LAST WEEK THE HSE announced it was launching an “immediate rapid review” of what it described as an ‘IT issue’ which led to a failure to inform hundreds of women of their smear test results.
The HSE said this problem impacted on how results letters were electronically triggered, but has not given any more details on how the issue arose.
This revelation and the review that will follow is just the latest development in a multi-faceted controversy that started in April last year with one high profile court case.
Stephen Teap said he is disappointed to see “one mistake on top of another” 15 months after the controversy first arose and at a time when the health service is attempting to restore confidence in the screening programme.
“When new stuff comes out after the scandal and we’re not involved or spoken to about it, we see things reverting back to the old way. That’s disheartening when we see nothing being learned - it’s a massive step back.”
Speaking to TheJournal.ie Teap described the latest revelation as “a whole systems failure”.
“It’s another communication failure. The woman wrote to the minister’s office after she had exhausted all of her options with CervicalCheck looking for her results and it wasn’t escalated to get her answers. ”
He said patient representatives like himself, Vicky Phelan and Lorraine Walsh had also been “kept out of the loop”.
“It’s extremely frustrating, we weren’t told until 45 minutes before [the story broke on] the Six One news,” he said.
“We’re working hard trying to restore trust in this programme and it can ruin all the good work done. We can’t be repeating the same problems around communication failures all over again.”
The CervicalCheck screening programme, which offers smear tests to women aged between 25 and 60 every three years, tests for cell changes in the cervix.
It is not a diagnostic tool – it does not test for cervical cancer.
Of the cell changes that are discovered, they are classed as either low-grade or high-grade. Some of these changes can clear up without any treatment, but other abnormalities could develop into cervical cancer if left untreated.
As with any screening process, there is a margin of error and so there can be both false negatives and false positives. This does not necessarily mean there is any negligence involved on the part of the laboratory that is reading the smears.
When the scandal was first revealed, the main complaint related to a review of possible false negatives in cases where women had later been diagnosed with cervical cancer. These women were not told at the time that they were included in this audit, or that they had previous false negatives.
In some cases, affected women and their families are claiming that there was also negligence in the reading of their smears by the labs (two of which are in the US). They claim their incorrect results do not fall under the normal margin of error of the screening programme.
Vicky Phelan won her High Court case and was awarded €2.5 million.
An audit that had been carried out after she was diagnosed with cancer revealed a 2011 smear test was a false negative. Phelan was not told of the result of this audit until 2017. By this time she had been diagnosed with cancer.
The HSE said reviews of smear tests found that in more than 200 cases there should have been an earlier intervention.
A helpline, which went down for the first 90 minutes of operation, was opened by the HSE for affected women to call. Health Minister Simon Harris also said the State would cover the cost for any women who was concerned and wished to have a repeat test to “reassure them”.
CercivalCheck clinical director Dr Gráinne Flannelly informed the HSE that she was stepping down from her position.
The HSE revealed 17 women whose cases were reviewed as part of the CervicalCheck audit had died. It had not been determined whether their deaths were caused by a delayed diagnosis.
Another woman who had a delayed diagnosis uncovered in the review went public with her story.
That woman was Emma Mihc Mhathúna, who told RTÉ in her interview that she had just been told that her diagnosis was terminal.
One of her smear test in 2013 had incorrectly come back as normal. She was first diagnosed in 2016 and had been given the all-clear in 2018 but the cancer returned.
Emma and her daughter Natasha had featured in a video produced by the HSE in a bid to increase the uptake of the HPV vaccine.
“My children are going to be without me and I’m going to be without them. I tried to do everything right … I don’t even know if my little baby is going to remember me,” she said.
HSE boss Tony O’Brien, who had announced he was stepping down, appeared before the Oireachtas Public Accounts Committee to answer questions about the scandal.
O’Brien said anyone found to have failed in their duty would be held to account.
Dr Gabriel Scally was appointed to lead an examination into the CervicalCheck screening programme.
His team was tasked with investigating details of the non-disclosure of information from CervicalCheck audits to patients. Scally was also asked to look at the the tendering, contracting and operation of the labs contracted by CervicalCheck.
