Everybody who yesterday evening listened to and watched Ms Vicky Phelan telling the story of how her cervical smear test was processed and then misdiagnosed, and then nobody actually had the courage to tell her about that for up to three years, would have been struck by the amazing courage and bravery of Vicky and her family. Vicky is a young woman, only 43, a wife and a mother of two children, aged 12 and 7. She was given the all-clear health wise following a cervical screening in 2011. However, in an internal audit carried out by CervicalCheck in 2014, Vicky's 2011 smear test was found to have had abnormalities. No-one informed Vicky, her family or her doctor about that audit or that result for another three years. I know the Tánaiste would agree that it is beyond words that Vicky had to face the prospect of terminal cancer, or the fact that information was knowingly withheld from her and her doctors which makes it completely inexplicable and frankly absolutely unacceptable.

However, the 2014 audit has also found incorrect results in up to 14 other women's tests. Yet it was only in 2016 that medical consultants were advised to deal with these women and tell them their results. Court documents suggest that CervicalCheck issued a circular in 2016 saying that the service would like the women's notes to be reviewed, and for the result to be "recorded". The circular also said "as a general rule of thumb the outcome should be communicated to the woman with a focus on the context of confronting the overall clinical scenario."

CervicalCheck then explained that the women may not have been aware of the actual audit. The approach has been cruel and bizarre in the extreme. It was also reported that doctors were asked to use their own judgment on whether to inform women about these misdiagnoses. This is absolutely unbelievable, particularly when Vicky and the 14 others were given the all-clear result years before.

How is this acceptable, medically, ethically or legally? Was the HSE aware in 2014 that the audit had taken place and was it made aware of the results in 2014? This programme is hugely important to our country, but given that it is paid for by the State, the company that undertakes and rolls out this programme must have obligations to the HSE concerning the way it informs people. Is a protocol in place between the HSE and CervicalCheck about audits and the sharing of information? If not, why not? How many audits have taken place since 2014 and how many other women are in the position faced by Vicky today? Finally, can the Tánaiste outline what will change as a result of what we know now, as a consequence of the bravery and the courage of Vicky Phelan?

I thank the Deputy for raising this issue. I think anybody who has listened to this story or read about it will come to the conclusion that this was a shameful series of events, particularly where information flow is concerned. The tragedy and challenges that Ms Vicky Phelan and her family are facing now have been made all the more difficult because of the failings in passing information on. For that, as Tánaiste I want to apologise to her and to her family.

It might be helpful for me to put on the record what is going to change as a result and how that has come about. In 2014, at the time when Vicky Phelan was diagnosed, CervicalCheck initiated clinical reviews for all notified cases of cervical cancer arising from screening. At that time, the information was used to inform improvements in the system and was not communicated to clinicians or to patients. This changed in late 2016, and subsequently current and historical outcomes of the audit process were made available to clinicians for communication to their patients on request. Ms Phelan rightly contends that she should have been made aware of the outcome of the audit process which related to her in 2014, and we agree with that. It has now been decided that patients will be advised as part of the process in the future. That will not be optional. It will be automatic. A process is also under way to identify any other women affected in the same way as Ms Phelan to ensure that they are informed as is necessary.

Each year, approximately 250,000 women have a cervical cancer screening, or smear test as most of us would know it, through CervicalCheck. CervicalCheck has found over 50,000 pre-cancerous changes in women, leading to appropriate early treatment, which of course is what this is all about. It is important to say that while this case is tragic and should not have happened in the way that it did, we cannot allow it to undermine confidence and faith in CervicalCheck as a whole. This is a screening programme. There is no such thing as a perfect screening programme. Mistakes can be made and mistakes were made in this case. However, it is true to say that cervical cancer screening aims to reduce the instance of mortality in cervical cancer. Instances of cervical cancer in Ireland have fallen by about 7% annually and continue to fall and CervicalCheck is playing a big part in that. However, that is no consolation to the Phelan family today.

