feedback from eurogentest workshop: annual management review, iqc and eqa berlin 9-10 th oct 2008...
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![Page 1: Feedback from EuroGentest Workshop: Annual Management Review, IQC and EQA Berlin 9-10 th Oct 2008 Jeremy Skinner CSci, FIBMS Quality Manager Genetics Centre](https://reader035.vdocuments.mx/reader035/viewer/2022062511/551bc169550346c3588b4aac/html5/thumbnails/1.jpg)
Feedback from EuroGentest Feedback from EuroGentest Workshop:Workshop:
Annual Management Review, Annual Management Review, IQC and EQA IQC and EQA
Berlin 9-10Berlin 9-10thth Oct 2008 Oct 2008
Jeremy Skinner CSci, FIBMSJeremy Skinner CSci, FIBMS
Quality Manager Genetics Quality Manager Genetics Centre GSTT (GSTS)Centre GSTT (GSTS)
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OROR
‘‘Quality is doing it right when Quality is doing it right when no-one is looking’ no-one is looking’
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EQAEQA
• ‘‘The main objective of external quality The main objective of external quality assessment is to establish inter-laboratory assessment is to establish inter-laboratory compatibility’compatibility’
• External evidence that test gives correct results - External evidence that test gives correct results - AccuracyAccuracy
• Participate in as many schemes as possible to Participate in as many schemes as possible to cover repertoirecover repertoire
• Make sure EQA coversMake sure EQA covers– Sample reception Sample reception – Sample preparation Sample preparation – Key analytical methodsKey analytical methods– InterpretationInterpretation
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IQCIQC
• WHO definition (1981)WHO definition (1981)– ‘‘The main objective of internal quality control The main objective of internal quality control
is to ensure day-to day consistency’is to ensure day-to day consistency’
• Verifying that test is giving consistent Verifying that test is giving consistent results – results – precisionprecision
• Identify potential errors and then define Identify potential errors and then define IQC in SOPsIQC in SOPs
Tests precise and accurate Tests precise and accurate
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Accuracy and precision
Poor accuracy andprecisionPoor assay,Poor operator
Good precision butpoor accuracyPoor assay,Good operator
Good precision andgood accuracyGood assay,Good operator
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Annual Management ReviewAnnual Management Review
• Needed to comply with CPA stds A11 (ISO 15189 Needed to comply with CPA stds A11 (ISO 15189 4.15.1)4.15.1)
• Follow-up on previous objectives Follow-up on previous objectives • Review of QMS Review of QMS
– Quality policyQuality policy– Quality manualQuality manual
• Overview of QMSOverview of QMS– Audits and NCs/QIsAudits and NCs/QIs– ComplaintsComplaints– User surveysUser surveys– Quality indicatorsQuality indicators
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Quality IndicatorsQuality Indicators
‘‘Quality Indicators for monitoring the Quality Indicators for monitoring the laboratory’s contribution to patient laboratory’s contribution to patient care’care’
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Results from AMRResults from AMR
• Formal action planFormal action plan– Quality objectives Quality objectives – Improvement to QMSImprovement to QMS– Improvement to processes Improvement to processes – Resources requiredResources required– Executive summary (for CPA)Executive summary (for CPA)
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