Quality Management Guidelines Research Articles

Guidelines for quality control and management of death cases in medical institutions (2023)

The report of death cases is an important source of information for cause analysis and monitoring of trends, which can reflect the death situation and characteristics of a population in a relatively accurate manner. It helps understand the health status of the population and the level of healthcare. The special deployment of case review for in-hospital deaths is not only the high priority for health authorities in terms of quality and safety of medical care but also a practical implementation of the concept that values people and life. Currently, there is a lack of scientific and standardized evaluation for the review of death cases in various specialties, excluding maternal and neonatal cases. To standardize the quality control and management of death cases in medical institutions, the Guidelines for quality control and management of death cases in medical institutions (2023) has been developed by the Hunan Province Resuscitation Quality Control Center. The members of the working group of this guideline visited medical institutions, conducted research, reviewed relevant guidelines from domestic and international sources, and integrated clinical experience to form a preliminary consensus. This consensus was submitted to the expert group for multiple discussions, underwent several revisions, and finally, it was sent to the experts in the form of a questionnaire for feedback. The guidelines clarify the scope, data collection, and quality control requirements for death case quality control, providing a reference for the quality control and management of death cases in medical institutions.

Developing a mapping procedure for urban forests using online map services and Sentinel-2A images

Accurate area statistics at the local government level are important for the scientific management of urban forests. A more consistent and robust mapping of urban forests can enable a comparison of the size and quality management guidelines at major cities in Asia. However, few administrative statistics have employed these scientific techniques. Therefore, a cover map of urban forests focusing on their types is needed for the quantitative and qualitative estimation and evaluation of urban forests. This study presents an approach for mapping urban forest cover for 2021 using Sentinel remote sensing images and aerial photographs from commercial maps. Cover maps of urban forests at a city scale were developed for three pilot study areas in Korea’s capital area. Labeling was performed for deciduous forests, coniferous forests, grasslands, wetlands, bare land, croplands, urban areas, and water bodies. The land cover classification was performed using machine learning models, including random forest (RF), support vector machines (SVM), and gradient tree boost classifier (GBT), and a comparison was made among them. All three methods performed well in the three study areas; the RF model was simple to use, and the SVM was better at detecting forest connections. The proposed mapping method, which focuses on forest types in cities, can be used to compare the area and connection of urban forests in cities.

Proposal to Improve the E-Commerce Platform Development Process with an Exploratory Case Study in Chile

Electronic commerce (e-commerce) is the buying and selling of goods and/or services over the internet. In recent years, e-commerce has experienced tremendous growth due to the popularity of and access to the internet throughout the world. Many companies have seen an opportunity in this market, starting to offer their products and/or services online. However, developing electronic commerce platforms can be complex and requires technical skills and specialized knowledge, which has become a problem due to the need to comply with the standards and requirements of customers who request to join these channels. Microenterprises in particular often need more resources and experience building e-commerce platforms. This is an exploratory case study, the objective of which is to design a proposal to improve an e-commerce platform development process for a computer enterprise from Valdivia, Chile, based on the international standard ISO 10008. Therefore, a solution is proposed for microenterprises to standardize their processes and improve their competitiveness in an increasingly demanding market, incorporating a methodology based on a review of quality management and customer satisfaction guidelines for e-commerce that allow the identification of internal and external failures, to prevent problems and achieve acceptable results. The proposal includes suggestions on how to improve the user experience on platforms, make the purchase and payment process more efficient, develop a support section for the computer microenterprise, and improve the security and privacy of customer data. The study of this quality regulation is one of the first at the national level, paving the way for developing proposals for other microenterprises in the country and, in turn, for the study and implementation of guidelines for business-to-consumer electronic commerce transactions (B2C ETC).

Analysis of Factors Influencing Indoor PM2.5 and CO2 Concentrations in Households using IoT Technology after Indoor Garden Installation

