Latest: Minister sends in medical team and launches helpline as CervicalCheck admit 'we could have done better'
The clinical director of CervicalCheck has today admitted that they could have done a better job of informing women about abnormalities in their smear tests.
A total of 206 women who developed cancer were wrongly given the all-clear, which was only discovered when their tests were reexamined after they were diagnosed.
Some of these women are yet to be informed of the mistake but now everyone who develops cervical cancer is told their smear will be reexamined.
Clinical director of CervicalCheck, Grainne Flannelly, says they welcome the independent review that has been ordered.
"We can all look at setting up new processes and saying 'we should have done better'," she said.
"I think in this scenario we could have done better in just trying to fast-forward the processes that we needed to do
"The system as it currently is.. all new women who have been diagnosed with cervical cancer have [been] given an information leaflet."
Her comments comes as it emerged the Minister for Health is to send a senior medical team into Cervical Check to take charge of the situation.
RTE report that the move is being done to ensure woman who may not have been told their cases have been audited will be informed after the weekend.
The broadcaster has also revealed that the Minister is to launched a helpline which will be operational from tomorrow.
The helpline can be contacted at 1800-454-555 from 9am tomorrow morning.
The Irish Countrywomen’s Association (ICA) has today paid tribute to Vicky Phelan for her "strength, courage and bravery in pursuing the matter of her cervical cancer case".
"Had Ms Phelan had the earlier intervention that she was entitled to, her prognosis would likely be a lot less guarded," a statement from the group read.
"It is in large part thanks to Ms Phelan that the public are now aware of this debacle which affects scores of other women."
The ICA has now called on the Government to ensure that the 206 patients thought to be affected are contacted immediately, with the offer of the best possible quality of care; immediately establish a helpline for women who have been affected; and to fast-track the proposal for Patient Safety Legislation to Cabinet.
Taoiseach Leo Varadkar has said that the Government will establish the full facts after it emerged that over 200 women may have been wrongly given the all-clear after their cancer tests.
"In terms of individual personnel, like I say, the Minister has initiated a review," he said.
"I don't want to be condemning any individual at this stage without knowing the facts, but we are going to make sure that we establish the facts of this affair.
"We want to make sure as well as a Government, that something good comes of this."
The Health Minister says he cannot have confidence in the managers of Cervical Check.
It has emerged more than 200 women may have been wrongly given the all clear after their cancer tests.
The Taoiseach has said he thinks most of them have since been informed but they are investigating that and have written to doctors.
Health Minister Simon Harris was asked if he has confidence in the managers of Cervical Check.
"I have full confidence in the screening programme," he said.
"It's so important that people use the screening programme, it saves lives, it has detected cancers and it helps reduce the rate of cervical cancer.
Truthfully in answer to your question, I can't say that I do [have confidence in the managers of Cervical Check] currently and that's why I've ordered a review.
"It is important that that review is allowed do its work."
The clinical director of the CervicalCheck programme says she is confident the system will stand up on review.
Grainne Flannely was asked for her response to the Health Minister's criticism of the managers of CervicalCheck.
"What he did say is that he has confidence in the cervical screening programme and recommended that women still take part in the screening programme," she said.
"Obviously he has considered a peer review or our programme. We would welcome that.
We think that our programme, on a peer review, will stand up with any other programme in the world.
Earlier: Simon Coveney asks women to 'continue to believe' in cervical check system
Tanaiste Simon Coveney has appealed to women to continue to believe in the cervical check system, saying some 250,000 women each year had smear tests under it and each year cervical cancer was down 7% as a result.
“I do want to appeal to people to continue to believe in that system, “ Mr Coveney said.
He was speaking on Radio Kerry during a visit to Killarney to celebrate the Liebehrr family and a €18 million refurbishment of the Dunloe Castle Hotel as part of their 60 year commitment to Killarney where they employ well over 1,000 people in engineering, manufacturing and hotels.
Mr Coveney said Vicky Phelan was an extraordinary person in highlighting through very tragic personal circumstances for her and her family a flaw in the cervical check system.
The policy changed in 2016 and an audit system introduced . There is an audit system to check previous smear test history. Doctors will now be required to pass information onto patients, and patients will automatically receive the information, Mr Coveney said.
Both the Department of Health and the HSE were looking into decision making process around what happened in the case of Ms Phelan, he also said.
“There are 250,00 women every year who have smear tests as part of the Cervical Check System. That system has been very, very successful in terms of reducing the rates of cervical cancer in Ireland which is down is down 7% every year since that checking system was introduced.
