Former Minister for Health Mary Harney was warned of “inconsistent reporting” of CervicalCheck smear reports by a US laboratory just a year after the screening service was set up, it has emerged.
The warning came from Gay Greene, a practice nurse in a busy Dublin clinic, who told Ms Harney in a 2009 letter that this could have “serious consequences”.
Ms Greene was particularly concerned that “practically all” the smears processed by Quest Diagnostics in the US were being deemed satisfactory, when it was known that smear takers sometimes failed to get a sufficient sample.
In a reply the same year, Ms Harney gave reassurances about quality assurance at the programme, and outlined changes that had been made leading to a big reduction in the proportion of unsatisfactory smears.
Despite Ms Greene’s warning, CervicalCheck’s reliance on US laboratories grew over the years that followed as the programme expanded.
In 2018, it emerged that more than 220 women with cervical cancer had earlier been given the all-clear based on smear tests carried out, mostly in the US, for CervicalCheck. These results were later found to be indicative of cervical cancer in a review but many of the women were not told of the earlier inaccuracies.
A subsequent report on the controversy by public health doctor Gabriel Scally found CervicalCheck was “doomed to fail at some point” due to a “demonstrable deficit” of clear governance and reporting lines between CervicalCheck, the National Screening Service and HSE management.
Mr Scally also found that Irish samples were being processed in many more individual US laboratories than CervicalCheck was aware of.
Asked this week about Ms Greene’s 2009 warning, Ms Harney referred the query to the Department of Health. She added: “As you will appreciate, it would be impossible for me to deal with a letter I got 13 years ago.”
Ms Greene, in letters shared this week with Irish Times columnist Justine McCarthy, wrote to the minister on March 27th, 2009 expressing concern over the “inconsistency” of the smear reports she was receiving from Quest, “many of which we have had to return via CervicalCheck”.
“In most cases these have been amended to the agreed protocol,” she said. “At present, with so many reports needing to be amended, it is wasting a lot of our time and causing confusion and unnecessary anxiety to our patients. I am also fearful that this inconsistent reporting could have serious consequences for some of them.”
She then asked: “As a nurse, should I be checking a cytologist’s work? If not – who is supposed to be checking it?
“All smear takers have, on occasion, taken insufficient smears, yet, as soon as Quest Diagnostics became involved, practically all the smears that we have submitted are deemed satisfactory. This is a worrying development.”
Ms Greene called on the minister to ensure that Ireland’s cytology expertise was not lost throughout the transfer of the CervicalCheck work to the US.
Ms Harney replied through her private secretary Darragh Scully on September 10th, five months after Ms Greene’s original letter.
She expressed regret about the delay in replying.
Ms Harney said CervicalCheck had a training unit dedicated to ensuring smear takers were competent. “This should naturally lead to a continual reduction in the level of inadequate smears.” In addition, smear takers with high or low levels of unsatisfactory or inadequate smears were required to undergo retraining.
While false negatives and positives can occur, the screening service had adopted a number of measures to minimise the risk of errors in the cervical screening programme, Mr Scully wrote, including effective governance structures, and quality assurance and evaluation of all elements of the programme.
Mr Scully also referred to the “complete changeover” from conventional to liquid-based cytology (LBC) preparations for cervical smears. “It is accepted that the use of LBC will inevitably lead to a dramatic drop in the unsatisfactory reporting rate from any laboratory and Irish laboratories had themselves reported significant drops in the number of unsatisfactory smears over the past number of years due to the introduction of LBC, falling from as high as 15 per cent to below 2 per cent.”
In relation to the appointment of Quest, Ms Harney said it was appointed following a “rigorous” procurement process, in which it had met all the required criteria. “The performance of all Quest Diagnostics laboratories is continually monitored and subject to audit as fully accredited laboratories.”
In May 2018, Ms Greene wrote to then minister for health Simon Harris, enclosing her letter to Ms Harney from 2009. She said the reply from Ms Harney “seemed to ignore some of the points that I raised and, in my opinion, did not deal with the issues about which I was very concerned”.
Mr Harris responded through his private secretary Paula Smeaton in August 2018 setting out the actions that had been taken in the preceding months in response to the CervicalCheck controversy. He said his advice was that there was no evidence the clinical and technical aspects of the cervical screening programme were below international standards.