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Introduction: The history of standardization relating to the activities of medical laboratories traces the development of quality system standards in the world, and their evolution. Content: In this study, we have included the key benchmarks that represent the stages of the quality system's evolution in recent decades. Accreditation of medical laboratories has become compulsory in most countries, regarding national or international standards. International acknowledgment of the effectiveness of the results delivered to the many stakeholders, particularly patients and prescribers, is conferred through the use of standards. Summary: The ISO 15189 standard represents the latest and most specific international standards for medical laboratories of all types. Outlook: More research is necessary to study if laboratory practices reflect the evolution of standards within the medical laboratory field.

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The pharmaceutical industry is increasingly embracing laboratory automation to enhance experimental efficiency and operational resilience, particularly through the integration of automated liquid handlers (ALHs). This paper explores the integration of the low-cost Opentrons OT-2 liquid handling robot with F. Hoffmann-La Roche AG's in-house workflow orchestration software, AutoLab, to overcome barriers to lab automation. By leveraging the OT-2's development-oriented interfaces and AutoLab's modular architecture, we achieved a user-friendly, cost-efficient, and flexible automation solution that aligns with FAIR (findable, accessible, interoperable, reusable) data principles. We demonstrate an advanced workflow development methodology, utilizing the software architecture, that facilitates the creation of two flexible pipetting protocols and medium complexity assays. This deep integration approach diminishes the learning curve for novice users while simultaneously enhancing the overall efficiency and reliability of the experimental workflow. Our findings suggest that such integrations can significantly mitigate the challenges associated with lab automation, including cost, complexity, and adaptability, paving the way for more accessible and robust automated systems in pharmaceutical research.

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Proficiency testing (PT) allows food laboratories to endorse their competency to provide food safety guarantees to producers and consumers. One of the recommended methods for assigning reference values in PT with a small number of participants consists in considering the results that a laboratory obtains by means of a calibration test based on certified reference material (CRM). The present study delves into the results from eight PT rounds on the determination of fat and crude protein from raw milk, with modifications in the number of samples and the analysis sessions from that required by the ISO 13528:2022. The uncertainty criterion of the assigned value established by the ISO 13528:2022 standard was met by 93% of the participating laboratories, which allowed most participants to be evaluated through z-score. The assigned values were generally compatible with the results obtained by the participants. Thus, it can be concluded that the design for the assignment of the reference value is appropriate for PT with a limited number of participants. It is recommended for future PT to limit the uncertainty of the CRM according to their availability and to update the standard deviation of the proficiency assessment for the Mid-Infrared Spectroscopy method (MIR).

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OBJECTIVES: This study aimed to assess the validity of external quality assessment (EQA) laboratory results across various cultural and environmental contexts and to identify potential improvement areas. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a 2-year study (2022 and 2023) in which EQA materials, related software and online training was provided by a commercial vendor to 100 laboratories in ten IFCC member society countries. The results were analysed on a monthly basis by the TF-GLQ, to show the number of submissions per country, tests per lab, acceptability rates, random failures and to get a measure of which analytes performed poorly. RESULTS: The EQA material was dispatched on a quarterly basis. Some countries had problems with customs releasing the material in a timely manner, resulting in laboratories not receiving them on time leading to no submission. We report here the results for the second year of the survey. The number of examinations varied between laboratories, ranging from seven to 84 analytes. Of the ten countries surveyed, six averaged greater than 90 % acceptable results over the whole 12-months cycle, one had unacceptable results for two of the nine months they returned results and the other four were considered to not perform to an acceptable standard. CONCLUSIONS: All 100 participating laboratories indicated satisfaction with the EQA survey and related services, including on-site training, and report handling. However, specimen receiving issues, suggest benefits in dispatching materials for a full 12-month cycle. Significant discrepancies in EQA performance indicate that four countries require long-term assistance, training and guidance. To ensure reliable patient results, promoting EQA in certain countries is essential to achieve the required level of quality.

