Updated: 21.25
A potentially considerable number of women diagnosed with cervical cancer have not had their tests audited, according to Health Minister Simon Harris.
He has told the Dáil that the numbers revealed so far this week may not be the full picture.
It means there could be more women who should have had their initial smear tests acted on.
Minister Harris told the Dáil more tests by CervicalCheck may need to be audited.
"I have to inform the House of some emerging information that I have received from the Serious Incident Management Team (SIMT) that I have been sent into CervicalCheck.
"Whilst I had previously been advised, and it had been commonly understood, that CervicalCheck clinic audit covered all cases notified to the National Cancer Registry, I have been informed this afternoon that this is not the case.
"While CervicalCheck has audited all cases notified to it, I have been informed that a potentially considerable number of cases will not have been subjected to an audit of their screening history.
Health Minister Simon Harris has addressed the Dáil | Image: Oireachtas screenshot
But he clarified: "These are not new cases of cancer, nor is it a group of women wondering if they have cancer.
"These are women who've already been diagnosed with cervical cancer and treated as such, but their cases have not been included in a clinical audit.
"Having now identified the issue, the SIMT will take steps to identify any additional cases of cervical cancer that occurred during this time period and were not audited.
"The screening history of these additional cases will be established, and if any of these women were screened through the CervicalCheck programme their case will be reviewed in further detail."
"Very serious breakdown"
In a statement on Tuesday night, the HSE said: "CervicalCheck carried out an audit of 1,482 previous cervical screening tests on women who were diagnosed with cervical cancer from 2008 to 2018.
"Clinical audit is used to test and assure the standard of work that is being done by a health service or facility.
"Of 1,482 women who were notified to CervicalCheck as being diagnosed with cervical cancer, it was found that in the cases of 208 women, on look-back, the screening test could have provided a different result or a warning of increased risk or evidence of developing cancer.
"Importantly, this audit was undertaken after the women were diagnosed. That is to say that the Cervical Screening Programme did not withhold information from any woman that delayed their diagnosis of cancer.
"Rather the audit process of their previous smears was undertaken as a response to them having been diagnosed and of this being notified to CervicalCheck."
It added: "The HSE Serious Incident Management Team (SIMT) has been working to uncover the details of what occurred in recent days and will continue to do so as the situation evolves.
"At this point it is clear that there has been a very serious breakdown in communicating to the women concerned that this audit was happening, and the outcomes of the audit.
"All those affected, who were not previously made aware of this, are now being contacted."
Women who have questions about their case can contact the CervicalCheck information phone line on 1800-45-45-55.
"They will be able to check the audit records for you and let you know if you are affected," the HSE added.
'Her actions will lead to improvements'
On the Vicky Phelan case, Minister Harris told the Dáil: "We are all here, I think we can agree, because Vicky Phelan spoke out.
"I recognise that to do so cannot have been easy for her or her family - but her courage and tenacity has done a great service to the women of Ireland, and her actions will ultimately lead to improvements for all".
Vicky Phelan | File photo
Labour's Alan Kelly said the minister dropped "a bombshell" with this latest news.
"What is the number of cases that have now not been audited?
"And in your speech you haven't told us.
"This is a bombshell - what volume of women have not had their cases audited?".
The Minister says he doesn't want to put any figures out there for how many more women might be affected because he doesn't know them
— Sean Defoe (@SeanDefoe) May 1, 2018
Briefing note
Earlier, the Government published a briefing note sent to the health minister concerning Ms Phelan's CervicalCheck case.
The note - which is available here - was sent to the minister on April 16th, before the case was heard at the High Court.
It advised the minister "that publicity around the case and/or settlement is likely".
The HSE's National Control Programme told the Department of Health "they do not consider this to be a patient safety incident but rather a reflection of the known limitations of the current screening test".
According to the memo, the current CervicalCheck testing method "produces a not insignificant number of false negative results" - saying the 'known limitation' is one of the reasons why women are screened regularly.
It said that CervicalCheck carried out a review of Ms Phelan's case in 2014, but adds: "At the time in 2014, the outcomes of clinical cancer audits were used by CervicalCheck for education and training purposes only".
Simon Harris was told Vicky Phelan's case was not a patient safety incident pic.twitter.com/BMc0cRImyv
— Sean Defoe (@SeanDefoe) May 1, 2018
The document also suggested that women who had their cases audited were being informed and had the right to request information.
It also said no quality issues had arisen with regard to the US lab examining smear tests.
Settlement
Ms Phelan settled her case against a US lab last week, after being wrongly informed in 2011 that she had the all clear.
Three years later, a review found the results were incorrect.
She was diagnosed with cervical cancer around the same time, but she only found out about that review last year.
Ms Phelan's case against the HSE was struck out, and the memo to Minister Harris states: "[The State Claims Agency] is of the view that a claim for exemplary damages in relation to the non-disclosure of the CervicalCheck standard review process is likely to fail / be dropped, in the absence of any evidence of bad faith by the HSE in this regard."
Meanwhile, the Taoiseach Leo Varadkar has said he will not fire HSE boss Tony O'Brien after the CervicalCheck scandal.
Sinn Féin leader Mary Lou McDonald had earlier suggested Mr O'Brien's position was untenable:
Sinn Féin say Tony O’Briens position as head of the HSE is untenable pic.twitter.com/7C4TTWaS1c
— Sean Defoe (@SeanDefoe) May 1, 2018
Mr Varadkar said there is no proof that sending the smear tests abroad for examination meant they were any less accurate than if they were examined here.
The Attorney-General has been asked to see if any cases similar to Vicky Phelan's are being taken so they can be settled without going to the courts.
The Taoiseach has also said he cannot rule out a Commission of Investigation into why women were not told their cancer checks were being audited - but warned it could take years if it went to that.
'Not supported by the facts'
Responding to the opposition calls for the HSE chief to resign or be sacked, Mr Varadkar told deputies: "The basis on which you've called for the dismissal of Tony O'Brien is based on an assertion that the decision to outsource these tests to the US in 2008 somehow cost lives [...] That is not yet supported by the facts.
"I think everyone, even Tony O'Brien, deserves a fair hearing before they are condemned."
His comments in the Dáil came after the Cabinet discussed a statutory investigation into the CervicalCheck scandal on Tuesday morning.
On Monday, the HSE confirmed that 17 women whose test results were reviewed as part of an audit of Ireland’s national cervical screening programme have died.
Of the 208 women whose results were scrutinised, only 46 were informed about the history of their smear tests.
It means some 162 women did not know there might be a problem with their cancer check.
Several investigations are to be conducted into the CervicalCheck programme in the wake of the recent revelations.
Reporting by: Sean Defoe, Stephen McNeice, Mick Staines and Jack Quann
