A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project.

BACKGROUND: Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household surveys. METHODS: Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen collection, storage, transport, and real-time monitoring of specimen quality, and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as a final quality check for quality of laboratory results. RESULTS: Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis, indicating high quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 Pima CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing. CONCLUSIONS: Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries.

Strengthening Applied Epidemiology in West Africa: Progress, Gaps, and Advancing a Regional Strategy to Improve Health Security.

The ability to prevent, promptly detect, and appropriately respond to a public health threat is essential for health security. Field epidemiology training has helped increase the quality and quantity of the public health workforce to strengthen disease surveillance, outbreak preparedness and response, and general public health capacity. We conducted a desk review on the status of the Field Epidemiology and Laboratory Training Program model in 16 countries in West Africa. We also developed a questionnaire and shared it with West African Health Organization (WAHO) member states to document their experiences and the status of training in their countries. WAHO organized a regional 3-day consultative meeting with major stakeholders in the region to examine progress, gaps, and challenges, and outline a roadmap to strengthen the Field Epidemiology and Laboratory Training Program. Stakeholders shared their experiences, engaged in discussions to identify strengths and gaps, and made plans on a way forward. Member states are at different levels of implementing field epidemiology and laboratory training programs in their countries, and, therefore, major gaps remain in the number and distribution of trained epidemiologists throughout West Africa. Member states implement different variants of the program and in some instances the same cadre of health workers are trained in different but comparable programs with different funding streams. Two member states had not begun implementing the training program. Developing regional centers of excellence was recommended in the long term while collaboration among member states to train the required number of epidemiologists to fill the acute needs could be helpful in the short and medium term. Curriculum harmonization and expansion, deployment and use of trained epidemiologists, accreditation of training institutions, and generation of indigenous funding streams are recommended to improve the Field Epidemiology and Laboratory Training Program in West Africa.

A Feasible Laboratory-Strengthening Intervention Yielding a Sustainable Clinical Bacteriology Sector to Support Antimicrobial Stewardship in a Large Referral Hospital in Ethiopia.

Background: Access to clinical bacteriology in low resource settings (LRS) is a key bottleneck preventing individual patient management of treatable severe infections, detection of antimicrobial resistance (AMR), and implementation of effective stewardship interventions. We sought to demonstrate the feasibility of a practical bundle of interventions aimed at implementing sustainable clinical bacteriology services at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia, and report on cost and intensity of supervision. Methods: Starting in Dec 2015, an intervention based on the CLSI QMS01-A guideline was established, consisting of (i) an initial needs assessment, (ii) development of key standard operating procedures, (iii) adaptation of processes for LRS, (iv) training and supervision of laboratory staff via consultant visits and existing online resources, and (v) implementation of a practical quality systems approach. A guiding principle of the bundle was sustainability of all interventions post implementation. Outcomes and challenges: An initial investment of ~US$ 26,200 for laboratory reagents, and a total of 50 visit-days per year from three Canadian and Norwegian microbiologists were committed. Twelve SOPs, including antimicrobial susceptibility testing, were adapted, and an automated blood culture platform was donated (bioMerieux). In the first 18 months of implementation of the intervention, the average volume of specimens analyzed in the lab went from 15/day to 75/day. The number of blood cultures tested increased from an average of 2/day to over 45/day. Antimicrobial susceptibility testing was introduced and cumulative antibiograms were generated for the institution. Quality control was implemented for all procedures and quality assurance tools implemented included external quality assurance and proficiency testing of six technologists with longitudinal follow-up. The laboratory is on the path toward SLIPTA accreditation by the African Society for Laboratory Medicine. Reagent costs, staff training and retention, and engagement of clinical personnel with the lab proved to be manageable challenges. Key external challenges include in-country supply-chain management issues, lack of competition among distributors, and foreign-currency exchange distortions. Conclusions: Using a relatively low-intensity intervention based on existing training tools and accreditation schemes, we demonstrate that establishment of reasonable-quality clinical bacteriology is not only within reach but also a critical step toward assessing the burden of AMR in settings like this one and implementing effective stewardship strategies.