What I want to say is that it is regrettable that Ms Phelan needed to take court action to establish the truth. It is certainly regrettable that decisions were not made before now to require patients to have automatic access to information that relates to them. That applies particularly in the cases of women who are diagnosed with cervical cancer, where audits automatically take place if they have previously been through a screening programme to establish whether any mistakes were made. Hopefully that answers some of the Deputy's questions.

We all agree on the importance of the CervicalCheck programme and the necessity to have full confidence in it. We need to restore this confidence. Anyone who listened to "Morning Ireland" this morning will not have had confidence in the information that was processed and presented. Will the Tánaiste confirm that the other 14 women identified in 2014 have been informed of their specific circumstances and that communication is open with them? Will he outline what will be done to ensure CervicalCheck realises the seriousness of this matter and what steps the organisation will take to rebuild public trust in this vital screening programme? Will the Minister for Health make himself available in the House next week to answer questions on this matter? Deputies and Senators may learn of concerns over the weekend that will need to be addressed next week as part of the process of beginning to rebuild trust in this vital screening programme? The Oireachtas must also outline its responsibility to Vicky Phelan and her family.

I heard the interview this morning, which raised some questions and did not provide full clarity in terms of the Health Service Executive's response. The clinical director of CervicalCheck has spoken on radio in the past hour and provided much more clarity on the issues. I thank both individuals for their efforts to bring clarity. I am sure the Minister will be happy to deal with questions as they arise. He has already met the directors of the HSE and the National Cancer Control Programme to discuss these issues and try to ensure we maintain confidence in a system that is vital to Irish women in terms of reducing the incidence of cervical cancer.

In terms of lessons learned, I assure Deputy Calleary that this matter is being taken extremely seriously by everybody concerned. For this reason, quick decisions have been taken today, not only to review but also to change the approach in terms of automatic entitlement to access information relating to patients, as opposed to relying on the judgment of a clinician or doctor to pass on that information.

I asked a question on the other 14 women concerned.

Work is under way to establish whether there are other women in the same category, that is, women who have not received the information they should have received. We will have more details when the work has concluded. It is not expected that there are many more women in this category but that needs to be confirmed. I hope the work will be completed quickly.

I, too, raise the case of Vicky Phelan. Anyone who watched or listened to her making a statement outside the Four Courts yesterday could not help but be moved by her heartbreaking words. Mr. Justice Cross described Ms Phelan as one of the most impressive witnesses he had ever encountered. She is a remarkably brave and courageous woman and I extend solidarity and support to her and her family at this extremely difficult time.

The details of Ms Phelan's case are shocking. To provide a timeline, on 24 May 2011, Ms Phelan had a smear test. She was given the all clear on 17 June 2011. On 9 June 2014, her next smear was found to be symptomatic and this triggered her inclusion in the review taking place at the time, which found, on 31 October 2015, that a serious error had been made. On 21 July 2016, Ms Phelan's doctor was informed of this but it was not until 27 September 2017 that Ms Phelan was informed. It is my understanding that the period between 21 July 2016 and 27 September 2017 is filled with correspondence between her doctor, Dr. Kevin Hickey, and Professor Gráinne Flannelly. I understand there was a dispute as to who had the responsibility to inform Ms Phelan. It seems that in all these cases the last person to know is the woman affected. According to Ms Phelan's solicitor, Mr. Cian O'Carroll, if her cervical cancer had been detected in 2011, Ms Phelan could have undergone treatment and stood a 90% chance of being cured. She now has terminal cancer.

Other women listening to Ms Phelan's story will be worried, confused and frightened. Documents from Ms Phelan's case indicate that up to 14 other women diagnosed with cervical cancer had previously been told their smear tests were normal. Anyone seeking reassurance will not have found it this morning if they listened to an interview with Dr. Jerome Coffey. In response to straightforward questions, Dr. Coffey obfuscated and avoided answering. He was not able to state how many women had been affected by misdiagnosis or whether all of them had been informed. He could not even indicate whether doctors were obliged to inform patients who had been misdiagnosed. While I did not hear the interview with Professor Flannelly, I was informed of it and significant questions remain outstanding. How many patients were misdiagnosed and have they been informed of their misdiagnosis?

