Dr Gabriel Scally, in his report, discovered that one laboratory analysed Irish women’s smear samples for years while unaccredited, while 16 laboratories were doing CervicalCheck work, and not six as he had originally been told, writes
It’s hard not to get tired and emotional while raking over the Dáil debates of the Noughties when screening failures and smear test backlogs were also making waves.
It’s hard not to let the cynicism drain you when you read about the State’s decision in 2007 to outsource the reading of smear tests to “fully accredited laboratories only”, on, of course, a “short term” basis.
You could argue that at the time the Government’s hand was sort of forced because the smear test backlog was climbing towards 40,000 and then health minister Mary Harney was getting it in the neck regularly from political opponents, screaming for the introduction of a long-promised national cervical cancer screening programme.
You could argue, as reported by the Irish Examiner in January 2007, that an intensive campaign by the Irish Cancer Society urging women to go for cervical screening had pushed the system to a point where the HSE had to send tens of thousands of tests overseas to be analysed.
The society’s then chief executive John McCormack rightly said at the time that he was making no apology for the campaign, which had overloaded the system.
Ten years later, with a national cervical cancer screening programme in place, the system similarly buckled when Health Minister Simon Harris offered free out-of-cycle smears to women worried for their health on foot of the Cervical Check controversy. Like McCormack, he made no apology.
Women had been let down by the system, and they were entitled to reassurance. The upshot was an unprecedented backlog of 80,000 unread smear tests, which is slowly reducing. Just as in 2007, the HSE has had to enlist the help of US outfit Quest Diagnostics. The parallels between now and then are striking.
“I think it is an appropriate solution to an unacceptable problem,” Tom Finn, then assistant national director of the HSE National Hospitals Office, said at the time.
He said slides would go to the US because no similar facility in the EU could cope with the volume.
Outsourcing was introduced by the National Hospitals Office in February that year, with 30,000 tests sent to Quest Diagnostics in Dallas, Texas, and Atlanta, Georgia.
In June, Mr Finn said the long delays women had had to endure before getting the results of cervical smear tests would be “a thing of the past by the end of this month”.
He said the work was outsourced only to fully accredited laboratories. He said outsourcing would be “short-term”.
More than a decade later, the notion of “short term” sounds as fanciful as permanently eliminating smear test backlogs. In the interim, Ireland has singularly failed to develop the laboratory capacity that would allow us to do the job ourselves.
This was an argument made at the time — why was the HSE prepared to pay millions to have tests processed overseas instead of investing in indigenous talent and facilities? At the time, it was all about expediency and fast-turnarounds.
Finn’s commitment to confine our outsourcing to accredited laboratories was also not honoured. We learned this week, in a “disturbing” addendum to the Scally Scoping Inquiry into the CervicalCheck Screening Programme, that one overseas laboratory analysing Irish women’s slides was doing so on an unaccredited basis, for, say, three years, during which time it processed more than 90,000 CervicalCheck slides.
This Manchester laboratory, in operation since 2016, was only accredited in April 2019 following the intervention of plain-speaking Dr Gabriel Scally, a man surely in line for canonisation, having held a mirror up to the health service, pointing out warts and all, when others were ducking for cover and engaging in doublespeak.
Dr Scally also discovered to his dismay that 16, and not six laboratories, as he was originally told, were doing CervicalCheck work, information as difficult to obtain as an honest answer in some quarters.
In his report last September, he outlined how it had taken site visits to the US and follow-up questioning to finally get laboratories to ‘fess up to the extent of their subcontracting, and 11 labs were identified.
This week, the number rose to 16. The main labs holding the CervicalCheck contracts largely argued that the sites doing subcontracted work were “affiliated” or “auxilliary” sites operating to the same quality assurance standards, but that is simply impossible to prove in cases where some of those labs no longer exist.
Moreover, these additional labs were not named in the contracts with CervicalCheck, which means they were doing the work of the screening service without its knowledge or approval. Scally tends to come down on the side of CervicalCheck in determining who is at fault for this spectacular oversight.
But perhaps the most controversial element of Scally’s supplementary report on the labs is that the Manchester lab was working unaccredited, and when the Irish National Accreditation Board (INAB) did eventually accredit it, having been unaware for a long period that it was operational, it did so retrospectively. How is this possible? Stable doors and bolting horses sounds like a fair analogy.
Having queried the situation yesterday via the Department of Business, Enterprise and Innovation, they said INAB “only became aware through the Scally inquiry process” that Medlab had proceeded to set up a satellite operation in Manchester.
And even though this operation “was not specifically surveyed by INAB in 2016”, “the accreditation standards being applied to the work of cytoscreeners in the Manchester laboratory were being reviewed by INAB in the context of its overall regular surveillance of MedLab’s Dublin facility”.
“This is because Medlab Dublin included the relevant data in material that it presented to INAB,” the statement said.
There’s no denying that screening has improved since the introduction of CervicalCheck in 2008. It’s no longer ad-hoc and opportunistic.
No-one doubts that women’s lives have been saved.
Prof Donal Brennan, consultant gynaecological oncologist at the Mater Misericordiae University Hospital has said they would “expect five times more women to die from cervical cancer if we did not have a screening programme”.
He has also pointed out that no screening test is 100% accurate and interval cancers will occur even in women who attend for regular smear tests.
Dr Scally has said that despite all his gloomy findings in relation to the labs, he has “not identified any evidence that the lab services used in the past or those currently used by CervicalCheck have provided, or are providing a service which does not meet acceptable standards in their country”. This is reassuring.
But the flaws in the programme that have emerged since Vicky Phelan stood on the steps of the High Court in April 2018 have rattled women’s confidence in the system so badly, that what should have been a showcase for successful population-based screening is now almost a template for how not to go about your business in the health service.