Bríd Smith (Dublin South Central, People Before Profit Alliance)
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439. To ask the Minister for Health further to Parliamentary Question No. 128 of 5 December 2018, if, following a review (details supplied) he will direct the HSE to provide the information requested. [51729/19]

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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440. To ask the Minister for Health further to Parliamentary Question No. 130 of 5 February 2019, if the analysis referred to the person with appropriate expertise is a reference to the 221 laboratory audit report, a report (details supplied) or a separate analysis; and if he will make a statement on the matter. [51730/19]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 439 and 440 together.

Earlier this year, the HSE completed a report which provides a breakdown of the laboratories in which the smear tests of the 221 women involved in the CervicalCheck audit were analysed. A supplementary report was also completed at the request of the 221+ Group, which sets out the breakdown over time. The reports have been shared with the 221+ Patient Support Group and with members of the Joint Oireachtas Committee on Health.

As outlined in previous responses to the Deputy, it would be expected that false negatives would have occurred in all labs contracted by CervicalCheck since its inception. In recognising the serious consequences that screening failures have for affected women, the RCOG Expert Panel also recognised the inability of cervical screening to prevent all cases of cervical cancer. The Panel acknowledged that screening failures are, unfortunately, inevitable given the limitations of cytology-based screening and should not be taken to suggest the programme overall is not working.

The performance of laboratories used by CervicalCheck has been analysed and compared by Dr Scally and that performance has been found to be within the quality standards required and expected. The RCOG Expert Panel also found that the CervicalCheck programme is working effectively and, crucially, that women can have confidence in the programme.

In regard to the Deputy's question of 5 February, I can confirm that the person with appropriate expertise referred to was in the context of the laboratory audit report.

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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441. To ask the Minister for Health further to Parliamentary Questions Nos. 322 and 323 of 24 September 2019, if the fact that the HSE has established an expert group to review clinical audit of interval cancers is a reference to a review (details supplied) or a different expert group. [51731/19]

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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443. To ask the Minister for Health if, following the Scally report and a review (details supplied), he will recommence the CervicalCheck audit that has been paused since May 2018; and if he will make a statement on the matter. [51750/19]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 441 and 443 together.

Since 2010, as part of quality assurance measures, CervicalCheck reviewed the screening history of every woman notified to it as having a diagnosis of cervical cancer, who had previously been screened by the programme. The objective of audit and quality review at CervicalCheck was to facilitate continued improvement and ongoing learning within the programme. Following the issues which arose in relation to the non-disclosure of audit findings, a decision was taken to pause the audit.

The Scoping Inquiry led by Dr Gabriel Scally made a number of recommendations, one of which was that “Audit should continue to be an important component of cervical screening as this complies with all good clinical practice. Common, robust and externally validated approaches to the design, conduct, evaluation and oversight of audits should be developed across the screening services.” (Recommendation 26).

This recommendation was accepted by Government, as were all of Dr Scally's recommendations. Actions to implement these recommendations were set out in an implementation plan which was approved by Government and is published on the website of my Department.

As set out in the implementation plan, the HSE has established an Expert Group within the National Screening Service to review the clinical audit processes for interval cancers across all screening programmes. This is separate to the work of the Independent Expert Panel Review led by the Royal College of Obstetrics and Gynaecology (RCOG Review). The Expert Group, which includes two patient representatives, will develop a report setting out recommendations for the operation of clinical audit processes across all screening programmes. The Expert Group is expected to complete its work at the end of this year, following which its recommendations will be implemented by the HSE. I expect that the detail requested by the Deputy regarding the timing of the recommencement of the audit will be informed by the Expert Group's work and this detail will become available once that work is complete.