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.

The threat of global climate change to the world’s water resources has jeopardized access to clean drinking water across the world and continues to devastate biodiversity and natural life globally. South Africa operates as a useful case study to understand and analyze the effectiveness of public policy responses to the perils of climate change on issues of water access and ecosystem preservation. After the new South African Constitution was enacted in 1997, protecting water resources and ensuring their equitable distribution across the nation’s population was a paramount goal of the young democratic government. The National Water Act was passed in 1998, nationalizing the country’s water infrastructure and putting in place programs seeking to ensure equitable distributive and environmental outcomes. Thus far, it has failed. Access to South Africa’s water resources is as stratified as access to its economy; its aquatic ecosystems remain in grave danger; and many of the same problems of South Africa’s Apartheid era still plague its efforts to create an equitable water system. Decision-making power continues to be concentrated in the hands of the wealthy, at the expense of historically marginalized groups, whose voices are still not adequately heard. Corporate actors still exert undue influence over legislative policy that favors economic growth over environmental sustainability. The looming threat of climate change is exponentially increasing the chances of disasters like Cape Town’s 2018 feared ‘Day Zero’. The National Water Act’s noble intentions were never actualized, and therefore the people of South Africa remain in serious danger of acute and chronic threats to their water supply.

This Project Report documents the accomplishments of an extraordinary group of students, faculty, and staff at the Arizona state University, who participated in a year-long, multidisciplinary, first-of-its-kind academic endeavor entitled “The Making of a COVID Lab.” The lab that is the focus of this project is the ASU Biodesign Clinical Testing Laboratory, known simply as the ABCTL.

Under the direction of Dr. Carolyn Compton, a group of seven Barrett honors students have embarked on a truly unique team thesis project to create a documentary on the process of creating a COVID-19 testing laboratory. This documentary tells the story of the ASU Biodesign Clinical Testing Laboratory (ABCTL), the first lab in the western United States to offer public saliva testing to identify the presence of COVID-19.