Minister says women who had delayed HPV test results face low clinical risk

A group of 52 women among those at the centre of the latest Cervical Check controversy over delayed test results face low risk of their conditions progressing, the Health Service Executive has said.

HSE chief clinical officer Dr Colm Henry said "in terms of clinical risk" 52 of the 800 women affected by the delay "had shown low-grade cytological changes which is at a very low risk of progression".

The 800 women had repeat test results, mainly checking for human papillomavirus (HPV), delayed and 52 who previously tested negative, tested positive.

The HSE said on Tuesday that it had learned last week that US company Quest Diagnostics had failed to send test results to the GPs of about 800 women. It said the tests were on samples which had been re-tested because their original mRNA HPV test was carried out outside the manufacturer's recommended timeframe.

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These women had previously been found to have had low-grade cytological changes from their smear test and since 2015, it had been the practice of CervicalCheck, the national cervical screening programme, to test women with low-grade abnormalities for the HPV virus.

The health service said Quest had re-tested these samples using a more sensitive DNA HPV test, which had a longer expiration period. It said this avoided the women having to undergo another smear test.

“As we would have expected, there are a small number of women whose HPV status changed as a result of the re-test using the more sensitive test,” the HSE said.

“The GPs of all of these 52 women, whose status had changed, received their test results in February.

“CervicalCheck records show that over half of these women have been referred on for further investigation, and we are currently confirming directly with GPs that all the women’s results have been discussed in full with her in each case.”

Reassurance

Minister for Health Simon Harris said it was "important that we provide reassurance to women in relation to an issue that clinicians are describing to me as having a very low clinical risk".

He said the new controversy was a cause of great frustration, great annoyance and great stress and should not have happened. He said he believed he and patient advocates should have been alerted before they were on July 10th.

"This IT glitch is unacceptable. It's unacceptable to me as Minister. It's unacceptable to the women of Ireland. It's unacceptable to the Government. It's unacceptable to the HSE."

Mr Harris was speaking after it emerged that his private office in the Department of Health had written on June 6th to the woman whose case had exposed the new controversy. The letter included an apology for any distress the delay caused and said the issue was a priority.

Speaking on Tuesday, Mr Harris said his private secretary knew there was an issue in relation to an individual woman.

“My department acted in a very expeditious manner in responding to that representation and only through responding to that individual did the IT glitch become apparent to the department on the 25th of June. In which case they said to the HSE: ‘What do you mean by an IT glitch, can you give us more information?”

The Minister said that a full report was handed to him on July 10th. “We can’t conflate issues here. A rep from a member of the public asking questions about the smear does not equate to a knowledge in relation to 800 women.”

Meanwhile the chairman of the “rapid” review into the controversy insisted that the process will be independent and that the outcome will be published.

Prof Brian MacCraith of Dublin City University said on Tuesday that health service staff who were assisting him in the review into the IT problems that led to delays in women being informed of repeat smear test results would be working only under his direction.