ASEBIR Quality Special Interest Group guidance for quality in assisted reproduction technology.

Assisted human reproduction has undergone rapid advances since its inception 45 years ago. To keep pace with these advances, assisted reproduction laboratories should adhere to a quality management system that addresses staffing and training, physical space and air quality, equipment maintenance and other operational matters, and ensures gamete and embryo handling in accordance with the latest quality and safety standards. Accordingly, this review aims to provide a reference document that highlights the critical aspects to consider when establishing and operating an ART laboratory. The review collates and expands upon published national and international guidelines and consensus documents, providing easier access to this large body of important information.

Staying on track - Keeping things running in a high-end scientific imaging core facility.

Modern life science research is a collaborative effort. Few research groups can single-handedly support the necessary equipment, expertise and personnel needed for the ever-expanding portfolio of technologies that are required across multiple disciplines in today's life science endeavours. Thus, research institutes are increasingly setting up scientific core facilities to provide access and specialised support for cutting-edge technologies. Maintaining the momentum needed to carry out leading research while ensuring high-quality daily operations is an ongoing challenge, regardless of the resources allocated to establish such facilities. Here, we outline and discuss the range of activities required to keep things running once a scientific imaging core facility has been established. These include managing a wide range of equipment and users, handling repairs and service contracts, planning for equipment upgrades, renewals, or decommissioning, and continuously upskilling while balancing innovation and consolidation.

Feasibility evaluation of a blood rotation system for efficient blood product utilization in remote island settings.

BACKGROUND AND OBJECTIVES: Geographical limitations in remote island medical facilities result in excessive wastage of blood products. To address this, we explored the feasibility of a novel blood rotation system, which enables the return and redelivery of blood products to/from the blood bank while ensuring the management of product quality, including temperature control. This study aimed to enhance the supply of blood products to these facilities. MATERIALS AND METHODS: The Japan Red Cross Nagasaki Blood Center, Nagasaki Goto Chuoh Hospital (NGCH) and Nagasaki University Hospital collaborated to coordinate the transport and supply of red blood cell (RBC) products. Type O, RhD-positive, irradiated RBC products were stored at a precise 4.0 ± 2.0°C in an active transport refrigerator (ATR). After transport from the Japan Red Cross Nagasaki Blood Center to NGCH, RBC products were held for 1 week in the ATR, and unused products were returned. Eligible returned products were reissued to the Nagasaki University Hospital. RESULTS: All the returned RBC products met the redelivery criteria. Among the 103 redelivered RBC preparations, 101 bags (98.1%) were successfully used. NGCH utilized 597 RBC products and discarded 80 samples. The ATR supplied 107 type O RBC bags without any wastage. The overall wastage rate was 10.2% during the study period compared with 24.2% in the same period in the previous year. CONCLUSION: This innovative supply and operation system ensures a consistent and secure RBC product supply to remote islands while maximizing blood product use.

A Broad-Scale Look at Nutrient Limitation and a Shift toward Co-limitation in United States Lakes.

There is a longstanding debate about the role of nitrogen (N) vs phosphorus (P) in limiting primary production in lakes and whether co-nutrient limitation should be considered for managing eutrophication. We evaluated nutrient limitation and eutrophication at a subcontinental scale. Using U.S. Environmental Protection Agency National Lakes Assessment data, we assessed broad-scale patterns in nutrient limitation and compared samples of all surveyed lakes and lakes resurveyed in multiple surveys. We found that N correlated more strongly with productivity in the western U.S., while P correlated more strongly in the eastern U.S. The aggregated subcontinental effect suggests the importance of factors like N-deposition, terrestrial vegetation, underlying geology, and land use for understanding drivers of nutrient dynamics in lakes. Our study showed how patterns can aggregate across subcontinental scales yet still demonstrate considerable variation when more deeply examined on an individual lake level. Overall, we found that nutrient limitation is dynamic over space and time, with most lakes being co-limited. The prevalence of co-limitation also increased from 2007 to 2017. Trophic states within each limitation category varied substantially. Our findings underscore the need for combined N and P reductions to mitigate accelerated eutrophication.

