The addition of the Quest Diagnostics Chantilly Laboratory as a CervicalCheck test facility took place without proper operational due diligence and risk assessment, according to a Rapid Review report.

The report found that, however well-motivated and taken in the context of a major backlog of samples, the decision to proceed with using the lab without first testing and validating that it could be seamlessly integrated into well-established operating processes led to system failure, with consequent impact on women and GPs.

The Rapid Review was established after RTÉ News revealed on 11 July, that the HSE and the Department of Health knew then that more than 800 women and many GPs were not told of CervicalCheck results, due to an IT problem.

It said that with the introduction of manual workarounds, the IT problem should have triggered "serious concerns, proactive risk management and escalation".

The report also found there was a gross underestimation of the scale and implications of the problem.

The primary casualty was communications with the women and GPs, with the breakdown in automated results generation, it concluded.

The report said there was a decision not to communicate with women about the IT problems and its implications for a full six months in 2019.

Report author Professor Brian MacCraith said that between February and last week, there was no communication with the majority of women involved.

"Throughout this review there was a constant theme of women frustrated by poor service and lack of information, their information," Prof MacCraith said.

The report said that within CervicalCheck there were too few people managing too many significant projects simultaneously.

The Health Service Executive has said it "accepts entirely" the findings of the review.


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HSE Chief Executive Paul Reid said a number of actions had been set out.

These include strengthening the management and organisation of CervicalCheck, developing a culture of putting women first, establishing a clinical evaluation and assessment of the women affected and establishing an audit of Quest's IT processes and interfaces, he said.

The woman whose case led to the problem becoming public has said that her only purpose has been to establish the truth of events.

Sharon said that she was concerned from today's report that her account of her dealings with the Department of Health were allegedly disputed by it.

Meanwhile, the report has also found that the number of women identified as part of the CervicalCheck IT problem is more than 4,080.

In the case of around 870 of the women, the problem led to results letters not being issued to them, or their GP in some cases.

In the other 3,200 or so cases, the results were issued to GPs, but not to the women concerned.

Arising from recommendations in the report, the development of a tracking system for smear tests is to be investigated, which would allow patients know at what stage their test was at.

The IT flaw was reportedly at one Quest Diagnostics facility in the US.

More recently new documents, secured by RTÉ News, showed that the Department of Health knew on 25 June that more than one person was affected.

Minister for Health Simon Harris has said he was first briefed on the issue on 10 July, the day RTÉ News first put questions to his department on the issue and to the HSE.

The Rapid Review has concluded that the first knowledge that Mr Harris had about the issue was on 10 July in a daily briefing.