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)

OROR

‘‘Quality is doing it right when Quality is doing it right when no-one is looking’ no-one is looking’

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

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

Accuracy and precision

Poor accuracy andprecisionPoor assay,Poor operator

Good precision butpoor accuracyPoor assay,Good operator

Good precision andgood accuracyGood assay,Good operator

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

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’

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)