Search

Analytical results are often used in scientific research, industrial and clinical applications to support decision making. Despite all efforts to ensure the reliability of analytical results (including method validation, internal quality control, use of certified reference materials, proficiency tests, and ISO 17025 accreditation), there will always be an uncertainty associated with the measured value. The measurement uncertainty expresses the quality of the analytical result and allows the comparability between analytical results or between the measured value and the specification limit(s). This work discusses the importance of measurement uncertainty, including the steps involved in the measurement uncertainty evaluation, the bottom-up and top-down approaches used in measurement uncertainty calculation, the measurement uncertainty evaluation in drug and medicine analyses, and the application of measurement uncertainty in conformity assessment for quality control, stability studies, and pharmaceutical equivalence.

As China is implementing "Healthy China" strategy, medicinal and edible food has attracted unprecedented attention due to the dual attributes of food and medicine. However, there is a lack of the quality control standard and the existing quality control research cannot fully reflect the dual attributes of medicinal and edible food, which consequently restrict the development of medicinal and edible food industry. This study reviewed the research status and proposed the strategy of quality control in line with the dual attribu-tes of medicinal and edible food, and clarified the research contents of quality control of medicinal and edible food of different types to provide references for the follow-up quality control of medicinal and edible food.

It is the aim of the Medical Informatics Funding Scheme and other national and local projects for digital networking in healthcare to facilitate the exchange and use of patient data between institutions in compliance with data protection regulations. This requires the integration of data from various sources-such as digital workplace systems, laboratory systems, picture archiving and communication (PAC) systems or tumor boards-into a data warehouse or research databases. Digital networking of service providers and research institutions will open access to high-performance and precision medicine (e.g., virtual molecular tumor boards) for even more patients, thereby providing data for basic and care research. Network medicine will establish the translational link between basic research (e.g., genome research) and patient care. Digitally integrated "real world" patient data will also facilitate a detailed analysis of health care and the quality of treatments.

Publication bias is a substantial problem for the credibility of research in general and of meta-analyses in particular, as it yields overestimated effects and may suggest the existence of non-existing effects. Although there is consensus that publication bias exists, how strongly it affects different scientific literatures is currently less well-known. We examined evidence of publication bias in a large-scale data set of primary studies that were included in 83 meta-analyses published in Psychological Bulletin (representing meta-analyses from psychology) and 499 systematic reviews from the Cochrane Database of Systematic Reviews (CDSR; representing meta-analyses from medicine). Publication bias was assessed on all homogeneous subsets (3.8% of all subsets of meta-analyses published in Psychological Bulletin) of primary studies included in meta-analyses, because publication bias methods do not have good statistical properties if the true effect size is heterogeneous. Publication bias tests did not reveal evidence for bias in the homogeneous subsets. Overestimation was minimal but statistically significant, providing evidence of publication bias that appeared to be similar in both fields. However, a Monte-Carlo simulation study revealed that the creation of homogeneous subsets resulted in challenging conditions for publication bias methods since the number of effect sizes in a subset was rather small (median number of effect sizes equaled 6). Our findings are in line with, in its most extreme case, publication bias ranging from no bias until only 5% statistically nonsignificant effect sizes being published. These and other findings, in combination with the small percentages of statistically significant primary effect sizes (28.9% and 18.9% for subsets published in Psychological Bulletin and CDSR), led to the conclusion that evidence for publication bias in the studied homogeneous subsets is weak, but suggestive of mild publication bias in both psychology and medicine., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: Jelte M. Wicherts is a PLOS ONE Editorial Board member. This does not alter the authors’ adherence to PLOS ONE Editorial policies and criteria.

The Centers for Medicare and Medicaid Services (CMS) introduced the Physician Quality Reporting System (PQRS) in 2007. PQRS was developed as a value-based, pay-for-reporting initiative intended to increase quality and decrease costs. Jefferson University Physicians (JUP) was an early participant in this voluntary program. In this article, the policy context for CMS's launch of PQRS and JUP's implementation strategy, lessons learned, and an account of benefits and barriers to participation are reviewed. In 2010, JUP achieved 94% provider participation and an average incentive of $772 per participating provider. Net incentives earned across JUP in 2010 topped $171 000, although these earnings were significantly offset by implementation and maintenance costs. PQRS represents CMS's first step toward aligning quality and cost in the ambulatory care setting. Faculty practice plans must be prepared to meet this challenge in order to avoid future penalties and to advance quality of care.