Quality control in the Netherlands; todays practices and starting points for guidance and future research.

OBJECTIVES: Adequate analytical quality of reported results is primarily ensured by performing internal quality control (iQC). Currently, several different iQC practices are in use. As a prelude to the revision of a Dutch guidance document on analytical QC, a questionnaire was sent out to gain insights in the applied practices and the need for guidance. METHODS: A questionnaire, containing 20 multiple-choice questions with possibilities for explanation and comment on iQC practices and aspects was distributed to all clinical chemistry laboratories within the Netherlands. Results were reported descriptively. RESULTS: Responses were received from 27 clinical laboratories (response 43 %). In 30 % the iQC was based on the analytical characteristics only, while 30 % used a 6-Sigma method, 19 % risk-based beyond 6-Sigma and 22 % used an alternative approach. 89 % of laboratories used a virtual analyzer model for iQC setup within one or more laboratory sites. Practices for determining standard deviation (SD) values included determining SD for each new iQC material (35 %), using historical SD values for new materials (35 %), and incorporating clinical tolerances into the SD value (31 %). Furthermore, 44 % of laboratories used patient moving averages for one or more tests. Daily iQC management was based on either "traffic lights" indicating in or out of control status, and review of all QC charts, often using multiple software systems. CONCLUSIONS: A large heterogeneity of iQC practices in clinical laboratories was observed in the Netherlands. Several starting points for further research and/or guidance were identified, particularly in relation to the determination of SD values, the virtual analyzer model and methods to ensure analyzer equivalence.

Ambient PM2.5 exposure and rapid population aging: A double threat to public health in the Republic of Korea.

Particulate matter with an aerodynamic diameter of ≤2.5 µm (PM2.5) can infiltrate deep into the respiratory system, posing significant health risks. Notably, the health burden of PM2.5 is more pronounced among the older adult population. With an aging population, the public health burden attributable to PM2.5 could escalate even if the current PM2.5 level remains stable. This study evaluated the number of deaths attributable to long-term PM2.5 exposure in the Republic of Korea between 2020 and 2050 and identified the PM2.5 concentration required at least to maintain the current PM2.5 health burden. To calculate mortality for 2020-2050, we performed a health impact assessment using 3-year (2019-2021) average population-weighted PM2.5 concentrations, age-specific population and mortality rates. In 2020, 33,578 [95% confidence interval (CI) = 31,708-35,448] deaths were attributable to PM2.5 exposure. Projecting forward, if the 2019-2021 average PM2.5 level remains constant, mortality is projected to be 112,953 (95% CI = 109,963-115,943) in 2050, more than three times higher than in 2020. To maintain the same level of health burden in 2050 as in 2020, the PM2.5 concentration needs to be immediately reduced to 5.8 µg/m3. In an age-specific analysis, the proportion of older adults (ages 65+) to total mortality would increase from 83% (2020) to 96% (2050), indicating that the rising mortality is predominantly driven by the aging population. By region, the reduction of PM2.5 concentrations, which is required immediately in 2020 to have the health burden in 2050 equal to that in 2020, varied from 3.6 µg/m3 in Goheung-gun (25% reduction) to 20.8 µg/m3 in Heungdeok-gu (82% reduction). Our study emphasizes the critical need for air quality management to consider aging populations when establishing PM2.5 air quality standards, as well as their associated policies and regulations.

Measurement uncertainty in clinical chemistry: ISO 20914 versus nordtest or intermediate precision versus bias.