Strengthening Global Health Security Through Africa's First Absolute Post-Master's Fellowship Program in Field Epidemiology in Uganda.

Uganda is prone to epidemics of deadly infectious diseases and other public health emergencies. Though significant progress has been made in response to emergencies during the past 2 decades, system weaknesses still exist, including lack of a robust workforce with competencies to identify, investigate, and control disease outbreaks at the source. These deficiencies hamper global health security broadly. To address need for a highly competent workforce to combat infectious diseases, the Uganda Ministry of Health established the Public Health Fellowship Program (PHFP), the advanced-level Field Epidemiology Training Program (FETP), closely modeled after the CDC's Epidemic Intelligence Service (EIS) program. The 2-year, full-time, non-degree granting program is the first absolute post-master's FETP in Africa for mid-career public health professionals. Fellows gain competencies in 7 main domains, which are demonstrated by deliverables, while learning through service delivery 80% of the time in the ministry of health. During 2015-2017, PHFP enrolled 3 cohorts of 31 fellows. By January 2018, PHFP had graduated 2 cohorts (2015 and 2016) of 19 fellows. Fellows were placed in 17 priority areas of the ministry of health. They completed 153 projects (including 60 outbreak investigations, 12 refugee assessments, 40 surveillance projects, and 31 applied epidemiologic studies), of which 49 involved potential bioterrorism agents or epidemic-prone diseases. They made 132 conference presentations, prepared 40 manuscripts for peer-reviewed publication (17 published as of December 2017), and produced 3 case studies. Many of these projects have resulted in public health interventions that led to improvements in disease control and surveillance systems. The program has produced 19 issues of ministry of health bulletins. One year after graduation, graduates have been placed in key public health decision-making positions. Within 3 years, PHFP has strengthened global health security through improvement in public health emergency response; identification, investigation and control of outbreaks at their sources; and documentation and dissemination of findings to inform decision making by relevant stakeholders.

Mozambique field epidemiology and laboratory training program: a pathway for strengthening human resources in applied epidemiology.

INTRODUCTION: In the last decades, Mozambique has been undergoing demographic, epidemiological, economic and social transitions, which have all had a notable impact on the National Health System. New challenges have emerged, causing a need to expand the preparation and response to emerging disease threats and public health emergencies. METHODS: We describe the structure and function of the Mozambique Field Epidemiology Training Program (MZ-FELTP) and the main outputs achieved during the first 6 years of program implementation (consisting of 3 cohorts). We also outline the contribution of the program to the National Health System and assess the retention of the graduates. RESULTS: The MZ-FELTP is a post-graduate in-service training program, based on the acquisition of skills, within two tracks: applied epidemiology and laboratory management. The program was established in 2010, with the objective of strengthening capacity in applied epidemiology and laboratory management, so that events of public health importance can be detected and investigated in a timely and effective manner. The program is in its seventh year, having successfully trained 36 health professionals in the advanced course. During the first six years of the program, more than 40 outbreaks were investigated, 37 surveillance system evaluations were conducted and 39 descriptive data analyses were performed. Surveillance activities were implemented for mass events and emergency situations. In addition, more than 100 oral and poster presentations were given by trainees at national and international conferences. CONCLUSION: The MZ-FELTP has helped provide the Ministry of Health with the human and technical resources and operational capacity, to rapidly and effectively respond to major public health challenges in the country. The continuous involvement of key stakeholders is necessary for the continuation, expansion and ongoing sustainability of the program.

The Einstein-Brazil Fogarty: A decade of synergy.

