A significant part of the examination of Irish CervicalCheck smear tests by a US company were carried out at a lab where staff were mainly involved in a training role to serve a large military healthcare facility in Texas.
Public healthcare veteran Dr Gabriel Scally, who carried out a scoping inquiry into the failure to tell women with cancer about a subsequent audit of smear tests, is continuing to investigate the role played by Clinical Pathology Laboratories (CPL) in Austin, Texas, which examined smears for CervicalCheck from 2010 to 2013.
Dr Scally's report into the controversy found that only two-thirds of the screeners examining Irish smear tests for abnormalities worked at CPL's Austin lab and that the lab outsourced the Irish tests to five other labs: in San Antonio and Victoria, Texas; Las Vegas, Nevada; Orlando, Florida, and Honolulu, Hawaii.
CervicalCheck, the National Screening Service and the wider Health Service Executive were unaware that the smear tests were outsourced by the Austin lab, he found.
CPL was the lab that settled the High Court action taken by Limerick woman Vicky Phelan for €2.5 million over a 2011 smear test that was misinterpreted at the time and that she only learned about in 2017.
Ms Phelan’s High Court settlement revealed the widespread non-disclosure of smear test audit results.
The controversy involves the cases of 221 women, of whom 18 have died.
Different result
The audits of the tests, conducted after the women’s cancers were diagnosed, found that the screening could have provided a different result and could potentially have led to an earlier medical intervention.
The 2010 CervicalCheck contract awarded to CPL, one of three companies hired to examine smear tests for the national cancer screening programme, only stipulated Austin as the location where cytology testing – the microscopic examination of cells – would be carried out.
The Scally report said CPL did not tell the scoping inquiry when it visited Texas that one third of the Irish test screeners were outside Austin. It subsequently revealed this in an email to the inquiry on September 3rd. The inquiry said it is notable that no data to quantify the amount of work undertaken elsewhere has been submitted
The Texan lab, owned by Australian healthcare company Sonic, recruited staff at its pre-existing laboratory in San Antonio and Austin to increase capacity to deal with the Irish workload, though Sonic said the additional staff at San Antonio was "to access the large medical and military community there".
San Antonio is home to a national centre for cytology within the US military, the Brooke Army Medical Centre, the largest military healthcare organisation run by the US Department of Defence.
“A significant part of the Irish CervicalCheck work was undertaken by laboratory staff whose main employment was elsewhere in a training role, or in another role with little screening workload,” the Scally report says.
Dr Scally has said he only learned of CPL's outsourcing of Irish smears in recent weeks and that he will compile a supplementary report for Minister for Health Simon Harris once he has investigated this further.
Accreditation
His report found that neither CPL nor Quest, the New Jersey lab also contracted by CervicalCheck, had the ISO 15189 accreditation – a standard that sets requirements for quality and competence in medical laboratories – as was required under the 2010 contract for providing services to the Irish programme.
The two labs said they were accredited by the College of American Pathologists, which they viewed as equivalent. CPL told the Scally inquiry that CervicalCheck accepted this at the time.
Dr Scally has said that he will investigate accreditation requirements further.
His report found that CervicalCheck carried out a quality assurance visit to CPL in 2011 and that “no assurance was given by CPL on a number of standards”. CPL also failed to address all concerns raised by CervicalCheck.
“The HSE responded appropriately, to the effect that the response from CPL was inadequate, but there is no record of what happened subsequently,” the report says.
