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.
“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.
“Why are they fighting these women so badly and making them spend the last few months of their lives fighting for justice for themselves and their children?” asked Lorraine Walsh (on left, with Vicky Phelan on right), a CervicalCheck survivor whose successful, but invasive, treatments for cervical cancer have left her unable to have children. “We have seen how [the late] Ruth [Morrissey] and Vicky [Phelan] and [the late Emma Mhic Mhathúna], and lots of others, have really been put through the mill in the High Court, and we are all wondering if we have to go through that torture just to get justice out of this,” Walsh told The Irish Times. (Photo copyright: The Irish Times.)
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.
Wait times blamed on the Irish National Health System’s ‘overstretched’ services and ‘under-resourced’ commitment to cancer genetic testing done by medical laboratories
Histopathologists in the UK and anatomic pathologists in the US understand the important role predictive genetic testing can play in helping patients understand their risk for certain types of breast, bowel, and ovarian cancers. While timely access to cancer testing may be routine in the United States, a report out of Ireland reveals patients in that country’s government-run healthcare system may have to wait up to two years or more for genetic counseling and testing.
UK Patients in Need of Genetic Services Are Switching from Public to Private Healthcare
While early access to genetic testing can provide opportunities for preventative treatments or earlier diagnosis of cancer, many patients in Ireland with a family history of cancer must wait months or years for genetic services. UCC Nursing Professor and Physiologist Josephine Hegarty, PhD, lead author of the ICS report, stated in a news release that “public cancer genetic services are overstretched. Waiting lists exist at every point on the pathway for people who need genetic services.”
She added, “Many patients spoken to seemed to abandon the waiting for overstretched public services in favor of paying for private testing and treatment.”
While the ICS report’s survey sample size was small—154 patients, family members, or members of the public—the data revealed:
One in seven respondents waited 13-24 months and one in 27 waited over 24 months for counseling and testing appointments.
Many people had changed from the public health system to private healthcare to speed up access to genetic testing.
The cumulative waiting time from referral to counseling, testing, receipt of genetic test results, and onwards to screening, surveillance, or prophylactic treatments [aka, preventive healthcare] can be up to four years, which patients see as time lost in terms of cancer prevention and early intervention.
Barriers to Genetic Services Affect Treatment Decisions
A separate survey of 52 healthcare professionals highlighted barriers for accessing services with six in 10 respondents saying they are under-resourced and four in 10 concerned about access to follow-up surgery for patients deemed to be at high risk.
In the ICS news release, breast cancer patient Margaret Cuddigan said genetic testing was not available to her at diagnosis.
“In those 13 months waiting for a result, I went through chemotherapy, a lumpectomy, and radiotherapy on my breast, only for a double mastectomy to be required once the BRCA mutation was known. Had I known this earlier, my course of treatment could have been very different,” Cuddigan said.
“I had to postpone a radiation treatment to go up to Dublin from Cork to do the genetic test, as it would have taken up to another 12 months in Cork, and then I waited over four months for the results. Once I received the news of the gene mutation, I had to navigate a path of risk-reducing surgeries,” she noted, adding, “I researched and sought out a surgeon myself.”
Long Waits for Genetic Testing Are Common in Single-Payer Healthcare
The waiting list for genetic cancer testing has long been an issue in Ireland. A 2017 article in the Irish Examiner, titled, “Woman Faces 18-month Wait for Vital Cancer Test,” brought to light the 18-month waiting time for BRCA1 and BRCA2 mutation testing for breast cancer. While the COVID-19 pandemic has further exacerbated the backlog of cancer treatment services, such issues are not new in single-payer healthcare systems.
Across the Irish Sea in Great Britain, some patients have experienced delays of six months before getting cancer test results. In “Shortage of Histopathologists in the United Kingdom Now Contributing to Record-Long Cancer-Treatment Waiting Times in England,” Dark Daily reported how prolonged wait times for cancer test results in the United Kingdom’s National Health Service are one disadvantage of a government-run, single-payer health system. With limited funds, frequently the government health program under invests in certain clinical services. It is not until several years later that the underinvestment reveals itself in the form of lengthy wait times.
