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Joint Committee on Health debate -
Wednesday, 16 May 2018

CervicalCheck Screening Programme: Discussion

The purpose of this morning's session is to meet officials from the Department of Health and representatives from the Health Service Executive, HSE, and CervicalCheck in order to get further clarification on the evolving situation in CervicalCheck, including the processes surrounding open disclosure, the quality of the screening programme and the impact this has on medical care of women. On behalf of the committee, I welcome Mr. Jim Breslin, Secretary General at the Department of Health, and Dr. Tony Holohan, chief medical officer of the Department. From the HSE, we welcome Mr. John Connaghan, interim director general; Mr. Damien McCallion, national director of the National Screening Service; Dr. Stephanie O'Keeffe, national director of strategic planning and transformation; and Dr. Peter McKenna, clinical director at the national women and infants' health programme.

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

Any opening statements made to the committee may be published on its website after this meeting. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make any charges against a person outside of the Houses or an official either by name or in such a way as to make him or her identifiable.

I invite Mr. Jim Breslin to make his opening statement.

Mr. Jim Breslin

I thank the committee for the opportunity afforded to me and Dr. Tony Holohan, chief medical officer of the Department, to meet members this morning and share some opening remarks. I would like at the outset to recall the bravery of Vicky Phelan, Ms Emma Mhic Mhathúna, and the loved ones of other women who have come forward in recent days. Their testimony and willingness to speak publicly about deeply personal matters has raised very serious questions. These questions related to how the health service engages with individuals when things go wrong and the fact that the audit results for these women were not conveyed as they should have been.

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 like to acknowledge the powerful and deeply generous nature of the advice that is given when women who have had such painful experiences encourage others to continue to participate in the programme in the interest 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 interest of current and future generations of Irishwomen. The Department is committed to discharging its particular responsibility to take the necessary steps, in association with the HSE, health professionals and others, to restore the trust of women in the CervicalCheck programme and, indeed, 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 so lessons are learned for the future.

The focus, however, 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 health and social care measures include a discretionary medical card for every woman affected, or her next of kin in cases where the woman has sadly died, so that they can 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 that have been prescribed by their treating clinician; primary care supports, including counselling, for the women affected, and also counselling services for the immediate family members of these women, including bereavement counselling where needed; and other health and social care supports, including travel costs and childminding.

An international clinical expert review panel is also being established as part of the Government’s investigation into CervicalCheck. 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 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 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 and will prepare individual reports for those affected, setting out the facts and their expert and independent assessment.

The Government has also announced that the State Claims Agency is advancing a new initiative aimed at expediting the 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. The Bill will also provide for mandatory reporting of these serious events to the appropriate regulatory authority, such as HIQA.

Yesterday, 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 the 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 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, one based upon the information available at the time and the other based on 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 major concern and a much different attitude. Based upon the information we had, however, we viewed the initiative taken to communicate audit findings to women in a positive light.

The widespread and still unfolding distress caused by the non-disclosure of the clinical audit results to the women concerned demands serious reflection, however. The Scally inquiry provides us with a mechanism to achieve an objective basis for introducing improvements, where these can be identified. The Department has at this stage publicly committed to engaging with the HSE on a full review of the implementation of its open disclosure policy.

As I have mentioned, the Government has approved the drafting of a patient safety Bill by the Department. This Bill will provide a mechanism to develop and introduce standards relating to clinical audit so as to 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 June. The Department will be subject to this inquiry and will be scrutinised by it, but the committee can be assured we will provide full support and co-operation and address any learning and recommendations as a matter of priority.

With the agreement of the Chairman, I will ask Dr. Tony Holohan to make some remarks.

I thank Mr. Breslin. Could Dr. Holohan make his opening statement?

Dr. Tony Holohan

I have been chief medical officer for ten years. I cannot recall a time in those years when patients were gripped by such widespread fear and concern as they are now. Of course, given the nature of the events that have unfolded in recent weeks, the fear and concern are entirely understandable, but it has been difficult to get real facts, which people can trust, into the public domain and hence into public understanding. I welcome the opportunity to contribute in this regard this morning.

We know things went wrong. It is true that lessons must be learned but it is important that we be clear about what actually came to light. Arising from the publicity following the Vicky Phelan court case, questions arose as to whether other patients might be in a similar situation. Had Vicky Phelan not highlighted her case, we might not have become aware that other women had not had the findings of the CervicalCheck clinical audit disclosed to them by their clinicians. We therefore owe a debt of gratitude to Vicky Phelan.

It has become clear since the case that the non-disclosure of clinical audit findings was widespread. It has also become clear that the issue of disclosure was the subject of dispute among some elements of the relevant clinical community. I can provide assurance that the Department was not aware of these issues until this controversy arose, towards the end of April. We have since had the opportunity to engage directly with a view to understanding, directing and investigating what happened.

Let me be clear on what we knew in 2016. First, no Minister was advised. Second, the decision not to escalate was a fair and reasonable decision based on the information available to the Department at the time.

It was reasonable because the information provided in the briefing notes provided by the HSE to the Department was evidence of ongoing improvement to how the service was being delivered, rather than the identification of problems that might require escalation to Ministers. The HSE has confirmed, and will confirm, that no systems of escalation within its organisation in relation to the implementation of the audit programme were activated.

In respect of CervicalCheck, it is important to point out how much has been achieved in recent years. Before 2008 in this country we had a disorganised arrangement of random screening where random women were getting too many smears and many others were not getting any smears at all. On an annual basis, we were doing more smears in the country at that time than we do currently. Smears were being examined in a wide range of laboratories, many of which were too small and not fit for purpose. There were no quality assurance arrangements in place and there were very long turnaround times for reporting of smear results. In 2008, the population-based programme which invites patients to come forward to their GPs for smears was established with those smears being sent to accredited laboratories and appropriate follow-up in colposcopy services. Prior to 2008, cervical cancer incidents were rising but we know that the impact since 2008 has been a 7% annualised reduction after 2010 in the incidence of cervical cancer, a clear impact of the programme.

Let me turn briefly to open disclosure. It is important, given some of the debate that has taken place, that we make the position of the Department clear. The Department does not and never has regarded open disclosure as optional. Open disclosure should happen in the right way, in every circumstance in which it is indicated. Patients simply must be informed. I know that this can be a challenge for the medical profession but professionals in this country are rising to that challenge. Our legislative approach is to encourage doctors to do the right thing in circumstances where disclosure is required. We know from international evidence that one of the reasons that disclosure does not always happen in the right way or at all is that doctors may fear the medico-legal consequences. We have directly addressed this fear through the voluntary disclosure legislation, the Civil Liability (Amendment) Act 2017. The regulations are to be signed within the coming weeks. That legislation provides that if doctors disclose appropriately, they will not contribute further to any legal risks they may have. That is intended to create a so-called safe space to encourage people to do the right thing.

That is not to say that we do not see a role for mandatory open disclosure, so a stepped approach is required. Therefore, following many months of work, we have secured Government approval for the patient safety Bill to introduce mandatory open disclosure for a specified list of serious reportable events. This is in line with the UK duty of candour. However, it goes further in that it is not just an obligation on organisations, as with the duty of candour in the UK, rather it is an obligation on doctors to disclose. Thus, the commitment to open disclosure in this country could be regarded as exceeding - when we have enacted that legislation - that which is placed on doctors in the UK.

It is really important that I am clear that we absolutely recognise that at the centre of this are tragic cases. We are fully sensitive to that. I want to engage, and the Department would wish to engage, directly with the individuals involved in these cases, as we have done in the past in other situations, to ensure we fully understand their perspectives and fully engage them in the process of further policy development and oversight so that we can ensure that any lessons that can be derived here can be properly applied to improvements in the future.

Mr. John Connaghan

I thank the Chairman for the invitation to attend this meeting. Several issues have already been covered by Mr. Breslin and Dr. Holohan so I will truncate my opening statement accordingly.

First, I would like to acknowledge and apologise for the confusion and alarm which has been created in relation to the CervicalCheck programme as a result of the failure to communicate with the women affected. This failure has ultimately impacted on every female in Ireland, their families, their spouses and their 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 both CervicalCheck and the HSE - has failed by any measure.

I sincerely apologise on behalf of the HSE and CervicalCheck to the women and their families who have been directly affected by what has happened and to all the women of Ireland who have been understandably frightened and concerned by what they have read and heard. We must learn lessons from what has happened. I assure the committee and especially the women of Ireland that I am determined that we will take on board these lessons. Together with my colleagues, we will work to bring about the changes needed with a view to ensuring that this does not happen again. The CervicalCheck programme 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.

In the short time that I have been interim director general, less than three days, I have asked for a full record search and a full chronology of events to be compiled. That exercise is now under way. The HSE last week provided three separate briefing notes at short notice to the Committee on Public Accounts, PAC, and we have also submitted them to this committee for information. Regrettably, there was not sufficient opportunity at the PAC meeting last week to provide appropriate context and interpretation of the three briefing notes. I have therefore brought colleagues to this committee who will be prepared to answer any questions of detail on these notes. The full record search has allowed three further briefing notes relating to the audit process. These briefing notes are provided to the committee here. It is fair to say that the language in all of the briefing notes is very functional and somewhat lacking in empathy for the women who were to be communicated with.

I have submitted an information note to the committee regarding the briefings that were submitted to PAC together with other information. In relation to the three specific briefings given to PAC last week, and which we have also copied to this committee, the context for the briefing given in March 2016 to the national director, health and well-being, HSE, the former director general of the HSE, and to the Department of Health was to raise awareness of the audit process that CervicalCheck was engaged in and the initial outcomes and next steps of that process. The intent of the CervicalCheck programme was that all treating clinicians would be given individual audit findings for their patients so that these could be in turn communicated to the women concerned, in line with guidelines at that time.

A key element within the March 2016 briefing was the assurance it gave that there was no systemic quality issues of concern with the programme. This is the most important element of an 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, European guidelines.

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

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. This issue concerned one laboratory, Quest Diagnostics, that challenged the CervicalCheck programme communications process with treating clinicians and invoked a dispute resolution process, as part of that contract. I have been advised that this is why "pause all letters" was listed as a next step in the briefing. It was imperative that CervicalCheck and the National Screening Service resolved this issue quickly so as to ensure it 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.

The thinking at that time was that if CervicalCheck were to continue sending letters, without that assurance that it had legal cover to do so, it could have created subsequent legal issues for the operation of the CervicalCheck programme, in addition to potential risks for any women seeking redress where the laboratory could claim its legal rights and entitlements were infringed by the process. This is why "await advice from solicitors" was one of the next steps 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 March 2016 briefing note states that "There is now a batch [or] accumulation of clinical audit case reports that have been completed". It was understood by those that were briefed that these case reports needed to be converted into individual letters in relation to each patient concerned.

The correspondence demonstrates that this work was happening at this time. This correspondence will be made available to the scoping inquiry.

CervicalCheck explained in the briefings how the audit and communications process was complex, multi-layered 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 that the logistics of sending out these communications needed to be carefully thought out so as to mitigate any risks relating to the manner, mode, content and logistics of the communication. This is, therefore, why "decide on the order and volume of dispatch to mitigate any potential risks" is set out as a next step in the briefing note. It is important to note that CervicalCheck issued the majority of the correspondence concerned during July and August 2016, with approximately 200 letters according to the July 2016 briefing notes.

We need to be realistic in our assessment of the communication process. The CervicalCheck programme did not close out the issues that were subsequently encountered regarding the breakdown in the process of treating clinicians discussing those 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. I can confirm at this point that the screening service is concluding an agreement with the faculty of pathology to provide guidance and direction for the screening programme. This will help us to provide the necessary clarity as we move forward.

It is also important that we look at some key facts. Most women’s smear test results are accurately reported. Every year, more than 250,000 smears are undertaken. For women who have received a normal result, the chance of going on to have cervical cancer by their next smear test three years later is less than 1%. Since 2008, the CervicalCheck programme has provided some 3 million screenings to over 1 million women. The programme has detected over 50,000 high-grade pre-cancerous changes in women, therefore reducing their risk of cervical cancer by 90%. These were women without any symptoms who, without that screening programme, would not have known that they had pre-cancerous changes. Latest figures show that the incidence of cervical cancer in Ireland reduced by 7% in the period 2010 to 2015, which is welcome.

I want to take this opportunity to say a few words briefly in defence 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 sub-optimal 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 process, we must ensure that healthcare professionals are not discouraged from taking part in clinical audit. Fostering an open culture which supports clinicians and encourages learning must be part of our ethos.

I should also say a few words on accountability. To me, accountability is the obligation for an organisation or individual to account for its, his or her activities, accept responsibility for them, and disclose the results in a transparent manner. As interim director general, it might also be useful to outline how I see myself discharging my 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, therefore, foster a culture of openness, transparency and both 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, 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 here, which was a collective failure, was on ensuring effective follow through on these good intentions. While the results of the audit were communicated to the relevant clinicians, the arrangements thereafter broke 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 has been profound for every woman affected and for their families. It has also undoubtedly 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 will conclude with four pledges. We will move swiftly and with compassion to provide effective support packages to the women and families who require support. As outlined by the Secretary General, we will do this with the minimum of fuss and bureaucracy and with empathy. We will fully, openly and transparently co-operate with the Scally inquiry and any subsequent inquiries. If there is a requirement to hold individuals to account on a personal basis, we will do so. In this 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.

I thank Mr. Connaghan. The way we will conduct the meeting this morning is we will offer each member of the committee 12 minutes to ask and receive answers to questions and I ask them to observe the time limit, if possible. Those who are not members of the committee will be allocated five minutes to ask questions and have them answered. With this in mind, I will begin.

I have a number of questions which I would like Mr. Connaghan to answer. Why was the information on the false negatives identified in the audit not brought to the attention of the secretary general of the HSE and the Minister for Health at the time, in regard to open disclosure? Why was it not escalated up the line? Where is the information regarding the number of false negatives identified from the various laboratories? We requested last week that we would get information on the quality of the reporting of each laboratory, but we still have not received that information. Why was open disclosure posing such a great difficulty in 2016 when it was already HSE policy in 2013? What was the issue that inhibited open disclosure?

I believe it was the responsibility of the CervicalCheck programme to make information available to patients. I do not think it was the responsibility of the treating clinicians. I would like Mr. Connaghan's comments on this because it was the CervicalCheck programme that took the smears, and I believe they were the appropriate people to contact patients and pass the information down the line.

With regard to the documents we received yesterday, in document No. 5 there is a table of cervical cancer cases notified to the National Cancer Registry in Ireland and another table of the cancers identified by CervicalCheck. Up to 2013, some 1,853 cancers were notified to the cancer registry yet the CervicalCheck screening programme had only 808. Did that not trigger alarm bells, that there was a growing disparity between the figures? Perhaps Mr. Connaghan will comment on this.

Was there any withholding of information over the period up to now, from women who specifically asked for information on their previous smears but were denied access to that information? Are there any issues in relation to cytology, other than the false negatives, that have led to delayed diagnosis and delayed treatment in the CervicalCheck programme, in other words, in the process of recall, getting appointments and access to colposcopy? Why is the proposed introduction of HPV testing of smears being delayed until November of this year? Surely that test could be introduced sooner.

Mr. John Connaghan

I will call on some of my colleagues because the Chairman has raised issues that precede my time in Ireland and my time as interim director general, and which are probably best answered by them.

I call on Dr. Peter McKenna to make some comments on the false negatives, the quality of reporting in laboratories and the questions raised about cytology and HPV.

Dr. Peter McKenna

The false negatives will come out when we look at the 209 cases to see which laboratories were responsible. This is complex to do because it depends on when the laboratory concerned came on board and when it left. Not all laboratories started and left at the same time. If a laboratory started early and reported a smear as negative, the patient will have had a longer time to develop a cancer. It is complicated to work out. It is not just a matter of seeing if all of the laboratories are represented proportionately in the number of smear tests they did but when they started doing them. That will be looked at. I could eyeball it - I have - but it will need more complex analysis than I could give it. It is not simple to do.

When might that information be available?

Dr. Peter McKenna

It will be given to an external expert to look at in detail. I have eyeballed it and there may be a simple explanation, but I would not be qualified to give the full story.

Mr. Damien McCallion

One of the options we are considering is asking the forthcoming international expert panel to look at it as part of its process, rather than have a range of processes. The director general has also mentioned that we have engaged with the faculty of pathology. Clearly, that was a vacuum. There was much analysis of laboratory results and different interpretations. We felt we needed to channel it into a formal process. We asked the faculty and hope to finalise tomorrow that it will provide support for the programme in dealing with that issue.

Dr. Peter McKenna

The false positive rate is what is usually looked at. It is the positive predictive value. It takes a couple of months because the smear needs to be matched with the histology report on the biopsy. That is easier to do. The laboratories all fall within a fairly narrow parameter in the early to mid-80s. That is acceptable. The false negative will take a long time to come through because there could be a five or six year gap between a negative smear and the diagnosis of an invasive cancer.

Mr. John Connaghan

The Chairman also asked a question about HPV testing and when it would come onstream. At this point, the plan is that towards the back end of this year we will introduce HPV testing after we have conducted the appropriate tendering and specification process. Dr. McKenna might want to say a few more words about the difference between HPV and cytology smear testing.

Dr. Peter McKenna

In very general terms, HPV testing will pick up more cases, but it will also pick up more negatives. That is why we cannot abandon cytology totally. If we did and just used the papilloma virus test, we would end up overtreating many women. The treatment is generally fairly innocuous, but it can on occasion result in infection and haemorrhage. If it is overzealous, there may be adverse outcomes in respect of future pregnancies. The idea that it is possible to pick up everything and that treatment is innocuous has to be weighed against the missing sum. I can talk about the over-disclosure element mentioned in a question.

I am sorry, but to return to HPV testing, is it not a combination of HPV testing and cytology that is to be instituted?

Dr. Peter McKenna

Yes, but HPV testing can be done on its own as a screening test. If it is negative, the chances of the person subsequently developing carcinoma are very small. It is very good at that. However, if it is positive, there may not be a disease present. It is possible to carry the virus and for it not to effect a person's cells. That is why we have to have cytology. HPV testing will pick up much and it is very good at producing the negative that a person is unlikely to develop the disease, but it will also pick up more false positives. That is why we need cytology and colposcopy.

I am sorry to interrupt-----

Dr. Peter McKenna

I was going to mention the open disclosure issue. The question between the clinicians and the programme is important. I was involved through hearing about it from clinicians. They were of the opinion that they were asked to give information that had been known to the programme for some time. They had not been involved in the collation of the material and at the outset, when it was probably inevitable that this was going to happen, they had not been involved in the construction of the audit or the dissemination of the outcome. That would explain their reluctance to give the information.

The principle of open disclosure, from a clinical point of view, is well established. If, for example, in the course of a hysterectomy I was to damage somebody's bladder, the onus would be on me to explain that I was sorry that I had done it and why it had happened. I would explain that it happened in so many instances, that it was unusual and again that I was very sorry. What would happen in that hypothetical example would be current and the error I would be disclosing was mine. The question of an audit is quite different. The information would be retrospective and I would be disclosing somebody else's error. That was not something with which the clinicians were immediately comfortable. It is a departure from what most people consider to be their normal day to day activity.

My question was did Dr. McKenna think it was the responsibility of CervicalCheck to communicate directly with the patient as opposed to through a third party.

Dr. Peter McKenna

I can see merit in it being done through the clinician. He or she would probably have a relationship with the patient that the programme would not. However, it was entirely predictable that false negatives would be found. The clinicians should have been brought on board at an earlier stage and their willingness to undertake this part of the work should not have been taken for granted. It should have been sought.

My time is probably running out, but I did ask a question about why the matter had not been brought to a higher authority within the Department of Health and the HSE.

Mr. Jim Breslin

We will start with the HSE because we pick it up after that.

Mr. John Connaghan

Clearly, there was a failure of escalation within the CervicalCheck programme. Looking at some of the briefing notes later produced in the system - I am talking, in particular, about those produced in October - there was some degree of assurance that the process was under way. The failure was not to complete the feedback loop. Communication was intended, but it should have been asked if it had actually been done. Mr. Breslin might want to say a few words.

Mr. Jim Breslin

In reviewing the detail and looking at the information available to the Department I can see that the sense within it was that it was a retrospective clinical audit for the purposes of quality assurance and that, importantly, a process had commenced to inform the women via their consultants. These two facts would not have raised serious concerns on the part of the Department. In fact, they would have been seen in a positive light in the context of commitment to operational improvement and a commitment to openness. The Department was updated over a period and the updates showed the progression of the process. They were showing that what people had set out to do was being done.

