Tuesday, 5 February 2019

Ceisteanna (43)

Louise O'Reilly


43. Deputy Louise O'Reilly asked the Minister for Health when his attention was drawn to delays relating to smear tests under the CervicalCheck programme, which meant slides could not be read within the requisite timeframe; the steps he took to alleviate the backlog; the steps he took to relay the delays to those affected through the appropriate channels; and if he will make a statement on the matter. [5462/19]

Amharc ar fhreagra

Freagraí ó Béal (6 píosaí cainte) (Ceist ar Health)

As ever, my question is straightforward. I would be grateful if the Minister, in his reply, could concentrate on the measures taken to alleviate the backlog and the communication with those who were impacted because it came to my attention that a number of women found out that there was an issue via the media, which is not acceptable. The Minister might detail exactly what he was doing to ensure everybody knew as much as he knew.

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+ 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.

There were two separate delays. Women should have confidence. Screening saves lives. I have seen it at close quarters. I have great faith in this programme but all that has happened has knocked the confidence that women deserve to have in it.

I refer to a letter that was sent to the Minister by Dr. Maitiú Ó Tuathail in August 2018. It refers to the turnaround time for processing smears of up to 12 weeks being problematic. He also states that he would request that this delay in the processing of smear samples be addressed as a matter of urgency. He advises that his organisation's members will have to deal with women who have yet another repeat smear to face. That is where the confidence slips. It is where a woman keeps being told she must come back. Women deserve to have confidence in the programme. Could the Minister advise us exactly what was done on foot of receipt of that letter raising concerns because my understanding is no reply was received?

The Deputy is a strong advocate of the screening programme. When raising this issue, she always has been. However, a charge was made in this House by the leader of Fianna Fáil on an occasion when Members knew I was not here to respond. The charge was that I offered free repeat smear tests to women against official advice. That is false. That decision was made in conjunction with my officials, including the Chief Medical Officer, and it was supported by Opposition politicians, including those present, because women wanted that reassurance. Many women took up that opportunity to have reassurance. These were not the only women getting the reassurance. In addition, there were also new women, who had never availed of the programme, taking up screening which we all believe is good.

I accept that has caused a backlog, which cannot be easily fixed merely by resources. If it could, I guarantee it would be done. There is an issue in trying to identify more capacity in what is already a shortage of cytology. The HSE is due to complete a capacity report in the next couple of weeks on how we can look at addressing this and I will act on that immediately.

It is not true for Members to state in this House that the repeat smear test was offered against official advice. That was not the case. Of course, some doctors had views on this matter. Many others welcomed it. Many GPs also wanted to know what were they to do when women were coming to them looking for that reassurance and whether they were to charge them when they had done nothing wrong.

A serious issue was raised by a representative body in August 2018. It details delays that were happening and the fact that its members were having to deal with women who were yet to have another test. Neither I nor any member of my party made that charge and I am glad that the Minister made it clear. Not putting the necessary resources in place before that offer was made, respecting the fact that it was right to do, caused this delay and this backlog. Whatever about the advice the Minister received in June, which is a matter he needs to sort out with the person who said that as it was not me, I refer to the letter he received in August. He has detailed actions that took place from December. I want to know what was done in August when this letter was received because that is approximately the time the backlog started, according to my friends and family.

I repeat it is important that women have confidence in this service because it should be a good service.

First, it is not true for anyone to suggest that GPs or many medical bodies oppose this decision. For example, my Department negotiated the provision of the repeat free smear test with the Irish Medical Organisation. We agreed a fee with the organisation. We paid GPs to provide this test and the Deputy agrees with me on this. Had we not done that, we would have had a situation where women who could afford the repeat smear test would have got it and women who could not would not have been reassured. This was one of the top queries coming in to the CervicalCheck helpline, with women stating they did not want to wait for their next date to come around and they would like the reassurance. The Deputy is entirely correct. That led to a significant number of additional women taking that test, many of whom got reassurance. It also obviously added to a backlog.

Long before we received that letter, and consistently, the HSE had been working to try to identify more capacity. Its first priority was to ensure the continuation of the screening, which is not something we could take for granted. We came within hours of not having laboratories provide screening. Once that was done, the next focus was rightly on trying to find additional capacity. They are working hard on that. I hope they can make some progress on it. I expect to receive the capacity report shortly.