Basic Theory And Application Of Autoverification In Clinical Laboratory Test Results

ObjectiveWith the rapid development of inspection technology and information technology,the pre-inspection and the intermediate inspection in the laboratory have been standardized and automated,but ther'e are still weak links in the approve and interpretation of the results of the post-inspection.In order to cope with the ever-increasing number of samples and the ever-increasing clinical testing program to meet the increasing quality and speed of the results of clinicians and patients,we urgently need to establish a safe and effective clinical laboratory autoverification to meet the needs of clinical data approve.The system promotes the automatic verification of inspection results and improves the efficiency of laboratory operations.Based on the normative documents and guidelines at home and abroad,combined with the actual situation of domestic hospitals,this study initially establishes the rules for autoverification of biochemical projects and discusses how to establish a safe,efficient and convenient laboratory autoverification system.MethodsStudy the domestic and international autoverification system research guidelines and requirements specifications,including CLSI AUTO 10-A,IS015189 CNAS-CL02.CAP 2013 Checklist and other specifications.Establish an autoverification team based on guidelines and specifications,clarify the content of autoverification,collect and analyze the status of laboratories,and determine the implementation methods and platforms for the autoverification.After the initial setting of the audit rules,and verify the validity of each rule and autoverification system,then use the real data to test the autoverification system and conduct the first human-machine comparison verification.After the man-machine comparison verification,the initial set value is revised according to the man?machine comparison verification result,the autoverification system is trial run,and finally the autoverification system is officially run,and the human-machine comparison verification is performed periodically to gradually optimize the autoverification system.After the autoverification system matures,expand the scope of application of autoverification gradually.The design of the automatic review process is based on the AUT010-A document guide and the industry standard of the Ministry of Health of China.Standardize the establishment nine types of autoverification rules such as specimen serum index confirmation,classification and application of instrument alarm information,identification of critical value,scope of audit,range of delta check,range of extreme values,qualitative conversion rules of quantitative items,logical judgment between projects,ana correlation between projects.Perform an alignment between manual and automated audit results to verify the validity and security of the audit process.ResultsThe implementation platform of this study was jointly set up by the Yijie Information System and the INFINITY of the ROCHE Biochemical Immune Pipeline Information Processing Center.The ROCHE original reagent project of ROCHE COBAS C 702 and COBAS C 502 on ROCHE automatic biochemical immunization line was used for the first time,including 27 test items and 4 calculation items.The first study collected 57,746 clinical chemistry specimens for the initial establishment of an automated review rule,collecting 1257 clinical chemistry specimens for the first human-machine comparison verification.The non-first postgraduate project involved in the first study was passed by default after the remarks were irregular.The overall report pass rate for the first study was 59.16%,and the average pass rate for individual projects was over 90%.The first study passed the man-machine comparison verification,and the error report autoverification rate was 0.00%.According to the analysis of the reasons for not passing the specimen,it is found that 31%of the reasons are due to the scope of the audit,and 60%of the reason is due to the delta check range.This statistical analysis indicates the direction for our later optimization.The secondary optimization uses all biochemical testing items of ROCHE COBAS C 702 and COBAS C 502 on the ROCHE automatic biochemical immunization line,including 43 biochemical testing projects and 8 calculation projects.The results of 30192 clinical chemistry specimens were collected for the secondary optimization of the autoverification system,and 632 clinical biochemical specimens were collected for secondary optimization verification.The secondary optimization study mainly improved the setting of all biochemical items detected on the biochemical immune pipeline,and optimized the setting of the automatic audit approve range and the delta check range.The secondary optimization setting removes the default pass setting of the irregular item,the overall pass rate is 61.14%,and the average pass rate of the individual project is above 95%.Through the secondary optimization of human-machine comparison verification,the error report automatic review rate is 0,00%.According to the analysis of the reasons for not passing the specimen,it was found that 49.2%of the reasons were due to the scope of the audit,and 30.6%of the reasons were due to the delta check range.The scope of the review and the delta check are still the main reasons why the report does not pass the autoverification rules.ConclusionAfter rigorously standardized research procedure and method,a clinical biochemical autoverification system can be established and applied in the laboratory based on laboratory data.The clinical biochemical autoverification system can effectively enhance work efficiency,improve attention to abnormal specimens,and reduce manual reporting error rate.At the same time,we must also be aware that automatic auditing involves all aspects.When a certain aspect is omitted or the system is invalid after setting,a large number of wrong reports will be automatically issued,which will have serious consequences for patients and clinical departments.