scholarly journals Quality Improvement in Clinical Research: ESA Utilization to improve Patient Safety Monitoring, time management, and Research Compliance.

Author(s):  
Maria Del Pino ◽  
Ana Bonmati ◽  
Patricia Mendoza

We analyzed the capabilities of Electronic Signature Administrators (ESA) in reporting adverse and serious adverse events (AE/SAE) in clinical trials to improve Principal Investigator (PI) oversight. The current and most conventional way to sing on AE/SAE reports, by wet ink paper signatures, faces long report completion times, miscommunications, and a high rate of error that can put the study and the patient at risk. We demonstrate here that ESAs can easily take over this task, speeding up the process and enhancing patient's safety and research compliance. Our results show that the average of 31 days to obtain wet-signatures on AE/SAE reports is reduced to merely 3 days after the implementation of ESA. We also found that research professionals spend more than half an hour in commuting each time they need to get PI signatures, while this time is zero if ESAs are used. Finally, an anonymous survey distributed to coordinators shows that ESAs can be well received when implemented since 86% have used an ESA and are satisfied with it or are interested in using it, while only 14% of the participants are either not interested or not satisfied.

2021 ◽  
Author(s):  
Athar Ali Tajik

AimsThis paper aims to address the research question: What is an effective framework to strategically select nationally reported serious adverse events in healthcare for investigation to improve patient safety? BackgroundThe healthcare system is globally under strain due to an aging population with increasing co-morbidities. Serious adverse events remain a consistent challenge. Patient safety can be improved by investigating cases and addressing underlying systemic risks. However, due to resource limitations, only a limited number of cases can be investigated. This necessitates a strategic selection of cases with the greatest potential for improving patient safety. This paper aims to develop a theoretical framework that identifies the key strategic issues that should be addressed when setting up a new national healthcare safety investigative body to select adverse events for investigation.MethodsThis study will primarily draw on semi-structured interviews with senior stakeholders in key healthcare regulatory agencies in Norway. For comparative purposes, a stakeholder from a key United Kingdom healthcare agency was also interviewed. The interview template is developed based on insights from a literature review and develop existing safety frameworks such as the Framework for Managing Risk. The paper also draws on selected tools from Strategy Management.ResultsA novel theoretical framework was developed to help set up case selection mechanism in a new national investigative body. The framework consists of four strategic themes that should be considered both sequentially and cyclically. Within each theme several key policy questions were identified.(1)Governance: role and powers, independence, and stakeholder engagement (2)Monitoring risk: adverse events, quality indicators, and unexplained variation(3)Strategic portfolio: broad coverage, vulnerable groups, and underreporting (4)Individual case selection: outcome, systemic risk, and learning potentialConclusionsPolicy makers should carefully consider the themes and questions in the proposed theoretical framework when setting up a new national safety investigative agency. In turn, this can ensure that the implemented selection mechanism identifies cases with the greatest potential to improve patient safety.


Author(s):  
Peter J. Hawrylak ◽  
Ajay Ogirala ◽  
Bryan A. Norman ◽  
Jayant Rajgopal ◽  
Marlin H. Mickle

Radio frequency identification (RFID) and Real Time Location Systems (RTLS) provide a wireless means to identify, locate, monitor, and track assets and people. RFID technology can be used for resource and patient location, to reduce costs, improve inventory accuracy, and improve patient safety. A number of pilot deployments of RFID and RTLS technology have yielded promising results, reduced costs, and improved patient care. However, there are three major issues facing RFID and RTLS systems, privacy, security, and location accuracy. As described in this chapter the privacy and security issues can be easily addressed by employing standard security measures. Location accuracy issues are physics-related and new advances continue to improve this accuracy. However, in hospital applications accuracy to the room level is sufficient.


Author(s):  
Hortensia De la Corte-Rodriguez ◽  
E. Carlos Rodriguez-Merchan ◽  
M. Teresa Alvarez-Roman ◽  
Monica Martin-Salces ◽  
Victor Jimenez-Yuste

Background: It is important to discard those practices that do not add value. As a result, several initiatives have emerged. All of them try to improve patient safety and the use of health resources. Purpose: To present a compendium of "do not do recommendations" in the context of hemophilia. Methods: A review of the literature and current clinical guidelines has been made, based on the best evidence available to date. Results: The following 13 recommendations stand out: 1) Do not delay the administration of factor after trauma; 2) do not use fresh frozen plasma or cryoprecipitate; 3) do not use desmopressin in case of hematuria; 4) do not change the product in the first 50 prophylaxis exposures; 5) do not interrupt immunotolerance; 6) do not administer aspirin or NSAIDs; 7) do not administer intramuscular injections; 8) do not do routine radiographs of the joint in case of acute hemarthrosis; 9) Do not apply closed casts for fractures; 10) do not discourage the performance of physical activities; 11) do not deny surgery to a patient with an inhibitor; 12) do not perform instrumental deliveries in fetuses with hemophilia; 13) do not use factor IX (FIX) in patients with hemophilia B with inhibitor and a history of anaphylaxis after administration of FIX. Conclusions: The information mentioned previously can be useful in the management of hemophilia, from different levels of care. As far as we know, this is the first initiative of this type regarding hemophilia.


