Quality Assurance Requirements Research Articles

The Practicability of Quality Assurance Mechanisms in Promoting Tanzanian Universities’ Compliance

<p style="text-align:justify">Compliance with any policies, laws and regulations, including university compliance with quality assurance mechanisms globally, depends on the practicability of those mechanisms. Like other countries, Tanzania has quality assurance mechanisms that require universities to comply. However, the existing audit reports have shown non-compliance cases to such mechanisms. This study sought to explore the practicability of the existing quality assurance mechanisms in promoting universities’ compliance in Tanzania. The documentary reviews, interviews, and focus group discussions were used to collect data from the 4 universities and 46 students, academics, and quality assurance directors and officers as a sample size selected purposively. The data were analysed through content analysis. The findings revealed that the existing quality assurance mechanisms are generally practicable; however, there are quality assurance requirements with practicability challenges due to contextual factors. Such requirements include senior academics in administrative duties, academics’ promotion, academics’ recruitment, inclusive and participatory teaching approaches, requirements with extra financial costs, examination scripts’ marking, and invigilation restrictions. This study concludes that the practicability challenges of some quality assurance mechanisms are one reason for non-compliance cases at some Tanzanian universities. It recommends that key stakeholders be involved in establishing mechanisms, and all contextual factors must be addressed to enhance practicability.</p>

Developing variables two-plan sampling scheme with consideration of process loss for lot sentencing

This paper considers a well-known two-plan sampling system, Tightened-Normal-Tightened (TNT) sampling scheme, which includes two single sampling plans (SSPs) with regulations for transitioning between tightened and normal inspections. Tightened inspection is conducted when there is a noticeable decline in quality, and normal inspection is employed when the quality is satisfactory. Most acceptance sampling plans evaluate product quality in terms of process yield, which does not differentiate between products that fall within specification limits. To address this issue, a new performance measure called the process loss index Le was developed, which accounts for the quality loss function. This index is determined by dividing the “expected quadratic loss” by the “square of half the specification width.” Using this index, two primary types of variables TNT sampling scheme were constructed and evaluated in this study. Their efficacy and features were investigated, discussed, and compared. The findings reveal that the TNT sampling strategy delivers the required quality assurance with a reduced sample size compared to the conventional SSP.

Analysis of core quality criteria and requirements for high-level waste disposal R&D based on the US NQA-1 and Korea KEPIC-QAP

This study presents the key quality criteria and requirements as well as an implementation plan for R&D related to the disposal of high-level waste. From the results of the analysis based on NQA-1 and KEPIC-QAP, it was found that test control, software control, design control and independent review of the report were derived as QA key criteria. In addition, the R&D organization should gradually expand the quality assurance criteria to increase R&D efficiency for licensing the construction of the spent nuclear fuel repository. In order to improve research quality, it is necessary to customize the quality requirements for the organization. That is, from the 18 quality criteria of NQA-1, such factors as the quality requirements of organization and quality assurance program, design and software control, document control, purchasing management, test control, quality assurance records, and audit can be selected as R&D quality assurance criteria. In other words, high-level waste disposal R&D should be performed considering not only nuclear quality standards but also research resources. However, as of yet, legal R&D quality assurance requirements in Korea are not specific and only general standards are presented.

Multi-Organizational Insights Into Radiological Safety Standards in High-Dose Rate Brachytherapy.

The review provides an extensive study of regulations and recommendations set forth by organizations worldwide in the domain of high-dose rate (HDR) brachytherapy for the prevention and mitigation of radiation hazards. The relevant reports and publications by the International Commission on Radiological Protection (ICRP), International Atomic Energy Agency (IAEA), American Association of Physicists in Medicine (AAPM), United States (US) Nuclear Regulatory Commission (NRC), and Atomic Energy Regulatory Board (AERB) were accessed, and necessary information was compiled to clarify and understand concepts, similarities, and differences in safety standards concerning to the topic. The regulations and guidance are categorized under three major components of safety, namely layout, equipment, and source. Layout category accesses structure, design, layout, and survey. The equipment category summarizes the requirements of equipment, installation, commissioning, quality assurance (QA) and performance, safety precautions and preparedness, safety procedures, and instructions. The source category includes requirements for sealed source possession and use, calibration, categorization, certification, licensing, QA tests, and security. IAEA gives inclusive guidance on radiation protection and regulatory requirements, forming the basis of reference for other organizations worldwide. AERB regulates the radiation facilities in India; therefore, most set-ups follow their safety standards and instructions.