The task group (TG) for quality assurance for robotic radiosurgery was formed by the American Association of Physicists in Medicine's Science Council under the direction of the Radiation Therapy Committee and the Quality Assurance (QA) Subcommittee. The task group (TG-135) had three main charges: (1) To make recommendations on a code of practice for Robotic Radiosurgery QA; (2) To make recommendations on quality assurance and dosimetric verification techniques, especially in regard to real-time respiratory motion tracking software; (3) To make recommendations on issues which require further research and development. This report provides a general functional overview of the only clinically implemented robotic radiosurgery device, the CyberKnife. This report includes sections on device components and their individual component QA recommendations, followed by a section on the QA requirements for integrated systems. Examples of checklists for daily, monthly, annual, and upgrade QA are given as guidance for medical physicists. Areas in which QA procedures are still under development are discussed.

The Traumatology Department of the University of Debrecen Medical and Health Science Center and that of the Kenezy Gyula Hospital of Hajdu Bihar County guarantees 24 hour service for outpatient trauma patients, which makes up around one hundred thousand cases per year. A very important element of the quality control is the continual assessment and supervision of the specialist performance, and the indicator is the change in the number of selected, incorrectly treated cases. The supervised cases make up a total of 24% of the total outpatient turnover. In 2003, 24313 injury cases, and in 2004, 23705 cases were examined with respect to documentation, and x-ray films. During the supervision, the treatment of the chosen cases are assessed weekly and discussed in conference. The case discussion is one of the valuable pillars of residence training. Our method contributes to the safeguarding of an appropriate standard for specialist work in an outpatient setting, and for this reason we wish to present it.

A programme was set up in the Essonne (France) between 1994 and 1998 to improve the quality of care for Type 2 diabetic patients. A consensus panel of general practitioners and diabetes specialists established guidelines based on the French St. Vincent recommendations. An audit involving 73 volunteer general practitioners (out of 965 in the Essonne) then evaluated compliance with these guidelines. Care and outcome were assessed in 505 (1995) and 604 (1996) Type 2 diabetic patients. The first audit cycle showed that defined standards were not met for several criteria and also revealed a lack of standardisation of HbA1c measurements and delayed intervention when blood glucose control was inadequate. Corrective measures were adopted: cooperative protocols for foot care, prevention of nephropathy and retinopathy, standardisation of HbA1c, and an educational programme at the primary health care level. The second audit cycle showed improvement in foot care (+33.6%), quality (+39.9%), prescription of HbA1c (+11.9%), and control of blood pressure (+11.9%) and blood lipids (+12.8%). The proportion of early interventions in case of inadequate glucose control increased significantly (+10.5%). However, some gaps persisted, mainly regarding screening for complications, diet counselling and patient education. This study shows that cooperation between general practitioners and diabetes specialists is feasible and effective in the context of a district-wide approach, and that it facilitates the adoption of international guidelines by local physicians. A project has been developed to provide structured diabetes care in general practice and better access to specialist services in order to improve the outcome of Type 2 diabetic patients.

A quality system for a medical laboratory should be directed on all fundamental aspects of its function. This implies the obligation to join the External Quality Assessment schemes, and to make use of its results. It means the setting-up of a quality system according to a medical translation of the items of the EN 45001 standard. And it means taking into account such professional aspects as registration and post-doctoral education, regular contacts with physicians and paying special attention to the suitability of tests. This whole process can be instituted on the basis of an ISO 9000 approach, which means specific standards for the medical laboratories, and inspection, in which the professionals should play an important role. The use of a quality manual facilitates the whole process. It should eventually lead to an accreditation system for medical laboratories. Cooperation in Europe on these aspects is important. An overview is given on the way the system works in the Netherlands.

