Simon Harris (Wicklow, Fine Gael) | Oireachtas source

While I had been advised, and it had been commonly understood, that the CervicalCheck clinical audit covered all cases notified to the national cancer registry, I have been informed this afternoon that this is not the case. While CervicalCheck has audited all cases notified to it, I have been informed that a potentially considerable number of cases will not have been subjected to an audit of their screening history. These are not new cases of cancer, nor is it a group of women wondering if they have cancer. These are women who have been diagnosed with cervical cancer and treated as such but their cases have not been included in a clinical audit. Having identified this issue, the SIMT will take steps to identify any additional cases of cervical cancer that occurred during this period and which were not audited. The screening history of these additional cases will be established, and if any of these women were screened through the CervicalCheck programme, their case will be reviewed in further detail with cytology review where necessary. This is an evolving situation but I am giving as much information to this House as I have as soon as I have it to be transparent with the Dáil.

We are all here, I think we can agree, because Vicky Phelan spoke out. I recognise that to do so cannot have been easy for her or her family. Her courage and tenacity has done a great service to the women of Ireland and her actions will ultimately lead to improvements for all. I think the background to the case is well understood at this point, but I want to be very clear about my own level of knowledge prior to the case becoming public and with regard to the information note I received on 16 April, which I have published today with only personal information redacted.

I was not notified at that time of the information which later became available, information such as the correspondence chain between doctors and the clinical director of the programme.

The full implications became clear to me only on Wednesday, 25 April, when Vicky Phelan spoke, and on Thursday, 26 April, at which point I acted swiftly.

The note outlined the details of an individual case. lt informed me of a legal process that was already underway. It informed me that mediation discussions had been held on 9 April and pre-trial discussions had been held with a judge on 10 and 12 April. It said that the matter may progress to the High Court on 19 April but that the case was likely to be settled before going to court. It said that the claim against the HSE was likely to be dropped in the absence of any bad faith by the HSE. It informed me that my Department had been advised by the National Cancer Control Programme that it did not consider this to be a patient safety incident. It informed me the National Screening Service had assured the Department that no quality issues have arisen in respect of the UK laboratory that performed the 2011 test referred to in the case. In an appendix with background information, the note outlined the clinical cancer audit process, including the fact that all current and historical clinical cancer audits had been communicated to treating clinicians in 2016 and that more recently women are informed of this audit process and have the option to request information on the outcomes of these reviews. It was not clear until after the details of this case became public that this process was not ensuring women were informed. Once I became aware of that I ordered immediate change, as is well documented.

Since 2008, a total of 3 million smear tests have been carried out by CervicalCheck. The cervical screening test is not a diagnostic test; it is a screening test. It is a test to indicate the possibility of pre-cancerous or cancerous lesions and to identify women who require further investigation or follow-up. Tests can produce false positive and false negative results. Women are screened at three-yearly intervals but cervical cancer may develop in the interval between a negative screening test and the next scheduled screening in any cervical screening programme.

It is a fact that the current primary screening test used by CervicalCheck is a cytology test that produces a not insignificant number of false negative results. I can, however, confirm that primary human papillomavirus screening will be introduced later this year. I took that decision in February and it will be introduced by October. I understand that the accuracy of HPV testing is significantly higher than liquid-based cytology testing, which is the testing used now. HPV testing is expected to result in fewer women receiving a false negative result. I am also of the view that testing for the HPV virus will be a more appropriate strategy for the cohort of women who have received vaccination against HPV. My decision to approve primary HPV screening was informed by a HIQA health technology assessment. The assessment found that HPV screening would benefit women by making the screening process more clinically effective as well as reducing unnecessary tests for most women. The HSE has advised that 1,482 cervical cancer cases have been audited by CervicalCheck covering the period from 2008 to 2018. The audit found that the majority of these cases involved patients who already had been referred for further investigation or treatment by CervicalCheck. In the case of 208 patients who were the subject of a detailed cytology review it found that the review differed from the original test.

Last Friday, the HSE established a serious incident management team. The team worked through the weekend to confirm the number of women involved and the extent to which the audit results had been communicated to them. Yesterday, it was reported to me that 162 of the 208 women involved had not been informed of the outcome of the audit process. Over the past two days we have been communicating with these women and I believe significant progress has now been made. Obviously, there will be a small number of cases where we might not succeed in initially making contact, such as a case where a woman may have moved abroad.

Like all Deputies, I was very sorry to learn that 17 of the patients involved have since died and I would like to sincerely express my sympathies to their families on the record of the House. Obviously, as yet we do not know the cause of death of these individual women but we will work with the families to ensure that is established. A helpline has been in operation since Friday and appropriate clinical staff will follow up on specific clinical questions. Between Friday and the close of business yesterday, approximately 6,000 calls were received. Unfortunately, there were some technical issues with the telephone line but I am informed that the HSE had worked to address this.

I am conscious that some women will be worried that they might have received an incorrect smear result and they might want a further test to be reassured. I have heard many women say that in recent days. This was one of the most persistent issues that came in through the helpline we established. I have, therefore, asked CervicalCheck to make the necessary arrangements to enable any woman who has had a CervicalCheck smear test and whose general practitioner considers that the woman should have a further test to access such a further test without charge. These arrangements are currently being worked through and will be confirmed this week. I wish to thank the doctor representative organisations for their co-operation and support in this matter.

