ABSTRACT
Objective To explore the differences of using different analytic quality requirements in the comparable validation of blood cell analysis multi-system range test comparable schemes for establishing appropriate analysis quality standards for laboratory.Methods According to WS/T 407-2012 Guideline for Comparability Verification of Quantitative Results in Medical Institution,the range test comparable method was established.According to different sources of analytic quality requirements from the WS/T 406-2012 Analysis Quality Requirements of Clinical Hematological Detection Routine Items,the US Clinical Laboratory Improvement Amendment (88),GB/T 20470-2006 Requirements of External Quality Assessment for Clinical Laboratories and biological variations,corresponding analysis quality requirements standard was designed.Results With the standards designed by using WS/T 406-2012,CLIA′-88 and GB/T 20470-2006 as the analysis quality requirements,only the comparison results of low concentration levels in 3 items of HBC,PLT and HCT were not passed,while other results all were passed;all results passed the consistency verification by suitably revising the analytic quality requirements of low value concentrations.With the biological variations as the analysis quality requirement,the comparison results in WBC three concentration levels,and HBG high and low concentration levels were passed,but other results were not passed.Conclusion The biological variations analytical quality requirements are relative demanding.Using WS/T 406-2012 Analysis Quality Requirements of Clinical Hematological Detection Routine Items and GB/T 20470-2006 Requirements of External Quality Assessment for Clinical Laboratories,fully considering the suitability of low concentration quality requirements and formulating appropriate analysis quality standards of laboratory are the important contents of laboratory comparable validation scheme.
ABSTRACT
Objective To discuss the value in quality improvement and continuous improvement through the way for determina-tion of target uncertainty in chemical quantitative detection project and regular evaluation of measurement uncertainty in different phase.Methods Based on the biological variability of quality specification and CNAS-TRL-001:CNAS technical report,to compare the five kinds of determination of target uncertainty.Method 1:the fundamental way(calculate the different levels of target impre-cision and bias);Method 2:biological variation of different grades of total allowable error;Method 3:the relative expanded uncer-tainty evaluation value based on target imprecision and bias;Method 4:the target relative expanded uncertainty based on biological variation of different grades;Method 5:the target relative expanded uncertainty based on the quality index of analysis.We used un-certainty evaluate index(UEI)to review the changes of uncertainty in different phase.Results The 14 conventional chemistry tests in 2013 with metrological traceability and participate in the Ministry of health EQA were as the target.There was no significant difference among the 2,3,4 method,the ratio of which reached the ideal value of uncertaninty target were not significantly different. In method 5,9 projects achieved the target of uncertainty requirements,accounted for 64.3%.TP,ALT,BUN,UA,CK,these5 pro-jects′UEI were less than 0,accounted for 35.7%;other 9 projects′UEI were more than 2.0%.Conclusion Method 5:the target relative expanded uncertainty based on the quality index of analysis which is based on WS/T403-2012 can give consideration to the quality standard of repeatability precision and bias in the laboratory at the same time,and is easy to be accepted for laboratory;method 4:the target relative expanded uncertainty based on biological variation of different grades is in the same way with the eval-uation of test results uncertainty,is better than method 2 and 3;method 1 is the fundamental way,can give the specific reasons when the test results cannot get the target uncertainty.Use UEI to assess the changes of uncertainty in different phase is more sensitive to changes of the test results′accuracy and its usefulness needs to be confirmed in practice.