The Government has confirmed a statutory inquiry will be established into the CervicalCheck controversy.
Taoiseach Leo Varadkar confirmed on Monday the Government will hold an inquiry into the failure of State’s national cervical cancer screening programme to tell women they were falsely given all-clear smear tests.
Minister for Health Simon Harris also said an independent external clincial review will be offered to each of the women involved.
The Health Service Executive (HSE) earlier confirmed 162 women were not informed of a delay in their cancer diagnosis.
A total of 17 of these women have died, but the cause of death is not yet known.
The Health Information and Quality Authority will be asked to conduct the examination and it will assess “who knew what and when”, Mr Harris said, adding that it will have statutory powers and will be able to compel documents and people.
Speaking outside Government Buildings, Mr Harris said it was essential confidence was restored and that women had faith in the CervicalCheck programme.
A review found the number of women involved has grown to 208 women. It had been believed it was 206 and it had been thought likely that about two-thirds of the women affected had not been told, but the total is larger than had been expected.
All the women will be contacted by their hospital on Monday, or Tuesday at the latest. Appointments will be offered this week or next week at the latest. The State will pay for these.
Speaking at a media briefing on Monday afternoon, the director general of the HSE Tony O’Brien apologised to the women for the failure to inform them of the delay in diagnosing their cancer.
Mr O’Brien said these practices were completely unacceptable but urged women not to be deterred from using the screening programme.
Asked who was to blame, Mr O’Brien said he does not have sufficient information to make that judgement. However, there had been a breakdown in communications, he added.
Mr O’Brien said the HSE will now examine if the same failures are occurring in other screening programmes.
Jerome Coffey of the National Cancer Register said there had been 6,000 calls to the CervicalCheck helpline, 2,000 of them on Monday morning alone.
Patrick Lynch, director of quality assurance at the HSE, acknowledged the considerable focus on and concern about the screening process. However, Mr Lynch said the screening programme was very important and had prevented deaths. It could not be 100 per cent accurate, he stressed.
Mr Varadkar said the inquiry would establish the facts around the controversy, attempt to understand “why these appalling communication failures happened” and look at whether a different testing system might have reduced the number of “false negative tests.”
The Taoiseach confirmed the Government’s plans for an inquiry while attending an event on Brexit in Dundalk just days after a terminally-ill mother of two, Vicky Phelan, settled a High Court case against a US laboratory subcontracted by CervicalCheck screening programme to assess the tests.
Ms Phelan’s discovered that a 2011 smear test that had initially showed no abnormalities was, three years later, found to be inaccurate, but she did not learn of the false test until September 2017. She was diagnosed with cancer in 2014.
Private correspondence disclosed in her court case showed that doctors disagreed for more than a year over who was responsible for telling women with cervical cancer about the false tests.
The controversy has also already led to the resignation of CervicalCheck’s clinical director Grainne Flannelly.”
“There will be an inquiry. We will be discussing across the day the details as to how that inquiry will operate,” said Mr Varadkar.
“That inquiry will establish the facts and we need to do that. It will also try to understand why these appalling communication failures happened and also look at the laboratory testing and whether a different form of testing might have reduced the number of false negatives, but again that’s something that needs to be inquired into.”
The Taoiseach spoke about “how filled with sadness I am” about Ms Phelan and her case, and for her and her family.
“I am very concerned for the other women and their families who must be very concerned who have have questions that they want answered. We will try to answer them as soon as we can,” he said.
He expressed that women with cervical cancer were not told about the inaccurate tests following an audit, even though it may not have helped them.
“I am very angry that many women and many patients were not informed of the clinical audit earlier, even though informing of that audit would not have made a difference in terms of treatment or outcome. They still should have ben told anyway. That is what open disclosure is all about,” he said. “If doctors have information about a patient, they should make that information available to the patient in a timely manner.”
Mr Varadkar said the Government would be introducing a new test later this year that is more accurate than the one that had been used but stressed that no screening test is 100 per cent accurate.
“There will always be a relatively high proportion of false negatives but this test is more accurate,” he said.
Mr Varadkar also urged women to continue being screened through smear tests, despite the scandal.
“Cancer screening does work. We know it works,” he said, pointing to statistics that show that the number of women diagnosed with cervical cancer had fallen by more than a third.
The Cabinet will also discuss this matter at its weekly meeting on Tuesday, and potential redress for the women affected is also to be considered.
Tánaiste Simon Coveney and Mr Harris said they did not believe such cases should be contested in the courts and the women involved should receive the full support of the State.
The advice of the Attorney General Séamus Woulfe will be required to assess if the State can prevent such legal cases from being taken.
Meanwhile, political leaders have called for accountability in response to the controversy.
Government figures are not ruling out further accountability measures but are insisting all of the facts must be established first.
More than 2,000 people contacted the CervicalCheck helpline over the weekend and return calls to these individuals will continue today.
The Oireachtas committee on health will meet this week and consider bringing in the HSE, the Department of Health and CervicalCheck to answer questions on the matter.