Quality Assessment Scheme Research Articles

Adverse Blood Transfusion Reaction Reporting at a Tertiary Care Hospital, Bhutan

Background and Objectives: Even though Blood Transfusion Service is considered as life-saving intervention, it is associated with the occurrence of uneventful reactions from the transfusion of blood and blood units. Bhutan Blood Bank is fragmented with different levels of services provided which leads to varied levels of adverse blood transfusion reaction reported. Study on the hemovigilance system at tertiary care hospital is conducted so as to study the frequency and types of reactions over a period of three years from 1st January 2019 to 31st December 2021. Methods: All ATRs occurring within a period of 3 years were studied according to the Blood Bank standard operating procedure. Adverse transfusion events related to blood and blood units were analyzed and classified on the basis of their clinical features and laboratory tests. Descriptive statistics were used to represent the adverse transfusion reactions. Results: During this period, a total of 19,961 blood and blood components were issued and 120 adverse transfusion events were reported. Most reaction reported were febrile non-hemolytic transfusion reaction, FNHTR (59.2%) followed by allergic reaction (22.5%) occurring predominantly in females (93%). Packed red cells were the common component causing adverse events (83 %) with most observable in Group A (42.5%) blood units. Conclusion: Febrile and allergic reactions are the most common type of reaction reported. Although such reaction type is least harmful but fatal reaction can occur and preventive measures must be taken to avoid such reactions. This preliminary study indicates the importance of having continuous monitoring and quality assessment scheme in addressing the issues of adverse transfusion reaction. Furthermore, establishing a hospital transfusion committee is vital for delivery of safe and efficient blood transfusion services.

Performance evaluation of SARS-CoV-2 antigen detection in the post-pandemic era: multi-laboratory assessment.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection is an indispensable tool for epidemic surveillance in the post-pandemic era. Faced with irregular performance, a comprehensive external quality assessment (EQA) scheme was conducted by the National Center for Clinical Laboratories (NCCL) to evaluate the analytical performance and status of SARS-CoV-2 antigen tests. The EQA panel included ten lyophilized samples containing serial 5-fold dilutions of inactivated SARS-CoV-2-positive supernatants of the Omicron BA.1 and BA.5 strains and negative samples, which were classified into "validating" samples and "educational" samples. Data were analyzed according to qualitative results for each sample. A total of 339 laboratories in China participated in this EQA scheme, and 378 effective results were collected. All validating samples were correctly reported by 90.56 % (307/339) of the participants and 90.21 % (341/378) of the datasets. The positive percent agreement (PPA) was >99 % for samples with concentrations of 2×107 copies/mL but was 92.20 % (697/756) for 4×106 copies/mL and 25.26 % (382/1,512) for 8×105 copies/mL samples. Colloidal gold was the most frequently used (84.66 %, 320/378) but showed the lowest PPAs (57.11 %, 1,462/2,560) for positive samples compared with fluorescence immunochromatography (90 %, 36/40) and latex chromatography (79.01 %, 335/424). Among 11 assays used in more than 10 clinical laboratories, ACON showed a higher sensitivity than other assays. The EQA study can help to validate whether it's necessary to update antigen detection assays for manufacturers and provide participants with information about the performance of assays to take the first step toward routine post-market surveillance.

A Multifactor Ring Signature based Authentication Scheme for Quality Assessment of IoMT Environment in COVID-19 Scenario

The quality of the healthcare environment has become an essential factor for healthcare users to access quality services. Smart healthcare systems use the Internet of Medical Things (IoMT) devices to capture patients’ health data for treatment or diagnostic purposes. This sensitive collected patient data is shared between the different stakeholders across the network to provide quality services. Due to this, healthcare systems are vulnerable to confidentiality, integrity and privacy threats. In the COVID-19 scenario, when collaborative medical consultation is required, the quality assessment of the framework is essential to protect the privacy of doctors and patients. In this paper, a ring signature-based anonymous authentication and quality assessment scheme is designed for collaborative medical consultation environments for quality assessment and protection of the privacy of doctors and patients. This scheme also uses a new KMOV Cryptosystem to ensure the quality of the network and protect the system from different attacks that hamper data confidentiality.