Objective: When nonradiologists perform radiologic procedures, rather than referring their patients to radiologists, utilization--and therefore costs--are high, and quality appears often to be poor. In light of these public policy concerns, the American College of Radiology developed a detailed descriptive analysis of radiology performed by nonradiologists., Materials and Methods: Medicare data from 1989, which make up a uniform record of one third of the nation's health care, were the source of the information. These data are reasonably, although not exactly, representative of patients of all ages. We measured radiologic work, and nonradiologists' share of it, in professional component relative value units, using the Medicare radiology relative value scale., Results: Nonradiologists performed 25% of all radiologic work in the United States; their share was 46% in offices and freestanding centers, 27% for hospital inpatients, and 8% for outpatients. Counting procedures (rather than work measured in relative value units), nonradiologists' share was 64% in offices and freestanding centers and 8% for inpatients. Nonradiologists performed two thirds of all work in sonography, half of interventional radiology/angiography, 15-17% of general radiology and nuclear medicine, and a few percent of CT/MR and radiation oncology. Cardiologists performed 10% of all radiologic work in the United States; internists 5%; and orthopedists, ophthalmologists, and family and general practitioners, 2% each. Almost half of radiologic work performed by nonradiologists consisted of coronary angiography and cardiac sonography, done principally by cardiologists. Radiologists do less than 5% of this work. Office and freestanding center general radiology, performed mostly by orthopedists and primary care physicians, accounted for one fourth of the radiologic work done by nonradiologists., Conclusion: The general radiology performed by nonradiologists is of a magnitude that easily could be transferred to radiologists, particularly because many unnecessary imaging studies would most likely be eliminated as a result. Such a transfer would reduce costs and probably improve quality but might sometimes decrease patient convenience. However, because many radiologists do not perform coronary angiography and cardiac sonography, a transfer of these responsibilities to radiologists would be problematic and likely to require extensive additional training of radiologists.

Objective: To study the quality of the information exchanged in internal notes between Primary Care and specialist doctors and to determine which features of both the professionals and the system of organisation are common to both., Design: Observational study of a crossover type in which the units under analysis were the inter-clinic notes exchanged., Setting: Information gathering was carried out by means of personal attendance at specialist out-patient clinics in Area V, Madrid., Materials: A sampling of 1,920 inter-clinic notes accompanying patients referred by 45 general physicians to 13 Specialist Care clinics, including both ordinary clinics and senior specialists., Measurements and Main Results: Criteria concerning the quality of documentation exchanged were defined both according to the clinical information contained and the legibility of the inter-clinic notes. The quality of information sent by the general physician was good in 45% of cases. The highest quality of information in the inter-clinic notes sent by the general physicians was linked to Primary Care team-work, MIR training and women doctors., Conclusions: The information accompanying patients referred from Primary Care to specialists is low-quality. Doctors working in Primary Care Teams produce higher quality inter-clinical notes.

Collaboration is essential to manage complex real world problems. We used phenomenologic methods to elaborate a description of collaboration between two departments at an academic medical center who considered their relationship to represent a model of effective collaboration. Key collaborative structures included a shared vision and commitment by leaders, rigorous quality improvement, clear delineation of roles with built-in flexibility, ongoing commitment to formal and informal communication channels and conflict resolution, relationship development grounded in respect and responsiveness, and shared training in a supportive learning environment with legitimate participation fostering skill development. This study reveals the complexity and resources required for collaboration which both explains why collaboration is not as easy to achieve and identifies processes that foster collaboration. (Contains 1 table.)

The use of plants for healing purposes has been prevalent in all cultures throughout history and continues to play a role in medicine today. While herbal medicine has much to offer, adverse effects can result from lack of quality control and standardization, consuming an inadequate dose, using the wrong herb, and reactions with modern drugs. To promote safe health care consumerism, a thorough examination of the herbs that are among the most widely used natural medications in America is suggested. Health educators have the opportunity to initiate discussions and implement lessons regarding herbal medicine. This teaching strategy invites students to access credible information related to herbal medicine needed for its safe implementation into daily lives.

The board certification movement was founded out of a concern for the quality of care, and today, more than 85% of all physicians licensed to practice medicine in the United States have been certified by an American Board of Medical Specialties (ABMS) member board. There is increasing evidence of a need for continuous monitoring and promotion of quality as well as for assessment and documentation that certified medical specialists are keeping up-to-date so that their continuing competence can be documented. To help, the ABMS established a program called Maintenance of Certification, a system that includes periodic examination of knowledge and the comprehensive evaluation of practice. Maintenance of Certification includes 4 major components: professional standing, including an unrestricted license to practice medicine; lifelong learning and self-assessment; demonstrated cognitive expertise; and practice performance assessment. The efforts of the Conjoint Committee on Continuing Medical Education press continuing medical education providers to facilitate self-directed learning and directed self-learning while driving lifelong learning and assessment into the clinical practices of all physicians who seek to continuously upgrade their knowledge, skills, and behaviors to provide quality medical care.

