Kielty, Lucy Ann
Purpose The purpose of this paper is to describe a study which aimed to develop and validate an assessment method for the International Electrotechnical Commission (IEC) 80001-1 (IEC, 2010) standard (the Standard); raise awareness; improve medical IT-network project risk management processes; and improve intensive care unit patient safety. Design/methodology/approach An assessment method was developed and piloted. A healthcare IT-network project assessment was undertaken using a semi-structured group interview with risk management stakeholders. Participants provided feedback via a questionnaire. Descriptive statistics and thematic analysis was undertaken. Findings The assessment method was validated as fit for purpose. Participants agreed (63 per cent, n=7) that assessment questions were clear and easy to understand, and participants agreed (82 per cent, n=9) that the assessment method was appropriate. Participant's knowledge of the Standard increased and non-compliance was identified. Medical IT-network project strengths, weaknesses, opportunities and threats in the risk management processes were identified. Practical implications The study raised awareness of the Standard and enhanced risk management processes that led to improved patient safety. Study participants confirmed they would use the assessment method in future projects. Originality/value Findings add to knowledge relating to IEC 80001-1 implementation.
Maqueda Palau, M; Pérez Juan, E
To determine the level of risk in the preparation and administration of antibiotics frequently used in the Intensive Care Unit using a risk matrix. A study was conducted using situation analysis and literature review of databases, protocols and good practice guidelines on intravenous therapy, drugs, and their administration routes. The most used antibiotics in the ICU registered in the ENVIN-HELICS program from 1 April to 30 June 2015 were selected. In this period, 257 patients received antimicrobial treatment and 26 antibiotics were evaluated. Variables studied: A risk assessment of each antibiotic using the scale Risk Assessment Tool, of the National Patient Safety Agency, as well as pH, osmolarity, type of catheter recommended for administration, and compatibility and incompatibility with other antibiotics studied. Almost two-thirds (65.3%) of antibiotics had more than 3 risk factors (represented by a yellow stripe), with the remaining 34.7% of antibiotics having between 0 and 2 risk factors (represented by a green stripe). There were no antibiotics with 6 or more risk factors (represented by a red stripe). Most drugs needed reconstitution, additional dilution, and the use of part of the vial to administer the prescribed dose. More than half of the antibiotics studied had a moderate risk level; thus measures should be adopted in order to reduce it. The risk matrix is a useful tool for the assessment and detection of weaknesses associated with the preparation and administration of intravenous antibiotics. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.
Matarazzo, Bridget B; Homaifar, Beeta Y; Wortzel, Hal S
This column is the fourth in a series describing a model for therapeutic risk management of the suicidal patient. Previous columns presented an overview of the therapeutic risk management model, provided recommendations for how to augment risk assessment using structured assessments, and discussed the importance of risk stratification in terms of both severity and temporality. This final column in the series discusses the safety planning intervention as a critical component of therapeutic risk management of suicide risk. We first present concerns related to the relatively common practice of using no-suicide contracts to manage risk. We then present the safety planning intervention as an alternative approach and provide recommendations for how to use this innovative strategy to therapeutically mitigate risk in the suicidal patient.
Simon, Robert I.
Guns in the home are associated with a five-fold increase in suicide. All patients at risk for suicide must be asked if guns are available at home or easily accessible elsewhere, or if they have intent to buy or purchase a gun. Gun safety management requires a collaborative team approach including the clinician, patient, and designated person…
Knox, G E; Kelley, M; Hodgson, S; Simpson, K R; Carrier, L; Berry, D
Downsizing and reengineering are facts of life in contemporary healthcare organizations. In most instances, these organizational changes are undertaken in an attempt to increase productivity or cut operational costs with results measured in these terms. Less often considered are potential detrimental effects on patient safety or strategies, which might be used to minimize these risks.
St Pierre, Michael
Safety culture is positioned at the heart of an organization's vulnerability to error because of its role in framing organizational awareness to risk and in providing and sustaining effective strategies of risk management. Safety related attitudes of leadership and management play a crucial role in the development of a mature safety culture ("top-down process"). A type marker for organizational culture and thus a predictor for an organization's maturity in respect to safety is information flow and in particular an organization's general way of coping with information that suggests anomaly. As all values and beliefs, relationships, learning, and other aspects of organizational safety culture are about sharing and processing information, safety culture has been termed "informed culture". An informed culture is free of blame and open for information provided by incidents. "Incident reporting systems" are the backbone of a reporting culture, where good information flow is likely to support and encourage other kinds of cooperative behavior, such as problem solving, innovation, and inter-departmental bridging. Another facet of an informed culture is the free flow of information during perioperative patient care. The World Health Organization's safe surgery checklist" is the most prevalent example of a standardized information exchange aimed at preventing patient harm due to information deficit. In routine tasks mandatory standard operating procedures have gained widespread acceptance in guaranteeing the highest possible process quality. Technical and non-technical skills of healthcare professionals are the decisive human resource for an efficient and safe delivery of patient care and the avoidance of errors. The systematic enhancement of staff qualification by providing training opportunities can be a major investment in patient safety. In recent years several otorhinolaryngology departments have started to incorporate stimulation based team trainings into their
St Pierre, M
Safety culture is positioned at the heart of an organisation's vulnerability to error because of its role in framing organizational awareness to risk and in providing and sustaining effective strategies of risk management. Safety related attitudes of leadership and management play a crucial role in the development of a mature safety culture ("top-down process"). A type marker for organizational culture and thus a predictor for an organizations maturity in respect to safety is information flow and in particular an organization's general way of coping with information that suggests anomaly. As all values and beliefs, relationships, learning, and other aspects of organizational safety culture are about sharing and processing information, safety culture has been termed "informed culture". An informed culture is free of blame and open for information provided by incidents. "Incident reporting systems" are the backbone of a reporting culture, where good information flow is likely to support and encourage other kinds of cooperative behavior, such as problem solving, innovation, and inter-departmental bridging. Another facet of an informed culture is the free flow of information during perioperative patient care. The World Health Organisation's "safe surgery checklist" is the most prevalent example of a standardized information exchange aimed at preventing patient harm due to information deficit. In routine tasks mandatory standard operating procedures have gained widespread acceptance in guaranteeing the highest possible process quality.Technical and non-technical skills of healthcare professionals are the decisive human resource for an efficient and safe delivery of patient care and the avoidance of errors. The systematic enhancement of staff qualification by providing training opportunities can be a major investment in patient safety. In recent years several otorhinolaryngology departments have started to incorporate simulation based team trainings into their curriculum
Orel, Howard; McGroarty, Molly; Marchegiani, Heather
Health care continues to evolve at a rapid rate. Over just the past decade, the industry has seen the introduction and widespread implementation of an electronic health record, increase in presence of nurse practitioners and physician assistants to help manage the shortage of physicians, and the introduction of accountable care organizations. It is with these changes that new challenges and opportunities emerge. One such challenge is the increase in the severity of medical malpractice claims throughout the nation. Another emerging challenge is the introduction of outcome-based reimbursements, with providers potentially losing a portion of their payment should the patient experience result in a preventable adverse event. These trends are resulting in providers continuously seeking innovative approaches to reducing risk and improving patient safety. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.
Gaffey, Ann D
We set priorities every day in both our personal and professional lives. Some decisions are easy, while others require much more thought, participation, and resources. The difficult or less appealing priorities may not be popular, may receive push-back, and may be resource intensive. Whether personal or professional, the urgency that accompanies true priorities becomes a driving force. It is that urgency to ensure our patients' safety that brings many of us to work each day. This is not easy work. It requires us to be knowledgeable about the enterprise we are working in and to have the professional skills and competence to facilitate setting the priorities that allow our organizations to minimize risk and maximize value. © 2016 American Society for Healthcare Risk Management of the American Hospital Association.
To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.
Rodrigues, S.P.; Ter Kuile, M.; Dankelman, J.; Jansen, F.W.
This study was conducted to adapt and validate a patient safety (PS) framework for minimally invasive surgery (MIS) as a first step in understanding the clinical relevance of various PS risk factors in MIS. Eight patient safety risk factor domains were identified using frameworks from a systems
Källberg, Ann-Sofie; Ehrenberg, Anna; Florin, Jan; Östergren, Jan; Göransson, Katarina E
The emergency department has been described as a high-risk area for errors. It is also known that working conditions such as a high workload and shortage off staff in the healthcare field are common factors that negatively affect patient safety. A limited amount of research has been conducted with regard to patient safety in Swedish emergency departments. Additionally, there is a lack of knowledge about clinicians' perceptions of patient safety risks. Therefore, the purpose of this study was to describe emergency department clinicians' experiences with regard to patient safety risks. Semi-structured interviews were conducted with 10 physicians and 10 registered nurses from two emergency departments. Interviews were analysed by inductive content analysis. The experiences reflect the complexities involved in the daily operation of a professional practice, and the perception of risks due to a high workload, lack of control, communication and organizational failures. The results reflect a complex system in which high workload was perceived as a risk for patient safety and that, in a combination with other risks, was thought to further jeopardize patient safety. Emergency department staff should be involved in the development of patient safety procedures in order to increase knowledge regarding risk factors as well as identify strategies which can facilitate the maintenance of patient safety during periods in which the workload is high. Copyright © 2017 Elsevier Ltd. All rights reserved.
Mansfield, James G; Caplan, Robert A; Campos, John S; Dreis, David F; Furman, Cathie
Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.
Vonnes, Cassandra; Wolf, Darcy
Falls are multifactorial in medical oncology units and are potentiated by an older adult's response to anxiolytics, opiates and chemotherapy protocols. In addition, the oncology patient is at an increased risk for injury from a fall due to coagulopathy, thrombocytopenia and advanced age. At our National Cancer Institute-designated inpatient cancer treatment centre located in the southeastern USA, 40% of the total discharges are over the age of 65. As part of a comprehensive fall prevention programme, bimonthly individual fall reports have been presented with the Chief Nursing Officer (CNO), nursing directors, nurse managers, physical therapists and front-line providers in attendance. As a result of these case discussions, in some cases, safety recommendations have not been followed by patients and families and identified as an implication in individual falls. Impulsive behaviour was acknowledged only after a fall occurred. A medical oncology unit was targeted for this initiative due to a prolonged length of stay. This patient population receives chemotherapeutic interventions, management of oncological treatment consequences and cancer progression care. The aim of this project was to explore if initiation of a Fall Prevention Agreement between the nursing team and older adults being admitted to medical oncology units would reduce the incidence of falls and the incidence of falls with injury. In order to promote patient and family participation in the fall reduction and safety plan, the Fall Risk and Prevention Agreement was introduced upon admission. Using the Morse Fall Scoring system, patient's risk for fall was communicated on the Fall Risk and Prevention Agreement. Besides admission, patients were reassessed based on change of status, transfer or after a fall occurs. Fall and fall injuries rates were compared two-quarters prior to implementation of the fall agreement and eight-quarters post implementation. Falls and fall injuries on the medical oncology unit
Virginio, Luiz A; Ricarte, Ivan Luiz Marques
Although Electronic Health Records (EHR) can offer benefits to the health care process, there is a growing body of evidence that these systems can also incur risks to patient safety when developed or used improperly. This work is a literature review to identify these risks from a software quality perspective. Therefore, the risks were classified based on the ISO/IEC 25010 software quality model. The risks identified were related mainly to the characteristics of "functional suitability" (i.e., software bugs) and "usability" (i.e., interface prone to user error). This work elucidates the fact that EHR quality problems can adversely affect patient safety, resulting in errors such as incorrect patient identification, incorrect calculation of medication dosages, and lack of access to patient data. Therefore, the risks presented here provide the basis for developers and EHR regulating bodies to pay attention to the quality aspects of these systems that can result in patient harm.
Certification of conformity in health care should provide assurance of compliance with quality standards. This also includes risk management and patient safety. Based on a comprehensive definition of quality, beneficial effects on the management of risks and the enhancement of patient safety can be expected from certification of conformity. While these effects have strong face validity, they are currently not sufficiently supported by evidence from health care research. Whether this relates to a lack of evidence or a lack of investigation remains open. Advancing safety culture and "climate", as well as learning from adverse events rely in part on quality management and are at least in part reflected in the certification of healthcare quality. However, again, evidence of the effectiveness of such measures is limited. Moreover, additional factors related to personality, attitude and proactive action of healthcare professionals are crucial factors in advancing risk management and patient safety which are currently not adequately reflected in certification of conformity programs.
Pfeiffer, Yvonne; Schwappach, David
National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts. Copyright © 2016. Published by Elsevier GmbH.
van Beuzekom Martie
Full Text Available Abstract Background Patient safety is one of the greatest challenges in healthcare. In the operating room errors are frequent and often consequential. This article describes an approach to a successful implementation of a patient safety program in the operating room, focussing on latent risk factors that influence patient safety. We performed an intervention to improve these latent risk factors (LRFs and increase awareness of patient safety issues amongst OR staff. Methods Latent risk factors were studied using a validated questionnaire applied to the OR staff before and after an intervention. A pre-test/post-test control group design with repeated measures was used to evaluate the effects of the interventions. The staff from one operating room of an university hospital acted as the intervention group. Controls consisted of the staff of the operating room in another university hospital. The outcomes were the changes in LRF scores, perceived incident rate, and changes in incident reports between pre- and post-intervention. Results Based on pre-test scores and participants’ key concerns about organizational factors affecting patient safety in their department the intervention focused on the following LRFs: Material Resources, Training and Staffing Recourses. After the intervention, the intervention operating room - compared to the control operating room - reported significantly fewer problems on Material Resources and Staffing Resources and a significantly lower score on perceived incident rate. The contribution of technical factors to incident causation decreased significantly in the intervention group after the intervention. Conclusion The change of state of latent risk factors can be measured using a patient safety questionnaire aimed at these factors. The change of the relevant risk factors (Material and Staffing resources concurred with a decrease in perceived and reported incident rates in the relevant categories. We conclude that
Banks, Peter; Brown, Richard; Laslowski, Alex; Daniels, Yvonne; Branton, Phil; Carpenter, John; Zarbo, Richard; Forsyth, Ramses; Liu, Yan-Hui; Kohl, Shane; Diebold, Joachim; Masuda, Shinobu; Plummer, Tim; Dennis, Eslie
Anatomic pathology laboratory workflow consists of 3 major specimen handling processes. Among the workflow are preanalytic, analytic, and postanalytic phases that contain multistep subprocesses with great impact on patient care. A worldwide representation of experts came together to create a system of metrics, as a basis for laboratories worldwide, to help them evaluate and improve specimen handling to reduce patient safety risk. Members of the Initiative for Anatomic Pathology Laboratory Patient Safety (IAPLPS) pooled their extensive expertise to generate a list of metrics highlighting processes with high and low risk for adverse patient outcomes. : Our group developed a universal, comprehensive list of 47 metrics for patient specimen handling in the anatomic pathology laboratory. Steps within the specimen workflow sequence are categorized as high or low risk. In general, steps associated with the potential for specimen misidentification correspond to the high-risk grouping and merit greater focus within quality management systems. Primarily workflow measures related to operational efficiency can be considered low risk. Our group intends to advance the widespread use of these metrics in anatomic pathology laboratories to reduce patient safety risk and improve patient care with development of best practices and interlaboratory error reporting programs. © American Society for Clinical Pathology 2017.
Coronado-Vázquez, Valle; García-López, Ana; López-Sauras, Susana; Turón Alcaine, José María
Patient safety and quality of care in a highly complex healthcare system depends not only on the actions of professionals at an individual level, but also on interaction with the environment. Proactive risk management in the system to prevent incidents and activities targeting healthcare teams is crucial in establishing a culture of safety in centres. Nurses commonly lead these safety strategies. Even though safety incidents are relatively infrequent in primary care, since the majority are preventable, actions at this level of care are highly effective. Certification of services according to ISO standard 9001:2008 focuses on risk management in the system and its use in certifying healthcare centres is helping to build a safety culture amongst professionals. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.
of health care professional’s behaviour, habits, norms, values, and basic assumptions related to patient care; it is the way things are done. The patient safety culture guides the motivation, commitment to and know-how of the safety management, and how all members of a work place interact. This thesis......Patient safety is highly prioritised in the Danish health care system, never the less, patients are still exposed to risk and harmed every day. Implementation of a patient safety culture has been suggested an effective mean to protect patients against adverse events. Working strategically...
Full Text Available This paper is intended to discuss a critical need expressed by present healthcare system of India, and how to provide a better health facility and diluting the medication errors caused by inappropriate management of the hospitals. Adverse events related to medication occur due to pathetic infrastructures, corporal punishment by the patient if unsatisfied, doctors on strike and working only for riches, trivial financial aid, and lack of basic amenities in the government-run hospitals of India. Government should reduce the barriers of awareness, accountability, ability, and action into accelerators of patient safety in the government organizations. Physicians, nurses, and pharmacists are truly the critical ingredient to rapid safety practice adoption. Various approaches like Technological Iatrogenesis, Computerized Provider Order Entry, and Electronic Health Record should be used. Although patient safety is recognized as a serious issue in health system, there is an urgent need for development and implementation of strategies for prevention and early detection of errors.
Johnstone, Megan-Jane; Kanitsaki, Olga
Nurses have a pivotal role to play in clinical risk management (CRM) and promoting patient safety in health care domains. Accordingly, nurses need to be prepared educationally to manage clinical risk effectively when delivering patient care. Just what form the CRM and safety education of nurses should take, however, remains an open question. A recent search of the literature has revealed a surprising lack of evidence substantiating models of effective CRM and safety education for nurses. In this paper, a critical discussion is advanced on the question of CRM and safety education for nurses and the need for nurse education in this area to be reviewed and systematically researched as a strategic priority, nationally and internationally. It is a key contention of this paper that without 'good' safety education research it will not be possible to ensure that the educational programs that are being offered to nurses in this area are evidence-based and designed in a manner that will enable nurses to develop the capabilities they need to respond effectively to the multifaceted and complex demands that are inherent in their ethical and professional responsibilities to promote and protect patient safety and quality care in health care domains.
van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula
A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a
Vogl, Thomas J. [University Hospital Frankfurt, Johann Wolfgang Goethe-University, Department of Radiology, Frankfurt (Germany); J. W. Goethe University of Frankfurt, Institute of Diagnostic and Interventional Radiology, Frankfurt (Germany); Honold, Elmar [Guerbet GmbH, Sulzbach (Germany); Wolf, Michael [Michael Wolf Information Systems, Puettlingen (Germany); Mohajeri, H.; Hammerstingl, R. [University Hospital Frankfurt, Johann Wolfgang Goethe-University, Department of Radiology, Frankfurt (Germany)
The purpose of this study was to review the rate of adverse events after contrast medium administration in the general population and at-risk patients (renal impairment, heart failure (NYHA III or IV), hypotension or hypertension, coronary artery disease, previous reaction to contrast media, asthma and/or allergies, dehydration, diabetes mellitus, poor general condition) under daily practice conditions in a post-marketing surveillance study. Two hundred and ten radiologists conducted various X-ray examinations in 52,057 patients. To document the safety of iobitridol in routine use, all patients undergoing X-ray examinations were included. Exclusion criteria were contraindications listed in the locally approved summary of product characteristics. The adverse event rate was 0.96% (at-risk patients 1.39%); the rate of serious adverse events 0.044% in all patients (at-risk patients 0.057%). Adverse events occurred more often in women than in men (P<0.001). In patients who had previously reacted to a contrast medium, adverse events were reported in 3.43% with mild to moderate symptoms. In 47.76% of these patients, a premedication was administered. There was no difference in the frequency of adverse events and serious adverse events whether premedicated or not (P=0.311 and P=0.295, respectively). Iobitridol was well-tolerated in 99.04% of cases (at-risk patients 98.61%). (orig.)
Dudding, Katherine M; Gephart, Sheila M; Carrington, Jane M
In this article, we examine the unintended consequences of nurses' use of electronic health records. We define these as unforeseen events, change in workflow, or an unanticipated result of implementation and use of electronic health records. Unintended consequences experienced by nurses while using electronic health records have been well researched. However, few studies have focused on neonatal nurses, and it is unclear to what extent unintended consequences threaten patient safety. A new instrument called the Carrington-Gephart Unintended Consequences of Electronic Health Record Questionnaire has been validated, and secondary analysis using the tool explored the phenomena among neonatal nurses (N = 40). The purposes of this study were to describe unintended consequences of use of electronic health records for neonatal nurses and to explore relationships between the phenomena and characteristics of the nurse and the electronic health record. The most frequent unintended consequences of electronic health record use were due to interruptions, followed by a heavier workload due to the electronic health record, changes to the workflow, and altered communication patterns. Neonatal nurses used workarounds most often with motivation to better assist patients. Teamwork was moderately related to higher unintended consequences including patient safety risks (r = 0.427, P = .007), system design (r = 0.419, P = .009), and technology barriers (r = 0.431, P = .007). Communication about patients was reduced when patient safety risks were high (r = -0.437, P = .003). By determining the frequency with which neonatal nurses experience unintended consequences of electronic health record use, future research can be targeted to improve electronic health record design through customization, integration, and refinement to support patient safety and better outcomes.
Keohane, Carol A; Dwyer, Kathy; Boulanger, Jason; Zigmont, Katherine; Babayan, Astrid; Cushing, Elizabeth; Walsh, Brian
Implementing evolving science into clinical practice remains challenging. Assimilating new scientific evidence into clinical protocols and best practice recommendations, in a timely manner, can be difficult. In this article, we examine the value of partnering with a captive medical malpractice insurance company and its Patient Safety Organization to use data and convening opportunities to build upon the principles of implementation science and foster efficient and widespread adoption of the most current evidence-based interventions. Analyses of medical malpractice and root-cause analysis data set the context for this partnership and acted as a catalyst for creating best practice guidelines for adopting therapeutic hypothermia in the treatment of neonatal encephalopathy. What follows is a powerful example of successfully leveraging the collective wisdom of healthcare providers across specialties and institutional lines to move patient safety forward while managing risk.
Procopio, Giuseppe; Grassi, Paolo; Testa, Isabella; Verzoni, Elena; Torri, Valter; Salvioni, Roberto; Valdagni, Riccardo; de Braud, Filippo
The aim of this study was to evaluate the safety profile of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) men with cardiovascular comorbidity, as little conclusive safety data are available in this patient subset. A retrospective analysis of mCRPC patients with controlled cardiovascular comorbidities, receiving AA 1000 mg administered orally once daily and prednisone 5 mg twice daily, between April 2011 and July 2012, was performed. All clinical and instrumental variables and toxicity data were analyzed by descriptive statistics: mean, standard deviation, minimum and maximum values for continuous variables, and absolute and relative frequencies for categorical variables. A total of 51 mCRPC patients were evaluated. Metastatic sites included the bone (74%), lungs, and liver (26%). All patients were previously treated with at least 2 lines of hormone and 1 docetaxel-based chemotherapy. Preexisting cardiac risk factors included hypertension (41%), cardiac ischemia (12%), arrhythmias (6%), dislipidemia (18%), and hyperglycemia (30%). No grade 3-4 adverse events were observed. Grade 1-2 adverse events included fluid retention (18%), asthenia (15%), and hypertension (16%). Median progression-free survival was 5.1 months (95% confidence interval, 0.5-12). Prostate specific antigen assessment revealed a good overall disease control rate (64%). AA appears to be safe and well tolerated even in patients with cardiovascular comorbidities or with increased risk factors for cardiovascular diseases.
Balaban, Richard B; Galbraith, Alison A; Burns, Marguerite E; Vialle-Valentin, Catherine E; Larochelle, Marc R; Ross-Degnan, Dennis
Evidence-based interventions to reduce hospital readmissions may not generalize to resource-constrained safety-net hospitals. To determine if an intervention by patient navigators (PNs), hospital-based Community Health Workers, reduces readmissions among high risk, low socioeconomic status patients. Randomized controlled trial. General medicine inpatients having at least one of the following readmission risk factors: (1) age ≥60 years, (2) any in-network inpatient admission within the past 6 months, (3) length of stay ≥3 days, (4) admission diagnosis of heart failure, or (5) chronic obstructive pulmonary disease. The analytic sample included 585 intervention patients and 925 controls. PNs provided coaching and assistance in navigating the transition from hospital to home through hospital visits and weekly telephone outreach, supporting patients for 30 days post-discharge with discharge preparation, medication management, scheduling of follow-up appointments, communication with primary care, and symptom management. The primary outcome was in-network 30-day hospital readmissions. Secondary outcomes included rates of outpatient follow-up. We evaluated outcomes for the entire cohort and stratified by patient age >60 years (425 intervention/584 controls) and ≤60 years (160 intervention/341 controls). Overall, 30-day readmission rates did not differ between intervention and control patients. However, the two age groups demonstrated marked differences. Intervention patients >60 years showed a statistically significant adjusted absolute 4.1% decrease [95% CI: -8.0%, -0.2%] in readmission with an increase in 30-day outpatient follow-up. Intervention patients ≤60 years showed a statistically significant adjusted absolute 11.8% increase [95% CI: 4.4%, 19.0%] in readmission with no change in 30-day outpatient follow-up. A patient navigator intervention among high risk, safety-net patients decreased readmission among older patients while increasing readmissions
Maurer, Martin, E-mail: email@example.com [Charite - University Medicine Berlin, Department of Radiology, Augustenburger Platz 1, 13353 Berlin (Germany); Heine, Oliver [Guerbet GmbH, Otto-Vogler-Str. 11, 65843 Sulzbach (Germany); Wolf, Michael [Michael Wolf Information Systems, Viktoriastr. 26, 66346 Puettlingen (Germany); Freyhardt, Patrick; Schnapauff, Dirk; Hamm, Bernd [Charite - University Medicine Berlin, Department of Radiology, Augustenburger Platz 1, 13353 Berlin (Germany)
Objective: To review the safety, the tolerability and the diagnostic effectiveness of iobitridol under daily practice conditions in the general population and at-risk patients in a post-marketing surveillance study. Materials and methods: A total of 160 639 patients (55.1% male, 43.6% female, mean age 58.6 years) were analysed in 555 centers. Patients underwent X-ray examinations using iobitridol (Xenetix, Guerbet, Sulzbach, Germany) as IV contrast medium (mean volume 85.6 ml). 21.8% of all patients had at least one risk factor (e.g., renal impairment), 7.3% were at-risk patients with allergies or who had previously reacted to contrast medium. Antiallergic pretreatment before contrast medium administration was given in 1144 patients (0.7%). Adverse events were documented and the image quality was assessed. Results: A diagnosis was possible in 99.5% of all cases. The image quality was rated good or excellent in 92.2%. The adverse event rate (e.g., nausea, urticaria) observed was 0.6% in all patients, 1.6% in patients with allergies and 6.0% in patients with a previous reaction to contrast medium. Adverse events occurred more often in women than in men (p < 0.001). Pretreatment did not decrease the rate of adverse events. The rate of adverse events was not increased in higher doses of iobitridol, even if administered to high-risk patients. Conclusions: Iobitridol was shown to be a safe and well-tolerated contrast medium with a low incidence of adverse events in patients with and without risk factors resulting in a good or excellent image quality in most patients.
Page 1 .... BMJ 2012;344:e832. Table 2. Unsafe medical care. Structural factors. Organisational determinants. Structural accountability (accreditation and regulation). Safety culture. Training, education and human resources. Stress and fatigue .... for routine take-off and landing, yet doctors feel that it is demeaning to do so?
Niehaus, F.; Novegno, A.
Risk assessment, including probabilistic analyses, has made great progress over the past decade. In spite of the inherent uncertainties it has now become possible to utilize methods and results for decision making at various levels. This paper will, therefore, review risk management in industrial installations, risk management for energy safety policy and prospects of risk management in highly industrialized areas. (orig.) [de
Sobottka, Stephan B; Eberlein-Gonska, Maria; Schackert, Gabriele; Töpfer, Armin
Due to the knowledge gap that exists between patients and health care staff the quality of medical treatment usually cannot be assessed securely by patients. For an optimization of safety in treatment-related processes of medical care, the medical staff needs to be actively involved in preventive and proactive quality management. Using voluntary, confidential and non-punitive systematic employee surveys, vulnerable topics and areas in patient care revealing preventable risks can be identified at an early stage. Preventive measures to continuously optimize treatment quality can be defined by creating a risk portfolio and a priority list of vulnerable topics. Whereas critical incident reporting systems are suitable for continuous risk assessment by detecting safety-relevant single events, employee surveys permit to conduct a systematic risk analysis of all treatment-related processes of patient care at any given point in time.
Aye, Myint M; Atkin, Stephen L
Diabetes is a lifelong condition requiring ongoing medical care and patient self-management. Exogenous insulin therapy is essential in type 1 diabetes and becomes a necessity in patients with longstanding type 2 diabetes who fail to achieve optimal control with lifestyle modification, oral agents, and glucagon-like peptide 1-based therapy. One of the risks that hinders insulin use is hypoglycemia. Optimal insulin therapy should therefore minimize the risk of hypoglycemia while improving glycemic control. Insulin degludec (IDeg) is a novel basal insulin that, following subcutaneous injection, assembles into a depot of soluble multihexamer chains. These subsequently release IDeg monomers that are absorbed at a slow and steady rate into the circulation, with the terminal half-life of IDeg being ~25 hours. Thus, it requires only once-daily dosing unlike other basal insulin preparations that often require twice-daily dosing. Despite its long half-life, once-daily IDeg does not cause accumulation of insulin in the circulation after reaching steady state. IDeg once a day will produce a steady-state profile with a lower peak:trough ratio than other basal insulins. In clinical trials, this profile translates into a lower frequency of nocturnal hypoglycemia compared with insulin glargine, as well as an ability to allow some flexibility in dose timing without compromising efficacy and safety. Indeed, a study that tested the extremes of dosing intervals of 8 and 40 hours showed no detriment in either glycemic control or hypoglycemic frequency versus insulin glargine given at the same time each day. While extreme flexibility in dose timing is not recommended, these findings are reassuring. This may be particularly beneficial to elderly patients, patients with learning difficulties, or others who have to rely on health-care professionals for their daily insulin injections. Further studies are required to confirm whether this might benefit adherence to treatment, reduce long
Lyman, Stephen; Sedrakyan, Art; Do, Huong; Razzano, Renee; Mushlin, Alvin I
Implantable cardioverter-defibrillators (ICDs) have diffused rapidly into clinical practice with little evaluation of their real-world effectiveness. To determine the effect of the adoption of ICD on patient safety, particularly with respect to physician volume and early outcomes. Retrospective cohort of all ICD implantations in New York state from 1997 to 2006, with follow-up at 90 days and 1 year. Setting New York state non-federal hospital discharges in which an ICD was implanted during the admission. Patients were followed forward for 1 year for subsequent admissions. Patients New York state residents undergoing ICD implantation. Effects of annual and career ICD implantation volume on 90-day complication, readmission, reprogramming, mortality and revision of the ICD within 1 year. This cohort (N = 38,992) represents a period of rapid adoption and implementation of this new technology, with frequency more than tripling between 1997 and 2006. We identified 6439 (16.5%) post-implantation complications and 1093 (2.8%) deaths within 90 days of implantation. The majority (73.4%) of physicians implanted one or fewer ICDs per year, and 11.0% of all implantations were performed by these very-low-volume operators. Patients treated by very-low-volume operators were more likely to die (RR = 1.8, 95% CI 1.3 to 2.4) or experience cardiac complications (RR = 4.7, 95% CI 3.3 to 6.8) even after the adjustment for case mix compared to operators who frequently performed ICD implantation. These findings suggest a need for safe and effective implementation strategies for new medical technologies, which minimize patient risk due to rapid diffusion among inexperienced providers and assure that the intended benefit can be maximised rapidly.
Full Text Available Mette Mogensen1, Gregor BE Jemec21Department of Dermatology, Gentofte Hospital, Hellerup, Denmark; 2Department of Dermatology, Roskilde Hospital, Health Sciences Faculty, University of Copenhagen, Roskilde, DenmarkIntroduction: In 2009, the WHO listed ultraviolet (UV radiation as a group 1 carcinogen. In spite of this, each year, millions of people tan indoor in Western countries. The aim of this review is to summarize evidence of tanning bed carcinogenesis and to present guidelines for use of tanning beds and patient safety advice.Methods: A narrative review of the literature was conducted based on both PubMed and Medline searches and on literature review of the retrieved papers.Results: Use of indoor tanning beds represents a significant and avoidable risk factor for the development of both melanoma and nonmelanoma skin cancers. Frequent tanners are more often adolescent females. Tanning beds have additional potential adverse effects such as burns, solar skin damage, infection, and possibly also addictive behavior.Discussion: The effort in preventing UV light-induced carcinogenesis should currently be aimed at developing new strategies for public health information. Tanning beds are one preventable source of UV radiation. In the majority of people solar UV radiation continues to be the major factor and therefore anti-tanning campaigns must always include sunbathers.Keywords: tanning beds, skin cancers, melanoma, nonmelanoma
Mogensen, Mette; Jemec, Gregor BE
In 2009, the WHO listed ultraviolet (UV) radiation as a group 1 carcinogen. In spite of this, each year, millions of people tan indoor in Western countries. The aim of this review is to summarize evidence of tanning bed carcinogenesis and to present guidelines for use of tanning beds and patient safety advice. A narrative review of the literature was conducted based on both PubMed and Medline searches and on literature review of the retrieved papers. Use of indoor tanning beds represents a significant and avoidable risk factor for the development of both melanoma and nonmelanoma skin cancers. Frequent tanners are more often adolescent females. Tanning beds have additional potential adverse effects such as burns, solar skin damage, infection, and possibly also addictive behavior. The effort in preventing UV light-induced carcinogenesis should currently be aimed at developing new strategies for public health information. Tanning beds are one preventable source of UV radiation. In the majority of people solar UV radiation continues to be the major factor and therefore anti-tanning campaigns must always include sunbathers
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van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula
A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe.
Rosse, F. van; Bruijne, M. de; Suurmond, J.; Essink-Bot, M.L.; Wagner, C.
Introduction: A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce,
Wilk, S; Siegl, L; Siegl, K; Hohenstein, C
In an analysis of a critical incident reporting system (CIRS) in out-of-hospital emergency medicine, it was demonstrated that in 30% of cases deficient communication led to a threat to patients; however, the analysis did not show what exactly the most dangerous work processes are. Current research shows the impact of poor communication on patient safety. An out-of-hospital workflow analysis collects data about key work processes and risk areas. The analysis points out confounding factors for a sufficient communication. Almost 70% of critical incidents are based on human factors. Factors, such as communication and teamwork have an impact but fatigue, noise levels and illness also have a major influence. (I) CIRS database analysis The workflow analysis was based on 247 CIRS cases. This was completed by participant observation and interviews with emergency doctors and paramedics. The 247 CIRS cases displayed 282 communication incidents, which are categorized into 6 subcategories of miscommunication. One CIRS case can be classified into different categories if more communication incidents were validated by the reviewers and four experienced emergency physicians sorted these cases into six subcategories. (II) Workflow analysis The workflow analysis was carried out between 2015 and 2016 in Jena and Berlin, Germany. The focal point of research was to find accumulation of communication risks in different parts of prehospital patient care. During 30 h driving with emergency ambulances, the author interviewed 12 members of the emergency medical service of which 5 were emergency physicians and 7 paramedics. A total of 11 internal medicine cases and one automobile accident were monitored. After patient care the author asked in a 15-min interview if miscommunication or communication incidents occurred. (I) CIRS analysis Between 2005 and 2015, 845 reports were reported to the database. The experts identified 247 incident reports with communication failure. All
Polcwiartek, Christoffer; Sneider, Benjamin; Graff, Claus
RATIONALE: Certain antipsychotics increase the risk of heart rate-corrected QT (QTc) prolongation and consequently Torsades de Pointes (TdP) and sudden cardiac death (SCD). Drug-induced Brugada syndrome (BrS) is also associated with SCD. Most SCDs occur in patients with additional cardiac risk fa...
Proux, Denys; Segond, Frédérique; Gerbier, Solweig; Metzger, Marie Hélène
Hospital Acquired Infections (HAI) is a real burden for doctors and risk surveillance experts. The impact on patients' health and related healthcare cost is very significant and a major concern even for rich countries. Furthermore required data to evaluate the threat is generally not available to experts and that prevents from fast reaction. However, recent advances in Computational Intelligence Techniques such as Information Extraction, Risk Patterns Detection in documents and Decision Support Systems allow now to address this problem.
Ridker, Paul M; Revkin, James; Amarenco, Pierre
BACKGROUND: Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS: In tw...
Madsen, Marlene Dyrløv
,demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health andpatient safety using a safety culture questionnaire survey......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address...
The presentation discusses the following issues: The objectives of the risk-based indicator programme. The characteristics of the risk-based indicators. The objectives of risk-based safety indicators - in monitoring safety; in PSA applications. What indicators? How to produce the risk based indicators? PSA requirements
Paper informs on the efforts to elaborate a feedback system for risk comprehensive evaluation and a system to improve structure safety foreseeing the possibility to control the latent risk, ensuring the qualitative evaluation of the safety level and improvement of safety culture in various branches of industry, first and foremost, in the electricity producing sector including the nuclear power industry [ru
Robert Kaba Alhassan
Full Text Available Patient safety and quality care remain major challenges to Ghana's healthcare system. Like many health systems in Africa, this is largely because demand for healthcare is outstripping available human and material resource capacity of healthcare facilities and new investment is insufficient. In the light of these demand and supply constraints, systematic community engagement (SCE in healthcare quality assessment can be a feasible and cost effective option to augment existing quality improvement interventions. SCE entails structured use of existing community groups to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements identified and rewards provided if the quality gaps are closed.This paper evaluates whether or not SCE, through the assessment of health service quality, improves patient safety and risk reduction efforts by staff in healthcare facilities.A randomized control trail was conducted in 64 primary healthcare facilities in the Greater Accra and Western regions of Ghana. Patient risk assessments were conducted in 32 randomly assigned intervention and control facilities. Multivariate multiple regression test was used to determine effect of the SCE interventions on staff efforts towards reducing patient risk. Spearman correlation test was used to ascertain associations between types of community groups engaged and risk assessment scores of healthcare facilities.Clinic staff efforts towards increasing patient safety and reducing risk improved significantly in intervention facilities especially in the areas of leadership/accountability (Coef. = 10.4, p<0.05 and staff competencies (Coef. = 7.1, p<0.05. Improvement in service utilization and health resources could not be attributed to the interventions because these were outside the control of the study and might have been influenced by institutional or national level developments between the baseline and follow-up period
Teh, Benjamin W; Brown, Christine; Joyce, Trish; Worth, Leon J; Slavin, Monica A; Thursky, Karin A
Neutropenic fever (NF) is a common complication of cancer chemotherapy. Patients at low risk of medical complications from NF can be identified using a validated risk assessment and managed in an outpatient setting. This is a new model of care for Australia. This study described the implementation of a sustainable ambulatory program for NF at a tertiary cancer centre over a 12-month period. Peter MacCallum Cancer Centre introduced an ambulatory care program in 2014, which identified low-risk NF patients, promoted early de-escalation to oral antibiotics, and early discharge to a nurse-led ambulatory program. Patients prospectively enrolled in the ambulatory program were compared with a historical-matched cohort of patients from 2011 for analysis. Patient demographics, clinical variables (cancer type, recent chemotherapy, treatment intent, site of presentation) and outcomes were collected and compared. Total cost of inpatient admissions was determined from diagnosis-related group (DRG) codes and applied to both the prospective and historical cohorts to allow comparisons. Twenty-five patients were managed in the first year of this program with a reduction in hospital median length of stay from 4.0 to 1.1 days and admission cost from Australian dollars ($AUD) 8580 to $AUD2360 compared to the historical cohort. Offsetting salary costs, the ambulatory program had a net cost benefit of $AUD 71895. Readmission for fever was infrequent (8.0%), and no deaths were reported. Of relevance to hospitals providing cancer care, feasibility, safety, and cost benefits of an ambulatory program for low-risk NF patients have been demonstrated.
Rossi, Elio G; Bellandi, Tommaso; Picchi, Marco; Baccetti, Sonia; Monechi, Maria Valeria; Vuono, Catia; Sabatini, Federica; Traversi, Antonella; Di Stefano, Mariella; Firenzuoli, Fabio; Albolino, Sara; Tartaglia, Riccardo
Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.
Elio G. Rossi
Full Text Available Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA and failure modes and effects analysis (FMEA. Methods: SEA is the selected tool for studying adverse events (AE and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS. This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN, and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.
The author discusses public attitudes to safety, industrial accidents and reactor accidents, in particular the accident at Three-Mile Island. Arguments in favour of nuclear power, including its relative safety, are presented
The report is structured as follows: 1. Risk-based safety indicators: Typology of risk-based indicators (RBIs); Tools for defining RBIs; Requirements for the PSA model; Data sources for RBIs; Types of risks monitored; RBIs and operational safety indicators; Feedback from operating experience; PSO model modification for RBIs; RBI categorization; RBI assessment; RBI applications; Suitable RBI applications. 2. Proposal for risk-based indicators: Acquiring information from operational experience; Method of acquiring safety relevance coefficients for the systems from a PSA model; Indicator definitions; On-line indicators. 3. Annex: Application of RBIs worldwide. (P.A.)
Elmaraezy, Ahmed; Ismail, Ammar; Abushouk, Abdelrahman Ibrahim; Eltoomy, Moutaz; Saad, Soha; Negida, Ahmed; Abdelaty, Osama Mahmoud; Abdallah, Ahmed Ramadan; Aboelfotoh, Ahmed Magdy; Hassan, Hossam Mahmoud; Elmaraezy, Aya Gamal; Morsi, Mahmoud; Althaher, Farah; Althaher, Moath; AlSafadi, Ammar M.
Background Recently, transcatheter aortic valve replacement (TAVR) has become the procedure of choice in high surgical risk patients with aortic stenosis (AS). However, its value is still debated in operable AS cases. We performed this meta-analysis to compare the safety and efficacy of TAVR to surgical aortic valve replacement (SAVR) in low-to-moderate surgical risk patients with AS. Methods A systematic search of five authentic databases retrieved 11 eligible studies (20,056 patients). Rele...
Bagger, Bettan; Taylor Kelly, Hélène; Hørdam, Britta
Improving patient safety is both a national and international priority as millions of patients Worldwide suffer injury or death every year due to unsafe care. University College Zealand employs innovative pedagogical approaches in educational design. Regional challenges related to geographic......, social and cultural factors have resulted in a greater emphasis upon digital technology. Attempts to improve patient safety by optimizing students’ competencies in relation to the reporting of clinical errors, has resulted in the development of an interdisciplinary e-learning concept. The program makes...
Gringeri, A; Santagostino, E; Mannucci, P M; Siracusano, L; Marinoni, A; Criscuolo, M; Carcagno, M; Fall, L S; M'Bika, J P; Bizzini, B
A randomized, placebo-controlled trial was designed to evaluate safety and immunogenicity of an anti-cytokine vaccine in high risk HIV-positive patients. This strategy was aimed to modulate the impaired cytokine regulation in AIDS. Twelve asymptomatic patients on antiretroviral therapy for at least 1 year and with CD4 cell counts between 100-300/mm3 were randomized to receive adjuvanted formol-inactivated interferon alpha-2a (IFN alpha) and continue the current antiretroviral treatment, whatever it was, or to receive the adjuvant alone and the current antiretroviral treatment. All patients received 4 i.m. injections monthly, followed by booster injections every 3 months. Clinical status, immunology and virology were monitored. Immune response to vaccination was evaluated in term of antibody detection (ELISA) and serum anti-IFN alpha neutralizing capacity. Only local discomfort and transient fever were reported. All vaccines except one showed increased levels of anti-IFN alpha Abs and developed serum IFN alpha neutralizing capacity. Viral load did not increase in vaccinees while it remained unchanged or even increased in placebo-treated patients. None of them showed HIV-related symptoms and all had their CD4 cell counts stabilized over 18 months, whereas 2 placebo-treated patients developed full-blow AIDS. In conclusion, anti-IFN alpha vaccine was safe and immunogenic. Stable clinical and immunological status over 18 months was observed in vaccinees coupled to increased serum IFN alpha neutralizing capacity.
