scholarly journals Use of failure modes and effects analysis to mitigate potential risks prior to implementation of an intravenous compounding technology

2021 ◽  
Author(s):  
Agnes Ann Feemster ◽  
Melissa Augustino ◽  
Rosemary Duncan ◽  
Anand Khandoobhai ◽  
Meghan Rowcliffe
Keyword(s):  
Medication Safety ◽  
Failure Modes ◽  
Risk Mitigation ◽  
New Technology ◽  
Hazard Index ◽  
Mitigation Strategies ◽  
Investigational Drug ◽  
Workflow Optimization ◽  
Proactive Approach ◽  
Risk Mitigation Strategies

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose The purpose of this study was to identify potential failure points in a new chemotherapy preparation technology and to implement changes that prevent or minimize the consequences of those failures before they occur using the failure modes and effects analysis (FMEA) approach. Methods An FMEA was conducted by a team of medication safety pharmacists, oncology pharmacists and technicians, leadership from informatics, investigational drug, and medication safety services, and representatives from the technology vendor. Failure modes were scored using both Risk Priority Number (RPN) and Risk Hazard Index (RHI) scores. Results The chemotherapy preparation workflow was defined in a 41-step process with 16 failure modes. The RPN and RHI scores were identical for each failure mode because all failure modes were considered detectable. Five failure modes, all attributable to user error, were deemed to pose the highest risk. Mitigation strategies and system changes were identified for 2 failure modes, with subsequent system modifications resulting in reduced risk. Conclusion The FMEA was a useful tool for risk mitigation and workflow optimization prior to implementation of an intravenous compounding technology. The process of conducting this study served as a collaborative and proactive approach to reducing the potential for medication errors upon adoption of new technology into the chemotherapy preparation process.

scholarly journals Medication Safety

2020 ◽  
pp. 435-453
Author(s):  
Hooi Cheng Soon ◽  
Pierangelo Geppetti ◽  
Chiara Lupi ◽  
Boon Phiaw Kho
Keyword(s):  
Medication Errors ◽  
Medication Safety ◽  
Risk Mitigation ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
Mitigation Strategies ◽  
Transitions Of Care ◽  
Patient Morbidity ◽  
Risk Mitigation Strategies ◽  
Core Areas

AbstractPharmacotherapy is the most common therapeutic intervention in healthcare to improve health outcomes of patients. However, there are many instances where prescribed medications resulted in patient morbidity and mortality instead. Medication errors can happen at any step of the medication use process, but a substantial burden of medication-related harm is focused primarily on three priority areas of healthcare delivery: transitions of care, polypharmacy and high-risk situations. This chapter highlights prevalence of issues concerning these three core areas and describes common medication errors as well as risk mitigation strategies to improve service delivery. An appreciation of these inherent risks will enable healthcare providers to navigate the pitfalls better and make efforts to ensure medication safety while providing health services.

Human factors–based risk analysis to improve the safety of doffing enhanced personal protective equipment

2018 ◽  
Vol 40 (2) ◽  
pp. 178-186 ◽  
Author(s):  
Ayse P. Gurses ◽  
Aaron S. Dietz ◽  
Elaine Nowakowski ◽  
Jennifer Andonian ◽  
Maggie Schiffhauer ◽  
...  
Keyword(s):  
Focus Group ◽  
Human Factors ◽  
Personal Protective Equipment ◽  
Failure Modes ◽  
Risk Mitigation ◽  
Mitigation Strategies ◽  
Protective Equipment ◽  
Contributing Factors ◽  
Safety Risks ◽  
Risk Mitigation Strategies

AbstractObjectiveTo systematically assess enhanced personal protective equipment (PPE) doffing safety risks.DesignWe employed a 3-part approach to this study: (1) hierarchical task analysis (HTA) of the PPE doffing process; (2) human factors-informed failure modes and effects analysis (FMEA); and (3) focus group sessions with a convenience sample of infection prevention (IP) subject matter experts.SettingA large academic US hospital with a regional Special Pathogens Treatment Center and enhanced PPE doffing protocol experience.ParticipantsEight IP experts.MethodsThe HTA was conducted jointly by 2 human-factors experts based on the Centers for Disease Control and Prevention PPE guidelines. The findings were used as a guide in 7 focus group sessions with IP experts to assess PPE doffing safety risks. For each HTA task step, IP experts identified failure mode(s), assigned priority risk scores, identified contributing factors and potential consequences, and identified potential risk mitigation strategies. Data were recorded in a tabular format during the sessions.ResultsOf 103 identified failure modes, the highest priority scores were associated with team members moving between clean and contaminated areas, glove removal, apron removal, and self-inspection while preparing to doff. Contributing factors related to the individual (eg, technical/ teamwork competency), task (eg, undetected PPE contamination), tools/technology (eg, PPE design characteristics), environment (eg, inadequate space), and organizational aspects (eg, training) were identified. Participants identified 86 types of risk mitigation strategies targeting the failure modes.ConclusionsDespite detailed guidelines, our study revealed 103 enhanced PPE doffing failure modes. Analysis of the failure modes suggests potential mitigation strategies to decrease self-contamination risk during enhanced PPE doffing.

