Two US clinical laboratories providing testing for the problem-laden program have been targets of lawsuits from women who allege their smear test results were misread
In Ireland, the nation’s health service continues to deal with the consequences from problems with its “CervicalCheck” service that is designed to provide timely screening for the early detection of cervical cancer. It became a national scandal when the news media learned that a number of women had received diagnoses of terminal cervical cancer due to failings in the screening program.
Throughout 2021, news reports have called attention to the efforts of the publicly-funded Health Service Executive (HSE) to regain the trust of women in that country. Earlier this year, TheJournal.ie wrote “the CervicalCheck controversy has been a complex and emotional series of tragedies and mistakes that damaged what is an important, free public health measure for women that could, along with the HPV vaccine, eradicate cervical cancer.”
This ongoing controversy provides cytopathologists and medical laboratory leaders in the US with yet another example of how easily trust in clinical laboratories can be lost when patients lose confidence in the accuracy of test results.
Missed Cancer Results in Nearly $3 Million Settlement
First launched in 2008, Ireland’s CervicalCheck program aimed to screen all Irish women between the ages 25 to 60 for cervical cancer. However, due to a claimed lack of in-house gynecological cytology testing capacity, Ireland’s HSE outsourced the nation’s entire caseload to two lab companies: New Jersey-based Quest Diagnostics and Sonic Healthcare’s Texas-based Clinical Pathology Laboratories (CPL), which received the majority of Irish Pap smear screenings for review.
A decade later, the public became aware of serious misdiagnoses involving the CervicalCheck program. In “Pap Test Errors in Ireland Attributed to Quest, CPL,” Dark Daily’s sister publication, The Dark Report (TDR), noted that 209 women in Ireland had been misdiagnosed in the nation’s cervical cancer screening program.
Concerns about the CervicalCheck program came to light in April 2018 when Vicky Phelan settled a €2.5 (US$2.9) million lawsuit with Ireland’s HSE and with US-based CPL. Phelan had been told that her 2011 Pap smear test result indicated no abnormalities. But a second test three years later revealed she had cervical cancer.
And though CervicalCheck discovered the 2011 false negative result during an internal review, neither the service nor her physician informed Phelan about the error until 2017.
During the Irish High Court proceedings, RTE, Ireland’s national public service media, reported that Phelan’s lawyers argued their client would have had a 90% chance of survival if she had received treatment in 2011.
HSE and CPL settled the lawsuit without admission of liability.
Additional Screenings Identify Hundreds of ‘Suboptimal Colposcopy’ Test Results
Following the Phelan settlement, Ireland’s CervicalCheck released a statement announcing its review of screening tests for 1,482 women diagnosed with cervical cancer between 2008 and 2018. That review identified 208 women whose “screening test could have provided a different result or a warning of increased risk or evidence of developing cancer.”
Of those 208 women, 162 had not been alerted about earlier audits revealing errors affecting their results.
Since then, 308 of the 1,034 women who participated in the program have been identified by a 2019 government-mandated review conducted by the Royal College of Obstetricians and Gynaecologists (RCOG) as having “a different cytology result from the original CervicalCheck result,” an Irish government press release noted.
The RCOG made recommendations for improvements but concluded “the small minority of cases in which suboptimal colposcopy contributed to a missed opportunity to prevent or diagnose a cancer at an earlier stage is probably inevitable when cases that end in cancer are reviewed, but this should not be taken to conclude that colposcopic practice in the CervicalCheck program is substandard.”
Women’s Trust in Ireland’s Cancer-Screening Program Is Broken
The Irish government established the CervicalCheck Tribunal in 2019 to provide the women with an alternate system for adjudicating claims.
However, in “The CervicalCheck Controversy: How a Vital Cancer Screening Service Is Fighting to Regain the Trust of Women,” online Irish news site TheJournal.ie reported that women’s trust in the screening program remains broken due to simmering CervicalCheck controversies.
“Though a 2019 review of Ireland’s cervical screening program found that it was in line with international standards, questions remain about how the service communicates with women who use it, the State’s method of procuring laboratories, and how to regain trust after waves of scandals,” TheJournal.ie wrote.
According to TheJournal.ie, the “issue at the heart of the CervicalCheck controversy” is HSE’s advice to doctors to not routinely provide smear test audit results to affected patients, but instead to “use their judgement in selected cases where it is clear that discussion of the outcomes of the review could do more harm than good.”
In “Cervical Cancer Controversy: ‘Why Are They Fighting These Women So Badly?’,” The Irish Times pointed out that justice has been elusive for the women whose lives have been lost or damaged by the CervicalCheck debacle. Women who die before their cases are concluded, the paper reported, lose any entitlement to general damages (approximately $587,000), though their families can seek damages for loss of a parent or spouse.
Are Women in the US in Danger?
Cian O’Carroll, a solicitor specializing in medical negligence and personal injury law who represents more than 60 CervicalCheck plaintiffs, maintains that women in the US should be concerned about the quality of their laboratory test results as well.
“In quite a number of cases we’re looking at, there are multiple errors,” he told CBS News, adding, “Not only did they get the tests wrong, but they got them very, very wrong.”
The CervicalCheck controversy highlights how quickly a health system and clinical laboratories can lose the trust of the patients they serve. Both Quest Diagnostics and Sonic’s Clinical Pathology Laboratories found themselves in an unwelcome news spotlight in Ireland, given their participation in a cervical cancer screening system that failed in multiple ways the women it was designed to serve.
These events are a reminder to other medical laboratories and pathology groups that accuracy of results is paramount to keeping the trust of patients and healthcare consumers. When a patient’s trust is lost, it is difficult if not nearly impossible to regain.
—Andrea Downing Peck