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THE CLINICAL DIRECTOR of CervicalCheck has said that she’d be surprised if women didn’t have questions after Vicky Phelan’s court case over an incorrect smear test made headlines yesterday.
Phelan, who’s a 43-year-old Limerick mother-of-two, was awarded €2.5 million over a missed abnormality in a smear test in 2011.
When she returned for a routine smear test three years later in 2014, she was told she had cervical cancer. After a number of tests, she was told she had between six and 12 months to live.
In a statement to TheJournal.ie, the screening programme said “a small additional number of women” had been in touch yesterday after widespread publicity of the case, and that it was committed to answering women’s questions so that they’d have confidence in the smear programme.
Questions were raised about CervicalCheck’s process after it emerged that a 2014 qualitative review of the 2011 smear test showed that abnormalities in her smear test had been missed. Despite this, Phelan was not told about the missed abnormality until 2017.
Speaking to TheJournal.ie, CervicalCheck director Professor Grainne Flannelly said that she empathised with Vicky Phelan’s situation.
I can understand her frustration, I honestly can. It took time and you think, ‘How could it take so long to do that?’
It did take a long time, we deeply regret that it took a long time for this lady to be told.
Having a cervical cancer diagnosis is a very difficult thing and has a big impact on the woman and her family. We profoundly regret that this has happened.
She added that at the time, they were implementing a new process of reviewing historical smears. She said that since then, the process of reviewing smear tests, informing clinicians and their patients has since been “smoothened out”.
Late last night the HSE said that since 2008, a total 1,482 cases of cervical cancer have been notified to the CervicalCheck programme.
In 442 cases, a review was warranted and of those cases, 206 cytology reviews suggested a different result that would have recommended an investigation to occur at an earlier stage.
This broke down as 173 cytology reviews suggesting that a referral to colposcopy might have been recommended earlier and for 33 cases a repeat smear might have been recommended to occur earlier.
The Minister for Health Simon Harris and the Director General of the HSE Tony O’Brien met today and agreed that an international peer review of the CervicalCheck programme would be undertaken in order to ensure ongoing confidence in the programme.
The Director of the National Cancer Control Programme has been ordered to establish this review as a matter of urgency.
Missed abnormalities vs misdiagnosis
Flannelly said that after headlines about the case, there was a need to clarify and highlight certain aspects of the screening programme.
The first thing to say is that cervical screening programmes aim to prevent many cancers developing – that’s why we get up in the morning.
“We cannot prevent all cancers, but the smear test works really well in intervals – that’s not to say that it’s the perfect test.”
The average gap between smear tests depends on the age of the person: for younger women, incidents of pre-cancers are higher, so they need to be done every three years. For older women it’s every 5 years. There’s no need for smears more often than that based as those times are based on how fast pre-cancers develop.
Another important distinction is that these screenings are not designed to diagnose. They select women who would benefit from further examination. It actually works better if you have a pre-cancerous abnormality rather than a cancerous problem.
She said that in relation to the 2014 review of Phelan’s smear, when a woman who has received a smear test is later diagnosed with cancer, the screening programme reviews those initial tests to inform their process.
“We control the quality of the test as much as we can. Quality control reviews are embedded at all levels of the programme and we think that’s really important part of the process.
We need to learn from patients and women who develop cancer by looking at those smear tests and by looking back at their cancer and how they were diagnosed. This is not so much a review because there is a problem, but a quality assurance approach that was put into place in 2010. It’s a continuous process – it happens all the time.
It’s been suggested that there are other women whose smear tests were incorrectly interpreted and who weren’t informed.
In an interview on RTÉ Morning Ireland yesterday, the head of the National Cancer Control Programme Dr Jerome Coffey said that the decision on whether doctors should tell their patients the result of a review was “between the physician and the patient”.
Speaking to reporters yesterday, Minister for Health Simon Harris said that “it’s absolutely essential that we establish that those doctors told their patients of the outcomes of those audits”.
“So today, Cervical Check will write to those doctors to confirm that they have informed their patients.
We can’t just presume they did, or expect or hope that they did, we have to make it absolutely sure that they did so that women can have absolute confidence in relation to that.
Responding to reports that clinicians had been told to withhold information of incorrect smears from patients, Flannelly said that their direction to clinicians was that whatever the outcome of the qualitative review was, women needed to be given the option of knowing the results of their smear test reviews.
