The U.S. Food and Drug Administration (FDA) 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 reliable laboratory data to diagnose, treat, prevent, and manage disease, especially during the COVID-19 pandemic.

Synensys 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 applied 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 on the complex human factors and challenges associated with change and expands the choices available to create long-term solutions to chronic system problems.

This research provides a roadmap for designing the future state of the laboratory data ecosystem envisioned through the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Collaborative Community to produce the safest, highest quality laboratory data outputs regardless of the laboratory setting. This research provides 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.