Dosimetry audit of the CyberKnife accelerator with the SHANE phantom

Introduction: The aim of this study was to propose a dosimetric audit of the CyberKnife system. Dosimetry audit is an important part of the quality assurance process in radiotherapy. Most of the proposed dosimetric audits are dedicated to classical medical accelerators. Currently, there is no commonly implemented scheme for conducting a dosimetric audit of the CyberKnife accelerator. Material and methods: To verify the dosimetric and geometric parameters of the entire radiotherapy process, as is required in E2E test procedure, the CIRS SHANE anthropomorphic phantom was used. A tomography with a resolution of 1.5 mm was prepared, five PTVs (Planning Target Volume) of different volumes were drawn; approximately: 88 cm3, 44 cm3, 15 cm3, 7 cm3, 1.5 cm3. Five treatment plans were made using the 6D Skull tracking method, FIXED collimators, RayTracing algorithm. Each treatment plan was verified in a slab Phantom, with a PinPoint chamber. The dose was measured by an ionization chamber type TM31010 Semiflex, placed in the center area of the target. Results: The result of the QA verification in slab phantom was up to 5,0%. The percentage difference for the measurement in the SHANE phantom was: 4.29%, -1.42%, -0.70%, 1.37%, -1.88% respectively for the targets: 88 cm3, 44 cm3, 15 cm3, 7 cm3, 1.5 cm3. Conclusions: By analyzing various approaches to small-field dosimetry audits in the literature, it can be assumed that the proposed CyberKnife dosimetric audit using the SHANE phantom is an appropriate method of verification of the radiotherapy process. Particular attention should be paid to the target volume, adjusting it to the system capabilities.

Fun and Easy Georeferencing with a New Online Tool from South Africa

A new online tool for georeferencing specimen records has been developed through the Natural Science Collections Facility (NSCF) in South Africa to address the need for rapid, high quality georeferencing of specimen collections in the region (Fig. 1). A dataset of specimen records with Darwin Core fields dwc:scientificName, dwc:country, optional dwc:stateProvince, dwc:locality or dwc:verbatimLocality, optional dwc:recordedBy, and a record identifier such as dwc:occurrenceID (see dwc.tdwg.org/terms for definitions) is first uploaded into the tool and a team of georeferencers then work to georeference the dataset. Fuzzy string matching is used to group similar locality strings and to search for potential matching georeferences from a georeference database. The tool aims to improve efficiency by storing georeferenced localities so that they can be reused when the same locality is encountered again in other datasets. Thus, a locality only needs to be georeferenced once, and that georeference is reused for any other permutations of that locality string. A georeference includes the most important metadata from the Darwin Core standard: a measure of uncertainty, dwc:georeferenceDate, dwc:georeferencedBy, dwc:georeferenceProtocol, dwc:georeferenceSources, and the all too often neglected dwc:geodeticDatum. dwc:georeferencedByID is included for recording the ORCID iD of the georeferencer to facilitate attribution further down the data publication pipeline. In theory, the process of georeferencing should become more efficient with time as the georeference database grows. The georeferencing process is gamified by showing each georeferencer their own numbers of georeferenced records as they work, and they can see activity of fellow georeferencers as the dataset statistics update in real time. Dataset owners can also see overall progress with the dataset and numbers of records georeferenced by each team member, which may be useful for management purposes. Once a dataset is completed, it is downloaded with the new georeferences so these can be incorporated back into the original source database. Within the landscape of currently available georeferencing tools the system presented here is specifically placed to facilitate the management of the georeferencing process for a dataset by a team of georeferencers. The georeferencing workflow still requires a full suite of tools for finding coordinates for localities, such as a GIS, gazetteers and online resources, as well as a specific georeferencing protocol. It essentially replaces the use of spreadsheets for doing georeferencing, or doing georeferences directly in a collection database, which can be inefficient. Related to this, it includes a quality assurance process whereby georeferences are checked for correctness and adherence to the protocol being used, and for identifying geographic and environmental outliers for each species within the dataset. In this way the tool supports current workflows and best practices for georeferencing (e.g. Chapman and Wieczorek (2020), Zermoglio et al. (2020)). The technology stack includes Firebase as the primary database, ElasticSearch for fuzzy string matching, and the user interface is built with the modern Javascript framework Svelte. The tool has been in use by the NSCF since April 2021 after being populated with approximately 300 000 existing georeferences for southern Africa from various sources, including the South African National Biodiversity Institute (SANBI) Gazetteer and several collections databases. While initial emphasis in developing the tool has focussed on southern Africa, the tool can be extended to other regions easily. Please contact [email protected] for further information.

