Systems Modeling of Lung Cancer Screening Programs to Improve Quality

Thesis (Master's)--University of Washington, 2016-08

Quality audit in the European higher education area. A comparison of approaches

The publication illustrates various approaches to auditing and reflects on their merit, as well as outlines the implementation of audits in different higher education systems across Europe. One focus is to show common aspects and apparent deviations concerning purpose and aim of the audit, national legislation, scope of the audit, external assessments and their effects. In addition it reflects on current and future challenges and developments. Contributions from twelve European quality assurance agencies provide an insight into their audit approaches. The publication is targeted at quality assurance agencies, higher education institutions and other stakeholders and aims to increase knowledge about different quality assurance procedures across borders. With contributions by: Kastelliz, Dietlinde; Müller Strassnig, Annina; Kohler, Alexander; Huertas, Esther; Adot, Esther; Perez de la Calle, Jose Antonio; Balboa, Esther; Danian, Rado Mircea; Sarbu, Oana; Pedersen, Lars; Moitus, Sirpa; Leetz, Friederike; Froestad, Wenche; van Galen, Stephan; Le Fort, Genevieve; McLaughlin, Maureen; Crum, Ailsa.

Product quality and compliance in the pharmaceutical industry

This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.

Equipment quality control

Mammography equipment must be evaluated to ensure that images will be of acceptable diagnostic quality with lowest radiation dose. Quality Assurance (QA) aims to provide systematic and constant improvement through a feedback mechanism to address the technical, clinical and training aspects. Quality Control (QC), in relation to mammography equipment, comprises a series of tests to determine equipment performance characteristics. The introduction of digital technologies promoted changes in QC tests and protocols and there are some tests that are specific for each manufacturer. Within each country specifi c QC tests should be compliant with regulatory requirements and guidance. Ideally, one mammography practitioner should take overarching responsibility for QC within a service, with all practitioners having responsibility for actual QC testing. All QC results must be documented to facilitate troubleshooting, internal audit and external assessment. Generally speaking, the practitioner’s role includes performing, interpreting and recording the QC tests as well as reporting any out of action limits to their service lead. They must undertake additional continuous professional development to maintain their QC competencies. They are usually supported by technicians and medical physicists; in some countries the latter are mandatory. Technicians and/or medical physicists often perform many of the tests indicated within this chapter. It is important to recognise that this chapter is an attempt to encompass the main tests performed within European countries. Specific tests related to the service that you work within must be familiarised with and adhered too.

Event-Code Interaction Directed Test Cases

The Graphical User Interface (GUI) is an integral component of contemporary computer software. A stable and reliable GUI is necessary for correct functioning of software applications. Comprehensive verification of the GUI is a routine part of most software development life-cycles. The input space of a GUI is typically large, making exhaustive verification difficult. GUI defects are often revealed by exercising parts of the GUI that interact with each other. It is challenging for a verification method to drive the GUI into states that might contain defects. In recent years, model-based methods, that target specific GUI interactions, have been developed. These methods create a formal model of the GUI’s input space from specification of the GUI, visible GUI behaviors and static analysis of the GUI’s program-code. GUIs are typically dynamic in nature, whose user-visible state is guided by underlying program-code and dynamic program-state. This research extends existing model-based GUI testing techniques by modelling interactions between the visible GUI of a GUI-based software and its underlying program-code. The new model is able to, efficiently and effectively, test the GUI in ways that were not possible using existing methods. The thesis is this: Long, useful GUI testcases can be created by examining the interactions between the GUI, of a GUI-based application, and its program-code. To explore this thesis, a model-based GUI testing approach is formulated and evaluated. In this approach, program-code level interactions between GUI event handlers will be examined, modelled and deployed for constructing long GUI testcases. These testcases are able to drive the GUI into states that were not possible using existing models. Implementation and evaluation has been conducted using GUITAR, a fully-automated, open-source GUI testing framework.

