The main stakeholders in external quality assessment (EQA) programs are the participants, in whose interests these challenges are ultimately organised. EQA schemes in the medical field contribute to improving the quality of patient care by evaluating the analytical and diagnostic quality of laboratory and point-of-care tests (POCT) by independent third parties and, if necessary, pointing out erroneous measurement results and analytical or diagnostic improvement potential. Other benefits include the option of using EQA samples for other important laboratory procedures, such as the verification or validation of in vitro diagnostic medical devices (IVD-MDs), a contribution to the estimation of measurement uncertainty, a means of training and educating laboratory staff through educational EQA programmes or samples, or even for independent and documented monitoring of staff competence, such as on samples with unusual or even exceptional characteristics. Participation in an EQA scheme for beneficiaries like medical, microbiological and histo- and molecular pathology laboratories, users of POCT and self-testing systems as well as National Metrology Institutes, calibration laboratories and reference laboratories that are dedicated to specific tasks and have particular expectations of the EQA scheme are presented here.

Background The Ministry of Health in Côte d'Ivoire and the International Training and Education Center for Health at the University of Washington, funded by the United States President’s Emergency Plan for AIDS Relief, have been collaborating to develop and implement the Open-Source Enterprise-Level Laboratory Information System (OpenELIS). The system is designed to improve HIV-related laboratory data management and strengthen quality management and capacity at clinical laboratories across the nation. Objective This evaluation aimed to quantify the effects of implementing OpenELIS on data quality for laboratory tests related to HIV care and treatment. Methods This evaluation used a quasi-experimental design to perform an interrupted time-series analysis to estimate the changes in the level and slope of 3 data quality indicators (timeliness, completeness, and validity) after OpenELIS implementation. We collected paper and electronic records on clusters of differentiation 4 (CD4) testing for 48 weeks before OpenELIS adoption until 72 weeks after. Data collection took place at 21 laboratories in 13 health regions that started using OpenELIS between 2014 and 2020. We analyzed the data at the laboratory level. We estimated odds ratios (ORs) by comparing the observed outcomes with modeled counterfactual ones when the laboratories did not adopt OpenELIS. Results There was an immediate 5-fold increase in timeliness (OR 5.27, 95% CI 4.33-6.41; P<.001) and an immediate 3.6-fold increase in completeness (OR 3.59, 95% CI 2.40-5.37; P<.001). These immediate improvements were observed starting after OpenELIS installation and then maintained until 72 weeks after OpenELIS adoption. The weekly improvement in the postimplementation trend of completeness was significant (OR 1.03, 95% CI 1.02-1.05; P<.001). The improvement in validity was not statistically significant (OR 1.34, 95% CI 0.69-2.60; P=.38), but validity did not fall below pre-OpenELIS levels. Conclusions These results demonstrate the value of electronic laboratory information systems in improving laboratory data quality and supporting evidence-based decision-making in health care. These findings highlight the importance of OpenELIS in Côte d'Ivoire and the potential for adoption in other low- and middle-income countries with similar health systems.

The COVID-19 pandemic has once again illuminated worldwide gaps in national and international public health preparedness in every corner of the globe. Laboratories and laboratory systems remain essential clinical tools and public health services for effective preparedness including pathogen detection, surveillance, and response. Although there have been significant investments in building diagnostic and laboratory capacity in the global south over the past 20 years, many gaps remain to strengthen national health systems and build a more resilient and collaborative global health network. These investments should be focused on system-wide strengthening with attention to governance, workforce, collaboration and transparency, biosafety and biosecurity, technology, and supply chains. Importantly, laboratory services should be recognized as an independent, essential building block of health systems and allocated adequate resources to function properly.

The shift to a colder season is generally accompanied by an annual increase in respiratory infections. In early September, 2023, European epidemiological surveillance systems reported the first annual signs of increased COVID-19 infections.1 Efforts to increase testing activity have started,2 and the expected rise in testing frequency calls for a precautionary reminder of the limitations of diagnostic testing and screening for infectious pathogens. Every diagnostic test system has unique performance characteristics, including its overall sensitivity and specificity, which reflect the assay design.

