Quality Assurance Requirements Research Articles

Increasing Levels of Evidence in Rhinoplasty: Stepping Up Our Role as Leaders in the Specialty.

Increasing Levels of Evidence in Rhinoplasty: Stepping Up Our Role as Leaders in the Specialty.

Verification of an independent dose calculation method for portal-specific QA of proton and carbon ion beams

ObjectiveTo verify the accuracy of an independent dose calculation method, as incorporated into an in-house developed treatment planning system (TPS), for performing quality assurance of dose distributions delivered to a water phantom planned by a clinical TPS. MethodsA Monte Carlo based track repeating algorithm was incorporated into an in-house treatment planning system for proton and carbon ion beams. Calculations were performed in a flat water phantom for both a traditional pencil beam algorithm and a new Monte Carlo algorithm, and then compared to measurements made at multiple depths with a 2D ionization array for 44 patient portals. The comparisons utilized a Gamma analysis. ResultsA total of 124 measurements were performed for proton and carbon ion patient portals. Using a small Gamma criteria of 2%/2 ​mm, an average of 93% and 97% of measurement points passed for each portal for pencil beam and Monte Carlo calculations, respectively. The passing rate was substantially higher for Monte Carlo calculations than for pencil beam calculations for portals that used a range shifter. ConclusionsThe implemented independent method has been verified against measurements. The high passing rate with small tolerances leads to the possibility of reducing the number of required quality assurance measurements.

Real-world data: Assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products.

Real-world data: Assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products.

Synthetic MRI for Radiotherapy Planning for Brain and Prostate Cancers: Phantom Validation and Patient Evaluation.

PurposeWe aimed to evaluate the accuracy of T1 and T2 mappings derived from a multispectral pulse sequence (magnetic resonance image compilation, MAGiC®) on 1.5-T MRI and with conventional sequences [gradient echo with variable flip angle (GRE-VFA) and multi-echo spin echo (ME-SE)] compared to the reference values for the purpose of radiotherapy treatment planning.MethodsThe accuracy of T1 and T2 measurements was evaluated with 2 coils [head and neck unit (HNU) and BODY coils] on phantoms using descriptive statistics and Bland–Altman analysis. The reproducibility and repeatability of T1 and T2 measurements were performed on 15 sessions with the HNU coil. The T1 and T2 synthetic sequences obtained by both methods were evaluated according to quality assurance (QA) requirements for radiotherapy. T1 and T2 in vivo measurements of the brain or prostate tissues of two groups of five subjects were also compared.ResultsThe phantom results showed good agreement (mean bias, 8.4%) between the two measurement methods for T1 values between 490 and 2,385 ms and T2 values between 25 and 400 ms. MAGiC® gave discordant results for T1 values below 220 ms (bias with the reference values, from 38% to 1,620%). T2 measurements were accurately estimated below 400 ms (mean bias, 8.5%) by both methods. The QA assessments are in agreement with the recommendations of imaging for contouring purposes for radiotherapy planning. On patient data of the brain and prostate, the measurements of T1 and T2 by the two quantitative MRI (qMRI) methods were comparable (max difference, <7%).ConclusionThis study shows that the accuracy, reproducibility, and repeatability of the multispectral pulse sequence (MAGiC®) were compatible with its use for radiotherapy treatment planning in a range of values corresponding to soft tissues. Even validated for brain imaging, MAGiC® could potentially be used for prostate qMRI.

Quality Prediction in Directed Energy Deposition Using Artificial Neural Networks Based on Process Signals

The Directed Energy Deposition process is used in a wide range of applications including the repair, coating or modification of existing structures and the additive manufacturing of individual parts. As the process is frequently applied in the aerospace industry, the requirements for quality assurance are extremely high. Therefore, more and more sensor systems are being implemented for process monitoring. To evaluate the generated data, suitable methods must be developed. A solution, in this context, was the application of artificial neural networks (ANNs). This article demonstrates how measurement data can be used as input data for ANNs. The measurement data were generated using a pyrometer, an emission spectrometer, a camera (Charge-Coupled Device) and a laser scanner. First, a concept for the extraction of relevant features from dynamic measurement data series was presented. The developed method was then applied to generate a data set for the quality prediction of various geometries, including weld beads, coatings and cubes. The results were compared to ANNs trained with process parameters such as laser power, scan speed and powder mass flow. It was shown that the use of measurement data provides additional value. Neural networks trained with measurement data achieve significantly higher prediction accuracy, especially for more complex geometries.

