Processing of Irish CervicalCheck samples halted after lab’s accreditation is suspended

The processing of CervicalCheck samples in Ireland has been stopped, after the State’s only lab had its accreditation suspended.

All cervical cancer samples are again being sent to the US for processing following the suspension of work at the National Cervical Screening Laboratory at the Coombe hospital in Dublin.

On Tuesday, the Irish National Accreditation Board suspended the HPV testing and cytology at the laboratory.

“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,” director Dr Cillian de Gascún told staff, in a message seen by The Irish Times.

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In light of the decision, the lab agreed with CervicalCheck that no additional samples would be processed, but that samples already in the system should be reported.

The suspension affected both public and private work at the lab.

CervicalCheck slides that were due to be processed at the Coombe will now be diverted to Quest Laboratories in the US, which already handles the vast majority of samples in the national screening programme.

“CervicalCheck and the HSE have been informed of INAB’s decision, but remain supportive of, and committed to, the future development of the NCSL,” Dr de Gascún told staff.

It is understood the lab received a major non-conformance notice during the accreditation process last year, relating to the appointment of a senior staff member.

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Staff attending a meeting on Wednesday were told this major non-compliance has since been resolved but that other non-compliance issues relating to management of the lab remain open.

The NCSL started processing samples in a dedicated €20 million new building last December. By this month, it planned to handle 10 per cent of the 300,000 samples received by CervicalCheck each year.

The repatriation of all cervical cancer screening to Ireland was one of the main promises by Government in the aftermath of the 2018 CervicalCheck controversy, which revealed a major lack of oversight of US labs by the Irish screening programme.

This is expected to take years due to a lack of qualified staff. The opening of the lab was delayed by a year, largely due to staffing and IT issues.

Confirming the suspension, the HSE said the Coombe was granted INAB accreditation last November “while the outstanding documents were being filed”.

“While the hospital has worked to complete the documentation, it is with regret that it reports it has not met its filing deadline.”

“The Coombe Hospital, in conjunction with the HSE, has therefore decided best practice is to pause its laboratory services to CervicalCheck until all documents are filed and accreditation restored.”

According to a statement, there is no change in the way samples are taken from women, and since they are being sent to the US for processing, no change in turnaround times.

The Coombe is working with INAB to ensure “all administrative matters” are addressed “in the shortest possible timeframe”, to enable screening to resume “in a timely manner,” the HSE said.