Water quality testing is crucial for protecting public health, especially considering the number of boil water advisories annually issued across Canada that impact daily life for residents in affected areas. To overcome these challenges, the development of drinking water safety plans and accessibility to regular testing using simple, rapid, and accurate materials are necessary. However, the significance of monitoring the accuracy of environmental microbiology testing laboratories cannot be overlooked. Participation in external quality assessment programs, such as those that include proficiency testing (PT), is a necessary risk management resource that ensures the effectiveness of these testing processes. Proficiency Testing Canada (PTC), in collaboration with the Canadian Microbiological Proficiency Testing (CMPT) program based at the University of British Columbia, have implemented a drinking-water microbiology PT program since 1996. Both PTC and CMPT are ISO/IEC 17043:2010-accredited EQA providers. The drinking water program provided PT challenges to subscribing testing laboratories twice per year. Each challenge consisted of four samples containing unknown concentrations of Escherichia coli (E. coli) and Enterobacter spp. Results from participants were assessed for accuracy based on the method of testing. This cross-sectional study evaluated 150 rural and metropolitan testing sites across Canada between 2016 and 2022. Multivariable logistic regression analysis was conducted to examine the impact of different testing methods and laboratory accreditation status on the proficiency scores. This approach enabled us to assess the association between multiple independent variables and the likelihood of achieving specific proficiency scores, providing insights into how testing methods and accreditation status affect overall performance. After adjusting for rural residence, testing time, and survey year, the membrane filtration method was positively associated with the likelihood of scoring satisfactory results compared to the enzyme-substrate method (OR: 1.75; CI: 1.37–2.24), as well as accreditation status (OR: 1.47; CI: 1.16–1.85). The potential for improvement in environmental laboratory testing performance through the implementation of regulated PT in drinking water safety plans is proposed, along with the need for reliable testing methods applicable to rapid drinking water microbiology testing.

Since 2019, the WHO recommends the development and implementation of National Essential Diagnostics List (NEDL) to facilitate availability of In-Vitro Diagnostics (IVDs) across the various tiers of the healthcare pyramid, facilities with or without a laboratory on-site. To be effective, the development of NEDL should take into consideration the challenges and opportunities associated with current modalities for organization of tier specific testing services in-country. We conducted a mixed-methods analysis set out to explore available national policies, guidelines and decision-making processes that affect accessibility of diagnostics in African countries; 307 documents from 48 African countries were reviewed and 28 in-depth (group) interviews with 43 key-informants in seven countries were conducted between June and July 2022. Of the 48 countries, Nigeria was the only one with formal NEDL. Twenty-five countries had national test menus (63% outdated, from 2015 or earlier) all specifying tests by laboratory tier (5 including the "community tier"), with additional details on equipment (20), consumables (12), and personnel requirements (11). The most popular criteria to select essential IVDs in the quantitative analysis relate to specificities of the tests, whereas in the qualitative study most mentioned were health care and laboratory contextual factors. Quality assurance and waste management for tests at "community tier" were highlighted as concerns by all the respondents. Additional barriers to implementation included the low decision-making power of Laboratory Directorates within the Ministry of Health, as well as the chronic budgetary gaps for clinical laboratory services and policy and strategic plan development outside of vertical programmes. Four countries out of seven would rather revise their test menus by updating them and add ''community tier", than developing a separate NEDL, the former being considered more operational. This study provides a unique set of practical recommendations to the process of development and effective implementation on NEDL in Africa.

