CEO SUMMARY: In Ireland, the big story in healthcare at the moment is the discovery that the nation’s cervical cancer screening program has failed hundreds of women who had pre-cancerous conditions or cervical cancer, but, as alleged in numerous court cases, their tests were inaccurate or the results not communicated to their physicians, or both. These cervical cancer screening tests were performed by Quest Diagnostics and Clinical Pathology Laboratories (CPL) in the United States.
ONCE AGAIN, THE DISCOVERY of serious lab test errors stretching over multiple years has become a national story. This time the national story is in Ireland but the case has significant implications for two American lab companies: Quest Diagnostics Inc. and Sonic Healthcare’s Clinical Pathology Laboratories (CPL) in Austin, Texas.
In Ireland, errors on screening tests for cervical cancer have dominated the headlines in recent months amid reports that 209 women in Ireland have been misdiagnosed in the nation’s cervical cancer screening program.
Cervical Cancer Screening
Last week, The Irish Times reported that nine new legal cases involving errors in cervical cancer screening were identified, bringing the number of pending court cases to 28. In addition, two more cases may be filed and, and two other cases have been settled after plaintiffs reached multimillion euro settlements.
One case was closed June 28 when Quest agreed to pay the plaintiff €7.5 million ($8.76 million in U.S. dollars). Previously CPL and the Irish Health Service settled another case for about US $3 million, the Irish Times reported.
The nine new cases were filed against Ireland’s National Screening Service. In each case, women claimed their cervical cancer was misdiagnosed, the newspaper reported.
The patient in the Quest case who settled is Emma Mhic Mhathúna. She charged that she was mistakenly cleared of cancer years ago.
CBS News reported that Mhathúna is a single mother of five children, who won a legal battle but is still fighting for her life. “I’m 37, learning about the process of dying,” she told CBS News reporter Roxana Saberi. “It’s not fair for children to have to go through that process.”
In 2016, Mhathúna was diagnosed with cervical cancer and later said that Quest missed the warning signs on screening tests she had undergone earlier.
Two years before, in 2014, government auditors found that the two U.S. labs and an Irish lab mistakenly cleared 209 women who were later diagnosed with cervical cancer, CBS News reported. “Since then, 18 of those women have died,” Saberi wrote. “But most of the women affected were never told.”
Bad News in Audit Report
One of those women who was not told about her diagnosis learned about the bad news by reading her own medical file earlier this year, CBS News reported. At the time, that patient, Vicky Phelan, did not know that she’d had cancer since 2011. Phelan was the first woman to sue and, in April, reached a settlement of some US$3 million with Ireland’s Health Service and CPL, according to CBS News.
After the case was settled, CBS quoted Phelan as saying, “My settlement will mostly be spent on buying me time and for paying for clinical trials to keep me alive, and to allow me to spend more time with my children.”
Attorney Cian O’Carroll is representing more than 60 women who say they were misdiagnosed, including five who are terminally ill, CBS News reported. O’Carroll told CBS that in the many of the cases he has reviewed, there are multiple errors. A high rate of errors means patients in the United States should be concerned, he added. “Not only did they get the tests wrong, but they got them very, very wrong,” he told CBS News.
U.S. Labs Asked to Comment
In a statement to CBS News, CPL said, “No screening program is 100% effective,” and, “We adhere to the highest clinical standards.” When asked for a comment by THE DARK REPORT, Quest refuted the reporting of CBS News and others that conveyed cervical cancer screening as a diagnostic test. We will publish Quest’s full comments about this matter in our next issue.
As a result of the misdiagnoses in Ireland, the College of American Pathologists is investigating CPL but it is not investigating Quest’s lab in Teterboro, N.J., which produced the report on Mhathúna’s case, CBS News reported. CAP could not be reached for comment before our press deadline.
The federal Centers for Medicare and Medicaid Services (CMS) declined a request from CBS News to say if it was investigating CPL or Quest. A CMS spokesperson said, “It’s CMS policy not to speculate on ongoing or forthcoming survey activities.”
On the issue of error rates, the CMS spokesperson said there is no federal “error rate” when reporting on cervical cancer test errors in the United States. “Each laboratory is free to design and monitor error rates for their own facility,” the spokesperson added.
For the Journal in Ireland, Sean Murray reported that Phelan, who is age 43, explained that her results from a routine Pap smear test in 2011 were normal. “While a smear test does not diagnose cervical cancer, an abnormal result would lead to further examinations to test the patient for cancer,” he explained.
Doctor Was Not Informed
In 2014, Phelan’s missed diagnosis of cancer was revealed during an audit of Pap smear test results. That same year, she had a second Pap smear test and this second test showed she could have cervical cancer, Murray added.
“Her doctor wasn’t informed of this diagnosis until 2016, and she herself wasn’t informed until a further year had passed,” he wrote. “In January of this year, she was given between six and 12 months to live.”
Phelan told Murray that there is no cure for her form of cancer. “Unfortunately, I don’t see the day, unless a breakthrough comes in the next couple of years, where I’m going to be able to say I’m cured,” she told Murray.
The current program for cervical cancer screening in Ireland was created almost a decade ago. In 2008, the Irish Health Service was concerned that it would not have the capacity to screen all Irish women aged 25 to 60 for cervical cancer. Its solution was to partner with clinical labs from the United States to outsource that testing. (See TDR, Aug. 31, 2009.)
Ireland’s new national cervical cancer screening program was launched on September 1, 2008. It is called “CervicalCheck.” Quest Diagnostics was awarded a contract to do nearly 100% of the pap testing. On July 1, 2008, just 60 days prior to that introduction, the Pap test outsourcing contract with Quest took effect.