scholarly journals Point-of-Care Testing Practices, Failure Modes, and Risk-Mitigation Strategies in Emergency Medical Services Programs in the Canadian Province of Alberta

2020 ◽  
Vol 144 (11) ◽  
pp. 1352-1371
Author(s):  
Anna K. Füzéry ◽  
Gerald J. Kost
Keyword(s):  
Emergency Medical Services ◽  
Failure Modes ◽  
Service Providers ◽  
Risk Mitigation ◽  
Point Of Care ◽  
Mitigation Strategies ◽  
Medical Services ◽  
Point Of Care Testing ◽  
Emergency Medical ◽  
Risk Mitigation Strategies

Context.— Emergency medical services (EMS) programs have been using point-of-care testing (POCT) for more than 20 years. However, only a handful of reports have been published in all of that time on POCT practices in field settings. Objective.— To provide an overview of POCT practices and failure modes in 3 of Alberta's EMS programs, and to propose risk-mitigation strategies for reducing or eliminating these failure modes. Design.— Details about POCT practices, failure modes, and risk-mitigation strategies were gathered through (1) conversations with personnel, (2) in-person tours of EMS bases, (3) accompaniment of EMS personnel on missions, (4) internet searches for publicly available information, and (5) a review of laboratory documents. Results.— Practices were most standardized and robust in the community paramedicine program (single service provider, full laboratory oversight), and least standardized and robust in the air ambulance program (4 service providers, limited laboratory oversight). Common failure modes across all 3 programs included device inoperability due to cold weather, analytical validation procedures that failed to consider the unique challenges of EMS settings, and a lack of real-time electronic transmission of results into the health care record. Conclusions.— A provincial framework for POCT in EMS programs is desirable. Such a framework should include appropriate funding models, laboratory oversight of POCT, and relevant expertise on POCT in EMS settings. The framework should also incorporate specific guidance on quality standards that are needed to address the unique challenges of performing POCT in field settings.

A Low-Fidelity Stochastic Model of Viral Spread in Aircraft to Assess Risk Mitigation Strategies

2021 ◽  
Author(s):  
Leigh McCue
Keyword(s):  
Large Scale ◽  
Risk Mitigation ◽  
Mitigation Strategies ◽  
Traffic Network ◽  
Computationally Efficient ◽  
Passenger Compartment ◽  
Stochastic Effects ◽  
Viral Spread ◽  
Risk Mitigation Strategies ◽  
Baseline Health

Abstract The purpose of this work is to develop a computationally efficient model of viral spread that can be utilized to better understand influences of stochastic factors on a large-scale system - such as the air traffic network. A particle-based model of passengers and seats aboard a single-cabin 737-800 is developed for use as a demonstration of concept on tracking the propagation of a virus through the aircraft's passenger compartment over multiple flights. The model is sufficiently computationally efficient so as to be viable for Monte Carlo simulation to capture various stochastic effects, such as number of passengers, number of initially sick passengers, seating locations of passengers, and baseline health of each passenger. The computational tool is then exercised in demonstration for assessing risk mitigation of intervention strategies, such as passenger-driven cleaning of seating environments and elimination of middle seating.

scholarly journals Management of Cardiac Implantable Electrical Devices in Patients Undergoing Radiofrequency Ablation for Spine Pain: Physician Survey and Review of Guidelines

2020 ◽  
Vol 4;23 (7;4) ◽  
pp. E335-E342
Author(s):  
Jason Friedrich
Keyword(s):  
Decision Making ◽  
Chronic Pain ◽  
Radiofrequency Ablation ◽  
Joint Pain ◽  
Risk Mitigation ◽  
Narrative Review ◽  
Mitigation Strategies ◽  
Web Based ◽  
Electrical Devices ◽  
Risk Mitigation Strategies

