International Organization For Standardization Research Articles

3D printing in surgery: relevance of technology maturity assessment in bioprinting research studies

Biological 3D printing (bioprinting) is an extension of what is defined as additive manufacturing in the American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards and is based on the automated printing of living cells and biomaterials. Researchers and experts in the field of biomaterial science, tissue engineering and regenerative medicine (TE&RM) are constantly pointing to the potential of biological 3D printing and scientific articles regularly announce the imminent clinical application. We argue in this article that these announcements are often premature and counterproductive as they focus heavily on technological progress but regularly ignore the critical stages that need to be completed in order to successfully translate atechnology into the healthcare market. The technology readiness level (TRL) scale is apotentially useful tool for measuring the relative maturity of atechnology in terms of overcoming aseries of critical milestones. We propose an adaptation of the TRL scale and use it to discuss the current state of research on biological 3D printing. Finally, we provide specific recommendations for optimizing future research projects to pave the way for clinical applications of biological 3D printing and thus achieve adirect positive impact on surgical patient care.

External Ventricular Drain Misadministration Events: Systematic Literature Review and Report of a Case.

External ventricular drain (EVD) is a common neurosurgical procedure with potential complications, including catheter misplacement, infection, mechanical obstruction, and inadvertent catheter pull-out. A less discussed but critical complication is the misadministration of medications into EVD. This project aimed to review the literature on EVD misadministration and discuss preventative measures, emphasizing the new International Organization for Standardization (ISO) standard for neuraxial connectors. A systematic review of PubMed, Embase, and SCOPUS databases was conducted to identify studies reporting misadministration in EVD systems. We also present a case of misadministration of a blood product into an EVD. Factors contributing to these events were researched, relevant guidelines from professional organizations were reviewed, and preventive strategies, including the novel NRFit® connector designed to prevent such errors, were discussed. The literature review identified 7 reports of 8 cases of misadministration involving substances such as gadolinium-based contrast agents, anesthetic agents, and antiepileptic drugs. In addition, we report a case of an 87-year-old man with multiple traumatic brain injuries, where a blood transfusion line was mistakenly connected to the EVD. This incident is the first reported case of blood misadministration through EVD. Despite immediate drainage and flushing of the EVD system with saline, the patient's condition did not improve, and he eventually died. Contributing factors included unfamiliarity with the EVD system, similarity to IV connectors, and poor visibility during procedures. Importantly, the novel ISO 80369 standard for all neuraxial connectors, including NRFit® connectors that have a 20% smaller nozzle outside diameter than traditional Luer connectors, has been recommended to prevent misconnection errors and mitigate associated risks. Misadministration to EVD connectors is a preventable event that highlights the need for enhanced safety solutions. Adoption of ISO standard neuraxial connectors, thorough training, and the use of distinctly marked equipment are critical steps in minimizing risks.

Mastering information security through standard implementation

This paper aims to enhance information security within an organization, considering the perennial concern for security in organizations utilizing ICT applications. Educational institutions also exhibit deficiencies in the domain of data security. The adoption of international organization for standardization (ISO) 27001-2013 served to pinpoint potential vulnerabilities and non-compliance with safety standards, aiming to minimize associated risks. Through this framework, an assessment of data security within public educational institutions in our country was conducted, focusing on a public university as a case study. Given the sensitive nature of this field, guidance is provided on identifying security-related issues based on ISO 27001 standards and on-ground situations. Surveys were employed, aligning with the required standards, to scan the prevailing situation. Data from surveys at public academic institution were collected and analyzed using the SPSS application. The findings underscore instances where security protocols can prevent or mitigate abuses, consequently enhancing the overall level of data security. Emphasizing education as a pivotal recommendation, this study advocates for educating personnel who handle sensitive data, derived from the application of these standards. This paper accounts for potential risks that could expose organizational weaknesses and thoroughly elucidates the steps and procedures undertaken in this approach, substantiated by illustrated examples.

Addressing the commercial determinants of menstrual health: a call to regulate menstrual product manufacturers.

