Laboratory Process Research Articles

A digital duplicating obturator with 3D printing technology

Obturators are vital for restoring function and appearance in patients with maxillofacial defects, though traditional fabrication involves multiple clinical visits and extended production time. This technique report details a digital approach using computer-aided design/manufacturing (CAD/CAM) and 3D printing to duplicate an obturator for a 74-year-old patient with maxillary bone necrosis. By using a chairside intraoral scanner, we obtained a digital model of the existing obturator, avoiding traditional impression-taking and reducing procedural discomfort. A 3D-printed obturator was fabricated, adjusted with a tissue conditioner, and refined to ensure optimal fit. Laboratory processes included using specialized materials and retention techniques. The digital workflow minimized patient visits and improved comfort, underscoring CAD/CAM and 3D printing's potential to enhance clinical efficiency and quality of life for patients requiring complex prosthetic rehabilitation. This approach highlights the practical benefits of integrating digital and analog methods in maxillofacial prosthetics. (Int J Maxillofac Prosthetics 2024;7:16-19)

Comparative Life Cycle Assessments of Laboratory and Pilot-Scale Mechanochemical Processes for Producing Carbonated Mineral Products as Cement Substitutes.

The use of carbonated mineral products in cement production reduces carbon emissions and enhances durability. This study evaluated the environmental sustainability of using mineral carbonated biomass fly ash (BFA) as a partial cement replacement in European cement production. Laboratory-scale and simulated large-scale scenarios were analysed. Incorporating 20% mineral carbonated BFA showed potential for a 33% reduction in the annual Global Warming Potential (GWP) of cement products. Energy consumption factors, such as ball milling and mineral carbonation processes, were evaluated using a machine learning model and comminution flow sheet model simulations. The machine learning model predicted CO2 absorption and energy requirements for mineral carbonation, showing greater efficiency in large-scale scenarios. Life cycle assessments consistently revealed GWP reductions for OPC-BFA mixtures, with additional emissions reductions when incorporating flow sheet modelling and machine learning data. However, the study's limitations include simplified CO2 flue gas treatment, use of the mean EU electricity mix, exclusion of transportation impacts, and reliance on simulation data. Additionally, the cement mix exhibited reduced compressive strength. This study highlights the potential of mineral carbonated BFA to reduce cement production's environmental impact while emphasising the need for balanced optimisation between sustainability and material performance.

From sampling to cellblock: The fully automated journey of cytological specimens.

In recent years, technological innovation have emerged to standardize pathology laboratory processes and reduce the handling of diagnostic samples. Among them is an automatic tissue embedding system that eliminates the need for manual activity in tissue paraffin embedding, thereby improving sample preservation. Unfortunately, this system cannot be used for cytological specimens due to the lack of an effective holder to support the procedure steps. In this study, we evaluated the performance of a commercial polymer matrix to enable and standardize the automatic paraffin embedding of cytological material from different organs and sources. Cytological samples from 40 patients were collected on the matrices and submitted for fully automatic workflow preparation, from formalin fixation until paraffin block, using the Sakura embedding system. Our results demonstrated the feasibility of the automated procedure, from loading cytological sample onto the matrix to obtaining the paraffin cellblock, thereby avoiding manual manipulation of cellular material. All samples resulted adequately processed and paraffin-embedded showing satisfactory tissue permeation by processing reagents, optimal preservation of cytoplasmic and nuclear details, and good quality of staining results on paraffin sections. Automated embedding of cytological samples eliminates the risk of lost specimens, reduces laboratory burden, standardizes procedures, increases diagnostic yield, and ultimately improves patients' management.

Sanitary sewer overflows, household sewage backups, and antibiotic-resistant bacteria: the new frontier of environmental health risks and disasters

Abstract Untreated sewage discharges leading to environmental contamination are increasingly common in communities across the globe. The cause of these discharges range from sewer lines in disrepair, blockages, and in the era of more extreme wet weather events, the infiltration of stormwater into the system during heavy downpours. Regardless of the driver of these events, the aftermath results in raw sewage spilling into local waterways, city streets, and commercial and residential structures. Historical research in public health has thoroughly documented the connection between exposure to untreated sewage and waterborne disease. Recent research has detected antibiotic-resistant bacteria at wastewater treatment facilities at a time when deaths by antibiotic-resistant infections are on the rise. However, no research has explored the exposure pathways of antibiotic resistant bacteria during sanitary sewer overflows and household-level sewage backups. In this commentary, we aim to introduce this new frontier of environmental health risks and disasters. To do this we describe the history of modern sanitation and sewer infrastructure with a particular focus on wastewater infrastructure in the U.S. We also explore emerging risks and current methods for identifying antibiotic-resistant bacteria in the environment. We end with future directions for interdisciplinary scholarship at the nexus of urban planning, engineering, and public health by introducing the Water Emergency Team (WET) Project. WET is a community-based multi-method effort to identify environmental risks in the aftermath of household backups through 1) residential surveys, 2) indoor visual inspections, 3) environmental sampling, and 4) laboratory processing and reporting. Our hope is that by introducing this comprehensive approach to environmental risks analysis, other scholars will join us in this effort and ultimately towards addressing this grand challenge of our time.

