Building Integrated Testing Programs for Infectious Diseases.

In the past 2 decades, testing services for diseases such as human immunodeficiency virus (HIV), tuberculosis, and malaria have expanded dramatically. Investments in testing capacity and supportive health systems have often been disease specific, resulting in siloed testing programs with suboptimal capacity, reduced efficiency, and limited ability to introduce additional tests or respond to new outbreaks. Emergency demand for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing overcame these silos and demonstrated the feasibility of integrated testing. Moving forward, an integrated public laboratory infrastructure that services multiple diseases, including SARS-CoV-2, influenza, HIV, tuberculosis, hepatitis, malaria, sexually transmitted diseases, and other infections, will help improve universal healthcare delivery and pandemic preparedness. However, integrated testing faces many barriers including poorly aligned health systems, funding, and policies. Strategies to overcome these include greater implementation of policies that support multidisease testing and treatment systems, diagnostic network optimization, bundled test procurement, and more rapid spread of innovation and best practices across disease programs.

Examining 7 years of implementing quality management systems in medical laboratories in sub-Saharan Africa.

BACKGROUND: Achievement of ISO15189 accreditation demonstrates competency of a laboratory to conduct testing. Three programmes were developed to facilitate achievement of accreditation in low- and middle-income countries: Strengthening Laboratory Management Towards Accreditation (SLMTA), Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) and Laboratory Quality Stepwise Implementation (LQSI). OBJECTIVE: To determine the level of accreditation and associated barriers and facilitators among medical laboratories in the WHO-AFRO region by 2020. METHODS: A desk review of SLIPTA and SLMTA databases was conducted to identify ISO15189-accredited medical laboratories between January 2013 and December 2020. Data on access to the LQSI tool were extracted from the WHO database. Facility and country characteristics were collected for analysis as possible enablers of accreditation. The chi-square test was used to analyse differences with level of significance set at <0.05. RESULTS: A total of 668 laboratories achieved accreditation by 2020 representing a 75% increase from the number in 2013. Accredited laboratories were mainly in South Africa (n = 396; 55%) and Kenya (n = 106; 16%), two countries with national accreditation bodies. About 16.9% (n = 113) of the accredited laboratories were registered for the SLIPTA programme and 26.6% (n = 178) for SLMTA. Approximately 58,217 LQSI users were registered by December 2020. Countries with a higher UHC index for access to HIV care and treatment, higher WHO JEE scores for laboratory networks, a larger number of registered LQSI users, with national laboratory policy/strategic plans and PEPFAR-priority countries were more likely to have an accredited laboratory. Of the 475 laboratories engaged in the SLIPTA programme, 154 attained ≥4 SLIPTA stars (ready to apply for accreditation) and 113 achieved ISO 15189 accreditation, with 96 enrolled into the SLMTA programme. Lower-tier laboratories were less likely to achieve accreditation than higher-tier laboratories (7.7% vs. 30%) (p < 0.001). The probability of achieving ISO 15189 accreditation (19%) was highest during the first 24 months after enrolment into the SLIPTA programme. CONCLUSION: To sustainably anchor quality improvement initiatives at facility level, national approaches including access to a national accreditation authority, adoption of national quality standards and regulatory frameworks are required.

Trends in antimicrobial resistance of bacterial pathogens in Harare, Zimbabwe, 2012-2017: a secondary dataset analysis.

BACKGROUND: Antimicrobial resistance is one of the most serious public health threats of the twenty-first century. The implementation of AMR surveillance in Zimbabwe is limited. However, data from a private laboratory in Harare revealed increasing resistance rates to common antibiotics like ampicillin (i.e., from 73.9% in 2011 to 74.6% in 2015). The increasing resistance rates indicate that Zimbabwe is affected by AMR. This study was done to determine the magnitude of AMR in Harare and determine the trends of AMR to first-line and to last-resort antibiotics and make recommendations to mitigate the problem. METHODS: A retrospective record review of data collected from the microbiology department at a private laboratory between January 2012 and December 2017 was done. The outcome of interest was the antibiotic susceptibility of bacterial isolates. Microsoft Excel 2016 was used to plot trends from 2012 to 2017 and Epi Info™7 was used for statistical analysis. RESULTS: A total of 23,432 isolates, of 12 medically important bacteria were analysed. Forty-three percent of the isolates were from urines, 36.7% were from pus swabs and 7% were from blood. The most common pathogen was Escherichia coli (43.2%), followed by Staphylococcus aureus (15.8%) and the least common was Neisseria gonorrhoea (0.2%). Resistance was highest to ampicillin followed by penicillin, both ranging between 70 and 100% over the six years. Statistically significant increases in resistance to commonly used antibiotics were observed in amoxicillin-resistant E. coli and Streptococcus pneumonia and third generation cephalosporin-resistant E. coli. There was an increase in resistance to last-line antibiotics i.e., fluoroquinolone-resistant Salmonella spp. and carbapenem-resistant Pseudomonas aeruginosa and Acinetobacter baumannii. However, methicillin-resistant S. aureus showed a decreasing trend. CONCLUSIONS: There is a high burden of drug resistance to common antibiotics in Harare and an emergence of resistance to last-line antibiotics.