Over the last two decades, menstrual health and hygiene have become increasingly common on the global health agenda. While governments and international organizations are adopting measures to make menstrual products more accessible, corporate actors producing them have only been subject to limited scrutiny. Yet, their products and commercial practices raise environmental, health, equity and societal issues, which warrant attention and regulation. As such, commercial disposable menstrual products are largely made up of plastic, sometimes as much as 90%. Menstrual pads and tampons also contain some chemicals, the health impact of which is still unclear. In addition, these products are often sold with high-profit margins, and marketing campaigns to sell such products tend to reinforce shame and secrecy. So far, no global standards exist to regulate menstrual products and manufacturers, and evidence in the field of menstrual health and hygiene is lagging behind. To fill this gap, countries have started to regulate menstrual products and the International Standards Organization is in the process of developing global standards to better regulate the content and labeling of menstrual products. To support the emergence of regulation in this area, this article conceptualizes for the first time a comprehensive framework for the regulation of menstrual product manufacturers. This framework encompasses five complementary measures to regulate the content; labeling; production and waste management; pricing; advertising and marketing of menstrual products. The article also calls for more research to produce evidence and for increased governmental and inter-governmental attention to menstrual product manufacturers.

BSDF Data generation for daylight applications: A call for international standardization

Standardized methods for generating angle-dependent, bidirectional, solar-optical properties for complex fenestration systems do not exist, which means that energy and daylight evaluations in building performance simulations often suffer from major inaccuracies. This position paper provides an overview of state-of-the-art data-driven methods for characterizing light scattering properties of fenestration materials and blind systems (e.g. fabrics, metal slats, patterned glazing), validation via laboratory, simulation and field tests, and salient issues in support of standardization of such methods via the International Standardization Organization (ISO). The ISO standard is intended to provide the fundamental underpinnings for recently mandated daylight standards that rely on bidirectional scattering distribution function data for climate-based daylight modelling and building performance simulations.

A systematic review of energy storing dynamic response foot for prosthetic rehabilitation.

The purpose of this paper is to undertake a systematic review on various mechanical design considerations, simulation and optimization techniques as well as the clinical applications of energy storing and return (ESAR) prosthetic feet used in amputee rehabilitation. Methodological databases including PubMed, EMBASE, and SCOPUS were searched till July 2022, and the retrieved records were evaluated for relevance. The design, mechanism, materials used, mechanical and simulation techniques and clinical applications of ESAR foot used in developed and developing nations were reviewed. 61 articles met the inclusion criteria out of total 577 studies. A wide variety of design matrices for energy- storing feet was found, but the clinical relevance of its design parameters is uncommon. Definitive factors on technical and clinical characteristics were derived and included in the summary tables. To modify existing foot failure mechanisms, material selection and multiple experiments must be improved. Gait analysis and International Organization for Standardization (ISO) mechanical testing standards of energy-storing feet were the methods for integrating clinical experimentation with numerical results. To meet technological requirements, various frameworks simulate finite element models of the energy-storing foot, whereas clinical investigations involving gait analysis require proper insight. Analysis of structural behavior under varying loads and its effect on studies of functional gait are limited. For optimal functional performance, durability and affordability, more research and technological advancements are required to characterize materials and standardize prosthetic foot protocols.

Research on the Response of Urban Sustainable Development Standards to the United Nations Sustainable Development Goals Based on Knowledge Graphs