Know-cap: um método para capitalização de conhecimento no desenvolvimento de software

The intensive character in knowledge of software production and its rising demand suggest the need to establish mechanisms to properly manage the knowledge involved in order to meet the requirements of deadline, costs and quality. The knowledge capitalization is a process that involves from identification to evaluation of the knowledge produced and used. Specifically, for software development, capitalization enables easier access, minimize the loss of knowledge, reducing the learning curve, avoid repeating errors and rework. Thus, this thesis presents the know-Cap, a method developed to organize and guide the capitalization of knowledge in software development. The Know-Cap facilitates the location, preservation, value addition and updating of knowledge, in order to use it in the execution of new tasks. The method was proposed from a set of methodological procedures: literature review, systematic review and analysis of related work. The feasibility and appropriateness of Know-Cap were analyzed from an application study, conducted in a real case, and an analytical study of software development companies. The results obtained indicate the Know- Cap supports the capitalization of knowledge in software development.

The quality of rapid HIV testing in South Africa: an assessment of testers’ compliance.

Background: The aim of this study was to assess the quality of rapid HIV testing in South Africa. Method: A two-stage sampling procedure was used to select HCT sites in eight provinces of South Africa. The study employed both semi-structured interviews with HIV testers and observation of testing sessions as a means of data collection. In total, 63 HCT sites (one HIV tester per site) were included in the survey assessing qualification, training, testing practices and attitudes towards rapid tests. Quantitative data was analysed using descriptive statistics and qualitative data was content analysed. Results: Of the 63 HIV testers, 20.6% had a nursing qualification, 14.3% were professional counsellors, 58.7% were lay HIV counsellors and testers and 6.4% were from other professions. Most HIV testers (87.3%) had had a formal training in testing, which ranged between 10-14 days, while 6 (9.5%) had none. Findings revealed sub-standard practices in relation to testing. These were mainly related to non-adherence to testing algorithms, poor external quality control practices, poor handling and communication of discordant results. Conclusion: Quality of HIV rapid testing may be highly compromised through poor adherence to guidelines as observed in our study.

Ambient Air Quality Monitoring in Metropolitan City of Lagos, Nigeria

Twenty one sampling locations were assessed for carbon monoxide (CO), carbondioxide (CO2), oxygen (O2), sulphur dioxide (SO2), nitrogen dioxide (NO2), nitrogen oxide (NO), suspended particulate matter (SPM) and noise level using air pollutants measurement methods approved by ASTM for each specific parameter. All equipments and meters were all properly pre-calibrated before each usage for quality assurance. Findings of the study showed that measured levels of noise (61.4 - 101.4 dBA), NO (0.0 - 3.0 ppm), NO2 (0.0 - 3.0 ppm), CO (1.0 – 42.0 ppm) and SPM (0.14 – 4.82 ppm) in all sampling areas were quite high and above regulatory limits however there was no significant difference except in SPM (at all the sampling points), and noise, NO2 and NO (only in major traffic intersection). Air quality index (AQI) indicates that the ambient air can be described as poor for SPM, varied from good to very poor for CO, while NO and NO2 are very good except at major traffic intersection where they were both poor and very poor (D-E). The results suggest that strict and appropriate vehicle emission management, industrial air pollution control coupled with close burning management of wastes should be considered in the study area to reduce the risks associated with these pollutants.

In-vitro evaluation of the quality of Paracetamol and Co-trimoxazole tablets used in Malawi based on pharmacopoeial standards

Objectives This study was an in-vitro evaluation of different brands of paracetamol and cotrimoxazole tablets, used or found in Malawi, based on Pharmacopoeia standards, in order to ascertain the existence and extent of substandard medicines in Malawi and to give an overview of their distribution in the public and private sectors. Methodology A cross-sectional analytical study was conducted using 11 samples each of paracetamol and cotrimoxazole tablets. Stratified random sampling was used to collect samples. Samples were analyzed using HPLC and Spectrophometric methods as outlined in the BP-2007 and USP-32 at the National Drug Quality Control Laboratory (NDQCL)-Lilongwe (under Pharmacy Medicines and Poisons Board-PMPB) and Orient Pharma Co. Ltd of Taiwan. The results were analyzed using Epi Info. Results and discussion Fifty percent of samples (n=22) were not registered in the country by the PMPB as required by the PMP Act with the majority of those coming from public health facilities. All paracetamol and cotrimoxazole samples complied with identification tests using spectrophotometric and HPLC method. Overall, 27.3% of samples failed to meet the BP-2007 standards for Active Ingredient content, while 22.7% of the samples failed the Friability test. The results from Malawi are similar in magnitude to those within surrounding countries in Africa. Conclusion This pilot study provides objective evidence to show that substandard and unregistered paracetamol and cotrimoxazole are present and being used in Malawi, and thus posing a considerable hazard to public health in Malawi. PMPB, together with the Ministry of Health, must continue to develop a quality assurance system to ensure that medicines are randomly and routinely checked.

