Negotiations between the HSE and the two main laboratories that examine smear tests for the CervicalCheck programme have reached a critical phase, with existing arrangements due to run out at the weekend.
The HSE says it has contingency plans in the event of it failing to make a deal with the laboratories, Quest Diagnostics in the US and MedLab Pathology in Dublin, before the existing agreement expires.
However, it declined to say what these contingency plans are.
Quest and MedLab test 90 per cent of samples.
While negotiations have been ongoing for the past month, sources say it is likely to be the end of this week before a final push for agreement is made, as some key negotiators are out of the country .
The main stumbling block in the negotiations is the insistence that the HSE should provide greater cover for what the laboratories regard as the changed claims environment in Ireland since this year’s controversy over the CervicalCheck programme.
Under existing agreements, the laboratories accept liability where findings of medical negligence are made. However, they are now fearful of a deluge of claims in the aftermath of the controversy.
Coombe Hospital
The laboratories want the State to provide some form of indemnity in cases where the courts make findings of negligence following a false negative smear test. The HSE, while willing to pay more than under previous contracts, is resisting this demand.
The laboratories fear false negative tests will be interpreted in the courts as negligent to an extent not seen in other jurisdictions.
Quest and MedLab each perform about 130,000 tests a year for the CervicalCheck programme, while the rest are carried out by the Coombe Hospital in Dublin.
The HSE declined to comment on the negotiations other than to say they were ongoing.
The question of whether negligence was involved in the reading of smear tests in the CervicalCheck programme may be answered in a review being carried out by the Royal College of Obstetricians and Gynaecologists. The Government has asked the college to examine the screening histories of about 1,850 women but its report is not expected for some months.
‘Errors must be stopped’
Meanwhile, the solicitor for the late Emma Mhic Mhathúna, one of the women in the CervicalCheck controversy, said it was inexcusable there was still not “a clear and determined” commitment from the State to investigating why her smear tests, and others, were misread.
Cian O’Carroll said Ms Mhic Mhathúna, who died aged 37 on Sunday, had been adamant she wanted accountability, and “that errors must be stopped”.
Ms Mhic Mhathúna, a mother of five, 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.
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.
She said 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.
“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.
