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

Wang, Zhongqing; Peng, Cheng; Kang, Hui; Fan, Xiaohui; Mu, Runqing; Zhou, Liping; He, Miao

doi:10.1186/s12911-019-0848-2

Cited by 21 publications

(13 citation statements)

References 27 publications

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“…Referring to the recent study by Wang and colleagues, we noted that in order to ensure medical safety, it is desired to expand knowledge by providing a system of self-check in terms of efficacy and specificity, based on clinical data, for coagulation tests [ 35 ]. In our research, self-verification was based on repeating the test determination from the same sample, evaluating also prior to centrifugation the quality of the specimen, related to the collected volume, hemolyzed plasma, and excluding by inversion both total and partial blood coagulation.…”

Section: Discussionmentioning

confidence: 99%

Chronometric vs. Structural Hypercoagulability

et al. 2020

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Prolonged tourniquet stasis induced by venepuncture can lead to the release of the plasma of cell lysis products, as well as tissue factor (TF), impairing the quality of coagulation test results. The accidental presence of TF in vitro can trigger the coagulation mechanism, generating a false decrease in prothrombin time (PT). Background and Objectives: Identification of short PT tests below the normal reference value that could suggest a situation of hypercoagulability. The study aimed to compare the results of the shortened PT tests at their first determination with the eventual correction following duplication of the analysis from the same sample. Materials and methods: Identification of the shortened PT tests has been carried out for a period of 4 months, upon 544 coagulation samples referred to the Hematology department of Sf. Spiridon County Clinical Emergency Hospital from Iasi, Romania. Results: Out of the 544 samples of which the results indicated a state of hypercoagulability, by repeating the determination from the same sample, for 200 (36.76%) PT tests (p = 0.001) the value was corrected, falling within the normal reference range. For 344 (63.24%) tests, the results suggested a situation of hypercoagulability. Conclusions: In order to guarantee the highest quality of the laboratory services, a proper interpretation and report of the patients’ results must be congruent and harmoniously associated to the actual clinical condition of the patient. Duplication of the PT determination from the same sample would exclude situations of false hypercoagulability and would provide significant improvement for the patient’s safety.

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Section: Discussionmentioning

confidence: 99%

Chronometric vs. Structural Hypercoagulability

et al. 2020

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“…Automated interventions such as an ordering system that alerts prescribers can educate them about requesting inappropriate or repeated testing (31). Moreover, auto verification is widely reported to have potential for facilitating safe, efficient, and reliable tools (30,34). We proposed a comprehensive plan to avoid errors in the early and final lab testing process.…”

Section: Lab Testing Process and Lis Usementioning

confidence: 99%

Error evaluation in the laboratory testing process and laboratory information systems

Yusof¹,

Arifin²

2022

J Med Biochemistry

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Introduction: The laboratory testing process consists of five analysis phases featuring the total testing process framework. Activities in laboratory process, including those of testing, are error-prone and affect the use of laboratory information systems. This study seeks to identify error factors related to system use and the first and last phases of the laboratory testing process using a proposed framework known as total testing process-laboratory information systems. Materials and Methods: We conducted a qualitative case study in two private hospitals and a medical laboratory. We collected data using interviews, observations, and document analysis methods involving physicians, nurses, an information technology officer, and the laboratory staff. We employed the proposed framework and Lean problem-solving tools namely Value Stream Mapping and A3 for data analysis. Results: Errors in laboratory information systems and the laboratory testing process were attributed to failure to fulfill user requirements, poor cooperation between the information technology unit and laboratory, the inconsistency of software design in system integration, errors during inter-system data transmission, and lack of motivation in system use. The error factors are related to system development elements, namely, latent failures that considerably affected the information quality and system use. Errors in system development were also attributed to poor service quality. Conclusion: Complex laboratory testing process and laboratory information systems require rigorous evaluation in minimizing errors and ensuring patient safety. The proposed framework and Lean approach are applicable for evaluating the laboratory testing process and laboratory information systems in a rigorous, comprehensive, and structured manner.

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“…According to published studies, almost all laboratories have performed personnel-based and automatic system audits with the same results, manually recorded consistency, and reached a conclusion after a statistical analysis of the results [2,4,9,10]. This method is simple to implement but has limitations:…”

Section: Current Status and Challengesmentioning

confidence: 99%

“…Autoveri cation is a powerful tool for the batch processing of test results and has been widely used in recent years. It has obvious advantages in reducing reporting errors, shortening turnaround time and improving audit e ciency [1][2][3][4][5]. Based on the American Clinical and Laboratory Standards Institute (CLSI) AUTO-10[6] standards and current review processes, we established an autoveri cation system including 11 rule categories.…”

Section: Introductionmentioning

confidence: 99%

Development and Implementation of A LIS-Based Validation System for Autoverification Toward Zero Defects in The Automated Reporting of Laboratory Test Results

Jin

Wang

Peng

et al. 2021

Preprint

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BackgroundValidation of the autoverification function is the most critical step to confirm its effectiveness before use. It is crucial to verify whether the programmed algorithm follows the expected logic and produces the expected results. In recent years, this process has always been centered on the assessment of human-machine consistency and mostly takes the form of manual recording, which is a time-consuming activity with inherent subjectivity and arbitrariness, and cannot guarantee a comprehensive, timely and continuous effectiveness evaluation of the autoverification function. To overcome these inherent limitations, we independently developed and implemented a laboratory information system (LIS)-based validation system for autoverification.MethodsWe developed a correctness verification and integrity validation method (hereinafter referred to as the "new method") in the form of a human-machine dialogue. The system records the personnel’s review steps and determines if the human-machine review results are consistent. If they are inconsistent, the laboratory personnel analyze the reasons for the inconsistency according to the system prompts, add to or modify the rules, reverify, and finally improve the accuracy of autoverification.ResultsThe validation system was successfully established and implemented. For a dataset consisting of 833 rules for 30 assays, 782 rules (93.87%) were successfully verified in the correctness verification phase, and 51 rules were deleted due to execution errors. In the integrity validation phase, 24 projects were easily verified, while the other 6 projects still required the addition of new rules or changes to the rule settings. From setting the rules to the automated reportion, the time difference between manual validation and the new method, was statistically significant (χ2=11.06, p=0.0009), with the new method greatly reducing validation time. Since 2017, the new method has been used in 32 laboratories, and 15.8 million reports have been automatically reviewed and issued without a single clinical complaint.ConclusionTo the best of our knowledge, this is the first report to realize autoverification validation in the form of a human-machine interaction.The new method can effectively control the risks of autoverification, shorten time consumption, and improve the efficiency of laboratory verification.

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

Cited by 21 publications

References 27 publications

Chronometric vs. Structural Hypercoagulability

Chronometric vs. Structural Hypercoagulability

Error evaluation in the laboratory testing process and laboratory information systems

Development and Implementation of A LIS-Based Validation System for Autoverification Toward Zero Defects in The Automated Reporting of Laboratory Test Results

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