O-285 The 6th edition of the WHO manual for the examination and processing of human semen: How should it affect our practice?

Abstract The WHO laboratory manual (World Health Organization 2021) has widened the scope of semen examination from primarily a prognostic tool for Medically Assisted Reproduction (MAR) by indicating the importance of evaluating men with possible disorders in male reproductive functions. Practical instructions for basic examination have been clarified and focused to measures of sperm production and motility as judged from sperm number, motility (vitality if poor motility) and sperm morphology. In addition to the recommendations by the WHO, an international standard based on the same laboratory science as the WHO manual has been published (International Organization for Standardization 2021) to facilitate for laboratories to provide reliable results of semen examination. Each ejaculate must be handled with great care before analysis begins. Time and temperature between sample collection and start of assessments is crucial. To reduce assessment variability, it is essential to ascertain that the examined aliquots are representative for the entire ejaculate and that the number of observations is sufficient to reduce the risk for significant influence of random factors. The former is handled both by aliquot volume (at least 50 µL for sperm concentration) and replicate assessment and comparison that the two assessments don’t differ too much. Regarding number of observations, 400 sperm counted in sperm concentration and in sperm motility assessments is required to reduce this source of errors to ± 10%. For assessment of sperm morphology and vitality a minimum number of observations is 200 spermatozoa. To achieve acceptable performance, thorough in-house training is necessary. There are protocols how to set up and run such schemes (Mortimer 1994, 1994). Basic medical laboratory standards also require that the laboratory regularly performs internal quality control to monitor that inter- and intra-personal variability is under control. Each laboratory should also participate in an external scheme for quality assessment (EQA) (International Organization for Standardization 2012). For the proper interpretation of semen examination results reference limits are important. However, the reference limits suggested by the WHO (World Health Organization 2021) come from a very mixed group of men and should therefore not be mistaken for true limits between fertility and infertility. The new WHO manual therefore argues for development of decision limits (when is it reasonable to act?) that are much more important than limits from a mixed population. It has been argued that semen examination must be better standardized (Björndahl et al. 2016), but the compliance has been almost non-existent (Vasconcelos et al. 2022) leading to even stronger appeals for stronger improvement of basic laboratory investigations of male reproductive functions (Björndahl et al. 2022) References Björndahl L, Barratt CL, Mortimer D, and Jouannet P. ‘How to count sperm properly': checklist for acceptability of studies based on human semen analysis. Hum Reprod 2016: 31; 227-232. Björndahl L, Barratt CLR, Mortimer D, Agarwal A, Aitken RJ, Alvarez JG, Aneck-Hahn N, Arver S, Baldi E, Bassas L, et al. Standards in semen examination: publishing reproducible and reliable data based on high-quality methodology. Hum Reprod 2022. International Organization for Standardization. ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence 2012. Geneva. International Organization for Standardization. ISO 23162:2021 Basic semen examination — Specification and test methods 2021. ISO, Geneva. Mortimer D. Laboratory standards in routine clinical andrology. Reproductive Medicine Review 1994: 3; 97-111. Mortimer D. Practical Laboratory Andrology 1994. Oxford University Press, Oxford. Vasconcelos AL, Campbell MJ, Barratt CLR, and Gellatly SA. Do studies published in two leading reproduction journals between 2011 and 2020 demonstrate that they followed WHO5 recommendations for basic semen analysis? Hum Reprod 2022. World Health Organization. WHO laboratory manual for the examination and processing of human semen. 6th edn, 2021. World Health Organization, Geneva.

Spurious Outlier in Cell Counter for Total White Blood Cell Count Parameter in Laboratory External Quality Assurance Program

