The IVD Industry Connectivity Consortium (IICC) celebrates its 10th Anniversary with the Publication of CLSI AUTO16 for Clinical Laboratories

2019/05/03

This April, the IVD Industry Connectivity Consortium (IICC) celebrated its 10th Anniversary. The event coincided with the official publication of the Clinical and Laboratory Standards Institute’s AUTO16 (Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition), the standard for which the IICC was initially founded as a global nonprofit, organization, dedicated to creating and encouraging the adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics. Its member organizations include Abbott Diagnostics, Beckman Coulter, Becton Dickinson, bioMérieux, Data Innovations, Orchard Software, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, and Systelab Technologies SA.

Over the years, the IICC has collaborated with CLSI, Integrating the Healthcare Enterprise (IHE), the Regenstrief Institute, and recently SHIELD (Systemic Harmonization and Interoperability Enhancement for Lab Data), an FDA-sponsored collaboration effort that brings together representatives of five federal agencies (Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, FDA, National Library of Medicine, Office of the National Coordinator for Health Information Technology), IVD manufacturers, key healthcare systems, and 10 other related international industry and standards development groups.

What started as informal discussions between CLSI and the informatics representatives from several key IVD vendors, was formalized in February of 2009 with the founding of the IVD Industry Connectivity Consortium (IICC) and appointment of its leadership and technical team. The path was clear: to build upon available technology and standards, to draw on the expertise and experience of existing standards organizations, and to define the scope of work relative to the types of data, types of IVD testing, and types of IT systems to be addressed.

“It has been an interesting journey” states Serge Jonnaert, IICC’s President, “The group had initially set a horizon of three years from start to final publication. It has taken a little longer than anticipated, but the IICC succeeded at delivering on its mandate and its standards are now gaining broad recognition and adoption” Through the collaboration with IHE, its first standard was published as the IHE LAW Profile, and was complemented in 2018 with LIVD:

• Laboratory Analytical Workflow Profile (IHE analog to CLSI AUTO16). The LAW profile standardizes the physical connections, message definitions, and workflow definitions necessary to achieve plug-and-play connectivity among instruments, middleware, and laboratory information systems (LISs) in the laboratory. The profile’s message definitions are based on the messaging standard developed by HL7, which is the standard specified in US meaningful use requirements for electronic laboratory reporting. IICC collaborated with the IHE pathology and laboratory medicine (PALM) domain to develop the LAW profile. The LAW Profile provides the basis for the CLSI AUTO16 standard. LAW is currently being implemented by major IVD companies, including Abbott, BD, Beckman Coulter, BioMérieux, Orchard Software, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, Sunquest, and many others.
• Digital Format for Publication of LOINC to Vendor Test Results (LIVD). The LIVD specification outlines an industry-defined format to facilitate the digital publication and exchange of IVD test results together with their associated logical observation identifiers names and codes (LOINCs). LOINCs are required with laboratory results reporting and on demand from physician laboratory customers. The LIVD specification assists laboratory personnel with the selection of appropriate LOINCs for their IVD test results. It reduces variability in the mapping and maintenance of LOINCs, reducing time and effort of laboratory professionals. It is also defined to allow LISs to automatically map IVD vendor test results to the appropriate LOINCs.

“What makes IICC so unique is its nimble, agile approach to standards development” adds Ed Heierman, the IIICC’s Chief Technology Officer and Informatics Software Architect at Abbott Diagnostics. “These are complex challenges to tackle with many stakeholders. Over the years we’ve succeeded at maintaining an open, very collaborative group, that has been able to develop well-defined, practical, modularized, and easy-to-implement standards.”

Adoption of the IICC standards has broad benefits for all stakeholders in the healthcare ecosystem. Laboratory leaders should not only become familiar with them; they should demand support of the standards from their IT organizations and vendors.

The IICC wants to recognize the companies and talent that over the years have contributed to its standards development and promotion efforts:

• Serge Jonnaert, IICC President, and Vice President, Technology M&A at the Corum Group Ltd
• Ed Heierman, IICC Chief Technology Officer, and Informatics Software Architect, Abbott
• Rob Bush, Board Member, and Founder and President, Orchard Software
• Rajeev Sehgal, Board Member, and Director of Informatics, Becton Dickinson
• Dr. Andrzej J. Knafel, Board Member, and Chief Software Architect, Roche Diagnostics International Ltd
• Laurent Lardin, Board Member, and Manager, Remote Services & Connectivity, BioMérieux

Previous members and contributors:

• Eric Olson, IICC President Emeritus; now founder and CEO of Babson Diagnostics
• Mojgan Lefebvre, IICC President Emeritus; now EVP and Chief Information Officer at Travelers
• Emery Stephans, IICC Initiator; now founder and CEO at Enterprise Analysis Corporation (EAC)
• Jay B. Jones, PhD, DABCC, Board Member Emeritus and former Director, Chemistry & Regional Labs, Geisinger Health System
• Patrick Collyer, former Director of Marketing, IT Solutions & Digital Strategy at Werfen Group
• Jean-Claude Lugeon, Head of Software Engineering at Metrohm
• Scott Goss, Chief Marketing Officer, Forefront Dermatology
• Carl Murray, Director Software Development at Beckman Coulter
• Jean Rhame, Principal Consultant at Clinical Consulting
• Jeff Raponi, Director of Global Marketing at Roche
• Jyh-Ching Yaur, VP, Engineering, Automation and Informatics at Siemens Healthineers

As the IVD Industry Connectivity Consortium maps its future, it continues to encourage IVD companies and industry representatives to actively participate in its activities. IVD companies interested in contributing can send an email to join@ivdconnectivity.org