Development and implementation of National External Quality Assurance Programs in a One Health approach: The Armenian experience.

INTRODUCTION: Early warning and objective evidence of systematic errors in laboratory diagnosis ensures evidence based corrective and preventive actions that instill patient safety and confidence. External quality assessment contributes significantly to the above as an essential component of laboratory quality assurance. However, implementation of External Quality Assessment in resource-limited settings is challenged by high costs of enrolling in international schemes. To ensure sustainability, a National External Quality Assessment Program in Armenia was developed using a One Health approach. METHODS: Through engagement of stakeholders from Ministry of Health and Department of Agriculture under Ministry of Economy the government of Armenia started the implementation of the Armenia Laboratory External Quality Assessment (ALEQA) program. Policies and procedures were defined, a web interface for return of results and feedback reporting was created. A training was offered for characterization of simulated samples for bacterial pathogens. Following a pilot survey, the program was successfully scaled up, with later addition of a Brucella serology discipline. RESULTS: The return rate of results was 100% for all surveys. There was an improvement in the performance of the laboratories from the 2015 to the 2019 surveys. The bacterial pathogens EQA survey's, was interrupted between 2017 and 2019. The Brucella Serology survey showed 77% of the 26 participating laboratories had satisfactory performance. CONCLUSION: This is one of the few National EQA Programs that have embraced the One Health approach to improve reach of EQA Programs in resource-limited settings in both human and veterinary laboratories.

National Biosafety Management System: A Combined Framework Approach Based on 15 Key Elements.

The pervasive nature of infections causing major outbreaks have elevated biosafety and biosecurity as a fundamental component for resilient national laboratory systems. In response to international health security demands, the Global Health Security Agenda emphasizes biosafety as one of the prerequisites to respond effectively to infectious disease threats. However, biosafety management systems (BMS) in low-medium income countries (LMIC) remain weak due to fragmented implementation strategies. In addition, inefficiencies in implementation have been due to limited resources, inadequate technical expertise, high equipment costs, and insufficient political will. Here we propose an approach to developing a strong, self-sustaining BMS based on extensive experience in LMICs. A conceptual framework incorporating 15 key components to guide implementers, national laboratory leaders, global health security experts in building a BMS is presented. This conceptual framework provides a holistic and logical approach to the development of a BMS with all critical elements. It includes a flexible planning matrix with timelines easily adaptable to different country contexts as examples, as well as resources that are critical for developing sustainable technical expertise.

Quality management system implementation in human and animal laboratories.

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.

Hepatitis B viral load in dried blood spots: A validation study in Zambia.

BACKGROUND: Access to hepatitis B viral load (VL) testing is poor in sub-Saharan Africa (SSA) due to economic and logistical reasons. OBJECTIVES: To demonstrate the feasibility of testing dried blood spots (DBS) for hepatitis B virus (HBV) VL in a laboratory in Lusaka, Zambia, and to compare HBV VLs between DBS and plasma samples. STUDY DESIGN: Paired plasma and DBS samples from HIV-HBV co-infected Zambian adults were analyzed for HBV VL using the COBAS AmpliPrep/COBAS TaqMan HBV test (Version 2.0) and for HBV genotype by direct sequencing. We used Bland-Altman analysis to compare VLs between sample types and by genotype. Logistic regression analysis was conducted to assess the probability of an undetectable DBS result by plasma VL. RESULTS: Among 68 participants, median age was 34 years, 61.8% were men, and median plasma HBV VL was 3.98logIU/ml (interquartile range, 2.04-5.95). Among sequenced viruses, 28 were genotype A1 and 27 were genotype E. Bland-Altman plots suggested strong agreement between DBS and plasma VLs. DBS VLs were on average 1.59logIU/ml lower than plasma with 95% limits of agreement of -2.40 to -0.83log IU/ml. At a plasma VL ≥2,000IU/ml, the probability of an undetectable DBS result was 1.8% (95% CI: 0.5-6.6). At plasma VL ≥20,000IU/ml this probability reduced to 0.2% (95% CI: 0.03-1.7). CONCLUSIONS: In a Zambian laboratory, we observed strong agreement between DBS and plasma VLs and high sensitivity in DBS at plasma VL ≥2,000IU/ml. As HBV treatment expands, DBS could increase access to HBV VL testing and care in SSA settings.