Technical framework for enabling high quality measurements in new approach methodologies (NAMs).

New approach methodologies (NAMs) are in vitro, in chemico, and in silico or computational approaches that can potentially be used to reduce animal testing. For NAMs that require laboratory experiments, it is critical that they provide consistent and reliable results. While guidance has been provided on improving the reproducibility of NAMs that require laboratory experiments, there is not yet an overarching technical framework that details how to add measurement quality features into a protocol. In this manuscript, we discuss such a framework and provide a step-by-step process describing how to refine a protocol using basic quality tools. The steps in this framework include 1) conceptual analysis of sources of technical variability in the assay, 2) within-laboratory evaluation of assay performance, 3) statistical data analysis, and 4) determination of method transferability (if needed). While each of these steps has discrete components, they are all inter-related, and insights from any step can influence the others. Following the steps in this framework can help reveal the advantages and limitations of different choices during the design of an assay such as which in-process control measurements to include and how many replicates to use for each control measurement and for each test substance. Overall, the use of this technical framework can support optimizing NAM reproducibility, thereby supporting meeting research and regulatory needs.

Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Conceito e aplicação da rastreabilidade de alimentos: uma revisão / Concept and application on food traceability: a review

A rastreabilidade de alimentos (RTA) é definida como um conjunto de procedimentos que permite detectar a origem e acompanhar a movimentação de um produto ao longo da cadeia produtiva, mediante elementos informativos e documentos registrados. A crescente complexidade da produção e distribuição de alimentos demanda o desenvolvimento de iniciativas que promovam maior segurança e qualidade de produtos. O objetivo deste trabalho foi realizar uma revisão da literatura científica sobre o conceito de rastreabilidade de alimentos e identificar as estratégias de aplicação desta ferramenta. Concluiu-se que a implementação da RTA está vinculada a ações governamentais por meio de legislações e órgãos de fiscalização, bem como o uso desta ferramenta ao longo da cadeia produtiva de alimentos requer cada vez mais recursos tecnológicos que possam integrar os diferentes agentes da cadeia de suprimentos.

Food traceability (RTA) is defined as a set of procedures that make it possible to detect the origin and monitor the movement of a product along the production chain, using information elements and registered documents. The growing complexity of food production and distribution demands the development of initiatives that promote greater product safety and quality. The objective of this work was to carry out a review of the scientific literature on the concept of food traceability and to identify strategies for applying this tool. It is concluded that the implementation of the RTA is linked to government actions through legislation and inspection bodies, as well as the use of this tool along the food production chain requires more and more technological resources that can integrate the different agents of the supply chain supplies.

Quality Tools and Strategy for Critical Alerts Process Improvements to Ensure Patient Safety.

Objectives A number of regulatory and accrediting bodies require the reporting of critical results on a timely basis (immediately or within the time frame established by the laboratory) to "the responsible, licensed caregiver" as timely notification of critical laboratory results can pivotally affect patient outcome. The aim of the study was to decrease the turnaround time (TAT) of critical result notification along with assurance of notification to the concerned caregiver or clinicians. The objectives was 30% reduction in the critical value notification TAT and identify factors associated with delayed reporting and root cause analysis for these factors by application of quality tools. Materials and Methods The study was conducted at the Institute of Human Behavior and Allied Sciences, Delhi, a tertiary center teaching Hospital, from April 2019 to June 2021. A value streamed Process Map of critical alert was prepared. The incidents related to failure were presented through Pareto chart. The possible causes were analyzed through the fishbone model. The failure mode prioritization was executed with Failure Mode and Effect Analysis (FMEA). Through extensive brainstorming, appropriate and feasible corrective actions were implemented. The effectiveness of the implemented plan was analyzed by reassessing the TAT of critical alert and feedback received by clinical caregivers. Results After implementation of corrective action plan using quality tools for 3 months, the average critical alert TAT was reduced to 21 minutes from 30 minutes (30% reduction). The median critical alert TAT for ICU, emergency, and IPD were reduced to 3 minutes (IQR: 1-7). During the pilot project, 156 critical value data were sent for feedback with treatment plan but was received only for 88 patients (56%). Conclusion Comprehensive utilization of quality tools has a potential role in patient safety by reducing the critical alert TAT as well as establishing an effective communication between laboratory personnel and clinicians.

