Stephen Donnelly (Wicklow, Fianna Fail)
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158. To ask the Minister for Health if the figure of 221 women being adversely affected by the CervicalCheck issues is accurate; and if he will make a statement on the matter. [48806/18]

Simon Harris (Wicklow, Fine Gael)
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This question relates to operational issues, and accordingly I have asked the HSE to respond directly to the Deputy.

However, the Deputy might note that, as advised at the Joint Oireachtas Committee on Health recently, the HSE will shortly commence a validation exercise to ensure data held by the National Screening Service in relation to the 221 women affected by the CervicalCheck audit is fully up to date. This will, for example, help with planning support needs for patients.

It should be noted that this piece of work is not an audit but, rather, aims to ensure the information already held is updated appropriately.

Róisín Shortall (Dublin North West, Social Democrats)
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159. To ask the Minister for Health the steps he is taking further to a report (details supplied); the extent of the review of cases proposed; the person or persons that will carry out this review; the length of time covered by the review; and when he expects the review to be completed. [48815/18]

Róisín Shortall (Dublin North West, Social Democrats)
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163. To ask the Minister for Health the number of persons that have been informed of a change to their test results with regard to a report (details supplied); and if there is a helpline for persons that may have concerns in this regard. [48819/18]

Róisín Shortall (Dublin North West, Social Democrats)
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164. To ask the Minister for Health the number of persons that have been informed of a change in their test result by those that were misinformed owing to a clerical error and those whose results were changed as a result of subsequent more advanced retesting of their original samples with regard to a report (details supplied), respectively. [48820/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 159, 163 and 164 together.

In relation to the issue which has been raised by the Deputy, I would note that officials of my Department have been in contact with the Health Service Executive (HSE). The HSE in turn have advised that in late October 2018, an error was discovered in correctly communicating a genetic test result by the Department of Clinical Genetics at Our Lady's Children’s Hospital Crumlin (OLCHC) following an enquiry by an oncologist for a patient with recurring cancer who had a genetic test, known as a BRCA test, in 2009. Crumlin Hospital are currently reviewing this incident as a matter of the utmost priority.

This error has been reported as an incident and is being managed in accordance with the HSE Incident and Risk Management policy, including in commencing an incident review process of this transcription error in correctly communicating the test result in a letter to the referring clinician. Direct contact has been made with the patient involved in this incident, with an offer made for an Open Disclosure meeting to take place at the discretion of the patient.

As a precaution, OLCHC has also instigated a review of the communication of all BRCA test results since 2006, firstly prioritising the 335 positive BRCA results processed by the Department of Clinical Genetics. This review of the correct communication of the positive BRCA test is currently underway and is expected to be completed in the forthcoming days. The hospital will then review the correct communication of the negative BRCA tests.

For the sake of clarity, I would also like to stress to the House that there is no concern regarding the accuracy of the BRCA test itself. The error which has occurred  relates to the correct communication of the test result.

A dedicated contact helpline has been set up  at OLCHC to assist patients with concerns. It is in operation from Monday to Friday, 9:00am-5:30pm. Patients wishing to contact the helpline should phone (01) 4096219.

Róisín Shortall (Dublin North West, Social Democrats)
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160. To ask the Minister for Health if guidelines exist in the HSE regarding the auditing of the issuance of test and or screening results for human error; and if he will make a statement on the matter. [48816/18]

Simon Harris (Wicklow, Fine Gael)
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As this is a service matter I have asked the HSE to reply directly to the Deputy.