Table of Contents
Abstract
CommitteeMembership
Foreword
1Scope
2Introduction
3StandardPrecautions
4Terminology
5OverviewoftheProcessforProvidingMolecularGenetic
TestingServicesandPathofWorkflow
6ApplicationofQualitySystemEssentialstoMolecular
GeneticTesting
7TechnicalProcessesofMolecularGeneticTesting
8PersonnelQualifications,Responsibilities,andCompetency
References
AppendixA-ExampleofaLaboratoryQualityManual
AppendixB-ACrosswalkofQualityStandardsofISO15189
andClinicalLaboratoryImprovementAmendment
RegulationsinRelationtoQualitySystem
Essentials
AppendixC-ExampleMoleculargeneticTestXYZTrainingForm
AppendixD-SampleTrainingGrid
AppendixE-QualityManagementDocumentsandRecordsfor
thePathofWorkflowofMolecularGeneticTesting
AppendixF-RequiredorRecommendedRetentionPractices
RelatedtoRecordsandReportsofMolecular
GeneticTesting
AppendixG-ExampleofaCompletedNonconformingEventRecord
AppendixH-sampleProcessforCorrectiveandPreventive
ActionActivities/Review
AppendixI-RecommendedorRequiredTestReportContent
AppendixJ-SampleFailureModesandEffectsAnalysis
AppendixK-InformedConsentforMolecularGeneticTesting
AppendixL-ExampleofaMolecularGeneticTestRequisitionForm
AppendixM-ExamplesofMolecularGeneticTestReports
AppendixN-RecommendedPracticesforRetentionofResidual
PatientSamples
AppendixO-CompetencyAssessmentExamples
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials Abstract
Specifies guidance for implementing international quality management system standards in laboratories that perform human molecular genetic testing for inherited or acquired conditions.
