National lab still not processing CervicalCheck samples after March 'temporary pause'

Returning smear processing to Ireland was a key aim for the campaigner, the late Vicky Phelan, whose revelations around her own case led to a scathing report on CervicalCheck by Dr Gabriel Scally. File picture: Gareth Chaney/Collins

The National Cervical Screening Laboratory is still not processing CervicalCheck samples following a "temporary pause" of its work in March.

It is not known when the screening laboratory will recommence its work.

More than €20m was committed by the State for the construction, fit-out, and staffing of the new laboratory at the Coombe Hospital, which began operating in December 2022 only to halt again a few months later. 

Sample processing was paused so the laboratory could complete its final accreditation documentation, as required by the Irish National Accreditation Board (INAB).

“The remaining documentation has been submitted to INAB and the Coombe Hospital is awaiting INAB’s response. We do not have a date for the resumption of processing of CervicalCheck samples at this time,” a HSE spokeswoman said.

“However, with sample processing at the Coombe Hospital currently paused, all CervicalCheck samples are being tested in Quest Diagnostics Inc. in the US.” It had been planned for the Irish laboratory to take up to 10% of the total annual samples this year.

“Women can be reassured that there is no change in the way that samples are processed,” the HSE said. “Sample takers are continuing to send their samples to the programme in the usual way, and women and their GPs are receiving their CervicalCheck results in the same way and within the usual timeframe.” 

On March 30, the HSE said the hospital had been granted INAB accreditation for HPV and cytology sample processing in November and that any outstanding documents were 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 HSE said.

The HSE insisted the quality and safety of the hospital’s laboratory services are not affected by this issue but with accreditation incomplete, the laboratory could not continue working.

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In a statement at the time, CervicalCheck said: “We are grateful to our quality-assured US laboratory provider for their support at this time, ensuring the new National Cervical Screening Laboratory can continue to work towards its aim to be processing 10% of CervicalCheck programme samples by the end of this year.” 

Outsourcing of smear tests began in 2007 in what was described as “ a short-term solution” by the HSE to address a huge backlog of smear tests. The decision was criticised even at the time.

Returning smear processing to Ireland was a key aim for the campaigner, the late Vicky Phelan, whose revelations around her own case led to a scathing report on CervicalCheck by Dr Gabriel Scally.