On-site evaluation as external quality assessment of microbiology laboratories involved in sentinel laboratory-based antimicrobial resistance surveillance network in Burkina Faso.

BACKGROUND: The laboratory-based surveillance of antimicrobial resistance (AMR) is a priority component of the multisectoral national action plan to combat AMR in Burkina Faso. This study aimed to assess the QMS of microbiology laboratories involved in the Sentinel laboratory-based antimicrobial resistance surveillance network in Burkina Faso. METHODS: A cross-sectional study was conducted from September 1st to November 30th, 2022. The external quality assessment (EQA) method used was on-site evaluation using a checklist that was developed and validated by a technical committee of experts. Teams of two, including an antimicrobial susceptibility test (AST) specialist and a QMS specialist, were trained on this checklist to conduct the assessment. Satisfactory performance was defined as any on-site evaluation score 80% and above with the aim of developing action plans to address gaps. RESULTS: All 18 laboratories were evaluated. The overall average performance score of the participating laboratories was 40%. The highest overall performance score was 58%, and the lowest overall performance score was 26%. The average overall scores were not significantly different between private and public laboratories (p value = 0.78). The only section of the checklist with the satisfactory performance concerned the "Analytical step of AST", with 76.5% (13/17) of the sentinel laboratories having a score ≥ 80%. CONCLUSION: The performance of the QMS of the sentinel laboratories in Burkina Faso for AMR surveillance was unsatisfactory, and a corrective action plan was proposed to support these laboratories in improving their QMS over the next 3 years.

Sentinel laboratory compliance with best practices in Burkina Faso's antimicrobial resistance surveillance network.

Background: Standardising procedures is the best way to harmonise and strengthen the quality of laboratory-based antimicrobial resistance surveillance. Since 2018, Burkina Faso has developed and disseminated the national manual of procedures for performing antibiotic susceptibility tests in sentinel laboratories within its national antimicrobial resistance surveillance network. Objective: Our study aimed to assess these sentinel laboratories' compliance with good practices for antibiotics susceptibility tests. Methods: Four teams evaluated the antimicrobial resistance sentinel sites laboratories throughout Burkina Faso from 19 to 28 September 2022. Eighteen out of 19 sentinel laboratories were evaluated. A four-member technical committee designed and validated the evaluation tool composed of three Microsoft Excel sheets. The evaluation emphasised quality controls for culture media, antibiotic discs and compliance with antimicrobial susceptibility testing procedures by the laboratories. Excel software was used for data recording and graphs and table design. The free R software version 4.2.0 was used for descriptive statistics. An overall score below 80% was considered noncompliance. Results: Most (83.33%) of the sentinel laboratories conducted at least one quality control activity for culture media, and 66.67% conducted at least one quality control activity for antibiotic discs. Over three-quarters (76.47%) of the laboratories were more than 80% compliant with the modified Kirby Bauer antimicrobial susceptibility testing method. Conclusion: The evaluation revealed the noncompliance of sentinel laboratories with the national procedure manual, particularly in the quality control component. What this study adds: This study has provided baseline data on the sentinel laboratories' compliance with the national antimicrobial susceptibility testing procedures manual, particularly in areas performing quality control checks or meeting quality indicators for culture media and antibiotic discs.

Implementation and performance evaluation of an integrated specimen referral system in Burkina Faso using the national courier services (2020-2022).

