Regulator was unaware of UK cancer test lab for three years
The regulator overseeing laboratories was unaware for three years that CervicalCheck tests from women in Ireland were being sent to a small unaccredited centre in Manchester, it was confirmed yesterday.
Dr Gabriel Scally, who investigated CervicalCheck, is concerned about the future use of the lab in Salford, Manchester, which is overseen by MedLab in Dublin.
His report revealed that it started to take tests with just one scientist on the staff in 2016, but was not independently accredited to ensure it met safety standards until he requested an inspection two months ago.
A spokesman for the Irish National Accreditation Board (INAB) said that in April 2016 MedLab made informal enquiries regarding the establishment of a Manchester facility.
"The position of INAB at that time was that such a proposal would potentially be acceptable on the basis that the facility would be established, controlled and managed under the direct control of MedLab Dublin. However, INAB did not receive any formal request in relation to this proposal and took no further action.
"Although the Manchester MedLab facility was not specifically surveyed by INAB prior to April 2019, the accreditation standards being applied to the work of the cytoscreeners in Manchester were reviewed by INAB in its annual surveillance visits to MedLab's Dublin facility," he said.
"This is because MedLab Dublin included relevant data from the Manchester facility for the annual INAB surveillance visits. A formal accreditation of the MedLab Manchester facility undertaken by INAB in April 2019 confirmed that it was fully operating to the required accreditation standards."
The HSE said it will continue to use the facility despite Dr Scally's comments.
There are four people on its staff looking at 30,000 screens per year, around 600 a week. Currently it is working on part of the backlog of 61,000 tests.
A HSE spokeswoman said the backlog was being reduced and was expected to be eliminated within months. It is not doing any HPV testing.