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Clinical Laboratories and Pathology Groups

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Health minister characterizes reports of 20% to 30% error rates as highly exaggerated

Questions about a possible high rate of errors in breast cancer testing done in the Canadian province of Quebec surfaced last week. Government health officials were forced to publicly acknowledge that they had received a report in April of a limited study that indicated an error rate of between 15% and 20% in hormone receptor testing, and an error rate as high as 30% in HER2/neu testing.

Following the first news reports of this situation last Thursday, Quebec health officials scrambled to respond to public concerns. In response to calls for the Health Ministry to release the full report to the public, Quebec’s Health Minister, Yves Bolduc, convened an extraordinary Sunday meeting that took place yesterday. He met with pathologists and oncologists from the province to review the details of the report on errors in breast cancer testing and determine a course of action.

What is interesting about this situation is that it was pathologists who conducted the survey of breast cancer testing accuracy among laboratories in Quebec, then submitted a report of their findings to provincial health officials. Part of the intense public reaction resulted from the disclosure that health officials, made aware of these problems in April, had not immediately taken steps to inform the public about the situation. Another factor is that the report is based on a sample of only 15 patients, whose specimens were sent to 25 of the 140 pathology laboratories in Quebec.

In fact, at the press conference yesterday, following his conference with pathologists and oncologists, Balduc stated that “Things that have been said about the study have been false… We can reassure people that the majority of tests that were done were good.”

Because of public concerns over the possibility of unacceptable error rates in breast cancer testing in Quebec, another press conference is scheduled for Monday afternoon. Quebec health officials are expected to discuss, in more detail, their assessment of the pathology study about the accuracy of hormone receptor testing and HER2/neu testing in the province.

In recent years, Canada has been rocked by disclosures of unacceptable error rates in breast cancer testing in other provinces, including Newfoundland/Labrador, Manitoba, New Brunswick, and Ontario. Quebec is now the fifth province in Canada to uncover inaccuracies in breast cancer testing. An analysis of these earlier episodes was published in the most recent issue of The Dark Report (“ER/PR Testing in Canada Continues to Make News, TDR, May 18, 2009).

This is an important story for the pathology profession in all major countries across the globe. For years, pathologists and laboratory professionals in Canada have warned health service officials that ongoing budget cuts and consecutive waves of regional laboratory restructuring would eventually undermine the quality, reliability, and integrity of laboratory testing.

In fact, following each disclosure about a new finding of unacceptable error rates in histopathology testing at some laboratory around the country, some experts raise the possibility that aspects of the laboratory medicine establishment in certain Canadian provinces may have finally reached a breaking point. The upcoming June 8 issue of The Dark Report will have exclusive analysis and commentary about the latest unfolding events concerning breast cancer testing in Quebec.

Related Information:

Cancer report blown out of proportion: Quebec minister

Quebec re-examining breast cancer study

Quebec breast cancer patients kept on hold

Minister, MDs agree there are reasons to worry over Quebec cancer report

The Dark Report