AIM: Measuring uncertainty (MU) is crucial to ensure the accuracy and precision of laboratory results. This study compares the ISO 20914 and Nordtest guidelines to analyze the MU values for 20 clinical chemistry analytes over six months. METHODS: The researchers calculated MU components, including within-laboratory reproducibility (Rw), laboratory analytical performance bias (u(bias)), and combined standard uncertainty (uc), based on internal quality control and external quality assessment data. The final expanded uncertainty (U) values were determined by multiplying the combined uncertainty with a coverage factor (k = 2 for 95% Confidence Interval), following each guideline's respective procedures. Clinical chemistry analytes were analyzed on Roche Cobas 6000 c501 auto analyzer (Roche Diagnostics, Mannheim, Germany) and manufacturer's kits were used analysis. RESULTS: The results show that 11 out of 20 clinical chemistry analytes met the targeted maximum allowable measurement uncertainty (MAU) values when calculated according to ISO 20914 guideline. Also, 11 out of 20 clinical chemistry analytes' MU values met the MAU values with the Nordtest guideline's recommended calculations. However, some tests met the MAU in the ISO 20914 approach but not in the Nordtest guideline, and vice versa. CONCLUSIONS: The study found that intermediate precision (uRw) in the ISO 20914 approach and performance bias (u(bias)) in the Nordtest approach significantly impacted MU values. The research highlights the importance of standardization in MU calculation approaches across clinical laboratories. These findings have implications for patient care and clinical decision-making, emphasizing the importance of selecting appropriate laboratory guidelines for routine use.

Up-to-date quality survey and evaluation of neonatal screening programs in China.

AIMS: To thoroughly evaluate the quality of the entire process of neonatal screening (NBS) in China. METHODS: We collected survey questionnaires from 54.4% (135/248) of NBS institutions in China and conducted on-site visits to 20 of these facilities to validate the data. The quality performance of the institutions was evaluated, and differences across various factors were analysed. RESULTS: Merely 62.5% of the provinces had acceptable performance in neonatal screening. Institutions with limited staff were more prone to organizational management shortcomings. Institutions in provinces with a per capita GDP below 10,000 USD exhibited lower quality control levels than those with a per capita GDP between 10,000 and 15,000 USD. Obstetrics departments have a lower awareness of quality control compared to other blood collection facilities. CONCLUSIONS: A nationwide, comprehensive quality control system for continuous enhancements in quality management, screening, diagnosis, and treatment is imperative to ensure prompt diagnosis and intervention.

A comprehensive assessment of quality management methods in the SMESH study.

BACKGROUND: This paper aims to instigate discussion and publication of methodologies applied to enhance quality management through comprehensive scientific reports. It provides a detailed description of the design, implementation, and results of the quality control program employed in the SMESH study. METHODS: Cross-sectional, multicenter, national study designed to assess the prevalence of human papillomavirus in sex workers and in men who have sex with men (MSM). Respondent-driven sampling recruitment was used. An online system was developed for the study and checkpoints were defined for data entry. The system checked the quality of biological samples and performed a retest with part of the sample. RESULTS: A total of 1.598 participants (442 sex workers and 1.156 MSM) were included. Fifty-four health professionals were trained for face-to-face data collection. The retest showed Kappa values ranging between 0.3030 and 0.7663. CONCLUSION: The retest data were mostly classified as indicating a strong association. The data generated by the checkpoints showed the successful implementation of the quality control program.

Key Factors Influencing the Operationalization and Effectiveness of Telemedicine Services in Henan Province, China: Cross-Sectional Analysis.

