Journal:Quality management system implementation in human and animal laboratories
Full article title | Quality management system implementation in human and animal laboratories |
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Journal | One Health |
Author(s) | Kachuwaire, Obert; Zakaryan, Arsen; Manjengwa, Julius; Davtyan, Zaruhi; Châtard, Jerome; Orelle, Arnaud; Tumanyan, Pertch; Petikyan, Aida; Hambardzumyan, Nune; Pierson, Antoine |
Author affiliation(s) | Integrated Quality Laboratory Services, Republican Veterinary-Sanitary and Phytosanitary Laboratory Services Center, Armenian Centers for Disease Control and Prevention |
Primary contact | Email: kachuwaire at iqls dot net |
Year published | 2021 |
Volume and issue | 13 |
Article # | 100278 |
DOI | 10.1016/j.onehlt.2021.100278 |
ISSN | 2352-7714 |
Distribution license | Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International |
Website | https://www.sciencedirect.com/science/article/pii/S2352771421000689 |
Download | https://www.sciencedirect.com/science/article/pii/S2352771421000689/pdfft (PDF) |
This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed. |
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 management systems (QMS) to ensure that these laboratories effectively play their critical role using a tailored stepwise approach can assist them to comply with World Health Organization's (WHO) International Health Regulations (IHRs), as well as 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 QMS strengthening program 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 standardized 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 management, 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
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