Abstract Accurate indel calling plays an important role in precision medicine. A benchmarking indel set is essential for thoroughly evaluating the indel calling performance of bioinformatics pipelines. A reference sample with a set of known-positive variants was developed in the FDA-led Sequencing Quality Control Phase 2 (SEQC2) project, but the known indels in the known-positive set were limited. This project sought to provide an enriched set of known indels that would be more translationally relevant by focusing on additional cancer related regions. A thorough manual review process completed by 42 reviewers, two advisors, and a judging panel of three researchers significantly enriched the known indel set by an additional 516 indels. The extended benchmarking indel set has a large range of variant allele frequencies (VAFs), with 87% of them having a VAF below 20% in reference Sample A. The reference Sample A and the indel set can be used for comprehensive benchmarking of indel calling across a wider range of VAF values in the lower range. Indel length was also variable, but the majority were under 10 base pairs (bps). Most of the indels were within coding regions, with the remainder in the gene regulatory regions. Although high confidence can be derived from the robust study design and meticulous human review, this extensive indel set has not undergone orthogonal validation. The extended benchmarking indel set, along with the indels in the previously published known-positive set, was the truth set used to benchmark indel calling pipelines in a community challenge hosted on the precisionFDA platform. This benchmarking indel set and reference samples can be utilized for a comprehensive evaluation of indel calling pipelines. Additionally, the insights and solutions obtained during the manual review process can aid in improving the performance of these pipelines.

SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element of analytical procedure standardisation that ensures comparability of results across different laboratories assessing the quality of medicines, which is important for the quality control of biologicals. Marketing authorisation involves providing information on RSs, but no specific requirements are given for the relevant section of the dossier. Therefore, it is necessary to develop the requirements for the appropriate guidelines.AIM. This study aimed to develop specific requirements for the materials that should be included in the Reference Standards section of the dossier for a biological product.DISCUSSION. The authors analysed national and international regulatory frameworks governing RSs for biologicals, including documents by the World Health Organisation (WHO), the Eurasian Economic Union, the International Organisation for Standardisation (ISO), and the Russian Federal Agency for Technical Regulation and Metrology. Additionally, the authors analysed the experience of RS certification and use at the Scientific Centre for Expert Evaluation of Medicinal Products. This article covers specific aspects of biological RS certification, considering the differences between measurement techniques and analytical procedures. The authors formulated the key requirements for the documents submitted in the dossier section on RSs for biologicals (biological reference materials). The methods (analytical procedures) used for RS certification should be described in accordance with the requirements for standard operating procedures. Adequate validation studies should establish the necessary validation characteristics of these analytical procedures. Additionally, this article presents the requirements developed to certify primary RSs for structure confirmation of proteins in novel biologicals. The values of certified characteristics and critical quality indicators should be established, and the RS production technology should be described and in compliance with WHO recommendations and/or Good Manufacturing Practice (GMP) standards. The basic certification stages are common to all types of RSs. The RS shelf life should be established in real-time stability studies, whereas accelerated stability testing may be useful for studying degradation mechanisms and the effects of short-term deviations from the specified storage conditions. In accordance with WHO recommendations, the Reference Standards section of the registration dossier should specify changes to the RS that require regulatory approval.CONCLUSIONS. The authors believe that the requirements for the materials in the Reference Standards section of the dossier for a biological product, as systematised in this study for inclusion in the relevant guidelines, will provide a unified approach to RS development, certification, and documentation for applicants, developers, and competent authority experts and will streamline RS consideration during marketing authorisation.

SCIENTIFIC RELEVANCE. The complexity of standardising immunobiologicals, including bacillus Calmette–Guérin (BCG) vaccines, requires improving the approach to statistical analysis of consistency in their quality indicators. Quality analysis tools include Shewhart control charts, which can be used for real-time and retrospective identification and analysis of trends in the processes of interest.AIM. This study aimed to analyse quality indicators of a BCG vaccine for bladder cancer immuno­therapy using Shewhart control charts to monitor consistency in manufacturing processes and quality testing of vaccines.MATERIALS AND METHODS. The study involved a retrospective analysis of the bacterial concentration, dispersity index, loss-on-drying, and potency data obtained during the quality control of Imuron-vac, a BCG vaccine for bladder cancer immunotherapy, in the past 5 years. As part of the statistical data analysis, the authors calculated the means, investigated the corre­lation between the test results provided by the manufacturer and the quality control results obtained at the testing centre (TC), and checked the distributions for normality. Individuals and moving range control charts were plotted and analysed for each quality indicator.RESULTS. The correlation coefficients (r) ranged from 0.34 to 0.70 for the data submitted by the manufacturer and the data obtained at the TC. Pearson’s goodness-of-fit test showed that the distribution of the quality control results obtained at the TC was normal, with χ² = 14.03 for the dispersity index values and χ² = 4.93 for the loss-on-drying measurements. Shewhart control charts for loss-on-drying and potency data suggested that the production process and/or the testing process deviated from the state of statistical control. Consistency monitoring of the bacterial concentration and the dispersity index showed that the state of statistical control was achieved. The authors established control limits for further real-time monitoring of the dispersity index consistency.CONCLUSIONS. Shewhart control charts are applicable to the quality control of BCG vaccines for bladder cancer immunotherapy at the TC. Continuous monitoring of consistency in quality indicators is needed to improve the standardisation of vaccine production processes and testing methods, as this standardisation will result in high product quality.