What we were not advised of was the subsequent widespread non-disclosure of the results. Had we been so advised, I think our attitude would have been very different. However, based on the information we had at the time, we looked at it as something that was worthwhile and being delivered. We were told that the process had finished with good progress being made and that the road set out had been gone down. Everything had been done as intended.

The process for an official in the Department is to engage with the issue and seek to manage it out with the HSE. It is only if they such issues are not resolved that they are escalated. We are a relatively small Department and I want to have responsibility within the Department for interacting with the HSE at various levels and to identify issues and raise them with the HSE. Sometimes we will get a very appropriate response and everything will be fine. Sometimes there is an issue, and then we need to push the issue to try to see it followed through. If at that stage more support is needed to resolve an issue, it is escalated. Simply to escalate every piece of information which comes into the Department from an organisation the size of the HSE would not be realistic and effective in terms of how we do our work.

I thank Mr. Breslin. We have to move on. We will get an opportunity to come back to some questions. I will now introduce the spokespersons for the various parties.

I thank the witnesses for coming here today. I wish Mr. Connaghan the very best of luck in his role. I would like to make a point to Mr. Breslin, as head of the Department, and Mr. Connaghan, as the interim director general for the HSE. Over the past two weeks this committee spent about eight hours with various senior representatives from the Department, HSE and CervicalCheck and we asked a lot of questions about who knew what. I do not want to get into a Jesuitical conversation about exactly how questions were phrased, but the distinct impression I was left with after eight hours in this room was that the first the office of the director general in the HSE and Department knew about any of this was 2008. It was very disappointing then to discover through the Committee of Public Accounts that there were detailed memos between the HSE and the Department as far back as 2006.

It was 2016.

Sorry, 2016. I thank the Chairman. I want to put on the record that that information should have been disclosed. Whether any of us asked the right question exactly, in the spirit of open disclosure and an investigation into open disclosure it was very disappointing that the information was not released. Yesterday we received an entire folder worth of correspondence from that time. Who knew what within the Department? My understanding is that none of the information in that folder and nothing to do with this issue was escalated to Mr. Breslin. Will he confirm whether that is correct?

Mr. Breslin stated that in his opinion something of this sort would not be escalated to a Minister. Within this documentation it clearly states that there is a substantial risk to public confidence in the national screening programmes due to the potential of woman who are being informed going to the media and talking about their very tragic cases. Is the potential loss of public confidence in a part of the health care system due to what happens in the media and public arena not exactly the sort of thing officials should bring to a Minister? Given that is what the warnings were, why was this not raised at any point with the then Minister and now Taoiseach, Deputy Leo Varadkar, or the current Minister, Deputy Harris?

Mr. Jim Breslin

The 2016 material was not escalated to me, and as the crisis has developed in recent days, I have become aware of the documentation which was put together. I appreciate the way the Deputy has put the question across in terms of the engagements we have had and what he has taken away from those engagements. I have been very clear and consistent throughout the process that there was a significant trawl of documentation under way in the Department of Health and I was not in a position to be definitive until we got to the end of that process. What happened on Thursday was that we effectively switched focus into a very focused look at some particular records to try to generate them. We had a significant trawl under way and I explained that to people as they asked me exactly what the Department knew on the overall issue.

The other question concerned the potential loss of public confidence. The generality of service delivered within health care is intimately involved with interaction with patients. There is almost no situation, other than in the back office, where issues being dealt with are not being dealt with with patients. There was a distinction around this which was that it was a quality assurance programme that was retrospective and did not bring someone in to tell him or her that he or she had a diagnosis of which he or she was unaware.

A risk was identified and communicated to the Department that there was the potential for a future loss of confidence in the programme due to media coverage. Is that not exactly the sort of thing which should be escalated to a Minister?

Mr. Jim Breslin

It should have been properly identified within the programme to put in place a strategy to manage that. In the interactions with the Department - Dr. Holohan can talk to this - the reassurance which was given around that was such that it seemed to be well attended to. It was the subsequent problems which emerged that have landed the problem where it is now. I will ask Dr. Holohan to comment.

Just to be clear on that, Mr. Breslin does not believe the fact that a risk was flagged with the Department to the effect that there was the potential for a future undermining of this programme because of negative media coverage is the sort of warning that should be escalated to a Minister.

Mr. Jim Breslin

The nature of this was a screening programme. That is important. It was a programme which was set up based on the technology being available to try to work through the relevant people in the age group and identify those who should have further follow-up treatment.

I understand what the programme is for. I am asking Mr. Breslin whether he believes the Department being told the HSE is going to do something which risks leading to a loss of confidence in the programme because of media and public reaction is not sort of warning that should be escalated to politicians.

Mr. Jim Breslin

It is embedded in a screening programme right from its initiation that one is putting in place a programme which will not identify every cervical cancer because of the population.

With the greatest of respect, Mr. Breslin is not answering the question. I understand it is inherent in a screening programme. I am going to ask him the question for the fourth time. The Department was told by the HSE that CervicalCheck was about to do something which could lead to a loss of confidence in the programme due to media coverage and the public reaction. That is exactly what has just happened. Is that not the sort of warning that the Department should escalate to a Minister?

Mr. Jim Breslin

We are now at a point where there is a very intense demonstration of that. The assessment done at the time was much closer to the ongoing operation of a screening programme. People who, as part of the delivery of screening, subsequently get cervical cancer will say they were screened and this is a real issue. From the very first day the screening programme was put in place, that was an issue present within it and something which was being managed with women when they came forward.

I am sorry to cut across Mr. Breslin, but I am conscious of time. With the greatest of respect, that is not what happened. This was not business as usual. The HSE decided, correctly, to do an audit which was international best practice. It also decided, correctly, that it was going to communicate the results of those audits to the clinicians. I understand at the time CervicalCheck believed the clinicians would communicate that to the women. The HSE was doing something new. It was flagging issues to the Department and saying that it was about to communicate for the first time with hundreds of women around Ireland and tell them that they got a false negative that was likely to lead to a loss of confidence in the programme. This is not business as usual. That is the warning which was flagged to Mr. Breslin. I am asking the question for the fifth time.

Is that not the type of warning that should be escalated to a line Minister?

Mr. Jim Breslin

I am not describing it as business as usual. Business as usual was when the programme was set up and I put the other extreme as being the very intense position in which we find ourselves. There is no doubt that in tackling a backlog of audit results and engaging with women, it was further along, but the judgment made was that it was not, within the gamut of issues being managed across the health service, of sufficient scale. It was being dealt with in an appropriate fashion according to a good, open approach with women, and the judgment was that it did not need to be escalated.

I thank the witness. I will move to the legal advice. One of the documents indicates that one of the cytology laboratory providers has sought legal advice with regard to the rights of the programme to communicate audit outcomes and the programme is liaising with the legal team on this. The legal team is reviewing the content of case reports. Did the Department take legal advice on this and, if so, from whom did it take the advice? At any point was the Attorney General's office made aware of the legal consultation going on with the Department?

Mr. Jim Breslin

No, the Department took no legal advice on it. The contract was held between CervicalCheck and the laboratories. We would not have sought legal advice in the Department.

Mr. Breslin stated earlier, "I believe a reasonable approach was taken by the Department at the time based upon the information available to it." The Department was told an audit was taking place, it was positive and it was international best practice. The Department was told the clinicians were being told, which was also positive and good practice. The Department was also told that CervicalCheck or the HSE was essentially opting out of open disclosure. In the documentation provided, it states that while CervicalCheck "supports the principles of open disclosure, it is recognised that there are limitations to its universal implementation". It goes on to elaborate on that and provide various opt-outs to clinicians if they believe it is not in the best interests of women or if the woman is deceased. Pro forma letters are provided to that end.

The policy of open disclosure was in place from 2013. Dr. Holohan stated that he does not regard open disclosure as optional. The HSE told the Department explicitly that it was opting out of full open disclosure. Does the witness believe the Department, in that sense, was correct in not interrogating that opt-out further?

Mr. Jim Breslin

I will ask Dr. Holohan to speak on that as he was involved in that interaction.

Dr. Tony Holohan

A key consideration for us was whether the HSE open disclosure policy was being complied with in this regard. The HSE open disclosure policy does not mention disclosure in every circumstance, irrespective of every consideration. There are mitigating circumstances and circumstances taken into account by clinicians. The HSE may wish to add to some of this. For example, we know that in the screening of this kind, international evidence tells us that up to 40% of patients would not wish to have this information disclosed. It is just one fact I would point to. It cannot be seen as something that happens in every situation, irrespective of the considerations. An approach to what might be termed non-optional disclosure does not mean clinical considerations or the realities of individual situations between clinicians and patients are not taken into account and precisely how and when that disclosure takes place.

It is important and it goes to the core of our policy in disclosure that it should not be seen as an event or the passing over of a piece of paper or information. It is a relationship with the patient where trust and confidence are maintained. The patient has a piece of information shared and sometimes it is bad news and difficult to take on board. Patients do not fully absorb it on the first occasion. There needs to be a proper and quality relationship.

The HSE flagged there would be limited or conditional disclosure. If I understand those comments correctly, Dr. Holohan has indicated his support for that. He has given incidents where non-disclosure might be okay. I want to be very clear on this. Is it the Department's view, based on Dr. Holohan's comments, that CervicalCheck, in putting conditions around open disclosure, acted correctly in its approach to disclosure?

Dr. Tony Holohan

I do not wish to be evasive in answering the question. I am happy to let the Scally process determine the answer to that. Our understanding-----

I am asking the opinion of the witness. We do not need the Scally process to determine his opinion, which is what I asked for.

Dr. Tony Holohan

I do not have full information on all the disclosures and how they happened which I need to answer that question definitively.

This is important. I know I am cutting across Dr. Holohan but the question I am asking does not require the Scally investigation. The question was whether Dr. Holohan was essentially comfortable or okay with the fact that the HSE was letting the Department know it was putting conditions around disclosure. The response explained when conditionality might be okay. The question is now whether Dr. Holohan believes CervicalCheck was correct in its opt-out approach. I am not asking him to comment on a case-by-case basis as I know he cannot do so. In the approach, was CervicalCheck correct in putting some conditionality around the disclosure?

Dr. Tony Holohan

I believe CervicalCheck believed it was complying with the open disclosure policy, which is not to say there are not lessons that can be learned.

The question was whether Dr. Holohan believes it was complying with the open disclosure policy.

Dr. Tony Holohan

Yes, I believe there was an honest attempt to comply with the open disclosure policy.

Was the information given to Dr. Holohan in terms of the opt-out in compliance with the open disclosure policy?

Dr. Tony Holohan

Give me that one again.

Does the witness believe the approach that CervicalCheck told him it was taking was in compliance with the HSE's open disclosure policy?

Dr. Tony Holohan

I would not have seen the HSE, in giving us this information, as flagging the characterisation that the Deputy is putting on it that this was now conditional or something less than the disclosure policy in place from 2013. The HSE may wish to comment on whether it believed that is what it was telling the Department. I do not believe that is what the HSE would say it was telling us.

This is important and I will read it again. It states that while CervicalCheck "supports the principles of open disclosure, it is recognised that there are limitations to its universal implementation, particularly for screening services where there is an inherent recognised error rate" and so forth. In its defence, CervicalCheck told the Department in 2016 that its approach to non-disclosure recognised there were limitations to its universal implementation, if the witness does not want to use the word "conditional". I am sure the witness has re-read this very carefully since, so does he believe CervicalCheck's approach and what it said it was doing was in compliance with the HSE's open disclosure policy?

Dr. Tony Holohan

I do, and I say this because it is not flagging the same thing. Disclosure operating in a screening environment is not the same. It is true to say the CervicalCheck programme did not have its own specific policy relating to open disclosure, and perhaps that is learning that can be applied. The only other jurisdiction we have been able to identify that has open disclosure specific to audit findings of this kind is England. Most jurisdictions throughout Europe do not have express policies and most that do have express policies not to disclose such information. All of those policies relating to disclosure recognise that this inherent fact is true, that open disclosure in a screening environment is different from normal clinical situations. That is not to say, therefore, that it is not in compliance with the open disclosure policy.

Thank you for allowing me the time, Chairman.

I thank the witnesses for coming in. I observed that they started their contributions by saying "sorry" but basically followed that by saying they did not think they had much to be sorry for. That is my reading of what has happened. Maybe after the questions I might change my mind.

I will go back to open disclosure.

Dr. Holohan was sent copies of these template letters. They were sent to him by email.

Dr. Tony Holohan

That is right.

In those letters it says nothing more than, "Please ensure that this correspondence is added to Ms [Surname]'s medical record", and, "If open disclosure is indicated in this case, please follow the local hospital guidelines." Then there is another comment which says, "Do not include if the woman is known to have passed away." To me that would be the very opposite of open disclosure. There is literally no reference to telling the woman anything. For the avoidance of doubt, if anyone is unsure about what it is people are angry about, it is that impression that has been given that information was deliberately withheld. We can get into a conversation about whether that information was material to a woman's health and well-being, but it was information that certainly could and should have been shared, and by my reading of it, any policy of open disclosure should have encouraged that information to be shared with the woman herself. Dr. Holohan is signing off on these letters. They explicitly exclude telling women. They simply say "ensure that the correspondence is added to [her] medical records" and, "If open disclosure is indicated [very much optional here] please follow the local hospital guidelines", unless of course she has passed away, in which case just stick a note on her file. That is the sort of stuff that makes people very angry. Dr. Holohan might advise us on those letters and when he signed off on them. It does not look like open disclosure to me, but perhaps he has an alternative view.

Around the same time as these letters were circulating, Dr. Holohan sent an email to Ms Conroy on the memo. In it he said they should have a chat about this. Does Dr. Holohan have any recollection of that? Was it a formal meeting? What would they have been discussing at that time? It strikes me that Dr. Holohan has come here to talk to us, in hindsight, about all he knows, but the truth is that he and his colleagues knew more than the women themselves. That information was available to him and his colleagues. It is not fair for people who would have had sight of these memos from February 2016 to pretend they are surprised at the revelations now. This would have been known to them all along. It is shocking to me that that sort of information would not have been escalated to the level of a Minister.

I am not sure I am satisfied with the explanation Dr. Holohan gave because it is clear when these memos are read through that the women are hardly mentioned at all but the media features. Dr. Holohan and his colleagues were getting themselves ready for some class of a media storm. He would have seen the Minister in the Dáil two weeks ago. The Minister was not pleased at being handed information just as he walked in the door, and I do not think anybody would be in those circumstances. This information was known to Dr. Holohan in February 2016 because he would have had sight of those memos, so it is not fair of him to pretend it is coming as a surprise to him now. On the process of escalation, it defies belief that it would not have been escalated to the level of a Minister, but maybe Dr. Holohan can explain his involvement in those template letters, because clearly they were sent to him for his own information. I am assuming he read them and he was happy with the content.

Dr. Tony Holohan

To take that question first, I was not signing off on these letters. They were offered as evidence of validation of the process. The documentation shows that the majority of these letters in relation to the backlog had already issued. I would know and understand that no one of these templates would actually look like the individual letter that would be sent to an individual patient. It reflects some of the considerations. It is important that the HSE would speak to this. That is how I would have perceived these letters with my understanding of screening and audit. I would not have taken some of those interpretations from them. Perhaps the HSE might wish to comment on that.

Dr. Holohan is a doctor.

Dr. Tony Holohan

I am.

I am not and I would have taken those interpretations from them. It is explicit in those letters not to tell them and to put a note in their file. That is what it says. It was sent to Dr. Holohan and it did not raise any flags or alarms, while at the same time the minutes of his meetings record that work was under way by the State Claims Agency to extend the architecture of the national incident management system to facilitate logging of incident cases from the screening programme. It is clear there were issues and then these letters come across his desk saying that there are issues but not to tell the women, whatever he does.

Dr. Tony Holohan

No. That is not the conclusion I would have taken from it. The reference to the State Claims Agency was the extension of the implementation of the national incident management system to the screening service. That has been in roll-out for a number of years, and the extension of that right across the clinical system still has not been fully completed but it is very significantly advanced. It is a prerequisite to being able to record incidents. What we need to be able to move to then, as we strengthen our implementation around open disclosure, is that system capturing the fact of open disclosure when adverse events have occurred. In dealing with adverse events, it is important to point out that the open disclosure policy relates to adverse events and it is correct to say that not every false negative is necessarily an adverse event. Some judgment is required on that and the letters provide those flexibilities. Those are templates that have to provide for any eventuality. Any individual letter that will issue in respect of an individual patient will look specific to that patient and I would have known that.

I am sorry to cut across Dr. Holohan. Not one of those letters provides for the eventuality of telling the woman herself.

Dr. Tony Holohan

The purpose-----

Would the HSE handle that matter?

I thank the Chair.

Dr. Stephanie O'Keeffe

The first thing to say about this, particularly in the interests of the women and the public who are terrified as a result of all this, is that the screening programme intended for the information to be disclosed. When this was first brought to my attention in February 2016, all of those briefings detailed that there was an accumulation of case reviews that had been completed. A decision was made the previous year to ensure that this information was given to women. A process was put in place to figure out the best way to do that. As Dr. McKenna mentioned and in relation to the Chair's question on who the best person to give this information was, they considered all those things. They looked at the open disclosure policy and the guidance for the disclosure of audit findings for cancer screening programmes to come up with a process that would support this. I have got emails from the screening programme stating that the programme has information on women's screening history that may be of benefit to her and we believe it should be disclosed.

The issue that they brought to my attention in February and March was the fact that they felt that some of the laboratories had queries once they found out that they were issuing letters to treating consultants so that the information could be given to patients. They were concerned, they escalated it to me and I supported them to resolve it so that those letters could continue to be given.

Deputy O'Reilly's questions on the interpretation in relation to the letters are very fair. The questions on whether the open disclosure policy was appropriate at the time are very fair, especially in hindsight, but they were looking at what the policies were in other jurisdictions on this type of disclosure in these circumstances. Their intent was that the information would go out.

In terms of Deputy O'Reilly's specific question on the letters, it is fair to say that these are templates. What that means is that every letter is individualised to the case, so when it says "if open disclosure is required" that is also a template letter for women who are getting the results of audit findings where there is no discordance between the cytology. Open disclosure would be required if there is a discordance. It is true that within the provisions here they have left space for clinical judgment. That needs to be reviewed and we need to look at it. In speaking to Professor Flannelly who was running the programme at that time and meeting individual women, and it can be seen in the first memo that she meets women, talks to people who are getting these results, and she is talking to consultants and so forth, my understanding was that there would be circumstances where it would not be advisable to tell a lady something like that, for example, if the person was close to passing away.

That absolutely has to be looked at, in terms of what kind of guidance can be given to clinicians in the context of wanting to be fully open and disclose this information, and some of the challenges there might be from a clinical perspective. It has to be reviewed in hindsight, but it is really important to say that those carrying out the programme, at all times, wanted the information to get into the hands of these women, and expected that it would.

It is funny, because the information did not get into their hands. A procession of very senior, very well paid people come before this committee and say that all they ever wanted was to share that information, yet mysteriously that information does not get shared. One wonders how that was happening, regardless of hindsight.

We asked for the breakdown from the laboratory this day last week, and at the time it was indicated that it would simply be a matter of hitting a button and that we would get it very quickly. We still have not received it, which is very worrying. The witnesses have told us how interested they are in sharing every bit of information with us. Mr. Connaghan has now explained that it might take some time to get it, but it strikes me as a bit bizarre that that information is not to hand.

Perhaps the witnesses might be able to explain the tendering process to us. It appears that around the time concerns were being raised the tender came up again. An expression of interest process was offered to the two outsourced companies which were already doing that work. Was this reviewed by anyone at any stage? We know what the Minister for Health at the time, Ms Harney, said about it; that it was great value for money and that it was a third cheaper. Was it reviewed in terms of quality, and did the review include the 60,000 files that were outsourced in 2007 to Quest Diagnostics?

Mr. John Connaghan

I will ask Dr. Peter McKenna to talk again about the laboratory breakdown, and Mr McCallion to speak about the tendering process and laboratories.

Mr. Damien McCallion

I am happy to supply a note that summarises the tendering process since the screening programme started. There was an original tender in 2008, which was awarded to two providers. In 2009 there was another tendering process, and a framework agreement was set up in 2012. I can provide that by copy to the committee. There were a number of other mini-competitions within that framework. The framework agreement provided for a number of laboratories, and the mini-competition was effectively a mini-competition within that for the supply of laboratories. For some number of years now, Quest Diagnostics and MedLab Pathology have been the two laboratories involved, with 10% of the testing undertaken by the Coombe hospital.

In terms of quality assurance - and the Deputy will appreciate that I have only looked at this in the last number of days - there is a quality assurance process around the laboratories which covers a range of areas, including the facilities, the staff qualifications, the specimens regime and data entry, among other things. I will not list everything out, but we can supply that information to the committee. It involves regular meetings with the laboratories. There is also a quality assurance group within the programme that looks at that area, including international expertise to support it from outside the Republic of Ireland. That is a brief summary of the process that is in place around the laboratories.

