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An independent investigation to be established by the Government into failures identified in the State’s CervicalCheck screening programme is to examine whether there may be implications for other cancer screening programmes, including BreastCheck or BowelScreen.
Minister for Health Simon Harris has confirmed the Health Information and Quality Authority (HIQA) will be asked to conduct an independent inquiry into the revelation that women diagnosed with cervical cancer should have received earlier intervention.
The cervical cancer test controversy arose after Limerick woman Vicky Phelan settled her action against a US laboratory, subcontracted by the CervicalCheck screening programme to assess the tests, without admission of liability for €2.5 million last week. Ms Phelan discovered that a 2011 smear test that had initially shown no abnormalities was, three years later, found to be inaccurate, but she was not told of the false test until September 2017. She is now suffering from terminal cancer.
It subsequently emerged that many other women had smear tests reviewed but had not been informed of the outcome.
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Following an audit over the weekend, the HSE said in the case of 208 women a negative smear test result was reversed. In total, 162 of these women - 17 of whom are now dead - were not told.
With the controversy deepening, more than 6,000 concerned women have contacted a Health Service Executive helpline since last Saturday.
The Cabinet will today discuss the scope of the HIQA investigation as well as a possible redress scheme for the women affected.
The issue is set to dominate proceedings in the Dáil this week, with Mr Harris expected to face questions about a briefing note he received from Department of Health officials on April 16th regarding the legal action brought by Limerick woman Vicky Phelan. The hearing of her action in the High Court commenced later that week.
The department had been notified of the impending case by the State Claims Agency a short time before that.
The Irish Times understands the briefing document advised the Minister that the case was being taken by Ms Phelan against a US laboratory but that the HSE was also being sued arising from the non-disclosure of the outcome of a cervical screening review.
Audit process
In an appendix to the briefing note the Minister was advised that all current and historical clinical cancer audit findings had been communicated to treating clinicians in 2016.
However, it also said that more recently women had been informed about the audit process and the options to request information.
The note said the department had been advised by the National Cancer Control Programme that it did not consider patient safety issues to be involved.
However, since Ms Phelan settled her action against a US laboratory subcontracted by the CervicalCheck screening programme to assess the tests, without admission of liability for €2.5 million last week, it has emerged that many other women had smear tests reviewed but had not been informed of the outcome.
Private correspondence disclosed in Ms Phelan’s case showed that doctors disagreed for more than a year over who was responsible for telling women with cervical cancer about the false tests.
Ms Phelan 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.
Taoiseach Leo Varadkar said yesterday the inquiry being set up 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”.
Lack of confidence
Meanwhile, HSE director-general Tony O’Brien yesterday said he would not have gone on television to express a lack of confidence in the management of the cervical cancer screening programme as Mr Harris did last Friday.
Responding to Mr O’Brien’s comments, the Minister last night said he was not “accountable to anyone within the HSE”.
“I didn’t have confidence and I didn’t think it would make sense to do anything but tell the truth in this situation. How could you have confidence? How could you possibly have confidence, there were letters appearing showing that a doctor who was heading up Cervical Check was writing to other doctors saying not to tell the patient?”
The inquiry being established will assess the level of knowledge in the HSE, CervicalCheck and the Department of Health, if the information was acted upon and if not, why not.
For the women involved, they will be offered the opportunity to meet an international clinical expert panel. Their findings will be sent to HIQA as part of their work.
Speaking yesterday, Mr Harris strongly criticised people working within the health service for failing to pass on important information to their patients.
Nothing could “cloud or mask” the fact that this had been kept from the women it affected, Mr Harris said.
“I genuinely don’t understand this, I genuinely don’t think the Irish public understands this, the idea that doctors received information pertaining to their patients and decided: ‘I don’t need to tell my patients that.’ And certainly, when all of us became aware of this in recent days and weeks, women not being told, I think people would have simply found that unbelievable,” he said.