Establishment and assessment of an autoverification system in a clinical chemistry laboratory
-
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。Abstract: Objective With the development of medical science and technology, the results of laboratory tests have become more and more significant for most clinical decisions. Therefore, under the premise of ensuring the accuracy and reliability 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 autoverification system for clinical biochemistry tests in our laboratory. Methods An autoverification system was established according to the documents of the AUTO-10A guideline of Clinical Laboratory 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, critical value, delta check, quality control and algorithms for special tests. A flowchart was constructed to summarize this system. 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. Autoverification 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 autoverification 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.
-
Key words:
- Autoverification /
- Turnaround time /
- Quality control
点击查看大图
计量
- 文章访问数: 224
- HTML全文浏览量: 37
- PDF下载量: 7
- 被引次数: 0