Survey and situation analysis of personal, employer-related, and environmental factors affecting participation in continuous professional development (CPD) programs of laboratory professionals in Africa.

OBJECTIVES: To determine the level and evaluate factors affecting the participation of laboratory professionals in continuous professional development (CPD) programs in eastern and southern Africa. METHODS: A survey was conducted among laboratory professionals from 14 countries. The CPD participation was defined as low if it was fewer than 2 CPD trainings in the past 2 years. Associations between categorical variables were tested for significance using Fisher exact test. RESULTS: Of the expected 400, 283 (70% response rate) individuals participated in the survey. Of these, 153 (54%) had low CPD participation and 199 (70%) were aware of CPD educational activities in their respective country. Those with diploma certificates attended more CPD programs (P < .001) than those with undergraduate and master's degrees. Awareness of CPD programs was associated with a higher level of CPD participation (P = .0001). Job satisfaction was significantly associated with high levels of CPD participation (P = .02). Other factors associated with high level of participation in CPD programs included affordability (P = .03), funding by employer (P = .0005), and awareness of legal CPD requirements (P = .002). CONCLUSIONS: The CPD programs are considered useful to an individual's professional development, although there was low participation. It is recommended that different formats and platforms be used to expand CPD programs.

Diagnostics for detection and surveillance of priority epidemic-prone diseases in Africa: an assessment of testing capacity and laboratory strengthening needs.

In 2023, Africa experienced 180 public health emergencies, of which 90% were infectious diseases and 75% were related to zoonotic diseases. Testing capacity for epidemic-prone diseases is essential to enable rapid and accurate identification of causative agents, and for action to prevent disease spread. Moreover, testing is pivotal in monitoring disease transmission, evaluating public health interventions and informing targeted resource allocation during outbreaks. An online, self-assessment survey was conducted in African Union Member States to identify major challenges in testing for epidemic-prone diseases. The survey assessed current capacity for diagnosing priority epidemic-prone diseases at different laboratory levels. It explored challenges in establishing and maintaining testing capacity to improve outbreak response and mitigate public health impact. Survey data analysed diagnostic capacity for priority infectious diseases, diagnostic technologies in use, existing surveillance programmes and challenges limiting diagnostic capacity, by country. The survey result from 15 Member States who responded to the survey, showed high variability in testing capacity and technologies across countries and diverse factors limiting testing capacity for certain priority diseases like dengue and Crimean-Congo haemorrhagic fever. At the same time diagnostic capacity is better for coronavirus disease 2019 (COVID-19), polio, and measles due to previous investments. Unfortunately, many countries are not utilizing multiplex testing, despite its potential to improve diagnostic access. The challenges of limited laboratory capacity for testing future outbreaks are indeed significant. Recent disease outbreaks in Africa have underscored the urgent need to strengthen diagnostic capacity and introduce cost-effective technologies. Small sample sizes and differing disease prioritisation within each country limited the analysis. These findings suggest the benefits of evaluating laboratory testing capacity for epidemic-prone diseases and highlight the importance of effectively addressing challenges to detect diseases and prevent future pandemics.

Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region.

Objectives: Coronavirus disease 2019 was declared a global pandemic in March 2020 with correct and early detection of cases using laboratory testing central to the response. Hence, the establishment of quality management systems and monitoring their implementation are critical. This study describes the experience of implementing the COVID-19 Laboratory Testing and Certification Program (CoLTeP) in Africa. Methods: Private and public laboratories conducting SARS-CoV-2 testing using polymerase chain reaction were enrolled and assessed for quality and safety using the CoLTeP checklists. Results: A total of 84 laboratories from 7 countries were assessed between April 2021 to December 2021 with 52% of these from the private sector. Among them, 64% attained 5 stars and were certified. Section 4 had the highest average score of 92% and the lowest of 78% in Section 3. Also, 82% of non-conformities (NCs) were related to sample collection, transportation, and risk assessments. Non-availability, inconsistency in performing, recording, instituting corrective actions for failed internal and external quality controls were among major NCs reported. Conclusions: Laboratories identified for SARS-CoV-2 testing by public and private institutions mostly met the requirements for quality and safe testing as measured by the CoLTeP checklist.

Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation.

BACKGROUND: The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. SLIPTA IMPLEMENTATION PROCESS: WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. PRELIMINARY RESULTS: By March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%. CONCLUSION: The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.

Training-of-trainers: A strategy to build country capacity for SLMTA expansion and sustainability.

BACKGROUND: The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme uses a training-of-trainers (TOT) model to build capacity for programme scale-up. The TOT strategy is designed to maximise utilisation of its graduates whilst minimising inconsistencies and ensuring high programme quality during global expansion. OBJECTIVES: To describe the SLMTA TOT programme approach. METHODS: The two-week training, led by carefully selected and trained master trainers, enables effective and authentic implementation of the curriculum by its graduates. The teachback methodology used allows participants to practise teaching the curriculum whilst learning its content. A trainer's toolkit provides all the materials necessary for teaching and must be followed faithfully during training. Two surveys were conducted to assess the effectiveness of the TOT strategy: one sent to 316 TOT graduates in 25 countries and the other sent to the programme leaders in 10 countries. RESULTS: By the end of 2013, 433 SLMTA trainers had been trained who, in turn, taught more than 1900 people to implement SLMTA in 617 laboratories in 47 countries. Ninety-seven percent of the 433 TOT graduates and 87% of the 38 master trainers are based in developing countries. Ninety-two per cent of the graduates have been utilised at least once in programme implementation and, as of August 2013, 87% of them were still actively involved in programme activities. Ninety-seven per cent of the graduates stated that the TOT workshop prepared them well for training or other programme tasks. CONCLUSION: The SLMTA TOT strategy is effective in building local capacity for global programme expansion whilst maintaining programme quality.

The impact of SLMTA in improving laboratory quality systems in the Caribbean Region.

BACKGROUND: Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow. OBJECTIVE: To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA) training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. METHOD: Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS). Audits were conducted at baseline, six months, exit (at 12 months) and post-SLMTA (at 18 months) using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. RESULTS: Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. CONCLUSION: The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation.

Health effects of agrochemicals among farm workers in commercial farms of Kwekwe district, Zimbabwe.

INTRODUCTION: Farm workers are at a very high risk of occupational diseases due to exposure to pesticides resulting from inadequate education, training and safety systems. The farm worker spends a lot of time exposed to these harmful agrochemicals. Numerous acute cases with symptoms typical of agrochemical exposure were reported from the commercial farms. We assessed the health effects of agrochemicals in farm workers in commercial farms of Kwekwe District (Zimbabwe), in 2006. METHODS: An analytical cross sectional study was conducted amongst a sample of 246 farm workers who handled agrochemicals when discharging their duties in the commercial farms. Plasma cholinesterase activity in blood specimens obtained from farm workers was measured using spectrophotometry to establish levels of poisoning by organophosphate and/or carbamates. Information on the knowledge, attitudes and practices of farm workers on agrochemicals use was collected using a pre-tested interviewer administered questionnaire. Bivariate and multivariate analyses were conducted to determine factors that were associated with abnormal cholinesterase activity. RESULTS: The prevalence of organophosphate poisoning, indicated by cholinesterase activity of 75% or less, was 24.1%. The median period of exposure to agrochemicals was 3 years (Q(1):=1 year, Q(3):=7 years). Ninety eight (41.5%) farm workers knew the triangle colour code for the most dangerous agrochemicals. Not being provided with personal protective equipment (OR 2.00; 95% CI: 1.07 - 3.68) and lack of knowledge of the triangle colour code for most dangerous agrochemicals (OR 2.02; 95% CI: 1.02 - 4.03) were significantly associated with abnormal cholinesterase activity. CONCLUSION: There was organophosphate poisoning in the commercial farms. Factors that were significantly associated with the poisoning were lack of protective clothing and lack of knowledge of the triangle colour code for most dangerous agrochemicals. We recommended intensive health education and training of farm workers on the use of agrochemicals, provision of adequate and proper personal protective equipment as mitigation measures to this problem.