Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management

2019 ◽  
Vol 57 (10) ◽  
pp. 1530-1538 ◽  
Author(s):  
Canan Karadağ ◽  
Nafi Nevrez Demirel
Keyword(s):  
Public Health ◽  
Risk Management ◽  
Quality Indicators ◽  
Failure Modes ◽  
Public Health Laboratory ◽  
Risk Level ◽  
Continual Improvement ◽  
Risk Levels ◽  
Analytical Process ◽  
Risk Treatment

Abstract Background Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units. Methods QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs. Results RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of “transcription errors”, for risk levels of “misidentified samples” and “not properly stored samples” and for the performance of “hemolyzed samples”. “Not properly stored samples” had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL. Conclusions Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.

The prospects of occupational risk management during reforms of regulatory legislation basis

2019 ◽  
pp. 39-44 ◽  
Author(s):  
Vadim B. Alekseev ◽  
Nina V. Zaitseva ◽  
Pavel Z. Shur
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Social Insurance ◽  
Well Being ◽  
Occupational Risk ◽  
Risk Level ◽  
Federal Law ◽  
Work Safety ◽  
Risk Levels ◽  
Legal Principles

Despite wide legislation basis of regulating relations in work safety and workers’ health, one third of workplaces demonstrate exceeded allowable normal levels of workers’ exposure to occupational hazards and present occupational risk for health disorders.In accordance to national legislation acts, evaluation should cover factors of occupational environment and working process, and occupational risk is understood in context of mandatory social insurance. This approach has been formed due to mostly compensatory trend in legal principles of work safety in Russia by now. Implementation of new preventive concept of work safety, based on idea of risk management for workers, necessitates development of legal acts that regulate requirements to evaluation of occupational risk and its reports with consideration of changes in Federal Law on 30 March 1999 №52 FZ “On sanitary epidemiologic well-being of population”.Those acts can include Sanitary Rules and Regulations “Evaluation of occupational risk for workers’ health”, that will contain main principles of risk assessment, requirements to risk assessment, including its characteristics which can serve as a basis of categorizing the risk levels with acceptability.To standardize requirements for informing a worker on the occupational risk, the expediency is specification of sanitary rules “Notifying a worker on occupational risk”. These rules should contain requirements: to a source of data on occupational risk level at workplace, to informational content and to ways of notifying the worker. Specification and implementation of the stated documents enable to fulfil legal requirements completely on work safety — that will provide preservation and increase of efficiency in using work resources.

scholarly journals THE MANAGEMENT OF PROCESS LEAD TIME IN THE RELEASE OF STERILE PHARMACEUTICAL BATCHES: A CASE STUDY OF OPTIMIZATION IN AN OFFICIAL BRAZILIAN PHARMACEUTICAL LABORATORY

2021 ◽  
Vol 16 (1) ◽  
pp. 42-51
Author(s):  
Maria Tereza de Sousa Silva ◽  
Edison Nunes da Silva Junior ◽  
Jorge Magalhães ◽  
Vanessa da Silveira dos Santos Pacheco
Keyword(s):  
Risk Management ◽  
Failure Modes ◽  
Pharmaceutical Product ◽  
Release Time ◽  
Risk Level ◽  
Management Tools ◽  
Release Process ◽  
Quality Program ◽  
Batch Release ◽  
Fmea Method

Medicines must comply with quality, safety, and efficacy pillars. Nowadays, organizations seek to incorporate new management models encouraged by quality program following the world trend regarding the technological revolution. The present research aims to improve the sterile pharmaceutical product batches release process, using the Failure Mode Effects Analysis (FMEA) method. This study addresses the gap in literature on quality risk management during batch release. The methodology uses a form adapted to the process in order to systematize the information, improving its comparison and analysis, thus estimating, the identification of potential failure modes and their effects on their performance. Made it possible to assign values for the severity, occurrence, and failure modes detection, to then determine the risk level and the priority of risk level. The results obtained showed the mitigation and elimination of failures in the process, as well as opportunities for improvement and causes of failures identification, improvement in the process performance indicators, greater reliability, and reduction in batch release time. Keywords: good manufacturing practices pharmaceutical industry, risk management, risk management tools

Risk management in radiation therapy with SEVRRA

2018 ◽  
Vol 6 (3) ◽  
Author(s):  
Geórgia Santos Joana ◽  
Marcello Gomes Gonçalves ◽  
Camila Salata ◽  
Flávia Cristina Teixeira ◽  
Emmilly Sandrini ◽  
...  
Keyword(s):  
Risk Management ◽  
Radiation Therapy ◽  
High Risk ◽  
Security Analysis ◽  
Regulatory Agencies ◽  
Risk Level ◽  
Risk Levels ◽  
Importance Analysis ◽  
Professional Resources ◽  
High Degree

