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1.
Rev. cientif. cienc. med ; 25(1): 21-27, sept. 2022.
Article in Spanish | LILACS | ID: biblio-1399796

ABSTRACT

INTRODUCCIÓN: la pandemia por la COVID-19 provocó desafíos abrumadores en la prestación de servicios de atención médica a nivel mundial de diversas maneras. Por lo que la calidad de la atención durante la pandemia podría haberse visto afectada. OBJETIVO: determinar la satisfacción del usuario externo sobre la calidad de atención en el Hospital de Pampas (Huancavelica, Perú) en el contexto de pandemia durante enero a marzo de 2021. MATERIALES Y MÉTODOS: estudio de diseño del tipo pretest-postest de un solo grupo. La muestra estudiada fue de 114 usuarios del Hospital de Pampas en el contexto de pandemia por COVID-19. Para valorar la satisfacción se utilizó el cuestionario SERVQUAL, conformado por 22 preguntas de expectativas, entregadas al usuario minutos antes de su ingreso a consulta y 22 preguntas de percepciones, evaluadas luego de que el paciente fuera atendido. RESULTADOS: el mayor número de pacientes fue del género femenino (66,67%), el rango etario que predominó fue de 30 a 59 años (53,51%), la mayoría (92,98%) cuenta con Seguro Integral de Salud y el tipo de usuario más frecuente son continuadores (76,32%). Se obtuvo una satisfacción global de 56,20% que dependen básicamente de las dimensiones de la calidad: seguridad (60,75%), empatía (61,58%) y aspectos tangibles (63,38%). CONCLUSIÓN: el porcentaje de satisfacción de la calidad del usuario externo fue de 56,20%. Se debe seguir mejorando en las dimensiones con buena satisfacción e implementar estrategias para los niveles de insatisfacción.


INTRODUCTION: the COVID-19 pandemic has brought daunting challenges to the delivery of healthcare services globally in a variety of ways. So, the quality of care during the pandemic could have been affected. OBJECTIVE: to determine the satisfaction of the external user regarding the quality of care at the Pampas Hospital (Huancavelica, Peru) in the context of a pandemic from January to March 2021. MATERIALS AND METHODS: single group pretest-posttest design study. The sample studied was 114 users of the Pampas Hospital in the context of the COVID-19 pandemic. To assess satisfaction, the SERVQUAL questionnaire was used, made up of 22 questions on expectations, given to the user minutes before entering the consultation and 22 questions on perceptions, evaluated after the patient was seen. RESULTS: the largest number of patients was female (66.67%), the predominant age range was 30 to 59 years (53.51%), most (92.98%) have Comprehensive Health Insurance. and the most frequent type of user are continuers (76.32%). An overall satisfaction of 56.20% was obtained, which basically depends on the dimensions of quality: security (60.75%), empathy (61.58%) and tangible aspects (63.38%). CONCLUSION: the percentage of satisfaction with the quality of the external user was 56.20%. You must continue to improve in the dimensions with good satisfaction and implement strategies for the levels of dissatisfaction.


Subject(s)
Male , Female , Adult , Middle Aged , COVID-19 , Quality of Health Care , Medical Care , Pandemics
2.
Vigil. sanit. debate ; 10(3): 106-121, agosto 2022.
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1393493

ABSTRACT

Introdução: Acidentes com animais peçonhentos são classificados como doenças tropicais negligenciadas e são atualmente a mais frequente causa de intoxicação em humanos no Brasil. O único tratamento disponível é a rápida administração de antivenenos específicos e de qualidade garantida. Para assegurar a eficácia e a segurança desses produtos, são realizados ensaios de determinação da potência in vivo para veneno e antiveneno, desde as etapas de produção até sua liberação final. Apesar dos diversos estudos sobre métodos   alternativos ao ensaio murino, nenhum método foi efetivamente validado. Objetivo: Compilar os métodos alternativos desenvolvidos para os antivenenos botrópicos, avaliando sua disponibilidade, perspectivas e aplicações em laboratórios de produção e controle da qualidade. Método: Foi realizada uma busca nas bases PubMed, BVS e Scopus entre novembro de 2021 e junho de 2022. Foram identificados 89 trabalhos, dos quais 31 foram selecionados de acordo com os critérios de elegibilidade. Resultados: Nos métodos alternativos identificados, observamos a preferência de 42,80% dos estudos por metodologias que utilizem linhagens celulares como método alternativo aos ensaios murinos, sendo que a maioria destes trabalhos 58,30% optou pela linhagem celular Vero. Conclusões: Pela diversidade das toxinas encontradas em cada gênero de serpentes, entende-se que é de extrema importância que o ensaio de potência dos antivenenos tenha como base a avaliação e a quantificação precisa da inibição da atividade biológica dos venenos. Ensaios de citotoxicidade são amplamente utilizados e têm acumulado evidências de sua adequação como importante ferramenta alternativa ao ensaio murino para o controle da qualidade de veneno e antiveneno antibotrópico.


