Orientaciones operativas para la evaluación y designación pública de las autoridades regulatorias como autoridades incluidas en la lista de la OMS

En el presente documento se describe el proceso de evaluación y designación pública de las autoridades regulatorias y los sistemas regulatorios regionales como incluidos en la lista de la OMS, de conformidad con los principios operativos de alto nivel definidos en el documento de política Evaluación y designación pública de las autoridades reguladoras como autoridades catalogadas por la OMS: documento de política. También se proporcionan detalles sobre los pasos, plazos y procesos involucrados en la evaluación y designación de una autoridad incluida en la lista de la OMS. Además, se describen el proceso y los criterios para la renovación, la reevaluación y la posible exclusión de la lista, la función y las responsabilidades del grupo consultivo técnico sobre autoridades incluidas en la lista de la OMS y los compromisos de la OMS y de las autoridades regulatorias que reúnan las condiciones necesarias. A los efectos del presente documento, el término “autoridad regulatoria”, a menos que se indique otra cosa, se refiere tanto a una autoridad regulatoria nacional como a un sistema regulatorio regional. En el anexo 1 se proporciona un glosario con las definiciones de los términos utilizados en el documento. Para obtener más información sobre el proceso de evaluación del desempeño para cada función, sírvase consultar el manual de evaluación del desempeño.

Blood bank quality control: pH assessment methods in platelet concentrates.

Platelet concentrates undergo progressive changes during storage, such as a decrease in pH. Additionally, pH and lactate production showed the strongest correlation with platelet survival in posttransfusion viability studies. pH measurement is a straightforward method for evaluating the quality control of blood components in blood bank practice. Our aim was to compare three pH assessment methods for canine platelet concentrates. The pH values of the canine platelet concentrates were assessed on the first day of storage using a calibrated pH meter, a portable gas analyzer and pH-indicator strips. The results from the pH meter and portable gas analyzer measurements were similar. The pH indicator strips presented higher average values compared to the other more reliable methods evaluated, which could result in the use of inadequate blood components. In conclusion, it is recommended to implement pH measurements using a pH meter for quality control in veterinary blood banks.

Evaluation of the quality of platelet concentrates obtained in a Peruvian hospital / Evaluación de la calidad de concentrados de plaquetas obtenidos en un hospital peruano

INTRODUCTION: Platelet concentrates are blood products obtained from donor's blood, and their conservation must be subject to a strict quality control process to guarantee a safe and high-performance product in treating diseases that require their use. METHODS: We designed a cross-sectional study to determine the total compliance rate in platelet concentrates obtained in the blood bank of the Cayetano Heredia Hospital in Lima during November and December of 2019. The Buffy method Coat obtained the platelet concentrates, and parameters such as platelet count and residual leukocytes, pH, and swirling effect were evaluated according to the National Hemotherapy and Blood Bank Program criteria. RESULTS: The platelet count had a mean of 6.66 ± 3.94 x 10¹°/µL, the platelet concentrates had a mean of 56.30 ± 6.22 mL, and all, without exception, had the presence of the Swirling phenomenon. The pH had a mean of 7.64 ± 0.15, while the leukocyte count had a mean of 4.22 ± 3.51 x 107/µL. Regarding compliance by the parameters evaluated, it was evident that the platelet and leukocyte count had moderate compliance rates of 43.6% and 24.1%, while the pH and swirling effect had rates of 100% in both cases. The total compliance rate was 54.9% (95% confidence interval: 46.0 to 63.5). CONCLUSIONS: The compliance rate of platelet concentrates is moderate, and it is necessary to implement a process of continuous quality improvement in the blood bank.

INTRODUCCIÓN: Los concentrados plaquetarios son hemoderivados obtenidos de la sangre, y su conservación debe estar supeditada a un estricto proceso de control de calidad para garantizar un producto inocuo y de alto rendimiento en el tratamiento de enfermedades que requieran su uso. MÉTODOS: Diseñamos un estudio transversal que tuvo por objetivo determinar la tasa de conformidad total en concentrados plaquetarios obtenidos en el banco de sangre del Hospital Cayetano Heredia de Lima durante los meses de noviembre y diciembre del año 2019. Los concentrados plaquetarios fueron obtenidos por el método de Buffy Coat y se evaluaron parámetros como el recuento de plaquetas y leucocitos residuales, pH y efecto swirling, según criterios del Programa Nacional de Hemoterapia y Bancos de Sangre. RESULTADOS: El recuento de plaquetas tuvo una media de 6.66 ± 3.94 x1010/µL y los concentrados plaquetarios tuvieron una media de 56.30 ± 6.22 mL, y todos sin excepción tuvieron presencia de fenómeno Swirling. El pH tuvo una media de 7.64 ± 0.15, mientras que el recuento de leucocitos tuvo una media de 4.22 ± 3.51 x107/µL. En cuanto al cumplimiento por parámetro evaluado, se evidenció que el recuento de plaquetas y leucocitos tuvieron tasas de conformidad de 43.6% y 24.1%, mientras que el pH y efecto swirling tuvieron tasas del 100% en ambos casos. La tasa de conformidad total fue 54.9% (CI95%: 46.0 a 63.5). CONCLUSIONES: La tasa de conformidad de los concentrados plaquetarios es moderada, y se requiere implementar un proceso de mejora continua de la calidad en el banco de sangre.

