Search Results (18)

This article examines whether the presentation of integrated reports (IRs), the external assurance of non-financial information, and the use of auditing standards affect market liquidity and the accuracy of earnings per share forecasts in the Chilean market following the publication of the International IR Framework. Using ordinary least squares estimations, results show that IRs significantly reduce information asymmetry, thereby improving market liquidity. This effect is reinforced when non-financial information is externally assured, particularly under the ISAE3000 standard. However, neither IRs nor external assurance significantly impact financial analysts’ earnings forecast accuracy, suggesting that such information serves a complementary role in their evaluations. This study contributes to the literature by providing empirical evidence on the role of IRs and assurance in emerging economies, emphasizing their effectiveness in enhancing transparency and liquidity. The findings have direct implications for companies, as they suggest that adopting IRs and obtaining external assurance can strengthen market perceptions and investor confidence, particularly when using the ISAE3000 standard. For regulators, the results highlight the potential benefits of promoting standardized sustainability disclosures and assurance mechanisms to foster transparency in capital markets. Investors, in turn, can use IR quality and assurance as signals of corporate credibility and long-term value creation. Full article

Glyphosate-based herbicides are the most widely used pesticides in the world; however, the toxicity of glyphosate (GlyP) toward humans, especially its carcinogenicity, is controversial. The aim of this work was to validate a rapid assay for measuring GlyP and its metabolite aminomethylphosphonic acid (AMPA) in urine for human biomonitoring. The analytes were purified via solid-phase extraction in the presence of isotopically labeled internal standards. An LC-MS/MS assay was developed using a column with a novel hybrid stationary phase combined with anion exchange and hydrophilic interaction liquid chromatography. Detection and quantification were performed using negative electrospray ionization in a hybrid triple quadrupole/linear ion trap mass spectrometer. The retention times for AMPA and GlyP were 1.44 and 7.24 min, respectively. Calibration curves showed a linear dynamic range of up to 40 µg/L, inter- and intra-run precisions <7.5%, and accuracies within 10% of the theoretical concentrations. The limits of quantification were 0.1 µg/L and 0.5 µg/L for GlyP and AMPA, respectively. The matrix effect bias was controlled using internal standards. Successful participation in external quality assurance exercises strengthens the validity of the method. The assay was applied to the measurement of GlyP and AMPA in the urine of 9 urban residents, 26 rural residents, and 12 agricultural workers; while AMPA was mostly not quantifiable, the median GlyP values were 0.1 and 0.34 µg/L in rural residents and workers, respectively. The assay is useful to assess GlyP and AMPA in human urine following different exposure scenarios. Full article

There are mixed reports on the inclusion and use of 21 deoxycortisol (21DF) as the primary decision marker for classical 21-hydroxylase deficiency. We hypothesize that this may be due to insufficient recognition of the presence and chromatographic separation of isomeric steroids. The aim of this study was to determine the comparative utility of 21DF for screening and diagnosis of CAH due to classical 21-hydroxylase deficiency using a second-tier LC–MS/MS method that included the separation of isomeric steroids to 17OHP and 21DF. For each baby sample, one 3.2 mm dried blood spot was eluted in a methanolic solution containing isotopically matched internal standards. Data were interrogated by univariate and receiver operator characteristic analysis. Steroid profile results were generated for 924 non-CAH baby samples (median gestational age 37 weeks, range 22 to 43 weeks) and 17 babies with 21-hydroxylase deficiency. The ROC curves demonstrated 21DF to have the best sensitivity and specificity for the diagnosis of classical 21-hydroxylase deficiency with an AUC = 1.0. The heatmap showed the very strong correlation (r = 0.83) between 17OHP and 21DF. Our data support 21DF as a robust marker for CAH due to 21-hydroxylase deficiency. We recommend that 21DF be incorporated into routine newborn screening panels as part of the second-tier LC–MS/MS method, follow-up plasma steroid panels, and external quality assurance material. Full article

Background: Health-related mobile applications (apps) are rapidly increasing in number. There is an urgent need for assessment tools and algorithms that allow the usability and content criteria of these applications to be objectively assessed. The aim of this work was to establish and validate a concept for orthopedic societies to rate health apps to set a quality standard for their safe use. Methods: An objective rating concept was created, consisting of nine quality criteria. A self-declaration sheet for app manufacturers was designed. Manufacturers completed the self-declaration, and the app was examined by independent internal reviewers. The pilot validation and analysis were performed on two independent health applications. An algorithm for orthopedic societies was created based on the experiences in this study flow. Results: “Sprunggelenks-App“ was approved by the reviewers with 45 (98%) fulfilled criteria and one (2%) unfulfilled criterion. “Therapie-App” was approved, with 28 (61%) met criteria, 6 (13%) unfulfilled criteria and 12 (26%) criteria that could not be assessed. The self-declaration completed by the app manufacturer is recommended, followed by a legal and technical rating performed by an external institution. When rated positive, the societies’ internal review using independent raters can be performed. In case of a positive rating, a visual certification can be granted to the manufacturer for a certain time frame. Conclusion: An objective rating algorithm is proposed for the assessment of digital health applications. This can help societies to improve the quality assessment, quality assurance and patient safety of those apps. The proposed concept must be further validated for inter-rater consistency and reliability. Full article