Background and objective: Plants are a natural and environmentally friendly way to improve indoor air quality. To evaluate indoor air quality, it is important to continuously measure and identify the influencing factors. This study aimed to identify the factors affecting PM<sub>2.5</sub> concentration in indoor spaces with indoor garden installations.Methods: Factors influencing the concentration of indoor, airborne PM<sub>2.5</sub> were monitored based on Internet of Things (IoT) technology. Ten households in South Korea were surveyed and categorized into Groups A (households without an indoor garden) and B (households with an indoor garden). An IoT-based device was used to monitor the indoor PM<sub>2.5</sub> concentration and several environmental factors, including the outdoor PM<sub>2.5</sub> (µg⋅m<sup>-3</sup>) and carbon dioxide (mL⋅m<sup>-3</sup>) concentrations, temperature (°C), and relative humidity (%). Further, the seasonal (spring, summer, fall, and winter) and temporal (dawn, morning, afternoon, and evening) variations in indoor PM<sub>2.5</sub> concentration were monitored.Results: The indoor PM<sub>2.5</sub> concentration decreased from 17.7 µg⋅m<sup>-3</sup> to 16.7 µg⋅m<sup>-3</sup>, and from 15.5 µg⋅m<sup>-3</sup> to 12.5 µg⋅m<sup>-3</sup> in Groups A and B, respectively. A regression analysis showed that the indoor PM<sub>2.5</sub> concentration was not significantly affected by the installation of the indoor garden (living rooms: <i>p</i> = .1577; kitchen: <i>p</i> = .4974); however, was influenced by the outdoor air conditions, as well as seasonal and temporal factors. Additionally, a subgrouping model demonstrated a statistical relationship between indoor garden installation and the environmental factors.Conclusion: These findings can assist in establishing guidelines for indoor air quality management.

Evaluation of the Application of Quality Management Systems in Projects Quality Management Guidelines According to the Specification ISO 10006:2017: A Case Study in the Department of Engineering Construction

The research aims, to identify the level of application of the quality management system in projects by ISO10006:2017, and to determine the size of the gap, between the actual reality and project operations within the seventh requirement of the specification, to achieve sustainable development. The case study method was adopted, and the reality of the application of the quality management system in projects was diagnosed. In the residential complex of Sumo Oil. The sample of the research. The data and information collection were mainly based on the checklist. Which included seven axes to evaluate the application of the quality management system in projects. A set of statistical methods were adopted, including (weighted arithmetic mean, percentage measurement, and gap size measurement). The research reached a set of important results, about the reality of the application of the system Quality management in projects. The most important of which was that the level of actual application of the seventh requirement of the specification in the surveyed department, was 94%, and the size of a gap of 6% was distributed among the procurement processes and operations related to risks and time, The value added value is to link the achievement of the seventh item requirements of the standard to achieve the dimensions of sustainable development.

Audit and Accreditation of ART Facilities in Japan; JISART’s Commitment Focusing on Quality Management Systems (QMS) and Patient Satisfaction

In Japan in 2018, 247,402 cycles of oocyte retrieval were performed at 592 facilities and 56,979 ART babies were born. 1 in 16 new births were as a result of ART. There is presently no law regulating ART and each facility operates under a system of self-regulation based on the requirements of the Japan Society of Obstetrics and Gynaecology. In 2000, systems for staffing, quality and safety management were not clearly structured. JISART (The Japanese Institution for Standardizing Assisted Reproductive Technology) was set up in 2003 with a view to improving quality of treatment and patient satisfaction. It is comprised of 31 private clinics with over 500 annual oocyte retrievals and all members are ISO9001 certified. With the Reproductive Technology Accreditation Committee playing a central role, a Code of Practice, guidelines for quality and safety management in ART, and audit checklists have been created. Specialist physicians, embryologists, nurses, administration staff and a patient support group conduct audits triennially, covering some 245 points. With respect to physicians, the audits look at whether there are systems in place for patient examinations and professional development, and at treatment outcomes and risk management. For embryologists and nurses, they examine qualifications, knowledge and technique along with records of equipment inspections and consent forms. Further, patients are interviewed to ascertain their satisfaction with and suggested areas for improvement to facilities and personnel. In Japan, the situation regarding ART is undergoing great changes, with audits having changed from on-site to online due to the COVID-19 pandemic and the government considering whether ART should be covered by national health insurance. In the conference, I will talk about the current situation regarding audits and suggest issues for further consideration.