Purpose: Co circumflex accent te d'Ivoire has a tiered public health laboratory system of 9 reference laboratories, 77 laboratories at regional and general hospitals, and 100 laboratories among 1,486 district health centers. Prior to 2009, nearly all of these laboratories used paper registers and reports to collect and report laboratory data to clinicians and national disease monitoring programs.Project: Since 2009 the Ministry of Health (MOH) in Co circumflex accent te d'Ivoire has sought to implement a comprehensive set of activities aimed at strengthening the laboratory system. One of these activities is the sustainable development, expansion, and technical support of an open-source electronic laboratory information system (OpenELIS), with the long-term goal of Ivorian technical support and managerial sustainment of the system. This project has addressed the need for a comprehensive, customizable, low-to no-cost, open-source LIS to serve the public health systems with initial attention to HIV clients and later expansion to cover the general population. This descriptive case study presents the first published summary of original work which has been ongoing since 2009 in Co circumflex accent te d'Ivoire to transform the laboratory information management systems and processes nationally.Impact: OpenELIS is now in use at 106 laboratories across Co circumflex accent te d'Ivoire. This article describes the iterative planning, design, and implementation process of OpenELIS in Co circumflex accent te d'Ivoire, and the evolving leadership, ownership, and capacity of the Ivorian MOH in sustaining the system. This original work synthesizes lessons learned from this 13-year experience towards strengthening laboratory information systems in other low resource settings.

In response to the coronavirus pandemic (COVID-19) and scale up of diagnostic testing, the Canadian Microbiology Proficiency Testing program created a new proficiency testing (PT) program for the molecular and antigen detection of SARS-CoV-2. The program was geared to point of care testing (POCT) sites located in each of the eight provincial Health Authorities across British Columbia, Canada, with the intention to monitor testing quality. The PT program consisted of 6 shipments in a year, each containing a set of 4 samples either positive for SARS-CoV-2 virus or negative. The program began with initial 23 sites enrolling in March 2021, expanding to >100 participants by December 2021. After the first two surveys, it was observed that testing performance (accuracy) was consistently acceptable for sites using nucleic acid technology (NAT), however performance by sites using rapid antigen detection (RAD) methods was poor, especially when testing the weakly positive samples. A root cause investigation of poor testing performance revealed gaps in the execution of testing methods and also in results interpretation. These quality issues were most commonly associated with new testers who lacked experience with diagnostic testing. Tester training and mentoring was reinforced as was retraining of personnel; sample processing instructions were modified, and a training video was also created for testing sites. As a result of these interventions, sites improved their testing accuracy and the performance of POCT sites using RAD methods came to more closely match the performance of sites utilizing NAT. Overall, the PT program was highly successfully and improved quality of testing in the province. This work demonstrates the critical value of an external quality assessment (EQA) partner towards improving patient and public health and safety, especially when testing is conducted outside of an accredited medical laboratory setting.

Routine viral load (VL) monitoring is the standard of care in Côte d’Ivoire and allows for effective treatment guidance for people living with human immunodeficiency virus (HIV) to reach viral load suppression (VLS). For VL monitoring to be effective in reducing the impact of HIV, it must be provided in accordance with national guidance. This study aimed to evaluate VL testing, VLS rates and adherence to national guidance for VL testing using data collected from three national laboratories. We collected data on VL testing between 2015–2018 from OpenELIS (OE), an open-source electronic laboratory information system. We merged data by unique patient ID for patients (0–80 years old) who received multiple VL tests to calculate time between tests. We defined VLS as HIV RNA ≤1,000 copies/mL based on Côte d’Ivoire national and WHO guidance at the time of data collection. We used the Kaplan-Meier survival estimator to estimate time between ART (antiretroviral therapy) initiation and the first VL test, time between subsequent VL tests, and to estimate the proportion of people living with HIV (PLHIV) who were virally suppressed within 12 months of ART initiation. At the first documented VL test, 79.6% of patients were virally suppressed (95% CI: 78.9–80.3). Children under 15 were the least likely to be virally suppressed (55.2%, 95% CI: 51.5–58.8). The median time from ART initiation to the first VL sample collection for testing was 7.8 months (IQR:6.2–13.4). 72.4% of patients were virally suppressed within one year of treatment initiation (95% CI:71.5–73.3). Approximately 30% of patients received a second VL test during the 4-year study period. The median time between the first and second VL tests was 24.9 months (IQR: 4.7->40). Most PLHIV received their first VL test within the recommended 12 months of ART initiation but did not receive subsequent VL monitoring tests within the recommended time frame, reducing the benefits of VL monitoring. While VLS was fairly high, children were least likely to be virally suppressed. Our findings highlight the importance of regular VL monitoring after the first VL test, especially for children.