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Over the past decade, increasing off-label use of quetiapine has been reported worldwide from various sources. We wanted to investigate how this is reflected in therapeutic drug monitoring (TDM) data. Requisitions for serum concentration measurements of quetiapine from a TDM service in Central Norway during 2001-2019 were obtained and analysed for age, gender, trends in quetiapine doses, serum concentrations and indicators of diagnoses. There were 19 759 requisitions from 7459 individuals. Daily doses of quetiapine decreased by 24 mg per year (95% CI: -25.61 to -21.48, p < 0.001, N = 4505). A corresponding decrease in quetiapine serum concentrations was not seen. The proportion of requisitions with diagnoses indicating reimbursable use was 13% for the whole study period. Mean daily doses were slightly higher in the reimbursable group, but declined over time in these samples, as well. To our understanding, these results signal a trend towards lower prescribed doses of quetiapine, possibly reflecting drug repurposing and/or off-label use. The discrepancy in the decrease of doses versus serum concentrations may reflect the intake of higher doses than prescribed and/or inappropriate TDM sampling. Our findings show that TDM data have limitations when it comes to making inferences about the use of quetiapine based on serum concentrations and clinical information on the requisitions.

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BACKGROUND: The integrity of clinical research and machine learning models in healthcare heavily relies on the quality of underlying clinical laboratory data. However, the preprocessing of this data to ensure its reliability and accuracy remains a significant challenge due to variations in data recording and reporting standards. METHODS: We developed lab2clean, a novel algorithm aimed at automating and standardizing the cleaning of retrospective clinical laboratory results data. lab2clean was implemented as two R functions specifically designed to enhance data conformance and plausibility by standardizing result formats and validating result values. The functionality and performance of the algorithm were evaluated using two extensive electronic medical record (EMR) databases, encompassing various clinical settings. RESULTS: lab2clean effectively reduced the variability of laboratory results and identified potentially erroneous records. Upon deployment, it demonstrated effective and fast standardization and validation of substantial laboratory data records. The evaluation highlighted significant improvements in the conformance and plausibility of lab results, confirming the algorithm's efficacy in handling large-scale data sets. CONCLUSIONS: lab2clean addresses the challenge of preprocessing and cleaning clinical laboratory data, a critical step in ensuring high-quality data for research outcomes. It offers a straightforward, efficient tool for researchers, improving the quality of clinical laboratory data, a major portion of healthcare data. Thereby, enhancing the reliability and reproducibility of clinical research outcomes and clinical machine learning models. Future developments aim to broaden its functionality and accessibility, solidifying its vital role in healthcare data management.

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Postmortem examination of deceased production animals with appropriate ancillary testing is fundamental to determining causes of morbidity and mortality. Reaching a definitive diagnosis is crucial to evidence-based herd management and treatment decisions that safeguard animal health and welfare, food safety, and human health. However, for a range of reasons, carcasses sometimes cannot be examined in a veterinary diagnostic laboratory. As a result, postmortem examinations of farmed animals, including cattle, are often performed on-farm by the referring veterinarian (rVet) with tissue samples submitted to a veterinary diagnostic laboratory for ancillary testing. For various reasons, field postmortems can be associated with lower diagnostic rates. We investigated real-time pathologist-assisted field postmortem examination (rtPAP) assistance to beef cattle rVets to gauge any improvement in attaining a final diagnosis. We found that rtPAPs improved the success of reaching a final diagnosis compared to unassisted field postmortem examinations. Both the participating bovine rVets and the pathologists saw benefits to the rtPAPs, with bovine rVets indicating that they would utilize this service in the future if available. Our proof-of-concept study demonstrated the positive role of rtPAPs in diagnosing beef cattle disease and speaks to the need for telepathology services supporting food animal rVets and producers.

