scholarly journals Adverse Events and Corrective and Preventive Actions

2021 ◽  
pp. 89-97
Author(s):  
Phuong Huynh ◽  
Renza Monteleone
Keyword(s):  
Adverse Events ◽  
Hospital Management ◽  
Quality System ◽  
International Standards ◽  
Quality And Safety ◽  
Biological Product ◽  
Legal Requirements ◽  
Preventive Actions ◽  
Robust System

AbstractEverything that is not compliant with SOP, guidelines, national and international standards, and legal requirements could affect the quality and safety of the cellular products and all processes. To guarantee the safety of cellular products, to protect recipients, donors, and personnel, it is necessary to have in place a robust system for reporting, investigating, and resolving all occurrences: errors, accidents, adverse events, biological product deviations, and complaints.In some case, the management of adverse events and other type of deviations is included in hospital management, but even in this case, the transplant programme quality system should have specific SOP that includes a system to manage any issues, actions to prevent adverse events and deviations, and a description of the step to resolve them.

State Marketing as a Factor in the Strengthening of Macroeconomic Indicators

2015 ◽  
Author(s):  
Anara Kamalova
Keyword(s):  
Foreign Trade ◽  
Public Services ◽  
International Standards ◽  
Effective Control ◽  
Kyrgyz Republic ◽  
Quality And Safety ◽  
External Market ◽  
The World ◽  
Macroeconomic Indicators ◽  
Internal Potential

This article deals with the state of marketing and its role in strengthening macroeconomic indicators of the Kyrgyz Republic, but it does not apply in the country properly. The need for the use of state marketing is intensifying with the entering of Kyrgyzstan to EEU as a member. To improve the structure of foreign trade, it is proposed marketing initiatives and research on the study of the external market, the internal potential of the country, specialization of production, the creation of "umbrella brand" for the country, the best way of satisfying consumers of public services, effective control of the quality and safety of products, regulation of the relevant parameters, that meet international standards, the fight against counterfeit, creating a positive image of Kyrgyzstan in the world and others.

scholarly journals Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Informed Consent ◽  
Adverse Events ◽  
Knee Arthroplasty ◽  
Evidence Based ◽  
Nocebo Effect ◽  
Legal Requirements ◽  
Consent Forms ◽  
Link Type ◽  
Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

scholarly journals Does Teleradiology Improve Inter-hospital Management of Head-Injury?

1997 ◽  
Vol 24 (3) ◽  
pp. 235-239 ◽  
Keyword(s):  
Head Injury ◽  
Adverse Events ◽  
Hospital Management ◽  
District General Hospital ◽  
Therapeutic Interventions ◽  
Head Injured ◽  
Hospital Transfer ◽  
Group 2 ◽  
Injured Patients ◽  
Group 1

ABSTRACT:Objective:In many countries, neurosurgical care is concentrated in regional centres, which often necessitates the inter-hospital transfer of patients with head injury for optimal treatment. The aim of this study was to evaluate the role of teleradiology in the management of head-injured patients when referred from a district general hospital to a tertiary neurosurgical centre.Methods:Prospective data were collected over a fifteen month period from March '95 to May '96. Head-injured patients referred without the facility of teleradiology (Group 1), were compared to similar patients referred with teleradiologie images (Group 2), with particular regard to therapeutic intervention before transfer and adverse events during transfer.Results:There were 28 patients in Group 1 and 35 in Group 2, of which 31 were transferred. Both groups were comparable with respect to age, admission Glasgow Coma Scale score, and intracranial pathology. For patients transferred with teleradiology consultation (Group 2), therapeutic interventions were more (32.1% vs. 10.7%, p = 0.06), adverse events during transfer were significantly lower (6.4% vs. 32.1%, p = 0.01), and transfer time was reduced (72 vs. 80 minutes, p = 0.38). Four patients in Group 2 were treated by a mobile neurosurgical team at the referring hospital because of rapid clinical deterioration.Conclusion:Our findings indicate that teleradiology has an important role in improving inter-hospital management of head-injured patients.