Decision making with respect to safety is becoming more and more complex. The risk involved must be taken into account together with numerous other factors such as the benefits, the uncertainties and the public perception. Can the decision maker be aided by some kind of system, general rules of thumb, or broader perspective on similar decisions? This question has been addressed in a joint Nordic project relating to nuclear power. Modern techniques for risk assessment and management have been studied, and parallels drawn to such areas as offshore safety and management of toxic chemicals in the environment. The report summarises the finding of 5 major technical reports which have been published in the NORD-series. The topics includes developments, uncertainties and limitations in probabilistic safety assessments, negligible risks, risk-cost trade-offs, optimisation of nuclear safety and radiation protection, and the role of risks in the decision making process. (author) 84 refs
Molano Álvarez, E; Guirao Moya, A; Esteban Sánchez, M E; Sanz Cruz, P; García Delgado, E; Sánchez-Izquierdo Riera, J Á
Continuous techniques of extracorporeal depuration (CTED) manage high volumes of fluid exchange and extensive control of its safety is required. To detect the risks of CTED and to determine its frequency per patient. An observational, retrospective study was performed. Inclusion criteria were patients admitted from January 2009 to December 2009, with CTED in the Polyvalent Intensive Care Unit (ICU) of the Hospital 12 de Octubre. We previously identified 10 risks that were detectable in the clinical records. We analyzed demographic and treatment variables. The quantitative variables were expressed as mean±SD and the qualitative ones as absolute and relative frequencies. SPSS 15.0(®). A total of 54 patients (11.7%), with ages 59.78±14.8, 42 men (77.8%) were included. In 81.4%, the indication was acute kidney failure; 80.3% were treated with hemodiafiltration. Mean hours of CTED were 112.9±139.9 and the medium of 2 filters per patient (recommended intakes 0-31). Risk/patient rate was: 100% of patients without monitoring of the Mg and P, and 3.7% (n=2) urea; in 16 (29.6%), there was coagulation of the circuit prior to 24 hours and in 25 (46.3%) the blood could not be returned; in 14 (29.3%), written regime was always lacking on the order for treatment. The dose was not reflected on the patient's chart in 2 (3.7%); in 3 patients (5.6%) with coagulation disorder, anticoagulants were prescribed in the circuit. In 1 (1.9%) bleeding was observed and in 10 (18.5%) there was mild hypothermia (35-32°C). A standardized monitoring of the Mg and P is required. The therapy should be prescribed in the medical treatment. The technique needs to be improved in order to prolong its duration and avoid blood losses. Copyright © 2010 Elsevier España, S.L. y SEEIUC. All rights reserved.
Greenberg, Marna Rayl; Moore, Elizabeth C; Nguyen, Michael C; Stello, Brian; Goldberg, Arnold; Barraco, Robert D; Porter, Bernadette G; Kurt, Anita; Dusza, Stephen W; Kane, Bryan G
The CDC reports that among older adults, falls are the leading cause of injury-related death and rates of fall-related fractures among older women are twice those of men. We set out to 1) determine patient perceptions (analyzed by gender) about their perceived fall risk compared to their actual risk for functional decline and death and 2) to report their comfort level in discussing their fall history or a home safety plan with their provider. Elders who presented to the Emergency Department (ED†) were surveyed. The survey included demographics, the Falls Efficacy Scale (FES) and the Vulnerable Elders Survey (VES); both validated surveys measuring fall concern and functional decline. Females had higher FES scores (mean 12.3, SD 5.9) than males (mean 9.7, SD 5.9 p = .007) in the 146 surveys analyzed. Females were more likely to report an increased fear of falling, and almost three times more likely to have a VES score of 3 or greater than males (OR = 2.86, 95% CI: 1.17-7.00, p = .02). A strong correlation was observed between FES and VES scores (r = 0.80, p fall risk with a provider; there was no difference between genders (p = .57). In this study, irrespective of gender, there appears to be a high association between subjects' perceived fall risk and risk for functional decline and death. The majority of patients are likely willing to discuss their fall risk with their provider. These findings may suggest a meaningful opportunity for fall risk mitigation in this setting.
Groves, Patricia S; Bunch, Jacinda L
The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.
Bonner, Laura; Felker, Bradford; Chaney, Edmund; Vollen, Karen; Berry, Karen; Revay, Barbara; Simon, Barbara; Kofoed, Lial; Ober, Scott; Worley, Linda
A suicidal patient requires a prompt, coordinated intervention. In this paper, we describe a process for developing a suicidality policy, which may help clinics develop effective, locally adapted policies...
Bondevik, Gunnar Tschudi; Hofoss, Dag; Husebø, Bettina Sandgathe; Deilkås, Ellen Catharina Tveter
Patient safety culture concerns leader and staff interaction, attitudes, routines, awareness and practices that impinge on the risk of patient-adverse events. Due to their complex multiple diseases, nursing home patients are at particularly high risk of adverse events. Studies have found an association between patient safety culture and the risk of adverse events. This study aimed to investigate safety attitudes among healthcare providers in Norwegian nursing homes, using the Safety Attitudes Questionnaire - Ambulatory Version (SAQ-AV). We studied whether variations in safety attitudes were related to professional background, age, work experience and mother tongue. In February 2016, 463 healthcare providers working in five nursing homes in Tønsberg, Norway, were invited to answer the SAQ-AV, translated and adapted to the Norwegian nursing home setting. Previous validation of the Norwegian SAQ-AV for nursing homes identified five patient safety factors: teamwork climate, safety climate, job satisfaction, working conditions and stress recognition. SPSS v.22 was used for statistical analysis, which included estimations of mean values, standard deviations and multiple linear regressions. P-values safety factors teamwork climate, safety climate, job satisfaction and working conditions. Not being a Norwegian native speaker was associated with a significantly higher mean score for job satisfaction and a significantly lower mean score for stress recognition. Neither professional background nor work experience were significantly associated with mean scores for any patient safety factor. Patient safety factor scores in nursing homes were poorer than previously found in Norwegian general practices, but similar to findings in out-of-hours primary care clinics. Patient safety culture assessment may help nursing home leaders to initiate targeted quality improvement interventions. Further research should investigate associations between patient safety culture and the occurrence
Leotsakos, Agnès; Ardolino, Antonella; Cheung, Ronny; Zheng, Hao; Barraclough, Bruce; Walton, Merrilyn
Education of health care professionals has given little attention to patient safety, resulting in limited understanding of the nature of risk in health care and the importance of strengthening systems. The World Health Organization developed the Patient Safety Curriculum Guide: Multiprofessional Edition to accelerate the incorporation of patient safety teaching into higher educational curricula. The World Health Organization Curriculum Guide uses a health system-focused, team-dependent approach, which impacts all health care professionals and students learning in an integrated way about how to operate within a culture of safety. The guide is pertinent in the context of global educational reforms and growing recognition of the need to introduce patient safety into health care professionals’ curricula. The guide helps to advance patient safety education worldwide in five ways. First, it addresses the variety of opportunities and contexts in which health care educators teach, and provides practical recommendations to learning. Second, it recommends shared learning by students of different professions, thus enhancing student capacity to work together effectively in multidisciplinary teams. Third, it provides guidance on a range of teaching methods and pedagogical activities to ensure that students understand that patient safety is a practical science teaching them to act in evidence-based ways to reduce patient risk. Fourth, it encourages supportive teaching and learning, emphasizing the need to establishing teaching environments in which students feel comfortable to learn and practice patient safety. Finally, it helps educators incorporate patient safety topics across all areas of clinical practice. PMID:25285012
The acceptable probability of major accidents in nuclear power is very small, and can not be determined from direct empirical evidence. Therefore, control of the level of safety is a complex problem. The difficulty is related to the fact that a variable, 'safety', which is not accessible to direct measurement, is to be tightly controlled. Control, therefore, depends on a systematic, analytical prediction of the target state, i.e., the level of safety, from indirect evidence. From a control theoretic point of view this means that safety is controlled by a system which includes openloop as well as closed loop control paths. The aim of the paper is to take a general systems view on the complex mechanisms involved in the control of safety of industrial installations like nuclear power. From this, the role of probabilistic risk analysis is evaluated and needs for further development discussed. (author)
Heard, S R; Roberts, C; Furrows, S J; Kelsey, M; Southgate, L
The performance procedures of the General Medical Council are aimed at identifying seriously deficient performance in a doctor. The performance procedures require the medical record to be of a standard that enables the next doctor seeing the patient to give adequate care based on the available information. Setting standards for microbiological record keeping has proved difficult. Over one fifth of practising medical microbiologists (including virologists) in the UK (139 of 676) responded to a survey undertaken by the working group developing the performance procedures for microbiology, to identify current practice and to develop recommendations for agreement within the profession about the standards of the microbiological record. The cumulative frequency for the surveyed recording methods used indicated that at various times 65% (90 of 139) of respondents used a daybook, 62% (86 of 139) used the back of the clinical request card, 57% (79 of 139) used a computer record, and 22% (30 of 139) used an index card system to record microbiological advice, suggesting wide variability in relation to how medical microbiologists maintain clinical records. PMID:12499432
De Backer, Ole; Götberg, Matthias; Ihlberg, Leo
increasingly used to treat patients with an intermediate risk profile. METHODS AND RESULTS: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC......)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3...
Crooks, Valorie A; Turner, Leigh; Cohen, I Glenn; Bristeir, Janet; Snyder, Jeremy; Casey, Victoria; Whitmore, Rebecca
Objectives Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism. Design We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically. Participants Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated. Results Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making. Conclusions Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose
Kouabenan , Dongo Rémi; Ngueutsa , Robert ,; Safiétou , Mbaye
International audience; This article examines the relationship between safety climate, risk perception and involvement in safety management by first-line managers (FLM). Sixty-three FLMs from two French nuclear plants answered a questionnaire measuring perceived workplace safety climate, perceived risk, and involvement in safety management. We hypothesized that a positive perception of safety climate would promote substantial involvement in safety management, and that this effect would be str...
Balatsas Lekkas, Angelos
This thesis identifies how design processes emerge during the use of devices in healthcare, by attending to assemblages where contingencies of risk and harm co-exist with the contribution of healthcare professionals to the safe care of patients. With support from the field of Science and Technology...... practices of interdisciplinary care....
Bagian, James P.
The traditional approach to patient safety in health care has ranged from reticence to outward denial of serious flaws. This undermines the otherwise remarkable advances in technology and information that have characterized the specialty of medical practice. In addition, lessons learned in industries outside health care, such as in aviation, provide opportunities for improvements that successfully reduce mishaps and errors while maintaining a standard of excellence. This is precisely the call in medicine prompted by the 1999 Institute of Medicine report ''To Err Is Human: Building a Safer Health System.'' However, to effect these changes, key components of a successful safety system must include: (1) communication, (2) a shift from a posture of reliance on human infallibility (hence ''shame and blame'') to checklists that recognize the contribution of the system and account for human limitations, and (3) a cultivation of non-punitive open and/or de-identified/anonymous reporting of safety concerns, including close calls, in addition to adverse events. (orig.)
van Rosse, F.
This thesis shows the first results of Dutch studies on the relation between ethnicity and patient safety. We used mixed methods to identify patient safety outcomes and patient safety risks in a cohort study in 4 urban hospitals among 763 Dutch patients and 576 ethnic minority patients. In a record
Part 1 of the paper advocates a rational approach to public safety based on unbiassed quantitative assessment of overall risks and benefits of any technological activity. It shows that improved safety should be attainable at less cost than is the case at present. Part 2 offers an explanation of why so little has been achieved in this direction and outlines the major errors in present practices. Part 3 suggests what might realistically be done towards the achievement of some of the possible benefits. Factors which are important in the study of safety and evidence supporting the arguments are discussed in six appendices. It is urged that the scientific and technological community should improve its understanding of safety as a specialization and should endeavour to lead rather than follow in our present political system
Flood, Chris; Matthew, Linda; Marsh, Rachel; Patel, Bhavesh; Mansaray, Mariama; Lamont, Tara
This study sought to evaluate potential reductions in risk associated with midazolam injection, a sedating medication, following a UK National Patient Safety Alert. This alert, 'Reducing risk of overdose with midazolam injection in adults', was sent to all National Health Service organizations as a Rapid Response Report detailing actions services should take to minimize risks. To evaluate any potential changes arising from this alert, a number of data sources were explored including reported incidents to a national reporting system for health care error, clinician survey and audit data, pharmaceutical purchasing patterns and feedback from National Health Service managers. Prior to the Rapid Response Report, 498 incidents were received by the National Patient Safety Agency including three deaths. Post-implementation of the Rapid Response Report (June 2009), no incidents resulting in death or severe harm had been received. All organizations reported having completed the Rapid Response Report actions. Purchase and use of risk-prone, high-strength sedating midazolam by health care organizations decreased significantly as did the increased use of safer, lower strength doses (as recommended in the Rapid Response Report). Organizations can achieve safer medication practices, better knowledge, awareness and implementation of national safer practice recommendations. Risks from inadvertent overdose of midazolam injection were reduced post-implementation of national recommendations. Ongoing monitoring of this particular adverse event will be required with a sustained patient safety message to health services to maintain awareness of the issue and reduction in the number of midazolam-related errors. © 2014 John Wiley & Sons, Ltd.
Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Ogink, Alice; van Ostenberg, Paul; Rinke de Wit, Tobias F.
Background Patient safety and quality care remain major challenges to Ghana's healthcare system. Like many health systems in Africa, this is largely because demand for healthcare is outstripping available human and material resource capacity of healthcare facilities and new investment is
Fire safety in healthcare premises has always been a challenge to those that discharge this duty. Statutory compliance should be a matter of course, but in an ever increasingly challenged NHS, even this is not a given. While the NHS is driven by managing very complex risk to deliver cutting edge healthcare, providers cannot be risk averse. Which risk, however, takes priority? Here Peter Aldridge, fire and corporate services manager at Leeds Teaching Hospitals NHS Trust, and Secretary to the National Association of Healthcare Fire Officers (NAHFO)--which will this month and next jointly stage fire safety seminars with IHEEM; see page 8--considers the key issues, with input from a fire officer at a leading mental health and community Trust.
Taking a fresh look at nuclear safety regulations, this study finds that the mandate and organization of the Nuclear Regulatory Commission (NRC) militate against its making sound decisions. The author criticizes failures to make hard decisions on societal risk, to clarify responsibility, and to implement cost-effective safety measures. Among his recommendations are reorganization of the NRC under a single authoritative administrator, separation of technical issues from social ones, and reform of the Price-Anderson Act. The author concludes that the worst eventuality would be to continue the current state of indecision. 161 references, 6 figures, 4 tables
Carter, N. T.
The nation's flood risk is increasing. The condition of U.S. dams and levees contributes to that risk. Dams and levee owners are responsible for the safety, maintenance, and rehabilitation of their facilities. Dams-Of the more than 90,000 dams in the United States, about 4% are federally owned and operated; 96% are owned by state and local governments, public utilities, or private companies. States regulate dams that are not federally owned. The number of high-hazard dams (i.e., dams whose failure would likely result in the loss of human life) has increased in the past decade. Roughly 1,780 state-regulated, high-hazard facilities with structural ratings of poor or unsatisfactory need rehabilitation. Levees-There are approximately 100,000 miles of levees in the nation; most levees are owned and maintained by municipalities and agricultural districts. Few states have levee safety programs. The U.S. Army Corps of Engineers (Corps) inspects 15,000 miles of levees, including levees that it owns and local levees participating in a federal program to assist with certain post-flood repairs. Information is limited on how regularly other levees are inspected. The consequence of a breach or failure is another aspect of risk. State and local governments have significant authority over land use and development, which can shape the social and economic impacts of a breach or failure; they also lead on emergency planning and related outreach. To date, federal dam and levee safety efforts have consisted primarily of (1) support for state dam safety standards and programs, (2) investments at federally owned dams and levees, and (3) since 2007, creation of a national levee database and enhanced efforts and procedures for Corps levee inspections and assessments. In Public Law 113-121, enacted in 2014, Congress (1) directed the Corps to develop voluntary guidelines for levee safety and an associated hazard potential classification system for levees, and (2) authorized support for the
Full Text Available Zheng-Xiong XiNational Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USAAbstract: Smoking is still the most prominent cause of preventable premature death in the United States and an increasing cause of morbidity and mortality throughout the world. Although the current treatments such as nicotine replacement therapy (NRT and bupropion are effective, long-term abstinence rates are low. Mechanism studies suggest that the pleasurable effects of smoking are mediated predominantly by nicotine, which activates the brain reward system by activation of brain α4β2 nicotinic acetylcholine receptors (nAChRs. Varenicline is a novel α4β2 nAChR partial agonist and has been found to be even more effective than NRT or bupropion in attenuating smoking satisfaction and in relieving craving and withdrawal symptoms after abstinence. Thus, varenicline has been recently approved to be a first-line medication for smoking cessation in the United States and European countries. Varenicline is generally well tolerated in healthy adult smokers, with the most commonly reported adverse effects being nausea, insomnia, and headache. However, growing postmarketing data has linked varenicline to an increase in neuropsychiatric symptoms such as seizures, suicidal attempts, depression, and psychosis as well as serious injuries potentially relating to unconsciousness, dizziness, visual disturbances, or movement disorders. Therefore, new safety warnings are issued to certain high risk populations, such as patients with mental illness and operators of commercial vehicles and heavy machinery. In particular, pilots, air traffic controllers, truck and bus drivers have been banned from taking varenicline.Keywords: nicotine, varenicline, α4β2 nicotinic acetylcholine receptor, nAChRs, partial agonist, smoking cessation
Full Text Available Guntram Schernthaner,1 Sarah Jarvis,2 Chaim Lotan,3 Martin Prázný,4 Christoph Wanner,5 Thomas C Wascher6 1Department of Medicine, Rudolfstiftung Hospital, Vienna, Austria; 2Richford Gate Medical Practice, London, UK; 3Cardiovascular Division, Heart Institute, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 4First Faculty of Medicine, Charles University, Prague, Czech Republic; 5Department of Medicine, University Hospital, Würzburg, Germany; 6First Medical Department, Hanusch-Krankenhaus, Vienna, Austria Abstract: Diabetes is a global health emergency projected to affect 642 million people by 2040. Type 2 diabetes (T2D represents 90% of diabetes cases and is associated with a range of cardiovascular (CV risk factors that are more than double the incidence of CV disease and significantly increase mortality rates. Diabetes treatments have typically focused on improving glycemic control but their effect on CV outcomes has remained uncertain. In 2008, the US Food and Drug Administration (FDA looked to address this knowledge gap and mandated CV outcome trials (CVOTs for all new antidiabetic therapies. In 2015, EMPA-REG OUTCOME® became the first CVOT to present results for a sodium/glucose cotransporter 2 (SGLT2; also known as SLC5A2 inhibitor, empagliflozin. Subsequently, a regional meeting of the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D brought together a respected faculty of international experts and 150 physicians from 14 countries to discuss the current unmet medical needs of patients with T2D, the results from the EMPA-REG OUTCOME study and the implications of these results for clinical practice. This article summarizes the current scientific evidence and the discussions that took place at the ACROSS T2D regional meeting, which was held in Vienna, Austria, on May 30, 2016. Keywords: type 2 diabetes, cardiovascular risk, SGLT2 inhibitor, CVOTs, empagliflozin
Donn, Steven M; McDonnell, William M
The Institute of Medicine has recommended a change in culture from "name and blame" to patient safety. This will require system redesign to identify and address errors, establish performance standards, and set safety expectations. This approach, however, is at odds with the present medical malpractice (tort) system. The current system is outcomes-based, meaning that health care providers and institutions are often sued despite providing appropriate care. Nevertheless, the focus should remain to provide the safest patient care. Effective peer review may be hindered by the present tort system. Reporting of medical errors is a key piece of peer review and education, and both anonymous reporting and confidential reporting of errors have potential disadvantages. Diagnostic and treatment errors continue to be the leading sources of allegations of malpractice in pediatrics, and the neonatal intensive care unit is uniquely vulnerable. Most errors result from systems failures rather than human error. Risk management can be an effective process to identify, evaluate, and address problems that may injure patients, lead to malpractice claims, and result in financial losses. Risk management identifies risk or potential risk, calculates the probability of an adverse event arising from a risk, estimates the impact of the adverse event, and attempts to control the risk. Implementation of a successful risk management program requires a positive attitude, sufficient knowledge base, and a commitment to improvement. Transparency in the disclosure of medical errors and a strategy of prospective risk management in dealing with medical errors may result in a substantial reduction in medical malpractice lawsuits, lower litigation costs, and a more safety-conscious environment. Thieme Medical Publishers, Inc.
In assessing the potential safety concerns of fusion, the experience from other energy sources lead to a variety of safety assessment approaches. The available approaches are: (1) The maximum possible accident approach; (2) The maximum credible accident approach; (3) The probabilistic total risk assessment. In the first approach, the mechanistic development of the events leading to the safety concern is ignored. Instead, the total radioactivity of the plant is assumed accessible to the public. Such an approach is obviously conservative and unrealistic. In the second approach a selection is made among the most severe of the possible accidents, and the progression of the accident is modeled as mechanistically as possible. In this case, the passive and active accident mitigation capabilities of the plant are taken into consideration. The result is expected to be that none or only a fraction of the total radioactivity can be released to the public. The adverse effect of this approach is to concentrate attention on a particular accident class, and perhaps not allow for other classes, a judgement that may later become undesirable. The probabilistic risk assessment requires the safety analysts to consider all classes of accidents and estimate both the probabilities of their occurrences and their consequences. Thus, the plant design in fact is subjected to a thorough investigation and the impact of alterations in design can be reflected in the total risk estimate. The disadvantage of this approach lies in the absence of well defined acceptable risk criteria as well as the large effect of public perception factors on the accepted risk. This paper will review the impact of application of these approaches in determination of the level of protection needed against activation product release to the atmosphere. (author)
Helman, Stephanie; Lisanti, Amy Jo; Adams, Ann; Field, Cynthia; Davis, Katherine Finn
High-risk low-volume therapies are those therapies that are practiced infrequently and yet carry an increased risk to patients because of their complexity. Staff nurses are required to competently manage these therapies to treat patients' unique needs and optimize outcomes; however, maintaining competence is challenging. This article describes implementation of Just-in-Time Training, which requires validation of minimum competency of bedside nurses managing high-risk low-volume therapies through direct observation of a return-demonstration competency checklist.
Aikaterini Toska; Panagiotis Kyloudis; Maria Rekleiti; Maria Saridi
Introduction: Due to a variety of circumstances and world-wide research findings, patient safety andquality care during hospitalization have emerged as major issues. Patient safety deficits may burdenhealth systems as well as allocated resources. The international community has examined severalproposals covering general and systemic aspects in order to improve patient safety; several long-termprograms and strategies have also been implemented promoting the participation of health-relatedagent...
The catastrophic accidents which have occurred in the last decade, in both developed and developing countries, have drawn the attention of decision-makers in the safety area to the urgent necessity to assess and manage risks from hazardous industrial activities which are concentrated in large industrialized areas. The aim of this paper is to review experience gained in conducting studies in the area of 'comparisons of risks in energy systems' and on the practical application of 'cost effectiveness of risk reduction analysis among different energy systems' (case studies). It is also the aim of the paper to discuss and propose a general framework for defining an 'integrated approach' to risk assessment and management in highly industrialized regions within a country. (author)
Ammouri, A A; Tailakh, A K; Muliira, J K; Geethakrishnan, R; Al Kindi, S N
Patient safety is considered to be crucial to healthcare quality and is one of the major parameters monitored by all healthcare organizations around the world. Nurses play a vital role in maintaining and promoting patient safety due to the nature of their work. The purpose of this study was to investigate nurses' perceptions about patient safety culture and to identify the factors that need to be emphasized in order to develop and maintain the culture of safety among nurses in Oman. A descriptive and cross-sectional design was used. Patient safety culture was assessed by using the Hospital Survey on Patient Safety Culture among 414 registered nurses working in four major governmental hospitals in Oman. Descriptive statistics and general linear regression were employed to assess the association between patient safety culture and demographic variables. Nurses who perceived more supervisor or manager expectations, feedback and communications about errors, teamwork across hospital units, and hospital handoffs and transitions had more overall perception of patient safety. Nurses who perceived more teamwork within units and more feedback and communications about errors had more frequency of events reported. Furthermore, nurses who had more years of experience and were working in teaching hospitals had more perception of patient safety culture. Learning and continuous improvement, hospital management support, supervisor/manager expectations, feedback and communications about error, teamwork, hospital handoffs and transitions were found to be major patient safety culture predictors. Investing in practices and systems that focus on improving these aspects is likely to enhance the culture of patient safety in Omani hospitals and others like them. Strategies to nurture patient safety culture in Omani hospitals should focus upon building leadership capacity that support open communication, blame free, team work and continuous organizational learning. © 2014 International
... Safety Stakeholder Meeting December 2009 The One & Only Campaign Patient Notification Toolkit Developing Documents for a Patient Notification Planning Media and Communication Strategies Writing for the Media Spokesperson Preparation Planning the ...
Sherman, H.; Castro, G.; Fletcher, M.; Hatlie, M.; Hibbert, P.; Jakob, R.; Koss, R.; Lewalle, P.; Loeb, J.; Perneger, Th.; Runciman, W.; Thomson, R.; Schaaf, van der T.W.; Virtanen, M.
Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety.
Pemberton, M N
Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.
Burger, Jan A; Keating, Michael J; Wierda, William G; Hartmann, Elena; Hoellenriegel, Julia; Rosin, Nathalie Y; de Weerdt, Iris; Jeyakumar, Ghayathri; Ferrajoli, Alessandra; Cardenas-Turanzas, Marylou; Lerner, Susan; Jorgensen, Jeffrey L; Nogueras-González, Graciela M; Zacharian, Gracy; Huang, Xuelin; Kantarjian, Hagop; Garg, Naveen; Rosenwald, Andreas; O'Brien, Susan
Ibrutinib, an orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK), is an effective treatment for relapsed chronic lymphocytic leukaemia (CLL). We investigated the activity and safety of the combination of ibrutinib with the monoclonal antibody rituximab in patients with high-risk CLL. In this single-arm phase 2 study, we enrolled adult patients with high-risk CLL at the MD Anderson Cancer Center (Houston, TX, USA). All enrolled participants had high-risk cytogenetic abnormalities (deletion 17p, TP53 mutation, or deletion 11q) or a short progression-free survival (PFS ibrutinib 420 mg together with rituximab (375 mg/m(2), intravenously, every week during cycle 1, then once per cycle until cycle 6), followed by continuous daily single-agent ibrutinib 420 mg until disease progression or until toxicities or complications precluded further treatment. The primary endpoint was progression-free survival in the intention-to-treat population. This study is registered with ClinicalTrials.gov number NCT01520519, and is no longer accruing patients. Between Feb 28, 2012, and Sept 11, 2012, we enrolled 40 patients with CLL with high-risk disease features, 20 of whom had deletion 17p (del[17p]) or TP53 mutations (16 previously treated, four untreated), 13 had relapsed CLL with deletion 11q (del[11q]), and seven a PFS less than 36 months after first-line chemoimmunotherapy. 18-month PFS in all patients was 78·0% (95% CI 60·6-88·5), whereas in those with a del(17p) or TP53 mutation it was 72·4% (45·6-87·6) Toxicity was mainly mild to moderate in severity (grade 1-2). Diarrhoea occurred in ten (25%) patients (grade 1 in nine patients and grade 2 in one), bleeding events in 14 (33%) patients (eight grade 1 and five grade 2), nausea or vomiting in 15 patients (38%) (ten grade 1 and five grade 2), and fatigue in seven (18%) patients (four grade 1 and three grade 2). Five patients (13%) had grade 3 infections (two lung infections, one upper respiratory tract
Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris
Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within
Okunribido, Olanrewaju O
This article is a report of a study of the effect of the seat cushion on risk of falling from a wheelchair. Two laboratory studies and simulated assistant propelled wheelchair transfers were conducted with four healthy female participants. For the laboratory studies there were three independent variables: trunk posture (upright/flexed forward), seat cushion (flat polyurethane/propad low profile), and feet condition (dangling/supported), and two dependent variables: occupied wheelchair (wheelchair) center of gravity (CG), and stability. For the simulated transfers there was one independent variable: seat cushion (flat polyurethane/propad low profile), and one dependent variable: perception of safety (risk of falling). Results showed that the wheelchair CG was closer to the front wheels, and stability lower for the propad low profile cushion compared to the polyurethane cushion, when the participants sat with their feet dangling. During the simulated transfers, sitting on the propad low profile cushion caused participants to feel more apprehensive (anxious or uneasy) compared to sitting on the polyurethane cushion. The findings can contribute to the assessment of risk and care planning of non-ambulatory wheelchair users.
Frush, Karen S.
Thousands of people are injured or die from medical errors and adverse events each year, despite being cared for by hard-working, intelligent and well-intended health care professionals, working in the highly complex and high-risk environment of the American health care system. Patient safety leaders have described a need for health care organizations to make error prevention a major strategic objective while at the same time recognizing the importance of transforming the traditional health care culture. In response, comprehensive patient safety programs have been developed with the aim of reducing medical errors and adverse events and acting as a catalyst in the development of a culture of safety. Components of these programs are described, with an emphasis on strategies to improve pediatric patient safety. Physicians, as leaders of the health care team, have a unique opportunity to foster the culture and commitment required to address the underlying systems causes of medical error and harm. (orig.)
Bishop, Andrea C; Macdonald, Marilyn
The risk associated with receiving health care has called for an increased focus on the role of patients in helping to improve safety. Recent research has highlighted that patient involvement in patient safety practices may be influenced by patient perceptions of patient safety practices and the perceptions of their health care providers. The objective of this research was to describe patient involvement in patient safety practices by exploring patient and nursing staff perceptions of safety. Qualitative focus groups were conducted with a convenience sample of nursing staff and patients who had previously completed a patient safety survey in 2 tertiary hospital sites in Eastern Canada. Six focus groups (June 2011 to January 2012) were conducted and analyzed using inductive thematic analysis. Four themes were identified: (1) wanting control, (2) feeling connected, (3) encountering roadblocks, and (4) sharing responsibility for safety. Both patient and nursing staff participants highlighted the importance of building a personal connection as a precursor to ensuring that patients are involved in their care and safety. However, perceptions of provider stress and nursing staff workload often reduced the ability of the nursing staff and patient participants to connect with one another and promote involvement. Current strategies aimed at increasing patient awareness of patient safety may not be enough. The findings suggest that providing the context for interaction to occur between nursing staff and patients as well as targeted interventions aimed at increasing patient control may be needed to ensure patient involvement in patient safety.
Schyve, Paul M
Patient safety is a prominent theme in health care delivery today. This should come as no surprise, given that "first, do no harm" has been the ethical watchword throughout the history of medicine, nursing, and pharmacy...
Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Przybylska, Kamila; Skrobała, Agnieszka; Valero, Marc; Jarvinen, Hannu
To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. The original data were collected as part of the ACCIRAD project through two online surveys. Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons. Copyright © 2017 Elsevier B.V. All rights reserved.
Park, Kwang Ok; Kim, Jong Kyung; Kim, Myoung Sook
This study was done to evaluate the experience of securing patient safety in hospital operating rooms. Experiential data were collected from 15 operating room nurses through in-depth interviews. The main question was "Could you describe your experience with patient safety in the operating room?". Qualitative data from the field and transcribed notes were analyzed using Strauss and Corbin's grounded theory methodology. The core category of experience with patient safety in the operating room was 'trying to maintain principles of patient safety during high-risk surgical procedures'. The participants used two interactional strategies: 'attempt continuous improvement', 'immersion in operation with sharing issues of patient safety'. The results indicate that the important factors for ensuring the safety of patients in the operating room are manpower, education, and a system for patient safety. Successful and safe surgery requires communication, teamwork and recognition of the importance of patient safety by the surgical team.
Christensen, Hanne Krarup
RATIONALE: The risk of recurrence following a stroke or transient ischemic attack is high, especially immediately after the event. HYPOTHESIS: Because two antiplatelet agents are superior to one in patients with non-cardioembolic events, more intensive treatment might be even more effective. SAMPLE...... SIZE ESTIMATES: The sample size of 4100 patients will allow a shift to less recurrence, and less severe recurrence, to be detected (odds ratio 0·68) with 90% power at 5% significance. METHODS AND DESIGN: Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (ISRCTN47823388) is comparing...... the safety and efficacy of intensive (combined aspirin, clopidogrel, and dipyridamole) vs. guideline antiplatelet therapy, both given for one-month. This international collaborative parallel-group prospective randomized open-label blinded-end-point phase III trial plans to recruit 4100 patients with acute...
Full Text Available Introduction: Due to a variety of circumstances and world-wide research findings, patient safety andquality care during hospitalization have emerged as major issues. Patient safety deficits may burdenhealth systems as well as allocated resources. The international community has examined severalproposals covering general and systemic aspects in order to improve patient safety; several long-termprograms and strategies have also been implemented promoting the participation of health-relatedagents, and also government agencies and non-governmental organizations.Aim: Those factors that have negative correlations with patient safety and quality healthcare weredetermined; WHO and EU programs as well as the Greek health policy were also reviewed.Method: Local and international literature was reviewed, including EU and WHO official publications,by using the appropriate keywords.Conclusions: International cooperation on patient safety is necessary in order to improvehospitalization and healthcare quality standards. Such incentives depend heavily on establishing worldwideviable and effective health programs and planning. These improvements also require further stepson safe work procedures, environment safety, hazard management, infection control, safe use ofequipment and medication, and sufficient healthcare staff.
Gómez-Huelgas, R; Sabán-Ruiz, J; García-Román, F J; Quintela-Fernández, N; Seguí-Ripoll, J M; Bonilla-Hernández, M V; Romero-Meliá, G
To assess the safety and efficacy of a basal-plus (BP) regimen with insulin glargine (as basal insulin) and insulin glulisine (as prandial insulin) with the main meal for elderly patients with type 2 diabetes mellitus (DM2) and high cardiovascular risk, following standard clinical practice. An observational, retrospective study was conducted in 21 centres of internal medicine in Spain. The study included patients aged 65 years or older with DM2, undergoing treatment with a BP regimen for 4 to 12 months before inclusion in the study and a diagnosis of cardiovascular disease or high cardiovascular risk. The primary endpoint was the change in glycated haemoglobin (HbA1c) from the introduction of the glulisine to inclusion in the study. The study included 198 patients (mean age, 74±6.4 years; males, 52%). After at least 4 months of treatment with the BP regimen, started with the addition of glulisine, the mean HbA1c value decreased significantly (9±1.5% vs. 7.7±1.1%; P<.001), and almost 24% of the patients reached HbA1c levels of 7.5-8%. Furthermore, blood glucose levels under fasting conditions decreased significantly (190.6±73.2mg/dl vs. 138.9±38.2mg/dl; P<.001). A total of 35 patients (17.7%) had some hypoglycaemia during the month prior to the start of the study, and 2 cases (1.01%) of severe hypoglycaemia were detected. The BP strategy could significantly improve blood glucose control in patients 65 years of age or older with DM2 and high cardiovascular risk and is associated with a low risk of severe hypoglycaemia. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.
McDonald, Kathryn M; Su, George; Lisker, Sarah; Patterson, Emily S; Sarkar, Urmimala
Missed evidence-based monitoring in high-risk conditions (e.g., cancer) leads to delayed diagnosis. Current technological solutions fail to close this safety gap. In response, we aim to demonstrate a novel method to identify common vulnerabilities across clinics and generate attributes for context-flexible population-level monitoring solutions for widespread implementation to improve quality. Based on interviews with staff in otolaryngology, pulmonary, urology, breast, and gastroenterology clinics at a large urban publicly funded health system, we applied journey mapping to co-develop a visual representation of how patients are monitored for high-risk conditions. Using a National Academies framework and context-sensitivity theory, we identified common systems vulnerabilities and developed preliminary concepts for improving the robustness for monitoring patients with high-risk conditions ("design seeds" for potential solutions). Finally, we conducted a face validity and prioritization assessment of the design seeds with the original interviewees. We identified five high-risk situations for potentially consequential diagnostic delays arising from suboptimal patient monitoring. All situations related to detection of cancer (head and neck, lung, prostate, breast, and colorectal). With clinic participants we created 5 journey maps, each representing specialty clinic workflow directed at evidence-based monitoring. System vulnerabilities common to the different clinics included challenges with: data systems, communications handoffs, population-level tracking, and patient activities. Clinic staff ranked 13 design seeds (e.g., keep patient list up to date, use triggered notifications) addressing these vulnerabilities. Each design seed has unique evaluation criteria for the usefulness of potential solutions developed from the seed. We identified and ranked 13 design seeds that characterize situations that clinicians described 'wake them up at night', and thus could reduce
Schneider, Antoine G; Bellomo, Rinaldo; Reade, Michael; Peck, Leah; Young, Helen; Eastwood, Glenn M; Garcia, Mercedes; Moore, Elizabeth; Harley, Nerina
Urine alkalinisation with sodium bicarbonate decreases renal oxidative stress and might attenuate sepsisassociated acute kidney injury (s-AKI). The safety and feasibility of urine alkalinisation in patients at risk of s-AKI has never been tested. We randomly assigned patients at risk of s-AKI (those with systemic inflammatory response syndrome [SIRS], oliguria and elevated [≥150 µg/L] serum neutrophil gelatinase-associated lipocalin [sNGAL] concentration) to receive sodium bicarbonate (treatment group) or sodium chloride (placebo group) in a 0.5 mmol/kg bolus followed by an infusion of 0.2 mmol/kg/hour. Among 50 patients with SIRS and oliguria, 25 (50%) had an elevated sNGAL concentration. Of these, 13 were randomised to receive sodium bicarbonate and 12 to receive sodium chloride infusion. Study drugs were infused for a mean period of 25.9 hours (SD, 10 hours). Severe electrolyte abnormalities occurred in seven patients (28%) (four [30.8%] in the treatment group and three [25%] in the placebo group). These abnormalities resulted in early protocol cessation in six patients (24%) and study drug suspension in one patient (4%). This adverse event rate was judged to be unacceptable and the study was terminated early. There was no difference between the two groups in sNGAL or urinary NGAL concentrations over time, occurrence of acute kidney injury, requirement for renal replacement therapy, hospital length-of-stay or mortality. Administration of sodium bicarbonate and sodium chloride solutions to patients at risk of s-AKI was associated with frequent major electrolyte abnormalities and early protocol cessation. The tested protocol does not appear safe or feasible.
Job creation is not the idea behind the demand for risk studies to be intensified in safety research. Risks are not only a target safety research should investigate, they are a subject that actually can be most adequately investigated by safety research. Assuming a neutral position between irrational fears and interest-minded problem minimization, that is the central approach and the ethics of a safety scientist. The Babylonian confusion of terminology experienced after the Chernobyl accident is a good example proving the necessity of fostering the neutral professionalism in safety research. (orig./DG) [de
Hunter, P.H.; Barg, D.C.; Baird, R.D.; Card, D.H.; de Souza, F.; Elder, J.; Felthauser, K.; Jensen, C.; Winkler, V.
A brief radiological safety and risk assessment of a nuclear power generation center with an adjacent on-site waste disposal facility at a specific site in the State of Utah is presented. The assessment was conducted to assist in determining the feasibility and practicality of developing a nuclear energy center (NEC) in Utah consisting of nine 1250 MWe nuclear pressurized water reactor (PWR) electrical generating units arranged in 3 clusters of 3 units each known as triads. The site selected for this conceptual study is in the Horse Bench area about 15 miles directly south of the town of Green River, Utah. The radiological issues included direct radiation exposures to on-site workers and the off-site population, release of radioactive material, and effects of these releases for both normal operations and accidental occurrences. The basic finding of this study is that the concept of an NEC in the Green River area, specifically at the Horse Bench site, is radiologically feasible
Bittner-Fagan, Heather; Davis, Joshua; Savoy, Margot
Communication among physicians, staff, and patients is a critical element in patient safety. Effective communication skills can be taught and improved through training and awareness. The practice of family medicine allows for long-term relationships with patients, which affords opportunities for ongoing, high-quality communication. There are many barriers to effective communication, including patient factors, clinician factors, and system factors, but tools and strategies exist to address these barriers, improve communication, and engage patients in their care. Use of universal precautions for health literacy, appropriate medical interpreters, and shared decision-making are evidence-based tools that improve communication and increase patient safety. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.
Suddle, S.I.; Waarts, P.H.
Safety is nowadays one of the main items on the agenda during the planning, realisation and management of most large-scale projects, particularly in infrastructure and building projects in intensively used areas such as multiple use of land projects. It is vital that safety aspects are properly
Van Gulijk, Coen; Hughes, Peter; Figueres-Esteban, Miguel; Dacre, Marcus; Harrison, Chris; HUD; RSSB
Computer scientists believe that the enormous amounts of data in the internet will unchain a management revolution of uncanny proportions. Yet, to date, the potential benefit of this revolution is scantily investigated for safety and risk management. This paper gives a brief overview of a research programme that investigates how the new internet-driven data-revolution could benefit safety and risk management for railway safety in the UK. The paper gives a brief overview the current activities...
Boch, Tobias; Luft, Thomas; Metzgeroth, Georgia; Mossner, Maximilian; Jann, Johann-Christoph; Nowak, Daniel; Meir, Franziska La; Schumann, Christiane; Klemmer, Jennifer; Brendel, Susanne; Fricke, Harald; Kunz, Claudia; Weiß, Christel; Hofmann, Wolf-Karsten; Nolte, Florian
In low risk MDS, increased apoptosis of erythroid progenitors mediated via CD95 (Fas) activation has been described to result in peripheral cytopenia. Blockade of the CD95 system can improve erythropoiesis in MDS. Asunercept (APG101) is a fusion protein consisting of the extracellular domain of human CD95 and the Fc domain of human IgG1 blocking the interaction between CD95 and its ligand. Here we report on results from a phase I study in 20 transfusion-dependent low and intermediate risk MDS patients treated with intravenous asunercept (EudraCT 2012-003027-37). Primary objectives were safety and tolerability as well as pharmacodynamic effects. Secondary objectives were hematologic improvement, incidence and time to leukemic progression as well as overall survival. Frequency and severity of adverse events were in range of what could be expected in a patient cohort comprising of elderly MDS patients. Two patients experienced a serious adverse event with a suspected relationship to asunercept. The incidence of disease progression was low. In the 20 patients a decrease of the transfusion need from a mean of 10,8 (±5,1) pRBCs during the 12 weeks treatment phase to a mean of 10,0 (±4,2) pRBCs at the end of the study was observed. In conclusion, asunercept was well tolerated and showed efficacy in transfusion-dependent low and intermediate risk MDS patients. Further clinical investigation is warranted, particularly in combination with erythropoiesis stimulating agents (ESAs). Copyright © 2018. Published by Elsevier Ltd.
Johnson, Hope L; Kimsey, Diane
A culture of patient safety requires commitment and full participation from all staff members. In 2008, results of a culture of patient safety survey conducted in the perioperative division of the Lehigh Valley Health Network in Pennsylvania revealed a lack of patient-centered focus, teamwork, and positive communication. As a result, perioperative leaders assembled a multidisciplinary team that designed a safety training program focusing on Crew Resource Management, TeamSTEPPS, and communication techniques. The team used video vignettes and an audience response system to engage learners and promote participation. Topics included using preprocedural briefings and postprocedural debriefings, conflict resolution, and assertiveness techniques. Postcourse evaluations showed that the majority of respondents believed they were better able to question the decisions or actions of someone with more authority. The facility has experienced a marked decrease in the number of incidents requiring a root cause analysis since the program was conducted. Copyright © 2012 AORN, Inc. Published by Elsevier Inc. All rights reserved.
Croskerry, Pat; Abbass, Allan; Wu, Albert W
The way that health care providers feel, both within themselves and toward their patients, may influence their clinical performance and impact patient safety, yet this aspect of provider behavior has received relatively little attention. How providers feel, their emotional or affective state, may exert a significant, unintended influence on their patients, and may compromise safety. We examined a broad literature across multiple disciplines to review the interrelationships between emotion, decision making, and behavior, and to assess their potential impact on patient safety. There is abundant evidence that the emotional state of the health care provider may be influenced by factors including characteristics of the patient, ambient conditions in the health care setting, diurnal, circadian, infradian, and seasonal variables, as well as endogenous disorders of the individual provider. These influences may lead to affective biases in decision making, resulting in errors and adverse events. Clinical reasoning and judgment may be particularly susceptible to emotional influence, especially those processes that rely on intuitive judgments. There are many ways that the emotional state of the health care provider can influence patient care. To reduce emotional errors, the level of awareness of these factors should be raised. Emotional skills training should be incorporated into the education of health care professionals. Specifically, clinical teaching should promote more openness and discussion about the provider's feelings toward patients. Strategies should be developed to help providers identify and de-bias themselves against emotional influences that may impact care, particularly in the emotionally evocative patient. Psychiatric conditions within the provider, which may compromise patient safety, need to be promptly detected, diagnosed, and managed.
... Organizations: Voluntary Relinquishment From Child Health Patient Safety Organization, Inc. AGENCY: Agency for... notification of voluntary relinquishment from Child Health Patient Safety Organization, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety...
... Organizations: Voluntary Relinquishment From HSMS Patient Safety Organization AGENCY: Agency for Healthcare... voluntary relinquishment from the HSMS Patient Safety Organization of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109...
