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Addendum J.pdf - Centers for Disease Control and Prevention

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Gaps Identified/Issues Needing Guidance Comprehensive review of literature, reports,documents to identify QA issues <strong>and</strong> concerns Identified QA concerns relating to preanalytic,analytic, postanalytic phases of testing; personnel;quality management Comparison of all relevant laboratory st<strong>and</strong>ards <strong>and</strong>guidelines to assess practices/areas needingguidance or clarification• Regulatory vs. voluntary• National vs. international• BGT vs. genetic testing in general <strong>and</strong> general laboratory Provided to workgroup to initiate discussion <strong>and</strong> elicitadditional insights11

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