Background The diagnosis and treatment of general practice often involve multi-system and multi-organ diseases, resulting in a large number of consultations. However, there is limited research on the current state of general practice consultation. Objective This study aims to collect relevant data on general practice consultation at Fuxing Hospital Affiliated with Capital Medical University, a tertiary general hospital and analyze the current situation of general practice consultation to improve the quality of general practice consultation at Fuxing Hospital and provide insights for hierarchical diagnosis and treatment. Methods The data of general practice consultation in Fuxing Hospital Affiliated to Capital Medical University from 2021 to 2022 were obtained through the hospital information system, and the basic information, consultation departments, consultation reasons, consultation diagnosis, and consultation opinions were classified and summarized. Results From 2021 to 2022, a total of 1 441 inpatients were admitted to the general practice department at Fuxing Hospital. Among them, 908 inpatients had consultation records. A total of 2 269 in-hospital consultations were issued, 966 consultations were executed while 303 were cancelled. Among the executed consultations, there were 987 males and 979 females. The age ranged from 17 to 101 years old, with an average age of (77.4±13.9) years old. A total of 31 clinical departments were involved, among which the top 6 departments with the most consultations were rehabilitation department, otolaryngology, ophthalmology, dermatology, infectious disease department and psychiatry. The most common diagnoses among these departments included dysfunction, sensorineural deafness, cataract , dermatitis, pulmonary infection and anxiety. The reasons for consultation included formulating initial treatment plans, adjusting current treatment plans, improving specialist examinations, assisting with specialized treatment and conducting specialist evaluations. The consultation treatment opinions can be roughly divided into professional evaluation, improving examinations, clarifying diagnosis, drug therapy, clinical operations, surgical treatment, nutritional therapy and rehabilitation acupuncture. Conclusion The diagnosis and treatment scope of general medicine includes common diseases and frequently occurring diseases in various systems, with a large demand for consultation. The spectrum of consultation diseases reflects the clinical needs and characteristics of the general medicine department of Fuxing Hospital Affiliated to Capital Medical University. Analyzing the current situation of consultation is conducive to making up for the shortcomings of general medicine, improving the quality of general consultation, and taking the first step towards referral between general medicine and specialists.

Background Administration of drugs by inhalation is a common route for the treatment of chronic airway diseases. The ability of patients to use an inhaler device is a key factor in the effectiveness of treatment. Recently, a new type of quantitative assessment instrument for inhalation drugs has been developed in China, which can measure peak inspiratory flow (PIF) and inspiratory volume (VI) under conditions with various internal resistance of inhalers, thereby accurately assessing the ability of patients to use inhaler. However, there are no quality testing methods and adoption standards for this type of instrument at home and abroad. Objective To perform quality testing of the inhalation drug quantitative assessment instrument and evaluate its technical performance, in order to explore the application value of the method. Methods Various internal resistance of dry powder inhalers (DPI) was simulated by the inhalation drug quantitative assessment instrument (PF810) in 5 different gears (R1-R5 from low to high) . A standard flow/volume simulator was used to test the flow, volume and impedance performance of the PF810 for inhalation. The flow test was performed at a fixed volume (3.000 L) and different flow rates (in the range of 0-2.000 L/s, with 0.250 L/s as the interval stepwise) . The volume was carried out at three flow rates of low (0.500 L/s) , medium (1.000 L/s) and high (1.500 L/s) , and at different volumes (1.000 L as the interval stepwise in the range of 1.000-4.000 L) . The Bland-Altman analysis chart method of GraphPad prism 9.0 software was used to evaluate the consistency of PIF and VI measurements of the inhalation drug quantitative assessment instrument with the actual values output by the simulator at different resistance gears. Results The results of quality control evaluation of flow detection showed that the percentages of repeatability, accuracy and linearity of flow detection meeting the performance requirements were 100.00% (40/40) , 95.00% (38/40) and 94.29% (33/35) . The accuracy and linearity of PF810 at R5 gear 1.500L /s and above did not meet the performance testing requirements, while those of other gears and flow rates met the requirements. The Bland-Altman consistency test showed 95% limit of agreement (LOA) of (-0.271- 0.107) L/s, with 96.00% (192/200) data points within the 95%LOA range. The results of volume test quality control evaluation showed that the pass rates of volume test repeatability, accuracy and linearity were all 100.00% (60/60, 60/60, 45/45) . The Bland-Altman consistency test showed that 95%LOA was (-0.058-0.017) L, and 100.00% (180/180) data points were within the 95%LOA range. The impedance measurement quality control evaluation results showed that the relative errors between the impedance value of PF810 and the internal resistance of the corresponding inhaler were all

