Quality Assurance Research Articles

Software solution for integration of frozen section quality assurance into daily practice.

Diagnoses rendered using the frozen section (FS) technique during surgical procedures are used to guide intraoperative decisions. Therefore, diagnostic FS errors have the potential to affect patient safety and quality of care. Diagnostic FS errors arise due to both technical and interpretative factors and present a challenge to surgical pathology laboratories to recognize, document, and manage in a timely fashion. Thus, there is a need to monitor discrepancies between FS and permanent diagnoses and effectively communicate with the clinical teams when an error is discovered to ensure an opportunity for timely interventions, if clinically indicated. Our FS practice is complex, with many contributing variables, such as a partially generalized FS pathology practice model among pathology faculty and/or surgeons with specific subspecialty expertise and different physical locations of FS facilities. We implemented a comprehensive frozen section quality assurance (FSQA) program using custom software solutions aimed at improving patient safety by monitoring recognition, increasing documentation, and facilitating communication in cases where there is a discordance between intraoperative and permanent diagnoses. Our FSQA program allows for categorizing frozen section discrepancies according to the source of error, such as interpretive vs technical errors, to understand how errors arise and todevelop appropriate mitigation strategies for reducing errors. Overall, our intervention to improve FSQA has engaged pathology faculty in a uniform and systematic manner, and our data show that our new FSQA program led to a markedly shortened time interval of FSQA, allowing for timely management and resolution of errors.

Shear Wave Method for Concrete Pavement Diagnostics

Field trials involving typical pavement constructability and rehabilitation issues at the Federal Aviation Administration’s National Airport Pavement Test Facility, the Minnesota Road Research Project, and various in service pavements using MIRA were verified. The trials indicate that, while the device is a useful portable pavement diagnostic alternative capable of consistent thickness measurement, reinforcement location, and distress evaluation, significant efforts and user expertise are required for measurement and data interpretation of large scale applications. Thus, a couple productive, objective signal interpretation methods are presented for automated analysis of reinforcement location in continuously reinforced concrete pavement as well as an initial distress indicator using two-dimensional ultrasonic signature analysis. This type of automation for multiple applications shows promise for the use of ultrasonic tomography to improve large scale pavement quality assurance, quality control, and rehabilitation projects in the future. Innovative imaging methods such as synthetic aperture focusing technique panoramic reconstructions and synthetic aperture focusing technique three-dimensional visualizations were also introduced to improve the ability to obtain relational information when dealing with larger scanned areas. Ultrasonic tomography is shown to be an accurate, reliable, and convenient alternative/supplement to traditional techniques or can be used to replace or reduce the need for forensic methods such as coring.

MR-linac: role of artificial intelligence and automation.

The integration of artificial intelligence (AI) into radiotherapy has advanced significantly during the past 5years, especially in terms of automating key processes like organ at risk delineation and treatment planning. These innovations have enhanced consistency, accuracy, and efficiency in clinical practice. Magnetic resonance (MR)-guided linear accelerators (MR-linacs) have greatly improved treatment accuracy and real-time plan adaptation, particularly for tumors near radiosensitive organs. Despite these improvements, MR-guided radiotherapy (MRgRT) remains labor intensive and time consuming, highlighting the need for AI to streamline workflows and support rapid decision-making. Synthetic CTs from MR images and automated contouring and treatment planning will reduce manual processes, thus optimizing treatment times and expanding access to MR-linac technology. AI-driven quality assurance will ensure patient safety by predicting machine errors and validating treatment delivery. Advances in intrafractional motion management will increase the accuracy of treatment, and the integration of imaging biomarkers for outcome prediction and early toxicity assessment will enable more precise and effective treatment strategies.

Perceived effectiveness and recommendations from a childbirth quality assurance and improvement programme in India’s private sector: a qualitative evaluation using the RE-AIM framework

IntroductionPrevious studies have revealed inconsistent quality of care in India’s private sector, where nearly one in three facility births take place. Manyata is a quality assurance and improvement programme launched...

Evaluating the accuracy of multiple rapid diagnostic tests for HIV detection in serum samples analysed during point-of-care proficiency testing assessments.

HIV rapid diagnostic tests are crucial for timely diagnosis, especially in resource-limited settings. The World Health Organization recommends sensitivity ≥99 % and specificity ≥98 %. This study assessed RDT performance across South Africa's provinces using a proficiency testing program. From April to June 2023, 25,458 blinded serum samples were sent to testing facilities for screening and confirmatory testing. Sensitivity, specificity, predictive values, and concordance (Cohen's Kappa) were evaluated. The response rate was 98.25 %. Sensitivity and specificity were both 98.7 %, with agreement at 98.7 % (kappa 0.97, p < 0.001). Northern Cape showed the lowest sensitivity (91.8 %) and specificity (92.0 %), while Gauteng, KwaZulu-Natal, and Mpumalanga exceeded 99 %. Although national RDT performance met WHO standards, Northern Cape's results reveal the need for improved training, quality assurance, and proficiency testing to strengthen diagnostic accuracy.

