HSE apologise and reveal 1,482 of 3,000 women diagnosed with cervical cancer since 2008 have been audited

HSE apologise and reveal 1,482 of 3,000 women diagnosed with cervical cancer since 2008 have been audited
Vicky Phelan.

Update - 9.08pm: The HSE have released a statement reiterating its deepest apologies to women for any worry caused by the CervicalCheck debacle.

They have revealed that around 3,000 women in Ireland have been diagnosed with cervical cancer in the past 10 years, and CervicalCheck carried out an audit of 1,482 previous cervical screening tests on those women.

Meanwhile, the Health Minister Simon Harris could bow to mounting pressure and replace the Government's planned cervical cancer HIQA-led inquiry with a full-scale commission of investigation after revealing the number of women affected could be "double" what was previously believed, writes Fiachra Ó Cionnaith.

Mr Harris contradicted Taoiseach Leo Varadkar by saying he is open to scrapping the initial HIQA plans after saying a "potentially considerable number" of cervical cancer cases over the past decade have failed to be included in the initial HSE review.

While admitting "quite frankly I don't know" how many more women are involved, Mr Harris said he agreed with Fianna Fáil health spokesperson Stephen Donnelly's suggestion the latest revelation could "double" the current 208 women affected by the scandal.

Watch the Dáil debate below

They said that the audit is used to test and assure the standard of work that is being done and it was undertaken after the women were diagnosed.

They said: "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.

"When CervicalCheck is notified that a woman has been diagnosed with cervical cancer, the women’s previous screening history can be reviewed. 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.

They said more than three million cervical screening tests have been performed in Ireland since 2008, and more than 50,000 cases of pre-cancer and cancer have been detected and treated following cervical screening.

Further information and updates for the public will be provided over the coming days on cervicalcheck.ie.

Update - 8.53pm: A patient advocacy group says women affected by the CervicalCheck debacle just want the truth.

CEO of Patient Focus, Brigid Doherty, says women she has spoken to could have avoided serious medical intervention if their irregular smears had been caught earlier.

She said: "Both of those were in their late 30s, early 40s, and they had hysterectomies so the choice is taken away from them.

That's huge, if you haven't completed your family.

"So, yes, disappointment, anger, but the big issue for the majority is the lack of communication, the open, honest communication.

"Of course this is what has affected the trust in the service, are we going to be told the truth?"

Update 7.43pm: A "potentially considerable number" of cervical cancer screening tests undertaken by Cervical Check have not been audited - meaning the scale of the cervical cancer crisis could be far higher than first believed, writes Fiachra Ó Cionnaith.

Health Minister Simon Harris told the Dáil tonight that the numbers revealed so far this week may not be the full picture.

The fresh revelations mean there could be many more women who should have had their initial smear tests acted on.

Earlier today, the Irish Cancer Society met with the Minister to seek reassurances on behalf of the women affected by the CervicalCheck scandal and all the women who are now worried about their smear results.

At that meeting, Minister Harris agreed to the society’s request that a letter be sent to all women of screening age addressing any concerns they may have about CervicalCheck and highlighting the value of the service.

Averil Power, Chief Executive at the Irish Cancer Society, said: "Vicky Phelan has repeatedly stressed she doesn’t want her experience to put women off going for smear tests. It is essential this message gets through to the women of Ireland and they are not deterred from availing of a test that could save their lives.

"Understandably, many women are confused and worried at present. It is essential the Government reassures them by writing to them, answering their questions and highlighting the value of the service."

Ms Power welcomed the Minister’s commitment to the move, and stressed that "everything possible must be done to help all the women affected by testing errors, and their families, on a one-one basis".

She said: "The Independent Clinical Review process must be set up as soon as possible and carried out in a supportive, patient-centred way.

"We want to make sure these women get the right support, clinical, psychological or otherwise."

Speaking at the start of the Dáil debate, Mr Harris said he was told in recent days that all cervical cancer cases notified to the National Cancer Registry since 2014 had been audited to ensure all correct measures were taken.

However, in a shock move, the Health Minister said he has now learned "this is not the case".

He said: "I have to inform the House of some emerging information that I have received late this afternoon from the serious incident management team.

"While I had previously been advised and it had been commonly understood that the Cervical Check clinical audit covered all cases notified by the National Cancer Registry, I have been informed this afternoon that this is not the case.

While Cervical Check 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.

"These are not new cases of cancer. Nor is it a group of women wondering if they have cancer. These are women who have already been diagnosed with cervical cancer and treated as such but their cases have not been included in a clinical audit," Mr Harris said.

"Vicky Phelan's case has highlighted a number of weaknesses in how people engage with health services.

"Given the gravity of the situation, it is vital we introduce a process where everyone understands what happened and what needs to be done to rectify it.