Mastering Snow Analysis: Enhancing Sampling Techniques and Introducing ACF Extraction Method with Applications in Svalbard.

Semi-volatile organic contaminants (SVOCs) are known for their tendency to evaporate from source regions and undergo atmospheric transport to distant areas. Cold condensation intensifies dry deposition, particle deposition, and scavenging by snow and rain, allowing SVOCs to move from the atmosphere into terrestrial and aquatic ecosystems in alpine and polar regions. However, no standardized methods exist for the sampling, laboratory processing, and instrumental analysis of persistent organic pollutants (POPs) in snow. The lack of reference methods makes these steps highly variable and prone to errors. This study critically reviews the existing literature to highlight the key challenges in the sampling phase, aiming to develop a reliable, consistent, and easily reproducible technique. The goal is to simplify this crucial step of the analysis, allowing data to be shared more effectively through standardized methods, minimizing errors. Additionally, an innovative method for laboratory processing is introduced, which uses activated carbon fibers (ACFs) as adsorbents, streamlining the analysis process. The extraction method is applied to analyze polychlorobiphenyls (PCBs) and chlorinated pesticides (α-HCH, γ-HCH, p,p'-DDE, o,p'-DDT, HCB, and PeCB). The entire procedure, from sampling to instrumental analysis, is subsequently tested on snow samples collected on the Svalbard Islands. To validate the efficiency of the new extraction system, quality control measures based on the EPA methods 1668B and 1699 for aqueous methods are employed. This study presents a new, reliable method that covers both sampling and lab analysis, tailored for detecting POPs in snow.

MRD Detection in B-Cell Non-Hodgkin Lymphomas Using Ig Gene Rearrangements and Chromosomal Translocations as Targets for Real-Time Quantitative PCR and ddPCR.

Minimal residual disease (MRD) diagnostics is of high clinical relevance in patients with indolent B-cell non-Hodgkin lymphomas (B-NHL), B-cell chronic lymphocytic leukemia (CLL), and multiple myeloma and serves as a surrogate parameter to evaluate treatment effectiveness and long-term prognosis. Real-time quantitative PCR (RQ-PCR) targeting circulating lymphoma cells is still the gold standard for MRD detection in indolent B-NHL and currently the most sensitive and the most broadly applied method in follicular lymphoma (FL) and mantle cell lymphoma (MCL). Alternatively, droplet digital PCR (ddPCR) can be used for MRD monitoring in multiple myeloma, mantle cell lymphoma, CLL, and FL with comparable sensitivity, accuracy, and reproducibility.The most broadly applicable MRD target in B-NHL is the junctional regions of the rearranged immunoglobulin heavy (IGH) and light chain genes. Complete and incomplete IGH and additionally IG kappa light chain rearrangements can be used as targets for MRD. Next-generation sequencing (NGS) of IG-rearrangements (IG-NGS) as new sequencing-based technology can overcome the limitation of PCR-based approaches and has a potential for higher sensitivity. Chromosomal translocations like the t(14;18)(q32;q21) translocation associated with IGH::BCL2 fusion in FL and t(11;14)(q13;q32) translocation in MCL leading to the IGH::CCND1 fusion can be used as MRD target in selected lymphoma subtypes. In patients with CLL, both flow-cytometry and RQ-PCR are equally suited for MRD assessment as long as a sensitivity of 10-4 is achieved.MRD diagnostics targeting the IG loci is complex and requires extensive knowledge and experience because the junctional regions of each clonal rearranged gene have to be identified before the patient-specific PCR assays can be designed for MRD monitoring. In addition, the presence and load of somatic hypermutation within the rearranged IGH gene occurring during B-cell development of germinal center and post-germinal center B-cell lymphomas may hamper appropriate primer binding leading to false-negative results. The translocations mentioned above have the advantage that consensus forward primers and probes, both placed in the breakpoint regions of chromosome 18 in FL and chromosome 11 in MCL, can be used in combination with a reverse primer placed in the IGH joining region of chromosome 14. PCR-based methods using allele-specific primers can reach a high sensitivity of up to 10-5. This chapter provides all relevant background information and technical aspects for the complete laboratory process from detection of the clonal IG gene rearrangements and the chromosomal translocations at diagnosis to the actual MRD measurements in clinical follow-up samples of B-NHL. However, it should be noted that MRD diagnostics for clinical treatment protocols has to be accompanied by regular international quality control rounds to ensure the reproducibility and reliability of the MRD results. This is available by the EuroMRD network ( https://euromrd.org ), a subgroup of ESHLO ( https://eslho.org ).

