El laboratorio de fertilidad masculina, su evolución en los últimos 20 años / The male fertility laboratory, its evolution over the last 20 years / O laboratório de fertilidade masculina, sua evolução ao longo dos últimos 20 anos

Resumen La mayor accesibilidad a los tratamientos de reproducción asistida (RA) y los avances de la criobiología produjeron cambios en los laboratorios de andrología. El objetivo de este trabajo fue analizar la demanda y evolución de las variables seminales en las últimas dos décadas, caracterizar el laboratorio andrológico actual, evaluar el impacto de la incorporación del aseguramiento de la calidad y la inclusión de los sistemas computarizados (CASA). Se utilizaron datos de las medias mensuales del control de calidad interno (n=22 528) y encuestas a profesionales de laboratorios andrológicos (n=65) y a médicos especialistas en fertilidad (n=33). La demanda global se redujo significativamente con el aumento de las solicitudes de primera vez. El volumen y recuento, variables dependientes de andrógenos, disminuyeron con los años. El criterio estricto en morfología disminuyó el porcentaje de normales; la mitad de los médicos encuestados recibieron resultados entre 0 y 10% y el 40% consideró que ponía en riesgo el valor clínico de la variable. El sistema CASA permitió objetivar la cinética espermática e incrementar el porcentaje de progresivos rápidos, pero pocos laboratorios lo incorporaron. El 66% de los médicos resuelven el factor andrológico severo por tratamientos clínicos y el 95% utiliza técnicas de RA. El análisis de semen es ejecutado fundamentalmente por bioquímicos especializados, con baja adhesión a la automatización y acreditación del laboratorio, pero con participación en programas de evaluación externa de calidad. La demanda disminuyó como consecuencia del aumento del tratamiento por RA. La reducción del porcentaje de formas normales compromete su utilidad clínica.

Abstract Increasing availability to assisted reproduction (AR) treatments in Argentina and advances in cryobiology resulted in changes in andrology laboratories. The aim of this study was to evaluate the demand and evolution of seminal variables in the last two decades, characterise the current andrology laboratory, evaluate the impact of the incorporation of quality assurance and the introduction of computer assisted semen analysis (CASA). Data were taken from internal quality control (IQC) monthly means (n=22 528) and professionals in charge of laboratories (n=65) and fertility physicians' (n=33) surveys. Overall demand decreased significantly while first-time orders increased. Sperm volume and sperm count -androgen dependent parameters- decreased over the years. Strict morphology criteria reduced the percentage of normal results; half of the physicians received results between 0 and 10% and 40% considered that it compromised the clinical value of the variable. The CASA system made it possible to objectify sperm kinetic, increasing the percentage of fast progressives, but few laboratories have incorporated it. Sixty-six percent of physicians resolve severe andrological factor by clinical treatments and 95% use AR techniques in those cases. Semen analysis is mainly performed by specialised biochemists, with low adherence to laboratory automatisation and accreditation, but with participation in external quality assessment programmes. The demand decreased because of the increase in AR treatment. The lower percentage of normal forms compromises their clinical utility.

Resumo O aumento do acesso aos tratamentos de reprodução assistida (RA) e os avanços na criobiologia levaram a mudanças nos laboratórios de andrologia. O objetivo deste trabalho foi analisar a demanda e a evolução das variáveis de sêmen nas últimas duas décadas, caracterizar o laboratório de andrologia atual, avaliar o impacto da incorporação da garantia da qualidade e a inclusão dos sistemas computadorizados (CASA). Foram utilizados dados das médias mensais do controle de qualidade interno (n= 22 528) e pesquisas a profissionais de laboratórios andrológicos e a médicos especialistas em fertilidade (n=33). A demanda geral diminuiu significativamente com o aumento das solicitações de primeira vez. O volume e a contagem de esperma, parâmetros dependentes de andrógenos, diminuíram ao longo dos anos. O critério morfológico rigoroso diminuiu a porcentagem de normais; metade dos médicos entrevistados recebeu resultados entre 0 e 10% e 40% considerou que isso comprometía o valor clínico do parâmetro. O sistema CASA, permitiu objetivar a cinética espermática e aumentar o percentual de progressões rápidas, mas poucos laboratórios o incorporaram. 66% dos médicos resolvem o fator andrológico grave por tratamentos clínicos e 95% utilizam técnicas de RA nesses casos. A análise do sêmen é realizada principalmente por bioquímicos especializados, com baixa aderência à automação e acreditação laboratorial, mas com participação em programas de avalação externa de qualidade. A demanda diminuiu como consequência do aumento do tratamento por RA. A diminuição em percentagem de formas normais compromete sua utilidade clínica.

