Written answers

Wednesday, 30 January 2019

Department of Health

Cancer Screening Programmes

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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205. To ask the Minister for Health the number of CervicalCheck claims that have been through the courts to date that have ended with a settlement with no admission of liability, a settlement with an admission of liability, a settlement with an admission of liability of which negligence was a part, a finding of negligence or a finding of no negligence, respectively. [4636/19]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The State Claims Agency has a statutory remit to manage personal injury claims, including claims in respect of clinical negligence, on behalf of Delegated State Authorities (DSA’s) including the Health Service Executive. The State Claims Agency can only comment on the liability of the State as a Defendant.

Regarding CervicalCheck cases, I have been informed by the State Claims Agency that to date, four cases have settled. In those cases, the State has admitted breach of duty in relation to the non-disclosure of the audit results. The Courts have not yet heard a case in full, in order to determine the issues of liability, whether for non-disclosure of audit results or the reading of the slides.

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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206. To ask the Minister for Health the reason the HSE has not clarified to date the number of the 221 women whose smear results were found to be discordant upon audit that had clearly discordant results; and the number involved that had clear false negatives which are an accepted and unavoidable feature of the screening test. [4637/19]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The Deputy's question relates to the limitations of screening, as well as of audit and review, as set out in the report of Dr Gabriel Scally. 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. False negatives are those samples where the slide was originally reported as negative but on review abnormal cells are found. As outlined in the report of the Scoping Inquiry, some screening programmes divide those false negatives into one of two groups:

1. Abnormalities that most screeners would not have detected;

2. Abnormalities that most screeners would have detected.

It is often a matter for professional judgement and discussion into which of these two groups any single false negative will fit. Following the Government decision on 8 May, I established an independent Expert Panel Review of Cervical Screening as part of the investigation into issues relating to the CervicalCheck Screening Programme. The review will be carried out by the Royal College of Obstetricians and Gynaecologists (RCOG) with expertise also sourced through the British Society for Colposcopy and Cervical Pathology.

The purpose of the review is to provide women who participated in the national CervicalCheck screening programme and who developed invasive cervical cancer with independent clinical assurance about the timing of their diagnosis and treatment. The panel will endeavour to determine, wherever possible, any failures to prevent cancer or to intervene at an earlier stage and will prepare individual written summary reports for those affected, setting out the facts and their expert and independent assessment of those facts.

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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207. To ask the Minister for Health if the roll-out of the new and more accurate HPV screening test for cervical cancer has been impacted or delayed by the controversy over the disclosure of cervical screening audit results in May 2018. [4638/19]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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I have asked the HSE to introduce HPV testing as the primary screening method for the prevention of cervical cancer as soon as possible. The HPV test is a more accurate testing mechanism than liquid-based cytology, which is the current testing mechanism, and its use will result in fewer false negative results, though it will not eliminate them completely. Its introduction is in line with developments in cervical screening internationally.

The introduction of HPV testing as the primary screening mechanism for CervicalCheck, with cytology as a reflex test, will require a reconfiguration of the laboratory work involved. A tendering process will be required for work to be carried out outside the public sector, and detailed capacity planning is ongoing to determine requirements.

There is no doubt that the issues which emerged last year have resulted in operational challenges for the HSE and the Screening Service, and that stabilisation of the programme in 2019 is an important element in supporting the switch to HPV testing. Accordingly, the HSE is working very actively to manage these challenges while progressing this major development as a priority.

Funding to implement the switch to HPV screening has been allocated in Budget 2019, along with funding to implement the recommendations of Dr Gabriel Scally’s inquiry in to the CervicalCheck Screening Programme and the extension of HPV vaccination to boys, illustrating the Government’s commitment to these essential projects.

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