HPLC Tests in Quality Control under the Market Surveillance Program for Medicinal Products Containing Amlodipine and Valsartan

Background: Quality is one of the three main characteristics of medicinal products. The quality assurance process is multi-stage: during the manufacturing, quality control is the commitment of the manufacturer, but after medicinal products become part of the distribution and pharmacy network, analytical quality control is carried out within the program for Market Surveillance. There are different approaches in conducting quality control of medicinal products under the Market Surveillance Program. Aim: The aim of the study is to compare the results obtained under two approaches: individual testing and testing by groups with the same active substance. Methods: In this study, comparative tests for assay and purity were carried out within two groups of medicinal products from the antihypertensive group containing Amlodipine besilate and Valsartan. Analyses were performed in accordance with the available pharmacopoeial monographs, as well as those from literature sources. Results: The results from the assay tests show a significant difference in the same product tested. Analytical methods for the determination of impurities also show different results when analyzing the same medicinal product. Conclusion: Considering the performed analytical tests, the obtained results can be used to make several conclusions and suggestions concerning the optimisation of the Annual Market Surveillance Program

Quality in Non-Licensed Radiopharmaceutical Products: Are We Achieving the Goal?

Radiopharmaceutical compounds, considered a special group of medicines, can be prepared outside the marketing authorisation track. Small-scale preparations at non-commercial sites thereby represent an important segment, however a lack of harmonisation in the regulation leads to extreme differences in the application and availability of radiopharmaceuticals across Europe. A number of guidelines and guidance documents have been issued by European Association of Nuclear Medicine (EAMN), Pharmaceutical inspection convention (PICs), European Directorate for the Quality of Medicines & HealthCare (EDQM) to achieve a good radiopharmacy practice for small-scale preparation. Nevertheless, in the case of non-licensed radiopharmaceuticals their consideration as magistral formulas, in some countries, makes it possible to waive regulatory inspections aimed to ensure those good practices enforcement. Moreover, special attention should be put on the quality assurance process for non-licensed starting materials, given that the final radiopharmaceuticals quality chiefly depends on it. This paper (chapter) will provide an insight into the quality standards applicable to starting materials, such as supplier qualification control, starting material re-test period, etc. in order to raise for discussion about how best to achieve a proven quality, efficacy, and safety for our radiopharmaceuticals (licensed or non-licensed).

