NDLI: Design and evaluation of a LIS-based autoverification system for coagulation assays in a core clinical laboratory

Content Provider	Springer Nature : BioMed Central
Author	Wang, Zhongqing Peng, Cheng Kang, Hui Fan, Xia Mu, Runqing Zhou, Liping He, Miao Qu, Bo
Abstract	Background 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. Methods 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). Results 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). Conclusions 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.
Related Links	https://bmcmedinformdecismak.biomedcentral.com/counter/pdf/10.1186/s12911-019-0848-2.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14726947
DOI	10.1186/s12911-019-0848-2
Journal	BMC Medical Informatics and Decision Making
Issue Number	1
Volume Number	19
Language	English
Publisher	BioMed Central
Publisher Date	2019-07-03
Access Restriction	Open
Subject Keyword	Health Informatics Information Systems and Communication Service Management of Computing and Information Systems Laboratory information systems Medical safety Autoverification Coagulation Turnaround time
Content Type	Text
Resource Type	Article
Subject	Health Informatics Computer Science Applications Health Policy
Journal Impact Factor	3.3/2023
5-Year Journal Impact Factor	3.9/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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