New CervicalCheck laboratory in the Coombe halts processing of samples after accreditation suspended

The €20m laboratory, which opened in December, has been processing a small number of samples with the vast majority going to laboratories run by Quest in the United States.

All samples are now being sent to Quest following the closure of the Dublin laboratory.

The Irish National Accreditation Board suspended the cytology and HPV testing carried out at the Irish laboratory “while outstanding documents are being filed.”

Work is underway to bring all administrative matters up to the grade needed as quickly as possible.

The suspension is not related to the quality of work carried out at the laboratory but is due to governance and documentation as well as change management which the accreditation body insisted needed to be upgraded.

The setting up of a laboratory in Ireland was a key recommendation following the CervicalCheck controversy,

It has been planned that the Irish laboratory would carry out around 10pc of around 300,000 samples early this year.

However, it will be many years before it is able to do all the workload, leaving CervicalCheck reliant on the US laboratory for a long time to come.

Dr Cillian de Gascun of the National Virus Reference Laboratory was appointed as the Coombe laboratory’s director in recent months.

A spokeswoman for the HSE said the Coombe Hospital has paused HPV and cytology sample processing for CervicalCheck while it completes its final accreditation documentation, as required by the Irish National Accreditation Board.

The hospital had been granted INAB accreditation for HPV and cytology sample processing in November 2022 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.

While the quality and safety of the hospital’s laboratory services are not affected by this issue, the hospital’s INAB accreditation for HPV and cytology sample processing has been suspended pending the completion of this process, she said.

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.”

“This means that the Coombe Hospital is not accepting HPV and cytology samples for a period of time.

"Samples currently in the screening process at The Coombe Hospital will continue to be reported, and results issued in the usual way. Results turnaround times are not affected.”

She said CervicalCheck samples go to one of two quality-assured lab providers. These are: Quest Diagnostics Inc in the US and the National Cervical Screening Laboratory at The Coombe Hospital in Dublin.

“With sample processing at the Coombe Hospital currently paused, all CervicalCheck samples are being tested in Quest Diagnostics Inc in the US.

“Women can be reassured that there will be no change in the way that samples are processed. Sampletakers can continue to send their samples to the programme in the usual way, and women and their GPs will receive their CervicalCheck results in the same way and within the usual timeframe.

“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 10pc of CervicalCheck programme samples by the end of this year.”

She said he work to  respond to  the accreditation board’s suspension of accreditation is already under way and is being treated with the highest priority.

The Coombe Hospital is working with INAB to ensure all administrative matters are addressed in the shortest possible timeframe. This will enable the HPV and cytology screening service to resume at the hospital in a timely manner.

“When service resumes we will update our website on www.hse.ie/cervicalcheck

“While this is an unfortunate temporary development, the National Screening Service is keen to acknowledge the work that has been done to-date by The Coombe Hospital, CervicalCheck, and the staff of the National Cervical Screening Laboratory in delivering a new purpose-built laboratory.

“The lab, funded by the Department of Health, was built and equipped within anticipated timeframes and to budget. It met its stated aim by being operational by the end of 2022. It has continued to build capacity whilst also focusing on recruitment.

“While the plan is that the laboratory will become the main processor of CervicalCheck samples, reaching that point will take time. Resilience will always be required in the system in the form of an alternative supplier; to ensure that in all eventualities, women’s samples will be processed in a quality assured lab within our key performance indicators.”