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Need Rigorous Validation For Home Brew Assays

CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. On…

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Quest’s Deficiencies Trigger QA/QC Questions

CEO SUMMARY: Experts in laboratory QA/QC and proficiency testing (PT) are following the news that Quest Diagnostics admitted to an 18-month problem with lab test accuracy in its home brew Vitamin 25(OH) D assay. It is recognized as a major failure in the existing system of labora…

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Inaccurate Results + Quest Dominates News Cycle

CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it repo…

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December 22, 2008 “Intelligence: Late Breaking Lab News”

Last Thursday, Sunquest Information Systems, Inc. of Tucson, Arizona, announced that it would purchase the “Outreach Advantage Solution” software system developed by Pathology Associates Medical Laborator ies of Spokane, Washington. PAML has spent most of this de…

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