Controles de calidad externos en el diagnóstico molecular de enfermedades genéticas. Impacto sobre la calidad de los estudios genéticos / External quality controls in the molecular diagnosis of genetic diseases. Impact on the quality of the genetic studies / Controles de qualidade externos no diagnóstico molecular de doenças genéticas. Impacto na qualidade dos estudos genéticos

Resumen La participación en programas de evaluación externa de la calidad (PEEC) dirigidos al diagnóstico de enfermedades genéticas permite obtener una medida objetiva del desempeño técnico y analítico de los laboratorios y es un requisito para la acreditación de los laboratorios clínicos bajo la norma ISO 15189. El objetivo de este estudio fue evaluar retrospectivamente el desempeño en los esquemas EMQN (European Molecular Genetics Quality Network) y CF Network (Cystic Fibrosis European Network) en el período 2014-2022. Se participó en un total de 88 esquemas. Se recolectó la información de nuestros puntajes y las medias de los laboratorios participantes en las categorías genotipificación, interpretación y exactitud de la información del paciente/informe. Se informó en forma completa el 90,9% (n=80) de los esquemas. El desempeño en genotipificación mostró puntajes superiores a la media en el 89,3% de los esquemas; 0,8% de los informes correspondieron a falsos negativos. En interpretación, el 66,7% de los esquemas evidenció un desempeño superior a la media y el 33,3% debajo de la media. La exactitud de la información del paciente/informe presentó puntajes superiores a la media en el 97,6% de los esquemas. Se observó una diferencia estadísticamente significativa en el porcentaje de esquemas con puntaje por encima de la media en el año 2022 (10/12 esquemas) respecto al año 2014 (1/6 esquemas) en la categoría interpretación (p=0,0128). En conclusión, la participación regular en PEEC tuvo impacto positivo en la calidad de los estudios y permite realizar mejoras continuas a partir de las recomendaciones sugeridas por estos programas.

Abstract Participation in external quality assessment programmes focused on rare genetic diseases makes it possible to assess the laboratory technical and analytical performance and it is a prerequisite for accreditation according to ISO 15189. The objective of this study was to perform a retrospective evaluation of our performance in the EMQN (European Molecular Genetics Quality Network) and the CF Network (Cystic Fibrosis European Network) programmes in the 2014-2022 period. The laboratory performance on genotyping, interpretation and clerical accuracy and patient identifiers in a total of 88 schemes were assessed. The information of our scores and the mean scores of all participating laboratories in the three categories were collected. A total of 90.9% of the schemes were fully completed. The performance in genotyping showed scores above the mean scores in 89.3% of the schemes; 0.8% of the reports correspond to false negative results. Regarding interpretation category, 66.7% of the schemes presented scores above the mean scores and 33.3% below the mean scores. The clerical accuracy and patient identifiers were above the mean scores in 97.6% of the schemes. A statistically significant difference in the percentage of schemes with a score above the mean for the interpretation category in the year 2022 (10/12 schemes) was observed compared to the year 2014 (1/6 schemes) (p=0.0128). In conclusion, regular participation in external quality assessment programmes had a positive impact on the quality of the studies and allows for continuous improvements based on the recommendations suggested by these programmes.

Resumo A participação em programas de avaliação externa da qualidade (PEECs) voltados para o diagnóstico de doenças genéticas permite obter uma mensuração objetiva do desempenho técnico e analítico dos laboratórios e é requisito para a acreditação dos laboratórios clínicos sob a norma ISO 15189. O objetivo desse estudo foi avaliar retrospectivamente o desempenho nos esquemas EMQN (European Molecular Genetics Quality Network) e CF Network (Cystic Fibrosis European Network) no período 2014-2022. Participou-se em um total de 88 esquemas. Foram coletadas informações de nossos escores e das médias dos laboratórios participantes nas categorias genotipagem, interpretação e precisão da informação do paciente/laudo. 90,9% (n=80) dos esquemas foram informados em sua totalidade. O desempenho na genotipagem apresentou escores acima da média em 89,3% dos esquemas; 0,8% dos laudos corresponderam a falsos negativos. Na interpretação, 66,7% dos esquemas apresentaram desempenho acima da média e 33,3% abaixo da média. A precisão das informações do paciente/laudo apresentou escores acima da média em 97,6% dos esquemas. Observou-se diferença estatisticamente significativa no percentual de esquemas com pontuação acima da média no ano de 2022 (10/12 esquemas) em relação ao ano de 2014 (1/6 esquemas) na categoria interpretação (p=0,0128). Em conclusão, a participação regular em PEECs teve um impacto positivo na qualidade dos estudos e permite fazer melhorias contínuas com base nas recomendações sugeridas por esses programas.

