摘要
目的对云南省15个中心血站实验室单盲标本考评,ELISA现场检测过程考核结果进行总结,分析和探讨检测过程考评在质量评价活动中的意义。方法质量考评活动中,由考评组现场对实验室单盲考评标本的检测过程进行考评,对考评标本检测结果和过程现场打分,统计分析各ELISA项目试剂的使用情况,按试剂分类统计检测结果。结果 15个中心血站实验室单盲考评标本检测结果均为满分,检测过程考评表相关条款平均得分106.73分,最低为78分。各实验室均配置了能够满足检测要求的自动化检测设备和检测试剂,3个小型血站实验室检测值Z-比分数有问题或不满意的结果较多。结论单盲考评标本现场检测过程考评,综合考评检测结果和过程,相较于仅对检测结果进行分析,更能够客观反映实验室实际情况,为参评实验室进一步贯彻实施法律法规、持续改进质量体系提供了详细和重要的依据。
Objective To summarize the results from the single-blind ELISA detection process on reference samples and field evaluation during the quality assessment of 15 blood bank laboratories in Yunnan province, to analyze and discuss the significance of the single-blind detection process and field evaluation on quality assessment. Methods During the quality assessment, the single-blind detection on the reference samples was evaluated. The test result and field evaluation terms were evaluated. ELISA reagent usage was statistically analyzed. According to the types of detection reagents, results were categorized and statistically analyzed. Results The results of all 15 blood bank laboratories'single-blind detection of reference samples achieved 100%. The average score of the field evaluation terms in the detection process was 106.73, with 78 the lowest score. All laboratories were equipped with the instruments and detection reagents that were appropriate for automatic detection. Three small blood banks had lower scores and unsatisfactory results. Conclusion The results of singleblind detection process and field evaluation on reference samples were adequate in 15 blood banks in Yunnan. According to the field evaluation, some laboratories harbor more risks and dangers. The synthesis of single-blind sample detection process and field evaluation would provide a more objective assessment on the laboratory environment than solely evaluation on the results. This kind of quality assessment provides a detailed and important basis for further implementation of the laws and regulations and continuous improvement of the system.
出处
《中国输血杂志》
CAS
北大核心
2015年第6期737-740,共4页
Chinese Journal of Blood Transfusion
关键词
检测过程
现场考核
单盲考评标本
ELISA检测
考评方法
detection process
field evaluation
single-blind reference samples
ELISA detection
evaluation method