"In the last two days significant progress has been made in contacting the 162 women whose audit results showed anomalies."

He revealed that the 1800 45 45 55 helpline had got around 6,000 calls by yesterday evening.

Reacting to the news Sinn Féin's health spokesperson Louise O'Reilly said it was "outrageous" that the scale of the issue was not yet known.

"There are women watching us this evening that are not aware of their own medical records - that is outrageous."

Fianna Fáil health spokesperson Stephen Donnelly went on to describe evenst as an "outrage".

"What we have seen so far is nothing short of an outrage ... and it has led to widespread fear and anger across Ireland."

Labour's Alan Kelly says the Minister has dropped a bombshell with the news.

Mr Kelly said: "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?"

Update 5.56pm: The Health Minister Simon Harris is making a statement in the Dáil on the CervicalCheck scandal in the next hour.

The Department of Health has released the briefing note given to Simon Harris before Vicky Phelan's case went to court.

It says not telling her about the audit of her cancer test was not a patient safety issue.

HSE apologise and reveal 1,482 of 3,000 women diagnosed with cervical cancer since 2008 have been audited

3.09pm: CervicalCheck memo: Dept was told Vicky Phelan case was not 'a patient safety incident'The Government has published a briefing note sent to Health Minister Simon Harris concerning the Vicky Phelan CervicalCheck case.

The note was sent to the minister on April 16, before the case was heard at the High Court.

It says "that publicity around the case and/or settlement is likely".

The National Screening Service and Jerome Coffey, Head of the National Cancer Control Programme, advised the Department of Health in writing that "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 has "low sensitivity" of 60%-75% which means that it "produces a not insignificant number of false negative results", saying the "known limitation" is one of the reasons women are screened regularly.

It says 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."

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.

HSE apologise and reveal 1,482 of 3,000 women diagnosed with cervical cancer since 2008 have been audited

Update 2.59pm: Women suing the State over cervical cancer misdiagnoses will not be dragged through the courts, the Dáil has heard.

Taoiseach Leo Varadkar said he has asked Attorney General Seamus Woulfe to settle cases quickly without legal actions, writes Juno McEnroe.

The Cabinet met this morning and discussed the fall-out from the Vickie Phelan case and the fact that three quarters of 208 women with cancer were not told of a delayed diagnosis.

Ms Phelan was forced to go to court where her case was settled but this was after the Government were aware of her situation.

Facing Dáil questions, Mr Varadkar said that it would be months rather than years before an inquiry would finish its work into the cancer tests scandal.

HSE apologise and reveal 1,482 of 3,000 women diagnosed with cervical cancer since 2008 have been audited

He also ruled out for the moment a commission of inquiry looking into the failed communications and inaccurate tests controversy as it would take too long and involve lawyers.

However, Labour's Brendan Howlin warned that HIQA may have limited powers during its investigation, including making adverse findings.

Mr Varadkar also told the Dáil that, as a former minister for health, he was not aware of patient safety issues around cervical cancer checks or any audits of such.

The Taoiseach has also said he will not fire HSE boss Tony O'Brien, saying there is no proof that sending the smear tests abroad for examination meant they were any less accurate than if they had been examined here.

Mr Varadkar said: "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.

"I explained why that is not yet supported by the facts and I think everyone, even Tony O'Brien, deserves a fair hearing before they are condemned."

Health Minister Simon Harris has later today agreed to take questions over Ms Phelan's case and the patients who were not told about inaccurate tests.

He will also publish documents, redacted, given to him in the lead-up to Ms Phelan's court case earlier this year and what advice was given about patient safety.

2.33pm: Simon Harris answers questions surrounding CervicalCheck smear test controversy

Minister for Health Simon Harris is answering questions in the Dáil surrounding the CervicalCheck smear test controversy.

The Department of Health is also expected to publish a memo that was sent to the Minister three days before Vicky Phelan’s High Court case over her treatment.

The memo reportedly indicated women were not automatically being given the results of their smear audits.

The Health Minister is due to clarify what he was told before the situation became public knowledge.

The Sinn Féin leader Mary Lou McDonald says the scandal means the head of the HSE Tony O'Brien should resign.

She said: "I think his position is untenable, I think he should step aside and if heis not prepared to do that I think he should be sacked."

Mary Lou McDonald.
Mary Lou McDonald.

Update 1.15pm: The Director General of the HSE Tony O'Brien said there was no question of anyone in the Cervical Check programme seeking to withhold information about cancer diagnoses.

He also said that he has not given any consideration to stepping down.

