figure that is usually looked at is the positive predictive value. That tells us the ones the laboratory is reporting as abnormal are genuinely abnormal. The rate between the laboratories the Deputy has in front of her is within the acceptable range of the early to mid-80s and that is considered to be an acceptable figure.

As regards the other question about whether there was a closed mind, the answer is "No." If there was a closed mind there would not have been a review. The very fact that people looked back on the individual results meant they were looking to see whether the headline figures were enough or whether, if they reviewed the individuals concerned who developed cancer, they could see if there was error. That would suggest to me there was no closed mind.

I think it was Irene Teap who had the two scans. I have been asked by somebody to ask the witnesses some questions about the detection rate between the labs. There is very significant public concern about people who have engaged with the screening programme, which I still encourage women to do. The high grade detection rate of lab A was half that of two other laboratories. What lab is selected by a GP, for example, to send the smear test to? Is it on a geographic basis or a medical supervision one? What is the means of deciding on the lab?

Dr. Peter McKenna

My understanding is that different laboratories receive tests from different parts of the country. Consequently, some of the laboratories might receive tests from a disproportionately high number of women who attend colposcopy clinics and therefore one would expect there to be a disproportionate number of high grade lesions. Within the country one would also expect there to be some variations between urban and rural. There would be socioeconomic parity reasons as well. Issues such as smoking which are socioeconomic are also a factor. As it is, if it is split geographically, there will be variation.

Dr. McKenna is saying there may be a cohort that is not similar so a direct comparison may not be a fair one.

Dr. Peter McKenna

It would not be a fair comparison because different laboratories get different types of patients to look at by virtue of where the smears come from in the country.

I do not understand if there is this supposed failsafe put into the system with regard to two people looking at the tests how something that is a fairly obvious anomaly would not be picked up in that context. What has been looked at in the context of the skillsets of the people who are conducting the tests? Is it of a similar standard? Is it something that has been considered at this stage?

Dr. Peter McKenna

That would be a question more for the laboratory and somebody who is involved in the inspection rather than me.

Mr. John Connaghan

In my limited time in office and with my limited knowledge, I visited the cervical cytology lab in the Coombe which is one of the suppliers. I saw first-hand what they were doing in terms of looking at the slides. It is a very onerous and intense process. It is double-manned; each slide is looked at twice. Within the Coombe there is an accredited training programme for the people involved in looking at the screens. Apart from that, I cannot give the Deputy any further information now but we can tell her later what that training programme encompasses and what international standards it accords with.

Mr. Damien McCallion

Yesterday we were asked to supply, which we will, the quality assurance guidelines for the laboratories. It covers a range of areas, including organisational matters, facilities, staff qualifications, the specimen regime and data entry etc. so we can supply the information the committee requested.

They will find one individual within a lab.

Mr. Damien McCallion

One other point of relevance is we have also engaged - we are hoping to meet them at some stage later this evening - with the faculty of pathology. With the absence of Professor Farrelly we wanted to strengthen the laboratory input into the programme. The faculty has agreed to come on board and provide that sort of advice and hopefully further assurance not just with regard to some of the queries the Deputy is talking about today but also with regard to the roll-out of the new model for HPV testing later in the year.

I want to move on to a couple of more questions. I was quite appalled by the means of communicating the terrible news - Stephen Teap went into it last night - to some of the families. They were put into a holding room. There was a mixture of people who had family who had died and women who were going to receive news that they had had a false negative and had gone on to have cervical cancer. They also talked about the social care programme that was announced last week and said they had not been contacted. This was after a catastrophic event. Have no lessons been learned about how to deal with people who should be at the centre of this and not part of some sort of administrative process? Is there any thought put into the recipients of the so-called services that will be provided? Is the Department of Health talking to the HSE? Who is talking to the people who were directly affected? I was completely appalled by it.

The Deputy will get another opportunity to ask a question.

Will the Chairman put me on the list?

Mr. John Connaghan

They are fair questions. I would be asking those kinds of questions if I was in the Deputy's position.

When I heard about the events, I asked Mr. Woods to contact the hospital group chief executives to ensure we had special support, and that the news was delivered in an empathetic fashion and in an appropriate way. I have been in contact with senior officials who are handling this and we are putting an individual, named person in charge of this for each community health organisation. I have set some expectations with the team as regards the number of people who need to be contacted regarding support packages in the next couple of days.

Mr. Damien McCallion

There were a number of elements to the programme, that is, the medical card element, the counselling supports and other clinical supports. The 209 women are the most important people in this process and, because they had already had contact with the hospitals, it was felt they should make the first contact to advise them about the local counselling service. Each of the nine community health organisations in the country has one person on their list to manage the whole process for each of the women in their area. The lists have been sent out and hospitals are making contact. The support person will be in touch with everyone. We have streamlined the medical card process and there will not be any filling out of forms. The support will be discussed with people to find out what works for them.

Vicky Phelan told us last night that sick women are contacting her. She is a sick women who is now fielding questions from other sick women. There has to be a person with whom they can engage directly because this is not fair.

Mr. Damien McCallion

A person and the person's number will be notified to each of the 209 women. This will link in to the hospitals and other services.

This relates to the 209 about whom we know so far. There may be further cases and this may only be the start of it.

Last week the Taoiseach, the commander in chief, made his great announcement but a week later it seems nothing has happened. There is to be a central contact person who will contact the 209 women through the hospitals but things need to happen more quickly.

Last week we were given three memos, one dated March 2016 and the other two dated July. In the pack that came last night there was a very similar memo, dated February 2016, which mentioned the pausing of letters, waiting for advice from solicitors, reactive communications, media headlines about screening not diagnosing and so on. How many other versions of this letter are there and how far do they go back?

Dr. Stephanie O'Keeffe

I was first invited to a meeting with the CervicalCheck team and the clinical professor in February 2016.

Dr. O'Keeffe said she was invited to a meeting with the CervicalCheck team but surely she is over that team.

Dr. Stephanie O'Keeffe

The team specifically asked me to come to a meeting to discuss-----

Are they not you? Dr. O'Keeffe speaks as though she were a guest of theirs.

Dr. Stephanie O'Keeffe

Absolutely. I meet with the National Cancer Screening Service on a monthly basis and it is part of my senior management team. The head of the service reported to me directly during that time.

Is that Dr. Coffey?

Dr. Stephanie O'Keeffe

No. It is another individual. I was invited to a particular meeting to show slides relating to the results of the audit findings. A number of things were discussed and, as I mentioned at the committee yesterday, the most important thing was that, having looked across the case findings, no systemic errors arose. It is really important to understand that an audit of clinical invasive cancers being carried out by the CervicalCheck programme-----

I have very limited time and I put a very specific question but I am getting a lot of background that I do not really need.

Dr. Stephanie O'Keeffe

A clinical audit of invasive cervical cancer is the last in a suite of tools to ensure a programme is working well. If somebody invites me, as national director, specifically to discuss this I am immediately interested in the findings of the audit. I want to know if there is anything in the audit that will present a problem for the women in the programme. At that meeting, the CervicalCheck programme wanted to ensure that the information it felt would be of benefit to patients could be disclosed to those patients. They had worked through a methodology in consultation with a range of stakeholders and they wanted me to resolve the specific problem they were encountering, which was that several laboratories had asked questions about letters they had already sent to consultants at that time.

I did not ask this question. I have a February 2016 memo. I want to know if this is the first. Last week we thought the March 2016 memo was the first.

Dr. Stephanie O'Keeffe

I will explain.

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

Mr. John Connaghan

I will answer it. There are six briefing notes.

There are six briefing notes. We now have four. When was the first?

Dr. Stephanie O'Keeffe

The first briefing note was one I asked for at that meeting, which I got the very next day.

What date was that?

Dr. Stephanie O'Keeffe

It was 26 February.

So this is the first.

Dr. Stephanie O'Keeffe

Yes.

Okay. We now have four so can we have the other two?

Dr. Stephanie O'Keeffe

You have all of them.

Do we have all of them?

Dr. Stephanie O'Keeffe

Yes.

Okay. I have some quick questions, requiring "Yes" "or "No" answers. Does the contract permit subcontracting to third party laboratories, as in the MedLab case about which we learned during "The Week in Politics" last Sunday?

Mr. John Gleeson

There is a requirement to have a back-up laboratory.

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

Mr. John Gleeson

Yes.

Is there anything to stop this laboratory further subcontracting to a fourth party laboratory?

Mr. John Gleeson

It cannot do it without notification. We would not allow it.

The Irish-based registered pathologist signs off on the subcontracted results from the third party laboratory to the first laboratory, which in this case was MedLab. Is that correct?

Mr. John Gleeson

Yes.

Do they do this by simply transcribing the results from the third party laboratory or do they look under a microscope themselves?

Mr. John Gleeson

The people in the laboratory facility in which the sample is processed look down a microscope.

An Irish-registered pathologist signs off on it on the blind, as it were.

Mr. John Gleeson

It has been screened.

The signing pathologist for a smear test done in the UK, at a third party laboratory, does so without personally looking under a microscope. Is that correct?

Mr. John Gleeson

They would authorise it-----

In the food industry, if you bought meat from me which I had bought it from Deputy Kelly but packaged as being from me, it would be against the law. Does that surprise you?

Mr. John Gleeson

No.

Is it not unusual that, when it comes to people's lives, medicine and testing, the pathologist who looks at this in the UK is not the signing laboratory? When this is sent to a doctor in Mayo, Sligo or anywhere else he or she just sees "MedLab, Sandyford" and the signature of the pathologist based at that location. Is that correct?

Mr. John Gleeson

I would have to check that.

My information is that it is the case. Mr. Gleeson needs to revise that immediately and inform GPs as to who did a test and what pathologist looked over it. It is extremely poor practice to have a pathologist doing work in the UK, or anywhere else, while a pathologist based here signs off on it without a re-examination of the results. I do not want to create hysteria or additional worry but, using the food industry analysis again, in the interest of traceability and accountability we need to know who is doing what. Otherwise, the poor pathologist at MedLab in Sandyford could be accused of mistakes for which he or she was not responsible.

Dr. Tony Holohan

I will make a general observation lest people misinterpret things. It is important that the pathology community has the chance to offer a view on whether this is an appropriate clinical standard or not. We should not operate on the basis of it being said on the record of this House. I would be concerned if the Deputy's point was left unanswered.

I appreciate that, but on the general practice, as I watch this whole thing develop, I have to say that we are going further in a direction in which accountability will be lost in clinical decision making and opinion. With no medical training and just applying basic common sense, I would say that someone should not be signing off on my work unless he or she is aware of its quality. It cannot just be assumed that I am great, particularly in a screening programme in which efficacy levels are not 100%. It is a very reasonable question to ask. The recommendation I have given is perfectly logical from a citizen's perspective, if not from an established clinician's perspective. We are sadly beginning to see that at least some are party to a culture of, in the words of Vicky Phelan, cover-up.

Dr. Holohan wants to respond to that.

Dr. Tony Holohan

I am not taking away from the specific question of the contract, it is just a more general point that if there was to be an assertion which was not answered, from a professional point of view, such arrangements would create concerns which would go beyond this particular issue. We should be in a position to hear from-----

We will immediately write to them. Dr. Holohan should write and we will write.

Dr. Tony Holohan

I suggest that the faculty of pathology should be asked to offer a view in respect of the general practice of clinicians signing off in the scenario the Deputy has described. There are many areas of clinical practice in which junior doctors or non-doctors take on and report on work which it is signed off on without being directly seen by those signing off. We should not create a concern about that.

Is Dr. Holohan undertaking to do that?

Dr. Tony Holohan

I am very happy to do that if the committee is happy with that.

When Dr. Holohan finds the answer he should state it publicly and not wait to come back in here. People need to be assured about this.

Dr. Tony Holohan

If I can get a response for the committee, we will put it on the website of the Department.

I know from Dr. Holohan's biographical information that he is the chief medical adviser to the Government. As I have asked in various fora already, I ask that as quickly as updates are available Dr. Holohan and the Taoiseach make some public utterances and put a few pounds into giving people out there assurance, as was done for Storm Ophelia, as opposed to waiting for information leaflets or whatever. Utterances should be put out in the broadcast media to provide not just the 209 women, but the entire female population of Ireland with assurance as to what is going on, who is doing what, what efficacy levels are, that things are safe and so on. We established that letters from CervicalCheck do not include efficacy levels, which they should. I recommend that is included. They also do not have the advice that if anxiety continues people should contact their GPs. Those are a few tangible, common-sense recommendations from someone with no medical training. I only know the situation from a service user's perspective. How am I doing on time? Am I okay?

I will tell the Deputy precisely. He has-----

I have five more minutes. Great.

-----one minute left, with Dr. Holohan to respond. The Deputy will get back in.

Dr. Tony Holohan

I do not want to use up the Deputy's time with the response but I would simply like to say that we agree with that suggestion. It is something we want to be able to do. We want to get back into a situation in which we can communicate with the public and address its fears.

I am sure RTÉ would be delighted to give the airtime to Dr. Holohan and the Taoiseach if they were to do such things. It would be very worthwhile.

This is the Deputy's last question. We can come back in a few minutes.

I have a last question. In terms of other screening programmes, have anomalies arisen in terms of testing and false negatives, which I know are different in other programmes? What communications protocols have been followed? I very much hope the answer is "No" to this next question. Was it the same process of preparing reactive media statements rather than contacting patients? Whoever wants to answer that can put his or her hand up, because I am not sure. I assume it is Dr. Holohan.

It is the HSE. The programmes are a branch of the HSE.

Mr. John Connaghan

We will call on Dr. Coffey or Mr. Gleeson.

Dr. Jerome Coffey

Obviously the focus has recently been on CervicalCheck but the HSE intends to review patient safety across all screening programmes - the three programmes for cancers and the programme for diabetic retinopathy. We are currently sourcing some international screening experts to support these programmes. Separately, we are conscious that Dr. Scally will be looking at the four programmes and we want to have resources in place to support his work.

We are paid by the State on a constant basis and we have work to do so we do not wait for Dr. Scally. It is good that the HSE will be co-operating with him, as will we, but I am looking for answers today. Have any issues arisen in any other screening programmes such as, for example, BreastCheck? I hope they have not. If they have, are we operating a communications process similar to the shambolic one we are seeing here?

Dr. Jerome Coffey

There are differences as the Deputy outlined.

There are differences in testing of course. They are different types of test.

Dr. Jerome Coffey

BreastCheck has had external accreditation of the highest European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services, EUREF, level for a number of years. This accreditation is valid until 2020 or so. There is no centralised audit process comparable to that which we have described in CervicalCheck.

There have been no anomalies or anything like that highlighted in any of the other screening programmes. There are not four memos going around talking about pausing letters and so on.

Dr. Jerome Coffey

I am not aware of paused letters in that context.

There is no discussion of media strategies or any of that.

Dr. Jerome Coffey

I am not aware of any.

Will Dr. Coffey check for us?

Dr. Jerome Coffey

I will.

The HSE might make a public statement on that as well in order to again assure women and patients throughout the country.

The screening programme includes cervical screening, breast screening and bowel screening. What was the fourth one?

Dr. Jerome Coffey

Diabetic retinopathy.

Those are the screenings for the public. One goes to one's GP for cervical screening, one has to go somewhere to get breast screening done-----

Dr. Jerome Coffey

There are mobile and fixed clinics.

Bowel screening is done at home.

Dr. Jerome Coffey

There are two stages. The primary test is a home test.

Bowel screening is done at home. That means the GP is not involved so in that situation if there was to be an issue BowelScreen has a direct line of communication with the individual who does the test at home. Is the GP involved?

Dr. Jerome Coffey

The GP is not involved with BreastCheck.

He or she is not involved with that either.

Dr. Jerome Coffey

The GP is not involved in bowel screening but I am open to correction on that. The test is posted directly to the patient, who later returns it. The laboratory then analyses it and if the test is abnormal the patient is referred to a colonoscopy unit for a colonoscopy in a hospital.

Right. I call Deputy Jonathan O'Brien who has ten minutes.

I would like to go back to the communications strategy if possible. I have a number of questions but I will try to focus on this issue and hit the nail on the head in terms of the strategy's purpose. Who was responsible for drafting or devising the communications strategy?

Dr. Stephanie O'Keeffe

The communications strategy would have been advised by the clinical professor of the time with the programme manager of CervicalCheck. Would the Deputy like some context in that regard?

Dr. Stephanie O'Keeffe

This audit, which CervicalCheck commenced in 2010 and which was carried out on cases dating back to 2008, provides information which could be of benefit for patients. CervicalCheck knew that once it put in place procedures that would allow women to get this information and to access it directly from CervicalCheck cases would quite clearly emerge because women would be perfectly entitled to seek legal redress. It would not have been in the interest of any patient attending the cervical cancer screening programme currently or in the future for no preparation to have been done in advance for media and public statements in this regard.

I am also responsible for the HPV vaccination programme. In 2014 and 2015 we had 90% uptake in that programme for young girls. That rate plummeted to 50% two years later as a result of adverse information and misinformation in respect of the efficacy and safety of that vaccine. The reason reactive communications were prepared was to ensure that if somebody took a legal case, and it was anticipated that women would as doing this audit creates the conditions for women to take legal cases-----

That was the strategy in terms of informing the women to ensure that they had all of the information.

Dr. Stephanie O'Keeffe

That is exactly right.

I am talking about the public communications strategy that was being put in place.

Dr. Stephanie O'Keeffe

It is exactly the same thing.

Dr. Stephanie O'Keeffe

Is the Deputy talking about the communications strategy and the whole range of memos from 2016?

