Evaluation of Diagnostic Microbiology Capacity and Barriers in Testing for HIV and TB at Peripheral Hospital-Based Laboratories in Oyo-State, Nigeria.

The prevalence of tuberculosis (TB) and human immunodeficiency virus (HIV) coinfection in Nigeria is currently around 19.1%. This indicates that the two diseases are still a burden on the nation"s health. The aim of this study was to evaluate the diagnostic microbiology capacity and the barriers in performing assay for TB and HIV at peripheral district-level hospital-based laboratories in Oyo State, Nigeria. Diagnostic microbiology capacity was estimated using a scale of 100-point where scores ≤ 49% were categorized as low, 50-79% fair and ≥80% good. Barriers to diagnosis were summarized in proportions. The diagnostic microbiology capacity revealed that 6 (35.3%) and 11 (64.7%) of the laboratories had "fair" and "low" capacity, respectively, to detect TB in cerebrospinal fluid/sputum. In testing for HIV, 3 (17.6%) of the laboratories had "fair capacity" and 14 (82.4%) had "low capacity" to detect CD4 count and HIV antibodies in blood serum. The major diagnostic barriers in almost all (94.1%) the laboratories were lack of culture supplies and nonavailability of reagents/testing kits. There was no diagnostic microbiology service with good capacity to facilitate case detection of HIV and TB at the peripheral hospitals. Hence there is a need to improve the supply of reagents, culture stock and testing kits. This will facilitate the detection of TB and HIV cases in peripheral communities. IMPORTANCE This study provided a snapshot knowledge of testing capabilities and commodity availability at state laboratories. The findings should inform the action of stakeholders to improve diagnostic microbiology capacity, consequently enhancing diagnostic measures in detecting human immunodeficiency virus and Mycobacterium tuberculosis.

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.

Deep learning early warning system for embryo culture conditions and embryologist performance in the ART laboratory.

Staff competency is a crucial component of the in vitro fertilization (IVF) laboratory quality management system because it impacts clinical outcomes and informs the key performance indicators (KPIs) used to continuously monitor and assess culture conditions. Contemporary quality control and assurance in the IVF lab can be automated (collect, store, retrieve, and analyze), to elevate quality control and assurance beyond the cursory monthly review. Here we demonstrate that statistical KPI monitoring systems for individual embryologist performance and culture conditions can be detected by artificial intelligence systems to provide systemic, early detection of adverse outcomes, and identify clinically relevant shifts in pregnancy rates, providing critical validation for two statistical process controls proposed in the Vienna Consensus Document; intracytoplasmic sperm injection (ICSI) fertilization rate and day 3 embryo quality.

Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience.

BACKGROUND: Immunocytochemical staining with p16/Ki67 has been suggested as a promising triage biomarker in cervical cancer screening. As dual staining is a subjective method, proper training may be required to ensure safe implementation in routine laboratories and reduce risk of misclassification. We determined concordance between novice evaluators and an expert, stratified by number of slides reviewed at three reading points. METHODS: The study was conducted at the Department of Pathology, Randers, Denmark. Women were eligible if they were aged ≥45, had been enrolled in one of two ongoing clinical studies, and had a dual stain slide available. Dual staining was performed using the CINtec plus assay. Slides were randomly selected from three reading points at which novice evaluators had reviewed <30, ~300, and ≥500 dual stain slides respectively. Level of concordance was estimated using Cohen's Kappa, κ. RESULTS: Of 600 eligible slides, 50 slides were selected for review as recommended by the manufacturer. Median age was 68 years (range: 58-74). Overall concordance was good (κ = 0.68, 95% confidence interval [CI]: 0.60-0.76), with an overall agreement of 84% (95% CI: 70.9%-92.8%). Concordance improved with increasing number of slides reviewed at a given reading point, from a moderate concordance (κ = 0.47, 95% CI: 0.05-0.90) after reviewing <30 slides to a good concordance (κ = 0.66, 95% CI: 0.20-0.88) and a very good concordance (κ = 0.88, 95% CI: 0.66-1.00) after reviewing ~300 and ≥500 slides, respectively. CONCLUSIONS: When interpreting dual stain slides from older women, concordance increased slightly as novice evaluators received more training and experience. Although further evaluation is warranted, these findings indicate that a significant amount of training and experience of novice evaluators may be needed to ensure accurate dual stain interpretation in this age group. Future studies should accurately describe training and experience of evaluators to enable a better comparison of concordance and diagnostic accuracy across studies. TRIAL REGISTRATION: NCT04114968 and NCT04298957.