In the new era of the vigorous development of digitalization and intelligence, digital technology has widely penetrated various fields. International authoritative standardization bodies, such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), proposed a timely new standard concept called Standards Machine Applicable, Readable, and Transferable (SMART) in order to meet this development trend. Its core feature is that the standard can be machine-readable, usable, understandable, and resolvable without human labor so as to achieve the goals of standard formulation, promotion, publicity, and implementation more effectively. Simultaneously, China’s standardization industry is responding to the strategic deployment of “new quality productivity” by actively promoting the digital development of standards and establishing standard information databases, standard formulation management systems, etc., which provide data support and a platform basis for applying new technologies. Advanced technologies such as big data, artificial intelligence, blockchain, and knowledge graphs can be combined with standardization to improve the efficiency of standard development, application accuracy, and implementation effects. To align with these trends, this study focuses on analyzing the responses of national and international standards in the field of urban sustainable development to the United Nations Sustainable Development Goals (UN-SDGs). This study proposes an innovative approach involving the application of knowledge graph technology to the standardization of urban sustainable development and establishing a response correlation between the indicator library for cities’ sustainable development (ILCSD) and SDGs. It also provides additional functions, such as the intelligent extraction of cities’ sustainable characteristic evaluation indicators and aided decision analysis, which greatly enhance the practicability and efficiency of the ILCSD as a technical tool. Based on knowledge graphs, this study analyzes the different responses of important standards in the field of urban sustainable development to the 17 SDGs, accurately identifies weak trends and gaps in standards, and provides a basis for improving the standardization system of urban sustainable development. Simultaneously, by comparing national and international standards and technologies, this study promotes the mutual recognition of standards, which can help China’s urban sustainable development work align with international standards. In addition, the process of establishing and maintaining knowledge graphs facilitates the continuous adoption of new standards through which the indicator library is automatically updated. Finally, in this study, we propose several inspirations for the standardization of urban sustainable development in China, such as an optimization standard system of benchmarking SDGs and a localization application of the original SDG indicators.

AI‐Augmented Software Engineering: Revolutionizing or Challenging Software Quality and Testing?

ABSTRACTWith organizations seeking faster, cheaper, and smarter ways of delivering higher quality software, many are looking towards generative artificial intelligence (AI) to drive efficiencies and innovation throughout the software development lifecycle. However, generative AI can suffer from several fundamental issues, including a lack of traceability in concept generation and decision‐making, the potential for making incorrect inferences (hallucinations), shortcomings in response quality, and bias. Quality engineering (QE) has long been utilized to enable more efficient and effective delivery of higher quality software. A core aspect of QE is adopting quality models to support various lifecycle practices, including requirements definition, quality risk assessments, and testing. In this position paper, we introduce the application of QE to AI systems, consider shortcomings in existing AI quality models from the International Organization for Standardization (ISO), and propose extensions to ISO models based on the results of a survey. We also reflect on skills that IT graduates may need in the future, to support delivery of better‐quality AI.

A Standard on Accessibility of the Immobable Cultural Heritage.

Architecture has always aimed to improve the quality of life for people by enhancing their interaction with the built environment. This applies not only to domestic settings but also to significant structures that represent our cultural heritage. However, the interaction between accessibility and cultural heritage may seem complex and challenging, even impossible at times. Cultural heritage is an essential part of our collective history and cultural identity. It is crucial to ensure that everyone can fully participate and enjoy it, especially when cultural heritage is integrated into people's daily lives, according to the United Nations Convention on the Rights of Persons with Disabilities. Moreover, improving the accessibility of cultural heritage objects enhances society's appreciation of immovable cultural heritage, emphasizing its significance and visibility. This conforms to the strategic objectives of the World Heritage Convention. This paper discusses the international standard known as ISO 5727 which aims to improve the accessibility of immovable cultural heritage in accordance with a Universal Design approach (UD). ISO 5727, currently under development within the framework of the International Organization for Standardization (ISO), is based on the Spanish standard, the UNE 41531 IN, published in 2018. The purpose of the standard is to provide general and technical criteria and a methodology for interventions in immovable cultural heritage to facilitate its use and enjoyment for all people. The standard should be considered in both restoration and rehabilitation projects, as well as in specific accessibility interventions. However, it should be noted that the standard does not cover accessibility measures related to management, like services, and maintenance. Nonetheless, it has been considered that these may be necessary complements or alternatives to the first. To carry out interventions effectively, it is advisable to adhere to a systematic approach towards the process and documentation involved. Firstly, accessibility objectives should be established. Then strategies to improve accessibility should be identified to focus on the purpose of the intervention. An analysis based on the current state of the cultural object, including its heritage values and accessibility conditions, would serve as a basis for establishing proposals for action. Once the options have been assessed jointly and comparatively, with the validation of all stakeholders- including users regardless of their abilities, age, or background- the proposals that can form part of an intervention plan can be decided on. The intervention plan will establish a set of measures that will configure the accessibility chain to meet the objectives of the intervention. ISO 5727 is conceived as a useful tool to enhance the conservation of immovable cultural heritage and to balance the achievement of specific social goals with the preservation of cultural values. This project is developed with the belief that accessibility can improve and expand the cultural and functional potential of cultural heritage.