ABSTRACT Radiation therapy is a complex treatment modality involving several technological and professional resources as well as a large number of attributions of these professionals with a high degree of interdependence. Thus there are many possibilities of failure in the treatment process that may lead to an accidental exposure. So regulatory agencies have established guidelines in their regulations in order to prevent accidental exposures through security analysis planning and risk management. The System of EValuation of Risk in RAdiotherapy, also known as SEVRRA, is based on the risk matrix methodology and allows the risk assessment of radiation therapy facilities in a prescriptive way, highlighting events leading to high-risk levels and severe consequences for individuals. With SEVRRA it is also possible to establish an importance analysis of the barriers proposed to avoid or mitigate such events.This work aimed to demonstrate the application of SEVRRA for the risk management of radiation therapy facilities. The risk profile of the facility was determined by identifying the highest risk level events, and the barriers of greater impact for the overall risk level. After implementing some missing barriers in the original facility profile, it was achieved a reduction from 31% to 8% in the number of events leading to high-risk level, showing the effectiveness of SEVRRA for the risk management in radiation therapy facilities.

scholarly journals Risk Assessment at the Plate Production Unit (PPL) of PT. INKA (Persero)

2021 ◽  
Vol 10 (3) ◽  
pp. 316
Author(s):  
Monalisa Ma'rifat ◽  
Atiya Thifal Rofifa ◽  
Tri Martiana
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
High Risk ◽  
Hazard Identification ◽  
Residual Risk ◽  
Production Unit ◽  
Risk Level ◽  
Risk Levels ◽  
Safety And Health ◽  
Medium Risk

Introduction: The plate manufacturing production unit is one of the work units in PT. INKA (Persero), which involves the interaction between humans and machines in its activities, heavy equipment, and materials, all of which can cause possible hazard impacts that can impact the safety and health of workers. The purpose of this study is to conduct risk assessment on occupational safety and health aspects by identifying risks, assessing risks, identifying control efforts and assessing residual risk as a form of efforts to prevent occupational accidents and occupational diseases, using existing resources effectively and efficiently. Method: This research is a type of qualitative research, through interviews and observations, with cross-sectional studies and descriptive analysis. The interviewees for this study were K3LH management managers, steel managers, and machine operators in the plate production unit (PPL). The tools in this study werean interview guide, Job Safety Analysis (JSA) and Hazard Identification Risk Assessment Determining Control (HIRADC) using the AS / NZS 4360: 2004 Risk Management Worksheet Standard Risk Matrix. Results: From the research, it was found that there are 94 hazards for 11 different machines. Regarding the risk levels, there are 9 extreme risk levels, 46 high risk levels, 33 medium risk levels and 6 low risk levels. Conclusion: There are still 61 risks with medium risk level and 6 remaining risks with high risk level that still need control. Control efforts have been implemented by PT. INKA (Persero) in accordance with the hierarchy of control, such as the use of PPE and the provision of work SOPs. Keywords: hazard identification, risk management, risk assessment, risk control, residual risk 

CONCEPTUALISING RISK CULTURE ON ERM IMPLEMENTATION IN CONSTRUCTION COMPANIES

2020 ◽  
Vol 17 (1) ◽  
pp. 59
Author(s):  
Ching Ching Wong
Keyword(s):  
Risk Management ◽  
Risk Identification ◽  
The Body ◽  
Risk Indicators ◽  
Construction Companies ◽  
Risk Appetite ◽  
Risk Culture ◽  
Risk Treatment ◽  
Managing Risk ◽  
The Relationship

Enterprise Risk Management (ERM) is an effective technique in managing risk within an organization strategically and holistically. Risk culture relates to the general awareness, attitudes and behaviours towards risk management in an organisation. This paper presents a conceptual model that shows the relationship between risk culture and ERM implementation. The dependent variable is ERM implementation, which is measured by the four processes namely risk identification and risk assessment; risk treatment; monitor and consult; communicate and consult. The independent variables under risk culture are risk policy and risk appetite; key risk indicators; accountability; incentives; risk language and internal relationships. This study aims to empirically test the relationship between risk culture and ERM implementation among Malaysian construction public listed companies. Risk culture is expected to have direct effects and significantly influence ERM. This study contributes to enhance the body of knowledge in ERM especially in understanding significant of risk culture that influence its’ implementation from Malaysian perspective.

scholarly journals Exploring the Willingness to Accept SARS-CoV-2 Vaccine in a University Population in Southern Italy, September to November 2020