The proper definition and quantification of human safety is discussed and from this basis the historical development of our present very high standard of safety is traced. It is shown that increased safety is closely associated with increased wealth, and the quantitative relationship between then is derived from different sources of evidence. When this factor is applied to the production of wealth by industry, a safety benefit is indicated which exceeds the asserted risks by orders of magnitude. It is concluded that present policies and attitudes in respect to the safety of industry may be diametrically wrong. (orig.) [de
Hellings, Johan; Schrooten, Ward; Klazinga, Niek; Vleugels, Arthur
PURPOSE: The purpose of this paper is to measure patient safety culture in five Belgian general hospitals. Safety culture plays an important role in the approach towards greater patient safety in hospitals. DESIGN/METHODOLOGY/APPROACH: The Patient Safety Culture Hospital questionnaire was
Starting with a comprehensive safety strategy as evolved over the past years and the present legal provisions for the construction and operation of nuclear power plants, the risk of the intended operation, of accidents and unforeseen events is discussed. Owing to the excellent safety record of nuclear power plants, main emphasis in discussing accidents is given to the precautionary analysis within the framework of the licensing procedure. In this context, hypothetical accidents are mentioned only as having been utilized for general risk comparisons. The development of a comprehensive risk concept for a completely objective safety assessment of nuclear power plants remains as a final goal. (orig.) [de
Health care tends to oversimplify patient safety concepts. We tend to think about patient safety as a linear dimension that is only associated with the progressive reduction in the number of errors and accidents, with the simple notion that fewer are always better. We consider figures in isolation from the underlying context and prerequisites that drive safety models and the reality of the clinical fields. There is no one ultimate reference model of safety, but many models that can be adapted to fit the various clinical fields requirements and constraints. It is therefore not necessarily a bad result to observe a lower safety figure in a medical domain compared to the figures obtained in nonmedical ultra-safe models. The poor figures may represent the best local safety optimization while coping with the special health care requirements such as a high frequency of unplanned and nonstandard challenges. The paper distinguishes three classes of safety models that fit different field demands: the resilient and adaptive model, the high reliability (HRO) model, and the ultra-safe model. The lecture benchmarks the traits of each model while highlighting the specific dimensions for optimization. The conclusion is that firstly, that since the task requirements dictate the relevance and choice of the model and not the other way around, it is counterproductive to impose a model that is inadequate for the task requirements. Either you move the requirements and change the model, or you keep the constraints, and try to locally optimize the model to the clinical and organizational needs. (author)
Elmaraezy, Ahmed; Ismail, Ammar; Abushouk, Abdelrahman Ibrahim; Eltoomy, Moutaz; Saad, Soha; Negida, Ahmed; Abdelaty, Osama Mahmoud; Abdallah, Ahmed Ramadan; Aboelfotoh, Ahmed Magdy; Hassan, Hossam Mahmoud; Elmaraezy, Aya Gamal; Morsi, Mahmoud; Althaher, Farah; Althaher, Moath; AlSafadi, Ammar M
Recently, transcatheter aortic valve replacement (TAVR) has become the procedure of choice in high surgical risk patients with aortic stenosis (AS). However, its value is still debated in operable AS cases. We performed this meta-analysis to compare the safety and efficacy of TAVR to surgical aortic valve replacement (SAVR) in low-to-moderate surgical risk patients with AS. A systematic search of five authentic databases retrieved 11 eligible studies (20,056 patients). Relevant Data were pooled as risk ratios (RRs) or standardized mean differences (SMD), with their 95% confidence interval, using Comprehensive Meta-Analysis and RevMan software for windows. At one-year of follow-up, the pooled effect-estimates showed no significant difference between TAVR and SAVR groups in terms of all-cause mortality (RR 1.02, 95% CI [0.83, 1.26], stroke (RR 0.83, 95%CI [0.56, 1.21]), myocardial infarction (RR 0.82, 95% CI [0.57, 1.19]), and length of hospital stay (SMD -0.04, 95% CI [-0.34, 0.26]). The incidence of major bleeding (RR 0.45, 95% CI [0.24, 0.86]) and acute kidney injury (RR 0.52, 95% CI [0.30, 0.88]) was significantly lower in the TAVR group, compared to the SAVR group. However, TAVR was associated with a higher risk of permanent pacemaker implantation (RR 2.57, 95% CI [1.36, 4.86]), vascular-access complications at 1 year (RR 1.99, 95%CI [1.04, 3.80]), and paravalvular aortic regurgitation at 30 days (RR 3.90, 95% CI [1.25, 12.12]), compared to SAVR. Due to the comparable mortality rates in SAVR and TAVR groups and the lower risk of life-threatening complications in the TAVR group, TAVR can be an acceptable alternative to SAVR in low-to-moderate risk patients with AS. However, larger trials with longer follow-up periods are required to compare the long-term outcomes of both techniques.
Aiello-Laws, Lisa B
The Joint Commission publishes its annual National Patient Safety Goals to guide accredited organizations in addressing high-risk, low-volume concerns related to patient safety. The 2010 list includes a goal to identify patients at risk for suicide, but do oncology nurses need to be concerned about the risk of suicide in patients with cancer?
Yassi, Annalee; Hancock, Tina
Patient safety within the Canadian healthcare system is currently a high national priority, which merits a comprehensive understanding of the underlying causes of adverse events. Not least among these is worker health and safety, which is linked to patient outcomes. Healthcare workers have a high risk of workplace injuries and more mental health problems than most other occupational groups. Many healthcare professionals feel fatigued, stressed, in pain, or at risk of illness or injury-factors they feel impede their ability to provide consistent quality care. With this background, the Occupational Health and Safety Agency for Healthcare (OHSAH) in British Columbia, jointly governed by healthcare unions and healthcare employers, launched several major initiatives to improve the healthcare workplace. These included the promotion of safe patient handling, adaptive clothing, scheduled toileting, stroke management training, measures to improve management of aggressive behaviour and, of course, infection control-all intended to improve the safety of workers, but also to improve patient safety and quality of care. Other projects also explicitly promoting physical and mental health at work, as well as patient safety are also underway. Results of the projects are at various stages of completion, but ample evidence has already been obtained to indicate that looking after the well-being of healthcare workers results in safer and better quality patient care. While more research is needed, our work to date suggests that a comprehensive systems approach to promoting a climate of safety, which includes taking into account workplace organizational factors and physical and psychological hazards for workers, is the best way to improve the healthcare workplace and thereby patient safety.
Simons, G R; Newby, K H; Kearney, M M; Brandon, M J; Natale, A
The objective of this study was to assess the safety and efficacy of transvenous low energy cardioversion of atrial fibrillation in patients with ventricular tachycardia and atrial fibrillation and to study the mechanisms of proarrhythmia. Previous studies have demonstrated that cardioversion of atrial fibrillation using low energy, R wave synchronized, direct current shocks applied between catheters in the coronary sinus and right atrium is feasible. However, few data are available regarding the risk of ventricular proarrhythmia posed by internal atrial defibrillation shocks among patients with ventricular arrhythmias or structural heart disease. Atrial defibrillation was performed on 32 patients with monomorphic ventricular tachycardia and left ventricular dysfunction. Shocks were administered during atrial fibrillation (baseline shocks), isoproterenol infusion, ventricular pacing, ventricular tachycardia, and atrial pacing. Baseline shocks were also administered to 29 patients with a history of atrial fibrillation but no ventricular arrhythmias. A total of 932 baseline shocks were administered. No ventricular proarrhythmia was observed after well-synchronized baseline shocks, although rare inductions of ventricular fibrillation occurred after inappropriate T wave sensing. Shocks administered during wide-complex rhythms (ventricular pacing or ventricular tachycardia) frequently induced ventricular arrhythmias, but shocks administered during atrial pacing at identical ventricular rates did not cause proarrhythmia. The risk of ventricular proarrhythmia after well-synchronized atrial defibrillation shocks administered during narrow-complex rhythms is low, even in patients with a history of ventricular tachycardia. The mechanism of proarrhythmia during wide-complex rhythms appears not to be related to ventricular rate per se, but rather to the temporal relationship between shock delivery and the repolarization time of the previous QRS complex.
Holmberg, J.; Niemelae, I.
The main objectives of the study are: to define risk measures and suggested uses of them in various living PSA applications for the operational safety management and to describe specific model features required for living PSA applications. The report is based on three case studies performed within the Nordic research project Safety Evaluation by Use of Living PSA and Safety Indicators. (48 refs., 11 figs., 17 tabs.)
Stone, Patricia W; Mooney-Kane, Cathy; Larson, Elaine L; Horan, Teresa; Glance, Laurent G; Zwanziger, Jack; Dick, Andrew W
System approaches, such as improving working conditions, have been advocated to improve patient safety. However, the independent effect of many working condition variables on patient outcomes is unknown. To examine effects of a comprehensive set of working conditions on elderly patient safety outcomes in intensive care units. Observational study, with patient outcome data collected using the National Nosocomial Infection Surveillance system protocols and Medicare files. Several measures of health status and fixed setting characteristics were used to capture distinct dimensions of patient severity of illness and risk for disease. Working condition variables included organizational climate measured by nurse survey; objective measures of staffing, overtime, and wages (derived from payroll data); and hospital profitability and magnet accreditation. The sample comprised 15,846 patients in 51 adult intensive care units in 31 hospitals depending on the outcome analyzed; 1095 nurses were surveyed. Central line associated bloodstream infections (CLBSI), ventilator-associated pneumonia, catheter-associated urinary tract infections, 30-day mortality, and decubiti. Units with higher staffing had lower incidence of CLBSI, ventilator-associated pneumonia, 30-day mortality, and decubiti (P working conditions were associated with all outcomes measured. Improving working conditions will most likely promote patient safety. Future researchers and policymakers should consider a broad set of working condition variables.
Sahlström, Merja; Partanen, Pirjo; Rathert, Cheryl; Turunen, Hannele
The aim of this study was to elicit patient safety experts' views of patient participation in promoting patient safety. Data were collected between September and December in 2014 via an electronic semi-structured questionnaire and interviews with Finnish patient safety experts (n = 21), then analysed using inductive content analysis. Patient safety experts regarded patients as having a crucial role in promoting patient safety. They generally deemed the level of patient safety as 'acceptable' in their organizations, but reported that patient participation in their own safety varied, and did not always meet national standards. Management of patient safety incidents differed between organizations. Experts also suggested that patient safety training should be increased in both basic and continuing education programmes for healthcare professionals. Patient participation in patient safety is still lacking in clinical practice and systematic actions are needed to create a safety culture in which patients are seen as equal partners in the promotion of high-quality and safe care. © 2016 John Wiley & Sons Australia, Ltd.
Zinck Pedersen, Kirstine
pragmatism, situated learning theory and science and technology studies, the paper contrasts the notion of ‘systemic’ learning expressed by the safety policy program with notions of learning as a socio-materially situated practice. Based on fieldwork conducted in 2010 in a Danish university hospital, I...... propose that learning, and more specifically learning from critical incidents, should be understood as a practical and experience-based activity as well as an equally individual and social achievement, which is always formed in relation to the specificities of the concrete situation. Parting from......The key trope of patient safety policy is learning. With the motto of going from ‘a culture of blame to a learning culture’, the safety program introduces a ‘systemic perspective’ to facilitate openness and willingness to talk about failures, hereby making failures into a system property. Within...
Faber, Michael Havbro; Sørensen, John Dalsgaard; Vrouwenvelder, A.C.W.M.
. Starting point is taken in a short outline of what is considered to comprise the present best practice rationale for life safety and health risk regulation. Thereafter, based on selected principal examples from different application areas, inconsistencies in present best practice risk quantification...... absolute level of individual life safety risk subject to assessment of acceptability. It is highlighted that a major cause of inconsistency in risk quantifications and comparisons originates from the fact that present regulations partly address societal activities and partly address applied technologies...
Brennan, Peter A; Brands, Marieke T; Caldwell, Lucy; Fonseca, Felipe Paiva; Turley, Nic; Foley, Susie; Rahimi, Siavash
Essential communication between healthcare staff is considered one of the key requirements for both safety and quality care when patients are handed over from one clinical area to other. This is particularly important in environments such as the operating theatre and intensive care where mistakes can be devastating. Health care has learned from other high-risk organisations (HRO) such as aviation where the use of checklists and human factors awareness has virtually eliminated human error and mistakes. To our knowledge, little has been published around ways to improve pathology specimen handover following surgery, with pathology request forms often conveying the bare minimum of information to assist the laboratory staff. Furthermore, the request form might not warn staff about potential hazards. In this article, we provide a brief summary of the factors involved in human error and introduce a novel checklist that can be readily completed at the same time as the routine pathology request form. This additional measure enhances safety, can help to reduce processing and mislabelling errors and provides essential information in a structured way assisting both laboratory staff and pathologists when handling head and neck surgical specimens. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Schwappach, David L B; Frank, Olga; Buschmann, Ute; Babst, Reto
Rationale, aims and objectives The study aims to investigate the effects of a patient safety advisory on patients' risk perceptions, perceived behavioural control, performance of safety behaviours and experience of adverse incidents. Method Quasi-experimental intervention study with non-equivalent group comparison was used. Patients admitted to the surgical department of a Swiss large non-university hospital were included. Patients in the intervention group received a safety advisory at their first clinical encounter. Outcomes were assessed using a questionnaire at discharge. Odds ratios for control versus intervention group were calculated. Regression analysis was used to model the effects of the intervention and safety behaviours on the experience of safety incidents. Results Two hundred eighteen patients in the control and 202 in the intervention group completed the survey (75 and 77% response rates, respectively). Patients in the intervention group were less likely to feel poorly informed about medical errors (OR = 0.55, P = 0.043). There were 73.1% in the intervention and 84.3% in the control group who underestimated the risk for infection (OR = 0.51, CI 0.31-0.84, P = 0.009). Perceived behavioural control was lower in the control group (meanCon = 3.2, meanInt = 3.5, P = 0.010). Performance of safety-related behaviours was unaffected by the intervention. Patients in the intervention group were less likely to experience any safety-related incident or unsafe situation (OR for intervention group = 0.57, CI 0.38-0.87, P = 0.009). There were no differences in concerns for errors during hospitalization. There were 96% of patients (intervention) who would recommend other patients to read the advisory. Conclusions The results suggest that the safety advisory decreases experiences of adverse events and unsafe situations. It renders awareness and perceived behavioural control without increasing concerns for safety and
Elizabeth M. Borycki
Full Text Available In this paper the author describes work towards developing an integrative framework for educating health information technology professionals about technology risk. The framework considers multiple sources of risk to health data quality and integrity that can result from the use of health information technology (HIT and can be used to teach health professional students about these risks when using health technologies. This framework encompasses issues and problems that may arise from varied sources, including intentional alterations (e.g. resulting from hacking and security breaches as well as unintentional breaches and corruption of data (e.g. resulting from technical problems, or from technology-induced errors. The framework that is described has several levels: the level of human factors and usability of HIT, the level of monitoring of security and accuracy, the HIT architectural level, the level of operational and physical checks, the level of healthcare quality assurance policies and the data risk management strategies level. Approaches to monitoring and simulation of risk are also discussed, including a discussion of an innovative approach to monitoring potential quality issues. This is followed by a discussion of the application (using computer simulations to educate both students and health information technology professionals about the impact and spread of technology-induced and related types of data errors involving HIT.
Patient safety can only exist in a culture of patient safety, which implies it is a value perceived by all. Culture predicts safety outcomes and leadership predicts the culture. Leaders are obligated to continually mitigate hazard and take action consciously. Healthcare workers should focus on preventing and reporting mistakes with the National Patient Safety Goals (NPSGs) in mind. These include: accuracy of patient identification, effectiveness of communication among caregivers, improving safety of medications, reducing infections, reducing risk of falls, and encouraging patients to be involved in care. Poor performers and reckless behavior need to be mitigated. If employees recognize their roles in the process, feel empowered,and have appropriate tools, resources,and data to implement solutions, errors can be avoided and patient safety becomes paramount.
The nuclear power industry deals in many kinds of risks, complicated by political stress and communication problems. Power plant design must prepare for the unexpected attack, physical as well as psychological, but a zero-defects technology is not possible. The public has not been made sufficiently aware of the risk the US takes if there is not enough energy because nuclear power has been curtailed. Energy shortages could drive industry and jobs abroad, force the public to turn to government for a solution, drive the country to energy allocation, and cause a nuclear war. Policies that prevent closing the nuclear fuel cycle are ineffective in preventing proliferation and counterproductive to national needs
Lucélia Ferreira Lima
Full Text Available Objective: To identify the risks reported at a public institution andto know the main patient risks from the nursing staff point of view.Methods: A retrospective, descriptive and exploratory study. Thesurvey was developed at a hospital in the city of Taboão da Serra, SãoPaulo, Brazil. The study included all nurses working in care areas whoagreed to participate in the study. At the same time, sentinel eventsoccurring in the period from July 2006 to July 2007 were identified.Results: There were 440 sentinel events reported, and the main risksincluded patient falls, medication errors and pressure ulcers. Sixty-fivenurses were interviewed. They also reported patient falls, medicationerrors and pressure ulcers as the main risks. Conclusions: Riskassessment and implementation of effective preventive actions arenecessary to ensure patient’s safety. Involvement of a multidisciplinaryteam is one of the steps for a successful process.
Stevenson, R Lynn; Moss, Lesley; Newlands, Tracey; Archer, Jana
The safety of patients and of employees in healthcare have historically been separately managed and regulated. Despite efforts to reduce injury rates for employees and adverse events for patients, healthcare organizations continue to see less-than-optimal outcomes in both domains. This article challenges readers to consider how the traditional siloed approach to patient and employee safety can lead to duplication of effort, confusion, missed opportunities and unintended consequences. The authors propose that only through integrating patient and employee safety activities and challenging the paradigms that juxtapose the two will healthcare organizations experience sustained and improved safety practice and outcomes. Copyright © 2013 Longwoods Publishing.
Encinares, Maxima; McMaster, Jeff James; McNamee, Jim
One of the unique roles of forensic nurses is to conduct risk assessments. Establishing a therapeutic nurse-patient relationship helps forensic nurses perform accurate and useful risk assessments. Accurate risk assessments can facilitate formulation of individualized risk management plans, designed to meet patients' needs and ensure public safety. The importance of forensic nurses' knowledge and application of appropriate communication and proper documentation cannot be overemphasized.
Corbally, Martin Thomas
Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out World Health Organization (WHO), errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO Surgical Pause/Time Out aims to capture these errors and prevent them, but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical Pause and Time Out, perhaps to avoid additional stress. In addition, surgeons, like pilots, are subject to the phenomenon of "plan-continue-fail" with potentially disastrous outcomes. If we wish to improve patient safety during surgery and avoid wrong site errors then we must include parents in the Surgical Pause/Time Out. A recent pilot study has shown that neither staff nor parents found it added to their stress, but, moreover, 100% of parents considered that it should be a mandatory component of the Surgical Pause nor does it add to the stress of surgery. Surgeons should be required to confirm that the planned procedure is in keeping with the operative findings especially in extirpative surgery and this "step back" should be incorporated into the standard Surgical Pause. It is clear that we must improve patient safety further and these simple measures should add to that potential.
Klingner, Jill; Moscovice, Ira; Tupper, Judith; Coburn, Andrew; Wakefield, Mary
Implementation of patient safety initiatives can be costly in time and energy. Because of small volumes and limited resources, rural hospitals often are not included in nationally driven patient safety initiatives. This article describes the Tennessee Rural Hospital Patient Safety Demonstration project, whose goal was to strengthen capacity for…
Background A constructive patient safety culture is a main prerequisite for patient safety and improvement initiatives. Until now, patient safety culture (PSC) research was mainly focused on hospital care, however, it is of equal importance in primary care. Measuring PSC informs practices on their
Rathert, Cheryl; Huddleston, Nicole; Pak, Youngju
Patient safety has been a highly researched topic in health care since the year 2000. One strategy for improving patient safety has been to encourage patients to take an active role in their safety during their health care experiences. However, little research has shed light on how patients view their roles. This study attempted to address this deficit by inductively exploring the results of a qualitative study in which patients reported their ideas about what they believe their roles should be. Patients with an overnight stay in the previous 90 days at one of three hospitals were surveyed using a mailing methodology. Of 1,040 respondents, 491 provided an open-ended response regarding what they believe the patient role should be. Qualitative analysis found several prominent themes. The largest proportion of responses (23%) suggested that patients should follow instructions given by care providers. Other prominent themes were that patients should ask questions and become informed about their conditions and treatments, and many implied that they should expect competent care. Our results suggest that patients believe they should be able to trust that they are being provided competent care, as opposed to assuming a leadership role in their safety. Our results suggest that engaging patients in safety efforts may be complex, requiring a variety of strategies. Managers must provide environments conducive to staff and patient interactions to support patients in this effort. Different types of patients may require different engagement strategies.
Martin Thomas Corbally
Full Text Available Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out (WHO,errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO surgical pause / Time Out aims to capture these errors and prevent them but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical pause and Time Out perhaps to avoid additional stress. In addition surgeons, like pilots, are subject to the phenomenon of plan continue fail with potentially disastrous outcomes.
Cappucci, A.J. Jr.
OSR limits are designed to protect the assumptions made in the facility safety analysis in order to preserve the safety envelope during facility operation. Normally, limits are set based on ''worst case conditions'' without regard to the likelihood (frequency) of a credible event occurring. In special cases where the accident analyses are based on ''time at risk'' arguments, it may be desirable to control the time at which the facility is at risk. A methodology has been developed to use OSR limits to control the source terms and the times these source terms would be available, thus controlling the acceptable risk to a nuclear process facility. The methodology defines a new term ''gram-days''. This term represents the area under a source term (inventory) vs time curve which represents the risk to the facility. Using the concept of gram-days (normalized to one year) allows the use of an accounting scheme to control the risk under the inventory vs time curve. The methodology results in at least three OSR limits: (1) control of the maximum inventory or source term, (2) control of the maximum gram-days for the period based on a source term weighted average, and (3) control of the maximum gram-days at the individual source term levels. Basing OSR limits on risk based safety analysis is feasible, and a basis for development of risk based limits is defensible. However, monitoring inventories and the frequencies required to maintain facility operation within the safety envelope may be complex and time consuming
Martijn, L.L.M.; Jacobs, A.J.E.; Maassen, I.I.M.; Buitendijk, S.S.E.; Wensing, M.M.
Objective: to describe the incidence and characteristics of patient safety incidents in midwifery-led care for low-risk pregnant women. Design: multi-method study. Setting: 20 midwifery practices in the Netherlands; 1,000 patient records. Population: low-risk pregnant women. Methods: prospective
Lark, Meghan E; Kirkpatrick, Kay; Chung, Kevin C
Despite progress within the past 15 years, improving patient safety in health care remains an important public health issue. The history of safety policies, research, and development has revealed that this issue is more complex than initially perceived and is pertinent to all health care settings. Solutions, therefore, must be approached at the systems level and supplemented with a change in safety culture, especially in higher risk fields such as surgery. To do so, health care agents at all levels have started to prioritize the improvement of nontechnical skills such as teamwork, communication, and accountability, as reflected by the development of various checklists and safety campaigns. This progress may be sustained by adopting teamwork training programs that have proven successful in other high-risk industries, such as crew resource management in aviation. These techniques can be readily implemented among surgical teams; however, successful application depends heavily on the strong leadership and vigilance of individual surgeons. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.
... Organizations: Delisting for Cause of Patient Safety Organization One, Inc. AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. SUMMARY: Patient Safety Organization One, Inc.: AHRQ has delisted Patient Safety Organization One, Inc. as a Patient Safety Organization (PSO...
... Organizations: Voluntary Relinquishment From UAB Health System Patient Safety Organization AGENCY: Agency for... notification of voluntary relinquishment from the UAB Health System Patient Safety Organization of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From the Patient Safety Group AGENCY: Agency for Healthcare Research and... voluntary relinquishment from The Patient Safety Group of its status as a Patient Safety Organization (PSO...
Joksimovich, V.; Orvis, D.D.
A primary focus of nuclear safety is the prevention of large releases of radioactivity in the case of low-probability severe accidents. An analysis of the anatomy of nuclear (Chernobyl, Three Mile Island Unit 2) and nonnuclear (Challenger, Bhopal, Piper Alpha, etc.) severe accidents yields four broad categories of root causes: human (operating crew response), machine (design with its basic flaws), media (natural phenomena, operational considerations, political environment, commercial pressures, etc.)-providing triggering events, and management (basic organizational safety culture flaws). A strong management can minimize the contributions of humans, machines, and media to the risk arising from the operation of hazardous facilities. One way that management can have a powerful positive influence is through the establishment of a proper safety culture. The term safety culture is used as defined by the International Atomic Energy Agency's International Safety Advisory Group
Goes, Alexandre Gromann de Araujo
This work deals with the fundamental concepts of risk and safety related to nuclear power generation. In the first chapter, a general evaluation of the various systems for energy generation and their environmental impacts is made. Some definitions for safety and risk are suggested, based on the already existing regulatory processes and also on the current tendencies of risk management. Aspects regarding the safety culture are commented. The International Nuclear Event Scale (INES), a coherent and clear mechanism of communication between nuclear specialists and the general public, is analyzed. The second chapter examines the thermonuclear generation program in Brazil and the role of the National Nuclear Energy Commission. The third chapter presents national and international scenarios in terms of safety and risks, available policies and the main obstacles for future development of nuclear energy and nuclear engineering, and strategies are proposed. In the last chapter, comments about possible trends and recommendations related to practical risk management procedures, taking into account rational criteria for resources distribution and risk reduction are made, envisaging a closer integration between nuclear specialists and the society as a whole, thus decreasing the conflicts in a democratic decision-making process
The dissertation is a critical examination of risk assessment and its role in public policy. Nuclear power safety safety issues are selected as the primary source of illustrations and examples. The dissertation examines how risk assessment studies develop a concept of risk which becomes decisive for policy choices. Risk-assessment techniques are interpreted as instruments which secure an evaluation of risk which, in turn, figures prominently in technical reports on nuclear power. The philosophical critique is mounted on two levels. First, an epistemological critique surveys distinctions between the technical concept of risk and more familiar senses of risk. The critique shows that utilization of risk assessment re-structures the concept of risk. The technical concept is contrasted to the function of risk within a decision-maker's conceptual agenda and hierarchy of values. Second, an ethical critique exposes the value commitments of risk assessment recommendations. Although some of these values might be defended for policy decisions, the technical character of risk assessment obfuscates normative issues. Risk assessment is shown to be a form of factual enquiry which, nonetheless, represents a commitment to a specific selection of ethical and social values. Risk assessment should not be interpreted as a primary guide to decision unless the specific values incorporated into its concept of risk are stated explicitly and justified philosophically. Such a statement would allow value questions which have been sublimated by the factual tone of the analytic techniques to be debated on clear, social and ethical grounds
Vaismoradi, Mojtaba; Jordan, Sue; Kangasniemi, Mari
This systematic review aims to synthesise the existing research on how patients participate in patient safety initiatives. Ambiguities remain about how patients participate in routine measures designed to promote patient safety. Systematic review using integrative methods. Electronic databases were searched using keywords describing patient involvement, nursing input and patient safety initiatives to retrieve empirical research published between 2007 and 2013. Findings were synthesized using the theoretical domains of Vincent's framework for analysing risk and safety in clinical practice: "patient", "healthcare provider", "task", "work environment", "organisation & management". We identified 17 empirical research papers: four qualitative, one mixed-method and 12 quantitative designs. All 17 papers indicated that patients can participate in safety initiatives. Improving patient participation in patient safety necessitates considering the patient as a person, the nurse as healthcare provider, the task of participation and the clinical environment. Patients' knowledge, health conditions, beliefs and experiences influence their decisions to engage in patient safety initiatives. An important component of the management of long-term conditions is to ensure that patients have sufficient knowledge to participate. Healthcare providers may need further professional development in patient education and patient care management to promote patient involvement in patient safety, and ensure that patients understand that they are 'allowed' to inform nurses of adverse events or errors. A healthcare system characterised by patient-centredness and mutual acknowledgement will support patient participation in safety practices. Further research is required to improve international knowledge of patient participation in patient safety in different disciplines, contexts and cultures. Patients have a significant role to play in enhancing their own safety while receiving hospital care. This
Mohr, David C; Eaton, Jennifer Lipkowitz; McPhaul, Kathleen M; Hodgson, Michael J
We examined relationships between employee safety climate and patient safety culture. Because employee safety may be a precondition for the development of patient safety, we hypothesized that employee safety culture would be strongly and positively related to patient safety culture. An employee safety climate survey was administered in 2010 and assessed employees' views and experiences of safety for employees. The patient safety survey administered in 2011 assessed the safety culture for patients. We performed Pearson correlations and multiple regression analysis to examine the relationships between a composite measure of employee safety with subdimensions of patient safety culture. The regression models controlled for size, geographic characteristics, and teaching affiliation. Analyses were conducted at the group level using data from 132 medical centers. Higher employee safety climate composite scores were positively associated with all 9 patient safety culture measures examined. Standardized multivariate regression coefficients ranged from 0.44 to 0.64. Medical facilities where staff have more positive perceptions of health care workplace safety climate tended to have more positive assessments of patient safety culture. This suggests that patient safety culture and employee safety climate could be mutually reinforcing, such that investments and improvements in one domain positively impacts the other. Further research is needed to better understand the nexus between health care employee and patient safety to generalize and act upon findings.
Lins, Christian; Gerka, Alexander; Lüpkes, Christian; Röhrig, Rainer; Hein, Andreas
In this paper, we present an approach for enhancing the safety of artificially ventilated patients using ambient process analysis. We propose to use an analysis system consisting of low-cost ambient sensors such as power sensor, RGB-D sensor, passage detector, and matrix infrared temperature sensor to reduce risks for artificially ventilated patients in both home and clinical environments. We describe the system concept and our implementation and show how the system can contribute to patient safety.
Miligy, Dawlat A
Laboratory data are extensively used in medical practice; consequently, laboratory errors have a tremendous impact on patient safety. Therefore, programs designed to identify and reduce laboratory errors, as well as, setting specific strategies are required to minimize these errors and improve patient safety. The purpose of this paper is to identify part of the commonly encountered laboratory errors throughout our practice in laboratory work, their hazards on patient health care and some measures and recommendations to minimize or to eliminate these errors. Recording the encountered laboratory errors during May 2008 and their statistical evaluation (using simple percent distribution) have been done in the department of laboratory of one of the private hospitals in Egypt. Errors have been classified according to the laboratory phases and according to their implication on patient health. Data obtained out of 1,600 testing procedure revealed that the total number of encountered errors is 14 tests (0.87 percent of total testing procedures). Most of the encountered errors lay in the pre- and post-analytic phases of testing cycle (representing 35.7 and 50 percent, respectively, of total errors). While the number of test errors encountered in the analytic phase represented only 14.3 percent of total errors. About 85.7 percent of total errors were of non-significant implication on patients health being detected before test reports have been submitted to the patients. On the other hand, the number of test errors that have been already submitted to patients and reach the physician represented 14.3 percent of total errors. Only 7.1 percent of the errors could have an impact on patient diagnosis. The findings of this study were concomitant with those published from the USA and other countries. This proves that laboratory problems are universal and need general standardization and bench marking measures. Original being the first data published from Arabic countries that
EVANS, C B
The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S&M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard.
Debourgh, Gregory A; Prion, Susan K
Nurses in practice and students in training often fear hurting a patient or doing something wrong. Experienced nurses have developed assessment skills and clinical intuition to recognize and intervene to prevent patient risk and harm. Beginning nursing students have not yet had the opportunity to develop an awareness of patient risk, safety concerns, or a clear sense of their accountability in the nurse role as the primary advocate for patient safety. In this Safety Manifesto, the authors call for educators to critically review their prelicensure curricula for inclusion of teaching and learning activities that are focused on patient safety and offer recommendations for curricular changes with an emphasis on integration of instructional strategies that develop students' skills for clinical reasoning and judgment. Copyright © 2012 Elsevier Inc. All rights reserved.
Khater, W A; Akhu-Zaheya, L M; Al-Mahasneh, S I; Khater, R
Patients' safety culture is a key aspect in determining healthcare organizations' ability to address and reduce risks of patients. Nurses play a major role in patients' safety because they are accountable for direct and continuous patient care. There is little known information about patients' safety culture in Jordanian hospitals, particularly from the perspective of healthcare providers. The study aimed to assess patient safety culture in Jordanian hospitals from nurses' perspective. A cross-sectional, descriptive design was utilized. A total number of 658 nurses participated in the current study. Data were collected using an Arabic version of the hospital survey of patients' safety culture. Teamwork within unit dimensions had a high positive response, and was perceived by nurses to be the only strong suit in Jordanian hospitals. Areas that required improvement, as perceived by nurses, are as follows: communication openness, staffing, handoff and transition, non-punitive responses to errors, and teamwork across units. Regression analysis revealed factors, from nurses' perspectives, that influenced patients' safety culture in Jordanian hospital. Factors included age, total years of experience, working in university hospitals, utilizing evidence-based practice and working in hospitals that consider patient safety to be a priority. Participants in this study were limited to nurses. Therefore, there is a need to assess patient safety culture from other healthcare providers' perspectives. Moreover, the use of a self-reported questionnaire introduced the social desirability biases. The current study provides insight into how nurses perceive patient safety culture. Results of this study have revealed that there is a need to replace the traditional culture of shame/blame with a non-punitive culture. Study results implied that improving patient safety culture requires a fundamental transformation of nurses' work environment. New policies to improve collaboration between
Lovink, M.H.; Kars, M.C.; Man-van Ginkel, J.M. de; Schoonhoven, L.
AIM: To explore the experiences of safety of adult patients during their haemodialysis treatment. BACKGROUND: Haemodialysis is a complex treatment with a risk for harm that causes anxiety among many patients. To date, no in-depth study of haemodialysis patients' emotional responses to conditions of
Blasco, Álvaro; Carratalá, Arturo; Lopez-Garrígos, Maite; Rodriguez-Borja, Enrique
Patient Safety emphasizes the reporting, analysis and prevention of medical errors that very often leads to adverse healthcare situations.1 in 10 patients are impacted by medical errors.The WHO calls the patient safety issue an endemic concern. A number of well-known experts of all areas in the medical field have collectedvery valuable information for a better patient treatment and higher safety culture in all medical disciplines.
Medical errors occur frequently. The harm and additional costs associated with those errors ask for effective safety management. According to the objective of minimal patient harm, safety management in health care should be proactive; that is, risks should be anticipated and reduced before patients
Shin, Sung Min; Lee, Sang Hun; Kang, Hym Gook [KAIST, Daejeon (Korea, Republic of); Lee, Seung Jun [UNIST, Ulasn (Korea, Republic of)
A report published by the U.S. National Research Council indicates that appropriate methods for assessing reliability are key to establishing the acceptability of digital instrumentation and control (I and C) systems in safety-critical plants such as NPPs. Since the release of this issue, the methodology for the probabilistic safety assessment (PSA) of digital I and C systems has been studied. However, there is still no widely accepted method. Kang and Sung found three critical factors for safety assessment of digital systems: detection coverage of fault-tolerant techniques, software reliability quantification, and network communication risk. In reality the various factors composing digitalized I and C systems are not independent of each other but rather closely connected. Thus, from a macro point of view, a method that can integrate risk factors with different characteristics needs to be considered together with the micro approaches to address the challenges facing each factor.
Narayan, Pradeep; Suri, S.; Singh, P.
The hazard and risk associated with magnetic resonance imaging is a matter of concern. In 1982, the Food and Drug Administration (FDA), USA issued guidelines to Hospital's Investigational Review Board (IRBs) in 'Guidelines for Evaluating Electromagnetic Exposure Risks for Trials of Clinical Nuclear Magnetic Resonance (NMR)'. In 1997, the Berufsgenossenschaft (BG), professional association for precision engineering and electronics of Germany, in their preliminary proposal for safety limits extended their concerns on static magnetic field. Owing to both time varying and static magnetic fields applied in Magnetic Resonance Imaging (MRI) this became of immediate concern to user community to assess the potential hazard and risk associated with the NMR system
Slovic, P; MacGregor, D; Kraus, N N
Descriptions of safety engineering defects of the kind that compel automobile manufacturers to initiate a recall campaign were evaluated by individuals on a set of risk characteristic scales that included overall vehicle riskiness, manufacturer's ability to anticipate the defect, importance for vehicle operation, severity of consequences and likelihood of compliance with a recall notice. A factor analysis of the risk characteristics indicated that judgments could be summarized in terms of two composite scales, one representing the uncontrollability of the damage the safety defect might cause and the other representing the foreseeability of the defect by the manufacturer. Motor vehicle defects were found to be highly diverse in terms of the perceived qualities of their risks. Location of individual defects within the factor space was closely associated with perceived riskiness, perceived likelihood of purchasing another car from the same manufacturer, perceived likelihood of compliance with a recall notice, and actual compliance rates.
Peterson, V.L.; Colwell, R.G.; Dickey, R.L.
This Safety Analysis and Risk Assessment Handbook (SARAH) provides guidance to the safety analyst at the Rocky Flats Environmental Technology Site (RFETS) in the preparation of safety analyses and risk assessments. Although the older guidance (the Rocky Flats Risk Assessment Guide) continues to be used for updating the Final Safety Analysis Reports developed in the mid-1980s, this new guidance is used with all new authorization basis documents. With the mission change at RFETS came the need to establish new authorization basis documents for its facilities, whose functions had changed. The methodology and databases for performing the evaluations that support the new authorization basis documents had to be standardized, to avoid the use of different approaches and/or databases for similar accidents in different facilities. This handbook presents this new standardized approach. The handbook begins with a discussion of the requirements of the different types of authorization basis documents and how to choose the one appropriate for the facility to be evaluated. It then walks the analyst through the process of identifying all the potential hazards in the facility, classifying them, and choosing the ones that need to be analyzed further. It then discusses the methods for evaluating accident initiation and progression and covers the basic steps in a safety analysis, including consequence and frequency binning and risk ranking. The handbook lays out standardized approaches for determining the source terms of the various accidents (including airborne release fractions, leakpath factors, etc.), the atmospheric dispersion factors appropriate for Rocky Flats, and the methods for radiological and chemical consequence assessments. The radiological assessments use a radiological open-quotes templateclose quotes, a spreadsheet that incorporates the standard values of parameters, whereas the chemical assessments use the standard codes ARCHIE and ALOHA
Pietikäinen, Elina; Reiman, Teemu; Heikkilä, Jouko; Macchi, Luigi
In this article, we explore how researchers can contribute to patient safety improvement. We aim to expand the instrumental role researchers have often occupied in relation to patient safety improvement. We reflect on our own improvement model and experiences as patient safety researchers in an ongoing Finnish multi-actor innovation project through self-reflective narration. Our own patient safety improvement model can be described as systemic. Based on the purpose of the innovation project, our improvement model, and the improvement models of the other actors in the project, we have carried out a wide range of activities. Our activities can be summarized in 8 overlapping patient safety improvement roles: modeler, influencer, supplier, producer, ideator, reflector, facilitator, and negotiator. When working side by side with "practice," researchers are offered and engage in several different activities. The way researchers contribute to patient safety improvement and balance between different roles depends on the purpose of the study, as well as on the underlying patient safety improvement models. Different patient safety research paradigms seem to emphasize different improvement roles, and thus, they also face different challenges. Open reflection on the underlying improvement models and roles can help researchers with different backgrounds-as well as other actors involved in patient safety improvement-in structuring their work and collaborating productively.
Feinstein, Karen Wolk; Grunden, Naida; Harrison, Edward I
The Pittsburgh Regional Healthcare Initiative (PRHI) is a coalition of 35 hospitals, 4 major insurers, more than 30 major and small-business health care purchasers, dozens of corporate and civic leaders, organized labor, and partnerships with state and federal government all working together to deliver perfect patient care throughout Southwestern Pennsylvania. PRHI believes that in pursuing perfection, many of the challenges facing today's health care delivery system (eg, waste and error in the delivery of care, rising costs, frustration and shortage among clinicians and workers, financial distress, overcapacity, and lack of access to care) will be addressed. PRHI has identified patient safety (nosocomial infections and medication errors) and 5 clinical areas (obstetrics, orthopedic surgery, cardiac surgery, depression, and diabetes) as ideal starting points. In each of these areas of work, PRHI partners have assembled multifacility/multidisciplinary groups charged with defining perfection, establishing region-wide reporting systems, and devising and implementing recommended improvement strategies and interventions. Many design and conceptual elements of the PRHI strategy are adapted from the Toyota Production System and its Pittsburgh derivative, the Alcoa Business System. PRHI is in the proof-of-concept phase of development.
McCay, Layla; Lemer, Claire; Wu, Albert W
Laboratory medicine has been a pioneer in the field of patient safety; indeed, the College of American Pathology first called attention to the issue in 1946. Delivering reliable laboratory results has long been considered a priority, as the data produced in laboratory medicine have the potential to critically influence individual patients' diagnosis and management. Until recently, most attention on laboratory safety has focused on the analytic stage of laboratory medicine. Addressing this stage has led to significant and impressive improvements in the areas over which laboratories have direct control. However, recent data demonstrate that pre- and post-analytical phases are at least as vulnerable to errors; to further improve patient safety in laboratory medicine, attention must now be focused on the pre- and post-analytic phases, and the concept of patient safety as a multi-disciplinary, multi-stage and multi-system concept better understood. The World Alliance for Patient Safety (WAPS) supports improvement of patient safety globally and provides a potential framework for considering the total testing process.
Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR
Full Text Available Abstract Background Many patients at high risk of cardiovascular disease do not achieve recommended low-density lipoprotein cholesterol (LDL-C goals. This study compared the efficacy and safety of low doses of rosuvastatin (10 mg and atorvastatin (20 mg in high-risk patients with hypercholesterolemia. Methods A total of 996 patients with hypercholesterolemia (LDL-C ≥ 3.4 and Results Rosuvastatin 10 mg reduced LDL-C levels significantly more than atorvastatin 20 mg at week 6 (44.6% vs. 42.7%, p Conclusion In high-risk patients with hypercholesterolemia, rosuvastatin 10 mg was more efficacious than atorvastatin 20 mg at reducing LDL-C, enabling LDL-C goal achievement and improving other lipid parameters. Both treatments were well tolerated.
Johnstone, Megan-Jane; Kanitsaki, Olga
It has been well recognized internationally that hospitals are not as safe as they should be. In order to redress this situation, health care services around the world have turned their attention to strategically implementing robust patient safety and quality care programmes to identify circumstances that put patients at risk of harm and then acting to prevent or control those risks. Despite the progress that has been made in improving hospital safety in recent years, there is emerging evidence that patients of minority cultural and language backgrounds are disproportionately at risk of experiencing preventable adverse events while in hospital compared with mainstream patient groups. One reason for this is that patient safety programmes have tended to underestimate and understate the critical relationship that exists between culture, language, and the safety and quality of care of patients from minority racial, ethno-cultural, and language backgrounds. This article suggests that the failure to recognize the critical link between culture and language (of both the providers and recipients of health care) and patient safety stands as a 'resident pathogen' within the health care system that, if not addressed, unacceptably exposes patients from minority ethno-cultural and language backgrounds to preventable adverse events in hospital contexts. It is further suggested that in order to ensure that minority as well as majority patient interests in receiving safe and quality care are properly protected, the culture-language-patient-safety link needs to be formally recognized and the vulnerabilities of patients from minority cultural and language backgrounds explicitly identified and actively addressed in patient safety systems and processes.
A proper management of ones risks consists in acting to exert prevention and protection capacities against the negative consequences of an event, but also by committing oneself into an offensive approach allowing to improve efficiency, quality and availability. Safety and efficiencies are mutual reinforcing goals aiming at ensuring the perenniality of industries and services. The implementation of a risk management approach in an industrial environment allows to reach a better reactiveness and to increase the efficiency of a system by the mastery of organization and processes. The activities in concern are those of industries and services: transports, energy and environment, automotive industry, petrochemistry, chemistry, food, space, health, defense industries, telecommunication, mining industry, information systems, textile industry, finances.. The topics approached during this meeting treat of: the relevance of risk-abatement resources with respect to risks criticality; the consistent management of uncertainties with respect to stakes; the mastery of components aging and the expression of aging-dependent availability, maintenance and safety policies; the expression of obsolescence-related renewing policies; the operating safety tools and methods applied to complex and computerized-controlled systems; the integration of social, organizational and human factors in technical decisions and companies management; transverse and global risk analysis and decision-aid approaches; the vigilance culture; crisis anticipation and management; the experience feedback on technical and organisational aspects; efficiency and risk mastery indicators; cost/benefit approach in risk management, and economic intelligence approaches. Nineteen presentations have been selected which deal with the mastery of risks and the operating safety at nuclear facilities. (J.S.)
Full Text Available Length of hospital stay (LHS is an indicator of clinical effectiveness. Early hospital discharge (≤72 hours is recommended in patients with acute coronary syndromes (ACS at low risk of complications, but reasons for prolonged LHS poorly reported.We collected data of ACS patients hospitalized at the Geneva University Hospitals from 1st July 2013 to 30th June 2015 and used the Zwolle index score to identify patients at low risk (≤ 3 points. We assessed the proportion of eligible patients who were successfully discharged within 72 hours and the reasons for prolonged LHS. Outcomes were defined as adherence to recommended therapies, major adverse events at 30 days and patients' satisfaction using a Likert-scale patient-reported questionnaire.Among 370 patients with ACS, 255 (68.9% were at low-risk of complications but only 128 (50.2%were eligible for early discharge, because of other clinical reasons for prolonged LHS (e.g. staged coronary revascularization, cardiac monitoring in 127 patients (49.8%. Of the latter, only 45 (35.2% benefitted from an early discharge. Reasons for delay in discharge in the remaining 83 patients (51.2% were mainly due to delays in additional investigations, titration of medical therapy, admission or discharge during weekends. In the early discharge group, at 30 days, only one patient (2.2% had an adverse event (minor bleeding, 97% of patients were satisfied by the medical care.Early discharge was successfully achieved in one third of eligible ACS patients at low risk of complications and appeared sufficiently safe while being overall appreciated by the patients.
