Risk Assessment Procedures Research Articles

Evaluation of the formal risk assessment practice in hospitals in England

In England, hospitals routinely conduct a formal risk assessment practice to ensure the safety of patients and staff. However, although specific criticisms have been made on the practice, few investigated the formal risk assessment practice in the literature. This study investigates the risk assessment policies and procedures of one hundred hospitals in the English National Health Service (NHS) through content analysis. Findings revealed that hospitals provided varied descriptions of the terms risk and risk assessment. The concept of risk was often defined to be an undesired event, and risk assessment was often explained with the involvement of risk control step. Despite the variety in the descriptions of the risk terms, all hospitals recommended following similar steps to undertake risk assessments. Risk matrices- and therefore risk scoring – are at the heart of the formal practice, which increases the possibility of wrong risk prioritisation. This study provides several recommendations for the improvement of current guidelines by considering both Safety-I and Safety-II approaches.

Procedures for Flow Cytometry-Based Sorting of Unfixed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infected Cells and Other Infectious Agents.

In response to the recent COVID‐19 pandemic, many laboratories are involved in research supporting SARS‐CoV‐2 vaccine development and clinical trials. Flow cytometry laboratories will be responsible for a large part of this effort by sorting unfixed antigen‐specific lymphocytes. Therefore, it is critical and timely that we have an understanding of risk assessment and established procedures of infectious cell sorting. Here we present procedures covering the biosafety aspects of sorting unfixed SARS‐CoV‐2‐infected cells and other infectious agents of similar risk level. These procedures follow the ISAC Biosafety Committee guidelines and were recently approved by the National Institutes of Health Institutional Biosafety Committee for sorting SARS‐CoV‐2‐infected cells. © 2020 International Society for Advancement of Cytometry

Assessment of landslide susceptibility using statistical modelling in the flysch zone of the Western Carpathians (NW Slovakia)

ABSTRACT Landslides represent one of the most frequent geodynamic phenomena in Slovakia. This contribution focuses on the relations of the selected landscape attributes and landslides in flysch area of the Western Carpathians. We presented three statistical methods of assessing and making a prognosis of the landslide hazard: multivariate, factor and zonal analysis. These methods complement each other and their aim is to analyse and recognize natural processes, which trigger the landslides in a more complex way. With multivariate analysis, we evaluated mutual interactions between the input attributes and determined their level of impact on landslide hazard. Using factor analysis, we extracted latent factors with the highest factor loads and identified the main factors that could trigger landslides. Areal extension of landslides in individual landscape attributes was expressed by zonal analysis, based on the superposition of the individual vector layers. Our evaluation shows that the slope predisposition to landslides is predominantly given by the geological, hydrogeological and morphological conditions. The proposed landslide risk assessment procedure allows for the functional sustainable development of the landscape development planning documents. The results presented in this paper are relevant for the area formed by flysch rock (Alps and Carpathians), but also for areas where clastic sediments alternate rhythmically.

Современные требования к оценке профессиональных рисков на объектах золотодобычи

Russia is currently in the process of modernizing its legislation, primarily in the areas of occupational safety and health, industrial safety and emergency safety, which concerns the management system for occupational and industrial safety on a state level. The aim of the modernization is to make a transition from the previous inefficient system to the modern one. The old system focuses on health compensation, medical and social assistance to the employees suffering work injuries and occupational risks, while the new system is based on a preventive approach that presupposes continuous improvement of the working conditions, industrial safety enhancement, development of a safe working behavior culture, and creation of a risk-management system. The purpose of the article is to analyze the occupational safety and health management innovations encouraging the employers to implement risk assessment and risk management, and to evaluate the occupational risks in gold mining processes. The authors have examined the modern procedures of risk assessment, evaluated the occupational risks for the gold mines of the Bodaibo district, Irkutsk region, analyzed the risks by two methods and identified high-risk professions. Possible reasons for the incompliance of the physical factors of the gold miners’ working environment with the claimed requirements have been analyzed. The investigated professions are classified as high- and middle-risk ones. The detailed study of the drilling-and-blasting site has concluded that the mechanical hazards caused by the rock fragmentation, dust, or noise are unacceptable. Thus, the priority measures on improving the working conditions should focus on eliminating these adverse factors.

