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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2015, Vol. 03 ›› Issue (01): 23-27. doi: 10.3877/cma.j.issn.2095-5820.2015.01.007

• Quality Control • Previous Articles     Next Articles

Appraisement of the external quality assessment for three biochemical tests in biochemistry laboratories by randomized blind sample test

Lihong Zhang1, Jian Zhao2, Ling Gai1, Jiali Wang3, Wei Zhang1, Yanping Zhang1, Yunling Dong1, Baohong Jiang1, Guanzhao Xu1,()   

  1. 1.Shandong Provincial Key Laboratory for Improving Birth Outcome Technique, Shandong Provincial Research Institute for Family Planning, Jinan 250002, China
    2.Jinan City Licheng District Family Planning Service Station, Jinan 250100, China
    3.Weifang City Fangzi District Maternal and Child Health Care Service Center, Weifang 261200, China
  • Received:2014-11-13 Online:2015-02-28 Published:2024-11-30
  • Contact: Guanzhao Xu

Abstract:

Objective

To investigate the real performance of the test for alanine aminotransferase(ALT), glucose (Glu) and creatinine (Cr) in clinical biochemistry laboratories from Shandong Family Planning system, and find the methods to improve the quality.

Methods

External quality assessment (EQA)was conducted twice a year among 138 hospitals from Shandong Province Family Planning system from 2013 to 2014. Besides the conventional EQA for ALT, Glu, Cr, five-batch quality control products randomly by the sample numbers were conducted on the first time of conventional EQA in 2014. Five samples were in the same concentration in test EQA with the conventional EQA. Five-batch quality control products were sent to all participating laboratories with the same codes in conventional EQA scheme while with different random codes. Performance was evaluated by accepted score which was calculated followed the US Clinical Laboratories Improvement Amendments of 1998 (CLIA’88).

Results

In four times of conventional EQAs,the passing rates of ALT were 93.4%, 99.3%, 97.1%, and 100% respectively; the passing rates of Glu were 96.4%, 97.8%, 97.8% and 99.3% respectively; the passing rates of Cr were 84.1%, 97.1%, 94.2% and 98.6%respectively. The passing rates of ALT and Glu in randomized blind sample test EQA (95.7%, 96.4%) were lower than in conventional EQA (97.1%, 97.8%). But the difference was not statistically significant (χ2 =0.415 and 0.515,P>0.05). The passing rates of Cr in randomized blind sample test EQA (86.2%) was statistically significantly (χ2 =4.105, P<0.05) lower than that in conventional EQA.

Conclusions

The performances of participating laboratories for clinical chemistry have improved year by year. Occasional use of randomized blind sample test EQA may help the EQA organizer to find the real performances of participants.

Key words: Alanine aminotransferase, Glucose, Creatinine, External quality assessment, Random codes

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