The Advantages of Adopting the ISO/IEC 17025: 2017 Lab Management System in Calibration and Testing Laboratories

International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards for testing and calibration laboratories are known as ISO/IEC17025:2017, which is the standard for laboratory certification. The testing laboratory's accreditation, the methods of execution, and the tangible advantages of working with such an organization. This study examined the advantages of ISO/IEC17025:2017 implementation in Chengalpat region's calibration and testing laboratories using a descriptive research design. The advantages of putting ISO/IEC 17025:2017 into practice are the main variable in the current study. The investigator utilized a method called purposive sampling. This research is based on a survey with 180 responses. After the data was gathered, analysis was done using SPSS 20. It has been found that to implement best practices and believe in the benefits, Top Management must fully understand the advantages of enacting the ISO/IEC 17025: 2017 Lab Management System, task and lab managers must fully understand the Lab Management System ISO/IEC 17025: 2017 implementation, the management tools for the Calibration and Testing Labs, the infrastructure that is being developed for the Labs, teams must collaborate, and accountability is linked to the Labs.

Hybrid Mentorship of Medical Laboratories to Achieve ISO 15189:2012 Accreditation in Malawi: The University of Maryland Malawi Experience.

As part of a laboratory strengthening program in Malawi to achieve and maintain International Organization for Standardization (ISO) 15189 accreditation, we intended to mentor selected HIV molecular laboratories to achieve this accreditation. Due to the COVID-19 pandemic, mentorship pivoted to a hybrid model using an Internet-based approach and on-site mentorships. We describe the implementation of this strategy, successes, and challenges. We conducted weekly, 1-hour virtual mentorship sessions for the 5 initial laboratories (cohort 1) selected based on their Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) performance score of 3 or more stars. Laboratories presented updates and supporting documents electronically, and trainings were conducted virtually. In September 2020, when travel restrictions were relaxed, we initiated hybrid mentorships and audits for cohort 1 laboratories. The same hybrid approach was used to mentor 4 additional laboratories in cohort 2. We performed descriptive analysis, and the Wilcoxon signed-rank test was used to compare the training pre-and post-test scores. Between March 2020 and May 2023, the team completed a total of 54 virtual mentorship sessions and 20 on-site visits across 9 laboratories. Overall, the team conducted 8 training sessions for 35 laboratory quality officers. Median score improvement (pre-test vs. post-test scores) was observed across individual trainings and across cohorts (P<.01). At the end of cohort 1, 4 of 5 (80%) laboratories were accredited. One laboratory that did not reach accreditation joined cohort 2. At the end of the mentoring period, all 5 cohort 2 laboratories were accredited. We demonstrated that using a hybrid mentorship model for accreditation was a successful strategy during the COVID-19 pandemic. For the first time in Malawi, this strategy resulted in accrediting 9 of the 10 HIV molecular laboratories in 3 years at a reduced cost. Continuous mentorship is key in the maintenance of accreditation.

