Audit Of Safety Research Articles

Разработка и внедрение системной модели аудита промышленной безопасности в организации

Information is provided on the legislative documents of the Russian Federation regulating the activities of organizations in the field of conducting internal audit of industrial safety. The relevance and expediency of applying the process approach at the stage of development and implementation of a system model of internal audit of industrial safety in an organization on the basis of GOST R ISO 19011—2021 is confirmed. The methodological substantiation of the process approach to the development of the industrial safety internal audit model using the well-known PDCA principle is given, the key issues of its applicability are considered. A matrix of processes and sub-processes was compiled in accordance with the typology of processes according to ISO (ISO/TC 176/SC 2/N 544R3), organization management processes, measurement, analysis and improvement processes, main processes and resource management processes, processes were also ranked by levels. The model was developed for creating a system model of internal audit of industrial safety in an organization based on the process approach, SADT structural analysis and design technology, and IDEF0 functional modeling methodology. The development of the main context diagram of the process of organizing and conducting an audit in the IDEF0 notation was carried out. The decomposition of processes of the second and third levels is considered, and all their functional connections are described. The presented process modeling methodology makes it possible to achieve a positive effect in terms of ensuring, minimizing costs and terms for developing a system model of an audit organization and conduct. It is demonstrated that the process approach used in the design of a system model of audit organization and conduct allows structuring the composition of processes, clearly defining the input and output parameters of processes, process participants, resources, ensuring control and adjustment of processes.

PO-2305 A Clinical Audit of Patient Safety in an Irish Radiotherapy Department

PO-2305 A Clinical Audit of Patient Safety in an Irish Radiotherapy Department

A clinical audit of patient safety in an Irish radiotherapy department

Abstract Introduction: Radiotherapy is an ever-changing field with constant technological advances. It is for this reason that risk management strategies are regularly updated in order to remain optimal. Methodology: A retrospective audit of all reported incidents and near misses in the audited department between 1 November 2020 and 30 April 2021 was performed. The root cause of each radiotherapy error (RTE), safety barrier (SB) and the causative factor (CF) would be defined by the Public Health England (PHE) coding system. The data will then be analysed to determine if there are any frequently occurring errors and if there are any existing relationships between multiple error. Results: 670 patients were treated during the study period along with 35 reports generated. 77·1% (n = 27) were incidents, and 22·9% (n = 8) were near misses. 2·8% (n = 1) were reportable incidents. The ratio of RTEs to prescriptions was 0·052:1 (5·2%). 37% of RTEs were associated with image production. Slips and lapses were involved in 54·2%. Adherence to procedures/protocols was a factor in 48·5% (n = 17). Communication was a factor in 11·4% (n = 4). Discussion: The proportion of Level 1 incidents was higher in this department (2·8%) than in the PHE report (0·9%). Almost one-third, 31·4% (n = 11) of errors stemmed from one technical fault in image production. SB breaches were prevalent at the pre-treatment planning stage of the pathway. A relationship between slips/lapses and non-conformance to protocols was identified. Conclusion: The rate of reported radiotherapy incidents in the UK is lower when compared with this department; this could be improved with the implementation of the quality improvement plan outlined above.

THE STEPS OF PRODUCTION RISK IDENTIFICATION AT THE INDUSTRIAL ENTERPRISE TO PROVIDE OCCUPATIONAL SAFETY

Problem statement. The development and implementation of key provisions to harmonize principles, methods, and risk assessment criteria for workers’ health with international approaches is a necessary condition for social and economic development of the state in order to integrate into global community. Moreover, the internal audit of occupational safety for the departments of the enterprise, according to the law of Ukraine «About occupational safety», should provide quantity assessment of professional and production risks for workers’ safety and health, taking into account the effect of hazardous factors for the workplace with harmful working conditions, as well as for production departments and the enterprise in general. The purpose of the research is to develop an algorithm to identify the level of production risk step by step for the workplace with admissible working conditions, for production departments with harmful working conditions and for the manufacturing enterprise in general. Conclusions. The research conducted has shown that the importance of professional and production risks should be taken into account to characterize not only occupational safety in the workplace with harmful and admissible working conditions, but also in the production departments and the manufacturing enterprise. The algorithm was developed to identify the level of production risks for the workplace with harmful and admissible working conditions, for the production departments considering all working places in order to compare accurately the risk level among production departments. The methods suggested for the annual internal audit of occupational safety at the enterprise departments allow taking high-priority actions for providing occupational safety, as well as developing enterprise policy in the field of occupational and production safety, and arranging necessary preparation for production certification according to the requirements of DSTU ISO 45001:2018 standard.

