THE OUTSOURCING OF screening smear tests in the US and the UK has been raised as an issue of concern in the latest report of the Scally Inquiry into the CervicalCheck controversy.

The supplementary report, which went to Cabinet and has been published today, has found that some of the laboratories where the tests were outsourced to no longer exist.

Speaking to the media today, Dr Scally said the number of laboratories thought to have carried out tests grew from six to 16.

When he first began the Scoping Inquiry in 2018 there were six labs involved in Cervical Check screening. 

When Dr Scally published his first report last September, he knew of 11. Since carrying out work for the latest report, a further four labs have been uncovered, he said. 

Today he revealed there were actually 16 labs – two in Ireland, two in UK and 12 in US. 

He criticised the labs for not telling the Scally inquiry at the “first possible opportunity” of the additional labs being used. 

Information about the other labs being used came “as much as a shock” to CervicalCheck, the HSE and to Dr Scally, he said. 

The lack of transparency to Irish women was “entirely unacceptable”, he added.

Retrospective accreditation

Particular concerns were raised about the lab in Salford in the UK, which only received accreditation retrospectively, which Dr Scally said he is very unhappy with. 

“I find the circumstances surrounding the screening of Irish women’s slides in Salford particularly surprising, and disturbing, in terms of the level of governance expected in a public health programme. The issues raised again emphasise the importance of creating effective quality assurance processes within the CervicalCheck programme,” Dr Scally states in the report.

Dr Scally added that he was “profoundly disappointed” the additional labs only came to light after the extensive probing by the inquiry. 

Today’s report finds that Clinical Pathology Laboratories (CPL) in Austin, Texas, who were tasked with the screening the tests, should have consulted in writing with CervicalCheck about whether outsourcing of Irish smear tests could take place. 

He noted that there appears to be no evidence that CervicalCheck was consulted about the outsourcing, but added one document of correspondence between CervicalCheck and one lab in 2009 discussed outsourcing.

The reply from CervicalCheck was that would involve “a level of risk we are not willing to take”. However, widespread outsourcing did take place. 

In his opinion, this outsourcing “lay outside the bounds of the contracts”. 

Speaking about his report today, Dr Scally said it is important people note “no cause for concern” about the standards of the labs being used in the past or the present was identified. 

He reiterated that no evidence was found in relation to the quality of the screening at any of the labs.

Dr Scally said he knows today’s report will “both help to reassure and make for unsettling reading” for some reason. He said it is important that those called to the screening programme take part. 

In his report, Dr Scally recommends that any future contracts awarded to labs should be a lot more explicit in what is expected, and should be “water-tight”. 

He added that “never again” should outsourcing take place without written permission being given in advance. 

He said there are a limited number of companies that can provide this service, which is why contracts continue to be awarded. 

Reaction 

Reacting to the report today, Lorraine Walsh and Stephen Teap – the two patient representatives appointed by the Minister for Health Simon Harris to a steering committee tasked with overseeing changes to the screening programme, said they were deeply disturbed by the findings of the report. 

Walsh said quality assurance of the screening programme was “non-existent” and “very poor”, but now it has been revealed that there were actually 16 labs carrying out the work, rather than six, labs the authorities were not even aware were being used.  

There are now serious questions about the accreditation of one lab, said Teap, who highlighted how the use of the lab in Salford only came to light in April of this year, yet retrospective accreditation was given dating back to 2016.

“Can the government stand over that?” he asked.

He stated that 90,000 smear tests were sent to the Salford lab and it wasn’t even accredited to do the work. “It is frightening to see how poor governance was around it,” said Walsh.

Teap said he has questioned the minister, the HSE and the health department about what reassurances can be given to the 90,000 who had their smear test sent to that lab and whether they can stand over the MedLab in Salford.

“I gave them every opportunity to give a solution to us,” he said, adding that the urgent reassurances are needed, but said offering additional smear tests would not be the answer. 

Dr Scally added today that a lot of positive work is being done improve the screening programme and to increase trust, which he said he welcomed. 

Dr Lorraine Doherty, Clinical Director CervicalCheck said:

“We passionately believe in cervical screening and the positive impact it has on the health, and lives of women. As Dr Scally said in his report, the continuation of cervical screening is of ‘crucial importance’. 

“Cervical screening can prevent 75% of cervical cancer cases. As a result of our national screening programme, one woman is diagnosed with cervical cancer every two days, while thousands of abnormalities are detected every year.

“Like all screening tests, cervical screening is not perfect. Some women will still develop cervical cancer despite regular screening. While the risk of cervical cancer can be reduced, it can’t be eliminated by screening. 

Dr Scally’s previous review into CervicalCheck last year identified 221 women subsequently diagnosed with cervical cancer who were not told that slides from an earlier screening could have been interpreted differently.

These issues came to light when women diagnosed with cervical cancer, such as Vicky Phelan and Emma Mhic Mhathúna came forward to tell their story.

Dr Scally subsequently proposed an overhaul of the screening programme.

In his last report, Dr Scally found that the biggest failure he identified in his four-month review was the non-disclosure of information from CervicalCheck audits to patients.

He also said that members of the medical profession need to sit down and hear from the women who were impacted by the scandal.

Health Minister Simon Harris has now asked Dr Scally to continue to oversee that his recommendations are being implemented.