International models of accreditation and certification for hospitals with a focus on nursing: a scoping review

BackgroundQuality assurance in hospitals is essential for ensuring patient safety, quality of care and efficiency. The nursing profession is a key contributor to healthcare quality, yet, a comprehensive overview and comparison of the role and scope of nursing as part of accreditation and certification schemes has been lacking. The aim was to identify if and to what extent international accreditation or certification schemes focus on nursing, and to compare their conceptual models and outcome indicators.MethodsA scoping review was conducted. A search strategy was developed together with a librarian and carried out in January 2024 in Medline, CINAHL, Web of Science Core Collection, Cochrane Reviews and Google Scholar. Additionally, authoritative websites of accreditation/certification holders were searched. Inclusion criteria were studies on international accreditation or certification schemes for hospital settings with relevance to nursing published in English or German. Screening and data analysis adhered to the Joanna Briggs Institute’s methodology, with reporting following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline (PRISMA-ScR).ResultsThe search identified 17.315 records. After removing duplicates and screening of titles/abstracts, 336 full-texts remained. A total of 124 studies were included, identifying seven international accreditation/certification schemes: European Foundation for Quality Management, Evaluation and Quality Improvement Program, International Organization for Standardization 9001, Joint Commission International®, Magnet Recognition Program®, Pathway to Excellence® Program, Qmentum®. The different schemes ranged from nursing-specific to having no specific focus on, but relevance for, nursing and varied in their topics, focus on structure, process and outcome quality and structure and content of requirements. Additionally, outcome indicators varied, with differences in the extent to which indicators were nurse-sensitive, compulsoriness of data collection, and use of external benchmarking.ConclusionsThe seven international schemes show large conceptual variations as to their focus on nursing and differences in the degree of nurse-specific outcome indicators. Hospital and nursing managers, policymakers, patients and the public need to understand the content and outcome dimensions of the schemes when making decisions or assessing hospital quality data.

LATERAL STIFFNESS EVALUATION OF RESIDENTIAL ISO CONTAINER MODULE: FULL-SCALED EXPERIMENTAL AND NUMERICAL STUDIES

International Organisation for Standardisation (ISO) containers, designed to protect contents against extreme conditions, are often repurposed as temporary shelters during disasters, conflict, or urbanization. However, modifying these containers for housing greatly affects their structural integrity. Several studies have numerically and experimentally investigated the structural strength of container structures. However, there was limited information on the lateral stiffness of a residential ISO container subjected to lateral load. A piece of valuable information when the container is applied to a multi-story structure. This study proposed to conduct physical tests on two full-scaled residential ISO container structures to evaluate their lateral stiffness. Considering the actual condition of a residential container, both samples were fabricated with different sizes of openings. The finite element models of the samples were developed and analysed employing Abaqus for comparison with other studies and the experimental results. The application for lateral stiffness of ISO containers subjected to wind load was discussed based on the current design standard. The outcome of the study widened the scope of the structural behaviour of an ISO container towards the lateral stiffness of a residential container structure.

Validating the accuracy of the Omron HBP-M4500 blood pressure measuring device according to the ISO81060-2:2018+ Amd 1:2020 protocol.

Blood pressure (BP) naturally undergoes fluctuations and variations, particularly during anesthesia administration during surgery, hemodialysis, upper and lower gastrointestinal endoscopy, exercise testing, arterial and venous catheterization, and rehabilitation. These changes in BP may lead to life-threatening events. The performance of the Omron HBP-M4500 device in monitoring blood pressure (BP) in the upper arm was validated according to the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd) 1:2020 protocol. The device was used to assess 113 participants in the inflation mode, and 107 participants in the deflation mode. All the patients fulfilled the inclusion criteria, including the arm circumference range and systolic and diastolic BP levels, outlined in the protocol. Data validation and analysis were performed according to the manufacturer's instructions. In criterion 1, the mean ± standard deviation (SD) values of the differences between the test device and reference BP were -0.6 ± 5.80/2.8 ± 6.78 mmHg (systolic/diastolic) and -1.0 ± 5.35/3.2 ± 6.52 mmHg for the inflation and deflation modes, respectively. These data fulfilled the ISO81060-2:2018+Amd1:2020 requirements of ⩽ 5 ±⁣⩽ 8 mmHg. In criterion 2, the differences were -0.6 ± 4.44/2.8 ± 6.26 and -1.0 ± 3.84/3.2 ± 6.09 mmHg for the inflation and deflation modes, respectively, fulfilling criterion 2 with SD values of ⩽ 6.91 and ⩽ 6.87 for systolic BP and ⩽ 6.34 and ⩽ 6.14 for diastolic BP in the inflation and deflation modes, respectively. These two criteria were fulfilled in both studies. The Omron HBP-M4500 device, either in inflation or deflation mode, fulfilled the criteria outlined in the ISO protocol. Therefore, this device is valuable for BP measurement in clinical and hospital settings.

