Bríd Smith (Dublin South Central, People Before Profit Alliance)
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165. To ask the Minister for Health the reason his reply to two previous parliamentary questions on the ISO accreditation of US-based labs stated that these labs had ISO status while the Scally report states they did not. [38941/18]

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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166. To ask the Minister for Health if screeners in US labs have the same levels or comparable levels of qualifications for screeners who examine cervical check slides here. [38942/18]

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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171. To ask the Minister for Health his views on the reference in the Scally report to the plans of a CervicalCheck provider to use laboratories in Australia to conduct future tests; if a risk assessment of such a practice will be conducted; and if he will make a statement on the matter. [38947/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 165, 166 and 171 together.

Earlier this year in response to Parliamentary Questions, I stated, as was my understanding then, that laboratories contracted by CervicalCheck met the programme’s standards and had ISO accreditation, certified by the relevant national authorities. The Report of the Scoping Inquiry established by Government has clarified that only some laboratories have ISO accreditation.

Dr Scally is providing me with a supplementary report which will investigate the matter of accreditation. I look forward to receiving this report.

However, it is important to be clear that Dr Scally's Report, published on 12 September, has provided welcome reassurance in relation to the laboratories currently contracted by CervicalCheck. He is satisfied with the quality management processes in the labs currently contracted by CervicalCheck, and he is clear that he has found no reason why the contracts with existing providers should not be extended pending the switch to HPV testing as the primary screening test.

The Report is a comprehensive and robust assessment of CervicalCheck, based on engagement with women and families involved, review of documentation, interviews with key personnel and visits to the laboratories involved. It makes fifty recommendations, including a significant number in relation to laboratories and procurement, the implementation of which I expect to provide all necessary assurance in relation to the services on an ongoing basis.

The Government has accepted all 50 of Dr Scally’s recommendations and I have asked the State bodies involved to move swiftly in relation to implementation.

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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167. To ask the Minister for Health the reason HSE documents that relate to the procurement and tendering of contracts for CervicalCheck were destroyed in 2017; and the steps he will take to ensure all such documents are retained and available for scrutiny in the future. [38943/18]

Simon Harris (Wicklow, Fine Gael)
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On 12 September, the Report of the Scoping Inquiry into the CervicalCheck programme, led by Dr Gabriel Scally, was published on the website of my Department following the Government meeting.

Dr Scally has emphasised in his Report that the continuation of cervical screening in the coming months is of crucial importance. In that context, I very much welcome the fact that he has found no reason why the existing contracts for laboratory services should not continue until the new HPV testing regime is introduced. The Report provides very welcome reassurance in regard to the quality management processes in place in the laboratories currently contracted by CervicalCheck.

As stated in the Report, the destruction of some of the original material relating to the CervicalCheck tender competitions in 2017 was in line with HSE policy for document retention and disposal. The Report sets out fifty recommendations, including a number in relation to laboratories and procurement, and the Government has committed to implementing these in full. They include a recommendation that "Winning proposals should be appended to the relevant contract and not destroyed until at least one year following the termination of the contract (and any extension thereof)" and this will be implemented.

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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168. To ask the Minister for Health the reason previous parliamentary questions that sought the identity of the labs involved in the false negative results that affected 221 women has not been revealed; and his plans to ensure this information is made available. [38944/18]

Simon Harris (Wicklow, Fine Gael)
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Screening tests are a balance of sensitivity and specificity and therefore include both false negative and false positive results which could affect the screening outcome and treatment of a person who may or who may not have a disease. It would be expected that they would have occurred in all labs contracted by CervicalCheck since its inception.

The Deputy may wish to be aware that according to Dr Scally’s report, conducting an audit or review of interval cancers is a good thing to do for the purposes of quality control and, particularly, learning. Dr Scally does point out that it is not without problems when it comes to comparability.

His review has summarised that, “no matter how closely the review panel tries to reproduce the original screening conditions, the conditions of a review are different – the fact that a review includes records of a patient known to have a serious condition, such as cancer, will heighten vigilance and increase reports of abnormality.”

Dr Scally is clear that finding discrepancies on review does not imply that the same findings should have been made under routine conditions. His report states that in a cervical screening programme the result is based on interpretation of appearances on a scan, slide or mammogram in circumstances where the boundary between normality and abnormality is not firmly drawn and this may result in debate between experts as to the appropriate classification of the sample or the interpretation of the image.

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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169. To ask the Minister for Health his plans to build up the capacity of public labs based here to conduct all CervicalCheck screening in the future on foot of the Scally report; if he will initiate a program of university graduate and undergraduate classes necessary to train the required number of medical scientists for such a scenario; and if he will make a statement on the matter. [38945/18]

Simon Harris (Wicklow, Fine Gael)
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My priority is and will remain the provision of services of the highest quality. It is important to be clear that the Report of the Scoping Inquiry into CervicalCheck, published on 12 September on the website of my Department, provides welcome reassurance on the quality of all laboratories currently contracted to provide services for CervicalCheck, including the private laboratories contracted both in Ireland and America (Medlab Pathology and Quest Diagnostics, respectively) and the Coombe Women and Infants University Hospital in Dublin.

Switching to HPV testing as the primary screening mechanism will require a reconfiguration of laboratory services. While it is likely that a tendering process will be needed to meet at least some of the HPV testing requirement,  the potential to use public laboratories in Ireland to carry out testing for the programme is being carefully assessed as part of the planning of this major project.

Bríd Smith (Dublin South Central, People Before Profit Alliance)
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170. To ask the Minister for Health if future contracts or procurement arrangements with a provider for CervicalCheck services will place the emphasis on awarding such contracts on criteria other than costs on foot of the Scally report; and if he will instruct the HSE to examine the workplace conditions, qualifications and workload of such screeners or examiners of slides. [38946/18]

Simon Harris (Wicklow, Fine Gael)
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On 12 September, the Report of the Scoping Inquiry into the CervicalCheck programme, led by Dr Gabriel Scally, was published on the website of my Department following the Government meeting.

Dr Scally has emphasised in his Report that the continuation of cervical screening in the coming months is of crucial importance. In that context, I very much welcome the fact that he has found no reason why the existing contracts for laboratory services should not continue until the new HPV testing regime is introduced. The Report provides very welcome reassurance in regard to the quality management processes in place in the laboratories currently contracted by CervicalCheck.

The Report includes fifty recommendations, many relating to the laboratories and approach to procurement. The Government has committed to implementing these in full. In particular, Recommendation 22 sets out that the procurement approach should maintain a balanced focus on qualitative factors, supplier experience, and innovation, alongside cost considerations and this will be implemented.

More broadly, the recommendations encompass proactive contract governance, measures to test performance and revision of programme standards. I am confident that the full implementation of the recommendations will ensure continuation of an effective, high quality service.