Determination of correction factors and correction coefficients for calculations of the absorbed dose

The need to control the dose received by a patient during radiation therapy (RT) is dictated by the quality assurance requirements, which encompass a broad system of organizational and technical measures aimed at achieving consistency and precision in dosimetry measurements. The ultimate goal of using a quality assurance system in RT is to ensure high accuracy in delivering the dose to the tumour, reducing the irradiation volumes of normal, healthy tissues and organs near the target (tumour lesion). It has been established that to enhance the effectiveness of radiation treatment and to reduce the number of complications in subsequent periods, it is necessary to irradiate the local target in the patient’s body with a dose error no greater than ±5%. To control the calculation of the absorbed dose in water using thermoluminescent (TL) dosimeters, irradiated on a gamma therapeutic device for remote radiation therapy, it is necessary to study the influence of various factors (fading, non-linearity of indications, energy dependence, reproduction of the TL signal, presence of a holder) on the magnitude of the TL signal. We have studied and identified various corrective factors and their error values that may affect the calibration of the system (TLD-100 powder (Rexon), thermoluminescent reader PCL-3). In determining the corrective factors to account for the daily drift of the PCL-3 device, the TL signal obtained during the exposure was adjusted based on the control powder indicators. As a control powder, TLD-100 (Rexon) was used, irradiated with an absorbed dose of 2 Gy under standard conditions and aged four months to obtain a stable TL signal.

Optimizing Quality Approaches and Investigating Lecturers' Perception for Course Quality Assurance in Higher Education

Courses are the fundamental building blocks of educational programs, serving as a tangible representation of student attainment and the desired learning outcomes of the program. Despite their pivotal role in education, however, a standardized framework for the development, implementation, and enhancement of course specifications remains elusive. Given that different programs may employ varying formats with differing levels of detail, it is critical to establish a universal framework that enables instructors to adhere to quality standards at the program level. To this end, leveraging the ASEAN University Network – Quality Assurance (AUN-QA) and Quality Matters Rubric, this study seeks to optimize course quality assurance requirements and assess lecturers' perception of these proposed guidelines. Drawing on document analysis, semi-structured interviews, and importance-level measurement, the findings of this study underscore the significance of eight criteria, comprising a total of 25 quality requirements, in ensuring course quality. These criteria include learning outcomes, structure and content, instructional approaches, learning assessment, learner support, staff, and output. Notably, these criteria align with the Plan-Do-Check-Act (PDCA) cycle theory, thereby promoting continuous improvement in education.

United States Navy nuclear accident dosimetry program: History and Current Status

Federal Regulations of the United States require that installations possessing sufficient quantities of fissile material to potentially constitute a critical mass, such that the excessive exposure of individuals to radiation from a nuclear accident is possible, shall provide appropriate nuclear accident dosimetry. The American National Standard ANSl/HPS N13.3–2013 Dosimetry for Criticality Accidents provides technical, quality assurance, and performance requirements for nuclear accident dosimeters (NAD). In 2023 the U.S. Navy operated 82 nuclear-powered ships, with the fleet being composed of 11 aircraft carriers, 68 submarines, having a total number of 98 reactors. Since 1968 the U.S. Navy has used fixed nuclear accident dosimeters (FNAD) mounted to the bulkheads surrounding naval nuclear propulsion reactors. Since 1968 the US Navy has used two nuclear accident criticality dosimeters. The first Navy accident dosimeter DT-518/PD was introduced in 1968. It was developed by the Naval Radiological Defense Laboratory in San Francisco, California under leadership of Eugene Tochilin. This dosimeter contains two indium foils for quick dose assessments using shipboard gamma instruments available on nuclear powered vessels and two sulfur pellets/LiF TLD-700 powder for final dose determination at the Naval Dosimetry Center. The newest Navy NAD is the DT-723/PD, which contains indium foil, gold foil, cadmium shielded gold foil, sulfur pellet and a LiF TLD-700 chip. This paper provides a brief description of the measurement procedures, results of the testing of both NADs and comparison of their performance.

