ABSTRACT
Objective To analyze the status of quality indicators(QI) on specimen acceptability and establish preliminary qual ity specification.Methods Web based External Quality Assessment system was used to collect data of laboratories partici pated in "Medical quality control indicators in clinical laboratory" from 2015 to 2017,including once in 2015 and 2017 and twice in 2016.Rate and sigma scales were used to evaluate incorrect sample type,incorrect sample container,incorrect fill level and anticoagulant sample clotted.The 25th percentile (P25) and 75th percentile (P75) of the distribution of each QI were employed to establish the high,medium and low specification.Results 5 346,7 593,5 950 and 6 874 laboratories sub mitted the survey results respectively.The P50 of biochemistry (except incorrect fill level),immunology and microbiology reach to 6σ.The P50 of clinical laboratory is 4 to 6σ except for incorrect sample container.There is no significant change of the continuous survey results.Based on results in 2017 to establish the quality specification,the P25 and P75 of the four QIs is 0 and 0.084 4 ％,0 and 0.047 6 ％,0 and 0.114 2 ％,0 and 0.078 4 ％,respectively.Conclusion According to the results of the survey,most laboratories had a faire performance in biochemistry,immunology and microbiology,and clinical laboratory needs to be strengthened.Laboratories should strengthen the laboratory information system construction to ensure the actual and reliable data collection,and make a long time monitoring to achieve a better quality.
ABSTRACT
Objective To carry out the current status of internal quality control by statistical analysis of the Internal Quality Control (IQC)data of homocysteine in 2014 March.Methods Web-based External Quality Assessment (EQA)system was used to collect IQC data of homocysteine from 292 EQA participant laboratories nationwide.The data include thecoefficient of variation (CV)of IQC data under control in March 2014 and long-term cumulative data.Acceptable rates of CVs of two-lot internal quality controls in homocysteine were calculated according to 5 criteria,that were 1/3TEa,1/4TEa and the speci-fications based on biological variation including the minimal,appropriate and optimal allowable imprecision.The instrument the participant laboratories used were sorted into 6 groups and the passing rate of each group were calculated by the 5 crite-ria.Results 292 laboratories reported the data of level 1 IQC for homocysteine,106 of which reported the data of level 2 IQC.The passing rate was different according to different criteria.The passing rate had few difference by the criteria of 1/3TEa and the minimal allowable imprecision based on biological variation,which were from 63.36% to 76.42%.It was also true for 1/4TEa and the appropriate allowable imprecision based on biological variation,which were from 34.25% to 57.55. The passing rate was only 10.62%~16.98% by the criteria of appropriate allowable imprecision based on biological varia-tion.Statistical results showed that instruments the participant mainly used were HITACHI (77/292),Olympus (61/292), Roche (19/292),Beckman (14/292),Abbott (10/292)and Simens (10/292).The passing rates of all the instrument group had few difference except Simens group.Conclusion Most of the laboratories could meet the criteria of 1/3TEa and the min-imal allowable imprecision based on biological variation.But less than half of the laboratories could meet the criteria of 1/4TEa and the appropriate and optimal allowable imprecision based on biological variation.The precision performance of ho-mocysteine among laboratories needs further improvement.