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IVD INTERNAL QUALITY CONTROLS WILL EASE CLIA QC REQUIREMENTS UNDER REVISED REGULATION; QC PHASE-IN FOR MODERATE COMPLEXITY TESTS TO BE EXTENDED

This article was originally published in The Gray Sheet

Executive Summary

Laboratories using test systems with advanced internal quality control capabilities will face less stringent QC requirements under upcoming revisions to regulations on the Clinical Laboratory Improvement Amendments of 1988. The Centers for Disease Control and Prevention is revising CLIA QC rules to replace the now-defunct plan for government validation of manufacturers' labeling as a means for laboratories to comply with the rules.

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