Analysis on the results of external quality assessment for quality indicators of clinical laboratory in China / 中华医院管理杂志

Objective:To analyze the implementation of the external quality assessment plan for quality indicators of clinical laboratories in China from 2016 to 2021, as well as that of the external quality assessment of 15 quality indicators in clinical laboratories, in order to provide reference for quality management of clinical laboratory specialties.Methods:The research data was collected from the external quality assessment plan for quality indicators, which was conducted by the National Center for Clinical Laboratories joining the clinical laboratory centers of 31 provinces (autonomous regions and municipalities directly). The essential information reported by each participating clinical laboratory from 2016 to 2021 and the external quality assessment data of 15 quality indicators in clinical laboratories were collected, followed by a descriptive analysis on the number of participating laboratories and the number of returns for each indicator. Median representation was used for the external quality assessment data of 15 quality indicators in clinical laboratories, and the TOPSIS method was applied to comprehensively evaluate the quality of the total testing process of participating clinical laboratories in each year.Results:From 2016 to 2021, the number of laboratories participating in the external quality assessment plan for quality indicators of clinical laboratory increased from 7 704 to 12 142. Quality indicators in pre-analytical phases: the incorrect sample type rate, incorrect sample container rater, and incorrect fill level rate had been decreasing year by year, reaching 0, 0, and 0.005 8% in 2021, respectively. The anticoagulant samples clotted rate had decreased from 0.068 6% in 2016 to 0.042 8% in 2021, and the blood culture contamination rate from 2017 to 2021 had been 0 without exception. The pre-examination turnaround time had been shortened from 28 minutes in 2016 to 2019 to 24 minutes in 2020 and 2021. Quality indicators in analytical phases: the intra-laboratory turnaround time had been extended from 45 minutes in 2016 to 2019 to 50 minutes in 2020 and 2021. Test covered by an IQC rate had been increasing year by year, reaching 60.61% in 2021. Test with inappropriate IQC performances rate was 0 in 2020 and 2021, the test covered by an EQA-PT control rate was 100%, and unacceptable performances in EQA-PT schemes rate from 2017 to 2021 was 0. The inter-laboratory comparison rate had increased from 1.56% in 2016 to 3.00% in 2021. Quality indicators in post-analytical phases: the incorrect laboratory reports rate, critical values notification rate and timely critical values notification rate had been 0, 100%, and 100%from 2016 to 2021 respectively. The comprehensive evaluation results of TOPSIS method showed that the overall quality level of clinical laboratory testing in 2020 was the highest, with Ci value of 0.850 5, while the lowest Ci value in 2016 was 0.143 6. Conclusions:The quality of clinical laboratory testing in China has been effectively improved. Clinical laboratories should continue to strengthen their monitoring of quality indicators, especially the intra-laboratory turnover time and the inter-laboratory comparison rate, for the purposes of identifying errors, analyzing causes and taking corrective measures to improve quality.

External quality assessment of laboratories in blood stations of Hebei Province in 2022: a retrospective analysis of HeBEQA project / 中国输血杂志

【Objective】 To conduct the laboratory quality assessment between 12 blood stations in Hebei province, analyze the results and explore the accuracy and comparability of testing, so as to improve the level of testing ability and quality management. 【Methods】 With reference to the external quality assessment rules of National Center for Clinical Laboratories and combined with the instructions of quality assessment samples, daily testing process of the laboratories were assessed. The quality indicators include blood cell count (WBC, RBC, Hb, HCT, MCV, MCH, MCHC and PLT), biochemical items (TP) and coagulation parameters (FIB and FⅧ). 【Results】 There are still problems in laboratories in terms of personnel operation, instrument maintenance and the impact of different reagent batches, especially in biochemical items and coagulation parameters. The pass rate of biochemical items was the lowest, only 72.75%, and that of blood cell count was the highest, reaching 98.75%. 【Conclusion】 With the progress of the project, the quality monitoring level of daily blood sampling tests in the quality control laboratory of each blood station has been improved. However, it is still necessary for each laboratory to improve the testing ability and quality management to a higher level in Hebei.