Transitions of Care—Disposition Planning

2019 ◽  
pp. 293-312
Author(s):  
Kimberly Kopecky ◽  
Pringl Miller
Keyword(s):  
Adverse Events ◽  
Care Transitions ◽  
Safety Data ◽  
Transitions Of Care ◽  
Transition Of Care ◽  
Quality And Safety ◽  
Care Continuum ◽  
Hospital Readmission Rates ◽  
National Patient ◽  
Policy Priority

Care transitions are a hot topic in healthcare delivery, research, and policy today because national patient quality and safety data have identified transition of care as a critical time during a patient’s care continuum when both quality and safety are potentially compromised. Poorly executed transitions of care are associated with preventable adverse events and hospital readmissions that are burdensome to patients and their caregivers, correlating to suboptimal outcomes and exorbitant costs. Therefore, reducing both adverse events during a care transition and hospital readmission rates is a matter of clinical and policy priority. High-risk surgical patients are particularly vulnerable to preventable adverse events and readmissions during care transitions because of the complexity of their care needs. To address this problem, governmental and other healthcare organizations are allocating resources and investing in research initiatives to improve, refine, and standardize the transition-of-care process in order to optimize quality of care throughout a patient’s care continuum.

scholarly journals Quality and Safety of Minimally Invasive Surgery: Past, Present, and Future

2014 ◽  
Vol 6 ◽  
pp. BECB.S10967 ◽  
Author(s):  
Bernadette McCrory ◽  
Chad A. LaGrange ◽  
M.S. Hallbeck
Keyword(s):  
Minimally Invasive Surgery ◽  
Adverse Events ◽  
Minimally Invasive ◽  
Invasive Surgery ◽  
Human Performance ◽  
Motor Vehicle ◽  
The United States ◽  
Quality And Safety ◽  
Surgical Errors ◽  
The Impact

Adverse events because of medical errors are a leading cause of death in the United States (US) exceeding the mortality rates of motor vehicle accidents, breast cancer, and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors because they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery (MIS) has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. To mitigate errors and protect patients, a multidisciplinary approach is needed to improve MIS. Clinical human factors, and biomedical engineering principles and methodologies can be used to develop and assess laparoscopic surgery instrumentation, practices, and procedures. First, the foundational understanding and the imperative to transform health care into a high-quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. Finally, the future of this field and the research needed to further improve the quality and safety of MIS is discussed.

Application of Material Standards and ISO Quality Management Systems

1998 ◽  
Author(s):  
Keith E. W. Coulson ◽  
Dennis G. Quinton ◽  
Thomas C. Slimmon
Keyword(s):  
Quality Management ◽  
Life Cycle Cost ◽  
Performance Testing ◽  
Quality System ◽  
International Standards ◽  
Energy Industry ◽  
Management Systems ◽  
Quality Management Systems ◽  
Full Life Cycle ◽  
The Impact

Since the early 1970’s, the pipeline construction and operation industry has supported the development and implementation of various material standards and specifications. The emphases within the pipeline energy industry was to standardize manufacturing and performance testing processes in the provision of a product which would ensure public safety and reliability of service. The pipeline segment of the energy industry has succeeded in incorporating minimum quality levels by way of industry standards, codes, regulatory requirements and propriety company standards. In addition to these minimum product requirements quality assurance programs have been introduced to enhance the likelihood of conformance to the applicable requirements. In 1975, Canada became the first country to prepare and publish quality system standards for commercial use (Z299 standards). International quality system standards development proliferated in the following years, leading to the establishment of the ISO/TC 176 work team which subsequently led to the issue of the internationally accepted ISO 9000 series of standards. This paper will review both the concept and stages of development of CSA pipe and coating standards. It will also analyze the impact that international standards for Quality Management Systems are having in establishing systematic approaches to assessing levels of quality during material manufacture. Finally, a vision of the possible road to the future will be drawn and the positive impacts for the pipeline industry will be projected from a full life cycle cost perspective.

scholarly journals Adverse events in deceased hospitalised cancer patients as a measure of quality and safety in end-of-life cancer care