Desafios dos laboratórios públicos da área de saúde ambiental para implantação e manutenção dos requisitos de normativas da qualidade para monitoramento da água de consumo humano / Challenges for public laboratories in the environmental health area for implementation and maintenance of quality regulatory requirements for monitoring human consumption water

Resumo Introdução O Ministério da Saúde (MS) é responsável pela vigilância da qualidade da água de consumo humano. A confiabilidade nos resultados do monitoramento de parâmetros analíticos minimiza riscos à saúde pública. Objetivo Retratar aspectos funcionais, a aplicação de ferramentas da qualidade e a aderência dos laboratórios públicos que atuam no monitoramento da água de consumo humano aos requisitos da norma ABNT NBR ISO/IEC 17025. Método A pesquisa foi realizada com 30 laboratórios públicos de todas as regiões do país, respondendo a um questionário elaborado com 49 perguntas sobre a formação e capacidade dos profissionais, garantia da validade dos resultados e sobre a determinação de parâmetros da qualidade da água. Resultados Dos 161 profissionais, 46% possuem mais de 10 anos de experiência e 65% têm formação superior. Capacitações específicas foram requeridas por todos. A validação dos métodos analíticos não foi realizada por 59%. Materiais de referência certificados são acessados por 41% e apenas 18% têm facilidade em adquiri-los. A participação em ensaios de proficiência foi reportada por 68% dos laboratórios, mas com poucos parâmetros avaliados e dificuldades em contratar provedores. Conclusão Evidenciou-se a necessidade de ações para fortalecimento da metrologia em laboratórios públicos que atuam na vigilância da qualidade da água.

Abstract Background The Ministry of Health (MS) is responsible for drinking water quality surveillance. Reliability in the results of monitoring analytical parameters minimizes public health risks. Objective To present functionals aspects and the application of quality tools by public laboratories that work to monitor the quality of drinking water. Method A survey was conducted with 30 public laboratories from all regions of the country, answering a questionnaire elaborated with 49 questions about the training and capacity of professionals, guaranteeing the validity of the results and about the determination of basic parameters of water quality. Results Of the 161 professionals, 46% have more than 10 years of experience and 65% have higher education. Specific training was required by everyone. The validation of the analytical methods was not performed by 59%. Reference materials are accessed by 41% and only 18% can acquire them easily. Participation in proficiency tests was reported by 68% of the laboratories, but with few parameters evaluated and difficulties in hiring providers. Conclusion The need for actions to strengthen metrology in public laboratories that work in water quality surveillance was highlighted.

A Survey of Data Quality Measurement and Monitoring Tools.

High-quality data is key to interpretable and trustworthy data analytics and the basis for meaningful data-driven decisions. In practical scenarios, data quality is typically associated with data preprocessing, profiling, and cleansing for subsequent tasks like data integration or data analytics. However, from a scientific perspective, a lot of research has been published about the measurement (i.e., the detection) of data quality issues and different generally applicable data quality dimensions and metrics have been discussed. In this work, we close the gap between data quality research and practical implementations with a detailed investigation on how data quality measurement and monitoring concepts are implemented in state-of-the-art tools. For the first time and in contrast to all existing data quality tool surveys, we conducted a systematic search, in which we identified 667 software tools dedicated to "data quality." To evaluate the tools, we compiled a requirements catalog with three functionality areas: (1) data profiling, (2) data quality measurement in terms of metrics, and (3) automated data quality monitoring. Using a set of predefined exclusion criteria, we selected 13 tools (8 commercial and 5 open-source tools) that provide the investigated features and are not limited to a specific domain for detailed investigation. On the one hand, this survey allows a critical discussion of concepts that are widely accepted in research, but hardly implemented in any tool observed, for example, generally applicable data quality metrics. On the other hand, it reveals potential for functional enhancement of data quality tools and supports practitioners in the selection of appropriate tools for a given use case.