In 2007, when the 60,000 smear tests were outsourced, was there a competitive process in place? Was there any quality assurance?

Mr. Damien McCallion

There certainly was a competitive process in 2008.

I am talking about 2007. It strikes me that in 2007 there was no competitive process, so the outsourcing was done. The company who already had the contract in 2008 would already have a significant head start. It just so happened that it was Quest Diagnostics.

Mr. Damien McCallion

I will have to check that. I will validate that claim and get back to the Deputy on that.

Last week we were told that we would have information very quickly. Can Mr. McCallion give an indication as to when we will have that information?

Mr. Damien McCallion

I can get the information on Quest Diagnostics to the committee in the next day or two.

That is what we were told last week.

Trying to get information that should be readily available has been like pulling teeth in the last few weeks. I do not believe it is acceptable. I am trying to do my job here. In order to get through this jigsaw I have made requests to the Secretary General and have asked parliamentary questions about when all the hospital groups and all the individual 11 hospitals involved were made aware of the audit programme. I have still not been told. That is unacceptable. I needed that information today. I asked for it on 3 May, long before the Scally investigation ever existed. Why have I not been given that information? It is a matter of sending an email to 14 people and telling them they have 24 hours to answer a simple question; when did they know about this audit? They will not tell me. I wanted to have that information to hand in order to ask Dr. O'Keeffe and Dr. Holohan questions here today. I cannot do my job because the witnesses are not facilitating me. It makes me wonder why that is the case.

The situation makes me wonder about the internal politics at play. The HSE was worried about the briefing that we got yesterday from Mr. McCallion and Dr. Holohan in case accountability was pushed downwards. I can understand that point of view. I am worried about ass-covering across organisations; it is undoubtedly happening. I have the HSE's organisational chart from 2016. Where are the national director of acute hospitals, Mr. Liam Woods, and the national director of quality assurance and verification, Mr. Patrick Lynch, who is now the chairman of the serious incident management team, SIMT?

Mr. John Connaghan

They are out of the country.

What are they doing?

Mr. John Connaghan

They are on leave.

When did they apply for leave?

Mr. John Connaghan

I will have to check the records on that. I believe they applied for leave several weeks ago. Mr. Woods certainly applied a number of weeks ago. I am not aware of Mr. Lynch's leave arrangements because there is no direct reporting line to him.

Dr. Stephanie O'Keeffe

I believe that Mr. Lynch had that leave in his diary for a long time.

We were told earlier that individuals would be held to account. We have the biggest health crisis in decades, and two important people in the story are out of the country. They should not be on leave, whether they had it planned for days, weeks or months. Those people are supposed to be in front of the Committee of Public Accounts tomorrow, of which I am Vice Chairman, and they will not be here. I suggest, through Mr. Breslin and through the Minister for Health, Deputy Harris, who I will contact, that they are here tomorrow. I have specific questions for both of them. They had key roles. When did they know about this? What did they do about it? What communications did they have from various people in this room, and others outside this room? It is not fair that Mr. McCallion is a plenipotentiary, answering questions for them. He cannot, to be fair. He has just been promoted, as has Mr. Connaghan, and I wish them the best.

Does Mr. Breslin know everything? Has he revealed everything he knows about the Department of Health?

Mr. Jim Breslin

The Deputy's first question was about the parliamentary question. The Deputy contacted me last Thursday night. We had a long-----

I may add that Mr. Breslin sent me a disgraceful response.

Mr. Jim Breslin

I did not send anything directly to the Deputy. The Deputy contacted me directly asking that I intervene in relation to his parliamentary questions, after a very long day at the Committee of Public Accounts. It was late on Thursday night. I assured the Deputy that I would personally intervene the following morning to try to establish whatever information I could for him. The first thing I did on Friday morning when I got to the office was to ensure that that detailed information was requested from the HSE as a matter of urgency. I followed that up on Friday and again on Monday, and last night I discussed the issue with Mr. McCallion to find out what information we were in a position to provide to the Deputy and to stress the urgency of doing so before the committee meetings this morning and tomorrow. Mr. McCallion assured me he would draft a response - and I am fairly sure he was doing that very early this morning - and get it the Department. Before I arrived I saw a letter that the Minister was to sign, addressed to the Deputy.

I saw the email for the letter to the Deputy for the Minister to sign, and he has now got that letter.

I have not got it. I came down here at 9 o'clock this morning and I have not got anything.

Mr. Jim Breslin

The letter is on its way to the Deputy. Mr. McCallion can talk to the contents of that letter.

To be honest, what I got was a disgrace. To say that because of the Scally inquiry I could not ask basic parliamentary questions-----

Mr. Jim Breslin

I accepted that last Thursday night.

Mr. Breslin did accept it last Thursday. What was worrying is the fact that he did not see it before it is issued.

Mr. Jim Breslin

I explained to the Deputy yesterday that the Department gets 11,000 parliamentary questions a year. I do not see the written parliamentary questions. We also get oral parliamentary questions, and I work with the Minister on signing off every one of those.

To save time, when it comes to this issue I suggest Mr. Breslin looks at what is coming out of his Department. Otherwise, he could be misled. Second, with regard to that, will Mr. Breslin please inquire who in his Department authorised sending back such a response? I am stuck for time so I have to keep going. Mr. Connaghan-----

Mr. Jim Breslin

It is important that if the Deputy puts a question I get an opportunity to answer it. I appreciate he is stuck for time but I also need the ability to answer properly every question that is put to me.

That is fine. Mr. Breslin has done that. Mr. Connaghan, will those two individuals be in front of us tomorrow?

Mr. John Connaghan

We will make inquiries. I think they are some distance away but we will certainly attempt to contact them.

Does Mr. Connaghan think it is good practice and good management that in the middle of a national crisis two of the most senior people, one who is chairman of the serious incident management team, SIMT, which went in to investigate this matter and was appointed by Mr. Connaghan's predecessor, and who are over acute hospitals, are out of the country?

Mr. John Connaghan

I will give a very brief reply on that. First, if Mr. Woods is not available, we can certainly supply his deputy. Second, regarding the overall management of this, this is now with Mr. McCallion. I would like Mr. McCallion to comment on that.

Can Mr. McCallion answer my question, please? Does he believe it is good management practice, in the middle of a national crisis, for these two senior individuals to be out of the country?

Mr. Damien McCallion

I do not think it is brilliant management practice, if I can answer the Deputy's question directly. In hindsight, holidays might have been arranged differently but in regard to this, who would know that this was coming up at this point in time if someone had booked a family holiday seven weeks ahead?

The public are watching this. That is not a good answer.

Mr. Damien McCallion

I took on the responsibility for the serious incident management team in recent days so that has become part of my brief, alongside taking over responsibility for the screening service as well. We did feel there was a natural point in terms of trying to bring those two things together to make sure that we have a single co-ordinated response.

Mr. McCallion has plenipotentiary status here. Specifically, when did Mr. Woods and Mr. Lynch become aware of the issues around CervicalCheck?

Dr. Stephanie O'Keeffe

I can take the first one actually.

Who is dealing with it?

Dr. Stephanie O'Keeffe

I was the person who would have briefed one of the individuals so I can answer that one, if the Deputy wishes.

Dr. Stephanie O'Keeffe

As I mentioned earlier, I would have received a briefing on the audit on the 25 February 2016, its findings and the challenge they were going to have with the laboratories. I would have requested a briefing after that and I would have emailed it to Patrick Lynch on 4 March for review and comment. Patrick Lynch would have helped me to resolve that issue with the laboratories by coming to a meeting with the-----

That is good information. I thank Dr. O'Keeffe for that. Some weeks back, Mr. Connaghan's predecessor appointed Mr. Lynch to go in as chair of the SIMT to investigate what had happened here. Is that correct?

Mr. John Connaghan

It is indeed, yes.

He is aware of all these issues since 4 March 2016.

Dr. Stephanie O'Keeffe


On 4 March 2016, he is aware of these issues. For nearly two and a quarter years, he is involved in the cycle of all the issues going on. Why did Mr. Connaghan's predecessor appoint somebody who was actually involved in the issue, was part of the decision making, or non-decision making process, to go in and act as the investigator on this issue when he was part of the process in the first place? The investigator is part of those being investigated as to what went on.

Mr. John Connaghan

Dr. O'Keeffe might want to comment further on that. Patrick Lynch had a particular role in the organisation regarding quality assurance so there was a logic in Patrick Lynch being able to head up an SIMT to be able to address this issue at the earliest opportunity.

Does Mr. Connaghan think it is appropriate for somebody to go in as head investigator in the Health Service Executive, HSE, of the serious incident management team, which is what it says on the tin, when he is privy to this issue and, as we now know, part of the non-disclosure and non-action in this issue? Does he think that is appropriate because I do not?

Mr. John Connaghan

It is a question of what Patrick Lynch was asked to do. He was asked to go in and head up a SIMT in regard to responding to the requirement to contact 209 women effectively and very quickly. The nature of the task he was asked to undertake two weeks ago is slightly different from the position the Deputy is outlining on assurance.

I do not agree. I believe the idea that he was asked to go in and investigate something he has been party to is ridiculous. Did Dr. O'Keeffe want to continue?

Dr. Stephanie O'Keeffe

Yes. To clarify, information regarding the actual audit was not perceived to be a problem at the time everybody heard abut it. It was perceived to be a good thing. An audit such as this one is the last tool in a suite of things we do to quality assure a programme. When people were briefed, they would have been briefed in the context of knowing that these type of things happen in screening programmes. They work at a population level but, unfortunately, they do not work for every single individual. Patrick Lynch would have been involved in supporting a constructive, positive process at the time. The abject failure here was in the execution of the communication between the treating clinician-----

I will come back to that. The reason I am glad Dr. O'Keeffe gave me the earlier date is because I want to know when both of these individuals were aware of this and involved in the process. I want to know the actions they took and when they took them. Dr. O'Keeffe did say that, and she has explained clearly that it would have been in the early days of March 2016, but we all know they were part of the conversations after that. Is that not true?

Dr. Stephanie O'Keeffe

Pardon me.

We all know Mr. Lynch would have been part of the conversation after that.

Dr. Stephanie O'Keeffe

No. Patrick Lynch would have stopped being involved in the process after we had resolved the laboratory issue.

Let us find that out. Mr. McCallion is here on Mr. Lynch's behalf.

Mr. Damien McCallion

In terms of the historical context-----

Mr. Lynch was not privy to any communications in July 2017 or anything like that.

Dr. Stephanie O'Keeffe

Not to my knowledge.

I am asking Mr. McCallion.

Dr. Stephanie O'Keeffe


Mr. Damien McCallion

I will have to verify that with Mr. Lynch.

Of course you will because he is not here. That is my point.

On the process by which the communications went to the clinicians, does Dr. O'Keeffe stand over all the memorandums with her name on them?

Dr. Stephanie O'Keeffe

I do.

Does she stand over their content, the tone and the way they were expressed-----

Dr. Stephanie O'Keeffe

I do.

-----even though her own Minister and others in both the Department of Health and the HSE have expressed deep concern about them and believe they should never have been written in that way? Dr. O'Keeffe stands over them.

Dr. Stephanie O'Keeffe

I have to stand over them because at the time I read them and I sent them on to individuals within the organisation who I understood needed to be briefed and understand them. It is important to say to the Deputy, and to other members here this morning, that those briefings were given in the context of either a verbal briefing before the person received it or a briefing at the time the person received it. In looking at those memorandums now, I can see all kinds of things. There was never an intention in the screening programme, for example, that those briefings being given to me would be distributed for the public. It was about trying to understand how it was that they were going to resolve the issue with regard to the challenge from the laboratories to send the letters to the consulting clinicians and what they were going to do about dealing with the historical cases.

I quote: "In cases where the woman has died, simply ensure the result is recorded in the woman's notes." Does Dr. O'Keeffe believe that was okay, and that it was ethical?

Second, on the real issue here, Dr. O'Keeffe was in charge of this area. Subsequently, I understand her position changed and it was no longer part of her area. Mr. Connaghan might tell us why that happened. The letters went out to clinicians in June 2016. What I do not understand is why they were not also sent to the hospital managers, which I would know now if the Department of Health actually did its job and told me the answer?

That is why I want to make up this jigsaw. Why were the letters not sent to the hospital managers? Second, why did Dr. O'Keeffe, in her role, not follow up to understand why these women, who were so badly affected, had not been told?

Dr. Stephanie O'Keeffe

The first question the Deputy asked, in respect of the letter, was whether I was happy from an ethical perspective that, within the process they had developed, they had come to a conclusion that if the patient had sadly died, they were going to ensure the record or the result of the audit findings would go on the medical note. At the time when this was being discussed, it was clear to me that they were involving many other parties from the colposcopy forum and a whole range of individuals with expertise in this area, including colleagues internationally, on the best approach. Within that context, I was satisfied that what they had come up with was appropriate in the context of the guidance document. I absolutely appreciate that, with hindsight, perhaps a different decision could have been made. At the time, the way it was explained was that there were all sorts of different family types and questions over who would be able to get the information, and that there could be legislative issues with regard to the divulging of information and so on. I genuinely do not want that to sound like a kind of excuse because I accepted at the time that this was what they had come up with as part of the process. I completely accept now, in the context of how all these women and their families found out about the matter in the context of this national controversy-----

Open disclosure.

Dr. Stephanie O'Keeffe

Pardon me.

Open disclosure.

Dr. Stephanie O'Keeffe

Yes, the intent of the programme was that women would find out and that, if somebody was deceased, in thinking that through and in looking at the guidance in other jurisdictions, bearing in mind that, as Dr. Holohan pointed out earlier, there were not many cases of jurisdictions that do it-----

We are caught for time. Could Doctor O'Keeffe answer the other two questions I asked before the Chairman cuts us off?

Dr. Stephanie O'Keeffe

Indeed. The next question was on whether I was in charge. I was in charge during the period the Deputy asked about. He asked why my role changed. Maybe I will go to the more-----

That was not one of my questions. That was for Mr. Connaghan.

Dr. Stephanie O'Keeffe

I will go to the last one, on why I did not follow up.

There are two more.

Dr. Stephanie O'Keeffe

Hospital managers?

Dr. Stephanie O'Keeffe

The hospital managers were not part of the actual open disclosure process of giving hospital managers confidential patient information in regard to the audit and the screening programme. They were not considered to be people who needed to receive patient information. It was the treating clinicians-----

They had no responsibility.

Dr. Stephanie O'Keeffe

They had no responsibility for the actual content of the letter. The hospital managers would have been made aware of the audit process and of the requirement to consult clinicians to disclose the information to patients through the memorandum of understanding that the CervicalCheck programme had with the hospitals. They would have had a memorandum of understanding with each of the 15 colposcopy units. In that process, the hospital managers would have signed it. As I understand it, there would have been a sub-clause underneath that would have stated what could be done if there were a duty of care. We received a copy of the memorandum of understanding, and that has made its way to the committee. It would not have been something I would have looked at when I was the national director of health and well-being. I refer to looking at a memorandum of understanding between the CervicalCheck programme and its 15 colposcopy units. There is a whole range of memorandums of understanding, between BowelScreen-----

Dr. O'Keeffe might answer my final question.

Dr. Stephanie O'Keeffe

It is a really important question that I have had to reflect-----

It is the most important question that I believe will be asked today.

Dr. Stephanie O'Keeffe

It is a very important question that I have had to reflect on fully in regard to how it is that something that was well intended at the outset resulted in somebody taking a case and Vicky Phelan reading the information in her notes without the consultant having disclosed it to her. That-----

Why did Dr. O'Keeffe not follow up? Why did she not do her job?

Dr. Stephanie O'Keeffe

I did follow up but all of those mechanisms failed. It is a very important question so let me respond.

It is the most important question today.

Dr. Stephanie O'Keeffe

Yes. In the briefing note the Deputy has, from October 2016, it is made very clear that the process we were engaged in over the period had concluded and that the historical letters had been sent to consulting clinicians. It is very clear within the memo that the programme was engaging colposcopists with treating clinicians to support the process of open disclosure and that they would be issuing letters at a pace of approximately four to six every month as they started to conclude reviews that were coming in. At that point, they were also hearing about cases that were coming through, which was always the intent. In carrying out this audit process and in sharing this information with women, the reason they were flagging the media piece was because we always knew that, once women had information, they would have absolutely every right to seek legal advice and legal address if they so chose. Therefore, we were expecting cases to come through. What I was not expecting, and what we were all not expecting, was that women would not be told.

After October 2016, I received a management report every month from the screening service stating the audit process was going well and that improvements were being made to the programme. In about May, June or July — I have the specifics here if the committee needs them — it would have stated in the management reports that three cases were going to the State Claims Agency. That reinforced to me the view that the process was working. Looking back, I could ask if I should have relied on my one-to-one management team meetings, my senior management team meetings and bimonthly risk reports. None of those things told me-----

None of it worked.

Dr. Stephanie O'Keeffe

None of them worked.

It was systemic failure if none of them worked.

Dr. Stephanie O'Keeffe

None of the usual assurance mechanisms that one would have as a national director and senior manager told me that there was a difficulty between the letters being issued and the communication to patients.

This is incredible. Is Dr. O'Keeffe saying there was a systemic failure in the whole process of reporting to her?

Dr. Stephanie O'Keeffe

I believe there was a failure in closing out a very well-intended audit review of cancer cases notified to the programme in 2008. There was a failure in closing that out in the system, and I believe there was a failure in the detection of the risk by CervicalCheck and the national screening service. There was a failure in detecting the risk and there was absolutely a failure in its escalation because it is clear to me that there was correspondence in 2017. When I was head of the service, there was correspondence within the system-----

I know there was.

Dr. Stephanie O'Keeffe

-----and I did not know about it. It was not escalated to me.

I hope Mr. Connaghan is listening to all this. There has to be accountability upwards and downwards.

I thank Dr. O'Keeffe. I call Senator Colm Burke. He is to be followed by Deputies Kate O'Connell and Margaret Murphy O'Mahony.

I thank the delegation for attending this morning. With regard to dealing with CervicalCheck, I have a number of questions about the clinicians at the front line. My understanding, on which I would like clarification, is that they were not advised of the clinical audit taking place and that they were not involved in it. Second, the first they heard of the clinical audit was when they got notification from CervicalCheck to advise them. I have reliable information informing me that, in one case, the person was advised there were adverse findings in the reviews of the smears of ten of his patients. The information all arrived in to him on the one day and he was asked to inform the patients. I want the delegates to clarify whether the clinicians at the front line in the 15 centres around the country were aware of the clinical audit before it started. Why were they not involved in the process and kept up to date as it developed? According to my information, the first involvement of the clinicians was when they were notified of the results of the clinical audit in respect of their patients.

There is information from February and March of 2016 that went out in June. There was then ongoing communication regarding who should advise the patients. My information is that there was a meeting on 1 September 2017 with the clinicians. There was a quite robust debate about the issue. Therefore, the issue was still not resolved on 1 September 2017 in respect of informing the patients or the backup support being provided to the clinicians. Surely alarm bells should have been rung at that stage indicating that, 12 months later, the process was still ongoing. Could I get some clarification on those questions?

Mr. John Connaghan

There are two questions: first, at what point were the clinicians first advised, and, second, why did alarm bells not ring? I will ask Dr. O'Keeffe to respond.

Dr. Stephanie O'Keeffe

My understanding from the documentation and from the briefings I have received is that there had been engagement with the consulting clinicians on the audit process and its methodology. One of the documents the committee has talks about the process development, that they engage with the colposcopy forum, they engage with the programme colposcopy services and histology laboratories, the cytology lab providers, the quality improvement division and the State Claims Agency. The documentation and briefings I had suggested that was engagement with the consultants and clinicians. The October briefing I have, which is very important from my perspective in trying to look back at this and understand how this could have happened, makes it very clear that there was ongoing engagement with the consultants in supporting them with this process. They had developed a guidance note for them and Professor Gráinne Flannelly herself was directly engaging with consultants as they called up, as well as patients. That was my understanding at the time.

It was not brought to my attention that there were difficulties at that stage. I would have known that it was an evolving process. They would have said that this is very challenging and that all the international evidence suggests that this type of disclosure is very challenging. They would have said, while the treating clinicians were the most appropriate people to do it and that was well-established, it was not an easy thing to do. They would have described research studies which would have shown the types of fears around this type of thing. There were actively engaging with that. They stated in October that this would continue. As I mentioned already to Deputy Kelly, there was no escalation or no early risk detection communicated on that not happening in practice.

