Standards Committee Research Articles

Special issue on all‐electric and hybrid‐electric flight

Special issue on all‐electric and hybrid‐electric flight

Quantification and Risk Assessment of Lead, Cadmium, Arsenic and Other Harmful Metals in Calcium Supplements in China

Harmful metals are easily enriched in the human body and damage our health. The aim of this study was to conduct risk assessment on commercially available calcium supplements in China by analyzing, the contents of 6 harmful metal elements, including arsenic, lead, cadmium, chromium, aluminum and mercury, and calcium according to Chinese National Standards and Joint Expert Committee on Food Additives. A total of 82 calcium supplements from China market was collected and analyzed for selected metal elements. The results showed the ranges of content of arsenic, lead, cadmium, chromium, aluminum, and mercury in calcium supplements were 0.01~15.34, 0.001~8.49, ND (not detected) ~1.104, 0.09~192.66, 3.32~761.11, and ND~0.036 mg/kg, respectively. Calcium supplements were more easily contaminated with lead, arsenic and chromium, but their contents were within the safe range. The exposure limits (MOE) of lead in calcium supplements for both children and adults was close to 1, which was close to the upper safe limit. Besides, the maximum daily exposure of chromium exceeded the maximum tolerable dose of chromium for children and adults, which should be taken seriously.

BSG 2024 IBD guidelines protocol (standard operating procedures)

IntroductionIn the past 5 years, there have been several advances in the management of inflammatory bowel disease (IBD). We aim for a new guideline to update the most recent guideline...

Functional Safety Standards Committee: Results and Perspectives

The Functional Safety Standards Committee (FSSC) turned one year old. This article describes the FSSC results both in terms of sponsorship of IEEE Computer Society safety-related standards (for example, IEEE P2851) and of nurturing new initiatives.

ISUOG Practice Guidelines (updated): performance of fetal magnetic resonance imaging.

ISUOG Practice Guidelines (updated): performance of fetal magnetic resonance imaging.

What Makes a Quality Health App? Developing a Global Research-based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: A Delphi Study.

The lack of an international standard for assessing and communicating health app quality and even of consensus about what makes a high-quality health app negatively affects uptake of such apps. At the request of the European Commission, international Standard Development Organizations (SDOs) CEN-CENELEC, ISO, and IEC have joined forces to develop a Technical Specification (TS) for assessing the quality and reliability of health and wellness apps. This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. A two-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42) or both (n=41) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the at most 100 requirement questions for uptake of health apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries spanning 6 continents who participated in the SDO technical committees, were invited to comment on 4 working drafts and afterwards vote on the TS. The final quality assessment framework includes 81 questions, 67 of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as 'Healthy and safe', 'Easy to use', 'Secure data', and 'Robust build'. The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2 to 4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs from 6 continents. These included 6 of the 10 most populous countries worldwide (China, India, the US, Pakistan, Brazil, and Russian Federation). A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers to enhance and efficiently demonstrate the quality of health apps, consumers and healthcare professionals to make informed decisions on health apps, and insurers to make reimbursement decisions on health apps.

Providing a Clear Path to the Direct Admission Process.

The aim of this study was to increase patient safety during care transitions through the development of a new process and electronic screening tool. Direct hospital admissions that are not clinically triaged can put the patient at an increased safety risk. Utilizing the electronic medical record and mnemonic situation, background, assessment, and recommendation (SBAR), an admission module was created to intake direct admission requests by transfer center nurses to ensure clinical triage and accurate bed placement. One hundred eighty-nine direct admissions met inclusion criteria. Thirteen patients were clinically screened, deemed not stable for the acute care setting, and sent to the emergency department. One direct admission safety event occurred involving a hypoglycemic patient upon arrival. Results indicate the new clinical screening program offered a safer way to directly admit patients to the inpatient setting. Implementation of the electronic SBAR handoff tool meets the Joint Commission standard of care transitions compliance. The significant workflow changes increased patient safety and will be expanded in the future to all service lines.

Guidelines for resident training in veterinary clinical pathology. IV: Laboratory quality management-Teaching domains, competencies, and suggested learning outcomes.