Yes. Dr. O'Keeffe is telling me that communications strategy was put in place for the benefit of the women who may have had questions. If they came to CervicalCheck and raised those questions the communications strategy was to ensure that they were given the answers.

Dr. Stephanie O'Keeffe

The communications strategy was to ensure that when women received information, if they wanted to get their files from CervicalCheck they could.

The communications strategy was to cater for if they then went public. If they legitimately sought legal redress through the courts and if it went public, then clearly there would be a message to the effect that the CervicalCheck programme failed them. This is something widely anticipated across all screening programmes. Screening will work at a population level but unfortunately it will not work for every individual.

The communication strategy was in the event of women deciding to take legal action and go public. That was the purpose of the communications strategy. Is that correct?

Dr. Stephanie O'Keeffe

The communication strategy was to assure the public.

It was to protect the-----

Dr. Stephanie O'Keeffe

It was to protect the functioning of the CervicalCheck programme. The uptake is at 80%. It was to try to ensure the programme continues to be a strong programme. It is only if we have a strong programme that we can reduce deaths from cervical cancer.

This goes back to the e-mail sent by Mr. Connaghan to several individuals on 11 May. He outlined the purpose of the communications strategy.

I wish to go back to what Mr. Breslin said earlier about why that particular strategy was not communicated up the line. This is the difficulty I have and this is why I am struggling to get my head around it. There is a communications strategy in place and the whole purpose of the communications strategy is to try to protect the efficacy of the CervicalCheck programme in the event that women who are taking legal action go public and there are headlines, as per the memorandum. The whole purpose of the communication strategy is to reassure other women to ensure that uptake of the programme is not harmed.

The difficulty I have is that the very people who would be asked questions publically and politically were not even aware that there was an issue in the first place. That is the aspect I am struggling with given that such effort went into the communications strategy to protect the integrity of the programme in the event that anything went wrong as a result of people going public, yet it seems there was absolutely no communication beyond a certain level. It did not reach Mr. Breslin. It did not reach anyone in political circles, for example, the Minister or members of Government. They would be the very first people to answer if questions were asked. The microphone is going to be stuck under the Minister's nose to answer the questions, but he was not aware of it. Can someone explain that to me?

Mr. Jim Breslin

They would be the very first people to have to respond to anything that happens in the health service. Officials within the Department engage with the HSE on issues in the health service all the time. They probe those issues and ask the HSE what are the issues. In this case, it is a positive issue. It is something that CervicalCheck has decided to do for quality assurance purposes and CervicalCheck also decided to inform the women. It is a positive issue. There is the potential in that for adverse publicity as it rolls out, but there is potential risk in many things that happen in the health service.

The approach in that situation is to discuss the matter with the HSE and ask about the risks that have been identified. The HSE will outline the risks it has identified. The Department will ask how to manage them. The HSE will explain how it intends to manage them and the Department officials will ask how they will know whether it is working. If it is not working, they will hear and see people and the reaction of those people. Those responsible will explain what they will do in that situation and an early warning system is then put in place. It is regularly updated. Let us consider the documentation. By and large, the documentation is suggesting it is progressing well.

It is progressing well because there was drip-feeding of the letters to clinicians.

Mr. Jim Breslin

It was not drip-feeding because there were quite a lot of letters going out. The documentation suggests it was progressing well. If the information coming from CervicalCheck suggested that this would be a big problem, then we would escalate the issue within the Department.

That would be because the Secretary General would not be aware of it.

Mr. Jim Breslin

That is true. At that point we would take that action. Otherwise, we would escalate all the potential risks within the health service and, to be frank, they are infinite. We engage with patients every single day.

I put it to Mr. Breslin that the communications strategy failed because the Minister was caught.

Mr. Jim Breslin

Absolutely. The issue is that the very thing that was said would be done was not done. Now, we have a communications problem.

Who was responsible for that?

Mr. Jim Breslin

This is the irony. We have a communications problem that is actually the reverse of what is set out in the memorandums.

Who is responsible for that?

Mr. Jim Breslin

The memorandums say this might happen when we tell women. What we now know is that only 20% of women were told. The issue is that it was escalated when first we heard of it. Then, the serious incident management team was put in place.

I will come back on the figure of 20% of women. I want to ask Mr. Gleeson several questions in the second round.

Let us go back to the communications strategy. There is a reference in the March document to the communications strategy being developed between CervicalCheck and the media within the HSE. I will have to double-check the details because it could be the October document, but one of the questions we asked about was the nature of the public relations interaction between the HSE and the Department of Health. Our question on that point was answered for today. That was on the back of the reference in the memorandum to the communications department within the HSE being involved in the drafting of the media strategy. The answer we have received today is that the HSE has a national director of communications – the relevant official is before the committee today. The answer stated that the relevant person in 2016 was Mr. Paul Connors and that Mr. Connors was not involved in discussions on media as per the comment in the memorandums received. Furthermore, the response stated that he had no knowledge of the matter until 12.50 p.m. on Wednesday, 25 April this year. Perhaps Mr. Connors can answer this question about the communications division of the HSE. Who was involved in 2016 in drafting or in discussions around the communications strategy that might be needed if there was an adverse fall-out from this? Why was Mr. Connors not aware of it?

Dr. Paul Connors

I will answer the second question first. I was not aware of it because I was not made aware of it, simply. I would have preferred, obviously, that I had been made aware of it, but I was not.

There seems to be a lot of people at senior level within the HSE and the Department who were made aware of nothing.

It is simply not credible that there is no coincidence. It is no coincidence that people in senior levels of the Department are not aware of things - this is simply my opinion. It is no coincidence that senior members of the communications division within the HSE are not made aware of things. The former director general of the HSE was not made aware of things. There seems to be a level at which people simply decided not to tell anyone above them anything. That goes for the Department, the HSE and CervicalCheck. Can someone explain that? I will allow Mr. Connors finish his response to my question. He said he was not made aware of it but that he wishes he had been. Whose responsibility was it to make Mr. Connors aware of it? Who were the people involved in devising that strategy?

That is your last question for now, Deputy. You will get a second opportunity.

Dr. Paul Connors

The CervicalCheck programme has had its own communications function since the end of 2016. Those responsible were primarily involved in developing the communications documents as well as proactive and reactive communications, which is the area Deputy O'Brien has been discussing with Dr. O'Keeffe. One of my people who works in the press office had sight of those documents, in the sense of both the proactive and the reactive functions - I am referring to 2016.

Was that person the press officer?

Dr. Paul Connors

It was one of my press officers. She is not here today so I would prefer, if it is okay with you, Chairman, if we do not need to name the person. The reactive side, as Deputy O'Brien has described it with Dr. O'Keeffe, would have had sight of the draft press releases and question-and-answer documents.

There were draft press releases. Is that correct?

Dr. Paul Connors

There was a draft press release in relation to that.

Will Dr. Connors get a copy for the committee?

Dr. Paul Connors

Again, it is a CervicalCheck document but I can get that, yes.

This is one of the questions that was not answered. We asked if we could have a copy of the communications strategy and it has not yet been provided.

Dr. Stephanie O'Keeffe

It is not that there was a communications strategy.

We have draft press releases.

Dr. Stephanie O'Keeffe

Yes. It is not like there is a strategy document that has a whole thing in it. It is a series of documents that one would typically need if one was going out to the media. For example, one has the Q&A and the information note for health care professionals and consultants. Also part of the communications strategy would have been that the people would have had media preparation. That would be a normal part. Right across my functions, I have got policy priority programmes in relation to sexual health and child health, and I will make sure that all those people have media training.

We have issues arising in relation to preparation. Our HIV and sexual health leader will have media training. Not everybody in the organisation at a senior level - Dr. Connors, for example - will be aware of all the media training that I will do with my colleagues when there are significant issues that need to be discussed in public so as to communicate them. For this particular work, there was, as the Deputy rightly said, an acknowledgement that there was a risk in relation to the effectiveness of the programme and it was putting in place a series of mechanisms to ensure they would be prepared when that inevitably happened. The shocking, horrendous thing here is that it happened and we did not realise that the issue was going to be that the women were not informed. All of those documents were developed on the basis that women would have been informed.

I disagree. Three options were given for informing women and I will return to these. There was certainly no intention to inform the families of women who had passed away. That is explicit in the documentation we have and it was attached to their medical files. In terms of other women, the approach was to inform them of the audit if it was considered appropriate, to do so at the appropriate time, and to ascertain whether it could do more harm than good to inform them. I presume this means if it would do more harm than good to the women rather than the organisation. There were, therefore, three different strands for informing women. In my opinion, there was never an intention to inform every woman because none of the documentation I have seen suggests that was the case. I will address many of these issues to Mr. Gleeson when I make my second contribution. It is astonishing that there is a lack of communication between senior management and middle management across all the organisation and people were not informed. That is not a coincidence. It stinks.

Before we move on, when was the first draft press release produced?

Dr. Stephanie O'Keeffe

I do not know but I suspect it would have been in the period February-March and by the summer. Mr. Connaghan might have a sense of that. I imagine they were probably constantly working on it.

Will Dr. O'Keeffe obtain a copy during the break for lunch?

Dr. Stephanie O'Keeffe

Yes.

If the committee had not pursued this line of inquiry, we would not have learned that a draft press release had been prepared.

The committee should have been given the full pack of documents. The HSE provided three memorandums last week and a draft press release was ready to go, if required. If we did not know there was a draft press release - fair dues to Deputy Jonathan O'Brien for teasing out that information - we would not have been able to ask questions about it. We would have left this meeting not knowing that the HSE had a draft press release ready. The witnesses will understand our position in this matter.

Mr. John Connaghan

It occurs to me that we, in the Health Service Executive and Department of Health, probably did this to anticipate not just being able to answer the simple question with, "Here are the documents that you want", but also to be able to think smarter around that and think, "Hang about, they also need that to make their job as easy as possible." For example, the committee asked for some documentation and there might well be some associated minutes and we should have the gumption - that is a Scottish word, apparently - to be able to supply what sits around that.

Will Mr. Connaghan make arrangements to have someone get the full package of documents during the break in order that we have them in the early afternoon? We need more than just the three specific memorandums provided last week. Deputy Peter Burke will now make a ten-minute contribution, after which we will suspend for one hour for lunch.

I thank the witnesses for attending. I will focus on the contract with the laboratories and my understanding of how that contract operates. Will Mr. Gleeson take me through the safeguards or risk procedures in place in the event that one of the laboratories is found not to be performing or limitations are found? How would the organisation identify that and how it would come to light?

Mr. John Gleeson

The laboratories have to be accredited to an international standard and that has to be independently certified. It is not done by us but by the national accreditation body. That is the first thing to be able to have and maintain registration. The second thing is that they must participate in external quality assurance schemes. These schemes, which are independent, receive a number of slides, which they grade and return. The slides are scored and they pass or fail. They have to maintain pass consistently. Third, they return quarterly metrics of great detail and depth about individual screener sensitivity and individual workloads. These are all referenced to the guidelines for quality assurance in cervical screening's cytopathology section where it sets out individual screener workloads and sensitivity requirements and individual pathologist's workload requirements. There is a lot in there and this is external quality assurance. We are constantly monitoring those and if they fall out of those, then we go to work to correct it immediately.

In any basic study of statistics, if something is being described as a false negative, it is an indication of a limitation in the test. If two or more false negatives are produced for one woman and it transpires that some of the slides are perverse in terms of either the rate of cells or the high-grade cells that were present or the woman had cancer at that time, would that not ring alarm bells immediately with the screening programme? What is the probability of this happening twice to the same woman?

Mr. John Gleeson

To be fair, I am not a pathologist so some of the clinical detail-----

This is a very simple mathematical formula.

Mr. John Gleeson

I agree with the Deputy and I know what he is saying on the numbers.

I am asking for a brief outline of the statistics.

Mr. John Gleeson

There are time factors there since every one of those tests was not taken on the same day or by the same screener in the same conditions. We are, therefore, talking about a time gap.

This is a central point. We hear the term "false negatives" being thrown around but there is also incompetence, pure and simple, where a slide has not been read correctly. As Vicky Phelan stated yesterday, given that cancer was prevalent in one of her slides, one could conclude the slide was not even read. That is how concerned she was. How are we getting on top of the limitation in respect of the test, in other words, false negatives? If more than one woman has more than one false negative slide for serious, high-grade instances, I cannot get my head around how the HSE did not see red lights flashing. It is basic statistics.

Mr. John Connaghan

The Deputy is raising important and fundamental questions in relation to the screening programme, particularly on the quality and effectiveness of the provision of that service and what it means. There is a document, which we can make available to the committee, Guidelines for Quality Assurance in Cervical Screening, which I think will be useful. In terms of answering directly as much as we possibly can with the information that is available today in this committee, bearing in mind that we do not have an international expert panel to put in front of the committee, I will ask if any of my clinical colleagues, specifically Dr. Peter McKenna, might comment on that.

We do not need an international expert to tell us that false negatives have arisen for a number of different women. The laws of probability would suggest the chances of this happening are negligible or zero. I cannot get my head around that.

Dr. Peter McKenna

There are a number of elements to speak to on that and a question underlies all of them.

The question is how can we rely on a test that will miss 20% to 30% of abnormalities. The fact of the matter is it was relied on because it was the best test available. With regard to the reliability of any individual test, depending on which literature one reads, it could fail between 10% and 40% of the time. For one test that is the failure rate. The success of a programme depends not on reading one smear but on going back three years later, three years later again and three or five years later again, depending on the age of the patient. It is a cumulative safety net that goes in under the patient. I agree that one test on its own is okay, but the benefit accumulates the more tests one has.

If we look at the international literature on this, in countries that have advanced screening programmes, many cancers will develop in women who have been appropriately screened. In Sweden, for example, 25% of cancers develop in women who have been appropriately screened and in the UK that figure is higher. To develop a cancer when in a screening programme is not an unusual event.

Just to clarify, we are exclusively relying upon these laboratories. At that time, we did not do any independent checking. Once the laboratories were accredited and quality assured, that was it from the HSE's point of view. Is that correct?

Mr. John Gleeson

We do quality assurance visits. We review their annual reporting rates at committee meetings. They are under review.

I still find it difficult to reconcile in my own mind that we have individual women with a number of false negatives. If the slide is that perverse, and it was the second slide in Ms Phelan's case as was detailed, in terms of how high grade it was or even how the prevalence of cancer was missed, is Mr. Gleeson able to see a variation between the laboratories? Is he able to answer that question? Is there a variation of anomalies that would suggest one of the laboratories could potentially be an outlier?

Mr. John Gleeson

We have not seen it from the numbers.

Mr. Gleeson has not seen anything that would suggest-----

Mr. John Gleeson

I suggest that we add the clinical review to this and see whether it sees something different from us, but we have not seen it from the numbers.

In terms of the two-way exchange of information from CervicalCheck and the National Cancer Registry that was not present, was that not a fundamental basic thing one would think should happen, that they should be reconciled and anyone on the National Cancer Registry should immediately be reverted back to the CervicalCheck register to see whether they had a smear test?

Mr. John Gleeson

They were never going to reconcile in the first place, because symptomatic cancers as distinct from screen-detected cancers are different. If a woman has symptoms, she goes to her doctor and a gynaecologist and is diagnosed with cervical cancer, as distinct from screening which is for women who do not have symptoms.

When someone is diagnosed, we obviously have to revert back to see whether the woman was screened and how accurate was the screening programme. That was not evident.

Mr. John Gleeson

We put in place an agreement between ourselves and the National Cancer Registry of Ireland. It is a separate legal entity that does statutory reporting, independent of the HSE. It does not have consent to share personal information with us but we have consent to share personal information with it.

Did the HSE try?

Mr. John Gleeson

We went as far as we could with the agreement, allowing for consent and data protection legislation.

Is that not present in other programmes, such as BreastCheck or BowelScreen? I know there are different demographics, but we were told here there is a two-way exchange of information with those independent programmes. If so, how was it possible in them and not in CervicalCheck?

Mr. John Gleeson

That may well be the case.

Is it the case? "May well be" is not good enough. I want to be very clear on this.

Mr. John Gleeson

I believe the-----

I want to be very clear on this.

We have Professor Kerri Clough-Gorr from the National Cancer Registry.

Professor Kerri Clough-Gorr

The answer is that we do have two-way exchange with BreastCheck.

I ask Ms Clough-Gorr to speak to the microphone. I know she has to turn her back to the Deputy, but for it to be picked up properly she needs to speak to the microphone.

Professor Kerri Clough-Gorr

We have a two-way transfer with BreastCheck. That is correct. We have not done one with CervicalCheck. That is correct. We do no exchanging with BowelScreen.

There is no exchange with BowelScreen, but to my memory we were told that there was a two-way exchange process on that.

We were told CervicalCheck is the only one with which there is not.

That is another issue. We were told that directly by the HSE.

Who said that?

The former director general of the HSE said it. It was one of the questions I asked.

CervicalCheck was the only one. I have been chasing this for weeks, as the committee knows.

Mr. Jim Breslin

I will not quote the record because I do not have it in front of me, but I have some recollection that the point made about bowel screening was that it was too early in the programme and it has only been established. We can check that record.

How long is the programme in place?

Professor Kerri Clough-Gorr

For bowel screening?

Professor Kerri Clough-Gorr

It is better to ask someone involved.

Mr. John Gleeson

Four years.

And that is considered too early?

Dr. Tony Holohan

If I may, in terms of understanding the earliness, what we are trying to do with an audit such as this is to determine whether anything in the diagnosis of a cancer that has emerged could have been different in the context of the screening. We have to allow an interval for the screening to operate and to start looking at cancers after that interval for that question to have any relevance. It could not be possible-----

If someone is diagnosed now

Dr. Tony Holohan

If we started looking at National Cancer Registry data or any other data on incident cancers at the start of the programme, they simply could not have been impeded by screening that had not commenced. We have to allow a period of time to elapse before it becomes a meaningful question.