Introduction: Accidents with venomous animals are classified as neglected tropical diseases and are currently the most frequent cause of intoxication in humans in Brazil. The only available treatment is the rapid administration of specific, quality-assured antivenoms. To ensure the efficacy and safety of these products, in vivo potency determination tests for venom and antivenom are performed during the production stages, until final release. Despite several studies on alternative methods to the murine assay, no method has been effectively validated. Objective: To compile alternative methods developed for Bothrops antivenoms, assessing the availability of the methods and the prospects and applications in Bothrops venom and antivenom production and quality control laboratories. Method: A search was conducted in PubMed, BVS, and Scopus databases between November 2021 and June 2022. 89 articles were identified, of which 31 were selected according to the eligibility criteria. Results: We observed in the alternative methods identified a preference of 42.80% of the studies for methodologies that use cell lines as an alternative method to the murine assays, and most of these works (58.30%) opted for a VERO cell line. Conclusions: Due to the diversity of toxins found in each genus of snakes, it is understood that the potency assay for antivenoms should be based on the evaluation and precise quantification of the inhibition of biological activity of venoms. Cytotoxicity assays are widely used and have been accumulating evidence of their suitability as an important alternative tool to the murine assay for quality control for Bothrops venom and antivenom.

3.
Vigil. sanit. debate ; 10(2): 93-102, maio 2022.
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1371254

ABSTRACT

Introdução: Os desvios da qualidade de medicamentos (DQM) apresentam grande relevância no âmbito da farmacovigilância, devendo ser  investigados e monitorados, uma vez que podem levar a uma grande variedade de desfechos clínicos. Objetivo: Discutir sobre a caracterização dos DQM no âmbito da farmacovigilância por meio de uma revisão narrativa da literatura. Método: Foi realizada uma busca abrangente em bases de dados utilizando-se os descritores: "farmacovigilância", "queixas técnicas (QT)", "DQM" e "sistemas de notificação", incluindo estudos relacionados diretamente ao tema proposto, realizados no Brasil e publicados no período de 2005 a 2020. Resultados: Os DQM podem estar relacionados a alterações no próprio medicamento, ao conteúdo e integridade da embalagem e à rotulagem. Dos 18 estudos selecionados (14 artigos, dois capítulos de livro e duas dissertações) contendo notificações de DQM na forma de QT de medicamentos, dois avaliaram exclusivamente notificações de QT de medicamentos (100,0%), enquanto o restante apontou que estas representavam de 0,6% a 70,0% do total de notificações realizadas em estabelecimentos de saúde do país. Os principais DQM evidenciados foram alterações no aspecto do produto, ausência/redução na quantidade do medicamento e problemas nas embalagens. Conclusões: Considera-se que as notificações envolvendo DQM representem um excelente indicador de qualidade dos medicamentos disponíveis no mercado, vindo a contribuir na qualificação de fornecedores e distribuição de produtos conformes à população.