Abstract Background & Aims: In the External Quality Assessment Program (EQAP), medical laboratories' test results are compared to their peers by statistical analysis. The present study aims to highlight issues related to the root cause for the outliers in EQAP, the factors which lie outside the laboratory operation. Material and Method: Indian Society of Haematology and Blood Transfusion and All India Institute of Medical Science (ISHTM AIIMS) EQAP samples were analyzed in HORIBA Yumizen H 550 and HORIBA Pentra 60 cell counter. Randox international quality assessment scheme hematology (RIQAS) was analyzed on Yumizen H 550 cell counter. Result: All CBC parameters performance except Total WBC were found satisfactory as Z score is below three in ISHTM AIIMS EQAS on Yumizen H 550 in both laboratories. In contrast, Yumizen H 550 cell counter showed unsatisfactory performance as the Z score was more than three in both laboratories. In RIQAS Yumizen H 550 cell, the counter-performance of all CBC parameters is satisfactory for all samples as SDI is less than three. Conclusion: Horiba Yumizen H 550 cell counter gives spurious outlier in the total WBC parameter for ISHTM AIIMS EQAS. Switching to other EQAPs can provide the solution to a constant outlier. Keywords: Cell counter, External quality assurance, Yumizen H 550, RQAS, Total WBC count

Principal Component Analysis and the Water Quality Index—A Powerful Tool for Surface Water Quality Assessment: A Case Study on Struma River Catchment, Bulgaria

The water quality assessment of the surface water bodies (SWBs) is one of the major tasks of environmental authorities dealing with water management. The present study proposes a water quality assessment scheme for the investigation of the surface waters’ physicochemical status changes and the identification of significant anthropogenic pressures. It is designed to extract valuable knowledge from the Water Frame Directive (WFD) mandatory monitoring datasets. The water quality assessment scheme is based on the Canadian Council of Ministers of the Environment water quality index (CCME-WQI), trend analysis of estimated WQI values, and Principal Component Analysis (PCA) using calculated excursions during the determination of WQI values. The combination of the abovementioned techniques preserves their benefits and additionally provides important information for water management by revealing the latent factors controlling water quality, taking into account the type of the SWB. The results enable the identification of the anthropogenic impact on SWBs and the type of the corresponding anthropogenic pressure, prioritization and monitoring restoration measures, and optimization of conducted monitoring programs to reflect significant anthropogenic pressures. The proposed simple and reliable assessment scheme is flexible to introducing additional water quality indicators (hydrological, biological, specific pollutants, etc.), which could lead to a more comprehensive surface water quality assessment.

First Round of External Quality Assessment Scheme for SARS-CoV-2 Laboratories During the COVID-19 Pandemic in Thailand.

The emergence of SARS-CoV-2 necessitated the rapid deployment of tests to diagnose COVID-19. To monitor the accuracy of testing across the COVID-19 laboratory network in Thailand, the Department of Medical Sciences under the Ministry of Public Health launched a national external quality assessment (EQA) scheme using samples containing inactivated SARS-CoV-2 culture supernatant from a predominant strain in the early phase of the Thailand outbreak. All 197 laboratories in the network participated; 93% (n=183) of which reported correct results for all 6 EQA samples. Ten laboratories reported false-negative results, mostly for samples with low viral concentrations, and 5 laboratories reported false-positive results (1 laboratory reported false positives and false negatives). An intralaboratory investigation of 14 laboratories reporting incorrect results revealed 2 main causes of error: (1) RNA contamination of the rRT-PCR reaction and (2) poor-quality RNA extraction. Specific reagent combinations were significantly associated with false-negative reports. Thailand's approach to national EQA for SARS-CoV-2 can serve as a roadmap for other countries interested in implementing a national EQA program to ensure laboratories provide accurate testing results, which is crucial in diagnosis, prevention, and control strategies. A national EQA program can be less costly and thus more sustainable than commercial EQA programs. National EQA is recommended to detect and correct testing errors and provide postmarket surveillance for diagnostic test performance.

Analytical variation concerning total 25-hydroxyvitamin D measurement, where are we now? A DEQAS review of current assay performance

The Vitamin D External Quality Assessment Scheme (DEQAS) distributes serum samples globally, on a quarterly basis, to assess participants’ performance of specific methods for 25-hydroxyvitamin D (25OHD) and other vitamin D metabolites. In this review an assessment of the state of the art in the performance of 25OHD methods is presented. This assessment is based on an analysis of data submitted by scheme participants for the 2021/22 distribution cycle, which comprised of four distributions each containing five DEQAS samples. These distributions enabled the assessment of performance across a wide concentration range and included samples containing endogenous 25OHD2. Overall analytical performance continues to improve, but there is still significant method variation and bias in some automated methods. These automated methods continue to be challenged in measuring 25OHD at the extremes of the measuring range and in the presence of 25OHD2. LC-MS/MS methods still show superior performance with regards to bias, but are out-performed by some automated methods in terms of assay variability. Through participating in an accuracy based EQA scheme, such as DEQAS, laboratories are able to assess the accuracy of their methods in comparison to a gold standard reference measurement procedure. It is crucial for all laboratories to be aware of the performance and limitations of their 25OHD assays and to educate their users accordingly in order to ensure reliable assessment of vitamin D status.