Phytochemical analysis and heavy metal level in selected commercial herbs sold in Iperu-Remo, Ogun State, Nigeria

Herbal drinks are popular drinks in Nigeria nevertheless; most herbal drinks do not adhere to WHO standards. This shows the need to examine the concentration of phytochemicals and specific heavy metals in some of the commercially sold herbs in Iperu-Remo was the objective of the study. Four (4) herbs were purchased from vendors. The major aim of the study was to estimate phytochemicals using standard methods while an atomic absorption spectrometer was used for heavy metals estimations. The findings revealed that the highest concentration of Alkaloid was recorded in Agbo Iba (4.11 mg/L), Phenolic compound in Agbo Iba (3.66 mg/L), Tannin was in Agbo Iba (0.411 mg/L), and Terpenoids was in Jedi Jedi (0.931 mg/L). The highest Arsenic (As) concentration was recorded in Opa Eyin (1.02 mg/L), followed by Agbo Iba (0.581 mg/L), Jedi Jedi (0.351 mg/L) while the lowest concentration was recorded in FIJK Flusher (0.0046 mg/L). The highest Cadmium (Cd) concentration was recorded in Opa Eyin (0.273 mg/L), followed by Agbo Iba (0.112mg/L), Jedi Jedi (0.087 mg/L) while the lowest was recorded in FIJK Flusher (0.002 mg/L). As and Cd concentration in the samples were above the WHO standard except for FIJK Flusher. Nigeria as well as other countries with similar practices should incorporate these herbs into the National Healthcare System because there is a need for quality assurance, safety, awareness and standardization of these herbs for the benefit of the consumers.

A decade of AGO QS-Mamma – Adherence to the Recommendations of The AGO Breast Committee for Diagnosis and Treatment in EBC in Routine Therapy in Germany

Introduction: The cure for Early Breast Cancer (EBC) is increasing over the last decades due to the improvement of diagnosis and therapy. Individualization of cancer treatment in EBC requires constant optimization by implementing current guidelines. The AGO (working group gynecologic oncology) QS-Mamma initiative, a quality assurance program (QS) of the AGO Breast Committee, was introduced to provide insight in guideline adherence in real world practice in Germany. We evaluated 10 years of QS-Mamma data to identify gaps and trends implementing those guidelines. Methods: QS-Mamma is a retrospective sample survey providing a representative overview of the treatment landscape for the treatment of breast cancer in Germany. The last six cohorts were analyzed over a period of ten years. Across all cohorts, an average of 264 centers documented a total of n=4,577 patients with EBC. Results: Testing for BRCA mutations in triple-negative patients increased significantly. Breast conserving surgery has been standard of care since the start of data collection; choice of surgical procedure depends primarily on tumor size and nodal status according to the patient´s preference, if possible. Axillary intervention has shifted towards SLNE or targeted axillary procedures in patients with negative preoperative nodal staging. Neoadjuvant systemic therapy (NAST) in operable EBC is established. Anthracycline administration in the adjuvant setting decreases. We noted an uptake on using platinum-containing CTx in TNBC, corresponding to AGO recommendations. Dual HER2 blockade is established in HER2 positive EBC with increased risk of relapse. Changes in guidelines are reflected in real-world data. Conclusion: Guideline adherence in breast cancer care is high and new treatments and diagnostic options are implemented promptly. Finally, escalation and de-escalation of treatment is depending on individual tumor characteristics resulting in the individual risk of recurrence. Guidelines should be flanked by real-world evidence to ensure and survey their impact.

Cross-border higher education and quality assurance: the role of international organisations

Purpose Over the years, International Organisations have started to look at Cross Border Higher Education (CBHE) with more attention, namely, at the impact and challenges entailed by this type of educational provision due to the emergence of low-quality offers and degree mills. This paper aims to discuss the role of these organisations in the development and promotion of CBHE and its quality assurance in Europe. Design/methodology/approach This paper conducts interviews using a previously drafted guideline with top-level managers of seven relevant international organisations involved in quality assurance at European and international level, namely, INQAAHE, EUA, ENQA, ESU, EQAR, ECA and EURASHE. It analysed the data collected using a grid created through the articulation of the guidelines’ questions and the empirical data. Findings The interviews’ content analysis indicated that these international organisations are important stakeholders in the development of CBHE quality assurance in Europe, particularly through the promotion of cooperation and trust between the different actors involved in it. These organisations can assume two different roles: a Technical-Professional Role and a Community Building Role. Originality/value This work’s originality stems from the fact that at least to our knowledge there is no other empirical work so far on the role and the views of different international organisations on the challenges CBHE entails for quality at the European level.

