Quality Control Points Research Articles

The influence of calibration on bias in quality control and patient results for TSH on Vitros XT 7600 analyzer.

Thyroid-stimulating hormone (TSH) is a glycoprotein secreted by the anterior pituitary gland and is regulated by negative feedback from the serum free thyroid hormones. In this study we aimed to quantitate the relative bias caused by calibration drifting as seen in our TSH Levey-Jennings quality control (QC) charts and assess the magnitude of bias on patients' samples. In the period from October 2021 to August 2022 we looked at the QC results of ten 28-days' calibration time intervals and calculated relative bias compared to the mean. For each time interval the mean from three QC points before and after calibration was calculated. The average from 10 pre- and post-calibration means was calculated and the relative bias, pre- and post-calibration, was then calculated. We used 5 patient samples with low, normal and high TSH concentrations and calculated relative bias pre- and post-calibration. The allowed relative bias for TSH is ± 6.7%. At both QC levels, with the respective means of 5.14 mIU/L (coefficient of variation, CV% = 3.1%) and 27.80 mIU/L (CV% = 3.2%) had their respective relative bias - 8.2% and - 7.9%. The patient samples with low (0.586 mIU/L), normal (2.89 mIU/L and 5.19 mIU/L) and high (20.5 mIU/L and 39.8 mIU/L) TSH had - 4.1%, - 4.0%, - 3.5%, - 5.1% and - 4.1%, respectively. Even though the relative bias exceeded allowable criteria for the QC samples, this was not manifested on the patients' samples.

High Throughput LC-MS/MS Method for the Quantitation of Mefenamic Acid in Rat Plasma by Protein Precipitation Technique Using 96 Well Plate Format

An advanced and validated high-throughput liquid chromatography-tandem mass spectrometry (LC-MS/MS) approach has been established to accurately determine the concentration of mefenamic acid in rat plasma. This method utilizes mefenamic acid D4 as the internal standard (ISTD). The analyte and ISTD underwent protein precipitation in a 96-well plate format and were then separated on a BDS Hypersil C8 column (3 μm, 100 x 4.6 mm) using a precise isocratic mobile phase of 2 mM ammonium formate by 0.1% formic acid and acetonitrile (30:70 v/v). The detection was performed on a triple quadrupole mass spectrometer utilizing positive ionization consideration. The approach demonstrated a concentration range of 20.659 to 20067.772 ng/mL, thru relative regaining reaching from 69.1 to 74.3%. The inter-batch precision was excellent, with a coefficient of variation (%CV) of ≤ 7.8%. Additionally, the inter-batch accuracy at four different quality control-points ranged from 97.0 to 100.4%, demonstrating high levels of accuracy. This method has been thoroughly validated and is extremely specific, accurate, and precise. It is perfectly suited for high-throughput investigation of mefenamic acid in rat plasma, making it ideal for routine analysis.

Quality control of gastric resection range in laparoscopic locally advanced gastric cancer

After nearly 30 years of exploration and practice, minimally invasive surgical techniques represented by laparoscopic technology have become an important means for the surgical treatment of gastric cancer. In China, laparoscopic radical resection for locally advanced gastric cancer has been extensively carried out. However, there are still controversies regarding the gastric resection range and methods for advanced gastric cancer. By reviewing relevant domestic and foreign guideline documents and combining team practice experience, this article elaborates on the key points of quality control of laparoscopic gastric resection range for locally advanced gastric cancer from aspects such as tumor localization and gastric resection range for upper, middle and lower gastric tumors. It aims to provide reference for carrying out and promoting laparoscopic radical gastrectomy more safely.

Design Reliability Analysis and Quality Control of Nuclear Pressure Reducing Valve

In order to improve the localization level of nuclear power and solve the “neck” problem of nuclear pressure reducing valve in CAP1400 project, the design reliability analysis and quality control requirements of domestic prototype of nuclear pressure reducing valve was studied. Through the analysis and application of the technical requirements of the pressure reducing valve, the control was strengthened from the reliability requirements of seismic analysis, identification test and quality control points, which provided a strong technical support for the localization of nuclear grade pressure reducing valve. The seismic analysis required that the stress, resonance frequency and deformation analysis on the dangerous section of the main parts of nuclear pressure reducing valve met the requirements of regulations and standards. The reliability control was carried out from three aspects: the selection of test medium, the stability control of pressure behind the valve and the requirements of failure operation performance. Quality point control taked quality control measures from three aspects: tooling design, standard application and test bench management. All measurements ensured that the design quality of nuclear pressure reducing valve meets the requirements. The successful development of the domestic prototype of nuclear grade pressure reducing valve shows the effectiveness of the design reliability analysis and quality control method, which provides a reference for the localization of equipment in the future.