The 2019 ASVCP Education Committee Forum for Discussion, presented at the annual ASVCP/ACVP meeting, identified a need to develop recommendations for teaching laboratory quality management principles in veterinary clinical pathology residency training programs. To present a competency-based framework for teaching laboratory quality management principles in veterinary clinical pathology residency training programs, including entrustable professional activities (EPAs), domains of competence, individual competencies, and learning outcomes. A joint subcommittee of the ASVCP Quality Assurance and Laboratory Standards (QALS) and Education Committees executed this project. A draft guideline version was reviewed by the ASVCP membership and shared with selected ACVP committees in early 2022, and a final version was voted upon by the full QALS and Education Committees in late 2022. Eleven domains of competence with relevant individual competencies were identified. In addition, suggested learning outcomes and resource lists were developed. Domains and individual competencies were mapped to six EPAs. This guideline presents a framework for teaching principles of laboratory quality management in veterinary clinical pathology residency training programs and was designed to be comprehensive yet practical. Guidance on pedagogical terms and possible routes of implementation are included. Recommendations herein aim to improve and support resident training but may require gradual implementation, as programs phase in necessary expertise and resources. Future directions include the development of learning milestones and assessments and consideration of how recommendations intersect with the American College of Veterinary Pathologists training program accreditation and certifying examination.

Life after Whitehall: The career moves of British special advisers

The article examines the post-government career moves of 521 former British special advisers who served from 1997 to 2017. Analysis of an original dataset mapping the first job each special adviser ‘landed-in’ after leaving government shows the vast majority land in corporate lobbying and policy advocacy roles. A minority become politicians, although many continue to work in political organisations. The least popular choice is public service. The findings challenge the ‘lure of power’ hypothesis and lend weight to increasing concerns about former political staff revolving to shadow lobbying. The findings point to potential lobbying regulation loopholes first raised by the UK Committee of Standards in Public Life. A multi-nominal logistic regression shows how party affiliation and occupational path dependency constrain career moves. Labour special advisers are less likely to become corporate lobbyists than Conservative and Liberal Democrat ones. Special advisers also tend to revolve back to similar professional roles held before an appointment.

A highly efficient luminescent cerium(III) coordination complex with pure-blue emission

Cerium(III) complexes are a kind of promising luminescent materials because of the spin- and parity-allowed doublet-doublet electron transition. Here, we report a stable luminescent cerium(III) complex with a photoluminescent quantum yield of up to 95% in thin film and a nanosecond fluorescent lifetime of 34 ns. The emission peak is at 438 nm and the Commission Internationale de l'Eclairage (CIE) coordinates (0.145, 0.083) exactly match the standard blue points recommended by National Television Standards Committee (NTSC).

Biomarkers Profile of the Mysterious 2019 Oil Spill on the Northeast Coast of Brazil and Discrimination from Unreported Events

In 2019, large amounts of oil reached the northeast coast of Brazil, causing damage to the environment and the local economy, especially in the state of Pernambuco. In order to correlate with possible sources, investigation was made of the geochemical biomarkers of the oils using “gold standard” forensic protocols from the European Committee for Standardization (CEN). The biomarkers study was improved by using gas chromatography-tandem mass spectrometry (GC-MS/MS), rather than the standard protocol that suggests use of the selected ion monitoring (SIM) method. Analysis was made of thirteen oil samples from the Pernambuco coast, in order to identify their degrees of similarity and the possible presence of oils from unreported spills. The use of eighteen diagnostic ratios and multivariate analysis revealed a cluster formed by eleven samples with biomarker distributions typical of oil from the 2019 spill. However, two samples had anomalous fingerprints, especially due to the absence of the 18α(H)-oleanane and 18β(H)-oleanane isomers. Both the CEN protocol applied for the classical biomarkers and a comprehensive Fourier transform mass spectrometry (FT-MS) analysis of polar compounds confirmed the dissimilarities between the samples. The findings suggested that these two oils could have originated from an event unrelated to the mysterious 2019 spill.

Interleukin-6 and interleukin-8 levels in children with aplastic anemia and its correlation with disease severity and response to immunosuppressive therapy.

