US-based lab paid more than €6.5m to analyse smear tests

A US-based laboratory has been paid more than €6.5 million over the past two years to analyse smear tests for CervicalCheck, the State's cervical cancer screening programme, the Health Service Executive has confirmed.

Figures provided to the Oireachtas committee on health on Thursday outline the sums paid in the past two years to three laboratories that process the screening tests – Quest Diagnostics of Teterboro, New Jersey, US; MedLab Pathology Ltd, Dublin; and the Coombe Women and Infants University Hospital, Dublin.

The HSE said Quest was paid some €6.59 million for 2016 and last year; MedLab received more than €5.84 million in the same period; and the Coombe received more than €1.45 million.

The practice of sending smear tests to the US has been criticised in recent weeks as the CervicalCheck controversy came to light.

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Quest is being sued by a number of women affected by the CervicalCheck scandal over claims that the testing missed their cancers.

High Court

The controversy came to light after Limerick woman Vicky Phelan, who has cervical cancer, settled a High Court case for €2.5 million against another US lab, Clinical Pathology Laboratories, a sister lab of MedLab, in April.

Ms Phelan sued when she discovered last year that a 2014 audit, carried out after she was diagnosed with cancer, revealed an incorrect smear test result in 2011, missing early signs of her cancer.

Since the settlement, the number of women or families affected has risen to 209, including 18 women who have died, with the potential to increase as a further 46 cases are being audited.

Dr Gabriel Scally, a Northern Ireland public healthcare specialist, is carrying out a scoping inquiry into the scandal for the Government. He has been tasked with examining whether sending the smear tests abroad is appropriate.

Minister for Health Simon Harris has said he would prefer if all tests were analysed in Ireland but will await Dr Scally's report before concluding how to proceed.

The figures provided to the Oireachtas committee also outline the number of tests carried out by each laboratory between 2008 and 2016.

The figures show that for 2015/2016 a total of 126,541 smear tests were seen by Quest, of which 126,317 were dealt with properly and 1,224 had an unsatisfactory result, according to the HSE.

Geography

The note from the HSE explains geography determines which tests are sent to the US laboratories. GP practices and clinics that carry out tests send the samples to one of the three laboratories.

Each laboratory caters for a different geographical area with the Coombe also picking up specific clinics, such as the family planning clinics, in the eastern region.

“Hence there is a different population profile with different characteristics including cancer prevalence in the catchment area of each laboratory,” the HSE said. “Each GP practice is aligned to a specific laboratory so all smears for a practice are handled by one laboratory.”

However, it insisted each of the three chosen labs meet CervicalCheck’s standards and have been certified by the relevant national authorities.

"The testing requirements are not different for different laboratories. The laboratories have robust quality assurance processes in place. There is a Quality Assurance Committee in place to oversee the work of the CervicalCheck programme that includes external international clinicians."