Determination of 24,25-dihydroxyvitamin D3 in Vitamin D External Quality Assessment Scheme samples using a reference measurement procedure

Ninety archived human serum samples from the Vitamin D External Quality Assessment Scheme (DEQAS) were analyzed using a reference measurement procedure (RMP) based on isotope dilution liquid chromatography – tandem mass spectrometry (ID LC-MS/MS) for the determination of 24,25-dihydroxyvitamin D3 [24,25(OH)2D3]. These 24,25(OH)2D3 results, in conjunction with concentration values assigned using RMPs for 25-hydroxyvitamin D2 [25(OH)D2] and 25-hydroxyvitamin D3 [25(OH)D3], provide a valuable resource for assessing the accuracy of measurements for 24,25(OH)2D3 and for investigating the relationship between 24,25(OH)2D3 and 25(OH)D3. Results for 24,25(OH)2D3 using the RMP were compared to DEQAS consensus values demonstrating that the consensus values were not sufficient to assess the accuracy of measurements among different laboratories and methods. A multivariable regression analysis approach using historical DEQAS consensus values for various total 25(OH)D assays was used to assess the contribution of 24,25(OH)2D3 concentration on the assay response. The response of several ligand binding assays for total 25(OH)D was shown to be impacted by the presence of 24,25(OH)2D3.

Results of the first German external quality assessment scheme for the detection of monkeypox virus DNA.

In May 2022, the monkeypox virus (MPXV) spread into non-endemic countries and the global community was quick to test the lessons learned from the SARS-CoV-2 pandemic. Due to its symptomatic resemblance to other diseases, like the non-pox virus varicella zoster (chickenpox), polymerase chain reaction methods play an important role in correctly diagnosing the rash-causing pathogen. INSTAND quickly established a new external quality assessment (EQA) scheme for MPXV and orthopoxvirus (OPXV) DNA detection to assess the current performance quality of the laboratory tests. We analyzed quantitative and qualitative data of the first German EQA for MPXV and OPXV DNA detection. The survey included one negative and three MPXV-positive samples with different MPX viral loads. The threshold cycle (Ct) or other measures defining the quantification cycle (Cq) were analyzed in an assay-specific manner. A Passing Bablok fit was used to investigate the performance at laboratory level. 141 qualitative datasets were reported by 131 laboratories for MPXV detection and 68 qualitative datasets by 65 laboratories for OPXV detection. More than 96% of the results were correctly identified as negative and more than 97% correctly identified as positive. An analysis of the reported Ct/Cq values showed a large spread of these values of up to 12 Ct/Cq. Nevertheless, there is a good correlation of results for the different MPXV concentrations at laboratory level. Only a few quantitative results in copies/mL were reported (MPXV: N = 5; OPXV: N = 2), but the results correlated well with the concentration differences between the EQA samples, which were to a power of ten each. The EQA results show that laboratories performed well in detecting both MPXV and OPXV. However, Ct/Cq values should be interpreted with caution when conclusions are drawn about the viral load as long as metrological traceability is not granted.