Background: More patients with cardiac implantable electrical devices (CIEDs) are presenting to spine and pain practices for radiofrequency ablation (RFA) procedures for chronic pain. Although the potential for electromagnetic interference (EMI) affecting CIED function is known with RFA procedures, available guidelines do not specifically address CIED management for percutaneous RFA for zygapophyseal (z-joint) joint pain, and thus physician practice may vary. Objectives: To better understand current practices of physicians who perform RFA for chronic z-joint pain with respect to management of CIEDs. Perioperative CIED management guidelines are also reviewed to specifically address risk mitigation strategies for potential EMI created by ambulatory percutaneous spine RFA procedures. Study Design: Web-based provider survey and narrative review. Setting: Multispecialty pain clinic, academic medical center. Methods: A web-based survey was created using Research Electronic Data Capture (REDCap). A survey link was provided via e-mail to active members of the Spine Intervention Society (SIS), American Society of Regional Anesthesia and Pain Medicine, as well as distributed freely to community Pain Physicians and any receptive academic departments of PM&R or Anesthesiology. The narrative review summarizes pertinent case series, review articles, a SIS recommendation statement, and multi-specialty peri-operative guidelines as they relate specifically to spine RFA procedures. Results: A total of 197 clinicians participated in the survey from diverse clinical backgrounds, including anesthesiology, physical medicine and rehabilitation, radiology, neurosurgery, and neurology, with 81% reporting fellowship training. Survey responses indicate wide variability in provider management of CIEDs before, during, and after RFA for z-joint pain. Respondents indicated they would like more specific guidelines to aid in management and decision-making around CIEDs and spine RFA procedures. Literature review yielded several practice guidelines related to perioperative management of CIEDs, but no specific guideline for percutaneous spine RFA procedures. However, combining the risk mitigation strategies provided in these guidelines, with interventional pain physician clinical experience allows for reasonable management recommendations to aid in decision-making. Limitations: Although this manuscript can serve as a review of CIEDs and aid in management decisions in patients with CIEDs, it is not a clinical practice guideline. Conclusions: Practice patterns vary regarding CIED management in ambulatory spine RFA procedures. CIED presence is not a contraindication for spine RFA but does increase the complexity of a spine RFA procedure and necessitates some added precautions. Key words: Radiofrequency ablation, neurotomy, cardiac implantable electrical device, zygapophyseal joint, spondylosis, neck pain, low back pain, chronic pain

scholarly journals Restarting elective endoscopy safely amidst an evolving pandemic and the impact of patient perception

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Christopher Nguyen ◽  
Kevin T. Kline ◽  
Shehzad Merwat ◽  
Sheharyar Merwat ◽  
Gurinder Luthra ◽  
...  
Keyword(s):  
Risk Mitigation ◽  
Mitigation Strategies ◽  
Transmission Risk ◽  
Dynamic Monitoring ◽  
Successful Model ◽  
Outpatient Procedures ◽  
Risk Patients ◽  
Risk Mitigation Strategies ◽  
Spread Of Infection ◽  
The Impact

Abstract Background The COVID-19 pandemic has led to disruptions in elective and outpatient procedures. Guidance from the Centers for Medicare and Medicaid Services provided a framework for gradual reopening of outpatient clinical operations. As the infrastructure to restart endoscopy has been more clearly described, patient concerns regarding viral transmission during the procedure have been identified. Moreover, the efficacy of the measures in preventing transmission have not been clearly delineated. Methods We identified patients with pandemic-related procedure cancellations from 3/16/2020 to 4/20/2020. Patients were stratified into tier groups (1–4) by urgency. Procedures were performed using our hospital risk mitigation strategies to minimize transmission risk. Patients who subsequently developed symptoms or tested for COVID-19 were recorded. Results Among patients requiring emergent procedures, 57.14% could be scheduled at their originally intended interval. COVID-19 concerns represented the most common rescheduling barrier. No patients who underwent post-procedure testing were positive for COVID-19. No cases of endoscopy staff transmission were identified. Conclusions Non-COVID-19 related patient care during the pandemic is a challenging process that evolved with the spread of infection, requiring dynamic monitoring and protocol optimization. We describe our successful model for reopening endoscopy suites using a tier-based system for safe reintroduction of elective procedures while minimizing transmission to patients and staff. Important barriers included financial and transmission concerns that need to be addressed to enable the return to pre-pandemic utilization of elective endoscopic procedures.

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