Evaluation of the quality of platelet concentrates obtained in a Peruvian hospital.

Introduction: Platelet concentrates are blood products obtained from donor's blood, and their conservation must be subject to a strict quality control process to guarantee a safe and high-performance product in treating diseases that require their use. Methods: We designed a cross-sectional study to determine the total compliance rate in platelet concentrates obtained in the blood bank of the Cayetano Heredia Hospital in Lima during November and December of 2019. The Buffy method Coat obtained the platelet concentrates, and parameters such as platelet count and residual leukocytes, pH, and swirling effect were evaluated according to the National Hemotherapy and Blood Bank Program criteria. Results: The platelet count had a mean of 6.66 ± 3.94 x 10¹°/µL, the platelet concentrates had a mean of 56.30 ± 6.22 mL, and all, without exception, had the presence of the Swirling phenomenon. The pH had a mean of 7.64 ± 0.15, while the leukocyte count had a mean of 4.22 ± 3.51 x 107/µL. Regarding compliance by the parameters evaluated, it was evident that the platelet and leukocyte count had moderate compliance rates of 43.6% and 24.1%, while the pH and swirling effect had rates of 100% in both cases. The total compliance rate was 54.9% (95% confidence interval: 46.0 to 63.5). Conclusions: The compliance rate of platelet concentrates is moderate, and it is necessary to implement a process of continuous quality improvement in the blood bank.

Introducción: Los concentrados plaquetarios son hemoderivados obtenidos de la sangre, y su conservación debe estar supeditada a un estricto proceso de control de calidad para garantizar un producto inocuo y de alto rendimiento en el tratamiento de enfermedades que requieran su uso. Métodos: Diseñamos un estudio transversal que tuvo por objetivo determinar la tasa de conformidad total en concentrados plaquetarios obtenidos en el banco de sangre del Hospital Cayetano Heredia de Lima durante los meses de noviembre y diciembre del año 2019. Los concentrados plaquetarios fueron obtenidos por el método de Buffy Coat y se evaluaron parámetros como el recuento de plaquetas y leucocitos residuales, pH y efecto swirling, según criterios del Programa Nacional de Hemoterapia y Bancos de Sangre. Resultados: El recuento de plaquetas tuvo una media de 6.66 ± 3.94 x1010/µL y los concentrados plaquetarios tuvieron una media de 56.30 ± 6.22 mL, y todos sin excepción tuvieron presencia de fenómeno Swirling. El pH tuvo una media de 7.64 ± 0.15, mientras que el recuento de leucocitos tuvo una media de 4.22 ± 3.51 x107/µL. En cuanto al cumplimiento por parámetro evaluado, se evidenció que el recuento de plaquetas y leucocitos tuvieron tasas de conformidad de 43.6% y 24.1%, mientras que el pH y efecto swirling tuvieron tasas del 100% en ambos casos. La tasa de conformidad total fue 54.9% (CI95%: 46.0 a 63.5). Conclusiones: La tasa de conformidad de los concentrados plaquetarios es moderada, y se requiere implementar un proceso de mejora continua de la calidad en el banco de sangre.

A comprehensive assessment of quality management methods in the SMESH study.

BACKGROUND: This paper aims to instigate discussion and publication of methodologies applied to enhance quality management through comprehensive scientific reports. It provides a detailed description of the design, implementation, and results of the quality control program employed in the SMESH study. METHODS: Cross-sectional, multicenter, national study designed to assess the prevalence of human papillomavirus in sex workers and in men who have sex with men (MSM). Respondent-driven sampling recruitment was used. An online system was developed for the study and checkpoints were defined for data entry. The system checked the quality of biological samples and performed a retest with part of the sample. RESULTS: A total of 1.598 participants (442 sex workers and 1.156 MSM) were included. Fifty-four health professionals were trained for face-to-face data collection. The retest showed Kappa values ranging between 0.3030 and 0.7663. CONCLUSION: The retest data were mostly classified as indicating a strong association. The data generated by the checkpoints showed the successful implementation of the quality control program.

Chemical profiling and quantification of flavones in several Pseudognaphalium and Gnaphalium species of Mexican gordolobo using UHPLC/PDA/MS.

