Contents: Background | Introduction | Challenges | Journey | Why LabKey | Results | Conclusion
Background
Texas Biomedical Research Institute (Texas Biomed) is an independent, nonprofit research organization dedicated to advancing scientific discoveries from the laboratory to clinical trials with minimal bureaucratic obstacles. The institution operates high-security Select Agent-registered BSL3/BSL4 research facilities, conducting critical work in infectious diseases, including Hepatitis C treatment, Ebola vaccine, and COVID-19 vaccine development. Given the important nature of its research, Texas Biomed must adhere to strict regulatory standards, including select agent inventory management under CDC and USDA Select Agent regulations.
Introduction
Managing select agent inventories presents a unique challenge due to stringent regulatory requirements. Historically, Texas Biomed relied on a combination of paper records, Excel spreadsheets, and a now-obsolete homegrown system for inventory tracking. Recognizing the need for an efficient and compliant solution, Texas Biomed set a goal in 2024 to migrate to a modern inventory management system. LabKey Sample Manager was selected for its flexibility, traceability, modern User Interface (UI), and ability to integrate with existing systems.
Challenges
Prior to adopting LabKey Sample Manager, Texas Biomed faced several significant challenges:
Disparate Inventory Systems: Inventory tracking was fragmented across paper logs, Excel spreadsheets, and an outdated homegrown system, making data retrieval cumbersome and inefficient.
Regulatory Compliance Risks: The previous system lacked robust audit trails and sample visibility, increasing the risk of non-compliance with select agent program requirements.
Limited Search and Reporting Capabilities: Researchers struggled to locate specific samples quickly, leading to inefficiencies in laboratory workflows.
Data Integrity Issues: Lack of enforced data entry validation resulted in inconsistencies across records. Manual reconciliation is extremely time-consuming.
Scalability Concerns: Managing growing sample volumes (tens of thousands select agent samples) in an outdated system was unsustainable.
The Journey
Recognizing these challenges, Texas Biomed initiated a structured migration process to Sample Manager:
System Evaluation and Selection: LabKey Sample Manager was chosen for its user-friendly interface, robust security features, and ability to track select agent inventory from acquisition to final disposition.
Data Migration Planning: A staged approach was adopted, beginning with a one-time snapshot of the previous inventory system.
Custom Configuration: Sample categories were structured into BSL-3 and BSL-4 liquid and solid categories for efficient data migration.
Barcode & Printer Integration: Existing barcodes from the previous system were mapped to LabKey’s format to avoid reprinting labels. BarTender integration streamlines the label printing process for future labels.
User Training and Testing: A test environment was established outside of the air-gapped network for staff to familiarize themselves with the system before and after full deployment.
Full Implementation and Compliance Audit: A 100% inventory audit was conducted post-implementation to ensure data accuracy and regulatory compliance.
Why LabKey
Texas Biomed selected LabKey Sample Manager for several key reasons:
Security in a Highly-Regulated Environment: The system can be installed on an air-gapped network to provide the highest security for sensitive data.
Regulatory Compliance: The system supports comprehensive audit logs and required inventory fields for select agent tracking.
Intuitive User Interface: Users adapted quickly with minimal training to the modern UI. Integration with existing label printer and barcode scanner reduces the learning curve.
Customizable Sample Tracking: The system allowed for flexible data entry fields, including dropdowns for sample source identification.
Integration with Existing Systems: LabKey was already being used for a primate electronic health record at Texas Biomed, reducing IT overhead.
Scalability and Efficiency: The system’s search and reporting capabilities significantly reduced the time required for audits and inventory checks.
Results
The transition to LabKey Sample Manager resulted in substantial improvements in inventory management:
Enhanced Compliance: Texas Biomed successfully met select agent program requirements with detailed audit trails and data integrity checks.
Improved Efficiency: The ability to locate and verify inventory items within 30 minutes (compared to days in the previous system) significantly streamlined workflows.
Data Centralization: All inventory data is now stored in a single, secure location, accessible for audits and reporting.
Time Savings: Annual spot-check audits are now completed faster using LabKey’s box map visualization tool and tracked using picklists.
Scalable Infrastructure: The new system can accommodate growing research needs without IT bottlenecks.
Conclusion
Texas Biomed’s migration to LabKey Sample Manager has transformed its select agent inventory management, ensuring regulatory compliance while enhancing operational efficiency. The implementation of a modern, scalable system has enabled researchers to focus on scientific discovery rather than administrative burdens, positioning Texas Biomed for continued success in infectious disease research.
Hear first hand from our collaborative webinar on Select Agent Management how Texas Biomed uses Sample Manager.