Lab Market Update

Quest, Sonic Issue Statements about Pap Test Issues in Ireland

To date, news reports say at least 221 women got false negative Pap results and 18 women have died

PROBLEMS WITH CERVICAL CANCER SCREENING IN IRELAND continue to make headlines in the Irish newspapers and roil the Irish health system. Caught up in this story are two billion-dollar lab companies that performed cervical cancer screening under contract to the Irish Health Service.

THE DARK REPORT provided its first coverage of these developments in its previous issue. (See: “Pap Test Errors in Ireland, Attributed to Quest, CPL,” July 9, 2018.) We asked both Quest Diagnostics and Sonic Healthcare, which owns Clinical Pathology Laboratories, for a comment on this matter.

In response, a Quest spokesperson provided the following statement:

We understand the deep and abiding trauma experienced by cancer patients and sympathize sincerely with them and their families. In the case of Ms. Mhic Mhathúna, we, together with the Irish Health Services, we (sic) have provided her and her family with significant financial redress which we hope will provide security for her family. The relative contribution of the various providers to this settlement will be decided at a later date.

Quest Diagnostics has been providing cervical cancer screening services for the Irish government since 2008. As a result of the cervical cancer screening program, cervical cancer rates in Ireland have dropped 7% in every year since 2010. Prior to Quest’s involvement in 2008, there was no Irish national screening program, women waited many months for results, and cervical cancer rates were actually increasing at about 4% per year.

We note that the June 30 CBS report, as well as reporting from other media outlets, have conveyed either explicitly or implicitly that cervical cancer screening is a diagnostic test. This is incorrect. A Pap smear is designed to identify individuals with cellular markers which may indicate future disease potential. The primary objective of any screening program is risk reduction and there are a number of steps in the screening process, including physician examination, consideration of personal and familial history, smear-taking, cytopathology, colposcopy, and/or histopathology.

The Irish government and health services have repeatedly stated that Quest’s performance is in accordance with both their requirements and international standards, a statement with which we fully agree. Moreover, Quest adheres to the rigorous U.S. standards, which include regulation by federal and state health authorities.

When asked for comment, officials at Sonic Healthcare referenced a statement they provided to the Austin American-Statesman, which reads:

What has happened to Mrs. Phelan and her family is tragic, and we deeply regret the outcome. We hope this settlement will allow Mrs. Phelan to gain additional treatment and an improved prognosis and quality of life.

CPL is one of two U.S., and two Irish laboratories, that have provided Pap smear testing for the Irish cervical screening program since 2008. These screens have been performed through manual examinations of individual slides, without the benefit of computer-based imaging and a separate HPV test, which together comprise the clinical standard in the U.S. and many other countries for cervical cancer screening.

Since 2008, more than three million screening tests were performed by the four laboratories contracted by the Irish Health Service Executive. This testing was performed to the highest quality standards in order to ensure the best possible outcomes for the women participating. Despite this, it is internationally recognized that no screening program is 100% effective and all have an inherent margin for error.

The results of cervical cancer screens conducted by our lab and three others are well above the accepted accuracy rate for the type of screening specified by the Health Service Executive in Ireland and have been continuously monitored and repeatedly endorsed by Irish health authorities as well as U.S. laboratory accrediting agencies.

Clinical Pathology Laboratories [a division of Sonic Healthcare] has a lengthy history of reading and evaluating Pap smears and performing other medical tests. We adhere to the highest clinical standards and are regularly reviewed by the appropriate U.S. governmental and private accrediting agencies, and have maintained continued accreditation for more than 20 years.

The Irish news media have published articles about women who have filed lawsuits against the labs and the Irish Health Service, saying their cervical cancer went undetected. Typically, these are mothers with young children who have only months to live because their cancer is untreatable.

It is possible that these failures are result of what could be systemic errors in the design and implementation of Ireland’s national cervical cancer screen program, called CervicalCheck, that was launched in 2008. Since then, more than 200 women reportedly got false negative reports and some have been diagnosed with cervical cancer.

Earlier this month, CBC News in Canada reported that as of July 9, 221 women in Ireland had been diagnosed with cervical cancer after receiving false negative results on Pap tests. Of these women, 18 had died.

Quality Control Audit in 2014

Since 2008, CervicalCheck reported that some 3,000 women in Ireland have been diagnosed with cervical cancer. During a routine quality control audit in 2014, CervicalCheck said it identified 221 women, who, “on look-back, the screening test could have provided a different result or a warning of increased risk or evidence of developing cancer.” Stated differently, at least some of their Pap screen test(s) were false negatives.

In implementing CervicalCheck, Irish health officials issued a series of tenders. By 2010, Quest Diagnostics and Sonic Healthcare, Ltd. were each performing about half of the 300,000 or so cervical cancer screenings done on behalf of Irish women each year.

Sonic built a lab in Ireland, MedLab Pathology, to do some of this testing and sent the balance to its Clinical Pathology Laboratory (CPL) division in Austin, Texas. Quest Diagnostics performed its share of Irish cervical cancer screening in its labs in the United States.

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