Distinct vulnerability to oxidative stress determines the ammonia sensitivity of crayfish (Procambarus clarkii) at different developmental stages

Red swamp crayfish (Procambarus clarkii) has increasingly become a high-value freshwater product in China. During the intensive cultivation, excessive ammonia exposure is an important lethal factor of crayfish. We investigated the toxic effects and mechanisms of ammonia on crayfish at two different developmental stages. A preliminary ammonia stress test showed a 96-h LC50 of 135.10 mg/L and 299.61 mg/L for Stage_1 crayfish (8.47 ± 1.68 g) and Stage_2 crayfish (18.33 ± 2.41 g), respectively. During a prolonged ammonia exposure (up to 96 h), serum acid phosphatase and alkaline phosphatase showed a time-dependent decrease. Histological assessment indicated the degree of hepatopancreatic injury, which was mainly characterized as tubule lumen dilatation, degenerated tubule, vacuolization and dissolved hepatic epithelial cell, increased with exposure time. Enhanced malondialdehyde level and reduced antioxidant capacity of hepatopancreas were also observed. The mRNA expression and activity of catalase and superoxide dismutase showed an initial up-regulation within 24 h, and then gradually down-regulated with the exposure time. In the post-treatment recovery period, the Stage_2 crayfish exerted a stronger antioxidant and detoxification capacity than that of the Stage_1 crayfish, and thus quickly recovered from the ammonia exposure. Our findings provide a further understanding of the adverse effects of ammonia stress and suggest guidelines for water quality management during crayfish farming.

The guidelines of the Federal Joint Committee on acute pain management : Background and consequences for the practice in hospitals

The quality of postoperative pain therapy in Germany shows a heterogeneous treatment practice and large differences in quality between individual institutions, The patient representatives in the Federal Joint Committee (G-BA) have therefore decisively campaigned for many years that instruments of non-legislative standards are employed in order to noticeably improve the quality of perioperative pain therapy for patients in Germany. As a result of these efforts, in October 2020 a binding specification for internal quality management was included in the quality management guidelines (QM-RL) by the G‑BA. This describes in concrete terms the structural and procedural requirements for an internal quality management of acute pain for all institutions in which operations and comparable potentially painful interventions are carried out. This article describes the content of this regulation and the resulting consequences for the institutions, the medical and administrative management and especially the role of anesthesia.

The effect of a mobile-learning curriculum on improving compliance to quality management guidelines for HIV rapid testing services in rural primary healthcare clinics, KwaZulu-Natal, South Africa: a quasi-experimental study

BackgroundDespite significant achievements made towards HIV testing, linkage to antiretroviral therapy treatment and viral load suppression, the Sub-Saharan region of Africa continues to be reported to have the highest prevalence of HIV/AIDS, with over 26 million people living with the disease. In light of the added burden on already overwhelmed health systems due to the Covid-19 pandemic, maintaining the reliability and accuracy of point-of-care diagnostics (POC) results is crucial to ensure the sustainability of quality service delivery. The integration of technology-based interventions into nurse education curricula is growing, to help prepare students for the current practice environment which requires access to large amounts of information. The aim of this study was to determine the effect of a Mobile Learning (mLearning) Curriculum on improving the quality of HIV rapid testing services in rural clinics of KwaZulu-Natal (KZN), South Africa.MethodsTo achieve the aim of this study, pre-test and post-test audits were conducted in a quasi-experimental design. Eleven clinics of KZN, with the highest availability and usage of POC diagnostics were selected from a cross-sectional study survey to constitute the sample of this study. The World Health Organization On-site Monitoring Checklist-Assessment of Quality System was adapted and used as an audit tool to evaluate four key quality components. The effect of the mLearning curriculum on HIV testing quality improvement was determined through statistically comparing pre-audit and post-audit results. The independent samples t-test and the Levene’s test were employed to evaluate the equality of measured variables for the two groups. The relationships between variables were estimated using the Pearson pair wise correlation coefficient (p) and correlations were reported as significant at p < 0.05.ResultsA total of 11 clinics was audited at the pretest and 7 clinics were audited post-piloting of the mLearning curriculum. The estimated level of compliance of the participating clinics to quality HIV rapid testing guidelines ranged between poor and moderate quality. The mLearning curriculum was shown to have no statistically significant effect on the quality of POC diagnostic services provided in rural clinics of KZN.ConclusionThe mLearning curriculum was shown to have no statistically significant effect on the quality of HIV rapid testing services provided in participating clinics; however, multiple barriers to the full adoption of the piloted curriculum were identified. The provision of reliable technology devices and improved internet connection were recommended to enhance the adoption of technology-based interventions necessary to improve access to relevant learning material and updated information.