For diagnosing SARS-CoV-2 infection and for monitoring its spread, the implementation of external quality assessment (EQA) schemes is mandatory to assess and ensure a standard quality according to national and international guidelines. Here, we present the results of the 2020, 2021, 2022 EQA schemes in Lombardy region for assessing the quality of the diagnostic laboratories involved in SARS-CoV-2 diagnosis. In the framework of the Quality Assurance Programs (QAPs), the routinely EQA schemes are managed by the regional reference centre for diagnostic laboratories quality (RRC-EQA) of the Lombardy region and are carried out by all the diagnostic laboratories. Three EQA programs were organized: (1) EQA of SARS-CoV-2 nucleic acid detection; (2) EQA of anti-SARS-CoV-2-antibody testing; (3) EQA of SARS-CoV-2 direct antigens detection. The percentage of concordance of 1938 molecular tests carried out within the SARS-CoV-2 nucleic acid detection EQA was 97.7%. The overall concordance of 1875 tests carried out within the anti-SARS-CoV-2 antibody EQA was 93.9% (79.6% for IgM). The overall concordance of 1495 tests carried out within the SARS-CoV-2 direct antigens detection EQA was 85% and it was negatively impacted by the results obtained by the analysis of weak positive samples. In conclusion, the EQA schemes for assessing the accuracy of SARS-CoV-2 diagnosis in the Lombardy region highlighted a suitable reproducibility and reliability of diagnostic assays, despite the heterogeneous landscape of SARS-CoV-2 tests and methods. Laboratory testing based on the detection of viral RNA in respiratory samples can be considered the gold standard for SARS-CoV-2 diagnosis. Full article

The extensive use of herbicides, such as glyphosate and glufosinate, in crop production during recent decades has raised concerns about human exposure. Nevertheless, analysis of trace levels of these herbicides in human biospecimens has been challenging. Here, we describe a method for the determination of urinary glyphosate, its degradation product aminomethylphosphonic acid (AMPA), and glufosinate using liquid chromatography-tandem mass spectrometry (LC–MS/MS). The method was optimized using isotopically labelled internal standards (¹³C₂, ¹⁵N-glyphosate, ¹³C, ¹⁵N, D₂-AMPA, and D₃-glufosinate) and solid-phase extraction (SPE) with cation-exchange and anion-exchange cartridges. The method provides excellent chromatographic retention, resolution and peak shape of target analytes without the need for strong acidic mobile phases and derivatization steps. The instrument linearity was in the range of 0.1–100 ng/mL, with R > 0.99 in the matrix for all analytes. The method detection limits (MDLs) and the method quantification limits (MQLs) were in the ranges of 0.12 (AMPA and glufosinate)–0.14 (glyphosate) ng/mL and 0.40 (AMPA)–0.48 (glyphosate) ng/mL, respectively. The recoveries of analytes spiked into urine matrix ranged from 79.1% to 119%, with coefficients of variation (CVs) of 4–10%. Repeated analysis of samples for over 2 weeks showed intra-day and inter-day analytical variations of 3.13–10.8% and 5.93–12.9%, respectively. The matrix effects for glyphosate, AMPA, and glufosinate spiked into urine matrix averaged −14.4%, 13.2%, and 22.2%, respectively. The method was further validated through the analysis of external quality assurance proficiency test (PT) urine samples. The method offers optimal sensitivity, accuracy, and precision for the urine-based assessment of human exposure to glyphosate, AMPA, and glufosinate. Full article

Monitoring of minimal residual disease (MRD) by flow cytometry (FCM) is a powerful prognostic tool for predicting outcomes in acute lymphoblastic leukemia (ALL). To apply FCM-MRD in large, collaborative trials, dedicated laboratory staff must be educated to concordantly high levels of expertise and their performance quality should be continuously monitored. We sought to install a unique and comprehensive training and quality control (QC) program involving a large number of reference laboratories within the international Berlin-Frankfurt-Münster (I-BFM) consortium, in order to complement the standardization of the methodology with an educational component and persistent quality control measures. Our QC and quality assurance (QA) program is based on four major cornerstones: (i) a twinning maturation program, (ii) obligatory participation in external QA programs (spiked sample send around, United Kingdom National External Quality Assessment Service (UK NEQAS)), (iii) regular participation in list-mode-data (LMD) file ring trials (FCM data file send arounds), and (iv) surveys of independent data derived from trial results. We demonstrate that the training of laboratories using experienced twinning partners, along with continuous educational feedback significantly improves the performance of laboratories in detecting and quantifying MRD in pediatric ALL patients. Overall, our extensive education and quality control program improved inter-laboratory concordance rates of FCM-MRD assessments and ultimately led to a very high conformity of risk estimates in independent patient cohorts. Full article