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BACKGROUND: Medical diagnostic laboratories are an essential work environment that plays an important role in diagnosing, treating, and being sensitive to diseases. One way to evaluate laboratories' performance is to calculate their efficiency. This study investigates the efficiency of laboratories that are related to health centers in the south of Iran. METHODS: This study was conducted in 2021. The input numbers include: the number of technical personnel and the number of cell counters, and the output data includes: the scores obtained from the level 2 health laboratory evaluation list. And efficiency was calculated with DEAP software. The analysis is accomplished by the assumption of input-oriented. FINDINGS: The efficiency of laboratories of Orzueeyeh and Ravar Cities had the highest efficiency with the assumption of variable returns to scale efficiency 1, and the model of all laboratories is the laboratory of Ravar City. The laboratories of Kuhbanan and Rabor cities had the lowest efficiency with the assumption of variable returns to scale efficiency of 0.859 and 0.899, respectively. The average scale efficiency, Variable returns to scale, and constant returns to scale for laboratories in the cities of Kerman province are 0.842, 0.943, and 0.895, respectively. CONCLUSIONS: To increase the efficiency of laboratories, significant resources and funds should be used, as well as few studies have been done on the efficiency of laboratories, which requires more attention.

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Background: The COVID-19 pandemic underscored the critical importance of biosafety in microbiology laboratories worldwide. In response, China has ramped up its efforts to enhance biosafety measures within its Centers for Disease Control and Prevention (CDC) laboratories. This study provides the first comprehensive assessment of biosafety practices across provincial, city, and county levels of CDC microbiology laboratories in China. Methods: We conducted a nationwide cross-sectional survey from 2021 to 2023, targeting staff from microbiology laboratories within CDCs at all administrative levels in China. Stratified sampling was employed to select respondents, ensuring a representative mix across different CDC hierarchies, job titles, and academic qualifications. The survey encompassed questions on biosafety training, the presence of BSL-2 and BSL-3 laboratories, adherence to general biosafety guidelines, and management practices regarding specimens, reagents, and consumables. Statistical analysis was performed to identify significant differences in biosafety practices among different CDC levels. Results: A total of 990 valid responses were received, highlighting a nearly universal presence (98.69%) of BSL-2 laboratories and a significant yet varied presence of BSL-3 laboratories across the CDC network. The survey revealed high levels of biosafety training (98.69%) and adherence to biosafety protocols. However, challenges remain in the consistent application of certain safety practices, especially at lower administrative levels. Notable differences in the management of specimens, reagents, and consumables point to areas for improvement in ensuring biosecurity. Conclusion: Our findings indicate a robust foundation of biosafety practices within CDC microbiology laboratories in China, reflecting significant advancements in the wake of the Biosecurity Law's implementation. Nevertheless, the variability in adherence to specific protocols underscores the need for ongoing training, resources allocation, and policy refinement to enhance biosafety standards uniformly across all levels. This study's insights are crucial for guiding future improvements in laboratory biosafety, not just in China but potentially in other countries enhancing their public health infrastructures.

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Epithelial mechanics and mechanobiology have become 2 important research fields in life sciences and bioengineering. These fields investigate how physical factors induced by cell adhesion and collective behaviors can directly regulate biologic processes, such as organ development and disease progression. Cell mechanics and mechanobiology thus make exciting biophysics education topics to illustrate how fundamental physics principles play a role in regulating cell biology. However, the field currently lacks hands-on activities that engage students in learning science and outreach programs in these topics. One such area is the development of robust hands-on modules that allow students to observe features of cell shape and mechanics and connect them to fundamental physics principles. Here, we demonstrate a workflow that engages students in studying epithelial cell mechanics by using commercial histology slides of frog skin. We show that by using recently developed artificial intelligence-based image-segmentation tools, students can easily quantify different cell morphologic features in a high-throughput manner. Using our workflow, students can reproduce 2 essential findings in cell mechanics: the common gamma distribution of normalized cell aspect ratio in jammed epithelia and the constant ratio between the nuclear and cellular area. Importantly, because the only required instrument for this active learning module is a readily available light microscope and a computer, our module is relatively low cost, as well as portable. These features make the module scalable for students at various education levels and outreach programs. This highly accessible education module provides a fun and engaging way to introduce students to the world of epithelial tissue mechanics.

