Change management and continuous assurance of laboratory information system-based autoverification rules aligned with ISO 15189:2022: a practical framework for clinical laboratories.

Abstract

Introduction: Laboratory information system (LIS)-based autoverification can improve turnaround time, consistency, and workload management, but rules may drift as analytical methods, reagent and calibrator lots, reference ranges, patient case mix, interfaces, and information systems change. This review proposes a standards-anchored framework for governing rules after rule implementation and maintaining patient safety across the rule life cycle.

Methods: Requirements from International Organization for Standardization (ISO) 15189:2022, ISO 22367:2026, Clinical and Laboratory Standards Institute (CLSI) AUTO15, archived CLSI AUTO10-A, and China Health Organization standard WS/T 616-2018 were integrated with select literature on autoverification and patient safety. No patient-identifiable data or new experimental data were used.

Results: The framework consisted of a life cycle model; a taxonomy of change triggers; a 6-domain low, moderate, and high risk assessment; proportionate verification or revalidation methods; a minimum version control and deployment record; monitoring indicators; and discipline-specific considerations for chemistry, immunoassay, hematology, and coagulation. It also defined reference-adjudicated false-pass and false-hold measures and presented a wholly synthetic potassium example.

Discussion: Laboratory information system-based autoverification rules should be managed as controlled, versioned, risk-sensitive clinical decision-support tools through structured change control, risk-proportionate verification or revalidation, and continuous monitoring throughout their life cycle.