If one looks at the letters exchanged between Gráinne Flannelly and Kevin Hickey, however, they highlighted that there were concerns. Going back to pre-June 2016, my information is that the clinicians were not engaged in the audit process or were not made aware that there was an audit process in place.

Dr. Stephanie O'Keeffe

The audit process methodology papers that would have been given to me that summer would suggest that they were. I am not aware of that.

Could it be checked?

Dr. Stephanie O'Keeffe


This is important because these are the people on the front line. The information I received is to the effect that the first they heard of the audit process was to be notified of the cases of patients where errors were made in the reading of the slides initially. They were now being asked to deal with this issue. That is my information. I am just wondering if that can be checked because I believe it is extremely important. They were being asked to deal with the issues all of a sudden.

Dr. Stephanie O'Keeffe

We will check that.

On 1 September 2017, there was a meeting of clinicians at which concerns were raised. Was Dr. O'Keeffe aware of that meeting and of the concerns being raised?

Dr. Stephanie O'Keeffe

To my knowledge, I was not aware of the meeting, although I was aware that they would be holding all kinds of meetings with consultants. The October briefing makes very clear at the end of it that they would have ongoing meetings. It stated several consultant doctors have engaged with the National Screening Service, NSS, CervicalCheck and the next steps to be taken, following communication of a review outcome, was that a short explanatory document was developed and accompanying letters issued to consultant doctors that can be found appended. In addition, it stated:

Administrative leads in the programme colposcopy services have been advised of the process. NSS CervicalCheck is providing additional support to consultant doctors in carrying out and assessing open disclosure requirements and appropriate protocols. Engagement between project consultant doctors would constitute an ongoing process.

I may not have known a meeting was happening exactly in September. However, I would have expected there to have been considerable levels of engagement to ensure the supports being put in place were actually being followed through.

However, this is September 2017, some 12 months after the letters went out. Was Dr. O'Keeffe not advised-----

Dr. Stephanie O'Keeffe

No, I was not advised.

-----that of the 200 or so people who had adverse outcomes in the audits, there was little disclosure made at that stage?

Dr. Stephanie O'Keeffe

No, I was not advised of that.

Would Dr. O'Keeffe not have requested that information?

Dr. Stephanie O'Keeffe

At one-to-one meetings, I would have a management report. We would also have a performance review meeting every month and a senior management team meeting every month. Typically, in those processes, there is a requirement of the senior management team to escalate any new or emerging risks, obviously within the risk register, to be able to detail them comprehensively and at a one-to-one meeting to brief me on anything that may be rising in any of the programmes across the NSS. Within all of those management reports, it states that the audit process was going well.

Given what has happened and given the fact that actually the communication to women happened in the context of a national controversy where people are worried could it be them or husbands whose wives have died are concerned, that was not the intention. It was not escalated to me. I was not in a position to either resolve it and I was also not in a position to be able to communicate to my boss that it was a risk or, indeed, to communicate it to the Department of Health.

The memo of October 2016 sets out a total of 203 letters have been issued to 29 consultant doctors for historical cases where cytology, prior to diagnosis of one or more smear tests, was reviewed. Did anyone check with the 29 consultants to ask what level of engagement had they with their patients? They had the letters from June. This is three or four months on. Was there not a need at that stage to identify what level of engagement had occurred?

Dr. Stephanie O'Keeffe

I think that in hindsight, yes, there should have been some kind of a feedback loop to make an assessment as to whether or not consultants were engaging in that. In hindsight, that is definitely something that should have been put in place.

Was the Department or HSE administration aware that there was an ongoing issue about consultants communicating information? At what stage did they become aware of that? They have told me that they made the case at an early stage in 2016 when they got the letters.

Dr. Stephanie O'Keeffe

That information was not relayed to me. Accordingly, I was not able to do anything about it. From my perspective with regard to the briefings that I had and those I had forwarded to both the director general and to the Department, the process was going according to plan and everybody had been briefed on it. Everybody knew what the plan was and what was the intention. There were no briefings or no escalations of that information that the NSS may have had regarding doctors being uncomfortable with the process.

From what I am aware of, there was clearly a formal escalation of that between the consultant in Limerick and between the clinical director of the CervicalCheck programme that was discussed within the NSS but it was not escalated to me at that time. Accordingly, I could neither resolve the issue for them nor support them in that. Neither could I escalate it myself.

The most important part of the review was the final element, namely advising the patient or the patient's family. There seems to have been no process in place to check that this final element was carried out completely.

Dr. Stephanie O'Keeffe

What the documentation would suggest and what we would have been expecting was that there would have been ongoing engagement with consultants on the letters. The Senator is correct that, in hindsight, there was not a final piece whereby the CervicalCheck programme went back to each of the consultants to check on each individual case with regard to what they did.

Surely the Department must have been concerned. There was an accumulation of results and the bigger the numbers, the greater the problem was going to be. This was identified in February 2016.

However, by September or October 2017 we still did not have the process fully in place about advising the patients and their families. We are talking about a period of 18 months. People surely must have become concerned at that stage.

Can we have the answer to that question and then we will move on?

Dr. Stephanie O'Keeffe

From the managers' reports I have, which stated the process was going well, the fact that the programme was telling me that cases were appearing was an indication to me that this was actually happening. My expectation was that patients were being told. If they were not being told, it would be for a very small minority of cases where a clinical judgment was being made and where a consultant could stand over that. Our expectation was that we would be seeing cases coming forward as women were given this information. Within the October briefing, one will see it states that cases were starting to come through. The expectation was that women would be told. It is an incredible deep regret that this did not happen and that people had to be told in the way of this national controversy.

I call Deputy O'Connell.

If it is all right, Deputy Durkan will speak ahead of me.

Thank you Chairman. How long do I have? Do I have ten minutes or half an hour?

The Deputy has 12 minutes.

Mr. Connaghan said it is quite clear in hindsight that the necessary actions as outlined in the open disclosure policy were not taken in a timely and effective manner. Who was driving that particular programme, who had the responsibility to ensure that the open disclosure policy was observed in the letter and the spirit? It would appear that a decision was taken to operate slowly in that particular direction and that this arose from a concern from clinicians regarding the undermining or pre-empting of legal cases that may have been pending Is that true?

Mr. John Connaghan

The responsibility for operating the open disclosure policy is a cascade. We have a national policy, and we expect the implementation of that to be taken forward in hospital groups, community healthcare organisations and organisations such as CervicalCheck. We would expect that within the organisation of CervicalCheck, it would have its own internal policies and procedures to ensure the open disclosure policy was effectively deployed.

In my remarks at the outset, I stated that it is quite self-evident that those internal policies and procedures did not take effect in this particular case. There should have been a flag raised earlier and we readily hold our hands up to that particular failure.

Was there a particular reluctance coming from any quarter as to the implementation of this policy? As this was an open disclosure policy, as announced by the Minister, why was it not followed through?

Mr. John Connaghan

In terms of follow-through I am aware, I cannot recall the dates, that there was a review carried out of the open disclosure policy. I believe it was two years after the introduction of the policy. Colleagues around the table may be able to say a little bit more about this. That review examined how well the open disclosure policy was being supported in certain units. I am not sure if anyone present recalls that review. We can make that available to the committee if it wants.

My follow-up question is that when the open disclosure policy was announced, were there expressions of dissatisfaction or concern within the system?

Mr. John Connaghan

I was not personally aware of these but then again I was not in Ireland at that particular time. I will look to colleagues to see if they had any recollection of that.

Can anyone answer this question?

Dr. Tony Holohan

In a general sense we had many examples of patient safety issues that arose over the years that would have identified that open disclosure was not happening effectively both before the introduction of the policy and afterwards. We were involved in some ourselves and I can give some examples including Portlaoise, where the baby deaths occurred. There was not just not open disclosure, there was active withholding of information from patients. At the same time and concurrent with the time period of this particular audit, a colonoscopy review was taking place arising from Wexford, where open disclosure was an escalation issue and a concern that was being raised on a continuing basis by the Department.

When those issues occurred, what action was taken then? Did somebody not take it in hand and say that we have this policy of open disclosure. Why are we deviating from it? Were the consequences anticipated at the time? It would appear that the consequences were serious? What action was taken following that by anybody?

Dr. Tony Holohan

There were actions at both levels. At the policy and legislative level, actions continued in terms of informing and prioritising the legislative effort, which is what I spoke about in my opening statement, that is, on supporting voluntary disclosure, creating the safe space and making disclosure more likely and setting standards for the disclosure that clinicians would do the right thing and support patients through that journey, while ultimately leading to the mandatory disclosure I spoke about briefly earlier.

Did some clinicians indicate they were not in favour of voluntary disclosure?

Dr. Peter McKenna

My understanding is that it was not expressed but what was expressed was that this was not their error to disclose. I think there is a difference between these.

Not necessarily. If the policy is for open disclosure and if some members of staff - I use that term in the all-embracing sense - were not in favour, there was then a conflict within the system. Did some clinicians state they were not in favour of open disclosure because there were cases pending in which such open disclosure, if now practiced, would leave certain people exposed? Would I be right in coming to that conclusion?

Dr. Peter McKenna

For individual cases I cannot say but in general, my understanding is they felt that the error had been on the part of the screening programme and therefore, it was the programme's information and it was up to it to disclose it. They were reluctant to take this on board. That is my understanding as to where this internal dispute, as it were, arose.

Mr. John Connaghan

Let me just add a couple of remarks to that from other jurisdictions.

Following a series of scandals in England and elsewhere over the past ten years, a number of policies were put in place by various Governments on things like the duty of candour. I expect that Irish clinicians would have been aware of that and of the growing movement towards open disclosure. I would be surprised if any clinician in Ireland at that point in time would have said that open disclosure was not a good thing.

In fact disclosure, as we see in respect of the other process, was undoubtedly a good thing.

I have no doubt that everybody decided that open disclosure was a good thing. We all agreed with that. But if someone does not practice that, in essence it means that it is not going to work. If there are people who are opposed to the concept of open disclosure, it will cause a glitch in the system, which it did, and it was a serious one. We would be entitled to know what happened at that level. I will come back to the laboratories in a moment.

Incidentally, is it correct that 50,000 high-grade pre-cancerous changes in women were detected, reducing their risk of cervical cancer by 90%? Then, I note there was a 7% reduction in cancer generally from 2010 to 2015. Is that in cervical cancer or all cancers?

Dr. Tony Holohan

Cervical cancer.

Dr. Peter McKenna

Cervical cancer.

Mr. John Connaghan

Cervical cancer.

Were disciplinary measures taken against anybody who had serious reservations about the operation and full implementation of full disclosure? Was anybody cautioned?

Mr. John Connaghan

That kind of detailed information is not available to us just now. We can certainly look to see if any disciplinary procedures came in turn to us in HSE. I am certainly not aware of any at this stage.

Dr. Stephanie O'Keeffe

Is this in relation to this issue or in relation to open disclosure more generally?

Generally but it would affect this issue as well.

You have two more minutes, Deputy Durkan.

Dr. Stephanie O'Keeffe

I do not know with regard to open disclosure more generally but on this particular issue, given that I did not know there were issues arising, I would not know and I suspect there would not have been anything like a disciplinary measure because it appears to me that the screening programme itself was not aware that the consultants were not disclosing the information to patients or at least they were not aware at the level we have subsequently found out.

Dr. Tony Holohan

To clarify and give complete information, open disclosure is provided for in the ethical code under the Medical Practitioners (Amendment) Act 2017 and as such it could be the basis of a complaint to be made by anybody against a medical practitioner so it would be open to a patient to make a complaint. It would be open to the HSE-----

That is if the patient knew.

Dr. Tony Holohan

Yes and it would be open to the HSE to make a complaint against any individual medical practitioner in respect of that provision if they wished.

Could I just clarify something with Dr. Holohan? Would that only apply if someone was registered with the Medical Council and he or she was a doctor?

Dr. Tony Holohan

Yes, it only applies to doctors.

I am just making sure people are aware of that.

Dr. Tony Holohan

Absolutely correct.

I have a number of other questions but I do not want to go on too long.

You have just one more minute, Deputy Durkan. Pick the most important one.

The accuracy and reliability of the screening tests ranges between 10%, 15% and 20%. How accurate is it? How accurate has it been shown to be and were any questions raised about that in the course of the debate that took place around this issue in 2016 or since then?

Mr. Jim Breslin

Could I point out to the committee that this is a really important question that has arisen over recent weeks? I know the Deputy is tight for time. If we could be given license to deal with that question once and try to get it clearly communicated, I will ask Dr. Holohan to do that for us.

Dr. Tony Holohan

Figures are used to describe the performance of this test and they are around 60% to 75%. We say about 70%. What that means is in a situation where something is present and one is trying to find it, there is a 70% chance that it will be picked up with the test and a 30% chance that it will be missed. That is where it is there - the finding is there - but when the great majority of women have a smear, their cervix and cells are normal. The following question then arises. If a person has a normal test, how certain can that person be that that normal test is actually correct and the test has been performed well? The answer in that situation is over 99% of the time.

How about the situation in the United States where the practice is to have the test every year as opposed to every three years? Was there not a danger that the practice followed here was not as good or all encompassing as that which applied in the United States and was open to a difficulty of this nature?

Dr. Tony Holohan

The United States does not have organised population based screening in the way we have.

Dr. Tony Holohan

We have a better organised screening programme. Our services in terms of performance and protecting the population from the incidence of cervical cancer works better in this country with our organised screening. The evidence is very clear that organised screening with pap smears at intervals of three years in accredited labs colposcopy services is the appropriate interval. There is little point in having more frequent smears in a situation where the other organisational features of a programme are not there.

In the ideal situation, what would be the ideal levels to achieve in terms of the frequency of screening, given that the two systems are not entirely compatible?

Dr. Tony Holohan

The intervals are very clear in our programme. They depend on the age of the woman. She comes back every three years and then every five years, depending on age, if the smears are normal. She may have to come back more frequently if there are abnormalities detected or go in to other parts of the programme.

I thank Dr. Holohan. I will move on but before I do I am obliged to offer witnesses and members of the committee an opportunity to take a break for a few minutes. We have to be out of here by 2.45 p.m. I am not saying we will be here until 2.45 p.m. but if we are to go on longer, I offer people the opportunity for a break if they wish to take one.

Mr. Jim Breslin

I do not think I will last until 2.45 p.m. If we could take a short break, we would come back immediately after that.

Will we take a ten minute break?

I would say we will be here until 2.45 p.m.

Mr. Jim Breslin

Without break, though, it might be-----

No, not without break.

Will we say 15 minutes then if we are going to proceed? We will return at 12.20 p.m.

At 12.15 p.m.

At 12.20 p.m.

Sitting suspended at 12.05 p.m. and resumed at 12.20 p.m.

Our next member to make observations is Deputy Margaret Murphy O'Mahony.

I thank the witnesses for coming in this morning. At the start, I give credit to Ms Phelan, Ms Mhic Mhathúna and the husbands of the deceased ladies who are going through a very difficult time. I acknowledge publicly the pain they are all going through. Although much of what I wanted to ask has been covered already, I have a number of questions for a number of the witnesses. I would like to use my time hearing their answers.

Dr. Holohan said it in his opening statement but I ask him to categorically state that no Minister, specifically the Minister for Health, was told anything about this at the time.

Dr. Tony Holohan

No Minister for Health was told anything about this at the time.

Dr. Tony Holohan

Or no other Minister, junior or otherwise.

Dr. Holohan has covered it but I am not satisfied. Will he elaborate more on why this happened? Why was the Minister for Health not told?

Dr. Tony Holohan

He was not told because the information we had was information about the process of implementation of arrangements to feedback findings from the clinical audit to patients. The updates we had from the HSE were updates that gave us assurance that the process was taking place over a number of months and that the HSE was problem-solving when issues arose to get through them. It completed that process around late summer or so in 2016. I am aware that a clinical audit of that nature is not a common thing in screening programmes internationally. That is a positive development. I knew that open disclosure arrangements in respect of those findings would be even less common. These are features that would have added to the value and the standing of our screening programme in international terms and we saw them as good developments. There was nothing in that in a broad sense of risk, problem or concern being escalated to us as part of all of that which would be the subject of disclosure. That was the information we had at the time. Clearly there were gaps in the system.

It is very clear to see in retrospect that if the arrangement had been in place to have absolute clarity tied down before the commencement of feeding back of those findings with regard to whose job it was, what precisely was going to be fed back by way of a clear open disclosure policy for the service and a clear feedback loop to tell the centre, in this case the screening programme, then this might not have happened. There is clear learning in respect of all of those things. Without getting ahead of where Dr. Scally will take us in terms of findings, at a minimum we can see these are developments that will enhance the screening programmes. The patient safety Bill, which the Minister brought to Cabinet last week, will give the Minister powers to essentially set guidelines for clinical audit that would ensure that when clinical audits are started - of this nature or elsewhere - that in advance of commencement those guidelines would be crystal clear on the question of responsibility for feedback to patients and on the question of feedback to the centre so there is verification the open disclosure has happened.

I accept Dr. Holohan's word on what he is saying but if I had been Minister for Health at the time I would have been very disappointed and I would be wondering about the whole system. Despite what Dr. Holohan said, I still think the Minister should have been informed. We could go around in circles.

Dr. Tony Holohan

In hindsight, I understand that. I am very happy to hear what Dr. Scally may or may not have to say on that particular question. We saw the escalation and the decision for escalation on its own merits as something worthwhile in broad terms. Not everything that I would be aware of either in terms of positive developments or, dare I say, in terms of negative developments in the system would be things I would see as necessary to escalate to the Minister. We operate on the basis that as much as we can we try to manage and resolve issues if they are things we can manage and resolve and we have a system for that. I will not tell the Deputy it is a perfect system. I will and would like to say it is a system that is getting better and better. For example, we have a patient safety protocol that has been in development and improvement between us and the HSE which captures the kind of information we really need to have when patient safety incidents arise so we are able to discriminate between those circumstances that we really need to be concerned about and where, as the Secretary General said earlier, we need to step in. There was evidence of that at the time. There were areas where we were stepping in with regard to other areas. In respect of this particular one, I understand the Deputy's question. We did not at the time see it as anything beyond positive developments by international standards. We were getting the assurances from the HSE around its implementation of that but I am very happy to hear what Dr. Scally has to say about it.

It is important that we learn from it and move forward.

Dr. Tony Holohan


This saga was being discussed over the weekend. People were coming to my clinics with friends and family. It was suggested to me that a culture of secrecy had crept into the Department and possibly a lack of transparency and disclosure. That is obvious. Will Mr. Breslin comment on this? Can he see why people would think it?

Mr. Jim Breslin

Obviously, I have to understand what somebody is saying when he or she says it, but I would be very disappointed if it was capable of being a true reflection of how the Department operated. I certainly feel we try to operate in a transparent fashion. We approach the need for transparency through our engagements with committees here, freedom of information requests and a range of other forms of accountability such as parliamentary questions. We are very serious about it. Dr. Holohan has spoken about probably some of the most difficult and sensitive engagements in which we have been involved when particular patient safety incidents required the Department to work with individuals and their families. We seek to do so in a very open and caring fashion. I do not say we have always got it right and that we get it right every time, but if somebody said it to me, I would take it very seriously because I would want to ensure, as we continued to develop the Department, it became one where its reputation would be quite the opposite of what has been said. I do not believe we have the veil of secrecy that is spoken about. Much of the interchange on health matters is done in a very open way and often the subject of correspondence between the HSE and the Department, the subject of media debate and so on. I do not believe it is our ethos. It is certainly not what I am trying to encourage in the Department and not what I see every day in my engagement with individuals. They are very professional public servants who are seeking to operate in a way that is accountable; therefore, I would be disappointed if it was the reality.

It is important that this not be the perception for everybody's sake.

My next question is for Mr. Connaghan and I mean it with respect. Does he see his current position as being a caretaker? Has it been indicated to him how long he will be in the position?

Mr. John Connaghan

Yes, it has. I will be in this position until such time as a person is appointed substantively to the post. I estimate that, in terms of international and national recruitment exercises, it will take a minimum of six and, possibly, nine months. It depends on the field and who is interested in it. However, in terms of discharging the duties of the post, the committee can hold me to account just as much as somebody who is in a permanent job.

Does Mr. Connaghan intend to apply for the post?

Mr. Jim Breslin

That might be unfair. Mr. Connaghan was only asked to take on the current role-----

Mr. John Connaghan

May I tell the Deputy after the committee meeting?

Mr. Connaghan can do so. He can buy me a cup of tea afterwards.

That was a good answer.

While Mr. Connaghan is in place, what are his plans for reform and rebuilding confidence in the system?

