Seven unapproved labs screening smear tests were not visited in probe
Up to seven of the unapproved laboratories in the US that screened smear tests from Ireland unknown to CervicalCheck have not been visited as part of a probe into their standards.
Dr Gabriel Scally recently revealed 16 labs in the US and the UK were involved in reading women’s slides from Ireland, but CervicalCheck had been aware of just six.
Appearing before the Oireachtas Health Committee yesterday, he said seven of the labs were not visited as part of his probe because they had since closed.
Nevertheless, Dr Scally and his team said, based on their evidence, the labs where tests were outsourced to were safe. They came to this conclusion based on records which they examined from the labs.
His recent report revealed the shocking extent of the transfer of slides to locations such as Grand Rapids in Michigan, Lansing in Illinois, Hawaii and Manchester in England.
The committee was told yesterday that in 2011 a team from CervicalCheck visited the main CPL lab in Austin, Texas, but were unaware that 40pc of the slides from Ireland were being outsourced to another centre in San Antonio.
He told Fianna Fáil TD Stephen Donnelly the data which he and his team recently examined included information from the unapproved labs.
Impossible
He was asked by Health Minister Simon Harris last September to examine the labs.
“Some of the labs no longer existed and it was physically impossible for us to visit them.
“The number of slides sent to some of them were very small,” he told Labour TD Alan Kelly.
Dr Scally said that “small labs are bad news”.
His investigation team were not told of any adverse incident which led to the closure of the labs and believed they were shut mainly due to staffing and other issues.
He said CervicalCheck was a passive recipient of what the labs which it contracted to read slides gave it.
CervicalCheck did not “actively manage” these contracts and until recently it had no in-house expertise in cytopathology, which studies disease at the cellular level.
During his investigation, he found that a lab in Manchester, which is part of Medlab in Dublin, was reading slides from Ireland but was not accredited.
The lab later received retrospective accreditation from the Irish National Accreditation Board after it was brought to its attention by Dr Scally.
He said he checked the website of the accreditation authority and found there was reference to the Manchester lab even though it was examining tests from Ireland.
Questioned by Fine Gael TD Kate O’Connell, Dr Scally said he had never “seen the like of” CervicalCheck’s organisation and structure.
He said: “We have 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.”
The largest outsourcing was carried out by CPL based in Austin, which worked for CervicalCheck from 2010 to 2013.
It sent tests to San Antonio, Las Vegas, Victoria, Hawaii and Florida.
Dr Scally remarked the distances between these labs were often considerable as Honolulu is almost 6,000km from Austin.
CPL defended the move on the grounds it had a spike in tests and wanted to maintain turnaround times.
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