IVD Interoperability Standard Could Improve Laboratory Efficiency

A new global Laboratory Analytical Workflow standard aims to provide plug-n-play connectivity between IVD tests and health informatics systems.

By Jean Rhame

                              

The IVD Industry Connectivity Consortium (IICC), in partnership with the International Healthcare Enterprise (IHE), has developed a global interoperability standard that is ready for laboratories and IVD manufacturers to adopt. The Laboratory Analytic Workflow (LAW) standard allows for plug-n-play connectivity between IVD analyzers, middleware, and laboratory information systems (LIS) or laboratory automations systems (LAS). The goal of this unified connectivity standard is to improve healthcare efficiency and, ultimately, patient care.

Using the HL7 standard, LAW provides a plethora of workflow capabilities, improvements, and efficiencies that are not currently supported by ASTM (LIS 2). Key benefits of LAW include substantially reduced connectivity costs and complexity, as well as support of federally mandated Meaningful Use guidelines. It further ensures the quality and integrity of laboratory results from order to delivery. Moreover, it promises to enhance operability between lab products manufactured by different companies and, in turn, reduces or even eliminates the opportunity for patient data and human errors. 

Driving development of this standard have been IVD industry and IT leaders, including Abbott Diagnostics, Beckman Coulter, BD, bioMérieux, Data Innovations, Orchard Software, Ortho Clinical Diagnostics, Siemens Healthcare, and Systelab. As such, LAW has been demonstrated to work with a number of different IVD manufacturers and LISs, and can currently be implemented in laboratories if vendors have incorporated the standard. In order to drive clinical adoption, laboratorians are encouraged to ask current and prospective IVD and LIS vendors if their products support LAW.

The IHE provides a detailed implementation and testing process to promote the adoption of standards-based interoperability by vendors and users of healthcare information systems. Gazelle is IHE’s test bed, which is currently in its second generation. LIS and IVD vendors have successfully used Gazelle to test LAW, confirming that the connection between information systems and the analyzer truly works. 

To further help those who wish to test LAW and other eHealth standards, the IHE conducts annual Connectathons in North America, Europe, and Asia. An industry-wide testing event in which participants can test their implementations with those of other vendors, Connectathons promote the adoption of standards-based interoperability solutions defined by IHE. Many IVD instrumentation manufacturers also attend Connectathons to simply prepare for future participation and gain information.

Recognizing the importance of LAW to the laboratory community, the Automation and Informatics Committee of the Clinical and Laboratory Standards Institute (CLSI) is preparing to present the standard to the CLSI Board for consideration as a CLSI publication. This action represents an important milestone for LAW and further validates the significant impact this standard could have on laboratory operations.

Detailed information on LAW profile, use cases, capabilities, and options can be found on the IICC Web site.

Jean Rhame serves as secretary and treasurer of the IICC. She can be reached at jrhame3@gmail.com.

 

 

[Image courtesy of ddpavumba/FREEDIGITALPHOTOS.NET]

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