Application of Quality-by-Design Approach in the Analytical Method Development for Quantification of Sugars in Sugarcane Honey by Reversed-Phase Liquid Chromatography

Produced in Madeira Island from regional sugarcane cultivars through a traditional manufacturing and storage process, sugarcane honey (SCH) is a black syrup recognized by its excellent quality. Its economic value has led to the emergence of adulterated SCH, whereby the identification of molecular markers became an essential task in order to overcome the fraudulent activities, protect its authenticity, and guarantee the consumer safety. In the present study, an analytical strategy based on ultrasound-assisted liquid-liquid extraction (USA-LLE) followed by reversed-phase liquid chromatography with a refractive index detector (LC-RI) was developed for the determination of sugars (glucose, fructose, sucrose, xylose, and mannose) in SCH samples from certified producers, supported on analytical quality-by-design (AQbD) approach, as a useful tool to establish its typicality. The application of AQbD was based on analytical risk assessment, multivariate statistics and quality control procedures for definition of the Method Operable Design Region (MODR). The optimal conditions into MODR were accomplished using BEH Amide column operating at a temperature of 80 °C and a flow rate of 300 μL min−1, with a mobile phase composed by acetone and water (85:15, v v−1) at a flow rate of 1.0 mL min−1. The robustness was determined by Monte Carlo simulation and capability analysis. The concentration-response function for all sugars was described by polynomial models. Accuracy was presented by recovery values between 98.2 and 119.5%. The analytical figures of merit validated the utility of AQbD in the systematic design of a LC-RI method with fine sensitivity for sugar analysis in SCH.

Assessing the wood sourcing practices of the U.S. industrial wood pellet industry supplying European energy demand

BackgroundAs the demand for wood pellets has increased in EU member states, so has a multi-pronged examination of the environmental effects of establishing a transatlantic trade in wood pellets between the U.S. and Europe. However, the nature of industrial wood pellet supply chains is poorly understood or little known. This work aimed to understand the feedstock sourcing strategies being used by the wood pellet industry in the southeast U.S., commonly applied approaches to documenting sustainability of these feedstocks, and drivers operating behind related developments.MethodsThis study used structured interviews of sustainability managers and procurement staff at pellet mills comprising 75% of the U.S. industrial pellet sector. The industry was classified into types of supply chains, based on the role of loggers, wood dealers, sawmills, and other wood product facilities in the supply chains. Additional classifications examined feedstock types and origins, number and type of suppliers, contractual relationships with suppliers, applied procurement systems, risk assessment and due-diligence methodologies, risk mitigation procedures, and supply chain certifications.ResultsThree main types of supply chains were identified within the U.S. industrial pellet sector, differentiated based on features of feedstock procurement, risk assessment procedures, and risk management. The study observed a slight shift toward using a higher proportion of wood residuals as feedstock in some of the larger pellet mills. Policy requirements, customer orders, and external pressures were driving the sector’s adoption of sustainability programs, with risk assessments and wood procurement procedures aligned to policy requirements.ConclusionsThe strength of a risk-based approach to sustainability documentation depends on the quality of source data on risks within a sourcing area, scale of analysis, and integration of risk assessments into procurement practices. Some risk categories are more difficult to assess and control. Challenges increase with increasing number and diversity of supply chain actors and depend on the nature of agreements between these entities for the conveyance of feedstocks to pellet mills. Fiber procurement is similar to pulpwood-using industries, but extending the risk assessment to residuals is complicated and challenging to the sector. The study identified a number of strategies in use within pellet mill supply chains for dealing with these challenges.