Introduction: Substandard drugs (SD) present great relevance in the area of pharmacovigilance and should be investigated and monitored as they can lead to several clinical outcomes. Objective: To discuss the characteristics of SD in the area of  pharmacovigilance through a narrative review. Method: A comprehensive search was performed on databases using the descriptors "pharmacovigilance", "technical complaints (TC)", "SD" and "notification systems" including studies directly concerning the subject conducted in Brazil and published between 2005 and 2020. Results: SD issues might be associated with drug product alterations, content and integrity of the package and labeling. Among the 18 selected studies (14 articles, two book chapters and two dissertations) regarding SD notifications reported as drug TC, two exclusively evaluated drug  TC notifications (100.0%), while the rest showed that this type of notification represented 0.6% to 70.0% of the total of notifications made in national health establishments. The main SD issues found were:  alterations on the product aspect; absence/reduction in the amount of drug product; and, package problems. Conclusions: Notifications involving SD issues are considered an excellent quality indicator for the drugs available in the market, which contributes to suppliers' qualification and provision of consistent products for the population.

4.
Int. j. high dilution res ; 21(1): 5-5, May 6, 2022.
Article in English | LILACS, HomeoIndex | ID: biblio-1396594

ABSTRACT

Quality control of ahomeopathic mother tincture begins with the analysis of the raw material. Once the product is obtained, some organoleptic characteristics and Physicochemical properties such as appearance, colour, odour, density, dry residue, alcohol content,and chemicalmarker are evaluated. In Brazil, mother tinctures from different suppliers may have high variability in terms of the specifications described in the homeopathic pharmacopoeia. Objective: The aim of the present study was to compare mother tinctures' quality control from different pharmaceutical suppliers based on Brazilian Homeopathic Pharmacopoeia 3rd edition. Methods: Five mother tinctures were selected according to the high number of requests in the pharmacies, also its monographs are in the Brazilian Homeopathic Pharmacopoeia (FHB) 3rd edition. The report of analysis of the product was provided by three homeopathic pharmacies from the city of Rio de Janeiro. The information in the reports wasevaluated and compared to its monograph. Results and discussion: In this study, it was found that the number of laboratories that provide homeopathic pharmaceutical ingredients is rather low. In addition, in some reports, a number of identification tests werenot described properly when compared to the monograph. Besides that, some information diverges from the pharmacopoeia, for example, absence of dry residue testing, replacement of the part of the plant used to prepare the mother tincture,and results that do not meet pharmacopoeia specifications. As can be seen, the quality and effectiveness of homeopathic medicines prepared from these tinctures may be compromised. Conclusion:In order to guarantee consumer protection and the quality and effectiveness of medicines, governments and regulatory agencies should requirea greater commitment from suppliers in the production of homeopathic inputs.


Subject(s)
Quality Control , Mother Tincture
5.
Afr. j. lab. med. (Print) ; 11(1): 1-6, 2022. tables, figures
Article in English | AIM | ID: biblio-1378850

ABSTRACT

Background: A national proficiency test (PT) programme is not currently implemented in most low-income countries. However, participation in such PT programmes assists improves test performance and result accuracy.Objective: This study assessed how well 11 government hospital laboratories performed 18 basic clinical chemistry tests and identified areas needing improvement.Methods: A cross-sectional study was carried out by the Division of Laboratories of the Ministry of Health of Togo from 01 July 2016 to 31 December 2016. The test performance was evaluated using panels provided by One World Accuracy, Canada (Vancouver). The Clinical Laboratory Improvement Amendments criteria were used in evaluating the laboratories, and their success rates were compared with the World Health Organization Regional Office for Africa's target of 80%.Results: The overall rate of acceptable results at the laboratories was over 80% for glucose, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, alkaline phosphatase and triglycerides tests. The laboratories using fully automated spectrophotometers had an acceptable results rate of 89% (p = 0.001). The overall performance of the laboratories by cycles varied from 71% to 82%.Conclusion: This national PT programme identified the tests, which laboratories must improve their performance (urea, creatinine, uric acid, bilirubin, cholesterol, total protein, calcium, magnesium, phosphorus). It demonstrated the need for the use of routine appropriate internal quality control in all laboratories. The proficiency test programme should be extended to all clinical laboratories and target all biology disciplines


Subject(s)
Male , Female , Quality Control , Clinical Chemistry Tests , Biochemistry , Clinical Laboratory Techniques , Engineering , Academic Performance
6.
Afr. j. lab. med. (Print) ; 11(1): 1-7, 2022. tables, figures
Article in English | AIM | ID: biblio-1378865