Aplastic anemia (AA) is an uncommon condition characterized by pancytopenia and hypocellular bone marrow. Interleukin (IL)-6 and IL-8 have been shown to inhibit myelopoiesis and are major mediators of tissue damage. The primary goal of this study was to determine the IL-6 and IL-8 levels in children with AA, as well as their relationship to illness severity and immunosuppressive medication response. The IL-6 and IL-8 levels were tested in 50 children aged 3-18 years who had AA. As controls, 50 healthy age and sex matched individuals were used. A sandwich enzyme-linked immunosorbent assay kit (solid-phase) was used to measure IL-6 and IL-8 levels quantitatively. The concentrations of IL-6 and IL-8 in pg/mL were used to represent the results. Immunosuppressive medication was given to the patients in accordance with the British Committee for Standards in Haematology Guidelines 2009. The patients' average age was 11.3 ± 3.7 years. Patients with AA had significantly higher IL-6 and IL-8 levels than controls (278.88 ± 216.03 vs. 4.51 ± 3.26; P < 0.001) and (120.28 ± 94.98 vs. 1.79 ± 0.78; P < 0.001), respectively. The IL-6 and IL-8 levels were also investigated with respect to AA severity, with statistically significant differences (P < 0.01) between different grading strata. Patients with very severe AA (VSAA) had the highest IL-6 levels (499.52 ± 66.19), followed by severe AA (SAA) (201.28 ± 157.77) and non-SAA (NSAA) (22.62 ± 14.63). For IL-8 levels, a similar trend (P < 0.01) was detected, with values of 209.81 ± 38.85, 92.12 ± 78.0, and 9.29 ± 10.68 for VSAA, SAA, and NSAA, respectively. After 6 months of immunosuppressive treatment (IST), mean levels of IL-6 and IL-8 in responders and nonresponders were again assessed. The mean IL-6 level in the responders' group (46.50 ± 45.41) was significantly lower, when compared to the nonresponders' group (145.76 ± 116.32) (P < 0.001). Similarly, the mean IL-8 level in the responder's group (33.57 ± 27.14) was significantly lower, compared to the nonresponder's group (97.49 ± 69.00) (P < 0.001). Children with AA had higher IL-6 and IL-8 levels than normal age- and sex-matched controls. Increased levels were linked to the severity of the condition, suggesting that IL may have a role in AA. IL levels can be monitored in AA patients during IST, which can assist in predicting response to IST.

Нормативно-методическое обеспечение стандартизации технологии блокчейн

The article provides information on the state of the issue in the field of standardization of development and application of distributed ledger technology and blockchain. The current state in the development of normative documents, including documents on standardization, is analyzed. The international experience in the development of documents on standardization is reflected on the example of the International Organization for Standardization and the International Telecommunication Union, as well as the experience of developing documents in the national standardization system on the example of technical committees for standardization. Possible scenarios for the use of distributed registry technology and blockchain in the national standardization system are considered, taking into account international experience and trends in the development, development and use of national standards in digital formats, as well as promising interaction with other information technologies that are already standardized at the international and national levels.

Utah History Textbooks and Utah History

Utah History Textbooks and Utah History

Report of Scientific Standardization Committee 2023

Report of Scientific Standardization Committee 2023

American National Standards Committee (ANSC) C63 ® Holds Summer Workshop in Grand Rapids

American National Standards Committee (ANSC) C63 ® Holds Summer Workshop in Grand Rapids

STANDARDIZATION OF THE ACTIVITIES OF STATE FINANCIAL CONTROL AND AUDIT BODIES

The article discusses the internal control standards adopted by the Internal Control Standards Committee of the International Organization of Supreme Audit Institutions, the construction and work process of the internal control system that meets these goals, the purpose and tasks of standardization, as well as the role of these standards in financial control and auditing. The articlealso provides information on the application of standards developed by the members of the Internal Control Standards Committee of the International Organization of Supreme Audit Institutions. Their educational perspectives are presented both in the context of good supervisory practices and in the context of examples of identified supervisory weaknesses. Purpose: The main purpose of the standards of financial control and auditing is to regulate the professional activity of private auditors and audit companies and to achieve the greatest objectivity in giving an opinion on the reliability of the audit, as well as to establish uniform quality criteria for comparing audit results. International audit standards are necessary to form uniform basic requirements that define the standards for audit quality and reliability and ensure a certain level of assurance of audit results by strictly observing all of the above requirements. Methodology: Induction, deduction and analysis methods were used in the research work. The result of the research: The presence of a single methodological platform in the standards of different types of control will increase the efficiency and effectiveness of all types of fifinancial control, as well as the possibilities of convergence between them. The introduction of uniform standards and the strengthening of the integration of financial control and audit institutions at different levels will allow the creation of a financial and budget control database, which, in turn, will allow not only more efficient planning of the work of all structural elements of the financialcontrol system, but also the preventio n of violations of the norms of financial and budget legislation. it will be the basis for imposing restrictions on the management positions of officials.