Numerical Simulation of the Marine Environmental Capacity of Jinpu Bay

Based on the study of the marine environmental capacity, a water quality model and a response field-based linear programming method are adopted here. Water quality control objectives are taken as the constraint conditions, according to the requirements of Jinpu Bay’s functional zoning. The pollutant response coefficient and water quality background value are combined with the values of the water concentration quality control points set in each functional area and the target value of the functional area wherein they are located. The maximum allowable emission intensity of inorganic nitrogen, phosphate and chemical oxygen demand (COD) can be calculated using the linear programming method of the maximum allowable emission of pollutants at estuaries or sewage outfall points on Jinpu Bay. The research results reveal the diffusion of marine pollutants and the marine environmental capacity of Jinpu Bay. Some rivers need to reduce the discharge intensity and some other outlets still have a certain residual capacity. Based on this, the environmental capacity of Jinpu Bay was evaluated, and a technical reference is provided for the economic development of the region and the formulation of pollutant emission control policies.

Application of Medical Record Quality Control System Based on Artificial Intelligence

In this study, we used artificial intelligence (AI) technology to explore for automated medical record quality control methods, standardize the process for medical record documentation, and deal with the drawbacks of manually implemented quality control. In this study, we constructed a medical record quality control system based on AI. We first designed and built, for the system, a quality control rule base based on authoritative standards and expert opinions. Then, medical records data were automatically collected through a data acquisition engine and were converted into structured data through a post-structured engine. Finally, the medical record quality control engine was combined with the rule base to analyze the data, identify quality problems, and realize automated intelligent quality control. This system was applied to the quality control of medical records and five quality control points were selected, including similarities in the history of the present illness, defects in the description of chief complaints, incomplete initial diagnosis, missing in formation in the history of menstruation, marriage, and childbirth, and mismatch between the chief complaints and the history of the present illness. We randomly selected 2 918 medical records of patients discharged in January 2022 to conduct AI quality control. Then we organized medical record quality control experts to conduct an accuracy review, made a comparison with previous manual quality control records, and analyzed the results. The number of quality problems that were verified in the accuracy review was taken as the gold standard and receiver operating characteristic (ROC) curves were drawn for the 5 quality control points. According to the accuracy review performed by medical record quality control experts, the accuracy of AI quality control reached 89.57%. For the sampled medical records, the results of AI quality control were compared with those of previous manually performed quality control and only one problem detected by manual quality control of the sampled medical records was not detected by the AI quality control system. The number of medical record quality problems correctly detected by AI quality control was about 2.97 times that of manual quality control. Analysis of the ROC curves showed that the AUC of the five quality control points of the AI quality control system were statistically significant (P<0.05) and all the AUC values approximated or exceeded 0.9. In contrast, results obtained through manually performed quality control found significant AUC (0.797) for only one quality control point-similarities in the history of present illness (P<0.05). Comparison of the AUC values of the two quality control methods showed that AI quality control system had an advantage over manually performed quality control for the five quality control points. Through the application of medical record quality control system based on AI, efficient full quality control of medical record documentation can be achieved and the detection rate of quality problems can be effectively improved. In addition, the system helps save manpower and improve the quality of medical record documentation.

Discussion on the main points of construction quality control in civil engineering

With the improvement of comprehensive development level, civil engineering is perceived a promoted position in the development of the whole market economy in China. Civil engineering is an important link for building construction. Good civil engineering construction management ensures the overall engineering quality control level. Through the reasonable analysis of construction standards, construction contents and construction steps of civil engineering, the actual construction control and management methods of civil engineering are defined, the effective control scheme of civil engineering quality is analyzed, and reasonable suggestions for solving problems are put forward, so as to realize effective control and management of civil engineering construction quality in China. This paper makes an analysis of the actual construction control and fully studies the measures and schemes of the actual construction quality control to improve the management efficiency of the construction quality control of civil engineering.