Ontario Dairy Producers’ Perceived Barriers and Motivations to the Use of Pain Control for Disbudding and Dehorning Calves: A Qualitative Study

Simple SummaryThis study aimed to understand influences on producer behaviour towards the use of pain mitigation for disbudding and dehorning. Calf comfort, post-operative performance, and better farmer experiences were common motivators for pain control use. Barriers included cost, education, and producer attitude. Quality assurance requirements for disbudding and dehorning practices were received well by participants; however, there were requests for more education surrounding the application of pain control for these procedures. Veterinarians were highly influential for participants and were mentioned as an avenue for the reduction of pain control barriers via producer education.Canadian dairy farmers are required to use a local anesthetic and analgesic prior to all disbudding and dehorning procedures. This study was done to investigate the opinions of Ontario dairy farmers on the use of pain control for disbudding and dehorning calves and their perspectives on the current requirements of the quality assurance program. Interviews were conducted with 29 dairy farmers across Ontario. All participants used a cautery iron to disbud or dehorn their calves and some form of pain control (i.e., NSAID and/or local anesthetic). Of the 29 producers that were interviewed, 22 (76%) were in compliance with the proAction requirements for pain control. Many participants felt positive about the use of pain control for these practices. Education from veterinarians was one of the most commonly listed resources to reduce barriers to pain control use by producers. A farmer’s attitude was highly referenced as an influence on producer behaviour. Although participants had positive views of pain control use, full compliance with national quality assurance requirements for disbudding and dehorning was not met by all. Producer education through veterinarians is a potential avenue to encourage the adoption of pain control use for disbudding and dehorning practices.

Analytical Quality of Glucose Measurements in Germany

The measurement quality of systems used for determination of glucose concentrations has to be sufficiently high to obtain measurement results that are reliable in a clinical context regarding the intended use (e. g., diabetes diagnosis and monitoring). The "Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen" (guideline of the German Medical Association on quality assurance in medical laboratory examinations) includes specifications on the internal and external quality assurance that are legally binding for glucose measurements in healthcare. In the opinion of the authors, however, there is room for improvement, and examples are provided. Systems for self-monitoring of blood glucose by patients do not fall under any legally binding requirements for quality assurance. With systems for continuous glucose monitoring, there are currently no technological means to regularly check measurement quality. Additionally, repeated manufacturer-independent evaluations, which could lead to improved measurement quality, are not available.

AAPM task group report 302: Surface-guided radiotherapy.

The clinical use of surface imaging has increased dramatically, with demonstrated utility for initial patient positioning, real‐time motion monitoring, and beam gating in a variety of anatomical sites. The Therapy Physics Subcommittee and the Imaging for Treatment Verification Working Group of the American Association of Physicists in Medicine commissioned Task Group 302 to review the current clinical uses of surface imaging and emerging clinical applications. The specific charge of this task group was to provide technical guidelines for clinical indications of use for general positioning, breast deep‐inspiration breath hold treatment, and frameless stereotactic radiosurgery. Additionally, the task group was charged with providing commissioning and on‐going quality assurance (QA) requirements for surface‐guided radiation therapy (SGRT) as part of a comprehensive QA program including risk assessment. Workflow considerations for other anatomic sites and for computed tomography simulation, including motion management, are also discussed. Finally, developing clinical applications, such as stereotactic body radiotherapy (SBRT) or proton radiotherapy, are presented. The recommendations made in this report, which are summarized at the end of the report, are applicable to all video‐based SGRT systems available at the time of writing.