BACKGROUND: Telemedicine has demonstrated its potential in alleviating the unbalanced distribution of medical resources across different regions. Henan, a province in China with a population of approximately 100 million, is especially affected by a health care divide. The province has taken a proactive step by establishing a regional collaborative platform for telemedicine services provided by top-tier provincial hospitals. OBJECTIVE: We aim to identify the key factors that influence the current operationalization and effectiveness of telemedicine services in Henan province. The insights gained from this study will serve as valuable references for enhancing the efficient operation of telemedicine platforms in low- and middle-income regions. METHODS: We analyzed service reports from the performance management system of telemedicine services in Henan province throughout 2020. Using descriptive statistics and graphical methods, we examined key influencing factors, such as management competency; device configuration; and hospital capability, capacity, and service efficacy, across hospitals at 2 different tiers. In addition, we used generalized linear models and multiple linear regression models to identify key operational factors that significantly affect the service volume and efficacy of 2 major telemedicine services, namely teleconsultation and tele-education. RESULTS: Among the 89 tier 3 hospitals and 97 tier 2 hospitals connected to the collaborative telemedicine platform, 65 (73%) and 55 (57%), respectively, have established standardized management procedures for telemedicine services. As the primary delivery method for telemedicine services, 90% (80/89) of the tier 3 hospitals and 94% (91/97) of the tier 2 hospitals host videoconferencing consultations through professional hardware terminals rather than generic computers. Teleconsultation is the dominant service type, with an average annual service volume per institution of 173 (IQR 37-372) and 60 (IQR 14-271) teleconsultations for tier 3 and tier 2 hospitals, respectively. Key factors influencing the service volume at each hospital include available funding, management competency, the number of connected upper tiers, and the number of professional staff. After receiving teleconsultations from tier 3 (65/89, 73%) and tier 2 (61/97, 63%) hospitals, patients reported significant improvements in their medical conditions. In addition, we observed that service efficacy is positively influenced by management competency, financial incentives, the number of connected upper or lower tiers, and the involvement of participating medical professionals. CONCLUSIONS: Telemedicine has become increasingly popular in Henan province, with a notable focus on teleconsultation and tele-education services. Despite its popularity, many medical institutions, especially tier 2 hospitals, face challenges related to management competency. In addition to enhancing the effectiveness of existing telemedicine services, health care decision-makers in Henan province and other low- and middle-income regions should consider expanding the service categories, such as including remote emergency care and telesurgery, which have promise in addressing crucial health care needs in these regions.

Analysis of Factors Related to Variation in Dissolution Profiles Estimated from Continuously Conducted Dissolution Tests of Generic Products.

The development of generic pharmaceuticals involves a bioequivalence study to ensure the therapeutic equivalence of the test formulation to the original innovative product. The formulation characteristics of generic products are expected to be maintained in the long term after approval. This study analyzed the factors contributing to the changes in the dissolution profiles of approved products during their life cycles. Cumulative data on the dissolution similarity of 1675 products of 127 ingredients tested by official laboratories in Japan were assessed according to Japanese bioequivalence guidelines with slight modifications. The products showing dissimilarities in dissolution profiles were analyzed for reporting year, therapeutic category, co-development, physical properties of the active pharmaceutical ingredient (API), and suspected reasons for dissolution change. The increase in the number of dissimilar products is related to the co-development of generic products. Although the solubility of the API was not associated with the dissolution change in the analysis of the total dissolution data, control of the API particle size is suggested to be important for drugs with poorly soluble APIs. Additionally, a risk factor for dissolution changes in the test solutions at a certain pH was the presence of acidic or basic residues. These results indicate the importance of proper development through a thorough evaluation of the formulation and process factors affecting the dissolution properties throughout the product lifecycle.

A script-enabled interactive checklist document for efficient management of electronic devices in a busy multimodality radiotherapy clinic.

PURPOSE: Develop an efficient, interactive, and instructive checklist document for the management of implanted electronic medical devices in a multimodality radiotherapy clinic. METHODS: The built-in scripting and interactivity of a popular commercial word processor was used to develop an interactive document that changes the information presented to the user based on drop-down selections. The interactivity and scripting were compatible with the radiation oncology information system (ROIS) which allows the document to be accessible by all team members and serve as a permanent record in a patient's electronic chart. RESULTS: The final interactive document, which was clinically deployed after beta testing with a group consisting of nurses and medical physicists, presents information and action plans to the user based on multiple departmental medical device decision trees that are specific to the combination of device, treatment modality, rhythm-pacing dependence for cardiac devices, and distance from the device to the treatment volume. CONCLUSION: A script-enabled interactive document was developed for a busy multimodality clinic, condensing multiple comprehensive departmental guidelines spanning multiple device types and treatment modalities into a single interactive checklist accessible within the ROIS. Given the wide accessibility of the commercial word processor, this approach could be adopted by other clinics to streamline their own respective workflows.