Scour Risk Assessment of Offshore Wind Turbine with Suction Bucket Foundation

Kim, D.-H. and Kim, Y.-J., 2020. Scour risk assessment of offshore wind turbine suction bucket foundation. In: Malvárez, G. and Navas, F. (eds.), Global Coastal Issues of 2020. Journal of Coastal Research, Special Issue No. 95, pp. 237–241. Coconut Creek (Florida), ISSN 0749-0208.Risk assessment procedure for offshore wind turbine support structures induced by scour was proposed. Probabilistic distribution of scour depth, a hazard curve, was calculated by using the C.S.U formula with parametric uncertainties. To get fragility curves of support structure, dynamic analysis was done with a certain assumed scour depth, given significant wave height and return period. Scour induced failure probability of support structure for a given wave height then can be found by integrating the multiplication of hazard and fragility. It is repeated for possible range of scour depths to form a risk curve. In numerical example, scour induced structural risk of 3MW offshore wind turbine supported by suction bucket foundation is evaluated. The proposed approach can be used in determining wind farm location where scour is significant.

Invasiveness of biofuel crops: implications for energy research and policy in Botswana

ABSTRACT In developed countries, biofuel development was largely driven by a desire to reduce greenhouse gas (GHG) emissions and increasing energy security, whereas in developing countries, in addition to energy security, the quest for rural development and employment creation incited an interest in biofuel production. Notwithstanding the benefits of biofuels, there are reservations about their potential invasiveness. These concerns stem from the fact that the traits that characterize an ideal biofuel crop such as rapid growth rate, tolerance to drought and low soil fertility as well as pest and disease resistance, match those of invasive plants. The objective of this paper was to review literature on experiences of other countries on invasiveness of biofuel crops, with a view to providing lessons for biofuel production in Botswana. The review has revealed that most plants proposed for biofuel production are classified as invasive. The review concludes with recommendations for the Government of Botswana: Improve the cultivation of indigenous wild plants with high oil content for biodiesel production, screening of exotic species through a science-based risk-assessment procedure to evaluate their invasive potential before embarking on large-scale cultivation, and development of appropriate management practices and regulations to mitigate risk of invasion.

Toxicity of a mixture of monoaromatic hydrocarbons (BTX) to a tropical marine microcrustacean

This study evaluated the toxicity of benzene, toluene, and xylenes (BTX), isolated and in binary mixtures to Mysidopsis juniae. The organisms were exposed to BTX, and combined effect patterns were predicted by applying the theoretical models of Concentration Addition and Independent Action. According to the LC50 of the isolated compounds, xylene (16.1 ± 2.4 mg L−1) was considered the most toxic, followed by toluene (38.0 ± 5.3 mg L−1) and, lastly, benzene (78.0 ± 2.9 mg L−1). The binary combinations showed deviations from additivity, with exposure to the xylene–benzene mixture presenting as antagonistic, while the xylene–toluene and toluene–benzene mixtures were better explained by a dose ratio deviation, with toluene being responsible for the antagonistic pattern. This study provides new insights into toxicity prediction of a BTX mixture, which adds value to the risk assessment procedure over evaluation of chemical hazards on a case-by-case basis.

Reliability analysis of riverbank stability accounting for the intrinsic variability of unsaturated soil parameters

The paper presents a probabilistic study aimed at investigating the role of the soil hydraulic response on the stability of existing river embankments, for which the uncertainty and the inherent variability of geotechnical and hydraulic properties are typically greater when compared to new flood defence structures. The study has been carried out with reference to a specific, thoroughly investigated 20 m-long segment of the river Secchia banks (northern Italy), which experienced a catastrophic sudden failure after a period of intense rainfall, in January 2014. By taking such well-documented case as a base, the proposed probabilistic analyses consider three key aspects, typically disregarded in routine risk assessment procedures: i) transient seepage flow through earth structures due to time dependent hydraulic loads, ii) unsaturated conditions of soils forming the river embankment, iii) uncertainty of the soil model parameters, with special emphasis placed on the impact of intrinsic variability of unsaturated soil parameters. The numerical results, obtained from the application of the Point Estimate Method, allow identifying the crucial role of suction distribution on the probability of failure of the riverbank slopes and clearly show that such probability can be significantly underestimated when the variability of hydraulic parameters is neglected.