Scientific relevance. The number of live bacteria is a quality parameter controlled at all stages of live plague vaccine production. Currently, live microbial cell counting uses a bacteriological method. However, flow cytometry has the potential to increase analytical accuracy and reduce testing time.Aim. This study aimed at testing the applicability of flow cytometry to assessing the quality of live plague vaccines.Materials and methods. The study quantified live microbial cells in 5 experimental batches of live plague vaccine as part of their quality control using the bacteriological method according to the State Pharmacopoeia of the Russian Federation (FS.3.3.1.0022.15). Cytofluorometry of the samples used the SynaptoGreen fluorescent dye.Results. The study quantified live microbial cells in live plague vaccine samples using the bacteriological method and flow cytometry. The results obtained by the bacteriological method ranged from 27.8±2.2 to 56.5±3.1% with an average of 39.8±5.4%. The results obtained by flow cytometry ranged from 29.2±1.2 to 59.1±2.1% with an average of 41.7±5.5%. The statistical analysis showed no significant difference between the results of vaccine quality control by both methods, as well as a high coefficient of determination.Conclusions. The results show that flow cytometry is an appropriate method for the quantification of live microbial cells as part of the quality control of plague vaccines. Being quick, easy, and highly informative, flow cytometry is preferable to traditional methods.

Objective. To evaluate the screening of blood samples for infectious disease markers at laboratories and blood banks in Latin America per the findings of an External Quality Assessment Program (EQAP). Methods. This qualitative analysis used data from the EQAP coordinated by the Fundação Pro Sangue Hemocentro de São Paulo with the support of the Pan American Health Organization to assess the performance of blood screening for infectious diseases from 2014 to 2018 in Latin America. Each participating laboratory or blood bank received an identical blind panel with 24 blood samples with variable reactivity for all the screening parameters. Panels were processed at each participating facility and results were returned to the Fundação Pro Sangue Hemocentro de São Paulo for individual and joint analyses. Two types of discrepant results were potential failures: false positive results (FPRs) and false nonreactive results (FNRRs). Results. A total of 23 136 samples were evaluated. Global rates of FPR, FNRR, and concordant results were 0.3%, 1.0% and 98.7%, respectively. Seven FNRRs were found for HBsAg (1.0%), 12 for syphilis (2.6%), and 21 for Chagas disease (2.9%). No FNRRs were found for the HIV, HCV, and HTLV viruses. The average accuracy of all the laboratories and blood banks participating in the EQAP during the study period was 99.5% (standard deviation, 0.5%). Conclusion. The findings of this qualitative analysis are positive for blood safety in Latin America, with an average accuracy of 99.5% among the participating laboratories and blood banks. This report reflects an important improvement in blood bank serological screening EQAP-PAHO report since the 2003.