BEST PRACTICE PENJAMINAN MUTU LULUSAN BERBASIS IASP 2020 DI SEKOLAH MENENGAH KEJURUAN

Tahun 2020, instrument akreditasi sekolah/madrasah mulai menggunakan Instrumen Akreditasi Satuan Pendidikan 2020 (IASP 2020). Dalam konteks IASP 2020, komponen mutu lulusan merupakan komponen yang memiliki bobot nilai paling tinggi dibandingkan dengan komponen lainnya. Penelitian ini bertujuan untuk mengeksplorasi proses penjaminan mutu lulusan berbasis akreditasi di Sekolah Menengah Kejuruan dengan menggunakan IASP 2020. Penelitian ini menggunakan metode penelitian studi kasus. Partisipan dalam penelitian ini ditentukan dengan metode purposive sampling, dengan kriteria: seluruh warga SMK yang telah mengalami proses penjaminan mutu lulusan dengan menggunakan IASP 2020. Jumlah partisipan dalam penelitian ini sebanyak 16 orang guru dan karyawan. Hasil penelitian menunjukan bahwa proses penjaminan mutu lulusan berbasis akreditasi dilakukan melalui program: 1) Persiapan: pemahaman IASP 2020, pembentukan tim penjamin mutu lulusan; 2) Melakukan EDS mutu lulusan berbasis IASP 2020; 3) Analisis kesenjangan antara hasil EDS dengan kondisi ideal; 4) Pemenuhan gap melalui perbaikan kinerja pada komponen mutu lulusan; 5) Evalusi program ketercapaian kinerja mutu lulusan dan tindak lanjut. Keywords: mutu lulusan; akreditasi; IASP 20203; Sekolah Menengah Kejuruan. Abstrak: In 2020, the school accreditation instrument began to use the 2020 Education Unit Accreditation Instrument (IASP 2020). In the context of the 2020 IASP, the component of graduate quality is the component that has the highest value weight compared to other components. This study aims to explore the process of quality assurance for accreditation-based graduates in Vocational High Schools using the IASP 2020. This study uses a case study research method. Participants in this study were determined by purposive sampling method, with the criteria: all SMK citizens who have undergone a graduate quality assurance process using IASP 2020. The number of participants in this study was 16 teachers and employees. The results showed that the accreditation-based graduate quality assurance process was carried out through the following programs: 1) Preparation: understanding IASP 2020, forming a graduate quality assurance team; 2) Conducting the 2020 IASP-based graduate quality EDS; 3) Gap analysis between EDS results and ideal conditions; 4) Fulfilling the gap through improving the performance of the graduate quality component; 5) Evaluation of the program for the achievement of the quality performance of graduates and the follow-up. Keywords: graduated qualities; accreditation; IASP 2020; Vocational Senior High School.

Evaluation of a collaborative model for successful implementation of a National CD4 enumeration EQA program in Cameroon

Participation in an EQA program is critical to the quality assurance process. Reliable and precise CD4 T-cells enumeration are essential to improve the clinical management of patients by evaluating the disease progression and by monitoring the effectiveness of ART in HIV-patients. The CIRCB, CD4 reference laboratory, in collaboration with the Canadian QASI-program, recruited sites, distributed and analyzed CD4-panels in 61 sites across Cameroon. A trend and performance analysis in the pre-analytical, analytical and post-analytical phases was performed. Continuous training and corrective actions carried out from 2014 to 2018 increased the number of participating sites from 15 to 61 sites, the number of unacceptable results decreased from 50 to 10%. Specific challenges included errors in pre analytic (17.5%), analytic (77.0%) and post-analytic (5.5%) phases. This EQA requires the application of good laboratory practices, fluidic communication between all the stakeholders, continuous training, application of specific on-site corrective measures, and timely equipment maintenance in order to avoid repetitive errors and to increase laboratory performance. It could be extended to other HIV-1 testing like viral load and EID point-of-care. Partnership with QASI serve as a model for implementation of a successful EQA model for resource limited countries wanting to implement EQA for HIV testing and monitoring in alignment with 90–90–90 targets.

Mechanism of the quality cost administration system

Strengthening the impact of the production and economic mechanism on increasing the economic efficiency of the production process and the quality of work is possible on the basis of choosing the most effective ways to achieve high end results of the national economic system of the country. One of these ways is the inclusion in the system of controlled parameters of the economic parameters of quality cost management, the use of which guarantees the quality coordination system to reach a given economically justified state. Adjustment of quality costs consists in maintaining the established proportions between the costs of quality assurance (quality) and the mismatch of work quality indicators, which is achieved by controlling the level of defects, maintaining certain conditions, rules and norms corresponding to the optimal mode of work on quality assurance and the optimal value costs. The quality assurance process is based on a classification represented by a range of activities aimed at ensuring the quality of tools, objects of labour, living labour and information data at all stages of the production process. The costing methodology is based on the selection of the costing object and costing units. Representation of work on quality assurance as an object of calculation, and hours of work or total amount of work as calculation units allows at the right time to present in value terms both the quality assurance process as a whole and the cost of quality for the product. The recommended mechanism of the cost management system in general is focused on a wide range of enterprises and associations, and its use allows to obtain the effect of minimizing the cost of quality, as well as improve the quality of work to ensure product quality, ice directly contribute to production efficiency and quality. Increase of economic benefit at the expense of cost control system solutions of the problem in the future is possible if its implementation on the basis of the theory of functional management development, conversion of static model into a dynamic coordination costs.