Meanwhile, it is cancer patients and their families who pay the price for underinvestment because delays in their cancer test results then delay timely treatment decisions. This is particularly true when an immediate start of therapy for an aggressive form of cancer is imperative.
ICS Executive Director, Advocacy and External Relations, Rachel Morrogh, argues the solution is prioritizing cancer prevention within the Health Service Executive, which runs Ireland’s national healthcare system.
“The reality is the focus must be on urgent care, but we’re missing chances to keep people healthy (through genetic testing),” Morrogh told the Irish Independent. “We can prevent four in 10 cancers, but we have to prioritize prevention. There needs to be a significant investment and the expansion of capacity across all the follow-on services that someone with a genetic risk of cancer may need, focusing on the development of a dedicated and resourced pathway for them.
Irish Cancer Society’s Director of Advocacy and External Affairs Rachel Morrogh (above left with Donal Buggy, Director of Services, Delivery and Innovation at ICS) maintains that “Patients [in the Irish healthcare system] need a dedicated group of multi-disciplinary doctors following them so that they can be offered options and psycho-oncology support when they need it.” She added, “The government must now listen to patients and those working in our hospitals and provide more resourcing and staffing.” (Photo copyright: Irish Examiner.)
The ICS report found that limited access to timely genetically-guided health and oncology services is the result of multiple barriers to care.
“It is apparent from engaging directly with service users that waiting lists exist at every point on the pathway for people who need genetic [cancer testing] services,” the report states. “For those who may have a genetic risk of cancer, the wait times for access to [genetic cancer] testing alone (before counselling treatment, prophylactic surgery, etc.) can be up to two years. Barriers to accessing cancer genetic services include costs of tests, long processing time for referrals to tests, restrictive referral criteria, and difficulty in accessing information on cancer genetic services.”
In the forward she wrote for the ICS report, ICS Chief Executive Officer Averil Power said her organization would continue its push for improved access to genetic testing services. “Government needs to not only expand capacity for testing and counselling, but also ensure that the follow-on services that are needed by people diagnosed with a genetic risk of cancer are in place and can be accessed swiftly.”
The ICS report is another reminder to histopathologists in the UK—as well as anatomic pathologists in the US—that a single-payer healthcare system comes with its own flaws and access-to-care issues.
Speakers at the Executive War College discuss how their laboratories are supporting integration in support of better information flows and clinical service enhancements
During the opening session yesterday morning, a common theme among the speakers was the tighter integration of clinical pathology laboratory testing within the healthcare continuum. Probably the most innovative example was offered by Scott W. Binder, M.D., Senior Vice Chair of the Department of Pathology and Laboratory Medicine at the Geffen UCLA School of Medicine in Los Angeles California.
Executive War College 2010 is now underway in New Orleans.
Irish health service plans to downsize and shut some pathology laboratories while building two or three new stand-alone clinical laboratories
DUBLIN, IRELAND—Pathology testing and clinical laboratories in Ireland will soon be involved in a major project to overhaul the entire system of laboratory medicine in this country of 4.5 million people. Today, your Dark Daily editor wraps up a week-long visit to medical laboratories in Dublin and the pending reorganization of clinical laboratories is a major topic among pathologists and clinical laboratory scientists.
Last year, Ireland’s Health Service Executive (HSE) issued a press release announcing the program to modernize the nation’s clinical laboratory service. The plan specifies that some pathology laboratories will be downsized or closed as regional laboratory testing networks are developed. Another major element in the plan is the creation of two or three “cold” laboratories—what North American laboratory professionals would recognize as a stand-alone clinical laboratory facility providing routine testing to general practice clinics—to serve this segment of the Irish healthcare system.