I do want to appeal to people to continue to believe in that system.
“Where there was a significant flaw here which is now being changed is that if a woman subsequently is diagnosed with cervical cancer, then there is an automatic check to see whether that person had had a smear test before that and why something wasn’t shown up. It’s in that audit system that unfortunately for Vicky Phelan a negative smear test was discovered but she wasn’t told about that and she should have been.”
Earlier: Outsourcing cervical test results to US labs makes it difficult to discuss findings
Questions have been raised about why cervical test results are outsourced to US labs.
Sam Coulter Smith was the Master of the Rotunda Maternity hospital when the decision was taken to stop checking results in this country.
He says it has made it hard to discuss findings.
"There were multidisciplinary meetings which were transatlantic, across timezones, across video conferencing," he said.
"[There were] language issues around it in different countries.
That goes some way towards explaining how we are where we are.
Not all women who have gotten incorrect test results have been informed yet.
The former Health Minister James Reilly has been highly critical of the failure to inform them sooner.
He says the current situation is 'untenable' and wants to know exactly who is to blame.
We need to know who made the decision not to inform patients? Who made the decision not to tell their doctors?
"We really need to do this urgently because this is a hugely important programme," he said.
Earlier: Up to 200 women may have had cancers missed in smear test
Update 8.05am: Up to 200 women who later developed cervical cancer had the same missed smear test as Vicky Phelan, it was admitted last night.
In the wake of the Phelan case, Health Minister Simon Harris yesterday ordered Cervical Check to write to the doctors of the women to ensure they communicated the error, where cancer indicators were missed.
Health Minister Simon Harris has said that up to 15 women a year since 2008 should have had their cases escalated in the wake of a smear test but did not.
Mr Harris and Tánaiste Simon Coveney apologised to Ms Phelan for the abject failure in informing her of her condition.
Mr Coveney said: “This is a shameful series of events, particularly in terms of information flow. The tragedy and challenges Vicky Phelan and her family are facing now have been made all the more difficult because of the failings in terms of the passing on of information. And for that I want to apologise to her and to her family.”
Mr Harris said the doctors in all of these cases would have been informed of the misdiagnosis but the letters are to ensure patients are told.
“What we know is that, since 2016, doctors have been receiving the results of the audits in relation to the smear tests of their patients,” he said.
It is absolutely essential that we establish that those doctors told their patients of the outcomes of those audits. Today, Cervical Check will write to those doctors and ask those doctors to confirm that they have informed their patients.
To date, since the screening programme began a decade ago, there have been 3m scans performed and a total of 1,400 confirmed diagnoses of cervical cancer.
Responding to the public outcry following Ms Phelan’s €2.5m settlement with the company which examined her smear, Mr Harris said the doctors would be called on to ensure all women affected were told if they have not been already.
Secondly, he announced a new policy to ensure patients are told about such mistakes in a timely fashion automatically, as opposed to leaving it to the discretion of the doctor.
Ms Phelan was diagnosed with cancer three years after her smear test results of 2011 were incorrectly reported as clear of abnormalities.
By the time she had another smear test in 2014, she had cervical cancer.
Ms Phelan, of Carrigeen, Annacotty, Co Limerick, along with her husband, Jim Phelan, has sued the HSE and Clinical Pathology Laboratories Inc, Austin, Texas, over the smear test taken under CervicalCheck and analysed in a US laboratory. She was given six to 12 months to live in January this year.
The case was raised in Dáil during leaders’ questions.
Fianna Fáil deputy leader Dara Calleary asked:
What will change as a result of what we know now as a consequence of the bravery and courage of Vicky Phelan?
In response, Mr Coveney said there will be changes as a result of what has happened.
He also stressed the importance of maintaining confidence in the national cervical cancer screening service.
Two separate investigations are to be launched into the circumstances of how Ms Phelan was not told of her mis-diagnosis for three years.
Mr Harris has said an external review is to be conducted by the director general of the HSE.
“I envisage the review will be external, I envisage it will involve international expertise but I will ask the DG to further clarify that,” he said.
But I think what we should do with our screening programme, we should look to ensure we are following absolute best international practice.
Meanwhile, the Public Accounts Committee is to investigate any potential breach in policy and financial loss to the taxpayer because of the mishandling of the Phelan case. The Dáil’s spending watchdog is to write to the HSE, the Department of Health and CervicalCheck to examine what happened in the Phelan case.
