Evaluation Study
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Designing and evaluating autoverification rules for thyroid function profiles and sex hormone tests.

Purpose Following the analytical phase, the current practice of many hospital laboratories involves the manual verification of all test results followed by the production of the report. However, manual verification is a time-consuming and tedious process. In this paper, we provide a detailed description of how to design autoverification rules for thyroid function test profiles and sex hormones. Materials and methods We used DM2 (Data manager 2) to construct the algorithm and build the database for autoverification of thyroid function test profiles and sex hormones, with reference to Boolean logic, Auto 10-A and CLSI'88. The rules consist of checking quality control, instrument error flags, critical values, the analytical measurement range (AMR), the limit range, consistency check and delta check. Firstly, we established the rules in the DM2, collected clinical specimens for validation, then tested the rules in a 'live' environment. Results Agreement was achieved between manual verification by two senior laboratory personnel and verification using the autoverification rules in 99.78% of the cases. The total autoverification rate for all tests was 77.06%. Following implementation of the rules, the laboratory turnaround time (TAT) was reduced by 54.55% and staffing numbers fell from three to two whole time equivalents (WTE). Statistical analysis resulted in a kappa statistic of 0.99 ( P < 0.001). Moreover, after implementing the autoverification rules, the error rate fell to 0.04%, indicating that errors were almost completely eliminated. Conclusion Implementing autoverification rules can reduce TAT, minimize the number of samples that require manual verification and allow for a reduction in staffing numbers. It also allows laboratory staff to devote more time and effort to the handling of problematic test results and contributing to improved patient care.

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