Modifying Regulatory Practices to Create a Safe and Effective Working Environment Within a Shared Resource Laboratory During a Global Pandemic.
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ABSTRACT:
SUBMITTER: Filby A
PROVIDER: S-EPMC7753821 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
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Modifying Regulatory Practices to Create a Safe and Effective Working Environment Within a Shared Resource Laboratory During a Global Pandemic.
Filby Andrew A Haviland David L DL Jones Derek D DD López Andrea Bedoya AB Orlowski-Oliver Eva E Rieger Aja M AM
Cytometry. Part A : the journal of the International Society for Analytical Cytology 20201127 1
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Project description:A biosafety plan is essential to establish appropriate practices for biosafety in a shared resource laboratory (SRL). A biosafety plan will contain the essential information for the use of biological samples on specific instrumentation, their apparent risks, and the steps that should be taken to mitigate these risks. Establishment of a biosafety plan can be a daunting task as the variety of pathogens that come through the SRL is highly diverse and may change over time; however, having a plan that can adapt to this variety will provide a framework for addressing concerns and educating personnel and users on biosafety practices. Using resources available at your institution and developing a robust relationship with health and safety personnel at your institution is key to generating an effective biosafety plan. Here we provide a basic underlying structure for a biosafety plan to aid SRL personnel in generating or maintaining their biosafety procedures, and provide guidance for establishing a dynamic, living biosafety plan.
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Project description:BackgroundCOVID-19 disease has had a profound impact worldwide since it was discovered in Wuhan, China, in December 2019. Laboratory testing is crucial to prompt identification of positive cases, initiation of treatment and management strategies. However, medical scientists are vulnerable to infection due to the risk of exposure in the laboratory and the community. This study sought to determine the awareness of laboratory safety measures, assess the personal efforts of medical scientists in creating a safe laboratory environment for testing and examine the laboratory safety enabling factors.MethodsThe data used for the study were generated among medical scientists in Nigeria through an internet-broadcasted questionnaire and were analyzed using IBM SPSS Statistics (version 25).ResultsThe majority of the respondents had a high awareness of laboratory safety measures (60.3%) and demonstrated good personal efforts in creating a safe laboratory testing environment (63%). The level of awareness of laboratory safety measures was significantly associated with respondents' level of education (χ2 = 6.143; p = 0.046) and influences respondents' efforts in creating a safe laboratory testing environment (p = 0.007). However, just a few respondents could convincingly attest to the availability of adequate and appropriate PPE with proper utilization training (45.1%), adequate rest and other welfare packages (45.8%) as well as access to appropriate Biological Safety Cabinets (BSCs) and other essential equipment in their laboratories (48.8%). Furthermore, a significant association existed between the availability of laboratory safety enabling factors and respondents' efforts in creating a safe environment for testing with the p-value ranging between < 0.0001 and 0.003.ConclusionThis study revealed that despite the high awareness of safety measures and good personal efforts of the study participants in creating a safe laboratory-testing environment, there was poor availability of safety facilities, equipment, support and welfare packages required to enhance their safety. It is, therefore, crucial to provide necessary laboratory biosafety equipment and PPE in order not to compromise medical scientists' safety as they perform their duties in COVID-19 pandemic response.
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Project description:Improved hygiene depends on the accessibility and availability of effective disinfectant solutions. These disinfectant solutions are unavailable to many communities worldwide due to resource limitations, among other constraints. Safe and effective chlorine-based disinfectants can be produced via simple electrolysis of salt water, providing a low-cost and reliable option for on-site, local production of disinfectant solutions to improve sanitation and hygiene. This study reports on a system (herein called "Electro-Clean") that can produce concentrated solutions of hypochlorous acid (HOCl) using readily available, low-cost materials. With just table salt, water, graphite welding rods, and a DC power supply, the Electro-Clean system can safely produce HOCl solutions (~1.5 liters) of up to 0.1% free chlorine (i.e.,1000 ppm) in less than two hours at low potential (5 V DC) and modest current (~5 A). Rigorous testing of free chlorine production and durability of the Electro-Clean system components, described here, has been verified to work in multiple locations around the world, including microbiological tests conducted in India and Mexico to confirm the biocidal efficacy of the Electro-Clean solution as a surface disinfectant. Cost estimates are provided for making HOCl locally with this method in the USA, India, and Mexico. Findings indicate that Electro-Clean is an affordable alternative to off-the-shelf commercial chlorinator systems in terms of first costs (or capital costs), and cost-competitive relative to the unit cost of the disinfectant produced. By minimizing dependence on supply chains and allowing for local production, the Electro-Clean system has the potential to improve public health by addressing the need for disinfectant solutions in resource-constrained communities.