Co-occurrence of anatoxin-a and microcystins in Lake Garda and other deep subalpine lakes

Cyanotoxins are a global concern in freshwaters and eutrophication and climate changes can have synergistic effects in exacerbating the problem. Deep Subalpine Lakes (DSL) are a group of lakes of huge economic and naturalistic importance in Italy. Together with eutrophication (occurred during 1960s and 1970s) and re-oligotrophication (from 1990 onward) these lake have been experiencing warming and increase of the water column stability. These changes have influenced the phytoplankton (comprised the cyanobacteria) community of the lakes. Four DSL lakes (Lakes Garda, Iseo, Como and Lugano) have been studied with the aim of comparing their toxic potential. For one of them (Lake Garda) an 8 years survey was conducted, allowing a long term trend analysis. Toxin analysis was conducted on a monthly basis by targeted LC-MS/MS. A screening for anatoxins, cylindrospermopsins, saxitoxins, microcystins (MCs) and nodularins was carried out. Among all the listed toxins, only one anatoxin and five MCs were detected in the lakes. In particular, the alkaloid Anatoxin-a (ATX) was found dominant Lakes Garda, Iseo and Como and absent in lake Lugano; the MC-[D-Asp3]RR was found as the most abundant MC in all four lakes. Four other minoritary MCs were also found. The two major toxins are produced by two different cyanobacteria (Tychonema bourrellyi and Planktothrix rubescens) which have however similar ecological traits. Peaks of these toxins occur in warmer months (typically between May and September) in the thermocline layer (around 20 m, in the considered lakes). In summer 2016, the highest concentrations of ATX and total microcystins (MCs) were registered in Lake Iseo (1100 and 430ngL-1, respectively), while in the other lakes values were approximately twice lower. In the lakes where it is present, ATX peak levels are much higher than MCs, thus highlighting the necessity of considering ATX in the procedures of risk assessment. The importance of ATX is expected to further grow in the future with respect to MCs, as demonstrated by the long term trend analysis carried out in Lake Garda that showed a clear decline for MCs from 2009 till 2016 and a relative constancy for ATX.

Flawed risk assessment of antifouling paints leads to exceedance of guideline values in Baltic Sea marinas

The seasonal variations of dissolved and bioavailable copper (Cu) and zinc (Zn) were studied in two recreational marinas in Sweden and Finland. The time series from the two marinas were characterized by rising concentrations during the spring boat launching, elevated concentrations all through the peak boating season, and decreasing concentrations in autumn when boats were retrieved for winter storage. This pattern shows a clear link between Cu and Zn concentrations and boating activity, with antifouling paints as the principal source. The leaching from antifouling paints was also found to significantly alter the speciation of dissolved Cu and Zn in marina waters, with an increase of the proportion of metals that may be considered bioavailable. This change in speciation, which occurred without any change in dissolved organic carbon (DOC), further increases the environmental risk posed by antifouling paints. In the Swedish marina, dissolved Cu and Zn exceed both Environmental Quality Standards (EQS) and Predicted No Effect Concentrations (PNEC), indicating that the current Swedish risk assessment (RA) of antifouling paints is failing to adequately protect the marine environment. An evaluation of the RA performance showed the underlying cause to be an underestimation of the predicted environmental concentration (PEC) by factors of 2 and 5 for Cu and Zn, respectively. For both metals, the use of inaccurate release rates for the PEC derivation was found to be either mainly (Cu) or partly (Zn) responsible for the underestimation. For Zn, the largest source of error seems to be the use of an inappropriate partitioning coefficient (KD) in the model. To ensure that the use of antifouling coatings does not adversely impact the sensitive Baltic Sea, it is thus recommended that the KD value for Zn is revised and that representative release rates are used in the RA procedure.

Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions

The regulation of pesticides in the European Union (EU) relies on a network of hard law (legislation and implementing acts) and soft law (non-legally binding guidance documents and administrative and scientific practices). Both hard and soft laws govern how risk assessments are conducted, but a significant role is left to the latter. Europe’s pesticide regulation is one of the most stringent in the world. Its stated objectives are to ensure an independent, objective and transparent assessment of pesticides and achieve a high level of protection for health and environment. However, a growing body of evidence shows that pesticides that have passed through this process and are authorised for use may harm humans, animals and the environment. The authors of the current paper – experts in toxicology, law and policy – identified shortcomings in the authorisation process, focusing on the EU assessment of the pesticide active substance glyphosate. The shortcomings mostly consist of failures to implement the hard or soft laws. But in some instances the law itself is responsible, as some provisions can only fail to achieve its objectives. Ways to improve the system are proposed, requiring changes in hard and soft laws as well as in administrative and scientific practices.

Preliminary flood risk assessment: Case study of systematic processing of available or readily derivable information

AbstractThe paper presents a methodological approach to preliminary flood risk assessment, which is conceptually based on the regional typing and integrated flood risk assessment. From the above conceptual bases, two key tasks arise: (1) establishing a basic spatial unit for preliminary flood risk assessment and (2) specifying its attributes in relation to the flood hazard and vulnerability (negative consequences), which correspond to assessment on a national scale. The basic spatial unit is defined as the municipality district. The methodological procedure of the preliminary flood risk assessment is based on an assessment of the impact of the district’s attributes on the potential of the flood hazard and negative flood consequences in the form of indicators, which are aggregated to subindices and indices. The flood risk potential index is determined as an aggregation of the flood hazard potential index and flood consequences potential index.

Improving Risk Assessment in the European Food Safety Authority: Lessons From the European Medicines Agency.

The recent Regulation (EU) 2019/1381, published on the 6th September 2019, aims to improve the transparency and sustainability of the EU risk assessment in the food chain by amending the General Food Law Regulation (EC 178/2002) and a number of other regulations related to the food sector. This Regulation is introduced as a response to the Fitness Check of the General Food Law Regulation as well as a response to public concerns expressed by a European Citizens’ Initiative on glyphosate and pesticides. This article evaluates the amendments introduced by Regulation 2019/1381with respect to the institutional and regulatory environment in the food chain and more specifically concerning the risk assessment procedure. For this purpose, we perform a comparison of the institutional and organizational characteristics of the European Food Safety Authority (EFSA) and European Medicines Agency (EMA) in relation to the processes of risk assessment and risk evaluation, especially the processes surrounding genetically modified foods and pesticides, and how these characteristics affect the politicization of these processes. We conclude that the risk assessment process followed by EFSA would have benefitted and become more effective and less politicized, if the recent Regulation 2019/1381 had introduced some of EMA’s institutional structures and methods on risk evaluation.

A Person-Centered Approach to Prison Behavior Based on Officers' Observations: Relations to Risk, Prison Misconduct, and Recidivism.

Incorporating measures of prison behavior into risk assessment and management procedures may assist in treatment planning, risk monitoring, and decision-making. A behavior rating scale was used to assess prison officers’ observations on externalizing, internalizing, and adaptive behavior in a sample of 277 sexual and violent offenders in correctional treatment in Berlin, Germany. The present study employed latent profile analysis to identify inmate subtypes with similar behavioral patterns. Results indicated a solution with five latent profiles that showed similarities with previous inmate typologies. The subtypes were termed “Aggressive-Psychopathic,” “Asocial,” “Situational,” “Inconspicuous, and “Inadequate-Dependent.” Analyses attested to the construct and predictive validity of the subtypes and involved the examination of differences on criminological characteristics, risk assessment instruments, various types of prison misconduct, and postrelease recidivism. This person-centered study illustrates the importance of attending to broader patterns of inmate behavior. The structured assessment of behavioral observations by prison officers can be a valuable and easy-to-implement approach to benefit from this largely neglected resource.