Effects of wind-driven current and thermal dynamics in a temperate monomictic reservoir: Implications for manganese transport and treatment in water supply systems.

Increasing manganese (Mn) concentrations in source water contribute to aesthetic and health-related concerns in drinking water. The challenges with Mn in drinking water primarily arise from elevated Mn concentrations in the water supply reservoir, with the inefficacy of Mn treatment largely attributed to fluctuating Mn levels in the water source. A three-dimensional Mn cycle model in a temperate monomictic reservoir, Tarago Reservoir, and a decision support system reflecting Mn variations in the local water treatment plant have been established in previous research. This study aimed to examine Mn variations from the reservoir to raw water and treated water under the influence of wind conditions during different stages of thermal structure, and discover valuable recommendations for Mn treatment in the local water supply system. We crafted 12 scenarios to scrutinize the impact of varying intensities of offshore and onshore winds on hydrodynamic processes and Mn transport during strong thermal stratification, weak thermal stratification, and turnover. The scenario analysis revealed that, during the gradual weakening of thermal stratification, offshore wind induced a substantial amount of Mn to the upper layers near the water intake point. Conversely, onshore wind hindered the upward transport of Mn. The simulated Mn in the raw water under the 12 scenarios indicated that the timing of turnover in the Tarago Reservoir is the primary concern for Mn treatment in the water treatment plant. Additionally, close attention should be given to the frequency and intensity of offshore winds during the weakening of thermal stratification.

Satellite imagery as a management tool for monitoring water clarity across freshwater ponds on Cape Cod, Massachusetts.

Water clarity serves as both an indicator and a regulator of biological function in aquatic systems. Large-scale, consistent water clarity monitoring is needed for informed decision-making. Inland freshwater ponds and lakes across Cape Cod, a 100-km peninsula in Massachusetts, are of particular interest for water clarity monitoring. Secchi disk depth (SDD), a common measure of water clarity, has been measured intermittently for over 200 Cape Cod ponds since 2001. Field-measured SDD data were used to estimate SDD from satellite data, leveraging the NASA/USGS Landsat Program and Copernicus Sentinel-2 mission, spanning 1984 to 2022. Random forest machine learning models were generated to estimate SDD from satellite reflectance data and maximum pond depth. Spearman rank correlations (rs) were "strong" for Landsat 5 and 7 (rs = 0.78 and 0.79), and "very strong" for Landsat 8, 9, and Sentinel-2 (rs = 0.83, 0.86, and 0.80). Mean absolute error also indicated strong predictive capacity, ranging from 0.65 to 1.05 m, while average bias ranged from -0.20 to 0.06 m. Long- and recent short-term changes in satellite-estimated SDD were assessed for 193 ponds, selected based on surface area and the availability of maximum pond depth data. Long-term changes between 1984 and 2022 established a retrospective baseline using the Mann-Kendall test for trend and Theil-Sen slope. Generally, long-term water clarity improved across the Cape; 149 ponds indicated increasing water clarity, and 8 indicated deteriorating water clarity. Recent short-term changes between 2021 and 2022 identified ponds that may benefit from targeted management efforts using the Mann-Whitney U test. Between 2021 and 2022, 96 ponds indicated deteriorations in water clarity, and no ponds improved in water clarity. While the 193 ponds analyzed here constitute only one quarter of Cape Cod ponds, they represent 85% of its freshwater surface area, providing the most spatially and temporally comprehensive assessment of Cape Cod ponds to date. Efforts are focused on Cape Cod, but can be applied to other areas given the availability of local field data. This study defines a framework for monitoring and assessing change in satellite-estimated SDD, which is important for both local and regional management and resource prioritization.

Green supply chain management practices and triple bottom line performance: Insights from an emerging economy with a mediating and moderating model.