Requirements for quality assurance from the directive REI Mining and other regulations

Abstract Many requirements for the quality assurance of the licensee and the independent measuring centre can be derived from the Directive for the “Surveillance of emission and immission of mining work” (REI Mining). However, these should be viewed within the context of “Instructions of measurement related to the surveillance of radioactivity in the environment and to the registration of radioactive emissions from nuclear installations” (MA). Further, it would be advisable to compare the REI Mining requirements to both the Directive for the “Surveillance of emission and immission from nuclear installations” (REI) as well as to the “General administration order to the integrated measuring and information system of the precautionary Radiation Protection Act” (AVV-IMIS). In this article, the various requirements are compared, their common and different aspects are discussed, and possible conclusions for the licensee, the independent measuring centre and the authority of supervision and licencing are presented.

The fundamentals of quality assurance during urodynamics

Measurement of sufficient accuracy for diagnosis to be made reliably is vital for key diagnostic tests from which treatment recommendations are derived. We describe the fundamental requirements for quality assurance in urodynamics, covering the key points for calibration, zeroing, resting pressures, live signals, transmission tests and annotation. These represent the features which must be demonstrated for all such tests.

The Challenges of the Competencies Model of Teacher Training: Examples from Chile

This paper reports on a qualitative evaluation of the conceptual coherence of current programs of teacher training in three Chilean universities. Influenced by the Bologna Accord’s emphasis on development of competencies, the national government recently called for a shift from teaching as transmission of disciplinary-based cognitive knowledge to a transdisciplinary development of cognitive and non-cognitive skills in knowledge production. The paper, based on narrative analysis, is the first assessment of how three universities have responded to the new approach. Intensive interviews with teacher training program directors asked about goals, decision criteria, and methods of assessing impact on teacher trainees. The most selective university is using formal mechanisms to validate trainees’ attainment of specified competencies. In the middle and less selective universities less attention is paid to internal validation and programs rely on informal assessment mechanisms not always consistent with quality assurance requirements. The paper concludes that all three universities are guided more by labor market demands and employability of their graduates than by educational theory or research on teaching practices.

Transitioning to Digital Systems: The Role of World Health Organization's Digital Adaptation Kits in Operationalizing Recommendations and Interoperability Standards.

The transition from paper to digital systems requires quality assurance of the underlying content and application of data standards for interoperability. The World Health Organization (WHO) developed digital adaptation kits (DAKs) as an operational and software-neutral mechanism to translate WHO guidelines into a standardized format that can be more easily incorporated into digital systems. WHO convened health program area and digital leads, reviewed existing approaches for requirements gathering, mapped to established standards, and incorporated research findings to define DAK components. For each health domain area, the DAKs distill WHO guidelines to specify the health interventions, personas, user scenarios, business process workflows, core data elements mapped to terminology codes, decision-support logic, program indicators, and functional and nonfunctional requirements. DAKs aim to catalyze quality of care and facilitate data use and interoperability as part of WHO's vision of SMART (Standards-based, Machine-readable, Adaptive, Requirements-based, and Testable) guidelines. Efforts will be needed to strengthen a collaborative approach for the uptake of DAKs within the local digital ecosystem and national health policies.

Mixed Education and Quality Standard in the University Teaching: A Theoretical Study

This study seeks to achieve the following objectives: (i) Introducing e-learning and blended learning, (ii) Introduction to university education, (iii) The study focused on the concept of total quality in education and standards and quality assurance requirements for blended learning, (iv) The study focused on highlighting the criteria for the success of blended learning and its benefits, (v) The study identified obstacles to the application of blended learning, (vi) Preparing a proposed design for the blended learning program. We adopt the descriptive-analytical method in collecting opinions, information, facts, and concepts related to the axes of the study, to build an integrated knowledge system, and to benefit from it in presenting what is referred to about the aspects related to the concept of blended learning, its application, quality assurance, success criteria, and benefits in the educational process. We hope that this study can give information for Mixed Education and Quality Standard in the University Teaching.

A Concept for Autonomous Quality Control for Core Inspection in Remanufacturing

Efforts to establish a sustainable circular economy and in particular Remanufacturing, which maintains the added value of products at a high level, are increasing. The overall Remanufacturing process is characterized by a high degree of uncertainty and therefore manual labor. This also applies to core inspection processes, which determine the condition of the returning core and allow for decisions upon its reusability and quality grade. Looking at the current state of research, it is noticeable that a systematic analysis of challenges for automation of visual core inspection and a successful implementation is missing. In this paper, complexity drivers and challenges are derived and requirements for future inspection and quality assurance in Remanufacturing are defined. The concept of autonomous visual core inspection is introduced and illustrated based on a use case. By incorporating approaches of artificial intelligence into inspection systems, handling of multidimensional uncertainty inherent in Remanufacturing may be successful using the proposed concept. Thus, automation in the present use case but also the adoption to similar use cases in Remanufacturing can be accomplished.