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 275
Author(s):  
Gabriella Di Giuseppe ◽  
Concetta Paola Pelullo ◽  
Giorgia Della Polla ◽  
Maria Pavia ◽  
Italo Francesco Angelillo
Keyword(s):  
Public Health ◽  
Faculty Member ◽  
Perceived Risk ◽  
Southern Italy ◽  
Severe Disease ◽  
Risk Level ◽  
Considerable Proportion ◽  
Willingness To Accept ◽  
University Population ◽  
To Receive

Understanding whether members of the university population are willing to receive a future vaccination against COVID-19 and identifying barriers may help public health authorities to develop effective strategies and interventions to contain COVID-19. This cross-sectional study explored the willingness to accept a future SARS-CoV-2 vaccine in a university population in Southern Italy. The perceived risk level of developing COVID-19 was 6.5 and it was significantly higher among females, younger subjects, and those who agreed/strongly agreed that COVID-19 is a severe disease. Only 21.4% of respondents were not worried at all regarding the safety of the vaccine. Males, not being married/cohabitant, being a faculty member, those who perceived a lower risk of developing COVID-19, and those who did not need information regarding the vaccination against COVID-19 were significantly more likely to have no concern at all regarding the safety of the vaccine. The vast majority (84.1%) were willing to receive a future vaccine against COVID-19. Almost coherently with predictors of concern on the safety of the vaccine, being male, not being married/cohabitant, being a faculty member, not being concerned at all that COVID-19 vaccination might not be safe, and agreeing that COVID-19 can have serious health consequences were significant predictors of the willingness to receive the vaccine against COVID-19. A considerable proportion of the population had a positive willingness to receive the future COVID-19 vaccine, although some concerns have been expressed regarding the effectiveness and safety and public health activities seem necessary to achieve the rate that can lead to the protection of the community.

Applying the risk principle to optimize accuracy and equity in correctional risk assessment: Results From a Simulation

2021 ◽  
pp. 0306624X2098652
Author(s):  
Grant Duwe
Keyword(s):  
Risk Assessment ◽  
Predictive Accuracy ◽  
Ethnic Disparities ◽  
Simulated Data ◽  
Risk Assessments ◽  
Risk Level ◽  
Risk Levels ◽  
Risk Principle ◽  
Changes In Risk ◽  
The Impact

As the use of risk assessments for correctional populations has grown, so has concern that these instruments exacerbate existing racial and ethnic disparities. While much of the attention arising from this concern has focused on how algorithms are designed, relatively little consideration has been given to how risk assessments are used. To this end, the present study tests whether application of the risk principle would help preserve predictive accuracy while, at the same time, mitigate disparities. Using a sample of 9,529 inmates released from Minnesota prisons who had been assessed multiple times during their confinement on a fully-automated risk assessment, this study relies on both actual and simulated data to examine the impact of program assignment decisions on changes in risk level from intake to release. The findings showed that while the risk principle was used in practice to some extent, the simulated results showed that greater adherence to the risk principle would increase reductions in risk levels and minimize the disparities observed at intake. The simulated data further revealed the most favorable outcomes would be achieved by not only applying the risk principle, but also by expanding program capacity for the higher-risk inmates in order to adequately reduce their risk.

scholarly journals COVID-19 Risk Assessment: Contributing to Maintaining Urban Public Health Security and Achieving Sustainable Urban Development

2021 ◽  
Vol 13 (8) ◽  
pp. 4208
Author(s):  
Jun Zhang ◽  
Xiaodie Yuan
Keyword(s):  
Public Health ◽  
Population Density ◽  
Prevention And Control ◽  
Floating Population ◽  
Sustainable Urban Development ◽  
Risk Level ◽  
Health Security ◽  
Main Factors ◽  
And Control ◽  
Epidemic Risk

As the most infectious disease in 2020, COVID-19 is an enormous shock to urban public health security and to urban sustainable development. Although the epidemic in China has been brought into control at present, the prevention and control of it is still the top priority of maintaining public health security. Therefore, the accurate assessment of epidemic risk is of great importance to the prevention and control even to overcoming of COVID-19. Using the fused data obtained from fusing multi-source big data such as POI (Point of Interest) data and Tencent-Yichuxing data, this study assesses and analyzes the epidemic risk and main factors that affect the distribution of COVID-19 on the basis of combining with logistic regression model and geodetector model. What’s more, the following main conclusions are obtained: the high-risk areas of the epidemic are mainly concentrated in the areas with relatively dense permanent population and floating population, which means that the permanent population and floating population are the main factors affecting the risk level of the epidemic. In other words, the reasonable control of population density is greatly conducive to reducing the risk level of the epidemic. Therefore, the control of regional population density remains the key to epidemic prevention and control, and home isolation is also the best means of prevention and control. The precise assessment and analysis of the epidemic conducts by this study is of great significance to maintain urban public health security and achieve the sustainable urban development.

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