Some 6,000 women are likely to be called for repeat smear tests, due to some samples being tested outside the recommended timeframe, the HSE has confirmed.
Earlier this week, it emerged that around 1,000 women had to undergo repeat testing, due to a backlog in laboratories.
While the national cervical screening programme, CervicalCheck, processes about 250,000 cervical screenings tests each year, last year, an additional 84,000 women came forward for screening. This was due to concerns about cervical screening following the CervicalCheck audit and ensuing scandal.
As such, almost 350,000 screening tests were submitted during 2018, and about 82,000 of these are still being processed.
This increased workload has led to ‘long and very regrettable delays' in the reporting of results, the HSE said. Results are currently taking an average of 22 weeks, when in the past, they would have been available in two to four weeks.
"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," the HSE said.
However, it has now emerged that a ‘separate issue' has arisen in relation to specific tests carried out by Quest Laboratories on behalf of CervicalCheck.
"Quest Laboratories has advised CervicalCheck of a specific problem in relation to standard HPV tests. These HPV tests are part of the cervical screening process and have been carried out by Quest outside of the manufacturer's recommended timeframe.
"Action is being taken to investigate the issue fully. Our expert clinical team has been reviewing any clinical impact or risk. Our programme has been working to validate the details of who has been affected, so that we can communicate with women to inform them in the first place," the HSE explained.
About 15 in every 1,000 tests processed by CervicalCheck every year are identified by laboratories as having abnormalities or changes in the cells of the cervix. These range from minor or low grade changes, to higher grade changes. Where low-grade changes are detected, samples are tested by laboratories for the human papillomavirus (HPV).
This is a standard HPV test carried out on all samples which report low-grade changes.
It now appears that some of these tests were undertaken outside of the recommended timeframe. According to Dr Peter McKenna, clinical director of the Women and Infant's Health Programme, evidence shows that these HPV tests are effective outside of the manufacturer's recommended timeframe, but as a precaution, some women will be asked to attend their GP for a repeat smear test ‘to confirm the result and to provide them with reassurance'.
"Our clinical review has assured us that this issue poses little risk to women's health, but based on our current assessment of the information provided by Quest, we expect that up to 6,000 women will likely be called for a repeat smear test. These tests will be processed by the laboratory as a priority," Dr McKenna noted.
According to Damien McCallion, interim national director of the National Screening Service, Quest first informed it of this issue at the end of November 2018.
"We established an expert clinical team to establish the facts with the laboratory and review the situation. Following a detailed validation process, we will very shortly be in a position to communicate with the women affected.
"We sincerely apologise for any concern that that may arise as a result of this. CervicalCheck is committed to communicating openly with women in the first instance, that process has been in planning for several weeks and we expect to be able to do that by the end of next week," he said.