The inflorescences of the Mexican gordolobo are used as a folk medicine to treat various respiratory diseases. Currently, the botanical species that bear the name Mexican gordolobo belong to the genera Gnaphalium and Pseudognaphalium. Despite a long history of traditional use, most Mexican gordolobo species have never been fully chemically characterized, and the range of constituents in the species has not been comprehensively reported. To establish a quality control and chemical characterization method, a total of 49 samples belonging to 18 species of Pseudognaphalium and four species of Gnaphalium were studied. Nine flavones were quantified using a UPLC-PDA method. The method was validated in terms of linearity (R2 > 0.99), precision (intra- and inter-day: 0.1-3.9%), accuracy (96-103%), detection limit (10 ng/mL), limit of quantification (25 ng/mL) and robustness. 3-Methylquercetin, luteolin, quercetin, 3,5-dihydroxy-6,7,8-trimethoxyflavone, apigenin and gnaphaliin A were present at relatively high levels in most of the samples analyzed. The samples of P. oxyphyllum and P. liebmannii showed the highest content of the 9 compounds analyzed. Whereas the samples of the 5 species of Gnaphalium showed the lowest levels, including non-detectable, of the 9 compounds quantified. This marks an important difference with Pseudognaphalium species. Furthermore, using UHPLC-ESI-QToF data with targeted and non-targeted approaches, 57 compounds, were identified in Mexican gordolobo samples. Flavonoids were the main group of compounds found in Mexican gordolobo.

[Oncology in French Guiana: A challenge to win]. / La cancérologie en Guyane : un défi à gagner.

French Guiana is an equatorial, multicultural, overseas territory in South America. The region is unique: a wealthy country with a universal healthcare system, but significant poverty, which bears little resemblance to its neighbors Brazil and Suriname. Cancer is the second leading cause of death. The incidence of cancer is lower than in France, stages are generally more advanced and the prognosis worse. To date, oncology has been organized through a joint venture between local institutions and healthcare professionals and a cancer center in mainland France, in line with the recommendations of the Institut National du Cancer. The implementation of a medical project and a complete medical studies curriculum in French Guiana is a tremendous opportunity for the development of oncology. The main challenges are consolidating medical care for patients, quality control, genetic oncology, molecular biology, implementation of radiotherapy and nuclear medicine, clinical and translational research, and teaching programs. Working in oncology in French Guiana is exciting because of the scientific interest (particular characteristics of cancers, notably the role of viral or micro-organism-induced carcinogenesis, genetic factors in these populations with African and Asian roots, and the importance of a public health policy) and human interest (patients from different cultures; all of them bring original approaches to health and illness that need to be deciphered in order to offer quality care). This requires the support of healthcare professionals who are enthusiastic about this unique adventure.

Assessing and Achieving Quality in Qualitative Research: Clues for Researchers in Training* / Valorar y lograr la calidad de la investigación cualitativa: claves para investigadores en formación / Avaliar e alcançar a qualidade da pesquisa qualitativa: chaves para pesquisadores em formação

This article deals with the particularities of the quality of qualitative research, under the double lens of valuing it and ensuring it. While achieving the quality of qualitative research concerns only those who have opted for this methodology, assessing it is everyone's business because researchers in training will encounter, in the literature reviews, qualitative studies on which they must reflect and estimate their quality. Appreciating the quality of a research work is a complex activity as it is situated within a context and conducted by individuals who use any of the means available to do so. The means they use are criteria as evaluation guides and criteria checklists. For researchers in training, I suggest some guiding criteria to evaluate qualitative publications and ensure quality during the research process, key issues that they must address.

Este artículo trata sobre las particularidades de la calidad de la investigación cualitativa, bajo la doble lente de valorarla y asegurarla. Mientras que alcanzar la calidad de una investigación cualitativa atañe solo a los que han optado por esta metodología, valorarla es asunto de todos, ya que los investigadores en formación se encontrarán en las revisiones bibliográficas con estudios cualitativos sobre los cuales deberán reflexionar y estimar su calidad. Apreciar la calidad de un trabajo de investigación es una actividad compleja ya que está situada en un contexto y llevada a cabo por personas que usan alguno de los medios disponibles para hacerlo. Los medios que usan son los criterios como guías de evaluación y los listados de verificación de criterios. Para los investigadores en formación sugiero unos criterios guía para la valoración de publicaciones cualitativas y para asegurar la calidad durante el proceso de investigación, unas cuestiones claves a las que deben atender.

Este artigo trata das particularidades da qualidade da pesquisa qualitativa, sob a dupla lente de valorizá-la e garanti-la. Embora alcançar a qualidade da pesquisa qualitativa seja do interesse de quem optou por esta metodologia, Avaliar é tarefa de todos, pois os pesquisadores em formação se encontrarão em revisões bibliográficas com estudos qualitativos, sobre os quais deverão refletir e estimar sua qualidade. Avaliar a qualidade de um trabalho de investigação é uma atividade complexa, pois está situada num context e é realizada por pessoas que utilizam qualquer um dos meios disponíveis para o fazer. Os meios que utilizam são critérios como guias de avaliação e listas de verificação de critérios. Aos pesquisadores em formação, sugiro alguns critérios norteadores para avaliar publicações qualitativas e para garantir a qualidade durante o processo de pesquisa, questões chaves que devem ser abordadas.

Biological parameters for quality evaluation of allografts from the Brazilian National Institute of Traumatology and Orthopedics tissue bank.

