[1]潘莉兰,邓 盼,祝卫平.湖北省临床化学常规检验项目不精密度分析[J].现代检验医学杂志,2015,30(02):160-162.[doi:10.3969/j.issn.1671-7414.2015.02.051]
　PAN Li-lan,DENG Pan,ZHU Wei-ping.Analysis of the Imprecision of Clinical Routine Chemistry Analysis Tests in Hubei Province[J].Journal of Modern Laboratory Medicine,2015,30(02):160-162.[doi:10.3969/j.issn.1671-7414.2015.02.051]
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湖北省临床化学常规检验项目不精密度分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年02期
页码:
160-162
栏目:
质量控制·实验室管理
出版日期:
2015-03-20

文章信息/Info

Title:
Analysis of the Imprecision of Clinical Routine Chemistry Analysis Tests in Hubei Province
作者:
潘莉兰; 邓 盼; 祝卫平
湖北省临床检验中心,武汉 430064
Author(s):
PAN Li-lan; DENG Pan; ZHU Wei-ping
Hubei Center for Clinical Laboratories,Wuhan 430064,China
关键词:
临床化学;  常规项目;  不精密度
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.02.051
文献标志码:
A
摘要:
目的 了解湖北省临床化学常规检验项目满足允许不精密度质量规范的水平。方法 收集2013年参加湖北省临床化学室内质控数据实验室间比对计划中值浓度水平的室内质控数据,分析钾、钠、氯、总钙、磷、葡萄糖、尿素、尿酸、肌肝、总蛋白、清蛋白、总胆固醇、三酰甘油、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、总胆红素、碱性磷酸酶、淀粉酶、肌酸激酶、乳酸脱氢酶和γ-谷氨酰基转移酶等21个临床化学常规检验项目的室内质控变异系数,采用1/3TEa,1/4TEa,WS/T403-2012和基于生物学变异导出的允许不精密度作为质量规范,分析实验室满足各质量规范标准所占的比例。结果 50%以上实验室能满足1/3 Tea,1/4 Tea,WS/T403-2012和基于生物学变异导出的最适、最低允许不精密度质量规范要求的项目有三酰甘油、丙氨酸氨基转移酶、肌酸激酶、总胆红素; 50%以上实验室不能满足以上所有质量规范的项目有氯和肌酐; 所有实验室不能满足基于生物学变异导出的最佳允许不精密度的项目有钠和总钙。以80%的实验室变异系数小于质量规范作为合格评价标准,21个项目中满足生物学变异最低质量规范的项目数最多,占66.7%,满足WS/T403-2012和生物学变异最佳质量规范的项目数最少,占14.3%。结论 参加湖北省室内质控数据实验室间比对的实验室21个项目的室内质控变异系数总体上是达到要求的,但部分项目的检测结果离散度大,实验室应根据该室的检测能力和质量规范标准设定合适的不精密度水平,并通过实验室的持续改进不断提高检验质量。
Abstract:
Objective To learn how well these items of Hubei Province meet the quality standards of allowed imprecision.MethodsCollected the indoor quality control data of median concentration levels from the laboratories which participated the project of interlaboratory comparisons of clinical chemistry indoor quality control data in Hubei Province.This paper was to analyze the variation coefficient of indoor quality control for21 routine clinical chemistry examination items which were K,Na,Cl,TCa,P,GLu,Urea,UA,Cr,TP,Alb,TC,TG,ALT,AST,TBil,ALP,AMS,CK,LDH and γ-GT.The other objective was to learn how well these items of Hubei Province meet the quality standards of allowed imprecision.Then took the 1/3 TEa,1/4 TEa,WS/T-403-2012 and minimum imprecision derived from biological variation as quality specification.And analyzed the percentage of laboratories in meeting the quality standards.Results The TG,ALT,CK and TBil in more than 50% of the participated laboratories could meet the quality standards of the1/3 TEa,1/4 TEa,WS/T-403-2012 and the lowest appropriate imprecision derived from biological variation.The Cl and Cr in more than 50% of laboratories couldn't meet the all above quality standards.The Na and TCa in all laboratories couldn't meet the quality standards of best imprecision derived from biologicalvariation.The evaluation criterion for qualified items setted was that the variation coefficient in more than 80% laboratories was less than the quality standard.Thus,the percentage of the items which meet the lowest quality standard ofbiological variation and the all 21 items was the most(66.7%).While the percentage of the items which met the quality standards of the WS/T403-2012 and thebest biological variation was the least(14.3%).Conclusion In short,the values of indoor variation coefficient of the 21 items in laboratories which participated the project of interlaboratory comparisons of clinical chemistry indoor quality control data generally met the requirements.But some items had a little higher degree of dispersion.The laboratories should setthe appropriate imprecision levels based on the detection capability and qualitystandards and improve the quality of examination through continuous efforts.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:潘莉兰(1970-),女,学士,副主任技师,主要从事临床检验质量管理和控制工作,Tel:027-87277958,E-mail:panlilan111@163.com。
更新日期/Last Update: 2015-03-20