Minimum standards for practices offering assisted reproductive technologies: a committee opinion.

This document is designed to provide a framework for assisted reproductive technology (ART) programs that meet or exceed the requirements suggested by the Centers for Disease Control and Prevention (CDC) for certification of ART laboratories. This document replaces the document, "Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies: A Committee Opinion," published in 2014.

Vigilância Nacional de Meningite Procdiimento Operacional Padrão para Pessoal do Laboratório / National Meningitis Surveillance Standard Operating Procedure for Laboratory Personnel

A meningite bacteriana é uma condição clínica que acarreta risco de vida, requerendo diagnóstico e tratamento precoces. Estima-se que ocorreram 2,8 milhões de casos de meningite em todo o mundo, em 2016 (Colaboradores GBDM Lancet 2018). Até 70% dos pacientes com meningite morrem sem tratamento (Rosenstein NEJM 2001). Mesmo com diagnóstico e tratamento adequados, cerca de 8 a 15% dos pacientes com meningite acabam por morrer e cerca de 20% dos sobreviventes poderão sofrer de perda de audição permanente e dificuldades de aprendizagem (OMS 2019). As crianças com menos de 5 anos de idade correm um risco maior de contraírem meningite bacteriana, que é causada por três agentes infecciosos principais: Streptococcus pneumoniae, Haemophilus influenzae e Neisseria meningitidis. Estão disponíveis vacinas eficazes contra estes agentes infecciosos. Moçambique, por exemplo, introduziu uma vacina pneumocócica conjugada 10-valente (PCV), em 2013, e dados da vigilância mostram que a prevalência da meningite pneumocócica de tipo PCV10 reduziu de 84,2% (48/57), em 2013, para 0% (0/3), em 2015 (Nhantumbo PLoS One 2017). No entanto, é importante manter uma vigilância robusta e ativa da meningite bacteriana em Moçambique devido a preocupações com o aumento de serotipos não incluídos na fórmula atual da vacina (Martcheva J R Soc Interface 2008) ou o surgimento de serotipos resistentes a múltiplos antibióticos (OMS 2017)...

A computer model for professional competence assessment according to ISO 15189.

Background As defined by ISO 15189 competence is the "demonstrated ability to apply knowledge and skills" thus, its assessment is fundamental for ensuring the quality of the total testing process in order to reduce the risk for the patient. We have developed a functional software for the measurement of professional competences in order to standardize the procedure and to collect all the data in a single platform, avoiding redundancy and dispersion. Methods Our model objectively assesses the skills, as they become measurable and comparable with appropriate standards and involves both managers and operators, to increase their active engagement. The assessment concerns everyone, but the standards to be met (numerical values) can vary according to the responsibilities. Several subjective and objective criteria are evaluated: each parameter can contribute in a variable proportion to the total skills measured according to the needs of the organization. Results The data are automatically analyzed and can be easily monitored in real time in the form of indicators, thanks to dashboards. The comparison between the skills required and those measured allows highlighting the gap useful for planning personalized training paths. Conclusions Our tool is reliable and highly adaptable to laboratories about competences to track criteria, standards and monitored indicators. The computerized management is a strategic action as it fulfills the requirements of registration, traceability, communication, data analysis and indicators development, which are the tenets of continuous improvement, and allows planning to be made on the basis of the actual training needs.

The Unmet Need: Low Performance of Laboratory Professionals in Malaria Microscopy, Oromia Regional State, Ethiopia.