Medicinal chemistry is a science that studies the methods of obtaining substances used for medical purposes, their structure, physical and chemical properties, the relationship between their chemical structure and their effect on the body, quality control methods, and what changes they undergo during storage. Physical, chemical and physico-chemical methods are used to solve the problems facing medicinal chemistry, and these methods are widely used in the synthesis and analysis of medicinal substances. [ABSTRACT FROM AUTHOR]

[Abstract]: Ganjiang (Zingiberis Rhizoma, ZR) and Jiangtan (Carbonized Zingiberis Rhizoma, CZR) have long been used in traditional Chinese medicine (TCM) with a rich history in the treatment of various ailments. While ZR and CZR obviously stem from the same botanical source, their attributes, chemical compositions, pharmacological behaviors, and clinical applications are different owing to variations in the extent of drying and processing they undergo. In this paper, data pertaining to ZR and CZR were retrieved from databases including China National Knowledge Infrastructure (CNKI), PubMed, Web of Science, and Google Scholar. These sources were scrutinized to elucidate the distinctions between ZR and CZR arising from carbonization processing in terms of their ethnopharmacology, quality control, chemical compositions, biological activities, pharmacological mechanisms, and clinical uses. In this study, a total of 56 chemical constituents were identified and isolated from ZR and CZR, which primarily encompassed volatile oils, gingerols, and diphenylheptane compounds. CZR's pharmacological effects include hemostatic, anti-oxidant, analgesic, antibacterial, anti-cancer, and other biological activities. ZR has pungent and warm properties. It is a Yang-supplementing herbal medicine for ailments exacerbated by cold or damp climatic influences. CZR is a product of ZR after undergoing high temperature, with diminished intensity of its pungent and warm attributes. This change leads to a more gradual treatment efficacy, renowned hemostatic effects and its ability to gently invigorate the spleen and effectively alleviate diarrhea. Currently, research on the pharmacological mechanism of CZR is mainly focused on the effects of CZR on coagulation and fibrinolysis. Although the healing effect of CZR has long been known, and some correlation has been found between the changing composition and the changing color of the decoctions, people still lack relatively clear processing mechanisms to reflect the characteristics and specific quality standards of the ingredients of CZR's hemostatic effect. This review provides a systematic summary on quality control, chemical composition, ethnopharmacology, and pharmacology of CZR, offering novel perspectives for advancing the exploration of additional carbonized herbal medicine and fostering their application in clinical settings.

To ensure accurate and consistent imaging of patients, medical imaging systems are controlled and tested using phantoms. Despite the availability of commercial standard phantoms for decades, 3D printing technology has gained special attention as a tool for producing accurate and costeffective tissue-mimicking phantoms. As artificial intelligence (AI) becomes increasingly prevalent in medical imaging, dedicated phantoms are needed for testing their reliability, robustness, and quality before they are implemented in clinical settings. In this context, 3D-printed imaging phantoms, which have specific requirements relevant to AI models, can play a crucial role. Due to its unique ability to create phantoms of almost any complexity, 3D printing technology seems a suitable approach for the quality control of AI models in medical imaging. The following reviews some of the works that used 3D-printed technology to create custom-built phantoms for use in Computed Tomography (CT), nuclear imaging, Magnetic Resonance Imaging (MRI), and ultrasound imaging. The focus of this short review is on the accuracy of 3D-printed technology in creating imaging phantoms. In the end, the potential of the 3D-printed phantoms in testing and quality control of AI-based algorithms in radiology is discussed.

Introduction: Good Clinical Laboratory Practices (GCLP) play a vital role in early and accurate diagnosis, providing highquality data, and timely sample processing. Adhering to a robust Quality Management System (QMS) that complies with GCLP standards is crucial for laboratory personnel in a clinical laboratory to deliver outstanding healthcare services and reliable, reproducible reports. Aim: To assess the Knowledge, Attitude, and Practice (KAP) of laboratory professionals towards quality in the laboratory through GCLP training. Materials and Methods: This pre-test, post-test quasiexperimental study was conducted in the Department of Biochemistry at ESIC Medical College and Hospital, Faridabad, Haryana, India, from February 2022 to June 2022. The study included 58 participants, consisting of 22 doctors and the remaining laboratory assistants. GCLP online training program was conducted every Friday in March 2022 for four weeks. An online questionnaire containing 34 questions was administered to all the participants before and after the training. Data were collected and analysed using a paired t-test. Results: A total of 58 responses were received from the participants via Google form before and after the training. The results indicate no significant difference in participants’ responses to 12 closed-ended questions regarding QMS before and after training. A similar trend was observed for 22 questions on a Likert scale, where participants rated their agreement, neutrality, or disagreement. Conclusion: The study demonstrates that all technical staff fully complied with GCLP guidelines and accreditation requirements. Furthermore, the laboratory staff acknowledges the importance of Standard Operating Procedures (SOPs), document maintenance, record-keeping, and identifying nonconformities, all of which contribute to effective traceability of the testing process in the clinical laboratory.

