The national cervical cancer screening service persisted with its policy of not directly informing women about misdiagnoses even after being repeatedly urged to do so by a gynaecologist for more than a year.
The dispute between CervicalCheck and Limerick gynaecologist Kevin Hickey over who bore responsibility for telling women they had been incorrectly given the all-clear on smear-test results is outlined in court papers.
One of the women, Vicky Phelan from Annacotty outside Limerick city, underwent a smear test in 2011 that showed no abnormalities but she was diagnosed with cervical cancer in 2014. It emerged from a 2014 audit of smear tests that she had wrongly received the all-clear, but she did not learn of this until September 2017.
Ms Phelan, whose cancer is terminal, received €2.5 million earlier this week in a settlement of her High Court action against US laboratory Clinical Pathology Laboratories in Austin, Texas.
Letters from Ms Phelan’s case show the depths of the dispute between CervicalCheck and Dr Hickey.
‘Inappropriate’
Dr Hickey told Gráinne Flannelly, clinical director of CervicalCheck, on July 19th, 2016, he felt it was “inappropriate for us” to tell the women their original smears had been re-reported showing different findings.
“It is the responsibility of the CervicalCheck to judge for themselves as to whether they have responsibility to these ladies to call them and acknowledge the alteration in their original smears after review,” he wrote.
Dr Flannelly replied on August 5th, 2016, telling Dr Hickey that there was a “balance” for healthcare professionals in communicating the results of an audit “particularly where women are unaware of its existence”.
“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,” she wrote.
Disagreed
“It is therefore up to you as clinical lead to use your clinical judgment with regard to these individual reports.”
Dr Hickey disagreed again in a follow-up letter.
“If their referral smears on review by the cancer screening service has been deemed to be a different result, then I think it falls to the cancer screening service to take the [responsibility] for this and to decide ultimately whether they wish this information to be relayed to the patients,” he wrote.
In October 2016, Dr Hickey offered to photocopy charts on the affected patients and to send them up to CervicalCheck so “she can decide if she wants to call the ladies in to discuss the audit with them herself”.
He repeated his objections again in a letter to Dr Flannelly in December 2016 because the treating clinicians “did not conduct the audit in the first place and also did not come up with the results”, he wrote.
On June 9th, 2017, Dr Hickey escalated his objections to Colette Cowan, chief executive of the University of Limerick Hospital Group, telling her that “the screening programme themselves should have a robust process in place to give further details of the audit process”.
Negative smear test
He referred to a case of one women who, just over a year before being diagnosed with cervical cancer, had a negative smear test only for the test to be re-reported showing that she had an abnormal growth of tissue. This was, he wrote, “a totally different result and of course could have impacted on her treatment”.
He told Ms Cowan he had highlighted the issue with other gynaecologists in the country “who are in agreement and we are in the process of trying to formulate a consensus response”.
“I really just wanted to make you aware of this whole process as I am uncomfortable with the way it is being currently dealt with,” he wrote.
Dr Flannelly and Dr Hickey continued to stress their opposing positions until the autumn of 2017.
On August 22nd, Dr Hickey told Dr Flannelly in a letter: “I must [emphasise] once again that I totally disagree with the manner in which the cervical screening programme have endeavoured to off-load all of the responsibility and communication of these results sole to the treating clinicians.”
Delayed diagnosis
Dr Hickey wrote to Vicky Phelan’s doctor on September 28th after telling the woman about the incorrect 2011 smear test. He relayed to her that Ms Phelan felt a radical hysterectomy so soon after her baby was born in 2011 “may have been a very significant intervention and the delayed diagnosis from that standpoint may have worked in her favour slightly”.
“We just wanted to let you know the results of this audit process, as it was only sent to us in communication as the treating gynaecologists and not to the patients themselves or the GPs,” he wrote.
