Mr. John Connaghan:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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