Table of Contents
Abstract
CommitteeMembership
Foreword
1Scope
2Introduction
3StandardPrecautions
4Terminology
5SurveyofRegulatoryandGuidanceDocuments
RegardingProficiencyTesting
6Design
7MaterialSourcing/Collection
8Production/Manufacture
9TransportationofSamplesforProficiency
TestingPrograms
10DocumentationtoExchangeInformation
11ProviderResultsReviewandEvaluation
12ComplementaryandSupplementaryApproachesto
ProficiencyTesting/ExternalQualityAssessmentPrograms
References
AppendixA-GloballyInfluentialDocumentsAddressing
ProficiencyTesting:Relevancetoandimpact
onStakeholders
AppendixB-ProcessChecklistExample
AppendixC-UsefulWebsitesforInformationinShipping
ProficiencyTesting/ExternalQuality
AssessmentSamples
AppendixD-ExampleRegistrationFormforProficiency
Testing/ExternalQualityAssessment
Challenge/Scheme
AppendixE-ExampleInstructionsManual
AppendixF-ExampleofClinicalInformationRelatedto
theProficiencyTesting/ExternalQuality
AssessmentSample
AppendixG-ExamplesectionsFromaProficiency
Testing/ExternalQualityAssessmentResult
ReportingForm
AppendixH-ExampleConfidentialityForm
AppendixI-ExampleDataFromaParticipantSummaryReport
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials Abstract
Specifies guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.