Background Competent leadership and management are imperative for delivering quality laboratory services; however, few laboratory managers receive job-specific training in organisational management and leadership. Objective To develop and evaluate participants’ competencies in organisational leadership and management as measured through learner and laboratory quality improvement assessments. Methods This professional development programme employed a mentored, blended learning approach, utilising in-person didactic and online training, with the practical application of a capstone project in the laboratories. Programme impact was evaluated through a series of pre- and post-laboartory assessments using the Stepwise Laboratory Improvement Process Towards Accreditation checklist, as well as learner-competency assessments through online quizzes and discussions. Results From 2016 to 2018, 31 managers and quality officers from 16 individual laboratories graduated from the programme having completed capstone projects addressing areas in the entire laboratory testing process. Laboratories increased their compliance with the International Organization for Standardization 15189 standard and all but two laboratories significantly increased their accreditation scores. Two laboratories gained three stars, two laboratories gained two stars, and five laboratories gained one star. Five laboratories subsequently achieved International Organization for Standardization 15189 accreditation in 2019. Conclusion This programme taught leadership theory to laboratory managers and allowed them to implement leadership and management practices in the laboratory setting. Programmes such as this complement existing laboratory quality management training programmes such as Strengthening Laboratory Management Toward Accreditation.

BACKGROUND:Understanding the differences in timing and composition of physical distancing policies is important to evaluate the early global response to COVID-19. A physical distancing intensity monitoring framework comprising 16 domains was recently published to compare physical distancing approaches across 12 U.S. States. We applied this framework to a diverse set of low and middle-income countries (LMICs) (Botswana, India, Jamaica, Mozambique, Namibia, and Ukraine) to test the appropriateness of this framework in the global context and to compare the policy responses in these LMICs with a sample of U.S. States during the first 100-days of the pandemic.RESULTS:The LMICs in our sample adopted wide ranging physical distancing policies. The highest peak daily physical distancing intensity during this period was: Botswana (4.60); India (4.40); Ukraine (4.40); Namibia (4.20); Mozambique (3.87), and Jamaica (3.80). The number of days each country stayed at peak policy intensity ranged from 12-days (Jamaica) to more than 67-days (Mozambique). We found some key similarities and differences, including substantial differences in whether and how countries expressly required certain groups to stay at home. Despite the much higher number of cases in the US, the physical distancing responses in our LMIC sample were generally more intense than in the U.S. States, but results vary depending on the U.S. State. The peak policy intensity for the U.S. 12-state average was 3.84, which would place it lower than every LMIC in this sample except Jamaica. The LMIC sample countries also reached peak physical distancing intensity earlier in outbreak progression compared to the U.S. states sample. The easing of physical distancing policies in the LMIC sample did not discernably correlate with change in COVID-19 incidence.CONCLUSIONS:This physical distancing intensity framework was appropriate for the LMIC context with only minor adaptations. This framework may be useful for ongoing monitoring of physical distancing policy approaches and for use in effectiveness analyses. This analysis helps to highlight the differing paths taken by the countries in this sample and may provide lessons to other countries regarding options for structuring physical distancing policies in response to COVID-19 and future outbreaks.

BACKGROUND:In 2019, there were 70.8 million forcibly displaced people worldwide. Among the top causes of morbidity and mortality were measles, diarrhea, respiratory illness, and malaria. Availability of accurate diagnostics that are of low complexity, affordable, and produce timely results on site without the need for expensive laboratory equipment, extensive training, or distant transport of samples, are essential tools in the response to humanitarian emergencies (HE). Early detection of infectious diseases with epidemic potential and coordinated outbreak response, can result in significant decrease in morbidity and mortality.CONTENT:This review explores the utility of point of care and rapid diagnostic tests (POCT/RDTs) in HE and presents a review and analysis of the low complexity, availability, and ease of use of these diagnostic modalities that make them helpful tools in these settings, despite the generally lower test performance metrics associated with them over conventional laboratory-based assays. We review the literature to understand how POCT/RDTs have been used in HE response to produce lifesaving information without the need for a robust system for transporting test samples to more sophisticated laboratories, as this is often prohibitive in areas affected by conflict or natural disasters.SUMMARY:We propose that POCT/RDTs be considered essential healthcare tools provided to countries following a HE and suggest that UN agencies and vulnerable countries include effective RDTs in their essential diagnostics as part of their national preparedness and response plans.

