Point-of-Care Testing (POCT) has been highlighted in the health care sector in recent decades. On the other hand, due to its low demand, POCT is at a disadvantage compared to conventional equipment, since its cost is inversely proportional to the volume of use. In addition, for the implementation of POCT to succeed, it is essential to rely on the work of a multidisciplinary team. The awareness of health professionals of the importance of each step is perhaps the critical success factor. The trend towards the continuous advancement of the use of POCT and the great potential of its contributions reinforce the need to implement quality management tools, including performance indicators, to ensure their results. This review presents some advantages and disadvantages concerning POCT and the real need to use it. A worldwide call for the availability of easy-to-use health technologies that are increasingly closer to the final user is one of the main reasons for this focus.

Introdução: Inúmeros questionamentos têm sido levantados com relação ao nível da qualidade dos serviços de saúde, principalmente a partir do início desta década. Uma abordagem que tem sido utilizada como base teórica para essa questão é a de organização da alta confiabilidade (HRO). Neste trabalho, propomos nova abordagem para o controle da qualidade analítica (CQA), com base nos princípios da teoria das HROs e com foco na ampliação do nível de segurança para os clientes no laboratório clínico. Objetivos: Propor uma abordagem complementar para o sistema de CQA, alinhado à teoria HRO, com foco na ampliação do nível de segurança do paciente. Materiais e métodos: Visando aprimorar a abordagem tradicional para o CQA, viabilizando a análise de estabilidade do sistema analítico com visão de longo prazo, propomos um modelo embasado em avaliação de erro aleatório e sistemático, utilizando cartas de controle avançadas. Para validar o modelo, realizamos simulações, utilizando dados reais obtidos da rotina (glicose, Vitros FS 5.1, OCD). Resultados: O ensaio em estudo foi avaliado em termos de desempenho de longo prazo, apresentando desempenho adequado (4,1 sigma) para seu uso diagnóstico. Discussão: O modelo proposto oferece alternativa multiferramenta, com base no conhecimento já amplamente estabelecido de controle estatístico de processos, visando à utilização no controle de estabilidade de longo prazo de métodos laboratoriais. Conclusão: A abordagem proposta como complementar ao sistema de controle de qualidade (CQ) tradicionalmente utilizado, envolvendo a aplicação sequencial e associada de diferentes ferramentas estatísticas, mostrou-se válida e útil para uma avaliação efetiva do desempenho do método e da estabilidade desse desempenho ao longo do tempo.

Background: The Six Sigma approach is a new technique to manage process quality performance in clinical laboratory, aligning quality and cost reduction targets. Objectives: The aim of this study was to evaluate the viability and the impact of the Six Sigma concepts in the clinical laboratory technical processes management. Methods: It was made a study to compare 14 serum anilities in two automated chemistry systems, Bayer ADVIA 1650 and Ortho-Clinical Diagnostics VITROS 950, using sigma-metrics. Sigma-metrics was calculated using different performance specifications. Results: The highest metrics were found in uric acid and triglycerides assays in both analyzers using Clinical Laboratory Improvement Amendments (CLIA) and biological variation based specifications. The lowest metrics were found in AST and ALT assays on ADVIA 1650 analyzer and chloride on VITROS 950 analyzer. Discussion: The results showed a tendency to higher sigma-metrics in anilities processed on VITROS 950 than ADVIA 1650. The specification limits definition showed to be an important step to a reliable performance evaluation using sigma-metrics. Conclusions: The use of sigma-metrics as an index of technical process quality performance allow the laboratory to design a cost-effective quality control system, aligning quality and cost goals, keeping the custumer satisfaction in a high level and the focus on financial condition of the organization.

We hope to see a global consensus on an acceptable quality standard for performing POCT that is adaptable, practical, and cost effective in primary care settings, ensuring patient safety, and minimizing the risk of harm.

Introdução: Para competir no mercado atual de medicina laboratorial, há a necessidade de processos com elevado nível de agregação de valor aos clientes e alta flexibilidade para atender às modificações constantes nos requisitos de clientes e legais, bem como capacidade de se adaptar às modificações no ambiente competitivo. Esses desafios exigem uma adaptação global do laboratório para uma visão baseada em processos. Objetivo: Avaliar criticamente uma iniciativa de mapeamento e redesenho de processos desenvolvida em um laboratório clínico de grande porte. Nessa análise crítica, serão apresentados e avaliados os resultados de um projeto de redesenho realizado na área técnica da empresa, incluindo processos técnicos e de apoio. Materiais e métodos: Foram mapeados 37 processos técnicos, utilizando metodologia adaptada e identificando as principais desconexões e oportunidades de melhoria. Cada processo foi sequencialmente analisado e redesenhado e um plano de ação foi gerado para a implementação de cada novo processo. Resultados: Após a implementação dos novos processos redesenhados, a produtividade de pessoal técnico aumentou em mais de 30%. Outro resultado importante foi obtido em termos de flexibilidade dos processos, principalmente em razão da nova estrutura de subáreas na área técnica. Discussão: Os principais pontos críticos do projeto estiveram relacionados com a disponibilidade de recursos de tecnologia da informação (TI) e a não priorização de medições nos processos no momento inicial do projeto. Conclusão: A iniciativa de redesenho de processos, se implementada com um roteiro planejado, orientada a resultados e alinhada à estratégia da organização, pode proporcionar resultados significativos para os laboratórios clínicos.