A rich, collaborative program funded by the US NIH Fogarty program in 2004 has provided for a decade of remarkable opportunities for scientific advancement through the training of Brazilian undergraduate, graduate and postdoctoral students from the Federal University and Oswaldo Cruz Foundation systems at Albert Einstein College of Medicine. The focus of the program has been on the development of trainees in the broad field of Infectious Diseases, with a particular focus on diseases of importance to the Brazilian population. Talented trainees from various regions in Brazil came to Einstein to learn techniques and study fungal, parasitic and bacterial pathogens. In total, 43 trainees enthusiastically participated in the program. In addition to laboratory work, these students took a variety of courses at Einstein, presented their results at local, national and international meetings, and productively published their findings. This program has led to a remarkable synergy of scientific discovery for the participants during a time of rapid acceleration of the scientific growth in Brazil. This collaboration between Brazilian and US scientists has benefitted both countries and serves as a model for future training programs between these countries.

Training and service in public health, Nigeria Field Epidemiology and Laboratory Training, 2008 - 2014.

The health workforce is one of the key building blocks for strengthening health systems. There is an alarming shortage of curative and preventive health care workers in developing countries many of which are in Africa. Africa resultantly records appalling health indices as a consequence of endemic and emerging health issues that are exacerbated by a lack of a public health workforce. In low-income countries, efforts to build public health surveillance and response systems have stalled, due in part, to the lack of epidemiologists and well-trained laboratorians. To strengthen public health systems in Africa, especially for disease surveillance and response, a number of countries have adopted a competency-based approach of training - Field Epidemiology and Laboratory Training Program (FELTP). The Nigeria FELTP was established in October 2008 as an inservice training program in field epidemiology, veterinary epidemiology and public health laboratory epidemiology and management. The first cohort of NFELTP residents began their training on 20th October 2008 and completed their training in December 2010. The program was scaled up in 2011 and it admitted 39 residents in its third cohort. The program has admitted residents in six annual cohorts since its inception admitting a total of 207 residents as of 2014 covering all the States. In addition the program has trained 595 health care workers in short courses. Since its inception, the program has responded to 133 suspected outbreaks ranging from environmental related outbreaks, vaccine preventable diseases, water and food borne, zoonoses, (including suspected viral hemorrhagic fevers) as well as neglected tropical diseases. With its emphasis on one health approach of solving public health issues the program has recruited physicians, veterinarians and laboratorians to work jointly on human, animal and environmental health issues. Residents have worked to identify risk factors of disease at the human animal interface for influenza, brucellosis, tick-borne relapsing fever, rabies, leptospirosis and zoonotic helminthic infections. The program has been involved in polio eradication efforts through its National Stop Transmission of Polio (NSTOP). The commencement of NFELTP was a novel approach to building sustainable epidemiological capacity to strengthen public health systems especially surveillance and response systems in Nigeria. Training and capacity building efforts should be tied to specific system strengthening and not viewed as an end to them. The approach of linking training and service provision may be an innovative approach towards addressing the numerous health challenges.

BSL-3 laboratory practices in the United States: comparison of select agent and non-select agent facilities.

New construction of biosafety level 3 (BSL-3) laboratories in the United States has increased in the past decade to facilitate research on potential bioterrorism agents. The Centers for Disease Control and Prevention inspect BSL-3 facilities and review commissioning documentation, but no single agency has oversight over all BSL-3 facilities. This article explores the extent to which standard operating procedures in US BSL-3 facilities vary between laboratories with select agent or non-select agent status. Comparisons are made for the following variables: personnel training, decontamination, personal protective equipment (PPE), medical surveillance, security access, laboratory structure and maintenance, funding, and pest management. Facilities working with select agents had more complex training programs and decontamination procedures than non-select agent facilities. Personnel working in select agent laboratories were likely to use powered air purifying respirators, while non-select agent laboratories primarily used N95 respirators. More rigorous medical surveillance was carried out in select agent workers (although not required by the select agent program) and a higher level of restrictive access to laboratories was found. Most select agent and non-select agent laboratories reported adequate structural integrity in facilities; however, differences were observed in personnel perception of funding for repairs. Pest management was carried out by select agent personnel more frequently than non-select agent personnel. Our findings support the need to promote high quality biosafety training and standard operating procedures in both select agent and non-select agent laboratories to improve occupational health and safety.