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Project description:In March 2020, with lockdown due to the coronavirus pandemic underway, the Francis Crick Institute (the Crick) regeared its research laboratories into clinical testing facilities. Two pipelines were established, one for polymerase chain reaction and the other for Serology. This article discusses the Cricks Flow Cytometry Science Technology Platform (Flow STP) role in setting up the Serology pipeline. Pipeline here referring to the overarching processes in place to facilitate the receipt of human sera through to a SARs-CoV-2 enzyme-linked immunosorbent assay result. We examine the challenges that had to be overcome by a research laboratory to incorporate clinical diagnostics and the processes by which this was achieved. It describes the governance required to run the service, the design of the standard operating procedures (SOPs) and pipeline, the setting up of the assay, the validation required to show the robustness of the pipeline and reporting the results of the assay. Finally, as the lockdown started to ease in June 2020, it examines how this new service affects the daily running of the Flow STP. © 2020 The Authors. Cytometry Part A published by Wiley Periodicals LLC on behalf of International Society for Advancement of Cytometry.
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Project description:BACKGROUND:Surgery and anesthesia are indivisible parts of health care, but safe and timely care requires more than operating rooms and skilled providers. One vital component of a functional surgical system is reliable blood transfusion. While almost half of all blood is donated in high-income countries (HICs), over eighty percent of the global population lives outside of these countries. High-income countries have on average 30 donations per 1000 people, and the average age of transfusion recipient is over 65. Most low-income countries (LICs) have fewer than five donations per 1000 people, where maternal hemorrhage and childhood anemia are the most common indications for transfusion. In LICs, greater than 50% of blood is administered to children under 5 years of age. This study aims to snapshot, by survey, available resources for transfusion and then discusses the infrastructure and cultural barriers to optimal transfusion practice. METHODS:In January 2019, a 10-question survey was sent electronically to physician anesthesiologists working in low- and middle-income countries to examine resources and practice patterns for blood transfusion. Subsequent discussions illustrate obstacles contributing to low availability of blood products and illuminate infrastructure and cultural barriers preventing optimal transfusion practices. SURVEY RESULTS:Acquiring whole blood takes hours. Clinicians wait days to receive packed red blood cells or platelets. Fresh frozen plasma is available but untimely. For many, protocols for massive transfusion are rare, and for transfusion, ratios are nonexistent. Complete blood counts take hours, and coagulation profiles are severely delayed. DISCUSSION OF INFRASTRUCTURE AND CULTURAL BARRIERS:With few voluntary, unpaid, donors and inconsistent supply of testing kits, donated blood is unsafe. Donors are seasonal for farming communities, endemic malaria areas, and student donors recruited through schools. Cultural beliefs fuel distrust. Transfusion specialists, concentrated in urban areas, see rural patients presenting late. Inadequate triaging and supervision jeopardize patients to shock. Inadequate blood storage leads to waste. Modeling systems from HICs fail to overcome hurdles faced by clinicians working with distinctive belief systems and unique patient populations.
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Project description:ObjectivesThere is scant research about laboratory monitoring in people taking conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for rheumatic disease. Our objective was to conduct a scoping study to assess the range of current attitudes and the variation in practice of laboratory monitoring of csDMARDs by rheumatologists and trainees.MethodsAustralian and overseas rheumatologists or trainees were invited through newsletter, Twitter and personal e-mail, to complete an anonymous online survey between 1 February and 22 March 2021. Questions focused on laboratory tests requested by csDMARD prescribed, frequency/pattern of monitoring, influence of additional factors and combination therapy, actions in response to abnormal tests, and attitudes to monitoring frequencies. Results were presented descriptively and analysed using linear and logistic regression.ResultsThere were 221 valid responses. Most respondents were from Australia (n = 53, 35%) followed by the US (n = 39, 26%), with a slight preponderance of women (n = 84, 56%), ≥ 11 years in rheumatology practice (n = 83, 56%) and in mostly public practice (n = 79, 53%). Respondents had a wide variation in the frequency and scheduling of tests. In general, respondents reported increasing monitoring frequency if patients had numerous comorbidities or if both methotrexate and leflunomide were being taken concurrently. There was a wide variety of responses to abnormal monitoring results and 27 (40%) considered that in general, monitoring tests are performed too frequently.ConclusionsThe results demonstrated a wide variation in the frequency of testing, factors that should influence this, and what responses to abnormal test results are appropriate, indicates a likely lack of evidence and the need to define the risks, benefits and costs of different csDMARD monitoring regimens.
