CervicalCheck scheme: Talks with testing labs ‘at critical stage’

Negotiations with the two laboratories carrying out the bulk of testing for the CervicalCheck programme are “at a critical stage” to ensure continuity of the national screening, the Health Service Executive has said.

The HSE said it has had “intensive negotiations” for a number of weeks with two labs Quest Diagnostics in New Jersey, and Medlab Pathology, which is based in Sandyford, south Dublin, about extending their long-running contracts with the health service beyond the expiry date next month.

The negotiations continue as a key report into the CervicalCheck controversy – where women were not informed about an audit of cancer cases revealing incorrect past smear test results – is due to be published.

The labs have threatened to withdraw from the screening programme unless the State indemnifies them on false negative cases where smear tests initially showing no abnormalities are later found to be incorrect.

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Under the current contracts, the labs indemnify the national screening service against any cases of false negatives and medical negligence that emerge in the course of their testing for the CervicalCheck programme.

The labs have reassessed the financial risk in light of the legal cases taken against them over the CervicalCheck controversy and want the State to underwrite them if they are to extend their contracts.

Ensuring continuity

A HSE spokeswoman said: “These negotiations are presently at a critical stage and every effort is being made to ensure continuity of our vital screening service.”

She would not comment further.

Medlab declined to comment on the negotiations. Queries sent to Quest Diagnostics went unanswered.

Details around the negotiations have emerged days before the publication of a report by Dr Gabriel Scally, the Northern Irish health service veteran, into the failure to tell women diagnosed with cervical cancer about clinical audits by CervicalCheck that showed a different result on past smear tests to their initial findings.

The report is expected to be critical of CervicalCheck and consultants for failing to inform the women about the results of the audits, though it is not expected to make adverse findings against any named individuals.

Minister for Health Simon Harris was briefed by Dr Scally on Monday about the contents of his report from his scoping inquiry ahead of the minister briefing the Cabinet on Wednesday.

Two of the women affected by the CervicalCheck controversy, Vicky Phelan and Lorraine Walsh, along with Stephen Teap, who only learned about about revised smears concerning his late wife Irene earlier this year, will be briefed by Dr Scally on Wednesday morning at the same time as Mr Harris briefs the Cabinet.

It fulfils a commitment made by the minister that the women and relatives of the deceased women affected by the controversy would be briefed ahead of the release of the report.

Vicky Phelan

Ms Phelan’s High Court settlement with Clinical Pathology Laboratories in Texas, a sister company of Medlab, in April led to scores of women learning that look-back audits – conducted in cases where they had been diagnosed with cervical cancer – showed different results on smears carried out prior to diagnosis.

Records disclosed in the Limerick woman’s case revealed that CervicalCheck and consultants were in a dispute for more than a year over who should tell women about the clinical audits and revised test results.

Quest and Medlab, which is owned by Australian company Sonic Healthcare, carried out 91 per cent of the 267,672 tests carried out in the 12 months to the end of August 2016, according to records disclosed by the HSE.

The remaining 9 per cent was carried out by the Coombe Hospital in Dublin. Quest was paid €3 million and Medlab €2.6 million for cytology testing in 2017.

The HSE said it was “committed to ensuring the continuity” of CervicalCheck, which it said had detected more than 50,000 high-grade pre-cancerous changes in women, reducing the risk of cervical cancer by 90 per cent. Incidence of cervical cancer reduced by about 7 per cent a year between 2010 and 2015, it said.