Determination of seven monoaromatic hydrocarbon metabolites by ultra performance liquid chromatography-tandem mass spectrometry

Monoaromatic hydrocarbons (MAHs) such as benzene, toluene, and xylene are important anthropogenic pollutants in the urban atmosphere. The detection of urinary MAH metabolites are included in human biomonitoring programs in several countries, including Canada, the United States, Italy, and Germany, because their evaluation is vital to monitor the exposure of humans to MAHs. To this end, herein, a method was developed for the determination of seven MAH metabolites through ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). An aliquot of 0.5 mL urine was fortified with an isotopic labeled internal standard solution before being hydrolyzed by 40 μL of 6 mol/L HCl solution, followed by extraction using a 96-well EVOLUTE®EXPRESS ABN solid-phase extraction plate. The samples were washed with 1.0 mL of methanol-water (10∶90, v/v) and eluted with 1.0 mL methanol. The eluate was diluted four times with water prior to use in instrumental analysis. Chromatographic separation was achieved using an ACQUITY UPLC HSS T3 column (100 mm×2.1 mm, 1.8 μm), with gradient elution using 0.1% formic acid as mobile phase A and methanol as mobile phase B. The detection of seven analytes was performed using a triple-quadrupole mass spectrometer equipped with a negative electrospray ionization source in the multiple reaction monitoring mode. The linear ranges of the seven analytes varied from 0.1-20 μg/L to 2.5-500 mg/L, with correlation coefficients greater than 0.995. The method detection limits were 1.5, 0.02, 0.1, 900, 0.6, and 4 μg/L for trans,trans-muconic acid (MU), S-phenylmercapturic acid (PMA), S-benzylmercapturic acid (BMA), hippuric acid (HA), 2-methyl hippuric acid (2MHA), and 3-methyl hippuric acid (3MHA)+4-methyl hippuric acid (4MHA), respectively. The limits of quantification were 5, 0.05, 0.4, 3000, 2, and 12 μg/L for MU, PMA, BMA, HA, 2MHA, and 3MHA+4MHA, respectively. The method was verified by spiking urine samples at three different concentration levels, with recovery rates ranging from 84% to 123%. The intra- and inter-day precisions were 1.8%-8.6% and 1.9%-21.4%, respectively. The extraction efficiencies were 68%-99%, and the matrix effects ranged from -11% to -87%. The urine samples obtained from the German external quality assessment scheme (round 65) were used to assess the accuracy of this method. Both high and low concentrations of MU, PMA, HA, and methyl hippuric acid were within the tolerance range. All analytes in the urine samples were found to be stable for up to seven days at room temperature (20 ℃, absence of light), with less than 15% change in concentration. Analytes in urine samples were found to be stable for at least 42 d at 4 ℃ and -20 ℃, or for six freeze-thaw cycles and up to 72 h in an autosampler (8 ℃). The method was applied to the analysis of 16 non-smokers' and 16 smokers' urine samples. The detection rates of MU, BMA, HA, and 2MHA were 100% in both non-smokers' and smokers' urine samples. PMA was detected in 75% non-smokers' and 100% smokers' urine samples. 3MHA+4MHA was detected in 81% non-smokers' urine and in all smokers' urine samples. Statistical differences were found for MU, PMA, 2MHA, and 3MHA+4MHA between the two groups (p<0.001). The established method has good robustness and can provide reliable results. The experiments were carried out in a high-throughput manner with large sample sizes, owing to the small sample volume, and allowed the successful detection of the seven MAH metabolites in human urine.

One Health surveillance-A cross-sectoral detection, characterization, and notification of foodborne pathogens.

Several Proficiency Test (PT) or External Quality Assessment (EQA) schemes are currently available for assessing the ability of laboratories to detect and characterize enteropathogenic bacteria, but they are usually targeting one sector, covering either public health, food safety or animal health. In addition to sector-specific PTs/EQAs for detection, cross-sectoral panels would be useful for assessment of the capacity to detect and characterize foodborne pathogens in a One Health (OH) perspective and further improving food safety and interpretation of cross-sectoral surveillance data. The aims of the study were to assess the cross-sectoral capability of European public health, animal health and food safety laboratories to detect, characterize and notify findings of the foodborne pathogens Campylobacter spp., Salmonella spp. and Yersinia enterocolitica, and to develop recommendations for future cross-sectoral PTs and EQAs within OH. The PT/EQA scheme developed within this study consisted of a test panel of five samples, designed to represent a theoretical outbreak scenario. A total of 15 laboratories from animal health, public health and food safety sectors were enrolled in eight countries: Denmark, France, Italy, the Netherlands, Poland, Spain, Sweden, and the United Kingdom. The laboratories analyzed the samples according to the methods used in the laboratory and reported the target organisms at species level, and if applicable, serovar for Salmonella and bioserotype for Yersinia. All 15 laboratories analyzed the samples for Salmonella, 13 for Campylobacter and 11 for Yersinia. Analytical errors were predominately false negative results. One sample (S. Stockholm and Y. enterocolitica O:3/BT4) with lower concentrations of target organisms was especially challenging, resulting in six out of seven false negative results. These findings were associated with laboratories using smaller sample sizes and not using enrichment methods. Detection of Salmonella was most commonly mandatory to notify within the three sectors in the eight countries participating in the pilot whereas findings of Campylobacter and Y. enterocolitica were notifiable from human samples, but less commonly from animal and food samples. The results of the pilot PT/EQA conducted in this study confirmed the possibility to apply a cross-sectoral approach for assessment of the joint OH capacity to detect and characterize foodborne pathogens.

