全国常规化学室间质评不合格项目原因调查分析  

Analysis of error sources for routine chemistry external quality assessment program in China

作　　者：赵海建[1] 张传宝[1] 曾洁[1] 张江涛[1] 马嵘[1] 杜忠礼 王治国[1] 

机构地区：[1]北京医院卫生部临床检验中心,100730

出　　处：《中华检验医学杂志》2016年第5期376-379,共4页Chinese Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划资助项目（2011AA02A102,2011AA02A116）;“十二五”国家科技支撑计划课题（2012BA137801）;北京市自然科学基金资助项目（7143182）

摘　　要：目的调查分析全国常规化学室问质量评价不合格项目的原因，为针对性采取纠正和预防措施提供依据。方法通过室间质量评价网络系统，针对2013年全国常规化学室间质量评价第一轮活动中的不合格项目，对其原因进行调查。并从笔误、方法问题、设备问题、技术问题、质评样本问题、评价方法问题、无法解释共7个方面进行分析。结果按要求上报项目不合格原因的实验室比例为33．3％－80．0％。主要不合格原因分别为：笔误6．5％（小数点位置错误70．1％、单位不正确20．8％、仪器或方法编码不正确8．1％）；方法问题45．1％（校准54．2％、试剂38．0％、室间质评物7．8％）；设备问题28．5％（未定期维护98．0％、管路2．0％）；技术问题8．2％（未遵循操作规程80．4％、质评物复溶错误10．6％、在设备上放置的顺序不正确9．0％）；无法解释11．7％（系统误差68．2％、随机误差31．8％）；无质评样本及评价方法的问题。对钠、氯、磷、直接胆红素、总铁结合力、铜、锌7个不合格项目分析系统进行分组统计，多数项目配套系统不合格的比例低于非配套系统。结论实验室应进一步加强质量控制工作，使用高质量的试剂，改进操作技术，增强责任心，以保证检测结果的可靠性。Objective To investigate and analyze the reasons of failure in external quality assessment（EQA） for routine chemistry and provide the basis for the corrective and preventive actions. Methods Based on the network system of NCCL EQA the reasons of failure in 2013 national routine chemistry external quality assessment program were investigated, among which the reasons were classified and analyzed with seven sources of problems which were clerical errors, methodological problems, equipment problems, technical problems, EQA materials problems, EQA Evaluation problems and unable to explain after investigation. Results The return rate of this root cause investigation for each analyte ranged from 33.3% to 80. 0%. The major reason for unacceptable analyte included clerical errors （6. 5% ） （ decimal point position error： 70. 1% ; unit error： 20. 8% ; instrument or method coding error： 8. 1%）, methodological problems （ 45.1% ） （ calibration： 54. 2% ; reagent： 38.0% ; EQA material： 7.8% ）, equipment problems （ 28.5% ） （ no regular maintenance： 98.0% ; pipeline error： 2. 0% ） , technical problems （8.2%） （ do not follow SOP： 80. 4% ; EQA material redissolve error： 10. 6% ; placing order error： 9. 0% ） and unable to explain （ 11.7% ） （ system error： 68. 2% ; random error： 31.8% ）. There were no EQA materials problems or EQA Evaluation problems in this survey. Analysis systems＇ grouping statistics were implemented for seven analytes including sodium, chlorine, phosphorus, direct bilirnbin, total iron binding capacity, copper, and zinc. Unsatisfied EQA proportions of mating system were lower than non- matching ones for the majority of analytes. Condutions Further work on EQA should be undertaken by clinical laboratories. Laboratories should use reagents with high quality as well as improve the operation technology and sense of responsibility. Only in this way, can the accuracy and reliability of testing results be guaranteed.

关 键 词：诊断试验 常规 临床化学试验 实验室 质量控制 

分 类 号：R446[医药卫生—诊断学] R197.323[医药卫生—临床医学]