Analysis of external quality assessment for laboratories of toxicological pathology diagnosis in 86 organizations in China from 2020 to 2021 / 中国职业医学

Objective To analyze result of the external quality assessment for laboratories of toxicological pathology diagnosis in organizations in China. Methods A total of 86 organizations that participated in the 2020-2021 external quality assessment in laboratory of toxicological pathology diagnosis (hereinafter referred to as "reference units") were selected as research subjects using convenient sampling method, and the assessment results were analyzed. Results The median of total score was 92, and the 0-100 percentiles were 64-100 in these 86 reference units. Among these reference units, 76 were rated as excellent, 10 as qualified, with the excellent and the qualified rate of 88.4% and 11.6%, respectively. No reference unit was rated as unqualified. The rates of excellence of the reference units in public health institutions, pharmaceutical research institutions, drug safety evaluation centers and testing companies were 95.7%, 84.2%, 85.7% and 86.7%, and the qualified rates were 4.3%, 15.8%, 14.3% and 13.3%, respectively. The distribution of excellence and qualification among the four types of reference units showed no statistical difference (P>0.05). The distribution of sample scores according to the three grades of poor, good, and excellent were 4.9%, 20.7%, and 74.5% in public health institutions, 8.6%, 23.7%, and 67.8% in pharmaceutical research institutions, 12.5%, 25.0%, and 62.5% in drug safety evaluation centers, and 5.4%, 17.5%, and 77.1% in testing companies. The proportion of excellence unit in public health institutions was higher than that in pharmaceutical research institutions (P<0.05). Conclusion The overall toxicological pathology diagnostic capabilities in China are good, and various types of reference units demonstrate comparable technical capabilities. However, there is a need for standardization of diagnostic terminology.

Inter-laboratory testing as a strategy for external quality assessment for qualitative detection of SARS-CoV-2 by real-time RT-PCR testing in India

To implement the strategy of test, track and treat to tackle the ongoing COVID-19 pandemic, the number of real-time RT-PCR–based testing laboratories was increased for diagnosis of SARS-CoV-2 in the country. To ensure reliability of the laboratory results, the Indian Council of Medical Research initiated external quality assessment (EQA) by deploying inter-laboratory quality control (ILQC) activity for these laboratories by nominating 34 quality control (QC) laboratories. This report presents the results of this activity for a period of September 2020 till November 2020. A total of 597 laboratories participated in this activity and 86 per cent of these scored ?90 per cent concordance with QC laboratories. This ILQC activity showcased India’s preparedness in quality diagnosis of SARS-CoV-2.

HIV Ag-Abdetection by ELISA: a retrospective analysis / 中国输血杂志

【Objective】 To conduct a retrospective analysis of HIV Ag-Ab detection by ELISA in our blood center, so as to provide reference for continuous improvement. 【Methods】 The reactive rate of HIV by each reagent, reactive rate of both reagents, re-test rate, concordance rate of initial-repeat test, and reagent utilization rate were counted, and the external quality assessment results were analyzed by PT score and z-ratio. 【Results】 The total reactive rate of HIV was 0.15%. The reactive rate by both reagents was 0.02%. The re-test rates, reactive rates, concordance rates and reagent utilization rates of the two reagents were 0.09% vs 0.08%, 0.07% vs 0.06%, 75.86% vs 78.21%, and 114.54% vs 113.92%, respectively. PT score was 100%, and z-ratio of 7 negative samples and 1 positive sample was less than 2, and of 2 positive samples was more than 3. 【Conclusion】 The laboratory quality monitoring indicators and external quality assessment can effectively monitor the operation of blood testing laboratory.

Detection ability of nucleic acid screen laboratory in blood bank based on NCCL external quality assessment data / 中国输血杂志

【Objective】 To evaluate the laboratory's NAT ability by analyzing the feedback reports of nucleic acid test (NAT) results of external quality assessment (EQA) of National Center for Clinic Laboratories (NCCL), so as to improve the laboratory management details and ensure blood safety. 【Methods】 The data of NCCL NAT EQA of blood screening laboratory of Tianjin Blood Center (a total of five occasions from Jan 2019 to Jun 2021) were statistically analyzed. 【Results】 From Jan 2019 to Jun 2021, the laboratory participated in EQA for five times and all the results were qualified. The test results of NAT EQA HIV RNA/HCV RNA/HBV DNA detected by R1, R2 and R4 were consistent with the reference results. R3 showed false positive results (CT value 40.46) in the single donation detection of sample No.1925 in HCV RNA. Unreported data of the laboratory was that in the first EQA in 2021, the R4 showed false positive results (CT value 35.8) in in the single donation detection of sample No.2113 in HIV RNA. 【Conclusion】 The performance of each NAT screening system in our laboratory is relatively stable except occasional false positive results influenced by every factor. Potential problems can be found and continuously improved by assaying EQA reports and the extended experimental results of EQA samples to further improve the detection ability.