Occupational Risk Assessment Method for Food Industry

The paper describes a method for assessing occupational risks at food processing facilities in Altai Krai; it defines a risk assessment procedure that takes into account the event probability and the severity of its consequences to be tracked and monitored; the paper also assesses the controls in place and outlines the additional controls that could be of use. The proposed method has been tested at a food processing facility in Altai Krai.

Comprehensive assessment of soil risk in a de-industrialized area in China

An integrated and quantitative evaluation method based on soil pollution, land use, risk receptor vulnerability, and risk source was developed to assess soil risk in a de-industrialized area. A case study was conducted to understand the spatial and temporal characteristics of soil risk, and the resulting comprehensive soil risk values ranged from 128.24 to 2,3670.50 in 2008 and from 104.08 to 3,8421.70 in 2015. However, this overall increase was inconsistent with the soil pollution trend. The extended Pearson correlation coefficient (ePCC) was calculated for 39,655 extracted data points to comprehensively characterize the risks associated with soil pollution. The ePCC was greater than 1 in most developed and undeveloped blocks, indicating that comprehensive soil risks in these regions were relatively stable and less affected by changes in soil pollution status upon de-industrialization. The ePCC was lower than 0.99 in approximately 35.23% of the study area blocks, where changes in human-land relationships were strong. This study highlighted the complexity of risk characteristics and trends after de-industrialization. Therefore, more precise and regionalized soil risk management methods based on comprehensive risk assessment procedures are required in de-industrialized areas.

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

IntroductionWhile medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice.MethodologyA semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns.ResultsThe participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy.ConclusionThe study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

Fuzzy-rough assisted refinement of image processing procedure for mammographic risk assessment

The use of computer aided diagnosis (CAD) systems, which are computer based tools for the automatic analysis of medical images such as mammogram and prostate MRI, can assist in the early detection and diagnosis of developing cancer. In the process of CAD for mammogram, the task of image processing (IP) plays a fundamental role in providing promising diagnostic results, by exploiting high-quality features extracted from the mammographic images. Normally, an IP procedure for mammographic images involves three mechanisms: region of interest (ROI) extraction, image enhancement (IE) and feature extraction (FE). However, an improper utilisation of IE may lead to an inferior composition of the features due to unexpected enhancement of any irrelevant or useless information in ROI. In order to overcome this problem, a fuzzy-rough refined IP (FRIP) framework is presented in this paper to improve the quality of mammographic image features hierarchically. Following the proposed framework, the ROI of each mammographic image is segmented and enhanced locally in the area of the block which is of the highest value of fuzzy positive region (FPR). Here, FPR implies a positive dependency relationship between the block and the decision with regard to the given feature set. The higher a block’s FPR value the more certain its underlying image category. To attain a high quality of the image enhancement procedure, the winner block will be further improved by a multi-round strategy to create a pool of IE results. As such, for a mammographic image, after embedding the candidate enhanced blocks into the original ROI, the respectively extracted features from the locally enhanced ROI are compared against each other on the basis of the value of FPR. A given image is therefore represented by a set of features which are supported by the premier FPR among all of the resulting extracted features. The quality of the extracted features by FRIP is compared against that of those directly extracted from the original images, from the globally enhanced images or from the randomly locally enhanced images in performing classification tasks. The experimental results demonstrate that the mammographic risk assessment results based on the features achieved by the proposed framework are much improved over those by the alternatives.