How long was CervicalCheck going before the audit was commenced?

Mr. John Gleeson

It started in 2010.

How long had it been established at that stage?

Mr. John Gleeson

CervicalCheck?

Mr. John Gleeson

It started on 1 September 2008.

Why was that able to go so quickly and BowelScreen was not? Another point I want answered is how come there were no data protection consent issues with exchanging information on BreastCheck.

Dr. Tony Holohan

At the point of bringing people in, the BreastCheck programme seeks the consent of those women for the passing on of that information. I understand, but there is no one here from the bowel screening programme to confirm, that the bowel programme will do that at the point of entry and intends to introduce that so the same arrangements can be made. It requires the express consent of the individual.

That is a simple issue, I imagine.

Dr. Tony Holohan

Of course it is.

When someone is going forward for a test they sign a form. It is not complicated.

Dr. Tony Holohan

That is what I am saying. They give that consent.

On bowel screening?

Dr. Tony Holohan

It has not commenced on bowel screening because the audit has not commenced. That is the reason. It intends to do it. That is exactly what I am saying.

That is not good enough.

Dr. Tony Holohan

If I may, I have just explained why the question of audit in this context is not relevant because the programme is too young.

Why did it start so quickly in CervicalCheck?

How many years was the CervicalCheck programme running before-----

I do not understand that.

It is there ten years.

Mr. Gleeson told me the audit commenced in 2010 and the programme started in 2008.

Professor Kerri Clough-Gorr

If I could just address the difference in-----

Dr. Tony Holohan

It is because of the disease intervals.

Professor Kerri Clough-Gorr

I want to address the differences in the data transfer, if I may. The difference with BreastCheck is that when the patients come in to sign to consent for their breast check, they sign a form that acknowledges that data will be transferred from them to us-----

The National Cancer Registry.

Professor Kerri Clough-Gorr

-----and-or from us to them. It is two way. That allows for the ability to take data from them, check it up against our national figures and return it. It is a two-way agreement. The CervicalCheck consent explicitly states we can get data from CervicalCheck, which we do and we use its data to speed up our registrations, but it has no provision for us to return data to it.

That is insane.

Something that Vicky Phelan's solicitor, Mr. Cian O'Carroll, said yesterday struck me in terms of people coming forward and making records available. Last Friday, he dispatched someone on advice from CervicalCheck to collect records, and the very words he used to describe what happened when the individual got there were that the person was escorted off the property. He said that here yesterday.

Mr. Damien McCallion

I will clarify that. Mr. O'Carroll spoke to me on Friday and he had an urgent request for records for a number of women who were terminally ill. I immediately agreed to release those records. He flagged that to me and I have been in contact, so I will look into that. The core point was there was some-----

Who did the marching?

Mr. Damien McCallion

I do not know. I received a text from Mr. O'Carroll on it and I will respond on that.

In terms of the issue, there were records available. We had to get some records from the laboratory and we gave those to Mr. O'Carroll. All those records were made available and the ones that were not collected on Friday were available on Friday.

Was the person in the room?

Mr. Damien McCallion

I do not know in terms of the detail of it so I will have to-----

We are only asking about disclosing a person's file on that. That speaks to a different level, from what we are hearing.

Mr. Damien McCallion

In fairness, if I might add to that. One of the things we have agreed is that we need to get a protocol in place that simply addresses that quickly and responsively for women and their legal advisers. We had a discussion on that earlier this morning to put that into place, not just for that solicitor but for other solicitors as well.

Before we conclude, is the screening programme under the national cancer control programme?

Dr. Jerome Coffey

In 2017, there was a decision to put the National Cancer Screening Service under my responsibility in the national cancer control programme. There was a two-month transition period. From 1 March, I had responsibility for the National Cancer Screening Service. In light of recent events, however, the former director general, DG, made the decision to put a full-time national director in charge of the National Cancer Screening Service from early May.

Interruptions.

If I may finish this one-----

Can the Chairman let him clarify that?

No. Just one moment. There is not a two-way exchange of information between CervicalCheck, which is part of the HSE and was part of the national cancer control programme, and the National Cancer Registry. Is that correct?

Professor Kerri Clough-Gorr

That is correct.

Mr. Gleeson said that because of that, he is not allowed have this two-way exchange of information.

Mr. John Gleeson

That is correct.

I am utterly confused at this point. I have the National Cancer Registry accounts for 2016 in front of me. The chairman of that board is Dr. Coffey, so he is telling me he cannot exchange information with himself.

Dr. Jerome Coffey

I think what Professor Clough-Gorr is saying is that there are different types of data transfer arrangements. They are not the same.

Professor Kerri Clough-Gorr

We are an independent Government-funded organisation.

The Department of Health-----

Professor Kerri Clough-Gorr

Yes.

I say this to the acting chief executive, and perhaps he will be moving on it. We have just heard that National Cancer Registry Ireland is an independently funded board under the Department of Health, but we find that the man sitting here from the HSE is the chairman of the board. Where is the independence in that?

Dr. Jerome Coffey

For the Chairman's information, I was appointed to the board at the end of May last year.

If the Secretary General of the Department of Health was setting up National Cancer Registry Ireland as an independent board of the Department, and no disrespect to him - it has nothing to do with his competence - I find it incongruous that he would put the national cancer programme director from the HSE in charge of that independent board.

Mr. Jim Breslin

The previous appointment was Dr. Susan O'Reilly. Dr. O'Reilly was in Dr. Coffey's role, which was head of the national cancer control programme within the HSE. The view that is being taken is that the relationship has to be a very good one and that for the hunting down of information the National Cancer Registry has to do in hospitals and all kinds of healthcare settings, it needs to have the support of a healthcare provider to accomplish what is a very rich dataset and one of the most renowned cancer registries. Allowing that cancer expertise and cancer service delivery to be part of the board is an important part of the cancer registry success.

Mr. Breslin has just made the case for why it should not just be another branch of the HSE. If it wants such a level of control, co-operation and exchange of information, it puts one of the HSE staff as chairman of the board.

Mr. Jim Breslin

With one complication, however, because it has been looked at. The National Cancer Registry has a total population remit, including private facilities and every kind of healthcare provider. Folding it into the HSE, therefore, would raise an issue about private providers and the release of information into the public system. It is an issue that can and has been looked at but it is not without its complications.

Chairman, can we get clarity on what in fairness was your question but we did not finish it? Dr. Coffey was answering it. Can we get the timelines and dates for when it moved from Dr. O'Keeffe to Dr. Coffey and the director it is now under?

Dr. Jerome Coffey

The decision was made in late December 2017. The transition took place over two months, with the transfer documents and due diligence process. I was responsible from-----

Who was in charge at that point, before the transfer?

Dr. Stephanie O'Keeffe

I was.

Dr. O'Keeffe was in charge until March of this year.

Dr. Stephanie O'Keeffe

Until 27 February.

It then transferred to Dr. Coffey.

Dr. Stephanie O'Keeffe

It then transferred to Dr. Coffey.

Who is Dr. O'Keeffe under now? She said there was a decision in May.

Dr. Jerome Coffey

The former director general brought in Mr. McCallion as a national director with sole responsibility for the National Cancer Screening Service and I remained in the national cancer control programme.

Mr. McCallion was also in the serious incident management team, SIMT, as of 10 May when queries started coming in about Mr. Lynch's role. He was doing that as well as this.

Mr. Damien McCallion

Yes. I was asked to step into the role, in light of the difficulties, on Thursday, 3 May.

Is there an organisational chart-----

Forget about it.

-----with names on it?

Where there are dots and where there are lines mean two totally different things as well.

Professor Kerri Clough-Gorr is the full-time executive of National Cancer Registry Ireland.

Professor Kerri Clough-Gorr

I am.

How many members of the board are linked to the HSE?

Professor Kerri Clough-Gorr

I think Dr. Coffey is the only one.

Is there remuneration for the board directors?

Professor Kerri Clough-Gorr

No.

That is good. That is helpful. I understand. I was getting concerned that there was a grant. Am I right in saying that the other directors of National Cancer Registry Ireland are independent of the HSE?

Professor Kerri Clough-Gorr

Yes.

It is helpful to know that at least because I was getting concerned that, on the one hand, there was a hand-in-glove operation when, on the one hand, the witnesses were telling me it was independent. I can see there is a commonality or whatever one would like to call it but it is not complete.

At this stage I will suspend for one hour to allow for a break. We will be back at 2.30 p.m.

Sitting suspended at 1.27 p.m. and resumed at 2.30 p.m.

We will resume our discussion but before doing so, Deputy Alan Kelly wishes to share some information with the committee.

On a point of information, the committee was sent some documentation on communications. but at lunchtime I was sent a pile of documentation, with a chronology of events. I will read it to the committee. It is headed "CervicalCheck chronology of events from UL hospitals and associated correspondence". Obviously, CervicalCheck was following proceedings here and has provided full appendices for all backed up documentation which I have shared with the committee. Obviously, I would like to have an opportunity to ask some questions about the documentation. I note that Mr. Woods has left, which is a pity.

I did not know that he was required.

Indeed. The Chairman did not know that this information was coming to us today. All of it has been shared with members of the committee. I only received it at lunchtime.

Have the witnesses seen the documentation?

I got it half an hour ago.

We will arrange for copies of it to be provided. It is correspondence that I have not seen yet.

It is obvious that the clinical lead in the hospital decided to send this on for clarity, given what has transpired here. That person wanted this to be made clear. I believe he or she did the right thing.

We will try to have copies of that documentation circulated.

Copies should be provided to everyone, to save them from printing it.

We will have copies circulated because people have not had the opportunity to print them. We will proceed in the meantime

Following on from what was discussed before the lunch break, I want to focus on the auditing process and the genesis of CervicalCheck as a programme We received screening data from the labs at both committees which refers to the period 2013 to 2016. The lab data we were given is from that time, but the audit precedes that time. Is there any reason we have not been given the lab data for the time of the audit? Can we have it please? My initial observations of the data suggest that they are quite chaotic. That might not be relevant, in light of some of the questions that were asked earlier. I want to point out that yesterday, at the Committee on Health, I asked Dr. Stephanie O'Keeffe to produce the audit methodology paper that was used. We still have not received it. It was mentioned yesterday.

Dr. Stephanie O'Keeffe

Yesterday, at the latter part of the meeting when the Deputy was gone, I mentioned that it was actually among the papers provided for that meeting. It was already there. The Deputy may not have had an opportunity to see it.

Okay, I missed that.

Dr. Stephanie O'Keeffe

I made a note and probably should have contacted the Deputy afterwards. It was among yesterday's papers.

I will have to get through it at some point. Does the witness have any answers as to why the data we received was unrelated to the time of the audit? Why was that decided? Who decided on that? I need a quick answer; I do not want to waste time.

Mr. Damien McCallion

We will have to check that for the Deputy. I cannot tell her why that is the case.

It seems strange. Dr. McKenna spoke earlier about the rate of false negatives in testing ranging between 10% and 40% in the international literature. Deputy Catherine Murphy asked earlier if there were any other issues that might explain why such discrepancies exist. When the witnesses were getting the audit data back from external labs was it delivered in one tranche or was it broken down per lab? Was it looked at on an individual lab basis? Yes or no will suffice as an answer.

Mr. John Gleeson

It is done on a case by case basis. A cervical cancer diagnosis is notified to us and that triggers a review. We do not know which lab is involved until the review is carried out and the lab is identified. There is no recognisable pattern for the first-----

The trigger is a cancer diagnosis, and then a review is initiated. Did the witness ever produce a spreadsheet naming the case and attaching it to the relevant laboratory? When the review was carried out, and person A's slide was taken out from laboratory X, was a chart ever produced with the concerning result versus laboratory?

Mr. John Gleeson

Yes, we looked at those figures.

Did the witness find out anything?

Mr. John Gleeson

No. We did not identify any patterns associated with any particular laboratories, which is the first job of a cancer audit.

Is it the case that one laboratory can be at 90% and another at 50%, and the average then would be 70%?

Mr. John Gleeson

We were not trying to do that.

The witness was not trying.

Mr. John Gleeson

We were looking at the number of cases per lab, the number of tests each had carried out and the number of tests that had been reported negative. We were not trying to average it out across laboratories.

The witness was aware of the actual false negatives on a per-lab basis.

Mr. John Gleeson

False negatives are also known as undercalls. There are low-grade undercalls and high-grade undercalls. Low-grade undercalls can be shifted to high-grade later.

We heard from the witnesses yesterday about the types of false negatives. Was the witness looking just at false negatives or at the types of false negatives? I understand that this is a screening process, but in the case of Vicky Phelan the retrospective slide had very clear evidence of cancer. Did the witness quantify the type of false negative, or the degree of the miss?

Mr. John Gleeson

Ms Phelan's slide did not show evidence of cancer. It showed high-grade abnormal cells, which would have indicated that a biopsy be carried out to confirm diagnosis.

That is irrelevant to my point.

Mr. John Gleeson

We did grade them. We looked at the change of grade. Some changed by one grade, and-----

If a set of eyes is looking at two smears there might be a false negative because of an interpretation error. However, the discrepancy on Vicky Phelan's false negative smear was almost impossible to miss. Was that degree of miss looked at?

Mr. John Gleeson

Yes, we characterised the degree of miss.

Does the witness have anything to show us in that regard?

Mr. John Gleeson

There were not enough similar results, in all of the tests that have been done, that would allow us to say that an individual, a laboratory or a pathologist was making consistent errors among the thousands of tests that were processed.

We heard evidence yesterday that in 2008 we had the highest rate of cervical cancer. Our slides were sent to another population group - the United States - where the parameters for testing are totally different and where those with private health insurance get smears. Was this looked at before this project began? Was epidemiological or population data looked at? It may be the case that there is a baseline difference and a population difference at the start. Were the differences looked at?

Mr. John Gleeson

The approach was that the laboratory had to be accredited. Furthermore, it was stipulated in the contract that the laboratory had to comply with the same quality assurance standards for cervical screening that cytopathologists would apply to laboratories. This had to apply regardless of location.

Does the witness believe there is no problem with that? If the populations are totally different might that lead to operator error? The baseline is different in different countries.

Mr. John Gleeson

The person looking at the slides is looking for abnormal cells.

If a person is looking at two sets of slides, one from Ireland, done every three years, and one from the States, done every year, is there a greater possibility of operator error?

Mr. John Gleeson

The person is looking at a slide in front of him or her, and whether the woman had a test last year or had a test three years ago is irrelevant. It does not matter if there was a test a year ago or three years ago. There is one slide in front of the person, and his or her job-----

I am talking about the slide that a person was looking at a second or a minute before. In the process of a person looking at slides-----

Dr. Peter McKenna

The American College of Gynaecologists recommends three-yearly smears in the US. Whether women have them more often or not is a matter between them and their private gynaecologist, but the recommendation is that they have smears three-yearly or five-yearly. That is very similar to the recommendations we have in Ireland.

When a person was diagnosed with cancer, triggering an audit, who audited the slides?

Was it the same lab? Was it a slide on a shelf or was it photographs of a microscopic image of a slide? Was it looked at by the same company? Was the review of the slide done by the same company that originally read the slide?

Mr. John Gleeson

It follows the procedure. The original reporting laboratory is asked to retrieve the slide from the archive, take it out, put a team on it -----

Mr. John Gleeson

----- its team first, review the slide and determine what the team sees. If they see more than two grade changes of difference that is it, and it is reported to us. They have said it. If they say it is still the same as the original interpretation, then it is sent to an external laboratory to see if that can be confirmed or otherwise. If there is a difference of opinion, it goes to a second external laboratory to seek the final interpretation on review of that slide, compared with the original.

They were policing or auditing themselves.

Mr. John Gleeson

They are required by contract to do it and report the outcome to us. If they do not see a difference we will go to an external laboratory. If they do, and it is a significant difference, there is no need to go to an external laboratory because they have told us.

Earlier, Dr. O'Keeffe said that she had seen slides in response to the audit findings. Does she recall this? It was when someone asked who had invited her -----

Dr. Stephanie O'Keeffe

Yes.

She said that the feelings that she had was that there were no systemic errors arising from the audit and that the CervicalCheck information could be informed to the patient. Does Dr. O'Keeffe base her clinical judgement on feelings or science?

Dr. Stephanie O'Keeffe

There are two responses to that. For clarity, I am not a clinical doctor; I am a social psychologist.

Dr. O'Keeffe is not a medical doctor, she is a doctor of psychology.

Dr. Stephanie O'Keeffe

Yes.

And Dr. O'Keeffe is in charge of health and well-being in the HSE.

Dr. Stephanie O'Keeffe

Yes, the division of health and well-being. It was not that I made that determination myself. In the March memo and in the February memo, it is stated that there are no systemic issues of concern as a result of the audit findings.

I have read the memo. However, Dr. O'Keeffe speaking here this morning in her role as head of health and well-being in the HSE, and her being a clinical psychologist with a PhD, referred to her feelings. She did say that here.

Dr. Stephanie O'Keeffe

I did and I will explain why. First, I want to clarify that judgment was not just based on a feeling but on the actual formal findings of this audit process. The reason I said "feelings", is because the meeting and the presentation happened quite some time ago. Very often one does not remember precisely what was said but one recalls how one felt. I remember feeling a sense of concern as to whether they were telling me that there could be some issue that they found as a result of the audits they had done and that there were quite so many. Within that, I was assured that the results were sound, as Mr. Connaghan and some of my colleagues have answered, and there was nothing within the data within the audit that suggested there was any systemic issue of concern within those findings. I also had a feeling, as I mentioned earlier, about listening about the lady who had cancer and who Professor Flannelly was going to meet. I remember the feeling of that conversation about what that must be like.

