P-O10 Mortality and Morbidity Reporting Quality

Background Mortality and morbidity (M&M) meetings in surgery are an important quality assurance process. These meetings contribute to learning, education and improvements in patient care. In order to achieve these outcomes effectively, M&M meeting require robust structure and process including accurate documentation of complications. Our hepato-pancreatico-biliary (HPB) unit conducts and records weekly M&M meetings based on consultant reported complications. However as there was no standardized documentation method of complications there was possible under-reporting. This realisation acted as a basis to investigate the robustness of our current reporting methodology of surgical complications and recommend changes in practice to achieve quality improvement. Methods Patients were selected retrospectively (May 20 - Sep 20) from M&M recording excel sheet which is maintained through our weekly meetings. Patient undergoing major HPB cancer resections were included. Day case procedures were excluded. Complications reported on excel sheet were compared against any additional mis-reported complications through review of online discharge letters, discharge summaries & investigations. The primary aim of this quality improvement project was to identify mis-reported complications. The secondary aims were to compare any change in Comprehensive complication Index (CCI) following addition of mis-reported complications. Results Total number of patients included in the study were n = 46. Postoperative surgical complications were recorded for n = 27 patients. 19 patients were identified to have unreported complications. Total number of unreported complications were 34. This amounted to average unreported complication per case at 1.78. Average CCI score was 14.4 before inclusion of unreported complications. There was a significant rise in average CCI score to 35.8; an increase of 21.6 CCI score after inclusion of unreported complications. Conclusions Unreported complications following major HPB cancer resection impact the quality of learning and education process in M&M meetings. It is essential to make complications reporting a robust process to prevent mis-reporting. We recommended use of Clavein-Dindo complications grading form as part of surgical clerking. This would help real time recording of surgical complications during postoperative journey of patients, help capture even minor complications. It would also be recommended to get these forms countersigned by responsible consultants before discharge of patients.

RF signal calibration for improvement of 3D mapping image to locate moisture distribution in rice silo

Grain storage is an important part of the post-harvest quality assurance process. The moisture level of the grains during storage is one of the primary problems. The current method of measuring rice grain moisture content is based on random sampling, which is relatively localised, and there is no real-time moisture content measurement available. The RF signal was used to build a new technique for detecting moisture and its presence in rice in real-time in this paper. The mapping of an RF signal, in particular, can be transformed into volumetric tomographic images that can be used to forecast moisture distribution.

Good surgical practice

This chapter discusses the duties of a doctor, which are outlined in the General Medical Council (GMC)’s Good medical practice. These have been adapted by the Royal College of Surgeons of England for surgical practice. The four domains of good medical practice include: knowledge, skills, and performance; safety and quality; communication, partnership, and teamwork; and maintaining trust. Clinical governance is a quality assurance process through which a health service is accountable for maintaining and improving the quality of care. In practice, it involves setting standards, performance monitoring, and reporting medical errors and is commonly said to be held up by ‘seven pillars’: clinical effectiveness; audit; risk management; education and training; patient and public involvement; using information and information technology; and staffing and staff management. The chapter then looks at the legal aspects concerning informed consent for a surgical procedure and end-of-life issues. It also outlines the principles of good prescribing in surgery.

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).