Laurencet, Marie-Eva; Girardin, François; Rigamonti, Fabio; Bevand, Anne; Meyer, Philippe; Carballo, David; Roffi, Marco; Noble, Stéphane; Mach, François; Gencer, Baris
Length of hospital stay (LHS) is an indicator of clinical effectiveness. Early hospital discharge (≤72 hours) is recommended in patients with acute coronary syndromes (ACS) at low risk of complications, but reasons for prolonged LHS poorly reported. We collected data of ACS patients hospitalized at the Geneva University Hospitals from 1st July 2013 to 30th June 2015 and used the Zwolle index score to identify patients at low risk (≤ 3 points). We assessed the proportion of eligible patients who were successfully discharged within 72 hours and the reasons for prolonged LHS. Outcomes were defined as adherence to recommended therapies, major adverse events at 30 days and patients' satisfaction using a Likert-scale patient-reported questionnaire. Among 370 patients with ACS, 255 (68.9%) were at low-risk of complications but only 128 (50.2%)were eligible for early discharge, because of other clinical reasons for prolonged LHS (e.g. staged coronary revascularization, cardiac monitoring) in 127 patients (49.8%). Of the latter, only 45 (35.2%) benefitted from an early discharge. Reasons for delay in discharge in the remaining 83 patients (51.2%) were mainly due to delays in additional investigations, titration of medical therapy, admission or discharge during weekends. In the early discharge group, at 30 days, only one patient (2.2%) had an adverse event (minor bleeding), 97% of patients were satisfied by the medical care. Early discharge was successfully achieved in one third of eligible ACS patients at low risk of complications and appeared sufficiently safe while being overall appreciated by the patients.
This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities and that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, 'ensuring' plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is 'safe.' Use of RACs requires quantitative estimates of consequence frequency and magnitude
Dinh, Nam; Szilard, Ronaldo
The concept of safety margins has served as a fundamental principle in the design and operation of commercial nuclear power plants (NPPs). Defined as the minimum distance between a system's 'loading' and its 'capacity', plant design and operation is predicated on ensuring an adequate safety margin for safety-significant parameters (e.g., fuel cladding temperature, containment pressure, etc.) is provided over the spectrum of anticipated plant operating, transient and accident conditions. To meet the anticipated challenges associated with extending the operational lifetimes of the current fleet of operating NPPs, the United States Department of Energy (USDOE), the Idaho National Laboratory (INL) and the Electric Power Research Institute (EPRI) have developed a collaboration to conduct coordinated research to identify and address the technological challenges and opportunities that likely would affect the safe and economic operation of the existing NPP fleet over the postulated long-term time horizons. In this paper we describe a framework for developing and implementing a Risk-Informed Safety Margin Characterization (RISMC) approach to evaluate and manage changes in plant safety margins over long time horizons
Verstappen, Wim; Gaal, Sander; Esmail, Aneez; Wensing, Michel
ABSTRACT Background: To improve patient safety it is necessary to identify the causes of patient safety incidents, devise solutions and measure the (cost-) effectiveness of improvement efforts. Objective: This paper provides a broad overview with practical guidance on how to improve patient safety. Methods: We used modified online Delphi procedures to reach consensus on methods to improve patient safety and to identify important features of patient safety management in primary care. Two pilot studies were carried out to assess the value of prospective risk analysis (PRA), as a means of identifying the causes of a patient safety incident. Results: A range of different methods can be used to improve patient safety but they have to be contextually specific. Practice organization, culture, diagnostic errors and medication safety were found to be important domains for further improvement. Improvement strategies for patient safety could benefit from insights gained from research on implementation of evidence-based practice. Patient involvement and prospective risk analysis are two promising and innovative strategies for improving patient safety in primary care. Conclusion: A range of methods is available to improve patient safety, but there is no ‘magic bullet.’ Besides better use of the available methods, it is important to use new and potentially more effective strategies, such as prospective risk analysis. PMID:26339837
Meneses Falcón, Carmen; Gil García, Eugenia; Romo Avilés, Nuria
Describe the risk behaviour relationships with road safety in adolescents. Cross-sectional descriptive study. Madrid and Andalusia Regions, representative samples. The sample included 3,612 in secondary school pupils from Madrid (n=1708) and Andalusia (n=1904). The survey was carried out during May and June 2007. The data collected included sociodemographic areas (age, sex, grade, father's profession, birth place, etc.) and risk situation and behaviour (risk behaviour as driver or passenger). 16.2% of the adolescents have been involved in a dangerous situation with motorcycles during the last year. 16.7% never use a helmet when riding a motorcycle and 62% do not wear one when riding a bicycle on the road; 17.4% frequently ride a motorcycle over the speed limit and 24.5% when driving a car. There are significant differences regarding sex, grade and region (Madrid or Andalusia). There are four factors which explain 62% of the variance: drug factor, speed factor, security factor and passenger factor. Two of these have twice the probability of having a dangerous situation when riding a motorcycle: drug factor (OR=1.96; 95% CI, 1.77-2.18) and the speed factor ((OR=2.13; 95% CI, 1.92-2.36). Adolescents in higher grades and living in Andalusia were less road safety conscious. This pattern should be taken into account when designing preventive actions in Road Safety Education. 2009 Elsevier España, S.L. All rights reserved.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From Emergency Medicine Patient Safety Foundation AGENCY: Agency for... notification of voluntary relinquishment from Emergency Medicine Patient Safety Foundation of its status as a...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From Northern Metropolitan Patient Safety Institute AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. SUMMARY: The Patient Safety and...
... Organizations: Voluntary Relinquishment From Cogent Patient Safety Organization, Inc. AGENCY: Agency for... for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze... Cogent Patient Safety Organization, Inc. of its status as a PSO, and has delisted the PSO accordingly...
... Organizations: Voluntary Delisting From Rocky Mountain Patient Safety Organization AGENCY: Agency for Healthcare... Organization: AHRQ has accepted a notification of voluntary relinquishment from Rocky Mountain Patient Safety Organization, a component entity of Colorado Hospital Association, of its status as a Patient Safety...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Delisting From Oregon Patient Safety Commission AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of delisting. SUMMARY: Oregon Patient Safety Commission: AHRQ...
... Patient Safety, a component entity of West Virginia Hospital Association, West Virginia Medical Institute (WVMI), and West Virginia State Medical. Association (WVSMA), of its status as a Patient Safety... Patient Safety, a component entity of West Virginia Hospital Association, West Virginia Medical Institute...
Singer, Sara J; Falwell, Alyson; Gaba, David M; Meterko, Mark; Rosen, Amy; Hartmann, Christine W; Baker, Laurence
Safety climate refers to shared perceptions of what an organization is like with regard to safety, whereas safety culture refers to employees' fundamental ideology and orientation and explains why safety is pursued in the manner exhibited within a particular organization. Although research has sought to identify opportunities for improving safety outcomes by studying patterns of variation in safety climate, few empirical studies have examined the impact of organizational characteristics such as culture on hospital safety climate. This study explored how aspects of general organizational culture relate to hospital patient safety climate. In a stratified sample of 92 U.S. hospitals, we sampled 100% of senior managers and physicians and 10% of other hospital workers. The Patient Safety Climate in Healthcare Organizations and the Zammuto and Krakower organizational culture surveys measured safety climate and group, entrepreneurial, hierarchical, and production orientation of hospitals' culture, respectively. We administered safety climate surveys to 18,361 personnel and organizational culture surveys to a 5,894 random subsample between March 2004 and May 2005. Secondary data came from the 2004 American Hospital Association Annual Hospital Survey and Dun & Bradstreet. Hierarchical linear regressions assessed relationships between organizational culture and safety climate measures. Aspects of general organizational culture were strongly related to safety climate. A higher level of group culture correlated with a higher level of safety climate, but more hierarchical culture was associated with lower safety climate. Aspects of organizational culture accounted for more than threefold improvement in measures of model fit compared with models with controls alone. A mix of culture types, emphasizing group culture, seemed optimal for safety climate. Safety climate and organizational culture are positively related. Results support strategies that promote group orientation and
Schwappach, David L B; Frank, Olga; Koppenberg, Joachim; Müller, Beat; Wasserfallen, Jean-Blaise
To assess patients' and healthcare workers' (hcw) attitudes and experiences with a patient safety advisory, to investigate predictors for patients' safety-related behaviors and determinants for staff support for the advisory. Cross-sectional surveys of patients (n= 1053) and hcw (n= 275). Three Swiss hospitals. Patients who received the safety advisory and hcw caring for these patients. Patient safety advisory disseminated to patients at the study hospitals. Attitudes towards and experiences with the advisory. Hcw support for the intervention and patients' intentions to apply the recommendations were modelled using regression analyses. Patients (95%) and hcw (78%) agreed that hospitals should educate patients how to prevent errors. Hcw and patients' evaluations of the safety advisory were positive and followed a similar pattern. Patients' intentions to engage in safety were significantly predicted by behavioral control, subjective norms, attitudes, safety behaviors during hospitalization and experiences with taking action. Hcw support for the campaign was predicted by rating of the advisory (Odds ratio (OR) 3.4, confidence interval (CI) 1.8-6.1, Ppatients (OR 1.9, CI 1.1-3.3, P= 0.034) and experience of unpleasant situations (OR 0.6, CI 0.4-1.0, P= 0.035). The safety advisory was well accepted by patients and hcw. To be successful, the advisory should be accompanied by measures that target norms and barriers in patients, and support staff in dealing with difficult situations.
Singh, Hardeep; Sittig, Dean F
Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety
Czakert, Judith; Lehmann, Yvonne; Ewers, Michael
In recent years there has been a growing trend towards nursing care at home in general as well as towards intensive home care being provided by specialized home care services in Germany. However, resulting challenges for patient safety have rarely been considered. Against this background we aimed to explore whether international recommendations for patient safety in home care in general and in intensive home care in particular already exist and how they can stimulate further practice development in Germany. A review of online English documents containing recommendations for patient safety in intensive home care was conducted. Available documents were analyzed and compared in terms of their form and content. Overall, a small number of relevant documents could be identified. None of these documents exclusively refer to the intensive home care sector. Despite their differences, however, the analysis of four selected documents showed similarities, e. g., regarding specific topics of patient safety (communication, involvement of patients and their relatives, risk assessment, medication management, qualification). Furthermore, strengths and weaknesses of the documents became apparent: e. g., an explicit understanding of patient safety, a literature-based introduction to safety topics or an adaptation of the recommendations to the specific features of home care were occasionally lacking. This document analysis provides interesting input to the formal and content-related development of specific recommendations and to practice development in Germany to improve patient safety in home care. Copyright © 2018. Published by Elsevier GmbH.
Kluge, S; Bause, H
The intensive care unit (ICU) is one area of the hospital in which processes and communication are of primary importance. Errors in intensive care units can lead to serious adverse events with significant consequences for patients. Therefore quality and risk-management are important measures when treating critically ill patients. A pragmatic approach to support quality and safety in intensive care is peer review. This approach has gained significant acceptance over the past years. It consists of mutual visits by colleagues who conduct standardised peer reviews. These reviews focus on the systematic evaluation of the quality of an ICU's structure, its processes and outcome. Together with different associations, the State Chambers of Physicians and the German Medical Association have developed peer review as a standardized tool for quality improvement. The common goal of all stakeholders is the continuous and sustainable improvement in intensive care with peer reviews significantly increasing and improving communication between professions and disciplines. Peer reviews secure the sustainability of planned change processes and consequently lead the way to an improved culture of quality and safety.
Kow, A W C; Ang, B L S; Chong, C S; Tan, W B; Menon, K R
While healthcare outcomes have improved significantly, the complex management of diseases in the hospitals has also escalated the risks in patient safety. Therefore, in the process of training medical students to be proficient in medical knowledge and skills, the importance of patient safety cannot be neglected. A new innovation using mobile apps gaming system (PAtient Safety in Surgical EDucation-PASSED) to teach medical students on patient safety was created. Students were taught concepts of patient safety followed by a gaming session using iPad games created by us. This study aims to evaluate the outcome of patient safety perception using the PASSED games created. An interactive iPad game focusing on patient safety issues was created by the undergraduate education team in the Department of Surgery, Yong Loo Lin School of Medicine at the National University of Singapore. The game employed the unique touched-screen feature with clinical scenarios extracted from the hospital sentinel events. Some of the questions were time sensitive, with extra bonus marks awarded if the student provided the correct answer within 10 s. Students could reattempt the questions if the initial answer was wrong. However, this entailed demerit points. Third-year medical students posted to the Department of Surgery experienced this gaming system in a cohort of 55-60 students. Baseline understanding of the students on patient safety was evaluated using Attitudes to Patient Safety Questionnaire III (APSQ-III) prior to the game. A 20 min talk on concept of patient safety using the WHO Patient Safety Guidelines was conducted. Following this, students downloaded the apps from ITune store and played with the game for 20-30 min. The session ended with the students completing the postintervention questionnaire. A total of 221 3rd year medical students responded to the survey during the PASSED session. Majority of the students felt that the PASSED game had trained them to understand the
Isiordia-Espinoza, M A; Aragon-Martinez, O H; Martínez-Morales, J F; Zapata-Morales, J R
The aim of this systematic review and meta-analysis was to assess the risk of surgical wound infection and the adverse effects of amoxicillin in healthy patients who required excision of third molars. We identified eligible reports from searches of PubMed, Medline®, the Cochrane Library, Imbiomed, LILACS, and Google Scholar. Studies that met our minimum requirements were evaluated using inclusion and exclusion criteria and the Oxford Quality Scale. Those with a score of 3 or more on this Scale were included and their data were extracted and analysed. For evaluation of the risk of infection the absolute risk reduction, number needed to treat, and 95% CI were calculated. For evaluation of the risk of an adverse effect the absolute risk increase, number needed to harm, and 95% CI were calculated using the Risk Reduction Calculator. Each meta-analysis was made with the help of the Mantel-Haenszel random effects model, and estimates of risk (OR) and 95% CI were calculated using the Review Manager 5.3, from the Cochrane Library. A significant risk was assumed when the lower limit of the 95% CI was greater than 1. Probabilities of less than 0.05 were accepted as significant. The results showed that there was no reduction in the risk of infection when amoxicillin was given before or after operation compared with an untreated group or placebo. In conclusion, this study suggests that amoxicillin given prophylactically or postoperatively does not reduce the risk of infection in healthy patients having their third molars extracted. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Rutter, Paul D; Panesar, Sukhmeet S; Darzi, Ara; Donaldson, Liam J
Objective To estimate the risk of death or severe harm due to bone cement implantation syndrome (BCIS) among patients undergoing hip hemiarthroplasty for fractured neck of femur. Setting Hospitals providing secondary and tertiary care throughout the National Health Service (NHS) in England and Wales. Participants Cases reported to the National Reporting and Learning System (NRLS) in which the reporter clearly describes severe acute patient deterioration associated with cement use in hip hemiarthroplasty for fractured neck of femur (assessed independently by two reviewers). Outcome measures Primary—number of reported deaths, cardiac arrests and periarrests per year. Secondary—timing of deterioration and outcome in relation to cement insertion. Results Between 2005 and 2012, the NRLS received 62 reports that clearly describe death or severe harm associated with the use of cement in hip hemiarthroplasty for fractured neck of femur. There was one such incident for every 2900 hemiarthroplasties for fractured neck of femur during the period. Of the 62 reports, 41 patients died, 14 were resuscitated from cardiac arrest and 7 from periarrest. Most reports (55/62, 89%) describe acute deterioration occurring during or within a few minutes of cement insertion. The vast majority of deaths (33/41, 80%) occurred on the operating table. Conclusions These reports provide narrative evidence from England and Wales that cement use in hip hemiarthroplasty for fractured neck of femur is associated with instances of perioperative death or severe harm consistent with BCIS. In 2009, the National Patient Safety Agency publicised this issue and encouraged the use of mitigation measures. Three-quarters of the deaths in this study have occurred since that alert, suggesting incomplete implementation or effectiveness of those mitigation measures. There is a need for stronger evidence that weighs the risks and benefits of cement in hip hemiarthroplasty for fractured neck of femur. PMID
Hill, Janice; Victor, Daniel
When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy  focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy  was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard
Zhang, Qiongwen; Li, Yulin; Li, Jing; Mao, Xuanyue; Zhang, Lijuan; Ying, Qinghua; Wei, Xin; Shang, Lili; Zhang, Mingming
To investigate the baseline status of patients' awareness, knowledge, and attitudes to patient safety in China, and to determine the factors that influence patients' involvement in patient safety. We conducted a cross sectional survey using questionnaires adapted from recent studies on patient safety from outside China. The items included medical errors, infection, medication safety, and other aspects of patient safety. The questionnaire included 17 items and 5 domains. The survey was conducted between Jan. 2009 and Dec. 2010 involving 1000 patients from ten grade-A hospitals in seven provinces or cities in China. Most patients from the surgery departments completed the questionnaires voluntarily and anonymously. Five reviewers independently input the data into Microsoft Excel 2003, and the data were double-checked. Data were analyzed using SPSS 15.0 software for differences in the perceptions and attitudes of patients toward patient safety among different genders, ages, and regions. We distributed 1000 questionnaires and collected 959 completed questionnaires (response rate: 96%). Among the respondents, 58% of patients did not know what medical error is. Sixty-five percent of patients wanted disclosure of all medical errors. After errors occurred, 58% of patients wanted explanations of all possible harms that had resulted. Among 187 patients who had experienced medical errors, 83% of patients had sought appropriate legal action. About 52% of patients understood hospital infection, but 28% patients did not know that infections could occur in hospital. Seventy-eight percent of patients thought that medical staff should wash their hands before examining patients. More than half of the patients (68%) were willing to remind the staff of hygiene if they saw unsanitary conditions in a health clinic. Only 14% of patients knew the side effects of medications that they took. The majority of patients surveyed expressed willingness to contribute to patient safety, but their
O. L. Zadvornaya
Full Text Available Purpose: modern strategies of management of the organization require the formation of special management approaches based on the analysis of the mechanisms and processes of the organization of medical activities related to possible risks in activity of medical personnel. Based on international experience and own research the authors have identified features of a system of management of personnel risk in medical activities, examined approaches showing the sequence and contents of the main practical activities of the formation, maintenance and development of the system of management of personnel risks. Emphasized is the need for further research and implementation of the system of management of personnel risk in health care organizations. Study and assessment of personnel risks affecting the security of medical activities aimed at the development of the system of personnel risk management, development of a system of identification and monitoring of HR risk indicators with a purpose to improve institutional management and increase efficiency of activity of medical organizations. Methods: in the present study, the following methods were used: systemic approach, content analysis, methods of social diagnosis (questionnaires, interviews, comparative analysis, method of expert evaluations, method of statistical processing of information. Results: approaches to predict the occurrence and development of personnel risks have been reviewed and proposed. Conclusions and Relevance: patient safety is a global issue affecting countries at all levels of development. Each year, the WHO identifies a number of systemic and technical aspects and trends in the field of patient safety related to actions of medical workers. Existing imbalances in the staffing of the health system of the Russian Federation increase the probability of potential risks in medical practice. The personnel policy of healthcare of the Russian Federation requires further improvement and
Creating socially useful richness is certainly the prime reason for companies to exist. Reaching this always moving target leads to seize opportunities and to take risks at the same time. For companies, risks and opportunities are two indissociable factors. Any decision making has to deal with an uncertain environment with random events of technological, economical, biological, human, environmental or natural origin. Because of the fear of uncertainty, risk acts as a brake to initiatives. In front of this problem, companies have to adopt a prevention policy based on a global and systemic approach, by identifying, evaluating, quantifying, sorting, mastering and managing unwanted events and by communicating about the way to treat them. In front of uncertainties, the operational safety, thanks to its methods and tools, supplies an incomparable contribution in the form of an help to any decision made with uncertainties. Operational safety contributes to the evaluation of costs and makes more realistic the economical estimations by taking into account the foreseeable and unforeseeable risks. The mastery of unwanted events, of their stakes and uncertainties, allows companies to carry out their projects in non-determined contexts and in a competitive environment. This colloquium concerns all socio-economical actors: industrialists, investors, decision makers, university and laboratory staffs, etc., who need a better evaluation of risks for a better mastery of their decisions in all sectors of activity. Seventeen papers of this conference, dealing with safety analysis and risk assessment at nuclear facilities and at other energy-related facilities, have been selected for Inis. (J.S.)
The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.
Hill, Janice L.; Baggs, Rhoda
Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.
Pelzang, Rinchen; Johnstone, Megan-Jane; Hutchinson, Alison M
Studies show that if quality of healthcare in a country is to be achieved, due consideration must be given to the importance of the core cultural values as a critical factor in improving patient safety outcomes. The influence of Bhutan's traditional (core) cultural values on the attitudes and behaviours of healthcare professionals regarding patient care are not known. This study aimed to explore the possible influence of Bhutan's traditional cultural values on staff attitudes towards patient safety and quality care. Undertaken as a qualitative exploratory descriptive inquiry, a purposeful sample of 94 healthcare professionals and managers were recruited from three levels of hospitals, a training institute and the Ministry of Health. Interviews were transcribed verbatim and analysed using thematic analysis strategies. The findings of the study suggest that Bhutanese traditional cultural values have both productive and counterproductive influences on staff attitudes towards healthcare delivery and the processes that need to be in place to ensure patient safety. Productive influences encompassed: karmic incentives to avoid preventable harm and promote safe patient care; and the prospective adoption of the 'four harmonious friends' as a culturally meaningful frame for improving understanding of the role and importance of teamwork in enhancing patient safety. Counterproductive influences included: the adoption of hierarchical and authoritative styles of management; unilateral decision-making; the legitimization of karmic beliefs; differential treatment of patients; and preferences for traditional healing practices and rituals. Although problematic in some areas, Bhutan's traditional cultural values could be used positively to inform and frame an effective model for improving patient safety in Bhutan's hospitals. Such a model must entail the institution of an 'indigenized' patient safety program, with patient safety research and reporting systems framed around local
Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S S; Al-Adawi, Samir
To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included 'organizational learning and continuous improvement' while conversely, 'non-punitive response to errors' was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman.
Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S.S.; Al-Adawi, Samir
Objective To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. Methods This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. Results The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included ‘organizational learning and continuous improvement’ while conversely, ‘non-punitive response to errors’ was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). Conclusion This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman. PMID:25170407
Benjamin, J.R.; Shinozuka, M.; Shah, H.C.
Acceptable risk is defined in terms of its five basic parameters: the hazard or problem; the probability of occurrence; the consequence; the possible alternative actions; and the value system of the community or the society. The problem of consistency in design at a site and between differing sites is discussed and solutions are suggested. Techniques for consistent deterministic and probabilistic setting limits and design standards are illustrated using data from AEC Reactor Safety Study, WASH-1400. The influence of level of consequence is discussed and a general methodology for decision analysis in resource allocation problem is briefly introduced and illustrated. The concept of acceptable risk is put in a quantitative format that can be used by engineers and planners. Bayesian statistical methods are introduced to develop the methodologies
Zavlin, Dmitry; Jubbal, Kevin T; Van Eps, Jeffrey L; Bass, Barbara L; Ellsworth, Warren A; Echo, Anthony; Friedman, Jeffrey D; Dunkin, Brian J
Metabolic syndrome (MetS) entails the simultaneous presence of a constellation of dangerous risk factors including obesity, diabetes, hypertension, and dyslipidemia. The prevalence of MetS in Western society continues to rise and implies an elevated risk for surgical complications and/or poor surgical outcomes within the affected population. To assess the risks and outcomes of multi-morbid patients with MetS undergoing open ventral hernia repair. Multi-institutional case-control study in the United States. The American College of Surgeons National Surgical Quality Improvement Program database was sampled for patients undergoing initial open ventral hernia repair from 2012 through 2014 and then stratified into 2 cohorts based on the presence or absence of MetS. Statistical analyses were performed to evaluate preoperative co-morbidities, intraoperative details, and postoperative morbidity and mortality to identify risk factors for adverse outcomes. Mean age (61.0 versus 56.0 yr, Phigh operative risk in a population that is generally prone to obesity and its associated diseases. Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... voluntary relinquishment from the Surgical Safety Institute of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the...
Garvey, Keelin A; Penn, Joseph V; Campbell, Angela L; Esposito-Smythers, Christianne; Spirito, Anthony
The contract for safety is a procedure used in the management of suicidal patients and has significant patient care, risk management, and medicolegal implications. We conducted a literature review to assess empirical support for this procedure and reviewed legal cases in which this practice was employed, to examine its effect on outcome. Studies obtained from a PubMed search were reviewed and consisted mainly of opinion-based surveys of clinicians and patients and retrospective reviews. Overall, empirically based evidence to support the use of the contract for safety in any population is very limited, particularly in adolescent populations. A legal review revealed that contracting for safety is never enough to protect against legal liability and may lead to adverse consequences for the clinician and the patient. Contracts should be considered for use only in patients who are deemed capable of giving informed consent and, even in these circumstances, should be used with caution. A contract should never replace a thorough assessment of a patient's suicide risk factors. Further empirical research is needed to determine whether contracting for safety merits consideration as a future component of the suicide risk assessment.
McKeon, Leslie M; Cunningham, Patricia D; Oswaks, Jill S Detty
Healthcare systems are recognizing "human factor" flaws that result in adverse outcomes. Nurses work around system failures, although increasing healthcare complexity makes this harder to do without risk of error. Aviation and military organizations achieve ultrasafe outcomes through high-reliability practice. We describe how reliability principles were used to teach nurses to improve patient safety at the front line of care. Outcomes include safety-oriented, teamwork communication competency; reflections on safety culture and clinical leadership are discussed.
de Haan, L.S.; Calsbeek, H; Wolff, André
Importance: There is a growing interest in enabling ways for patients to participate in their own care to improve perioperative safety, but little is known about the effectiveness of interventions enhancing an active patient role. Objective: To evaluate the effect of patient participation on
Full Text Available Background. Recent studies have shown a lower risk of surgical site infections (SSI after laparoscopic distal gastrectomy compared to open surgery. This is a phase 2 study aiming to determine the incidence of SSI after laparoscopic distal gastrectomy without using antimicrobial prophylaxis (AMP. Methods. cT1N0 gastric cancers that were subject to laparoscopic distal gastrectomy were enrolled. Based on the unacceptable SSI incidence of ≥12.5% and the target SSI incidence of ≤5%, 105 patients were enrolled with an α of 0.05 and a power of 80% (ClinicalTrials.gov, NCT02200315. Results. In intention-to-treat analysis, patients did not reach the target SSI rate (12.4%, 95% confidence interval=6.8%–19.8%. Of patients, 44 patients had a protocol violation, such as extended lymph node dissection (LND or inappropriate nonpharmacological SSI prevention measures. Per-protocol analysis excluding these patients (n=61 showed a SSI rate of 4.9%, which was within the target SSI range. Multivariate analysis revealed that extracorporeal anastomosis and extended LND were independent risk factors for SSI. Conclusions. This study failed to reach the target SSI rate without using AMP. However, per-protocol analysis suggests that no AMP might be feasible when limited LND and adequate SSI prevention measures were performed.
Singh, Ranjit; Singh, Ashok; Fish, Reva; McLean, Don; Anderson, Diana R; Singh, Gurdev
There are international calls for improving education for health care workers around certain core competencies, of which patient safety and quality are integral and transcendent parts. Although relevant teaching programs have been developed, little is known about how best to assess their effectiveness. The objective of this work was to develop and implement an objective structured clinical examination (OSCE) to evaluate the impact of a patient safety curriculum. The curriculum was implemented in a family medicine residency program with 47 trainees. Two years after commencing the curriculum, a patient safety OSCE was developed and administered at this program and, for comparison purposes, to incoming residents at the same program and to residents at a neighboring residency program. All 47 residents exposed to the training, all 16 incoming residents, and 10 of 12 residents at the neighboring program participated in the OSCE. In a standardized patient case, error detection and error disclosure skills were better among trained residents. In a chart-based case, trained residents showed better performance in identifying deficiencies in care and described more appropriate means of addressing them. Third year residents exposed to a "Systems Approach" course performed better at system analysis and identifying system-based solutions after the course than before. Results suggest increased systems thinking and inculcation of a culture of safety among residents exposed to a patient safety curriculum. The main weaknesses of the study are its small size and suboptimal design. Much further investigation is needed into the effectiveness of patient safety curricula.
As several decades have passed since the construction of nuclear power plants began, residents have become gradually less interested in nuclear safety. The Tokai criticality accident in 1909, however, had roused residents in Tokai-Mura to realize that they live with nuclear technology risks. To prepare a field of risk communication, the Tokai-Mura C 3 project began as a pilot research project supported by NISA. Alter the project ended, we are continuing risk. communication activities as a non-profit organisation. The most important activity of C 3 project is the citizen's inspection programme for nuclear related facilities. This programme was decided by participants who voluntarily applied to the project. The concept of the citizen's inspection programme is 'not the usual facility tours'. Participants are involved from the planning stage and continue to communicate with workers of the inspected nuclear facility. Since 2003, we have conducted six programmes for five nuclear related organisations. Participants evaluated that radiation protection measures were near good but there were some problems concerning the worker's safety and safety culture, and proposed a mixture of advice based on personal experience. Some advice was accepted and it did improve the facility's safety measures. Other suggestions were not agreed upon by nuclear organisations. The reason lies in the difference of concept between the nuclear expert's 'safety' and the citizen's 'safety'. Residents do not worry about radiation only, but also about the facility's safety as a whole including the worker's safety. They say, 'If the workers are not safe, you also are unable to protect us'. Although the disagreement remained, the participants and the nuclear industry learned much about each other. Participating citizens received a substantial amount of knowledge about the nuclear industry and its safety measures, and feel the credibility and openness of the nuclear industry. On the other hand, the nuclear
Anesthesia is necessary for surgery; however, it does not deliver any direct therapeutic benefit. The risks of anesthesia must therefore be as low as possible. Anesthesiology has been identified as a leader in improving patient safety. Anesthetic mortality has decreased, and in healthy patients can be as low as 1:250,000. Trends in anesthetic morbidity have not been as well defined, but it appears that the risk of injury is decreasing. Studies of error during anesthesia and Closed Claims studies have identified sources of risk and methods to reduce the risks associated with anesthesia. These include changes in technology, such as anesthetic delivery systems and monitors, the application of human factors, the use of simulation, and the establishment of reporting systems. A review of the important events in the past 50 years illustrates the many steps that have contributed to the improvements in anesthesia safety
Nuclear Safety Commission's taskforce on 'Introduction of Safety Regulation Utilizing Risk Information' completed the interim report on its future subjects and directions in December 2005. Although current safety regulatory activities have been based on deterministic approach, this report shows the risk informed approach is expected to be very useful for making nuclear safety regulation and assurance activities reasonable and also for appropriate allocation of regulatory resources. For introduction of risk informed regulation, it also recommends pileups of experiences with gradual introduction and trial of the risk informed approach, improvement of plant maintenance rules and regulatory requirements utilizing risk information, and establishment of framework to assure quality of risk evaluation. (T. Tanaka)
Pucher, PH; Tamblyn, R; Boorman, D; Dixon-Woods, Mary Margaret; Donaldson, L; Draycott, T; Forster, A; Nadkarni, V; Power, C; Sevdalis, N; Aggarwal, R
The use of simulation-based training has established itself in healthcare but its implementation has been varied and mostly limited to technical and non-technical skills training. This article discusses the possibilities of the use of simulation as part of an overarching approach to improving patient safety, and represents the views of the Simnovate Patient Safety Domain Group, an international multidisciplinary expert group dedicated to the improvement of patient safety. The application and ...
Valleé, Jean-Charles Le; Charlebois, Sylvain
Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.
Gieras, Izabella; Sherman, Paul; Minsent, Dennis
This article examines the role a clinical engineering or healthcare technology management (HTM) department can play in promoting patient safety from three different perspectives: a community hospital, a national government health system, and an academic medical center. After a general overview, Izabella Gieras from Huntington Hospital in Pasadena, CA, leads off by examining the growing role of human factors in healthcare technology, and describing how her facility uses clinical simulations in medical equipment evaluations. A section by Paul Sherman follows, examining patient safety initiatives from the perspective of the Veterans Health Administration with a focus on hazard alerts and recalls. Dennis Minsent from Oregon Health & Science University writes about patient safety from an academic healthcare perspective, and details how clinical engineers can engage in multidisciplinary safety opportunities.
Hemsley, Bronwyn; Georgiou, Andrew; Hill, Sophie; Rollo, Megan; Steel, Joanne; Balandin, Susan
To review the research literature on the experiences of patients with communication disabilities in hospital according to the Generic Model of patient safety. In 2014 and 2015, we searched four scientific databases for studies with an aim or result relevant to safety of hospital patients with communication disabilities. The review included 27 studies. A range of adverse event types were outlined in qualitative research. Little detail was provided about contributing or protective factors for safety incidents in hospital for these patients or the impact of the incidents on the patient or organisations involved. Further research addressing the safety of patients with communication disabilities is needed. Sufficient detail is required to identify the nature, timing, and detection of incidents; factors that contribute to or prevent adverse events; and detail the impact of the adverse events. In order to provide safe and effective care to people with communication disabilities in hospital, a priority for health and disability services must be the design and evaluation of ecologically appropriate and evidence-based interventions to improve patient care, communication, and reduce the risk of costly and harmful patient safety incidents. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Leitner, Jesse A.
Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.
Bittar, Julio; Arenas, Paula; Chiurchiu, Carlos; de la Fuente, Jorge; de Arteaga, Javier; Douthat, Walter; Massari, Pablo U
Current transplant success allows recipients with previous contraindications to transplant to have access to this procedure with more frequency and safety. The concept of high-risk patient has changed since the first stages of transplantation. In the first studies, the high-risk concept was based on probability of early graft failure or on a patient's clinical condition to cope with high perioperatory morbimortality. Later on, this concept implied immunological factors that were crucial to ensure transplant success because hypersensitized or polytransfused patients experienced a higher risk of acute rejection and subsequent graft loss. Afterward, the presence of various comorbidities would redefine the high-risk concept for renal transplant mainly considering recipient's clinical aspects. Currently, the change in epidemiological characteristics of patients starting dialysis causes that we now deal with a greater increase of elderly patients, diabetic patients, and patients with history of cardiovascular disease. Today, high-risk patients are those with clinical features that predict an increase in the risk of perioperative morbimortality or death with functioning graft. In this review, we will attempted to analyze currents results of renal transplant outcomes in terms of patients and graft survival in elderly patients, diabetic patients, and patients with previous cardiovascular disease from the most recent experiences in the literature and from experiences in our center. In any of the groups previously analyzed, survival offered by renal transplant is significantly higher compared to dialysis. Besides, these patients are the recipient group that benefit the most with the transplant because their mortality while remaining on dialysis is extremely high. Hence, renal transplantation should be offered more frequently to older patients, diabetic patients, and patients with pretransplant cardiac and peripheral vascular disease. A positive attitude toward renal
Risk of Hippocampal Metastases in Small Cell Lung Cancer Patients at Presentation and After Cranial Irradiation: A Safety Profile Study for Hippocampal Sparing During Prophylactic or Therapeutic Cranial Irradiation
Kundapur, Vijayananda; Ellchuk, Tasha; Ahmed, Shahid; Gondi, Vinai
Purpose: Neurocognitive impairment (NI) in patients with small cell lung cancer (SCLC) after whole brain radiation treatment (WBRT) is a significant cause of morbidity. Hippocampal avoidance (HA) during WBRT may mitigate or prevent NI in such patients. However, this has not been tested in SCLC patients. The estimated risk of metastases in the HA region (HM) in patients with SCLC at diagnosis or after WBRT is unknown. Our study aimed to determine the risk of HM in patients with SCLC and to assess correlated clinical factors. Methods and Materials: Patients with SCLC who experienced brain metastases (BM) at presentation (de novo) or after WBRT treated at the Saskatoon Cancer Centre between 2005 and 2012 were studied. Relevant neuroimaging was independently reviewed by a neuroradiologist. HM was defined as metastases within 5 mm of the hippocampus. Logistic regression analysis was performed to assess correlation between various clinical variables and HM. Results: Seventy eligible patients were identified. Of 59 patients presenting with de novo BM, 3 patients (5%, 95% confidence interval [CI]: 0%-10.7%) had HM. Collectively there were 359 (range, 1-33) de novo BM with 3 (0.8%, 95% CI: 0%-1.7%) HM deposits. Twenty patients experienced progression of metastatic disease in the brain after WBRT. Of the 20 patients, only 1 patient (5%, 95% CI: 0%-14.5%) experienced HM. On logistic regression, no factors significantly correlated with HM. Conclusion: The overall incidence of HM before or after WBRT in SCLC patients is low, providing preliminary support for the safety of HA during planned clinical trials of HA-WBRT for SCLC
Risk of Hippocampal Metastases in Small Cell Lung Cancer Patients at Presentation and After Cranial Irradiation: A Safety Profile Study for Hippocampal Sparing During Prophylactic or Therapeutic Cranial Irradiation
Kundapur, Vijayananda, E-mail: Vijayananda.firstname.lastname@example.org [Saskatoon Cancer Center, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan (Canada); Ellchuk, Tasha [Department of Radiology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan (Canada); Ahmed, Shahid [Saskatoon Cancer Center, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan (Canada); Gondi, Vinai [Cadence Health Brain Tumor Center and Cadence Health Proton Center, Chicago, Illinois (United States)
Purpose: Neurocognitive impairment (NI) in patients with small cell lung cancer (SCLC) after whole brain radiation treatment (WBRT) is a significant cause of morbidity. Hippocampal avoidance (HA) during WBRT may mitigate or prevent NI in such patients. However, this has not been tested in SCLC patients. The estimated risk of metastases in the HA region (HM) in patients with SCLC at diagnosis or after WBRT is unknown. Our study aimed to determine the risk of HM in patients with SCLC and to assess correlated clinical factors. Methods and Materials: Patients with SCLC who experienced brain metastases (BM) at presentation (de novo) or after WBRT treated at the Saskatoon Cancer Centre between 2005 and 2012 were studied. Relevant neuroimaging was independently reviewed by a neuroradiologist. HM was defined as metastases within 5 mm of the hippocampus. Logistic regression analysis was performed to assess correlation between various clinical variables and HM. Results: Seventy eligible patients were identified. Of 59 patients presenting with de novo BM, 3 patients (5%, 95% confidence interval [CI]: 0%-10.7%) had HM. Collectively there were 359 (range, 1-33) de novo BM with 3 (0.8%, 95% CI: 0%-1.7%) HM deposits. Twenty patients experienced progression of metastatic disease in the brain after WBRT. Of the 20 patients, only 1 patient (5%, 95% CI: 0%-14.5%) experienced HM. On logistic regression, no factors significantly correlated with HM. Conclusion: The overall incidence of HM before or after WBRT in SCLC patients is low, providing preliminary support for the safety of HA during planned clinical trials of HA-WBRT for SCLC.
How to improve patient safety remains an intractable problem, despite large investment and some successes. Academics have argued that the root of the problem is a lack of a comprehensive 'safety culture' in hospitals. Other safety-critical industries such as commercial aviation invest heavily in staff training to develop such a culture, but comparable programmes are almost entirely absent from the health care sector. In rock climbing and many other dangerous activities, the 'buddy system' is used to ensure that safety systems are adhered to despite adverse circumstances. This system involves two or more people using simple checks and clear communication to prevent problems causing harm. Using this system as an example could provide a simple, original and entertaining way of introducing medical students to the idea that human factors are central to ensuring patient safety. Teaching the buddy system may improve understanding and acceptance of other patient safety initiatives, and could also be used by junior doctors as a tool to improve the safety of their practice. © Blackwell Publishing Ltd 2012.
This paper dealt with the safety measure S 05 'Sump clogging risk'. Problem specification contains: (1) to determine the effective strainer surface needed to be available in order to assure sufficient coolant volumes for a reliable operation of emergency systems; (2) to determine quantity and structure of insulation material which can be dislodged and can induce strained clogging; (3) to verify properties of insulation material with regard to its thermal degradation as a result of a long-term reactor unit operation; (4) to design and erect strainers so to assure sufficient congestion of emergency pump intake lines in post-accident regimes; (5) to design seismically resistant strainers with a capability to resist dynamic impacts from adjacent piping; (6) to assure monitoring of the strainer condition in real time with signals sent to the main control room
Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki
In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.
Liu Bin; Luo Yun; Hu Penghua; Zhu Disi
Based on the modern safety risk management theories and according to the actual situation, risk management for work safety in uranium mines is discussed from three aspects: risk identification,risk analysis and evaluation, and risk control. Referring to the '4M(Men,Machine,Medium,Management) factors' and 'Three types of hazards' theory, the classification of uranium mine accidents and risk factors are analyzed. In addition, the types and evaluation indexes of major risks of uranium mines as well as the 'spot, line, area' model of risk identification and analysis and the 'hierarchical' risk control mechanism are also studied. (authors)
McCaughey, Deirdre; McGhan, Gwen; DelliFraine, Jami L; Brannon, S Diane
Nurses and aides are among the occupational subgroups with the highest injury rates and workdays lost to illness and injury in North America. Many studies have shown that these incidents frequently happen during provision of patient care. Moreover, health care workplaces are a source of numerous safety risks that contribute to worker injuries. These findings identify health care as a high-risk occupation for employee injury or illness. The purpose of this study was to examine the relationships among patient care, employee safety perceptions, and employee stress. Using the National Institute for Occupational Safety and Health Model of Job Stress and Health as a foundation, we developed and tested a conceptual workplace safety climate-stress model that explicates how caring for high-risk patients is a safety stressor that has negative outcomes for health care providers, including poor workplace safety perceptions and increasing stress levels. We introduced the concept of "high-risk patients" and define them as those who put providers at greater risk for injury or illness. Using a nonexperimental survey design, we examined patient types and safety perceptions of health care providers (nurses, aides, and allied health) in an acute care hospital. Health care providers who care for high-risk patients more frequently have poor safety climate perceptions and higher stress levels. Safety climate was found to mediate the relationship between high-risk patients and stress. These findings bring insight into actions health care organizations can pursue to improve health care provider well-being. Recognizing that different patients present different risks and pursuing staffing, training, and equipment to minimize employee risk of injury will help reduce the staggering injury rates experienced by these employees. Moreover, minimizing employee stress over poor workplace safety is achievable through comprehensive workplace safety climate programs that include supervisor, management
Gangolells, Marta; Casals, Miquel; Forcada, Núria; Roca, Xavier; Fuertes, Alba
Research and practice have demonstrated that decisions made prior to work at construction sites can influence construction worker safety. However, it has also been argued that most architects and design engineers possess neither the knowledge of construction safety nor the knowledge of construction processes necessary to effectively perform Construction Hazards Prevention through Design (CHPtD). This paper introduces a quantitative methodology that supports designers by providing a way to evaluate the safety-related performance of residential construction designs using a risk analysis-based approach. The methodology compares the overall safety risk level of various construction designs and ranks the significance of the various safety risks of each of these designs. The methodology also compares the absolute importance of a particular safety risk in various construction designs. Because the methodology identifies the relevance of each safety risk at a particular site prior to the construction stage, significant risks are highlighted in advance. Thus, a range of measures for mitigating safety risks can then be implemented during on-site construction. The methodology is specially worthwhile for designers, who can compare construction techniques and systems during the design phase and determine the corresponding level of safety risk without their creative talents being restricted. By using this methodology, construction companies can improve their on-site safety performance. Copyright 2010 Elsevier Ltd. All rights reserved.
Agnew, Cakil; Flin, Rhona; Mearns, Kathryn
To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.
Soelberg Sorensen, P.
Currently, more than ten drugs have been approved for treatment of relapsing-remitting multiple sclerosis (MS). Newer treatments may be more effective, but have less favorable safety record. Interferon-β preparations and glatiramer acetate treatment require frequent subcutaneous or intramuscular...... disease activity can choose between dimethyl fumarate and teriflunomide or the “old injectable.” Patients with very active MS may choose a more effective drug as the initial treatment. In case of side effects on one drug, switch to another drug can be tried. Suboptimal effect of the first drug indicates...... escalation to a highly efficacious drug. A favorable benefit-risk balance can be maintained by appropriate patient selection and appropriate risk management on therapy. New treatments will within the coming 1-2 years change our current treatment algorithm for relapsing-remitting MS....
The report describes a study to develop a safety classification proposal or classi- fication recommendations based on risks for selected equipment of a nuclear power plant. The application plant in this work is Loviisa NPP unit 1. The safety classification proposals are to be considered as an exercise in this pilot study and do not necessarily represent final proposals in a real situation. Comparisons to original safety classifications and technical specifications were made. The study concludes that it is possible to change safety classes or safety signifi- cances as considered in technical specifications and in in-service-inspections into both directions without endangering the safety or even by improving the safety. (au)
Gaertner, Jan; Vent, Julia; Greinwald, Ralf; Rothschild, Markus A; Ostgathe, Christoph; Kessel, Rene; Voltz, Raymond
Especially when caring for patients approaching the end of life, physicians and nursing staff feel committed to fulfilling as many patient desires as possible. However, sometimes a patient's "final will" may threaten public safety. This can lead to severe conflicts, outweighing the physician's obligation and dedication to care for the patient and to respect his autonomy. Yet, public safety can be threatened if confidentiality is not broken. This article provides a concise summary of the medicolegal and ethical fundamentals concerning this difficult situation. If the patient's and others' health and safety are at risk, physicians may (and in some countries must) break medical confidentiality and disclose confidential patient information to the police and other authorities. Physicians should be able to professionally deal with such a conflict in all patients, not only in patients with advanced illness. Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Leonhardt, Kathryn Kraft
Community engagement is widely endorsed but poorly defined as a strategy to improve patient safety. With strong evidence that engaging patients can positively influence health outcomes, it is presumed that community engagement could improve patient safety. Leaning on the models from other disciplines such as public health, the adequate knowledge and application of the principles of community engagement are critical for this approach to be effective. This article provides a description of the theories supporting patient partnership and community engagement, reviews critical elements of successful community-based programs, and identifies the potential for empowering communities to improve patient safety.