СИСТЕМА МЕНЕДЖМЕНТА КАЧЕСТВА В МЕДИЦИНСКОЙ ОРГАНИЗАЦИИ: ОТ ОСНОВ ДО ПРОЦЕССНОЙ МОДЕЛИ

Objective: To analyse the effectiveness of the quality management system (QMS) based on the amount of income for improving the quality of care in medical institutions Methods: Publications on patient safety and quality management system research were identified and analysed based on the library collection resources of the Mari State University, Yoshkar-Ola, Russia and research databases. A total of 727 results were retrieved, of which the authors preselected 121 based on keywords used; after analysing significant publications, 46 sources were finally selected. Results: The quality of medical care includes the internal audit of the quality and patient safety in hospital care. In turn, the internal audit of quality and patient safety can be limited to a 'simplified model' of the quality management system. n adequately compiled, an up-to-date, applicable checklist is intended for use in the audit process. The quality of audits, the designing of effective audit procedures, and the correct completion of checklists depend on the skills and competencies of the auditor. Integrating lean manufacturing into an existing quality management system may increase the cost of 'maintenance' of these systems. However, in the long term, the economic benefit will be more evident due to continuous quality improvement, cost reduction and growth of organisational maturity. The quality management system can be used as a method for assessing the effectiveness of the management process of a medical organisation at different levels: middle, auxiliary, and managerial. In this case, the quality management system becomes a superstructure over the management system based on hierarchical groups. Conclusion: A quality management system is a complex organisational model of a medical organisation that allows you to identify and improve processes, identify inconsistencies and solve them by considering the 'transparency' and 'understanding' of processes. Keywords: Quality management system, medical organisation, process management model, the safety of medical activities, lean manufacturing, checklist, audit.

An audit of safety reporting in randomized controlled trials over a five-year period in a high impact factor journal.

Randomized controlled trials [RCTs] form the corner-stone of evidence-based medicine. RCTs published in high impact factor journals such as the New England Journal of Medicine [NEJM] are a key driver of clinical practice and policy decisions. RCTs are expected to report both efficacy and safety, however, safety reporting in many studies tends to be poor. The present audit was undertaken with the primary objective of evaluating safety reporting during a five-year period in all RCTs published in the NEJM. PubMed alone was searched for RCTs published in NEJM from 2013-17. Each RCT was searched for the following outcome measures -whether the trial was sponsored by pharmaceutical industry or investigator initiated, phase of trial, nature of intervention and therapeutic area in terms of reporting of safety outcomes [with 'P values' or '95% confidence interval']. A total of n=623 articles reported safety outcomes of which 275/623 (44.1%) articles reported statistics for safety outcome. There was significant difference in reporting of safety statistics between investigator initiated studies and pharmaceutical industry sponsored studies, [cOR=4.0, 95% CI 2.8- 5.5 P < 0.001]; phase 3 and phase 4 trials, [cOR 0.67, 95% CI 0.5 - 0.9, P = 0.02]; trials involving drugs and surgery, [ cOR 2.07, 95% CI 1.2-3.5, P = 0.01] and in therapeutic areas, cardiovascular and oncology [cOR 0.26, 95% CI 0.1-0.4, P < 0.0001]. Safety reporting in RCTs continues to take a back seat relative to efficacy reporting and is worse for pharmaceutical industry funded studies. Safety reporting should be emphasized in the CONSORT guidelines.

Strengthening Inspection and Audit of Occupational Safety and Health in Coal Mining Enterprises in Vietnam

Coal mining is one of the heavy, hazardous industries. Therefore, workers in this industryalways face high risks of occupational accidents and diseases. According to the annual report of theMinistry of Labor, Invalids and Social Affairs (MoLISA), the situation of occupational accidents andillnesses in the mining sector in recent years has increased both in terms of number and severity, and thisincludes fatal occupational accidents in the coal mining industry. Currently, the authorities have beenimplementing inspection of occupational safety and health (OSH) to prevent and limit the situation. In thescope of this article, the author focuses on clarifying the position and the role of OSH inspecting whilepresenting and analyzing the results of the inspection of OSH legislation compliance within the coalmining industry nationwide. From there, proposing several solutions to strengthen inspection of OSH,prevent and limit occupational accidents and diseases in the coming time, contributing to improving theefficiency of state management of OSH in the coal mining industry in Vietnam today.

Colonic stenting in acute malignant large bowel obstruction: audit of efficacy and safety in a Singapore tertiary referral centre.

