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Genetic Testing In Brief

This article was originally published in The Gray Sheet

Executive Summary

CLIA "Lite": A "kinder, gentler CLIA" will be initially applied to labs that perform genetic testing, allowing flexibility in timeframes to meet compliance requirements, according to CMS Director of Outcomes and Improvement Judith Yost. A draft "frequently-asked-questions" document about certification to the Clinical Laboratory Improvement Amendments of 1998 is in development and will be posted on the 1CLIA website upon completion in the coming months, CMS says. For labs coming into compliance, Yost advises directors to prioritize CLIA regs in the following order: personnel qualifications (especially lab director competency and training); quality control (correlation with a "gold standard"); proficiency testing (external mechanisms to ensure accuracy twice a year); and quality assurance (internal lab assessment of all CLIA requirements). Improved performance in CLIA labs also has become apparent, Yost reports at the HHS Secretary's Advisory Committee on Genetic Testing meeting May 14-15 in Baltimore, Maryland. "When we first visited laboratories, somewhere between 30-35% of labs had strict quality issues; now we're down to 6-8%"...

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