Tony O'Brien
Tony O'Brien

Tony O'Brien says the clinical review of cases was triggered by cases of cancer. Tony O'Brien told RTE's Sean O'Rourke that it is an issue of concern and disappointment that he wasn't informed of Vicky Phelan's case, but this is secondary to the work of the serious management team, dealing with cases and restoring confidence in the Cervical Check programme. Hea said: "That's kind of secondary to the bigger issue now, which is the crisis of confidence which has ensued."

Clarifying what he meant by secondary, he said "not for today".

Mr O'Brien added that a case management will be undertaken to find out why Vicky Phelan's case was not escalated in the way it should have been. He said the fact that he used to be the director of Cervical Check, makes this quite personal for him.

By international benchmarks, he said, the labs were performing as they should be and were subject to high quality standards. In addition, he added that the US labs are only dealing with Irish patients and Irish smear tests are not being mixed in with a greater cohort of US patients, who are tested yearly.

The smear test is not, he stressed, a diagnostic test but a screening one and there is no laboratory in the world that can provide 100% accuracy on that type of cytology.

"The reality is that the cytology test is not 100% effective, it has a level of assurance which is well below 100%. All of the literature, all of the information given to anyone who uses the Cervical Check programme makes it clear and the term that's often used about women getting the all clear, no one gets the all clear, either an abnormality is detected or it's not," he said.

He explained that liability arising from an error, outside the exceptional margin of error, would lie with the laboratory. Mr O'Brien said the HSE is working hard to restore confidence in the programme.

This included, he said, new clinical governance and the establishment of a helpline to offer reassurance to women. Anyone, he said, that wanted their case to be re-examined would be accommodated. He said that explanations from former Clinical Director of Cervical Check Professor Grainne Flannelly, while not satisfactory, were the truth.

"She was telling the truth that while she had engaged in a process which sought to have women informed, there was a missing link in that process," he said, "in that the central programme office did not have verification that individual women had been provided with that information'.

He said she stood down because she is deeply committed to the programme and wanted to help restore confidence in it. Mr O'Brien said there wouldn't be a programme without her commitment over the last number of years. He also said that he spoke to Professor Flannelly at length before she announced her resignation, asking her to consider carefully her decision.

He also spoke of being in favour for a mandatory duty of candour being enshrined in law.

Meanwhile, a patient advocacy group says the CervicalCheck scandal has shown we have gone backwards in terms of Open Disclosure.

Several inquiries are due to take place into how 17 women died who had been screened for cervical cancer.

Donal Buggy, Irish Cancer Society
Donal Buggy, Irish Cancer Society

162 out of 208 women whose files were audited were not told they were part of a HSE lookback.

Bridget Doherty is CEO of Patient Focus – and they have been hearing from women who had abnormal smears that were missed – as well as those who could have had earlier, less invasive treatment.

"We have talked for years about Open Disclosure so why they didn't practice this this time, we just want to know why," said Ms Doherty.

It's not acceptable. We are absolutely horrified and we're disappointed because we're gone backwards in a sense.

She described the impact on the women who have been in touch with Patient Focus.

"Both of those were in their late 30s-early 40s and both of those had hysterectomies so you know, the choice is taken away from them and that's huge if you haven't completed your family."

A HIQA investigation will now take place – with the terms of reference due in around two weeks.

A clinical investigation will also take place, but will that be enough to restore confidence in cancer screening programmes?

Donal Buggy from the Irish Cancer Society says while they have no specific concerns about breast check and the Bowel screen programme – there will need to be changes.

"We would like to see them internationally benchmarked against best practice and that information to be made publicly available on an annualised basis as part of this review in order that we can have the confidence that our screening services in Ireland are as good as the screening services anywhere else in the world.

"And that's the minimum that we should expect."

Update 1pm: Elaine Loughlin, Political Correspondent

Sinn Féin president Mary-Lou McDonald has called on HSE director general Tony O'Brien to resign in the wake of the CervicalCheck scandal.

The Dáil is due to discuss the failures in cervical screenings this afternoon after emerged that 17 women who initially received incorrect results have since died. their cause of death is as yet unconfirmed.

The HSE have also confirmed that at least 208 women who have been since diagnosed with cervical cancer were initially told their tests were negative.

Speaking outside Leinster House, Ms McDonald said she "doesn't believe for a second" that a "a full appreciation of the scale" of the the failings within CervicalCheck.

She said Tony O'Brien was told "categorically" that the outsourcing of smear tests to the US had led to cases being missed.

"He was told this by the very committee that had responsibility for quality assurance, Tony O'Brien, from what I can ascertain, ignored that advice up to and including a scenario where the committee charged with quality assurance stepped aside, now that's quite and astonishing turn of events," she said.

"Tony O'Brien presides over the HSE an organisation, and let it be said with the backing of Government, that has aggressively pursued women though the courts in circumstances where they knew that fault was on the side of the State and the HSE itself and yet he has seen fit to preside over all of that.

