Development and Laboratory Application of a Quantitative Biorisk Management Audit Checklist Aligned with ISO 35001:2019 and ISO 15190:2020 for Tiered One Health Laboratory Networks in Uganda

Background: ISO 35001:2019 and ISO 15190:2020 introduced proactive, risk- and performance-based approaches to laboratory biorisk management (BRM) but do not provide scored, field-ready audit instruments. Uganda’s Ministry of Health lacked a single quantitative tool for equitable BRM assessment across a tiered, multisectoral One Health laboratory network. This study developed and evaluated a quantitative BRM audit checklist aligned with ISO 35001:2019 and ISO 15190:2020 and assessed its suitability for national benchmarking. Methods: A 19-domain, 413-mark checklist was developed by cross-mapping ISO 35001:2019, ISO 15190:2020, ISO 15189:2022, WHO Laboratory Biosafety Manual (4th edition), CWA 15793/16393, and ISO 9000/14001/45001 into scoreable Yes/Partial/No criteria verified through document review, observation, and interview. A dynamic denominator excluded nonapplicable items to enable equitable scoring across facility tiers. The tool was applied in national baseline (2022, n = 91) and follow-up (2023, n = 111) audits. Results: Mean national BRM performance increased from 26.3% (very high risk) in 2022%–39.7% (high risk) in 2023. The tool distinguished performance by facility tier, sector, ownership, and accreditation status in the expected directions. Persistently weak domains included management of compressed/liquefied gases and performance evaluation, while lighting and electrical safety remained consistently strong. Conclusion: The checklist operationalizes ISO, WHO, and World Organization for Animal Health BRM requirements into a reproducible, tier-adjustable scoring instrument that showed consistent, expected-direction differences across facility groups and a documented improvement in national performance across two audit cycles, pending formal psychometric validation, offering a transferable model for multisectoral low- and middle-income countries laboratory networks.