Together with prime contractor, Deloitte, Synensys’ primary challenge was the interoperability and utility of in vitro diagnostic (IVD) test data. Key issues included data quality hazards, such as inaccurate, incomplete, or missing lab results when data is exchanged between non-affiliated health institutions. Additionally, clinical care data was often trapped in silos, making it difficult to exchange, analyze, and interpret. There were also inconsistencies in data standards, with variations in how data was collected, manipulated, transmitted, and used across different systems and organizations.

To tackle these challenges, the team implemented several solutions. They conducted a system safety analysis using System Theoretic Process Analysis (STPA) to identify unsafe control actions and potential risks. An integrated approach to managing laboratory data was promoted to ensure it was understandable, reproducible, and useful. Stakeholder engagement was a key part of the process, with interviews conducted with 50 key informants and findings presented at various forums and conferences. Additionally, 15 risk mitigation strategies were developed to improve patient safety, interoperability, and standardization.

The solutions led to significant positive impacts. Data quality was improved, enhancing the reliability of lab test results and improving clinical decision making and patient access to accurate lab results. Interoperability was strengthened, with improved feedback loops between Laboratory Information Systems (LIS) and Electronic Health Records (EHR), facilitating better data exchange. Patient safety was also enhanced, with 200 unsafe control actions identified and strategies implemented to mitigate risks, reducing the likelihood of patient harm due to lab data errors.