An external quality assessment feasibility study; cross laboratory comparison of haemagglutination inhibition assay and microneutralization assay performance for seasonal influenza serology testing: A FLUCOP study.

External Quality Assessment (EQA) schemes are designed to provide a snapshot of laboratory proficiency, identifying issues and providing feedback to improve laboratory performance and inter-laboratory agreement in testing. Currently there are no international EQA schemes for seasonal influenza serology testing. Here we present a feasibility study for conducting an EQA scheme for influenza serology methods. We invited participant laboratories from industry, contract research organizations (CROs), academia and public health institutions who regularly conduct hemagglutination inhibition (HAI) and microneutralization (MN) assays and have an interest in serology standardization. In total 16 laboratories returned data including 19 data sets for HAI assays and 9 data sets for MN assays. Within run analysis demonstrated good laboratory performance for HAI, with intrinsically higher levels of intra-assay variation for MN assays. Between run analysis showed laboratory and strain specific issues, particularly with B strains for HAI, whilst MN testing was consistently good across labs and strains. Inter-laboratory variability was higher for MN assays than HAI, however both assays showed a significant reduction in inter-laboratory variation when a human sera pool is used as a standard for normalization. This study has received positive feedback from participants, highlighting the benefit such an EQA scheme would have on improving laboratory performance, reducing inter laboratory variation and raising awareness of both harmonized protocol use and the benefit of biological standards for seasonal influenza serology testing.

Examination of discordant external quality assessment scheme results

An external quality assessment scheme (EQAS) is a form of external quality assurance that provides evaluation of laboratory performance based on the analysis of a collection of samples supplied by an external agency. EQAS performance has been shown to reflect the quality of patient specimen testing in a clinical laboratory.

Quality indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies.

In the last few decades, quality in laboratory medicine has evolved in concert with the transformation and the changes (technological, scientific and organizational) in this sector. Laboratory professionals have faced great challenges, at times being overwhelmed, yetalso involved in this progress. Worldwide, laboratory professionals and scientific societies involved in laboratory medicine have raised awareness concerning the need to identify new quality assurance tools that are effective in reducing the error rate and enhancing patient safety, in addition to Internal Quality Control (IQC) procedures and the participation in the External Quality Assessment Schemes (EQAS). The use of Quality Indicators (QIs), specifically designed for laboratory medicine are effective inassessing and monitoring all critical events occurring inthe different phases of Total Testing Process (TTP), in particular, in the extra-analytical phases. The Model ofQuality Indicators (MQI), proposed by the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of the International Federation of Clinical Chemistry andLaboratory Medicine (IFCC) and validated by experts in consensus conferences, is an important window of opportunity for the medical laboratory to demonstrate the use of an effective quality assurance tool fit for this purpose. Aim of this paper is to provide an update of the state-of-the-art concerning the most used QIs data collected in 2021 and the Quality Specifications (QSs) proposed for their evaluation. Moreover, a strategy for the future is proposed in order to improve the MQI and encourage its use in medical laboratories throughout the world.