Bone allografts are clinically used in a variety of surgical procedures, and tissue banks are responsible for harvesting, processing, quality testing, storing, and delivering these materials for transplantation. In tissue banks, the bone is processed for the removal of all organic content, remaining only the tissue structure (scaffold). However, several studies have shown that even after using different processing methods, viable cells, functional proteins, and DNA may still persist in the tissue, which constitute the main causes of graft rejection. Therefore, the objective of this study was to establish techniques and biological parameters for quality validation of allografts. To this end, we propose the use of 3 combined methods such as microscopy, histology, and molecular biology techniques to evaluate the quality of allografts harvested and processed by the Brazilian National Institute of Traumatology and Orthopedics (INTO) tissue bank according to the donation criteria of the Brazilian National Health Surveillance Agency and the Brazilian National Transplant System. Bone fragments from different processing stages showed no viable cells on histology, an intact extracellular matrix on scanning electron microscopy, and gradual reduction in DNA amount. Different techniques were used to demonstrate the quality of allografts produced by the INTO tissue bank and to establish biological parameters for ensuring the safety and quality of these products. Future studies need to be undertaken to assess and validate the efficacy of the decellularization process in larger bone grafts with diverse architectural configurations.

RawVegetable 2.0: Refining XL-MS Data Acquisition through Enhanced Quality Control.

We present RawVegetable 2.0, a software tailored for assessing mass spectrometry data quality and fine-tuned for cross-linking mass spectrometry (XL-MS) applications. Building upon the capabilities of its predecessor, RawVegetable 2.0 introduces four main modules, each providing distinct and new functionalities: 1) Pair Finder, which identifies ion doublets characteristic of cleavable cross-linking experiments; 2) Diagnostic Peak Finder, which locates potential reporter ions associated with a specific cross-linker; 3) Precursor Signal Ratio, which computes the ratio between precursor intensity and the total signal in an MS/MS scan; and 4) Xrea, which evaluates spectral quality by analyzing the heterogeneity of peak intensities within a spectrum. These modules collectively streamline the process of optimizing mass spectrometry data acquisition for both Proteomics and XL-MS experiments. RawVegetable 2.0, along with a comprehensive tutorial is freely accessible for academic use at: http://patternlabforproteomics.org/rawvegetable2.

On the need of in vivo verifications as quality control for intraoperative electron radiotherapy in breast cancer.

INTRODUCTION: Intraoperative electron radiotherapy (IOERT) is a technique aiming to deliver radiotherapy during oncological surgery. In breast IOERT, the applicator and shielding disc placement are correlated with organs at risk (OAR) irradiation, in vivo verification of these parameters is scarcely reported. The aim of our study is to report and analyze possible causes of the misalignment using radiochromic films and compare our results to others reported in the bibliography. METHODS: From November 2019 to April 2023, in vivo verifications were performed for 33 patients. IOERT was performed using a LIAC 10 MeV (Sordina, Italy) electron accelerator. We attached a radiochromic film to the upper side of the polytetrafluoroethylene cover of the shielding disc. The percentage of the irradiation area outside the disc was recorded and various parameters (applicator angulations, prescription depth, tumor location and breast size) were analyzed to find possible correlations. RESULTS: For 29 patients, 20 Gy were prescribed while 10 Gy were prescribed to 4 patients. The average irradiated area outside the disc was 19% (0-56%) corresponding to a surface of 4.5 cm2 (0-17.4 cm2). The applicator of 5 cm was used for most of the patients. The mean prescription depth was 1.4 cm (0.5-2.5 cm). We found no correlation between the analyzed parameters and misalignment. CONCLUSION: This study confirms the presence and magnitude of the misalignments. We strongly recommend in vivo verifications as a quality check during IOERT procedures. The misalignment has no correlation with tumor localization parameters, so the solution could be based on technical improvements of the applicator.

Importancia de la vigilancia poscomercialización en las vacunas contra SARS-CoV-2 / Importance of post-marketing surveillance of SARS-CoV-2 vaccines

Introducción: La vacunación ha sido una de las intervenciones sanitarias más costo-efectivas, por su impacto en el control de las enfermedades inmunoprevenibles. La pandemia ocasionada por SARS-CoV-2 condujo al desarrollo mundial de más de doscientas vacunas en diferentes fases de investigación con diversas plataformas. Objetivo: Caracterizar la evaluación del control de calidad de las vacunas contra SARS-CoV-2 y los eventos adversos de las aprobadas contra otros agentes patógenos en las diferentes etapas del ensayo preclínico y clínico. Métodos: Se realizó una búsqueda en Google Académico y PubMed/Medline de artículos publicados entre 1969 y marzo de 2021. Se seleccionaron los de mayor relevancia. Desarrollo: Las vacunas se desarrollaron en un corto tiempo ante la pandemia de COVID-19, sin comprometer el adecuado control de los ensayos clínicos. Aunque resultan seguras, no están exentas de eventos adversos; por ello se debe vigilar su seguridad durante el proceso de poscomercialización. Muchas de ellas han comprometido su seguridad. Conclusiones: Las vacunas deben poseer inmunogenicidad, eficacia y seguridad comprobadas. Los eventos adversos pueden surgir en cualquier etapa de la investigación; por tanto, resulta fundamental la vigilancia en la fase de poscomercialización(AU)