Analysis on the difference of circulating threshold of polymerase chain reaction in blood screening of external quality assessment / 中国输血杂志

【Objective】 To analyze the difference of circulating threshold (Ct) of polymerase chain reaction (PCR) in blood station laboratories during the external quality assessment, and to put forward suggestions for the quality improvement of participating laboratories. 【Methods】 From 2018 to 2021, the blood station laboratories participated in the external laboratory quality assessment of CITIC including blood screening items with nucleic acid testing method. The data of Roche diagnostic reagent group were used as the source, and the detected Ct values of three groups of quality control samples of HBV A subtype (400 IU/mL), HCV 1b subtype (400 IU/mL) and HIV B genotype (500 IU/mL) were used as the objects. The data were grouped according to quality control (sample) batches, reagent batches and different laboratories. Using the statistical method of variance analysis (assuming P<0.05 as significant), the detected Ct value of each group was analyzed. 【Results】 For the three items (HBV/HCV/HIV), the grouping data involving 42 batches of quality control (13/12/17), 28 batches of reagent (11/8/9) and 57 laboratories (19/19/19) were selected. The grouping analysis of quality assessment batches shows that there was no significant difference between HBV and HCV quality assessment batches, and there was no significant difference between other HIV batches except the two batches of HIV quality assessment samples released in 2021. The grouping analysis of each reagent batch showed that there was no significant difference between each reagent batch for HCV and HIV detection, while there was significant difference between two batches of HBV reagents. After excluding the data groups with significant differences in the quality control batch groups and the reagent batch groups, the detected Ct value of each laboratory group had extremely significant differences in the three items of HBV, HCV and HIV. Through pairing analysis, it was found that four laboratories had significant differences with most other laboratories in the three items, mainly manifested in the high mean value of Ct. 【Conclusion】 For the blood station laboratories with correct test results of quality assessment samples, there are differences in Ct values detected by PCR, which may be mainly caused by the detection ability of the participating laboratories.

External quality control and training of semen analysis in the Netherlands: starting point for further reduction of outcome variability / 亚洲男科学杂志(英文版)

Semen analysis is characterized by high levels of intra- and inter-laboratory variability, due to a low level of standardization, high subjectivity of the assessments, and problems with automated procedures. To improve consistency of laboratory results, quality control and training of technicians are important requisites. The goals of this study are to evaluate the results of an external quality control (EQC) program and standardized training by ESHRE Basic Semen Analysis Courses (BSAC) on the variability in manual assessments of semen parameters. We performed retrospective analyses of (1) the interlaboratory variability in the Dutch EQC program and (2) the interobserver variability in BSACs for concentration, motility, and morphology assessments. EQC data showed that the interlaboratory coefficient of variation (CV) for concentration assessment decreased (range from 24.0%-97.5% to 12.7%-20.9%) but not for morphology and motility assessments. Concentration variability was lower if improved Neubauer hemocytometers were used. Morphology assessment showed highest CVs (up to 375.0%), with many outliers in the period of 2007-2014. During BSAC, a significant reduction of interobserver variability could be established for all parameters (P < 0.05). The absence of an effect in the EQC program for motility and morphology might be explained by respectively the facts that motility assessment was introduced relatively late in the EQC program (since 2013) and that criteria for morphology assessment changed in time. BSAC results might have been influenced by the pretraining level of participants and the influence of external factors. Both EQC and training show positive effects on reducing variability. Increased willingness by laboratories to change their methods toward standards may lead to further improvements.

Method and application of high efficient preparation of procalcitonin standby reference material based on protein recombination technology / 中华检验医学杂志

Objective:To construct a prokaryotic expression vector for human retinol binding protein 4 (hRBP4) that allows technicians to obtain hRBP4 purified protein with low cost, high efficiency, high concentration and high purity.Methods:The hRBP4 coding sequence provided by National Center for Biotechnology Information was optimized by E. coli codons, and a synthetic DNA fragment was cloned into the PET-28A (+) prokaryotic expression vector to construct a recombinant hRBP4 expression plasmid. The recombinant protein was transformed into E. coli BL21, and the induced expression conditions (temperature, rotate speed and isopropyl β-d-thiogalactoside concentration) were optimized. The recombinant protein was purified by His fusion tag. Results:The recombinant hRBP4 prokaryotic expression plasmid was successfully constructed, and the expression concentration and induction temperature of the recombinant protein were optimized. The results of sodium dodecyl sulfate polyacrylamide gel electrophoresis showed that a band with a relative molecular weight of 26 000 daltons was clearly visible in the purified product. The purified hRBP4 protein could be detected clinically, and there was a good linear relationship between the dilution ratio and the detection concentration.Conclusions:The recombinant hRBP4 protein has high purity, high concentration, and short production cycle. It has the potential to become a candidate for reference materials for laboratory quality evaluations.