Interhospital variation in surgical treatment of screen-detected breast cancer in the South of the Netherlands.

The effectiveness of the Dutch breast cancer screening programme depends on the quality of the full trajectory, from the first screening to the final treatment of a screen-detected breast cancer. Interhospital variation in breast cancer treatment has been explored by several studies, however, not specifically in a screen-detected breast cancer population. The current study compares the treatment strategies of women with screen-detected breast cancer between hospitals in the South of the Netherlands. A total of 1450 women with screen-detected breast cancer, who participated in the Dutch screening programme between January 2009 and July 2019, were included in this retrospective analysis of a prospectively obtained database. Breast cancer treatment (i.e. preoperative MRI, neoadjuvant systemic therapy and type and outcomes of surgery) was compared between hospitals using multivariate analysis. Statistically significant interhospital variation was observed in the use of preoperative MRI (range 20.8-35.8%, p<0.001), neoadjuvant systemic therapy (range 4.0-13.3%, p<0.001) and breast conserving surgery (range 70.0-87.1%, p<0.001). These differences persisted after adjustment for case-mix. In patients with invasive breast cancer treated by breast conserving surgery, the mean volume of the resection specimen ranged from 381 to 541ml between hospitals (p<0.001). However, this was not accompanied by significant differences in the percentage of patients with positive resection margins (range 2.9-5.7%, p=0.34). We observed significant interhospital variation in the management of women with screen-detected breast cancer. Quality assurance in screen-detected breast cancer may reduce these differences, but evolving breast cancer care and more personalised approaches should be accounted for.

Examining Middle Leaders’ Quality Assurance Instruments in Assessing Classroom Activities: A Case of Six Schools in Two Districts of Gauteng Province

Examining Middle Leaders’ Quality Assurance Instruments in Assessing Classroom Activities: A Case of Six Schools in Two Districts of Gauteng Province

Change in Nurses’ Reactions to Psychosocial Work Environment Factors During the Accreditation Period

In the modern healthcare system, significant focus is given to ensuring the quality of services, leading to the necessity of selecting the most suitable quality improvement measure for healthcare organizations. However, it has not been clear which quality improvement measure is the most appropriate for the healthcare services sector, as quality is understood and assessed differently in this field compared to other sectors. Various regulatory methods for healthcare service organizations are used worldwide, including licensing, accreditation, and certification. The application of quality assurance standards in healthcare organizations is based on the fact that these organizations seek to change their current practices to improve outcomes. Implementing each quality measure elicits certain reactions from healthcare professionals, which are not always favorable to the organization. This article examines the impact of accreditation on the changes in psychosocial work environment factors experienced by nurses during each accreditation phase.

Exploring How Quality Assurance Manages Prison students ' Access to Distance E-Learning Education

Exploring How Quality Assurance Manages Prison students ' Access to Distance E-Learning Education

An exploration of governance in teaching hospitals in the Netherlands focused on educational objectives

BackgroundMany countries are improving medical education in teaching hospitals through more focus on internal quality assurance, for example by creating new stakeholders like hospital-wide education committees. Adequate oversight is thought essential to ensure the quality of medical education. How teaching hospitals distribute roles and responsibilities for quality control across educational stakeholders to organize this oversight is rarely investigated. This study aims to answer the following exploratory question: Who are the primary stakeholders involved in educational governance, and what are their roles in safeguarding educational quality in teaching hospitals?MethodsWe conducted an exploratory qualitative study of educational governance structures in all teaching hospitals in the Netherlands with at least three training programs. We carried out document analysis of recent governance codes, documents drafted by Dutch teaching hospitals to describe their methods of internal governance for the national accreditor, and analyzed the data using a thematic analysis approach through the lens of organizational theories of Mintzberg and Freidson.ResultsThe study identified key stakeholders in quality management of medical education in all teaching hospitals of the Netherlands. An overview of their roles and responsibilities is given and a stakeholder map is drafted. Teaching hospitals gave the hospital-wide education committee three different roles: an advisory role, a quality controller role and a conflict mediation role.DiscussionHospitals have set up the assignment of decision-making power in different ways, creating different variants of hospital-wide education committees and potentially causing them to be less effective at quality management. Whether these different roles affect the quality management of medical education in practice requires practice-oriented research. The study reveals remarkable ambiguity regarding the assignment and exercise of decision-making power between actors. This study contributes to the literature by identifying key actors and their roles in the quality management of postgraduate medical education, providing a foundation for follow-up research.