Mr. John Connaghan

There are three things, some of which I referenced as part of my closing remarks. I would like to restore confidence in the cervical smear process and our ability to furnish the committee and to get the right people in front of it that it wants to see. Those are my immediate priorities. In terms of mid-term priorities, implementation of the Sláintecare report will figure quite highly. I can see many benefits in it. I come from a system which has geo-aligned health authorities with funding provided on a weighted capitation basis and devolved authority to a lower level. I think that is good because with devolved authority comes more power but also more responsibility. That is good and we should do it.

I have a particular interest in encouraging the growth of clinical directorates at local level, both in hospitals and community healthcare organisations. That is where decision making and power are moved nearer to the front line by investing clinicians with a degree of budget responsibility. I am a particular fan of it and have operated it very successfully in other jurisdictions.

Another objective of mine is to ensure the values we must observe in terms of the principles of public life - transparency, openness and personal and organisational accountability - are also quite up on my agenda. Last but not least, one of the interests I had in applying for the job of deputy director general of operations was related to trying to improve the performance of the health system in Ireland, from elective, emergency and scheduled care points of view and to transform what we were doing in changing the model of care to a better one.

I wish Mr. Connaghan the best of luck in performing his role. Many members of the committee were members of the Oireachtas Committee on the Future of Healthcare. When we hear Mr. Connaghan talk about geo-alignment and clinicians in directorship roles, many of us get very excited about that prospect. In particular, Deputy Bernard J. Durkan is very excited about geo-alignment. I genuinely wish Mr. Connaghan the best of luck in that regard.

I refer to Professor Scally's letter that was put into the public domain yesterday. As a member of the committee, the people concerned have been before us since after 10 a.m. Obviously, there is value in the conversation. In no way am I trying to shut down any conversation about the CervicalCheck scandal, or whatever we want to call it, but, as indicated by Mr. Breslin in his exchange with Deputy Alan Kelly, there are only 24 hours in the day. He was answering calls late last Thursday night. When we are questioning whether people are on holidays and so on, the committee might take on a responsibility to perhaps pause for a moment and let people in the Department and the HSE work with Professor Scally who is very well qualified. I have heard nobody criticise him in his role or his level of competence. It is not as if we have been told that this issue will be referred to in 2020. We have been told it will be referred back by the end of June. I understand the preliminary report is due to be presented in a couple of weeks. While I understand the value for the public and committee members in extracting information, I wonder about the material impact of such sessions in the overall investigation. I also think that discussing the issue in this forum at this time may be contributing to a lack of confidence in the smear programme which, as we all know from the evidence, has actually saved lives since its introduction. This is my own view. Perhaps we might discuss it when all of the contributions to the committee have concluded. I support what Professor Scally said in his letter. Perhaps we might pause and reflect on the issue until the interim report comes out.

I want to focus on auditing. My understanding is a fundamental principle of auditing involves what one does with the information when one receives it. Mr. Connaghan will be very familiar with the National Institute for Health and Clinical Excellence from his time in the United Kingdom. It is also used as the standard for many of us in our practice. At the heart of clinical audit is clinical governance. It involves reviewing notes and, fundamentally, seeking ways to serve the patient better. That is what appears to have been lost.

I am asking about the person who was responsible for designing the audit process. Dr. O'Keeffe referred to the process that was set up. It seems very strange that when the audit process started, what would be done with the information when it was received was not considered. How did that happen in the clinical audit process? Who is responsible for not designing the process correctly? Perhaps whoever answers the question will state whether a similar non-ideal audit process is happening in, perhaps, BreastCheck and BowelScreen.

Mr. John Connaghan

I will start with a couple of remarks on the purpose of clinical audit and will then turn to colleagues who might be able to best tackle some of the detail. Clinical audit is the systematic review and evaluation of current practice against research-based standards with a view to improving clinical care for service users. That is the objective. Colleagues might correct me on this but one of the primary objectives in conducting the audit on cervical cytology was to feed back into the training of those who were interpreting those results, as well as furnishing the women concerned with the results of those audits. There is a dual purpose, based on my understanding. One of my clinical colleagues who has been involved in audit might want to make more detailed comments.

Dr. Stephanie O'Keeffe

While I might leave coming back with a clinical response to Dr. Peter McKenna or Dr. Tony Holohan, I know that Professor Gráinne Flannelly established the CervicalCheck programme. It was established in 2008 and 2010, it was decided that it would be audited. I understand that the programme was governed through an independent statutory agency at the outset and then, during the period of austerity, was merged into the HSE, into the national cancer control programme. In 2010, it started the audit. When the open disclosure guidelines were initially published, the service reflected on the information that it had and decided that this information would be of benefit for patients. It is of benefit for patients anyway because those involved in the service are trying to improve all elements of the care pathway, from the letters that they issue if there is no one at the address or to general practitioners, GPs. There are many parts of the cervical screening process that could fail. The audit looks at all of those processes. It is of huge benefit to patients in identifying any problems. It is important to note that with this particular audit, the cervical screening service has stated that there are no systemic issues of note and that the programme is working well. The open disclosure element, with regard to making a decision that the information on individual patients' reviews is of benefit to patients, was the right decision to make in 2010. It will be interesting to finally hear Dr. Scally's findings on this with regard to the journey. It has clearly been a process that has been evolving. Whether those decision-making points many years ago were the right decisions, that is, to continue with the process approach rather than making finite decisions that we would stop all the cases that we reviewed up to that point and only do open disclosure prospectively, the service committed to ensuring, in the decision that it made, that the information it had would benefit all patients who had been diagnosed with invasive cervical cancer and had a history of screening.

My question is whether the process was flawed from the outset.

Dr. Peter McKenna

One could say that it was. I say that because I have been involved in research ethics committees for a long time. It is a moot point whether all audit should go in front of a research ethics committee or not but something of this magnitude would have benefitted from review. On such a committee, one would have had, as well as colleagues and service users, an ethicist. A core principle for successful work is that one does not impose a duty on somebody who is not represented in one's protocol. At the heart of this is that clinicians were expected to do something that they had not been involved in from a very early stage. If they had been, then much of the subsequent debate as to who should have done the informing would have been short-circuited.

To summarise, if the clinicians were involved in the creation of this audit process, this may have been flagged earlier. The conversation would have arisen about who will tell the person or family affected by this. The absence of clinicians in that initial audit design process led to the issues that started to happen in summer 2016.

Dr. Peter McKenna

That would be my view. In fairness, Professor Flannelly was both a clinician and in charge of the service. That just highlights the difficulty in representing both constituent parties.

Was Professor Flannelly in a full-time post?

Dr. Stephanie O'Keeffe

She was not in a full-time post.

If she is to blame in the sense that her head has rolled, which I mean in the nicest possible way, surely there is a deficit now that she is gone, in the sense that she did a lot of work on the HPV vaccine. To my mind, she can be given credit for being involved in the reversal of the downward trend in the HPV vaccine. Just because her head has rolled in this instance is not to say that she never did any good, since she had significant impact on the HPV vaccine uptake. The witnesses outlined two roles that she had in a half-time job, which I imagine is probably 18 hours a week - I do not know. Many of us here do 18 hours of work in a day. It seems like a very important role. Now it is vacant. It was a half-time role, which was filled by a clinician. Is there a move to get that filled as quickly as possible?

Dr. Peter McKenna

I thank Deputy O'Connell for acknowledging the work for which Professor Flannelly was responsible and did, as well as some of her achievements. In the short term, I am here to provide some gynaecological advice. It is a long time since I was involved directly in colposcopy but, having done that in the past, I would have some knowledge, though certainly not as much as her. I understand that the position she vacated is to be advertised this weekend.

Mr. Damien McCallion

Yes. I was going to say that. There is clearly a vacuum and, in fairness, Dr. McKenna has stepped in. It is a critical role. Mr. John Connaghan mentioned clinical leadership. It is essential. When one gets a strong combination, that is when services will typically work best. The post is being advertised. I sent the details to human resources, HR, to try to get the post out.

As a half-time role or full-time role?

Mr. Damien McCallion

A point on clinical leadership is that it is important that the clinicians involve still practice. I have the old job description and we just have to review that and look at what we think the appropriate mix is.

Does the job description state that this is a half-time role and that the rest of one's time should be spent in the real world, for want of a better term?

Mr. Damien McCallion

We have to agree the proportion of that. Dr. Peter McKenna and I have a copy of that and are talking to human resources.

Was it in her original one?

Mr. Damien McCallion


The point that it was half-time and of being engaged.

Mr. Damien McCallion

That is not unusual in many of the clinical roles.

I think it is a good thing.

Mr. Damien McCallion

It ensures there is a balance in professional practice and keeping up to date.

Dr. Tony Holohan

I will come in on the clinical audit and patient safety Bill in a moment. With regard to Professor Flannelly, I can also point out, while others are pointing out what she did with the HPV vaccine, that she was one of the people instrumental in helping to get the political buy-in to establish the programme. She had recently come back, if I recall correctly, from the UK and I remember her testimony about her shock at seeing women who were young coming with late stage presentations of gynaecological malignancies that were often preventable. The programme that she developed and directed for ten years is another contribution that she has made to saving lives.

She was there from the outset-----

Dr. Tony Holohan

She was.

-----and would have noticed when she returned from the UK that we had a very high level of cervical cancer relative to our European counterparts, and that there was a critical need. She became highly aware, as a witness mentioned earlier, that we are doing about the same amount of smear tests now as we did ten years ago. They simply are being done differently.

Everybody is getting a go at it here. In Sláintecare, we talk about a single-tier health service based on need, not ability to pay. In this case, it is actually a success story in the sense we have managed to - I want to phrase this correctly - get to every woman and every demographic in the country, when we were not doing this ten years ago.

Dr. Tony Holohan

That is correct. There is still another 20% we would like to get to. The uptake rate is about 80%, which is good, but we still have the message of wanting to have women come back into a programme they can trust. That has turned around a rising incidence of cervical cancer that we had in 2008 into one that is falling now at about 7% per year. That is a significant contribution that will be made to mortality and survival.

If I am not wasting the Deputy's question time, I want to comment on the reference to NICE and to point out some of the kinds of learnings we have. We have more of the architecture now than we might have ever had before in terms of implementation. Legislatively, there has been the patient safety Bill I mentioned earlier, giving the Minister guidelines to set capacity. We also have a ministerially-appointed committee, chaired by Dr. Karen Ryan, a palliative care consultant, with a broad range of consultants called the national clinical effectiveness committee that, essentially, oversees the endorsement of national guidelines, early warning scores and so on, with which the Deputy might be familiar, as well as clinical audit. The first clinical audit that was endorsed through that mechanism was the trauma audit last year, which directly informed the trauma strategy that was approved by Government as a consequence. That is the kind of structured approach to audit that we have and which will give us the kind of machinery, if I can put it in those terms, to enable verifiable implementation of some of the learnings we will have from all of this.

Thank you. There is time for one more question.

I am on 15 minutes and Deputy Kelly had 21 and 57 seconds, so I have still a bit to go yet.

You do not have to reach that target.

It is not a target; I am just pointing it out. A lot of the narrative in the media and in here has been around who knew what and when, and it was Vicky Phelan who used that phrase initially, if I remember correctly. It seemed to be very clear from all the documentation we received that there is no evidence this was ever escalated to ministerial level. From the evidence, I think we can see that is the case. Dr. Holohan should please intervene if I am not stating things that are factually correct because it is very confusing. What I am confused about is this idea that we moved from the period of February-March 2016 up to summer of 2016, when there was an issue with the lab getting involved and this pause was put on, and then we moved into the summer months where, it is my understanding, those within the Department thought the process was going ahead and there was nothing flagged to them to suggest there was any reason to be alerted to anything untoward, yet we are told here today they did not know that the treating clinicians had a problem with telling patients the information.

It was Senator Colm Burke who mentioned how many clinicians were involved - I think the number was 29. It is a small community. They talk, and there are medical people within the Department and within the HSE structure. I do not understand how, even on the grapevine, it did not filter down that there was an issue among the consultant clinicians who were treating women who had active cancer, given this was a retrospective look-back at their smears. If that is the case, the fact the HSE was operating in a vacuum is even more apparent. It seems incredible to me that some doctor at some conference, or some gynaecologist, would not pick up the phone and say, "Did you get a letter from CervicalCheck making you tell whoever about whatever?" That element seems incredible. I am not accusing anybody. I am just trying to get to where we are probably going next in the story.

Dr. Tony Holohan

I will try to answer that and I may hand over to Dr. O'Keeffe. I can say, from my own point of view, that any interfaces I would have had with that professional group were almost exclusively focused on the obstetrics side of that, given all of the policy issues we have been dealing with in recent years.

Dr. Stephanie O'Keeffe

I think it is clear from the documentation that the CervicalCheck programme was engaging with clinicians through the colposcopy forum and through the 15 colposcopy centres providing the services on down through the histopathology labs. It is clear in the documentation, when they are talking about how they develop the audit process, and it is certainly very clear throughout the briefings, particularly in the October briefing, that they are actually stating - for example, in the paragraph I read out earlier today - that they are engaging with consultants and clinicians in an ongoing way to support them with this process, writing out to the clinicians with regard to the support for the communications and the support to be able to have this conversation with women. All of those documents are there. It is the case, however, that if there were issues or concerns arising within CervicalCheck, and I say "if" because the only person who can really give us that answer fully is not here today, because the person who engaged with those consulting clinicians in the main was Professor Flannelly herself, then either she felt it was being dealt with or it was not escalated as an issue.

To set the context, I would like to comment briefly about the response to the whole tragic controversy. While I understand the pressures that are on the system since the controversy broke, I would like to highlight one particular case that really brings home the anguish and worry of women across the country, and that is the case of Jacinta Doyle. She is a Wexford woman and mother of two who had a smear in 2011 which did not flag any issues but, in 2012, when she presented to her doctor with chronic back pain, she was referred for a scan - which she had to pay for privately, incidentally - and that is when her diagnosis was made. My concern is the ongoing firefighting approach we have seen since the controversy broke. This lady spent 12 days trying to get answers as to where she goes next. She initially called the helpline on 28 April but got no response. She then called on 3 May but got no response. She then contacted CervicalCheck via a Facebook post on 7 May. It was only on 10 May that she was told her original smear was tested in the US and that this lab was no longer used.

That constant drip-feed of these stories we hear in the media is not reassuring to the women of Ireland. Furthermore, from a general practice point of view, it is only really in the past few days that we have got any clear direction in order to provide the free smear programme, which GPs are more than happy to do. While it is clear that, for patients with medical cards, we can use an STC, or special-type claim, and put the medical card number on it, for private patients I understand we are instructed to use the patient's PPS number. Can the witnesses clarify if there is a breach of data protection, as I understand there may be some issue in this regard?

Second, Dr. Holohan stated in his submission:

It has become clear since the case that the non-disclosure of clinical audit findings was widespread. It has also become clear that the issue of disclosure was the subject of dispute among some elements of the relevant clinical community. I can provide assurance that the Department was not aware of these issues until this controversy arose...

It is very difficult for people watching this today to understand or believe how this could be the case. I would like an answer as to how the Department was not aware of this until the controversy broke. Really and truly, the women of Ireland need reassurance about this. While I am not suggesting Dr. Holohan is misinforming the committee, it is very difficult for people to understand this.

Dr. Holohan said he has been chief medical officer for the last ten years and he has escalated many issues to various Ministers, be it Ms Harney or Deputy Martin, over the years. He has a long-standing history of doing this, which is to be welcomed. Why did he feel this was not an issue that needed escalation?

In hindsight, do the witnesses feel this decision was a misjudgment?

Looking at the Minister's diary from 26 November 2015, I can see that the then Minister for Health attended a HSE directorate meeting. Did any of the witnesses attend that meeting?

Mr. John Connaghan

Could the Senator repeat the date?

It was 26 November 2015. It would be interesting to find that out. There was also a meeting on 28 January 2016 at 2.30 p.m. The Minister had a meeting with the Department, the director general and the HSE. Was any of the witnesses in attendance at that meeting?

Mr. Damien McCallion

I will take the first question. In terms of the response, I acknowledge the scale of what has happened and of trying to put a cohesive response in place. The screening programme is a relatively small service. CervicalCheck has just over 30 staff, which includes managing and running the service day to day. The helpline was effectively inundated in those first number of days with a very low response rate. To date, there have been over 17,800 calls as of our report last night. A total of 14,290 of those have been responded to. This still leaves a very significant number. As I think I explained at one committee meeting last week, I do not want to go over old ground but in simple terms, we set up four call centres to try to deal with this. One is in Cork, which takes the initial calls. Typically, it is able to handle 25% to 30% of the calls at the first point of contact from the women who are concerned. All of the others are requesting callback from a clinician. That is one of the key issues for us at the moment in terms of making enough clinical staff available to deal with the responses. We triage those calls into a number of categories. One is where a woman has a normal smear history so the call is taken to Limerick where the centre is based and they go on to the system to pull down the information for that woman so it is not actually just a phone call and a conversation. It involves looking at their full clinical history so that we can then determine who is best placed to talk to that woman about the concerns she expressed. If the woman has a normal smear history, our call centre in Waterford or public health take that call. If there is an abnormal smear history, there are two centres in Dublin and Limerick, which we try to resource to take those calls. The final category are people who have had a cancer history or colposcopy. We have put a model in place for the hospitals where the women contact them directly. It is fair to say that there is significant stress and strain in that model. Obviously, we had to put it in very quickly. We brought in some expertise around call centre management but it is after the act. One would certainly not be doing this in the normal course of events.

In respect of the case mentioned by the Senator-----

This lady had a history of cervical cancer and she still had to have three contacts with the service.

Mr. Damien McCallion

I appreciate that. I will take the specific case and then the broader learning from it. I became aware of the specific case late last night and have asked for the woman to get a callback this morning. It came to me through a different source and I have asked for an arrangement to be put in place for her this morning. We are taking them chronologically so that people are waiting for the shortest period of time possible but in terms of clinical resources, we are pulling the resources from the hospitals. That is where the clinical staff are based. The screening service itself has a very small pool of clinical staff who can answer those questions. The cancer screening programme is also supporting it. We are looking from all the agencies - those that are contracted and those that are not. We have looked at cross-Border options. We have tried to ensure that no stone is left unturned to maximise that. We have made some progress but I accept that it is still an extensive delay for some people in getting through. Our priority is to look at those women who have had a history first. These women are being prioritised with the hospitals, which are working through those cases this week. That is the overall response. With regard to the specific case mentioned by the Senator, last night, I asked that the woman in question receive a call this morning.

We dealt with the Senator's question about escalation in his absence.

Do the witnesses have any update regarding my second question about the potential breach of data protection using PPS numbers?

Mr. Damien McCallion

Along with Dr. Jerome Coffey, I would have signed the letter that went to GPs last week. That was an attempt to put clarity into the system. There was clearly some confusion as to what the arrangements were and also with our primary care GP adviser. Our understanding is that we were able to use that. There have been some queries back and we are solving those but the advice we took at the time was that this was an appropriate mechanism to ensure that GPs were reimbursed for seeing all patients because this is a population health screening programme. It does not just apply to medical card holders.

There was a question about ministerial meetings or meetings the Minister may have attended.

Mr. Jim Breslin

I am happy to speak to that.

The committee addressed that question when I was in the Seanad.

Mr. Jim Breslin

I am happy to speak to that question concerning meetings. I will check my diary as the Senator has given the information. There was a meeting on 26 November 2015, which is in my diary. I would have attended it. It was a meeting between the Minister and the HSE directorate. On 26 November, my guess-----

So Cervical screening was not discussed at that meeting?

Mr. Jim Breslin

No. I would need to check timelines but the date of 26 November would indicate to me that it was probably a discussion about the national service plan, which was being finalised during that period. I have checked my diary for 28 January 2016. That is in the diary but it is marked "cancelled".

What disturbs me is that this has been presented as normal. It is normal because there is a failure rate and everybody should know so really the women should have known. I do not like that because it suggests it was the women's fault because they did not know that there would be a 30% failure rate. All of this stuff makes really interesting reading in the documentation provided so far. The reason for this is that one can see a clear escalation in terms of the number of cases and what people were thinking along the way. If we go to the March 2016 briefing note, we see the logging of cases. Work is under way by the State Claims Agency to extend the architecture of the national incident management system to facilitate logging of incident cases for screening programmes. That would suggest that we know that we have something here that may escalate. What I am trying to get at is people's awareness of the existence of a really big problem. How often do normal meetings to brief the Minister about what is happening take place?

Mr. Jim Breslin

We have a range of different meetings. We tend to have a set piece about every six weeks between the Minister and the management board.

So every six weeks. When did the audit start? I know it was initiated in 2010. When did it actually start being done?

Dr. Stephanie O'Keeffe

As far as I understand, it started being done in 2010 but it went back to all cases since the initiation of the screening programme in 2008.

