An unaccredited Manchester laboratory that screened more than 90,000 smears without the knowledge or approval of CervicalCheck should be the focus of an ongoing expert review of the screening history of women with cervical cancer, patient representatives have said.
The laboratory in Salford has since been granted retrospective accreditation by the Irish National Accreditation Board (INAB), covering periods when the board did not even know that the facility was operational.
The revelations are contained in a report by Gabriel Scally who also found that the number of laboratories involved in CervicalCheck work was 16 and not six, as he was originally told. Moreover, the national screening service was neither aware nor had approved their involvement in CervicalCheck work.
“This is a very, very worrying situation, unacceptable really,” Dr Scally told RTÉ news.
The companies involved in outsourcing were Quest Diagnostics, who used four additional labs in the US not named in their contract with CervicalCheck, and Dublin-based MedLab Pathology Ltd, who were outsourcing to Salford, where 91,559 smears were screened between 2016 and 2018.
Quest blamed the decision to outsource on the rise in the number of women seeking smears on foot of the death from cervical cancer of reality TV star Jade Goody in 2009.
“Unfortunately the laboratory companies acted without going through the proper process in asking for permission to use other labs,” Dr Scally said at the launch of his supplementary report yesterday.
Dr Scally said the Manchester lab was only accredited in April this year and he only learned of its existence last October.
He said it was “a legitimate public concern” that screening slides from Ireland were being examined by labs “not listed in any correspondence” between the companies operating the service and CervicalCheck.
CervicalCheck campaigner Vicky Phelan said the ongoing review of the screening histories of more than 1,700 women with cervical cancer by the Royal College of Obstetricians and Gynaecologists (RCOG) should focus on the Manchester lab.
“I think they will have some questions to answer,” Ms Phelan told RTÉ.
She said CervicalCheck patients needed the Department of Health to make a statement that would reassure them in relation to a lab that was not accredited until this year.
Health Minister Simon Harris said the report found “no evidence to suggest deficiencies in screening quality in any lab”.
“I hope that this will reassure Irish women that they can trust the results they receive from the CervicalCheck programme,” he said.
Stephen Teap of the 221+ patient support group asked “if the Government can stand over the fact that the UK lab was retrospectively given accreditation”.
Labour health spokesman Alan Kelly asked if Mr Harris could “assure Irish women today that their smears which were carried out at a previously unaccredited lab were performed to accredited standards”.
Sinn Féin health spokeswoman Louise O’Reilly said the report’s finding that the HSE had, over time, reduced the emphasis in its tenders on quality assurance and capacity while increasing the weighting for fee proposal, required explanation.
On the upside, Dr Scally said his scoping team had “not identified any evidence” that the laboratory services used by CervicalCheck, “have provided, or are providing, a service which does not meet acceptable standards in their country of operation”.
He also praised the HSE for progress made in implementing the recommendations of his Scoping Inquiry into the CervicalCheck controversy, published last September.
However the 221+group said they had “ not yet had evidence to believe that the wider shortcomings that led to this total system failure are being addressed”.