The HSE's chief clinical officer, Colm Henry, has said he regrets not checking whether women with cervical cancer were being told about false negative smear tests when he learned about it last August.
Dr Henry said he was told last summer the CervicalCheck national screening programme had changed its communication policy and the affected women would be told about discrepancies in past tests. However, he did not follow up to verify that they had been informed.
He was speaking at a press conference in Dublin convened by the State's chief medical officer, Dr Tony Holohan, to address public concerns about the national screening programme in the wake of the scandal involving women with cervical cancer not being told about false smear test results.
Dr Henry said he learned, after a meeting between the CervicalCheck screening programme and leading clinicians on September 1st, 2017, the programme’s communication policy had changed following a year-long dispute with doctors over whose responsibility it was to tell the women.
At the time, he was the HSE’s national clinical adviser to the country’s acute hospitals.
“In retrospect, had I known that this didn’t happen – that patients weren’t being informed – even in my then role as an adviser with no authority over these people, I would certainly have done things differently,” he told reporters at the event in the Royal College of Physicians. “But I was basing my actions at the time on the assumption that people were following through on what they told me they were doing.”
Face value
He took assurances CervicalCheck’s communication policy had changed “at face value”, he said.
“Do I regret that now? Of course I do. I had no reason to doubt what they were telling me. If I was going back now, with the benefit of hindsight, I regret I didn’t go further. At the time I acted as best I could,” he said.
Asked whether he should consider his position in light of his knowledge of the communications failures, he replied: “I had no involvement in the screening programme at the time.”
Dr Holohan said he learned women had not been told only on Thursday of last week following the High Court case taken by Limerick mother-of-two Vicky Phelan, who secured a €2.5 million settlement from a US laboratory which assessed a test for CervicalCheck.
Ms Phelan discovered a 2011 smear test that had originally shown no abnormalities was, three years later, found to be inaccurate, but she was not told of the false test until September 2017.
In the aftermath of her case, a HSE audit found that of 1,482 women diagnosed with cervical cancer in the past decade, errors were found in 208 cases where tests showed no abnormality but should have raised a cancer warning. Some 162 were found not to have been told. Of the 208, 17 have since died.
The cases of a further 1,518 women with cervical cancer who were not screened by CervicalCheck will also be audited.
Correspondence from the case shows that Dr Henry was made aware of the dispute between CervicalCheck and the doctors in August 2017 over who should tell the women about the tests.
Dr Holohan defended Dr Henry's actions, saying he did not believe there was any requirement for Dr Henry to escalate his concerns about the issue to the Department of Health last summer.
“I don’t think that it is necessary that every issue that is identified within the HSE requires for its effective management to be escalated to the department,” he said.
The State’s chief medical officer sought to reassure the public that there was no problem with the quality of the screening programme itself.
“Clearly there was a substantial failure in terms of communications that should not have happened, that needs to be adequately explained and needs to be fully investigated,” he said.
Dr Henry described the controversy as a “failure of clinical governance”.
Dr Jerome Coffey, director of the National Cancer Control Programme, said there was "a tiny, tiny probability" – less than one in 100 – of false negative smear tests. He praised the CervicalCheck screening programme for helping to reduce the incidence of cervical cancer by about 7 per cent a year.