Chronic Exposure to Sublethal Concentrations of Aquatic Nitrite Change Nose and Gut Morphology and Associated Microbiomes in Channel Catfish

Nitrite is a common pollutant that can enter waterways via agricultural runoff or build up in aquaculture ponds when nitrogenous waste is converted to nitrite. Preliminary studies by the Huertas lab found that exposure to sublethal concentrations of aquatic nitrite alters the microbiome of goldfish and bioaccumulates in the olfactory epithelia, gills and brain. These studies also showed a negative impact on the olfactory tissue of exposed fish, which could lead to higher susceptibility to nasal pathogens. Our objective is to assess nitrite bioaccumulation in tissues and the alteration of the microbiome in the key aquaculture species channel catfish (Ictalurus punctatus). We hypothesize that the relative abundance and diversity of bacteria in the nose and gut microbiomes of channel catfish will be altered due to elevated nitrite exposure and that nitrite will bioaccumulate in tissues.Channel catfish were exposed to 0 mM (control), 0.2 mM, and 2 mM concentrations of nitrite. A total of six 500 liter tanks were used in a two‐phase experiment. For phase one, 16 fish per tank were placed into three 0 mM nitrite tanks and three 2 mM nitrite tanks. The 2 mM fish were kept for 12 hours before sampling. For phase two, 24 of the phase one control fish were placed into three 0.2 mM tanks and the remaining 24 control fish were left in the three control tanks for a total of 8 fish per tank. Phase two lasted 30 days with sub‐samplings at day five and 30. All fish were sampled for nose, gut, muscle, gill, brain, blood, liver, and kidney tissues for biochemical, microbial, or histological analysis. Upon dissection, fish from the 2 mM tanks exhibited marked methemoglobinemia due to nitrite‐induced oxidation of hemoglobin. The mortality rates were 0.04%, 0.08%, and 92% for the control, 0.2 mM, and 2 mM treatments respectively. The nose and gut microbiomes will be sequenced using whole genome shotgun sequencing to determine the microbial composition and measure changes in relative abundance. Histological analysis showed oxidative damage in all tissues from individuals exposed to 2 mM and partial damage in tissues of the 0.2 mM treatment.Because the microbiome is a powerful barrier against pathogens, disruption of the microbiome could lead to higher rates of disease infection and transmission in fish. Alteration of the nasal microbiome may increase mortality from the bacteria that cause septicemia in catfish, Edwardsiella ictaluri, whose common routes of infection are the nose or gut. Changes to the microbiome could be the missing link between nitrite and increased susceptibility to E. ictaluri infections in intensive farming. In the long term, this research aims to provide guidelines for water quality management in order to decrease the rate of bacterial infection and transmission in aquaculture systems.

Evaluation of the performance measurement of construction project by the Bureau of Public Procurement (BPP) in Anambra State, Nigeria

The study evaluates the performance measurement of construction project by Bureau of Public Procurement (BPP) in Awka-South Local Government Area of Anambra State. A survey design was adopted for the study. Two research questions and two hypotheses guided the study. The population of the study comprised 180 construction professionals. The sample was made up of 124 construction professionals selected through simple random sampling technique. The questionnaire containing 30 items was used to collect data, and the data collected were analyzed using mean, standard deviation and T-test. The findings of the study revealed that the impact of evaluation by BPP on construction projects include contractors’ tendency to: do the right job the first time, complete work on time, identify problems and deficiencies, provide adequate training to employees, minimize interruptions of operations, use high quality materials, works as team players and provide correct documentation and invoices. The recommendations were made. One of the recommendations is that the construction industry should provide quality management guidelines and should be enforced by the consultants on projects. Stakeholders should be committed to quality management and adequate motivation should be given to workers.

Quality assessment of cold chain storage facilities for regulatory and quality management compliance in a developing country context.

Supply chain management is essential for cold chain medicines since they are temperature-controlled and must be maintained within a specific temperature range to ensure product integrity and quality. In Nigeria, guidelines that address drug distribution do not adequately address the issue of cold chain management in addition to challenges in implementation. Given the chaotic medicines distribution system, this study examined the quality of practice of supply chain management of cold chain products in line with the World Health Organisation's Expert Committee report on Specifications for Pharmaceutical Preparations. The study was set in Abuja Nigeria and descriptive survey was used to explore cold chain supply management. A checklist developed from regulatory requirements stipulated by the World Health Organisation covering documentations, storage and distribution guidelines was used to assess supply chain management of cold chain medicines across various facilities. Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 25. The results from this study showed that most of the storage facilities assessed (66.7%) did not meet up to the required standards of quality management for cold chain products. In addition, 50.4% of retail and hospital pharmacy facilities performed poorly in cold chain management practices. Many of aspects of quality management guidelines and regulations were not met by the facilities. Most facilities (66.7%) do not have their equipment calibrated, 43.6% of the hospital and retail pharmacies assessed do not have an automated system to cater for power failure while 37.6% do not perform a temperature check on cold chain products before receiving from suppliers. The study has shown that the levels of the supply chain assessed for quality management and regulatory compliance performed poorly. There was limited availability and use of validated quality monitoring systems for cold chain medicines in these facilities.