Magrabi, Farah; Ong, Mei-Sing; Coiera, Enrico
Alongside their benefits health IT applications can pose new risks to patient safety. Problems with IT have been linked to many different types of clinical errors including prescribing and administration of medications; as well as wrong-patient, wrong-site errors, and delays in procedures. There is also growing concern about the risks of data breach and cyber-security. IT-related clinical errors have their origins in processes undertaken to design, build, implement and use software systems in a broader sociotechnical context. Safety can be improved with greater standardization of clinical software and by improving the quality of processes at different points in the technology life cycle, spanning design, build, implementation and use in clinical settings. Oversight processes can be set up at a regional or national level to ensure that clinical software systems meet specific standards. Certification and regulation are two mechanisms to improve oversight. In the absence of clear standards, guidelines are useful to promote safe design and implementation practices. Processes to identify and mitigate hazards can be formalised via a safety management system. Minimizing new patient safety risks is critical to realizing the benefits of IT.
The article introduces the background and status quo of regulations on the nuclear safety in China, and points out the inadequacies existing with the current regulations. The author explains the risk-informed safety management concerning its development, status quo, and achievements made, in an attempt to make out the trend of improving regulations on the nuclear safety through risk-informed methods. Combining the U.S. development program of establishing risk-informed regulations on the nuclear safety, the author narrates principles and features of the new regulations system, and provides suggestions for the promotion of risk-informed safety management and establishment of risk-informed regulations on the nuclear safety. (author)
Significance of Fukushima nuclear power accident requested reconsideration of safety standards, of which we had usually no doubt. Risk assessment standard (JIS B 9702), Which was used for repetition of database preparation and cumulative assessment, defined allowable risk and residual risk. However, work site and immediate assessment was indispensable beside such assessment so as to ensure safety. Risk of casualties was absolutely not acceptable in principle and judgments to approve allowable risk needed accountability, which was reminded by safety culture proposed by IAEA and also identified by investigation of organizational cause of Columbia accident. Actor of safety culture would be organization and individual, and mainly individual. Realization of safety culture was conducted by personnel having moral consciousness and firm sense of mission in the course of jobs and working daily with sweat pouring. Safety engineering/technology should have framework integrating human as such totality. (T. Tanaka)
Aarts, J.; Nøhr, C.
for the third conference with the theme: The ability to design, implement and evaluate safe, useable and effective systems within complex health care organizations. The theme for this conference was "Designing and Implementing Health IT: from safe systems to patient safety". The contributions have reflected...... and implementation of safe systems and thus contribute to the agenda of patient safety? The contributions demonstrate how the health informatics community has contributed to the performance of significant research and to translating research findings to develop health care delivery and improve patient safety......This volume presents the papers from the fourth International Conference on Information Technology in Health Care: Socio-technical Approaches held in Aalborg, Denmark in June 2010. In 2001 the first conference was held in Rotterdam, The Netherlands with the theme: Sociotechnical' approaches...
Hendee, William R.; Herman, Michael G.
Beginning in the 1990s, and emphasized in 2000 with the release of an Institute of Medicine report, healthcare providers and institutions have dedicated time and resources to reducing errors that impact the safety and well-being of patients. But in January 2010 the first of a series of articles appeared in the New York Times that described errors in radiation oncology that grievously impacted patients. In response, the American Association of Physicists in Medicine and the American Society of Radiation Oncology sponsored a working meeting entitled ''Safety in Radiation Therapy: A Call to Action''. The meeting attracted 400 attendees, including medical physicists, radiation oncologists, medical dosimetrists, radiation therapists, hospital administrators, regulators, and representatives of equipment manufacturers. The meeting was cohosted by 14 organizations in the United States and Canada. The meeting yielded 20 recommendations that provide a pathway to reducing errors and improving patient safety in radiation therapy facilities everywhere.
Full Text Available Introduction. Patient safety and the avoidance of inhospital adverse events is a key focus of clinical practice and medical audit. A large of proportion of medical errors affect surgical patients in the peri-operative setting. Safety checklists have been adopted by the medical profession from the aviation industry as a cheap and reliable method of avoiding errors which arise from complex or stressful situations. Current evidence suggests that the use of periooperative checklists has led to a decrease in surgical morbidity and hospital costs. Aim. To assess the quality of implementation of a modified patient safety checklist in a UK district general hospital. Methods. An observational tool was designed to assess in real time the peri-operative performance of the surgical safety checklist in patients undergoing general surgical, urological or orthopaedic procedures. Initiation of the checklist, duration of performance and staff participation were audited in real time. Results. 338 cases were monitored. Nurses were most active in initiating the safety checklist. The checklist was performed successfully in less than a minute in most cases. 11-24% of staff (according to professional group present in the operating room did not participate in the checklist. Critical safety checks (patient identity and procedure name were performed in all cases across all specialties. Variations were noted in checking other categories, such as deep vein thrombosis (DVT prophylaxis or patient warming. Conclusions. There is still a potential for improving the practice and culture of surgical patient safety activities. Staff training and designation of patient safety leadership roles is needed in increasing compliance and implementation of patient safety mechanism, such as peri-operative checklists. There is significant data to advocate the need to implement patient safety surgical checklists internationally
Spencer, Christine S; Roberts, Eric T; Gaskin, Darrell J
The reduction of adverse patient safety events and the equitable treatment of patients in hospitals are clinical and policy priorities. Health services researchers have identified disparities in the quality of care provided to patients, both by demographic characteristics and insurance status. However, less is known about the extent to which disparities reflect differences in the places where patients obtain care, versus disparities in the quality of care provided to different groups of patients in the same hospital. In this study, we examine whether the rate of adverse patient safety events differs by the insurance status of patients within the same hospital. Using discharge data from hospitals in 11 states, we compared risk-adjusted rates for 13 AHRQ Patient Safety Indicators by Medicare, Medicaid, and Private payer insurance status, within the same hospitals. We used multivariate regression to assess the relationship between insurance status and rates of adverse patient safety events within hospitals. Medicare and Medicaid patients experienced significantly more adverse safety events than private pay patients for 12 and 7 Patient Safety Indicators, respectively (at P patients had significantly lower event rates than private payers on 2 Patient Safety Indicators. Risk-adjusted Patient Safety Indicator rates varied with patients' insurance within the same hospital. More research is needed to determine the cause of differences in care quality received by patients at the same hospital, especially if quality measures are to be used for payment.
Aronovitch, Sharon A
The risk of falling increases with age. Falls in the elderly have been found to raise mortality and morbidity rates and are a leading cause of premature admission to long-term care facilities. Attention to known intrinsic and extrinsic factors that predispose to falling is important in community dwelling and institutionalized older adults. New government guidelines for long-term care facilities have helped focus attention on the safety aspect of fall risk and information about the physical and psychological impact of falling is increasing. Implementation of fall prevention protocols, including the use of fall risk assessment tools, may help reduce the incidence of falls and resultant complications.
Many organizations in the world are committed to gender parity. Increasing number of women is working in the fields of radiation medicine and in industries dealing with radiation. Women patients may be exposed to radiation in radiology, radiation oncology, nuclear medicine, interventional cardiology, dentistry etc. Radiation safety of women staff and women patients is different from their male counterparts because of conception and pregnancy. So, fetal health is a matter of concern in the above. Also, the excess relative risk of radiation induced cancers in females relates to higher risk of thyroid cancer and high radiosensitivity as compared to males
The Fusion Safety Program (FSP) at the Idaho National Engineering Laboratory (INEL) conducts safety research in materials, chemical reactions, safety analysis, risk assessment, and in component research and development to support existing magnetic fusion experiments and also to promote safety in the design of future experiments. One of the areas of safety research is applying probabilistic risk assessment (PRA) methods to fusion experiments. To apply PRA, we need a fusion-relevant radiological dose code and a component failure rate data base. This paper describes the FSP effort to develop a failure rate data base for fusion-specific components
Chen, I-Chi; Li, Hung-Hui
Patient safety is a critical component to the quality of health care. As health care organizations endeavour to improve their quality of care, there is a growing recognition of the importance of establishing a culture of patient safety. In this research, the authors use the Hospital Survey on Patient Safety Culture (HSOPSC) questionnaire to assess the culture of patient safety in Taiwan and attempt to provide an explanation for some of the phenomena that are unique in Taiwan. The authors used HSOPSC to measure the 12 dimensions of the patient safety culture from 42 hospitals in Taiwan. The survey received 788 respondents including physicians, nurses, and non-clinical staff. This study used SPSS 15.0 for Windows and Amos 7 software tools to perform the statistical analysis on the survey data, including descriptive statistics and confirmatory factor analysis of the structural equation model. The overall average positive response rate for the 12 patient safety culture dimensions of the HSOPSC survey was 64%, slightly higher than the average positive response rate for the AHRQ data (61%). The results showed that hospital staff in Taiwan feel positively toward patient safety culture in their organization. The dimension that received the highest positive response rate was "Teamwork within units", similar to the results reported in the US. The dimension with the lowest percentage of positive responses was "Staffing". Statistical analysis showed discrepancies between Taiwan and the US in three dimensions, including "Feedback and communication about error", "Communication openness", and "Frequency of event reporting". The HSOPSC measurement provides evidence for assessing patient safety culture in Taiwan. The results show that in general, hospital staffs in Taiwan feel positively toward patient safety culture within their organization. The existence of discrepancies between the US data and the Taiwanese data suggest that cultural uniqueness should be taken into
Many documents have been prepared that try to define the scope of the criticality analysis and that suggest adding probabilistic risk analysis (PRA) to the deterministic safety analysis. The report of the US Department of Energy (DOE) AL 5481.1B suggested that an accident is credible if the occurrence probability is >1 x 10 -6 /yr. The draft DOE 5480 safety analysis report suggested that safety analyses should include the application of methods such as deterministic safety analysis, risk assessment, reliability engineering, common-cause failure analysis, human reliability analysis, and human factor safety analysis techniques. The US Nuclear Regulatory Commission (NRC) report NRC SG830.110 suggested that major safety analysis methods should include but not be limited to risk assessment, reliability engineering, and human factor safety analysis. All of these suggestions have recommended including PRA in the traditional criticality analysis
Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting. A prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients
Mueller, Frank Hugo Heinz
Non-interventional study in outpatient, contrast-enhanced CT: 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least 'possible' relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5% of patients showed one or more risk factors (e.g. impaired renal function 4.4%, diabetes mellitus 8.5%, hypertension 20.6%). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5-50.5%). Oral hydration was the main preventive measure in patients with renal risk factors (<8%) followed by intravenous hydration (1%). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74%), but were classified as serious in only 3 patients (0.03%). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10 000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive measures and
Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting. A prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients
Mueller, Frank Hugo Heinz [Radiology and Nuclear Medicine Center, Ludwigshafen (Germany)
Non-interventional study in outpatient, contrast-enhanced CT: 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least 'possible' relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5% of patients showed one or more risk factors (e.g. impaired renal function 4.4%, diabetes mellitus 8.5%, hypertension 20.6%). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5-50.5%). Oral hydration was the main preventive measure in patients with renal risk factors (<8%) followed by intravenous hydration (1%). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74%), but were classified as serious in only 3 patients (0.03%). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10 000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... Safety Monitoring, Inc. due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component...
Hammar, L.; Andersson, Kjell
'Safety awareness' is proposed as a possibly constructive concept for the purpose of promoting initiatives in nuclear safety work and gaining improved understanding when communicating on nuclear safety. Safety is thus conceived as resulting essentially from and actually constituting awareness of critical factors in regard of safety. The concept aims specifically at promoting the view of 'safety' as 'awareness of required conditions for being in control of risk'. It aims as well at making clearer sense in calling for constant improvement of safety, according to practice in a safety culture. This proposed view would be expected to lead to applying the usual types of safety criteria but offers the merit of attracting due attention to 'awareness goals' in process oriented safety management which are fundamental to maintaining and improving safety. Applications are discussed in regard of communicating on nuclear safety between decision-makers and the general public, developing and maintaining safety culture, integrating specialist expert contributions in over-all safety assessment, setting safety goals and using safety indicators
Edwards, Marc T
Despite concerted effort to improve quality and safety, high reliability remains a distant goal. Although this likely reflects the challenge of organizational change, persistent controversy over basic issues suggests that weaknesses in conceptual models may contribute. The essence of operational improvement is organizational learning. This article presents a framework for identifying leverage points for improvement based on organizational learning theory and applies it to an analysis of current practice and controversy. Organizations learn from others, from defects, from measurement, and from mindfulness. These learning modes correspond with contemporary themes of collaboration, no blame for human error, accountability for performance, and managing the unexpected. The collaborative model has dominated improvement efforts. Greater attention to the underdeveloped modes of organizational learning may foster more rapid progress in patient safety by increasing organizational capabilities, strengthening a culture of safety, and fixing more of the process problems that contribute to patient harm.
Rahman, A.; Arumsari, F.; Maryani, A.
Many high rise building constructed in several universities in Indonesia. The high-rise building management must provide the safety planning and proper safety equipment in each part of the building. Unfortunately, most of the university in Indonesia have not been applying safety policy yet and less awareness on treating safety facilities. Several fire accidents in university showed that some significant risk should be managed by the building management. This research developed a framework for measuring the high rise building safety index in university The framework is not only assessed the risk magnitude but also designed modular building safety checklist for measuring the safety implementation level. The safety checklist has been developed for 8 types of the university rooms, i.e.: office, classroom, 4 type of laboratories, canteen, and library. University building safety index determined using risk-implementation matrix by measuring the risk magnitude and assessing the safety implementation level. Building Safety Index measurement has been applied in 4 high rise buildings in ITS Campus. The building assessment showed that the rectorate building in secure condition and chemical department building in beware condition. While the library and administration center building was in less secure condition.
Gokcek, O.; Temme, M.I.; Derby, S.L.
This paper describes a risk allocation technique used for determining nuclear power plant design reliability requirements. The concept of risk allocation-optimum choice of safety function reliabilities under a maximum risk constraint - is described. An example of risk allocation is presented to demonstrate the application of the methodology
Twetman, Svante; Fontana, Margherita
Risk assessment is an essential component in the decision-making process for the correct prevention and management of dental caries. Multiple risk factors and indicators have been proposed as targets in the assessment of risk of future disease, varying sometimes based on the age group at which...... they are targeted. Multiple reviews and systematic reviews are available in the literature on this topic. This chapter focusses primarily on results of reviews based on longitudinal studies required to establish the accuracy of caries risk assessment. These findings demonstrate that there is a strong body...... of evidence to support that caries experience is still, unfortunately, the single best predictor for future caries development. In young children, prediction models which include a variety of risk factors seem to increase the accuracy of the prediction, while the usefulness of additional risk factors...
C. van der Starre (Cynthia)
markdownabstract__Abstract__ The publication of the breakthrough report “To Err is Human” by the Institute of Medicine was the launch of patient safety initiatives all over the world. In the intensive care unit (ICU) of the Erasmus MC-Sophia Children’s Hospital this resulted in the institution
Full Text Available Abstract Background Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS, and a patient incident reporting tool (PIRT - to help the NHS prevent patient safety incidents by learning more about when and why they occur. Methods To develop the PMOS 1 literature will be reviewed to identify similar measures and key contributory factors to error; 2 four patient focus groups will ascertain practicality and feasibility; 3 25 patient interviews will elicit approximately 60 items across 10 domains; 4 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis. To develop the PIRT 1 individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2 nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50 will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their
Kristensen, Solvejg; Mainz, Jan; Bartels, Paul
such as culture, infections, surgical complications, medication errors, obstetrics, falls and specific diagnostic areas. CONCLUSION: The patient safety indicators recommended present a set of possible measures of patient safety. One of the future perspectives of implementing patient safety indicators...... for systematic monitoring is that it will be possible to continuously estimate the prevalence and incidence of patient safety quality problems. The lesson learnt from quality improvement is that it will pay off in terms of improving patient safety....
This report presents the results of an effort to identify and rank reactor safety and risk issues identified from past Probabilistic Risk Assessments (PRAs) and other safety analyses. Because of the varied scope of these analyses, the list of issues may be incomplete. Nevertheless, those studies comprised ordered analyses to whatever their respective depths; hence, they warranted scrutiny for whatever insights they could reveal with respect to issue importance. The top-ranked issues in terms of their contribution to the uncertainty in risk are described in some detail. All of these risk issues are compared to the generic safety issues for completeness and omissions
Wu Mingliang; Zheng Jianhua
Nuclear fuel remains in the core during the outage of CANDU unit, but there are still nuclear safety risks such as reactor accidental criticality, fuel element failure due to inability to properly remove residual heat. Furthermore, these risks are aggravated by the weakening plant system configuration and multiple cross operations during the outage. This paper analyzes the phases where there are potential nuclear safety risks on the basis of the typical critical path arrangement of the outage of Qinshan NPP 3 and introduces a series of CANDU-specific risk control measures taken during the past plant outages to ensure nuclear safety during the unit outage. (authors)
Nutrition care is not always recognised as a patient safety issue. This article explores the origins of the patient safety initiative and seeks to identify possible connections between nutrition care and patient safety. Examples of tools that can be used to improve the safety of nutrition care are provided. This is also a call to action ...
Suurmond, Jeanine; Uiters, Ellen; de Bruijne, Martine C.; Stronks, Karien; Essink-Bot, Marie-Louise
Objectives. We explored characteristics of in-hospital care and treatment of immigrant patients to better understand the processes underlying ethnic disparities in patient safety. Methods. We conducted semistructured interviews with care providers regarding patient safety events involving immigrant
Cararro, Telma Elisa; Gelbcke, Francine Lima; Sebold, Luciara Fabiane; Kempfer, Silvana Silveira; Zapelini, Maria Christina; Waterkemper, Roberta
This study is aimed at identifying the knowledge of nursing students about the subject area of patient safety and its relationship with the teaching of biosecurity. Exploratory qualitative study conducted at the Universidade Federal de Santa Catarina (Federal University of Santa Catarina), with 17 students in the third phase of the Undergraduate Nursing Program. Three categories emerged after an exhaustive reading of the responses caring for self and others; biosecurity and care for the environment; biosecurity: health education and continuing education in health services. The following issues were identified, students' concern about risk prevention, care and self care as prerogatives for patient's safety; and education as a proposal for the minimization of risks. The study of biosecurity is considered important in undergraduate studies, minimizing losses and mistakes in the undergraduate students' conduct.
Binkhorst, J.; Kingma, S.F.
This article deals with risk controversies in emerging policy networks regarding school safety in the Netherlands. It offers a grounded account of the interpretations of school risks and safety measures by the various stakeholders of the policy network, in particular, schools, local government and
Megan Orsulaka; Vladislav Kecojevicb; Larry Graysona; Antonio Nietoa [Pennsylvania State University, University Park, PA (United States). Dept of Energy and Mineral Engineering
This article presents an application of a risk assessment approach in characterising the risks associated with safety violations in underground bituminous mines in Pennsylvania using the Mine Safety and Health Administration (MSHA) citation database. The MSHA database on citations provides an opportunity to assess risks in mines through scrutiny of violations of mandatory safety standards. In this study, quantitative risk assessment is performed, which allows determination of the frequency of occurrence of safety violations (through associated citations) as well as the consequences of them in terms of penalty assessments. Focus is on establishing risk matrices on citation experiences of mines, which can give early indication of emerging potentially serious problems. The resulting frequency, consequence and risk rankings present valuable tools for prioritising resource allocations, determining control strategies, and could potentially contribute to more proactive prevention of incidents and injuries.
Mira, J J; Guilabert, M; Vitaller, J; Ignacio, E
To compare the information on patient safety received by students of medicine and nursing. Cross-sectional study was conducted using a convenience sample of medical and nursing students of 3 Universities. The Latin Patient Safety Student Information and a test of 5 questions with 5 options were used. A sample of 79 students in each group was enrolled to detect differences of .3 units (bilateral estimation), considering 80% statistical power and 95% confidence interval. A total of 144 students replied (74 nursing and 70 medicine students). Nursing students achieved higher scores in the communication with patients factor (3.8 vs 3.2, P<.001) and proactive attitude to identify risks for patient safety (4.3 vs 3.8, P<.001). Medical students were more aware of the inevitability of adverse events (2.3 vs 3.1, P<.001). Ten (7%) students had only one fault in the test, and only one (1%) answered all questions correctly. The training in patient safety should be improved both in nursing and medicine, although nursing students receive more information. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.
Leonard, Sarah; O'Donovan, Anita
Minimizing errors and improving patient safety has gained prominence worldwide in high-risk disciplines such as radiation therapy. Patient safety culture has been identified as an important factor in reducing the incidence of adverse events and improving patient safety in the health care setting. The aim of distributing the Hospital Survey on Patient Safety Culture (HSPSC) to radiation therapy departments worldwide was to assess the current status of safety culture, identify areas for improvement and areas that excel, examine factors that influence safety culture, and raise staff awareness. The safety culture in radiation therapy departments worldwide was evaluated by distributing the HSPSC. A total of 266 participants were recruited from radiation therapy departments and included radiation oncologists, radiation therapists, physicists, and dosimetrists. The positive percent scores for the 12 dimensions of the HSPSC varied from 50% to 79%. The highest composite score among the 12 dimensions was teamwork within units; the lowest composite score was handoffs and transitions. The results indicated that health care professionals in radiation therapy departments felt positively toward patient safety. The HSPSC was successfully applied to radiation therapy departments and provided valuable insight into areas of potential improvement such as teamwork across units, staffing, and handoffs and transitions. Managers and policy makers in radiation therapy may use this assessment tool for focused improvement efforts toward patient safety culture. Copyright © 2017 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.
Slater, Beverley L.; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John
Introduction: Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based…
Full Text Available The paper presents a concept of a multi-level pedestrian safety management system. Three management levels are distinguished: strategic, tactical and operational. The basis for the proposed approach to pedestrian safety management is a risk-based method. In the approach the elements of behavioural and systemic theories were used, allowing for the development of a formalised and repeatable procedure integrating the phases of risk assessment and response to the hazards of road crashes involving pedestrians. Key to the method are tools supporting pedestrian safety management. According to the risk management approach, the tools can be divided into two groups: tools supporting risk assessment and tools supporting risk response. In the paper attention is paid to selected tools supporting risk assessment, with particular emphasis on the methods for estimating forecasted pedestrian safety measures (at strategic, national and regional level and identification of particularly dangerous locations in terms of pedestrian safety at tactical (regional and local and operational level. The proposed pedestrian safety management methods and tools can support road administration in making rational decisions in terms of road safety, safety of road infrastructure, crash elimination measures or reducing the consequences suffered by road users (particularly pedestrians as a result of road crashes.
Smith, Meredith Y; Benattia, Isma
Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and
Heget, Jeffrey R; Bagian, James P; Lee, Caryl Z; Gosbee, John W
In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities. To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond. NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.
Full Text Available Abstract Background Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs on patient safety were examined. Methods A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. Results A total of 68 GPs responded (51.5% response rate. None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. Conclusion The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy
Gaal, Sander; Verstappen, Wim; Wensing, Michel
Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.
Lundgaard, Mette; Rabøl, Louise; Jensen, Elisabeth Agnete Brøgger
This paper describes the process that lead to the passing of the Act for Patient Safety in the Danisk health care sytem, the contents of the act and how the act is used in the Danish health care system. The act obligates frontline health care personnel to report adverse events, hospital owners...... to act on the reports and the National Board of Health to commuicate the learning nationally. The act protects health care providers from sanctions as a result of reporting. In January 2004, the Act on Patient Safety in the Danish health care system was put into force. In the first twelve months 5740...... adverse events were reported. the reports were analyzed locally (hospital and region), anonymized ad then sent to the National Board af Health. The Act on Patient Safety has driven the work with patient safety forward but there is room for improvement. Continuous and improved feedback from all parts...
de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M
Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical
Yang, Joon-Eon [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)
The safety goal is an answer of each country to the question 'How safe is safe enough?'. Table 1 shows some examples of the safety goal. However, many countries including Korea do not have the official safety goal for NPPs up to now since the establishment of safety goal is not just a technical issue but a very complex socio-technical issue. In establishing the safety goal for nuclear facilities, we have to consider various factors including not only technical aspects but also social, cultural ones. Recently, Korea is trying to establish the official safety goal. In this paper, we will review the relationship between the safety goal and Probabilistic Safety Assessment (PSA). We will also address some important technical issues to be considered in establishing the safety goal for NPPs from PSA point of view, i.e. a multi-unit risk issue and the uncertainty of PSA. In this paper, we reviewed some issues related to the safety goal and PSA. We believe that the safety goal is to be established in Korea considering the multi-unit risk. In addition, the relationship between the safety goal and PSA should be also defined clearly since PSA is the only way to answer to the question 'How safe is safe enough?'.
Hanskamp-Sebregts, M.E.; Zegers, M.; Boeijen, W.M.J.; Westert, G.P.; Gurp, P.J.M. van; Wollersheim, H.C.
BACKGROUND: Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its
Webb, Jennifer; Sorensen, Asta; Sommerness, Samantha; Lasater, Beth; Mistry, Kamila; Kahwati, Leila
The use of health information technology (IT) has been shown to promote patient safety in Labor and Delivery (L&D) units. The use of health IT to apply safety science principles (e.g., standardization) to L&D unit processes may further advance perinatal safety. Semi-structured interviews were conducted with L&D units participating in the Agency for Healthcare Research and Quality's (AHRQ's) Safety Program for Perinatal Care (SPPC) to assess units' experience with program implementation. Analysis of interview transcripts was used to characterize the process and experience of using health IT for applying safety science principles to L&D unit processes. Forty-six L&D units from 10 states completed participation in SPPC program implementation; thirty-two (70%) reported the use of health IT as an enabling strategy for their local implementation. Health IT was used to improve standardization of processes, use of independent checks, and to facilitate learning from defects. L&D units standardized care processes through use of electronic health record (EHR)-based order sets and use of smart pumps and other technology to improve medication safety. Units also standardized EHR documentation, particularly related to electronic fetal monitoring (EFM) and shoulder dystocia. Cognitive aids and tools were integrated into EHR and care workflows to create independent checks such as checklists, risk assessments, and communication handoff tools. Units also used data from EHRs to monitor processes of care to learn from defects. Units experienced several challenges incorporating health IT, including obtaining organization approval, working with their busy IT departments, and retrieving standardized data from health IT systems. Use of health IT played an integral part in the planning and implementation of SPPC for participating L&D units. Use of health IT is an encouraging approach for incorporating safety science principles into care to improve perinatal safety and should be incorporated
National Aeronautics and Space Administration — Aviation safety systems have undergone dramatic changes over the past fifty years. If you take a look at the early technology in this area, you'll see that there was...
Risk management of which risk assessment is part, and safety regulations are common in the offshore oil and gas industry management system. The process of conducting risk assessment is mostly a challenge for operational personnel assigned to perform this function. The most significant problem is the decision to use ...
Dijkman, A.; Terwoert, J.
The advancement in new technologies, substances and new ways of working make it necessary to look beyond traditional methods of risk management. General drivers to emerging occupational safety and health (OSH) risks are: globalisation; demographic changes; technical innovations; changes in risk
signals, motivating approach. Novelty, and the detection of certain olfactory and visual cues associated with spoilage or contamination, act as orientation or threat signals and motivate closer inspection or avoidance. Anticipatory affects are an inherent part of these behaviour regulation systems...... problematic food safety behaviours are likely to occur. The presentation will begin with an overview of the relevant psychological mechanisms that regulate approach and avoidance behaviour with respect to potentially hazardous foods. Learned representations of familiarity and reward value act as safety...
Donaldson, Nancy E; Plank, Rosemary K; Williamson, Ann; Pearl, Jeffrey; Kellogg, Jerry; Ryder, Marcia
...) Venous Access Device (VAD) Patient Safety Interdisciplinary Education Project was to develop a 30-hour/one clinical academic unit VAD patient safety course with the aim of expediting clinician adoption of critical concepts...
Considine, Julie; Currey, Judy
To argue that if all nurses were to adopt the primary survey approach (assessment of airway, breathing, circulation and disability) as the first element of patient assessment, they would be more focused on active detection of clinical deterioration rather than passive collection of patient data. Nurses are the professional group that carry the highest level of responsibility for patient assessment, accurate data collection and interpretation. The timely recognition of, and response to deteriorating patients, is dependent on the measurement and interpretation of pertinent physiological data by nurses. Discursive paper. Traditionally taught and commonly used approaches to patient assessment such as 'vital signs' and 'body systems' are not evidence-based nor framed in patient safety. The primary survey approach as the first element in patient assessment has three major advantages: (1) data are collected according to clinical importance; (2) data are collected using the same framework as most organisation's rapid response system activation criteria; and (3) the primary survey acts as a patient safety checklist, thereby decreasing the risk of failure to recognise, and therefore respond to, deteriorating patients. The vital signs and body systems approaches to patient assessment have significant limitations in identifying clinical deterioration. The primary survey approach provides nurses with a consistent, evidence-based and sequenced approach to patient assessment in every clinical setting. All nurses should use a primary survey approach as the first element of patient assessment in every patient encounter as a patient safety strategy. © 2014 John Wiley & Sons Ltd.
Raab, Stephen S
Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.
.... The Army's Class A aviation mishap rate declined after it implemented risk management (RM) principles in 1987. This reduction caught the attention of Air Force leadership who have since stated that the application of operational risk management...
Pitts, Samantha I; Maruthur, Nisa M; Luu, Ngoc-Phuong; Curreri, Kimberly; Grimes, Renee; Nigrin, Candace; Sateia, Heather F; Sawyer, Melinda D; Pronovost, Peter J; Clark, Jeanne M; Peairs, Kimberly S
While there is growing awareness of the risk of harm in ambulatory health care, most patient safety efforts have focused on the inpatient setting. The Comprehensive Unit-based Safety Program (CUSP) has been an integral part of highly successful safety efforts in inpatient settings. In 2014 CUSP was implemented in an academic primary care practice. As part of CUSP implementation, staff and clinicians underwent training on the science of safety and completed a two-question safety assessment survey to identify safety concerns in the practice. The concerns identified by team members were used to select two initial safety priorities. The impact of CUSP on safety climate and teamwork was assessed through a pre-post comparison of results on the validated Safety Attitudes Questionnaire. Ninety-six percent of staff completed science of safety training as part of CUSP implementation, and 100% of staff completed the two-question safety assessment. The most frequently identified safety concerns were related to medications (n = 11, 28.2), diagnostic testing (n = 9, 25), and communication (n = 5, 14). The CUSP team initially prioritized communication and infection control, which led to standardization of work flows within the practice. Six months following CUSP implementation, large but nonstatistically significant increases were found for the percentage of survey respondents who reported knowledge of the proper channels for questions about patient safety, felt encouraged to report safety concerns, and believed that the work setting made it easy to learn from the errors of others. CUSP is a promising tool to improve safety climate and to identify and address safety concerns within ambulatory health care. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.
The aim of this paper is to review key theories of risk and safety and their implications for nursing. The concept of of patient safety has only recently risen to prominence as an organising principle in healthcare. The paper considers the wider social context in which contemporary concepts of risk and safety have developed. In particular it looks at sociological debates about the rise of risk culture and the risk society and their influence on the patient safety movement. The paper discusses three bodies of theory which have attempted to explain the management of risk and safety in organisations: normal accident theory, high reliability theory, and grid-group cultural theory. It examine debates between these theories and their implications for healthcare. It discusses reasons for the dominance of high reliability theory in healthcare and its strengths and limitations. The paper suggest that high reliability theory has particular difficulties in explaining some aspects of organisational culture. It also suggest that the implementation of high reliability theory in healthcare has involved over reliance on numerical indicators. It suggests that patient safety could be improved by openness to a wider range of theoretical perspectives.
Williamson, B D.P.
The historical developments which have led to a reduction in the hazards or potential hazards to patients in dental radiography are reviewed. Based on a simple risk estimate, the safety of present-day techniques employed in routine dental radiography is assessed. Also included in the review is a description of techniques used and results obtained from the National Radiation Laboratory's (NRL) surveillance programme of patients' exposure to irradiation in dental radiography. The possibilities of and need for achieving further reductions of irradiation are discussed.
The aim of this review paper was to determine the best sanitation health risk and safety planning approach for sustainable management of urban environment. This was achieved by reviewing the concept of sanitation safety planning as a tool. The review adopted exploratory research approach and used secondary data ...
V. A. Nikolayev
Safety of transportation in Russia is subject to a variety of threats. Discussed in the article are characteristics of major threats to transportation security. State transportation policy directions that make it possible to ensure the security of cargo and passenger transportation are shown. A listof activities and innovative risk management tools that provide for improved safety of railway transportation is proposed.
V. A. Nikolayev
Full Text Available Safety of transportation in Russia is subject to a variety of threats. Discussed in the article are characteristics of major threats to transportation security. State transportation policy directions that make it possible to ensure the security of cargo and passenger transportation are shown. A listof activities and innovative risk management tools that provide for improved safety of railway transportation is proposed.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... Research and Quality (AHRQ), HHS. ACTION: Notice of delisting. SUMMARY: The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21--b-26, provides for the...
Facincani, Tila; Guimarães, Maia Nogueira Crown; De Sousa Dos Santos, Sigrid
The adverse effects of yellow fever (YF) vaccine in dialysis patients are not well known. There is concern about the risks and benefits of the vaccine in immunocompromised patients living in endemic areas, particularly given the risk of resurgence of urban YF with the spread of Aedes aegypti mosquitoes. The purpose of this study was to assess the coverage and safety of YF vaccine in chronic dialysis patients. A cross-sectional study of 130 chronic dialysis patients was performed. Data were collected on clinical characteristics and YF vaccine status. Patients not vaccinated against YF or without a booster vaccination within the last 10 years were referred to receive the vaccine, and adverse effects were monitored. Previous vaccination was verified in 44 patients within the last 10 years and in 26 patients at more than 10 years ago, with no mention of adverse effects. Thirty-six patients had never been vaccinated and 24 had an unknown vaccination status. Of the total 86 patients referred for immunization, 45 actually received the YF vaccine, with 24.4% experiencing mild local adverse effects and 4.4% experiencing fever. No serious adverse effects attributable to YF vaccine were observed (anaphylaxis, neurological or viscerotropic disease). YF vaccine coverage among hemodialysis patients is low, and the vaccine appeared to be safe in this population with a small sample size. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
Pinto, Abel; Ribeiro, Rita A; Nunes, Isabel L
In work environments, the main aim of occupational safety risk assessment (OSRA) is to improve the safety level of an installation or site by either preventing accidents and injuries or minimizing their consequences. To this end, it is of paramount importance to identify all sources of hazards and assess their potential to cause problems in the respective context. If the OSRA process is inadequate and/or not applied effectively, it results in an ineffective safety prevention program and inefficient use of resources. An appropriate OSRA is an essential component of the occupational safety risk management process in industries. In this article, we performed a survey to elicit the relative importance for identified OSRA tasks to enable an in-depth evaluation of the quality of risk assessments related to occupational safety aspects on industrial sites. The survey involved defining a questionnaire with the most important elements (tasks) for OSRA quality assessment, which was then presented to safety experts in the mining, electrical power production, transportation, and petrochemical industries. With this work, we expect to contribute to the main question of OSRA in industries: "What constitutes a good occupational safety risk assessment?" The results obtained from the questionnaire showed that experts agree with the proposed OSRA process decomposition in steps and tasks (taxonomy) and also with the importance of assigning weights to obtain knowledge about OSRA task relevance. The knowledge gained will enable us, in the near future, to build a framework to evaluate OSRA quality for industrial sites. © 2012 Society for Risk Analysis.
Barny, M.-H.; Brenot, J.; Moreau, A.
Employees of the French centre of Saclay have been interviewed twice in November 1984 and March 1987 about their risks at the workplace, their views on safety, their protective attitudes, and also about the Chernobyl accident in the second survey. Perceived risks are compared, safety measures and protection teams are judged, importance of the Chernobyl accident is appreciated. Differences in perception between the various professional groups are pointed out. The main results are briefly presented hereafter. (author)
McTiernan, Patricia; Wachter, Robert M; Meyer, Gregg S; Gandhi, Tejal K
The opening keynote session of the 16th Annual National Patient Safety Foundation Patient Safety Congress, held 14-16 May 2014, featured a debate addressing the merits and challenges of accountability with respect to key issues in patient safety. The specific resolution debated was: Certain safety practices should be inviolable, and transgressions should result in penalties, potentially including fines, suspensions, and firing. The themes discussed in the debate are issues that healthcare professionals and leaders commonly struggle with in their day-to-day work. How do we draw a line between systems problems and personal failings? When should clinicians and staff be penalised for failing to follow a known safety protocol? The majority of those who listened to the live debate agreed that it is time to begin holding health professionals accountable when they wilfully or repeatedly violate policies or protocols put in place by their institutions to protect the safety of patients. This article summarises the debate as well as the questions and discussion generated by each side. A video of the original debate can be found at http://bit.ly/Npsf_debate. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
White, Donald E
Safety/security risk assessments no longer need to spook nor baffle healthcare safety/security managers. This grid template provides at-at-glance quick lookup of the possible threats, the affected people and things, a priority ranking of these risks, and a workable solution for each risk. Using the standard document, spreadsheet, or graphics software already available on your computer, you can easily use a scientific method to produce professional looking risk assessments that get quickly understood by both senior managers and first responders alike!
Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.
Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the feedback of a patient safety culture assessment. Methods: Twenty four hospitals participated in a patient safety culture assessment in 2012. Hospital departments received feedback in a report and on a web...
Liang Chen; Yang Gong
Purpose: The current development of patient safety reporting systems is criticized for loss of information and low data quality due to the lack of a uniformed domain knowledge base and text processing functionality. To improve patient safety reporting, the present paper suggests an ontological representation of patient safety knowledge. Design/methodology/approach: We propose a framework for constructing an ontological knowledge base of patient safety. The present paper describes our desig...
Hanskamp-Sebregts, M.E.; Zegers, M.; Boeijen, W.M.J.; Westert, G.P.; Gurp, P.J.M. van; Wollersheim, H.C.
BACKGROUND: Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little i...
The objectives of the Tank Waste Remediation System (TWRS) Safety and Technical Integration (STI) programmatic risk management program are to assess, analyze, and handle risks associated with TWRS STI responsibilities and to communicate information about the actions being taken and the results to enable decision making. The objective of this TWRS STI Risk Management Plan is to communicate a consistent approach to risk management that will be used by the organization
... Organizations: Voluntary Delisting From Community Medical Foundation for Patient Safety AGENCY: Agency for... Medical Foundation for Patient Safety, of its status as a Patient Safety Organization (PSO). The Patient... notification from Community Medical Foundation for Patient Safety, PSO number P0029, to voluntarily relinquish...
Carrasco-Sánchez, F J; Ostos-Ruiz, A I; Soto-Martín, M
Heart failure (HF) and diabetes mellitus are 2 clinical conditions that often coexist, particularly in patients older than 65 years. Diabetes mellitus promotes the development of HF and confers a poorer prognosis. Hypoglycaemic agents (either by their mechanism of action, hypoglycaemic action or adverse effects) can be potentially dangerous for patients with HF. In this study, we performed a review of the available evidence on the safety of diabetes drugs in HF, focused on the main observational and experimental studies. Recent studies on cardiovascular safety have evaluated, although as a secondary objective, the impact of new hypoglycaemic agents on HF, helping us understand the neutrality, risks and potential benefits of these agents. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.
... Organizations: Voluntary delisting AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS ACTION: Notice... Patient Safety Corporation of its status as a Patient Safety Organization (PSO). The Patient Safety and... the listing of PSOs, which are entities or component organizations whose mission and primary activity...
Aven, T.; Ylönen, M.
The current safety regulations for industrial activities are to a large extent functionally oriented and risk-based (informed), expressing what to achieve rather than the means and solutions needed. They are founded on a probability-based perspective on risk, with the use of risk assessment, risk acceptance criteria and tolerability limits. In recent years several risk researchers have argued for the adoption of some new types of risk perspectives which highlight uncertainties rather than probabilities in the way risk is defined, the point being to better reflect the knowledge, and lack of knowledge, dimension of risk. The Norwegian Petroleum Safety Authority has recently implemented such a perspective. The new ISO standard 31000 is based on a similar thinking. In this paper we discuss the implications of these perspectives on safety regulation, using the oil & gas and nuclear industries as illustrations. Several suggestions for how to develop the current safety regulations in line with the ideas of the new risk perspectives are outlined, including some related to the use of risk acceptance criteria (tolerability limits). We also point to potential obstacles and incentives that the larger societal and institutional setting may impose on industry as regards the adoption of the new risk perspectives. - Highlights: • Some new types of risk perspectives have been promoted. • They have been implemented for example by the Norwegian Petroleum Safety Authority. • The paper studies the implication of these perspectives on the risk regulation. • Suggestions for how to develop the regulations are provided • Obstacles and incentives for the implementation of the perspectives are pointed to.
Shafiq, Jesmin; Barton, Michael; Noble, Douglas; Lemer, Claire; Donaldson, Liam J.
Errors from radiotherapy machine or software malfunction usually are well documented as they affect hundreds of patients, whereas random errors affecting individual patients are more difficult to be discovered and prevented. Although major clinical radiotherapy incidents have been reported, many more have remained unrecognised or have not been reported. The literature in this field is limited as it is mostly published as a result of investigation of major errors. We present a review of radiotherapy incidents internationally with the aim of identifying the domains where most errors occur through extensive review and synthesis of published reports, unpublished 'Grey literature' and departmental incident data. Our review of radiotherapy-related events in the last three decades (1976-2007) identified more than seven thousand (N = 7741) incidents and near misses. Three thousand one hundred and twenty-five incidents reported patient harm of variable intensity ranging from underdose increasing the risk of recurrence, to overdose causing toxicity, and even death for 1% (N = 38); 4616 events were near misses with no recognisable patient harm. Based on our review, a radiotherapy risk profile has been published by the WHO World Alliance for Patient Safety that highlights the role of communication, training and strict adherence to guidelines/protocols in improving the safety of radiotherapy process.
Niall, R.; Hunt, M.; Wierman, T.E.
To ensure that the design and operation of both nuclear and non- nuclear hazardous facilities is acceptable, and meets all societal safety expectations, a rigorous deterministic and probabilistic assessment is necessary. An approach is introduced, founded on the concept of an ''Integrated Safety Assessment.'' It merges the commonly performed safety and risk analyses and uses them in concert to provide decision makers with the necessary depth of understanding to achieve ''adequacy.'' 3 refs., 1 fig
Estimates range from 65-90 percent of catastrophic mishaps are due to human error. NASA's human factors-related mishaps causes are estimated at approximately 75 percent. As much as we'd like to error-proof our work environment, even the most automated and complex technical endeavors require human interaction... and are vulnerable to human frailty. Industry and government are focusing not only on human factors integration into hazardous work environments, but also looking for practical approaches to cultivating a strong Safety Culture that diminishes risk. Industry and government organizations have recognized the value of monitoring leading indicators to identify potential risk vulnerabilities. NASA has adapted this approach to assess risk controls associated with hazardous, critical, and complex facilities. NASA's facility risk assessments integrate commercial loss control, OSHA (Occupational Safety and Health Administration) Process Safety, API (American Petroleum Institute) Performance Indicator Standard, and NASA Operational Readiness Inspection concepts to identify risk control vulnerabilities.
This paper presents a method of standardizing safety-system reliability on an entirely new basis: all hypothetical accidents are approximated as groups, for each of which one proposes permissible frequencies on the basis of the risk concept. In this risk concept, the ''average person'' is a person living near a nuclear station or working in it, who is of average age, average state of health, and so on. Therefore, the risk can be found by summing the estimated individual risks for a particular group in the population followed by division by the number of people in that group. Basic assumptions in deriving permissible safety-system reliability are presented. Estimated permissible failure probabilities are given to illustrate the proposed method and to refine the initial data. The probabilities may also be used to lay down the reliability requirements for safety systems in particular nuclear stations on the risk basis
Gibbs, S.J.; Pujol, A. Jr.; Chen, T.S.; Malcolm, A.W.; James, A.E. Jr.
Computer simulation methods for determining patient dose from dental radiography have demonstrated that patient risk from a two-film interproximal examination ranges from 1.1 X 10(-8) to 3.4 X 10(-7) using 90-kVp beams, depending on film speed, projection technique, and age and sex of the patient. Further, changing from a short-cone round-beam to a long-cone technique with rectangular collimation reduces risk by a factor of 2.9, independent of other factors
Abdi, Zhaleh; Ravaghi, Hamid; Abbasi, Mohsen; Delgoshaei, Bahram; Esfandiari, Somayeh
Purpose - The purpose of this paper is to apply Bow-tie methodology, a proactive risk assessment technique based on systemic approach, for prospective analysis of the risks threatening patient safety in intensive care unit (ICU). Design/methodology/approach - Bow-tie methodology was used to manage clinical risks threatening patient safety by a multidisciplinary team in the ICU. The Bow-tie analysis was conducted on incidents related to high-alert medications, ventilator associated pneumonia, catheter-related blood stream infection, urinary tract infection, and unwanted extubation. Findings - In total, 48 potential adverse events were analysed. The causal factors were identified and classified into relevant categories. The number and effectiveness of existing preventive and protective barriers were examined for each potential adverse event. The adverse events were evaluated according to the risk criteria and a set of interventions were proposed with the aim of improving the existing barriers or implementing new barriers. A number of recommendations were implemented in the ICU, while considering their feasibility. Originality/value - The application of Bow-tie methodology led to practical recommendations to eliminate or control the hazards identified. It also contributed to better understanding of hazard prevention and protection required for safe operations in clinical settings.