By 2010, Sonic Healthcare Ltd, of Sydney, Australia, had won a contract to perform about half of the Irish pap tests annually. It opened up MedLab Pathology Ltd, in Dublin, Ireland, and split its share of these tests between that location and its Clinical Pathology Laboratory division in Austin, Texas.
As part of this national screening service, women aged 25 to 60 are invited to see a general practitioner or a designated clinic for a free smear test once every three years to check for possible signs of cervical cancer. The tests are designed to identify abnormalities or changes to the cells of the cervix which can be a precursor to cancer, O’Doherty explained. The test is not designed to catch already-existing cancer.
Since the screening program was established in 2008, the numbers of women getting screened has risen each year. Current statistics show that more than 270,000 women get such a test every year and about 80% of women due a Pap smear test in any given year now have it, O’Doherty reported.
According to the most recent annual data from 2016, 187 women who were screened were diagnosed with cervical cancer, she wrote. Each year about 90% of Pap smear tests are declared normal. If there is a finding of concern, then about 18,000 women are referred for a colposcopy. In about half of those 18,000 cases, pathologists will identify pre-cancerous abnormalities, O’Doherty explained. “Most will undergo treatment as outpatients, while some will not need treatment yet but will be scheduled for a repeat test within a year,” she added.
More Cases to Be Reviewed
O’Doherty also reported that, in addition to the 209 women identified to date, at least 1,500 other women diagnosed with cervical cancer over the past 10 years did not have their cases reviewed to see if they were previously screened and, if so, if that screening should have led to an earlier cancer detection.
The National Cancer Registry was notified about these cases, she reported, but the CervicalCheck system was not notified. “CervicalCheck says it has a policy of sharing data with the registry because it asks women for their consent to do so, but that isn’t reciprocated by the National Cancer Registry,” she wrote. “CervicalCheck says it is now working on a data-sharing partnership with the registry.”
What Action Will Be Taken?
There are many troubling issues raised by these developments. At least one experienced Irish cytopathologist is on record as pointing out that the U.S. laboratories are detecting about one-third fewer cases of “pre-cancer” than Irish labs.
It would seem that government healthcare regulators in both the United States and Ireland would want to investigate this significant difference in testing outcomes. It would be appropriate for healthcare officials from both countries to collaborate on a detailed inquiry to determine if there is a quality and/or accuracy difference in how labs in both countries perform cervical cancer testing.
Pathologist, Other Physicians Were Concerned About Ireland’s Plan to Outsource Pap Tests
WHEN OFFICIALS IN IRELAND were considering a national cervical cancer screening program, a pathologist warned about potential problems. His warnings seem prescient now. This spring, Denise Calnan reported for the Independent in Ireland that a pathologist who worked for the National Cervical Screening Programme (NCSP) said he raised concerns 10 years ago about sending Pap smear tests outside of Ireland for testing. He predicted quality assurance problems would manifest in about 10 to 15 years, Calnan wrote.
At the time, Dr. David Gibbons was chair of the Cytology/Histology Group within the Quality Assurance Committee of the NCSP. This spring he was interviewed on RTE Radio One’s Morning Ireland show, saying he warned Tony O’Brien, who at the time was the chief executive officer of National Cancer Screening Programme. Gibbons said he told O’Brien that the outsourcing of cervical Pap smear tests to labs in the United States would lead to missed cases or misdiagnoses, Calnan reported. At the time, Gibbons predicted that these problems would show up in 10 to 15 years.
Concerns Were Dismissed
After raising these concerns, and then learning that officials dismissed their concerns, Gibbons said he and other “very well-qualified scientists” resigned, Calnan reported.
In those early years of the program, Gibbons was not alone. Dr. Andrew Jordan, Chairman of the National Association of General Practitioners, said he and other GPs were unhappy that screening tests were being sent outside of Ireland. “We were embracing a system where women were getting an annual smear, where we were telling women they would be okay for three to five years,” he told Calnan.
“We would obviously prefer smears to be examined and looked at here in Ireland,” he added. “We have an excellent pathology service and some of the best trained doctors in the world.”
One member of the pathology service in Ireland was Gibbons, who ran a large screening lab in Dublin and who from 2006 to 2008 was the Quality Assurance chair of the Quality Assurance committee for the NCSP. “At that time, we had a backlog due to under-resourcing,” Gibbons told Calnan.
Fewer Pre-Cancer Cases
One issue, in particular, caused concern. The labs in the United States were finding fewer cases of pre-cancer, he said. “They were predicting fewer pre-cancer cases in a batch of similar population size to us,” Gibbons said of the labs in the United States. “We were finding 1.8 cases per 100; they were finding 1.2. This was a third of a difference.”
In the United States, the standard of care calls for a Pap smear test is as often as yearly. Ireland has a three-year screening system.
“So even though they do the tests quickly in the United States, they do it once a year,” Gibbons told Calnan. “So they have a substandard screen, but more often. We were getting one third of the high-grade cases we were finding in our population.”
When he expressed those concerns, Gibbons said the lower numbers were dangerous and would lead to problems that would not become apparent for 10 years, Calnan reported. Unfortunately for the more than 200 women in Ireland who had a missed diagnosis, it turns out Gibbons’ prediction was correct.
Back in 2008, Mary Harney, then the Minister for Health, defended the contract by observing that the price submitted by Quest Diagnostics was one-third less than any bid put forth by an Irish laboratory—while also noting that Quest’s services were “quality assured” and it would meet the 10-day turnaround requirement.