Organizational Climate Management in the Context of Initial Mathematics Teacher Education

Objective: This study aims to analyze the impact of organizational management on motivation, satisfaction and commitment in teacher training in the context of Chilean quality assurance policies that emphasize a positive school climate and good coexistence. Methods: Using a Likert scale with a Cronbach’s alpha of 0.957, we surveyed 62 students in a mathematics teacher education program. A multiple linear regression analysis was conducted to examine how motivation, satisfaction, and engagement were related to organizational management and climate. Findings: The results show that motivation and satisfaction are significant predictors, explaining 61.5% of the variance in organizational management, while commitment also influences climate, but to a lesser extent. These results underscore the importance of motivation and satisfaction for effective organizational management and suggest that these factors may be more important than commitment in shaping a positive organizational climate. Novelty/Improvement:This study contributes to the literature by highlighting the need for management models that are tailored to specific educational contexts and calls for future research to examine additional variables that influence organizational climate in higher education to improve our understanding of the factors that influence educational environments. Doi: 10.28991/ESJ-2024-SIED1-018 Full Text: PDF

MAGNESIUM –PICRATE COMPLEXES AS COUPLING AGENTS TO ENHANCE UV-VISIBLE SPECTROPHOTOMETRIC DRUG ANALYSIS

This research investigates the production of magnesium-picrate complexes and their use as coupling agents to improve UV-Visible spectrophotometric detection and quantification of vital medicinal medicines. The analyzed pharmaceuticals comprise Diclofenac Sodium, Ciprofloxacin HCl, Levoceitrizine 2HCl, Levofloxacin Hemihydrate, Nimesulide, Piroxicam BCD, and Terbinafine HCl. The synthesized magnesium-picrate complexes, upon heating with medication solutions, exhibited substantial increases in absorbance at their specific characteristic wavelengths. The increases were documented as 70.82%, 47.95%, 64.11%, 64.05%, 39.24%, 81.16%, and 87.10%, respectively, reflecting increased molar absorptivity. The 90% yield of magnesium-picrate complexes and their capacity to improve spectrum detection highlight their promise in optimizing UV-Visible spectrophotometric techniques for pharmaceutical quality assurance.

Magnetic resonance imaging safety in Asia-Oceania: call for action.

Magnetic Resonance Imaging (MRI) safety is a critical concern in the Asia-Oceania region, as it is elsewhere in the world, due to the unique and complex MRI environment that demands attention. This call-for-action outlines ten critical steps to enhance MRI safety and promote a culture of responsibility and accountability in the Asia-Oceania region. Key focus areas include strengthening education and expertise, improving quality assurance, fostering collaboration, increasing public awareness, and establishing national safety boards. By implementing these actions, we aim to significantly reduce MRI-related incidents and create a culture of safety across diverse healthcare settings in the Asia-Oceania Region.

SOCIAL AND HEALTH IMPLICATIONS OF THE USE OF TRADITIONAL APHRODISIACS (KAYAN MATA) AMONG MARRIED WOMEN IN NORTHERN NIGERIA

People over time, have considered the possibility to arouse sexual desires with drugs and food. However, how this is largely attended to, based on the uniqueness of the different groups and cultures. Prior to the use of modern vaccines, traditional aphrodisiacs such as herbal or animal extracts were purported to boost erotic pleasure, induce sexual desire and stimulate genitalia. In recent years, the use of aphrodisiacs has become popular with the increased prevalence of sexual problems worldwide. Aphrodisiacs refer to any substance (food or drug) that stimulates sexual desire and enhance sexual desire and performance. In Northern Nigeria, traditional aphrodisiacs known as Kayan mata, are sold by the roadside and in herbal chemists, most of which are not certified fit for human consumption. Dispensers do not have any information on their manufacturing dates, expiry dates, batch number nor chemical compositions as well as the prescribed dosage. The acceptance and use of Kayan mata among women in Northern Nigeria is associated with the desire to have influence over decision-making and control partners in intimate relationship. However, many issues have been presented in different quarters with respect to the use and demand for traditional aphrodisiacs. Nevertheless, little is known about the social and health implications of the use of these substances. This, therefore requires further interrogation to broaden the horizon of the public on the increasing phenomenon. Secondary sources of data were employed for this work. Also, Social Exchange Theory provided theoretical orientation to issues related to the thrust of the paper. A large number of married women use traditional aphrodisiac which are mainly sold by traditional healers. Therefore, there is need to set up more orthodox care facilities for sexual dysfunction and community health education on female sexual dysfunction. Furthermore, there is the need for quality assurance, safety and standardization of these substances for the benefit of the consumers.

