The US-based laboratory used by CervicalCheck to carry out cervical screening was using the wrong protocol for three years to re-examine samples from women from Ireland, it was confirmed yesterday.
Quest Diagnostics in New Jersey was date-stamping a HPV virus test on samples showing low-grade abnormalities from the time they arrived in the lab instead of from the point they were taken at a GP surgery in Ireland, the HSE told the Irish Independent. This is not in keeping with the timescale recommendations for the test.
Dr Peter McKenna, of the HSE's Women and Infant's Health Programme, said yesterday the women involved would be contacted at the end of next week.
"Our clinical review has assured us this issue poses little risk," he said.
Since 2015, smear samples sent to the three labs used by CervicalCheck which screen positive for low-grade abnormalities on a standard test are re-examined in the lab to find out if the woman is positive for the HPV virus.
If she tests positive, she is advised to go for further investigation. The HSE said yesterday Quest was the only one of its three laboratories that was not following the proper protocol.
Quest brought it to the attention of CervicalCheck in November of last year and it has been doing a lookback since.
Asked why it took three years for this to come to light and why CervicalCheck had not discovered it through its own surveillance, a spokeswoman said it had "guidelines in place for all laboratories".
She said it also required labs to undertake and demonstrate their own quality assurance and Quest identified the problem through this process.
Dr Gabriel Scally, who carried out a scoping inquiry into CervicalCheck following the controversy which erupted last year, described quality assurance procedures by the screening programme as non-existent.
The revelations about Quest are separate to the rising concern about the ongoing backlog of tests which are leaving women waiting up to six months for results
CervicalCheck said 84,000 women availed of the offer of free tests, which were aimed at reassurance as the controversy raged.
A backlog of tests for about 82,000 women is still being processed.
Fianna Fáil leader Micheál Martin, who raised concerns about the backlog in the Dáil earlier this week, said yesterday: "I asked a very basic question: Why did Minister Simon Harris go against official and expert advice at the time when he made the announcement that he was offering free smears to everybody?"
A spokeswoman for Mr Harris said he met with the HSE to discuss the latest issue regarding HPV testing yesterday. He was assured by the HSE the offer of a repeat smear test is a 'precautionary measure' and there is an 'exceedingly low clinical risk' to the women involved.
"The minister was made aware in December of a potential issue regarding HPV testing and that work was underway by the HSE to assess if there was action required," she said.
"He sought regular updates on all matters relating to Cervical Check but to date, a final report on the HPV testing issue has not been received."
The issue has been discussed at the CervicalCheck steering committee, which includes patient representatives, and referenced in weekly reports. However, it is important to state the full report from the HSE is not available and was not made available to the committee members.