ABSTRACT

Objective: This study aimed to determine the sigma metrics of analytes when using different total allowable error guidelines.Methods: A retrospective analysis was performed on 19 general chemistry analytes at Charlotte Maxeke Johannesburg Academic Hospital in South Africa between January 2017 and December 2017. Sigma metrics were calculated on two identical analysers, using internal quality control data and total allowable error guidelines from the Ricos biological variation database and three alternative sources (the Royal College of Pathologists of Australasia, the Clinical Laboratory Improvements Amendment, and the European Federation of Clinical Chemistry and Laboratory Medicine). Results: The sigma performance was similar on both analysers but varied based on the guideline used, with the Clinical Laboratory Improvements Amendment guidelines resulting in the best sigma metrics (53% of analytes on one analyser and 46% on the other had acceptable sigma metrics) and the Royal College of Pathologists of Australia guidelines being the most stringent (21% and 23%). Sodium and chloride performed poorly across all guidelines (sigma < 3). There were also month-to-month variations that may result in acceptable sigma despite poor performance during certain months.Conclusion: The sigma varies greatly depending on the total allowable error, but could be a valuable tool to save time and decrease costs in high-volume laboratories. Sigma metrics calculations need to be standardised


Subject(s)
Quality Control , Pathology , Total Quality Management , Clinical Chemistry Tests , Diagnostic Errors , Laboratories
7.
Braz. J. Pharm. Sci. (Online) ; 58: e19538, 2022. tab, graf
Article in English | LILACS | ID: biblio-1383993

ABSTRACT

Abstract The globalization of the pharmaceutical market has enabled access to a considerable number of new medicinal products. Consequently, the circulation of substandard medicinal products has also increased. To minimize this problem, post-marketing quality sampling and testing programs are performed to monitor and confirm that the medicinal products available in the market meet appropriate quality requirements. In this review, the post-approval sampling and testing procedures of six regulatory authorities were compared with the goal of strengthening these market surveillance systems. Similarities were observed between the procedures adopted by different regulatory authorities. However, the agencies were not always transparent about the results of these monitoring procedures. A probable mismatch between the registration procedures and the quality requirements listed in official compendiums was observed, which resulted in dissonance and contradiction between the specifications approved by the regulatory authorities and those required in the pharmacopeias. Therefore, strengthening harmonization projects related to these activities can help minimize such difficulties.


Subject(s)
Pharmaceutical Preparations/analysis , Pharmaceutical Preparations/standards , Sampling Studies , Quality Control , Total Quality Management , Marketing
8.
Article in Chinese | WPRIM | ID: wpr-907164

ABSTRACT

Objective To provide direction for the improvement of quality control of hospital preparations and ensure the safety for clinical use by analyzing the hospital preparation deviations in recent three years. Methods A retrospective analysis on 59 minor hospital preparation deviations from 2017 to 2019 was conducted. Brainstorming, fishbone drawing and, Minitab software were used to analyze the root causes of deviations from five aspects: personnel, machine, materials, methods and environment. The preventive and corrective measures were implemented. The results were evaluated. Results 1 significant deviation (1.7%), 24 major deviation (40.7%), and 34 minor deviation (57.6%) were identified among the 59 casses of preparation deviation. With the implementation of preventive and corrective measures, the total number of deviations in 2018 was significantly reduced compared to that in 2017. The total number of deviations in 2019 was about the same as that in 2018. The human factors need to be focused. Conclusion The pharmaceutical preparation deviations in our hospital have been reduced. The further quality improvements for pharmaceutical preparations will be carried out by following the regulations of pharmaceutical production quality management standards and pharmaceutical production supervision and administration measures.