Vicky Phelan's case has highlighted a number of major weaknesses in how people experience our health service. I believe that immediate actions are required to address these weaknesses and to provide assurance to the public with regard to the quality and performance of the cervical screening programme. Given the gravity of the situation as well as the impact it has had on Vicky Phelan and a number of other women, I think it is vital that we ensure we put in place a process to allow all of us - patients, doctors and policymakers alike - to understand exactly what happened and what steps we need to rectify the situation. I have, therefore, directed HIQA to commence a statutory investigation to examine the clinical and managerial governance of CervicalCheck. This investigation will place a particular focus on the quality assurance systems, clinical audit processes and communications with patients. It is crucial for all of us to get this information. A statutorily empowered investigation by HIQA, the body established by these Houses for this very purpose, is the most appropriate way forward in this instance.

As part of this investigation an international peer review group will be established to examine our cervical screening programme against international best practice and standards. HIQA has been asked to identify any implications that may apply to other cancer screening programmes. This will ensure that any learning will have wider impact and serve to improve all our screening programmes. I am conscious, while looking at a programme and how to improve it, that individual women have been impacted and we need to ensure they can get independent clinical answers. I have now decided to appoint an international expert clinical panel to provide all women concerned with an individual clinical review. A liaison nurse specialist will be appointed to ensure the women involved receive all the support they require. I met the Irish Cancer Society this afternoon to ask that the society would meet the panel and ensure the panel and the relevant processes are put in place in a way that is supportive of women patients as well as to ensure women get the answers they need. The work of the expert panel will be completed as soon as possible. I hope it will have its work concluded by July.

Since 2008, CervicalCheck has undertaken tendering processes to award contracts for cytology testing of cervical smear tests. In 2013, the national cytopathology training centre at the Coombe Women and Infants University Hospital was engaged to carry out some of the laboratory tests. Currently, the testing of cervical smear tests is carried out by three institutions with approximately 50% of the testing done in Ireland and the remaining 50% done abroad. I realise this has been the source of much public discussion in recent days. I have been assured that all three laboratories meet quality assurance standards and are certified by the relevant national authorities. However, the introduction of HPV testing later this year as the primary screening mechanism for CervicalCheck, with cytology as reflex test, will involve a reconfiguration of laboratory work. It will also provide an opportunity for further tendering processes to be undertaken for any laboratory work carried out outside the public sector.

This issue in recent days has shone a real spotlight on our open disclosure practices or lack thereof in some cases. Of course open disclosure involves an open and consistent approach to communicating with patients and their families when things go wrong in healthcare. It is a human experience for all involved and one that should not be hindered by other concerns and fears. The HSE open disclosure policy has been in place since 2013 and the HSE committed to its full implementation in the HSE service plan this year. The Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners sets outs the duties of medical doctors in respect of open disclosure and duty of candour. It states that patients and their families, where appropriate, are entitled to honest, open and prompt communication about adverse events that may have caused them harm. When discussing events with patients and their families, doctors should acknowledge that the event happened and explain how it happened; apologise, if appropriate; and assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.

The Civil Liability (Amendment) Act 2017 includes provisions for open disclosure of serious events including certain protections for information given to the patient at an open disclosure meeting. This approach creates a safe space for healthcare staff to be open and transparent with patients, who can be given as much information as possible as early as possible, including an apology. In the course of Dáil consideration of the Civil Liability (Amendment) Bill, I gave a commitment to bring forward separate legislation to provide for mandatory open disclosure of serious events. I wish to acknowledge the work of Deputy Clare Daly in this regard. I intend to bring a memorandum to Government next week proposing a patient safety Bill. This Bill will include measures to support patient safety objectives and to provide for mandatory open disclosure to patients of those serious events which will be the subject of mandatory external notification. I will prescribe a list of reportable events that are required to be notified by public and private providers and this will include screening.

There has been much criticism about the way the State handled Vicky Phelan's legal proceedings. I accept that criticism. I think there is a difficulty with our tort laws in that they are slow to provide for persons who have suffered harm within the health care system. However, the State Claims Agency is delegated to manage all claims against the State and neither I nor my Department has any role or function in this regard.

There also have been calls for greater accountability across the health system. For my own part, I am clear that accountability and good governance are central to the organisation and functioning of the health system. I have called it out in recent days where I did not see that come to the fore. As part of my Department's response to Sláintecare, it is proposed to examine how best to strengthen accountability in our health care system. Other jurisdictions have managed to do this, therefore, why can Ireland not? Steps will be identified to consider how accountability for all staff across the health service can be strengthened.

My Department also expects to publish a new code of conduct for health and social care providers this month. This will be an important driver in the delivery of the patient safety agenda, both in terms of policy and service delivery. The code will apply to all service providers and individuals who come into contact with a user of health or social services.

I want to assure this House and, more importantly, the women of Ireland that I am taking every possible action to ensure that an incident such as this does not happen again. I acknowledge the very difficult circumstances that Vicky Phelan and her family are now in, and I would like to thank her for her bravery in bringing this to light. I still think it is bizarre that doctors had information in relation to patients that they did not share with their patients. That paternalistic attitude is something that should concern us all.

In all of this debate, however, it is important we do not lose sight of the fact that many cancer screening programmes have resulted in the lives of many women being saved. We must do all we can to ensure women continue to attend for smear testing. We acknowledge things went wrong but we are determined to put things right. I hope the actions I have outlined will help in that regard. Tomorrow the Joint Committee on Health with meet relevant officials from the HSE, CervicalCheck, the National Cancer Control Programme and my Department. I expect all those agencies to be upfront and forthwith and I do not expect a commencement of any investigation to stop that exchange of legitimate democratic debate here in our Parliament.

This evening I will continue to do what I have done since this incident came into the public domain and since I have known all about it, which is to be as transparent and open as I can, and I hope to work constructively with colleagues across this House to put this right.

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