Were there not any red flags in the audit from 2010 to 2016?

Dr. Stephanie O'Keeffe

No, the audit would review every single case of invasive cervical cancer notified to the screening programme. They would do a case review and there would be findings. What is really important to convey to the public because there have been significant levels of confusion with regard to this-----

I only have five minutes so I really need to get to the bottom of this.

Dr. Stephanie O'Keeffe

-----is that there were no systematic quality issues of concern as a result of the audit process.

So between 2010 and 2016, everything was hunky dory? There were no problems, nothing was being flagged and there was nothing of interest?

Dr. Stephanie O'Keeffe

Between 2010 and 2016, most of the historical work had been concluded and fully concluded in the sense that letters were issued to consulting clinicians by September. The October briefing would indicate they were pretty much sent by September. The bulk of them were issued during July and August.

I have gone through all of that. I am trying to find out about the five-year period between 2010 and 2016. Was there nothing there that caused concern?

Dr. Stephanie O'Keeffe

The audit was continuing within CervicalCheck.

There was nothing there that caused concern to anybody at any point?

Dr. Stephanie O'Keeffe


I return to the meetings with the Minister. Who sets the framework for those meetings? Is there a regular agenda? How is it decided?

Mr. Jim Breslin

There is a regular agenda. Certainly in my time in the Department, it has tended to congregate around particular items such as the legislative programme and where we are in respect of it. There is a discussion of significant issues where we might highlight issues to the Minister.

There could be a discussion of a service plan, if we were in the process of agreeing a service plan with the HSE. A legislative programme would certainly always feature and significant issues would always feature as well.

There would be nothing around flagging up anything that might be a critical incident or that might be of any concern to the Minister. Is Mr. Breslin saying that categorically? I find it absolutely incredible that, given all this paperwork and how things were escalating, including the number of cases escalating, at no point would anyone think it merited informing the Minister. Was the view simply that these were only women so it did not matter?

Mr. Jim Breslin

Absolutely not.

I cannot get my head around why the Secretary General would not have deemed it serious enough when he saw the escalation and the State Claims Agency was involved and so on. I cannot get my head around why no one would mention it to the Minister.

Mr. Jim Breslin

Senator Conway-Walsh is obviously looking at it and talking about it as escalating. The numbers-----

I was referring to the number of cases.

Mr. Jim Breslin

I will be able to help on this point. In considering the number of cases, the word is not "escalating" but rather "increasing". That increase was seen as a good thing because the objective was to inform women and letters were issuing. Escalation in the parlance we are now using is referring to something that has gone wrong. Actually, the reports were giving increased levels of comfort that the objective that had been set had been accomplished.

Mr. Breslin has cited that in August 2016 a total of 120 letters had been issued by that stage with no adverse reaction. Can Mr. Breslin explain to me what "no adverse reaction" means?

Mr. Jim Breslin

I was not engaged at the time but my expectation is that it reflects the interest of the programme in trying to maintain trust in the programme; ensure that individual issues do not become issues that undermine the credibility of the overall programme and that they are managed well; and ensure that a good communications process is put in place.

Is that the same as the view taken in April 2016? At that stage the relevant document stated that as the volume of letters increased the risk of an individual reacting to the content, if and when shared, was a concern. Does Mr. Breslin mean by that women reacting to-----

Mr. Jim Breslin

I wish to clarify one point. Senator Conway-Walsh is directing the question to me. I did not write the memorandum.

Who wrote the briefing?

The Senator has one minute remaining.

All of this seems to suggest the Department was waiting for the women to react but hoping that they would not react to it. Then, if they did react the Department had the headlines in mind. The approach suggests if the women were going to react or speak out then the Department had to be prepared. To me it seems like a defence mechanism. I take what Mr. Breslin says about confidence is the screening but-----

Mr. Jim Breslin

One fact is relevant to making a judgment on that. If the intention was to withhold information, what was the process of generating letters all about? It was the opposite of withholding information. It was generating individual reports and issuing letters for the purposes of passing that information out into the system to be passed on to individual women. I am looking at this in reflection and trying to be objective about it. If the purpose was to withhold information, those letters would never have been generated. I do not believe they would have been.

I am going to ask one final question because it is relevant today. Let us suppose a person wants her file. Maybe this question is relevant to Mr. Connaghan as well. Let us suppose a woman wants her medical file today. How is she going to get it? How long is it going to take her? If a woman goes to her general practitioner and seeks a medical file from the consultant, how long will it take her to get it? Who is responsible for giving it to her?

Dr. Stephanie O'Keeffe

The March memorandum makes clear that the CervicalCheck programme has always facilitated it. This is iterated throughout all the other briefing notes as well. Since 2008 the programme has facilitated the provision of information to women and their legal representatives whenever they require it. The information note to consultants states that women have a right to access information on all their files and that they can also go to the CervicalCheck programme to get that information.

Let us suppose a person wants her medical file tomorrow. How long would it take for someone to get a medical file, not only from CervicalCheck but across the board?

Dr. Stephanie O'Keeffe

If a woman was calling CervicalCheck to get that information, the programme would arrange it on the basis of whatever the administrative time is needed to locate the file, get it and send it on. Those involved would do that as quickly as possible. That has always been explained throughout the process. CervicalCheck has never had a difficulty with giving information. The programme has always taken the view that it is a woman's right to have that information. That is repeated throughout the briefings and-----

I know what is repeated in the briefing.

We have to move on.

I appreciate that. Thank you for letting me in, Chairman. People have great difficulty in getting access to their medical records. I call on Mr. Connaghan to address that within the system. When people ask for their medical records, they should get them in a timely way.

Thank you very much, Senator Conway-Walsh. We will now do a second round. We are going to reduce the time to six minutes so that everyone can get in. You might not have been here, Deputy Donnelly, but we have to be out of the room by 2.45 p.m. so we want to give everyone a chance.

Thank you, Chairman. I want to go back to where the non-disclosure process failed, that is to say, between the consultants and their patients. Mr. Breslin said earlier that the general issues in the 2006 documentation covered the fact that there was going to be disclosure to patients and this could lead to risks and so forth. None of that was escalated to Mr. Breslin or the Minister. My question is specifically on the issue of consultants not relaying the information to patients. When did the Department first become aware that was happening?

Mr. Jim Breslin

I think I did answer this at the previous committee meeting. The knowledge of that was consequent on the Vicky Phelan case. There was no knowledge in the Department of the widespread non-disclosure that has taken place. The first we were aware of it was consequent on the Vicky Phelan case. Then, our awareness of it was only increased and heightened by the information arising from looking at the 208 or 209 cases and trying to identify through the serious incident management-----

I appreciate that. In the interest of time I am going to keep going. No one in the Department had any knowledge before April of this year that consultants may not have been passing the information on to patients. Is that correct?

Mr. Jim Breslin

I do not believe so and none of the records shows that anyone in the Department was aware of it.

I thank Mr. Breslin for that.

The next thing I want to ask relates to more damaging non-disclosure. There is widespread belief in a clinical link between non-disclosure and outcomes for the women involved. My understanding is that there is no clinical link. In other words, had the women been told about the identification of the false negatives the day they were identified it would have made no difference to their clinical treatment and outcomes. Maybe this is a question for the doctors on the panel. Am I correct in that belief?

Dr. Peter McKenna

Yes, Deputy Donnelly is correct.

I am seeking a brief answer for reasons of time.

Dr. Peter McKenna

That is absolutely correct.

Now, I believe there is potentially a causal issue. It relates to what I regard as misleading information given to the women. The briefing note states:

As with all screening tests, cervical screening is not 100% accurate. Screening cannot give a ‘yes’ or ‘no’ answer and a negative screening result does not mean that the disease will not develop in future.

That is what people were told. Will the medics before the committee indicate whether they believe giving that information made sense? In reality we now know is that had the disease been present or had abnormalities been present there was only a 70% chance that the screening would actually pick them up. Do the medics before the committee believe stating that screening is not 100% accurate was appropriate? Many people, including me, would be led to believe that the accuracy percentage is perhaps in the high 90s. Could that have led women to being less vigilant with regard to becoming symptomatic, given that they were told screening is not 100% accurate? I would have taken it that I was meant to believe it was 99% accurate but that I had the all-clear. Is it possible that there is a causal link between clinical outcomes for women and information that suggested the screening was more accurate than it actually was?

Dr. Peter McKenna

I wish to answer that. It is important to stress in documentation to the patient that one smear alone is not an effective protection against developing cancer in future.

The chances of detecting cancer are much better if women take part in the programme and have regular smears. That is an important component of any programme and should be included. I contributed to the confusion myself when I was here on the last occasion and I am very sorry for that. I apologise in particular to Deputy O'Reilly to whom I gave information that lacked clarity. If one looks at 100 abnormal -----

I am sorry to cut across Dr. McKenna but we do not need to go over the statistical accuracy issue. I ask Dr. McKenna to answer the question I asked.

Dr. Peter McKenna

The question is, I think, whether the documentation given should say one smear-----

That is not the question I asked. I am not asking Dr. McKenna what he thinks the documentation should say. He knows what I am asking him. Could he answer the question I asked please?

Dr. Holohan also wants to contribute.

Dr. Tony Holohan

I wish to make a more general observation that-----

No, I do not want a general observation; I want an answer to the question I have asked.

Dr. Tony Holohan

Statistically, that is still correct but-----

I know that less than 100%, mathematically, can include 70% but-----

Dr. Tony Holohan

It is close to 100%-----

-----that is not the question I am asking.

Dr. Tony Holohan

I understand that.

Can someone answer the question I am asking?

Dr. Peter McKenna

It is actually correct. The chances of one woman having a smear that is misleading, for that one woman, is about 1%. It depends on the incidence of the disease in the community but it is quite a different question to a question on the chances of an abnormal smear being missed.

I understand that. I am not looking for a statistical conversation about it. Can Dr. McKenna answer the question I have asked?

Dr. Stephanie O'Keeffe

I think the Deputy asked, if I heard him correctly, whether the information given to women in the leaflets that deals with false negatives and false positives and the fact that the test is not 100% accurate led to a false reassurance and to women being less vigilant. We would have to go back and look at the data but I would be fairly confident that the coverage of the programme has been increasing year on year, which would suggest that that is not the case. The coverage of the programme is increasing year on year. It is now up to 80% and was at 79% a year ago. That means that more of the population is being covered over that period of time, which means more of the population is coming for their results. The target is 80% and we are now at 80%. As Dr. Holohan has said earlier, we would like to see that go even higher but it is a very high participation level-----

That still does not address the question I asked. Dr. O'Keeffe is talking about the percentage of the population covered. I am talking about an individual woman. An individual woman is told that the test is not 100% accurate. That is the information she is given and that is the information consultants are given. The reality is that if that woman has pre-cancerous cells, the screening has about a seven in ten chance of spotting them. If I were told that the test was not 100% accurate, I would not infer from that information that the test was only 70% accurate. Do the witnesses believe the information provided to women is accurate or misleading? If it is misleading, is it reasonable to suppose that it could have led to less vigilance than might otherwise have been the case, which could have clinical repercussions?

Dr. Tony Holohan

It is still technically correct. Accuracy refers to the combination of both sensitivity and specificity. In other words, when we add up all of the correct numbers, whether correct positives or negatives, it will be over 99%. An individual woman can have confidence that her result is more than likely 99% accurate. Within that however, the Deputy is correct about the sensitivity and there is a question here to which we must be open. If, when the Scally process finishes, there are recommendations on risk communication they will need to be taken on board. Across the practice in medicine we have encouraged too much, in an almost paternalistic sense, dependence on tests that are always fallible. People get the sense that they are 100% effective with every result but in reality, there is no test of which I am aware for which that is actually true. The phrase that is conventionally understood for general diagnostic work of "all clear" is not something that is accurate. Therefore, we need to be more clear in the way we communicate risk in the context of tests than we have been historically.

I just want to note that as far as I am concerned, I still have not had a straight answer to the question. I am not asking Dr. McKenna if the information provided to patients is statistically or mathematically true. I am asking, in the context of a patient walking into a GP's surgery, whether he believes it is accurate or misleading in terms of the quality of the test.

Dr. Peter McKenna

I said earlier today and the last time I was here that I would amend and improve the information. I would also explain that if the result of one smear is negative, that is good but that in order to benefit from the programme, women need to enter into it in a continuous manner. That will improve their chances of not getting cancer in the future. The Deputy is correct when he says that it might give false reassurance but it is, on the other hand, accurate.

I call Deputy Louise O'Reilly.

I wish briefly to go back to one of the questions I asked regarding the first outsourcing that preceded the main outsourcing decision. I want to be really clear about what I want from Mr. McCallion, who promised to provide the information to us. I want to see all of the information about the original decision in 2007 to outsource 60,000 tests to Quest Laboratories.

Mr. Damien McCallion

I gathered that information during the break for the Deputy. In 2007, the tendering authority was the National Cancer Screening Service board. The tender went on eTenders in December 2007 and closed in February 2008. There were seven tenderers and an award was made on 8 May 2008.

That is for the 60,000 smears.

Mr. Damien McCallion

That is for the first tender under the contract. I will have to check-----

We are not talking about the same thing because we know that 60,000 tests were outsourced in 2007, before the ongoing outsourcing-----

Mr. Damien McCallion

I will have to check but that is the first tender-----

They were outsourced by a man called Mr. Finn.

Mr. Damien McCallion

To the best of my knowledge that is the first tender but I will confirm that. I have not seen the figure of 60,000 before but I will try to confirm that. I will link with the Deputy-----

It was in the Irish Independent. It is not news. That information was published in the Irish Independent newspaper last year.

When the decision to outsource was taken in 2008, according to the Dáil record there were accredited laboratories in Beaumont Hospital, the Rotunda Hospital, the Royal College of Surgeons in Ireland, RCSI and St. James's Hospital. There was also an arrangement with Antrim and Altnagelvin Hospitals and St. Luke's Hospital had just received accreditation. Is that right?

Mr. Damien McCallion

I would have to go back and check the history of that tender-----

I ask Mr. McCallion to check whether that would have been the level of laboratory availability in 2008.

I refer now to the minutes of the meeting between the Department, the National Cancer Control Programme, NCCP, and the National Screening Service, NSS, of 3 August. On page 4 it says that the clinical audit is "ongoing" and that a total of 120 letters had been issued so far, with "no adverse reaction". I ask Dr. Holohan to indicate if that is correct. If 120 letters had been issued at that stage, does that mean that 120 women were told or that 120 clinicians had been advised?

Dr. Tony Holohan

Dr. Stephanie O'Keeffe will be in better position to respond but I would have understood that to mean that 120 letters had issued from the programme and that there had been no adverse media-----

Dr. Tony Holohan

Issued to clinicians from the programme. That is what I would have understood-----

The letters were issued to clinicians with an instruction to them, presumably based on the template letters.

Dr. Tony Holohan

That would have been my understanding.

The instruction to them was not to disclose, was it not, Dr. O'Keeffe? Let us be very clear here. The instruction in the case of the deceased was to stick a note on her file but there was no instruction at all to disclose. In no way, shape or form was there an instruction to disclose in any of those template letters.

Dr. Stephanie O'Keeffe

As I said, one would have to look at the individual letters. The programme has told me that these templates would have been amended for the specific purposes of each individual piece of correspondence going to consulting clinicians. The reason the letter says "if open disclosure is indicated in the case" is that for some people, there is no discordance between the two reviews. However, for other people, open disclosure is indicated in the case. While I accept that it is not mandatory or total open disclosure and that clinical judgment is allowed for within the documentation and advice to doctors, one can also see that the programme is suggesting to the doctors how best to communicate the information and how important it is to do so.

Time is very short. It is breathtaking that people come in here and defend those letters but best of luck with that. Of those 120 letters sent to clinicians, does the HSE have information on how many women were advised of their own history and their own results?

Dr. Stephanie O'Keeffe

No, we do not.

Nobody thought to follow that up. Everybody just thought it was happening.

Dr. Stephanie O'Keeffe


When it says "no adverse reaction", there was clearly an expectation of some form of adverse reaction - as anyone would expect - because the HSE team was also busy at the time preparing a media strategy for potential adverse reaction. The witness has said that 120 letters had been issued with no adverse reaction. Did nobody think that might have been because the information was not getting to the women?

Dr. Stephanie O'Keeffe

In a number of the memos, it states that some cases were being taken. Preparing for the adverse reaction was, again, back into ensuring that the reputation of the programme would be minded as women would talk about this in a public forum. We were expecting women to do that. We were expecting women to seek their files from CervicalCheck and, if they chose, to seek legal redress. There was an expectation-----

Was a flag not raised when 120 letters went out and there was no adverse reaction, as recorded in the minutes? Much of what we are discussing here has to do with us looking at information that should have had a red flag. The HSE team seemed completely unconcerned. Now, that HSE team seems concerned with apologising and telling us that with hindsight it would, of course, have been different. However, the witness and her colleagues are not paid for their hindsight. They are paid to take action when an issue comes up. An adverse reaction was expected. There was no adverse reaction and yet nobody thought to question it. If that is the case-----

I thank Deputy O'Reilly. We will take that answer and then we will move on. I call Dr. Holohan.

Dr. Tony Holohan

It may be helpful to address this as it has come up a number of times in the context of people after they have died. The current medical practitioner ethical code from 2016 states that "if it is unclear whether the patient consented to the disclosure of information after their death, you should consider how the disclosure might benefit or cause distress to the deceased’s family or carers.". That is the current set of guidance for medical practitioner and the code under which doctors operate.

That just really underlines the need for mandatory disclosure and legislation for that.

Did Mr. McCallion want to say something?

Mr. Damien McCallion

No, that is fine.

We are going to ask Deputy Alan Kelly for his observations.

I have one observation, one comment and a couple of questions. There is much commentary and let us not beat about the bush. People are looking for political accountability and to know if any Ministers were aware of anything. That is blatantly obvious. I would like to move away from that. I address my questions to Dr. Holohan and Mr. Breslin. I ask for clarity which would put this away. Is it possible to send out an email in the Department of Health, by next week, asking anybody with any knowledge in respect of this issue to bring it forward? I also ask that by this day next week that information be provided on all meetings or discussions that anyone is aware of, and are in any way documented, about CervicalCheck since 2011. I refer to the number of meetings that took place on CervicalCheck or the national screening programme internally in the Department.

Mr. Jim Breslin

Why 2011?

Mr. Jim Breslin

Why 2011?

I want to go back to 2011 because much of the case history goes back through three Ministers for Health. That is my request. The witness does not really get to-----

Mr. Jim Breslin

My undertaking is to produce all the records and we talked about 2007 earlier.

That is fine.

Mr. Jim Breslin

I refer to all the records that relate to Dr. Scally's terms of reference. A full record search is under way in the Department of Health.

Mr. Jim Breslin

We will be searching every email. There are 40 million of them since 2008.

Basically, we-----

Mr. Jim Breslin

We will search every one of those and I will do that to a standard that I-----

That is perfect.

Mr. Jim Breslin

-----will be able to satisfy my accountability to produce any shred of a record that exists within the Department.

That is okay. We do not have the ministerial management advisory committee, MinMAC, meetings for the last number of years. CervicalCheck has never been on the agenda of a MinMAC meeting, which is extraordinary. I have made my request. It includes three Ministers and six advisers. That is nine people in total.

Mr. Jim Breslin

The Deputy has made the request but I want it to be clear that I do not want it noted that I am doing something separate from the overall process I am doing. That is a full record search related to the terms of reference for the investigation being carried out by Dr. Gabriel Scally. I will have that completed as soon as I can. I have a full team in place doing that-----

That is okay.

Mr. Jim Breslin

-----seven days a week at the moment.

As long as it includes all references to Ministers and advisers.

Mr. Jim Breslin

It will.

We have been through other committees and other Departments about private emails and private phones and all of that. I ask Mr. Breslin to make sure it is all covered. The second issue is just an observation. Mr. Breslin has said he was not told about any of these issues until the Vicky Phelan case came to light. I accept that. How does he feel that senior management in the HSE - the top tier, bar Mr. Tony O'Brien - was aware of these issues in respect of the process and audit since March 2016? I refer to the evidence of Dr. O'Keeffe. Some of the senior managers were also aware of the Vicky Phelan case since the summer of 2017. Does that not tell Mr. Breslin that there is a serious failure both in management in the HSE and also in the overlap of communications with the Department?

Mr. Jim Breslin

Deputy Kelly has a view on that but it is not a view that I share.

That is okay.

Mr. Jim Breslin

I think the Deputy's view is that in and of itself, as he has described, that is a representation of how things have happened and that also means that there is some dysfunction between the HSE and the Department. I believe during the course of the morning, there has been a lot of reasonable and plausible presentation of the information showing that the core issue of widespread non-disclosure existed within the CervicalCheck programme and was not escalated sufficiently both within the HSE and within the Department. We have talked about the management systems that were working within the HSE at the time. That is a separate question but I cannot blame someone for not passing on something if he or she did not know it.