9.
Article in Chinese | WPRIM | ID: wpr-942338

ABSTRACT

ObjectiveTo identify Dendrobium flexicaule and its related species, and analyze the differences in polysaccharide composition and D-mannose content, so as to provide theoretical basis for the accurate identification and quality control of Dendrobium medicinal materials. MethodNine samples of Dendrobium (S1-S9) were identified by DNA barcoding and infrared spectroscopy, and the contents of polysaccharides and D-mannose were determined by ultraviolet spectrophotometry (UV) and high performance liquid chromatography (HPLC), respectively. UV detection condition was 488 nm, HPLC detection conditions were the mobile phase of 20 mmol·L-1 ammonium acetate solution-acetonitrile (81.5∶18.5) and the detection wavelength at 250 nm. ResultDNA barcoding results showed that samples S1-S3 were D. nobile, samples S4-S5 were D. officinale, sample S6 was D. huoshanense, and S7-S9 were D. flexicaule. One-dimensional infrared spectroscopy showed that only D. nobile had stable characteristics at the wavenumber of 1 570-1 467 cm-1, showing a "W" shape, while no absorption peak was found at the wavenumber of 842-740 cm-1, but the other Dendrobium samples had stable absorption peaks at the wavenumber of 842-740 cm-1. In the first derivative spectrum, at the wavenumber of 785 cm-1, D. huoshanense presented a "V" shape, while the rest of Dendrobium presented a "W" shape. At the wavenumber of 1 110 cm-1, D. flexicaule had a stable characteristic peak. In the second derivative spectrum, at the wavenumber of 1 125 cm-1, D. officinale presented an "M" shape, and the rest of Dendrobium was approximately "W" shape. The results of determination showed that the contents of polysaccharides in samples S1-S9 were 9.35%, 9.12%, 32.78%, 49.38%, 48.97%, 32.48%, 32.95%, 39.41% and 25.32%, and their contents of D-mannose were 1.39%, 0.47%, 13.57%, 3.04%, 33.85%, 23.57%, 16.64%, 17.47% and 19.49%, respectively. Among them, D. flexicaule had high polysaccharide and D-mannose contents. ConclusionBoth DNA barcoding and infrared spectroscopy can be used to identify D. flexicaule and its related species, and infrared spectroscopy is cost-effective and easy to operate. At the same time, D. flexicaule has high contents of polysaccharides and D-mannose, which can provide a scientific basis for rapid identification of D. flexicaule and its relatives, and provides a reference for its quality control, and resource development and utilization.

10.
Article in Chinese | WPRIM | ID: wpr-940791

ABSTRACT

ObjectiveBased on the inhibitory activity of phosphodiesterase (PDE), a method for determining the anti-inflammatory activity of Qingjin Huatantang was established to supplement and improve the quality control system of this famous classical formula. MethodHigh performance liquid chromatography (HPLC) was used to determine the activity of PDE, and the dose-effect relationship of inhibiting PDE activity of Qingjin Huatantang was investigated. The mobile phase consisted of methanol-0.5% acetic acid aqueous solution (5∶95), and the detection wavelength was 254 nm. By measuring the PDE inhibition rate of multiple batches of Qingjin Huatantang water extract lyophilized powder, biological activity was marked with the activity of the neutralizing enzyme in the international unit U. ResultWhen the concentration of reaction substrate (cyclic adenosine monophosphate) was 50 μmol·L-1 and the reaction time was 60 min, the enzymatic reaction was stable with 4 U·mL-1 of PDE. In this reaction system, when the concentration of Qingjin Huatantang water extract lyophilized powder was 0.11-3.0 g·L-1, the inhibitory effect of PDE showed a concentration-dependent relationship. It was determined that the concentration of Qingjin Huatantang water extract lyophilized powder to be tested was 1 g·L-1, which showed a significant and stable inhibitory effect on PDE, and the inhibitory rate was >45%, that is, 1 mg of Qingjin Huatantang water extract lyophilized powder could neutralize the activity of 1.8 U PDE at least. ConclusionThis study establishes a biological activity evaluation method of Qingjin Huatantang based on the inhibitory activity of PDE, and the anti-inflammatory activity of Qingjin Huatantang is characterized by international unit U of PDE activity, which can provide a new method for the determination of biological activity of traditional Chinese medicine compounds.