Variability in International Society on Thrombosis and Haemostasis-Scientific and Standardization Committee endorsed Bleeding Assessment Tool (ISTH-BAT) score with normal aging in healthy females: contributory factors and clinical significance

BackgroundBleeding assessment tools are key screening tests used in the evaluation of patients with suspected inherited bleeding disorders. The International Society on Thrombosis and Haemostasis-Scientific and Standardization Committee endorsed Bleeding Assessment Tool (ISTH-BAT) has differing reference ranges for adult males (0-3), adult females (0-5), and children (0-2), reflecting differing bleeding symptoms and exposure to hemostatic challenges in these healthy population subgroups. Age is known to markedly impact bleeding score in individuals with von Willebrand disease. However, the influence of age on bleeding score in healthy adult controls is poorly understood. ObjectivesWe aimed to assess variability in ISTH-BAT score with age among healthy control females. MethodsWe used the legacy “Merging Project” dataset of normal healthy controls upon which current ISTH-BAT normal ranges are based. We included women, totaling 646 individuals. The normal range (middle 95th percentile) of total ISTH-BAT and grouped subdomain scores between age quartiles was assessed. ResultsThe normal range of ISTH-BAT scores increased with age, ranging from 0 to 4 in the youngest quartile (age range, 18-30) to 0 to 6 in the oldest (age range, 52-88). This increased variability with aging was related both to high menorrhagia domain scores in older women and an increase in postprocedural bleeding with accumulated exposure to hemostatic challenges. ConclusionsCumulatively, our data highlight that normal aging leads to increased variability in bleeding scores in healthy adult females. Further refinement of the ISTH-BAT with age-adjusted reference ranges may improve the sensitivity and specificity of the tool among females.

Factor V Leiden-independent activated protein C resistance: Communication from the plasma coagulation inhibitors subcommittee of the International Society on Thrombosis and Haemostasis Scientific and Standardisation Committee

Activated protein C resistance (APC-R) due to the single-nucleotide polymorphism factor V Leiden (FVL) is the most common cause of hereditary thrombophilia. It is found predominantly in Caucasians and is uncommon or absent in other populations. Although FVL is responsible for >90% of cases of hereditary APC-R, a number of other F5 variants that also confer various degrees of APC-R and thrombotic risk have been described. Acquired APC-R due to increased levels of coagulation factors, reduced levels of inhibitors, or the presence of autoantibodies occurs in a variety of conditions and is an independent risk factor for thrombosis. It is common for thrombophilia screening protocols to restrict assessment for APC-R to demonstrating the presence or absence of FVL. The aim of this Scientific and Standardisation Committee communication is to detail the causes of FVL-independent APC-R to widen the diagnostic net, particularly in situations in which in vitro APC-R is encountered in the absence of FVL. Predilution clotting assays are not FVL specific and are used to detect clinically significant F5 variants conferring APC-R, whereas different forms of acquired APC-R are preferentially detected using the classical activated partial thromboplastin time-based APC-R assay without predilution and/or endogenous thrombin potential APC-R assays. Resource-specific recommendations are given to guide the detection of FVL-independent APC-R.

Challenges in the management of women with type 2B von Willebrand disease during pregnancy and the postpartum period: evidence from literature and data from an international registry and physicians’ survey—communication from the Scientific and Standardization Committees of the International Society on Thrombosis and Haemostasis

BackgroundManagement of women with type 2B von Willebrand disease (VWD) during pregnancy is challenging because of dysfunctional von Willebrand factor (VWF) and the complexity resulting from discrepant VWF/factor VIII (VWF/FVIII) levels, impaired platelet-dependent VWF activity, progressive thrombocytopenia, and risks associated with the use of desmopressin. There is a lack of high-quality evidence to support clinical decision making. ObjectivesIn this study, we examined the current diagnostic and management approaches and outcomes in women with VWD during pregnancy. MethodsData were collected via 3 avenues: literature review, an international registry, and an international survey on physicians’ practices for the management of pregnancy in women with VWD. The registry and survey were supported by the International Society on Thrombosis and Haemostasis. ResultsData on clinical and laboratory features, management and bleeding complications, and pregnancy outcomes of a total of 55 pregnancies from 49 women across the globe (literature: 35, registry: 20) and data reported by 112 physicians were analyzed. We describe the largest dataset on pregnancies in women with type 2B VWD available to date. The data highlight the following key issues: a) bleeding complications remain a concern in these patients, b) the target safe VWF level and the ideal monitoring approach are unknown, c) there is a wide range of hemostatic management practices in the type and timing of treatment, and d) physicians have diverse views on the mode of delivery and use of neuraxial anesthesia. ConclusionWe conclude that an international consensus and guidance are critically required for better care and improved outcomes in this patient cohort.