Reabilitação estética de dente conóide: relato de caso

As aesthetics advance in modern dentistry, people's expectations of their smiles become ever higher. Microdontia or conoid tooth, which refers to teeth smaller than normal, is one of the abnormalities that causes major aesthetic complaints due to its characteristics. Conoid teeth have a prevalence of 0.6 to 9.9%, with conical upper lateral teeth affecting approximately 55,000 people, with women being more susceptible than men. Many factors must be considered when restoring anterior teeth, depending on patient expectations and dental practice. The direct composite resin technique has stood out for providing aesthetic benefits, preserving tooth structure, being performed in a single consultation, being cheaper and not requiring any laboratory process. The objective of this study was to report a clinical case of aesthetic rehabilitation in a conoid tooth in the upper left lateral incisor with composite resin restoration using the direct technique. Clinical planning is essential for choosing the technique and restorative material to be used. Despite the various techniques proposed for the treatment of conoid lateral incisors, the aesthetic reanatomization with a direct veneer of composite resin, with diagnostic waxing, used in this study, was effective and inexpensive, allowing a minimally invasive treatment and possible posterior adjustments, enabling the restoration of self-esteem and the harmony of the patient's smile.

Liquid Handling Technologies: A Study through Major Discoveries and Advancements

Liquid handling is an essential process in laboratories involving automatically transferring accurate amounts of liquids for various task completions such as sample preparation, pipetting, dilution, and mixing. Automated liquid handling systems (ALHS) help to minimize the errors, complications, and difficulties that are faced with manual methods of liquid handling by efficiently enhancing the accuracy, precision, and reproducibility of experimental workflows and have transformed life sciences aiding research in various fields. Processes like Nuclear Magnetic Resonance (NMR) spectrometry, mass spectrometry, and acoustic droplet ejection with ALHS showcase tremendous potential. Outdated manual machinery is being replaced rapidly with automated tools. We have observed that these laboratory setups are sophisticated and costly. It is challenging to access such technologies, especially in poor or developing countries. At the nanoscale level, handling and evaporation of biomaterials becomes a great issue. Multitudinous devices can combat the cost issue along with utilization of single equipment without the enhancement of add-on modules. Liquid handling devices enhance the quality of experiments contributing to efficient dealing of circumstances like COVID-19. They aid in genomics and proteomics and play a pivotal role in liquid manipulation, drug screening, quantifications, forensic studies and many more. Liquid handling devices with robotic equipment can perform multiple tasks and can assist in a wide range of fields. We anticipate that in the coming years, our laboratories will be furnished with advanced, robotic technologies and cause a revolution in the scientific scenery.

7956 Assessing Factors Influencing Polycystic Ovarian Syndrome Using Hybrid Multi-Criteria Decision Analysis

Abstract Disclosure: N.B. Trivedi: None. J. Amin: None. M. Patel: None. S. Patel: None. P. Rana: None. A. Rajani: None. V. Dave: None. Polycystic Ovarian Syndrome (PCOS) is a complex hormonal disorder having multifactorial origins. This study aims to apply Multi-Criteria Decision Analysis (MCDA) methods like Decision Making Trial and Evaluation Laboratory (DEMATEL) and Analytical Hierarchy Process (AHP) to prioritize factors influencing PCOS. In our study, 10 criteria impacting PCOS were identified through extensive literature review. AHP and DEMATEL were used via matrices, assessed by 13 experts. AHP determined relative importance/weights while DEMATEL assessed interconnectedness among criteria. AHP revealed that family history held the highest weight (0.22) while Insulin resistance held the lowest weight at 0.04. The results obtained from DEMATEL indicated that factors like obesity, insulin resistance, diet, psychological stress and sedentary lifestyle displayed higher D+R values, suggesting a strong influence on other factors; indicating their significant impact on the syndrome. The division of criteria into cause and effect groups based on D-R values revealed that family history, environmental factors, diet, sedentary lifestyle and psychological stress appear to be causative and sleep disturbances, low-grade inflammation, excess androgen and insulin resistance seem to be the consequences of PCOS. In AHP the criteria are treated as being independent to each other and their hierarchal order is determined. However, in realistic scenarios factors may have some sort of interdependency/relationship with one another. To identify that interdependency which AHP fails to focus on, DEMATEL was used. DEMATEL ensues that Insulin resistance along with obesity, sedentary lifestyle, and psychological stress show strong level of influence and interconnectedness, indicating a significant impact on the syndrome. However, insulin resistance, when treated as an independent criterion in AHP, displays lower weightage. In the end, improved PCOD treatment would come from targeted interventions and strategies that centre on the variables with a higher D+R value. When the criteria were considered independent of each other in AHP, highest weight is conferred to family history (despite of it having moderately low level of influence/interconnectedness on other criteria as ensued from DEMATEL) thus prompting more research in the direction of investigating genetic and familial factors associated with PCOS. This could consequently lead to early diagnosis and effective long term management. The combined methodology (DEMATEL+AHP) ensures comprehensive assessment of PCOS factors. Previous studies might have focused on individual factors separately or failed to adequately explore their interrelationships and relative importance. MCDA can be further employed in healthcare to assess conflicting treatment modalities, risk factors etc. for other multifactorial disorders. Presentation: 6/2/2024

Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-labelled Nano Molecules.

