Inexcusable that lab which misread Mhic Mhathúna tests not investigated - solicitor

It is inexcusable there is still not “a clear and determined” commitment from the State to investigating why the smear tests of the late Emma Mhic Mhathúna and others were misread, her solicitor has said.

Cian O’Carroll said Emma, who died aged 37 on Sunday, had been adamant she wanted accountability, “that errors must be stopped”.

But he said while the State had a right to send in Hiqa to investigate why errors happened in the laboratories reading smear tests this had not been done.

“But the State, the National Screening Service has a responsibility and under the contract they have a right to send in Hiqa to investigate why those errors happened in those laboratories and they have an obligation to do it under normal standards of public health and public safety. They haven’t done it.”

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Ms Mhic Mhathúna, a mother-of-five, was one of the women affected by the CervicalCheck controversy. She was one of 221 women with cervical cancer found to have received incorrect smear tests during a clinical audit of past tests by the CervicalCheck screening programme.

She was diagnosed with cervical cancer in 2016, having previously received two incorrect smear-test results. She had sued the HSE and US laboratory Quest Diagnostics Incorporated and was awarded €7.5 million last June. Liability was admitted.

Mr O’Carrolltold RTÉ’s Today with Sean O’Rourke show it is one of “the enduring frustrations of her case and of the 221 women affected by this scandalous catalogue of errors, people would think that the two critically misread smears that the lab Quest Diagnostics and the State admitted liability for, you would think that the State would have had those slides and those errors investigated - they haven’t.

Scally report

When asked if this issue had already been covered by the Scally Report, Mr O'Carroll said Dr Scally did not look at the 221 errors. "The experts are not looking at the laboratory at all, they're repeating the process that's already been done of looking at those 221 cases, they've already been looked at while there are other cases to be looked at in the 1800 or so that they're looking at, they're going to be adding nothing to the understanding of what happened with those 221 cases - it will simply say they were misread to this degree and that degree of error caused x amount of harm to that particular patient.

“They’re not looking at the lab at all so that means if you want to have confidence in a laboratory you must know that each error is investigated. We’ve spoken to cervical screening experts around the world - they have all said that it is essential whenever a single critical error occurs that it’s investigated within the laboratory and that involves debriefing the person who made the error and finding out what caused it.

“That has never been done.”

Red dress

Mr O'Carroll paid tribute to Ms Mhic Mhathúna saying she thought everything through, including wearing a red dress to the High Court on the day of her settlement.

He last communicated with her by text last Thursday, discussing a routine court appeal next week. She had been concerned about wheelchair access in the Four Courts but when he told her she would not need to use a wheelchair, she responded that she planned on wearing roller skates.

“She never showed me the sadness. The pain didn’t form part of our conversations. She was completely dedicated to pushing the case for her children.”

He said she questioned the ways litigation was carried out. During the case when it was suggested that a psychologist should interview her children to determine how they would be impacted by her death, “Emma asked why is that acceptable, why should her children be put through a psychological investigation?

“She could see through systems and situations, cut to the point at the heart of it and challenged us who worked with her, for her, constantly, which is difficult, nobody likes being challenged all the time, but ultimately it meant we were able to do a much better job for her.

“She said herself that figures mean nothing, money means nothing in the grand scheme of things. It is however, an important provision for the future and that’s what she wanted put in place.”

Existing contracts

A spokeswoman for the Department of Health said the Government established two parallel lines of investigation into the CervicalCheck controversy including a scoping inquiry led by Dr Gabriel Scally and an independent clinical expert review led by the Royal College of Physicians, with expertise sourced also from the British Society of Colposcopy and Cytopathology.

The Scally report “presents no evidence that the rates of discordant smear reporting or the performance of the programme fell below what is expected in a cervical screening programme. Dr Scally has also undertaken to carry out a supplementary report into certain further aspects of the laboratories.

“Crucially, he has confirmed that he finds no reason why the existing contracts for laboratory services should not continue until the new HPV regime is introduced. This is very welcome reassurance for women in Ireland,” she said.

She added that the scope of the expert review led by the Royal College of Physicians includes all cases of cervical cancer in Ireland since CervicalCheck was established, to include the 1,482 cases notified to CervicalCheck since then and a further 1,630 cases registered by the National Cancer Registry of Ireland which had not been notified to CervicalCheck. It will examine those women within this cohort who were screened by the programme, approximately 1,856 women from within the total (subject to final validation in the course of the review). Women who developed cancer and who were screened by CervicalCheck will be identified and their screening histories will be examined. This will provide independent clinical assurance to women about their screening history.

The Department also stressed again the limitations of screening. “As Dr Scally states in his report, it is generally accepted that cervical screening and breast screening can prevent some, but not all cancers. He notes that for every 1,000 women screened, around 20 women will have precancerous changes. The current smear test will identify 15 of these women, while the HPV test will correctly identify 18 of these women. False negatives are an inherent part of a cervical screening programme and screening alone cannot prevent all cancers. However, a well organised screening programme, when combined with HPV vaccination for boys and girls, can bring us very close to eliminating the disease. The introduction of the HPV test as the primary screening test, and the introduction of the HPV vaccine for boys, subject to the outcome of HIQA’s assessment of it due later this year, are priorities for for the Minister.”