Introduction: In 2017, the Ministry of Health and Public Hygiene (MoH) of Burkina Faso designed and piloted a specimen transport system using the national courier services (La Poste BF) in 4 districts. Based on satisfactory performance indicators, the MoH set a vision aimed at scaling up this system to strengthen disease detection and surveillance of epidemic prone diseases across the country. This work describes the implementation process, performances, and lessons learned. Methodology: This work describes the implementation process, performances, and lessons learned. Under the leadership of the Directorate of Population Health Protection within the MoH, a stepwise approach was used to bring together multiple partners across sectors to develop the first needed documents including a guide, an implementation plan, Standard Operating Procedures, and data collection tools. Then, the execution phase included equipment purchase, trainings, and consensus on a financing mechanism. Key indicators were defined to allow performance monitoring. Result: The integrated biological specimen referral system (SITEB) was officially launched in January 2020 to transport human biological specimens of priority diseases including COVID-19 from district level to reference laboratories nationwide. As of December 31, 2022, La Poste BF transported 168,856 packages containing 206,314 specimens from all 13 regions. 99.66% of packages were delivered in <24 h as required, and 99.68% of specimens were in good condition at reception. COVID-19 specimens represented respectively 18% and 63% of samples transported in 2020 and 2021. Discussion: The political will combined with the experience gained during the pilot phase and the commitment and support from all stakeholders laid to the foundation of the effective implementation of this system. Collaboration between two government entities (MoH and Minister of Transport, Urban Mobility, and Road Safety) to benefit public health has led to reasonable pricing for sustainability. Although all documents integrate the "One Health" approach, the system ensures the transport of only human samples for now. Despite security constraints, Burkina Faso has successfully set up a system using the national postal service to ensure the routine transport of specimens for all diseases under laboratory surveillance including laboratory tests for HIV and TB from the district level to reference laboratories nationwide. This system has also proved to be useful and efficient in managing public health emergency.

A Multilingual Tool for Standardized Laboratory Biosafety and Biosecurity Assessment and Monitoring.

Control of infectious diseases requires the handling of infectious materials by both clinical and public health laboratories with exposure risks for laboratory personnel and environment. A comprehensive tool for assessing the capacity to manage these risks could enable the development of action plans for mitigation. Under the framework of the Global Health Security Agenda action package for biosafety and biosecurity, the authors developed a tool dedicated to assessing laboratory biosafety and biosecurity. The Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) assesses the status of all laboratory biosafety core requirements across 10 different modules. It consists of a standardized spreadsheet-based tool that provides automatic scoring. It is designed to support national, regional, and global efforts to strengthen biosafety in clinical, public health, and veterinary laboratories. The BSS LAT was first used in Burkina Faso in collaboration with the African Society for Laboratory Medicine and the US Centers for Disease Control and Prevention to support the country in strengthening their biorisk management system. Since then, it has been successfully used in other countries (ie, Armenia, Burundi, Cameroon, Ghana, Guinea, Kazakhstan, Liberia), various settings (medical and veterinary laboratories), and translated into several languages (eg, English, French, Russian). The BSS LAT is a multipurpose tool that assists with standardization of biosafety and biosecurity requirements for all laboratories working with infectious materials, serves as a self-assessment guide for laboratories to develop improvement plans and reinforce capacities, and serves as a training guide for individual laboratories and networks or at the national level. The BSS LAT can also be used as a monitoring tool for the assessment of biosafety and biosecurity across all laboratories working with infectious materials at the national, regional, and global levels.

Strengthening Biorisk Management Capacities in Burkina Faso: Contribution of the Global Health Security Agenda.

The Global Health Security Agenda and the International Health Regulations (2005) recommend that countries strengthen the capacity of their national laboratory systems to comply with the International Health Regulations. To efficiently and effectively direct these efforts, the US Centers for Disease Control and Prevention-in collaboration with the Ministry of Health Directorate of Laboratories, the African Society for Laboratory Medicine, and Integrated Quality Laboratory Service-assessed Burkina Faso's national laboratory system using the World Health Organization Laboratory Assessment Tool. Based on gaps observed in biorisk management, the Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) was developed to assess 10 public laboratories handling dangerous pathogens. This tool uses a specific scoring matrix with quantitative output. Composite assessment scores for the 9 primary modules (capacity areas) were reported, with the highest scores reported in cleaning, disinfection, sterilization, waste management (42%), and good laboratory practices (40%), and the lowest scores in biosecurity/biosafety (33%), documents/regulations (18%), emergency management (16%), and risk management (5%). To address challenges identified in the assessments, a set of activities was planned with a focus on biorisk management. Results from an evaluation conducted 1 year later, using the BSS LAT, showed an increase in the average score of all indicators from 25% to 45% and an increase in the biorisk management module score from 5% to 35%. This evaluation process was a decisive step toward strengthening the capacity of the laboratory system in Burkina Faso. Global Health Security Agenda investments and activities have made a lasting impact on improving biosafety and biosecurity in public health laboratories. To ensure sustainability, a strong laboratory quality management program based on a mentorship system is greatly needed.