Mrowca, B.; Eltawila, F.
Safety-security interface is a term that is used as part of the commercial nuclear power security framework to promote coordination of the many potentially adverse interactions between plant security and plant safety. Its object is to prevent the compromise of either. It is also used to describe the concept of building security into a plant's design similar to the long standing practices used for safety therefore reducing the complexity of the operational security while maintaining or enhancing overall security. With this in mind, the concept of safety-security interface, when fully implemented, can influence a plant's design, operation and maintenance. It brings the approach use for plant security to one that is similar to that used for safety. Also, as with safety, the application of risk-informed techniques to fully implement and integrate safety and security is important. Just as designers and operators have applied these techniques to enhance and focus safety, these same techniques can be applied to security to not only enhance and focus the security but also to aid in the implementation of effective techniques to address the safety-security interfaces. Implementing this safety-security concept early within the design process can prevent or reduce security vulnerabilities through low cost solutions that often become difficult and expensive to retrofit later in the design and/or post construction period. These security considerations address many of the same issues as safety in ensuring that the response of equipment and plant personnel are adequate. That is, both safety and security are focused on reaching safe shutdown and preventing radiological release. However, the initiation of challenges and the progression of actions in response these challenges and even the definitions of safe shutdown can be considerably different. This paper explores the techniques and limitations that are employed to fully implement a risk-informed, safety-security interface
Schwappach, David L B; Meyer Massetti, Carla; Gehring, Katrin
Foreign-language (FL) patients are at increased risk for adverse drug events. Evidence regarding communication barriers and the safety of pharmaceutical care of FL patients in European countries is scarce despite large migrant populations. To investigate Swiss public pharmacists' experiences and current practices in counselling FL patients with a focus on patient safety. In a cross-sectional study heads of public pharmacies in Switzerland were surveyed using an electronic questionnaire. The survey assessed the frequency of communication barriers encountered in medication counselling of FL patients, perceptions of risks for adverse drug events, satisfaction with the quality of counselling provided to FL patients, current strategies to reduce risks, and preferences towards tools to improve safety for FL patients. 498 pharmacists completed the survey (43 % response rate). More than every second pharmacist reported at least weekly encounters at which they cannot provide good medication counselling to FL patients in the regional Swiss language. Ad-hoc interpreting by minors is also common at a considerable number of pharmacies (26.5 % reported at least one weekly occurrence). Approximately 10 % of pharmacies reported that they fail at least weekly to explain the essentials of drug therapy (e.g. dosing of children's medications) to FL patients. 79.8 % perceived the risk of FL patients for adverse drug events to be somewhat or much higher compared to other patients. 22.5 % of pharmacists reported being concerned at least monthly about medication safety when FL patients leave their pharmacy. However, the majority of pharmacists were satisfied with the quality of care provided to FL patients in their pharmacy [78.6 % (very) satisfied]. The main strategy used to improve counselling for FL patients was the employment of multilingual staff. Participants would use software for printing foreign-language labels (41.2 %) and multilingual package inserts (42.0 %) if these were
Dodds, Mark A.; Bochicchio, Kristi Schoepfer
The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.
Ramanujam, Rangaraj; Abrahamson, Kathleen; Anderson, James G
Patient safety is an ongoing challenge in the design and delivery of health-care services. As registered nurses play an integral role in patient safety, further examination of the link between nursing work and patient safety is warranted. The present study examines the relationship between nurses' perceptions of job demands and nurses' perceptions of patient safety. Structural equation modeling is used to analyze the data collected from a survey of 430 registered nurses at two community hospitals in the USA. As hypothesized, nurses' perception of patient safety decreases as the job demands increase. The level of personal control over practice directly affects nurses' perception of the ability to assure patient well-being. Nurses who work full-time and are highly educated have a decreased perception of patient safety, as well. The significant relationship between job demands and patient safety confirms that nurses make a connection between their working conditions and the ability to deliver safe care.
de Feijter, Jeantine M.; de Grave, Willem S.; Dornan, Tim; Koopmans, Richard P.; Scherpbier, Albert J. J. A.
Evidence that medical error can cause harm to patients has raised the attention of the health care community towards patient safety and influenced how and what medical students learn about it. Patient safety is best taught when students are participating in clinical practice where they actually encounter patients at risk. This type of learning is…
Full Text Available Medication error has been identified as a major factor affecting patient safety. Many innovative efforts such as Computerised Physician Order Entry (CPOE, a Pharmacy Information System, automated dispensing machines and Point of Administration Systems have been carried out with the aim of improving medication safety. However, areas remain that require urgent attention. One main area will be the lack of continuity of care due to the breakdown of communication between multiple healthcare providers. Solutions may include consideration of “health smart cards” that carry vital patient medical information in the form of a “credit card” or use of the Malaysian identification card. However, costs and technical aspects associated with the implementation of this health smart card will be a significant barrier. Security and confidentiality, on the other hand, are expected to be of primary concern to patients. Challenges associated with the implementation of a health smart card might include physician buy-in for use in his or her everyday practice. Training and technical support should also be available to ensure the smooth implementation of this system. Despite these challenges, implementation of a health smart card moves us closer to seamless care in our country, thereby increasing the productivity and quality of healthcare.
Sellappans, Renukha; Chua, Siew Siang; Tajuddin, Nur Amani Ahmad; Mei Lai, Pauline Siew
Medication error has been identified as a major factor affecting patient safety. Many innovative efforts such as Computerised Physician Order Entry (CPOE), a Pharmacy Information System, automated dispensing machines and Point of Administration Systems have been carried out with the aim of improving medication safety. However, areas remain that require urgent attention. One main area will be the lack of continuity of care due to the breakdown of communication between multiple healthcare providers. Solutions may include consideration of "health smart cards" that carry vital patient medical information in the form of a "credit card" or use of the Malaysian identification card. However, costs and technical aspects associated with the implementation of this health smart card will be a significant barrier. Security and confidentiality, on the other hand, are expected to be of primary concern to patients. Challenges associated with the implementation of a health smart card might include physician buy-in for use in his or her everyday practice. Training and technical support should also be available to ensure the smooth implementation of this system. Despite these challenges, implementation of a health smart card moves us closer to seamless care in our country, thereby increasing the productivity and quality of healthcare.
Nielsen, N.M.; Hartford, D.N.D.; MacDonald, T.F.
Risk assessment has received increasing attention in recent years as a means of aiding decision making on dams by providing systematic and rational methods for dealing with risk and uncertainty. Risk assessment is controversial and decisions affecting risk to life are the most controversial. Tolerable criteria, based on the risks that society is prepared to accept in order to avoid excessive costs, set bounds within which risk-based decisions may be made. The components of risk associated with dam safety are addressed on an individual basis and criteria established for each component, thereby permitting flexibility in the balance between component risk and avoiding the problems of placing a monetary value on life. The guiding principle of individual risk is that dams do not impose intolerable risks on any individual. A risk to life of 1 in 10 4 per annum is generally considered the maximum tolerable risk. When considering societal risk, the safety of a dam should be proportional to the consequences of its failure. Risks of financial losses beyond the corporation's ability to finance should be so low as to be considered negligible. 17 refs., 3 figs
Lee, John C; McCormick, Norman J
.... The first half of the book covers the principles of risk analysis, the techniques used to develop and update a reliability data base, the reliability of multi-component systems, Markov methods used...
Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial.
Sabatine, Marc S; Leiter, Lawrence A; Wiviott, Stephen D; Giugliano, Robert P; Deedwania, Prakash; De Ferrari, Gaetano M; Murphy, Sabina A; Kuder, Julia F; Gouni-Berthold, Ioanna; Lewis, Basil S; Handelsman, Yehuda; Pineda, Armando Lira; Honarpour, Narimon; Keech, Anthony C; Sever, Peter S; Pedersen, Terje R
The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes. FOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2·2 years. In this prespecified analysis, we investigated the effect of evolocumab on cardiovascular events by diabetes status at baseline, defined on the basis of patient history, clinical events committee review of medical records, or baseline HbA 1c of 6·5% (48 mmol/mol) or greater or fasting plasma glucose (FPG) of 7·0 mmol/L or greater. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospital admission for unstable angina, or coronary revascularisation. The key secondary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. We also assessed the effect of evolocumab on glycaemia, and on the risk of new-onset diabetes among patients without diabetes at baseline. HbA 1c was measured at baseline then every 24 weeks and FPG was measured at baseline, week 12, week 24, and every 24 weeks thereafter, and potential cases of new-onset diabetes were adjudicated centrally. In a post-hoc analysis, we also investigated the effects on glycaemia and diabetes risk in patients with prediabetes (HbA 1c 5·7-6·4% [39-46 mmol/mol] or FPG 5·6-6·9 mmol/L) at baseline. FOURIER is registered with ClinicalTrials.gov, number NCT01764633. At study baseline, 11 031 patients (40%) had diabetes and 16 533 (60%) did not have diabetes (of whom 10 344 had prediabetes and 6189 had normoglycaemia). Evolocumab significantly reduced cardiovascular outcomes
Ruud, Stian [Section for Control Systems, DNV Maritime, 1322 Hovik (Norway)], E-mail: Stian.Ruud@dnv.com; Mikkelsen, Age [Section for Lifting Appliances, DNV Maritime, 1322 Hovik (Norway)], E-mail: Age.Mikkelsen@dnv.com
The International Maritime Organisation (IMO) has recommended a method called formal safety assessment (FSA) for future development of rules and regulations. The FSA method has been applied in a pilot research project for development of risk-based rules and functional requirements for systems and components for offshore crane systems. This paper reports some developments in the project. A method for estimating target reliability for the risk-control options (safety functions) by means of the cost/benefit decision criterion has been developed in the project and is presented in this paper. Finally, a structure for risk-based rules is proposed and presented.
Ruud, Stian; Mikkelsen, Age
The International Maritime Organisation (IMO) has recommended a method called formal safety assessment (FSA) for future development of rules and regulations. The FSA method has been applied in a pilot research project for development of risk-based rules and functional requirements for systems and components for offshore crane systems. This paper reports some developments in the project. A method for estimating target reliability for the risk-control options (safety functions) by means of the cost/benefit decision criterion has been developed in the project and is presented in this paper. Finally, a structure for risk-based rules is proposed and presented
Ginsburg, Liane; Gilin, Debra; Tregunno, Deborah; Norton, Peter G; Flemons, Ward; Fleming, Mark
Objective To examine the psychometric and unit of analysis/strength of culture issues in patient safety culture (PSC) measurement. Data Source Two cross-sectional surveys of health care staff in 10 Canadian health care organizations totaling 11,586 respondents. Study Design A cross-validation study of a measure of PSC using survey data gathered using the Modified Stanford PSC survey (MSI-2005 and MSI-2006); a within-group agreement analysis of MSI-2006 data. Extraction Methods Exploratory factor analyses (EFA) of the MSI-05 survey data and confirmatory factor analysis (CFA) of the MSI-06 survey data; Rwg coefficients of homogeneity were calculated for 37 units and six organizations in the MSI-06 data set to examine within-group agreement. Principal Findings The CFA did not yield acceptable levels of fit. EFA and reliability analysis of MSI-06 data suggest two reliable dimensions of PSC: Organization leadership for safety (α=0.88) and Unit leadership for safety (α=0.81). Within-group agreement analysis shows stronger within-unit agreement than within-organization agreement on assessed PSC dimensions. Conclusions The field of PSC measurement has not been able to meet strict requirements for sound measurement using conventional approaches of CFA. Additional work is needed to identify and soundly measure key dimensions of PSC. The field would also benefit from further attention to strength of culture/unit of analysis issues. PMID:18823446
Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.
Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.
Full Text Available Country risk, sustainability an economic safety are becoming more important in the contemporary economic world. The aim of this paper is to present the importance of comparison formalisation of country risk, sustainability, and economic safety indices for strategic alignment. The work provides an analysis on the relationship between country risk, sustainability an economic safety in EU countries, based on statistical data. Investigations and calculations of rankings provided by Euromoney Country Risk Index, European Economic Sustainability Index as well as for Economic Security Index were made and the results of EU country ranking based on three criteria were provided. Furthermore, the data for the Baltic States was summarised and the corresponding index of consistency for random judgments was evaluated.
Ewing, D.J.F.; Campbell, J.F.
This paper gives a regulatory view of probabilistic safety assessment as seen by the Nuclear Installations Inspectorate (NII) and in the light of the general regulatory risk aims set out in the Health and Safety Executive's (HSE) The tolerability of risk from nuclear power stations (TOR) and in Safety assessment principles for nuclear plants (SAPs), prepared by NII on behalf of the HSE. Both of these publications were revised and republished in 1992. This paper describes the SAPs, together with the historical background, the motivation for review, the effects of the Sizewell and Hinkley Point C public inquiries, changes since the original versions, comparison with international standards and use in assessment. For new plant, probabilistic safety analysis (PSA) is seen as an essential tool in balancing the safety of the design and in demonstrating compliance with TOR and the SAPs. (Author)
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From the Coalition for Quality and Patient Safety of Chicagoland (CQPS.... SUMMARY: The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41,42...
Cooper, Andrew J P; Lettis, Sally; Chapman, Charlotte L; Evans, Stephen J W; Waller, Patrick C; Shakir, Saad; Payvandi, Nassrin; Murray, Alison B
Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data.
Gilkey, Melissa B; Earp, Jo Anne L; French, Elizabeth A
Program planning for patient safety is challenging because intervention-oriented surveillance data are not yet widely available to those working in this nascent field. Even so, health educators are uniquely positioned to contribute to patient safety intervention efforts because their theoretical training provides them with a guide for designing and implementing prevention programs. This article demonstrates the utility of applying health education concepts from three prominent patient safety campaigns, including the concepts of risk perception, community participation, and social marketing. The application of these theoretical concepts to patient safety programs suggests that health educators possess a knowledge base and skill set highly relevant to patient safety and that their perspective should be increasingly brought to bear on the design and evaluation of interventions that aim to protect patients from preventable medical error.
Thomas, Kali S.; Hyer, Kathryn; Castle, Nicholas G.; Branch, Laurence G.; Andel, Ross; Weech-Maldonado, Robert
Purpose of the study: Studies have shown that patient safety culture (PSC) is poorly developed in nursing homes (NHs), and, therefore, residents of NHs may be at risk of harm. Using Donabedian's Structure-Process-Outcome (SPO) model, we examined the relationships among top management's ratings of NH PSC, a process of care, and safety outcomes.…
Tien, Duc A; Woodson, Erika A; Anne, Samantha
The outcomes of 2 patients with cochlear implants (CIs) who underwent adenotonsillectomy (AT) with inadvertent use of monopolar cautery are presented. The safety data regarding monopolar cautery use in CI recipients is also reviewed. This is a retrospective case series of 2 CI recipients that underwent AT with monopolar cautery and literature review of electrocautery safety in the setting of CI. Two patients with CIs underwent AT with use of monopolar cautery inadvertently by surgeons that do not routinely perform cochlear implants as part of his or her clinical practice. Patient 1 was a 9-year-old female who had AT for obstructive sleep apnea (OSA) after undergoing unilateral CI for profound congenital sensorineural hearing loss (SNHL) 8 years ago. Patient 2 was a 7-year-old female who underwent AT for OSA 4 months after undergoing unilateral CI for congenital SNHL. Both patients had no immediate signs of complications with their CI use postoperatively. Both patients demonstrated unchanged postoperative neural response telemetry and behavioral audiometric testing. Patient 1 continues to have no CI-related complications 3.5 years after the procedure. Patient 2 has been followed for at least 3 months by audiometric testing and 10 months by otolaryngologist with no CI-related complications. Although animal and cadaveric studies suggest that monopolar cautery may be safely used in patients with cochlear implants, there have been no in vivo human studies that have evaluated the risk to the patient or implant. This is a report of a small, unintended experience with 2 patients, both of whom exhibit no complications or changes to CI function thus far. © The Author(s) 2016.
Heuser, F.W.; Hoertner, H.; Kersting, E.
The most important results of the technical system investigations for Phase B of the German Risk Study and the insight gained from them are discussed in connection with the risk analyses in judging the safety-related design. The results of the German Precursor Study for the Biblis A and B plants are given. There is also a comparison of the German with more recent American risk analyses. (DG) [de
Das, B.K.; Noreen Norfaraheen Lee Abdullah
The objective of this chapter is to acquaint the reader with radiation safety measures which can be pursued to minimize radiation load to the patient and staff. The basic principle is that all unnecessary administration should be avoided and a number of simple techniques be used to reduce radiation dose. For example, the kidney excretes many radionuclides. Drinking plenty of fluid and frequent bladder emptying can minimize absorbed dose to the bladder. Thyroid blocking agents must be used if radioactive iodine is being administered to avoid unnecessary radiation exposure to the thyroid gland. When it is necessary to administer radioactive substances to a female of childbearing age, the radiation exposure should be minimum and information whether the patient is pregnant or not must be obtained. Alternatives techniques, which do not involve ionizing radiation, should also be considered. (author)
Risk-Based techniques have been developed for commercial nuclear power plants for the last eight years by a team working through the ASME Center for Research and Technology Development (CRTD). System boundaries and success criteria is defined using the Probabilistic Risk Analysis or Probabilistic Safety Analysis developed to meet the Individual Plant Evaluation. Final ranking of components is by a plant expert panel similar to the one developed for the Maintenance Rule. Components are identified as being high risk-significant or low risk-significant. Maintenance and resources are focused on those components that have the highest risk-significance. The techniques have been developed and applied at a number of plants. Results from the first risk-based inspection pilot plant indicates safety due to pipe failure can be doubled while the inspection reduced to about 80% when compared with current inspection programs. Pilot studies on risk-based testing indicate that about 60% of pumps and 25 to 30% of valves in plants are high safety-significant The reduction in inspection and testing reduces the person-rem exposure and resulting in further increases in safety. These techniques have been documented in publications by the ASME CRTD which are referenced. (author)
Lee, John C
The book has been developed in conjunction with NERS 462, a course offered every year to seniors and graduate students in the University of Michigan NERS program. The first half of the book covers the principles of risk analysis, the techniques used to develop and update a reliability data base, the reliability of multi-component systems, Markov methods used to analyze the unavailability of systems with repairs, fault trees and event trees used in probabilistic risk assessments (PRAs), and failure modes of systems. All of this material is general enough that it could be used in non-nuclear a
Recent studies indicate again that there is a deficit in the use of electronic health records (EHR) in German hospitals. Despite good arguments in favour of their use, such as the rapid availability of data, German hospitals shy away from a wider implementation. The reason is the high cost of installing and maintaining the EHRs, for the benefit is difficult to evaluate in monetary terms for the hospital. Even if a benefit can be shown it is not necessarily evident within the hospital, but manifests itself only in the health system outside. Many hospitals only manage to partly implement EHR resulting in increased documentation requirements which reverse their positive effect.In the United States, electronic medical records are also viewed in light of their positive impact on patient safety. In particular, electronic medication systems prove the benefits they can provide in the context of patient safety. As a result, financing systems have been created to promote the digitalisation of hospitals in the United States. This has led to a large increase in the use of IT systems in the United States in recent years. The Universitätsklinikum Eppendorf (UKE) introduced electronic patient records in 2009. The benefits, in particular as regards patient safety, are numerous and there are many examples to illustrate this position. These positive results are intended to demonstrate the important role EHR play in hospitals. A financing system of the ailing IT landscape based on the American model is urgently needed to benefit-especially in terms of patient safety-from electronic medical records in the hospital.
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Safeguards for patient safety. 312.88 Section 312... Severely-debilitating Illnesses § 312.88 Safeguards for patient safety. All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing...
Developing an effective communication strategy about different food hazards depends not only on technical risk assessments (for example related to health or the environment) but must also take into account consumer perceptions and preferences. In addition, consumers make decisions about food choices
Review of the assumptions underlying the use of limit lines in nuclear regulation and risk comparisons led to an alternative approach, where frequency-consequence curves are divided into two components: number of accidents during a specified time period and consequences conditional upon the occurrence of an unwanted event. This approach leads to a neat separation between natural and technological disasters. To compare probability distributions when stochastic dominance principles are not applicable, risk indices based on a linearized moments model (LMM) were established. The LMM permits explicit introduction of individual, societal or group opinions, thus incorporating the various perceptions of risks by society directly into the evaluation process. A questionnaire was applied to elicit empirical data which were then compared with the predictions of the linearized moments model. Furthermore the LMM also allows the comparison of events in those cases where the cumulative probability distributions cross each other. For the evaluation of a probability distribution that crosses the limit line, the risk index of the limit line (calculated by using the LMM) should be compared to the index of the accident under consideration
Slemon, Allie; Jenkins, Emily; Bungay, Vicky
The discourse of safety has informed the care of individuals with mental illness through institutionalization and into modern psychiatric nursing practices. Confinement arose from safety: out of both societal stigma and fear for public safety, as well as benevolently paternalistic aims to protect individuals from self-harm. In this paper, we argue that within current psychiatric inpatient environments, safety is maintained as the predominant value, and risk management is the cornerstone of nursing care. Practices that accord with this value are legitimized and perpetuated through the safety discourse, despite evidence refuting their efficacy, and patient perspectives demonstrating harm. To illustrate this growing concern in mental health nursing care, we provide four exemplars of risk management strategies utilized in psychiatric inpatient settings: close observations, seclusion, door locking and defensive nursing practice. The use of these strategies demonstrates the necessity to shift perspectives on safety and risk in nursing care. We suggest that to re-centre meaningful support and treatment of clients, nurses should provide individualized, flexible care that incorporates safety measures while also fundamentally re-evaluating the risk management culture that gives rise to and legitimizes harmful practices. © 2017 The Authors Nursing Inquiry published by John Wiley & Sons Ltd.
Views are expressed on the use of quantitative techniques for the determination of value judgements in nuclear safety assessments, hazard evaluation, and risk prediction. Caution is urged when attempts are made to quantify value judgements in the field of nuclear safety. Criteria are given the meaningful application of reliability methods but doubts are expressed about their application to safety analysis, risk prediction and design guidances for experimental or prototype plant. Doubts are also expressed about some concomitant methods of population dose evaluation. The complexities of new designs of nuclear power plants make the problem of safety assessment more difficult but some possible approaches are suggested as alternatives to the quantitative techniques criticized. (U.K.)
McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R
Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.
Wallis, Katharine Ann
New Zealand's treatment injury compensation claims data set provides an uncommon no-fault perspective of patient safety incidents. Analysis of primary care claims data confirmed medication as the leading threat to the safety of older patients in primary care and drew particular attention to the threat posed by antibiotics. For most injuries there was no suggestion of error. The no-fault perspective reveals the greatest threat to the safety of older patients in primary care to be, not error, but the risk posed by treatment itself. To improve patients' safety, in addition to reducing error, clinicians need to reduce patients' exposure to treatment risk, where appropriate. © 2015 Annals of Family Medicine, Inc.
Lovink, Marleen H; Kars, Marijke C; de Man-van Ginkel, Janneke M; Schoonhoven, Lisette
AIM: To explore the experiences of safety of adult patients during their haemodialysis treatment. BACKGROUND: Haemodialysis is a complex treatment with a risk for harm that causes anxiety among many patients. To date, no in-depth study of haemodialysis patients' emotional responses to conditions of
Dahlke, Sherry; Hall, Wendy A; Baumbusch, Jennifer
The aim of this secondary qualitative descriptive analysis was to examine how nurses construct a definition of older peoples' safety risks and provide care while working within organisational contexts that are focused on diminishing patient risks. Numbers of older patients are increasing in acute hospital contexts-contexts that place their focus on patient safety. Nurses need to manage tensions between older peoples' risks, evidence-informed practice decisions, limited resources and organisational emphases on patient falls. To date, their practice dilemmas have not been well examined. A secondary qualitative descriptive analysis was conducted using data that were collected between June 2010 and May 2011 to examine nursing practice with hospitalised older people. All field notes and transcribed data were reviewed to generate themes representing 18 Registered Nurses' perceptions about safe care for hospitalised older people. The first author generated categories that described how nurses construct definitions of safety risks for older people. All authors engaged in an iterative analytic process that resulted in themes capturing nurses' efforts to provide care in limited resource environments while considering older peoples' safety risks. Nurses constructed definitions of patient safety risks in the context of institutional directives. Nurses provided care using available resources as efficiently as possible and accessing co-worker support. They also minimised the importance of older people's functional abilities by setting priorities for medically delegated tasks and immobilising their patients to reduce their risks. Nurses' definitions of patient risk, which were shaped by impoverished institutional resources and nurses' lack of valuing of functional abilities, contributed to suboptimal care for older adults. Nurses' definitions of risk as physical injury reduced their attention to patients' functional abilities, which nurses reported suffered declines as a result
This paper shows the output of the software package HySTAR, the Hydrogen Safety, Training and Risk Workplace. This is the software output of the CTFA, Canadian Hydrogen Safety Program projects. It shows the Hydrogen Virtual Interactive Expert Workplace, a guide for permitting and code enforcement for officials and other parties involved in approving hydrogen energy facilities. It also shows the Hydrogen Codes and Standards Report (Site Level) as well as Hydrogen Distances and Clearances Report
Ilizastigui Pérez, F.
The Safety Report (SR) plays a crucial role within the nuclear licensing regime as the principal means for demonstrating the adequacy of safety analysis for a nuclear facility to ensure that it can be constructed, operated, maintained, shut down, and decommissioned safely and in compliance with applicable laws and regulations. It serves as the basis for granting authorizations for the commencement of the main stages of the facility’s life cycle as well as decision-making processes related to safety. Historically, the majority of nuclear safety reports have operated under rather prescriptive regimes, with emphasis placed on demonstrations of the robustness of the facility’s design (design safety) against prescriptive technical requirements set by the regulatory body, and less attention paid to demonstrating the adequacy and effectiveness of Operator’s management system for managing risks to daily operation.
Galt, Kimberly A; Fuji, Kevin T; Faber, Jennifer
To implement a communication network for safety problem identification and solution sharing among rural community pharmacists and to report participating pharmacists' perceived value and impact of the network on patient safety after 1 year of implementation. Action research study. Rural community pharmacies in Nebraska from January 2010 to April 2011. Rural community pharmacists who voluntarily agreed to join the Pharmacists for Patient Safety Network in Nebraska. Pharmacists reported errors, near misses, and safety concerns through Web-based event reporting. A rapid feedback process was used to provide patient safety solutions to consider implementing across the network. Qualitative interviews were conducted 1 year after program implementation with participating pharmacists to assess use of the reporting system, value of the disseminated safety solutions, and perceived impact on patient safety in pharmacies. 30 of 38 pharmacists participating in the project completed the interviews. The communication network improved pharmacist awareness, promoted open discussion and knowledge sharing, contributed to practice vigilance, and led to incorporation of proactive safety prevention practices. Despite low participation in error and near-miss reporting, a dynamic communication network designed to rapidly disseminate evidence-based patient safety strategies to reduce risk was valued and effective at improving patient safety practices in rural community pharmacies.
This paper discusses the concept of risk as understood in the UK, with particular reference to the use of probabilistic safety assessment (PSA) in nuclear safety decision making. The way 'risk' appears in UK fundamental legislation means that the concept cannot be limited to evaluation of numerical probabilities of physical harm. Rather the focus is on doing all that is reasonably practicable to reduce risks: this entails applying relevant good practice and then seeking further safety measures until the money, time and trouble required are grossly disproportionate to the residual risk. PSA is used to inform rather than dictate such decisions. This approach is reinforced by considering how far any practical PSA can be said to measure risk. The behaviour of complex socio-technical systems such as nuclear power stations does not meet the conditions under which probability theory can be applied in an absolutely objective statistical sense. Risk is not an intrinsic real property of such systems. Rather PSA is a synthesis of data and subjective expert judgements, dependent on the extent of detailed knowledge of the plant. There are many other aspects of engineering judgement involved in safety decisions which cannot be so captured. (author)
Drummond, M F; Shannon, H S
This paper considers how the economic aspects of risk assessment in chemical safety can be strengthened. Its main focus is on how economic appraisal techniques, such as cost-benefit and cost-effectiveness analysis, can be adapted to the requirements of the risk-assessment process. Following a discussion of the main methodological issues raised by the use of economic appraisal, illustrated by examples from the health and safety field, a number of practical issues are discussed. These include the consideration of the distribution of costs, effects and benefits, taking account of uncertainty, risk probabilities and public perception, making the appraisal techniques useful to the early stages of the risk-assessment process and structuring the appraisal to permit continuous feedback to the participants in the risk-assessment process. It is concluded that while the way of thinking embodied in economic appraisal is highly relevant to the consideration of choices in chemical safety, the application of these principles in formal analysis of risk reduction procedures presents a more mixed picture. The main suggestions for improvement in the analyses performed are the undertaking of sensitivity analyses of study results to changes in the key assumptions, the presentation of the distribution of costs and benefits by viewpoint, the comparison of health and safety measures in terms of their incremental cost per life-year (or quality-adjusted life-year) gained and the more frequent retrospective review and revision of the economic analyses that are undertaken.
In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.
Veser, Anke; Schlueter, Franz-Hermann; Raskob, Wolfgang; Landman, Claudia; Paesler-Sauer, Juergen; Kessler, Guenter
The book on the safety of light-water reactors includes the following chapters: Part I: Physical and technical safety concept of actual German and future European light-water reactors: (1) Worldwide operated nuclear power plants in 2011, (2) Some reactor physical fundamentals. (3) Nuclear power plants in Germany. (4) Radioactive exposure due to nuclear power plants. (5) Safety concept of light-water reactors. (6) Probabilistic analyses and risk studies. (7) Design of light-water reactors against external incidents. (8) Risk comparison of nuclear power plants and other energy systems. (9) Evaluation of risk studies using the improved (new) safety concept for LWR. (19) The severe reactor accidents of Three Mile Island, Chernobyl and Fukushima. Part II: Safety of German LWR in case of a postulated aircraft impact. (11) Literature. (12) Review of requirements and actual design. (13) Incident scenarios. (14) Load approach for aircraft impact. (15) Demonstration of the structural behavior in case of aircraft impact. (16) Special considerations. (17) Evaluation of the safety state of German and foreign nuclear power plants. Part III: ROSOS as example for a computer-based decision making support system for the severe accident management. (19) Literature. (20) Radiological fundamentals, accident management, modeling of the radiological situation. (21) The decision making support system RODOS. (22) RODOS and the Fukushima accident. (23) Recent developments in the radiological emergency management in the European frame.
Risk patterns in drug safety study using relative times by accelerated failure time models when proportional hazards assumption is questionable : an illustrative case study of cancer risk of patients on glucose-lowering therapies
Ng, Edmond S-W; Klungel, Olaf H; Groenwold, Rolf H H; van Staa, Tjeerd-Pieter
Observational drug safety studies may be susceptible to confounding or protopathic bias. This bias may cause a spurious relationship between drug exposure and adverse side effect when none exists and may lead to unwarranted safety alerts. The spurious relationship may manifest itself through
Zhang, Limao; Wu, Xianguo; Skibniewski, Miroslaw J.; Zhong, Jingbing; Lu, Yujie
This paper presents a systemic decision support approach for safety risk analysis under uncertainty in tunnel construction. Fuzzy Bayesian Networks (FBN) is used to investigate causal relationships between tunnel-induced damage and its influential variables based upon the risk/hazard mechanism analysis. Aiming to overcome limitations on the current probability estimation, an expert confidence indicator is proposed to ensure the reliability of the surveyed data for fuzzy probability assessment of basic risk factors. A detailed fuzzy-based inference procedure is developed, which has a capacity of implementing deductive reasoning, sensitivity analysis and abductive reasoning. The “3σ criterion” is adopted to calculate the characteristic values of a triangular fuzzy number in the probability fuzzification process, and the α-weighted valuation method is adopted for defuzzification. The construction safety analysis progress is extended to the entire life cycle of risk-prone events, including the pre-accident, during-construction continuous and post-accident control. A typical hazard concerning the tunnel leakage in the construction of Wuhan Yangtze Metro Tunnel in China is presented as a case study, in order to verify the applicability of the proposed approach. The results demonstrate the feasibility of the proposed approach and its application potential. A comparison of advantages and disadvantages between FBN and fuzzy fault tree analysis (FFTA) as risk analysis tools is also conducted. The proposed approach can be used to provide guidelines for safety analysis and management in construction projects, and thus increase the likelihood of a successful project in a complex environment. - Highlights: • A systemic Bayesian network based approach for safety risk analysis is developed. • An expert confidence indicator for probability fuzzification is proposed. • Safety risk analysis progress is extended to entire life cycle of risk-prone events. • A typical
Brix, Gunnar; Nekolla, Elke A.; Nosske, Dietmar; Griebel, Juergen
The introduction of positron emission tomography (PET)/magnetic resonance (MR) systems into medical practice in the foreseeable future may not only lead to a gain in clinical diagnosis compared to PET/computed tomography (CT) imaging due to the superior soft-tissue contrast of the MR technology but can also substantially reduce exposure of patients to ionizing radiation. On the other hand, there are also risks and health effects associated with the use of diagnostic MR devices that have to be considered carefully. This review article summarizes biophysical and biological aspects, which are of relevance for the assessment of health effects related to the exposure of patients to both ionizing radiation in PET and magnetic and electromagnetic fields in MR. On this basis, some considerations concerning the justification and optimization of PET/MR examinations are presented - as far as this is possible at this very early stage. Current safety standards do not take into account synergistic effects of ionizing radiation and magnetic and electromagnetic fields. In the light of the developing PET/MR technology, there is an urgent need to investigate this aspect in more detail for exposure levels that will occur at PET/MR systems. (orig.)
Hypothyroidism is currently a condition that can be treated, but not cured. Although levothyroxine reverses stigmata of hypothyroidism in most individuals, some patients feel dissatisfied with 'monotherapy', and this has stimulated interest in 'combination therapy' with both levothyroxine and liothyronine. A search of PubMed was conducted using terms including hypothyroidism, treatment, benefits, risks, and safety. Based on the articles identified, the body of evidence regarding the efficacy of traditional levothyroxine is reviewed. Concerns with levothyroxine therapy including impaired quality of life in treated patients, thyroxine-predominant hormone ratios, and inadvertent iatrogenic thyroid disease are discussed. The trials of combination therapy performed since 1999 were reviewed. The heterogeneity of these trials, both in terms of design and results, is discussed. The potential for new trials to determine whether combination therapy can reverse the dissatisfaction associated with monotherapy, while avoiding non-physiologic hormone ratios, inadvertent thyrotoxicosis, and unacceptable side effects is discussed. Expert commentary: Research regarding which therapy fully reverses hypothyroidism at a tissue and cellular level is ongoing. The field would be advanced by the development of an extended release preparation of liothyronine. In the future regeneration of functional thyroid follicles from stem cells may offer hope for curing hypothyroidism.
Zhao, Yi-Meng; Wu, Li; Zhang, Shuo; Zhang, Li; Gao, Xue-Min; Sun, Xiao-Bo; Wang, Chun
In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and development of Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea and loose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation and judgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over
Analgesics--in particular when self-prescribed or taken over the long term--may have a negative effect on safety on the road. This applies not only to vehicle drivers, but also to cyclists and pedestrians. Psychotropic effects of analgesics of all three WHO categories play a major causal role. Impairments may take the form of sleepiness, impaired vision, giddiness, loss of muscular tone or cardiovascular reactions. On the other hand, untreated severe pain has a high risk potential, since it may reduce both cognitive and psychomotoric performance. During the stabilization phase or dose adjustment of opioids, the patient must cautioned not to drive, and particular care must be taken in patients on concomitant or long-term medication or drinking excessive alcohol. In the last resort, the prescription of an analgesic is an individual decision involving both physician and patient.
Lee, Yii-Ching; Wu, Hsin-Hung; Hsieh, Wan-Lin; Weng, Shao-Jen; Hsieh, Liang-Po; Huang, Chih-Hsuan
The Sexton et al.'s (2006) safety attitudes questionnaire (SAQ) has been widely used to assess staff's attitudes towards patient safety in healthcare organizations. However, to date there have been few studies that discuss the perceptions of patient safety both from hospital staff and upper management. The purpose of this paper is to improve and to develop better strategies regarding patient safety in healthcare organizations. The Chinese version of SAQ based on the Taiwan Joint Commission on Hospital Accreditation is used to evaluate the perceptions of hospital staff. The current study then lies in applying importance-performance analysis technique to identify the major strengths and weaknesses of the safety culture. The results show that teamwork climate, safety climate, job satisfaction, stress recognition and working conditions are major strengths and should be maintained in order to provide a better patient safety culture. On the contrary, perceptions of management and hospital handoffs and transitions are important weaknesses and should be improved immediately. Research limitations/implications - The research is restricted in generalizability. The assessment of hospital staff in patient safety culture is physicians and registered nurses. It would be interesting to further evaluate other staff's (e.g. technicians, pharmacists and others) opinions regarding patient safety culture in the hospital. Few studies have clearly evaluated the perceptions of healthcare organization management regarding patient safety culture. Healthcare managers enable to take more effective actions to improve the level of patient safety by investigating key characteristics (either strengths or weaknesses) that healthcare organizations should focus on.
Siti Masrochah; Yeti Kartikasari; Ardi Soesilo Wibowo
Radiographic examination of the thorax children aged 1-3 years have a high sufficiently failure. This failure is caused by the movement and difficulty positioning the patient, resulting in the risk of repeat radiographs to patient safety particularly unnecessary radiation risks. It is therefore necessary to develop research on children design fixation devices. This research aims to create a design tool fixation on radiographs children to support radiation safety and patient safety. This research is a descriptive exploratory approach to tool design. The independent variables were the design tools, variable tool function test results, and radiographic variables controlled thorax. The procedure is done by designing data collection tools, further trials with 20 samples. Processing and analysis of data is done by calculating the performance assessment tool scores with range 1-3. The results showed that the design tool of fixation in the form of standard radiographic cassette equipped with chairs and some form of seat belt fixation. The procedure uses a tool fixation is routine radiographic follow thorax child in an upright position. Function test results aids fixation is to have an average score of 2.66, which means good. While the test results for each component, the majority of respondents stated that the reliability of the device is quite good with a score of 2.45 (60 %), convenience tool with a score of 2.60 (70 %), quality of the radiographs did not incontinence of the thorax radiograph with a score 2.55 (85 %), the child protection (security) with a score of 2.70 (70 %), good design aesthetic design with a score of 2.80 (80 %), addition of radiation from the others on the use of these tools do not need with a score of 2.80 (80 %), and there is no additional radiation due to repetitions with a score of 2.85 (90 %). (author)
G. V. Celano
Full Text Available Toxoplasmosis, parasitic pathology supported by Toxoplasma gondii, is a typical example of multi-issue and inter-disciplinary on which, with equal intensity, converge the interests of various branches of human and veterinary medicine. The aim of research was the assessment of risk communication to pregnant women by doctors gynecologists involved in ASL’s territorial about toxoplasmosis, which can have serious effects on pregnancy and the unborn child. The results acquired during the investigation showed the need to develop and implement appropriate information campaigns and proper nutrition education.
A procedure of ISA (Integrated Safety Analysis) for uranium fuel fabrication/enrichment facilities has been under the development aiming to utilize risk information for safety regulations in this project. Activities in the fiscal year 2012 are summarized in the paper. There are two major activities in the year. First one is a study on ISA procedure for external events such as earthquakes. Second one is that for chemical consequences such as UF6 and HF. Other than the activities a fundamental study on a policy of utilizing risk information was conducted. The outline and results are provided in the chapter 1 and 2 respectively. (author)
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Introduction The risk management project of The University Hospital “A. Gemelli” aims to define the necessary procedures to manage clinical risk, by identifying the structures involved within this process, so that all of the personnel can contribute to a measurable improvement in the safety of both patients and staff.
Methods The Risk Management Program is comprised of 5 long-term phases: Phase 1 - Strategy Definition and Communication: a clear and shared Risk Management Strategy is indispensable to guarantee a coordinated action plan, in order to focus all of the interventions towards the achievement of common and measurable results. Phase 2 - Risk Management System Governance: all of the organisational structures have been activated in order to effectively manage the Risk Management System. The system has been introduced to interact within all areas of the hospital and to transfer information. Phase 3 - Promotion within the Organisation: this phase fosters the aims of the project within the whole organisation, by stressing the concept of “learning from errors”. This is crucial if organisational and healthcare workers are to understand the true aims of risk prevention and protection and offer to contribute to the process. Phase 4 - Risk Assessment: a data survey system was created and institutionalized. This phase begins with an analysis of the information flow, in order to estimate the probabilities that certain risks occur, and ends with defining the interventions to undertake. Risk assessment makes it possible to forecast the consequences of certain risks and thus prioritise those for prevention. Phase 5 - Risk Management: this consists of planning and implementing all of the actions necessary to prevent risks, protect and finance (in terms of prevention A. Gemelli University Hospital.
Results The results achieved are remarkable especially when one
The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S and M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard
Boddice, Sandra Dawn; Kogan, Polina
Below you will find summaries of published research describing investigations into patient safety issues related to falls and medications. The first summary provides details on the incidence of falls associated with the use of walkers and canes. This is followed by a summary of a fall-prevention intervention study that evaluated the effectiveness of widespread dissemination of evidence-based strategies in a community in Connecticut. The third write up provides information on three classes of medications that are associated with a significant number of emergency room visits. The last summary describes a pharmacist-managed medication reconciliation intervention pilot program. For additional details about the study findings and interventions, we encourage readers to review the original articles.
Carlesi, Katya Cuadros; Padilha, Kátia Grillo; Toffoletto, Maria Cecília; Henriquez-Roldán, Carlos; Juan, Monica Andrea Canales
ABSTRACT Objective: to identify the relationship between the workload of the nursing team and the occurrence of patient safety incidents linked to nursing care in a public hospital in Chile. Method: quantitative, analytical, cross-sectional research through review of medical records. The estimation of workload in Intensive Care Units (ICUs) was performed using the Therapeutic Interventions Scoring System (TISS-28) and for the other services, we used the nurse/patient and nursing assistant/patient ratios. Descriptive univariate and multivariate analysis were performed. For the multivariate analysis we used principal component analysis and Pearson correlation. Results: 879 post-discharge clinical records and the workload of 85 nurses and 157 nursing assistants were analyzed. The overall incident rate was 71.1%. It was found a high positive correlation between variables workload (r = 0.9611 to r = 0.9919) and rate of falls (r = 0.8770). The medication error rates, mechanical containment incidents and self-removal of invasive devices were not correlated with the workload. Conclusions: the workload was high in all units except the intermediate care unit. Only the rate of falls was associated with the workload. PMID:28403334
Katya Cuadros Carlesi
Full Text Available ABSTRACT Objective: to identify the relationship between the workload of the nursing team and the occurrence of patient safety incidents linked to nursing care in a public hospital in Chile. Method: quantitative, analytical, cross-sectional research through review of medical records. The estimation of workload in Intensive Care Units (ICUs was performed using the Therapeutic Interventions Scoring System (TISS-28 and for the other services, we used the nurse/patient and nursing assistant/patient ratios. Descriptive univariate and multivariate analysis were performed. For the multivariate analysis we used principal component analysis and Pearson correlation. Results: 879 post-discharge clinical records and the workload of 85 nurses and 157 nursing assistants were analyzed. The overall incident rate was 71.1%. It was found a high positive correlation between variables workload (r = 0.9611 to r = 0.9919 and rate of falls (r = 0.8770. The medication error rates, mechanical containment incidents and self-removal of invasive devices were not correlated with the workload. Conclusions: the workload was high in all units except the intermediate care unit. Only the rate of falls was associated with the workload.
Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris
Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.
Wang, O.S.; Rainey, T.E.; Zentner, M.D.
A full-scope level III probabilistic risk assessment (PRA) has been completed for N reactor, a US Department of Energy (DOE) production reactor located on the Hanford Reservation in the state of Washington. Sandia National Laboratories (SNL) provided the technical leadership for this work, using the state-of-the-art NUREG-1150 methodology developed for the US Nuclear Regulatory Commission (NRC). The main objectives of this effort were to assess the risks to the public and to the on-site workers posed by the operation of N reactor, to identify changes to the plant that could reduce the overall risk, and to compare those risks to the proposed NRC and DOE quantitative safety goals. This paper presents the methodology adopted by Westinghouse Hanford Company (WHC) and SNL for individual health risk evaluation, its results, and a comparison to the NRC safety objectives and the DOE nuclear safety guidelines. The N reactor results, are also compared with the five NUREG-1150 nuclear plants. Only internal events are compared here because external events are not yet reported in the current draft NUREG-1150. This is the first full-scope level III PRA study with a detailed quantitative safety goal comparison performed for DOE production reactors
Findlay, Ú.; Best, H.; Ottrey, M.