Top-down and bottom-up approaches to video quality of experience studies; overview and proposal of a new model

Modern video streaming services require quality assurance of the presented audiovisual material. Quality assurance mechanisms allow streaming platforms to provide quality levels that are considered sufficient to yield user satisfaction, with the least possible amount of data transferred. A variety of measures and approaches have been developed to control video quality, e.g., by adapting it to network conditions. These include objective matrices of the quality and thresholds identified by means of subjective perceptual judgments. The former group of matrices has recently gained the attention of (multi) media researchers. They call this area of study “Quality of Experience” (QoE). In this paper, we present a theoretical model based on review of previous QoE’s models. We argue that most of them represent the bottom-up approach to modeling. Such models focus on describing as many variables as possible, but with a limited ability to investigate the causal relationship between them; therefore, the applicability of the findings in practice is limited. To advance the field, we therefore propose a structural, top-down model of video QoE that describes causal relationships among variables. This novel top-down model serves as a practical guide for structuring QoE experiments, ensuring the incorporation of influential factors in a confirmatory manner.

Development of a novel fibre optic beam profile and dose monitor for very high energy electron radiotherapy at ultrahigh dose rates

Objective. Very high energy electrons (VHEE) in the range of 50–250 MeV are of interest for treating deep-seated tumours with FLASH radiotherapy (RT). This approach offers favourable dose distributions and the ability to deliver ultra-high dose rates (UHDR) efficiently. To make VHEE-based FLASH treatment clinically viable, a novel beam monitoring technology is explored as an alternative to transmission ionisation monitor chambers, which have non-linear responses at UHDR. This study introduces the fibre optic flash monitor (FOFM), which consists of an array of silica optical fibre-based Cherenkov sensors with a photodetector for signal readout. Approach. Experiments were conducted at the CLEAR facility at CERN using 200 MeV and 160 MeV electrons to assess the FOFM’s response linearity to UHDR (characterised with radiochromic films) required for FLASH radiotherapy. Beam profile measurements made on the FOFM were compared to those using radiochromic film and scintillating yttrium aluminium garnet (YAG) screens. Main results. A range of photodetectors were evaluated, with a complementary-metal-oxide-semiconductor (CMOS) camera being the most suitable choice for this monitor. The FOFM demonstrated excellent response linearity from 0.9 Gy/pulse to 57.4 Gy/pulse (R 2 = 0.999). Furthermore, it did not exhibit any significant dependence on the energy between 160 MeV and 200 MeV nor the instantaneous dose rate. Gaussian fits applied to vertical beam profile measurements indicated that the FOFM could accurately provide pulse-by-pulse beam size measurements, agreeing within the error range of radiochromic film and YAG screen measurements, respectively. Significance. The FOFM proves to be a promising solution for real-time beam profile and dose monitoring for UHDR VHEE beams, with a linear response in the UHDR regime. Additionally it can perform pulse-by-pulse beam size measurements, a feature currently lacking in transmission ionisation monitor chambers, which may become crucial for implementing FLASH radiotherapy and its associated quality assurance requirements.

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry.

Implementing any radiopharmaceutical therapy (RPT) program requires a comprehensive review of system readiness, appropriate workflows, and training to ensure safe and efficient treatment delivery. A quantitative assessment of the dose delivered to targets and organs at risk (OAR) using RPT is possible by correlating the absorbed doses with the delivered radioactivity. Integrating dosimetry into an established RPT program demands a thorough analysis of the necessary components and system fine-tuning. This study aims to report an optimized workflow for molecular radiation therapy using 177Lu with a primary focus on integrating patient-specific dosimetry into an established radiopharmaceutical program in a radiation oncology setting. We comprehensively reviewed using the Plan-Do-Check-Act (PDCA) cycle, including efficacy and accuracy of delivery and all aspects of radiation safety of the RPT program. The GE Discovery SPECT/CT 670DR™ system was calibrated per MIM protocol for dose calculation on MIM SurePlan™ MRT software. Jaszcak Phantom with 15-20 mCi of 177Lu DOTATATE with 2.5 µM EDTA solution was used, with the main energy window defined as 208 keV ±10% (187.6 to 229.2 keV); the upper scatter energy window was set to 240 keV ±5% (228 to 252 keV), while the lower scatter energy window was 177.8 keV ±5% (168.9 to 186.7 keV). Volumetric quality control tests and adjustments were performed to ensure the correct alignment of the table, NM, and CT gantry on SPECT/CT. A comprehensive end-to-end (E2E) test was performed to ensure workflow, functionality, and quantitative dose accuracy. Workflow improvements and checklists are presented after systematically analyzing over 400 administrations of 177Lu-based RPT. Injected activity to each sphere in the NEMA Phantom scan was quantified, and the MIM Sureplan MRT reconstruction images calculated activities within ±12% of the injected activity. Image alignment tests on the SPECT/CT showed a discrepancy of more than the maximum tolerance of 2.2 mm on any individual axis. As a result of servicing the machine and updating the VQC and COR corrections, the hybrid imaging system was adjusted to achieve an accuracy of <1 mm in all directions. Workflows and checklists, after analysis of system readiness and adequate training for staff and patients, are presented. Hardware and software components for patient-specific dosimetry are presented with a focus on hybrid image registration and correcting any errors that affect dosimetric quantification calculation. Moreover, this manuscript briefly overviews the necessary quality assurance requirements for converting diagnostic images into dosimetry measurement tools and integrating dosimetry for RPT based on 177Lu.

