Next-Generation In Vitro Diagnostic Instrument Interface—AUTO16

Written by: Ed Heierman, PhD

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):

• Enhanced order management
• Enhanced test result identification and information
• HL7 v2.5.1 communication
• Support for LOINC^®, JLAC10, UCUM, and SNOMED CT^® vocabularies

In addition to presenting LAW content in a consolidated and easy to read format, AUTO16 also:

• Provides a roadmap for implementing the LAW Profile
• Provides a roadmap for integrating LAW-conforming IVD systems
• Includes security considerations applicable to the LAW Profile
• Highlights differences between the LAW Profile and the existing CLSI LIS01 and LIS02 standards
• Contains message examples

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).