A high-throughput quality control method for assessing the serial dilution performance of dose–response plates with acoustic ejection mass spectrometry

This study aimed to develop a streamlined method for evaluating the dilution ratio of drug dose–response plates created by automated liquid handlers in the early stages of drug discovery. The quantitative techniques commonly used for this purpose have restrictions due to their limited linear dynamic range and inaccuracies in assessing serial dilution performance. To address this challenge, we describe a method based on acoustic ejection mass spectrometry (AEMS). The method involves using standard compounds and an internal standard to evaluate each dilution point in quality control (QC) plates. The samples are transferred to a chromatography-free tandem mass spectrometry system through an acoustic source, enabling the analysis of one sample per three seconds from a microtiter plate. This approach provides precise, accurate, label-free, and rapid data acquisition to support high-throughput screening efforts.

Biodistribution-based Administration of cGMP-compliant Human Umbilical Cord Mesenchymal Stem Cells Affects the Therapeutic Effect of Wound Healing.

Although mesenchymal stem cells (MSCs) are used as therapeutic agents for skin injury therapy, few studies have reported the effects of dosing duration and delivery frequency on wound healing. In addition, before the clinical application of MSCs, it is important to assess whether their usage might influence tumor occurrence. We described the metabolic patterns of subcutaneous injection of hUC-MSCs using fluorescence tracing and qPCR methods and applied them to the development of drug delivery strategies for promoting wound healing. (i) We developed cGMP-compliant hUC-MSC products with critical quality control points for wound healing; (ii) The products did not possess any tumorigenic or tumor-promoting/inhibiting ability in vivo; (iii) Fluorescence tracing and qPCR analyses showed that the subcutaneous application of hUC-MSCs did not result in safety-relevant biodistribution or ectopic migration; (iv) Reinjecting hUC-MSCs after significant consumption significantly improved reepithelialization and dermal regeneration. Our findings provided a reference for controlling the quality of MSC products used for wound healing and highlighted the importance of delivery time and frequency for designing in vivo therapeutic studies.

Expert consensus on the standardization and clinical application of genotyping for human leukocyte antigens

The genes encoding human leukocyte antigens (HLA) are located in the region of 6p21.31 of the human chromosome, accounting for 1/3 000 of the human genome. The area is seen as a structurally complex, with the characteristics of multi-gene inheritance, high polymorphism, haplotype inheritance, linkage disequilibrium, racial diversity, and regional distribution. In recent years, with the continuous innovation of HLA genotyping technology, new issues and challenges have emerged in terms of the standardization of the technology platform, the implementation of the performance validation and verification plan for clinical testing projects, quality control of the entire testing process, analysis and interpretation of results, consultation and selection of donors, and clinical application. This consensus, in combination with the current status of HLA genotyping technology in clinical practice in China, systematically sorts out the key contents in the standardization and clinical application of the HLA genotyping technology platform. The first part proposes the basic requirements for the standardization of the HLA typing technology platform from the perspectives of personnel, instrumentation, reagents and consumables, experimental methods, environmental settings, and introduces the methods and performance indicators for confirming the performance of HLA genotyping with next-generation sequencing (NGS) technology. The second part elaborates on the key points of quality control during the entire process of HLA genotyping procedure, quality control of result reporting and releasing, and management of result interpretation and bioinformatics systems. The last part describes the clinical consultation and application promotion of HLA genotyping. After widely soliciting revisions and discussions from domestic experts in the field of HLA and transplantation, the consensus aims to promote the development and clinical application of the HLA gene in related medical field.

Improving conformance checking in process modelling: a multiperspective algorithm

Business process model and notation (BPMN) is a popular notation used for process modelling mainly due to its high expressiveness. However, BPMN has shortcomings when dealing with specific domains (namely Hazard Analysis and Critical Control Points systems), struggling to model activity duration, quality control points, activity effects and monitoring nature. To tackle these limitations, the business process model and notation extended expressiveness (BPMN-E2) was proposed. In this paper, a multiperspective conformance checking algorithm is developed focusing on detecting non-conformity between an event log and a process model, regarding the information provided by the new elements within BPMN-E2. The proposed algorithm follows a two-step approach that starts by converting the model into a directly follows model (annotated with conformance rules), which is then used in a second phase to perform conformance checking effectively. This modular approach allows to apply the proposed algorithm to other process model notations than BPMN-E2. An event log clustering technique was also developed to downsize large-event logs without compromising data relevance. In this way, both the multiperspective algorithm and the log-downsize clustering technique here proposed are a key contribution to improve conformance checking in process modelling, as evinced in the proof-of-concept provided.