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Background: Ensuring equitable physical access to SARS-CoV-2 testing has proven to be crucial for controlling the COVID-19 epidemic, especially in countries like Nepal with its challenging terrain. During the second wave of the pandemic in May 2021, there was immense pressure to expand the laboratory network in Nepal to ensure calibration of epidemic response. The expansion led to an increase in the number of testing facilities from 69 laboratories in May 2021 to 89 laboratories by November 2021. We assessed the equity of physical access to COVID-19 testing facilities in Nepal during 2021. Furthermore, we investigated the potential of mathematical optimisation in improving accessibility to COVID-19 testing facilities. Methods: Based on up-to-date publicly available data sets and on the COVID-19-related daily reports published by Nepal's Ministry of Health and Population from May 1 to November 15, 2021, we measured the disparities in geographical accessibility to COVID-19 testing across Nepal at a resolution of 1 km2. In addition, we proposed an optimisation model to prescribe the best possible locations to set up testing laboratories maximizing access, and tested its potential impact in Nepal. Findings: The analysis identified vulnerable districts where, despite ramping up efforts, physical accessibility to testing facilities remains low under two modes of travel-walking and motorized driving. Both geographical accessibility and its equality were better under the motorised mode compared with the walking mode. If motorised transportation were available to everyone, the population coverage within 60 min of any testing facility (public and private) would be close to threefold the coverage for pedestrians within the same hour: 61.4% motorised against 22.2% pedestrian access within the hour, considering the whole population of Nepal. Very low accessibility was found in most areas except those with private test centres concentrated in the capital city of Kathmandu. The hypothetical use of mathematical optimisation to select 20 laboratories to add to the original 69 could have improved access from the observed 61.4% offered by the laboratories operating in November to 71.4%, if those 20 could be chosen optimally from all existing healthcare facilities in Nepal. In mountainous terrain, accessibility is very low and could not be improved, even considering all existing healthcare facilities as potential testing locations. Interpretation: The findings related to geographical accessibility to COVID-19 testing facilities should provide valuable information for health-related planning in Nepal, especially in emergencies where data might be limited and decisions time-sensitive. The potential use of publicly available data and mathematical optimisation could be considered in the future. Funding: WHO Special Programme for Research and Training in Tropical Diseases (TDR).

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Predicting the blood-brain barrier (BBB) permeability of small-molecule compounds using a novel artificial intelligence platform is necessary for drug discovery. Machine learning and a large language model on artificial intelligence (AI) tools improve the accuracy and shorten the time for new drug development. The primary goal of this research is to develop artificial intelligence (AI) computing models and novel deep learning architectures capable of predicting whether molecules can permeate the human blood-brain barrier (BBB). The in silico (computational) and in vitro (experimental) results were validated by the Natural Products Research Laboratories (NPRL) at China Medical University Hospital (CMUH). The transformer-based MegaMolBART was used as the simplified molecular input line entry system (SMILES) encoder with an XGBoost classifier as an in silico method to check if a molecule could cross through the BBB. We used Morgan or Circular fingerprints to apply the Morgan algorithm to a set of atomic invariants as a baseline encoder also with an XGBoost classifier to compare the results. BBB permeability was assessed in vitro using three-dimensional (3D) human BBB spheroids (human brain microvascular endothelial cells, brain vascular pericytes, and astrocytes). Using multiple BBB databases, the results of the final in silico transformer and XGBoost model achieved an area under the receiver operating characteristic curve of 0.88 on the held-out test dataset. Temozolomide (TMZ) and 21 randomly selected BBB permeable compounds (Pred scores = 1, indicating BBB-permeable) from the NPRL penetrated human BBB spheroid cells. No evidence suggests that ferulic acid or five BBB-impermeable compounds (Pred scores < 1.29423E-05, which designate compounds that pass through the human BBB) can pass through the spheroid cells of the BBB. Our validation of in vitro experiments indicated that the in silico prediction of small-molecule permeation in the BBB model is accurate. Transformer-based models like MegaMolBART, leveraging the SMILES representations of molecules, show great promise for applications in new drug discovery. These models have the potential to accelerate the development of novel targeted treatments for disorders of the central nervous system.