Introduction: Vaccination has been one of the most cost-effective health interventions, due to its impact on the control of immunopreventable diseases. The pandemic caused by SARS-CoV-2 led to the worldwide development of more than two hundred vaccines in different phases of research with diverse platforms. Objective: To characterize the quality control assessment of vaccines against SARS-CoV-2 and adverse events of those approved against other pathogens at different stages of preclinical and clinical trials. Methods: We searched Google Scholar and PubMed/Medline for articles published between 1969 and March 2021. The most relevant articles were selected. Development: Vaccines were developed in a short time in the face of the COVID-19 pandemic, without compromising the adequate control of clinical trials. Although they are safe, they are not free of adverse events; therefore, their safety should be monitored during the post-marketing process. Many of them have compromised their safety. Conclusions: Vaccines should possess proven immunogenicity, efficacy and safety. Adverse events can arise at any stage of research; therefore, post-marketing surveillance is essential(AU)

Panorama do controle de qualidade em laboratórios clínicos e a experiência do Instituto Adolfo Lutz / Overview of quality control in clinical laboratories and the Adolfo Lutz Institute experience

No cenário dos laboratórios clínicos é de suma importância controlar e melhorar continuamente a qualidade dos serviços para obtenção de resultados confiáveis. Para alcançar essa condição, é imprescindível acompanhar os avanços tecnológicos. Uma das causas fundamentais tem sido a introdução e o monitoramento de indicadores de qualidade, tais como as especificações de desempenho analítico, principalmente a precisão e a exatidão. São componentes-chave desse processo a utilização do controle de qualidade interno (CQI) e a participação em programas de avaliação externa da qualidade (AEQ). Este relato de experiência se propõe a apresentar algumas tendências passadas e presentes da utilização do controle de qualidade nos processos de monitoramento da fase analítica em laboratórios clínicos. Destina-se também a compartilhar a experiência do Instituto Adolfo Lutz (IAL) no desenvolvimento e na implementação de programas de controle de qualidade em ensaios sorológicos, contextualizando seu propósito e benefício dos resultados. A qualidade em laboratórios clínicos torna-se cada vez mais relevante à medida que as evidências científicas destacam o seu papel importante no processo de tomada de decisão clínica e no monitoramento de pacientes. No desempenho de suas atividades, o Centro de Imunologia do IAL tem contribuído para a melhoria da qualidade dos resultados oferecidos à população pelos laboratórios da sub-rede do estado de São Paulo.

In the clinical laboratories setting, it is extremely important to continuously control and improve the quality of services to obtain reliable results. To achieve this condition, it is essential to keep up with technological advances. One of the fundamental causes has been the introduction and monitoring of quality indicators such as the analytical performance specifications in particular accuracy and precision. The key components of this process are the use of internal quality control (IQC) and participation in external quality assessment programs (EQA). This experience report intends to present some past and present trends in the use of quality control for monitoring analytical phase in clinical laboratories. It is also intended to share the experience of the Adolfo Lutz Institute (IAL) in the development and implementation of quality control programs in serological assays, which contextualizes their purpose and benefit of the results. The quality in clinical laboratories has become increasingly relevant as scientific evidence highlights the important role it plays in the clinical decision-making and patient monitoring process. In carrying out its activities, the Center of Immunology at IAL has contributed for improving the quality of results offered to the population by laboratories of the sub-network of São Paulo State.

Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application

Abstract A simple, rapid, precise, accurate and sustainable spectrofluorimetric method (SFM) was developed, validated and applied for the determination of 4-aminobenzoic acid and aromatic amino acids (phenylalanine, tryptophan and tyrosine). These compounds are used in biopharmaceutical formulations and therefore must be analyzed by quality control laboratories to meet the criteria established in pharmacopoeias. In general, potentiometric titration (PT) is described in the compendia as the official analytical technique. However, this method showed low sensitivity and selectivity, and moreover was performed with a non-aqueous solvent (acetic acid), which led to higher consumption of reagents and consequently to the formation of residues. Therefore, the SFM was developed in aqueous medium at pH 7.2 using phosphate buffer. It was successfully validated according to the ICH guidelines and showed good linearity range (r>0.999), specificity, accuracy and precision (within and between days) and robustness. The test results were compared between the SFM and PT using raw material samples, while according to the F- and t-tests at 95% confidence level, no statistical difference was found between the methods

Development of blood transfusion external quality assessment program at national scale / Desarrollo de un programa de evaluación externa de calidad de la transfusión sanguínea a nivel nacional

