Dr Cillian de Gascun: ‘Notwithstanding what happened in 2018, this is a positive news story’

A solution to the bitter and continuing controversy over cervical cancer screening in Ireland may ultimately be found in a sleek new four-storey building at the back of the Coombe Hospital.

This is the €20 million National Cervical Screening Laboratory (NCSL), a dedicated facility built to ensure that the screening of samples provided by Irish women to CervicalCheck is returned home from the US.

Over the past year, as a result of IT and staffing problems affecting existing laboratories in the Coombe, all CervicalCheck samples were processed by Quest Laboratories in the US. Before then, 90 per cent of samples went to the US.

But since the end of last month the new lab has been processing CervicalCheck slides, albeit in small numbers. This marks the beginning of a process that is ultimately supposed to end with all slides being processed here in Ireland.

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Confidence in CervicalCheck was badly shaken in 2018, when Vicky Phelan sued the HSE and the American laboratory that processed her cervical smear test. The Kilkenny woman’s High Court action and refusal to be silenced with a confidentiality clause in a €2.5 million settlement around the misreading of past smear test results led to dozens of other women diagnosed with cervical cancer discovering that earlier screenings could have been interpreted differently.

Although Dr Gabriel Scally’s subsequent report upheld standards at the US labs, he was critical of CervicalCheck’s oversight of the work being done across the Atlantic.

CervicalCheck “ran a really botched audit, it didn’t have proper quality assurance of the laboratories in America,” he said last November. “Slides were sent to labs all over the place that CervicalCheck had no idea about, that didn’t meet the required quality standards that were asked for in the contracts.”

[ Processing of cervical cancer slides restarts in Coombe after break of over a year ]

The loss of confidence in CervicalCheck has not gone away, owing to ongoing rows and the tragic deaths of women embroiled in the controversy, the latest that of Phelan in November. Meanwhile, critics claim screening should never have been outsourced to foreign labs more than a decade ago.

Confidence in the service may improve now that the new lab in the Coombe has finally started operating. In the week before Christmas it began processing CervicalCheck slides, the first time this has happened on Irish soil in over 12 months, since the service suffered a cyberattack in December 2021.

Shortly before New Year, The Irish Times was given the first tour of the new facility, which unites the three central elements of testing – HPV (human papillomavirus) testing, cytology and histology – on separate floors under one roof. Fitted out to a high standard, the building houses sophisticated PCR machines for testing for the HPV virus as well as multi-headed microscopes for analysing slides. However, many rooms are currently empty, pending the recruitment of urgently-needed staff.

Since 2020, screening has been a three-stage process. Samples are first tested for presence of the HPV virus, which causes about 90 per cent of cervical cancers. HPV turns up in about 12 per cent of samples, and these are screened for abnormal cells (cytology). If an abnormality is detected – and this can happen in 40-50 per cent of HPV-detected samples – the woman is offered a colposcopy, or examination of the cervix (histology).

“Notwithstanding what happened in 2018, this is a positive news story - the fact that we’re developing a lab like this,” says the NCSL’s interim director, Dr Cillian de Gascun. “It is unique to have a stand-alone screening service having HPV, cytology and histology together, allowing us to become an international centre of excellence.”

The new lab will become “a jewel in the crown” of Irish screening services, he believes, “but it will take a couple of years to get there”.

The past year has been chastening. Repeated deadlines were set for restarting the processing of slides but were not met. The cyberattack proved to be the straw that broke the camel’s back for a service that was already under strain from staffing difficulties and the weight of expectations following the CervicalCheck crisis. And yet the existing lab continued to service private clients.

Dr de Gascun, who was brought in by the Coombe as interim director of the lab last October, attributes the delays to multiple factors, including the original cyberattack, IT issues, staff illness and recruitment problems.

“The last 12 months have been very difficult. It was a perfect storm, there was no single issue that justified that delay, but just the constellation of things,” he says.