The current study explores the dynamics of business practices in Pakistan's Small and Medium Enterprises (SMEs). This research focusing on how "green supply chain management" (GSCM), Industry 4.0 technologies (IND), total quality management (TQM) and sustainable performance (SP) are interconnected. The study collected data from 382 SMEs owners and managers and data analysis was conducted utilizing by SPSS and SmartPLS. The results indicate that employ GSCM pattern has constructive impact on SMEs overall performance in terms of their social and financial aspects. Interestingly IND act as intermediaries among GSCM and sustainable performance underscoring their potential to translate sustainability efforts into outcomes. Moreover, our survey reveals that TQM have a crucial function in enriching the relationship between Industry 4.0 technologies and sustainable performance by executing as a moderator. It further highlighting the value of adopting a quality focused approach to maximize the causal factor of advancements on sustainability output. The findings of this survey research offering insights for practitioners, SMEs, and policy makers alike by highlighting the significance of integrating practices such as GSCM, IND and effective quality management to enhance SME efficiency. These outcomes further contribute to an understanding of the mechanics at play, within SMEs while offering guidance for organizations maneuvering the changing landscape of sustainable business practices and IND.

Temporal variations in micropollutant inlet concentrations matter when planning the design and compliance assessment of stormwater control measures.

Stormwater Control Measures (SCMs) contribute to reducing micropollutant emissions from separate sewer systems. SCM planning and design are often performed by looking at the hydrological performance. Assessment of pollutant removal and the ability to comply with discharge concentration limits is often simplified due to a lack of data and limited monitoring resources. This study analyses the impact of using different time resolutions of input stormwater concentrations when assessing the compliance of SCMs against water quality standards. The behaviour of three indicator micropollutants (MP - Copper, Diuron, Benzo[a]pyrene) was assessed in four SCM archetypes, which were defined to represent typical SCM removal processes. High resolution MP data were extrapolated by using high resolution (2 min) measurements of TSS over a long period (343 events). The compliance assessment showed that high resolution input concentrations can result in a different level of compliance with water quality standards, especially when discharged concentrations are close to the limit values. This study underlines the importance of considering the high temporal variability of stormwater micropollutants when planning and designing SCMs to identify the most effective solutions for stormwater pollution management and to ensure a thorough consideration of all the environmental implications.

Climate change and future water demand: Implications for chlorine and trihalomethanes management in water distribution systems.

The global change in surface water quality calls for increased preparedness of drinking water utilities. The increasing frequency of extreme climatic events combined with global warming can impact source and treated water characteristics such as temperature and natural organic matter. On the other hand, water saving policies in response to water and energy crisis in some countries can aggravate the situation by increasing the water residence time in the drinking water distribution system (DWDS). This study investigates the individual and combined effect of increased dissolved organic carbon (DOC), increased temperature, and reduced water demand on fate and transport of chlorine and trihalomethanes (THMs) within a full-scale DWDS in Canada. Chlorine and THM prediction models were calibrated with laboratory experiments and implemented in EPANET-MATLAB toolkit for prediction in the DWDS under different combinations of DOC, temperature, and demand. The duration of low chlorine residuals (<0.2 mg/L) and high THM (>80 µg/L) periods within a day in each scenario was reported using a reliability index. Low-reliability zones prone to microbial regrowth or high THM exposure were then delineated geographically on the city DWDS. Results revealed that water demand reduction primarily affects chlorine availability, with less concern for THM formation. The reduction in nodal chlorine reliability was gradual with rising temperature and DOC of the treated water and reducing water demand. Nodal THM reliability remained unchanged until certain thresholds were reached, i.e., temperature >25 °C for waters with DOC <1.52 mg/L, and DOC >2.2 mg/L for waters with temperature = 17 °C. At these critical thresholds, an abrupt network-wide THM exceedance of 80 µg/L occurred. Under higher DOC and temperature levels in future, employing the proposed approach revealed that increasing the applied chlorine dosage (which is a conventional method used to ensure sufficient chlorine coverage) results in elevated exposure toTHMs and is not recommended. This approach aids water utilities in assessing the effectiveness of different intervention measures to solve water quality problems, identify site-specific thresholds leading to major decreases in system reliability, and integrate climate adaptation into water safety management.