Analysis of Testing Methods of Large-scale Information Software

Software testing is an extremely important work link in software engineering. It runs through the entire life cycle of software engineering to ensure that software development meets requirements and can meet certain software quality requirements. With the continuous expansion of the scale of information systems, simple software testing can no longer meet the requirements of system and software quality assurance. This requires practitioners to gradually begin to think about and improve the testing methods of large-scale information software. For large-scale information software, testing will be embedded in each unit, and the software testing process will be organized in a more macroscopic way of thinking and organization. This article will summarize a series of methods suitable for large-scale information software testing through the research of software testing and the practice of the author. It is hoped that the research in this article can provide some help for the testing of large-scale information software, and also provide help for the precipitation and improvement of the author's own work.

ЗАБЕЗПЕЧЕННЯ ЯКОСТІ В НАЦІОНАЛЬНІЙ СИСТЕМІ КВАЛІФІКАЦІЙ: ПИТАННЯ СТАНДАРТИЗАЦІЇ

The article presents a study of quality assurance problems of the National Quali­fications System of Ukraine by reforming the domestic standardization system in the context of its integration into the European Qualifications System. In view of this, three components of the quality system were identified, namely, quality of standardization, quality of assessment and quality of documentation. The study is also focused on issues of legal regulation of the quality of professional and educational standards. In particular, differences in the legal regu­lation of educational standards of vocational pre-higher and higher education were identified. A certain legal uncertainty in the use of the terms "learning outcomes" and "competencies" and the inconsistency of the use of these terms with the EU Council Recom­mendations of 2017 and international and national standards were revealed. Along with this, a number of short­comings were found. Particularly, there is an unresolved problem of assigning professional qualifications to the levels of the National Qualifications Framework (NQF). The need for independent review (expertise) of projects of professional standards was emphasized. The issue of assessment standards was considered. For instance, the lack of such standards poses a threat to the quality of professional qualifications, especially qualifications of levels 2-4 of the NQF of Ukraine, since educational institutions have the right to assign such qualifications, in addition to qualification centers. Examples of corporate assessment standards, in particular, by the American Psychological Association, were considered. It is noted, that the formation of motivation of young people and employees to obtain modern and competitive skills оn the labor market is not enough. The outdated approach to personnel training by providers of educational services also needs to be reviewed. It is shown that the National Qualifications System of Ukraine requires quality assurance tools and the use of terms harmonized with EU legislation and practice.

Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India

To meet the unprecedented requirement of diagnostic testing for SARS-CoV-2, a large number of diagnostic kits were authorized by concerned authorities for diagnostic use within a short period of time during the initial phases of the ongoing pandemic. We undertook this study to evaluate the inter-test agreement and other key operational features of 5 such commercial kits that have been extensively used in India for routine diagnostic testing for COVID-19. The five commercial kits were evaluated, using a panel of positive and negative respiratory samples, considering the kit provided by National Institute of Virology, Indian Council of Medical Research (2019-nCoV Kit) as the reference. The positive panel comprised of individuals who fulfilled the 3 criteria of being clinically symptomatic, having history of contact with diagnosed cases and testing positive in the reference kit. The negative panel included both healthy and disease controls, the latter being drawn from individuals diagnosed with other respiratory viral infections. The same protocol of sample collection, same RNA extraction kit and same RT-PCR instrument were used for all the kits. Clinical samples were collected from a panel of 92 cases and 60 control patients, who fulfilled our inclusion criteria. The control group included equal number of healthy individuals and patients infected with other respiratory viruses (n = 30, in each group). We observed varying sensitivity and specificity among the evaluated kits, with LabGun COVID-19 RT-PCR kit showing the highest sensitivity and specificity (94% and 100% respectively), followed by TaqPath COVID-19 Combo and Allplex 2019-nCoV assays. The extent of inter-test agreement was not associated with viral loads of the samples. Poor correlation was observed between Ct values of the same genes amplified using different kits. Our findings reveal the presence of wide heterogeneity and sub-optimal inter-test agreement in the diagnostic performance of the evaluated kits and hint at the need of adopting stringent standards for fulfilling the quality assurance requirements of the COVID-19 diagnostic process.