Acute malignant large bowel obstruction (MBO) occurs in 8%-15% of colorectal cancer patients. Self-expandable metal stents (SEMS) have progressed from a palliative modality to use as bridge to surgery (BTS). We aimed to assess the safety and efficacy of SEMS for MBO in our institution. The data of patients undergoing SEMS insertion for MBO were reviewed. Technical success was defined as successful SEMS deployment across tumour without complications. Clinical success was defined as colonic decompression without requiring further surgical intervention. Rates of complications, median time to surgery, types of surgery and rates of recurrence were studied. Seventy-nine patients underwent emergent SEMS placement from September 2013 to February 2020. Their mean age was 68.8 ± 13.8 years and 43 (54%) patients were male. Mean tumour length was 4.2 cm ± 2.2 cm; 89.9% of malignant strictures were located distal to the splenic flexure. Technical and clinical success was 94.9% and 98.7%, respectively. Perforation occurred in 5.1% of patients, with none having stent migration or bleeding. Fifty (63.3%) patients underwent SEMS insertion as BTS. Median time to surgery was 20 (range 6-57) days. Most (82%) patients underwent minimally invasive surgery. Primary anastomosis rate was 98%. Thirty-nine patients had follow-up beyond 1-year posttreatment (median 34 months). Local recurrence and distant metastasis were observed in 4 (10.3%) and 5 (12.8%) patients, respectively. Insertion of SEMS for acute MBO has high success rates and a good safety profile. Most patients in this audit underwent minimally invasive surgery and primary anastomosis after successful BTS.

Параллель между экономической дестабилизацией и созданием безопасных условий труда в субъектах малого предпринимательства в Республике Узбекистан

Small business plays a significant role in the economy of the state and in providing employment for the population. This is confirmed by the statistical indicators of the share of small business in the gross domestic product of the Republic of Uzbekistan over the past 5 years — in 2020 it reached 48 %, while the share of employment in the small business sector was 68 %. Considering that the small business sector during the pandemic often escaped the attention of the state control over working conditions, it can be concluded that a significant part of the small business employees works in potentially unsafe conditions. The main economic and social problems in the sphere of small and medium-sized businesses, directly or indirectly affecting occupational safety are considered in the article. Analysis of the statistical data revealed the dependence between the economic destabilization, and an increase in incidents: their growth in 2020 amounted to almost 50 % in relation to 2019. It is concluded that forcing small businesses to work in accordance with the international codes and the current Occupational safety and health management system in the event of a crisis is inappropriate. Proposals were formulated on transforming the work of such enterprises, considering their capabilities, in three stages: mass audit of Occupational safety and health management system of small enterprises considering their structural and target differences; systematization of occupational safety management processes in the small businesses; introduction of Occupational safety and health management system as the main anti-crisis measure for the small businesses.

QUALIFICATION REQUIREMENTS FOR INDIVIDUALS AND ORGANIZATIONS WHICH CONDUCT THE AUDIT ON CIVIL PROTECTION, TECHNOGENIC AND FIRE SAFETY

Introduction. In this study, the problem of audit concept definition scarcity in legal documents (expert assessment) of civil protection, technological, and fire safety was considered. Specific qualification requirements, structure, rights, respon-sibilities, reports, a system for conducting and results registration of auditor inspections and audit organizations working in civil protection field and fire safety inspection have not been approved.Today, the issue of audit (expert assessment) of civil protection, technological, fire safety, and insurance of facilities is becoming the most pressing issue. Society, and in particular businesses, are reorienting themselves to European standards of doing business, where property insurance is necessary, and it guarantees them compensation in the case of an emergency.Purpose. The main purpose of the article is to highlight the problem of the lack of a rightful audit concept in civil protection, technological, and fire safety.Methods. Expert assessment of the state of businesses, institutions, and organizations, regardless of their ownership form, makes it possible to get a full picture of object shortcomings, proposals for their elimination, without prosecuting officials quickly and efficiently and without terminating the installation, units and the object as a whole. The audit is a kind of state supervision (control) in the field of civil protection, technological, and fire safety, but without administrative and legal consequences. Based on legal documents analysis in the field of civil protection and fire safety, processing of auditors' feedback, and practical experience of the authors of the article, the main scientific results are proposed.Results. The authors show organizational structure of audit associations. Also, the authors’ qualification requirements for auditors (experts) and their assistants, including the availability of relevant education, experience in practical, teaching, and research work in the field of civil security, and passing the qualifying examination was proposed.Conclusion. According to this organizational structure, high-class auditors create an association that will determine (organize) the activities of all levels of experts. The next step is the high-class experts, who form the relevant associations on a territorial basis, which control the activities of the first and second class experts. The last step is the first and second class auditors, who report to the higher class auditors in their activities.The proposed results should be taken into account in the existing regulations on auditing or a separate regulation in the field of civil protection, technological, and fire safety.