[How the implementation of a school for people with Parkinson's disease can succeed-Results of a consensus study and a formative evaluation]. / Wie die Umsetzung einer Schule für Menschen mit Parkinson-Krankheit gelingen kann ­ Ergebnisse eines Konsensusverfahrens und einer formativen Evaluation.

BACKGROUND: As the most rapidly increasing neurodegenerative disease worldwide, Parkinson's disease is highly relevant to society. Successful treatment requires active patient participation. Patient education has been successfully implemented for many chronic diseases, such as diabetes and could also provide people with Parkinson's disease with skills to manage the disease better and to participate in shared decision making. MATERIAL AND METHODS: To prepare the implementation of a concept for patient education for people with Parkinson's disease, a structured consensus study was conducted and a pilot project formatively evaluated. The structured consensus study included experts from all over Germany. It consisted of two online surveys and an online consensus conference. The formative evaluation was conducted as three focus groups. Transcripts were evaluated using content-structuring qualitative content analysis. RESULTS: From the consensus procedure 59 consented statements emerged, mainly regarding the contents of a patient school and a group size of 6-8 persons. Only two statements could not be consented. The formative evaluation detected a tendency towards a positive attitude for a digital training format and a very positive evaluation of the contents. DISCUSSION: Overall, important recommendations for a patient school can be drawn from this study. The following subjects require further investigation: format, inclusion criteria, group composition and inclusion of caregivers.

[Benefits and approaches of a quality management system in biomedical research laboratories]. / Vorteile und Ansätze eines Qualitätsmanagementsystems in biomedizinischen Forschungslaboratorien.

Quality in biomedical research is a much-discussed topic among experts, research institutes, and funding organizations. Quality issues are frequently reported in the scientific and general press (e.g., stability of study results after test retake - "replication crisis"). Quality management systems are a globally accepted and established tool to guide and manage quality and to address quality problems. However, the notion of quality management is often met with resistance among researchers: low resources, too much regulation, restriction of research, and unnecessary bureaucracy are counter-arguments.The idea of implementing a quality management system for research laboratories is nothing new worldwide. There are various approaches by scientists and organizations to establish a quality management system in research laboratories and to develop a value-added system for themselves. Their expectations are an optimization of the research processes as well as an increase in effectiveness and efficiency.This report summarizes publications concerning quality measures and management in biomedical research and explains the background and advantages of quality management systems in organizations, laboratories, and research. A currently ongoing project of the Robert Koch Institute is presented as an outlook. The article is based on a literature review in English and German. In addition, internationally and nationally applicable and relevant guidelines were considered.

[Discharge management strategies in German general hospitals : A nationwide survey of professionals responsible for clinical risk management]. / Strategien des Entlassmanagements in deutschen Allgemeinkrankenhäusern : Deutschlandweite Befragung von Verantwortlichen des klinischen Risikomanagements.

BACKGROUND: Transitions from inpatient care are associated with risks for the safety of patients. In 2017, the framework agreement on discharge management was legally defined. There is currently a lack of empirical data in Germany on the implementation of measures to ensure safe transitions of patients after inpatient care. The aim of this study is to provide an overview of the discharge management strategies implemented by German general hospitals. METHODS: Between March and May 2022, specific discharge management strategies as well as structural and organizational characteristics were assessed in a nationwide survey of 401 general hospitals, and descriptive statistics and group comparisons were performed. RESULTS: Seven of nine strategies surveyed were implemented in > 95% of all hospitals. The evaluation of discharge planning was only implemented in 61% of the hospitals, and systematic documentation, analysis, and evaluation of readmissions in 54%. Hospitals with a higher number of hospital beds reported significantly less often about "early contact with follow-up care providers" and "organization of a seamless transition to follow-up care." DISCUSSION: A large part of the strategies in discharge management from inpatient treatment is implemented in German general hospitals. However, measures for evaluation and the systematic analysis of discharge processes and readmissions of patients have only been partially implemented. However, these are necessary to systematically evaluate and potentially improve the discharge processes.