THE HSE HAS confirmed that 1,000 smear tests expired due to the CervicalCheck backlog, and that the women affected needed to be retested.

These samples expired after smears were not transferred onto laboratory slides within the six-week timeframe. This was caused by a “high demand on resources” in laboratories as a result of the free repeat smear tests announced last year.

Around 82,000 smear tests are still currently being processed by laboratories; this compares with a previous figure of 23,000 before the CervicalCheck controversy.

Yesterday in response to questions by Fianna Fáil leader Mícheál Martin, Taoiseach Leo Varadkar said that because of the backlog, some smear tests expired due to the CervicalCheck backlog, but didn’t give the exact number of samples affected. 

Today, the HSE confirmed that around 1,000 smear tests expired due to the backlog – this is separate to the announcement earlier today that 6,000 smear test samples had to be repeated due to some samples held by US laboratory Quest Diagnostics expiring.

These 6,000 smear tests will need to be repeated in relation to an error in the second part of the smear test examination, which is carried out if abnormalities are identified. It’s recommended that this testing is done within a 30-day window, but it was discovered that this didn’t happen in 6,000 cases.

The HSE was notified of the error in November; the Dáil was told today that the 6,000 women affected would be notified next week.

This evening, the HSE told TheJournal.ie that a second group of women will need to have a repeat smear examination.

In a statement, the HSE explained that smear test samples must be sent to the laboratory and made into slides within six weeks of the smear test date. After six weeks, the sample is deemed expired and cannot be processed.

“Transferring slides to samples in this timeframe was being achieved by the laboratories used by CervicalCheck until they experienced a high demand on resources following the announcement of free repeat smear tests in April 2018,” the HSE said.

“In some cases, the increased volume resulted in a delay transferring samples to slides.”

Due to this backlog, a very small proportion of the overall samples had expired before they had been transferred to slides for testing. Repeat testing was required in about 1,000 cases.

CervicalCheck has been in touch with women about this and with their GPs, and sincerely apologises to all women whose screening test results have been delayed. We assure them that we are making every effort to improve the situation.

Earlier this month, Health Minister Simon Harris told the Dáil that the rate of expired samples and vials was 0.29% between April and October 2018.

This compares with 0.25% for the same period in 2017, he said.

Free test

In order to reassure women of the integrity of the smear test screening programme,  Harris announced that from 1 May 2018, women who had availed of a CervicalCheck smear test were able to get a second test free of charge to alleviate concerns women had about the results they had received.

This significantly increased the volume of smear tests being requested and processed.

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The increase is due to a number of factors: the announcement of out-of-cycle smears, or free repeat smear tests; an increase in the number of women attending their regular smears; and an increase in colposcopy referrals, which could be related to the increase in smear tests.

There is currently a 22-week wait for smear test results; this compares with a 2 – 4 week wait before the CervicalCheck controversy or the announcement of free repeat smear tests.

In October, Simon Harris was warned by officials that the delay in results was “intensifying concern” among women and that after the publication of Dr Gabriel Scally’s report, there was “no clinical rationale for the continued provision of out-of-cycle smears”.

In that same month, a gynaecologist in the Mid-West wrote to Simon Harris to warn him of the pressure the health system was under, saying that there had been a delayed diagnosis in their colposcopy unit due to the surge in demand caused by the free repeat smear tests.

In June, two months after the announcement of free repeat smear tests, the CEO of the company that runs the Sandyford lab, which examines 50% of cervical smears, wrote to Harris to warn him that the increased demand was putting the CervicalCheck programme “in jeopardy”. 

Cervical Check processes about 250,000 cervical screening tests each year. In 2018, an additional 84,000 women came forward for screening, due to concerns about cervical screening following the CervicalCheck audit.