Design of Manufacturing Systems Based on Digital Shadow and Robust Engineering

In the era of digital transformation, industry is facing multiple challenges due to the need for implementation of the Industry 4.0 standards, as well as the volatility of customer demands. The latter has created the need for the design and operation of more complex manufacturing systems and networks. A case study derived from Process Industries (PIs) is adopted in this research work in order to design a framework for flexible design of production lines, automation of quality control points, and improvement of the performance of the manufacturing system. Therefore, a Digital Shadow of a production line is developed to collect, analyze and identify potential issues (bottlenecks). An edge computing system for reliable and low-latency communications is also implemented. The digital model is validated using statistical Design Of Experiments (DOE) and ANalysis Of VAriance (ANOVA). For the assessment of what-if scenarios, the Digital Shadow model will be used in order to evaluate and find the desired solution. Ultimately, the goal of this research work is to improve the design and performance of the industry’s production section, as well as to increase the production rate and the product mix.

Chinese expert consensus on the pelvic exenteration for primary rectal cancer beyond total mesorectal excision planes and locally recurrent rectal cancer (2023 edition)

Pelvic exenteration is often required for primary rectal cancer beyond total mesorectal excision (PRC-bTME) and locally recurrent rectal cancer (LRRC). Some patients with radical resection can achieve long-term survival, but they need to face risks, such as huge surgical trauma, serious perioperative complications, permanent loss of organ function and decline in quality of life. Preoperative evaluation of PRC-bTME and LRRC should emphasize multidisciplinary collaboration, and develop individualized diagnosis and treatment strategies. The principles of function preservation and risk-benefit balance in surgery oncology should be followed, and R0 resection should be emphasized. Perioperative complications, surgical trauma and organ function loss should be minimized to achieve the best quality control and balance point. This consensus was formulated by the Colorectal Cancer Committee of the Chinese Medical Doctor Association and the Gastrointestinal Surgery Committee of China International Exchange and Promotive Association for Medical and Health Care. The draft was formed based on the summary of domestic and foreign research progress and expert experience. After discussion, review and modification by experts, an anonymous voting was conducted for each major opinion, and in-depth verification was carried out according to the principles of evidence-based medicine. Finally, the Chinese expert consensus on the pelvic exenteration with primary rectal cancer beyond total mesorectal excision planes and locally recurrent rectal cancer (2023 edition) was formed. This consensus mainly summarizes the indications and contraindications of PE for PRC-bTME and LRRC, preoperative diagnosis and evaluation, perioperative treatment, as well as the resection scope, surgical methods, reconstruction of related organs, safety and complications of PE, postoperative follow-up and other issues, in order to provide guidance for PE in patients with PRC-bTME and LRRC.

Discussion on the construction quality control points of bridge concrete

Bridge engineering is China’s infrastructure construction engineering, related to the national economic development, is an important link to maintain contact. Concrete construction is an important construction link in bridge engineering. The quality of concrete construction affects the overall construction level of bridge engineering. In order to ensure the construction quality of bridge engineering, the quality control of concrete construction should be strengthened. This paper analyzes the main problems of bridge concrete construction quality control and discusses the key points of bridge concrete construction.

Sirtuins at the Crossroads between Mitochondrial Quality Control and Neurodegenerative Diseases: Structure, Regulation, Modifications, and Modulators.

