临床实验室生化免疫项目自动审核程序的建立与应用

Developing and application of an autoverification system for clinical chemistry and immunology test results

目的 使用临床实验室信息系统（LIS）开发生化免疫项目的自动审核程序,评估程序的有效性,并应用于常规工作.方法 设计自动审核的流程,并将其编写为LIS系统的自动审核程序,在程序中设置审核参数,包括自动审核允许范围、历史结果比较允许范围、项目关联性比较参数等.统计每个检验项目的自动审核通过率、分析不通过原因、汇总问题进行分析,根据评估结果修改程序和参数,并由主管技师以上职称的工作人员对自动审核的检验报告进行评估,直到自动审核结果与人工审核结果全部相符,将自动审核程序应用于常规工作.统计每个检验项目自动审核通过率,比较使用自动审核程序前后样本周转时间（TAT）的变化.结果 在实验室信息系统中开发了自动审核程序,并应用于对50个生化免疫项目执行自动审核.单个检验项目自动审核通过率为91.1％ ～96.6％,检验报告自动审核通过率达74％.使用自动审核程序后,TAT由111.6（53.9 ～270.7）min缩短为87.2（45.4 ～202.4）min,其中从仪器出结果到审核的时间由原来的18.6（1.0～99.3）min缩短到0.1（0 ～58.3）min.审核人员由3名减至1名.结论 本室自建的自动审核程序可应用于临床生化免疫检验项目的自动审核.使用自动审核程序可以明显缩短TAT、提高工作效率.周密的流程设计、合理的参数设置、全面的评估验证是建立安全高效的检验报告自动审核系统的保证.

Objective To develop and validate an autoverification system for biochemistry and immunology test results for application in routine work.Methods Algorithms was designed and translated into the laboratory information system.Parameters including verify limit,delta check,logic relation between tests was set up in the system.Verification rate of every test and the causes of fails were analyzed,according to which the system and parameters were modified.The autoverified reports were evaluated by chief technicians.Only when all of the autoverified results pass the evaluation,the system applied for routine work of releasing the results.Autoverification rate and turnaround time（TAT） were calculated for evaluation of the efficiency of the system.Results A brand new autoverification system was developed and applied for routine work.The autoverification rate for each single test was 91.1%-96.6%.The autoverification rate for reports was 74%.With the autoverification system,the media of TAT reduced from 111.6 （53.9-270.7） min to 87.2 （45.4-202.4） min,whereas the time from instrument finishing analysis to releasing the reports reduced from 18.6（1.0-99.3） min to 0.1 （0-58.3） min.The number of staff specified for results validation reduced from three to one.Conclusions The newly developed system can be used for autoverification of biochemistry and immunology test results.The autoverification system can greatly reduce TAT and raise working efficiency.It＆#39;s essential to employ carefully designed algorithm,appropriate parameters and comprehensive evaluation when developing a new autoverification system.