Labs that rely on LIS‑based autoverification see faster results, steadier outputs, and lighter workloads. Yet the rules that drive these checks can become outdated as new analyzers arrive, reagents change, calibrators shift, reference ranges evolve, and the mix of patients varies. Interfaces and the underlying information system may also be updated, creating a constant risk of drift. To keep patient safety intact, a clear plan for handling these changes is essential.
The new framework pulls together several international and national standards, including ISO 15189:2022, ISO 22367:2026, CLSI AUTO15, the archived CLSI AUTO10‑A, and China’s WS/T 616‑2018. It is built around a lifecycle model that maps every stage from creation to retirement. A taxonomy lists the most common change triggers,