They did know it.

Mr. Jim Breslin

In respect of widespread non-disclosure, I have not heard-----

I did not say anything about non-disclosure. There were issues in the audit process. Dr. O'Keeffe has identified that she had to inform other people at senior management level in the HSE. She told us in evidence earlier that she did so in respect of Mr. Lynch on 3 March.

Mr. Jim Breslin

The clinical audit process, and this is at the core of the position as we have articulated it, itself is now being viewed as a timebomb and a bad thing and something that should never have been gone near. However, that is not how it was viewed at the time. It was viewed in a very positive light.

Mr. Jim Breslin

Just having information and knowledge of a clinical audit programme is not a warning.

Having knowledge later on, however, when issues started to arise and then still doing nothing is the point I am making. There is a track record here of people who knew about information within the HSE and did not inform the Department of Health. If Mr. Breslin is not concerned about that from March 2016 to when he found out about the Vicky Phelan case, then that is extraordinary.

Mr. Jim Breslin

It has to be the case that there was information somewhere within the HSE. It has to be-----

At senior management level.

Mr. Jim Breslin

I think-----

The two gentlemen that we do not know yet-----

Mr. Jim Breslin

I think we need to follow that trail all the way.

I agree with Mr. Breslin. Can I ask-----

The Deputy has one more minute.

I am going to do what my colleague did and say there were eight or nine minutes there. I will take them-----

I did not overstay my welcome on the last occasion. I kept to the rules.

If the rules-----

The rules apply to everybody.

The Deputy is not chairing.

I am not chairing but-----

I will take the same time as the previous speaker.

I am sorry about that.

Deputy Durkan is not the Ceann Comhairle.

As concisely as possible please.

-----everybody on the committee must be treated equally-----

This is ridiculous.

-----with no exceptions.

Can I ask my question please? I direct this question to Dr. O'Keeffe. This is intriguing me. Why did the first memo happen on the date it did? Why was there a decision to do a memo in March 2016? It was March 2016, was it?

Dr. Stephanie O'Keeffe

It was March.

Why did it start then? Had it anything to do with the fact that one of the two women, who took legal cases before they unfortunately passed away, Lord rest them, had been told about her situation in respect of a number of smears taken some years previously? She had been notified just prior to that date.

Was there any correlation between the fact that she had just been told and this document and the process of communicating it upwards or across? Subsequently the case went legal in April and the lady, unfortunately, passed away in June. I have spoken to members of her family. They are going through a legal process, which is not very nice and is contrary to some other evidence we have heard in respect of the State Claims Agency. I want to know because the family wants to know whether there is any correlation in that case which is actually referenced in the document. It references one case which, I presume, is this one. The lady also did not make the meeting on 3 March because she was too sick to attend. She was never able to have the meeting with CervicalCheck.

I thank the Deputy.

To conclude, is there a correlation between this memo on this date of all dates and the fact that she had been told in February? Obviously, she was not able to make her appointment, which is referenced in the documentation.

Dr. Stephanie O'Keeffe

Categorically not.

I ask Dr. O'Keeffe to answer my question. What stimulated the memo?

Dr. Stephanie O'Keeffe

The briefing was stimulated by the fact that a batch had accumulated. There was a process CervicalCheck had started to instigate. A laboratory suggesting CervicalCheck should not be sending letters to treating clinicians threatened the process. In that context, I received a presentation the day before the first meeting, which for the record was in February. I received a presentation from Professor Flannelly on the audit. Although there are many other meetings I do not particularly remember, I remember a lot about the particular meeting because it was new information. I remember initially feeling a sense of concern about the audit as to whether it was throwing up any factor or issue with the integrity of the screening programme. I satisfied myself that it was not and was happy with that. We addressed the issue with the laboratory and it was going to continue to engage, although that became a little more problematic in March, as can be seen from the briefings.

I also genuinely remember Professor Flannelly talking about the case from the perspective of what we should do as part of it. CervicalCheck was certainly conscious to alert me to the fact that it was engaging in this and that it intended for patients to receive their information. I actually remember Professor Flannelly telling me that CervicalCheck would be providing the lady with all of the information on advice received from its solicitor. I remember saying at the time that there was no need to wait for the solicitor and that the person could be given the information. However, CervicalCheck was very conscious that, because it was engaging in the process with the intent that women would receive the information and knew that it clearly would result in cases, it wanted to ensure it could protect the totality of the programme. It knew that cases would come up in carrying out the audit.

From my perspective as a national director, it was very important to ensure there was nothing else within the findings of the audit that was troubling or concerning and that we had a safe programme. We do have a very safe programme. What is being found through the audit is within all of the normal parameters. While I absolutely accept the criticism that the briefings are very process oriented and not personal, the conversations are personal. There was a personal conversation about the difficulties in having that conversation. However, as can be seen in the February briefing, there was a statement to the effect that this is what CervicalCheck did and that Professor Flannelly would meet patients, which she went on to do. That is what happened at the first briefing.

I thank Dr. O'Keeffe for answering the question.

Mr. John Connaghan

The Deputy asked me about Mr. Patrick Lynch and Mr. Liam Woods. Mr. Lynch has left the country and is uncontactable. During the break I was able to make contact with Mr. Woods before he boarded his plane. He will be here tomorrow morning.

I am not going to use my full six minutes, lest others think I am butting in on them. I have two questions, one of which I asked earlier in respect of document No. 11 which we received yesterday. On page 4 there is a reference to 317 cases as having been flagged for further review which focused on more than one area. It states:

In most (although not all) of these reviewed cases there may have been an opportunity for earlier intervention. This includes instances of pre-cancerous cell changes that were not detected, no referral or a delay in referral to colposcopy, and a delay in diagnosis or treatment.

Are these issues other than the cytology that are affecting the clinical treatment of women? Perhaps the delegates might speak about it.

My other question is addressed to Dr. Holohan. Will he expand on the advice he gave to the then Minister in 2015 that we should go for voluntary rather than mandatory disclosure?

I am not sure who would like to take those questions. It is really about further delays in diagnosis, other than those caused by false negatives.

Dr. Peter McKenna

The Chairman is correct when he says the cases of the 208 ladies focused on cytology as the problem. There are other problems such as the ones mentioned by the Chairman which may have resulted in delays or incomplete treatment. They will also be looked at.

Does that imply that there were other reasons for delays in diagnosis?

Dr. Peter McKenna

Yes. That could well be the case.

That is very important.

Dr. Peter McKenna

Yes, it is very important.

It has not been explored at all in any of these meetings.

Dr. Peter McKenna

That is correct.

Will Dr. Holohan speak about the advice he gave to the then Minister?

Dr. Tony Holohan

The advice I gave was that there had been advocacy for mandatory open disclosure in all circumstances. The advice I gave reflected on a review and examination of the international evidence which showed that, although it was almost counterintuitive, it was the case that mandatory open disclosure in all circumstances carried with it risks in the sense that it, first, sometimes conferred a view among medical practitioners that the risk of medical legal actions was increased, which could make them less likely and less willing to make such disclosures. If it is applied as written in all situations, as opposed to being targeted at the most serious cases, as we plan to do, it will unnecessarily bureaucratise the reporting and potentially lead to mandatory disclosure.

The reality is culture is what is important as opposed to law. The law may say something, but, frankly, doctors do not tend to look to it for guidance in conducting clinical practice. Something in the law might lead to more box-ticking style reporting. We want to encourage the safe space and support the culture of open disclosure in its development by ensuring that when something goes wrong which is the reality and a feature of everyday clinical practice because the sciences, people and technologies are not perfect, the first thing that is done is that, rather than withdrawing from patients, as we have seen happen in some patient safety instances, doctors, nurses and other senior staff will metaphorically put their arms around the patients and support them through understanding. That is a relationship that is built over time; it is not a single event. Putting something in legislation on its own will not deliver that culture.

The view is that the combination of mandatory reporting, where appropriate, and voluntary support by giving doctors assurance that protection will be available in wider circumstances if they come forward and do the right thing in the so-called safe space will lead to and support more a culture of open disclosure. We will have standards for how that open disclosure should be done, recorded and so on. The science on it, so to speak, is not absolute. These are judgments. There is not a huge body of international evidence in that regard, but it tends to point in that direction. There are other areas of social science and so on where these questions also play out. The extent of mandatory reporting can sometimes actually drive down reporting, increase fear on the part of those reporting and so on.

That was the reason for the advice which the Oireachtas committee reflected in its report.

Is it possible to see the advice provided in 2015? Is it in writing?

Dr. Tony Holohan

It is and I have conveyed it to the Deputy's office since our last meeting, but I will be very happy to do so again. If it has not reached the Deputy, my apologies. It should have gone to his office late last week or early this week.

This is the advice provided for the then Minister, Deputy Leo Varadkar, saying why mandatory disclosure should not be legislated for. Is that right?

Dr. Tony Holohan

Yes. The last time the Deputy asked me to give him the material which had informed that advice.

Did Dr. Holohan provide the actual advice? There is the material backing up the advice and then there is the advice. Did he provide the advice?

Dr. Tony Holohan

I did.

Dr. Tony Holohan

I can check, and anything that we have in relation to that-----

Maybe Dr. Holohan can share it with the committee.

Dr. Tony Holohan

I am very happy to do so.

There are three Fine Gael members and I am not sure whether they have had an internal discussion on who is next.

There has been an internal discussion and I am next.

I call Deputy O'Connell.

I refer back to the audit process. At the outset, Dr. O'Keeffe mentioned audit process methodology papers. Could we have those please?

Dr. Stephanie O'Keeffe


If those papers exist, we need to look at the actual flawed process of disseminating information to the real person affected, which I spoke about in my previous contribution. Dr. Holohan is a medical doctor who has dedicated the bulk of his life to healthcare, and from the evidence we have had of him before this committee, the Sláintecare committee and any other committee he has come before where I have been present, he has contributed a lot to public health in Ireland and he has always engaged with the committees in an open and frank manner. How does he feel as the head doctor, which I assume is the correct term-----

The chief medical officer.

Yes, but the chief medical officer is the top doctor in the Department. How does he feel about somebody who is not a clinician making a call that this did not need to be escalated to him? Does it really annoy him that he is not given all the information, because I imagine it would really annoy him? Does it really annoy him that he was not fully aware of stuff that we all agree he should have been made aware of?

Dr. Tony Holohan

If the Deputy is referring to the specifics of this case-----

Yes, sorry, in this case, not in general.

Dr. Tony Holohan

The people who could have given me that information were not aware themselves. We have heard the account of the systems that led to that situation. The people whom I dealt with bilaterally did not have the knowledge. If somebody had knowledge in a general sense that should have been passed to me then, yes, in general terms I would be concerned about that.

If it is the case that the person who was conducting the audit process, and I am specifically speaking about Dr. O'Keeffe, did not make the decision to escalate this up to chief medical officer level in the Department, how could that have happened in her role? I am trying not to be personal here but how could that have happened? How could we have started off with an audit process that was flawed because how the results would get to the patient was not considered? How was it not considered, discussed or known by Dr. O'Keeffe that treating clinicians would perhaps have an issue in giving the information to a patient? As one of the gentlemen present said, it would be a departure from normal day-to-day activities. How does Dr. O'Keeffe feel about how she did her role, in the sense that she did not make a decision or consider a pathway to informing the patients? Does she think she did her job right? I am not looking for another head here. I am just trying to get to who made that decision and what it was based on, or was it just that Dr. O'Keeffe did not know? Maybe it is as simple as that she did not know what to do and that she was not equipped-----

Dr. Stephanie O'Keeffe

No. The intent and the expectation was that once the letters were with the consulting clinicians, the process would simply ensue and the consulting clinicians would speak to their individual patients. That was the expectation and-----

Dr. O'Keeffe's expectation.

Dr. Stephanie O'Keeffe

That was my expectation. That was everybody's expectation.

With respect, I am not asking about everybody's expectation, I am just asking about Dr. O'Keeffe's expectation.

Dr. Stephanie O'Keeffe

Yes, that was my expectation and not alone did I not hear about any evidence that would contradict that expectation - it was not raised with me formally or informally that there was - but I was given assurances that the process was proceeding well consistently on a month-by-month basis for the entirety of 2017.

Yes, and Dr. O'Keeffe referred to this. Does she not accept that at her level, perhaps she should not just accept what she is told? Does she not accept, and I would think that it would have been fairly obvious to anyone who had worked in clinical medicine, that doctors would have had an issue disclosing information that was not part of their testing? A woman with active cancer has a consultant in charge, so more than likely it was not at the GPs where they had the smear done, it was with the next doctor. I would have thought it was fairly basic that one would assume that clinicians would have a problem disseminating the information down.

Dr. Stephanie O'Keeffe

That was not relayed to me-----

It never occurred to Dr. O'Keeffe.

Dr. Stephanie O'Keeffe

It was not relayed to me. The October briefing made clear there are significant levels of communication between the CervicalCheck programme and the consulting clinicians, that they would continue to engage, that the letters had issued and that they had the information notes for the consulting clinicians and that the process was going well. All of the updates I got, verbally and in written form, stated the process was going well.

Was Dr. O'Keeffe not suspicious that it was all going a bit too well?

Dr. Stephanie O'Keeffe

If I had been suspicious I would have done something about it. I did not have any suspicion. The issue that arose in 2017 of which I should have formally been made aware was not communicated to me through the governance lines.

I understand our next speaker is Senator Colm Burke and I understand Deputy Durkan has deferred to Senator Swanick.

I will remain here. I will not go home early yet.

I thank the Deputy for his co-operation.

My first question is for Dr. McKenna. I understand the audit was carried out on all of the people who had already received cancer treatment or who were in the course of cancer treatment.

Dr. Peter McKenna

It was on those people whom the screening service knew about, which, as we now know, was not everybody who had cervical cancer.

That is the audit that was carried out. My understanding is that 275,000 smears are taken per annum. With regard to people who have not been identified with cancer, is there any view now that a sample audit should be done of people who have been advised they are all clear, just because of what has occurred? Does Dr. McKenna believe an audit should be done in respect of this at present? Is he satisfied the programme as it currently functions is doing so in a proper manner?

Dr. Peter McKenna

The information I have available is that the laboratories currently employed by the programme are working to an acceptable standard but I appreciate that the Royal College of Obstetricians and Gynaecologists, RCOG, in London will give its advice as to what sort of scrutiny should be applied.

Dr. Holohan wishes to come in.

Dr. Tony Holohan

I can give an update on this. My office is making the arrangements with the RCOG and the British Society for Colposcopy and Cervical Pathology, which will conduct the independent expert clinical audit, which will start with all of the cases of cancer that have been notified since 2008 at the inception of the programme, and bring them right the way through an assessment to come to a determination in respect of each of the individual cases.

When that is finished, does Dr Holohan believe there may be an issue whereby we may have to do an audit of people who have not been identified with cancer, to see whether the results over the past two years are safe?

Dr. Tony Holohan

It is quite possible that such a recommendation or something like it could come, either from the Scally process or the process of the RCOG, and we will be very open if this is to be the case.

I want to go back to the memos of February 2016, and this question is for Dr. O'Keeffe. The February 2016 briefing note stated the legal team was reviewing the content of case reports to be communicated and would advise.

The note continued, "Await advice of solicitors." Is the advice of solicitors on how the information should be communicated in writing and is it available?

Dr. Stephanie O'Keeffe

It is. The legal advice emphatically supported the position of the CervicalCheck programme that it had a right, and indeed an obligation, to communicate that information to patients but that it had to be very careful about how it did so.

When was that legal advice furnished?

Dr. Stephanie O'Keeffe

If the Senator looks at the details for March, he will see this was being resolved. We had a meeting on 27 April with the team in CervicalCheck to agree the way forward. CervicalCheck then had a meeting to resolve the issue. In or around April, there would have been legal advice. I can give what I have to the Senator.

That is April 2016.

Dr. Stephanie O'Keeffe


There was still a problem by September 2017, at which time the information had not gone out to patients. Surely, having already received that legal advice in April 2016, more than 14 months later someone in CervicalCheck, the Department or anyone else who was aware that the information was not being given out must have been aware of the seriousness of that legal advice not being followed through.

Dr. Stephanie O'Keeffe

Again, the intent of the programme was that the information be communicated to patients. This was what they sought through the process they established and what they expected when the letters would be sent out. They engaged in a whole series of activities to ensure the consultants were supported in doing that. I cannot say what happened within the CervicalCheck programme or the national screening service around that time because, as I said, any concerns that were raised with them were not reported to or discussed with me. We know of one consultant's specific concern, which I know was discussed previously.

My understanding is that consultants other than Dr. Kevin Hickey in Limerick had raised issues about getting the information out there.

Dr. Stephanie O'Keeffe

I am not aware of that.

Has the HSE looked for that information from CervicalCheck?

Dr. Stephanie O'Keeffe

We have asked CervicalCheck for that information. We have asked CervicalCheck why the information was not escalated and so on. Again, the Scally inquiry will have to determine this fully, but within the CervicalCheck programme I think there was a lack of a perception of what that risk might mean once CervicalCheck realised, certainly with the correspondence from Dr. Hickey, that that information was not being communicated to patients. However, I cannot really comment because I was not involved in any of the conversations and had none of the information. There is a clear risk-----

However, by June 2016, more than 200 letters went out to 29 clinicians, as I understand it. I find it strange that we now have only a written record of one medical clinician being concerned about getting the information out there. Is Dr. O'Keeffe saying the other 28 did not communicate at all and, at the same time, the information did not get out to the 200 patients?

Dr. Stephanie O'Keeffe

Clearly, we know from the process that some of the consultants did communicate with the women but, unfortunately, what we have found out through the exercise that was undertaken underneath the symptoms is that it was a minority of women who had received communication and were informed. The Senator would have to speak to CervicalCheck directly but, from the programme's perspective, those involved seemed to think the correspondence from Dr. Hickey was specific to him. That is my sense.

One last question, Senator.

I will ask one last question. Was CervicalCheck aware that Dr. Hickey may have been conveying the concerns of other clinicians?

Dr. Stephanie O'Keeffe

I really do not know because I was not involved in any of the conversations. I know that my colleague, Dr. Colm Henry, as the national clinical adviser for the acute hospitals division at the time, directly intercepted to try to resolve what was an issue. However, I was not party or privy to any of the conversations about it. I was not aware of it at all.

However, Dr. Colm Henry would have been aware of the legal advice going back to April 2016.

Dr. Stephanie O'Keeffe

No, he would not have. Regarding Dr. Henry's role at that time, all kinds of matters concerning doctors across all kinds of specialties and subspecialties get raised to an acute hospital divisional clinical lead, and Dr. Henry would go in to try to resolve the programme and move on. Dr. Henry genuinely would not have been aware, nor would I have expected him to be aware, of any of the context of this. He would have been presented with a problem, supported its resolution and moved on to something else.

I thank Deputy Durkan for allowing me to speak before him. Going back to the meeting of 26 November 2015, we heard Mr. Breslin's evidence. He is categorical in his opinion that there was no discussion about CervicalCheck at that meeting. Are the minutes of the meeting at his disposal?

Mr. Jim Breslin

I believe that, as per the convention, because the Minister went to Dr. Steevens' Hospital to meet the HSE directorate, the Department did not take an official minute of the meeting. I think there would have been notes if issues had to be followed up but I do not believe we have official minutes. It might be worth checking. Usually, the secretariat comes from the HSE if there are HSE minutes.

This is two and a half years ago and, obviously, people forget things. It would be unusual not to take minutes of such a meeting, that is, a directorate meeting.

Mr. Jim Breslin

If it were a Department meeting, we would supply a secretariat and have a note taker there.

Could Mr. Breslin provide those notes to the committee?

Mr. Jim Breslin

I think it is a question for the HSE to check if a secretariat was present.

This is very important.

Mr. Jim Breslin

There were officials in attendance.

Dr. Stephanie O'Keeffe

I would have to look at my diary. I expect that I was at all those meetings, unless I was on annual leave. I would expect to be at directorate meetings during that time.

We cannot be categorical, then, that this was not discussed at that meeting. We cannot say for sure.

Dr. Stephanie O'Keeffe

I can absolutely say for sure that this process was not discussed at any of those meetings. I would have briefed the director general, DG, on a one-to-one basis. I met him frequently. It would not have been escalated to the directorate, to the best of my knowledge. We can go through absolutely everything but it is certainly not within my memory.

Would the witnesses be able to-----

Mr. John Connaghan

We will immediately start to check-----

It is very important.

