Tuesday, 5 February 2019

Questions (51)

Lisa Chambers


51. Deputy Lisa Chambers asked the Minister for Health the number of women who have received a notification asking them to take another smear test in view of the fact their original one was made unreliable as a result of being delayed; and if he will make a statement on the matter. [5255/19]

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Oral answers (8 contributions) (Question to Health)

How many women have received a notification asking them to take another smear test in the light of the fact that an original test was made unreadable or unreliable as a result of a delay arising because of the CervicalCheck scandal? The Minister made a political promise last May to extend free smear testing and it resulted in 84,000 additional and unscheduled smear tests being added to a system that was already overloaded. He might have been aware at the time that this would put additional pressure on the system and the political promise he made was not resourced.

The Deputy's party leader raised this matter in the Dáil last Tuesday week and referred to me making this "political promise", as she calls it, against official advice. I hope the Deputy or Deputy Michéal Martin will clarify the official advice I was not following because I clarified for the House this afternoon that I followed the advice of my officials, including the Chief Medical Officer, in providing this important reassurance for women. It was welcomed by many members of the Deputy's party and across the House.

The Deputy made an important point about resources, but it is an issue of capacity. As I stated to Deputy Kelly, it was almost impossible to estimate how many would take up the offer of reassurance or how long the period of unease would be. Almost 350,000 screening tests were submitted to CervicalCheck laboratories during 2018, of which approximately 82,000 are still being processed. The increased workload has led to delays in the reporting of results. Results are being reported, as I stated, on average within 22 weeks of the test being taken. Owing to this processing backlog in the period April to December 2018, a proportion of cervical screening samples were not transferred to slides within the six-week timeframe. Repeat testing was required in 550 cases or 0.25% of total samples. This compares with a rate of 0.23% for the same period in 2017. CervicalCheck contacted the women concerned and their GPs to inform them of this issue and invite them to attend for a repeat smear test in three months, as repeat tests can only be carried out three months after the last test to allow time for cells to grow back.

I am conscious that there are two matters and I want to be clear on them. As I indicated, Quest Diagnostics has advised of an issue related to a number of human papillomavirus, HPV, tests carried out outside of the manufacturer's recommended timeframe of 30 days. The HSE advises that, subject to final confirmation, approximately 4,600 women will require a retest - the original estimate was 6,000 - and that the vast majority of letters to the women concerned have now issued. The clinical risk is deemed to be exceedingly low. I know that is a message all of us and patient advocates will want to get out. The two separate issues are the backlog, with 550 women recalled for repeat smear tests through their GP, and HPV testing, which has resulted in 4,600 women being recalled on a precautionary basis for a retest, despite the clinical risk being exceedingly low.

The Minister has said the Chief Medical Officer advised him to offer reassurance, but was he advised to offer repeat free smear tests to every woman in the country who wanted one? Was that the clinical advice given to the Minister? My information is that he was advised this would put additional stress on the system, that the capacity was not available and that he was repeatedly advised, month on month, to end the free smear tests because the backlog had started to build. There has been an attempt to muddy the waters with references to tests in 2015 that had expired. The focus is on the additional tests that took place from May to December last year, with 80,000 to 100,000 additional and unscheduled smear tests putting extra pressure on the system. We do not know the clinical impact of that decision and the delays. When will the backlog be cleared? When a woman presents for a smear test today - she may have high-grade or low-grade changes - her test will not be read for six months. If there is an interpretation of a smear slide that there are low-grade changes, the second part of the test - the HPV element - is necessary to decide if a colposcopy is required. The impact of a delay meant that women were not reassured, but rather there was additional panic and anxiety because of the lack of results. The six-month waiting time is an average and the wait is beyond six months for some women. As the Minister has said not all women have yet been notified, is he saying some of the 4,600 women in question are waiting for a letter? Another impact is delayed referral for a colposcopy and potentially delayed treatment. When will the backlog be cleared and has everyone in question been contacted?

The Deputy has said I was advised month on month to end the repeat smear tests by officials, I presume, or medical experts working for me or the HSE. I ask her or her party leader to clarify who advised me to do that. I have told her in this House that I worked hand in glove with the officials in my Department, including the Chief Medical Officer, at a very intense time. I could reference some of the calls made by the Deputy's party colleagues who sought free repeat smear tests to be provided, but I will not. They were making such calls for good reason, with members of my party and Members across the House. It was one of the primary queries coming to the helpline. I took the decision, but I did so with bipartisan support across the House. GPs spoke about the importance of being able to provide a repeat smear test without being worried about whether a woman could afford it if she sat in front of them looking for it.

As I indicated to Deputy Kelly in response to his similar question, the clinical advice given to me by the HSE is that the risk is very low, although I do not in any way suggest waiting does not cause worry and stress. On the specifics of HPV testing, there were 4,600 women who would require a retest on a precautionary basis, despite the clinical risk being exceedingly low. My briefing tells me that the vast majority of letters to the women concerned have been issued, but I will get the Deputy a very specific figure.

CervicalCheck became aware of this matter in November last year and we are now in February. Why have some women in the group of 4,600 not yet been notified three months on? When will the backlog be cleared? If a woman presents for a smear test today, when will she receive her results? My understanding is that, with current capacity, it will take in excess of one year to clear the backlog. Will the Minister update the House on how he is getting on in securing extra capacity and resources, as it is my understanding he is finding it difficult to source the extra capacity? Why are we still waiting to inform some of the women, as the Minister knew about this last November? When will the backlog be cleared? What is the update on increasing capacity and resources?

Accuracy is important. I did not know about this last November; I knew on 5 December that there was a potential issue highlighted by Quest Diagnostics that might or might not have required action, and that work was being done in that regard. I understand that only as recently as this week did my Department finally receive the report from the HSE as it was a major body of work to, first, ascertain the exact women who needed to be recalled and if there was a need for the precautionary retest to take place. I have been informed that there are 4,600 women who will need to be offered a retest as a precautionary measure arising from better quality assurance resulting from Dr. Scally's report. I will check how many are outstanding and revert to the Deputy directly as, truthfully, I do not know the number.

The Deputy is entirely correct that we are finding it extraordinarily challenging to find additional capacity because there is a cytology shortage globally. The Deputy will accept that it is not an issue of writing a cheque or providing more funding. The HSE - particularly Mr. Damien McCallion - is working extraordinarily hard and due to provide me with a capacity report in the coming weeks that I will be happy to share with the Oireachtas and relevant committees. The HSE is working extremely hard in trying to find additional capacity which is vital to clear the backlog.

When will it be cleared?

With some laboratories the backlog is beginning to decrease as levels begin to return to more normal levels, but it has not decreased in all laboratories. Currently, the average waiting time is 22 weeks, which is far too long for women, for whom I understand it is causing significant concern. I want to see it reduced. Extra capacity is key in that regard. I should point out that not all of the backlog is due to repeat smear tests as other women entered the screening programme for the first time who had never been involved with it. That is, of course, good.