Automated 3D semantic segmentation of PCB X-ray CT images and netlist extraction

Printed Circuit Board (PCB) design reconstruction is essential for addressing part obsolescence, intellectual property recovery, compliance, quality assurance, and enhancing national capabilities. Traditional methods for PCB design extraction, both non-geometry-based and geometry-based, have limitations in accuracy, efficiency, and scalability. This paper presents an automated approach, combining image processing and machine learning, to achieve 3D semantic segmentation of PCB X-ray Computed Tomography (X-ray CT) images and subsequent netlist extraction. By employing a 3D U-Net architecture with a ResNet-18 backbone and training on synthetic data, we introduce a first-of-its-kind method for direct 3D semantic segmentation, significantly improving over previous efforts. Our approach eliminates the need for extensive labeled datasets by using inherently labeled synthetic data. Further, this method enhances ease of segmentation by significantly reducing or eliminating the preprocessing effort required for 2D image stacks. It also improves universality by expanding the scope of application beyond images with specific 2D stack criteria, segmenting the 3D image in its entirety. Additionally, this method enables the processing of images of PCBs that have undergone bending, which is common among PCBs with a thickness below a certain threshold. The implications of this approach extend beyond PCBs, finding applications in various physical and biological sciences where 3D image segmentation is crucial. This methodology includes high-resolution 3D imaging, watershed segmentation, machine learning-based semantic segmentation, and netlist extraction. Validation with both synthetic and real-world PCB datasets shows high accuracy and robustness, offering a scalable solution for PCB design reconstruction.

Roller-Compacted Concrete Pavement, An Industry Perspective

This paper presents a summary of findings and experiences in implementing Roller- Compacted Concrete Pavement (“RCC Pavement”) at industrial distribution facilities. The author’s experiences in RCC Pavement involved defining and taking complete responsibility from concept to completion, including but not limited to, material selection, mixture design, structural design, production, transportation, placement and curing. Using ten-plus years of experience and incorporating pertinent research findings, processes and tests lead to the development of Quality Assurance (“QA”) Processes and Quality Control (“QC”) tests/observations. Continuous improvement has been made on developing a QC program. The author’s experiences involved the use of RCC Pavement as a finished surface and dictated a high performance RCC Pavement (compressive and flexural strength as high as 40 MPa and 5MPa, respectively after only 7 days); therefore, all placement utilized an ABG paver and vibrating screed with dual tamping bars to obtain high density RCC Pavement while minimizing roller displacement and maximizing smoothness and riding characteristics of the final RCC Pavement surface. Size of the projects has limited these experiences to production of RCC Pavement through the use of either a wetbatch concrete plant or a dry-batch concrete plan in conjunction with a horizontal shaft mixer.

Development of complex generics: Insights into trends, challenges, and market opportunities

Complex generics are generic versions of pharmaceutical products containing formulations, routes of delivery, dosage forms, drug-device combination products, active ingredients in complex form or features that may make it difficult for products to prove bio-equivalency. NBCD (Non-Biological Complex Drugs) offers workable options for approving complicated generics through optimal utilization of USFDA’s current shortened approval processes, 505(j) and 505(b) (2). The FDA awarded funding on August 2020 to establish the Centre for Research on Complex Generics (CRCG) to address issues related to complex generic development. Complex Generics Face Key Challenges such as bioequivalence standards, substitutability, patent/exclusivity issues, and lifecycle quality assurance. PLGA (poly (lactic-co-glycolic acid)) is a preferred inactive ingredient for long-acting injectable medications with complex formulations. Challenges in creating long-acting injectable/implantable (LAI) drug products are drug loading and release issue, physicochemical properties of PLGA etc. To achieve critical “time-to-market” strategic and operational goals, biopharma businesses should implement Good Regulatory Practices by specifying the where, what, when, and how. Biopharma businesses should select industry partners with clinical experience, worldwide regulatory knowledge, and quality/compliance competence to quickly deliver verified results to avoid problems in the shift to complex generics. The complex generics market is poised for significant growth, increasing from $84 billion in 2024 to $170 billion by 2035, at a compound annual growth rate (CAGR) of 8%. In future the complex generics market will evolve through innovative drug delivery methods, personalized treatment approaches, advanced manufacturing techniques, increased biosimilar products, strategic partnerships to address shifting healthcare needs.