In light of the increasing detrimental effects on sustainability, the reverse logistics supply chain (RLSC) has emerged as one of the remedies in the construction industry, whereby the bulk of demolition waste (DW) is returned into the production cycle. Quality assurance (QA) plays an important role in RLSCs, which needs an information-rich environment enriched with external stakeholders’ influence strategies. However, due to ineffective external stakeholders’ influence, useful information is not available, making macro-level uncertainties for QA. Given this, the current study aimed to identify the macro-level uncertainties for QA in the RLSC of DW. The study used a qualitative approach involving 21 semi-structured interviews representing five external stakeholder categories. The study found the regulatory uncertainties are the root causes that propagate through incentivizing and contractual uncertainties to influence QA in the RLSC. The external stakeholders could employ measures such as ‘reforming regulatory instruments’, ‘employing effective incentivizing schemes’ and ‘active involvement of forward supply chain actors’ to minimize uncertainties at their source. The external and internal stakeholders can use these findings as a roadmap to determine suitable measures to overcome macro-level uncertainties in the RLSC. Furthermore, the study paved an avenue to integrate stakeholder theory and organizational information processing theory (OIPT) in future research. Full article

The article discusses the issues of forming a study program in the context of the process’ compliance with the recommendations provided by Standards and Guidelines for Quality Assurance in the European Higher Education Area (ESG), which are relevant for Ukrainian higher education. The study achieved its goal: the main prerequisites for the formation of the study program (SP) were analyzed, its structural and semantic parameters were determined, and a step-by-step model of concluding a quality study program in accordance with the ESG guidelines was suggested. The search for the materials on which the study was based was conducted using the following databases: scientometric (Scopus, Web of Science), the information system (online platform) of the National Agency for Quality Assurance in Higher Education (NAQA), and the “Legislation of Ukraine” database. Quantitative methods included an online questionnaire, qualitative methods included system analysis, and other comparative method were used. Due to the contradictions between the interpretations of the concepts at the level of legislation and internal regulations, a definition of the “formation of the study program” concept is suggested. The components of the SP formation process, the resources required for the formation of the quality SP, and an analysis of positive and negative practices from the NAQA accreditation procedure experience, based on which the optimal model of the SP as a dynamic system based on ESG guidelines was developed, which has a functional character and is based on theoretical generalization of the latest approaches and real cases of Ukrainian HEIs, were discussed. Full article

This study aims to identify the role of higher education quality assurance in achieving sustainable development goals. To support this aim, the following objectives were formulated: to discuss and summarize the best practices of QA agencies in promoting SDGs, to identify how Ukrainian universities consider SDGs in their policies, to develop recommendations for internal, and external quality assurance systems regarding SDG achievement. This qualitative study is based on a case study, observation, and questionnaire methods. Ukrainian higher education quality assurance systems are taken as a case study for this article. Primary data are collected through an online questionnaire and observation of Ukrainian universities’ publicly available information regarding sustainable development activities at their official websites. Additionally, some publicly available documents, reports, and materials on the experience of foreign quality assurance agencies are also reviewed, compared, and contrasted. The results of the research can be used at national levels where higher education standards should include competence in sustainable development goals, at institutional level to improve HEIs’ quality assurance system, and at the study program level to include SDG consideration as one of the requirements during internal quality assurance procedures. Full article

Pathology results are central to modern medical practice, informing diagnosis and patient management. To ensure high standards from pathology laboratories, regulators require compliance with international and local standards. In Australia, the monitoring and regulation of medical laboratories are achieved by conformance to ISO15189-National Pathology Accreditation Advisory Council standards, as assessed by the National Association of Testing Authorities (NATA), and an external quality assurance (EQA) assessment via the Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP). While effective individually, integration of data collected by NATA and EQA testing promises advantages for the early detection of technical or management problems in the laboratory, and enhanced ongoing quality assessment. Random forest (RF) machine learning (ML) previously identified gamma-glutamyl transferase (GGT) as a leading predictor of NATA compliance condition reporting. In addition to further RF investigations, this study also deployed single decision trees and support vector machines (SVM) models that included creatinine, electrolytes and liver function test (LFT) EQA results. Across all analyses, GGT was consistently the top-ranked predictor variable, validating previous observations from Australian laboratories. SVM revealed broad patterns of predictive EQA marker interactions with NATA outcomes, and the distribution of GGT relative deviation suggested patterns by which to identify other strong EQA predictors of NATA outcomes. An integrated model of pathology quality assessment was successfully developed, via the prediction of NATA outcomes by EQA results. GGT consistently ranked as the best predictor variable, identified by combining recursive partitioning and SVM ML strategies. Full article

