Simon Harris (Wicklow, Fine Gael) | Oireachtas source

Last week, I published the Supplementary Report of the Scoping Inquiry into the CervicalCheck Screening Programme following a Cabinet meeting and today I welcome the opportunity to discuss the report's findings and speak about the issues at its core. At the outset, I would like to place on the record of this House my sincere gratitude to Dr. Gabriel Scally and his team for not only the comprehensive work undertaken over the past number of months but the way in which he has gone about robustly establishing the truth and the facts and putting in place a comprehensive implementation plan. This work is crucial to our aim of providing a world-class cervical screening programme that inspires trust and confidence among the women of this country. Government has accepted this report, and, indeed, Dr. Scally's previous reports, and my focus now is on ensuring the full implementation of all his recommendations. Considerable work is already ongoing in the HSE, National Cancer Registry Ireland and my Department on these recommendations and in his supplementary report Dr. Scally acknowledged the significant progress that is being made.

On completion of the final report of the scoping inquiry last September, Members will be aware that I requested Dr. Scally to do further work to address some outstanding issues relating to the laboratories which had been referenced in that report. This supplementary report confirms that the number of laboratories involved in CervicalCheck's work was greater than originally thought or than was known to CervicalCheck. We now know the number of laboratories that provided screening for the Irish programme was 16. We also know that the use of many of the additional laboratories was not approved in advance by CervicalCheck. Clearly, this situation should not have arisen, and the implementation of all of Dr. Scally's recommendations is vital to ensure this does not arise in the future. However, the core question is whether the use of these additional laboratories resulted in a quality problem. Dr. Scally says there is no evidence to suggest deficiencies in screening quality in any laboratory. This is a crucial and important message that we all must communicate to women in this country who are rightly looking for assurance and information. I hope that this will reassure women that they can trust the results they receive from the CervicalCheck programme and that they should continue to attend for their scheduled screenings. Indeed, we see already that women are attending in large numbers for screening.

It is worth noting that in this report Dr. Scally has also points to an important safeguard, which is that double reading of all Irish slides takes place, including on slides screened in the US. This is different to the general US practice where slides are examined by a single screener. Furthermore, Dr. Scally is very clear that the two major accreditation standards in use, that is the ISO standard and the CAP standard, are comparable. He says they do not create any cause for concern in terms of the quality of laboratory services provided. All but one laboratory had the appropriate accreditation at the time they were providing screening services to the HSE. Dr. Scally has found that all of the laboratories used in the US were accredited but expressed concern about accreditation in relation to one laboratory in Salford, in the UK. This is ancillary to the main MedLab facility in Dublin.

Accreditation is an important process in providing assurance about quality, of course, but the question remains was there any deficiency in screening. Dr. Scally states that there is no evidence of any such deficiency. He indicates that it is reassuring that the performance data for the screeners based in this ancillary laboratory were part of that reviewed by the scoping inquiry in mid-2018. At that time, the inquiry concluded there was no reason, on quality grounds, the existing contracts for laboratory services should not continue. The HSE has said this concurs with its own ongoing performance monitoring in regard to MedLab Pathology. While he has been clear there is no evidence of deficiency in screening quality, Dr. Scally is also clear on the need to have the right quality assurance systems in place. This is being addressed now as part of the implementation of Dr Scally's recommendations.

CervicalCheck now has a national laboratory QA lead in place which is a key and important step, and work is continuing to strengthen governance, quality assurance and management in the CervicalCheck programme and the wider National Screening Service. We have already seen these improvements in the work done by the HSE to quality assure the additional laboratories in the US prior to entering into a new contract with these for additional screening capacity, and this has been acknowledged by Dr. Scally. I asked him if he is he satisfied with those new arrangements and he stated that he is.

Dr. Scally has made two further recommendations in his supplementary report. Actions to implement these will be incorporated in the approved implementation plan which has been in place since last December. There are more than 160 actions in the plan and 48 of these had been implemented by the end of quarter 1 this year.

I am pleased to state that Dr. Scally has acknowledged the substantial and important progress that has been made to date in implementing the recommendations of his first and final reports.

We are now at a point where we have made important progress in a number of areas: we will begin the tribunal legislation recommended by Mr. Justice Meenan in this House next week; the ex gratiascheme has been established; the Royal College of Obstetricians and Gynaecologists review is well under way; the HSE has secured additional capacity to support our screening programme and the backlog is quickly and substantially shrinking; preparations are ongoing within the HSE for the switch to HPV primary testing; and the vaccine for boys will be introduced in September.

We must have a strong and sustainable screening programme in which women can have full confidence. Since CervicalCheck was set up in 2008, cervical cancer rates decreased from approximately 14 cases per 100,000 women in the years 2009 to 2011 to ten cases per 100,000 women in the years 2013 to 2015. A well organised screening programme, when combined with HPV vaccination for boys and girls - with all of us in this House supporting that vaccination programme - can bring us very close to eliminating cervical cancer. Our national goal is to effectively eradicate cervical cancer. My priority now is ensuring that Dr. Scally’s recommendations are fully implemented because this will make that goal a reality.

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