Aim: To improve patient safety in radiotherapy (RT) through the analysis and publication of radiotherapy errors and near misses (RTE). Materials and methods: RTE are submitted on a voluntary basis by NHS RT departments throughout the UK to the National Reporting and Learning System (NRLS) or directly to Public Health England (PHE). RTE are analysed by PHE staff using frequency trend analysis based on the classification and pathway coding from Towards Safer Radiotherapy (TSRT). PHE in conjunction with the Patient Safety in Radiotherapy Steering Group publish learning from these events, on a triannual and summarised on a biennial basis, so their occurrence might be mitigated. Results: Since the introduction of this initiative in 2010, over 30,000 (RTE) reports have been submitted. The number of RTE reported in each biennial cycle has grown, ranging from 680 (2010) to 12,691 (2016) RTE. The vast majority of the RTE reported are lower level events, thus not affecting the outcome of patient care. Of the level 1 and 2 incidents reported, it is known the majority of them affected only one fraction of a course of treatment. This means that corrective action could be taken over the remaining treatment fractions so the incident did not have a significant impact on the patient or the outcome of their treatment. Analysis of the RTE reports demonstrates that generation of error is not confined to one professional group or to any particular point in the pathway. It also indicates that the pattern of errors is replicated across service providers in the UK. Conclusion: Use of the terminology, classification and coding of TSRT, together with implementation of the national voluntary reporting system described within this report, allows clinical departments to compare their local analysis to the national picture. Further opportunities to improve learning from this dataset must be exploited through development of the analysis and development of proactive risk management strategies
Smith, Scott Alan; Yount, Naomi; Sorra, Joann
A number of private and public companies calculate and publish proprietary hospital patient safety scores based on publicly available quality measures initially reported by the U.S. federal government. This study examines whether patient safety culture perceptions of U.S. hospital staff in a large national survey are related to publicly reported patient safety ratings of hospitals. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (Hospital SOPS) assesses provider and staff perceptions of hospital patient safety culture. Consumer Reports (CR), a U.S. based non-profit organization, calculates and shares with its subscribers a Hospital Safety Score calculated annually from patient experience survey data and outcomes data gathered from federal databases. Linking data collected during similar time periods, we analyzed relationships between staff perceptions of patient safety culture composites and the CR Hospital Safety Score and its five components using multiple multivariate linear regressions. We analyzed data from 164 hospitals, with patient safety culture survey responses from 140,316 providers and staff, with an average of 856 completed surveys per hospital and an average response rate per hospital of 56%. Higher overall Hospital SOPS composite average scores were significantly associated with higher overall CR Hospital Safety Scores (β = 0.24, p Consumer Reports Hospital Safety Score, which is a composite of patient experience and outcomes data from federal databases. As hospital managers allocate resources to improve patient safety culture within their organizations, their efforts may also indirectly improve consumer-focused, publicly reported hospital rating scores like the Consumer Reports Hospital Safety Score.
The book covers the following chapters: (I) Between threat and promise: Political change and the corporate perception, the burden of the atomic bomb, promise of nuclear energy risk criticism in the pre-ecological phase, nuclear risk as investment restraint; (II) Risk policy at the insurability limit: hazard knowledge, safety production and insurance expertise in the German nuclear policy (1955-1962); (III) Risk policy beyond the catastrophe, insurability interpretation, concepts and conflicts (1957-1968); (IV) Scandalization of risk policy: safety production, confidence and expertise in the nuclear controversial debate (1969 - 1979); (V) Nuclear risk policy and the challenge of the ''risk society'' (1975-1986); (VI) From safety production to hazard probe: atomic energy And the change of insurance.
Operators and regulators of nuclear power plants agree on the importance of maintaining safety and controlling accident risks. Effective safety and risk management requires treatment of both technical and organizational components. Probabilistic Risk Assessment (PRA) provides tools for technical risk management. However, organizational factors are not treated in PRA, but are addressed using different approaches. To bring both components together, a framework of Risk Informed Decision Making (RIDM) is needed. The objective tree structure of the International Atomic Energy Agency (IAEA) is a promising approach to combine both elements. Effective collaboration involving regulatory and industry groups is needed to accomplish the integration. (author)
Renton, T; Master, S
Since the 'Francis Report', UK regulation focusing on patient safety has significantly changed. Healthcare workers are increasingly involved in NHS England patient safety initiatives aimed at improving reporting and learning from patient safety incidents (PSIs). Unfortunately, dentistry remains 'isolated' from these main events and continues to have a poor record for reporting and learning from PSIs and other events, thus limiting improvement of patient safety in dentistry. The reasons for this situation are complex.This paper provides a review of the complexities of the existing systems and procedures in relation to patient safety in dentistry. It highlights the conflicting advice which is available and which further complicates an overly burdensome process. Recommendations are made to address these problems with systems and procedures supporting patient safety development in dentistry.
Oliveira, João Lucas Campos de; Silva, Simone Viana da; Santos, Pamela Regina Dos; Matsuda, Laura Misue; Tonini, Nelsi Salete; Nicola, Anair Lazzari
To assess the knowledge of multiprofesional residents in health about the security of the patient theme. Cross-sectional study, quantitative, developed with graduate courses/residence specialties of health in a public university of Paraná, Brazil. Participants (n=78) answered a questionnaire containing nine objective questions related to patient safety. Data were analyzed using descriptive statistics, in proportion measures. The minimum 75% of correct answers was considered the cutoff for positive evaluation. The sample was predominantly composed of young people from medical programs. Almost half of the items evaluated (n=5) achieved the established positive pattern, especially those who dealt with the hand hygiene moments (98.8%) and goal of the Patient Safety National Program (92.3%). The identification of the patient was the worst rated item (37.7%). In the analysis by professional areas, only the Nursing reached the standard of hits established. Knowledge of the residents was threshold. Verificar o conhecimento de residentes multiprofissionais na área da saúde sobre o tema segurança do paciente. Estudo transversal, quantitativo, desenvolvido com pós-graduandos dos cursos/especialidades de residência da área da saúde de uma universidade pública do Paraná. Os participantes (n=78) responderam um questionário contendo nove questões objetivas relacionadas com a segurança do paciente. Os dados foram analisados por estatística descritiva, em medidas de proporção. O mínimo de 75% de acertos foi considerado ponto de corte para avaliação positiva. A amostra foi composta por profissionais predominantemente jovens, oriundos de programas médicos. Quase metade dos itens avaliados (n=5) alcançou o padrão de positividade estabelecido, com destaque para os que trataram dos momentos de higienização das mãos (98,8%) e o objetivo do Programa Nacional de Segurança do Paciente (92,3%). A identificação do paciente foi o pior item avaliado (37,7%). Na an
Vartak, Smruti; Ward, Marcia M.; Vaughn, Thomas E.
Purpose: To assess patient safety outcomes in small urban and small rural hospitals and to examine the relationship of hospital and patient factors to patient safety outcomes. Methods: The Nationwide Inpatient Sample and American Hospital Association annual survey data were used for analyses. To increase comparability, the study sample was…
Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; van Gurp, Petra J; Wollersheim, Hub
Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011-July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient
Background Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Methods and design Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. Discussion We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to
Saura, Rosa Maria; Moreno, Pilar; Vallejo, Paula; Oliva, Glòria; Alava, Fernando; Esquerra, Miquel; Davins, Josep; Vallès, Roser; Bañeres, Joaquim
Since its inception in 2006, the Alliance for Patient Safety in Catalonia has played a major role in promoting and shaping a series of projects related to the strategy of the Ministry of Health, Social Services and Equality, for improving patient safety. One such project was the creation of functional units or committees of safety in hospitals in order to facilitate the management of patient safety. The strategy has been implemented in hospitals in Catalonia which were selected based on criteria of representativeness. The intervention was based on two lines of action, one to develop the model framework and the other for its development. Firstly the strategy for safety management based on EFQM (European Foundation for Quality Management) was defined with the development of standards, targets and indicators to implement security while the second part involved the introduction of tools, methodologies and knowledge to the management support of patient safety and risk prevention. The project was developed in four hospital areas considered higher risk, each assuming six goals for safety management. Some of these targets such as the security control panel or system of adverse event reporting were shared. 23 hospitals joined the project in Catalonia. Despite the different situations in each centre, high compliance was achieved in the development of the objectives. In each of the participating areas the security control panel was developed. Stable structures for safety management were established or strengthened. Training in patient safety played and important role, 1415 professionals participated. Through these kind of projects not only have been introduced programs of proven effectiveness in reducing risks, but they also provide to the facilities a work system that allows autonomy in diagnosis and analysis of the different risk situations or centre specific safety issues. Copyright © 2014. Published by Elsevier Espana.
Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter
Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity
This revised and updated version of the report first published in 1987 by Karlsruhe Nuclear Center has been prepared by scientists of the Center who are experts in nuclear science and technology. The idea was to fulfill the so-to-speak ''creditor's'' obligation in the public debate about nuclear energy and its hazards, and to provide the general public not so familiar with the subject matter with information and insight for better understanding, hoping that the general public on their part will fulfill their ''debtor's'' obligation by trying to get properly informed. Chapters 1 and 6 of the report have been revised and brought up to date, while chapter 3 has been fully re-written, taking as a main source of reference the 1989 publication of Phase B of the German Risk Study on nuclear power plant. Chapters 2 and 5 are new in this report, dealing with less broadly known applications of radioactive substances in science, medicine and technology, and with the radiological situation in Germany after the Chernobyl reactor accident. (orig./DG) [de
Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O
Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108
Abstract. This paper presents and discusses two approaches to “the sociotechnical”, one coming from the Tavistock tradition and the other from actor network theory. These two differ in important ways and from the latter it follows that what patient safety means must be scrutinized and unpacked....... The paper thus rudimentarily discusses central contributions to the problematization of patient safety. Last it is argued that research that provide data on the processes of medical interventions where events, decisions and entities become transformed through their interactions is needed in order to further...... nuance the problem of patient safety. Keywords. Sociotechnical, patient safety, actor network theory, adverse events....
Johnson, Todd R; Zhang, Jiajie; Patel, Vimla L; Keselman, Alla; Tang, Xiaozhou; Brixey, Juliana J; Paige, Danielle; Turley, James P
To examine how patient safety considerations are incorporated into medical device purchase decisions, individuals involved in recent infusion pump purchasing decisions at three different health care...
Lane, D.A.; Kamphuisen, P.W.; Minini, P.; Buller, H.R.; Lip, G.Y.H.
ackground: Patients with atrial fibrillation (AF) and previous ischemic stroke are at high risk of recurrent stroke, but are also perceived to be at increased bleeding risk while treated with anticoagulants. Methods: Post-hoc analyses examined the efficacy and safety of anticoagulation of 4576 AF
Abraham, G [Ghafari Associates, Inc. 17101 Michegan Avenue Dearborn, MI 48126-2736 (United States); Kummler, R H [Department of Chemical engineering Wayne Stae University Detroit, MI 48202 (United States); louvar, J [Research Services Basf Corporation Wyandotte, MI 48192 (United States)
Section 304 of the 1990 clean air amendments (CAAA) directed the US occupational safety and health administration (OSFA) to develop a chemical process safety standard to protect workers on-site from accidents involving hazardous substances. OSHA issued 29 CFR 1910.119, process safety management of Highly hazardous chemicals (PSM) in 1992. Section 112 r of the CAAA further mandated that a standard be developed to protect the environment from accidental releases of hazardous substances. The US environmental protection agency (EPA) proposed such a standard in 1993 (58 Fr 54190) and revised their proposal in 1995). The final rule for risk management and accidental release prevention is more comprehensive and extensive than OSHA`s PSM standard. In this paper we will discuss the concepts of both programs, the classes of substances that would trigger a facility`s need for compliance and review the regulations for risk management.
Abraham, G.; Kummler, R.H.; louvar, J.
Section 304 of the 1990 clean air amendments (CAAA) directed the US occupational safety and health administration (OSFA) to develop a chemical process safety standard to protect workers on-site from accidents involving hazardous substances. OSHA issued 29 CFR 1910.119, process safety management of Highly hazardous chemicals (PSM) in 1992. Section 112 r of the CAAA further mandated that a standard be developed to protect the environment from accidental releases of hazardous substances. The US environmental protection agency (EPA) proposed such a standard in 1993 (58 Fr 54190) and revised their proposal in 1995). The final rule for risk management and accidental release prevention is more comprehensive and extensive than OSHA's PSM standard. In this paper we will discuss the concepts of both programs, the classes of substances that would trigger a facility's need for compliance and review the regulations for risk management
Lansberry, Linden; Strasburger, Tom
Risk management is a huge task that requires diligent oversight to avoid penalties, fines, or lawsuits. Add in the burden of limited resources that schools face today, and the challenge of meeting the required training, reporting, compliance, and other administrative issues associated with a safety program is almost insurmountable. Despite an…
Kozine, Igor; Duijm, Nijs Jan; Lauridsen Kurt
The current paper gives an overview of the legislation and the methods used in safety and risk management in the chemical industry within Europe and in particular within the European Union. The paper is based on a report that has been written for the SOS-1 project under the Nordic nuclear safety research (NKS). Safety- and risk-related matters in the process industry, in particular, in chemical, within the EU are subject to consideration at three levels: (1) EU legislation, (2) European/intemational standardisation, and (3) socio-economic analysis. EC Directives define the 'essential requirements', e.g., protection of health and safety, that must be fulfilled when goods are placed on the market or some industry is put into operation. The European standards bodies (CEN, CENELEC and ETSI) have the task of establishing the corresponding technical specifications, meeting the essential requirements of the Directives, compliance with which will provide a presumption of conformity with the essential requirements. Such specifications are referred to as 'harmonised standards'. Compliance with harmonised standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. This view is stated in the 'New Approach' to technical harmonisation and standardisation (details can be found on the web page: http://europe.eu.int/comm/enterprise/newapproach/standardization/index .html). Standardisation as well as the regulation of technical risks is increasingly being undertaken at European or international level. The European legislator limits its role to the affirmation of overall objectives, and leaves it to the economic players to draw up the technical procedures and standards to specify in detail the ways and means of attaining them. Many countries have introduced requirements that new legislation and/or administrative regulations be subject to socio-economic analysis. In this respect there is a
Damon, Dennis R.; Mattern, Kevin S.
The U.S. Nuclear Regulatory Commission conducted a comparison of two standard tools for risk informing the regulatory process, namely, the Probabilistic Risk Assessment (PRA) and the Integrated Safety Analysis (ISA). PRA is a calculation of risk metrics, such as Large Early Release Frequency (LERF), and has been used to assess the safety of all commercial power reactors. ISA is an analysis required for fuel cycle facilities (FCFs) licensed to possess potentially critical quantities of special nuclear material. A PRA is usually more detailed and uses more refined models and data than an ISA, in order to obtain reasonable quantitative estimates of risk. PRA is considered fully quantitative, while most ISAs are typically only partially quantitative. The extension of PRA methodology to augment or supplant ISAs in FCFs has long been considered. However, fuel cycle facilities have a wide variety of possible accident consequences, rather than a few surrogates like LERF or core damage as used for reactors. It has been noted that a fuel cycle PRA could be used to better focus attention on the most risk-significant structures, systems, components, and operator actions. ISA and PRA both identify accident sequences; however, their treatment is quite different. ISA's identify accidents that lead to high or intermediate consequences, as defined in 10 Code of Federal Regulations (CFR) 70, and develop a set of Items Relied on For Safety (IROFS) to assure adherence to performance criteria. PRAs identify potential accident scenarios and estimate their frequency and consequences to obtain risk metrics. It is acceptable for ISAs to provide bounding evaluations of accident consequences and likelihoods in order to establish acceptable safety; but PRA applications usually require a reasonable quantitative estimate, and often obtain metrics of uncertainty. This paper provides the background, features, and methodology associated with the PRA and ISA. The differences between the
In this article the role of the ward manager in promoting patient safety is explored. The background to the development of the patient safety agenda is briefly discussed and the relationship between quality and safety is illustrated. The pivotal importance of the role of the ward manager in delivering services to patients is underlined and literature on patient safety is examined to identify what a ward manager can do to make care safer. Possible actions of the ward manager to improve safety discussed in the literature are structured around the Leadership Framework. This framework identifies seven domains for the leadership of service delivery. Ward managers use their personal qualities, and network and work within teams, while managing performance and facilitating innovation, change and measurement for improvement. The challenge of promoting patient safety for ward managers is briefly explored and recommendations for further research are made.
Deciding on 'how safe is safe enough?' includes value judgements with implications of an ethical and political nature. As regulators are accountable to governments, parliaments and the general public, regulatory decision-making should be characterized by transparency with respect to how such value judgements are reflected in risk assessments and regulatory decisions. Some approaches in this respect are discussed in the paper, based on more than fifteen years of experience in nuclear regulatory decision-making. Issues discussed include: (1) risk profiles and safety goals associated with severe reactor accidents--individual health risks, societal risks and risk of losing investments; (2) risk profile-based licensing of the Swedish SFR final disposal facility for low and intermediate level radioactive waste
Full Text Available In the last few years we have observed an upward trend in the employment of ibuprofen as anti-inflammatory and antipyretic therapy. Therefore the pediatrician has often a precious option in the anti-inflammatory and antipyretic treatment in children instead of using steroids and paracetamol. In clinical practice ibuprofen can be used in the treatment of headache, toothache, otalgy, dysmenorrhea, neuralgia, arthralgia, myalgia, abdominal pain and fever: it is the first choice for these common diseases. However, the use of steroids is a routine, even if non-corticosteroid anti-inflammatory molecules could be useful. Certainly steroids are powerful anti-inflammatory, indicated for the treatment of chronic inflammatory disorders and in acute respiratory and allergic diseases. Beside, thanks to their chemical and pharmacological profile, they also provide patients with an antipyretic effect. However, the use of steroids must be reserved to cases in which other classical antipyretics such as non-steroidal anti-inflammatory drugs are not effective. The possible side effects and risks associated with stepping down steroids must be considered. Although “steroids-phobia” should be discouraged, steroids are to be reserved only as the first indication. In all other cases the pediatrician can use ibuprofen, whose efficacy and safety are widely demonstrated by now.
Donnelly, S.K.; Harvey, S.B. [Amec Foster Wheeler, Toronto, Ontario (Canada)
Critical infrastructure assets such as nuclear power generating stations are potential targets for malevolent acts. Probabilistic methodologies can be applied to evaluate the real-time security risk based upon intelligence and threat levels. By employing this approach, the application of security forces and other protective measures can be optimized. Existing probabilistic safety analysis (PSA) methodologies and tools employed. in the nuclear industry can be adapted to security applications for this purpose. Existing PSA models can also be adapted and enhanced to consider total plant risk, due to nuclear safety risks as well as security risks. By creating a Probabilistic Security Model (PSM), safety and security practitioners can maximize the safety and security of the plant while minimizing the significant costs associated with security upgrades and security forces. (author)
Gong, Yi-Chun; Liu, Jing-Tao; Ma, Peng-Lin
Early adequate fluid loading was the corner stone of hemodynamic optimization for sepsis and septic shock. Meanwhile, recent recommended protocol for fluid resuscitation was increasingly debated on hemodynamic stability vs risk of overloading. In recent publications, it was found that a priority was often given to hemodynamic stability rather than organ function alternation in the early fluid resuscitation of sepsis. However, no safety limits were used at all in most of these reports. In this article, the rationality and safety of early aggressive fluid loading for septic patients were discussed. It was concluded that early aggressive fluid loading improved hemodynamics transitorily, but was probably traded off with a follow-up organ function impairment, such as worsening oxygenation by reduction of lung aeration, in a part of septic patients at least. Thus, a safeguard is needed against unnecessary excessive fluids in early aggressive fluid loading for septic patients. Copyright © 2017 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Production and hosting by Elsevier B.V. All rights reserved.
A procedure of probabilistic risk assessment (PRA) for a reprocessing facility has been under the development aiming to utilize risk information for safety regulations in this project. Activities in the fiscal year 2012 are summarized in the paper. A major activity is a fundamental study on a concept of serious accidents, requirements of serious accident management, and a policy of utilizing risk information for fabrication and reprocessing facilities. Other than the activity a study on release and transport of aerial radioactive materials at a serious accident in a reprocessing facility has been conducted. The outline and results are provided in the chapter 1 and 2 respectively. (author)
Moore, David A
The world of safety and security in the chemical process industries has certainly changed since 11 September, but the biggest challenges may be yet to come. This paper will explain that there is a new risk management paradigm for chemical security, discuss the differences in interpreting this risk versus accidental risk, and identify the challenges we can anticipate will occur in the future on this issue. Companies need to be ready to manage the new chemical security responsibilities and to exceed the expectations of the public and regulators. This paper will outline the challenge and a suggested course of action.
An opinion investigation was realized in october 1999 by the IPSN to know the public opinion concerning the risks and safety perception. Five subjects were treated: the public care subjects (social and environment); the science and scientists image; the food risks; the opinion on the nuclear activities (interveners ability and credibility, nuclear controversy, radioactive wastes and nuclear accidents); the french people cares about the risks. The methodology and the analysis of the poll results are detailed. Tables of data investigation are also included. (A.L.B.)
Shkrum, Michael James; Kent, Jessica
Any autopsy has safety and risk management issues, which can arise in the preautopsy, autopsy, and postautopsy phases. The London Health Sciences Department of Pathology and Laboratory Medicine Autopsy Checklist was developed to address these issues. The current study assessed 1 measure of autopsy safety: the effectiveness of the checklist in documenting pathologists' communication of the actual or potential risk of blood-borne infections to support staff. Autopsy checklists for cases done in 2012 and 2013 were reviewed. The frequency of communication, as recorded in checklists, by pathologists to staff of previously diagnosed blood-borne infections (hepatitis B/C and human immunodeficiency virus) or the risk of infection based on lifestyle (eg, intravenous drug abuse) was tabulated. These data were compared with medical histories of the deceased and circumstances of their deaths described in the final autopsy reports. Information about blood-borne infections was recorded less frequently in the checklists compared with the final reports. Of 4 known human immunodeficiency virus cases, there was no checklist documentation in 3. All 11 hand injuries were documented. None of these cases had known infectious risks. The Autopsy Checklist is a standardized means of documenting safety and risk issues arising during the autopsy process, but its effectiveness relies on accurate completion.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act... delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3...
Brighton, P.W.M.; Fearnley, P.J.; Brearley, I.G. [Health and Safety Executive, Bootle (United Kingdom). Offshore Safety Div.
In the past two years HSE has assessed around 250 Safety Cases for offshore oil and gas installations, building up a unique overview of the current state of the art on fire and explosion risk assessment. This paper reviews the explosion risk methods employed, focusing on the aspects causing most difficulty for assessment and acceptance of Safety Cases. Prediction of overpressures in offshore explosions has been intensively researched in recent years but the justification of the means of prevention, control and mitigation of explosions often depends on much additional analysis of the frequency and damage potential of explosions. This involves a number of factors, the five usually considered being: leak sizes; gas dispersion; ignition probabilities; the frequency distribution of explosion strength; and the prediction of explosion damage. Sources of major uncertainty in these factors and their implications for practical risk management decisions are discussed. (author)
Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney
Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining
Full Text Available Background: The first step in cultivating the culture of safety in the operating room is the assessment of safety culture among operating room personnel. Objective: To assess the patient safety culture of operating room personnel at the Department of Surgery, Faculty of Medicine Siriraj Hospital, and compare attitudes among different groups of personnel, and compare them with the international standards. Methods: We conducted a cross-sectional survey of safety attitudes among 396 operating room personnel, using a short form of the Safety Attitudes Questionnaire (SAQ. The SAQ employed 30 items to assess safety culture in six dimensions: teamwork climate, safety climate, stress recognition, perception of hospital management, working conditions, and job satisfaction. The subscore of each dimension was calculated and converted to a scale score with a full score of 100, where higher scores indicated better safety attitudes. Results: The response rate was 66.4%. The overall safety culture score of the operating room personnel was 65.02, higher than an international average (61.80. Operating room personnel at Siriraj Hospital had safety attitudes in teamwork climate, safety climate, and stress recognition lower than the international average, but had safety attitudes in the perception of hospital management, working conditions, and job satisfaction higher than the international average. Conclusion: The safety culture attitudes of operating room personnel at the Department of Surgery, Siriraj Hospital were comparable to international standards. The safety dimensions that Siriraj Hospital operating room should try to improve were teamwork climate, safety climate, and stress recognition.
Suñol, R; Vallejo, P; Groene, O; Escaramis, G; Thompson, A; Kutryba, B; Garel, P
This study is part of the Methods of Assessing Response to Quality Improvement Strategies (MARQuIS) research project on cross-border care, investigating quality improvement strategies in healthcare systems across the European Union (EU). To explore to what extent a sample of acute care European hospitals have implemented patient safety strategies and mechanisms and whether the implementation is related to the type of hospital. Data were collected on patient safety structures and mechanisms in 389 acute care hospitals in eight EU countries using a web-based questionnaire. Subsequently, an on-site audit was carried out by independent surveyors in 89 of these hospitals to assess patient safety outputs. This paper presents univariate and bivariate statistics on the implementation and explores the associations between implementation of patient safety strategies and hospital type using the chi(2) test and Fisher exact test. Structures and plans for safety (including responsibilities regarding patient safety management) are well developed in most of the hospitals that participated in this study. The study found greater variation regarding the implementation of mechanisms or activities to promote patient safety, such as electronic drug prescription systems, guidelines for prevention of wrong patient, wrong site and wrong surgical procedure, and adverse events reporting systems. In the sample of hospitals that underwent audit, a considerable proportion do not comply with basic patient safety strategies--for example, using bracelets for adult patient identification and correct labelling of medication.
Ginsburg, Liane R; Chuang, You-Ta; Berta, Whitney Blair; Norton, Peter G; Ng, Peggy; Tregunno, Deborah; Richardson, Julia
To examine the relationship between organizational leadership for patient safety and five types of learning from patient safety events (PSEs). Forty-nine general acute care hospitals in Ontario, Canada. A nonexperimental design using cross-sectional surveys of hospital patient safety officers (PSOs) and patient care managers (PCMs). PSOs provided data on organization-level learning from (a) minor events, (b) moderate events, (c) major near misses, (d) major event analysis, and (e) major event dissemination/communication. PCMs provided data on organizational leadership (formal and informal) for patient safety. Hospitals were the unit of analysis. Seemingly unrelated regression was used to examine the influence of formal and informal leadership for safety on the five types of learning from PSEs. The interaction between leadership and hospital size was also examined. Formal organizational leadership for patient safety is an important predictor of learning from minor, moderate, and major near-miss events, and major event dissemination. This relationship is significantly stronger for small hospitals (learning from safety events. Formal leadership support for safety is of particular importance in small organizations where the economic burden of safety programs is disproportionately large and formal leadership is closer to the front lines.
Kristensen, Solvejg; Christensen, Karl Bang; Jaquet, Annette
OBJECTIVES: Current literature emphasises that clinical leaders are in a position to enable a culture of safety, and that the safety culture is a performance mediator with the potential to influence patient outcomes. This paper aims to investigate staff's perceptions of patient safety culture...... in a Danish psychiatric department before and after a leadership intervention. METHODS: A repeated cross-sectional experimental study by design was applied. In 2 surveys, healthcare staff were asked about their perceptions of the patient safety culture using the 7 patient safety culture dimensions...... in the Safety Attitudes Questionnaire. To broaden knowledge and strengthen leadership skills, a multicomponent programme consisting of academic input, exercises, reflections and discussions, networking, and action learning was implemented among the clinical area level leaders. RESULTS: In total, 358 and 325...
Schiff, Gordon D; Reyes Nieva, Harry; Griswold, Paula; Leydon, Nicholas; Ling, Judy; Federico, Frank; Keohane, Carol; Ellis, Bonnie R; Foskett, Cathy; Orav, E John; Yoon, Catherine; Goldmann, Don; Weissman, Joel S; Bates, David W; Biondolillo, Madeleine; Singer, Sara J
Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all Pcoaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.
Ford, Eric W; Silvera, Geoffrey A; Kazley, Abby S; Diana, Mark L; Huerta, Timothy R
Purpose - The purpose of this paper is to explore the relationship between hospitals' electronic health record (EHR) adoption characteristics and their patient safety cultures. The "Meaningful Use" (MU) program is designed to increase hospitals' adoption of EHR, which will lead to better care quality, reduce medical errors, avoid unnecessary cost, and promote a patient safety culture. To reduce medical errors, hospital leaders have been encouraged to promote safety cultures common to high-reliability organizations. Expecting a positive relationship between EHR adoption and improved patient safety cultures appears sound in theory, but it has yet to be empirically demonstrated. Design/methodology/approach - Providers' perceptions of patient safety culture and counts of patient safety incidents are explored in relationship to hospital EHR adoption patterns. Multi-level modeling is employed to data drawn from the Agency for Healthcare Research and Quality's surveys on patient safety culture (level 1) and the American Hospital Association's survey and healthcare information technology supplement (level 2). Findings - The findings suggest that the early adoption of EHR capabilities hold a negative association to the number of patient safety events reported. However, this relationship was not present in providers' perceptions of overall patient safety cultures. These mixed results suggest that the understanding of the EHR-patient safety culture relationship needs further research. Originality/value - Relating EHR MU and providers' care quality attitudes is an important leading indicator for improved patient safety cultures. For healthcare facility managers and providers, the ability to effectively quantify the impact of new technologies on efforts to change organizational cultures is important for pinpointing clinical areas for process improvements.
Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek
Current geometric design guides provide deterministic standards where the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from these standards. Several studies have advocated probabilistic geometric design where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a risk measure of the implication of deviation from design standards. However, there is currently no link between measures of design reliability and the quantification of safety using collision frequency. The analysis presented in this paper attempts to bridge this gap by incorporating a reliability-based quantitative risk measure such as the probability of non-compliance (P(nc)) in safety performance functions (SPFs). Establishing this link will allow admitting reliability-based design into traditional benefit-cost analysis and should lead to a wider application of the reliability technique in road design. The present application is concerned with the design of horizontal curves, where the limit state function is defined in terms of the available (supply) and stopping (demand) sight distances. A comprehensive collision and geometric design database of two-lane rural highways is used to investigate the effect of the probability of non-compliance on safety. The reliability analysis was carried out using the First Order Reliability Method (FORM). Two Negative Binomial (NB) SPFs were developed to compare models with and without the reliability-based risk measures. It was found that models incorporating the P(nc) provided a better fit to the data set than the traditional (without risk) NB SPFs for total, injury and fatality (I+F) and property damage only (PDO) collisions. Copyright © 2011 Elsevier Ltd. All rights reserved.
Charles, Marie-Jocelyne; Harmon, Bart J; Jordan, Pamela S
The United States Department of Defense (DoD) has transformed health care delivery in its use of information technology to automate patient data documentation, leading to improvements in patient safety...
Randall, Ed J.
This book is about the risk politics of food safety. Food-related risks regularly grab the headlines in ways that threaten reasoned debate and obstruct sensible policy making. The author explains why this is the case. He goes on to make the case for a properly informed and fully open public debate about food safety issues. He argues that this is the true antidote to the politics of scare, scandal and crisis.\\ud \\ud The book skilfully weaves together the many different threads of food safety a...
Kang, Hyun Gook; Jang, Seung-Cheol
Risk factors of safety-critical digital systems affect overall plant risk. In order to assess this risk effect, a risk model of a digitalized safety system is required. This article aims to provide an overview of the issues when developing a risk model and demonstrate their effect on plant risk quantitatively. Research activities in Korea for addressing these various issues, such as the software failure probability and the fault coverage of self monitoring mechanism are also described. The main risk contributors related to the digitalized safety system were determined in a quantitative manner. Reactor protection system and engineered safety feature component control system designed as part of the Korean Nuclear I and C System project are used as example systems. Fault-tree models were developed to assess the failure probability of a system function which is designed to generate an automated signal for actuating both of the reactor trip and the complicated accident-mitigation actions. The developed fault trees were combined with a plant risk model to evaluate the effect of a digitalized system's failure on the plant risk. (authors)
Willmer, D R; Haas, E J
As national and international health and safety management system (HSMS) standards are voluntarily accepted or regulated into practice, organizations are making an effort to modify and integrate strategic elements of a connected management system into their daily risk management practices. In high-risk industries such as mining, that effort takes on added importance. The mining industry has long recognized the importance of a more integrated approach to recognizing and responding to site-specific risks, encouraging the adoption of a risk-based management framework. Recently, the U.S. National Mining Association led the development of an industry-specific HSMS built on the strategic frameworks of ANSI: Z10, OHSAS 18001, The American Chemistry Council's Responsible Care, and ILO-OSH 2001. All of these standards provide strategic guidance and focus on how to incorporate a plan-do-check-act cycle into the identification, management and evaluation of worksite risks. This paper details an exploratory study into whether practices associated with executing a risk-based management framework are visible through the actions of an organization's site-level management of health and safety risks. The results of this study show ways that site-level leaders manage day-to-day risk at their operations that can be characterized according to practices associated with a risk-based management framework. Having tangible operational examples of day-to-day risk management can serve as a starting point for evaluating field-level risk assessment efforts and their alignment to overall company efforts at effective risk mitigation through a HSMS or other processes.
Wagner, C.; Smits, M.; Sorra, J.; Huang, C.C.
Objective. It is believed that in order to reduce the number of adverse events, hospitals have to stimulate a more open culture and reflective attitude towards errors and patient safety. The objective is to examine similarities and differences in hospital patient safety culture in three countries:
Wagner, C.; Smits, M.; Sorra, J.; Huang, C.C.
Objective: It is believed that in order to reduce the number of adverse events, hospitals have to stimulate a more open culture and reflective attitude towards errors and patient safety. The objective is to examine similarities and differences in hospital patient safety culture in three countries:
Wagner, C.; Smits, M.; Sorra, J.; Huang, C.C.
OBJECTIVE: It is believed that in order to reduce the number of adverse events, hospitals have to stimulate a more open culture and reflective attitude towards errors and patient safety. The objective is to examine similarities and differences in hospital patient safety culture in three countries:
... Organizations: Voluntary Delisting AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION... Creighton Center for Health Services Research and Patient Safety (CHRP) Patient Safety Organization (PSO... the listing of PSOs, which are entities or component organizations whose mission and primary activity...
... Organizations: Voluntary Delisting AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice of... entity of Harbor Medical, Inc., of its status as a Patient Safety Organization (PSO). The Patient Safety... the listing of PSOs, which are entities or component organizations whose mission and primary activity...
... Organizations: Voluntary Delisting AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice of..., LLC of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement... or component organizations whose mission and primary activity is to conduct activities to improve...
... Organizations: Voluntary Delisting AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice of.... Patient Safety Group (A Component of Helmet Fire, Inc. of its status as a Patient Safety Organization (PSO... the listing of PSOs, which are entities or component organizations whose mission and primary activity...
... Organizations: Voluntary Delisting AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION... Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109... the listing of PSOs, which are entities or component organizations whose mission and primary activity...
The aim of this study was to assess attitudes towards and knowledge of medication safety in inflammatory bowel disease (IBD). IBD patients frequently require long-term treatment with potentially toxic medications. Techniques are employed to improve patient awareness of medication safety, but there are sparse data on their effectiveness.
... Healthcare Technology Foundation of its status as a Patient Safety Organization (PSO). The Patient Safety and... notification from the ACCE Healthcare Technology Foundation, PSO number P0017, to voluntarily relinquish its status as a PSO. Accordingly, the ACCE Healthcare Technology Foundation was delisted effective at 12:00...
The Productive Mental Health Ward programme has been developed to improve efficiency and safety in the NHS. Patients in a medium-secure mental health unit used patient safety crosses as a tool for self-reflection as part of their recovery journey. This article describes how the project was set up as well as initial findings.
Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.
Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the
Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J. M.; Wagner, Cordula; Zwart, Dorien L. M.
Background: Patient safety culture, described as shared values, attitudes and behavior of staff in a health-care organization, gained attention as a subject of study as it is believed to be related to the impact of patient safety improvements. However, in primary care, it is yet unknown, which
Houck, Noreen M; Colbert, Alison M
Workplace bullying is strongly associated with negative nursing outcomes, such as work dissatisfaction, turnover, and intent to leave; however, results of studies examining associations with specific patient safety outcomes are limited or nonspecific. This integrative review explores and synthesizes the published articles that address the impact of workplace nurse bullying on patient safety.
H.W. Huang; D.M. Zhang; B.M. Ayyub
Over the last decades, geo-structures are experiencing a rapid development in China. The potential risks inherent in the huge amount of construction and asset operation projects in China were well managed in the major project, i.e. the project of Shanghai Yangtze tunnel in 2002. Since then, risk assessment of geo-structures has been gradually developed from a qualitative manner to a quantitative manner. However, the current practices of risk management have been paid considerable attention to the assessment, but little on risk control. As a result, the responses to risks occurrences after a comprehensive assessment are basically too late. In this paper, a smart system for risk sensing incorporating the wireless sensor network (WSN) on-site visualization techniques and the resilience-based repair strategy was proposed. The merit of this system is the real-time monitoring for geo-structural performance and dynamic pre-warning for safety of on-site workers. The sectional convergence, joint opening, and seepage of segmental lining of shield tunnel were monitored by the micro-electro-mechanical systems (MEMS) based sensors. The light emitting diode (LED) coupling with the above WSN system was used to indicate different risk levels on site. By sensing the risks and telling the risks in real time, the geo-risks could be controlled and the safety of geo-structures could be assured to a certain degree. Finally, a resilience-based analysis model was proposed for designing the repair strategy by using the measured data from the WSN system. The application and efficiency of this system have been validated by two cases including Shanghai metro tunnel and underwater road tunnel.
Full Text Available Inadequate patient handoffs have been an area of focus for patient safety improvement. Insufficient communication and risks or “shortcuts” taken by staff members during handoffs could negatively affect the safety of patients in a department of obstetrics and gynecology. Other factors that contribute to inadequate handoffs are the caregiver feeling fatigued or stressed, level of urgency, volume of information, language barriers, noise, lighting, ambiguity of describing treatment, not allotting enough time for questions asked, and/or interruptions from other staff members. There have been several methods developed for improving the handoff process, such as the mnemonic devices SBAR, SHARQ, I PASS THE BATON, and the 5 P's. A new method for improving the quality of patient handoffs has been developed and presented in this article. It is a mnemonic device entitled “HANDOFFS”. It covers key aspects of what a handoff process should entail. Teamwork is essential to effective communication, and by using a mnemonic such as this, team members can work together in a more positive and accessible environment that will result in improved patient safety.
Warmerdam, Amanda; Newnam, Sharon; Sheppard, Dianne; Griffin, Mark; Stevenson, Mark
In Australia, more than 30% of the traffic volume can be attributed to work-related vehicles. Although work-related driver safety has been given increasing attention in the scientific literature, it is uncertain how well this knowledge has been translated into practice in industry. It is also unclear how current practice in industry can inform scientific knowledge. The aim of the research was to use a benchmarking tool developed by the National Road Safety Partnership Program to assess industry maturity in relation to risk management practices. A total of 83 managers from a range of small, medium and large organisations were recruited through the Victorian Work Authority. Semi-structured interviews aimed at eliciting information on current organisational practices, as well as policy and procedures around work-related driving were conducted and the data mapped onto the benchmarking tool. Overall, the results demonstrated varying levels of maturity of risk management practices across organisations, highlighting the need to build accountability within organisations, improve communication practices, improve journey management, reduce vehicle-related risk, improve driver competency through an effective workplace road safety management program and review organisational incident and infringement management. The findings of the study have important implications for industry and highlight the need to review current risk management practices. Copyright © 2016 Elsevier Ltd. All rights reserved.
Conroy, Tiffany; Feo, Rebecca; Boucaut, Rose; Alderman, Jan; Kitson, Alison
Ensuring and maintaining patient safety is an essential aspect of care provision. Safety is a multidimensional concept, which incorporates interrelated elements such as physical and psychosocial safety. An effective nurse-patient relationship should ensure that these elements are considered when planning and providing care. This article discusses the importance of an effective nurse-patient relationship, as well as healthcare environments and working practices that promote safety, thus ensuring optimal patient care.
Full Text Available Introduction: ”Exposing to danger” or in other words, “risk” is a process which is led to an uncertain result in every field. Project risks are uncertain contingent events or situations that if they occur will have positive or negative effects on project’s objectives. Todays, research and educational process and more complicated and the professional risk management become much more difficult, as a result. .Material and Method: In this research, the health and safety issues have been studied and analyzed using ISO 14121 and the environmental issues by EMEA to determine the risk level separately for research laboratories and to prioritize corrective measure in each field (school. .Result: The finding in this study showed that from all the main risks within the rage of 38-86 percent have been decreased. Moreover average of the risk level for the health, safety and environment cases showed a significant decrease (Pvalue<0.0001 by implement controlling and protective countermeasures compariy to the priority state without any measures. . Conclusion: The risk assessment with hazards control strategy based on ISO 14121 is a compatible method in laboratory site as universities and other reasearch sites.
Cho, Sumi; Lee, Eunjoo
Recently, the patient's role in preventing adverse events has been emphasized. Patients who are more knowledgeable about safety issues are more likely to engage in safety initiatives. Therefore, nurses need to develop techniques and tools that increase patients' knowledge in preventing adverse events. For this reason, an educational smartphone application for patient safety called "Safe Patients" was developed through an iterative process involving a literature review, expert consultations, and pilot testing of the application. To determine the effect of "Safe Patients," it was implemented for patients in surgical units in a tertiary hospital in South Korea. The change in patients' knowledge about patient safety was measured using seven true/false questions developed in this study. A one-group pretest and posttest design was used, and a total of 123 of 190 possible participants were tested. The percentage of correct answers significantly increased from 64.5% to 75.8% (P effectively improve patients' knowledge of safety issues. This will ultimately empower patients to engage in safe practices and prevent adverse events related to surgery.
Vlayen, Annemie; Schrooten, Ward; Wami, Welcome; Aerts, Marc; Barrado, Leandro Garcia; Claes, Neree; Hellings, Johan
The aim of this study was to measure differences in safety culture perceptions within Belgian acute hospitals and to examine variability based on language, work area, staff position, and work experience. The Hospital Survey on Patient Safety Culture was distributed to hospitals participating in the national quality and safety program (2007-2009). Hospitals were invited to participate in a comparative study. Data of 47,136 respondents from 89 acute hospitals were used for quantitative analysis. Percentages of positive response were calculated on 12 dimensions. Generalized estimating equations models were fitted to explore differences in safety culture. Handoffs and transitions, staffing, and management support for patient safety were considered as major problem areas. Dutch-speaking hospitals had higher odds of positive perceptions for most dimensions in comparison with French-speaking hospitals. Safety culture scores were more positive for respondents working in pediatrics, psychiatry, and rehabilitation compared with the emergency department, operating theater, and multiple hospital units. We found an important gap in safety culture perceptions between leaders and assistants within disciplines. Administration and middle management had lower perceptions toward patient safety. Respondents working less than 1 year in the current hospital had more positive safety culture perceptions in comparison with all other respondents. Large comparative databases provide the opportunity to identify distinct high and low scoring groups. In our study, language, work area, and profession were identified as important safety culture predictors. Years of experience in the hospital had only a small effect on safety culture perceptions.
Abstract The book deals with the analysis of work hazards and safety in industrial enterprises in Peninsular Malaysia, Southeast Asia. It traces the development of this theme of conflict within the context constituted by state, labour market and labour-management relations in Malaysia. The book...... and safety, when compared with the influence of local conditions? What kind of process develops, as local theory about work hazards are formed among workers. And, which are the opportunities for changing working environment institutions in Malaysia? The first part of the book discusses traditions...... by the state from Burawoy, Beronius, and Adesina about production politics and social relations in the labour process provides an integrated perspective on individual risk perceptions, safety practices in enterprises, and government regulation. The empirical data were collected during the period 1989...
Alvarado-Cabrero, Isabel; Valencia-Cedillo, Raquel
Health care workers are experiencing increasing numbers of occupational illnesses. Safety practices in anatomical pathology laboratories (APL) are crucial to prevent unnecessary exposures to both chemical and biological agents. The main goal of this study was to determine if pathologists perceptions and actual practice mirror regulatory guidelines. Current available recommendations for APL were reviewed and used to construct an online survey distributed to pathologists. The survey was completed by 121 participants. Eighty-seven (72 %) of respondents reported receiving inadequate safety training. Most pathologists (82 %) were not well-informed about biosafety practices. Sixty-three (52 %) participants felt that the risks of chemical and infectious disease exposures in the APL were low. Most respondents reported having a needle stick or cut (71 %). Eighty-six (71 %) of participants reported musculo skeletal problems. This study indicated that there is a need for improving training in anatomical pathology safety practices in Mexican laboratories as daily practices do not reflected current guidelines.
Lee, C. K.; Park, G. Y.; Lee, Y. J.; Choi, J. G.; Kim, D. H.; Lee, D. Y.; Kwon, K. C.
In the Korea Nuclear I and C Systems Development (KNICS) project the platforms for plant protection systems are developed, which function as a reactor shutdown, actuation of engineered safety features and a control of the related equipment. Those are fully digitalized through the use of safety-grade programmable logic controllers (PLCs) and communication networks. In 2006 the Regulatory Guide 1.152 (Rev. 02) was published by the U.S. NRC and it describes the application of a cyber security to the safety systems in the Nuclear Power Plant (NPP). Therefore it is required that the new requirements are incorporated into the developed platforms to apply to NPP, and a cyber security risk assessment is performed. The results of the assessment were input for establishing the cyber security policies and planning the work breakdown to incorporate them
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient... delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3...
