Alan Kelly (Tipperary, Labour)
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235. To ask the Minister for Health if his Department has concluded the number of CervicalCheck cancer cases that need to be reviewed by the Royak College of Obstetrics and Gynaecology, RCOG, review; the number of those cases which were and were not part of the original audit, respectively; the number of cases added from the cross-checking with the National Cancer Registry; the number of cases he expects to be added as a result of the use of the 18-month audit timeline; the person in the HSE who decided the 18-month timeframe; if his attention has been drawn to this timeline; if so, when; his views on this timeline; if there will be cases that are part of the RCOG review that originate from post 1 January 2018; and the number of cases expected to be added also as a result of the audit of CervicalCheck being ceased. [43085/18]

Simon Harris (Wicklow, Fine Gael)
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The Independent Expert Panel Review of cervical screening, to be led by the Royal College of Obstetrics and Gynaecology, with expert input from the British Society for Colposcopy and Cervical Pathology, will include women who have been diagnosed with invasive cervical cancer and who had previously had smear tests through the national CervicalCheck screening programme. Some of these women have had their cases audited by the programme already, and some have not.

The overall cohort for the review includes 3,112 women in Ireland who were diagnosed with invasive cervical cancer since the beginning of CervicalCheck in September 2008. This figure is made up of:

- 1,482 cases known to CervicalCheck, who have had their cases audited by the programme.

- 1,630 additional cases who were not known to CervicalCheck prior to 2018. These are cases that were registered on the National Cancer Registry of Ireland, as of the 5th May 2018,. These cases have not been audited by CervicalCheck.

Within this overall cohort, the number of women who had previously been screened by the CervicalCheck programme is approximately 1,850. All of these cases will be reviewed by the Independent Clinical Expert Review, whether or not they were previously audited by CervicalCheck.

The 221 women known to be affected are those whose history was audited by CervicalCheck and for whom the audit showed a differing cytology recommendation to their original test. It is to be expected that more cases of discordant results will be found once the Review led by the RCOG has concluded.

In regard to clinical audit within CervicalCheck, this was paused pending the outcome of the Scoping Inquiry. Dr Scally’s report makes two recommendations in relation to clinical audit to improve the service going forward, and these will be part of the implementation plan which I intend to bring to Government.

In relation to the 18 month audit timeline, I have asked the HSE to respond directly to the Deputy on this issue.

Alan Kelly (Tipperary, Labour)
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236. To ask the Minister for Health when the audit of CervicalCheck will recommence by the HSE; and his plans to ensure women who, chronologically and statistically based on previous smear analysis, need to have new smears carried out in a timely fashion do not have their future health outcomes potentially negatively affected by the fact they are now part of a larger number of smears in circumstances in which there are backlogs and some slides are going out of date in view of the commitment he gave to allow all women have a free smear test. [43086/18]

Simon Harris (Wicklow, Fine Gael)
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Following the emergence of issues relating to CervicalCheck earlier this year, the audit process was paused pending the outcome of the two reviews established by Government.

The first of these was the report of the Scoping Inquiry into issues surrounding CervicalCheck. Dr Scally’s report was published on my Department's website on 12 September and includes 50 recommendations, all of which have been accepted by Government. These include two recommendations relating specifically to auditing cervical screening. Dr Scally recommends that common, robust and externally validated approaches to all aspects of audit should be developed across the screening services. He also advises that there should be two patient advocates involved in the oversight of clinical audit for the screening services. Both of these recommendations will be implemented.

I want to see audit of cervical screening recommence as soon as possible, but it must be done in the right way and in the robust way that Dr Scally recommends, and there is obviously some work required to ensure that happens.

In relation to the second query, on 1 May, following a Government Decision, I asked CervicalCheck to make the necessary arrangements to provide that any woman who had had a CervicalCheck smear test, and whose GP considered that they should have a further test, could access such a test without charge. This decision was taken considering the need to provide reassurance to women.

The HSE advises that CervicalCheck laboratory activity remains significantly above normal levels. This is a result both of out-of-cycle smears, and also increased uptake generally. This has impacted turnaround times for results of smear tests.

The HSE also advises that every effort is being made to ensure that tests are processed as quickly as possible, having regard to the high standards required for testing. This is a priority concern for my Department and the HSE. The recent agreements reached with the contracted labs includes arrangements to address the backlog in testing.

I think it is important to emphasise that smear tests are a screening and not a diagnostic process, and if any women is concerned or is experiencing any symptoms, she should consult with her GP.