The processing of CervicalCheck samples in Ireland has been stopped and no date for the resumption of screening has been given after the State’s only lab had its accreditation suspended.
The National Cervical Screening Laboratory (NCSL) is already nine months behind targets for taking over the screening for cervical cancer from US labs, it disclosed yesterday.
The NCSL was due to process 10 per cent of CervicalCheck slides by the end of this month, but now says it will reach this target only at the end of the year.
From Wednesday all Irish samples are again being sent to the US for processing after the Irish National Accreditation Board (INAB) suspended HPV testing and cytology at the laboratory, located at the Coombe hospital in Dublin.
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Both the Coombe and the HSE insisted the suspension arose because of “administrative delays” around paperwork to be filed for accreditation, and had nothing to do with the quality of screening in the lab. The Coombe said it took the decision, in conjunction with the HSE, to “pause” its laboratory services to CervicalCheck until all documents were filed and accreditation restored.
NCSL director Dr Cillian de Gascún told staff on Tuesday, in an email seen by The Irish Times, the decision to suspend accreditation was made by INAB.
“While I appreciate that this is very disappointing for all of us, I would like to assure you that it is not related to the technical quality of the work performed in the laboratory but rather to documentation related to governance structures and change management processes within the NCSL,” Dr de Gascún said.
Screening at the Coombe stopped for a year due to staffing and IT issues, but resumed last December when a purpose-built €20 million lab was opened.
Last November, public health expert Dr Gabriel Scally, who has investigated the 2018 controversy over CervicalCheck, highlighted a range of issues he said needed to be resolved before screening could resume. These include the level of staffing and, in particularly, the lack of a person qualified to act as lead pathologist.
“This suspension highlights the danger of putting all your screening eggs in one basket,” Dr Scally said on Thursday, adding that Ireland was “lucky” to have the option of sending samples to Quest in the US.
The lab received a big nonconformance notice during the accreditation process last year, relating to the appointment of a senior staff member.
Staff attending a meeting on Wednesday were told this big noncompliance has since been resolved but that other noncompliance issues relating to management of the lab remain open.
These are understood to relate to the change management process and changes to the organisational structure in the lab.
The repatriation of all cervical cancer screening to Ireland was one of the main promises by Government in the aftermath of the CervicalCheck controversy, which revealed a big lack of oversight of US labs by the Irish screening programme.
The Coombe said that up to Wednesday it was processing 500 samples a week. Twelve additional staff have been recruited, and five more posts are under recruitment.
Stressing that the suspension would have “no impact” on women using the service, it said work to address the issue was already under way and was being treated “with the highest priority”.