Converting to an international unit system improves harmonization of results for SARS-CoV-2 quantification: Results from multiple external quality assessments

The detection of SARS-CoV-2 vRNA in clinical samples has relied almost exclusively on RT-qPCR as the gold standard test. Published results from various external quality assessments ("ring trials") worldwide have shown that there is still a large variability in results reported for the same samples. As reference standards of SARS-CoV-2 RNA are available, we tested whether using standard curves to convert Ct values into copies/mL (cp/mL) improved harmonization. Nine laboratories using 23 test systems (15 of which were unique) prepared standard dilution curves to convert Ct values of 13 SARS-CoV-2 positive samples to cp/mL (hereafter IU/mL). The samples were provided in three rounds of a virus genome detection external quality assessment (EQA) scheme. We tested the precision and accuracy of results reported in IU/mL, and attempted to identify the sources of variability. Reporting results as IU/mL improved the precision of the estimated concentrations of all samples compared to reporting Ct values, although some inaccuracy remained. Variance analysis showed that nearly all variability in data was explained by individual test systems within individual laboratories. When controlling for this effect, there was no significant difference between all other factors tested (test systems, EQA rounds, sample material). Converting results to copies/mL improved precision across laboratory test systems. However, it seems the results are still very specific to test systems within laboratories. Further efforts could be made to improve accuracy and achieve full harmonization across diagnostic laboratories.

Six Sigma metrics as an indicator for Randox International Quality Assessment Scheme in clinical biochemistry laboratory

Context: Six Sigma methodology represents an evolution in quality assessment and management that has been implemented widely in industry and health sector since the mid-1980s. It consists of five steps: define, measure, analyze, improve, and control (DMAIC). Randox International Quality Assessment Scheme (RIQAS) program Target Score (TS) is a performance indicator, and Sigma metrics is considered as a gold standard for overall performance. Aim: The aim of this study is to present the TS and Sigma metrics observed in clinical chemistry laboratory in SSK Hospital associated with Lady Hardinge Medical College to evaluate the analytical performance of T3, T4, and thyroid-stimulating hormone (TSH) parameters. The study period is from June to August 2022. Materials and Methods: The Sigma metrics for the various analytes was calculated by the following equation: Σ = TEa − bias/CV (TEa—total allowable error, CV—coefficient of variation). Acceptable performance criteria: standard deviation index (SDI) &lt;2; TS &gt;50; the closer a value is to 120, the better the performance, &lt;40 is unacceptable; and %deviation should be less than the defined acceptable limits which is unique to each analyte, the closer the value is to zero, the better is the performance. Results: Our RIQAS results lie in acceptable range except for T3 in the month of August in which TS was unacceptable. Our laboratory Sigma metrics were below three sigmas. The findings of our exercise emphasize the need for a detailed evaluation, and we promote the use of Sigma metrics in quality assurance in the best interest of the patient. Conclusion: Quality check strategies were applied according to the TS and sigma values.

Influence factors of lead in whole blood in the German External Quality Assessment Scheme by ICP-MS

To investigate the influence factors of lead in whole blood in the German External Quality Assessment Scheme(G-EQUAS) biological materials by inductively coupled plasma mass spectrometry(ICP-MS) from 2018 to 2020. ICP-MS was used to determine lead in whole blood of G-EQUAS by optimizing the reaction gas mode, sample dilution ratio, internal standard element, isotope and so on, analyzed the result. This study indicated that selection of internal standard elements, isotopes, matrix effect and physical effect may affect the accuracy of ICP-MS determination of lead in biological samples. Avoided the factors that may affect the result when determining lead in whole blood by ICP-MS.

한영 문학번역 텍스트에의 Juliane House의 번역품질 평가이론 적용: 사례 연구

This study considers Juliane House’s (2015) translation quality assessment (TQA) scheme for Korean-to-English literary translation evaluation. Unlike typical literary translation evaluations, House’s scheme is based on Systemic Functional Linguistics (SFL) framework, which involves functional aspects of language. This case study is the first to utilize House’s TQA for Korean-to-English translated texts. The results reveal that House’s (2015) TQA has more advantages than disadvantages in terms of evaluating the English translation of Korean texts. We are able to utilize the functional aspects of the texts in cultural and situational contexts as the evaluative elements such as field, tenor, and mode using corpus analysis.

Annual Report on the External Quality Assessment Scheme for Clinical Parasitology in Korea (2020–2021)

Annual Report on the External Quality Assessment Scheme for Clinical Parasitology in Korea (2020–2021)