Tuesday, 9 October 2018

Questions (297)

Bríd Smith

Question:

297. Deputy Bríd Smith asked the Minister for Health further to Parliamentary Question Nos. 165, 166 and 171 of 26 September 2018, if he will answer the specific questions (details supplied) contained in the original questions which to date his reply did not answer. [40928/18]

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Written answers (Question to Health)

As outlined in previous Parliamentary Questions to the Deputy, 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. I again emphasise that false positives and false negatives are unavoidable and happen in every screening programme.

The Deputy has asked about the qualifications of screeners employed by laboratories outside of this country which provide services to CervicalCheck, and about a risk assessment in relation to the potential use of another laboratory. These are matters which directly relate to the quality of services provided by contracted laboratories.

The Scoping Inquiry, led by Dr.. Gabriel Scally, reported in September. Its terms of reference, developed following cross-party engagement, included examination of the tendering, contracting, operation, conflict of interest arrangements, performance information and performance management, accreditation and quality assurance of contracted cytology laboratory services since the inception of the CervicalCheck programme. Dr. Scally's report was the result of a period of intensive work which included visits to the contracted laboratories.

Dr. Scally is clear in his report that the Inquiry is satisfied with the quality management processes in the laboratories contracted by CervicalCheck. All of the laboratories visited by the Scoping Inquiry are meeting the regulatory requirements current in their own country. Crucially, he has confirmed that there is no reason, on quality grounds, why the existing contracts for laboratory services should not continue until the new HPV testing regime has been introduced. This provides welcome reassurance for women in Ireland about the quality of these services.

Dr. Scally has undertaken to carry out a supplementary report into certain further aspects of the laboratories, including accreditation. He has also made a number of key recommendations in relation to laboratory services which I intend to implement and which will help to ensure that the cervical screening programme meets the highest possible standards.