Aligning Quality Assurance Requirements and Water Quality Monitoring Goals

Key TakeawaysIncreasingly rigid quality assurance/quality control (QA/QC) requirements can negatively affect protection of public health for treatment technique rules (TTRs).Hold times for chlorine and pH could be lengthened using a data quality objective (DQO) approach.Parameters that monitor process control need to be better balanced regarding the desire for more robust monitoring and the need for more defensible data.Significant conflicts arise between QA/QC requirements and water quality protection, and use of DQOs could help realign TTR method with purpose.

Molecular Fingerprinting and Hybridity Authentication in Cowpea Using Single Nucleotide Polymorphism Based Kompetitive Allele-Specific PCR Assay.

Optimization of a breeding program for increased genetic gain requires quality assurance (QA) and quality control (QC) at key phases of the breeding process. One vital phase in a breeding program that requires QC and QA is the choice of parents and successful hybridizations to combine parental attributes and create variations. The objective of this study was to determine parental diversity and confirm hybridity of cowpea F1 progenies using KASP (Kompetitive Allele-Specific PCR)-based single nucleotide polymorphism (SNP) markers. A total of 1,436 F1 plants were derived from crossing 220 cowpea breeding lines and landraces to 2 elite sister lines IT99K-573-1-1 and IT99K-573-2-1 as male parents, constituting 225 cross combinations. The progenies and the parents were genotyped with 17 QC SNP markers via high-throughput KASP genotyping assay. The QC markers differentiated the parents with mean efficiency of 37.90% and a range of 3.4–82.8%, revealing unique fingerprints of the parents. Neighbor-Joining cladogram divided the 222 parents into 3 clusters. Genetic distances between parents ranged from 0 to 3.74 with a mean of 2.41. Principal component analysis (PCA) depicted a considerable overlap between parents and F1 progenies with more scatters among parents than the F1s. The differentiation among parents and F1s was best contributed to by 82% of the markers. As expected, parents and F1s showed a significant contrast in proportion of heterozygous individuals, with mean values of 0.02 and 0.32, respectively. KASP markers detected true hybridity with 100% success rate in 72% of the populations. Overall, 79% of the putative F1 plants were true hybrids, 14% were selfed plants, and 7% were undetermined due to missing data and lack of marker polymorphism between parents. The study demonstrated an effective application of KASP-based SNP assay in fingerprinting, confirmation of hybridity, and early detection of false F1 plants. The results further uncovered the need to deploy markers as a QC step in a breeding program.

A Diamond-Based Dose-per-Pulse X-ray Detector for Radiation Therapy

One of the goals of modern dynamic radiotherapy treatments is to deliver high-dose values in the shortest irradiation time possible. In such a context, fast X-ray detectors and reliable front-end readout electronics for beam diagnostics are crucial to meet the necessary quality assurance requirements of care plans. This work describes a diamond-based detection system able to acquire and process the dose delivered by every single pulse sourced by a linear accelerator (LINAC) generating 6-MV X-ray beams. The proposed system is able to measure the intensity of X-ray pulses in a limited integration period around each pulse, thus reducing the inaccuracy induced by unnecessarily long acquisition times. Detector sensitivity under 6-MV X-photons in the 0.1–10 Gy dose range was measured to be 302.2 nC/Gy at a bias voltage of 10 V. Pulse-by-pulse measurements returned a charge-per-pulse value of 84.68 pC, in excellent agreement with the value estimated (but not directly measured) with a commercial electrometer operating in a continuous integration mode. Significantly, by intrinsically holding the acquired signal, the proposed system enables signal processing even in the millisecond period between two consecutive pulses, thus allowing for effective real-time dose-per-pulse monitoring.