“We’re building a new service here which wasn’t there before. I think had any one thing happened, there wouldn’t be a justification for the delay. I don’t think people appreciate how disruptive the cyberattacks were - bear in mind that the Coombe had two because they were affected by the HSE one [in mid-2021] and they had their own in December.

“Every time something happened and we got on top of one thing, something else seemed to come along.”

[ ‘Inconsistent’ smear reporting flagged a decade before CervicalCheck controversy ]

The service got caught between focusing on getting the processing of slides back up and running in the existing Coombe facilities, or concentrating on putting those services into the new building. When it concentrated on the latter, supply chain issues delayed the completion of the new lab, causing knock-on delays in restarting the screening work.

“We wanted to build a robust and resilient service. We didn’t want to rush things back and then not be able to sustain them. It would be worse to bring it back and then stop again.”

The plan is to increase the number of samples processed in the lab to 10 per cent of the overall number by the end of March. It will take the Coombe up to five years to assume responsibility for processing the vast bulk of CervicalCheck slides.

Even that aim depends on getting qualified staff. At present, the lab employs the whole-time equivalent of 1.5 consultant staff, with another specialist due to start shortly. Dr de Gascun admits this is “barely a roster”, given that two pairs of eyes are needed to look at every slide where abnormalities have been identified.

Cases referred to consultants involve the assessment of at least 5,000 cells on a slide. Doing this work, getting a second opinion and authorising a report is estimated to take an average of 12 minutes per slide.

“The problem is we haven’t been training consultants in histopathology or cytopathology for the last number of years, though in a positive development cytopathology is now back on the training scheme for specialist registrars.”

To make up the staffing shortfall, the service will continue to rely on support from experienced colleagues in the UK, and may look to making joint appointments of consultants with other large Irish hospitals. Ultimately, up to eight consultants will be needed to oversee the CervicalCheck workload.

Dr de Gascun is a virologist, rather than a cancer specialist, who was prominent during the Covid-19 pandemic as head of the National Virus Reference Laboratory. He has been appointed for an initial six-month period but may have to stay longer if a permanent successor is not found in that period.

The ultimate aim for all of this is to try and make cervical cancer a rare disease.

—  Dr Cillian de Gascun

The creation of a dedicated Irish cervical screening lab will address many of the criticisms levelled since 2018, as well as helping to build home-grown expertise.

“I think we should be self-sufficient. We should have an a lab in Ireland because it’s important to train our staff, but equally I think it’s important that we don’t look at the service we’re getting from Quest and say that it’s a lesser service, because there’s no evidence that it is.”

“There was never any issue with the quality of the service provided by American labs. There were samples going to labs that CervicalCheck was unaware of, but the actual quality of the service provided wasn’t impugned.”

The testing in place back in 2018 was capable of detecting abnormalities in about 15 out of every 20 samples; the HPV method since introduced has pushed this success rate up to about 18 out of 20.

Though each slide is looked at by two different screeners, “there’s still that 10 per cent” of cases where abnormalities can be missed, he points out.

[ Vicky Phelan obituary: A courageous advocate who gave a voice to Irish women suffering in silence ]

Dr de Gascun believes it has become very difficult to have “nuanced conversations” about the limitations of screening. “People want ‘it’s good or it’s bad’. It’s like Covid; there’s no single intervention that’s going to be a magic bullet, but a combination of screening and vaccination will help us. The ultimate aim for all of this is to try and make cervical cancer a rare disease.”

That, experts hope, will happen sooner than many people think. The HPV vaccine that prevents against this sexually-transmitted virus was introduced for girls in 2010 and for boys in 2019. In just a few years, a generation of women reaching the age of sexual activity will be protected against the virus that causes the vast majority of cervical cancers. HPV screening should ensure 90 per cent of the cancers that could still occur are picked up early.

“We’re hoping we won’t have the same number of samples coming through in five to 10 years time.”