Small animal Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) imaging techniques are crucial in preclinical cancer research, necessitating meticulous attention to radiotracer synthesis, quality assurance, and in vivo injection protocols. This study presents a comprehensive workflow tailored to enhance the robustness and reproducibility of small animal PET experiments. The synthesis process in the radiochemistry laboratory using 68Ga is detailed, highlighting stringent quality control and assurance protocols for each radiotracer production. Parameters such as concentration, molar activity, pH, and purity are rigorously monitored, aligning with standards applicable to human studies. This methodology introduces streamlined syringe preparation and a custom-designed 30G cannula for precise intravenous injections into mice. Monitoring of animal health during scanning, including temperature and heart rate, ensures their well-being throughout the procedure. Dosages for PET and SPECT scans are predetermined to balance data acquisition with minimizing radiation exposure to animals and researchers. Similarly, CT scans employ pre-programmed settings to limit radiation exposure, especially pertinent in long-term studies assessing treatment effects. By optimizing these steps, the workflow aims to standardize procedures, reduce variability, and enhance the quality of small animal PET/SPECT/CT imaging. This resource provides valuable insights for researchers seeking to improve the accuracy and reliability of preclinical investigations in molecular imaging, ultimately advancing the field.

B-107 Advancing Parasitology Laboratory Quality and Processes Through Artificial Intelligence (AI) and Automation

Abstract Background This research emphasizes the profound impact of intestinal parasitic infections on developing countries, particularly in regions such as sub-Saharan Africa, South and Central America, China, and East Asia. With over 1.5 billion people globally affected and 450 million facing serious illness and a mortality rate of 155,000 cases per year, the socio-economic hindrances posed by these infections necessitate innovative approaches for control and eradication. The integration of artificial intelligence (AI) and machine learning (ML) into parasitology, exemplified by the “Automated Diagnosis of Intestinal Parasites” (ADIP), from brazilian Portuguese “Diagnóstico Automatizado de Parasitas Intestinais” (DAPI) system, showcases a paradigm shift. This advanced system, combining simple and complex decision-making mechanisms, demonstrates promising results, achieving high agreement compared to TF-Test (three fecal test). Methods Data were extracted through reports from the laboratory information system (LIS) from January-December 2023. TF-test was replaced by ADIP system in October 2023. Data were analyzed using Microsoft Excel software, with a bibliographic survey in national and international repositories. Results The parasitology laboratory of AFIP implemented artificial intelligence (AI) with ADIP equipment associated with system LIS automation, automating the analysis of approximately 38,000 monthly stool samples. The ADIP classification, image analysis and subsequent algorithm allowed a reduced examination time, since approximately 90% of samples could be released automatically, optimizing the whole process. In addition, after a three-month period using only ADIP, positivity results increased from 7,63% (TF-test) to 9,53%. Our database is periodically reviewed by specialized professionals who validate positive results, ensuring the security of information obtained by artificial intelligence, bringing efficiency, safety, and quality to the laboratory processes. Conclusions Artificial intelligence (AI) in parasite identification and the automated results system promises a bright future. Collaboration between the scientific community and data scientists is crucial to enhance laboratory processes. Through these tools, it is possible to focus on continuous improvements, increased efficiency, and, most importantly, without sacrificing accuracy and result quality. With new technologies associated with the parasitology field, detailed records can be ensured, previously challenging to obtain, showcasing each step from result acquisition to issued report. Process improvement in parasitology brings optimizations, suggesting the potential for team reduction without compromising quality and improving the takt time.

B-290 Static Analytical Scopes and Lab Processes - An Existing Public Health Hazard

Abstract Background Most chromatographic-based procedures have defined analytical scopes. This allows for laboratories to include the most relevant analytes in test panels and for care providers to know exactly what is included and excluded in ordered tests. Analytical scopes can be developed based on drug trend data, consensus body recommendations, or mandatory guidelines. However, it is reasonable to conclude that strictly adhering to these scopes, or not having robust processes in place that permit for rapid scope changes, will result in the underreporting of drug use in a population or miss a relevant drug finding for a single patient. For example, SAMHSA’s minimum mandatory guidelines for urine workplace drug testing does not include fentanyl. While true the number of fentanyl positive cases that are missed in this population is speculative, a factual case in point is made by evaluating laboratory results for a major novel psychoactive substance (NPS) drug class - designer benzodiazepines (DB). We performed a retrospective review to study the frequency that designer benzodiazepines would have been missed in reporting without further intervention by laboratory staff. Methods Blood samples were screened by ELISA and LC-TOF/MS. Confirmation testing using two different LC-MS/MS panels was conducted on samples that screened presumptive positive for benzodiazepines. Analytical results were retrieved from the laboratory’s data management system using the following criteria: a) date range: Feb 2023 to Feb 2024, b) blood matrix, c) DUID testing cases where benzodiazepine screening was performed by ELISA and by LC-TOF/MS, and d) at least one DB was reported regardless of the presence of other drugs. Results Nine parent DB or their metabolites were identified in the 46 cases in this study: 8-aminoclonazolam (n=3), alpha-hydroxyetizolam (n=2), bromazolam (n=35), clonazolam (n=2), deschloroetizolam (n=1), etizolam (n=1), flubromazolam (n=7), flualprazolam (n=1), and pyrazolam (n=1). Benzodiazepine screening by ELISA and LC-TOF/MS was positive for 45 and 46 cases, respectively. In the 45 cases that screened positive by ELISA, 41 did not confirm positive for any classical benzodiazepine (CBZ) which included alprazolam, diazepam, lorazepam, clonazepam, temazepam, oxazepam, and the nordiazepam metabolite. Only 4 cases tested positive for both a DB and CBZ (alprazolam or clonazepam) simultaneously. Conclusions While it is understood that defined analytical scopes are a laboratory necessity, care providers, law enforcement, public policy decision makers, and communities at large need to understand the limitations and regulations surrounding analytical test procedures. For some testing, a laboratory is obligated to follow mandatory guidelines, but from a clinical or medicolegal perspective, the risk is two-fold. The first is that the causative drug producing any untoward effects goes unrecognized. The second is that symptoms displayed are attributed to the presence of other drugs. This work stresses the importance of sincere collaboration between laboratories and entities that are responsible for analytical scope development and providing funding to ensure the appropriateness of real-time drug surveillance and reporting efforts.