Ethiopia aims to diagnose and treat all clinical malaria within 24 hours of fever onset in its stride to eliminate the disease by 2030. Microscopy remains to be the mainstay for diagnosis at the health center and hospital level. Continuous evaluation and performance upgrading of malaria microscopists is one of the cornerstones in this effort. We assessed the performance of malaria microscopists compared with reference readers in diagnosing, identifying the species, and quantifying parasitemia. A total of 174 microscopists were enrolled from health facilities located in 86 districts in Oromia region (Ethiopia) from January 2017 to June 2018. Panel slides with known Plasmodium species, diagnostic blood stage, and parasite density were prepared by the reference readers. Sociodemographics, education, in-service training, and routine practice of participants were captured. Sensitivity, specificity, percent agreement, and kappa score were calculated. An overall low performance was observed that could threaten the malaria diagnostic service. Of all the slides distributed (1,218), only 17.0% of the positive and 30.0% of the negative slides were correctly identified and 22.4% were correctly quantified. Compared with the reference readers, participants had lower competence in diagnosing (74.3% agreement and kappa 0.45) and identifying the species (71.2% agreement and kappa 0.40). Two-fifths of the participants were graded as "in training" with respect to identifying the species (41.0%) and the diagnostic stages (40.0%). An in-service training/retraining and supportive supervision are needed to raise and maintain the competence of microscopists in settings with a recent decline in malaria transmission and aiming for ultimate elimination of the disease.

A risk-based approach to cognitive bias in forensic science.

Over the past decade, the potential impact of cognitive bias in forensic science has instigated much discussion and debate between academics, scientists and those in the justice sector. Evidence of bias influencing subjective decision-making across a range of forensic disciplines has been described in the literature. Forensic service organisations are being urged to address cognitive bias in subjective decision-making by designing processes or procedures to limit access to (irrelevant) contextual information or reduce dependence on cognitive functions. Although some laboratories have implemented bias mitigating strategies, with varying impact on operational efficiency, there has been no systematic assessment of the risk posed by cognitive bias. Forensic Science SA assessed the potential impact of bias on forensic interpretations across multiple disciplines, using a risk management framework. This process proved useful in assessing the effectiveness of existing bias mitigating strategies and identified the latent level of risk posed. While all forensic organisations should seek to implement bias limiting measures that are simple, cost-effective and do not adversely impact efficiency, using a risk-based approach has contextualised the limited benefit of introducing resource hungry measures, as postulated in the literature. That is not to suggest that forensic organisations should dismiss the potential influence of cognitive bias but they need to strike an appropriate balance between risk and return, as they do with any business risk.

Does Gender Bias Still Affect Women in Science?

The percentage of women employed in professional scientific positions has been low but is increasing over time. The U.S. National Institutes of Health and the National Science Foundation have both implemented programs to improve women's participation in science, and many universities and companies have diversity and equity programs. While most faculty and scientists believe that they are fair and unbiased, numerous well-designed studies published in leading peer-reviewed journals show that gender bias in sciences and medicine is widespread and persistent today in both faculty and students. Recent studies show that gender bias affects student grading, professional hiring, mentoring, tenure, promotion, respect, grant proposal success, and pay. In addition, sexual harassment remains a significant barrier. Fortunately, several studies provide evidence that programs that raise conscious awareness of gender bias can improve equity in science, and there are a number of recommendations and strategies for improving the participation of women.

Scientific papers: Which type would you prefer?

It's very important to enhance the quality of scientific papers produced by postgraduates and scholars from academic institutions. To encourage their academic and professional development, these young scientists should be encouraged to compose nonresearch articles, in addition to original research articles, including short essays, perspectives and reviews.

Advancing Science: How Bias Holds Us Back.

As scientists and engineers, we must recognize the overwhelming evidence that we each harbor bias that influences our professional decisions. Yet, solving today's increasingly complex public health challenges requires diverse perspectives from multidisciplinary teams. We all have the opportunity to actively promote a more representative scientific community; let's harness the power of collective action to build diverse teams that deliver the most innovative science.