Delphi methodology in healthcare research: How to decide its appropriateness.

The Delphi technique is a systematic process of forecasting using the collective opinion of panel members. The structured method of developing consensus among panel members using Delphi methodology has gained acceptance in diverse fields of medicine. The Delphi methods assumed a pivotal role in the last few decades to develop best practice guidance using collective intelligence where research is limited, ethically/logistically difficult or evidence is conflicting. However, the attempts to assess the quality standard of Delphi studies have reported significant variance, and details of the process followed are usually unclear. We recommend systematic quality tools for evaluation of Delphi methodology; identification of problem area of research, selection of panel, anonymity of panelists, controlled feedback, iterative Delphi rounds, consensus criteria, analysis of consensus, closing criteria, and stability of the results. Based on these nine qualitative evaluation points, we assessed the quality of Delphi studies in the medical field related to coronavirus disease 2019. There was inconsistency in reporting vital elements of Delphi methods such as identification of panel members, defining consensus, closing criteria for rounds, and presenting the results. We propose our evaluation points for researchers, medical journal editorial boards, and reviewers to evaluate the quality of the Delphi methods in healthcare research.

Design of Predictive Tools to Estimate Freshness Index in Farmed Sea Bream (Sparus aurata) Stored in Ice.

This research studied sea bream freshness evolution through storage time in ice by determining different quality parameters and sensory profiles. Predictive models for freshness index, storage time, and microbial counts were designed from these data. Physico-chemical parameters were assessed to evaluate the quality of fish; microbial growth was controlled to ensure food safety, and sensory analyses were carried out to characterize quality deterioration. Predictive models were developed and improved with the aim of being used as tools for quality management in the seafood industry. Validation was conducted in order to establish the accuracy of models. There was a good relationship between the physico-chemical and microbiological parameters. Sensory analysis and microbial counts allowed for the establishment of a shelf-life of 10 days, which corresponded to a poor quality (according to the European Community's system of grading fish for marketing purposes), with a freshness index lower than 50%. Sensory profiles showed that gill and flesh texture were the most vulnerable attributes during storage in ice related to spoilage. The predictive models for the freshness index (%) and ice storage time (h) exhibited an accuracy close to 90% following practical validation.

Indicadores de sustentabilidade em medicina laboratorial / Sustainability indicators in laboratory medicine

O artigo apresenta os princípios conceituais sobre desenvolvimento sustentável, sustentabilidade e avalia a evolução e os impactos na economia, no meio ambiente e na sociedade. Discutem-se a aplicabilidade dos conceitos de sustentabilidade empresarial na medicina laboratorial e os desafios inerentes à implantação no laboratório clínico. O impacto dos indicadores de sustentabilidade e seu papel no processo de gestão também são analisados criticamente sob a ótica do balanço socioambiental. O texto apresenta ainda algumas ferramentas para avaliação e interpretação dos indicadores e sua aplicação no processo de análise crítica. Finalmente, o artigo descreve a importância dos indicadores de sustentabilidade na prática do benchmarking e sua aplicabilidade no laboratório clínico.

The article presents the conceptual principles on sustainable development and sustainability. Furthermore, it evaluates the progress and impacts on the economy, environment and society. It discusses the applicability of the concepts of corporate sustainability in laboratory medicine and the challenges of deployment in the clinical laboratory. The impact of sustainability indicators and their role in management are also critically reviewed from the perspective of social and environmental balance. Additionally, the text provides some tools for evaluation and interpretation of indicators and their corresponding application in the critical analysis process. Lastly, the article describes the importance of sustainability indicators in the practice of benchmarking and its applicability in the clinical laboratory.