On those feelings that Dr. O'Keeffe had during that period, I note that I met Dr. O'Keeffe at the health committee yesterday, where she said that nobody told her that there was an issue in failure regarding the closing out of the audit process. Yesterday, Dr. O'Keeffe did not indicate that she had any feelings about concerns. Yesterday, she gave me the impression that from all the evidence she had seen or that had been given to her, there was no reason for alarm. I questioned her yesterday as to whether she thought it might be all going a bit too well. I asked did she not think at some point that it was going a bit well, the doctors were grand about telling the patients and everyone seems happy. Dr. O'Keeffe never seemed to question that. She did say that at the committee yesterday.

Dr. Stephanie O'Keeffe

That is correct. Up until the memo of October 2016, it is clear from both the briefings that are there and what would have been articulated by the programme, that the process was progressing well. We had dealt with the legal challenge from Quest Diagnostics, it was possible to restart sending the letters and the words were incredibly reassuring in respect of what those concerned were doing in reaching out to consultants.

Had Dr. O'Keeffe's feelings of concern had dissipated at that point?

Dr. Stephanie O'Keeffe

Once I was aware in February that there were no systemic issues, that concern was gone. There were no further concerns after the February meeting with regard to the actual findings of the audit. There was a concern that the threat from Quest Diagnostics could pause us sending those letters, there was a concern that the dispute resolution process that it wanted to invoke could further delay the process of sending the letters to the consulting clinicians which would go on to patients. That was resolved within three months so that concern was over. The final thing from my perspective, which had been escalated to me for me to support in addressing, was to ensure that the historical letters that they had, of which the vast majority were sent over a two-month period in 2016, were actually sent. The programme assured me then, and the evidence demonstrates that the programme did this, that as new cases were coming in and as the audit findings were being produced, that it would continue to send letters on an ongoing basis, on a scale of about four to six per month. In October, it was clear to me - and I briefed those who I needed to brief accordingly - that this process was going quite well.

I was not asked about my feelings after that particular period, effectively 2016. What I said yesterday was that in 2017, it was not brought to my attention that there was a breakdown in that process with regard to consultants having a difficulty relaying that information to patients. That is a matter of fact. It was not brought to my attention.

Who should have done that? Who does Dr. O'Keeffe think should have escalated that?

Dr. Stephanie O'Keeffe

It should have been through the governance management. It should have been escalated through the National Screening Service.

Can Dr. O'Keeffe give us the title? It is very hard to follow on the chart with the dots and the lines.

Dr. Stephanie O'Keeffe

The health and well-being division has several services. It has a €230 million budget-----

I am not asking that. Who should have -----

Dr. Stephanie O'Keeffe

It says right underneath that it is the assistant national director of the National Screening Service. That is where the information should have come through. I can see from the evidence before members that there was correspondence during 2017 that formally relayed that there was a concern with regard to consultants relaying that information to their patients and that was not escalated to me. Therefore I was not aware of it and could not help resolve it.

This is the Deputy's final question. She can get another opportunity.

I just want to say that in the world of science, we like to separate fact and feelings.

Dr. Stephanie O'Keeffe

I think that feelings are exceptionally important in this work especially in what we are talking about right now.

Maybe if feelings are so important we should have used them when we were trying how to decide on dealing with telling patients. Feelings might have really come to the fore if we were putting patients at the centre of this, not data.

Earlier, Dr. O'Keeffe referred to her role in the HPV vaccine programme. I refer to any elected Deputy in this House who, through their reckless and irresponsible contributions, has previously contributed to the downward trend in the uptake of the HPV vaccine. Dr. O'Keeffe quoted figures earlier, I thought that the rates were 87% down to 51% and now we are back up to 62%, but maybe I am wrong. As a direct result of people in these Houses making reckless, ill-informed commentary on the HPV vaccine -----

Including Ministers in the Department of Health.

----- including many people, women will die in future. It is worth mentioning that today. Many people are talking out of multiple sides of whatever orifice one might say they have been talking from.

Deputy Shane Cassells is next. We are now on ten-minute slots and we will then start with the first round of speakers from earlier this morning.

I welcome the witnesses. I will start with the opening statements at the beginning of today's meeting and the reflection on the testimony from yesterday evening. I am conscious that the opening statements obviously were updated last night to take account of the testimony heard then. Given that, and that the testimony was from the people who were affected, I want to dwell on it. They are not just some newspaper headline from this morning and then we shuffle on.

Mr. Breslin says on page 4 of his statement "we are seeking to achieve a health service where the relationship with patients is open, honest, listening and supportive". They are all good buzz words, but according to Stephen Teap the culture is to "protect and deny". If Mr. Breslin's opening words were that he had the privilege of hearing the words of Stephen Teap and Vicky Phelan, their closing remarks, especially when he heard Mr. Teap say the culture was to protect and to deny, obviously resonated with him. There should be no false platitudes for the people who appeared before the committee last night. Mr. Breslin cannot on the one hand agree with some of their words and on the other hand disagree with others. Does he accept that there is an endemic culture to protect and to deny?

Mr. Jim Breslin

I absolutely accept that we as a health service have fallen down tragically-----

I am using Mr. Teap's words. I am not making this a charged environment. We had a key witness who lost his wife and was directly impacted. He chose his words very carefully and said the culture was to protect the system and to deny. I ask, with no false platitudes for that man, whether Mr. Breslin accepts his words last night, not that there was a falling down but that there was a culture to protect and to deny?

Mr. Jim Breslin

I absolutely accept his perspective on this. It is a very honest perspective. If I had lived through what he has lived through I could not see that I would not conclude in any other way, given how unacceptably he has been dealt with and how his late wife was dealt with. I fully accept-----

I do not want Mr. Breslin to empathise with him, but to answer either "Yes" or "No". Does he accept the accuracy of Mr. Teap's words? I am not asking if Mr. Breslin has empathy with him, that he would feel the same way, but if he accepts what he has said, "Yes" or "No".

Mr. Jim Breslin

The issue for all of us in reaching a conclusion on that is to do it independently and to have Dr. Scally understand exactly where this went wrong and the extent to which it goes as far as Mr. Teap has said it does. I acknowledge in my opening statement that we are not there in terms of an open culture. I recognise that. Dr. Scally will look at that in detail and will give us the perspective that somebody who is expert and independent can give.

I always say that witnesses' choice of language here is very important . There is a difference between not having an open culture and having a culture that seeks to protect and deny. It is a nuanced difference. Mr. Breslin says there is not a culture of openness. That is different from accepting that there is a culture of denying truth coming to the surface. If he is able to accept that there is not a culture of openness, is he able to accept that there is equally a culture that tries to suppress information coming to light?

Mr. Jim Breslin

I do not think it would be-----

Mr. Breslin is the head man, so I am asking about his sense of the organisation he controls, not just at managerial level but throughout it. We know from being in political parties that leadership comes from the top and that is reflective of the people and troops on the ground. If Mr. Breslin, as Accounting Officer, can accept that there is not a culture of openness in his organisation, can he, analysing from the here and now and not from an independent perspective but from his perspective as head of the organisation, accept there is one that seeks to suppress information and ensure it does not come to light because people are trying to protect, as Stephen Teap said? One wonders what they are trying to protect.

Mr. Jim Breslin

It would be wrong if, due to the way the Deputy is putting his question-----

I am putting it fairly straight.

Mr. Jim Breslin

Can I finish?

Yes, that is no problem.

Mr. Jim Breslin

It would be very wrong for me to seek to come down on a side where the Deputy would then say that I am opposite to that of a man who has lived through what he has lived through. I am listening to his perspective 100% and seeking to learn from the experience he and others have gone through. That is where I-----

I am not asking Mr. Breslin to come down against a man who has suffered a bereavement; I am asking him to analyse Mr. Teap's words very distinctly. Mr. Teap said there was a culture of protect and deny. I am sure he would say that he would prefer the truth here today, rather than Mr. Breslin trying to protect his feelings. Mr. Breslin should not use the shield of saying that he will not come down against a man who suffered a bereavement. Mr. Teap would far prefer if Mr. Breslin were honest. Mr. Breslin is the head man and he said there is not a culture of openness in his organisation. The follow-up question to that is: does he have a sense, a feeling or whatever he wishes to call it that there is a culture of trying to suppress information? It is something that frustrates many people here. What is his analysis of that?

Mr. Jim Breslin

I understand exactly what he said. However, within the Department of Health, I see lots of evidence that we are open. I have to live with both of those realities. Mr. Teap's reality is an absolutely tragic and harsh one which we have to avoid in the future. The way to do that is by becoming more open.

In his opening remarks, Mr. Breslin spoke of the brave testimony. This galls me. There is no point in coming here to talk about brave testimony if one is not going to give substance to what is being discussed. He referred to how this raised "profound questions". They are not just questions but profound questions. If these questions are so profound can I ask Dr. Holohan, when he reflects on the memorandums from 2016, why the profoundness of the issue did not jump off the page at that stage? Can Mr. Breslin say why the profoundness did not jump off the page to whatever Department of Health official reviewed it at the time? Has Mr. Breslin sought out or spoken to that person?

Mr. Jim Breslin

In my opening statement and early in the meeting I sought to distinguish two things, and the more they are interwoven the more difficult it is to understand what has arisen. The memorandums in 2016 refer to a clinical audit that was to be communicated to women. What we are now dealing with is the widespread non-communication of that information. The Department was not aware of that. The HSE has confirmed that the Department was not aware of it.

I thought Mr. Breslin said earlier that there was somebody in the Department who would have had sight of that.

Mr. Jim Breslin

To repeat, the 2016 memorandums were summarising the position, which was that CervicalCheck had a clinical audit which it wished to communicate to the women. It was setting about doing that. That is what we had in 2016. That is not what we have today.

Will Dr. Holohan respond on the profoundness of the situation?

Dr. Tony Holohan

Our understanding of the memorandums is exactly as the understanding of their intention was - that these were confirmation of an organisation seeking to disclose information to women and making preparations to do that. We had a series of meetings in which we had this information available to us. We were able to track and assure ourselves that preparations were not only continuing but proceeding and progressing to a conclusion in the late summer with those letters issuing. That gave us assurance that two things were happening in our screening programme, namely, the introduction of clinical audit and feeding those findings back to the patients concerned. That would put us towards the fore in international practice in this area. We had confirmation that was happening. What the Secretary General and I are saying is that what has come to light is that in 2016, in fact, that information was not being disclosed. That fact did not become known to us until the end of April.

I find the language used amazing. The witness referred to a memorandum seeking to disclose, yet this is a memorandum that used language referring to preparing reactive communications for media headlines that "screening did not diagnose my cancer". Yesterday that headline manifested itself in the flesh and blood of Vicky Phelan when she appeared before the committee. She was not screaming. She calmly put her position that screening did not diagnose her cancer.

In many of their opening contributions, members of the committee prefaced their remarks by stating how angry they were coming to the meeting this morning. I am willing to bet that their anger is not just the result of this hearing but of cumulative hearings with the HSE and the Department of Health in which we have dealt with issues such as the Grace case, and the former director general appeared before the committee to deal with that, and how a communication problem exists. It is an ongoing thing. It is not just this case. In my two years in the Oireachtas I have never encountered another section of Government that finds communicating so difficult. Mr. Breslin stated that the women who have gone public have drawn attention to their experience in the hope of change. He probably also heard Vicky Phelan say in her concluding remarks last night that in the past few weeks, they have not seen evidence that there is a culture that indicates a willingness to change.

In fact, she said she would not have been here, that she would have been at home with her two kids, if she thought there was a willingness to change. Again, I go back to the fact that the witnesses are saying these people's evidence is being very brave, but they came before the committee last night and said they do not believe the HSE and they do not see that willingness. There is therefore obviously some disconnect. I keep going back to the people impacted because they, not any of us, are the people living with this. There are people within a management structure who have the self-awareness that people should be notified or, more worryingly, the self-awareness that people should not be notified. How is the HSE going to assuage people's fears that there is no willingness to change? The people here last night did not see such a willingness.

Mr. Jim Breslin

I understand why they do not believe. I would not it if I were them. I would not believe words said in a committee room if I were them. I would only believe it when I saw it. We all absolutely understand the challenges we have in turning around the health service such that a situation is created whereby people's experience when things go right is much better and, when things go wrong, is equally empathetic, sympathetic and caring. We have a huge amount of work to do. It is not one individual who has to do that work. As a nation we have a huge amount of work to do. That is why I am in the job I am in, that is why I continue in the job I am in and that is why I will not be happy until I have given it everything I can.

I appreciate that it is not one person who must do the work. Obviously, that ultimately comes down to leadership. I refer to the previous director general of the HSE and the culture I spoke about. That culture does not just emanate out of thin air; there had to be some kind of analysis from the HSE's point of view and the Minister's point of view as to why this lead to a case of suppression of information. May I ask-----

This is the last question. The Deputy will have an opportunity to come back in again.

I refer to questioning earlier from Deputy Cullinane. When asked about the process of informing patients and how the 200 letters were issued by CervicalCheck to consultants - and Deputy Cullinane asked about women who had CervicalCheck tests specifically - I think the answer was zero, but Dr. O'Keeffe interjected and said that was not the case because some women had reached out to CervicalCheck and, by virtue of that, had had engagement. However, this goes to the root of the problem. It was a reverse process. They had to reach out. There was no one picking up the phone to them, and it was disingenuous to say there had been contact. Dr. O'Keeffe herself said they had to reach out. This goes back even to the whole point of the process in which we are involved now, people who are afraid, queuing to access a helpline and waiting God knows how long to get a response. Would Dr. O'Keeffe accept that?

Dr. Stephanie O'Keeffe

There are probably two things to say about that. I was reflecting on both the March memo and the October memo, at the end of page 2 of which it is stated to me that there is a legal case proceeding at that particular time and "In addition, four letters from legal representatives of women seeking copies of all medical records have been received." It is clear, by the way, across all these memos that CervicalCheck has always furnished women with their medical records whenever they have requested them. The memo goes on to say:

Two of these requests relate to women recently diagnosed, with the programme only having just initiated the cancer audit process in these cases. Two women have directly enquired informally about their diagnosis and have been informed of the cancer audit process and that any review findings will be communicated to their consultant doctors.

Therefore, to answer the initial part of the Deputy's question, it is clear that the clinical director of CervicalCheck did reach out and directly talk to women, so the answer there is not a zero.

To respond to the other part of the Deputy's question regarding the methodology that CervicalCheck chose at the time, it had these audit findings. It stated in February that these audit findings could provide information to women as to why their cancers were not prevented and information on the effectiveness and limitations of screening. In March they said to me that the gist of the situation is that the programme has information on the woman's screening history that may be of benefit to her and which they believe should be disclosed. In April, they said this represented six and a half years of screening and that the process which had been evolving then clearly underscored the need to offer women an opportunity to learn about the audit and to choose to know the result. The July information for healthcare professionals that all members have been furnished with says this. I know there are queries about the letters and I would love to be able to get to those questions, but the information note to healthcare professionals states:

Where the review outcome suggests that the abnormality was not detected on a cytology or histology test or that, under treatment, a colposcopy might have been a factor, at the appropriate time, please inform the woman that a cervical cancer audit process exists, that her history has been reviewed and that she can be informed of the outcome if she so wishes.

There are two things here. There is how CervicalCheck actually went about that process and whether it was the right process. The view at the time was that the consulting clinician was the person who was best placed to be able to give that information to the woman. We might have some questions about that and the processes and procedures CervicalCheck put around it. The abject failure here, which is the tragedy we are all observing and what we are hearing, is that it did not effectively happen in the end. Not all of the consultants heeded that particular advice - some of them did, but the vast majority did not - and told the woman that a review had been done of her case and gave her the opportunity, if she so wished, to learn about the outcomes of the review. That did not happen, and that is the awful thing we face right now because the reality is that cervical cancer is a reality in all our lives. No screening programme in the world can stop all cervical cancer cases from happening, and the awful thing is that if we continue with our screening programme, we will have more stories in time about women whose cancers were not prevented by cervical screening. That is a tragedy and a travesty. We can try to improve it with HPV testing, but it is a reality. The thing going forward is that what the CervicalCheck programme intended to happen needs to happen.

Very finally-----

Finally.

-----following on from Dr. Holohan's appearance at yesterday's health committee meeting, he said in his statement that it was fair and reasonable not to tell women about incorrect smear tests in 2016. One Minister has now backed calls for Dr. Holohan to resign, saying his position is untenable. Stephen Teap said yesterday people needed to be removed while inquiries take place. Given the magnitude and the seriousness of Ministers making such statements, has Dr. Holohan reflected on his position?

Dr. Tony Holohan

What the Deputy has said about what I said yesterday is incorrect. I did not say that yesterday. I said it was fair and reasonable not to escalate the fact of knowledge of a clinical audit and plans to disclose to patients. That is what was known in 2016. It was fair and reasonable not to escalate that to the Minister because it was something in the category of potential. What has come to light in recent weeks, which the Deputy is conflate with this, is the fact that that information was not disclosed. It was not fair and reasonable not to disclose that information. That is not my view, it never was my view, and I never said what the Deputy said.

What about the Government Minister making that statement in respect of-----

Dr. Tony Holohan

I have no knowledge of that and I have no comment to make on it. May I make a more general observation?

Yes, just one final observation.

