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Jeremy Skinner CSci, FIBMS Quality Manager Genetics Centre GSTT (GSTS)

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Jeremy Skinner CSci, FIBMS Quality Manager Genetics Centre GSTT (GSTS) ‏. Feedback from EuroGentest Workshop: Annual Management Review, IQC and EQA Berlin 9-10 th Oct 2008. OR. ‘Quality is doing it right when no-one is looking’. EQA. - PowerPoint PPT Presentation
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  • Feedback from EuroGentest Workshop:Annual Management Review, IQC and EQA Berlin 9-10th Oct 2008 Jeremy Skinner CSci, FIBMSQuality Manager Genetics Centre GSTT (GSTS)

  • ORQuality is doing it right when no-one is looking

  • EQAThe main objective of external quality assessment is to establish inter-laboratory compatibilityExternal evidence that test gives correct results - AccuracyParticipate in as many schemes as possible to cover repertoireMake sure EQA coversSample reception Sample preparation Key analytical methodsInterpretation

  • IQCWHO definition (1981)The main objective of internal quality control is to ensure day-to day consistencyVerifying that test is giving consistent results precisionIdentify potential errors and then define IQC in SOPs

    Tests precise and accurate

  • Accuracy and precisionPoor accuracy andprecisionPoor assay,Poor operatorGood precision butpoor accuracyPoor assay,Good operator

    Good precision andgood accuracyGood assay,Good operator

  • Annual Management ReviewNeeded to comply with CPA stds A11 (ISO 15189 4.15.1)Follow-up on previous objectives Review of QMS Quality policyQuality manualOverview of QMSAudits and NCs/QIsComplaintsUser surveysQuality indicators

  • Quality IndicatorsQuality Indicators for monitoring the laboratorys contribution to patient care

  • Results from AMRFormal action planQuality objectives Improvement to QMSImprovement to processes Resources requiredExecutive summary (for CPA)

  • *GSTS=Guys and St Thomas Technology Services 15 minutes max 10 presentation 5 questionsMention Ian Sharp audit course and Greenwich*Something from the course*Are there any tests which arent covered? How do we EQA these? Didnt mention IQA-difficult for Genetics/control samples. If you only get extracted DNA how do we test our extraction methods?Sometimes difficult to get EQA for rare diseases could get round this by sending samples to collaborating labs.**Something I got from Ian, one of my favourite slides to illustrate what we want.*Now on to the AMR part of the workshop.Get all reports ready before hand and circulate before the meeting so that the meeting discusses proposals and actions for the quality objectives rather than ploughing though long reports. Tips-go for easy topics first.End on positive note. Can do one area per month (if you were just starting off) but may be logistically difficult.*CPA standard A11.1 h)=AMR agenda itemH6.4 The laboratory shall establish quality indicators to monitor and evaluate performance throughout critical aspects of pre-examination, examination, and post examination processes and their relationship to effective patient care. The objectives of quality indicators, their methodology and duration of measurement shall be established prior to implementation. ISO 15189 = 4.14.6 note 2 the laboratory should establish quality indicators for systematically monitoring and evaluating the laboratorys contribution to patient care. *Some pictures of what the groups came up with. As you can see there is a wide range of indicators we could use really up to you to define and monitor- and you probably monitor these any way. ***Could also have number of rejected samples against total number of samples. *Who does what and by when and circulate to all staff so that they are aware of objectives.Improvement to QMS e.g. getting Q-pulse what would and will be the cost implications Improvement to processes e.g. what new tests/techniques will be introduced resource implicationsQuality objectives listed as QOs in controlled document then managed via the lab directors and minuted in the lab meetings (QM)-what we do at GSTSCould have review over 12 months one subject per month-impractical for us.Follow-up at management meetings.

    *Picture of the group*Workshop activity. Good small group work from a variety of experience and backgrounds (although courses now very expensive).

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