Introduction: External quality assessment is a crucial component in ensuring the quality of blood transfusion testing laboratories. Objectives: To develop a procedure for generating external quality assessment items for blood transfusion testing to evaluate participants' performance. Methods: Experimental research was conducted at Quality Control Center for Medical laboratory- University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam. Three items, including red blood cell, serum, and atypical antibody serum samples, were assessed for homogeneity and stability; 5 assessment areas, including ABO grouping, Rh grouping, compatible cross matches, Coombs test, and screening of atypical antibodies, were utilized to evaluate the performance of 38 participants in the 2020-2021 period. Results: Red blood cell and serum samples maintained quality for a specific period at controlled temperatures, while serum samples with atypical antibodies showed stability at different temperatures. The participants demonstrated high satisfactory performance in ABO grouping, Rh grouping, Coombs test, and screening for atypical antibodies. However, the most unsatisfactory performance was reported in crossmatching, with 15 percent of participants unsatisfactory results. Conclusion: The procedure of production of proficiency testing items has been successfully developed, and its application at the national level is suggested to improve the quality of blood transfusion laboratories(AU)

Introducción: La evaluación externa de calidad es esencial para asegurar la calidad de los laboratorios de pruebas de transfusión sanguínea. Objetivos: Desarrollar un procedimiento para generar elementos de evaluación externa de calidad y evaluar el rendimiento de los participantes en pruebas de transfusión sanguínea. Métodos: Estudio experimental realizado en el Centro de Control de Calidad para Laboratorios Médicos de la Universidad de Medicina y Farmacia en la Ciudad de Ho Chi Minh, Vietnam. Se evaluaron muestras de glóbulos rojos, suero y suero con anticuerpos atípicos para homogeneidad y estabilidad. Se utilizaron 5 áreas de evaluación, incluida la agrupación ABO, la agrupación Rh, las coincidencias cruzadas compatibles, la prueba de Coombs y la detección de anticuerpos atípicos, para evaluar el desempeño de 38 participantes, en el período 2020-2021. Resultados: Las muestras de glóbulos rojos y suero mantuvieron la calidad durante un período específico a temperaturas controladas, mientras que las muestras de suero con anticuerpos atípicos mostraron estabilidad a diferentes temperaturas. Los participantes obtuvieron un alto rendimiento en algunas áreas, como la agrupación ABO y Rh, la prueba de Coombs y la detección de anticuerpos atípicos. Sin embargo, las pruebas de compatibilidad reportaron un rendimiento insatisfactorio en un 15 por cientode los participantes. Conclusión: El procedimiento desarrollado cumple con los criterios de calidad, y se sugiere su aplicación a nivel nacional para mejorar la calidad de los laboratorios de transfusión sanguínea(AU)

Avaliação da qualidade dos registros do processo de enfermagem por meio de auditoria retrospectiva / Quality assessment of nursing process records through retrospective audit / Evaluación de la calidad de los registros del proceso de enfermería a través de auditoría retrospectiva

Objetivo: analisar a qualidade dos registros do processo de enfermagem e compará-la segundo as unidades de internação. Método: estudo transversal, retrospectivo que analisou 258 prontuários, entre os meses de março e julho de 2022, de pacientes internados no ano de 2019, em um hospital de grande porte da região Centro-Oeste. Para mensurar a qualidade dos registros, utilizou-se o instrumento Quality of Diagnoses, Interventions and Outcomes, validado para o Brasil. Pesquisa aprovada pelo Comitê de Ética. Resultados: considerando as dimensões dos diagnósticos de enfermagem como processo e como produto, os escores médios gerais de 4,5(±2,6) e 7,1(±4,1), respectivamente. Quanto às dimensões intervenções e resultados de enfermagem, médias de 3,0(±2,1) e 4,7(±4,8). Observaram-se variações das médias de escores entre as unidades analisadas, com diferença significativa (p<0,001). Conclusão: os resultados demonstraram baixos escores de qualidade dos registros do processo de enfermagem, e a média de escores divergiu entre as unidades de internação analisadas(AU)

Objective: To analyze the quality of nursing process records and compare them according to hospitalization units. Method: a cross-sectional, retrospective study that analyzed 258 medical records, between the months of March and July 2022, of patients admitted in 2019, in a large hospital in the Midwest region. The Quality of Diagnoses, Interventions and Outcomes instrument, validated for Brazil, was used to measure the quality of the records. The study was approved by the Ethics Committee. Results: considering the dimensions of nursing diagnoses as a process and as a product, the overall mean scores were 4.5(±2.6) and 7.1(±4.1), respectively. As for the dimensions of nursing interventions and outcomes, the mean scores were 3.0(±2.1) and 4.7(±4.8). There were variations in the mean scores between the units analyzed, with a significant difference (p<0.001). Conclusion: The results showed low quality scores for nursing process records, and the mean scores differed between the inpatient units analyzed(AU)