Dr. Tony Holohan

Deputy Cassells has raised an important point regarding patient involvement. I do not intend, through this committee, to speak directly to patients. I will find a means of making direct contact with the patients concerned because that is what we do. We have been engaged in a number of situations like this before whereby in tragic situations we find ourselves in contact with patients who have been bereaved. An obvious example is Portlaoise hospital, where I myself led an investigation which uncovered in the baby deaths the fact that it involved not just open disclosure, but deliberate concealment and lies were told. We wrote that in the report and we have continued to engage with patients from there and from a variety of other areas. We had two of the bereaved mothers as part of the maternity strategy, which is approved by Government, we have had patient involvement in our cancer strategy, and it has overhauled completely the attitude of our cancer services. We have a patient experience survey. It is happening for the second time this month throughout our hospital system, and we are one of the few countries in the world in this regard. We have patient safety statements now which require each hospital, for maternity services first and now for hospital services generally, to publish information about safety each month in order that people can see this and to create transparency and visibility. We have built in the Department of Health a national patient safety office. The then Minister for Health, Deputy Varadkar, brought those proposals to Cabinet in late 2015 to give what we call a patient safety surveillance function. One of the things we uncovered as part of the work we have done in recent years is that different parts of our system knew difference pieces of information about safety and we did not join up that information to create a common understanding. The work we are doing seeks to do that.

However, I absolutely accept that that is not enough to respond to any of the harms and bereavements that have occurred for some of the patients about whom the Deputy has spoken. It will all be cold comfort to them. Culture change is difficult, but our experience is that working with patients in these situations - and working with them directly, as opposed to through the media - is the best means of ensuring their objective, which is to have their terrible experiences fully and directly inform the work we do.

Sending the information through the media is half the problem.

Dr. Tony Holohan

We are absolutely prepared to engaged with them. These are not empty words in terms of our commitment to ensure-----

As Mr. Breslin said, the proof will be in the pudding, not in statements.

Dr. Tony Holohan

We will be happy to account for it.

We are back to the starting sequence of Deputies David Cullinane, Alan Kelly, Catherine Murphy, Marc MacSharry and Jonathan O'Brien. We are into strict ten-minute slots and if someone wants to come back in again, that is fine.

Because of the time limit, I will be very direct and expect direct responses.

The difficulty with some of what Dr. O'Keeffe said earlier is that it chimes with what is in the draft press statement we received today. Essentially, it is part of a communications strategy to divert attention away from the real problem. All we hear from her and others in that regard is that screening is not 100% accurate. Everybody in this room accepts that and that is not the issue. The issue is that women were not informed when CervicalCheck was informed of wrong smear test results. They were not given information that they should have been given. Dr. O'Keeffe knows that this is this issue, as I do. She has raised the two cases in which people did contact CervicalCheck about their smear test results and were not given information directly. They were told that the information would be given to their consultants. The consultants were given the responsibility of deciding whether they should tell the patients. We know that some did and that some did not. The facts are that no woman received information directly from CervicalCheck and that that was a failing on the part of the programme.

I want to put a question to Mr. Connaghan. We found out last week that there had been three memos in March and July 2016 that had been shared with individuals in the HSE and the Department. They eventually reached the director general of the HSE, Mr. Tony O'Brien. All three were given to him. Is that correct?

Mr. John Connaghan

Yes. The original three were given to Mr. Tony O'Brien.

Why were they given to him?

Dr. Stephanie O'Keeffe

They were given to the director general to brief and inform him of what was happening in the clinical audit.

Why brief and inform him?

Dr. Stephanie O'Keeffe

I briefed and informed him because I considered the issue to be important and-----

Why did Dr. O'Keeffe consider it to be important enough to brief and inform the director general?

Dr. Stephanie O'Keeffe

I considered it to be important enough to go to the director general because clearly we were going to be giving very important information to patients through consulting clinicians that would result in their having full access to their files. They were to be willingly provided with access to their files, which would provide them with an opportunity to seek redress, if they so wished. Internationally, the programme would have advised me that very often-----

It was important enough to go to the director general's office. That was the judgment call Dr. O'Keeffe made.

Dr. Stephanie O'Keeffe

Yes.

The same information was given to the Department. There was a Tracey Conroy. Is she in the room? Is she still within the organisation? She was one of two individuals given copies of the email. Dr. Holohan was one of the two individuals in the Department who received the same information, but, unlike Dr. O'Keeffe, he did not give it to his line manager, Mr. Breslin. Did Dr. Holohan not see it in the same light as Dr. O'Keeffe? Was it not important enough for Mr. Breslin to have the information?

Dr. Tony Holohan

I did not.

Was that a failing on Dr. Holohan's part?

Dr. Tony Holohan

No, it was not a failing on my part. If the Deputy will allow me to explain-----

It was a failing on Dr. Holohan's part.

Dr. Tony Holohan

That is the Deputy's judgment.

It is more than my judgment. I am not the only person who would say it. We had one of the Ministers responding to questions yesterday put during Leaders' Questions and saying Ministers had been kept in the dark, that if they had had information, they could have taken different decisions. There was a block in the Department of Health and the information was not relayed. Dr. Holohan took it upon himself not to give the information to the relevant people, even though it would have been obvious to anybody in his job that it was relevant and should be given to the senior people in the Department. For some reason, he did not do it and he has not given us any credible reason. Here is his chance.

Dr. Tony Holohan

It was a judgment. I said yesterday and say again today that I think it was a fair and reasonable judgment. It was made based on circumstances at the time. We did not have information of the kind that has now come out. It was information that was confirming to me that our screening programme was making enhancements and improving-----

I will stop Dr. Holohan there.

Dr. Tony Holohan

I am sorry, but the Deputy has not allowed me to give him the explanation.

Let the witness finish answering the question. I will give the Deputy an opportunity.

He is talking about one memo. In order that we are fair, we are talking about three memos and seven meetings at which this issue was discussed. We know all of the information on informing women and the communications strategy. This is the entire package, of which Dr. Holohan was aware and at no point, not in one memo but in the entire history, did he ever give the information to Mr. Breslin or the Minister for Health. That is the point I am making.

Dr. Tony Holohan

I understand. I am going to describe my understanding of the entire history and then why I felt it was a fair and reasonable judgment not to escalate any concern in respect of it. My entire understanding was an organisation was making plans and preparations to disclose information to women, which was good by international and national standards. It was preparing to do so and was awake and alive to the potential risks in doing so, problem-solving and tracking the numbers and reporting to us in the context of regular meetings we had in different fora. Each time we met to consider a range of issues to do with cancer and then a range of issues to do with health and well-being we received an update. The updates were continuing to assure us that it was progressing. That is what I understood it to mean. I understood it in the context of a population-based programme, what the value of all of this would be and what preparations would need to be made by the screening service to ensure it went well. We now know that it did not, but we did not have that information at the time.

On 31 March-----

Dr. Tony Holohan

That is my understanding. Will the Deputy now let me explain why I did not believe it should be escalated? When we look at the escalation of issues broadly related to patient safety, there are categories that we use. The top category and the most significant involves a situation where we have information on a service which is still open and into which patients are still going and which is not safe. That is the most significant issue that might require an intervention and there have been such examples. The next most significant involves a situation where something comes to light and where we know that patients have been through a service, harm has occurred, they have been exposed in some way to something and a lookback needs to be conducted in order that those patients can be identified and some service offered to them to try to remediate what has happened. The next level would be where something else has happened, but it is an individual case in which we do not believe there are wider risks to the public. However, the merits of the case are also something that consider by way of escalation. In the particular case we had potential for something to become a matter of reporting. That potential could be realised at any point over a period of time. If I were to say to the Minister, frankly, that we were giving him warning of a potentia casel in March of 2016 and something were to happen six months later, I do not think he would able to rely on it - I would have to let him know at the point at which in order that there would be readiness and-----

I think I have a fair gist of Dr. Holohan's response.

Dr. Holohan should finish his last sentence.

Dr. Tony Holohan

The point I make is that-----

I have a lot of questions to ask.

I know, but in fairness to the witness, serious allegations have put been put to him that a Minister said he should resign. The allegations have been put to him at this meeting and he is entitled to respond to such a comment.

He is not responding to that comment.

Dr. Tony Holohan

The Secretary General made it clear earlier that if I was to relay to a Minister all of the things that I know that have happened and also all of the things that have the potential to happen simply to demonstrate after the fact that I had told the Minister, I would not be doing my job. My job is to manage things and make judgments for which I am happy to account. Therefore, I say I have no problem with and welcome the accountability that will be brought by the Scally process. I am very happy to answer for all of the judgments I have made. I am very happy to take any learning that will come from it, either for me or the Department and apply it.

Dr. Holohan has a lot to say, but, unfortunately, in my view, he did not say the right thing or do the right thing at the time. That is my judgment and view. He gave his view.

Dr. Tony Holohan

I respect the Deputy's view.

I must point out that when a member of the committee makes a statement on his view in respect of witness X, Y and Z, that is the view of the individual member, not the collective view of the Committee of Public Accounts. The committee has not made any such decision. Members have their opinions and are entitled to them. Witnesses must not go away thinking something is the collective view of the committee just because one person says it. It is a personal view.

I made it very clear to you and Dr. Holohan that that was my opinion. I am trying to separate emotion from my role, which is to put questions. That is what I have done and will continue to do.

I remind Dr. Holohan that on 29 June in a Q & A document which the Chairman will also have seen, it is stated that in 317 cases flagged for review there might have been an opportunity for earlier intervention. They included incidences of pre-cancerous cell changes that had not been detected and a delay in diagnosis and treatment. I can tell Dr. Holohan that if I saw that, it would be serious enough for me to move it up the chain.

I will move on to my next set of questions.

Who wrote the circular that was given to the hospital consultants? I know that it came from the office of the national director of strategic projects and transformation, but who wrote the circular to consultants saying that they had discretion?

Dr. Stephanie O'Keeffe

It was a circular from the CervicalCheck programme.

Which individuals wrote it?

Dr. Stephanie O'Keeffe

I imagine that Professor Gráinne Flannelly wrote it with the programme manager, Mr. John Gleeson.

Did Mr. Gleeson have a role in writing that circular?

Mr. John Gleeson

Yes.

Mr. Gleeson knew that, when he was writing it, discretion would be given to consultants to inform the women.

Mr. John Gleeson

I wrote it in the context of the HSE's open disclosure policy, with which I am required to comply and in which a specific clause states that clinical judgment can be exercised. We were not in a position to override a doctor's clinical judgment and tell him or her to do anything. We told doctors to comply with the policy. That is what the wording meant. We were not trying to give them a way out. We were just trying to be consistent with the overall policy.

I am certainly not going to give Mr. Gleeson or anyone else a way out. Everyone outside this room and some within it believe that those women should have been given the information. In fact, Stephen Teap said yesterday that if someone had information and did not share it, that person was covering up. Mr. Gleeson is one of those - there may be others in the room - who wrote that circular, had no difficulty at the time with giving consultants discretion in informing women and signed off on a strategy that allowed for the next of kin of those women who had passed away not to be informed and only to have the information noted on the women's files. Mr. Gleeson is one of the people who made that decision. Like many others who have questions to answer, he has not to my knowledge given a satisfactory answer as to why he did so. Does he still stand over the fact that he and others took a decision that allowed women not to be informed of their misdiagnoses?

Mr. John Gleeson

At all opportunities, we were trying to think of the woman in this. The woman has been diagnosed with cervical cancer. This is a serious business. What is in her best interests? Everything that we put out-----

The women will make that judgment call.

Mr. John Gleeson

I am aware of that, Deputy.

What Stephen Teap said yesterday was that, if his wife had only had five minutes left to live, she would have wanted to know. Mr. Gleeson does not get to make that judgment call.

Mr. John Gleeson

No, I do not.

The women should have been informed. Mr. Gleeson made that judgment call.

Mr. John Gleeson

I did not make that judgment call.

I will ask Mr. Gleeson a fair question. Does he still stand over the strategy, of which he was a part, that these women should not be informed directly?

Mr. John Gleeson

The strategy, the information and what I wrote were consistent with the guidance in open disclosure at the time. The information that went to the consultants showed our clear bias, in that, if it was at all possible, we wanted them to disclose to the women.

CervicalCheck did not. I went through the strategy earlier.

Mr. John Gleeson

Dr. O'Keeffe referred to the notes.

According to the March 2016 memo, the strategy was to decide "on the order and volume of dispatch to mitigate any potential risks" - those were not risks to women, but to the HSE - and to continue preparing a "reactive communications response". The strategy was to minimise the number of women to be informed. It was done in the first instance by allowing consultants to do it. Only one in four did. The second strand of CervicalCheck and other people's strategy was that, if women came forward, they would be made to sign confidentiality clauses. The third part was to challenge the women through the courts. That is what happened. Mr. Gleeson is one of the few people in the State who still seems to think that it was appropriate at the time not to tell the women.

When the former director general was before us, he said that people in the organisation had failed. He was talking about people who allowed a situation to develop in which women were not informed. It strikes me that Mr. Gleeson is one of those individuals. I am concerned that he still holds the view that he took the right decision at the time.

Mr. John Connaghan

I wonder whether I might-----

No. I will let Mr. Gleeson finish.

Mr. John Gleeson

The Deputy is talking about what I know now. Like Dr. O'Keeffe mentioned, I know now that the disclosure did not happen. I did not know at the time that it would not. I accept that we made a mistake. I am not saying that we did not.

Was CervicalCheck guided by the-----

Mr. John Gleeson

I apologise for it and we have apologised. Regarding the final step, we communicated what information we held as far down the line along the best channel we thought would get it to the woman in her interests, which was to deal with her treating clinician. We sent the information to those clinicians. We then tried to deal with any potential blockage to that. I now know it did not work. I apologise for that and have done so previously. As mentioned, there was an error in closing out the loop. That was a mistake. It was an error that we will have to fix.

The term "closing out the loop" does not cut it for those who-----

Mr. John Gleeson

It means ensuring something happens.

It does not cut it for those women. Was the decision by one of the labs essentially to send legal letters instructing the HSE and CervicalCheck not to send out letters one of the reasons for women not being informed?

Mr. John Gleeson

The lab's comments were that the cancer audit process was good, it would continue to participate in it as it had been doing all along, and it wanted us to ensure that the information we were providing in the disclosure was clear and consistent. That was the legal representation.

Was the legal representation made by one of the labs a contributing factor to the decision not to inform all of the women? The memo states: "Pause all letters."

Mr. John Gleeson

The lab wanted an opportunity to discuss that push by us to provide information to women. We discussed the matter with the lab and went right ahead.

Why did the March memo state "Pause all letters"? What was the rationale?

Mr. John Gleeson

They had sought a meeting.

Who had sought a meeting?

Mr. John Gleeson

The laboratory.

The Deputy has run out of time.

This is my final point. The laboratory was part of the problem in terms of not wanting the women to get the information. According to a briefing note that Arthur Cox gave to the HSE, there were no contractual issues and CervicalCheck was free to send the letters.

Mr. John Gleeson

Correct.

That was not done until June. It was done on the basis of agreement with the lab, even though the HSE's own legal advice was that-----

Mr. John Gleeson

No, that is not correct, Deputy.

It is. I have all of the documentation and information we have been given. A briefing note from Arthur Cox told the HSE that there was no breach in contract and CervicalCheck was free to send the letters. It was not until June that a decision was taken to do so, and CervicalCheck reached an agreement with the lab. It strikes me that pressure from one of the labs contributed, at least in part, to these women not getting the information they should have been given.

The Deputy has concluded. Mr. Connaghan will make a final response.

Dr. Stephanie O'Keeffe

Would the Chairman mind if I responded to the Deputy's statement? It is important.

Deputy Kelly will be the next member to contribute.

Dr. Stephanie O'Keeffe

Deputy Cullinane raised two substantive issues, the last of which was very important. From my perspective, the period of time that it took the CervicalCheck programme, with the national screening service, to resolve the issue with Quest Diagnostics was quick. The lab had an opportunity to invoke a dispute resolution process. That was part of its contract. The screening service managed to resolve the issue quickly. The pause was for a three-month period. The process got back on track quickly so that, by October 2016, the bulk of the historical letters had issued.

The second important question that the Deputy asked was a genuine one around whether the open disclosure policy that they used at the time was right and fit for purpose. One of the things that we know from the fresh look-----

When Dr. O'Keeffe says "they", who is she talking about?

Dr. Stephanie O'Keeffe

The CervicalCheck programme. In retrospect, it is legitimate to ask whether the open disclosure policy that it had developed was fit for purpose. The Irish Medical Council's 2016 guide to professional conduct and ethics states that patient information remains confidential. Even where an individual consents to his or her information being released, the Irish Medical Council's ethical guidelines state that how the disclosure might benefit or cause distress to the deceased's family needs to be considered. Releasing patient information about someone who is deceased might be limited by law.

When I examined the policy, I understood at the time that there were significant considerations that clinicians had to make, but we need to have a conversation about mandatory disclosure.

Before we move to Deputy Kelly, I would like to highlight that we received three batches of documentation during the lunch break. We will note and publish them on our website. One relates to the Civil Liability (Amendment) Act 2017 and an up-to-date briefing note on the statutory instrument. Another document is an email from the HSE with two versions of the draft press statement on this issue and a CervicalCheck cancer review questions and answers document. They are dated June and November 2016. The third document is a CervicalCheck chronology of events at University Hospital Limerick and associated correspondence.

When did Dr. O'Keeffe become aware that the patients were not informed?

Dr. Stephanie O'Keeffe

Unfortunately, I became aware that the patients were not informed through hearing about Vicky Phelan's case.

On what date?

What month approximately?

Dr. Stephanie O'Keeffe

Whenever it came out in the media.

Dr. Stephanie O'Keeffe

Yes.