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.

[National External Quality Assessment for medical biology laboratories in Burkina Faso: an overview of three years of activity]. / Contrôle national de qualité des laboratoires d'analyses de biologie médicale du Burkina Faso: bilan de trois années d'activités.

We report results of the National External Quality Assessment for (NEQA) laboratories in Burkina Faso, a country with limited resources located in West Africa whose epidemiology is dominated by infectious diseases. The national laboratory network consists of 160 laboratories including 40 private. The Government of Burkina Faso has adopted a national laboratory policy. One of the objectives of this policy is to improve the quality of laboratory results. One of the strategies to achieve this objective is the establishment of a NEQA. The NEQA is a panel testing also called proficiency testing. It is mandatory for all laboratories to participate to the NEQA. The NEQA is organized twice a year and covers all areas of laboratories (bacteriology-virology, biochemistry, hematology, parasitology and immunology). The review of three years of activity (2006-2008) shows the following results: (1) for microscopic examination of bacteria after Gram staining, the error rate decreased from 24.7% in 2006 to 13.1% in 2007 and 13% in 2008; (2) errors rate in reading slides for the microscopic diagnosis of malaria were 23.4%, 14.6% and 10.2% respectively in 2006, 2007 and 2008; (3) for biochemistry, the percentages of unsatisfactory results were respectively 12.5%, 14.8% and 13.8% in 2006, 2007 and 2008 for the overall parameters assessed. The analysis of the results generated by the laboratories during these three years shows a quality improvement. However, the NEQA should be strengthened through ongoing training and quality control of reagents and equipment.

Analytical performance of eight rapid point-of-care tests routinely used for the detection of HBsAg in Burkina Faso: A cross-sectional study.

BACKGROUND: In limited resources countries, HBsAg-rapid diagnostic test (RDT) represents a good alternative for the diagnosis of hepatitis B virus (HBV) infection. Due to many factors that can influence their analytical performances, an evaluation with local biological samples before using on a large scale is recommended. OBJECTIVES: The aims of the study were: (i) to evaluate the analytical performance of eight commercial RDTs used in Burkina Faso for the detection of HBsAg using serum from blood donors, and (ii) to propose an algorithm using these RDTs based on their analytical performance. STUDY DESIGN: 109 HBsAg-positive and 216 HBsAg-negative samples were included in this evaluation. A modified version of the World Health Organization (WHO) algorithm for the detection of HBsAg was used as the gold standard. A pairwise combination of RDTs performance was done to choose the best diagnostic algorithm. RESULTS: All RDTs presented an excellent specificity (Sp) (≥99.0 %) except Accucare HBsAg® test. Sensitivity (Se) ranged from 90.8 % (95 % CI: 87.9-93.7) for Rapid Signal™ HBsAg to 92.8 % (95 % CI: 90.3-95.5) for SD BioLine® HBsAg and Artron® HBsAg. The pairwise combinations of the Se and Sp of RDTs showed no improvement in diagnostic performance. CONCLUSION: The RDTs evaluated in this study have good sensitivities and excellent specificities indicating their use in clinical practice and for HBV mass screening in Burkina Faso. However, their use should be monitored in the context of blood transfusion. Furthermore, according to our algorithm, each positive sample should be confirmed by another RDT of good Se.

Designing and Piloting a Specimen Transport System in Burkina Faso.

