Doctor raised concerns 11 years ago about outsourcing of smear testing, court told

He and other pathologists raised their concerns with Tony O’Brien

 Paul and Ruth Morrissey. Photograph: Collins Courts

Paul and Ruth Morrissey. Photograph: Collins Courts

 

A consultant pathologist has told the High Court he raised concerns about the outsourcing of the smear slides of Irish women to US laboratories eleven years ago and warned of “problems in the long term”.

Dr David Gibbons resigned as chair of the cytology/histology group within the quality assurance committee of the National Cervical Screening Programme along with seven others after raising their concerns in 2008.

“We were very worried. We felt it would cause problems in the long term,” he said.

Up to eight Irish testing laboratories were “mothballed” when the first contract for testing of the Irish smear tests was given to a US laboratory in 2008, he said.

Dr Gibbons was giving evidence in the continuing action by terminally ill Ruth Morrissey who has sued the HSE and two US laboratories over alleged misreading of her smear slides in 2009 and 2012.

On Wednesday, Dr Gibbons said data from slides tested by US laboratories around 2008 showed 2.4 percent of all slides tested in Irish laboratories reported pre-cancerous cells.

The US laboratories found 40 per cent less, he said.

He said the US had a low sensitivity test but a shorter recall time of one year compared with Ireland’s three year recall.

He and other pathologists had raised their concerns about outsourcing with the then head of the National Screening Service Tony O’Brien.

He said the main problem was two different systems were being put together and you could not have low sensitivity testing with a long recall interval. There was a “huge furore” at the time about the issue.

“You run the risk of missing pre cancer over a period and there was a danger of allowing cancer to develop that would not have developed otherwise.”

Cross examined by Patrick Hanratty SC, for the HSE, Dr Gibbons was asked if he had a grudge against the HSE over outsourcing. He said he “certainly didn’t.”

Ms Morrissey (37) and her husband Paul Morrissey, Kylemore, Schoolhouse Road, Monaleen, Co Limerick, have sued the HSE; US laboratory Quest Diagnostics Ireland Ltd, with offices at Sir John Rogerson’s Quay, Dublin: and Medlab Pathology Ltd with offices at Sandyford Business Park, Dublin 18.

They allege failure to correctly report and misinterpretation of her smear samples taken in 2009 and 2012.

They claim a situation developed where Ms Morrissey’s cancer spread unidentified, unmonitored and untreated until she was diagnosed with cervical cancer in June 2014.

It is further claimed a review of the 2009 and 2012 smears took place in 2014 and 2015 with the results sent to Ms Morrissey’s treating gynaecologist in 2016 but she was not told until May 2018 of those review results which showed her smears were reported incorrectly.

The HSE admitted it owed a duty of care to Ms Morrissey but not her husband.The laboratories deny all claims.

In evidence earlier on Wednesday, CervicalCheck Programme Manager John Gleeson said Quest Diagnostics had questioned the need to release the results of audits on Irish smear tests but that was short lived.

A legal letter arrived, he would not say they strongly disagreed, but they questioned the need for it.

“It was short lived and put aside,” he said. He presumed the laboratory was concerned about litigation.

Patrick Treacy SC, for Ms Morrissey, asked why results of the audit review of her smear slides were sent to Ms Morrissey’s treating consultant in 2016, one year and two weeks after they became known.

Asked what was the explanation for the delay of over a year, Mr Gleeson said: “We were working on a historic case load, we got to Ruth Morrissey in June 2016.”

Mr Gleeson was also asked about the Quest Diagnostics laboratory contract with the HSE and about Ruth Morrissey’s 2009 slide being sent to a laboratory in Wyoming which, it is claimed, was not specified in the HSE contract.

Asked had he heard about the Wyoming laboratory before being asked in court about it, Mr Gleeson said it was raised in the Scally Report and before that his immediate response was he did not remember hearing that name.

Asked if the slide had been sent to laboratory not agreed with the HSE, he said he would be unhappy “if it were done without our say so”.

The case continues on Thursday before Mr Justice Kevin Cross.