Desenvolvimento e avaliação de um sistema de cálculo de dose independente para controle de qualidade de IMRT do tipo jaws-only

Dissertação (mestrado)—Universidade de Brasília, Faculdade Gama, Programa de Pós-Graduação em Engenharia Biomédica, 2015.

Inter-professional clinical handover in post-anaesthetic care units: tools to improve quality and safety

OBJECTIVES: To examine quality and safety in inter-professional clinical handovers in Post Anaesthetic Care Units (PACUs) and make recommendations for tools to standardize handover processes.
DESIGN: Mixed methods combining data from observations and focus groups.
SETTING: Three PACUs, one public tertiary hospital and two private hospitals.
PARTICIPANTS: Observations were made of 185 patient handovers from anaesthetists to nurses. Eight focus groups were conducted with 62 staff (15 anaesthetists and 47 nurses) across the study sites.
INTERVENTION: Inter-professional clinical handovers in PACU's.
MAIN OUTCOME MEASURES: Characteristics of the structure and processes that support safe inter-professional PACU handover practice.
RESULTS: Characteristics of the process, content, activities and risks during anaesthetist to nurse patient handover into the PACU were integrated into four steps in the PACU handover process summarized by the acronym COLD (Connect, Observe, Listen and Delegate), a verbal communication tool (ISoBAR), a checklist of critical information for safe patient transfer into PACU and a matrix of factors perceived to increase handover risk.
CONCLUSIONS: The standard structure and checklists for optimal content of patient handovers were derived from existing practices and consensus, hence, expected to provide ecologically valid and practical resources to improve quality and safety during clinical handovers in the PACU.

Reporting usability defects-do reporters report what software developers need?

Reporting usability defects can be a challenging task, especially in convincing the software developers that the reported defect actually requires attention. Stronger evidence in the form of specific details is often needed. However, research to date in software defect reporting has not investigated the value of capturing different information based on defect type. We surveyed practitioners in both open source communities and industrial software organizations about their usability defect reporting practices to better understand information needs to address usability defect reporting issues. Our analysis of 147 responses show that reporters often provide observed result, expected result and steps to reproduce when describing usability defects, similar to the way other types of defects are reported. However, reporters rarely provide usability-related information. In fact, reporters ranked cause of the problem is the most difficult information to provide followed by usability principle, video recoding, UI event trace and title. Conversely, software developers consider cause of the problem as the most helpful information for them to fix usability defects. Our statistical analysis reveals a substantial gap between what reporters provide and what software developers need when fixing usability defects. We propose some remedies to resolve this gap.

Combination of product quality management and exports: The case of Colombian fruits companies

Quality management provides to companies a framework to improve quality in overall systems, reduction of costs, reallocation of resources efficiently, correct planning of strategies, prevent or correct errors in the right time and increase the performance of companies. In this text, we discuss the different theories in this field, their obligatory or non-obligatory compliance, the importance of quality management for exporting companies and a case study of a Colombian firm that its main objective is to manage quality. In conclusion, we find out that there is different types of quality management systems such as Juran’s trilogy, Deming 14 points, Six sigma, HACCP, and so on; also that companies have to manage suppliers and that quality has a positive influence on exports volume; in the case of Colombian small and medium enterprises, it can be mentioned that the majority has implemented tools regarding quality management but is not enough.