In the United States, clinical testing is monitored by the federal and state governments, held to standards to ensure the safety and efficacy of these tests, as well as maintaining privacy for patients receiving a test. In order for the ABCTL to lawfully operate in the state of Arizona, it had to meet various legal criteria. These major legal considerations, in no particular order, are: Clinical Laboratory Improvement Amendments compliance; FDA Emergency Use Authorization (EUA); Health Insurance Portability and Accountability Act compliance; state licensure; patient, state, and federal result reporting; and liability. <br/>In this paper, the EUA pathway will be examined and contextualized in relation to the ABCTL. This will include an examination of the FDA regulations and policies that affect the laboratory during its operations, as well as a look at the different authorization pathways for diagnostic tests present during the COVID-19 pandemic.
As much as SARS-CoV-2 has altered the way humans live since the beginning of 2020,<br/>this virus's deadly nature has required clinical testing to meet 2020's demands of higher<br/>throughput, higher accuracy and higher efficiency. Information technology has allowed<br/>institutions, like Arizona State University (ASU), to make strategic and operational changes to<br/>combat the SARS-CoV-2 pandemic. At ASU, information technology was one of the six facets<br/>identified in the ongoing review of the ASU Biodesign Clinical Testing Laboratory (ABCTL)<br/>among business, communications, management/training, law, and clinical analysis. The first<br/>chapter of this manuscript covers the background of clinical laboratory automation and details<br/>the automated laboratory workflow to perform ABCTL’s COVID-19 diagnostic testing. The<br/>second chapter discusses the usability and efficiency of key information technology systems of<br/>the ABCTL. The third chapter explains the role of quality control and data management within<br/>ABCTL’s use of information technology. The fourth chapter highlights the importance of data<br/>modeling and 10 best practices when responding to future public health emergencies.
The privatization of prisons within Arizona has been a hot button issue and needs to be further analyzed to determine their benefits and expenses. To begin this investigation into the effectiveness of private prisons within Arizona and possible steps that need to be taken for its rehabilitation certain definitions and prior research need to be understood. Following this explanation, areas such as costs analysis across different types of prisons, liability rates across differing types of prison guards, and the differing psychology of different types of prisons can be examined to gain an overall assessment of the current performance of privatized prisons within Arizona. After this in-depth analysis of the current private prison system within Arizona, the flaws of the system will become abundantly clear and the solutions that should be implemented to alleviate these problems will be discussed.
As much as SARS-CoV-2 has altered the way humans live since the beginning of 2020, this virus's deadly nature has required clinical testing to meet 2020's demands of higher throughput, higher accuracy and higher efficiency. Information technology has allowed institutions, like Arizona State University (ASU), to make strategic and operational changes to combat the SARS-CoV-2 pandemic. At ASU, information technology was one of the six facets identified in the ongoing review of the ASU Biodesign Clinical Testing Laboratory (ABCTL) among business, communications, management/training, law, and clinical analysis. The first chapter of this manuscript covers the background of clinical laboratory automation and details the automated laboratory workflow to perform ABCTL’s COVID-19 diagnostic testing. The second chapter discusses the usability and efficiency of key information technology systems of the ABCTL. The third chapter explains the role of quality control and data management within ABCTL’s use of information technology. The fourth chapter highlights the importance of data modeling and 10 best practices when responding to future public health emergencies.
This project is designed as part of the multi-student ASU Biodesign Clinical Testing Laboratory (ABCTL) thesis project sponsored and organized by Dr. Carolyn Compton, professor of Life Sciences at ASU and medical director with the ABCTL. This project divides students into teams with Business, Law, Laboratory, IT, and Documentary focused groups, with the goal of providing a comprehensive overview of the operations of the ABCTL as a reference for other institutions and to produce a documentary film about the laboratory. As a member of the IT team, this writeup will focus on quality control throughout the transfer of data in the testing process, security and privacy of data, HIPAA and regulatory compliance, and accessibility of data while maintaining such restrictions.
As much as SARS-CoV-2 has altered the way humans live since the beginning of 2020, this virus's deadly nature has required clinical testing to meet 2020's demands of higher throughput, higher accuracy and higher efficiency. Information technology has allowed institutions, like Arizona State University (ASU), to make strategic and operational changes to combat the SARS-CoV-2 pandemic. At ASU, information technology was one of the six facets identified in the ongoing review of the ASU Biodesign Clinical Testing Laboratory (ABCTL) among business, communications, management/training, law, and clinical analysis. The first chapter of this manuscript covers the background of clinical laboratory automation and details the automated laboratory workflow to perform ABCTL’s COVID-19 diagnostic testing. The second chapter discusses the usability and efficiency of key information technology systems of the ABCTL. The third chapter explains the role of quality control and data management within ABCTL’s use of information technology. The fourth chapter highlights the importance of data modeling and 10 best practices when responding to future public health emergencies.
Change within the cannabis industry could lead to drastic improvements in social justice. Ever since marijuana was first regulated in the United States in the early 1900s, it has been used as the justification for the excessive incarceration and disenfranchisement of targeted groups, specifically, Black and Latino populations. Now, the growing popularity of marijuana, from both the recreational and entrepreneurial perspective, has led to the legalization of recreational cannabis in 15 states. <br/>Although this enterprise is highly profitable and alluring for consumers and business owners, the problem of underrepresentation of minority owned businesses within the industry still remains. This underrepresentation symbolizes the unjust ability for this enterprise to capitalize on those victimized by past drug regulations and on a larger scale, how it perpetuates institutionalized racism. The criminalization of marijuana not only allows for certain groups to remain successful in this booming billion-dollar operation, but also ensures that others remain unseen and left behind. <br/>This thesis aims to show the ways in which the legal cannabis industry can expand and encourage minority-owned businesses to venture into the sector. In this paper, I will attempt to outline the history of cannabis regulation and anti-drug campaigns, and illustrate the lack of diversity within the cannabis industry. I will also touch upon the remedies and reparations for racial inequality and how public policy can address entrepreneur’s demands in future policy considerations and industry practices.
My personal experience with chronic illness served as inspiration for my thesis. At the age of five, I was diagnosed with severe asthma. The following year, I was hospitalized with pneumonia for nearly a month. Despite my health issues, I had a supportive family and grew up relatively well. During my freshman year of college, I hardly experienced any respiratory or allergy problems. Unfortunately, this time period was very short-lived. Due to rapid expansion, the natural flora and fauna of the desert has changed significantly within the last decade. Throughout the remainder of my undergraduate experience, I had a series of respiratory relapses that resulted in numerous medical withdrawals. In addition to health problems, I discovered the college environment poses unique challenges for students with chronic illnesses. Ultimately, this led me to delve deeper into this topic for my thesis.