Quality of the ISO 9000 series of standards-perceptions of quality management experts

PurposeThe authors of this study, who adopted a holistic view of the international organization for standardization (ISO) 9000 series of standards, aimed to evaluate the current status of the standards within the framework of the quality movement. Specifically, the evaluation covered two dimensions, i.e. the significance of the content included in the standards and the quality of the standards’ elaboration, which encompasses such issues as, for instance, their correctness, relevance to current trends in quality management, comprehensibility, etc.Design/methodology/approachThe paper is based on a review of the scientific literature, analysis of the current and all previous versions of the international standards and the results of a survey, through which data were collected from 73 quality management experts from 17 different countries. To evaluate the results, an importance-performance analysis was performed.FindingsAs the results of the research demonstrated, experts in quality management have accepted the ISO 9000 standards series. However, this positive view refers mainly to the very idea of developing quality management standards and these standard’s content structure (components included in them). Study participants assigned a low rating to the quality of the standards’ elaboration. Therefore, improving the following aspects of the standards is essential: definitions, guidelines explaining the requirements for a quality management system, self-assessment tools and guidelines concerning quality management concerning chosen forms of activity.Research limitations/implicationsThe research described here in has both practical and social implications. First, it delineates the direction needed to improve standardizations, whose use need not be strictly limited to quality management but can be successfully used to improve the standards in other areas of management. Therefore, the conclusions of this research directly contribute to increasing both the effectiveness and the quality of the standard organizations. The significant consequences of this research for managers are the identification of ISO 9000 components which they will find are the most useful.Practical implicationsThe research described herein has both practical and social implications. First, it delineates the direction needed to improve standardizations, whose use need not be strictly limited to quality management. However, it can be successfully used to improve the standards in other areas of management. Therefore, the conclusions of this research directly contribute to increasing both the effectiveness and the quality of the standard organizations. The significant consequences of this research for managers are the identification of ISO 9000 components, which they will find are the most useful.Originality/valueMost research treats ISO 9000 standards as a benchmark for their studies on quality management systems implemented in organizations. The standards themselves are rarely the subject of a study, and so this paper fills a gap in the research and provides insights into desired directions for standards improvement.

Quality management and US regulatory auditing guidelines for medical device manufacturers

Quality management and US regulatory auditing guidelines for medical device manufacturers

Comparison of the guidelines on good agricultural and collection practices in herbal medicine of the European Union, China, the WHO, and the United States of America

Owing to modern developments in the traditional medicine industry, more people now acknowledge the efficacy of traditional medicine. As the demand for herbal medicines gradually increases, the focus of the industry will shift to how to increase production while maintaining the high quality of raw materials and final products to promote the international trade in herbal medicines. In the long history of herbal medicine, many countries and regions have formulated relevant standards to regulate the cultivation of local herbs to ensure the safety and reliability of the products. Due to cultural and historical differences, the policies for formulating herbal cultivation standards vary greatly between regions, which hinders the international trade of herbal medicines. This paper collates the guidelines of good agricultural and collection practices of the European Union, China, World Health Organization and the United States, and makes a comprehensive comparison of its contents such as production environments, production area suitability, air, soil, and water standard regulations, inter alia. This article aims to explore the differences in good agriculture and collection practice in herbal medicine in various regions and provides a reference for the development of international guidelines for herbal quality management, which will aid with the development of herbal medicine quality standardization globally and exchange services in the trade of herbal medicines.

Dermatoses among patients aged 60 years and above attending a tertiary referral center: A cross-sectional study from North Kerala

