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.

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.

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.

Biases encountered in long-term monitoring studies of invertebrates and microflora: Australian examples of protocols, personnel, tools and site location.

Monitoring forms the basis for understanding ecological change. It relies on repeatability of methods to ensure detected changes accurately reflect the effect of environmental drivers. However, operator bias can influence the repeatability of field and laboratory work. We tested this for invertebrates and diatoms in three trials: (1) two operators swept invertebrates from heath vegetation, (2) four operators picked invertebrates from pyrethrum knockdown samples from tree trunk and (3) diatom identifications by eight operators in three laboratories. In each trial, operators were working simultaneously and their training in the field and laboratory was identical. No variation in catch efficiency was found between the two operators of differing experience using a random number of net sweeps to catch invertebrates when sequence, location and size of sweeps were random. Number of individuals and higher taxa collected by four operators from tree trunks varied significantly between operators and with their 'experience ranking'. Diatom identifications made by eight operators were clustered together according to which of three laboratories they belonged. These three tests demonstrated significant potential bias of operators in both field and laboratory. This is the first documented case demonstrating the significant influence of observer bias on results from invertebrate field-based studies. Examples of two long-term trials are also given that illustrate further operator bias. Our results suggest that long-term ecological studies using invertebrates need to be rigorously audited to ensure that operator bias is accounted for during analysis and interpretation. Further, taxonomic harmonisation remains an important step in merging field and laboratory data collected by different operators.

NUPLAM: Gestão 2003/2007

Apresenta o NUPLAN - Núcleo de Pesquisas em Alimentos e Medicamentos da Universidade Federal do Rio Grande do Norte. Ele é responsavel pela área de pesquisas e produção de medicamentos públicos, criado em 1991, foi interditado em 2003, por estar em desacordo com a Resolução 210 de 04 de agosto de 2003. Após a reforma adequando às necessidades e padrões da Anvisa, passou a ser referência em produção de medicamentos de auto-custo e de medicamento de última geração