Quality management system implementation in human and animal laboratories.

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

Journal

One health (Amsterdam, Netherlands)
ISSN: 2352-7714
Titre abrégé: One Health
Pays: Netherlands
ID NLM: 101660501

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 02 12 2020
revised: 31 05 2021
accepted: 07 06 2021
entrez: 30 6 2021
pubmed: 1 7 2021
medline: 1 7 2021
Statut: epublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 34189238
doi: 10.1016/j.onehlt.2021.100278
pii: S2352-7714(21)00068-9
pmc: PMC8217679
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100278

Informations de copyright

© 2021 The Authors. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

The authors declare no conflict of interest with respect to the research, authorship, and/or publication of this article.

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Auteurs

Obert Kachuwaire (O)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Arsen Zakaryan (A)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Julius Manjengwa (J)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Zaruhi Davtyan (Z)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Jerome Châtard (J)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Arnaud Orelle (A)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Pertch Tumanyan (P)

Republican Veterinary Sanitary, Phytosanitary Center for Laboratory Services, Yerevan, Armenia.

Aida Petikyan (A)

National Centre for Disease Control and Prevention, SNCO, Yerevan, Armenia.

Nune Hambardzumyan (N)

National Centre for Disease Control and Prevention, SNCO, Yerevan, Armenia.

Antoine Pierson (A)

Integrated Quality Laboratory Services (IQLS), Lyon, France.

Classifications MeSH