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CLIA-Compliant Analytical Method Validation Plan and ...

LRN-C Analytical Method Validation PLAN & TEMPLATE 20131 TABLE OF CONTENTS List of LRN Clients and Requirements for Analytical Method Performance Method Performance Specifications and Validation Analytical Method Validation Plan and TemplateFOR LRN-C LABORATORIESISSUES IN BRIEF: LRN-C Analytical Method Validation PLAN & TEMPLATE DECEMBER 2013 LIST OF ACRONYMSEQA External Quality AssessmentHPLC-MS/MS High-Performance Liquid Chromatography Tandem Mass SpectrometryIS Internal StandardLDT Laboratory Developed Test(s)LOD Limit of DetectionLOQ Limit of QuantitationPK/PD Pharmacokinetic/Pharmacodynamic modelingTEa Total Allowable ErrorULOL Upper Limit of Linearity APHL PUBLIC HEALTH LABORATORIES2 INTRODUCTION The Laboratory Response Networki (LRN)

analytical toxicology services that meet needs for emergency response, investigation and patient care. The Clinical Laboratory Improvement Amendmentsiii (CLIA) applies to LRN-C clinical tests (tests on human blood, urine or other tissue) as do LRN Network requirements. These dual requirements include method validation procedures.

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