Justine McCarthy: CervicalCheck scandal did not die with Vicky Phelan

The academic cap Vicky Phelan wore when the University of Limerick made her an honorary doctor in 2018 was carried to the altar by her 11-year-old son, Darragh, during her memorial service in Mooncoin last Sunday. The sight of it evoked a happy memory. The late cervical cancer campaigner had looked especially radiant that June day when her alma mater paid tribute to her “positive impact on women’s healthcare”. Surrounded by her family and friends, she relished the accolade from an institution she respected.

There was one notable absentee. The university’s chancellor, Mary Harney, the former Minister for Health who established the CervicalCheck national screening programme in 2008, did not attend.

Perhaps it was for the best. One cannot imagine that the freshly conferred doctor of letters, who was dying from cancer after the disease went undetected by Clinical Pathology Laboratories, an outsourced centre in America, would have restrained her characteristic blunt-speaking articulacy in the presence of the former politician. Had Phelan known that a nurse had written to Harney in the early months of the CervicalCheck programme, warning her there were dangerous errors being made in the system, the former minister would have been unlikely to escape an eloquent tongue-lashing.

The numbers of smear samples deemed unsatisfactory for testing had plummeted to almost zero

—  Gay Greene

Phelan died last month without ever knowing that in 2009 — more than two years before Clinical Pathology Laboratories in Texas misread her smear test in 2011 and reported no abnormalities — the potential for a high level of potentially fatal mistakes had been brought to Harney’s attention. On March 27th, 2009, Gay Greene, a clinic nurse in a Dublin city medical practice, wrote to Harney expressing “concern at the inconsistency of smear reports that we have received from Quest [another US laboratory company], many of which we have had to return via CervicalCheck in Limerick”. She said that, in most cases, the reports had subsequently been amended.

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In the letter — which has been shared with The Irish Times — she said an additional “worrying development” was that the numbers of smear samples deemed unsatisfactory for testing had plummeted to almost zero. In her experience prior to the introduction of outsourcing, the difficulty in obtaining sufficient cells for testing meant “a few [smears] a week” would be returned to the clinic having been deemed inadequate for testing.

“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,” wrote Greene, who is now retired from nursing. “I am also fearful that this inconsistent reporting could have serious consequences for some of them.”

So prescient was her letter she might have been writing it with a crystal ball in one hand. “As a nurse, should I be checking a cytologist’s work? If not, who is supposed to be checking it?” Greene asked Harney. Deploring the loss of expertise in Irish laboratories because of outsourcing, she said: “I feel most strongly that you must rectify this as soon as possible.”

The reply from Harney’s private secretary came five months later, aloofly stating: ‘The delay in replying is regretted’

Considering that Dr David Gibbons, in anticipation of precisely such errors, had resigned the previous year as chairman of the cytology group on the National Cervical Screening Programme’s quality assurance committee, a swift response to Greene’s letter might have been expected. The reply from Harney’s private secretary came five months later, aloofly stating: “The delay in replying is regretted.” It sought to reassure Greene that the lower rate of rejected smears was explained by a new liquid-based method of testing and better training and that there were “effective governance structures, quality assurance and continual evaluation” of performance and standards.

Dr Gabriel Scally reported in 2019 that the use of many laboratories in the US and UK for Irish screening had not even been approved as contractually required. He identified 16 overseas laboratories testing Irish samples — not the total of six the Irish authorities had told him about.

The same year that Greene wrote to Harney, Ruth Morrissey’s smear slide came back all clear. So did her next one three years later, in 2012. In February 2019, aged 38 and terminally ill, she listened in the High Court as Gibbons testified in her action against the HSE, Quest Diagnostics and MedLab Pathology. He explained that the American testing system used a lower sensitivity test than Ireland used, but it recalled women annually for routine smears, while the Irish scheme operated a three-year recall. This mismatch, he said, risked missing about 1,000 cases of pre-cancer every year.

When Phelan’s case blew the CervicalCheck scandal open in 2018, Greene wrote another letter. This one was to Simon Harris, then the minister for health, on August 2nd, 2018. She enclosed her original letter to Harney and the tardy, evasive reply she had received. She told Harris she was doing so to highlight the imperative to “listen to people on the ground”. Harris’s private secretary wrote back on May 20th, stating that the government was “committed to a full commission of investigation”.

That has not happened. Scally, whose work has been excellent but was conducted as a “scoping inquiry” without the statutory powers of a commission or tribunal, advised it was unnecessary.

Scally has revealed that other campaigning cervical cancer women have recently been refused treatment by some doctors.

Testing continues to be conducted in overseas laboratories and the audit of cervical cancer patients’ tests has not resumed since it was stopped in 2018

There is a sense that, following Phelan’s death, the CervicalCheck scandal has been comprehensively dealt with and can now be neatly filed away in the annals of history. Phelan’s achievements in getting answers, contrition, redress and reforms were magnificent, but she ran out of time. There is still much to be done. Testing continues to be conducted in overseas laboratories and the audit of cervical cancer patients’ tests has not resumed since it was stopped in 2018.

The one question there has been no attempt to answer is why did it happen? Was the decision to outsource testing made for pragmatic reasons or ideological ones? Because Scally’s remit did not extend to examining former ministers, Department of Health and HSE senior officials and documents, the public remains in the dark about any lobbying, advice, tender bids and correspondence pertaining to a decision that proved lethal for many young women and their families.

Is it plausible that Greene was the only health professional in the country who noticed the frequency of errors and raised the alarm? Scally has answered the who, what, where and when of this tragedy. But it defies belief that, five years since the CervicalCheck scandal of non-disclosure of information was revealed, the women of Ireland still do not know the answer to the fundamental question: Why?