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Project description:Systemic administration of interleukin (IL)-12 has been shown to induce potent anti-tumor immune responses in preclinical cancer models. Previous clinical trials using bolus IL-12 injection through maximal tolerable dosing (MTD) strategies indicated limited efficacy alongside unwanted side-effects. Our group developed IL-12-loaded PLGA nanospheres (IL12ns) that release their contents systemically in a slow, controlled manner. An immune diagnostic platform (IDP), capable of monitoring therapeutic response through peripheral blood sampling, was designed alongside this immunostimulatory therapy. The systemic immune responses from MTD and IL12ns dosing strategies were analyzed using this IDP in healthy mice. Importantly, the MTD was associated with aberrant peripheral immune stimulation, evidenced by increased IL-12, interferon gamma (IFNG), and IL-10 signaling. The immune-protective effects of IL12ns were supported by increases in pro-inflammatory plasma cytokines/chemokines without the maladaptive transcriptomic signatures in circulating peripheral immune cells. These data ultimately support the necessity of a vector system for safe immunostimulatory IL-12 therapy.
2024-01-16 | GSE241939 | GEO
Project description:OBJECTIVES:The aim of this study was to identify current problems and potential solutions to improve the working environment for the delivery of safe surgical care in the UK. DESIGN:Prospective, questionnaire-based cross-sectional study. SETTING/PARTICIPANTS:Following validation, an electronic questionnaire was distributed to postgraduate local education and training board distribution lists, the Royal College of Surgeons of Edinburgh (RCSEd) mailing lists and trainee organisations. This consisted of a single open-ended question inviting five open-ended responses. Throughout the 13-week study period, the survey was also published on a number of social media platforms. RESULTS:A total of 505 responders completed the survey, of which 35% were consultants, 30% foundation doctors, 17% specialty trainees, 11% specialty doctors, 5% core trainees and <1% surgical nurse practitioners. A total of 2238 free-text answers detailed specific actions to improve the working environment. These responses were individually coded and then grouped into nine categories (staff resources, non-staff resources, support, working conditions, communication and team work, systems improvement, patient centred, training and education, and miscellaneous). CONCLUSIONS:The results of this study have identified a number of key areas that, if addressed, may improve the environment for the delivery of safer surgical care. Common themes that emerged across all grades included: increased front-line staff; a return to a 'firm' structure to improve team continuity; greater senior support; and improved hospital facilities to help staff rest and recuperate. While unlimited funding remains unrealistic, many of the suggestions could be implemented in a cost-neutral fashion and include insightful ideas for remodelling or restructuring the workforce to improve the efficiency of the surgical team. The findings of this study formed the basis of a set of recommendations published by the RCSEd as a discussion paper.
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Project description:Evidence suggests that mangroves protect economic activity in coastal areas. We estimate this protection from mangroves and coastal elevation globally, examining both "direct" and "indirect" exposure events (< 100 km vs. ≥ 100 km distance from a cyclone's "eye", respectively). We find that higher elevation (≥ 50 m) or wide mangroves (≥ 10 m seaward width) alone shelter economic activity from indirect cyclone exposure, whereas protection from direct cyclone exposure occurs only in high elevation communities with wide mangroves. Our results reveal that the majority of these "safe havens" are in upper middle-income countries but provide significant benefits to populations in lower middle-income countries.
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Project description:BackgroundThe initiatives of precision medicine and learning health systems require databases with rich and accurately captured data on patient characteristics. We introduce the Clinical Registry, AdminisTrative Data and Electronic Medical Records (CREATE) database, which includes linked data from 4 population databases: Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH; a national clinical registry), Sunrise Clinical Manager (SCM) electronic medical record (city-wide), the Discharge Abstract Database (DAD), and the National Ambulatory Care Reporting System (NACRS). The intent of this work is to introduce a cardiovascular-specific database for pursuing precision health activities using big data analytics.MethodsWe used deterministic data linkage to link SCM electronic medical record data to APPROACH clinical registry data using patient identifier variables. The APPROACH-SCM data set was subsequently linked to DAD and NACRS to obtain inpatient and outpatient cohort data. We further validated the quality of the linkage, where applicable, in these databases by comparing against the Alberta Health Insurance Care Plan registry database.ResultsWe achieved 99.96% linkage across these 4 databases. Currently, there are 30,984 patients with 35,753 catheterizations in the CREATE database. The inpatient cohort contained 65.75% (20,373/30,984) of the patient sample, whereas the outpatient cohort contained 29.78% (9226/30,984). The infrastructure and the process to update and expand the database has been established.ConclusionsCREATE is intended to serve as a database for supporting big data analytics activities surrounding cardiac precision health. The CREATE database will be managed by the Centre for Health Informatics at the University of Calgary, and housed in a secure high-performance computing environment.
| S-EPMC8134941 | biostudies-literature