Audit of occupational health and safety in an enterprise of the ceramic sector in the state of Amazonas/Brazil

Este trabalho objetiva conduzir uma auditoria de saúde e segurança ocupacional em uma empresa do setor cerâmico no estado do Amazonas. Com relação à abordagem do problema, este estudo caracteriza-se como quantitativo e exploratório no que tange os objetivos. A técnica de pesquisa utilizada foi o estudo de caso em uma empresa do setor cerâmico localizada no estado do Amazonas. Entre os principais resultados estão análise mais aprofundada das atividades desenvolvidas na empresa, identificando os fatores de riscos nos diferentes setores, identificando padrões mais positivos e negativos, podendo assim verificar se estão de acordo com o que está estabelecido. A relevância do estudo reside na aplicação de um instrumento que possibilita identificar os principais fatores de risco relacionados à saúde e segurança ocupacional.

Limiting infusion and observation times for infliximab and vedolizumab in the COVID-19 pandemic: a UK multicentre audit of practice and safety

Background:Infusions units in the UK are under increasing pressure, and this has been increased by the SARS-COV-2 pandemic. People with inflammatory bowel disease (IBD) are considered vulnerable, requiring enhanced social distancing or shielding, as defined in the UKz government's recommendations for COVID-19. Evidence that post-infusion observation time is unnecessary for infliximab (IFX) and vedolizumab (VDZ) exists in the literature, but the summary of product characteristics for both agents states that anywhere from 0.5 hours to 2 hours of observation post-infusion is required.Methods:A call was put out using the Royal College of Nursing's Facebook page, and IBD nurses from eight trusts in the UK took part. Data were gathered on trusts' current practice, infusion times for IFX and VDZ and reported infusion reactions.Results:Two (25%) trusts reported already having reduced post-infusion observation periods for people receiving IFX infusions 1–3; this increased to three units (37.5%) for infusions 4–9 and six (75%) for infusions &gt;10. No infusion reactions were seen after the first 20 minutes of infusion time in 3934 IFX and 1265 VDZ infusions.Conclusions:The audit results suggested that there is no safety signal reduced post-infusion observation time, supporting evidence already present in the literature, and this can support increased capacity in infusion units. The time burden for people with Crohn's disease (CD) or ulcerative colitis (UC) is reduced, which is increasingly important during the pandemic. The reduced length of time that people need to spend at hospital offers trusts an option to help shield those who need to be protected from COVID-19.

TECHNOLOGY FOR CONDUCTING AN EXTERNAL AUDIT OF FIRE SAFETY

TECHNOLOGY FOR CONDUCTING AN EXTERNAL AUDIT OF FIRE SAFETY

P007: Audit of safety and feasibility of magseedt localised wide local excisions at a single centre

Introduction: Wire-localised wide local excision (W-WLE) is a widely practiced approach for impalpable breast tumours. Challenges such as wire migration and logistics of same day insertion are often encountered. MagseedT is a metallic marker clip for localisation and can be inserted up to 30-days in advance. The present audit has assessed the safety and feasibility of MagseedT in comparison to W-WLEs.

122 - Audit of safety and tolerability of combination platinum-pemetrexed-pembrolizumab in advanced non-squamous NSCLC in the real-world setting of a UK Cancer Centre

122 - Audit of safety and tolerability of combination platinum-pemetrexed-pembrolizumab in advanced non-squamous NSCLC in the real-world setting of a UK Cancer Centre

АУДИТ БЕЗОПАСНОСТИ ДОРОЖНОГО ДВИЖЕНИЯ НА ФЕДЕРАЛЬНЫХ ТРАССАХ КРАСНОЯРСКОГО КРАЯ

The paper considers an assignment and an essence of audit of road traffic safety. As an example, the authors have determined a priority section on federal roads of Krasnoyarsk Territory for conducting the audit. On the basis of detailed analysis of road conditions that affect the risk of accidents appearance and research of road traffic accidents mechanism on that section the authors have developed measures on decreasing accident rate. Efficiency of the proposed measures are verified with the use of PC–Crash program for modeling and reconstruction of road traffic accidents.

Behavioral audit of safety as a tool for decreasing occupational health and safety risk of healthcare providers

The causes of the high infection rate of health workers in case of unfavorable epidemic situation,as well as occupational risks of health workers related to work conditions characterized by the presence of a complex of unfavorable factors of production environment; noted the combined effects of behavioural risk factors for health of health workers with professional risk, enhancing the cumulative negative impacts in professional deformation of the part of health workers, neglecting the requirements of safe labour; stressed the need for preventive work based on continuous and effective monitoring and evaluation of improvement actions, improvement and development of the management system of occupational health and safety is regulated by the system of standards for labor safety, a significant lack of which in healthcare institutions is the lack of such an effective interactive tool for enhancing motivation.

