Journal of the National Cancer Institute Advance Access originally published online on June 10, 2008
JNCI Journal of the National Cancer Institute 2008 100(12):836-844; doi:10.1093/jnci/djn200
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© Oxford University Press 2008.
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Breast Cancer Testing Scandal Shines Spotlight on Black Box of Clinical Laboratory Testing
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A Canadian public inquiry into botched estrogen receptor tests has shaken public confidence in cancer care and raised questions about the oversight of laboratories that perform crucial tests that often determine which treatment breast cancer patients receive. The public inquiry, now under way in Newfoundland, is charged with investigating events that led to a breakdown of estrogen receptor (ER) testing at a laboratory run by Eastern Health, the provincial health care delivery system in Newfoundland and Labrador. Through the inquiry, the public learned that between 1997 and 2005 nearly 400 of about 1,000 breast cancer patients received incorrect test results of the ER status of their breast tumors. Of these patients, more than 100 have since died, leaving grieving families wondering if inaccurate test results cost their loved ones lives.
Nearly every newly diagnosed breast cancer tumor is tested to determine its ER status. Patients whose tumors test ER positive
Slow Changes
Creating Greater Accountability
Fallout
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