Simulation-based Optimization of User Interfaces for Quality-assuring Machine Learning Model Predictions

Quality-sensitive applications of machine learning (ML) require quality assurance (QA) by humans before the predictions of an ML model can be deployed. QA for ML (QA4ML) interfaces require users to view a large amount of data and perform many interactions to correct errors made by the ML model. An optimized user interface (UI) can significantly reduce interaction costs. While UI optimization can be informed by user studies evaluating design options, this approach is not scalable, because there are typically numerous small variations that can affect the efficiency of a QA4ML interface. Hence, we propose using simulation to evaluate and aid the optimization of QA4ML interfaces. In particular, we focus on simulating the combined effects of human intelligence in initiating appropriate interaction commands and machine intelligence in providing algorithmic assistance for accelerating QA4ML processes. As QA4ML is usually labor-intensive, we use the simulated task completion time as the metric for UI optimization under different interface and algorithm setups. We demonstrate the usage of this UI design method in several QA4ML applications.

Investigating systemic and social dynamics of food loss and waste: An application of waste regime theory to food production in Aotearoa New Zealand

This research investigates the relationships of social and discursive effects on food loss and waste (FLW) in primary food production through a case study of the kiwifruit industry in Aotearoa New Zealand by using ‘waste regime theory’, which was first developed by Science and Technology Studies scholar Zsuzsa Gille as an organising concept. Qualitative data from semi-structured interviews and analysis of industry and policy documents are interpreted through thematic analysis to explore the production, politics and representation of FLW, and to demonstrate the ways in which these factors interact to enact a ‘food waste regime’. The findings identify two distinct discourses of FLW: either as consequence of supply chain dynamics, or as a consequence of market driven quality assurance (QA) requirements. The former is seen as opening possibilities for technical interventions. The other is seen to be a baked-in structural reality of the industry that doesn’t allow for any strategic intervention. Either discourse arguably has the effect of invisibilising different aspects of FLW in the sector and potentially reducing the perceived need interventions by managers at a systemic level in the sector.

Magistral Phage Preparations: Is This the Model for Everyone?

Phage therapy is increasingly put forward as a promising additional tool to help curb the global antimicrobial resistance crisis. However, industrially manufactured phage medicinal products are currently not available on the European Union and United States markets. In addition, it is expected that the business purpose-driven phage products that are supposed to be marketed in the future would mainly target commercially viable bacterial species and clinical indications, using fixed phage cocktails. hospitals or phage therapy centers aiming to help all patients with difficult-to-treat infections urgently need adequate phage preparations. We believe that national solutions based on the magistral preparation of personalized (preadapted) phage products by hospital and academic facilities could bring an immediate solution and could complement future industrially manufactured products. Moreover, these unlicensed phage preparations are presumed to be more efficient and to elicit less bacterial phage resistance issues than fixed phage cocktails, claims that need to be scientifically substantiated as soon as possible. Just like Belgium, other (European) countries could develop a magistral phage preparation framework that would exist next to the conventional medicinal product development and licensing pathways. However, it is important that the current producers of personalized phage products are provided with pragmatic quality and safety assurance requirements, which are preferably standardized (at least at the European level), and are tiered based on benefit-risk assessments at the individual patient level. Pro bono phage therapy providers should be supported and not stopped by the imposition of industry standards such as Good Manufacturing Practice requirements. Keywords: antimicrobial resistance; antibiotic resistance; bacterial infection; bacteriophage therapy; magistral preparation.

Examens cycliques de programmes dans les établissements d’enseignement post-secondaire : le temps et les efforts sont-ils justifiables?