I understand there is a contractual obligation to inform women within four weeks if a problem is identified with a smear test. If a problem is found in a subsequent review, why does a similar contractual obligation not apply? Given the contractual obligation to inform women of problems identified in a smear test, why are women not told as soon as possible of problems identified with a smear test in a subsequent review?

In answer to the Deputy's final question, that is what we are changing. Many of us listened to Vicky Phelan who is an incredibly courageous woman. In the midst of all the challenges she is facing, she focused on the hope that something good may come from this. I hope that is the case and we have an obligation to ensure it is the case. The key issue is the information flow. Once the State has a piece of information that is relevant to a woman in these circumstances, she should be entitled to have this information immediately. It should not move between offices, physicians or anyone else without the patient having automatic access to it. The decision taken this morning was to change the approach and not before time.

It is important that we use accurate language in this discussion. This is not about misdiagnosis. A smear test is not a diagnosis but a screening mechanism that can spot early signs of change which need to be followed up in terms of potential cancer treatment. This is different from a full diagnosis. In this case, we had what was effectively a false negative from the screening programme. Such false negatives occur because there is no perfect screening programme in place anywhere in the world. The view of those involved in CervicalCheck is that the systems in place here are as good as those in place anywhere in the world and better than most. In that regard, CervicalCheck is open to peer review, independent assessment and so on.

Unfortunately in this case, there was a false negative. When Vicky Phelan was subsequently diagnosed with cervical cancer, the audit and checking system, which operates in all such cases to ascertain whether somebody who has a diagnosis of cancer previously had a smear test, found that the result of the smear test was incorrect. Ms Phelan's solicitor has raised the question as to whether the story would have been different in terms of treatment options and so on if this had been known earlier.

The key issue, as Ms Phelan correctly noted, is access to information. We will change this immediately to ensure that anybody who is in a similar position in the future will not have to access information through the courts, which is how Ms Phelan had to do it.

Information is, clearly, part of this. I have already said that it is disgraceful that she was the last to know, as was the delay before she was informed. It appears that there was almost a battle between the doctors and CervicalCheck as to who had the obligation to tell her. That is wrong. It is disgraceful. However, there is more to this than knowledge. Professor John Shepherd is one of the medical experts called in this case. He said he was struck by the obviousness of the abnormalities found on the slide which was reviewed. They should have been spotted speedily. These US laboratories have been used for ten years or so and concerns were first expressed about them by organisations such as the Well Woman Centre in or around 2007. Of course, there will be mistakes. It is not possible to have a programme in which there are no mistakes. Nevertheless, it is worth asking whether we are going to engage in a review of the rate of misses from these laboratories. Such a review is vital to restore public confidence. This is a very important programme and we all want it to be funded properly in order that as many people as possible might be screened. However, we need to know that the quality of checking in those laboratories is up to scratch and that there are not more things being missed in them than are missed anywhere else.

I accept absolutely that we have to ask all of the hard questions after a case like this. However, I want also to reassure people, particularly those outside the House, that CervicalCheck rates very well in comparison with similar screening systems in other parts of the world. There is no perfect system and human errors will occur in screening programmes, particularly with 250,000 people a year having smear tests. That seems to have been what happened here, but I do not know for sure. I know, however, that this screening system is open to independent assessment, if that is what people are seeking, in order to show that it rates well by international standards. All of us have the responsibility, however, to reassure women that this is a good screening programme which is saving lives, albeit we need to assess it constantly to ensure that improvements which can be made are made. As to information flow within the health system, that is a correction we are making this morning. Nevertheless, it is essential to reinforce the importance of smear tests and CervicalCheck in general in light of the number of lives it saves and the reduction by 7% per annum in the number of women diagnosed with cervical cancer on foot of the programme. Having said that, questions must be answered. If necessary, an independent assessment should be part of the follow-up process.

What about the US contracts?

Well-----

I call Deputy Michael Healy-Rae. I provided an extra minute for Deputy Ó Laoghaire's question, which, I know, relates to an important issue.