Thursday, 25 October 2018

Ceisteanna (261)

Catherine Murphy


261. Deputy Catherine Murphy asked the Minister for Health the steps he has taken to introduce legislation and policy on mandatory open disclosure, independent of the patient safety Bill and in respect of the cervical smear scandal; if he will provide a start and end date including full disclosure on the 1,800 smears yet to be audited; the breakdown of the new assessment packages being negotiated with laboratories carrying out smear slide analysis including mandatory site audits; and if he will make a statement on the matter. [44459/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

It is my intention to bring forward proposals in the coming weeks for Government approval to establish an Independent Patient Safety Council. The Council will have as its first task the completion of a detailed overhaul of existing policy on Open Disclosure reflecting the full range of Dr Scally’s recommendations in this regard.

The Department of Health is continuing to engage with the HSE in line with Dr Scally's recommendations; the HSE has also assured that staff are being made aware of the procedures required in relation to the undertaking of Open Disclosure. I'm advised that the HSE is also engaging with the post-graduate training bodies and other relevant bodies in relation to ensuring that its open disclosure policy is revised in line with the recommendations of the Scally Report.

The Independent Clinical Expert Panel Review which is being led by the Royal College of Obstetricians and Gynaecologists (RCOG) is examining the results of screening tests of all women who have developed cervical cancer who participated in the screening programme since it was established. This review will provide independent clinical assurance to women about the timing of their diagnosis, and any issues relating to their treatment and outcome. In light of the particular sensitivities surrounding this issue, it was decided that written, informed consent will be sought from women or the next-of-kin of women who have passed away before they are included in the review. The process of seeking consent from women for their inclusion in the review is ongoing. Almost 1,600 letters have now issued; approximately 813 consent forms are reported to have been returned up to end of last week, with 97% of women who have responded agreeing to take part in the review.

It is expected that a review of this complexity will take a number of months to complete. Upon completion, each woman involved will receive an individual report of the outcome of their review. I will be presented with an aggregate report, which I intend to publish.

In regard to the laboratories currently contracted by CervicalCheck, I understand that the Deputy's question relates to quality assurance. Dr Scally's Final Report, which was published in September, provided welcome reassurance about the laboratories currently contracted by Cervical Check. Dr Scally clearly stated that he is satisfied with the quality management processes in these labs. It is very important to say that Dr Scally confirmed that he found no reason why the existing contracts for laboratory services should not continue until the new HPV regime is introduced.  I am happy to say that Heads of Agreement have been signed with the contracted labs to extend their contracts pending the introduction of HPV testing as the primary screening test. This allows for the continuation of the service without interruption. This is subject to formal conclusion of the contract, so it would not be appropriate to give any further detail at this stage.