[Assessing the correlation between international collaboration and academic influence in parasitic diseases: a case study of National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention].

OBJECTIVE: To investigate the activity of scientific research and international collaboration in National Institute of Parasitic Diseases (NIPD), Chinese Center for Disease Control and Prevention (China CDC) from 2002 to 2012, and assess the relationship between international collaboration and academic influence at an individual level. METHODS: Non-bibliometric indicators including number and structure of scientific research personnel, number of projects and funds, visiting frequency, etc, were used to assess the activity of scientific research and international collaboration, and bibliometric indicators including publications and h index, were employed to estimate the academic influence of senior professionals in NIPD, China CDC. The relationship between the international collaboration and international academic influence in the control and research of parasitic diseases was evaluated by using analysis of covariance and generalized linear models. RESULTS: There was an increase tendency of the number of projects, funds and visiting frequency in NIPD, China CDC since the foundation of the institute in 2002, notably after 2011. The h2 index of NIPD, China was 7. Analysis of covariance and generalized linear model analysis revealed that the number of international partners (F = 81.75, P < 0.0001) , number of international projects (F = 22.81, P < 0.0001) , number of national projects (F = 7.30, P = 0.0110), and academic degree (F = 3.80, P = 0.0330) contributed greatly to individual academic influence, while visiting frequency, professional title and length of service had no significant association with h index. CONCLUSION: Elevation of international collaboration projects and development of long-term, stable international partnership may enhance the institutional and individual international academic influence in the field of parasitic diseases.

An educational web-based external quality assessment outcome and evaluation: first experiences with urinary sediment and hemostaseology.

External quality assessment is a standard procedure for many medical laboratories, especially those accredited according to ISO 15189. INSTAND has developed web-based quality control surveys (WQ) with integrated case-based learning in collaboration with the Institute for Teaching and Educational Research in Health Sciences (IDBG), University of Witten/Herdecke. The WQs were presented via a weblink using the learning management system CASUS. Laboratories registered with INSTAND for conventional EQAs covering the same topic were invited to participate in the WQs. Statistics were calculated with the INSTAND EQA-evaluation program and with the "Statistical Program for Social Sciences" (SPSS Version 20). While the two pilot surveys (hemostaseology) were designed for laboratory technicians, WQ III (urine sediment) addressed the whole laboratory team. From the invited laboratories more than 80% participated successfully and the evaluations showed that, in general, more than half the participants solved the tasks as a team. The web-based EQAs were well accepted by the users, with some technical problems in WQ III and moderate criticism on the images and relevance for daily practice in the evaluation sheets. Well above 80% would like to participate in further WQs and would recommend them to other laboratories. Thus web-based quality control surveys can emerge as an important supplement to conventional EQAs.

Training laboratory technicians from the Ethiopian periphery in the MODS technique enables rapid and low-cost diagnosis of Mycobacterium tuberculosis infection.

Tuberculosis (TB) is a leading cause of morbidity and mortality and is frequently complicated by emergence of drug-resistant strains. Diagnosis of TB in developing countries is often based on the relatively insensitive acid-fast staining that does not enable susceptibility profiling. Microscopic observation drug susceptibility assay (MODS) is an inexpensive, simple method that enables rapid TB culture coupled with susceptibility testing. A 3-week MODS training of three Ethiopian laboratory technicians was conducted at Hadassah-Hebrew University Medical Center, Israel. Results of the trainee readings were blindly assessed by an experienced instructor. Two hundred fifty-five (255) trainee culture readings were evaluated throughout the course. The sensitivity and specificity were 75-100% and 31.5-100%, respectively. Multivariate analysis revealed that sensitivity and duration of incubation were positively correlated, although specificity was positively correlated with the length of training. MODS can be reliably performed by laboratory technicians inexperienced in culture techniques in developing countries, with high sensitivity and specificity reached after a brief learning period.

Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan.

BACKGROUND: This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. METHODS: A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. RESULTS: The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. CONCLUSION: The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too.