Mr. John Connaghan

-----whether there are any notes. We will also check whether there are any handwritten notes or formal notes.

Great. I thank Mr. Connaghan. That is my first point. Will the HSE get back to me?

Mr. John Connaghan

Yes we will, as soon as we have that available.

Mr. Connaghan might supply the committee with-----

Mr. Jim Breslin

Yes, we will supply the notes to the committee.

How long should that take?

Mr. Jim Breslin

To get the minutes?

Mr. Jim Breslin

We should be able to do that within the next day or two. I will get back to the Senator.

To move to my second point, we heard from the evidence earlier that the Department, the Secretary General, did not take legal advice. Is that correct?

Mr. Jim Breslin


Can the witnesses confirm or deny whether the HSE took legal advice at that time?

Mr. John Connaghan

Sorry. At what time, Senator?

Dr. Stephanie O'Keeffe

Yes. The legal advice was sought.

Dr. Stephanie O'Keeffe

The CervicalCheck programme sought legal advice so as to be able to resolve the issue with the laboratory Quest Diagnostics, which was threatening to invoke the dispute resolution clause within its contract, as well as advice on the fact that the CervicalCheck programme was sending letters to treating clinicians which held patient information on the results of the clinical audit.

Who provided that legal advice?

Dr. Stephanie O'Keeffe

Arthur Cox. It is within the documentation. The Senator can see it there.

I thank the Senator.

Chairman, may I just make a point? I am sorry. It will be very quick.

Hold on, Chairman.

It will. I ask Deputy Durkan to bear with me.

This is an example of what I am talking about. I asked Mr. Breslin earlier specifically about this legal advice-----

There may be an opportunity for the Deputy to come back in, but I must be fair to the other speakers-----

Sure. That is true. Sorry.

I call Deputy Durkan.

It is a well-known game. It is called politics. Let us deal with the matter in a different fashion. I have a comment to make and it is not personal in any way. In no way have I any acrimony towards any of the personalities involved at all.

However, my long-time view is that the HSE is an inappropriate structure to deliver health services to the country at large. Comparisons have been made with the greater Manchester area, the population of which is equal, but they do not apply as geographically it is vastly different. In recent years we have had complaints from the regions about a lack of accountability, liaison, consultation and so on. It will never work and this is a classic example of why not. In the communication system, either up or down the line, the chain of command did not operate. The communication that should have taken place never did. This will be repeated time and again. The Minister has promised to change the system. I hope he does because if he does not, whoever sits on the other side of the room will be here again in two or three years, or perhaps six months, but it is inevitable that these things will happen again.

We did not dwell on the dispute between Quest Diagnostics and CervicalCheck. When the issue arose initially, legal advice was sought on full public disclosure. Am I correct in assuming that legal advice was sought in that regard or was the public disclosure policy in abeyance?

Dr. Stephanie O'Keeffe

My understanding at the time from the briefings I had received was that the CervicalCheck programme was seeking legal advice on whether there was any impediment to it being able to send the letters to the treating clinicians with a view to telling the women the information. It received legal advice that it could go ahead but that it had to be careful about the mode, method and content, that the individual details needed to be clear and so on. I recall one email had legal advice appended to it. There is possibly an awful lot more in the CervicalCheck programme and I will be happy to furnish whatever documentation the Deputy wishes to see.

I refer again to the nature of the dispute between Quest Diagnostics and CervicalCheck. This is the dispute that had to be resolved.

Dr. Stephanie O'Keeffe

My understanding is and the briefings state that not only was Quest Diagnostics asking questions, it had also formalised a concern. My worry at the time was how long it might take since, if a dispute resolution process was invoked, sometimes these things could take forever. In fairness to the programme, once it received its legal advice, it met the relationship manager, or whatever the individual's title was at the time, with the CervicalCheck programme, the national screening service, and the issue was resolved between them. My understanding is they did not necessarily have an issue with the letters being sent, but that they did have a concern that there might be something in the letters that might bias the interpretation, or something like it. One meeting seemed to settle it and there was possibly some correspondence back and forth, but it was settled and the programme resumed the sending of letters.

In the context of full disclosure or lack thereof, was the State Claims Agency consulted or involved at any time?

Dr. Stephanie O'Keeffe

It was. Deputy Kate O'Connell asked about the audit process methodology overview. It is attached to the February memorandum. Deputies will have the February memorandum on the audit process review methodology. On page 2 of the document, it states:

The cancer audit process continues to evolve since it was initiated in 2010. The audit process, outcomes and proposed developments have been presented to and developed in conjunction with: CervicalCheck colposcopy forum; programme colposcopy services and histology laboratories; cytology laboratory providers; Quality Improvement Division; State Claims Agency.

The understanding earlier in the process was that there would have been significant exchanges with these parties.

Presumably, the State Claims Agency was not in favour of full disclosure. Is that correct?

Mr. Jim Breslin

I do not think one could make that presumption at all.

Dr. Stephanie O'Keeffe

I do not think-----

I am asking the question for somebody to contradict me.

Mr. Jim Breslin

I think that if representatives of the State Claims Agency were here, they would probably state a case that would be the reverse. Representatives of the State Claims Agency were present when I was at the meeting of the Committee on Public Accounts on Thursday. They explained the totality of the role as also including advice on risk. Their advice in a healthcare setting is on taking an open approach, identification of incidents early and giving a response early, rather than waiting for legal writs to fly. If one looks at the State Claims Agency's database, it has hundreds of thousands of incidents. It wants everyone to feed in issues that happen within the health service and be proactive in responding to them. I would be very surprised if anyone in the State Claims Agency was to say they were in favour of closing things down. I think they would take an open attitude to issues as they arose.

If we take it that the audit was well under way in 2013 and that there is an average of eight scheduled meetings with the Minister for Health annually, there would have been around 32 scheduled meetings during that period, between 2013 and 2018. Is that the case?

Mr. Jim Breslin

I will not quote a number, but there could be an interval of six to eight weeks between meetings, something like that.

Therefore, there would have been around 32 meetings. It is utterly unbelievable there could have been 32 scheduled meetings with the Minister for Health while all of this going on and that it did not warrant the HSE mentioning it to him, whether on or off the record.

Mr. Jim Breslin

If we had, it would have been entirely inconsistent with the general view on the issue, which was that it had not been escalated in any other fashion through the management processes of the HSE or the Department.

Whose general view was it? In the first review in March it was stated everyone would be communicated with, that the women would be communicated with. Who made the decision not to communicate the information?

Mr. Jim Breslin

Will the Senator repeat the question?

One of the documents, the summary status report of March 2016, states the women would be communicated with.

Dr. Stephanie O'Keeffe

All of the memos refer to the fact that there was an intent for the information to be communicated to the patients concerned. Clearly, that did not happen for the majority of women in that the consultant doctors did not talk to them about the results.

I just want to know who made the decision or reversed it. The decision was that the clinician be requested to discuss the outcome with the woman. Who made the decision to reverse it?

Dr. Stephanie O'Keeffe

Nobody made the decision to reverse it; that is still the case and was the case during the time period on which we are focused.

In that case, why were the women not told?

Dr. Stephanie O'Keeffe

One would have to ask the doctors concerned.

Therefore, the doctors were told to do so and it was the doctors who did not tell the women. Is that what Dr. O'Keeffe is saying?

Dr. Stephanie O'Keeffe

Yes. The doctors received letters that gave them the information; they received the guidance. As one can see from the audit process methodology, processes were in place to consult people on the whole thing. There may be some very genuine reasons within that because when the CervicalCheck programme was developing its approach to open disclosure and the intent was to give the information to women - this is something on which we will have to reflect in hindsight - it did envisage that there would be circumstances where it might not be either appropriate-----

Therefore, Dr. O'Keeffe is saying the doctors received the information and they decided not to give it to the women.

Dr. Stephanie O'Keeffe


Can we have the minutes of those approximately 32 meetings with the Minister for Health? Can they be supplied to the committee? I refer to the period between 2013 and 2018.

Mr. Jim Breslin

We have reviewed them. There is no reference whatsoever to this issue. If people want to see the minutes, I am happy to make them-----

Yes, I think we should see them. We need to know the nature of the discussions. I think we need to comparatively consider the things the Department discussed and the level of seriousness of the issues that were discussed, so that we can make up our own minds around this.

We have 25 minutes left before we have to vacate the room. I propose to give each of the remaining members a minute to ask a question and to get a reply. If members go on any longer they are eating into the time of their colleagues, if that is not too broad a term. I call on Deputy Donnelly.

Could the Chair come back to me after Deputy O'Reilly?

Of course. I apologise for taking Deputy Donnelly by surprise. I know we will not take Deputy O'Reilly by surprise.

Yes, I am shocked.

Can the witnesses explain the difference between urgent and non-urgent cases? I am looking through the minutes and I see that some referrals are urgent and some are non-urgent. The reason I ask is that I have been contacted by several people who tell me that they experienced symptoms following a smear test that did not show up anything. I will not get into a discussion about percentages. By virtue of the fact that they had recently had a smear test with a clear result, these women tell me that they are being categorised as non-urgent. In some instances the fear, or indeed the fact, is that they have developed cancer in the intervening time.

Mr. John Connaghan

Is this question related to the distinction between low-grade and high-grade concerning smear tests? If it is, I will ask Dr. McKenna to respond.

No. It is related to the urgent and non-urgent categories, as they apply to women who have had symptoms of cervical cancer in the immediate aftermath of several negative smear tests.

Mr. John Connaghan

That is fine. I ask Peter McKenna to respond.

Dr. Peter McKenna

Anybody who has symptoms that would suggest cervical cancer, irrespective of how many negative smears they have, should be seen urgently.

They are not being seen urgently. Could Dr. McKenna comment on that? They are being referred to as non-urgent.

Dr. Peter McKenna

They should be. If they have symptoms suggestive of cancer, they should be.

It is helpful that Dr. McKenna has communicated that to me, but it might be more helpful if he communicated that to his clinicians.

I want to thank everybody. I know we are into our fifth or sixth hour here and I know the witnesses are dealing with this issue at the same time, so I want to thank them all for their time. It is appreciated.

I refer specifically to the women being supported. The HSE data on Monday indicated that about two in every five women looking for a return call had yet to receive one. Could the witnesses give us a quick update on how many of the women who have requested a callback are still waiting for one, how long they have now been waiting, and when we are going to have this resolved?

Mr. Damien McCallion

I will outline the total numbers first. Some 10,666 women had requested callbacks from a clinician as of yesterday. The number of women who have yet to receive one is now 3,562. As to when this will be closed out, I note that at the moment there has not been a significant drop in call volume. Effectively we have to plan on the basis of two things. One is that we will have to plan to continue with this for a certain period, until people have a certain level of satisfaction. Then the call volume may drop. Second, I note that the CervicalCheck helpline was always there, but it had a different purpose. It was intended to facilitate and advise. My view is that in light of this we will have to strengthen it beyond the current week so that it provides greater assurance to women. Moreover, the people manning the line will have to be clinical staff.

To answer the Deputy's question about how long it will take, I think that will be contingent on the duration of the issue. If people call us then we have an obligation to get back to them, and we will continue to do that. That is challenging. I described it earlier. We need clinical staff, whom we are trying to pull out of services and hospitals. Those women who have more complex needs, in the sense that they have a history of colposcopy or cancer, need to talk to an oncology or a gynaecology nurse as well as medical support. We will have to monitor that week by week. I cannot give a date by which we will have dealt with all the queries, because the situation is changing each day. As I say, while there have been some dips in the number of outstanding queries, it has typically come back up again.

In the long term, I have mentioned that I do believe we will need to strengthen the helpline to provide support to people over the next six, nine or 12 months as we hopefully turn the corner, give women assurance on the screening service and deal with the many questions, some of which have been captured over the last week or two. As I have mentioned, it was largely an administrative line.

Deputy Kelly has one minute.

I will take it, because I know that Deputy Durkan will be watching the clock. I thank the witnesses for their time today. I know they have given a considerable amount of time, and that they are all under pressure. Let us call a spade a spade. It is the issue everyone is discussing and it is a national crisis, so I appreciate their time. I also appreciate their frankness. There have probably been some learnings today for Mr. Connaghan and that will continue tomorrow, trust me. I am one of the few people who are on both committees. I wish to say to Dr. O'Keeffe that we will probably need more information by tomorrow about the relevant teams, what they did and how the issue was escalated.

My question relates to the national performance oversight group. This issue surely came up in the group's work. How did it come up? What was dealt with? What was done? Can we have the minutes of meetings relating to this period please?

Mr. John Connaghan

Dealing with those in reverse order, the committee can certainly have all the minutes of the national performance oversight group. I believe this issue was mentioned the group's meeting on March 16. That was merely a mention that the audit was taking place. We, that is the national performance oversight group, were advised that it was taking place. There is nothing in the minutes of those meetings that fostered any action. If there was an issue with communication at the time, nothing in the minutes outlines a concern.

Then those minutes obviously do not reflect the conversation that took place at those meetings.

Mr. John Connaghan

Sorry, can the Deputy repeat the question?

Does Mr. Connaghan believe that those minutes reflect the actual discussions and conversations that took place around those issues?

Mr. John Connaghan

Yes I do. The reason I say that is that we have not only tracked the minutes, we have tracked the written record of the note-taker for that set of minutes.

Does it not seem strange to Mr. Connaghan that these issues were not brought up?

Briefly, I thank everyone for their contribution here this morning. It is very much appreciated. I note that there is a lot of misinformation out there. For instance, on Sunday evening I had a discussion with nurses who believed that the audit was carried out in respect of people who had not been diagnosed with cancer, and that information was kept from them. Given this type of misinformation, is a plan being put in place to get up-to-date information out and give some clarity to the general public? I wonder if the Department or the HSE has any plans to address this issue at the present time, because it is extremely important to rebuild confidence in the whole system.

Mr. John Connaghan

The question of regaining confidence is a very important one. I will ask Mr. McCallion to speak about our information strategy there.

Mr. Damien McCallion

There are a couple of points to make. Certainly we are trying to get some updates out. We have tried to get some speakers who can perhaps give reassurance from a clinical perspective. I think it would be fair to say that this has been difficult in the past seven or eight days, because there is so much going on around this that information simply does not get through.

We have tried to look at communication from two perspectives. One is the communication with women themselves through the programme, the direct communication. The other perspective concerns getting greater reassurance into the system. We all talk to people who have different views - friends, relatives etc. - and as the Senator says, there is misinformation out there. Hopefully over the coming weeks we will put a plan in place to try to create some reassurance. That has been difficult, to be frank. Although the issue has attracted huge attention, as in the situation the Senator describes, it is difficult to get simple messages across to people who are clearly and understandably very anxious, concerned and unsure of exactly what all this means for them. We are seeing that in our hospitals. Apart from the phone line that I mentioned earlier, they are getting a huge number of calls straight to their colposcopy units. These are placing huge strains on the service. It is our intention to bring together a small group of patients, general practitioners and key people to look at how we can navigate through this, and hopefully provide some reassurance and greater clarity for women.

To be blunt, the difficulty in the last six or seven days has been that with so much happening it is very difficult to translate that through. We are putting messages out but I have to say that we probably need to step back and look at how we might land that much more powerfully in the coming weeks.

Mr. Jim Breslin

It is essential that we continue to try to do what Mr. McCallion described, although it is very hard to break through on something as distressing as this with the factual information that was mentioned. I will make a suggestion. As we have gone through this issue over recent weeks, and the committee has played a valuable role in that, we have tended in our discussions to intersperse the public health and public interest explanation of this issue with, quite legitimately, other questions related to scrutiny and accountability. It is hard to have the public health and public interest message communicate itself in a situation where we are also doing the historical record and the scrutiny and accountability. Both are absolutely legitimate and I wonder, and it might not involve the players here at all, if there is any way we could give some collective thought to a more concentrated public health and public interest discussion on explanation and trying to put that out. The nature of the programme is such that we also must talk about the public interest and public health dimensions of sustaining the programme. I absolutely recognise the need for accountability but-----

That is fair.

We will be able to include that in our meeting next week.

Yes, it is our duty to do that.

Dr. Peter McKenna

I wish to acknowledge that the HSE has been slow to get out some of the good news. However, in the environment that pertained in the country over the past several weeks, it was difficult to get a moderate voice heard. Moderation was interpreted as a cover-up so the only two positions were outrage or covering up and it was difficult to get a moderate message out. The atmosphere that has been created here today signals to me that it might be possible to change the environment and get the good news out. Personally, I wish to thank the committee for the atmosphere that has been created today. It will give us encouragement to get a more moderate message out.

Like other members, I thank the witnesses for appearing before the committee today and for remaining with us into the afternoon to acknowledge the seriousness of the issue and the manner in which it affects women's health, for whom it is a very serious issue. Some of them, unfortunately, have passed on and some are still with us. We should take this opportunity to wish them well. Given the events of the past few years that have come to public notice in recent times, have any specific lessons been learned which could be applied to the operation and delivery of health services in the future, with particular reference to acute and sensitive areas such as this?

Dr. Tony Holohan

I can identify some, and we may have touched on some earlier. Some of the obvious lessons, notwithstanding that investigations are taking place, relate to audits. Before they commence, it should be absolutely crystal clear whose responsibility it is to communicate. In respect of specialised services such as screening services there should be specific service open disclosure policies. We will need to look again at the open disclosure policy and update it in the light of the lessons that have emerged from this and develop open disclosure policy specific to the screening programmes. That can be said. Each of the audits would have feedback loops so we can be sure that if there are open disclosure policies we will know whether they are being implemented effectively. Those are a minimum set of responses.

What about communications throughout the system to keep everybody informed of progress, lack of progress or stalled progress in a particular area?

Dr. Stephanie O'Keeffe

There are lessons relating to communications not just within the system but also communications when something like this emerges. It is a sad reality that the very thing that the CervicalCheck programme was trying to prevent actually was something that happened that was far worse and more catastrophic, particularly for the individuals who were impacted. It is difficult for the people involved in terms of what they intended and what actually happened in the end. It is very important in that context for the public and, most importantly, for the women impacted to understand how sorry we are about all of that. That is really important.

Also, a broader, mature conversation needs to happen around the area of open disclosure and situations such as whether one discloses if somebody has passed away. As Dr. Holohan said, the Medical Council guidelines are that one does not do that. The country needs to have that conversation because sometimes people might say: "I would have preferred not to have had that information". There probably needs to be a broader debate about that and also with regard to screening programmes more generally. No screening programme is 100% effective and there probably needs to be broader communications in that regard.

The point I was trying to emphasise is that we should not have a situation a couple of years hence where somebody could say that he or she was not informed.

Mr. John Connaghan

The conversation we had previously about the establishment of local ownership through a clinical directorate and local management with a grip on operational issues is very important in this respect. We should learn lessons from that and consider what we can do in terms of the development of the service.

I will not take more than a minute. It perturbs me to hear the witness say this should have been handled in a more calm, measured way when 18 women are dead and over 200 are affected by this. There are women fighting for their lives. I cannot apologise for there being anger about this. I beg Mr. Connaghan to address the protectionism and the power and control that exist within the HSE. Please do that. I have many years of experience of dealing with the HSE and the Department of Health. There are some excellent and good people in the system. They should be brought to the fore and the others should be made accountable. Get rid of the protectionism, power and control because it costing people their lives and not only in the situation we are discussing today.

Dr. Stephanie O'Keeffe

I wish to make a final point which is really important. It is the case that in these screening programmes not everybody will be protected against cervical cancer. While it works for the population, it does not work for every individual. It is really important to say that this crisis is not about the fact that there are women and families impacted by cervical cancer. Cervical cancer is a reality in all our lives and even with the best screening programme in the world we would still-----

We understand that. Why did the programme not say 30% in the leaflet? Why did it say that there is just a small chance? Why did the programme not instruct GPs to tell women when they were having their smears that there is a 30% chance that it might not be good and that if the women were having any symptoms they should disclose them? Why did the programme not make that a priority in its communications? I have seen HSE communications in action throughout the system. It needs to get the basic communications right.

Mr. John Connaghan

I thank the Senator for her remarks. I hope the evidence we have given today has given some degree of reassurance on the position the HSE will take in future. Let me take what the Senator said as a personal challenge over the coming months.

The meeting this morning was held in a very respectful manner. We appreciate the pressure the witnesses are under, but we also appreciate the anger among the public. There is a balance to be struck between strident and discordant voices and a reasoned interrogation of what is happening. Hopefully, that balance is being struck now. I appreciate you coming here this morning at short notice.

On behalf of the committee I thank the representatives from the HSE, the Department of Health and CervicalCheck for assisting us in continuing to explore the matter. I hope everyone has benefited from the meeting.

The joint committee adjourned at 2.40 p.m. until 9 a.m. on Wednesday, 23 May 2018.