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In September 2022, Synensys, LLC, a service-disabled veteran-owned small business (SDVOSB) safety management company, was awarded a research contract by The U.S. Food and Drug Administration (FDA) 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 Announcement (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.

To meet the testing demand generated from COVID-19, additional diagnostic testing capacity was developed through point-of-care (POC) testing outside the hospital (i.e., physician office lab, non-clinical commercial settings, community health settings, etc.) and at-home testing kits, also known as over-the-counter (OTC) testing. The rapid growth of OTC and POC testing during COVID-19 through the FDA’s Emergency Use Authorization (EUA) of 25+ COVID-19 tests (antigen and molecular tests) prompted the White House to purchase 1 billion at-home COVID-19 tests in 2022, with over 600 million of these tests distributed to U.S. households between January and September 2022.

OTC and POC testing have enabled the U.S. to rapidly scale testing capacity outside traditional health system settings, such as hospitals or clinics. Reliable end-user test data is also essential for improving pre-market design and unique device identifier (UDI) assignment of OTC/POC tests. Real-world data (RWD) collection, documentation, and aggregation from OTC/POC testing at the patient, health system, and public health level is also challenging due to low self-reporting in OTC settings and less structured data integration controls in POC settings, leading to gaps in the patient electronic health record, and ultimately, the under-reporting of critical test results to public health agencies, thus hindering disease management efforts.

By incorporating the OTC/POC testing domains, our research will:

  • Provide a more complete laboratory ecosystem safety control structure to the stakeholder community.
  • Identify OTC/POC system hazards and unsafe control actions.
  • Create system re-design opportunities and stronger control mechanisms to ensure OTC/POC safety and efficacy across the test lifecycle.
  • Establish a systems-based approach to a more safe and effective testing system, regardless of the testing environment.
  • Improve the quality, precision, accuracy, and reliability of real-world data from the laboratory data ecosystem for better decision-making and policymaking.

Synensys logoSynensys, headquartered in Peachtree City, Georgia, is a trusted leader 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 in medicine and aviation, with expertise in change management, human factors, systems strengthening, research, strategy, training, gap analyses, and safety performance analytics.

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