Dynamic Simulation Model of Miniature Tracked Forestry Tractor for Overturning and Rollover Safety Evaluation

This study proposes a method to construct a dynamic simulation model to implement the lateral overturning and backward rollover characteristics of an actual tractor. Based on theoretical analysis, factors affecting these characteristics are identified, which include tractor weight, track width, wheelbase, location of mass center, weight distribution, heights of front and rear axles, and geometric shapes. The location of the mass center of the actual tractor is measured based on the standard test procedure set by the International Organization for Standardization, and the remaining influencing factors are derived through measurements. A three-dimensional (3D) model of the tractor is constructed to reflect all these factors. Additionally, a simulation model utilizing this 3D model is developed using a commercial dynamic simulation software program. The ability of the model to simulate the overturning and rollover characteristics of the actual tractor is verified by comparing the static sidelong falling angle and minimum turning radius with those of the actual tractor. The errors between the characteristics of the actual tractor and those of the 3D model and dynamic simulations are shown to be less than 5%, thus indicating that the proposed method can effectively simulate the overturning and rollover characteristics of the actual tractor.

River suspended-sand flux computation with uncertainty estimation using water samples and high-resolution ADCP measurements

Abstract. Measuring suspended-sand fluxes in rivers remains a scientific challenge due to their high spatial and temporal variability. To capture the vertical and lateral gradients of concentration in the cross-section, measurements with point samples are performed. However, the uncertainty related to these measurements is rarely evaluated, as few studies of the major sources of error exist. Therefore, the aim of this study is to develop a method to determine the cross-sectional sand flux and estimate its uncertainty. This SDC (for sand discharge computing) method combines suspended-sand concentrations from point samples with ADCP (acoustic Doppler current profiler) high-resolution depth and velocity measurements. The MAP (for multitransect averaged profile) method allows obtaining an average of several ADCP transects on a regular grid, including the unmeasured areas. The suspended-sand concentrations are integrated vertically by fitting a theoretical exponential suspended-sand profile to the data using Bayesian modeling. The lateral integration is based on the water depth as a proxy for the local bed shear stress to evaluate the bed concentration and sediment diffusion along the river cross-section. The estimation of uncertainty combines ISO standards and semi-empirical methods with a Bayesian approach to estimate the uncertainty due to the vertical integration. The new method is applied to data collected in four rivers under various hydro-sedimentary conditions: the Colorado, Rhône, Isère, and Amazon rivers, with computed flux uncertainties ranging between 18 % and 32 %. The relative difference between the suspended-sand flux in 21 cases calculated with the proposed SDC method compared to the International Organization for Standardization (ISO) 4363 standard method ranges between −40 % and +23 %. This method that comes with a flexible, open-source code is the first to propose an applicable uncertainty estimation that could be adapted to other flux computation methods.