The one thing puzzling me is the fact that Dr. O'Keeffe is telling us that in February, the people in CervicalCheck, with whom she meets every month, asked her to come to a special meeting to discuss this audit. Am I right in saying that?

Dr. Stephanie O'Keeffe

February 2016.

Absolutely. During that period, Dr. O'Keeffe is involved in the memo explaining what was going to happen if the story broke. I think we were told there are now eight versions. Mr. Connaghan said there are eight versions of that memo.

Dr. Stephanie O'Keeffe

Six.

We have seen two versions of the question-and-answer session here and two drafts of press releases. In her role as national director for health and wellbeing, Dr. O'Keeffe was informed about this problem and had detailed meetings and all these items of correspondence commencing in February 2016. A lot of this was to inform the patient and if the story broke, they had all the information for the Minister up the line. Now Dr. O'Keeffe is telling me the first time she heard about the 200 patients not being informed was over two years later. Did she make no inquiries during the two years in which she was national director meeting these people month in, month out? To quote her words, she met them monthly. Did she never think of asking what had actually happened? She probably met them 20 times in the intervening period.

Dr. Stephanie O'Keeffe

I did.

I am utterly at a loss to understand. She was aware of this problem in February 2016 as the most senior person - national director. If there was a concern for the patient, I would have assumed that at the monthly meetings, she would have asked how things were going. It has emerged today - if it has not yet emerged - that out of the approximately 200 cases, approximately 40 were notified by their consultants. We now know that even to this point, well over two years later, 80% of the people were not notified. It makes a mockery of the concept of open disclosure. It was ignored on a wholesale basis. This is why I opened here about open disclosure a few hours ago. I do not believe the concept exists. It is remarkable that 20% of the consultants took it upon themselves to do it when the general approach across the board was that 80% were ignoring this issue. We have discussed this open disclosure policy previously. The State Claims Agency has spoken to us. It would help it in its work if there was a greater level. We have been dealing with this issue for a year. Can Dr. O'Keeffe explain how she was made aware of this issue in February 2016 and over two years later, she is now hearing for the first time that 80% of the patients were never informed in writing?

Dr. Stephanie O'Keeffe

The crucial date is the October 2016 briefing and what came after that because October 2016 was the last full briefing I would have received. Deputy Kelly and the Chairman are quite right in that there would have been 14 months of one-to-one meetings plus a monthly senior management team meeting and a monthly performance oversight meeting that fed into multiple points of view, MpoV, which discussed risk. There were a range of risk meetings in between. I have to tell the committee honestly that the CervicalCheck clinical audit was on the management reports from the National Screening Service, NSS, during that time telling me that the audit process was going well and that continuous improvements were being made. I have the specific details but from about May, within that there would have been one case going to the State Claims Agency. Later on in the month, maybe about September or October, three cases went to the State Claims Agency. Clearly, I must reflect on whether there was anything else I could have done to become more aware of this but I was reassured that it was handling it well. I had confidence in the CervicalCheck programme that it was happening.

There were individual cases with the State Claims Agency.

Dr. Stephanie O'Keeffe

I was informed that it was going well at those one-to-one meetings. Clearly, I can see now-----

There is a clear breakdown. When Dr. O'Keeffe was asked whether she remembered what happened in that meeting in 2016, she told us about how she felt at the meeting. She does not have documentary notes. Her feeling at the meeting was concern for the people. It is the normal response we get and we take it as probably a far more intuitive response that Dr. O'Keeffe felt for the person who had a particular difficulty. Where did her feeling for those people go during the next two years and two months? She is the one who brought up her feelings for the people when she first heard about it. What happened in-----

Dr. Stephanie O'Keeffe

From a management perspective, you rely on the assurances you get from your staff. That is how it works. You get eight direct reports and you have monthly meetings and risk assessments-----

I am not worried about the monthly meeting. Dr. O'Keeffe was the national director-----

Dr. Stephanie O'Keeffe

And I asked about it and the actual management reports said it was going well so in that context, I took those assurances for real.

How could Dr. O'Keeffe accept it was going well when we know two years on that 80% of the patients were never contacted? Can she document what was going well? Something was going well but not contacting the patients-----

Dr. Stephanie O'Keeffe

What I been briefed on, what I had briefed others on and what the Department had been briefed on was that the process was put in place so that the consulting clinicians would relay the information to their patients. My understanding is that this was actually happening.

How did Dr. O'Keeffe think that?

Dr. Stephanie O'Keeffe

Because the October briefing told me that several consultant doctors had engaged with the NSS and CervicalCheck and the next steps to be taken following communication of a cytology review outcome, a short explanatory document was developed to accompany the letters issued to consultant doctors in addition to-----

That is from whom to whom?

Dr. Stephanie O'Keeffe

That is the October briefing.

From whom?

Dr. Stephanie O'Keeffe

From CervicalCheck telling me that in addition, administrative leads in programme colposocopy services had been advised of the process, NSS CervicalCheck was providing additional support to consultant doctors in respect of carrying out open disclosure requirements and appropriate protocols and engagement between CervicalCheck and the consultant doctors would constitute an ongoing process. The summary was that communication with stakeholders and patients was being appropriately managed at that time. Because of the catastrophe that has happened and the majority of these patients ended up finding out in a way never envisaged by CervicalCheck or any of us and the usual management tools you use to be told these things did not turn up this information.

Where was Dr. O'Keeffe's concern for the patients during this time? We have heard that processes, policies and procedures were in place. Not once did she refer to the patients. All I heard from that last paragraph was about consultants, procedures, protocols, policies and open disclosure. I have not heard about the patient. Is there a reference to the patient in the report on which Dr. O'Keeffe is relying rather than something about how somebody was going to do something? Was there any confirmation that patients were informed?

Dr. Stephanie O'Keeffe

After all that has happened, I respect the Chairman's question but the summary in the October briefing was that communication with stakeholders and patients was being appropriately managed at the time. My assumption on the basis of the work we had done over 2016 was that the treating clinicians would disclose this information to patients. I was absolutely reassured and this is very important because all the briefings say it.

Dr. O'Keeffe was aware and we heard it previously from the HSE. I must go back to where I started. I am only dealing with one topic personally today, which is open disclosure. Dr. O'Keeffe knows and it has been stated by the HSE and everybody that the fear of litigation prevented open disclosure in most cases. Dr. O'Keeffe was aware that the fear of litigation was a real factor in preventing open disclosure. She was aware of it at that time because we did not even have the Civil Liability (Amendment) Act 2017 in place never mind the statutory instruments. She had to have known that at that time there was a risk of litigation in respect of the consultants who were going to be involved in open disclosure. That was seen as one of the main barriers to open disclosure which Dr. O'Keeffe knew was there at that time so how could she have presumed that all of these consultants were going to ignore the fear of litigation and talk to all the patients?

Dr. Stephanie O'Keeffe

Probably the bigger question for all of us is how we all could have assumed that this was going to happen.

But we are relying on Dr. O'Keeffe. We are relying on senior people in the HSE.

Dr. Stephanie O'Keeffe

The other thing, which I was going to mention to the Chairman when he started off with those questions, is that I am not sure. I am not a lawyer. In some respects, you can see that even though it was a minority, some consultants did choose to follow through with the letter.

Retrospectively, because I was not aware of it at the time, it is clear from the communication with the consultant, Dr. Kevin Hickey, that he understood what was required by the CervicalCheck programme. My understanding is that it was not a fear of litigation because they were not at fault. It was really about the communication to the patient about something that had failed, that should have worked previously and how that information could be communicated.

While I agree with the Chair that medical ethics and legal issues are involved in many cases of open disclosure, in this instance it was not the consultants' fault. The treating clinicians were not responsible for what had happened. However, it was deemed that they were the appropriate people to tell. I accept the Chair's questions because of what has happened but I did not think that there was anything going wrong. Perhaps I should have but I did not.

I will call Deputy Kelly shortly. Can Dr. O'Keeffe understand, however, that it is reasonable that we ask this question? She has said that she does.

Dr. Stephanie O'Keeffe

I can.

This was brought to her attention in a special meeting in February 2016 and then the first she knew about the outcome of that whole process was when she heard about Vicky Phelan two years and two months later. I call Deputy Kelly. I am sorry for that interjection. I do not want to take up his time.

The Chair takes much longer than ten minutes.

Well-----

I am only joking.

It is the Chair's privilege. Go on.

Absolutely, I could not agree more.

Can I just ask something?

One quick question.

I cannot find the document we referred to earlier, the audit methodology paper. It is supposed to be in the file. Can anyone direct me to where it is in the documentation? I am looking for the methodology paper from the outset. Is it the overview document?

Dr. Stephanie O'Keeffe

It says the title of the document is "Audit Process Method Overview".

Sorry Chair for interrupting. That is an overview. What I was looking for yesterday at the Oireachtas Joint Committee on Health - I think I was very clear - is the genesis of the audit process, when it was set out. Can we have that?

Dr. Stephanie O'Keeffe

If that exists.

Is it being worked on? Is it in the documentation? Does anyone know?

Mr. Jim Breslin

There is an overview document. That is what we discussed yesterday.

That is all that is in it. That is not what we want.

Mr. Jim Breslin

I do not know if the document the Deputy is looking for exists.

We ask Mr. Breslin to get it to us when he can. I call Deputy Kelly.

That saved me some time, I was going to put the same question. Mr. Connaghan saw what transpired there. If that has not told him a lot, I do not know what will. The difference between Mr. Gleeson and Dr. O'Keeffe is that Mr. Gleeson said "sorry". He apologised. I hate to say this to Dr. O'Keeffe but I do not believe that anyone watching this would have confidence that she did her job properly. She said that she "assumed", she used the word "think", and said that there was a reliance on the staff. I presume Mr. Gleeson is part of that. We saw the State Claims Agency cases coming through. For over two and a quarter years, as the Chair has outlined, Dr. O'Keeffe did not once probe it. For me, that is at the absolute nub of what is going on here.

Let me explain something to Dr. O'Keeffe. We are politicians. We are not clinicians. Some of us have medically-orientated qualifications - I refer to my colleague on the left. If there was an iota of a mention of this issue in anything to do with the Department of Health, the Minister for Health, Deputy Simon Harris, would be out of a job. Deputy Leo Varadkar would probably not be Taoiseach. That is the likelihood of where we would end up. This is transfixing the nation. People are absolutely appalled and disgusted. Pick whatever word one chooses.

For over two and a quarter years, or whatever timeframe one desires, there was a catastrophic failure in CervicalCheck at management level, and possibly at other levels, and Dr. O'Keeffe has not even said sorry. She has not apologised. It is not good enough to say that she assumed. It not good enough to say that she relied on legal cases. It should have been probed. It should have been dealt with. It should have been a monthly issue and an issue that was constantly referred to on and on and on again.

I have gone through all the documentation, probably more than most. I could write a book on it. I have so many documents now that I am in information overload. There is no way I can see any justification for this. There is no way in which Vicky, Stephen and the others can get any comfort from anything that Dr. O'Keeffe has said or from any of the processes that were in place. In respect of Mr. Gleeson, I am wondering how this makes him feel. Dr. O'Keeffe feels that she has been let down. I do not know what way that makes Mr. Gleeson feel. He works for her obviously. Does he feel that he has let her down? In fairness, at least he apologised. Does Mr. Gleeson feel that he did his job but people did not listen or does he feel that-----

Mr. John Gleeson

I think that - with the then clinical director of the programme at the time - we tried to move forward as far as we could in making women aware of information that belonged to them. We encountered some feedback and that sort of thing. We tried to address it and deal with it. We made note to people about where this might be an issue. I do not directly report to Dr. O'Keeffe. I kept it on the executive management team of the programme. We are managing a programme that deals with a population. There is a huge number of-----

Sorry, I am not being rude but we are stuck for time.

Mr. John Gleeson

We pushed as far as we could and we addressed and we were addressing-----

I am sorry, I have addressed Dr. O'Keeffe as Ms O'Keeffe. I want to ask who let her down?

Dr. Stephanie O'Keeffe

It was clearly important within the monthly meetings and the management reports given to me, that where there was even a perception of any kind of risk with regard to the expectation I had - and those that I briefed would also have had - it should have been coming through from that process.

Who let Dr. O'Keeffe down?

Dr. Stephanie O'Keeffe

The governance line with regard to the national screening service. I should have been informed through the head of the national screening service.

Who let her down?

Dr. Stephanie O'Keeffe

If it is okay Chair, I prefer not to mention names.

The witness is not to comment on a person who is not here-----

I am not talking about a person. I am talking about-----

-----or identify them.

-----positions.

Dr. Stephanie O'Keeffe

The person who reported directly to me, who was the head of the national screening service, should have told me about this.

Okay. This is what happens. We have seen this before. Spread the blame around and then there is no culpability and there are no issues. I think we all know what we are talking about here. There was a seismic or catastrophic failure across the board. From all the documentation, we can see that the manner in which this was dealt with, not just from a management point of view but from a process point of view, was a disgrace.

I have a range of other questions. When it comes to the 16 June note that went to clinicians, Professor Gráinne Flannelly is no longer here but she is one of the clinicians. It was expected that the clinicians were all going to tell their patients. I believe that was wrong. I believe CervicalCheck should have done that. We know now that a small percentage of clinicians did tell their patients. Did Professor Flannelly tell her patients? Seeing as it was through her-----

Dr. Stephanie O'Keeffe

I cannot speak for Professor Flannelly.

I know, but it would be interesting to find out, seeing as that was a policy that was there. I will just leave that there for others to probe. I have loads of other questions and I will be back later. I address my next question to Mr. Connaghan. Has he had an opportunity to look at the documentation that has been provided?

Mr. John Connaghan

Very briefly but I am prepared to take questions and ask colleagues to help.

Of course, I would expect Mr. Connaghan is.

Obviously, they felt the need to provide this documentation, given the information we had earlier on relating to what happened. Mr. Woods has gone and Mr. Lynch is not here, even though he was party to it. The documentation does what it says on the tin. If one correlates the documentation with the report of the colposcopists' meeting, one sees that all they achieved in six months was to set up a briefing leaflet for patients. We should remember that Vicky Phelan is one of these patients. It states: "It is envisaged that the woman will be able to tear off the notification slip and send it directly to the CervicalCheck programme to opt in to receiving this information." We are talking about open disclosure but, after six months, all we have are opting in and tearing off a slip. We now know that 80% of women were not told. How does that make Mr. Connaghan feel?

Mr. John Connaghan

I will have to read the 30 pages to give the Deputy a better answer. The Scally review will have to take a look at processes. The Deputy raises the question of whether there was a process failure in how we were to communicate the information.

It is also made very clear in the documentation that there are discrepancies in lists in CervicalCheck.

Is there an appendix number at the top of the page?

No, but the Chairman should trust me as I have taken notes. I only got this at lunchtime.

This is the middle of last year and it had taken months to say the lists provided to clinicians were not accurate. How could they do this?

Mr. John Connaghan

That communication needs to be double and triple checked. The Deputy is right to ask how we can inform patients appropriately if we do not have the right lists.

There was correspondence of 13 July to all other general managers across the HSE. I know most of them myself but what did they do? Did this come to a head because they took the lead and demanded that it be sorted? Will Mr. Connaghan get back to this committee with the information on what they did? Will he do what Limerick did and send us on the chronology and documentation so that we can see what all of them did?

There is documentation in the booklet for clinicians telling them that, in cases where a woman has died, the next steps should be to ensure the result is recorded in the woman's notes. We also see this in the draft letters. The Criminal Justice (Theft and Fraud Offences) Act 2001 came to mind when I read this and a failure to provide information such as this needs to be investigated under that Act. I say this as softly as I can. The Act refers to delaying or not providing information to the next of kin. Stephen, from one of the affected families, sat here yesterday and he was not provided with that information. We all know that this is a disgrace. Open disclosure? My backside.

We are not being provided with all the information on a range of questions. I encourage people watching this to consider the Protected Disclosures Act and to come forward with information to us, or perhaps the Chair of the health committee. There has to be a protected process, such as the Committee of Public Accounts or the health committee, in which this information is brought forward because people in the HSE are still in their positions but have skin in the game. Stephen asked yesterday that they be stood aside and I suggest it should be done without prejudice, because some people may not want to come forward as things stand.

I have been on this theme with Mr. Connaghan for about two days and I pray and hope he is listening to me. I do not want the whole Scally process to be, for want of a better word, corrupted by the fact that these people are not coming forward while people who are part of the issue remain in position.

Mr. John Connaghan

I will supply one piece of information I was asked for this morning. I undertook to check on Mr. Patrick Lynch's leave arrangements. I did that in two ways. I accessed his annual leave card which had been signed off, as I had thought, by the previous director general. No date is appended to the signature but I further checked with Mr. Lynch as to when he booked his flights, which was on 17 January. I estimate that his leave arrangement was made prior to that date.

It was not signed off.

Mr. John Connaghan

It was signed off.

Mr. Connaghan said there was no signature.

Mr. John Connaghan

There is a signature but there is no date beside it.

The watching public do not care about this. What is more worrying for me is that, in order to make this jigsaw come together, Mr. Woods is gone and he was not here to answer questions. Everyone is entitled to leave but I will not take leave during a general election because I have to fight it. We are talking about critical people at the highest level under the director general in the HSE, but they are away during the biggest national health crisis in years. That is not acceptable to anybody watching or listening to this.

What is the salary scale for somebody at directorate level in the HSE?

Mr. John Connaghan

It varies from €100,000 to approximately €165,000.

I would guess the people of whom I speak are at the higher end of that scale.

Mr. John Connaghan

At director level they would not be.