Background The Ministère de le Santé et de l’Hygiène Publique in Côte d’Ivoire and the international community have invested in health information systems in Côte d’Ivoire since 2009, including electronic laboratory information systems. These systems have been implemented in more than 80 laboratories to date and capture all test results produced from these laboratories, including HIV viral load (VL) testing. In 2018 the national HIV programme in Côte d’Ivoire requested international support to develop real-time tools such as dashboards to aggregate and display test-specific data such as HIV VL testing to support the country’s programmatic response to HIV. Intervention The VL dashboard was adapted in 2018 using source software code obtained from the Kenyan Ministry of Health and modified for the Ivorian context. The dashboard enables users to assess relevant clinical data from all Ivoirians living with HIV who undergo VL testing through dashboard data visualisations, including the number of VL tests, kinds of samples tested, and VL levels stratified by demographics and geographic location. Lessons learnt The VL dashboard enables rapid analysis of VL testing data from across the country and enables the national HIV programme, donors and partners to respond rapidly to issues pertaining to access, turn-around times and others. Recommendations Adapting existing open-source software is an effective and efficient way to implement transformative tools such as dashboards. The VL dashboard will likely be an essential tool for Côte d’Ivoire to meet the United Nations Programme on HIV/AIDS 90-90-90 targets.

Introduction: The COVID-19 pandemic has forced a new look (or modernization) for both the obligations and approaches to achieve best-practices in global health learning. These best-practices have moved beyond traditional, face-to-face (F2F), classroom-based didactics to the use of innovative online, asynchronous and synchronous instructional design and the information and communication technology (ICT) tools to support it. But moving to this higher level of online in-service and pre-service training, key obligations (e.g., stopping neocolonialization, cultural humility, reversing brain drain, gender equity) must guide the modernization of instructional design and the supporting ICT. To positively impact global health training, educators must meet the needs of learners where they are. Purpose: We describe a set of multi-communication methods, e-Learning principles, strategies, and ICT approaches for educators to pivot content delivery from traditional, F2F classroom didactics into the modern era. These best-practices in both the obligations and approaches utilize thoughtful, modern strategies of instructional design and ICT. Approach: We harnessed our collective experiences in global health training to present thoughtful insights on the guiding principles, strategies, and ICT environment central to develop learning curricula that meet trainee needs and how they can be actualized. Specifically, we describe five strategies: 1. Individualized learning; 2. Provide experiential learning; 3. Mentor … Mentor … Mentor; 4. Reinforce learning through assessment; and 5. Information and communication technology and tools to support learning. Discussion: We offer a vision, set of guiding principles, and five strategies for successful curricula delivery in the modern era so that global health training can be made available to a wider audience more efficiently and effectively.

Background: Providing professional development opportunities to staff working in clinical laboratories undergoing quality improvement programs can be challenged by limited funding, particularly in resource-limited countries such as Cambodia. Using innovative approaches such as video conferencing can connect mentors with practitioners regardless of location. This study describes and evaluates the methods, outputs, and outcomes of a quality improvement program implemented in 12 public hospital laboratories in Cambodia between January 2018 and April 2019. The program used mixed intervention methods including both in-person and remote-access training and mentorship. Methods: Training outputs were quantified from the activity reports of program trainers and mentors. Program outcomes were measured by pre- and postimplementation audits of laboratory quality management system conformity to international standards. Variations in improved outcomes were assessed in relation to the time spent by laboratory personnel in video conference training and mentoring activity. An additional cross-sectional comparison described the difference in final audit scores between participating and nonparticipating laboratories. Results: Laboratories significantly improved their audit scores over the project period, showing significant improvement in all sections of the ISO 15189 standard. Pre- and postaudit score differences and laboratory personnel participation time in remote mentoring activities showed a strong monotonic relationship. Average input per laboratory was 6,027 +/- 2,454 minutes of participation in video conference activities with mentors. Audit scores of participating laboratories were significantly higher than those of laboratories with no quality improvement program. Conclusion: Laboratories improved significantly in ISO 15189 conformity following structured laboratory quality management systems training supported by remote and on-site mentoring. The correlation of laboratory participation in video conference activities highlights the utility of remote video conferencing technology to strengthen laboratories in resource-limited settings and to build communities of practice to address quality improvement issues in health care. These findings are particularly relevant in light of the COVID-19 pandemic.