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Methamphetamine (MA) is one of the most virulent illicit drugs that can be synthesized from household materials leading to its prevalent trafficking and local manufacturing in clandestine drug laboratories (clan labs). The significant problems of tracing MA in clan labs and monitoring drug abusers lie in the lag time between sample collection and analysis and the number of tests done. Capillary electrophoresis (CE) is a rapid separation technique amenable to miniaturization and field testing. Herein, we developed a simple transient isotachophoretic (tITP)-CE method to detect MA and its precursor pseudoephedrine (PSE) in clan labs and non-invasive biological fluids. The method was implemented on the ETD-100, a commercial fully automated portable CE instrument with an integrated swab-based extraction system. Within 2 min of insertion of the swab, MA and PSE were automatically extracted with a leading electrolyte (LE) and then separated on covalently modified capillaries. The ETD-100 showed a limit of detection (LOD) and quantification (LOQ) of MA 0.02 and 0.05 µg/swab and 0.02 and 0.06 µg/swab of PSE, with an enhancement factor of 118 and 328, respectively, when compared to a normal non-tITP injection. The intra and inter-day relative standard deviation in terms of migration time were in the range of 0.75-1.93 % for both MA and PSE and were 2.0-2.4 % for both MA and PSE peak height. The method was demonstrated with the detection of spiked MA and PSE on different household materials as well as in non-invasive biological fluids with a recovery above 60 %.

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While office-based laboratories (OBLs) have been increasing in popularity, only a small proportion of the current interventional radiology (IR) workforce works in an OBL. With the relative lack of an IR presence in OBLs compared to other endovascular specialists, combined with the growth of the OBL space, the presence of IR within OBLs will likely increase in the coming years. This article addresses the value interventional radiologists (IRs) can bring to the OBL, with primary impacts being the ability to impact a larger proportion of the population than is traditionally cared for in most hospital settings, the ability to positively influence multidisciplinary care teams and the financial leverage inherent in procedural diversification not readily afforded by other specialists working in the OBL space. IR-specific pitfalls in the OBL space are also addressed, including difficulties in obtaining patient referrals, investor relationships, and group practice arrangements. Despite potential challenges, IRs have a lot to offer within the OBL space, and conversely, the OBL space provides a mechanism for IRs to increase their reach and improve career longevity.

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For handling safely infectious agents, European laboratories must comply with specific EC Directives, national regulations and recommendations from the World Health Organization (WHO). To prevent laboratory acquired infections (LAIs) and pathogens dissemination, a key biosafety rule requires that any infectious material (clinical specimens or research samples) manipulated outside a biosafety cabinet (BSC) must be inactivated unless the lack of infectivity is proven. This inactivation process is a crucial step for biosafety and must be guided by a rigorous experimental qualification and validation procedure. However, for diagnostic or research laboratories, this process is not harmonized with common standard operation procedures (SOPs) but based on individual risk assessment and general international guidelines which can pose problems in emergency situations such as major outbreaks or pandemics. This review focuses on viral inactivation method, outlining the current regulatory framework, its limitations and a number of ways in which biosafety can be improved.