Sirtuins (SIRT1-SIRT7), a family of nicotinamide adenine dinucleotide (NAD+)-dependent enzymes, are key regulators of life span and metabolism. In addition to acting as deacetylates, some sirtuins have the properties of deacylase, decrotonylase, adenosine diphosphate (ADP)-ribosyltransferase, lipoamidase, desuccinylase, demalonylase, deglutarylase, and demyristolyase. Mitochondrial dysfunction occurs early on and acts causally in the pathogenesis of neurodegenerative diseases, including Alzheimer's disease (AD), Parkinson's disease (PD), and Huntington's disease (HD). Sirtuins are implicated in the regulation of mitochondrial quality control, which is highly associated with the pathogenesis of neurodegenerative diseases. There is growing evidence indicating that sirtuins are promising and well-documented molecular targets for the treatment of mitochondrial dysfunction and neurodegenerative disorders by regulating mitochondrial quality control, including mitochondrial biogenesis, mitophagy, mitochondrial fission/fusion dynamics, and mitochondrial unfolded protein responses (mtUPR). Therefore, elucidation of the molecular etiology of sirtuin-mediated mitochondrial quality control points to new prospects for the treatment of neurodegenerative diseases. However, the mechanisms underlying sirtuin-mediated mitochondrial quality control remain obscure. In this review, we update and summarize the current understanding of the structure, function, and regulation of sirtuins with an emphasis on the cumulative and putative effects of sirtuins on mitochondrial biology and neurodegenerative diseases, particularly their roles in mitochondrial quality control. In addition, we outline the potential therapeutic applications for neurodegenerative diseases of targeting sirtuin-mediated mitochondrial quality control through exercise training, calorie restriction, and sirtuin modulators in neurodegenerative diseases.

Machining Quality Prediction of Marine Diesel Engine Block Based on Error Transmission Network

In view of the high precision requirement of the marine diesel engine body and the difficulty of quality control, a quality prediction method of the body, based on a process error transfer network, is proposed. First, according to the processing information of the body, the network nodes and edges are abstracted to establish the process error transfer network of the body. Then, the key quality control points and key quality features of the diesel engine body are determined by the PageRank and node degree. The key quality features obtained from the network analysis are taken as the output, and the corresponding process errors and process parameters are taken as the input. Finally, the quality prediction model of the body is established based on SVR algorithm, and the C, g parameters of SVR algorithm are optimized by the K-fold cross-validation method and grid search method to improve the prediction accuracy of the body processing quality.

Analysis of Key Points of Steel Structure Construction Quality Control in Steel Structure Workshop

Analysis of Key Points of Steel Structure Construction Quality Control in Steel Structure Workshop

Key Points of Quality Control of Water-stabilized Gravel Base Construction in Highway Reconstruction Project

Key Points of Quality Control of Water-stabilized Gravel Base Construction in Highway Reconstruction Project

Development and clinical application of an electronic health record quality control system for pulmonary aspergillosis based on guidelines and natural language processing technology.

BackgroundThere are considerable differences in the diagnosis and treatment of pulmonary aspergillosis (PA) between specialized hospitals and primary hospitals or developed areas and underdeveloped areas in China. There is a lack of electronic systems that assist respiratory physicians in standardizing the diagnosis and treatment of PA.MethodsWe extracted 26 quality control points from the latest guidelines related to PA, and developed a PA quality control system of electronic health record (EHR) based on natural language processing (NLP) techniques. We obtained PA patient records in the Department of Respiratory Medicine of the First Affiliated Hospital of Guangzhou Medical University to verify the effectiveness of the system comparing with manually evaluation of respiratory experts.ResultsWe successfully developed quality control system of PA; 699 PA medical records from EHR of the First Affiliated Hospital of Guangzhou Medical University between January 2015 and March 2020 were obtained and assessed by the system; 162 defects were found, which included 19 medical records with diagnostic defects, 76 medical records with examination defects, and 80 medical records with treatment defects; 200 medical records were sampled for validation, and found that the sensitivity and accuracy of quality control system for pulmonary aspergillosis (QCSA) were 0.99 and 0.96, F1 value was 0.85, and the recall rate was 0.77 compared with experts’ evaluation.ConclusionsOur system successfully uses medical guidelines and NLP technology to detect defects in the diagnosis and treatment of PA, which helps to improve the management quality of PA patients.

Chemical Change and Quality Control in Winemaking

Wine is an alcoholic beverage made from grapes that are greatly consumed in the modern society. Winemaking also known as vinification, is a process of converting fruit juice, in particular those from grapes into wine through the process called fermentation. The winemaking process involved many chemical changes, such as alcoholic fermentation, and malolactic fermentation (MLF). Microbiota which is used in the winemaking has great impact on the quality of wine, additionally, may cause negative attributes to some type of wines. Therefore, the modern wine industry tries its best to pay more attention to some critical quality control points to avoid off-flavors, and aim to produce wines with pleasant tastes with healthy substances, such as wine with antioxidant properties.