Efficient specimen transport systems are critical for early disease detection and reporting by laboratory networks. In Burkina Faso, centralized reference laboratories receive specimens from multiple surveillance sites for testing, but transport methods vary, resulting in potential delays and risk to specimen quality. The ministry of health and partners, under the Global Health Security Agenda implementation, piloted a specimen transport system for severe acute respiratory illness (SARI) surveillance in 4 Burkina Faso districts. A baseline assessment was conducted of the current specimen transport network structure and key stakeholders. Assessment results and guidelines for processing SARI specimens informed the pilot specimen transport system design and implementation. Monitoring and evaluation performance indicators included: proportion of packages delivered, timeliness, and quality of courier services (missed or damaged packages). Our baseline assessment found that laboratorians routinely carried specimens from the health center to reference laboratories, resulting in time away from laboratory duties and potential specimen delays or loss of quality. The pilot specimen transport system design engaged Sonapost, the national postal service, to transport specimens from SARI sites to the influenza national reference laboratory. From May 2017 to December 2018, the specimen transport system transported 557 packages containing 1,158 SARI specimens; 95% (529/557) were delivered within 24 hours of pick-up and 77% (892/1,158) within 48 hours of collection. No packages were lost. This article highlights lessons learned that may be useful for other countries considering establishment of a specimen transport system to strengthen laboratory system infrastructure in global health security implementation.

Implementation of a national external quality assessment program for medical laboratories in Burkina Faso: challenges, lessons learned, and perspectives.

OBJECTIVES: The National External Quality Assessment (NEQA) program of Burkina Faso is a proficiency testing program mandatory for all laboratories in the country since 2006. The program runs two cycles per year and covers all areas of laboratories. METHODS: All panels were validated by the expert committee before dispatch under optimal storage and transport conditions to participating laboratories along with report forms. RESULTS: Performance in the last 5 years varied by panel, with average annual performance of bacteriology panels for all laboratories rising from 75% in 2006 to 81% in 2010 and with a best average performance of 87% in 2007 and 2008. During the same period, malaria microscopy performance varied from 85% to 94%, with a best average performance of 94% in 2010; chemistry performance increased from 87% to 94%, with a best average annual performance of 97% in 2009. Hematology showed more variation in performance, ranging from 61% to 86%, with a best annual average performance of 90% in 2008. Average annual performance for immunology varied less between 2006 and 2010, recording 97%, 90%, and 95%. Except for malaria microscopy, annual performances for enrolled panels varied substantially from year to year, indicating some difficulty in maintaining consistency in quality. CONCLUSIONS: The main challenges of the NEQA program observed between 2006 to 2010 were funding, sourcing, and safe transportation of quality panels to all laboratories countrywide.

Strengthening public health laboratory capacity in Thailand for International Health Regulations (IHR) (2005).

INTRODUCTION: Thailand conducted a national laboratory assessment of core capacities related to the International Health Regulations (IHR) (2005), and thereby established a baseline to measure future progress. The assessment was limited to public laboratories found within the Thai Bureau of Quality and Safety of Food, National Institute of Health and regional medical science centres. METHODS: The World Health Organization (WHO) laboratory assessment tool was adapted to Thailand through a participatory approach. This adapted version employed a specific scoring matrix and comprised 16 modules with a quantitative output. Two teams jointly performed the on-site assessments in December 2010 over a two-week period, in 17 public health laboratories in Thailand. The assessment focused on the capacity to identify and accurately detect pathogens mentioned in Annex 2 of the IHR (2005) in a timely manner, as well as other public health priority pathogens for Thailand. RESULTS: Performance of quality management, budget and finance, data management and communications was considered strong (>90%); premises quality, specimen collection, biosafety, public health functions, supplies management and equipment availability were judged as very good (>70% but ≤90%); while microbiological capacity, staffing, training and supervision, and information technology needed improvement (>60% but ≤70%). CONCLUSIONS: This assessment is a major step in Thailand towards development of an optimized and standardized national laboratory network for the detection and reporting of infectious disease that would be compliant with IHR (2005). The participatory strategy employed to adapt an international tool to the Thai context can also serve as a model for use by other countries in the Region. The participatory approach probably ensured better quality and ownership of the results, while providing critical information to help decision-makers determine where best to invest finite resources.