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通过ISO 15189认可实验室质量指标制定及监测情况调查
引用本文:章晓燕,费阳,王薇等. 通过ISO 15189认可实验室质量指标制定及监测情况调查[J]. 西北植物学报, 2016, 0(9): 32-34
作者姓名:章晓燕  费阳  王薇等
摘    要:

目的 了解目前我国通过ISO 15189认可的实验室质量指标制定及监测情况。 方法 设计质量指标制定及监测情况调查表并下发给185家认可实验室,要求在10月31日前以邮件形式回报结果,使用Microsoft Excel 2010软件进行统计分析。 结果 共85家(占45.95%)实验室回报结果,76家临床实验室,9家独立实验室。不同认可实验室制定的质量指标数量及分布差异较大。76家临床实验室共设置质量指标1105项,每家实验室平均14.5项。9家独立实验室设置质量指标195项,每家实验室平均21.7项。临床实验室制定了更多的检验前、检验中质量指标,独立实验室在设置质量指标时还包括了较多的检验后、支持性过程和其他质量指标。 结论 目前我国认可实验室质量指标制定及监测情况尚不理想。在推进质量指标一致化的同时,实验室应加强宣贯与教育,建议一套完整、科学和实用的质量指标体系。



关 键 词:质量指标  ISO 15189认可  临床检验  检验全过程

Survey on Establishment and Monitoring of Quality Indicators in ISO 15189 Accredited Laboratories
Abstract: Objective To investigate and analyze the current situation of establishment and monitoring of quality indicators in ISO 15189 accredited laboratories. Methods A questionnaire for the survey on establishment and monitoring of quality indicators was designed and sent to 185 accredited laboratories, and it should be reported back before October 31 by e-mail. The results were analyzed using Microsoft Excel 2010. Results Totally 85 laboratories (45.95%) submit the survey results, including 76 clinical laboratories and 9 independent ones. There are significant differences in numbers and distribution among different laboratories. Totally 1 105 quality indicators are developed in 76 clinical laboratories, the average is 14.5. Totally 195 quality indicators are developed in 9 independent laboratories, the average is 21.7. More quality indicators in pre-analytical, analytical processes were formulated in clinical laboratories, whereas more quality indicators in supporting, post-analytical and other processes in independent laboratories. Conclusion The current situation of establishment and monitoring of quality indicators in accredited laboratories is unsatisfactory. There is a need in advancing the uniformity of quality indicators, meanwhile, laboratories should strengthen the propaganda and education to establish a completed, scientific and practical quality indicator system.
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