Objetivo: analizar la calidad de los registros del proceso de enfermería y compararla según las unidades de hospitalización. Método: estudio transversal, retrospectivo, que analizó 258 historias clínicas, entre marzo y julio de 2022, de pacientes internados en 2019 en un gran hospital de la región Centro-Oeste. Para medir la calidad de los registros, se utilizó el instrumento Quality of Diagnoses, Interventions and Outcomes (Calidad de Diagnósticos, Intervenciones y Resultados), validado para Brasil. El Comité de Ética aprobó la investigación. Resultados: considerando las dimensiones de los diagnósticos de enfermería como proceso y como producto, las puntuaciones medias globales fueron 4,5(±2,6) y 7,1(±4,1), respectivamente. En cuanto a las dimensiones de las intervenciones de enfermería y los resultados, los promedios fueron de 3,0(±2,1) y 4,7(±4,8). Hubo variaciones en los promedios de las puntuaciones entre las unidades analizadas, con una diferencia significativa (p<0,001). Conclusión: Los resultados mostraron bajas puntuaciones de calidad en los registros de procesos de enfermería, y los promedios de las puntuaciones difirieron entre las unidades de hospitalización analizadas(AU)

Procedimiento para desarrollar la función calidad en laboratorios clínicos docentes en la Universidad Médica de Camagüey / Procedure to Develop the Quality Function in Teaching Clinical Laboratories at The Medical University of Camagüey

Introducción: Garantizar la obtención de resultados analíticos de calidad en el trabajo de los laboratorios clínicos resulta de vital importancia, de ahí se infiere la necesidad de formar profesionales competentes que dominen y pongan en práctica la normativa nacional e internacional vigente relacionada con la calidad, el papel de la función calidad es hacer que ésta sea un aspecto inseparable del desempeño y la responsabilidad de cada empleado. Objetivo: Establecer el procedimiento para el desarrollo de la gestión de la función calidad en los laboratorios clínicos docentes. Métodos: Se realizó una investigación en sistemas y servicios de salud, en la cual se aplicaron técnicas y herramientas propias de la ciencia aplicada de la calidad. Resultados: Diseño de un procedimiento, con su representación en forma de diagrama de flujo con la explicación de los pasos incluidos en él, posteriormente se describe el procedimiento para garantizar su adecuación y aplicabilidad en cualquier institución que así lo considere pertinente. Conclusiones: El procedimiento diseñado para el desarrollo de la función calidad establece la secuencia lógica de pasos a seguir para lograr su implementación(AU)

Introduction: Guaranteeing procurement of quality analytical results in the work of clinical laboratories is of vital importance, hence the need to train competent professionals who master and put into practice the current national and international regulations related to quality. The role of the quality function is to make this an inseparable aspect of the performance and responsibility of each employee. Objective: To establish the procedure for the development of quality function management in teaching clinical laboratories. Methods: Research was carried out on health systems and services, in which techniques and tools from applied quality science were applied. Results: Design of a procedure was achieved with representation in the form of a flow chart with the explanation of the steps included in it. Then the procedure is described to guarantee adequacy and applicability in any institution that considers it relevant. Conclusions: The procedure designed for the development of the quality function establishes the logical sequence of steps to follow to achieve its implementation(AU)

External quality control program in infectious diseases screening at laboratories and blood banks in Latin America: an analysis of the past 5 years / Programa de control externo de la calidad en el tamizaje de enfermedades infecciosas en laboratorios y bancos de sangre de América Latina: análisis de los últimos 5 años / Programa externo de controle de qualidade na triagem de doenças infecciosas em laboratórios e bancos de sangue da América Latina: análise dos últimos 5 anos

[ABSTRACT]. Objective. To evaluate the screening of blood samples for infectious disease markers at laboratories and blood banks in Latin America per the findings of an External Quality Assessment Program (EQAP). Methods. This qualitative analysis used data from the EQAP coordinated by the Fundação Pro Sangue Hemocentro de São Paulo with the support of the Pan American Health Organization to assess the performance of blood screening for infectious diseases from 2014 to 2018 in Latin America. Each participating laboratory or blood bank received an identical blind panel with 24 blood samples with variable reactivity for all the screening parameters. Panels were processed at each participating facility and results were returned to the Fundação Pro Sangue Hemocentro de São Paulo for individual and joint analyses. Two types of discrepant results were potential failures: false positive results (FPRs) and false nonreactive results (FNRRs). Results. A total of 23 136 samples were evaluated. Global rates of FPR, FNRR, and concordant results were 0.3%, 1.0% and 98.7%, respectively. Seven FNRRs were found for HBsAg (1.0%), 12 for syphilis (2.6%), and 21 for Chagas disease (2.9%). No FNRRs were found for the HIV, HCV, and HTLV viruses. The average accuracy of all the laboratories and blood banks participating in the EQAP during the study period was 99.5% (standard deviation, 0.5%). Conclusion. The findings of this qualitative analysis are positive for blood safety in Latin America, with an average accuracy of 99.5% among the participating laboratories and blood banks. This report reflects an important improvement in blood bank serological screening EQAP-PAHO report since the 2003.