My point stands, nevertheless. I asked for information relating to the meetings of the lead colposcopists. We asked for the minutes but we got them once, in October. Why did we not get the follow-on meetings, the meetings with gynaecologists? I ask the journalists watching to go through the published list and ask why so many of these clinicians did not ask about the best way of informing patients when they were at these meetings. The volume of clinicians who were not party to this is incredible and somebody should dig into this.

Mr. Damien McCallion

I actually checked that out and had someone look through the documentation over the last couple of days. Obviously we were here yesterday, but as of last night they were the only minutes found. The other meeting of which I am aware-----

What happened in October? There was a meeting in October.

Mr. Damien McCallion

There were two meetings but no minutes for the second meeting could be traced.

I have one last question for Mr. McCallion. On what date did he take over from Mr. Lynch?

Mr. Damien McCallion

Thursday, 3 May.

No. When did he take over from Mr. Lynch?

Mr. Damien McCallion

Yes, that is when I took over from Mr. Lynch. I have only been here ten or 12 days. It was 3 May, two weeks ago.

Mr. John Connaghan

The transfer of responsibility from Mr. Lynch to Mr. McCallion took place on Friday, 11 May.

It was 11 May.

Mr. John Connaghan

Yes. Friday, 11 May.

Mr. Damien McCallion

My apologies, I was talking about the day I started.

It was Friday, 11 May.

Mr. John Connaghan

Yes, Friday, 11 May. Mr. McCallion started on 3 May.

It is amazing that Mr. Lynch transferred responsibility at the same time the question of an "investigator" being part of the investigation arose. That is an amazing coincidence.

Mr. John Connaghan

The rationale at that particular point in time was that Mr. McCallion had significant experience from his previous role in emergency management. If the previous director general was here he would have explained this. We took the position at that point that we needed some very senior management in to get a grip on this. That is why Mr. McCallion was called in.

It is amazing because there were many media queries around that same time.

My general observation is that there has been a kind of industry of meetings and there has been very poor communication. The culture has been very internally focused with the patient on the outside. That is my impression. It was interesting that last night, when we were talking to Ms Vicky Phelan and Mr. Stephen Teap, they were looking for the patient to be at the centre of our health service. That is the only way it is going to be reformed. Doing that will be a mammoth task judging by what we are seeing here. There are so many other areas we could explore in the health service but this one area is certainly shining a light on the processes, the culture and all of that. It is a mountain that needs to be climbed and climbed quickly.

Mr. John Connaghan

Would the Deputy mind if I commented on that?

Can Mr. Connaghan keep it short because I have very little time and I have many questions to ask?

Mr. John Connaghan

I am sorry. In that case I will make a comment after the Deputy has finished.

Last night Mr. Teap asked how many of the 209 women, 18 of whom have died, have been diagnosed with terminal cancer. Does Mr. Connaghan have that figure?

Mr. John Connaghan

Can we take this query away in order to consider the information? Could the Deputy perhaps rephrase the question so that I entirely understand what she is asking for?

Yes. Obviously there are different outcomes depending on when one is told of a cancer diagnosis.

Mr. John Connaghan

That is correct.

The outcome becomes much poorer if one is informed later. People can be diagnosed with a terminal cancer when there is nothing that can be done or when they must consider different types of experimental medicine. Can Mr. Connaghan give us some indication of the numbers? Does he have an idea of how many are at the very late stages?

Mr. John Connaghan

If I take the typical four stages of cancer progression - stage 1, stage 2 , stage 3 and stage 4, which is the most severe period in terms of the progression of cancer - I think the Deputy is asking us to take the 209 patients and subdivide them into these stages. The only issue I have with that is that we are still subject to patient confidentiality. I would be loath to say that we could automatically provide that if there was going to be a patient confidentiality issue but I will look to some of my clinical colleagues for advice on that.

Mr. Damien McCallion

To add to that, Deputy Jonathan O'Brien had actually asked for that information previously and we had a discussion on it. We do not capture that information at the moment. It is not held in the details. We would have to go back to the hospital and to the patients, leaving aside the issue of whether people would want to share their information.

I completely understand about confidentiality, but could we be given a ratio or some other understanding of where we are without the potential for individuals to be identified? That is essentially what I am looking for. I do not want to use up all of the time.

Dr. Tony Holohan

May I make a comment on the more general situation?

Can Dr. Holohan keep it very quick?

Dr. Tony Holohan

The National Cancer Registry collects information on the stage at the time of diagnosis, but to my knowledge there are no systematic measures in place to track progression through changes in whole patient populations or groups. It is just not done.

So it is not captured. Okay. On open disclosure, the witnesses described exactly what is required in that regard. We have heard that the Medical Council guidelines were updated in recent years. There were clinicians on both sides of this discussion that went on over the period of a year and a half. There was the programme manager for CervicalCheck, who is a doctor, and there were consultants and there was dialogue going back and forth.

Mr. Jim Breslin

The Deputy may be referring to the clinical director. I am not certain of the terminology, but the programme manager is not a consultant. The clinical director is a consultant.

I am looking at appendix 14 and the dialogue that happened. This was in the correspondence we received from Deputy Kelly. They are quite extensive letters, not short emails.

Mr. Jim Breslin

That may just be an error in the title but the individual is obviously a consultant.

The individual is a doctor.

Mr. Jim Breslin

Yes.

Where do the Medical Council guidelines come in with regard to that doctor and the other doctors who were in dialogue with one another and not with the individuals? Can one make a complaint to the Medical Council in that regard? This is the absence of open disclosure. These are people who are governed by the Medical Council and these guidelines. Does that matter? Is there a sanction?

Dr. Tony Holohan

The Deputy is absolutely right. The ethical code under the Medical Practitioners Act 2007, as amended in 2017, is the guide that binds every doctor. A failure to comply with its requirements can be grounds upon which a patient or any other person can make a complaint against an individual medical practitioner. The Deputy is correct in that respect. If I may just comment, some of what is being said here is a more general issue for the profession. In general terms the profession itself has espoused and continues to espouse its commitment to the values of openness, honesty and open disclosure. Perhaps not every single member of the profession has fully discharged those obligations appropriately. I am not making a judgment in respect of this. It is very important that the profession, on its own and in its own standing, finds means to make clear to the public its commitment to those values because, independent of the roles of the HSE and the Department of Health, very significant societal charges are being made in a broad sense about the values ascribed to open disclosure, trust and honest on the part of individual medical practitioners. I hope the profession can find a means, through its collegiate structure and elsewhere, to reassure the public about its commitment to these principles.

To be clear, this would constitute a breach of open disclosure.

Dr. Tony Holohan

I am not making a judgment on that but if, in an individual case, the requirements of open disclosure under the Medical Council guidelines were not met, that would be grounds for a person to make a complaint to the council against an individual practitioner.

Another issue came as a bit of a surprise. There are many numbers being talked about. There was almost 1,500 and then there was another 1,500. I know that there are two different groups of individual cases. One relates to an audit and I am not quite sure to what the other group relates. There is confusion about the number of cases which were reviewed. I understand that some cancers would present without people having been screened and that there is nothing to look back at. We were told last night that there are five or six different categories and I have also seen that somewhere in the documentation we have received. Could we have some sort of brief outline of what exactly we are talking about with regard to all of the numbers that are out there? To be perfectly honest it is very difficult to reconcile them.

Mr. John Connaghan

That is a very good question.

Perhaps Professor Kerri Clough-Gorr could come in with her perspective on the overall national number of cervical cancers. She should speak to the microphone and not mind who is behind it.

Professor Kerri Clough-Gorr

It is hard not to make eye contact. It is a case of active versus passive registration. The CervicalCheck group does passive registration of cancer. When it is notified, it logs it as a cancer. What it does not do is actively determine whether every person who has gone through the screening programme has had a cancer. That is its process. Our process involves the responsibility to actively find cancer cases throughout the nation. That is beyond the public system; it is private and public.

Dr. Clough-Gorr is not getting to the question.

Professor Kerri Clough-Gorr

The Deputy asked about the two populations. What happened was that we took its population and matched it with the full population because it wanted to know who else had received a diagnosis of cancer and had not been passively notified. It had the people who had been notified directly to CervicalCheck. We gave it diagnoses that it had not received through its notification process. They are the two numbers. We gave it approximately 1,600 other diagnoses, but they included many people who were older and not in the screening programme. Therefore, the number would come down when CervicalCheck matched our extra cases with its cases. I do not know the actual numbers. CervicalCheck is carrying out that analysis.

I will let Professor Clough-Gorr back in.

Dr. Tony Holohan

The independent clinical audit shall happen under the auspices of the Royal Hospital of Obstetricians and Gynaecologists and involve another organisation in the United Kingdom called the British Association of Colposcopists and Cytopathologists. It will have teams that will conduct an audit, starting with all of the patients about whom we know through the registration process. Through what it calls an algorithm - a series of steps - it will identify those cases that need to be reviewed, review the charts and bring the process through to the end in ordere that we can have, in broad terms, an answer for each individual. That will happen independently.

There are people expecting telephone calls who may not receive one and who may have nothing to worry about. Part of what is causing the confusion is a misunderstanding about some of the numbers and some of the groups of people involved. It would be very helpful if we could drill down to identify the number of look-backs and what the categories were. When one is told it is not possible to look back because somebody did not have a screening, it makes perfect sense. It makes perfect sense with those who may be older. Given the numbers, however, the perception is that everybody was in the same category. That is certainly what I am picking up. I believe there is a public information awareness exercise to be conducted in that regard. I accept the point made and what one has to go through, but there is also a public information piece.

Mr. John Connaghan

I ask Mr. McCallion to help very briefly.

Mr. Damien McCallion

I agree on the need for public information and the concern about numbers. The important point is that these are all women who have or have had cervical cancer. The CervicalCheck programme went through 1,400 cases, of which 209 were the women identified as having a different interpretation. They were the immediate priority. The issue that then emerged was that there were a number of women in the National Cancer Registry with whom the CervicalCheck programme had not made contact. That is the group for which we have taken the data from the National Cancer Registry. We are matching them through with the screening programme and it will come up with a number which will be much lower than 1,600, which is the total. We had a discussion with the Department without knowing the final number. We will probably be asking the new review team to prioritise the women in question in order that they will be contacted first to make them aware. All that is being said is that they have had cervical cancer, were in contact with the screening programme and have smears that need to be audited as a result. It is not making a conclusion as to whether there was a difficulty. They will be the next priority once we know who they are. Through the faculty process, we want the Royal College of Obstetricians and Gynaecologists to prioritise the women early to offer them certainty. I accept that it has been very complex with all of the numbers, particularly for women who are listening to all of this.

I have two other questions, one of which relates to the HSE contract and the threat associated with the legal letters, initially in February. The HSE is the body paying for this work and setting the terms of the contract. Was the indemnity issue, whereby confidentiality was being sought, anticipated? Can the witnesses talk us through the control the HSE has over a contract for which it has responsibility? It does not make sense that the people contracted to do the work are pretty much dictating the terms of the contract. It tends to be the other way round. "He who pays the piper calls the tune" is a bit of a cliché from that point of view.

I have another question, on a different topic. Perhaps my last question might be answered first.

Dr. Stephanie O'Keeffe

The contract was between CervicalCheck and the laboratories. Like any standard contract, there is a dispute resolution clause in order that one could invoke a formal process so as to resolve an issue. I will let Mr. John Gleeson who has managed the contracts reply to the Deputy's question, if that is acceptable.

Mr. John Gleeson

My understanding is that if a case were to proceed related to a charge or an allegation against the laboratory, the indemnification would be called in to indemnify the HSE and the laboratory would proceed with its defence. If the HSE is included in the proceedings, the State Claims Agency is involved in its defence. Also involved is the laboratory, if it is included in the charge. It is a case by case matter. The State Claims Agency would really be better able to advise on the distinction in respect of indemnity, who indemnifies who and who deals with the plaintiff, or whoever is bringing the charges.

Dr. O'Keefe mentioned dispute resolution. The clause is pretty standard in any commercial contract. One side can take issue with the other and a formal process is initiated to sort it out. It is separate.

I ask that we contact the Sate Claims Agency about the contract and indemnity because it seems we need to be thinking about contracts in the future where there is no legitimate communication with patients. They cannot be an impediment. Can we make contact with the State Claims Agency to gain some understanding of it?

This relates to those signing the contracts and the question of when they are next up for renewal. The HSE signs the contract, not the State Claims Agency. Therefore, the HSE also has responsibility. We will do as the Deputy proposes.

Last week I asked the State Claims Agency whether there were other screening programmes, in respect of which court actions had been initiated. I was told that there were four in the case of BreastCheck. Are they in the same range in terms of what has emerged? There are 11 in regard to cervical screening. We do not know whether all 11 relate to the same thing. I presume they do. Have the four related to BreastCheck to do with the screening programme? In much of the correspondence we have received, there are concerns or suggestions people with lower level skills will be taken on to try to make sure there are no delays in the programme. Do we know anything about this? Once the number is available and the issue known about, it has the potential to undermine another vital screening programme.

Mr. Damien McCallion

We sought the list from the State Claims Agency of all cases against all programmes. Dr. Coffey might elaborate on this. We have a list, but it does not give us details of individual cases. Therefore, we sought information from it on all other cases. I include the four to which the Deputy referred.

Earlier this morning, when Deputy Marc McSharry asked his question, we responded that, in regard to the other screening programmes, not only was the external review looking at it in terms of Dr. Scally's inquiry but that we were also bringing in some resources ourselves to look across all programmes across the entire area of quality and patient safety. It is just to make sure and satisfy ourselves that we can do it. We are still awaiting details of cases from the State Claims Agency.

According to Deputy Jonathan O’Brien, we were told last week that they were on the basis of misdiagnosis.

Mr. Damien McCallion

I do not have the details. I would be speculating. I got a list of the case numbers and details and so on, but we did not get the individual clinical instances. We have to look at that.

Can it be recalled?

My recollection, when the question was asked, is that I brought it up and asked what was the nature of it. The information was given that the four of them are claims of misdiagnosis. That will be on the transcripts.

Mr. Jim Breslin

There might have been a reference to the reading of the mammogram by a radiologist. That is the only recall-----

Within some of the documentation that members received this week there was quite a bit of discussion about delays, the shortage of staff and delays in different parts of the country. Are the witnesses satisfied that there is not a problem with the screening programme with regard to its capacity? It is important that we know this at this stage. These will be historical cases if court action has been initiated. Can I get an answer on this?

Dr. Coffey will respond and then we will have Deputy MacSharry.

Dr. Jerome Coffey

I do not have any further details on State Claims Agency cases. I am not sure what the correspondence referred to by the Deputy specifies. I am aware, however, that as the age extension from 65 to 69 is implemented, there is pressure in the BreastCheck workforce to find enough mammographers. There is an international shortage and there are very aggressive recruitment campaigns being run by BreastCheck to try to meet those needs.

Can we go to Deputy MacSharry?

Okay. I will come back to this again.

A point was raised at the committee meeting yesterday which was attended by Vicky Phelan and Stephen Teap. I do not know if it was covered earlier as I have been in and out of this meeting. If the issue was covered then please stop me and I will move on to my other questions. The point was about looking at the efficacy rate in various laboratories, the percentage of tolerable error and if the statistics fall within a certain percentage, the box is ticked and we move on. Do we need to look at the magnitude of the error and the consequence of the error? Is there any assessment of how we need to act in this context?

Mr. Jim Breslin

I believe that Mr. Gleeson answered this earlier.

Was this covered earlier?

Mr. John Gleeson

Not in detail.

Would the witness like to cover it again? I am sorry for missing the response. An error is an error is an error. One error could be a typo but another error could lead to catastrophic events. Are we just looking at this statistically or are we analysing the impacts of different types of errors that are being shoved into the statistical percentage that is acceptable in international best practice?

Mr. John Gleeson

We analysed the impacts as well. If it is considered that it should have reported or could have reported a different result, what is the recommendation, which is the impact? It would have recommended an earlier follow-up such as returning in six months for another test or a referral to colposcopy. If that did not happen, then that is an impact. The Deputy referred to general standards, and acceptable ranges would be positive predictive values. We would want it high in the 80s, which it is. It is scoring-----

Dr. O'Keeffe mentioned that earlier on but I wondered if Ireland just takes the international statistics and practices as the way to do it or if we look at it in a little more detail.

Mr. John Connaghan

I have asked the same questions myself in the short time I have had on this. I have taken some advice from one of our colleagues inside the screening service. I will ask Dr. McKenna to say a word or two on this. We need to be aware of one factor. Depending on the life or the time of the screening programme, when we make international comparisons, it must be taken into consideration, for example, if something has been started fairly recently or if it has been running for 20 years. There are differences in the detection rates and the downstream recording of high-grade versus low-grade incidences. Doing international comparisons purely on statistics around laboratories needs to be treated with a little bit of caution. This is why the faculty we are constructing to provide advice in that regard, the review by the Royal College of Obstetricians and Gynaecologists, will also be important because we need to compare not just within Ireland but also against international best practice. Perhaps Dr. McKenna would also like to say something about that.

Dr. Peter McKenna

When we move from the population to the particular, which is what we are doing here and which is what has fuelled the entire controversy, we are looking at a very different thing from screening. My calculation would be that for a woman in Ireland, her chance of dying of cervical cancer is 150. If the woman is in the screening programme, the chances go out to about one in 10,000, and there is a smear error causing that one. We are looking at a very select population. I am not sure what the experience is internationally in looking at these failures. It is an entirely different sort of thing to do than looking at population-based statistics.

Ireland could be pioneering in this regard and show the world how it should be done.