The Taoiseach promised that the government would endeavour to ensure that no woman would have to go to court, stating that mediation would be offered in all cases. He would later have to roll back on that.
Health Minister Simon Harris agreed to fund a new patient advocacy service to assist those affected by the CervicalCheck scandal.
At the end of June, Emma Mhic Mhathúna agreed to a €7.5 million settlement over her incorrect smear test results.
As part of the settlement, the HSE admitted liability for failing to disclose the findings of the audit while the laboratory Quest Diagnostics admitted liability for misreading the smears.
Another high profile case, that of Ruth Morrissey, came before the High Court.
Ruth and her husband Paul Morrissey told the court that she had two smear tests incorrectly reported and that she now had terminal cancer. They took a case against the HSE US-based lab Quest Diagnostics and Irish firm Medlab Pathology Ltd.
Vicky Phelan criticised the fact that impacted women were still forced to go to court for compensation, despite Taoiseach Leo Varadkar’s assurances.
Varadkar acknowledged that he should have been more clear when making promises back in May, stating that mediation is “not the holy grail” in all cases.
Stephen Teap accused the Taoiseach of being more “reactive than proactive”.
He spoke of the “brutality” of the courts process for the women affected, who he said shouldn’t have to fight their corner.
It emerged that some women may have to get repeat cervical smears as their samples were going out of date because of the backlog.
“I am aware of reports of a recent development of a bottleneck in the analysis of cervical smears, whereby smears are not analysed in a timely fashion thus forcing the woman to re-attend and the doctor to repeat the smear,” Dr Rita Doyle of the Medical Council said.
“This is unacceptable to both patients and doctors. This could have the potential to have a further negative impact on the public’s confidence in screening services which would be very concerning.”
Dr Scally’s report was published, but not before part of it was leaked to the media. He made 50 recommendations in total.
In it he said there were significant failures in the governance structures of the screening programme, describing it as “doomed to fail”. The biggest failure, he said was the non-disclosure of information from CervicalCheck audits to patients.
Scally also said members of the medical profession needed to sit down and hear from the women impacted by the scandal.
The Taoiseach said he was “embarrassed for his own profession” reading the report.
The HSE confirmed 94% of women who responded to a request to be included in a review of smear tests had given their consent.
Over 1,300 letters were sent to women who had been diagnosed with cervical cancer since screening began in 2008 as part of the review by the Royal College of Obstetricians and Gynaecologists (RCOG).
Emma Mhic Mathúna died, just five months after being told her cancer was terminal. At her funeral in Kerry she was described as a wonderful mother, funny, and a woman with an unbreakable spirit.
The 221+ CervicalCheck patient support group was launched by Vicky Phelan, Lorraine Walsh and Stephen Teap.
Left Behind / SoundCloud
It emerged that a consultant in the Mid-West had written to Health Minister Simon Harris in October warning him that the offer of free repeat smear tests was “dangerous” and it would put the screening programme at risk.
“It is impossible to meet the current demand within recommended guidelines, making the system unsafe,” he wrote in his letter, telling the minister that his region alone had seen a 300% increase in referrals for further examination.
A month and a half after Harris had announced free repeat smear tests would be available, the Sydney based company that runs the laboratory in Dublin tasked with examining smears had also expressed concern.
The CEO of the company that runs the lab warned that the situation was “critically urgent” as staff struggled to deal with a huge surge in tests coming into the lab.
TheJournal.ie also revealed that the CervicalCheck Project Team, which is a team of Department of Health officials and cancer experts, asked the minister to end the offer of free smear rechecks as it was putting pressure on the healthcare system. By October 2018 there had been 42,000 out-of-cycle (repeat) smear tests taken.
“…screening programmes are a balance of benefit and disbenefit. The frequency of screening is a key factor in achieving this balance. Overscreening, with smears taking place too frequently, is likely to tip the balance towards increased harms from screening.”
Campaigner Orla Church, who received false negatives on her smear tests in 2011 and 2014, died. She was described by the 221+ support group as “a wonderfully courageous, strong and inspiring person” who campaigned tirelessly for all of those affected by the scandal.
