临床化学检验结果自动审核程序的建立与应用  

Establishment and application of autoverification procedure for clinical chemistry test results

作　　者：李晓博 普智飞 陶春林 高红 Li Xiaobo;Pu Zhifei;Tao Chunlin;Gao Hong(Hangzhou DIAN Medical Testing Center,Hangzhou 310030,China)

机构地区：[1]杭州迪安医学检验中心,310030

出　　处：《中华检验医学杂志》2018年第7期547-553,共7页Chinese Journal of Laboratory Medicine

摘　　要：目的针对常规生化检测项目，制定自动审核规则，借助实验室信息管理系统实现检验结果的自动审核。方法依据美国临床和实验室标准协会（CLSI）AUTO－10A及医学实验室质量和能力认可准则（ISO15189：2012）的指导意见，在室内质控在控的基础上，实验室设计自动审核逻辑，设置六大审核规则，包括室内质控规则、样本状态判断规则、逻辑紊乱规则、值域及多次结果比较（ΔCheck）规则（包括危急值、警示值、参考区间）、关联矛盾规则、异常模式规则，并将审核逻辑和规则搭建在实验室信息系统中。对2016年10月至2017年4月本中心实验室常规生化检测项目，分别按项目、条码统计自动审核通过情况，并与临床诊断信息及人工审核情况进行比较。结果按项目统计自动审核通过率超过65%，按条码统计通过率为45%左右，与临床诊断符合率92%，经过规则的进一步完善，与人工审核相比较，通过一致率从97.48%提高到100%，不通过一致率从82.98%提高到85.21%。结论（1）设置的自动审核逻辑和规则可以实现半数常规生化检验结果的自动审核，且与人工审核判断通过有较高的一致率；（2）新增加的规则必须经过一定周期的验证，方可正式应用；（3）自动审核可以实现检验后步骤的自动化，缩短报告审核时间，提高工作效率。（中华检验医学杂志，2018, 41：547－553）ObjectiveTo develop autoverification rules to assistant the verification of biochemical results, based on laboratory information management system. MethodsDesigned six kinds of autoverification logic rules according to the guidelines of Clinical and Laboratory Standards Institute （CLSI） AUTO-10A and Accreditation Criteria for the Quality and Competence of Medical Laboratories（ISO15189： 2012）, based on in-control of the Internal Quality Control. Those rules inculds： logic disorder rules, critical value rules, warning value rules, delta check rules, relevant contradictions rules, abnormal mode rules, etc. Those rules was setted up in laboratory information management system of Dian Diagnostics. From October 2016 to April 2017, The status of autoverification was checked according to the items and bar code, and compared with clinical diagnostic and manual review. ResultsThe passing rate of autoverification is over 65% when counted according to tests and is 45% when counted according to sample code, the coincidence rate is 92% with clinical diagnosis.In passing results of autoverification, the coincidence rate is 97.48% to 100% when campared with manual verification, and in not-passing results, the coincidence rate is 82.98% to 85.21%. Conclusion（1）Autoverification can verify half of routine biochemical test results by setting intelligent logics and rules. （2）Autoverification rules must be verified by a certain amount of test results before they can be formally applied. （3）Autoverification could improve the speed and efficiency of post-test steps.（Chin J Lab Med, 2018, 41： 547-553）

关 键 词：实验室 医院 临床化学试验 自动化 实验室 临床实验室信息系统 

分 类 号：R446.1[医药卫生—诊断学]