Building and Validating an Autoverification System in the Clinical Chemistry Laboratory

Clinical laboratories must respond to challenges such as reducing manpower requirements, increasing service quality, simplifying processes, and decreasing the report release turnaround time (TAT). In addition to the introduction of automated equipment and the development of a laboratory information system (LIS) technology, another way to raise working efficiency is to build an autoverification (AV) system, 1-3 by which test reports are AV against report check rules based on the LIS or middleware. Middleware is information software installed between the LIS and the instruments. It delivers information such as the test orders from the LIS to the instrument and the test results of the instrument back to the LIS. In an AV system, the verification rules and the criteria of the test results are built into the middleware, so instead of the results requiring a manual check, they are AV by computer. These verifications include limit check rules, critical values, comparison with former results (delta check), and consistency of related results (consistence check). After the check rules are set, each medical technologist performs the test result verifications based on the same judgment platform. 6] Central laboratories deal with an enormous number of tests each day and are always under pressure to quickly report the test results. With an AV system, at least 80% of the test reports can be AV without the need of manual intervention, thereby allowing medical technologists to concentrate on the test reports intercepted in middleware. In May 2008, a laboratory automation system (LAS) was installed in our laboratory. After 2 years of operation trials, LAS had taken the place of most of the manual efforts. In 2010, the utilization of middleware in an AV system was planned. In order to validate whether the verification rules could actually be implemented and meet our requirements, a validation and management mechanism based on a CAP checklist and the CLSI guideline This manuscript gives a detailed description of the entire validation and management process, and an evaluation of the benefits brought by the AV system to the laboratory.