The journey of Malaysian external quality assurance program for general diagnostic histopathology

@#International Academy of Pathology, Malaysian Division has initiated and run the external quality assurance program for general diagnostic histopathology since the year 2017. This article introduces the educational philosophy of this external quality assurance program and the technicalities in running such a national program. Challenges in ensuring the successful running of this program to gain wide acceptance by histopathology laboratories in Malaysia as well as experience in overcoming these challenges are detailed. This article charts the future direction of this external quality assurance program.

Establishment of a candidate reference method for plasma normetanephrine and its application in the external quality assessment program / 中华检验医学杂志

Objectives:To establish a candidate reference method of isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS) for the determination of human plasma normetanephrine, and to evaluate the performance of the method. The method was used to quantify the samples of the external quality assessment program, and to initially evaluate the detection status of plasma normetanephrine.Methods:The isotope standard solution of normetanephrine was selected as the internal standard, the gravimetric method was used for sampling, and the standard curve method was used for quantification. Protein precipitation combined with weak cation solid phase extraction was used for pretreatment, and ultra-high liquid chromatography-coupled triple quadrupole mass spectrometry was used for LC/MS analysis. According to the relevant EP documents, the specificity, matrix effect, detection limit, quantification limit, precision, accuracy, and uncertainty of the method were estimated. This method is used to quantify the samples of the 2020 National Center for Clinical Laboratories external quality assessment program of normetanephrine. Taking the average value of this method as the target value, the optimal allowable total error standard of biological variation as the evaluation limit, the quality of the laboratory testing was evaluated.Results:The method had good specificity, and the interferences and matrix effects did not affect the detection results. The detection limit and quantification limit of plasma normetanephrine were 1.08 pg/g and 3.54 pg/g, respectively. The intra-batch coefficient of variation ( CV) and total CV were 0.43%-1.10% and 0.61%-1.42%, respectively. The relative recovery rates were 98.5%～101.9%. The relative expansion uncertainty of the four plasma samples were 3.10%, 2.34%, 2.16%, and 1.73%, respectively. The results of the external quality assessment program showed that the pass rates of the 202013 and 202014 samples were 80% and 85%, respectively. Conclusions:The study established a candidate reference method of ID-LC/MS/MS for the measurement of plasma normetanephrine. The method is accurate, precise and simple, and is expected to be used as a reference method for the determination of plasma normetanephrine, and can be applied to quantify the samples of the external quality assessment program.

Establishing allowable total error for serum total folate in external quality assessment / 中华检验医学杂志

Objective:To establish the allowable total error (TEa) of the national external quality assessment (EQA) program in line with the current quality level of serum folate measurement in China.Methods:The data of serum total folate test in the clinical laboratory of a hospital in Beijing in 2016 were collected, and the Stata SE 15 software was used for Monte Carlo simulation to obtain the false-negative rate under different bias and inaccuracy conditions. The Origin Pro 9.1 software was used to make the contour figure. The TEa of serum total folate test is derived based on the acceptable false-negative rate. National EQA data of serum total folate in 2020 were collected to calculate the pass rate of participating laboratories and the laboratory pass rate of quality control products at each level under the five TEa derived from the analysis performance on clinical outcomes, biological variation, and the evaluation criterion of national EQA.Results:Based on the influence of analytical performance on clinical outcomes, the TEa was 10%. Under this TEa, the pass rate of the first EQA program of serum total folate in 2020 was more than 80%, and the pass rate of the second time was 73.1%. Under the minimum (46.57%) and appropriate level of TEa (15.52%) derived from biological variation and national EQA evaluation criterion, the pass rate of serum total folate in the two EQA programs in 2020 exceeded 85%.Conclusion:The analytical performance of serum total folate in China cannot meet the requirements of TEa derived based on the effect of analytical performance on clinical outcomes. An appropriate level of TEa derived based on biological variation (15.52%) is suggested as the recommended criterion for the TEa of serum total folate test.

External quality assessment of NAT blood screening: an inter laboratory analysis / 中国输血杂志

【Objective】 To summarize and analyze the results of local laboratories participating in China International Transfusion Infection Control (CITIC) Nucleic Acid Testing (NAT) External Quality Assessment (EQA). 【Methods】 The basic situation, test reagents, and abnormal results of 9 domestic laboratories participating in NAT EQA from 2018 to 2020 were collected and analyzed. 【Results】 Among 7 545 testing results, submitted by 48 laboratories using 8 test reagents throughout 9 occasions of CITIC, 64% (4 830/7 545) used imported and 36% (2 715/7 545), domestic reagents. Thirty-one abnormal results were reported, with false negative in 61.29% (19/31), false positive 6.45% (2/31), and others 32.25% (10/31). False negative results only appeared in samples with low viral load of HBV A genotype(40 IU/mL), HCV 1b subtype(40 IU/mL) and HIV B genotype(250IU/mL), relatively concentrated in a few laboratories. The frequency of abnormal results was 0.08 per laboratory per CITIC test. 【Conclusion】 The detection capacity of domestic blood stations has been significantly improved along with the routine NAT practice and regular NAT EQA participation over 5~10 years, but laboratory management still needs to be further strengthened to ensure the reagent testing performance and blood safety.

