CLSI AUTO16
Next-Generation In Vitro Diagnostic Instrument Interface
AUTO16 establishes a next-generation connectivity standard for in vitro diagnostic (IVD) instruments, based on the Laboratory Analytical Workflow (LAW) Profile. This standard provides implementation guidance, security considerations, and best practices to help IVD manufacturers and medical laboratories improve interoperability, reduce installation costs, and enhance patient data integrity. By streamlining instrument-to-laboratory information system communication, AUTO16 enables more efficient, secure, and standardized data exchange in clinical laboratories.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute standard AUTO16—Next-Generation In Vitro Diagnostic Instrument Interface defines a connectivity standard based on the Laboratory Analytical Workflow (LAW) Profile1 of the Integrating the Healthcare Enterprise organization, which originated from the work of the IVD Industry Connectivity Consortium. In addition to the LAW Profile, this standard includes implementation and integration guidance, security considerations, examples, and other supplemental information. The intended users of this standard are in vitro diagnostic system manufacturers, as well as the personnel and information technology management of medical laboratories.
This standard specifies requirements for the data exchange associated with the analytical workflow between medical laboratory in vitro diagnostic (IVD) instruments and the systems managing their work. This data exchange includes test orders and test results for both patients and QC specimens. Additional guidance is also provided to aid in the standard’s adoption and implementation. This standard applies to all medical laboratory specialties (including blood bank testing). The intended users of this standard are IVD instrument vendors, IVD software systems vendors (LIS and middleware), and medical laboratory information technology (IT) personnel.
This standard:
• Does not apply to point-of-care information exchange, which is already standardized by CLSI document POCT014
• Does not apply to imaging information exchange, which is already standardized by digital imaging and communications in medicine (DICOM) • Is not intended to standardize the features of IVD instruments or IVD software systems, only their external connectivity
• Does not apply to communication between systems already covered by other Integrating the Healthcare Enterprise (IHE) profiles (ie, laboratory testing workflow [LTW] and laboratory device automation [LDA])
• Does not cover calibration data, configuration information, standardization of test or analyte nomenclature (eg, LOINC®a [Logical Observation Identifiers Names and Codes]), or process status monitoring
• Does not discuss data privacy requirements
This document is available in electronic format only.
Clinical and Laboratory Standards Institute standard AUTO16—Next-Generation In Vitro Diagnostic Instrument Interface defines a connectivity standard based on the Laboratory Analytical Workflow (LAW) Profile1 of the Integrating the Healthcare Enterprise organization, which originated from the work of the IVD Industry Connectivity Consortium. In addition to the LAW Profile, this standard includes implementation and integration guidance, security considerations, examples, and other supplemental information. The intended users of this standard are in vitro diagnostic system manufacturers, as well as the personnel and information technology management of medical laboratories.
This standard specifies requirements for the data exchange associated with the analytical workflow between medical laboratory in vitro diagnostic (IVD) instruments and the systems managing their work. This data exchange includes test orders and test results for both patients and QC specimens. Additional guidance is also provided to aid in the standard’s adoption and implementation. This standard applies to all medical laboratory specialties (including blood bank testing). The intended users of this standard are IVD instrument vendors, IVD software systems vendors (LIS and middleware), and medical laboratory information technology (IT) personnel.
This standard:
• Does not apply to point-of-care information exchange, which is already standardized by CLSI document POCT014
• Does not apply to imaging information exchange, which is already standardized by digital imaging and communications in medicine (DICOM) • Is not intended to standardize the features of IVD instruments or IVD software systems, only their external connectivity
• Does not apply to communication between systems already covered by other Integrating the Healthcare Enterprise (IHE) profiles (ie, laboratory testing workflow [LTW] and laboratory device automation [LDA])
• Does not cover calibration data, configuration information, standardization of test or analyte nomenclature (eg, LOINC®a [Logical Observation Identifiers Names and Codes]), or process status monitoring
• Does not discuss data privacy requirements
This document is available in electronic format only.