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This report reviews national data from all Member States on measles, rubella, and congenital rubella syndrome (CRS) elimination in the Region of the Americas during 2019-2023. It includes an analysis of compliance with vaccination coverage, surveillance indicators, and measles outbreaks, as well as an analysis of the response capacity of the laboratory network and a country case study that meets all indicators. The sources of information were the integrated epidemiological surveillance system for measles and rubella of the Pan American Health Organization (PAHO)/World Health Organization (WHO) and the Joint Reporting Form (eJRF), among others. From 2020 to 2022, regional coverage with first (MMR-1) and second doses (MMR-2) decreased to rates below 90%. The regional suspected case notification rate was maintained above the minimum expected 2.0 suspect cases per 100,000 population, except in 2021. During 2019 to 2023, 18 countries experienced outbreaks, with two of the outbreaks resulting in re-established endemic transmission. In conclusion, two countries in the Americas have not maintained measles elimination, but by the end of 2023 no country showed endemic measles transmission. One of the countries that lost its certification of elimination in 2018 managed to be reverified in 2023; the other is pending reverification. All countries maintained rubella elimination. Despite these challenges, the sustainability of the elimination of these diseases remains a health priority in the Region.

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This study aimed to assess dental technologists/technicians knowledge, attitudes, and practice during the COVID-19 pandemic in Saudi Arabia. This cross-sectional study was conducted among workers in dental laboratories in Saudi Arabia. A validated questionnaire was developed based on previous literature and distributed online. The questionnaire assessed the study population's knowledge, attitude, and practice regarding infection control protocol for COVID-19. Descriptive statistics of categorical variables were conducted. The response rate was 58.3%, where most respondents are male at a rate of 97%. Most of the participants (82%) were aware of the various infection control measures for COVID-19 in a dental laboratory. Forty-eight participants showed a level of knowledge range between 80 and 100%, while 27 and 30 participants reported moderate and low level of knowledge, respectively. Only 67% of the participants strongly agree that dental cast and fabricated/repaired restorations should be transferred in a very close and protective package to control infection. About 70% of participants indicated they always wear protective gear/goggles and should be warned while working in the dental laboratory. As the pumice slurry was utilized frequently to clean and polish the prostheses, 66% of participants agreed that pumice slurry should be always changed regularly. Regarding COVID-19 infection control procedures, dental technologists/technicians showed good knowledge, attitude, and practice; however, considering how infectious the virus is, more measures should be taken into consideration. Effective communication and collaboration between the laboratory and the dental clinic are essential for infection control.

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An organizational culture of biosafety and biosecurity is critical for effective management of transboundary animal diseases. One essential aspect of this work is keeping important pathogens studied in veterinary laboratories under control. Türkiye is among the countries that are both endemic and disease-free for foot-and-mouth disease (FMD) virus, and it has a unique institute dedicated to FMD diagnosis, control, and vaccine production. To build an organizational safety culture within this institute and strengthen awareness of the importance of safe and secure handling of FMD, 4 staff members previously trained in biorisk management developed and provided trainings to all institute staff. The institute's 173 personnel were divided into 3 groups by job description based on direct or indirect work with FMD virus. All 3 groups received training that addressed biosecurity, biosafety, biorisk awareness, and insider threat; the trainings varied in length by group. Three-quarters (n=130, 75%) of all institute staff completed their training and were asked to complete knowledge surveys using a Likert scale survey before and after their training. A majority (n=104, 80%) of those participants completed both the pretraining and posttraining surveys. All 3 training groups' posttraining surveys showed improved awareness above baseline scores, and all 3 groups scores reached the targeted threshold goal. Group 2 demonstrated a realization that some of the knowledge and habits they had acquired through experience were incorrect. Scores for several individual questions decreased at posttraining, and these results will need further evaluation. The overall training results prompted the institute to provide periodic updates to employees to sustain the organizational safety culture. With this study, the institute now has a dedicated group of biorisk management representatives. This work serves as a wake-up call for established institutions that rely on staff experience to foster an organizational culture of biosafety and biosecurity.

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