Quality management system implementation in human and animal laboratories.

Area of Science:

• Public Health
• Laboratory Science
• Veterinary Medicine

Background:

• Effective detection of emerging health threats requires robust laboratory networks with high-quality testing.
• International Health Regulations (IHRs) and World Organization for Animal Health (OIE) guidelines necessitate strong laboratory quality systems.
• A tailored, stepwise approach can improve laboratory quality management systems (QMS) and compliance.

Purpose of the Study:

• To strengthen laboratory quality management systems in Armenia's human and veterinary sectors.
• To improve the capacity of laboratories to detect and respond to health threats.
• To ensure compliance with international health regulations and guidelines.

Main Methods:

• A quality management system strengthening program was implemented in 15 Armenian laboratories (human and veterinary) from 2017-2020.
• Key staff received training, and implementation plans were developed to address identified gaps.
• Routine mentorship and baseline/post-implementation audits using standardized checklists assessed improvements.

Main Results:

• Baseline audit scores for human labs ranged from 21%-46%; veterinary labs scored 37%-60%.
• Post-implementation, human lab scores improved by 7%-39%; veterinary lab scores improved by 12%-19%.
• Significant improvements were observed in organizational structure, human resources, equipment, supply chain, and data management.

Conclusions:

• The project successfully improved QMS implementation in both human and veterinary laboratories.
• Central facilities achieved readiness for international accreditation.
• This One Health approach simultaneously strengthened human and veterinary laboratory networks, a novel strategy.