Houwing, R. H.; Rozendaal, M; Wouters-Wesseling, W; Buskens, E.; Keller, P; Haalboom, JRE
Hip fracture patients have a high risk of pressure ulcers (PU). We followed 121 hip fracture patients for the development of pressure ulcers and evaluated a risk assessment tool for sensitivity and specificity. More than half of the patients presented with PU, mostly stage I. Risk factors for PU
Palacios-Derflingher, Luz; O'Beirne, Maeve; Sterling, Pam; Zwicker, Karen; Harding, Brianne K; Casebeer, Ann
Safety culture has been shown to affect patient safety in healthcare. While the United States and United Kingdom have studied the dimensions that reflect patient safety culture in family practice settings, to date, this has not been done in Canada. Differences in the healthcare systems between these countries and Canada may affect the dimensions found to be relevant here. Thus, it is important to identify and compare the dimensions from the United States and the United Kingdom in a Canadian context. The objectives of this study were to explore the dimensions of patient safety culture that relate to family practice in Canada and to determine if differences and similarities exist between dimensions found in Canada and those found in previous studies undertaken in the United States and the United Kingdom. A qualitative study was undertaken applying thematic analysis using focus groups with family practice offices and supplementary key stakeholders. Analysis of the data indicated that most of the dimensions from the United States and United Kingdom are appropriate in our Canadian context. Exceptions included owner/managing partner/leadership support for patient safety, job satisfaction and overall perceptions of patient safety and quality. Two unique dimensions were identified in the Canadian context: disclosure and accepting responsibility for errors. Based on this early work, it is important to consider differences in care settings when understanding dimensions of patient safety culture. We suggest that additional research in family practice settings is critical to further understand the influence of context on patient safety culture.
Plint, Amy C; Stang, Antonia S; Calder, Lisa A
Patient safety in the context of emergency medicine is a relatively new field of study. To date, no broad research agenda for patient safety in emergency medicine has been established. The objective of this study was to establish patient safety-related research priorities for emergency medicine. These priorities would provide a foundation for high-quality research, important direction to both researchers and health-care funders, and an essential step in improving health-care safety and patient outcomes in the high-risk emergency department (ED) setting. A four-phase consensus procedure with a multidisciplinary expert panel was organized to identify, assess, and agree on research priorities for patient safety in emergency medicine. The 19-member panel consisted of clinicians, administrators, and researchers from adult and pediatric emergency medicine, patient safety, pharmacy, and mental health; as well as representatives from patient safety organizations. In phase 1, we developed an initial list of potential research priorities by electronically surveying a purposeful and convenience sample of patient safety experts, ED clinicians, administrators, and researchers from across North America using contact lists from multiple organizations. We used simple content analysis to remove duplication and categorize the research priorities identified by survey respondents. Our expert panel reached consensus on a final list of research priorities through an in-person meeting (phase 3) and two rounds of a modified Delphi process (phases 2 and 4). After phases 1 and 2, 66 unique research priorities were identified for expert panel review. At the end of phase 4, consensus was reached for 15 research priorities. These priorities represent four themes: (1) methods to identify patient safety issues (five priorities), (2) understanding human and environmental factors related to patient safety (four priorities), (3) the patient perspective (one priority), and (4) interventions for
François, P; Sellier, E; Imburchia, F; Mallaret, M-R
An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. We performed a brief review of the literature for studies reporting data on CREX established in hospitals. The review was performed using the main bibliographic databases and Google search results. The CREX is designed to analyse incidents reported by professionals. The method includes monthly meetings of a multi-professional committee that reviews the reported incidents, chooses a priority incident and designates a "pilot" responsible for investigating the incident. The investigation of the incident involves a systemic analysis method and a written synthesis presented at the next meeting of the committee. The committee agrees on actions for improvement that are suggested by the analysis and follows their implementation. Systems for the management of health care, including reporting systems, are organized into three levels: the medical unit, the hospital and the country as a triple loop learning process. The CREX is located in the base level, short loop of risk management and allows direct involvement of care professionals in patient safety. Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
One of the most important components of effective safety and risk management for nuclear power stations is a healthy safety culture. DNV has developed an approach for risk informed safety culture assessment that combines two complementary paradigms for safety and risk management: loss prevention - for preventing and intervening in accidents; and critical function management - for achieving safety and performance goals. Combining these two paradigms makes it possible to provide more robust systems for safety management and to support a healthy safety culture. This approach is being applied to safety culture assessment in partnership with a Canadian nuclear utility. (author)
Palojoki, Sari; Mäkelä, Matti; Lehtonen, Lasse; Saranto, Kaija
The aim of this study was to analyse electronic health record-related patient safety incidents in the patient safety incident reporting database in fully digital hospitals in Finland. We compare Finnish data to similar international data and discuss their content with regard to the literature. We analysed the types of electronic health record-related patient safety incidents that occurred at 23 hospitals during a 2-year period. A procedure of taxonomy mapping served to allow comparisons. This study represents a rare examination of patient safety risks in a fully digital environment. The proportion of electronic health record-related incidents was markedly higher in our study than in previous studies with similar data. Human-computer interaction problems were the most frequently reported. The results show the possibility of error arising from the complex interaction between clinicians and computers.
Full text of publication follows: whether concerning mad cow disease, asbestos, nuclear, OGM or now, dioxin in French meat, public health risks have been making the headlines of newspapers for a while. And, firms whose activity is associated with these risks are in effect in the defendants box. Therefore, communicating becomes difficult: their word is suspect and, debates quite rapidly exceed the firm competencies to become a socio-cultural conflict. This paper explores in nuclear fields the essential role of safety authorities in such communication cases. Our surveys and the comparative case study between the pipe at La Hague and 'contaminated' nuclear transports in France are eloquent: the messages of nuclear firms is perceived through their image of a State within the State built from the past and reinforced by the negative prism of the news. Regular and technical arguments (the respect of norms) entertain the debate rather than hush it. That is why we could infer an objective, and independent opinion is required, one different from the firm, the public and ministries: its role of referee could allow a constructive dialog between the public and the firm. Risk communication nature and efficiency depend on that (cf. the diagram). As a solution, we think about a legitimate authority organization identified by the public first, but by other actors as well. From the public point of view, if we see the place of pressure groups (e.g. Greenpeace) in the debate as a measure of the lack of trust in the independence of safety authorities, we can infer that it is a reaffirmation of democracy which is demanded by the French public, which could be satisfied with powerful safety authorities. That is why safety authorities have an essential role to play, beyond this of control, in nuclear risk communication towards the public. Diagram: communication path between a nuclear firm and the public during conflict. (author)
Sanne, Johan M.
Organizational changes focused on process orientation are taking place among Swedish nuclear power plants, aiming at improving the operation. The Swedish Nuclear Power Inspectorate has identified a need for increased knowledge within the area for its regulatory activities. In order to analyze what process orientation imply for nuclear power plant safety a number of questions must be asked: 1. How is safety in nuclear power production created currently? What significance does the functional organization play? 2. How can organizational forms be analysed? What consequences does quality management have for work and for the enterprise? 3. Why should nuclear power plants be process oriented? Who are the customers and what are their customer values? Which customers are expected to contribute from process orientation? 4. What can one learn from process orientation in other safety critical systems? What is the effect on those features that currently create safety? 5. Could customer values increase for one customer without decreasing for other customers? What is the relationship between economic and safety interests from an increased process orientation? The deregulation of the electricity market have caused an interest in increased economic efficiency, which is the motivation for the interest in process orientation. among other means. It is the nuclear power plants' owners and the distributors (often the same corporations) that have the strongest interest in process orientation. If the functional organization and associated practices are decomposed, the prerequisites of the risk management regime changes, perhaps deteriorating its functionality. When nuclear power operators consider the introduction of process orientation, the Nuclear Power Inspectorate should require that 1. The operators perform a risk analysis beforehand concerning the potential consequences that process orientation might convey: the analysis should contain a model specifying how safety is currently
Frantzeskou, Elpida; Kastania, Anastasia N; Riza, Elena
Background: This is, to the best of our knowledge, the first occupational health study in Greek fishing. Aim: The aim of the study is to determine the risks for health and safety in Greek fisheries workers by exploring their health status and the health risk factors present in their occupational...... injury, of which half caused more than one day absence, while 14% had a near drowning experience. The health risks factors studied include excessive weight, cardiovascular incidents and dermatological, musculoskeletal, respiratory, hearing, stress, and anxiety problems. The occupational health risk...... factors include alcohol, fatty food consumption, smoking, and lack of physical exercise. Conclusions: The health effects observed are causally related to diet, smoking, and exercise, which in turn relate to the specific working conditions and culture in small-scale fishing that need to be taken...
Chakraborty, S.; Prohaska, G.; Flodin, Y.; Grint, G.; Habermacher, H.; Hallman, A.; Isasia, R.; Melendez, E.; Verduras, E.; Karsa, Z.; Khatib-Rahbar, M.; Koeberlein, K.; Schwaeger, C.; Matahri, N.; Moravcik, I.; Tkac, M.; Preston, J.
In a Concerted Action (CA), sponsored by the European Commission within its 5th Framework Program, a consortium of eleven partners from eight countries has reviewed and evaluated the application of Safety Performance Indicators (SPIs), which - in combination with other tools - can be used to monitor and improve the safety of nuclear power plants. The project was aimed at identification of methods that can be used in a risk-informed regulatory system and environment, and to exploit PSA techniques for the development and use of meaningful additional/alternative SPIs. The CA included the review of existing indicator systems, and the collection of information on the experience from indicator systems by means of a specific questionnaire. One of the most important and challenging issues for nuclear plant owners and/or regulators is to recognize early signs of deterioration in safety performance, caused by influences from management, organization and safety culture (MOSC), before actual events and/or mishaps take place. Most of the existing SPIs as proposed by various organizations are considered as 'lagging' indicators, that is, they are expected to show an impact only when a downward trend has already started. Furthermore, most of the available indicators are at a relatively high level, such that they will not provide useful information on fundamental weaknesses causing the problem in the first place. Regulators' and utilities' views on the use of a Safety Performance Indicator System have also been a part of the development of the CA. (author)
England, A.; Azevedo, K.B.; Bezzina, P.; Henner, A.; McNulty, J.P.
Purpose: To establish an understanding of patient safety within radiography education across Europe by surveying higher education institutions registered as affiliate members of the European Federation of Radiographer Societies (EFRS). Method: An online survey was developed to ascertain data on: programme type, patient safety definitions, relevant safety topics, specific areas taught, teaching and assessment methods, levels of teaching and curriculum drivers. Responses were identifiable in terms of educational institution and country. All 54 affiliated educational institutions were invited to participate. Descriptive and thematic analyses are reported. Results: A response rate of 61.1% (n = 33) was achieved from educational institutions representing 19 countries. Patient safety topics appear to be extremely well covered across curricula, however, topics including radiation protection and optimisation were not reported as being taught at an ‘advanced level’ by five and twelve respondents, respectively. Respondents identified the clinical department as the location of most patient safety-related teaching. Conclusions: Patient safety topics are deeply embedded within radiography curricula across Europe. Variations exist in terms of individual safety topics including, teaching and assessment methods, and the depth in which subjects are taught. Results from this study provide a baseline for assessing developments in curricula and can also serve as a benchmark for comparisons. - Highlights: • First European report on patient safety (PS). • PS deeply embedded within training curricula. • Terms and definitions largely consistent. • Some variety in the delivery and assessment methods. • Report provides baseline and opportunities for comparisons.
There is a trend of growing interest and demand for greater access of unmanned aircraft (UA) to the National Airspace System (NAS) as the ongoing development of UA technology has created the potential for significant economic benefits. However, the lack of a comprehensive and efficient UA regulatory framework has constrained the number and kinds of UA operations that can be performed. This report presents initial results of a study aimed at defining a safety-risk-based UA classification as a plausible basis for a regulatory framework for UA operating in the NAS. Much of the study up to this point has been at a conceptual high level. The report includes a survey of contextual topics, analysis of safety risk considerations, and initial recommendations for a risk-based approach to safe UA operations in the NAS. The next phase of the study will develop and leverage deeper clarity and insight into practical engineering and regulatory considerations for ensuring that UA operations have an acceptable level of safety.
Alotaibi, Yasser K; Federico, Frank
Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety. This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient's safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes.
Mattson, Malin; Hellgren, Johnny; Göransson, Sara
Leader communication is known to influence a number of employee behaviors. When it comes to the relationship between leader communication and safety, the evidence is more scarce and ambiguous. The aim of the present study is to investigate whether and in what way leader communication relates to safety outcomes. The study examines two leader communication approaches: leader safety priority communication and feedback to subordinates. These approaches were assumed to affect safety outcomes via different employee behaviors. Questionnaire data, collected from 221 employees at two hospital wards, were analyzed using structural equation modeling. The two examined communication approaches were both positively related to safety outcomes, although leader safety priority communication was mediated by employee compliance and feedback communication by organizational citizenship behaviors. The findings suggest that leader communication plays a vital role in improving organizational and patient safety and that different communication approaches seem to positively affect different but equally essential employee safety behaviors. The results highlights the necessity for leaders to engage in one-way communication of safety values as well as in more relational feedback communication with their subordinates in order to enhance patient safety. Copyright © 2015 Elsevier Ltd. and National Safety Council. Published by Elsevier Ltd. All rights reserved.
Schneider, Eric C; Ridgely, M Susan; Quigley, Denise D; Hunter, Lauren E; Leuschner, Kristin J; Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C
This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.
Full Text Available Purpose: The current development of patient safety reporting systems is criticized for loss of information and low data quality due to the lack of a uniformed domain knowledge base and text processing functionality. To improve patient safety reporting, the present paper suggests an ontological representation of patient safety knowledge. Design/methodology/approach: We propose a framework for constructing an ontological knowledge base of patient safety. The present paper describes our design, implementation, and evaluation of the ontology at its initial stage. Findings: We describe the design and initial outcomes of the ontology implementation. The evaluation results demonstrate the clinical validity of the ontology by a self-developed survey measurement. Research limitations: The proposed ontology was developed and evaluated using a small number of information sources. Presently, US data are used, but they are not essential for the ultimate structure of the ontology. Practical implications: The goal of improving patient safety can be aided through investigating patient safety reports and providing actionable knowledge to clinical practitioners. As such, constructing a domain specific ontology for patient safety reports serves as a cornerstone in information collection and text mining methods. Originality/value: The use of ontologies provides abstracted representation of semantic information and enables a wealth of applications in a reporting system. Therefore, constructing such a knowledge base is recognized as a high priority in health care.
Sahlström, Merja; Partanen, Pirjo; Turunen, Hannele
To analyze patient safety incidents (PSIs) reported by patients and their use in Finnish healthcare organizations. Cross-sectional study. About 15 Finnish healthcare organizations ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland. The study population included all Finnish patients who had voluntarily reported PSI via web-based system in 2009-15. Quantitative analysis of patients' safety reports, inductive content analysis of patients' suggestions to prevent the reoccurrence incidents and how those suggestions were used in healthcare organizations. Patients reported 656 PSIs, most of which were classified by the healthcare organizations' analysts as problems associated with information flow (32.6%) and medications (18%). Most of the incidents (65%) did not cause any harm to patients. About 76% of the reports suggested ways to prevent reoccurrence of PSIs, most of which were feasible, system-based amendments of processes for reviewing or administering treatment, anticipating risks or improving diligence in patient care. However, only 6% had led to practical implementation of corrective actions in the healthcare organizations. The results indicate that patients report diverse PSIs and suggest practical systems-based solutions to prevent their reoccurrence. However, patients' reports rarely lead to corrective actions documented in the registering system, indicating that there is substantial scope to improve utilization of patients' reports. There is also a need for strong patient safety management, including willingness and commitment of HCPs and leaders to learn from safety incidents.
Marek L. Kowalski
Full Text Available Abstract One of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing, deliberate induction in the office of allergic symptoms to offending compounds (provocation tests or intentional application of potentially dangerous substances (allergy vaccine to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation. Information on the risk of diagnostic and therapeutic procedures in allergic diseases has been accumulated in the medical literature for decades; however, except for allergen specific immunotherapy, it has never been presented in a systematic fashion. Up to now no single document addressed the risk of the most commonly used medical procedures in the allergy office nor attempted to present general requirements necessary to assure the safety of these procedures. Following review of available literature a group of allergy experts within the World Allergy Organization (WAO, representing various continents and areas of allergy expertise, presents this report on risk associated with diagnostic and therapeutic procedures in allergology and proposes a consensus on safety requirements for performing procedures in allergy offices. Optimal safety measures including appropriate location, type and required time of supervision, availability of safety equipment, access to specialized emergency services, etc. for various procedures have been recommended. This document should be useful for allergists with already established
Rostagno, Marcos H
All farm animals will experience some level of stress during their lives. Stress reduces the fitness of an animal, which can be expressed through failure to achieve production performance standards, or through disease and death. Stress in farm animals can also have detrimental effects on the quality of food products. However, although a common assumption of a potential effect of stress on food safety exists, little is actually known about how this interaction may occur. The aim of this review was to examine the current knowledge of the potential impact of stress in farm animals on food safety risk. Colonization of farm animals by enteric pathogens such as Escherichia coli O157:H7, Salmonella, and Campylobacter, and their subsequent dissemination into the human food chain are a major public health and economic concern for the food industries. This review shows that there is increasing evidence to demonstrate that stress can have a significant deleterious effect on food safety through a variety of potential mechanisms. However, as the impact of stress is difficult to precisely determine, it is imperative that the issue receives more research attention in the interests of optimizing animal welfare and minimizing losses in product yield and quality, as well as to food safety risks to consumers. While there is some evidence linking stress with pathogen carriage and shedding in farm animals, the mechanisms underlying this effect have not been fully elucidated. Understanding when pathogen loads on the farm are the highest or when animals are most susceptible to infection will help identifying times when intervention strategies for pathogen control may be most effective, and consequently, increase the safety of food of animal origin.
Nganje, William E.
This paper develops a dynamic framework for efficient quantitative risk assessment from the simplest general risk, combining three parameters (contamination, exposure, and dose response) in a Kataoka safety-first model and a Poisson probability representing the uncertainty effect or jump processes associated with food safety. Analysis indicates that incorporating jump processes in food safety risk assessment provides more efficient cost/risk tradeoffs. Nevertheless, increased margin of safety...
... 42 Public Health 1 2010-10-01 2010-10-01 false Continued protection of patient safety work product... GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.208 Continued protection of patient safety work...
... 42 Public Health 1 2010-10-01 2010-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a) Privilege...
... 42 Public Health 1 2010-10-01 2010-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.212 Nonidentification of patient safety work product. (a...
Arriaga Redondo, María; Sanz López, Ester; Rodríguez Sánchez de la Blanca, Ana; Marsinyach Ros, Itziar; Collados Gómez, Laura; Díaz Redondo, Alicia; Sánchez Luna, Manuel
Due to the complexity and characteristics of their patients, neonatal units are risk areas for the development of adverse events (AE). For this reason, there is a need to introduce and implement some tools and strategies that will help to improve the safety of the neonatal patient. Safety check-lists have shown to be a useful tool in other health areas but they are not sufficiently developed in Neonatal Units. A quasi-experimental prospective study was conducted on the design and implementation of the use of a checklist and evaluation of its usefulness for detecting incidents. The satisfaction of the health professionals on using the checklist tool was also assessed. The compliance rate in the neonatal intensive care unit (NICU) was 56.5%, with 4.03 incidents per patient being detected. One incident was detected for every 5.3 checklists used. The most frequent detected incidents were those related to medication, followed by inadequate alarm thresholds, adjustments of the monitors, and medication pumps. The large majority (75%) of the NICU health professionals considered the checklist useful or very useful, and 68.75% considered that its use had managed to avoid an AE. The overall satisfaction was 83.33% for the professionals with less than 5 years working experience, and 44.4% of the professionals with more than 5 years of experience were pleased or very pleased. The checklists have shown to be a useful tool for the detection of incidents, especially in NICU, with a positive assessment from the health professionals of the unit. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.
Kanerva, Anne; Kivinen, Tuula; Lammintakanen, Johanna
Purpose The organisational level and leadership development are crucial elements in advancing patient safety, because patient safety weaknesses are often caused by system failures. However, little is known about how frontline leader and director teams can be supported to develop patient safety practices. The purpose of this study is to describe the patient safety development process carried out by nursing leaders and directors. The research questions were: how the chosen development areas progressed in six months' time and how nursing leaders view the participatory development process. Design/methodology/approach Participatory action research was used to engage frontline nursing leaders and directors into developing patient safety practices. Semi-structured group interviews ( N = 10) were used in data collection at the end of a six-month action cycle, and data were analysed using content analysis. Findings The participatory development process enhanced collaboration and gave leaders insights into patient safety as a part of the hospital system and their role in advancing it. The chosen development areas advanced to different extents, with the greatest improvements in those areas with simple guidelines to follow and in which the leaders were most participative. The features of high-reliability organisation were moderately identified in the nursing leaders' actions and views. For example, acting as a change agent to implement patient safety practices was challenging. Participatory methods can be used to support leaders into advancing patient safety. However, it is important that the participants are familiar with the method, and there are enough facilitators to steer development processes. Originality/value Research brings more knowledge of how leaders can increase their effectiveness in advancing patient safety and promoting high-reliability organisation features in the healthcare organisation.
Kozine, Igor; Duijm, Nijs Jan; Lauridsen Kurt [Risoe National Laboratory, Roskilde (Denmark). Systems Analysis Department
The current paper gives an overview of the legislation and the methods used in safety and risk management in the chemical industry within Europe and in particular within the European Union. The paper is based on a report that has been written for the SOS-1 project under the Nordic nuclear safety research (NKS). Safety- and risk-related matters in the process industry, in particular, in chemical, within the EU are subject to consideration at three levels: (1) EU legislation, (2) European/intemational standardisation, and (3) socio-economic analysis. EC Directives define the 'essential requirements', e.g., protection of health and safety, that must be fulfilled when goods are placed on the market or some industry is put into operation. The European standards bodies (CEN, CENELEC and ETSI) have the task of establishing the corresponding technical specifications, meeting the essential requirements of the Directives, compliance with which will provide a presumption of conformity with the essential requirements. Such specifications are referred to as 'harmonised standards'. Compliance with harmonised standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. This view is stated in the 'New Approach' to technical harmonisation and standardisation (details can be found on the web page: http://europe.eu.int/comm/enterprise/newapproach/standardization/index .html). Standardisation as well as the regulation of technical risks is increasingly being undertaken at European or international level. The European legislator limits its role to the affirmation of overall objectives, and leaves it to the economic players to draw up the technical procedures and standards to specify in detail the ways and means of attaining them. Many countries have introduced requirements that new legislation and/or administrative regulations be subject to socio-economic analysis
Merrill, Katreena Collette
The purpose of this study was to explore the relationship between nurse manager (NM) leadership style and safety climate. Nursing leaders are needed who will change the environment and increase patient safety. Hospital NMs are positioned to impact day-to-day operations. Therefore, it is essential to inform nurse executives regarding the impact of leadership style on patient safety. A descriptive correlational study was conducted in 41 nursing departments across 9 hospitals. The hospital unit safety climate survey and multifactorial leadership questionnaire were completed by 466 staff nurses. Bivariate and regression analyses were conducted to determine how well leadership style predicted safety climate. Transformational leadership style was demonstrated as a positive contributor to safety climate, whereas laissez-faire leadership style was shown to negatively contribute to unit socialization and a culture of blame. Nursing leaders must concentrate on developing transformational leadership skills while also diminishing negative leadership styles.
Full Text Available Kamran MA Aziz Aseer Diabetes Center, Aseer Central Hospital, Ministry of Health, Abha, Saudi Arabia Abstract: Diabetes management during Ramadan fasting is challenging to the physician in terms of minimizing the risk of hypoglycemia. As compared to oral hypoglycemic agents (OHAs and sulfonylureas (SUs, which carry a higher and significant risk of hypoglycemia, newer antidiabetic agents such as dipeptidyl peptidase-4 (DPP-4 inhibitors have demonstrated lower risk of hypoglycemia during Ramadan fasting, with better patient compliance. In addition to diabetes education and pre-Ramadan assessments, the physician should also consider use of DPP-4 inhibitors (such as vildagliptin during Ramadan fasting to minimize the risk of hypoglycemia in type 2 diabetic subjects. Severe episodes of hypoglycemia have been demonstrated in recent research and clinical trials with OHAs/SUs. Conversely, these research observations have also demonstrated comparative safety and efficacy with lower risk of hypoglycemia associated with vildagliptin. Current research review has collected evidence-based clinical trials and observations for the drug vildagliptin to minimize the risk of hypoglycemia during Ramadan fasting, while at the same time focusing the role of diabetes self-management education (DSME, pre-Ramadan assessments, and patient care. Keywords: hypoglycemia, DPP4-inhibitors, oral hypoglycemic agents, Ramadan fasting, type 2 diabetes, vildagliptin
Roewekamp, M.; Berg, H.P.
Different types of data are necessary to perform risk based fire safety assessments and, in particular, to quantify the fire event tree considering the plant specific conditions. Data on fire barriers, fire detection and extinguishing, including also data on secondary effects of a fire, have to be used for quantifying the potential hazard and damage states. The existing German database on fires in nuclear power plants (NPPs) is very small. Therefore, in general generic data, mainly from US databases, are used for risk based safety assessments. Due to several differences in the plant design and conditions generic data can only be used as conservative assumptions. World-wide existing generic data on personnel failures in case of fire fighting have only to be adapted to the plant specific conditions inside the NPP to be investigated. In contrary, unavailabilities of fire barrier elements may differ strongly depending on different standards, testing requirements, etc. In addition, the operational behaviour of active fire protection equipment may vary depending on type and manufacturer. The necessity for more detailed and for additional plant specific data was the main reason for generating updated German data on the operational behaviour of active fire protection equipment/features in NPPs to support risk based fire safety analyses being recommended to be carried out as an additional tool to deterministic fire hazard analyses in the frame of safety reviews. The results of these investigations revealed a broader and more realistic database for technical reliability of active fire protection means, but improvements as well as collection of further data are still necessary. (author)
Rahn, F.J.; Sursock, J.P.; Hosler, J.
The Electric Power Research Institute (EPRI) started a program entitled risk-based prioritization in 1992. The purpose of this program is to provide generic technical support to the nuclear power industry relative to its recent initiatives in the area of operations and maintenance (O ampersand M) cost control using state-of-the-art risk methods. The approach uses probabilistic risk assessment (PRA), or similar techniques, to allocate resources commensurate with the risk posed by nuclear plant operations. Specifically, those items or events that have high risk significance would receive the most attention, while those with little risk content would command fewer resources. As quantified in a companion paper,close-quote the potential O ampersand M cost reduction inherent in this approach is very large. Furthermore, risk-based methods should also lead to safety improvements. This paper outlines the way that the EPRI technical work complements the technical, policy, and regulatory initiatives taken by others in the industry and provides an example of the approach as used to prioritize motor-operated valve (MOV) testing in response to US Nuclear Regulatory Commission (NRC) Generic Letter 89-10
Mikkelsen, Kim Lyngby; Thommesen, Jacob; Andersen, Henning Boje
Objectives Validation of a Danish patient safety incident classification adapted from the World Health Organizaton's International Classification for Patient Safety (ICPS-WHO). Design Thirty-three hospital safety management experts classified 58 safety incident cases selected to represent all types.......513 (range: 0.193–0.804). Kappa and ICC showed high correlation (r = 0.99). An inverse correlation was found between the prevalence of type and inter-rater reliability. Results are discussed according to four factors known to determine the inter-rater agreement: skill and motivation of raters; clarity...
Putnam, Luke R; Levy, Shauna M; Kellagher, Caroline M; Etchegaray, Jason M; Thomas, Eric J; Kao, Lillian S; Lally, Kevin P; Tsao, KuoJen
Effective communication and patient safety practices are paramount in health care. Surgical residents play an integral role in the perioperative team, yet their perceptions of patient safety remain unclear. We hypothesized that surgical residents perceive the perioperative environment as more unsafe than their faculty and operating room staff despite completing a required safety curriculum. Surgeons, anesthesiologists, and perioperative nurses in a large academic children's hospital participated in multifaceted, physician-led workshops aimed at enhancing communication and safety culture over a 3-y period. All general surgery residents from the same academic center completed a hospital-based online safety curriculum only. All groups subsequently completed the psychometrically validated safety attitudes questionnaire to evaluate three domains: safety culture, teamwork, and speaking up. Results reflect the percent of respondents who slightly or strongly agreed. Chi-square analysis was performed. Sixty-three of 84 perioperative personnel (75%) and 48 of 52 surgical residents (92%) completed the safety attitudes questionnaire. A higher percentage of perioperative personnel perceived a safer environment than the surgical residents in all three domains, which was significantly higher for safety culture (68% versus 46%, P = 0.03). When stratified into two groups, junior residents (postgraduate years 1-2) and senior residents (postgraduate years 3-5) had lower scores for all three domains, but the differences were not statistically significant. Surgical residents' perceptions of perioperative safety remain suboptimal. With an enhanced safety curriculum, perioperative staff demonstrated higher perceptions of safety compared with residents who participated in an online-only curriculum. Optimal surgical education on patient safety remains unknown but should require a dedicated, systematic approach. Copyright © 2015 Elsevier Inc. All rights reserved.
Carayon, Pascale; Wood, Kenneth E
Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety.
Carayon, Pascale; Wood, Kenneth E.
Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety. PMID:20543237
Jaimes, Camilo; Murcia, Diana J.; Miguel, Karen; DeFuria, Cathryn; Sagar, Pallavi; Gee, Michael S.
Analysis of safety reports has been utilized to guide practice improvement efforts in adult magnetic resonance imaging (MRI). Data specific to pediatric MRI could help target areas of improvement in this population. To estimate the incidence of safety reports in pediatric MRI and to determine associated risk factors. In a retrospective HIPAA-compliant, institutional review board-approved study, a single-institution Radiology Information System was queried to identify MRI studies performed in pediatric patients (0-18 years old) from 1/1/2010 to 12/31/2015. The safety report database was queried for events matching the same demographic and dates. Data on patient age, gender, location (inpatient, outpatient, emergency room [ER]), and the use of sedation/general anesthesia were recorded. Safety reports were grouped into categories based on the cause and their severity. Descriptive statistics were used to summarize continuous variables. Chi-square analyses were performed for univariate determination of statistical significance of variables associated with safety report rates. A multivariate logistic regression was used to control for possible confounding effects. A total of 16,749 pediatric MRI studies and 88 safety reports were analyzed, yielding a rate of 0.52%. There were significant differences in the rate of safety reports between patients younger than 6 years (0.89%) and those older (0.41%) (P<0.01), sedated (0.8%) and awake children (0.45%) (P<0.01), and inpatients (1.1%) and outpatients (0.4%) (P<0.01). The use of sedation/general anesthesia is an independent risk factor for a safety report (P=0.02). The most common causes for safety reports were service coordination (34%), drug reactions (19%), and diagnostic test and ordering errors (11%). The overall rate of safety reports in pediatric MRI is 0.52%. Interventions should focus on vulnerable populations, such as younger patients, those requiring sedation, and those in need of acute medical attention. (orig.)
Jaimes, Camilo [Massachusetts General Hospital, Harvard Medical School, Division of Neuroradiology, Department of Radiology, Boston, MA (United States); Murcia, Diana J. [Massachusetts General Hospital, Harvard Medical School, Division of Abdominal Imaging, Department of Radiology, Boston, MA (United States); Miguel, Karen; DeFuria, Cathryn [Massachusetts General Hospital, Harvard Medical School, Quality and Safety Office, Department of Radiology, Boston, MA (United States); Sagar, Pallavi; Gee, Michael S. [Massachusetts General Hospital for Children, Harvard Medical School, Division of Pediatric Imaging, Department of Radiology, Boston, MA (United States)
Analysis of safety reports has been utilized to guide practice improvement efforts in adult magnetic resonance imaging (MRI). Data specific to pediatric MRI could help target areas of improvement in this population. To estimate the incidence of safety reports in pediatric MRI and to determine associated risk factors. In a retrospective HIPAA-compliant, institutional review board-approved study, a single-institution Radiology Information System was queried to identify MRI studies performed in pediatric patients (0-18 years old) from 1/1/2010 to 12/31/2015. The safety report database was queried for events matching the same demographic and dates. Data on patient age, gender, location (inpatient, outpatient, emergency room [ER]), and the use of sedation/general anesthesia were recorded. Safety reports were grouped into categories based on the cause and their severity. Descriptive statistics were used to summarize continuous variables. Chi-square analyses were performed for univariate determination of statistical significance of variables associated with safety report rates. A multivariate logistic regression was used to control for possible confounding effects. A total of 16,749 pediatric MRI studies and 88 safety reports were analyzed, yielding a rate of 0.52%. There were significant differences in the rate of safety reports between patients younger than 6 years (0.89%) and those older (0.41%) (P<0.01), sedated (0.8%) and awake children (0.45%) (P<0.01), and inpatients (1.1%) and outpatients (0.4%) (P<0.01). The use of sedation/general anesthesia is an independent risk factor for a safety report (P=0.02). The most common causes for safety reports were service coordination (34%), drug reactions (19%), and diagnostic test and ordering errors (11%). The overall rate of safety reports in pediatric MRI is 0.52%. Interventions should focus on vulnerable populations, such as younger patients, those requiring sedation, and those in need of acute medical attention. (orig.)
Full Text Available According to A. Maslow’s  hierarchy of human needs the need for safety and security is a priority for mankind. The concept ‘safety culture’ appeared only in 1986, when theChernobyldisaster made the whole world muse upon human relationship with technology . This global catastrophe was a caution, but not for everyone. Potent academic systems and elaborated instruments of a huge economical value have been invoked in maintaining the satisfaction of biogenetic needs, whereas any manual on safety topic has not been issued yet. Even such progressive communities as the European Union, elaborating long-term strategic decisions, do not find clear and reasonable principles that would encourage to choose safe technologies with respect to present and future generations. Giving way to the ostensible effectiveness of centralized technologies such as equipment, communication, energetic that are well-disposed to big business, the majority of politicians and even scientists are not able to estimate the risk that is programmed in the choice of dangerous and insecure technical decisions. It is not still realized that none of the technologies is worth a human life or safety.The level of social maturity is a factor stipulating the merge of two concepts ‘safety’ and „a person“. At the time when industrial priorities were dominant the concept ‘safety techniques’ had been used putting stress on peculiarities of working with technical devices and on the ways manpower could be adjusted to them. Later the term ‘Safety of labour’ appeared. It drew attention to the labour process and its peculiarities. The assimilation of European culture has determined the introduction of the notion ‘personnel safety and health’ to labour relations. The postindustrial stage of humanity development brings the new understanding of major values. Individual is now identified as a personality as well as human life is understood as the major value. The natural
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Yasser K. Alotaibi
Full Text Available Since the original Institute of Medicine (IOM report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety. This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient’s safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes.
Case managers may think their job doesn't involve patient safety, but they promote safety by ensuring a safe discharge and are in a position to see safety breaches and mistakes all over the hospital. CMS includes discharge planning in its worksheets for surveyors to use to assess a hospital's compliance with Medicare Conditions of Participation. Because they work with patients from admission to discharge, case managers know which clinicians are competent, those who are not, and may observe safety breaches like failure to wash hands and leaving the catheter in too long. Case managers should spend enough time with their patients to know their situations at home and their support systems and use the information to create workable and safe discharge plans. Hospitals should create an environment and a culture where case managers and other clinicians feel comfortable speaking up when they see safety breaches.
Brereton, S.; McLouth, L.; Odell, B.
The National Ignition Facility (NIF) is a proposed U.S. Department of Energy inertial confinement laser fusion facility. The candidate sites for locating the NIF are: Los Alamos National Laboratory, Sandia National Laboratory, the Nevada Test Site, and Lawrence Livermore National Laboratory (LLNL), the preferred site. The NIF will operate by focusing 192 laser beams onto a tiny deuterium-tritium target located at the center of a spherical target chamber. The NIF mission is to achieve inertial confinement fusion (ICF) ignition, access physical conditions in matter of interest to nuclear weapons physics, provide an above ground simulation capability for nuclear weapons effects testing, and contribute to the development of inertial fusion for electrical power production. The NIF has been classified as a radiological, low hazard facility on the basis of a preliminary hazards analysis and according to the DOE methodology for facility classification. This requires that a safety analysis be prepared under DOE Order 5481.1B, Safety Analysis and Review System. A draft Preliminary Safety Analysis Report (PSAR) has been written, and this will be finalized later in 1996. This paper summarizes the safety issues associated with the operation of the NIF and the methodology used to study them. It provides a summary of the methodology, an overview of the hazards, estimates maximum routine and accidental exposures for the preferred site of LLNL, and concludes that the risks from NIF operations are low
Verstappen, Wim; Gaal, Sander; Bowie, Paul; Parker, Diane; Lainer, Miriam; Valderas, Jose M.; Wensing, Michel; Esmail, Aneez
ABSTRACT Background: Healthcare can cause avoidable serious harm to patients. Primary care is not an exception, and the relative lack of research in this area lends urgency to a better understanding of patient safety, the future research agenda and the development of primary care oriented safety programmes. Objective: To outline a research agenda for patient safety improvement in primary care in Europe and beyond. Methods: The LINNEAUS collaboration partners analysed existing research on epidemiology and classification of errors, diagnostic and medication errors, safety culture, and learning for and improving patient safety. We discussed ideas for future research in several meetings, workshops and congresses with LINNEAUS collaboration partners, practising GPs, researchers in this field, and policy makers. Results: This paper summarizes and integrates the outcomes of the LINNEAUS collaboration on patient safety in primary care. It proposes a research agenda on improvement strategies for patient safety in primary care. In addition, it provides background information to help to connect research in this field with practicing GPs and other healthcare workers in primary care. Conclusion: Future research studies should target specific primary care domains, using prospective methods and innovative methods such as patient involvement. PMID:26339841
Verstappen, Wim; Gaal, Sander; Bowie, Paul; Parker, Diane; Lainer, Miriam; Valderas, Jose M; Wensing, Michel; Esmail, Aneez
Healthcare can cause avoidable serious harm to patients. Primary care is not an exception, and the relative lack of research in this area lends urgency to a better understanding of patient safety, the future research agenda and the development of primary care oriented safety programmes. To outline a research agenda for patient safety improvement in primary care in Europe and beyond. The LINNEAUS collaboration partners analysed existing research on epidemiology and classification of errors, diagnostic and medication errors, safety culture, and learning for and improving patient safety. We discussed ideas for future research in several meetings, workshops and congresses with LINNEAUS collaboration partners, practising GPs, researchers in this field, and policy makers. This paper summarizes and integrates the outcomes of the LINNEAUS collaboration on patient safety in primary care. It proposes a research agenda on improvement strategies for patient safety in primary care. In addition, it provides background information to help to connect research in this field with practicing GPs and other healthcare workers in primary care. Future research studies should target specific primary care domains, using prospective methods and innovative methods such as patient involvement.
Enge, I.; Edgren, J.
This volume contains six contributions dealing with the properties, safety and economic aspects (lower risks but higher costs of new low-osmonality contrast media compared to the older high-osmonality, ionic ones) of contrast media used in radiology, and risks involved in procedures for administering of radiologic contrast media. (H.W.). refs.; figs.; tabs
Candura, S M; Verni, P; Minelli, C M; Rosso, G L; Cappelli, M I; Strambi, S; Martellosio, V
The present paper tries to identify the occupational risk factors (physical, chemical, biological, psychological), variable depending on jobs and tasks, to which the heterogeneous public safety/security workers are exposed. The fight against criminality and public order maintenance imply (sometimes fatal) traumatic risks, and expose to psychophysical and sensorial tiring, unfavourable macro- and microclimatic conditions, the risk of baropathy (air navigation, underwater activities), noise (generated by firearms and several other sources), vibrations and shakings (automatic weapons, transport vehicles), the risk of electric injury, ionizing (X and gamma rays) and non-inonizing (ultraviolet rays, microwaves and radiofrequencies, electromagnetic fields) radiations. Chemical hazards include carbon monoxide and other combustion products (fires, urban traffic), substances released in chemical accidents, tear gases, lead (firing grounds, metal works, environmental pollution), solvents, lubrificants and cutting oils (mechanic repair and maintenance), laboratory materials and reagents, irritant and/or sensitizing agents contained in gloves. The main biological risks are tetanus, blood-borne diseases (viral hepatitis, AIDS), aerogenous diseases (e.g., tuberculosis, Legionnaire's disease, epidemic cerebrospinal meningitis), dog- or horse-transmitted zoonosis. Finally, emotional, psychosomatic and behavioural stress-related disorders (e.g., burn-out syndrome, post-traumatic stress disorder) are typically frequent. The presence of numerous and diversified hazards among public safety/security forces imposes the adoption of occupational medicine measures, including risk assessment, health education, technical and environmental prevention, personal protective devices, sanitary surveillance and biological monitoring, clinical interventions (diagnosis, therapy and rehabilitation of occupational accidents and illnesses), prompt medico-legal evaluation of occupational
Ilan, Roy; Fowler, Robert
The science of safety is well established in such disciplines as the automotive and aviation industry. In this brief history of safety science as it pertains to patient care, we review remote and recent publications that have guided the maturation of this field that has particular relevance to the complex structure of systems, personnel, and therapies involved in caring for the critically ill.
Novegno, A.; Askulaj, Eh.
Problems of accident prevention in industry and power engineering are considered for the sake of environment and human health protection. Investigations into comparison of power system risks are conducted; based on the data obtained a possibility to control the risk has appeared. The IAEA provides an active assistance in realization of a program of coordinated investigations on the risk assessment using the cost-benefit method. For each NPP investigation into all types of its effect on the environment (risk for personnel and population under normal radioactivity releases and in case of accidents), is conducted. Two approaches to calculating the impacts of accidents at NPPs-'determination' one, based on the designed accident and safety probability evaluation exist. Regional approach appears to be the best one when solving the problems of risk control. Attention is paid to a joint project of the IAEA-UNO and WHO related to risk assessment and control for human health and environment protection at power and other complex commercial systems
Xia, Nini; Wang, Xueqing; Griffin, Mark A; Wu, Chunlin; Liu, Bingsheng
While risk perception is a key factor influencing safety behavior, the academia lacks specific attention to the ways that workers perceive risk, and thus little is known about the mechanisms through which different risk perceptions influence safety behavior. Most previous research in the workplace safety domain argues that people tend to perceive risk based on rational formulations of risk criticality. However, individuals' emotions can be also useful in understanding their perceptions. Therefore, this research employs an integrated analysis concerning the rational and emotional perspectives. Specifically, it was expected that the identified three rational ways of perceiving risk, i.e., perceived probability, severity, and negative utility, would influence the direct emotional risk perception. Furthermore, these four risk perceptions were all expected to positively but differently influence safety behavior. The hypotheses were tested using a sample of 120 construction workers. It was found that all the three rational risk perceptions significantly influenced workers' direct perception of risk that is mainly based on emotions. Furthermore, safety behavior among workers relied mainly on emotional perception but not rational calculations of risk. This research contributes to workplace safety research by highlighting the importance of integrating the emotional assessment of risk, especially when workers' risk perception and behavior are concerned. Suggested avenues for improving safety behavior through improvement in risk perception include being aware of the possibility of different ways of perceiving risk, promoting experience sharing and accident simulation, and uncovering risk information. Copyright © 2017 Elsevier Ltd. All rights reserved.
Myles, Paul S; Leslie, Kate; Chan, Matthew T V; Forbes, Andrew; Peyton, Philip J; Paech, Michael J; Beattie, W Scott; Sessler, Daniel I; Devereaux, P J; Silbert, Brendan; Schricker, Thomas; Wallace, Sophie
Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. Of 10,102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·83–1·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (pnitrous oxide use in major non-cardiac surgery. Nitrous oxide did not increase the risk of death and cardiovascular complications or
Hari Prasad, M.; Vinod, Gopika; Saraf, R.K.; Ghosh, A.K.
Probabilistic Safety Assessment has become a key tool as on today to identify and understand Nuclear Power Plant vulnerabilities. As a result of the availability of these PSA studies, there is a desire to use them to enhance plant safety and to operate the nuclear stations in the most efficient manner. Risk Monitor is a PC based tool, which computes the real time safety level and assists plant personnel to manage day-to-day activities. Risk Monitor is a PC based user friendly software tool used for modification and re-analysis of a nuclear Power plant. Operation of Risk Monitor is based on PSA methods for assisting in day to day applications. Risk Monitoring programs can assess the risk profile and are used to optimize the operation of Nuclear Power Plants with respect to a minimum risk level over the operating time. This report presents the background activities of Risk Monitor, its application areas and the step by step procedure for the user.to interact with the software. This software can be used with the PSA model of any Nuclear Power Plant. (author)
Aim: The overall aim of the thesis was to investigate patient safety culture, team performance and the use of simulation-based team training for building patient safety in intensive care nursing. Methods: Quantitative and qualitative methods were used. In Study I, 220 RNs from ten ICUs responded to a patient safety culture questionnaire analysed with statistics. Studies II-IV were based on an evaluation of a simulation-based team training programme. Studies II-III included 53 RNs from seven I...