IICC LAW and LIVD specifications added to ONC’s Interoperability Standards Advisory for Clinical Laboratories

2019/10/15

The Office of the National Coordinator for Health Information Technology (ONC) recently adopted the IIVD Industry Connectivity Consortium’s Laboratory Analytical Workflow (LAW) and LOINC for IVD (LIVD) specifications in its Interoperability Standards Advisory (ISA).

The Interoperability Standards Advisory (ISA) process represents the model by which the Office of the National Coordinator for Health Information Technology (ONC) will coordinate the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, and research purposes. ONC is organizationally located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS).

“We are excited about the ONC’s addition of the IICC’s LAW and LIVD specifications to the Interoperability Standards Advisory” stated Serge Jonnaert, President of the IIVD Industry Connectivity Consortium “clinical laboratories and IVD vendors want clear guidance on interoperability standards. The ONC’s ISA provides just that.”

The Laboratory Analytical Workflow (LAW) specifications defines plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory. It standardizes the data flow of IVD patient and QC test work order steps and results. The Clinical and Laboratory Standards Institute (CLSI) published LAW as the AUTO16 Next-Generation In Vitro Diagnostic Instrument Interface standard.

The LOINC for IVD (LIVD) specification outlines an industry-defined format to facilitate the publication and exchange of LOINC codes for vendor IVD test results, based on either vendor IVD test transmission codes or manual test identification, for use by laboratory personnel or laboratory applications. The format can be used as-is by IVD software systems to automate the mapping between vendor IVD test transmission codes and LOINC codes, significantly reducing the risk of erroneously mapped test results and units of measure (UCUM). Health Level 7 International (HL7 ®) is developing a FHIR® Implementation Guide for LIVD Mapping.

Both specifications can be found on the ISA under the heading Exchanging InVitro Diagnostics (IVD) Test Orders & Results

https://www.healthit.gov/isa/exchanging-invitro-diagnostics-ivd-test-orders-results

For more information on the LAW and LIVD specifications:

The IVD Industry Connectivity Consortium (IICC) is a global, nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics in clinical laboratories. This will improve healthcare efficiency and patient care. 

For more information contact:

Serge Jonnaert, President
serge.jonnaert@ivdconnectivity.org