АНАЛІЗ ІСНУЮЧОЇ МЕТОДИКИ ПРОВЕДЕННЯ АУДИТУ БЕЗПЕКИ КОМП’ЮТЕРНИХ СИСТЕМ В ДЕРЖАВНИХ ОРГАНАХ

Предметом статті є аналіз існуючих методик проведення аудиту безпеки, які нормативно закріплені в Україні та використовуються посадовими особами Державної служби спеціального зв’язку та захисту інформації України. Результати. Проаналізовано існуючу методику проведення перевірок захищеності інформації в інформаційнотелекомунікаційних системах державних органів, органів місцевого самоврядування, підприємств установ та організацій. Враховуючи недоліки існуючої системи проведення перевірок з захисту інформації та введенням в дію Закону України «Про основні засади забезпечення кібербезпеки України» від 05.10.2017 року № 2163-VIII запропоновано підходи до проведення перевірок кіберзахисту державних інформаційних ресурсів та інформації, вимога щодо захисту якої встановлено законодавством. Висновок. Обґрунтована необхідність розробки методології визначення реального стану захищеності інформаційних систем, в яких циркулює інформація, що потребує захисту згідно вимог законодавства України.

Membrane-filtration based plasma exchanges for atypical hemolytic uremic syndrome: Audit of efficacy and safety.

While complement blockade with eculizumab is recommended as first-line therapy of atypical hemolytic uremic syndrome (aHUS), plasma exchanges (PEX) remain the chief option for anti-factor H (FH) antibody associated disease and when access to eculizumab is limited. We reviewed adverse events (AEs) and adverse outcomes (eGFR <30 mL/min/1.73 m2 or death), in all patients with aHUS managed with membrane-filtration based PEX at one tertiary care center over 5.5 years. During January 2013 to June 2018, 109 patients with aHUS (74 with antibodies to FH), aged median (range) 7.6 (0.5-18) year weighing 22.1 (6-90) kg, underwent 2024 sessions of PEX. AE, in 12.1% patients, were usually self-limiting and included chills (5.5%), vomiting/abdominal pain (3.3%), hypotension (1.6%), urticaria (1.5%), seizures (0.2%), hypocalcemia (0.2%), and hemorrhage (0.1%); plasma hypersensitivity and severe reactions were rare. Rate of catheter-related infections was 1.45/1000 catheter-days. Filter reuse (OR 1.69; 95% CI 1.26-2.26; P < .001) and >20 sessions of PEX/patient (OR 1.99; 95% CI 1.27-3.10; P = .002) were independently associated with adverse events; infusion of IV calcium gluconate during PEX was protective (OR 0.26; 95% CI 0.16-0.43; P < .001). Hematological remission was achieved in 96.3% patients after 6 (5-8) PEX sessions; 80.8% and 89.6% patients were dialysis independent by one and 3 months, respectively. PEX is safe and associated with satisfactory short-term outcomes in children with aHUS. Prolonged PEX and filter-reuse are associated with complications.

Quantifying the risk of nosocomial infection within Ebola Holding Units: a retrospective cohort study of negative patients discharged from five Ebola Holding Units in Western Area, Sierra Leone.

A central pillar in the response to the 2014 Ebola virus disease (EVD) epidemic in Sierra Leone was the role of Ebola Holding Units (EHUs). These units isolated patients meeting a suspect case definition, tested them for EVD, initiated appropriate early treatment and discharged negative patients to onward inpatient care or home. Positive patients were referred to Ebola Treatment Centres. We aimed to estimate the risk of nosocomial transmission within these EHUs. We followed up a cohort of 543 patients discharged with a negative EVD test from five EHUs in the Western Area, Sierra Leone, and examined all line-listed subsequent EVD tests from any facility in the Western Area to see whether the patient was retested within 30 days, matching by name, age and address. We defined possible readmissions as having the same name and age but uncertain address, and confirmed readmissions where name, age and address matched. We found a positive readmission rate of 3.3% (18 cases), which included 1.5% confirmed readmissions (8 cases) and 1.8% possible readmissions (10 cases). This is lower than rates previously reported. We cannot ascertain whether EVD was acquired within the EHUs or from re-exposure in the community. No demographic or clinical variables were identified as risk factors for positive readmission, likely due to our small sample size. These findings support the EHU model as a safe method for isolation of suspect EVD patients and their role in limiting the spread of EVD.