Addendum J.pdf - Centers for Disease Control and Prevention
Addendum J.pdf - Centers for Disease Control and Prevention
Addendum J.pdf - Centers for Disease Control and Prevention
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Background-Current Oversight <strong>for</strong> Genetic Testing CLIA regulations• General requirements <strong>for</strong> non-waived testing as applicable• Specialty of clinical cytogeneticso Specific QC requirementso Qualification requirements <strong>for</strong> technical supervisor• Requirements <strong>for</strong> molecular amplification procedures FDA requirements <strong>for</strong> IVD products State requirements (e.g., New York <strong>and</strong> Washingtonstate programs) Voluntary professional practice <strong>and</strong> accreditationguidelines (e.g., ACMG, CAP, CLSI) Good laboratory practices
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