"My view is that Tony O'Brien's position is untenable, I don't believe he has credibly led the HSE," said Ms McDonald.

Update 12pm: Fianna Fáil have called for a memo given to health minister Simon Harris about cancer patient Vickie Phelan's case to be published in full and for a Dáil debate on the tests scandal.

Speaking in Leinster House this morning, health spokesman Stephen Donnelly said he had met the minister and officials but that the five-page memo was redacted.

Fianna Fáil want the memo published.

Fianna Fáil's Stephen Donnelly.
Fianna Fáil's Stephen Donnelly.

Mr Donnelly was highly critical of a the culture in the Health Service Executive which he said was “rotten” and “quite possibly sinister”.

But he said the focus this week on the cervical cancer controversy must be on the women and their families and in particular those who were not told about their false negative cancer tests.

We now know sadly some of them are deceased. In the first instance, the focus must be on engaging with those women, with those families, providing support, providing counselling where needed.

There was also a need to look at how the information had been disseminated, it was added.

He said after meeting Minister Harris this morning that they had looked at the memo of the information given to Mr Harris on April 16, just days before Ms Phelan's case went to court.

He said there were important questions that needed to be asked such why women were not told of the false negative test results, who took that decision within the HSE and why clinicians had not passed on information to patients.

The party want to know who ultimately made a decision to withhold the information for years.

But Mr Donnelly also had some tough words for the HSE, adding that there was a culture of gagging orders and not passing on clinician information.

“There is a culture in parts of the HSE which I believe is rotten, is potentially quite sinister and has not served the public well,” he said.

- Juno McEnroe

Update 10.45am: Doctors will have to inform patients of screening programme problems under proposed Patient Safety Bill

Doctors will have to inform patients of problems with screening programmes – under a proposed Patient Safety Bill.

The Health Minister Simon Harris says mandatory open disclosure will apply for serious reportable incidents – including screening.

162 women with Cervical Cancer were not told they were part of a review of the Cervical Check programme, and could have benefited from earlier intervention.

Andrew Jordan from the National Association of GPs says patients deserve to be told everything about their care.

He said: "We have a responsibility to people, if somebody has a terminal diagnosis we owe them, we have a responsibility, they have to put their affairs in order, they may need to make a will.

"If you don't inform the patient you may deny them that opportunity, so you haven't got the right not to disclose."

Simon Harris.
Simon Harris.

It is also being reported that a memo given to Health Minister Simon Harris about the cervical cancer scandal on April 16 stated women were being told about the missed diagnoses.

There have been calls for Mr Harris to publish the memo in the Dáil this afternoon.

According to Independent.ie the memo referred to Vicky Phelan's case and is unlikely to be published because it contains Ms Phelan's personal information.

Earlier: Cabinet to approve statutory investigation into CervicalCheck scandal this morning

The cabinet will approve a statutory investigation into the CervicalCheck scandal this morning.

The Minister for Health wants HIQA to investigate why 162 women were not told their smear tests were being reviewed.

208 women had their smear tests audited but just 46 of those were informed - meaning the remainder did not know there might be a problem with their cancer check.

17 women who were part of the review died.

Vicky Phelan.
Vicky Phelan.

The figures came to light after terminally ill Vicky Phelan settled a case last week after having her own diagnosis delayed, leading to her cancer being more developed when she learned of it.

Health watchdog HIQA is now being asked to carry out a root and branch review of the CervicalCheck programme.

It will look at communication with patients and quality assurance of the tests carried out.

The screening programme here will be compared with international best standards and HIQA will be asked to look at any implications for other cancer screening programmes.

An expert panel will also be set up to offer the women involved an independent clinical review and provide them with any supports needed.

Cabinet is expected to sign off on the plan this morning.

Next week Simon Harris will bring forward proposals to make it mandatory for doctors to have to tell patients about serious reportable events affecting them.

He believes affected women should get an independent review.

He said: "I think it is really important that women who have been impacted by this have an opportunity to have an independent clinical review probably with clinicians from abroad who can advise them of their case, all of that facts around it and indeed review their case.

"I then want that independent clinical expert panel to inform HIQA's investigation and the work of the international peer review group."

The Institute of Obstetricians and Gynaecologists says patients need to be informed of all results, including those of any reviews.

It is also encouraging women to continue having smear tests and is working to restore public confidence in the screening programme.

Dr Cliona Murphy, the Institute's Chair and Consultant Obstetrician at the Coombe hospital says screening is necessary.

She said: "It is important to remember that screening is a very important public health initiative and over the last ten years CervicalCheck has saved many lives.

"We would have expected maybe five times more women to die from cervical cancer if we did not have the screening programme."

- Digital Desk

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