Quality of Same-Day Sputum Smears Microscopy and Presumptive Tuberculosis Patients Drop-out at Health Facilities of Addis Ababa, Ethiopia / 결핵

Analysis of the Development Status of Clinical Pharmacogenomics Based on External Quality Assessment from 2014 to 2019 in China / 中国药房

OBJECTIVE：To provide reference for promoting individualized medication in clinic. METHODS ：Information on external quality assessment （EQA）projects and approved kits for the guidance of chemical drug use were collected from the websites of National Center for Clinical Laboratories （NCCL） and National Medical Products Administration （NMPA） as of December 31，2019. The number of laboratories participating in each evaluation project was count. Taking EQA projects of clopidogrel and warfarin drug metabolism gene polymorphism detection as examples ，who was with the highest participation rate ， the methods and reagent kits of each laboratory were analyzed so as to analyze the current status of the clinical pharmacogenomics （PGx）in China. RESULTS ：The number of PGx genetic test EQA projects conducted by NCCL increased from 3（2014）to 9 （2019）. The total number of participating laboratories was 926 in 2018，and 1 249 in 2019. The number of laboratories of warfarin and clopidogrel drug metabolism gene polymorphism detection increased from 57 to 300.5 for warfarin and from 124 to 374.5 for clopidogrel. The more widely used methods were fluorescent PCR and PCR-chip hybridization. The number of reagent kits currently approved by NMPA was 7 for warfarin and 15 for clopidogrel ，respectively. But some of the laboratories participating in EQA used self-prepared reagents yet. CONCLUSIONS ：The clinical PGx is in its infancy ，and the awareness of laboratories about EQA is improving；the main method was fluorescence PCR ，but the use of self-made reagents in laboratories is still common ，regulations concerning the approval ，use and supervision still need to be further improved.

Programa de Evaluación Externa de la Calidad "Prof. Dr. Daniel Mazziotta": una nueva etapa asegurando la mejora continua de la calidad / External Quality Assessment Program "Prof. Dr. Daniel Mazziotta ": a new stage ensuring continuous quality improvement

Las determinaciones de los laboratorios clínicos tienen un papel muy importante en la evaluación, diagnóstico, tratamiento y evolución del estado de salud de las personas. La confiabilidad de sus resultados se logra a través del aseguramiento de la calidad y mejora continua. El Programa de Evaluación Externa de la Calidad "Prof. Dr. Daniel Mazziotta" acompaña a los laboratorios de análisis clínicos desde hace 31 años brindando distintas herramientas para garantizar la calidad analítica. Ofrece los servicios de evaluación externa de la calidad, suministro de material para control de calidad interno para determinaciones en Química Clínica y soluciones para control de instrumental y pruebas de suficiencia. Desde la creación del programa se establecieron objetivos estratégicos a desarrollarse en tres etapas: establecimiento, consolidación y apoyo a la gestión de la calidad. Se genera ahora una nueva etapa, cuyo objetivo final es la acreditación. Como primer paso de este ciclo, se implementó un sistema de gestión de la calidad (SGC) de acuerdo a los requisitos establecidos en la norma argentina IRAM-ISO 9001:2015. En agosto de 2019, el Instituto Argentino de Normalización y Certificación (IRAM), representante en Argentina de la International Organization for Standarization (ISO), certificó que el SGC del programa cumple lo establecido en dicha norma. Su aplicación tiene como objetivo asegurar que los servicios ofrecidos satisfagan las necesidades de los laboratorios clínicos cumpliendo los requisitos legales requeridos y asegurando la mejora continua. El objetivo de este trabajo fue describir las acciones realizadas en la implementación del SGC y la posterior certificación de IRAM-ISO 9001:2015, por el IRAM.

Clinical laboratory determinations have a very important role in the evaluation, diagnosis, treatment and evolution of the health status of people. The reliability of their results is achieved through quality assurance and continuous improvement. The External Quality Assessment Programme Prof. Dr. Daniel Mazziotta has been accompanying clinical analysis laboratories for 31 years offering different tools to ensure analytical quality. It provides the services of external quality assessment, supply of material for internal quality control for determinations in Clinical Chemistry and solutions for instrumental control and sufficiency tests. Since the creation of the program, strategic objectives have been established to be developed in three stages: establishment, consolidation and support for quality management. A new stage is now being generated, whose final objective is accreditation. As a first step of this cycle, a quality management system (QMS) was implemented according to the requirements established in the IRAM Argentina standard-ISO 9001:2015. In August 2019, the Argentine Institute for Standardization and Certification (IRAM), representative in Argentina of the International Organization for Standardization (ISO), certified that the Programme's QMS complies with the provisions of said standard. Its application aims to ensure that the services offered meet the needs of clinical laboratories by fulfilling the legal requirements and ensuring continuous improvement. The objective of this work is to describe the actions carried out in the implementation of the QMS and the subsequent IRAM-ISO 9001: 2015 certification by the IRAM.

