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The U.S. Food and Drug Administration (FDA) has awarded Synensys a research contract to conduct the study “Improving the Reliability, Interoperability, Agility, and Quality of Laboratory Data Exchanges using System Safety Engineering Methods” under an FDA Broad Agency Agreement (BAA). With over 13 billion laboratory tests performed across the U.S. each year, patients, providers, public health officials, and researchers depend on the reliable laboratory data to diagnose, treat, prevent, and manage disease especially during the COVID-19 pandemic.

team iconSynensys and their project team including experts from the Massachusetts Institute of Technology, the University of Nebraska Medical Center, the College of American Pathologists, and Deloitte Consulting, LLP will apply systems thinking to assess, measure, document, and analyze the safety and quality of the laboratory data ecosystem. Systems thinking is a holistic approach to analysis that focuses on the way that a system’s constituent parts interrelate and how they work within the context of larger systems. Among other benefits, systems thinking provides a new perspective of the complex human factors challenges associated with change and expands the choices available to create long-term solutions to chronic system problems.

Safety and quality assurance is currently managed at each component level of the ecosystem (i.e., In-Vitro Diagnostic (IVD) manufacturers, standards, accreditation, licensing, and local laboratory professionals). It is important to manage laboratory safety and quality at each level of the laboratory ecosystem: the device, individual laboratory, across laboratory and EHR technology systems, hospitals, health system and information exchanges. However, that multi-level approach alone is insufficient to address complex safety and quality issues across the entire ecosystem, as the sum of the parts does not necessarily equal the whole when it comes to safety.

This research will provide a roadmap for designing the future state of the laboratory data ecosystem envisioned through the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Initiative to produce the safest, highest quality laboratory data outputs regardless of the laboratory setting. This research will provide concrete recommendations aimed at enhancing laboratory system safety, improving data-driven decision-making, streamlining data curation, and increasing trust in laboratory results, system interoperability, public reporting, and future public health research.

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Synensys, headquartered in Peachtree City, Georgia, is a trusted partner in safety management technology and performance improvement for Federal, Military, Commercial, and international organizations since 2005. The Synensys team consists of seasoned safety and quality professionals, with expertise in change management, safety management, research, human factors, systems strengthening, strategy, learning, gap analyses, and safety performance analytics.

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