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[Biorisk Management for Clinical Diagnostic Laboratories]
Rinsho Byori. the Japanese Journal of Clinical Pathology
|January 30, 2019
Summary
Clinical diagnostic laboratories face unique biorisks from unknown samples. Integrating a biorisk management system with quality management enhances safety and efficiency by proactively reducing incidents.
Area of Science:
- Clinical diagnostics
- Laboratory biosafety and biosecurity
- Risk management
Background:
- Clinical diagnostic laboratories aim to provide high-quality services, necessitating robust quality management, safety, and biosecurity.
- Handling clinical samples of unknown nature presents significant biorisks, challenging traditional risk assessment methods.
- Existing biosafety guidelines may not adequately address the "undetermined risk" associated with these samples.
Purpose of the Study:
- To comprehensively review and define biorisk management in clinical diagnostic settings.
- To explore existing biorisk assessment approaches, including the role of human factors and communication.
- To propose integrating biorisk management systems with established Quality Management Systems.
Main Methods:
- Systematic review of literature, including books, documents, articles, and standard guidelines on biorisk management and biosafety.
- Analysis of how biorisk is defined and assessed, considering human factors and communication strategies.
- Evaluation of the potential for integrating biorisk management with existing International Organization for Standardization (ISO) Quality Management Systems.
Main Results:
- Biorisk management is crucial for clinical laboratories, especially when dealing with samples of undetermined risk.
- Effective communication and incident reporting are vital components of successful biorisk management.
- Integration with existing Quality Management Systems offers a logical framework for enhancing laboratory safety and efficiency.
Conclusions:
- A proactive biorisk management system, integrated with quality management, can significantly improve laboratory safety and diagnostic process efficiency.
- This approach moves beyond accident prevention to proactively reduce near misses and incidents.
- Implementing such a system supports clinical diagnostic laboratories in fulfilling their mission of providing high-quality services.
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