Dr. Tony Holohan

The remit of the scoping inquiry to look at policies and procedures, if they are all the ones that should be there and if they were followed appropriately, are part and parcel of the terms of reference. The Deputy's question is a fair one. It is at the heart of our considerations in putting together those terms of reference.

I think we know the answer.

Dr. Tony Holohan

The second part of it is the clinical audit. That is a question that each person will have. We must be sure that we do not just have measures that track overall rates from a quality assurance point of view. We must also have capacity to learn from the individual circumstances and that all the policies and procedures are fit for purpose. Those questions will be answered independently through the processes that are in the-----

I think I have those answers already. From the evidence we are hearing, those answers are going to show us that everybody did what they were supposed to do in their own little box and everybody else in their little boxes thought it was tickety-boo because the person in the box next door was doing their job. The outcome will be that there was a row going on between consultants and CervicalCheck, the people were not told the information and now we are in this mess. I do not believe that the public will accept that as an outcome. This, however, is what will be said in two years or whenever the commission of investigation or the scoping report is out. We have heard from Dr. O'Keeffe that everybody feels they did the right thing at the right time, but they did not.

We were all a little bit uncomfortable after Dr. Holohan left the last day. I was going to the TV3 studios and I was handed a statement that said Dr. Holohan knew about the memos. Dr. Holohan made the decision that it was fair and reasonable not to escalate the issue to the Minister. If Dr. Holohan was the Minister and the chief medical officer had made the same decision not to escalate the issue, how would Dr. Holohan feel?

Dr. Tony Holohan

I would still believe it was a fair and reasonable decision.

If he had been the Minister, Dr. Holohan would have said it was tickety-boo, that he knew the doctor was doing the right thing.

Dr. Tony Holohan

I would not say it was tickety-boo. I would understand it in the context of the general escalation environment. I would want-----

Are there comparisons with other medical crises when people would have died and where it would have taken as long or where Dr. Holohan, even during his time as deputy chief medical officer in 2001, would have taken an independent decision not to escalate it?

Dr. Tony Holohan

Yes. I do not want to waste the members' time by going through the answer I gave earlier on but I had set out a framework for criteria-----

Is there is a matrix for escalation of issues?

Dr. Tony Holohan

When we hear about something, the biggest issue is if the risk tells us that a service might be unsafe and needs an immediate intervention. We have responded in those kinds of situations. Clearly we escalate the issue immediately in those situations where there has been a failure for people who have gone through a service and have been exposed, of which there are examples but I will not waste the Deputy's time by talking through them, and where patients have to be identified through a look-back to be offered some service to help mitigate what is happening. The next level down is when an individual case does not have wider safety ramifications but which still has to be brought to the Minister's attention. This case is in the category, at the time in 2016, of something that could potentially cause a difficulty. Every population based programme such as screening and immunisation carries with it the risk of publicity arising from how errors are reported if there are cases. This is a well-known and internationally recognised phenomenon. Any screening programme or immunisation programme carries with it that potential.

Then let us say-----

Dr. Tony Holohan

If I escalated every potential risk that I am aware of and if I escalated all of the actual risk that I am aware of, I would not be doing my job. My job is not to escalate issues. My job is to manage and to oversee managing. I do escalate where it is appropriate.

Dr. Holohan's biography says that he has to advise the Government and the Minister for Health.

Dr. Tony Holohan

Which I do. I stand over the advice that I give in that context we refer to.

My job is not to tell the Government everything I know.

But Dr. Holohan seems also to be managing the information he chooses to share.

Dr. Tony Holohan

I make professional judgments on it.

I appreciate that Dr. Holohan makes professional judgments.

I will move on to Mr. Breslin for a second. Am I correct that there are monthly management meetings involving Mr. Breslin and the Minister, and the assistant secretary within the Department who would be relevant to acute hospitals?

Mr. Jim Breslin

They are not exactly monthly. They are every six to eight weeks, I would say.

Every two months, let us say. Therefore, there are six a year. Does Dr. Holohan attend those meetings too?

Dr. Tony Holohan

We have a weekly management meeting but, yes, I am in the same-----

No, the one that the Minister attends.

Dr. Tony Holohan

Yes, absolutely.

Does Dr. Holohan attend those meetings?

Dr. Tony Holohan

I do, indeed.

In the 12 meetings in the relevant period, did this ever come up?

Mr. Jim Breslin

No.

Was there no remote reference, such as, "That thing is going well"?

Mr. Jim Breslin

No, it never came up.

Did, "It is not going well", never come up once? Okay. Does the Minister always attend those meetings?

Mr. Jim Breslin

Pretty much. If the Minister cannot attend, they do not go ahead.

They do not go ahead. It is not that the special adviser sits in.

Mr. Jim Breslin

No.

Did that ever happen?

Mr. Jim Breslin

Not to my recall was the senior Minister absent from one of those. There may have been an engagement in the past where a Minister had to leave early and we stayed talking through some of the issues with a Minister of State or whatever, but the Minister attends.

Do the witnesses all feel that they have plenipotentiary status in their own relevant roles, they are responsible for this and they make professional judgment calls on whether issues are escalated or not?

Mr. Jim Breslin

I am not sure about plenipotentiary. We certainly do a lot of work that we have to do independently and not be referring back all the time to the Minister. That is the nature of the amount of-----

With what Mr. Teap stated yesterday, 18 women are dead but it is not important enough to escalate it. One can understand people's frustration. From where I am sitting, I am sure anybody looking in could be forgiven for thinking the Minister's role is quasi-ceremonial. He gets to stand in for the shot but, really, that it is.

Mr. Jim Breslin

That is not true at all. If one takes the discussions that we have had this morning about all of the work that has been done legislatively, the Minister has driven that agenda. The previous Minister-----

That is a good point actually. Let us just look at that and let us look at collective responsibility of Ministers for the non-commencement of section 32B of the Civil Liability and Courts Act 2004, as introduced by the Legal Services Regulation Act 2015, which would have prevented some of the difficulty in this regard, as well as the non-commencement of section 2 of the Civil Liability (Amendment) Act in terms of periodic payments to victims. Both Ministers have done splendid jobs in pushing that agenda. We had the announcement last week of the package of measures, which was welcomed by our two guests yesterday evening on which, as of today, nothing has happened. They seem to be doing a great job at talking the talk but when it comes to walking the walk, it is about standing in for the shot, although, as an aside, they are conspicuous by their absence over the course of the past week where there has been a marked reduction in the number of shots or television appearances.

What changes have been made in Mr. Breslin and Dr. Holohan's approach to escalation? Another question relates to the assistant secretary for acute hospitals. The Department's statement of Thursday night last stated that the memos had gone to the chief medical officer's office and to acute hospitals. The latter is an assistant secretary's responsibility. Did he or she, whoever it is, ever say it to Mr. Breslin?

Mr. Jim Breslin

No.

Mr. Jim Breslin

On Tuesday, I placed all of this into the public domain.

Mr. Jim Breslin

Including the records.

I must have missed that because I was probably preparing for this.

Mr. Jim Breslin

I appreciate that.

I am sorry, if I did. What do they talk about, if they do not talk about this sort of stuff?

Mr. Jim Breslin

We talk about dozens of things that either are being developed by the Department in order to improve the health services or are issues arising in the health services. As the chief medical officer, CMO, has outlined, the first objective that officials within the Department have is to engage with the HSE on an issue and check out whether the issue being dealt with is a good issue. If the HSE is going to do something bad, try to stop it; if it is not prepared to stop it, escalate it; and if it is a good thing, support it, see are there any issues in it and manage the situation. On occasion - the CMO has outlined them - we absolutely do escalate issues. We have escalated dozens and dozens of issues. We go in. We find an issue with a service. We actually have to close the service down. We have to move something. We work with the HSE on this all of the time.

Okay, I get the point. Since this debacle of last week and the professional judgment not to escalate, has the Minister issued any guidance to the Department stating, "Gentlemen, I want to know everything from now on"?

Mr. Jim Breslin

I do not see a management paradigm that would involve the Minister knowing.

I just asked. I did not ask Mr. Breslin to tell me to justify my question. I just asked him.

Mr. Jim Breslin

The Minister has not issued something along the lines of what the Deputy has just said.

Have there been no guidelines from the Minister since this debacle stating, "Anything like this happening, guys, I want to know first thing, morning or night"? Has no new protocol been put in place?

Mr. Jim Breslin

We have talked about-----

They had a chat.

Mr. Jim Breslin

I beg the Deputy's pardon.

They had a talk about it. They had a chat about it, Mr. Breslin said.

Mr. Jim Breslin

We have talked about the relationship around this issue, how the issue was perceived in 2016, the reality of what actually happened post 2016 and the fact that there were issues in 2017 that - had we known about them - we would have escalated, which I have said straight up this morning.

I am more talking about tomorrow, if something happens. Has the Minister introduced any protocol to ensure that he or she would know immediately?

Mr. Jim Breslin

One can, and we do have-----

I would say it is a "Yes" or "No", with respect.

Mr. Jim Breslin

We have protocols but we also have to have judgment.

All right. We have established that the protocols, based on professional judgment, might not be in the public interest as we would see it.

Mr. Jim Breslin

I do not agree with that. I believe judgment is-----

I appreciate Mr. Breslin does not agree with it but nobody has exclusivity on being correct.

Mr. Jim Breslin

That is true.

What I am asking, based on the debacle of the last number of weeks, is whether the line Ministers relevant to this area introduced any new protocols or adjusted protocols in order that the same thing does not happen again, or is it a case of steady as she goes where they are happy enough with how the protocols were?

Mr. Jim Breslin

Preventing the same thing requires judgment. We cannot absent judgment from the management of the health services. It will always require judgement. Otherwise, it is artificial intelligence.

I can only say, in my humble lowly back bench opinion, had I been a Minister while all this was going on, one of the first things I would have done would have been to tell the Secretary General and CMO that from now on, I would want a list every morning of what was going on. I simply asked the question, "Has the line Minister introduced any new protocol or directions?"

Mr. Jim Breslin

I think I have answered the Deputy's question.

It is a yes or no question. Mr. Breslin has not.

Mr. Jim Breslin

I think I have answered it.

It is yes or no.

Mr. Jim Breslin

I have told the Deputy that no new protocol has been issued. I have answered the Deputy's question.

No. Okay, Mr. Breslin has answered the question. The answer is no. Am I done?

The next speaker will be Deputy Jonathan O'Brien.

I have one question. I missed what Mr. Breslin stated a minute ago about the escalation to the Minister. Mr. Breslin was saying if he knew then what he knows now he would have escalated this issue.

Mr. Jim Breslin

Yes.

What exactly was Mr. Breslin referring to?

Mr. Jim Breslin

The widespread non-disclosure of the information to the women.

Okay. Let us go through this. We are back into an important issue. Let Mr. Breslin say it.

Mr. Jim Breslin

As soon as we learnt of that, the serious incident-----

Rather than Mr. Breslin saying "that", of what did the Department learn? I want him to state it.

Mr. Jim Breslin

Sorry, the widespread non-disclosure of the information to the women.

Is that 80% of the 200?

Mr. Jim Breslin

Yes.

Mr. Breslin became aware of the non-disclosure, whereby 80% of the 200 patients had not been notified of that around the time of the court case.

Mr. Jim Breslin

In two stages. Immediately post the court case, we understood there to be a problem. Then once the serious incident management team over the course of a weekend traced the 208, as it was then, cases and we found 46 of them had been-----

Approximately 20%.

Mr. Jim Breslin

Then we knew this was widespread.

Here we are. Listening to what has been said at the meeting, we are at a crunch of an issue here. Mr. Breslin was saying that he, as Secretary General, and Dr. Holohan, as chief medical officer, had they known quite some time ago that 80% of these cases had not been notified to the patients, they would have escalated that information to the Minister.

Mr. Jim Breslin

Yes, and not just to the Minister. We would have escalated it within the HSE. It would have formed part of our performance dialogue. We would have had it as a top-level issue in terms of our engagement with the HSE management team.

Mr. Breslin, as Accounting Officer, is ultimately responsible for the €15 billion budget that the Oireachtas gives him to spend wisely on its behalf.

There was a serious breakdown in information getting to Mr. Breslin, with the non-disclosure of information to 80% of the 208 women involved. It only emerged recently. That information could or should have been known about but was not known about. It goes without saying that Mr. Breslin considered that knowledge so serious that, had he known, he would have escalated it to the Minister promptly. He must be seriously regretting that the information was not given to him at an earlier date.

Mr. Jim Breslin

Absolutely.

Would Mr. Breslin think that was the most serious failing in this whole issue?

Mr. Jim Breslin

It is a very serious failing. The very fact that it happened is a serious issue which we all regret. Second, the need to address all of the questions that people have asked, the issues arising and the uncertainty among women relating to that would have been to the fore. We would have mobilised a response and started to get ahead of the issue instead of, as people have said, reacting to events that made their way into the public domain.

To go back to the interim chief executive of the HSE, we are now hearing that the information about these patients and people needing to be informed was in the HSE early in 2016. Mr. Breslin is saying that had he known, after a short period, if that had not happened, it would have been a matter so serious that it required escalation to a Minister. While I am not talking about Mr. Connaghan personally, Mr. Breslin considered the fact that that situation was not managed, and that the patients were not informed of the facts obtained during that period, a serious issue. Had he known that, it would have gone straight to the Minister the next day he was in town. There is a serious failure with the HSE not monitoring the fact that the patients were not being informed. Mr. Breslin says it was so serious that, had he known about it, he would have informed the Minister. Does Mr. Connaghan take the point? We are trying to make Dr. Scally's job easier. We are putting responsibility in. We are getting to the kernel of not following through on a situation. It was well-known in the HSE that Mr. Breslin has said what he said. He should have known. If he had known the situation, he would have moved on it.

Mr. John Connaghan

That sentiment from Mr. Breslin would also apply to some of my colleagues. If they had known the scale of this at the time, they would have taken action. On escalation, I would expect that a manager would deal with it without having to escalate it. One only needs to escalate it if one cannot actually deal with it. What is the point in escalating and extending the timescales if one has the wherewithal to solve the problem one's self? Escalating, which is passing the problem up-----

I understand that.

Mr. John Connaghan

-----is sometimes not the best thing to do. We need to have a culture imbued to say that this is a person's issue and that he or she needs to deal with it forthwith.

This problem is that a system was not put in place by the people in charge in the HSE to be on top of this during that two-year period.

Mr. John Connaghan

I have captured it using common parlance, which is that there was no feedback loop. There was an assumption that it was happening but that assumption was clearly wrong. Perhaps the lesson we need to learn here is that we need an audit trail that asks, if there was an action, if it has been closed out and done, when it was done and whose responsibility it is to complete it.

I do not want to do the work of the scoping inquiry. It has a job to do. I will ask a couple of questions. We know there were six memos. The first was in February and the last was in October. The one in February talks about the laboratories looking at legal advice and the four steps. I can understand the rationale behind all of those steps when it is put in the context of what was happening. The issue was not the audit process but the communication of the results of that audit process to women. The very last memo, which is from October, said that there was now an engagement between CervicalCheck and the consultant doctors, which would be an ongoing process to inform women. Dr. O'Keeffe said the communication with the stakeholders and patients was being appropriately managed at this time. At that stage in October, is it fair to say that Dr. Holohan and Dr. O'Keeffe were of the opinion that this was being addressed, women were going to be informed through their clinicians and that was the instruction that was given? Was that the witnesses' understanding and, as far as they were concerned, there was no need to escalate it up the line? Is that a fair assessment?

Dr. Tony Holohan

Yes.

We now know that there was a breakdown in that. Clinicians did not inform women. Dr. Holohan and Dr. O'Keeffe said that they did not become aware of this until recent weeks, when this all came out after Vicky Phelan's case. Somebody must have been aware in those intervening periods where there was an understanding that all of the women would be informed through their clinicians. The policy was open disclosure and informing everyone. We found out when the Vicky Phelan case became public knowledge that that did not happen. There is a period there where somebody must know that that was not happening and that there was ongoing correspondence between clinicians and CervicalCheck about who was responsible or who was most appropriate to inform the women. Is there anyone in this room who was aware of those difficulties?

Dr. Peter McKenna

We were informed around July of last year that there were difficulties in communication between the screening group and the doctors concerned.

Who informed Dr. McKenna of that?

Dr. Peter McKenna

We were informed through the Limerick clinical director.

That is in the notes we have. The first that anyone in this room, in the HSE, CervicalCheck or the Department, became aware was in July 2017. From October to July, there was no knowledge of any issues with clinicians not relaying that information.

Dr. Peter McKenna

The first time it was indicated to Dr. Henry and me was in July.

What did the witnesses do with that information?

Dr. Peter McKenna

When the information came in, we got it from one side, the clinicians. They said there was a process here that they were not happy about. They gave their side of the story. The first thing that we did was to undertake to hear the other side of the story, which was to write to the screening service and get the reply.

That would have been Professor Gráinne Flannelly. Then it comes back to CervicalCheck. Was that the first time that Mr. Gleeson was aware of an issue with clinicians not informing their patients?

Mr. John Gleeson

No, I do not think so.

When did Mr. Gleeson become aware?

Mr. John Gleeson

I do not have a date. Professor Flannelly would have commented over the months from October 2016 as the historic letters, the dated cases going back, had all been cleared and we were now in current mode. As a case arose, we were communicating that she had a chat with some clinician, they met somewhere and they might have discussed a case. It was proceeding and she did not raise any issue until the one that Dr. McKenna refers to where there was a serious block. We discussed it at the executive management team and said we will try to go to work on that and release that block. We cannot have that.

So between October and July, Mr. Gleeson would have been aware that there were some issues but that it was not a major issue and it was not until July, when he