11.
Article in Chinese | WPRIM | ID: wpr-940744

ABSTRACT

After the completion of the pilot work of traditional Chinese medicine formula granules (TCMFGs), the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work, this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards, mainly involving the executive standards and distinguishing technologies of raw materials, the adding process of excipients in the procedure item, the rationality of quality control methods, the information content and reproducibility of characteristic chromatograms, the nomenclature and accessibility of reference materials, etc. The common problems such as the coverage of standards, specification differences, and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards, accelerate the research and development of reference materials, advocate the use of high-quality raw materials, explore the evaluation methods of high-quality products, and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards, promote the continuous improvement of TCMFGs standard system, and ensure the healthy and orderly development of the TCMFGs industry.

12.
Article in Chinese | WPRIM | ID: wpr-940577

ABSTRACT

As intelligent production of traditional Chinese medicine (TCM) has been inevitable, informatization and automation of the production process have become the precondition for realizing intelligent manufacturing of TCM, of which the accumulation of critical material attribute and the critical quality attribute are the basis. The study of material properties is of great significance to achieve the quality control of the final product in the process, but there is a lack of systematic induction and summary of the research on the attribute of TCM pills. Therefore, the authors analyzed and summarized the attributes of raw materials, excipients and intermediates in the pill unit process according to the classification of powder properties, rheological properties and texture properties. What’s more, the impact of material attributes on the quality of the final product was summarized. Besides, this review summarized the attribute characterization techniques involved in the pill process and provided some suggestions for the characterization of product quality attributes. Finally, based on the concept of quality by design (QbD), the authors proposed that the study of material attribute should be combined with process analytical technology (PAT), and the focus of drug quality control should be moved forward to guide equipment upgrading, so as to realize intelligent continuous manufacturing of TCM pills.

13.
Article in Chinese | WPRIM | ID: wpr-940232

ABSTRACT

The quality of Chinese materia medica is the premise to ensure its safety and effectiveness in clinical application, and the standardization of Chinese materia medica quality is the most important to realize the sustainable development of traditional Chinese medicine (TCM). At present, the quality control system of Chinese materia medica has been transformed from a single chemical evaluation to the overall quality control guided by clinical efficacy. However, some quality control items of decoction pieces are still lacking or imperfect in the drug standard of prescription, which makes it difficult to guarantee the effectiveness and safety of Chinese materia medica in clinical application. Based on this, the quality control models and innovative ideas of Chinese materia medica were analyzed and discussed from the perspectives of chemical analysis, biological evaluation and clinical application in this paper. Aiming at the existing problems and actual needs in the control system of Chinese materia medica, this paper proposed the improvement strategies in accordance with the characteristics of TCM, in order to provide theoretical basis for the related research on quality control of Chinese materia medica.

14.
Article in Chinese | WPRIM | ID: wpr-940135

ABSTRACT

The quality of Chinese materia medica is the premise to ensure its safety and effectiveness in clinical application, and the standardization of Chinese materia medica quality is the most important to realize the sustainable development of traditional Chinese medicine (TCM). At present, the quality control system of Chinese materia medica has been transformed from a single chemical evaluation to the overall quality control guided by clinical efficacy. However, some quality control items of decoction pieces are still lacking or imperfect in the drug standard of prescription, which makes it difficult to guarantee the effectiveness and safety of Chinese materia medica in clinical application. Based on this, the quality control models and innovative ideas of Chinese materia medica were analyzed and discussed from the perspectives of chemical analysis, biological evaluation and clinical application in this paper. Aiming at the existing problems and actual needs in the control system of Chinese materia medica, this paper proposed the improvement strategies in accordance with the characteristics of TCM, in order to provide theoretical basis for the related research on quality control of Chinese materia medica.