The HSE confirmed it had been aware since November that thousands of women would need repeat smear tests. This was because HPV tests in one lab (carried out as an additional process with low-grade abnormality smears) were being done outside the recommended timeframe.
Speaking to the Oireachtas Health Committee, representatives from CervicalCheck said there were 78,000 slides in the smear test backlog.
They said they were concerned about the length of time it was taking for results to come back – an average wait of 93 days at the time.
A new report from Dr Gabriel Scally was published as part of his review of the CervicalCheck programme. He expressed concern that the “deeply flawed” open disclosure policy that existed prior to the scandal remained in place.
He also said the HSE’s implementation plan may be “overly-ambitious” with too many activities concentrated within a single time period.
The Department of Health confirmed the cost of providing out-of-cycle smear tests was €9.6 million.
May 2019
The High Court awarded €2.1 million to Limerick woman Ruth Morrissey and her husband Paul over the alleged misreading of her cervical smear tests and the failure to inform her about it.
Speaking to reporters outside the court, Morrissey said she wanted to “move on and spend whatever quality time I’ve left with my daughter”.
In making his award, Mr Justice Cross had said standard of ‘absolute confidence’ should be enshrined in the screening programmes so that the possibility of delivering false negative results could be eliminated.
The Royal College of Surgeons warned this statement could have a “grievous impact” on cancer screening programmes as there is always a risk of false negatives and false positives.
A new report from Dr Scally raised concerns about outsourcing as it revealed smear tests from Ireland were sent to 16 different laboratories. Particular concerns were raised about the lab in Salford in the UK, which Scally said only received accreditation retrospectively from the Irish National Accreditation Board (INAB).
The Taoiseach described the outsourcing of testing by companies the HSE had contracts with to other laboratories was “serious” and could be a breach of contract.
The State Claims Agency decided to appeal the judgement in Ruth and Paul Morrissey’s case to the Supreme Court.
Minister Harris said there was concern about the phrase “absolute confidence” and the impact this definition in the judgement could have on screening services. He said he “would like a mechanism” to protect Ruth Morrissey’s award.
Appearing before the Oireachtas Health Committee, Dr Gabriel Scally said the emphasis on price in the HSE’s procurement process for screening tests became a more important factor than quality assurance.
His most recent report had shown the emphasis on quality assurance dropped from 25% in the 2008 tender process for laboratories to 15% in the 2012 tender.
Meanwhile, the weighting for the fee proposal increased from 20% in 2008 to 40% in 2012.
The committee also heard that laboratories that had been visited over the years by the screening programme’s quality assurance team “didn’t include many of the places to which the work was actually being sent”.
On 12 July, the HSE ordered a rapid review after 800 women did not receive their CervicalCheck test results because of an IT glitch.
The issue occurred at Quest Diagnostics Chantilly facility in Virginia, USA which currently performs HPV testing for the CervicalCheck service. The affected tests took place between 1 October 2018 and 25 June this year and were mainly repeat tests for HPV that had to be done because previous tests were not completed within the appropriate timeframe.
The HSE said it became aware of the problem in June – Minister Harris said he only became aware of it last Wednesday. His department had said it became aware of the existence of the ‘IT issue’ on 25 June through information supplied by the HSE.
However correspondence obtained by RTÉ has revealed a private secretary for the minister wrote on 6 June to the woman whose case brought the issue to the fore.
Meanwhile, the backlog of smear tests continues to create issues. One woman told TheJournal.ie that her GP noticed a visual abnormality in her cervix during her smear test and she was told she would have to wait until the results were back before she could get an assessment.
A consultant in one of the country’s 15 colposcopy clinics said that before the scandal, in situations like this where a visual abnormality was noticed, the woman would be given an appointment before her results were back:
We had the capacity to see them in the clinic and still be able to see patients with abnormal smears in an appropriate time frame , but now we can’t because of the increased number of patients.
He said there is now a “long waiting list of people to be seen in colposcopy who could have cancer”.
The Health Minister has said the backlog will be “effectively gone” by mid-September when the Dáil and Seanad resume after the summer recess.
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