Objectives: With the rise in life expectancy at birth, geriatric population contributes to a significant proportion of those seeking medical aid. Skin problems in the elderly are very common and vary according to region and ethnicity. It is essential for dermatologists to have a better understanding of the pathophysiology of geriatric skin disorders to formulate quality management guidelines. This study was undertaken to document the frequency and the clinical pattern of various physiological and pathological changes in the elderly skin. Materials and Methods: A cross-sectional study was carried out in 200 consecutive patients aged 60 years and above and who attended the Dermatology outpatient clinic of a tertiary referral center in North Kerala. A pre-set pro forma was used to document the patient characteristics, the comorbidities, the medications used, and the clinical findings. Results: All the study participants (100%) had one or more dermatoses. The age of the study population ranged from 60 to 89 years (mean 67.7 ± 6.2 years). This was a female preponderant study with a female to male ratio of 1.4:1. Hypertension (36%), hyperlipidemia (27%) and diabetes mellitus (26%) were the common comorbidities observed. Graying of hair was the most common physiological change, followed by wrinkling. Pruritus was the most common presenting complaint (136, 68%). Statistically significant association was noted between xerosis and generalized pruritus. Fungal infections (30.5%) outnumbered other infections and infestations. Changes of severe photoaging were less frequent. One patient had skin malignancy (basal cell carcinoma). Significant association was noted between photoaging and male sex, smoking, and sun exposure. Limitations: Study conducted in a tertiary referral center not reflecting the status in the community was the major limitation. Conclusion: Photoaging and skin cancers are less frequent in darker skin type. Healthy lifestyle, nutritious diet, frequent application of emollient, better skin care, and judicious use of sunscreen can delay the process of cutaneous aging. More prospective studies in different population groups may go a long way in improving the current knowledge about the less known aspects of geriatric dermatoses.

Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

BackgroundLimited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems.MethodsAn exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance.ResultsPolicy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.ConclusionsThe EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

Practicing Results Based Management for Enhancement of Quality and Performance of Social Development and Humanitarian Programmes

The theme of this paper is centred on the application of Results Based Management (RBM) as a tool to achieve high quality management standards and enhance performance. It is originated from the ‘Theory of Change’ which is pursued globally to reap investment benefits. Whereas the corporate sector utilizes tools like the ISO 9000 series and Total Quality Management (TQM) guidelines, the Not for Profit (NPO) sector has developed its own quality approaches by trial and error. One of the much appreciated methodologies among United Nations (UN) agencies and NPOs is the concept and practice of Results Based Management (RBM). Since its adoption by the UN system in 1997, RBM is known as the ‘Gold Standard' among its practitioners. This particular perspective has neither been debated in the Quality Management context nor in RBM literature. However, due to successful and continued adherence to RBM practice by the UN agencies and member states in planning, monitoring and evaluation of development programmes including the Millennium Development Goals (MDGs) and its successor agenda of Sustainable Development Goals (SDGs), it has become imperative to discuss the RBM role in Quality Management. Overall it is partly a description of this extraordinary management concept and practice and partly a fusion of experiences of the authors in the UN agencies and NPO sector.

Quality Control of Next-Generation Sequencing-Based HIV-1 Drug Resistance Data in Clinical Laboratory Information Systems Framework.

Next-generation sequencing (NGS) in HIV drug resistance (HIVDR) testing has the potential to improve both clinical and public health settings, however it challenges the normal operations of quality management systems to be more flexible due to its complexity, massive data generation, and rapidly evolving protocols. While guidelines for quality management in NGS data have previously been outlined, little guidance has been implemented for NGS-based HIVDR testing. This document summarizes quality control procedures for NGS-based HIVDR testing laboratories using a laboratory information systems (LIS) framework. Here, we focus in particular on the quality control measures applied on the final sequencing product aligned with the recommendations from the World Health Organization HIV Drug Resistance Laboratory Network.

Designing a Regional Economic Security System

The need for design of a regional economic security system is determined by high external dependence of the Russian economy and by absence of firm levers influencing international means of interaction. Low social and economic indexes of Russia in relation to extreme critical values indicate unsatisfactory state of its economic security. In accordance with the Strategy of economic security of the Russian Federation until 2030 determination of national security threats and identification of the key indicators becomes a necessary attribute of the Russian economics. The present article reveals the mechanism of a regional economic security system development including stages of economic indexes dynamics analysis and building an IDF0 model. Design is based on the international standards of quality management for design (ISO 10006:2017 Quality management systems – Guidelines for quality management in projects) and on requirements to a quality management system (ISO 9001:2015 Quality management systems – Requirements). Complex analysis is associated with assessment of accession rates normalized importance including building of a neural network and carrying out cluster analysis. Complex analysis of accession rates of the Russian region economic indexes using SPSS Statistics software resulted in identification of the determining factors for clustering. In order to improve stability of a regional economic security system all the processes are synchronized in the optimal mode, verified and validated to provide consistency of output data and input parameters. There are options to change significant relations with processes and stages of a regional economic security system design in order to adjust IDF0 model of a regional economic security system.