CLSI AUTO16
Next-Generation In Vitro Diagnostic Instrument Interface
This standard applies to the exchange of analytical testing data between in vitro diagnostic instruments and health care informatics systems.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI 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 In Vitro Diagnostic (IVD) Industry Connectivity Consortium. In addition to the LAW Profile, CLSI AUTO16 includes implementation and integration guidance, security considerations, examples, and other supplemental information. The intended users of CLSI AUTO16 are IVD system manufacturers, as well as the personnel and information technology management of medical laboratories.
CLSI AUTO16-Ed2 replaces AUTO16-Ed1, published in 2019. This edition incorporates updates made to the LAW Profile as of IHE PaLM Technical Framework Revision 11.0. These updates include:
- Correcting the result predicate in LAB-29
- Clarifying the Health Level Seven version used for OBX-2
- Supporting Additional Result Identifiers in OBX-3
- Adding details for providing Container Identifier, Carrier Identifier, and Position in Carrier in a query
- Aligning conformance lengths
- Correcting the placement of PATIENT Group in LAB-29
CLSI AUTO16 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. CLSI AUTO16 applies to all medical laboratory specialties (including blood bank testing). The intended users of CLSI AUTO16 are IVD instrument vendors, IVD software systems vendors (LIS and middleware), and medical laboratory information technology (IT) personnel.
CLSI AUTO16:
- Does not apply to point-of-care information exchange, which is already standardized by CLSI POCT01
- 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, Logical Observation Identifiers Names and Codes [LOINC®]), or process status monitoring
- Does not discuss data privacy requirements
This document is available in electronic format only.
AUTO16Ed1: AUTO16Ed1E
CLSI 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 In Vitro Diagnostic (IVD) Industry Connectivity Consortium. In addition to the LAW Profile, CLSI AUTO16 includes implementation and integration guidance, security considerations, examples, and other supplemental information. The intended users of CLSI AUTO16 are IVD system manufacturers, as well as the personnel and information technology management of medical laboratories.
CLSI AUTO16-Ed2 replaces AUTO16-Ed1, published in 2019. This edition incorporates updates made to the LAW Profile as of IHE PaLM Technical Framework Revision 11.0. These updates include:
- Correcting the result predicate in LAB-29
- Clarifying the Health Level Seven version used for OBX-2
- Supporting Additional Result Identifiers in OBX-3
- Adding details for providing Container Identifier, Carrier Identifier, and Position in Carrier in a query
- Aligning conformance lengths
- Correcting the placement of PATIENT Group in LAB-29
CLSI AUTO16 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. CLSI AUTO16 applies to all medical laboratory specialties (including blood bank testing). The intended users of CLSI AUTO16 are IVD instrument vendors, IVD software systems vendors (LIS and middleware), and medical laboratory information technology (IT) personnel.
CLSI AUTO16:
- Does not apply to point-of-care information exchange, which is already standardized by CLSI POCT01
- 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, Logical Observation Identifiers Names and Codes [LOINC®]), or process status monitoring
- Does not discuss data privacy requirements
This document is available in electronic format only.
AUTO16Ed1: AUTO16Ed1E