Quality Certification and Business Performance: The Portuguese Large Firms’ Case

Objective: Observe the existence of a relationship between quality certification, financial performance and bankruptcy prediction, as well as the supposed superiority of the quality certified Portuguese large companies. Theoretical Reference: In the continuous pursuit for quality, as well as its certification, the International Standard Organization (ISO), suggests, from a theoretical perspective, a possible relationship of the last one with the going concern, contributing to the companies’ economic and financial sustainability. Method: We selected Portuguese large companies (according to recommendation 2003/361/EC) with Economic Activity Codes (NACE) D and G, certified with ISO 9000 or 9001, totalling 91 companies, along with computed average company from each of these sectors. We used univariate and multivariate techniques (MDA), models of business failure prediction, considered in previous studies as the most effective for the Iberian economy (Peres and Antão, 2018; Peres and Antão, 2019), aiming to assess the companies’ performance, as well as the supposed superiority of those quality certified companies. Results and Discussion: In neither of the analysis, univariate and multivariate, was observed a superior performance of the certified companies compared to others, indicating that quality certification is not effectively related to the companies’ economic and financial performance optimization. Implications of the Research: Uncover the influence of quality certification on the economic-financial position of companies, allowing for deeper investigation into bankruptcy, sustainability and value creation. Originality/Value: The specificities of the sectors and business size, crises and the increasing of business closures make it vital to identify what will influence performance and sustainability, as no studies have been identified on this topic, focusing on Portuguese Large companies, certified via ISO 9000 or 9001.

Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

Environmental Life Cycle Assessment of a U.S. Hospital-based Radiology Practice.

Background Climate change, driven primarily by human-induced greenhouse gas (GHG) emissions, poses major risks to human health. Health care contributes 8.5% of GHG emissions in the United States. Purpose To estimate the life cycle environmental impact of diagnostic radiology services within a single academic medical center. Materials and Methods This process-based life cycle assessment (LCA) of a diagnostic radiology department serving adult inpatient, outpatient, and emergency department patients in a U.S. hospital followed International Organization for Standardization (ISO 14040:2006) guidelines. System components included production and distribution of imaging equipment; energy use of imaging equipment, including MRI, CT, radiography and fluoroscopy, and US; production and use of other capital equipment; production of single-use, semidurable, and durable supplies and linens; and production and energy use from onsite data storage. Meters monitored the power usage of selected imaging equipment during April 2023. Modeling assumed an equipment lifespan of 10 years. Results are reported in kilotons of CO2 equivalent (kt CO2e) emissions per scan and over a 10-year period. A sensitivity analysis assessed variability of data. Results Over a decade, these radiology services generated 4.6 kt CO2e GHG emissions, with MRI responsible for 48% (2.2 of 4.6 kt CO2e) and CT responsible for 24% (1.1 of 4.6 kt CO2e) of cumulative emissions. Clinical use of imaging equipment (all modalities) accounted for 54% of departmental GHGs (2.5 of 4.6 kt CO2e). Other notable contributions include the production of imaging equipment (11%, 0.49 of 4.6 kt CO2e), the production and use of picture archiving and communication system workstations (11%, 0.48 of 4.6 kt CO2e), and linens production and laundering (10%, 0.47 of 4.6 kt CO2e). Conclusion Energy consumption from clinical use of imaging equipment accounted for more than 50% of departmental GHG emissions, with MRI and CT equipment as the major emitters. Other notable GHG contributors include the production of imaging equipment, the production and use of picture archiving and communication system workstations, and linens production and laundering. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Thrall in this issue.

Article: Exploring Shortcomings in International Trade Law in Light of the Expansion of Artificial Intelligence

The objective of this paper is to explore the shortcomings in international trade law (ITL) in view of the expansion of Artificial Intelligence (AI), and to propose some recommendations. AI is contributing to the development of international trade while giving rise to other concerns, such as nontariffs measures. Addressing the legal challenges posed by the integration of AI into various facets of society, including international trade, is of major importance. In this context, this paper explores a number of provisions of the General Agreement on Tariffs and Trade (GATT) 1994, those of the General Agreement on Trade in Services (GATS), and ends with those of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Finally, the article proposes some recommendations to better take into account the concerns that AI may give rise to in the multilateral trading system. It highlights the need for close partnership between the World Trade Organization (WTO), the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC) to better maximize the benefits of AI while minimizing the risks in the context of international trade. Also, it highlights the importance of harmonizing regulations on the trade of AI products and AI-driven trading and the need for a change in legal design that goes beyond mere incremental adjustments.