2020 ◽  
Author(s):  
Ellinor Christin Haukland ◽  
Christian von Plessen ◽  
Carsten Nieder ◽  
Barthold Vonen
Keyword(s):  
Palliative Care ◽  
Adverse Events ◽  
End Of Life ◽  
Cancer Patients ◽  
Cancer Care ◽  
Quality And Safety ◽  
Negative Consequences ◽  
Specialist Palliative Care ◽  
Early Integration ◽  
Anticancer Treatment

Abstract Background: Anticancer treatment exposes patients to negative consequences such as increased toxicity and decreased quality of life, and there are clear guidelines recommending limiting use of aggressive anticancer treatments for patients near end of life. The aim of this study is to investigate the association between anticancer treatment given during the last 30 days of life and adverse events contributing to death and elucidate how adverse events can be used as a measure of quality and safety in end-of-life cancer care Methods: Retrospective cohort study of 247 deceased hospitalised cancer patients at three hospitals in Norway. The Global Trigger Tool method were used to identify adverse events. We used Poisson regression and binary logistic regression to compare adverse events and association with use of anticancer treatment given during the last 30 days of life. Results: 30 % of deceased hospitalised cancer patients received some kind of anticancer treatment during the last 30 days of life, mainly systemic anticancer treatment. These patients had 62 % more adverse events compared to patients not being treated last 30 days, 39 vs. 24 adverse events per 1 000 patient days (p<0.001, OR 1.62 (1.23 – 2.15). They also had twice the odds of an adverse event contributing to death compared to patients without such treatment, 33 vs. 18 % (p=0.045, OR 1.85 (1.01 – 3.36)). Receiving follow up by specialist palliative care reduced the rate of AEs per 1 000 patient days in both groups by 29 % (p= 0.02, IRR 0.71, CI 95% 0.53 – 0.96). Conclusions: Anticancer treatment given during the last 30 days of life is associated with a significantly increased rate of adverse events and related mortality. Patients receiving specialist palliative care had significantly fewer adverse events, supporting recommendations of early integration of palliative care in a patient safety perspective.

scholarly journals Adverse events in deceased hospitalised cancer patients as a measure of quality and safety in end-of-life cancer care

2020 ◽  
Author(s):  
Ellinor Christin Haukland ◽  
Christian von Plessen ◽  
Carsten Nieder ◽  
Barthold Vonen
Keyword(s):  
Palliative Care ◽  
Adverse Events ◽  
End Of Life ◽  
Cancer Patients ◽  
Cancer Care ◽  
Quality And Safety ◽  
Negative Consequences ◽  
Specialist Palliative Care ◽  
Early Integration ◽  
Anticancer Treatment

Abstract Background: Anticancer treatment exposes patients to negative consequences such as increased toxicity and decreased quality of life, and there are clear guidelines recommending limiting use of aggressive anticancer treatments for patients near end of life. The aim of this study is to investigate the association between anticancer treatment given during the last 30 days of life and adverse events contributing to death and elucidate how adverse events can be used as a measure of quality and safety in end-of-life cancer careMethods: Retrospective cohort study of 247 deceased hospitalised cancer patients at three hospitals in Norway in 2012 and 2013. The Global Trigger Tool method were used to identify adverse events. We used Poisson regression and binary logistic regression to compare adverse events and association with use of anticancer treatment given during the last 30 days of life.Results: 30 % of deceased hospitalised cancer patients received some kind of anticancer treatment during the last 30 days of life, mainly systemic anticancer treatment. These patients had 62 % more adverse events compared to patients not being treated last 30 days, 39 vs. 24 adverse events per 1 000 patient days (p<0.001, OR 1.62 (1.23 – 2.15). They also had twice the odds of an adverse event contributing to death compared to patients without such treatment, 33 vs. 18 % (p=0.045, OR 1.85 (1.01 – 3.36)). Receiving follow up by specialist palliative care reduced the rate of AEs per 1 000 patient days in both groups by 29 % (p= 0.02, IRR 0.71, CI 95% 0.53 – 0.96).Conclusions: Anticancer treatment given during the last 30 days of life is associated with a significantly increased rate of adverse events and related mortality. Patients receiving specialist palliative care had significantly fewer adverse events, supporting recommendations of early integration of palliative care in a patient safety perspective.

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