Basel III regulation intent is to increase the resiliency of banks through effective risk management practices that can reduce significant idiosyncratic operational losses. A systemic risk event that leads to significant losses in a bank holding company (BHC) can expose them to become insolvent and cause significant volatility and unpredictable negative impact on the United States economy. The viral spread of operational losses through global markets by interconnected multinational banks can be compared to viruses spread through interconnected countries and the significant losses incurred; this can be referred to as idiosyncratic viral loss theory. This idiosyncratic viral loss theory discusses systemic operational losses that are evident in human error, fraud, and legal expenses that are aligned to systemic operational risk. The occurrences of significant losses that are idiosyncratic in nature and that are linked to failed internal processes, people, systems, and external events are defined by the Basel Committee on Banking Supervision as operational risk losses; these losses’ idiosyncratic nature makes them comparable to viruses. This study employs the Compliance and Ethics Group’s (OCEG’s) standard that integrates governance, risk management, internal control, assurance, and compliance (GRC capability model) into one functional goal to improve quality and principled performance through measurable tools that may enhance effectiveness and efficiency practices. This study concerns senior manager activities that can be effective towards meeting effective risk management practices posed by the Basel III regulation for BHCs, which may reduce the spread of significant losses in the banks. Through the use of a qualitative e-Delphi study, 10 banking finance experts were convened to build consensus on effective risk management practices. Data were collected from three electronic questionnaires submitted through Qualtrics. Data were analyzed using theoretical triangulation, coding, and thematic analysis. Four important considerations were identified that could bolster effective risk management practices: (a) a comprehensive enterprise-wide risk; (b) controlling fraud; (c) going beyond the minimum risk assessment requirements set forth by the banking regulators; (d) independent risk identification and management. These considerations towards effective risk management practices may help reduce systemic operational losses viral spread in banks. Full article

The National Institute of Allergy and Infectious Diseases (NIAID) Virology Quality Assurance (VQA) established a robust proficiency testing program for Sanger sequencing (SS)-based HIV-1 drug resistance (HIVDR) testing in 2001. While many of the lessons learned during the development of such programs may also apply to next generation sequencing (NGS)-based HIVDR assays, challenges remain for the ongoing evaluation of NGS-based testing. These challenges include a proper assessment of assay accuracy and the reproducibility of low abundance variant detection, intra- and inter-assay performance comparisons among laboratories using lab-defined tests, and different data analysis pipelines designed for NGS. In collaboration with the World Health Organization (WHO) Global HIVDR Laboratory Network and the Public Health Agency of Canada, the Rush VQA program distributed archived proficiency testing panels to ten laboratories to evaluate internally developed NGS assays. Consensus FASTA files were submitted using 5%, 10%, and 20% variant detection thresholds, and scored based on the same criteria used for SS. This small study showed that the SS External Quality Assurance (EQA) approach can be used as a transitional strategy for using NGS to generate SS-like data and for ongoing performance while using NGS data from the same quality control materials to further evaluate NGS assay performance. Full article

COVID-19, caused by a member of the coronavirus family of viruses, has spread to most countries around the world since it was first recorded in humans in China in late 2019. Closing universities and cancelling all face-to-face activities have become a COVID-19 inevitable reality in many parts of the world. Its impact on university programs, particularly to maintain academic standards and quality assurance procedures, has become significantly more challenging and complex. New ways of working digitally, to minimize disruption to daily operations, have also led to enormous anxiety and uncertainty within the student population, and meeting students’ expectations has also become significantly more difficult. This paper reviews actions taken by universities to safeguard high academic standards and quality assurance procedures during this time and appraise the challenges and impacts on students’ academic performance. Full article

HIV drug resistance is a major global challenge to successful and sustainable antiretroviral therapy. Next-generation sequencing (NGS)-based HIV drug resistance (HIVDR) assays enable more sensitive and quantitative detection of drug-resistance-associated mutations (DRMs) and outperform Sanger sequencing approaches in detecting lower abundance resistance mutations. While NGS is likely to become the new standard for routine HIVDR testing, many technical and knowledge gaps remain to be resolved before its generalized adoption in regular clinical care, public health, and research. Recognizing this, we conceived and launched an international symposium series on NGS HIVDR, to bring together leading experts in the field to address these issues through in-depth discussions and brainstorming. Following the first symposium in 2018 (Winnipeg, MB Canada, 21–22 February, 2018), a second “Winnipeg Consensus” symposium was held in September 2019 in Winnipeg, Canada, and was focused on external quality assurance strategies for NGS HIVDR assays. In this paper, we summarize this second symposium’s goals and highlights. Full article