[RESUMEN]. Objetivo. Evaluar el tamizaje de muestras de sangre en las que se analizan marcadores de enfermedades infecciosas en laboratorios y bancos de sangre de América Latina según los resultados de un programa de evaluación externa de la calidad (EQAP, por su sigla en inglés). Métodos. Este análisis cualitativo utilizó datos del EQAP —coordinado por la Fundação Pro Sangue Hemocentro de São Paulo con el apoyo de la Organización Panamericana de la Salud— para evaluar la eficacia del tamizaje sanguíneo para la detección de enfermedades infecciosas que se realizó entre el 2014 y el 2018 en América Latina. Cada laboratorio o banco de sangre participante recibió un panel idéntico para análisis a ciegas compuesto por 24 muestras de sangre con reactividad variable para todos los parámetros del tamizaje. Los paneles se procesaron en cada establecimiento participante y los resultados se enviaron a la Fundação Pro Sangue Hemocentro de São Paulo donde se realizaron análisis individuales y conjuntos. Había dos tipos de resultados discrepantes que eran posibles fallas del tamizaje: los positivos falsos (PF) y los negativos falsos (NF). Resultados. En total se evaluaron 23 136 muestras. Las tasas generales de PF, NF y resultados concordantes fueron, respectivamente, del 0,3%, 1,0% y 98,7%. Se obtuvieron siete NF en casos de HBsAg (1,0%), 12 en casos de sífilis (2,6%) y 21 en casos de enfermedad de Chagas (2,9%). No se obtuvieron NF en casos de infección por virus del VIH, el VHC o el VLTH. La precisión promedio de todos los laboratorios y bancos de sangre participantes en el EQAP durante el periodo de estudio fue del 99,5% (desviación típica: 0,5%). Conclusión. Los resultados de este análisis cualitativo son positivos en lo referente a la seguridad sanguínea en América Latina, con una precisión promedio del 99,5% entre los laboratorios y bancos de sangre participantes. Este informe refleja la considerable mejora del tamizaje serológico que se realiza en los bancos de sangre, en comparación con los resultados del informe del EQAP que contó con el apoyo de la OPS y se publicó en el 2003.

[RESUMO]. Objetivo. Avaliar a triagem de marcadores de doenças infecciosas em amostras de sangue realizada em laboratórios e bancos de sangue da América Latina de acordo com os resultados de um Programa Externo de Avaliação de Qualidade (EQAP, na sigla em inglês). Métodos. Esta análise qualitativa usou dados do EQAP coordenado pela Fundação Pró-Sangue Hemocentro de São Paulo, com o apoio da Organização Pan-Americana da Saúde, para avaliar o desempenho da triagem de sangue quanto a doenças infecciosas no período de 2014 a 2018 na América Latina. Cada laboratório ou banco de sangue participante recebeu um painel cego idêntico com 24 amostras de sangue de reatividade variável para todos os parâmetros de triagem. Os painéis foram processados em cada estabelecimento participante e os resultados foram devolvidos à Fundação Pró-Sangue Hemocentro de São Paulo para análises individuais e conjuntas. Dois tipos de resultados discrepantes representavam falhas em potencial: resultados falso-positivos e resultados falso-negativos (não reativos). Resultados. Foram avaliadas 23.136 amostras. As taxas globais de resultados falso-positivos, falso-negativos e concordantes foram de 0,3%, 1,0% e 98,7%, respectivamente. Foram encontrados sete resultados falso-negativos para HBsAg (1,0%), 12 para sífilis (2,6%) e 21 para doença de Chagas (2,9%). Não houve resultados falso-negativos para os vírus HIV, HCV e HTLV. A acurácia média de todos os laboratórios e bancos de sangue que participaram do EQAP durante o período do estudo foi de 99,5% (desvio padrão de 0,5%). Conclusões. Os resultados desta análise qualitativa são positivos para a segurança do sangue na América Latina, com uma acurácia média de 99,5% entre os laboratórios e bancos de sangue participantes. Este rela- tório reflete uma melhoria importante na triagem sorológica dos bancos de sangue em relação aos resultados do relatório do EQAP apoiado pela OPAS que foi publicado em 2003.

Performance evaluation of the sterilization process with Bowie & Dick test and biological indicator in the quality control of a blood bank in Peru.

Managing contaminated waste in blood banks is a crucial process that must end with the safe disposal of blood products. In this sense, practical methods and indicators must be used to guarantee the operability of autoclave equipment and the sterility of treated waste to mitigate the risk of biological exposure and hospital biosafety. We designed a cross-sectional study to evaluate the performance the autoclaving process with Bowie & Dick test and biological indicator at the Hemotherapy and Blood Bank Unit of the Cayetano Heredia Hospital in Peru. Fifty autoclaving processes were carried out independently for the Bowie & Dick tests and biological indicators based on Geobacillus stearothermophilus spores. Autoclaving was programmed at 134°C for 3.5 minutes for the Bowie & Dick test, while, for the biological indicator, it was programmed at 121°C for 5 minutes. Both in the presence of contaminated waste. The autoclaving process evaluated by the Bowie & Dick test had a compliance rate of 80% (CI95: 66.3%-90.0%), while, by the biological indicator, 90% (CI95: 78.2%-96.7%). We did not find significant differences between the results of both tests (P = .689; Fisher exact test). The compliance rate in the autoclaving process within the blood bank of a Peruvian Hospital is acceptable; however, there are actions for continuous improvement, especially at the vacuum level in the autoclaving process.