Background Robust analysis of DNA sequencing data needs to include a set of quality control steps to ensure that technical bias is kept to a minimum. A metric easily obtained is the frequency of each of the nucleobases for each position across all sequencing reads. Here, we explore the differences in nucleobase compositions of various library types produced by standard experimental methodologies. Methods We obtained the compositions of nearly 3000 publicly available datasets and subjected them to Uniform Manifold Approximation and Projection (UMAP) dimensionality reduction for a two-dimensional representation of their composition characteristics. Results We find that most library types result in a specific composition profile. We use this to give an estimate of how strongly the composition of a test library resembles the profiles of previously published libraries, and how likely the test sample is to be of a particular type. We introduce Librarian, a user-friendly web application and command line tool which enables checking base compositions of test libraries against known library types. Conclusions Library preparation methods strongly influence the per position nucleobase content. By comparing test libraries to a database of previously published library types we can make predictions regarding the library preparation method. Librarian is a user-friendly tool to access this information for quality assurance purposes as discrepancies can flag potential irregularities very early on.

Introduction: External quality assessment is a crucial component in ensuring the quality of blood transfusion testing laboratories. Objectives: To develop a procedure for generating external quality assessment items for blood transfusion testing to evaluate participants' performance. Methods: Experimental research was conducted at Quality Control Center for Medical laboratory- University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam. Three items, including red blood cell, serum, and atypical antibody serum samples, were assessed for homogeneity and stability; 5 assessment areas, including ABO grouping, Rh grouping, compatible cross matches, Coombs test, and screening of atypical antibodies, were utilized to evaluate the performance of 38 participants in the 2020-2021 period. Results: Red blood cell and serum samples maintained quality for a specific period at controlled temperatures, while serum samples with atypical antibodies showed stability at different temperatures. The participants demonstrated high satisfactory performance in ABO grouping, Rh grouping, Coombs test, and screening for atypical antibodies. However, the most unsatisfactory performance was reported in crossmatching, with 15% of participants unsatisfactory results. Conclusion: The procedure of production of proficiency testing items has been successfully developed, and its application at the national level is suggested to improve the quality of blood transfusion laboratories.

In Colombia, Micrurus snakebites are classified as severe according to the national clinical care guidelines and must be treated with specific antivenoms. Unfortunately, these types of antivenoms are scarce in certain areas of the country and are currently reported as an unavailable vital medicine. To address this issue, La Universidad de Antioquia, through its spin-off Tech Life Saving, is leading a project to develop third-generation polyvalent freeze-dried antivenom. The goal is to ensure access to this therapy, especially in rural and dispersed areas. This project aims to evaluate the physicochemical and preclinical parameters (standard quality characteristics) of a lab-scale anti-elapid antivenom batch. The antivenom is challenged against the venoms of several Micrurus species, including M. mipartitus, M. dumerilii, M. ancoralis, M. dissoleucus, M. lemniscatus, M. medemi, M. spixii, M. surinamensis, and M. isozonus, following the standard quality characteristics set by the World Health Organization (WHO). The antivenom demonstrates an appearance consistent with standards, 100% solubility within 4 min and 25 s, an extractable volume of 10.39 mL, a pH of 6.04, an albumin concentration of 0.377 mg/mL (equivalent to 1.22% of total protein), and a protein concentration of 30.97 mg/mL. Importantly, it maintains full integrity of its F(ab′)2 fragments and exhibits purity over 98.5%. Furthermore, in mice toxicity evaluations, doses up to 15 mg/mouse show no toxic effects. The antivenom also demonstrates a significant recognition pattern against Micrurus venoms rich in phospholipase A2 (PLA2) content, as observed in M. dumerilii, M. dissoleucus, and M. isozonus. The effective dose 50 (ED50) indicates that a single vial (10 mL) can neutralize 2.33 mg of M. mipartitus venom and 3.99 mg of M. dumerilii venom. This new anti-elapid third-generation polyvalent and freeze-dried antivenom meets the physicochemical parameters set by the WHO and the regulators in Colombia. It demonstrates significant efficacy in neutralizing the venom of the most epidemiologically important Micrurus species in Colombia. Additionally, it recognizes seven other species of Micrurus venom with a higher affinity for venoms exhibiting PLA2 toxins. Fulfilling these parameters represents the first step toward proposing a new pharmacological alternative for treating snakebites in Colombia, particularly in dispersed rural areas, given that this antivenom is formulated as a freeze-dried product.