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临床化学检验结果自动审核系统的建立与评价 被引量:4

Establishment and assessment of an autoverification system in a clinical chemistry laboratory
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摘要 目的随着医学科学技术的发展,实验室检测结果对大部分临床决策的影响越来越显著。因此,在保证检验结果准确性、可靠性的前提下,缩短周转时间(TAT)是当前临床实验室的工作重点之一。本研究的目的是建立一套适合本实验室的临床化学检验结果自动审核系统并进行应用效果评价。方法研究以雅培C16000生化分析仪以及中间体软件IM、实验室信息系统(LIS)为基础,参考美国临床实验室标准化协会(CLSI)AUTO-10A文件、美国病理学会(CAP)清单和ISO15189文件,从自动审核范围确认规则、危急值审核规则、历史比对值审核规则、逻辑条件审核规则和质量控制审核规则五个层面建立相应的自动审核规则,构建自动审核流程图,并比较了采用自动审核系统前后样本周转时间(TAT)的变化情况,分析报警状况分布以及人工审核与自动审核的一致性。结果共产生了435条自动审核条目,并根据这些审核条目构建了自动审核流程图。采用自动审核系统后,325 000例样本的通过率为52.3%,门诊和住院标本的TAT在自动审核前后的差异具有统计学意义(均P<0.05),门诊和住院标本的平均TAT分别缩短了43 min和60 min、自动审核和人工审核的符合率为99.98%。结论本研究建立了符合本实验室的临床化学检验结果自动审核系统,该系统可以显著缩短TAT,具有很高的安全性,值得在实验室推广和应用。 Objective With the development of medical science and technology, the results of laboratory tests have be- come more and more significant for most clinical decisions. Therefore, under the premise of ensuring the accuracy and re- liability of the test results, shortening the turnaround time (TAT) is one of the focuses of current clinical laboratories. The purpose of this study is to establish an autoverifieation system for clinical biochemistry tests in our laboratory. Meth- ods An autoverifieation system was established according to the documents of the AUTO-10A guideline of Clinical Labo- ratory Standards Institute (CLSI), the checklist of the College of American Pathology (CAP) and the ISO 15189 rules. This system was applied in our laboratory information system (LIS) , the Abbott C1600 biochemistry analyser and its managing software IM. This autoverification system consisted of five domains for every test: autoverification limits, criti- cal value, delta check, quality control and algorithms for special tests. A flowchart was constructed to summarize this sys- tem. Turnaround time (TAT) before and after using this system was compared. Consistency rate between autoverification and manual verification was analysed. Results A total of 435 rules were released and a flowchart was constructed. Auto- verification rate in 325 000 specimens was 52.3%. The TAT of the outpatients and hospital samples before and after using this system was statistically significant ( all P 〈 0.05 ). The TATs for specimens of outpatients and inpatients was shortened to 43 and 60 minutes. The most frequent reasons for autoverification failure were autoverification limit and delta check. The consistency rate between autoverification and manual verification was 99.98%. Conclusion An autoverifi- cation system that is suitable for our laboratory has been established. This autoverification system can significantly shorten the TAT. The system is very safe and worthy of promotion and application in the laboratory.
作者 闫绍荣 何令伟 钱定良 丁继光 YAN Shao-rong;HE Ling-wei;QIAN Ding-liang;et al(Department of Laboratory Medicine, Rui' an People' s Hospital, Rui' an, Zhejiang 325200, Chin)
出处 《中华全科医学》 2018年第7期1171-1174,共4页 Chinese Journal of General Practice
基金 2013年浙江省医药卫生一般研究计划(2013KYB252)
关键词 自动审核 样本周转时间 质量管理 Autoverification Turnaround time Quality control
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