FLOWCHART FOR HANDLING DEVIATING EQA-RESULT Gunn B B Kristensen, Kristine Solem and Pål Rustad NKK, Norsk Klinisk-kjemisk Kvalitetssikring e-mail:[email protected] Is there any explanation in the comment External cause1 letter? Yes NO NO Internal cause2 Do the acceptance limits indicate a considerable deviation? Yes Yes Internal/external cause3 Is the deviation in accordance with previous EQA results? NO NO Internal cause4 Were the results for internal quality control (IQC) OK in the period the analysis was performed? Yes Internal cause5 NO Were the reagents and calibration status OK? Yes Yes Has the manufacturer changed the recommendation regarding reagents, calibrator or the given value of the calibrator recently? Internal/external cause6 NO Is the assigned value (AV) traceable to a reference method? NO Yes External cause8 Is the deviation representative for your method? Yes External cause7 Yes NO Is the deviation representative for your method? NO External cause9 Is AV calculated from original results? Yes NO NO External cause10 Is AV calculated on sufficient number of results (<4)? NO Yes NO Internal cause11 Was the instruction from the EQA organizer followed? Yes NO External cause12 Has the EQA organizer registered the correct method and result? NO Internal cause13 Yes Has the laboratory registered the correct method and result? Yes NO External cause14 Have the samples been sent in a proper way? Yes Internal cause NO 15 Is the analysis performed in the way the manufacturer prescribe? Yes Yes Is the variation in the EQA results for your method large? NO Internal/external cause17 If several samples are measured – is the deviation systematic for all? NO Internal cause18 Yes Does repeated analysis of stored material also give a deviation? Yes Internal/external cause19 External cause16 NO NO Does re-analysis of new material sent from the EQA organizer also give a deviation? NO External cause20 Yes Is the instruction letter correct? Yes UNKNOWN CAUSE21 The flowchart consists of several questions indicating possible causes for the deviating result, further explained in the comments corresponding to the footnote numbers, see attachment
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