15.
Article in Chinese | WPRIM | ID: wpr-934409

ABSTRACT

Objective:To establish and evaluate a new real-time quality control method that can identify the random errors by using the backpropagation neural network (BPNN) algorithm and taking blood glucose test as an example.Methods:A total of 219 000 blood glucose results measured by Siemens advia 2 400 analytical system from January 2019 to July 2020 and derived from Laboratory Information System of Beijing Chaoyang Hospital Laboratory Department was regarded as the unbiased data of our study. Six deviations with different sizes were introduced to generate the corresponding biased data. With each biased data, BPNN and MovSD algorithms were used and tested, and then evaluated by traceability method and clinical method.Results:For BPNN algorithm, the block size was pre-set to 10 and the false-positive rate in all biases was within 0.1%. For MovSD, however, the optimal block size and exclusive limit were 150 and 10% separately and its false-positive rate in all biases was 0.38%, which was 0.28% higher than BPNN. Especially, for the least two error factors of 0.5 and 1, all the random errors were not detected by MovSD; for the error factor larger than 1, random errors could be detected by MovSD but the MNPed was higher than that of BPNN under all deviations. The difference was up to 91.67 times. 460 000 reference data were produced by traceability procedure. The uncertainty of BPNN algorithm evaluated by these reference data was only 0.078%.Conclusion:A real-time quality control method based on BPNN algorithm was successfully established to identify random errors in analytical phase, which was more efficient than MovSD method and provided a new idea and method for the identification of random errors in clinical practice.

16.
Article in Chinese | WPRIM | ID: wpr-934408

ABSTRACT

Objective:To explore the feasibility of using the sigma metrics calculated with the data of internal quality control for the comparison of the analytical performance between different biochemical analyzers.Methods:The internal quality control results of twenty-five biochemical assays in the biochemical analyzers of the department of clinical laboratory in Cancer Hospital from February 1, 2021 to July 31, 2021 were collected. The formula sigma =( TEa- Bias)/ CV was used to calculate the sigma metrics of two different levels of the biochemical assays including albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, cholesterol, creatine kinase, chlorine, creatinine, γ- glutamyltranspeptidase, blood glucose, high density lipoprotein cholesterol, immunoglobulin A, immunoglobulin G, immunoglobulin M, potassium, lactate dehydrogenase, low density lipoprotein cholesterol, sodium, inorganic phosphorus, total bilirubin, triglyceride, total protein, urea, uric acid. The imprecision was obtained by the coefficient of variation of internal quality control. The bias was calculated by the deviation between the mean of internal quality control of the comparison instrument and the target instrument. The allowable total error ( TEa) was based on People's Republic of China Health Industry Standard (WS/T403-2012) or EQA standard of National Center for Clinical Laboratories (NCCL). Compared the sigma values of the comparison instrument relative to the target instrument with the average percentage bias obtained by the traditional comparison method. Quality goal index was used to analyze the causes of poor performance and judge the results of comparison. Results:Compared with the target instrument Beckman AU5800-3, the comparison instrument Beckman AU5800-1 had 10 assays with σ>6, accounting for 40%, 23 assays with σ>3, accounting for 92%, and only albumin and blood glucose showed σ<3. Through statostical analysis, the comparisons of all assays were passed. The comparison instrument Beckman AU5800-2 had 8 assays with σ>6, accounting for 32%, 20 assays with σ>3, accounting for 80%. Only alkaline phosphatase, calcium, lactate dehydrogenase, total protein and urea showed σ<3. Through statostical analysis, the comparisons of GGT and IgM failed. For the traditional comparison method, the percentage bias between the comparison instruments and the target instrument were all within the range of the evaluation standard. But there was no significant correlation between the σ value and the average bias of the traditional comparison method, and the biases were correlated.Conclusions:Using the sigma metrics calculated with the data of internal quality control for the comparison of different detection systems is a convenient and operable method. It can monitor the comparability between different detection systems in the laboratory at any time and be the supplement of the traditional comparison method.