A-188 Modal Failure and Effects Analysis, FMEA methodology, as a strategy to increase patient safety

Abstract Background Patient safety during the clinical care process is considered a priority in healthcare. Failure Mode and Effects Analysis (FMEA) is a proactive and systematic method of process evaluation and is used to identifying where and how each phase of the analytical process could fail allowing the detection of the causes and the effects they produce on the quality of the results that are issued. A regular use of this tool makes possible to identify the most critical steps, propose improvement strategies and evaluate their impact. The aim of the study is to evaluate applicability of the FMEA tool to identify errors in the pre analytical, analytical, and post analytical phase of a clinical laboratory as well as the main causes and effects, to reduce them by proposing improvement strategies Methods For each phase into which the laboratory activity is divided, the frequency and type of errors that are made and their final consequences on the patient are evaluated. A risk index (NPR=OxDxS) is calculated for each error considering the frequency with which it occurs (O), the ease with which it is detected (D) and the severity of the consequences on the patient (S). Values goes from 1 (rarely) to 10 (often). Improvement actions are proposed for all errors with a risk index greater than 100 and this index is re-evaluated after the implementation of that improvement measures. This same analysis is performed for three times over the last 10 years (in 2014, 2019 and 2023). Results In FMEA analysis carried out in 2014, a total of 40 errors were identified in the pre-analytical phase (63.5% of the total), 12 in the analytical phase and 11 in the post-analytical phase. 50% of the total errors detected required improvement strategies because they had an NPR≥100 value. In the 2023 evaluation, a total of 27 errors were identified in the pre-analytical phase, 10 in the analytical phase, and 5 in the post-analytical phase but only 6 required improvement strategies, which represents an 80% reduction in the most critical errors for patient safety. However, the pre-analytical phase continues to be the most critical, as it continues to account for 64% of the total errors identified, including the lack of identification of the patient or sample and the inadequate prior preparation of the patient. In analytical and post-analytical phases, the NPR values obtained in 2023 decrease significantly over analysis carried out in 2014 and its not needed to apply improvement strategies. Automation and the IT tools significantly reduce the number of errors with high NPR values, but it is undoubtedly the involvement of service professionals that makes the difference over the years. Conclusions The use of the FMEA methodological tool allows the design of appropriate indicators to detect and reduce errors in the clinical laboratory. Its application as part of a good quality control allows a continuous improvement in the laboratory process and consequently a guarantee of quality for the patient

B-109 Six Sigma Analysis for Enhancing Biochemistry Internal Quality Control in a Private Laboratory in India

Abstract Background This abstract outlines a comprehensive study on the application of Six Sigma methodologies to optimize internal quality control processes in a private biochemistry laboratory in India. Data collection was performed using Bio-Rad Assayed Chemistry Control on the Roche cobas 6000 instrument, facilitated by Bio-Rad Unity software. The study adheres to Clinical Laboratory Improvement Amendments (CLIA) 2024 guidelines, specifically focusing on Total Error (TEa). Methods The analytical performances of Cobas c501 insturment as analyse by running biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, Amylase, Lipase, CK, LD, ALT, ALP, LDH, HDL-C, Ca2+, cholesterol, TG, HDL LDL, total protein, albumin, Na+, K+, and Cl−) and glucose on Cobas 400 were evaluated. Biases and CV were obtained from internal quality control programs using biorad unity software. The performance of each instrument was assessed using the σ scale; the benchmark performance was <3 σ (improvement needed); “world-class” quality was six sigma. Results Analytes such as “Alk PO4,” “ALT,” “Amylase,” “Bilirubin,” “CK,” “GGT,” “LD,” “Phosphorus,” “HDL,” “LDL Cholesterol,” “Triglycerides,” and “Uric acid” exhibited impressive sigma scores exceeding 6. Meanwhile, analytes including “Calcium,” “Total Cholesterol,” “Potassium,” “Total Protein,” “Urea,” and “Glucose” achieved sigma scores between 4 and 6, demonstrating noteworthy performance within acceptable bounds. Conclusions This study contributes valuable insights to laboratory management, specifically in the context of biochemistry testing in private Indian laboratories. The adoption of Six Sigma principles, coupled with adherence to CLIA 2024 guidelines and the utilization of advanced instrumentation and software, ensures compliance with regulatory requirements and fosters a culture of continuous improvement. This positions the laboratory to deliver high-quality and reliable results in the dynamic landscape of healthcare diagnostics.

