Title
Design and evaluation of a LIS-based autoverification system for coagulation assays in a core clinical laboratory.
Abstract
The autoverification system for coagulation consists of a series of rules that allow normal data to be released without manual verification. With new advances in medical informatics, the laboratory information system (LIS) has growing potential for the autoverification, allowing rapid and accurate verification of clinical laboratory tests. The purpose of the study is to develop and evaluate a LIS-based autoverification system for validation and efficiency. Autoverification decision rules, including quality control, analytical error flag, critical value, limited range check, delta check and logical check, as well as patient’s historical information, were integrated into the LIS. Autoverification limited range was constructed based on 5 and 95% percentiles. The four most commonly used coagulation assays, prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FBG), were followed by the autoverification protocols. The validation was assessed by the autoverification passing rate, the true-positive cases, the true-negative cases, the false-positive cases, the false-negative cases, the sensitivity and the specificity; the efficiency was evaluated in the turnaround time (TAT). A total of 157,079 historical test results of coagulation profiles from January 2016 to December 2016 were collected to determine the distribution intervals. The autoverification passing rate was 77.11% (29,165/37,821) based on historical patient data. In the initial test of the autoverification version in June 2017, the overall autoverification passing rate for the whole sample was 78.75% (11,257/14,295), with 892 true-positive cases, 11,257 true-negative cases, 2146 false-positive cases, no false-negative cases, sensitivity of 100% and specificity of 83.99%. After formal implementation of the autoverification system for 6 months, 83,699 samples were assessed. The average overall autoverification passing rate for the whole sample was 78.86% and the 95% confidence interval (CI) of the passing rate was [78.25, 79.59%]. TAT was reduced from 126 min to 101 min, which was statistically significant (P < 0.001, Mann-Whitney U test). The autoverification system for coagulation assays based on LIS can halt the samples with abnormal values for manual verification, guarantee medical safety, minimize the requirements for manual work, shorten TAT and raise working efficiency.
Year
DOI
Venue
2019
10.1186/s12911-019-0848-2
BMC Medical Informatics and Decision Making
Keywords
Field
DocType
Laboratory information systems, Medical safety, Autoverification, Coagulation, Turnaround time
Mann–Whitney U test,Data mining,Prothrombin time,Partial thromboplastin time,Turnaround time,Medical physics,Confidence interval,Medicine,Percentile
Journal
Volume
Issue
ISSN
19
1
1472-6947
Citations 
PageRank 
References 
0
0.34
0
Authors
8
Name
Order
Citations
PageRank
Zhong-qing Wang114020.28
Cheng Peng200.34
Hui Kang395.63
Xia Fan400.34
Runqing Mu500.34
liping zhou602.37
Miao He7165.48
Bo Qu800.34