17.
Article in Chinese | WPRIM | ID: wpr-934394

ABSTRACT

Objective:To develop a self-made plasma quality control material for non-invasive prenatal testing (NIPT) and evaluate its performance.Methods:139 NIPT-negative maternal plasmas stored in the genetic department of Shaoxing maternal and child health hospital from January 1, 2019 to June 30, 2021 were divided into male groups (19 cases) and female groups (120 cases) according to the neonatal gender. 9360 cases from September 2020 to September 2021 were enrolled as clinical validation cases.First step, 200 μl plasma from a 47 years-old non-pregnant healthy women was used as a matrix. Different amounts (0.1, 0.2, 0.5, 2.5, and 5 μl) of positive DNA from fetal chromosome aneuploidy (T21, T18, T13) detection kit were added. The appropriate volume of positive DNA was 0.5 μl according to the test results. Second step,Plasma in male and female group was treated as matrix. 0.5 μl positive DNA was added per 205 μl. Plasma matrix from female group showed good repeatability and the sensitivity was 100%.Third step, evaluate the self-made plasma quality control material, including storage stability, matrix uniformity and repeatability, and the effect of different batch numbers of positive DNA, by calculating Z score and the CV of fetal DNA concentration (FF).Results:Plasma matrix from female group showed good repeatability and the sensitivity was 100%, while the sensitivity of male group was only 84%. The CV of FF in female matrix was 3.9% in the repetitive experiments. After adding 0.5 μl positive DNA, the mean FF of self-made positive plasma quality control was 5.63%±0.42%, Z values>6, and the CV was 7% after storage of three months. Considering the concentration variation of positive DNA in different lots, 1 μl of positive DNA should be added when the FF of positive DNA is lower than 10%.Used in 9360 clinical cases from September 2020 to September 2021, all positive plasma quality control materials showed positive results, and the positive predictive value of trisomy 21 was 100%.Conclusions:The NIPT self-made positive plasma quality control material has been successfully developed in this study. The preliminary experimental results show that it has good repeatability and stability, which is suitable for clinical application.

18.
Article in Chinese | WPRIM | ID: wpr-934351

ABSTRACT

Objective:To prepare the control materials of point-of-care(POC) glucose testing and evaluate their homogeneity, stability and matrix effects.Methods:The high, medium and low concentration control materials were prepared from patient leftover whole blood, which was centrifuged, fixed, washed, filtered, and aliquoted. The homogeneity and stability of the control materials were evaluated according to CNAS (China National Accreditation Service for Conformity Assessment, CNAS) GL29:2010"Reference materials-General and statistical principles for certification". The control materials were used to evaluate the matrix effects in POC glucose detection systems by Deming regression, according to the Clinical and Laboratory Standards Institute (CLSI) EP14-A3. Meanwhile, these control materials were used as the internal quality control, and their coefficients of variation ( CV) were calculated. One-way ANOVA and t-Test were used to analyze the results. Results:The homemade materials at three concentrations showed good homogeneity[ F< F0.05(9, 20)]. When the control materials were stored at 2-8 ℃, the stable phases for the opened and closed bottles were 10 days and 15 days, respectively, and there was no statistically significant difference between the results of the first day( P>0.05). The control materials at three concentrations also showed good applicability and there were no matrix effects in 10 POC glucose systems. When the control materials were detected in the internal quality control, the CVs of the high, medium and low concentrations were 0.63%, 0.66% and 1.65%, respectively, which were all below 7.5%. Conclusions:The homemade human control materials of POC glucose testing showed good homogeneity, stability and applicability. They met the requirements of quality control in hospital settings, which provided a good application prospect of the quality management of POC glucose testing.

19.
Article in Chinese | WPRIM | ID: wpr-934340

ABSTRACT

Patient based real time quality control (PBRTQC) is a quality control method that uses the test results of clinical specimens from patients to monitor the analysis performance of the test process in real time and continuously. Although the International Federation of Clinical Chemistry and Laboratory Medicine PBRTQC working group had recommended that this method should be popularized in clinical practice in 2020, there is still certain lagging in cognition, research and application of PBRTQC in domestic clinical laboratories. This paper highlights the research progress, operation categories, clinical application value, domestic standard guidelines, PBRTQC procedure establishment, performance verification, implementation principles, application status and prospects of PBRTQC, so as to promote the recognition, acceptance, reference and wide application of PBRTQC in domestic clinical laboratories.

20.
Article in Chinese | WPRIM | ID: wpr-934339

ABSTRACT

The delta checks are one of the patient-based quality control options to identify the errors and the significant changes in patients′ condition. Compared with the traditional internal quality control method, the delta checks have the characteristics of real-time monitoring, with no additional detecting cost, thus the delta checks are widely used in clinical laboratories. In addition, the delta checks are also useful in the auto-verification system to screen out the abnormal results for manual verification. This article reviewed the delta checks′ development history, parameters selection, application values in quality control and auto-verification.

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