A-195 Combination of Lean Mindset, Robotics and Digitalization allowed us to manage a 2.5 times increase in workload in our central reference lab

Abstract Background Our Agilus Diagnostics, Gurugram, India is a Central Reference Laboratory and part of the pan-India network over 400 lab in India. Our Gurugram lab delivers 3,200 tubes in the serum work area in 17 hour operations daily and is ISO 15189 and CAP accredited.In Jan 2023, our lab started to support Govt PHC Program samples and our workload increased to 8000 tubes. This was a clear operational and clinical challenge for us with a 2.5 x jump in workload. To achieve this goal, a lean mindset with process improvement steps were to be applied required across the total testing process. This lean approach was supported by cobas ® Lab Automation systems managed by navify ® Lab Operations informatics automation solution. This poster explains our journey of planning, implementing, and delivering on our goal of predictable operational efficiency when faced with this challenge. Methods We took 4 major steps We redesigned lab processes using lean process improvement operational dashboards. This poster will show the metric we track which help eliminate waste in the system. We optimized our total lab automation solution with smart load balancing across cobas ® Pro integrated analyzers and staff friendly recursive workflow. Clear and strict use of off peak hours for maintenance and QC procedures and standardized predictable schedule of operation. This poster will share our time table with key milestones across the 24 hours We built on the Informatics solution using 5 layered Auto verification rules based decision framework. IQC, Systems Flags check, Sample Quality checks, Biological Reference check, custom Auto verification Range, Critical ranges Delta check Criteria, Clinical Correlation Rule are all part of the auto verification logic framework. Results We were able to deliver the following results.Lean process design led to 53% simplification. Number of process steps reduced to 29 from 62 steps across the total testing process. Total Lab Automation has helped improve 90 percentile production TAT by 46% from 250 mins to 135 mins Our 90 % TAT CV has significantly reduced making our production predictable. Over 17,500 results / day reported are subject to auto verification with 87 % of all results auto-verified and auto-approved. Not a single additional employee was added in the analytical or post analytical areas of the lab operations Conclusions Lean Mindset complemented by Total Laboratory Automation along with Decision Automation on an Informatics solution has enhanced lab performance in terms of TAT, Efficiency, and Staff Motivation. This poster will also demonstrate using incremental effectiveness analysis comparative data of key performance indicators, such predictability in production, and efficiency of workforce, senior staff time saved, before and after technology deployment. The challenge of increase in sample workload is real in India and this approach allows for a sustainable way to ensure patient impact with minimum burden on our workforce.

B-013 Improving the Workflow of Blood and Coagulation Tests in clinical laboratory through the Utilization of Laboratory Automation Track Systems

Abstract Background The Laboratory Automation Track System (TLA) is an automated system designed for executing highly repetitive tasks within a laboratory, commonly applied in biochemical and immunological testing systems. It aims to reduce human errors in specimen handling, enhance the overall process quality, and provide better Turnaround Time (TAT) from specimen collection to result reporting. For the first time in our laboratory, we have integrated the blood and coagulation systems with TLA. Consequently, we seek to evaluate the differences in the testing workflow and reporting efficiency of the blood and coagulation systems after being connected to TLA. Methods Abbott GLP systems Track was the TLA system for connecting with blood and coagulation systems. Two Sysmex XN-9100 fully automatic hematology systems and two Sysmex CS-5100 fully automatic coagulation analyzers were developed for blood and coagulation system, respectively. TUNYEN Laboratory Information System was established for Laboratory information system (LIS). Results Through the analysis of quality indicators and integration with intelligent information systems, improvements have been made, including the reduction of blood collection tube usage, efficient manpower utilization management, tracking of specimen progress and achievement of timely reporting rates.(1)Approximately 2,915 blood collection test tubes are saved every month, with a converted cost of 0.15 USD per tube, and a total saving of 437 USD. And reduce the carbon emissions of 32 kgCO2e, comply with the spirit of ESG sustainable development.(2)The TLA no longer requires staff to collect and deliver specimens as in the past,reducing staff and enhancing work efficiency.One of manpower was saved and new inspection items were developed.(3)Tracking of specimen progress:The laboratory has set up a specimen tracking system to monitor the specimen delivery location and provide timely response to the clinical status.The one-hour TAT for blood and coagulation increased from 82.0% and 76.9% before improvement to 91.8% and 93.3% after improvement respectively. Conclusions The implementation of Laboratory Automation Track Systems (TLA) leads to a reduction in medical errors and specimen sample volume, while also enhancing accuracy and precision, thereby improving the safety of laboratory staff. Although the introduction of TLA may require an initial investment, it brings the benefits of automation, offering ease and efficiency to laboratory processes.