Cyclical program reviews (CPRs), also called periodic or academic reviews at institutions of higher education, are undertaken to ensure that academic programs meet a variety of objectives related to teaching and learning, as well as professional credentialing, quality assurance, and institutional requirements. Preparing, reviewing, and implementing a CPR requires significant time and effort for those assigned to this task, especially if the program has never previously been through a CPR. Much has been written on how to undertake a CPR (Bresciani, 2006), what measures are useful in assessing programs (Jayachandran et al., 2019), and some of the problems that external reviewers encounter with CPRs (Halonen &amp; Dunn, 2017). This article, however, provides new insights concerning important considerations that should be addressed when preparing to undertake a CPR—from the perspectives of both administrators and faculty at smaller institutions where the number of faculty may be small and resources for the CPR process are often limited. Drawing on a case study of CPRs in several social sciences programs and a broader survey of those involved in CPRs from 2015-2020 at a small Western Canadian university, the authors identify key issues in preparing a CPR, such as the timing of the review, the advantages and disadvantages of an individual approach versus a team approach in preparing the CPR, the role of administrators in the CPR process, the importance of institutional templates in preparing the CPR, and the need for clearly identified program learning outcomes to guide the CPR process. This article also examines how a pandemic can impact the CPR process.

Demand forecasting and inventory management as requirements for quality assurance in a bakery company

This paper is a case study on the influence of inventory management on the results and profitability of a bakery located in the municipality of Nova Iguaçu, in the state of Rio de Janeiro. As a general objective, this study sought to identify the extent to which demand forecasting influences the inventory management of the bakery studied. To this end, the intermediate objectives were to evaluate how demand forecasting is applied, to verify how information on raw material stock levels is managed at the bakery and, finally, to report on how the adoption of a stock control methodology has a positive impact on the quality of service and the bakery's results. The theoretical reference research used a literature review as its methodology, but as far as the case study is concerned, local observations were made and a questionnaire was applied to the operation's manager, comprising ten discursive questions. Based on the analysis of the data collected, the results of the research made it clear how important it is to optimize stocks at the company in order to obtain better results and reduce freight costs, making it financially healthier and, consequently, increasing its profitability. To this end, the need for theoretical and technical knowledge, updating, integration of information, stock management strategy and investment in technologies and tools for stock control and management has become apparent.

Business Rules Driven Automated Quality Assurance Governance System for Higher Education

Although higher education institutes have paid serious attention to quality assurance, implementation issues have been reported frequently. Since the existing information systems do not adequately support automatic verification, manual verification of quality assurance compliances has become a challenge. Therefore, this study first analysed the prevailing higher education quality assurance context to identify the prevailing issues. Secondly, Quality Assurance Governance System integrated with a quality assurance rule manipulation mechanism was designed based on the business rules concept to address the identified issues. Thirdly, the key modules of the proposed Quality Assurance Governance System were developed as a proof-of-concept. Finally, the proposed quality assurance rules manipulation mechanism and modules of the Quality Assurance Governance System were evaluated. The study found that one of the main issues in the existing systems is the lack of integration among various modules and a rule manipulation mechanism. Therefore, the study concludes that quality assurance requirements could be better captured as rules using the proposed rule templates, while rule manipulations and compliance could be verified in real-time through the proposed Quality Assurance Governance System. Nevertheless, the results of the evaluation suggest that rigid rule implementations may make the system inflexible and create stakeholder resistance. Thus, this can be mitigated by implementing the proposed rule enforcement levels.

Analysis of the Suitability of Fish Auction Place in PPN Pekalongan Based on Kepmen-KP 52A 2013 and Sustainability Development

Development and construction of fisheries port facilities can be done by improving the suitability and optimization of fish auction as one of the functional facilities. Fisheries development can run well if the Fish Auction Place (TPI) has facilities and work systems that are in accordance with applicable regulations. Data were collected using observation, questionnaire, and in-depth interview with 20 respondents. This research aims to analyze the suitability of TPI at PPN Pekalongan based on the Decree of the Minister of Marine Fisheries Number 52 A of 2013 concerning Requirements for Quality Assurance and Safety of Fishery Products in the Process of Production, Processing, and Distribution at TPI PPN Pekalongan. This research used scoring analysis to analyze the suitability of TPI is scoring analysis by observing the physical condition of TPI and then comparing it to Kepmen-KP/52A/Year 2013, while the data analysis of sustainability of fish auction place at PPN Pekalongan was evaluated using RAPFISH method. According to the result a suitability of fish auction place in fish auction Pekalongan fish landing site category in based on Kepmen-KP/52A/2013 obtained an average score of 3.3 which indicates that it is quite suitable but there are still many indicators that are not in accordance with existing regulations. Criteria for fish marketing places obtained an average score of 3.92 which is categorized as appropriate but still needs attention for several aspects of fish marketing places. The status and sustainability index of the management of fish auction place in Pekalongan fish auction for the ecological and technological dimensions are less sustainable, while the economic and social dimensions are quite sustainable. The conclusion that can be drawn is that the condition of the Fish Auction Place at PPN Pekalongan is categorized as quite suitable and still needs improvement in facilities and infrastructure, while for the sustainability status of the Fish Auction Place at PPN Pekalongan also still needs improvement in the ecological, economic, social and technologic dimensions.

