LAST UPDATE | 16 Jul 2019

MINISTER FOR HEALTH Simon Harris said the latest CervicalCheck scandal affecting around 800 women is of low clinical risk and insists he was unaware of the issue until 10 July. 

Meanwhile, this evening the HSE said it learned last week that Quest Diagnostics had failed to send test results to the GPs of around 800 women. The tests were on samples which were retested because their original mRNA HPV test was carried out outside the manufacturer’s recommended timeframe.

It said that out of the 800 women, there are a small number whose HPV status changed as a result of the retest using the more sensitive test. A total of 52 who previously tested negative tested positive.

It was reported by RTÉ this morning that a private secretary for Simon Harris wrote back to the woman who exposed the most recent CervicalCheck crisis on 6 June.

Harris said he was made aware of an IT glitch affecting the results of around 800 women on 10 July.

It said that these women had previously been found to have had low-grade cytological changes from their smear test. Since 2015 it has been the practice of CervicalCheck to test women with low grade abnormalities for the HPV virus. 

Quest retested these samples using a DNA HPV test, which has a longer expiration period. “This avoided the woman having to get another smear test,” said the HSE.

The HSE said the GPs of all of the 52 women whose status had changed received their test results in February of this year. CervicalCheck records show that over half of these women have been referred on for further investigation, and the HSE is currently confirming directly with GPs that all the women’s results have been discussed in full with her in each case.

Dr Colm Henry, Chief Clinical officer of the HSE said;

“In terms of clinical risk the women affected had shown low-grade cytological changes which is at a very low risk of progression.”

That said, we want to apologise again to any woman that has been affected by this issue and we are continuing to keep in contact with them in relation to what has happened and any action that they need to take. The delays in results being forwarded are not acceptable, and the HSE’s ongoing independent review into this incident will be investigating this in full detail.

Complaint

Today, Minister Harris said that although his Department were aware of a complaint from an individual about their smear results in June, it did not know at this time there was a large-scale IT issue affecting the results of hundreds of women. 

“My private secretary knew that there was an issue in relation to an individual woman contacting the Department of Health looking for her smear,” said Harris. 

“Sadly, due to the significant backlog, that hasn’t been a rare query in recent months.

“A rep from a member of the public asking a question about the smear does not equate to a knowledge in relation to 800 women being delayed or an IT glitch.”

He said that the Department became aware of the glitch on 25 June. A report was then sought from the HSE, and this report was received in July, which was when the Minister was informed of the glitch.

“The full report landed on 10 July and it was conveyed to me that evening,” said Harris.

RTÉ reports that in the region of 50 women have proven to be positive for the HPV virus after the re-tests.

Harris said that he met with the Chief Clinical Officer of the HSE today who assured him there is a “very low clinical risk” in relation to this situation. 

“I’m also assured that all of our GPs who are involved with women here that letters have gone to the very significant majority of them and the rest will receive them this week.” 

New review

An immediate rapid review commissioned by the HSE and led by DCU President Brian MacCraith into this recent controversy was announced yesterday. 

“The Review will examine the series of events within the Cervical Check programme that occurred following reported IT issues in Quest Diagnostics relating to the HPV test expiration for a number of women and the retesting process,” said MacCraith in a statement today. 

The review will focus entirely on the time the IT issues first emerged up to 11 July 2019. 

The final report will be sent to the HSE CEO on 2 August and will also be published. MacCraith said he has already spoken with the individual who brought this issue to light. 

“The review is independent and is being carried out solely by me. Otherwise I would not have agreed to take on this role,” said MacCraith. 

Last Thursday, RTÉ reported that an estimated 800 women who underwent CervicalCheck screening between October 2018 and 25 June 2019 were not issued their results due to an IT issue. 

Many of these tests were repeat tests for HPV. 

CervicalCheck campaigner Stephen Teap, whose wife Irene died of cervical cancer last year, said that the HSE needs to explain what this means for those affected. 

“This is a cause of great frustration, great annoyance and great stress to women,” said Minister Harris. 

“This should not have happened. This IT glitch should not have happened.

“My priority as minister has to be to make sure that those 800 women get their results and get them to the GPs and that process is well underway at this stage and I expect to conclude this week.”

Harris was speaking today at the launch of the Dublin Rape Crisis Centre 2018 Annual Report.