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Using CQAS Data in the Laboratory

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Using CQAS Data in the Laboratory

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    1. Using CQAS Data in the Laboratory Brendan J Fitzpatrick Chief Medical Scientist Haematology Dept.,

    2. Quality Issues – my profile 36 yrs Laboratory experience >30 yrs in Haematology Used to be Public (HSE) now Private FIBMS CSci, - Haematology MIBiol CBiol, - Biochemistry MSc. – Management of Operations Poster Presentations on Quality 2006 NEQAS Annual Meeting, Belfast Won the Mitchell Lewis Award 2008 NEQAS Annual Meeting, Durham 2008 IEQAS Annual Meeting Dublin

    3. Quality Issues – the laboratory perspective

    4. Quality Issues – the problems

    5. Quality Issues – the APTT problem APTT showing a pattern of ‘Negative’ D.I.’s

    6. With a Reference Range of 22.5 - 31.0 seconds for the batch of APTT Reagent, a frequency of 12 – 16% short APTTs was identified by a 6 month lookback on the work. Simultaneously plotting of Normal and Abnormal control showed the following: Quality Issues – the APTT problem

    7. Quality Issues – the APTT problem

    8. Quality Issues – the APTT problem

    9. Quality Issues – the APTT problem

    10. Quality Issues – the APTT problem

    11. Quality Issues – the APTT problem

    12. Quality Issue Solved ??

    13. Quality Issues – Summary Problem identified – e.mailed ‘Inspector Clouseau’ (Sue) Simultaneously looked at ‘specific’ group in CQAS Reports Identified ‘possible’ affected individuals from Special Survey information As Batch of APTT Reagent was nearing expiry date – obtained new batch early Validated performance locally and by 2 CQAS Trials – implemented and problem solved

    14. Quality Issues – the FIBRINOGEN problem Situation here is Main Analyser (560) is performing OK, the Backup Analyser (540) is yielding higher results than 560 which is causing data to be ‘trimmed’ by CQAS Only 3 users still with CA 500 series and one does not participate in Fibrinogen estimation Solutions tried; recalibration, ‘fresh’ reagents, match 540 to 560.

    15. Quality Issues – the FIBRINOGEN problem

    16. Quality Issues – the FIBRINOGEN problem

    17. Quality Issues – the FIBRINOGEN problem

    18. Quality Issues – the FIBRINOGEN problem

    19. Quality Issues – the FIBRINOGEN problem

    20. Quality Issues – the FIBRINOGEN problem

    21. Quality Issues – Problems Resolved ?

    22. Quality Issues – Solutions

    23. Quality Issues – Final Word

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