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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 |
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| Survey on Establishment and Monitoring of Quality Indicators in ISO 15189 Accredited Laboratories |
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| Abstract: |
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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. |
| Key words: quality indicator,ISO 15189 accreditation,clinical laboratory,total testing process |
