Thousands of women are at risk of having their smear tests expire – while it has emerged more than 4,000 were not given their results due to an .
The HSE ordered the rapid review after a patient called Sharon contacted the Department of Health in February about delayed results.
Initially it was thought 800 women were affected by the technical blunder at one of the US labs hired to process smear tests, but the probe found a total of 4,088 are impacted.
After an examination of the CervicalCheck system by DCU president Prof Brian MacCraith, a number of flaws have been identifed.
In 3,215 cases, the results were issued to GPs but the women were not informed.
The HSE said it plans to contact those affected in the next two weeks and that clinical risk is deemed to be low. In 3,025 cases, the tests are at risk of expiry.
Responding to the MacCraith Report, Taoiseach Leo Varadkar said: “I do have confidence in the service.
“We know those programmes have saved a lot of lives and they have also helped pick up a lot of cancers early, meaning people got treated earlier. CervicalCheck, BreastCheck, our colorectal cancer screening programme work.
“But it is never the case that any screening programme can pick up all abnormalities – they almost always miss somewhere, around a third.”
The report also found failings in the use of an additional lab in the US to test Irish samples.
It said: “The addition of the QD Chantilly Laboratory as a CervicalCheck test facility took place without proper operational due diligence, risk assessment of the downstream implementation and, therefore, risk mitigation.”
Prof MacCraith found this led to a “systems failure”.
He said there was a “constant theme of women frustrated by poor service and lack of information, their information”.
Prof MacCraith found there are “too few people managing too many significant projects simultaneously” within the system.
HSE chief Paul Reid apologised to those affected and said he wants to develop a culture of “putting women first”.
He added there are plans to strengthen the management, organisation and resourcing and capability of the CervicalCheck programme.
The development of a tracking system for smear tests is to be investigated, while internal audits are to be implemented for Quest Systems where the IT glitch occurred.
Labour’s Alan Kelly said: “We are hearing some good suggestions today by the HSE about a possible introduction of a smear tracking system, but the question has to be asked, why does it take a scandal like this for proper quality control to be implemented?
“We have had so many cock-ups with the way women have been treated by various arms of the State when it comes to CervicalCheck.
“The pace of change is moving too slowly.”