A-181 The Effectiveness Module to Reduce Laboratory Error Reporting Rates

Abstract Background In a hospital in central Taiwan, the number of tests conducted in 2022 was 1.88 million, there were 26 cases of laboratory error reports, with an error rate of 14 cases per million. Error reports may lead to diagnostic errors, posing a significant risk to patient safety. Therefore, our team aims to establish a simple and universal module that can be applicable to various laboratory operations to minimize errors. Methods Initially, we conducted an analysis of error causes, identifying 25 cases of human error and 1 case of computer system error. Human errors were categorized according to the laboratory process, including 4 specimen identification errors, 3 procedural errors, 9 typing errors, 7 validation of analytical data errors, and 2 instances of failure to communicate issues during handover. The proximate cause of human error was non-compliance with SOPs, and the root cause was inadequate SOPs leading to inconsistent practices. We reviewed the workflow, implemented corrective actions, revised SOPs, and provided training for personnel. Additionally, three important strategies were introduced: 1.High-Frequency Audits: Corrective actions were included in the internal audit checklist, initially increasing the frequency to at least once a month for the first 3 months, followed by at least once every 6 months within the next 6 months. If no further occurrences were noted, audits could be conducted annually or not. Each audit should be completed within 20 minutes to avoid excessive burden, with direct observation of operations and random questioning being the preferred audit methods. 2. Audit deficiencies should be documented: Personnel were requested to conduct cause analysis and improvements. This not only expressed the supervisor's commitment to improvement but also provided an opportunity to discover reasons why countermeasures cannot not be implemented, allowing for strategic adjustments until successful implementation. 3.Case-Based Training: Benchmark cases were developed into teaching materials, and compiled errors regularly for looking for patterns or trends to identity key steps. Make these key steps the focus of your educational training. Results In 2023, 1.94 million tests were conducted, there were 4 error reports, with an error rate of 3 cases per million, all were attributed to human error. In another hospital in southern Taiwan, laboratory error reports were primarily due to human error. From June 2022 to July 2023, a total of 3.46 million tests were conducted, there were 14 error reports and an error rate of 5 cases per million. After implementing the same improvement module from August to December 2023, a total of 1.56 million tests were conducted, there were 2 error reports and an error rate of 2 cases per million, all were attributed to human error. Conclusions We applied this improvement module to two hospitals in central and southern Taiwan, resulting in a significant reduction in error rate. The key factors of effectiveness were utilizing high-frequency audits to ensure sustained results, and demonstrating the positive attitude of supervisors during the process. This motivated personnel to demand higher standards from themselves, ultimately showcasing remarkable improvements.

B-324 Pilot Study Result of EQA for Fecal Immunochemical Test for Hemoglobin Using a Novel Ready-to-Use Sample Material

Abstract Background The primary screening method for colorectal cancer is fecal immunochemical test (FIT) detecting human hemoglobin (Hb) in feces. There are several tests on the market both for automated analyzers and point-of-care testing (POCT). To ensure high quality results, the tests should be monitored with appropriate quality assessment procedures including participation in external quality assessment (EQA) programs. By participating in an EQA program using a stool-like material, clinical laboratories and POCT sites can fulfil the ISO 15189 requirements of monitoring the complete laboratory process from pre- to postanalytical phases in addition to the quantitative analytical phase of FIT. Here we present the first results of an international EQA pilot study for quantitative FIT using a novel ready-to-use stool-like material, performed by EQA provider Labquality. Methods 40 participants from 8 countries using 9 different FIT reagents were recruited for the pilot study performed in 2023. A set of artificial stool samples containing human hemoglobin uniformly was shipped to the participants at ambient temperature. The sample material is developed by HECTEF (Health Care Technology Foundation, Japan). The participants were instructed to collect the sample with their test specific sample collection kit and perform analysis according to the manufacturer’s instructions as a regular patient sample. Quantitative results (µg Hb/g feces) and qualitative interpretations (positive/negative) were reported in Labquality’s electronic platform LabScala. The quantitative target value was a method group consensus mean. A questionnaire regarding the usability of the sample material was sent to all participants. Results Sample S001 contained no Hb and all participants (40/40) reported a result corresponding to the lower detection limit of their test in use or a low numeric result most likely explained by unspecific background. All reported a negative interpretation. Sample S002 was a high positive sample for Hb. The measured value exceeded the upper detection limit of 4/9 tests (Exdia iFOB, Precision Biosensor; Fecal Occult Blood (iFOB) Neo, Boditech; FOB Test, VedaLab; NADAL FOB Quant test, Nal von Minden). The mean values and CV% were 116 µg/g and 8% for iFOBT, Aidian; 192 ug/g and 4% for Standard iFOB FIA, SD Biosensor; 144 µg/g and 45% for FOB assay kit FOB Gold, Sentinel Diagnostics (different clinical chemistry analyzers used); 91 µg/g and 26% for OC-Sensor FIT, Eiken Chemical. All participants responded a positive qualitative clinical interpretation. The majority of the responders on the feedback questionnaire (26/35) found the samples to be easy to use including comments of the sample being user-friendly and ready-to-use, resembling a patient sample and easy to apply with the test specific sample collection kit. Conclusions The fecal-like sample used in this Labquality’s EQA pilot study evaluates the complete analytical process including the preanalytical, analytical and postanalytical phases. An EQA scheme using this sample material is more compliant to ISO 15189 requirements compared to schemes where liquid or lyophilized samples are used. The new sample material used on this pilot study was positively received by most of the participants and it was compatible with all tests included in the study.

