HSE was aware of US lab issues with smear tests in 2007

The HSE was aware of issues around the testing of cervical smear samples at labs in the US as far back as 2007, when a consultant pathologist in Cork University Hospital sought a review of samples that were given the all clear, despite patients being at risk of cervical cancer.

The company in question, however, later secured a contract for cytology laboratory testing for the national cervical screening programme.

Over a decade ago, a medical industry newspaper reported concerns at CUH over the testing.

The Irish Medical Times reported that one slide in a batch of smear tests sent back to Cork University Hospital from Quest Diagnostics in Texas in March 2007 was classed as negative, meaning no abnormal cell changes were detected.

It said another was classed ‘inadequate’, meaning the slide could not be read properly and the patient should be re-screened within three months.

However, a consultant pathologist in Cork University Hospital discovered in June that both women actually have high-grade dyskaryosis which means they could be at risk of cervical cancer, although this can be prevented if detected early enough.

The HSE then asked the US lab to review the two cases from a “quality perspective”, an Irish Medical Times article noted in September 2007.

The Irish Medical Times report resurfaced yesterday having been discovered by PJ Coogan, host of Cork’s 96FM Opinion Line, during his research for an on-air discussion of the continuing CervicalCheck controversy.

In 2007, the Irish Medical Times also reported problems in Ireland interpreting the results provided by the US labs “due to the difference in testing and reporting methods between the US and Ireland”.

“A translation table was then compiled and sent to GPs and other smear-takers so they could easily translate the results,” it said.

“Consultant pathologists at the Cork lab informed the HSE a number of times that they did not want to be responsible for interpreting the results, for clinical liability reasons, and because of the difference in the method used to test the smears,” the Irish Medical Times reported.

The Irish Examiner yesterday asked the HSE what, if any, action was taken in 2007 when the issues with Quest Diagnostics were discovered.

This newspaper also asked the HSE if it informed the Department of Health of the problem when it arose in 2007.

A spokesperson for the HSE said it was “working on getting this response as soon as we can”, but no answers were provided at time of going to press.

The Department of Health said the issues raised relate to the performance of labs which will be subject to the scoping inquiry led by Dr Gabriel Scally.

In April 2008, the Irish Medical Times had given another warning about outsourcing smear tests, in an article titled “Risk to patients as smear tests are to be sent abroad”.

The article came months before the National Cancer Screening Service awarded the contract for cytology laboratory testing for the national cervical screening programme to Quest Diagnostics.

A cytology lab had to carry out a minimum of 25,000 tests over the previous year, and it had to be accredited, to pass the pre-qualification stage of the tender, according to the article.

“The decision could lead to a cancer scandal on the scale of the breast cancer fiasco in Portlaoise, said a well-informed source, who spoke on the condition of anonymity,” the Irish Medical Times said.

“The source added that the decision was motivated by cost and will have a detrimental effect on the quality of screening”.

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