She added that in around half of similar cases in the UK where women receive serious cervical cancer diagnoses, women don’t want to know the results of those reviews.
Women who have had a cervical cancer diagnosis can want to focus on their treatment – not everyone wants to have the results of a review after a diagnosis.
Battling cervical cancer
She said that as it stands, one in 5 women haven’t had their smear test, “so it’s very important that the message gets out that women should be a part of this programme”.
She added that the CervicalCheck programme compared favourably to the NHS, and is still one of the most effective ways of preventing cervical cancer.
Every year around 250,000 women have smear tests through Cervical Check and that the programme has found over 50,000 women with pre-cancerous changes.
“It’s really important that women are reassured by our programme. They need to know that we take our quality metrics seriously and it’s maintained within a very narrow target.
“We’re trying to reassure women that quality underpins every aspect of the screening programme and that it holds its head high in context of other screening programmes around the world. It’s not perfect but we’re constantly trying to make it better.”
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So, it is not necessary to disclose to a patient that the patient has been the subject of an overlooked or missed Cervical scan check even if or when the error is subsequently discovered.
There is truism that sometimes the more serious problem is not the initial mistake but how the mistake is subsequently addressed.
Ahhh the HSE, the paragon of excellence in medical practice, and at least “learning lessons” from their, weekly, monumental fXk ups.
Going back a few years ago, I had to pay for a smear as I was under 25 (not covered on cervical check scheme under the age of 25). I paid my doctor surgery €150 for the nurse there to do the test. I received a phone call a few days later from the ‘Private out-sourced laboratory’ demanding payment of €80 something over the phone before they would release my test results. Test results eventually came back about 2/3 weeks later a letter from my GP to my home to say I had low-grade inflammation (didn’t know what that was at the time) and I had 3 repeat smears every 3 months after this.. never any follow-up. Fast forward a few years, I’m now 25 and applied for the free cervical check, I’m not filled with enthusiasm for the service having heard Mrs Phelan’s case and the couple of hundred other women who have been misdiagnosed. Playing with people’s lives is no joke.
The medical profession will always make some mistakes, if in doubt get tested again/& or seek other opinions! At the end of the day follow your instincts x
@Colette Kearns: You can get tested as often as you like, but when the results are false, when doctors are not obliged to notify you of results and when it takes years for results to filter through to you, then it’s too late. Multiple tests won’t help
@Colette Kearns: True, however there should be 100% trust in getting the initial check. The way it’s been handled, the outcome for some people is just unacceptable. My wife and sisters had the check, they are not tempted to hop over the border and get it done there again.
@Gerard McConnell: *now* tempted
I missed a cervical check due to a severe sports injury I got last year. Two months later i received a letter from the cervical check saying I was all clear for a test I never got.
@Eileen O’Sullivan: that is very serious. I hope you followed this up.
And who was it who missed the correct diagnosis on the smears? One individual or several? Regular HSE pathologist or a Locum?
@Rathminder: It’s a private lab. The HSE have outsourced the service. However, the bigger issue is that when they discovered the mistake, no one saw the necessity to inform the patient for 2/3 years by which time it was too late. It’s a chain of incompetency and complete disdain for people’s lives
@Rathminder: tested by cervical screeners. Used to be done in Ireland. They were read by two highly trained screeners, takes years to become proficient at this skill. They then outsourced to states where smears are read once only. In doing this they also lost all these expertise in Ireland. Very short sighted. Such an absolute shame.
someone make this decision and sentenced this poor women a criminal prosecution should be brought against this person or persons.
250000 per year x 8 yrs=2,500,000
206/2,500,000= 0.0000824 x 100/1
False negative result of 0.00824%
While I know there are people behind the percentage, no test is 100% sensitive and specific especially when it relies on human interpretation but a 0.00824% of being given the all clear when it may not of been are fairly good odds, the patients should of obviously been told as soon as possible and there is no excuse for that, while it wouldn’t of changed the clinical prognosis it would of alleviated a lot of the stress and emotional pain of finding 3 years later, that’s way open disclosure is very important for patient and doctor
@daveyt: apologies, I was a little off in the stats, true false neg is no. of false negs/(false neg + true positive) which comes in at 0.410309524757997%, if u take as quoted the true positives as 50,000, not as good as I previously said but still a good test,
Apologies again for the brain fart
@daveyt: Why has this and your previous post gotten only 3 likes?
I guess science and reason isn’t as interesting as panic and finger pointing. The level of hysteria over this case is astounding.
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