I thank the Deputy for the question and the succinct way in which she put it. I interpret this question as her specifically referring to the issue that has arisen in respect of secondary HPV testing and she can tell me if she wishes me to talk more broadly.
I welcome the opportunity to clarify this matter in the House. Unfortunately, quite a bit of misinformation was put out, although not by the Deputy, for the sake of making political charges in recent weeks.
Where low grade changes are detected on a cervical smear test, a second so-called "triage test", which looks for the HPV virus, is carried out by laboratories. If HPV is found, women are recommended to attend for further testing. If HPV is not found, women are recommended to attend for routine screening again in three to five years. In the test used by the laboratory concerned, the manufacturer's recommendation is that the test for HPV should be carried out within 30 days of the sample having been given by a woman.
The current issue first came to light due to ongoing improvement work across the screening programme, including strengthening of its quality assurance processes, as recommended in Dr. Scally's report. The HSE was advised by Quest Diagnostics that there was a concern relating to secondary HPV testing within the recommended timeframe. The HSE convened an expert clinical team to establish the facts with the company and review the situation.
As I have stated previously, on 5 December I was informed by my Department that an issue had arisen and that the HSE was working to establish the facts and what action, if any, may be required, and received subsequent interim updates pending completion of the work of the expert clinical team and final confirmation of the position.
My priority, exactly as the Deputy suggested, was to seek to ensure that women were the first to be communicated with on this issue, and to learn the lessons of the past regarding CervicalCheck. I have heard patient advocates speak about this. Indeed, I met the members of 221 Plus group for a number of hours last week and they also wanted to hear the information first. It was always my priority, when all the facts were known, to make sure women hear directly or through their doctors. I am advised that Quest Diagnostics has now provided details of all the samples it knows to be affected, and that the vast majority of letters to women affected have now been issued by the HSE.
The HSE has advised that clinical research shows that HPV tests remain effective - this is important - when they are performed outside the recommended timeframe and that there is little risk of inaccuracy. In fact, it was defined as "exceedingly low risk" by the acting clinical director of the programme. Nevertheless, this is a precautionary measure. It is right and proper to do this.
I will come back in on other matters in a moment.