Laboratories need leaders who can effectively utilize the laboratories' resources, maximize the laboratories'capacity to detect disease, and advocate for laboratories in a fluctuating health care environment. To address this need, the University of Washington, USA, created the Certificate Program in Laboratory Leadership and Management in partnership with WHO Regional Office for the Eastern Mediterranean, and implemented it with 17 participants and 11 mentors from clinical and public health laboratories in 10 countries (Egypt, Iraq, Jordan, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, and Yemen) in 2014. Designed to teach leadership and management skills to laboratory supervisors, the programme enabled participants to improve laboratory testing quality and operations. The programme was successful overall, with 80% of participants completing it and making impactful changes in their laboratories. This success is encouraging and could serve as a model to further strengthen laboratory capacity in the Region.

Objective To implement a mentored laboratory quality stepwise implementation (LQSI) programme to strengthen the quality and capacity of Cambodian hospital laboratories.Methods We recruited four laboratory technicians to be mentors and trained them in mentoring skills, laboratory quality management practices and international standard organization (ISO) 15189 requirements for medical laboratories. Separately, we trained staff from 12 referral hospital laboratories in laboratory quality management systems followed by tri-weekly in-person mentoring on quality management systems implementation using the LQSI tool, which is aligned with the ISO 15189 standard. The tool was adapted from a web-based resource into a software-based spreadsheet checklist, which includes a detailed action plan and can be used to qualitatively monitor each laboratory's progress. The tool translated into Khmer included a set of quality improvement activities grouped into four phases for implementation with increasing complexity. Project staff reviewed the laboratories' progress and challenges in weekly conference calls and bi-monthly meetings with focal points of the health ministry, participating laboratories and local partners. We present the achievements in implementation from September 2014 to March 2016.Findings As of March 2016, the 12 laboratories have completed 74-90% of the 104 activities in phase 1,53-78% of the 178 activities in phase 2, and 18-26% of the 129 activities in phase 3.Conclusion Regular on-site mentoring of laboratories using a detailed action plan in the local language allows staff to learn concepts of quality management system and learn on the job without disruption to laboratory service provision.

The ongoing threat from Influenza necessitates the development of new vaccine and adjuvant technologies that can maximize vaccine immunogenicity, shorten production cycles, and increase global vaccine supply. Currently, the most successful adjuvants for Influenza vaccines are squalene-based oil-in-water emulsions. These adjuvants enhance seroprotective antibody titers to homologous and heterologous strains of virus, and augment a significant dose sparing activity that could improve vaccine manufacturing capacity. As an alternative to an emulsion, we tested a simple lipid-based aqueous formulation containing a synthetic TLR4 ligand (GLA-AF) for its ability to enhance protection against H5N1 infection. GLA-AF was very effective in adjuvanting recombinant H5 hemagglutinin antigen (rH5) in mice and was as potent as the stable emulsion, SE. Both adjuvants induced similar antibody titers using a sub-microgram dose of rH5, and both conferred complete protection against a highly pathogenic H5N1 challenge. However, GLA-AF was the superior adjuvant in ferrets. GLA-AF stimulated a broader antibody response than SE after both the prime and boost immunization with rH5, and ferrets were better protected against homologous and heterologous strains of H5N1 virus. Thus, GLA-AF is a potent emulsion-free adjuvant that warrants consideration for pandemic influenza vaccine development.