CLSI’s AUTO16 (and its analog the IICC/IHE Laboratory Analytical Workflow (LAW) Profile) defines plug-n-play connectivity between instruments, middleware, and laboratory information systems in the clinical laboratory. More specifically, it defines the physical connection, transfer security, message definitions, and workflow definitions that standardize the data flow of IVD patient and QC test work order steps and results. LAW also provides capabilities not currently supported by CLSI LIS01/LIS02 (ASTM):
In addition to presenting LAW content in a consolidated and easy to read format, AUTO16 also:
AUTO16/LAW is currently being implemented by all major IVD companies. In addition, AUTO16 supports industry IVD Test Result semantic interoperability initiatives such as SHIELD (Systemic Harmonization and Interoperability for Enhancement of Laboratory Data).