ObjectivesIn the laboratory medicine segment, benchmarking is the process in which institutions seek to compare with the macro environment (performance comparison and best practices with different laboratories) and improve their results based on quality indicators. The literature has highlighted the vulnerability of the pre-analytical phase in terms of risks and failures and the use of interlaboratory comparison as an opportunity to define a strategic performance benchmark aligned with the laboratory medicine sector, which has been a promising strategy to ensure continuous improvement, identifying within the pre-analytical process the critical activities to guarantee patient safety. In this context, this paper aims to present the three-year experience (2016–2018) of the Benchmarking Program and Laboratory Indicators – in Portuguese, Programa de Benchmarking e Indicadores Laboratoriais (PBIL) – with emphasis on pre-analytical indicators and their comparison against literature references and other programs of benchmarking in the area of laboratory medicine. PBIL is organized by the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML) in conjunction with Controllab and coordinated by a Brazilian group with representatives from different countries.MethodsThe data presented in this paper involving the performance results of 180 laboratories with active participation. Results are presented in percentage (%, boxplot graphical in quartiles) and Sigma metric, recognized as the metric that best indicates the magnitude of failures in a process. The Pareto Chart was used to facilitate ordering and to identify the main errors in the pre-analytical phase. The Radar Chart was made available in this work for the purpose of comparing the results obtained in Sigma by the PBIL and IFCC Working Group Laboratory Errors and Patient Safety (WG LEPS).ResultsIn the study period, just over 80% of the pre-analytical failures are related to Blood culture contamination (hospital-based and non-hospital-based laboratories), Recollect and Non-registered exams, with failure rates of 2.70, 1.05 and 0.63%, respectively. The performance of the PBIL program participants was in line with the literature references, and allowed to identify benchmarks in the laboratory medicine market, target of PBIL, with best practices were observed for some indicators.ConclusionsThe results of the program demonstrate the importance of an ongoing program comparative performance-monitoring program for setting more robust goals and consequently reducing laboratory process failures. Even with these promising premises and results, the contextualized analysis of the program indicators, point to a still significant number of failures in our market, with possibilities for improvement in order aiming to ensure more robust and effective processes.

Strawberries are of high social and economic importance and the crop is mainly produced at small family enterprises. Strawberries are repetitively amongst products in which unauthorized pesticide residues are determined. The PARA program launched in Brazil by ANVISA has disclosed that many samples have residues above the maximum residue limit (MRL). The present study appraised the pesticide residues detected in strawberries produced in the state of Rio Grande do Sul and marketed at the CEASA / RS. Along the harvesting seasons of 2018 and 2019, 62 strawberry samples were collected at the CEASA-pavilion destined for growers from the state of Rio Grande do Sul. Each sample was tested for 238 active ingredients of pesticides. Of the 62 samples retrieved, 40% were considered satisfactory and 60% resulted as unsatisfactory. Of the 25 satisfactory samples, three samples did not present any residues, and 22 had residues below the MRL. Of the 37 samples with an unsatisfactory outcome, 11 had active ingredients not allowed (NA) for use on strawberries, 13 presented active ingredients above the MRL and 13 reports presented the sum of both: residues above the MRL and NA. Thirty five different active ingredients were detected in the samples summing up to a total of 303 detection events. The active ingredients detected most frequently were procymidone (66.13%); carbendazim (53.22%) and difenoconazole (50%).

Repeated presence of strawberries amongst produce with pesticide residues results in questionings related to the risks involved by its consumption. Deterministic and probabilistic risk assessment methods might be used depending on the available data. In the present study, both methods were used to estimate risks of pesticide intake by strawberry consumption. Strawberry samples along two years were analyzed via the multiresidue method. Results of active ingredients (a.i.) concentrations were organized and used for calculations for intake estimates. On the deterministic method, intake was calculated based on the data of a.i. concentration and consumption data coming from an online questionnaire and body weight between 5 and 70 kg. On the probabilistic method, the concentrations of a.i. and body weight of 60 kg were evaluated in two scenarios: a) consumption data from an online questionnaire or b) consumption data retrieved from Family Budget Survey of the Brazilian Institute of Geography and Statistics. In the 62 strawberry samples, 38 a.i. were quantified and in 25 samples the residue analyses were considered satisfactory and 37 had an unsatisfactory outcome. In the deterministic approach, 23% of the a.i. had a calculated intake higher than the acceptable daily intake (ADI) and risk concentrated in body weights between 5 and 30 kg. The risk is low when considering a body weight of 60 kg. All a.i. tested in the first scenario of the probabilistic method pointed towards some possibility of intake being higher than the ADI. In the second scenario, only the a.i. procymidone exceeded the ADI.