Quality management system implementation in human and animal laboratories

Abstract

Background: The ability to rapidly detect emerging and re-emerging threats relies on a strong network of laboratories providing high quality testing services. Improving laboratory quality systems to ensure that these laboratories effectively play their critical role using a tailored stepwise approach can assist them to comply with the World Health Organization's (WHO) International Health Regulations (IHRs) and the World Organization for Animal Health's (OIE) guidelines. Methods: Fifteen (15) laboratories in Armenia's human and veterinary laboratory networks were enrolled into a quality management system strengthening programme from 2017 to 2020. Training was provided for key staff, resulting in an implementation plan developed to address gaps. Routine mentorship visits were conducted. Audits were undertaken at baseline and post-implementation using standardised checklists to assess laboratory improvements. Results: Baseline audit general indicator scores ranged from 21% to 46% for human laboratories and 37% to 60% for the veterinary laboratories. Following implementation scores improved ranging from 7 to 39% for human laboratories and 12% to 19% for veterinary laboratories. Conclusion: In general, there has been improvement for both human and veterinary laboratories in the areas of QMS implementation, particularly in organizational structure, human resources, equipment management, supply chain and data management. Central facilities developed systems that are ready for international accreditation. This One Health strengthening project ensured simultaneous strengthening of both human and veterinary laboratories which is not a common approach.

Keywords

• Laboratory quality management
• One Health
• Laboratory assessments
• Veterinary laboratory
• Public health laboratory
• Standardization