通过ISO 15189认可实验室质量指标制定及监测情况调查

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。

Survey on Establishment and Monitoring of Quality Indicators in ISO 15189 Accredited Laboratories

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.