Verification of the analytical performance of the serum total cholesterol assay on Abbott Architect ci8200

Serum total cholesterol measurement is an essential aspect of preventive healthcare as high levels of cholesterol are linked to various diseases such as atherosclerosis, heart attacks, and strokes. Serum cholesterol measurement is a simple blood test that assesses the levels of cholesterol in the bloodstream. It is an important diagnostic tool that helps healthcare professionals evaluate a patient's risk of developing cardiovascular disease and make decisions regarding treatment and lifestyle changes. Our study aims to verify the analytical performance of the serum total cholesterol assay method using an Abbott kit on the Architect ci8200 automated system in the biochemistry laboratory of the Mohammed VI University Hospital of Oujda. The analytical performance of the kit was verified through flexible scope A by performing a performance study on the Architect ci8200. We evaluated the repeatability, the reproducibility, the imprecision of the measurements and the comparison between two Architect ci8200 automatons. All the results obtained are in conformity with the acceptability criteria recommended by the supplier and the Valtec protocol of the ‘Société Française de Biologie Clinique’ (SFBC), and the study is globally satisfactory. The analytical performance of the Architect ci8200 automated system was satisfactory for a reliable determination of total cholesterol. Verification of methods of dosage in the medical laboratory is crucial to ensure the accuracy, precision, and reliability of laboratory test results. Verification involves confirming that the test method employed is appropriate for the intended use, produces results that are consistent with the claimed performance characteristics, and meets the laboratory's quality control and quality assurance requirements.

The Influence of Internal and External Quality Audit on The Sustainability of Surabaya Merchant Marine Polytechnic

Purpose: The era of globalization and free markets forces universities to organize themselves by introducing internal quality assurance to guarantee the quality of education and services. In addition to internal quality assurance, universities as labor producers also require quality assurance from certification bodies outside the university. Several previous studies examined the influence of internal and external quality audits on work productivity and employee performance. In this study, the effect was seen to be different from before, namely knowing the effect of internal and external quality audits on the sustainability of the Surabaya Merchant Marine Polytechnic. The purpose of this study was to determine whether internal and external quality audits affect the sustainability of the Surabaya Merchant Marine Polytechnic.&#x0D; Design/methodology/approach: This study uses quantitative research with a population and the sample is a work unit at the Surabaya Merchant Marine Polytechnic which is involved with internal and external quality audits. The data collection method in this study was to use questionnaires using multiple linear regression analysis. Tests in this study used SPSS statistics version 26.&#x0D; Findings: The conclusion of this study is that there is a significant influence between internal and external quality audits on the sustainability of the Surabaya Merchant Marine Polytechnic either partially or simultaneously. The variable that has the dominant influence on this study is the internal quality audit.&#x0D; Paper type: Research Paper.

Coordination of chemical analyses under the European Human Biomonitoring Initiative (HBM4EU): Concepts, procedures and lessons learnt.

The European Human Biomonitoring Initiative (HBM4EU) ran from 2017 to 2022 with the aim of advancing and harmonizing human biomonitoring in Europe. More than 40,000 analyses were performed on human samples in different human biomonitoring studies in HBM4EU, addressing the chemical exposure of the general population, temporal developments, occupational exposure and a public health intervention on mercury in populations with high fish consumption. The analyses covered 15 priority groups of organic chemicals and metals and were carried out by a network of laboratories meeting the requirements of a comprehensive quality assurance and control system. The coordination of the chemical analyses included establishing contacts between sample owners and qualified laboratories and monitoring the progress of the chemical analyses during the analytical phase, also addressing status and consequences of Covid-19 measures. Other challenges were related to the novelty and complexity of HBM4EU, including administrative and financial matters and implementation of standardized procedures. Many individual contacts were necessary in the initial phase of HBM4EU. However, there is a potential to develop more streamlined and standardized communication and coordination in the analytical phase of a consolidated European HBM programme.