2021 ◽  
Vol 10 (1) ◽  
pp. e001086
Author(s):  
Claire Cushley ◽  
Tom Knight ◽  
Helen Murray ◽  
Lawrence Kidd

Background and problemThe WHO Surgical Safety Checklist has been shown to improve patient safety as well as improving teamwork and communication in theatres. In 2009, it was made a mandatory requirement for all NHS hospitals in England and Wales. The WHO checklist is intended to be adapted to suit local settings and was modified for use in Gloucestershire Hospitals NHS Foundation Trust. In 2018, it was decided to review the use of the adapted WHO checklist and determine whether improvements in compliance and engagement could be achieved.AimThe aim was to achieve 90% compliance and engagement with the WHO Surgical Safety Checklist by April 2019.MethodsIn April 2018, a prospective observational audit and online survey took place. The results showed compliance for the ‘Sign In’ section of the checklist was 55% and for the ‘Time Out’ section was 91%. Engagement by the entire theatre team was measured at 58%. It was proposed to move from a paper checklist to a wall-mounted checklist, to review and refine the items in the checklist and to change the timing of ‘Time Out’ to ensure it was done immediately prior to knife-to-skin.ResultsFollowing its introduction in September 2018, the new wall-mounted checklist was reaudited. Compliance improved to 91% for ‘Sign In’ and to 94% for ‘Time Out’. Engagement by the entire theatre team was achieved 100% of the time. Feedback was collected, adjustments made and the new checklist was rolled out in stages across all theatres. A reaudit in December 2018 showed compliance improved further, to 99% with ‘Sign In’ and to 100% with ‘Time Out’. Engagement was maintained at 100%.ConclusionsThe aim of the project was met and exceeded. Since April 2019, the new checklist is being used across all theatres in the Trust.


2013 ◽  
Vol 2 (3) ◽  
pp. 25 ◽  
Author(s):  
Jane Carthey

The paper summarises previous theories of accident causation, human error, foresight, resilience and system migration. Five lessons from these theories are used as the foundation for a new model which describes how patient safety emerges in complex systems like healthcare: the System Evolution Erosion and Enhancement model. It is concluded that to improve patient safety, healthcare organisations need to understand how system evolution both enhances and erodes patient safety.


2017 ◽  
Vol 22 (03) ◽  
pp. 124-125
Author(s):  
Maria Weiß

Hatch LD. et al. Intervention To Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit. Pediatrics 2016; 138: e20160069 Kinder auf der Neugeborenen-Intensivstation sind besonders durch Komplikationen während des Krankenhausaufenthaltes gefährdet. Dies gilt auch für die Intubation, die relativ häufig mit unerwünschten Ereignissen einhergeht. US-amerikanische Neonatologen haben jetzt untersucht, durch welche Maßnahmen sich die Komplikationsrate bei Intubationen in ihrem Perinatal- Zentrum senken lässt.


Author(s):  
Fateh Bazerbachi ◽  
Akira Dobashi ◽  
Swarup Kumar ◽  
Sanjay Misra ◽  
Navtej S Buttar ◽  
...  

Abstract Background Endoscopic cyanoacrylate (glue) injection of fundal varices may result in life-threatening embolic adverse events through spontaneous gastrorenal shunts (GRSs). Balloon-occluded retrograde transvenous occlusion (BRTOcc) of GRSs during cyanoacrylate injection may prevent serious systemic glue embolization through the shunt. This study aimed to evaluate the efficacy and safety of a combined endoscopic–interventional radiologic (BRTOcc) approach for the treatment of bleeding fundal varices. Methods We retrospectively analysed the data of patients who underwent the combined procedure for acutely bleeding fundal varices between January 2010 and April 2018. Data were extracted for patient demographics, clinical and endoscopic findings, technical details, and adverse events of the endoscopic–BRTOcc approach and patient outcomes. Results We identified 30 patients (13 [43.3%] women; median age 58 [range, 25–92] years) with gastroesophageal varices type 2 (53.3%, 16/30) and isolated gastric varices type 1 (46.7%, 14/30) per Sarin classification, and median clinical and endoscopic follow-up of 151 (range, 4–2,513) days and 98 (range, 3–2,373) days, respectively. The median volume of octyl-cyanoacrylate: Lipiodol injected was 7 (range, 4–22) mL. Procedure-related adverse events occurred in three (10.0%) patients, including transient fever, non-life-threatening pulmonary glue embolism, and an injection-site ulcer bleed. Complete gastric variceal obturation was achieved in 18 of 21 patients (85.7%) at endoscopic follow-up. Delayed variceal rebleeding was confirmed in one patient (3.3%) and suspected in two patients (6.7%). Although no procedure-related deaths occurred, the overall mortality rate was 46.7%, primarily from liver-disease progression and co-morbidities. Conclusion The combined endoscopic–BRTOcc procedure is a relatively safe and effective technique for bleeding fundal varices, with a high rate of variceal obturation and a low rate of serious adverse events.


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