B-118 Comparison of Statistical Methods, Chauvenet Test, and Interquartile Deviation for Urinary Sediment Inter Microscopists Evaluation

Abstract Background Comparison among microscopists is a quality process aimed at achieving comparability of analyses among collaborators who perform microscopy or manual analysis examinations, as in the case of urinary sediment examination. The current laboratory process evaluates red blood cell and white blood cell counts among microscopists within the same unit, aiming to identify discrepant counts through the application of statistical tools, with Chauvenet Statistics and Interquartile Deviation (IQD) being the most common in the literature. The purpose was to systematically compare Chauvenet Statistics and IQD as evaluation criteria for the comparison among microscopists for urinary sediment examination in our laboratories. Methods A total of 45 laboratory units within a total of 684 participants were analyzed throughout 2023. The results reported by microscopists from the same unit were evaluated using Chauvenet Statistics and IQD, calculating the adequacy rate for each type of assessment. Results Adopting IQD as the evaluation criterion, adequacy rates of 94.20% for red blood cell counts and 93.73% for white blood cell counts were observed. Using Chauvenet Statistics, the adequacy rates were 96.20% for red blood cells and 95.65% for white blood cells. This difference stems from 233 results identified as inadequate by the IQD method but deemed adequate by Chauvenet Statistics. In these cases, the results did not exhibit a normal distribution, approaching an expected distribution for categorical (discrete) variables. Additionally, 35 results identified as inadequate by Chauvenet Statistics were evaluated as adequate by the IQD method. These occurrences were observed when the reported results approached a normal distribution. Conclusions Regarding Chauvenet Statistics, IQD is a more efficient statistical tool for use as an evaluation criterion in the comparison among microscopists who perform red and white blood cell counts for urinary sediment examination in the selected laboratory units. However, the present study illustrated that each of the statistical tools will be more efficient in identifying outliers depending on the dataset analyzed. Therefore, it is important to consider the laboratory's epidemiology and population to decide which statistical tool is most suitable for each scenario.

B-232 One Year Post-Implementation Experience Using a Custom Designed DNA Contamination Detection Module for a Clinical Myeloid Neoplasm Next Generation Sequencing Assay

Abstract Background In complex automated clinical laboratory Next Generation Sequencing (NGS) workflows, numerous opportunities exist for contamination events to occur. For oncology testing applications, detection of these events is crucial for accurate results reporting. A contamination detection module (MICon) using microhaplotype (MH) regions and an in-house designed analysis model was developed for use in a NGS assay for myeloid neoplasms (NGSHM) [1]. Variant detection for NGSHM has a validated analytical sensitivity of 2% variant allele frequency (VAF). Gross contamination events can potentially cause erroneous false positive variant detection whereas true low VAF mutations may be masked and evade detection. The following study was performed to evaluate MICon module performance on samples processed over the course of a year. Methods MH regions contain highly conserved tandem single nucleotide polymorphisms (SNPs) with high global heterogeneity occurring within a 300-nucleotide span. From the work of Kidd et al [2], 27 MH regions covering 92 SNPs and spanning 16 chromosomes were selected for inclusion in the 47 gene NGSHM target-capture panel. Sequencing was performed on a NovaSeq 6000 and analyzed through an internal bioinformatics pipeline, which incorporates the MICon module. MICon uses a binary classification model incorporating VAFs from MH regions, number of MH genotypes, and the contamination estimation score from verifyBamID to compute a single value on a 0-100 scale. Scores <50 are classified as non-contaminated and scores ≥50 require further investigation. Results The dataset was comprised of 10,990 samples. A total of 10,232 patient cases (93.1%) had non-contaminated MICon scores <50. Control replicates accounted for 261 samples (2.4%). There were 497 patient cases (4.5%) with MICon scores ≥50. Of the 497 patient cases, 137 (27.6%) had undergone hematopoietic stem cell transplantation (HSCT) and 114 (22.9%) contained gross chromosomal abnormalities, representing iatrogenic or tumor biological factors. An additional 135 (27.2%) of cases were contaminated from laboratory processing errors, 45 (9.1%) occurred due to chemistry failures during run processing, and 66 (13.2%) had an undetermined cause for a high score, representing laboratory-related and unknown factors. Overall, the 135 laboratory processing errors detected accounted for 1.3% of patient cases analyzed by the laboratory. These cases were repeated, and the non-contaminated results were accurately reported. Conclusions Herein it was shown the implementation of MICon has improved patient safety over the course of a year. The 1.3% of patient cases identified as arising from laboratory processing errors were successfully reprocessed. While the overall rate of laboratory processing errors appears low, the absolute number can be significant in a high-volume test setting, despite reliance on highly automated processes. Value is added by MICon through identifying errors that could result in the release of inaccurate patient results. By detecting previously unrealized errors, MICon has become an invaluable asset to the NGSHM assay by enhancing patient laboratory testing safety.