As determinações laboratoriais clínicas têm um papel muito importante na avaliação, diagnóstico, tratamento e evolução do estado de saúde das pessoas. A confiabilidade de seus resultados é alcançada através da garantia de qualidade e melhoria contínua. O Programa de Avaliação da Qualidade Externa "Prof. Dr. Daniel Mazziotta" apoia os laboratórios de análises clínicas há 31 anos, oferecendo diferentes ferramentas para garantir a qualidade analítica. Oferece os serviços de: avaliação externa de qualidade, fornecimento de material de controle interno de qualidade para determinações em Química Clínica e soluções para controle instrumental e testes de suficiência. Desde a criação do programa, os objetivos estratégicos foram estabelecidos para serem desenvolvidos em três etapas: estabelecimento, consolidação e suporte para a gestão da qualidade. Uma nova etapa é agora gerada, cujo objetivo final é a Acreditação. Como primeira etapa desse ciclo, um sistema de gestão da qualidade (SGQ) foi implementado de acordo com os requisitos estabelecidos na norma IRAM Argentina - ISO 9001:2015. Em agosto de 2019, o Instituto Argentino de Normalização e Certificação (IRAM), representante na Argentina da Organização Internacional de Normalização (ISO), certificou que o SGC do programa está em conformidade com as disposições da referida norma. Sua aplicação visa garantir que os serviços oferecidos satisfaçam as necessidades dos laboratórios clínicos, atendendo aos requisitos legais exigidos e garantindo a melhoria contínua. O objetivo deste trabalho é descrever as ações realizadas na implementação do SGQ e a subsequente certificação da IRAM-ISO 9001:2015, pela IRAM.

External Quality Assessment in blood morphology testing in Mongolia / Эрүүл мэндийн лаборатори

Background@#We organized the MEQAS (Mongolian External Quality Assessment Scheme) since 2008, on basis of the Cooperation agreement between Ministry of Health and Sysmex Corporation in the establishment of Hematology external quality control and reference laboratory system.</br> Therefore, since 2017 year we have set up from 1^st to 4^th External Quality Assessment (EQA) for blood morphology testing.@*Method@#This EQA for blood morphology testing included 177 clinical pathologists, 57 technologists, and 36 technicians (270 participants in total). We assessed their ability to distinguish the blood cells on a real-time basis online.@*Result, discussion@#Out of all participants, the clinical pathologists got marks ranging 70.1%, technologists got 59.0%, technicians got 58.2%. Continual trainings should be organized by different programs for laboratory specialists. A real-time online method was adopted in an EQA for the first time. This allowed the participants to know their results immediately after completing the assessment. </br> The overall results of the participants were generated in form of graphs immediately after the completion of the EQA. This allowed for visualization of areas where the percentage of correct answers were low, which were explained extensively during the discussion of answers. </br> As the results directly reflect the knowledge and skills of each participants, this form of EQA is suggested to be an extremely useful mean for determining the future education platform.@*Conclusions@#</br>1. The ability of clinical pathologists to distinguish blood cells and to interpretation are unsatisfactory. </br> 2. The ability of biomedical technologists and technicians to distinguish blood cells are unsatisfactory.

Annual Report of Korean Association of External Quality Assessment Service on Histocompatibility Testing (2018)

Here, we report the results of the first histocompatibility proficiency testing (PT) performed by the Korean Association of External Quality Assessment Service in 2018. The directly prepared PT specimens of whole blood, sera, and mononuclear cell suspensions were distributed to participants biannually. The number of participants was comparable to that in the previous external PT program, and the response rate was 88%–100%. The accuracy rates for human leukocyte antigen (HLA) A, B, C, DR, and DQ low and high resolution typing were 100%/100%, 100%/98%, 100%/99%, and 99%/98%, respectively; HLA-B27 typing, 99.1%; T cell and B cell crossmatching, 3.1% and 6.0%, respectively; and HLA antibody screening and identification, 100% and 100%, respectively. The results of HLA crossmatching were not reported from four participants due to poor cell viability. Further improvements of the specimen delivery process, grading criteria for crossmatching, and format of participant summary are warranted.