More than 200 women diagnosed with cervical cancer should have received earlier intervention than they actually did, reviews carried out by the State’s national screening programme for the condition have suggested.

The figures, that cover a 10-year period, were released by the Health Service Executive in the wake of the controversy surrounding Vicky Phelan, the mother of two from Co Limerick who was given incorrect cancer test results and is now terminally ill.

Ms Phelan settled a High Court action for €2.5 million earlier this week against a US laboratory over a 2011 smear test which wrongly gave a negative result for cancer. She was diagnosed with cancer in 2014 and only told of the false negative in the smear test in September 2017.

Government Ministers on Thursday apologised to Ms Phelan, with Tánaiste Simon Coveney acknowledging her case involved “a shameful series of events”.

International best practice

Minister for Health Simon Harris has now ordered a review of the cervical screening programme to ensure it is operating in accordance with international best practice.

The HSE last night said that since 2008 the CervicalCheck programme had been notified of 1,482 cases of women who developed cervical cancer.

It said in the majority of these cases there had been no requirement for further review.

These communications which related to events prior to the diagnosis had no impact on the care management and treatment of the women after they were diagnosed

However, in 442 cases – almost 30 per cent of the total – a review was warranted, and in almost half of these cases, earlier intervention was suggested.

According to the HSE, of those 442 cases, 206 cytology reviews suggested “a different result that would have recommended an investigation to occur at an earlier stage”.

The vast majority of these cases (173) suggested a referral to a colposcopy (examination of the cervix) might have been recommended earlier, while for 33 cases “a repeat smear might have been recommended to occur earlier”.

Minister for Health Simon Harris said a review would ensure that all women who had received incorrect cancer tests in recent years would be told of the outcome and that arrangements would be put in place to ensure it was automatic that women would be informed of incorrect results. File photograph: iStockPhoto

The HSE said treating clinicians were informed of the review findings and were asked to communicate directly with their patients as they considered clinically appropriate.

“These communications which related to events prior to the diagnosis had no impact on the care management and treatment of the women after they were diagnosed,” the HSE said.

Mr Harris and HSE director-general Tony O’Brien met on Thursday and agreed an international peer review of the CervicalCheck programme would be undertaken in order to ensure ongoing confidence in the programme.

Taoiseach Leo Varadkar, speaking in Belgium, said patients “have a right to know” if they they have been given a false negative test, and that there was a “duty of candour” on doctors to ensure that patients know as soon as possible.

Gráinne Flannelly, clinical director of CervicalCheck, said she regretted it took some time for some women to find out they had received incorrect test results from the national screening programme.

Previous clear tests

Ms Phelan’s solicitor, Co Tipperary-based Cian O’Carroll, has said that CervicalCheck documents released to him as part of her court case appeared to show a further 14 women in addition to his client who were diagnosed with cancer and who had previously had clear smear tests.

This balance is best judged by the clinician who knows the patients and who has been looking after the woman, taking into consideration the individual clinical context

Correspondence from Ms Phelan’s court case showed Dr Flannelly and Limerick gynaecologist Kevin Hickey clashed for more than a year over who was responsible for informing women in the Limerick area about the screening programme’s false test results: CervicalCheck or the doctor treating the women.

Dr Flannelly said she believed the doctors were the best people to decide whether to tell patients.

“There is a balance in terms of communicating the results of an audit, particularly where women are unaware of it’s [sic] existence, she wrote in August 2016.

“This balance is best judged by the clinician who knows the patients and who has been looking after the woman, taking into consideration the individual clinical context. It is therefore up to you as clinical lead to use your clinical judgment with regard to these individual reports.”

Dr Hickey told her in a letter in August 2017 – after more than a year of correspondence on the subject – that he thought it “totally inappropriate” that the treating clinicians had to inform the women about the tests, without the screening programme discussing the process directly with them or accepting responsibility for it.