Consider Steven Cryos’ words, “When disaster strikes, the time to prepare has passed.” Witnessing domestic water insecurity in events such as Hurricane Katrina, the instability in Flint, Michigan, and most recently the winter storms affecting millions across Texas, we decided to take action. The period between a water supply’s disruption and restoration is filled with anxiety, uncertainty, and distress -- particularly since there is no clear indication of when, exactly, restoration comes. It is for this reason that Water Works now exists. As a team of students from diverse backgrounds, what started as an honors project with the Founders Lab at Arizona State University became the seed that will continue to mature into an economically sustainable business model supporting the optimistic visions and tenants of humanitarianism. By having conversations with community members, conducting market research, competing for funding and fostering progress amid the COVID-19 pandemic, our team’s problem-solving traverses the disciplines. The purpose of this paper is to educate our readers about a unique solution to emerging issues of water insecurity that are nested across and within systems who could benefit from the introduction of a personal water reclamation system, showcase our team’s entrepreneurial journey, and propose future directions that will this once pedagogical exercise to continue fulfilling its mission: To heal, to hydrate and to help bring safe water to everyone.

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.

Consider Steven Cryos’ words, “When disaster strikes, the time to prepare has passed.” Witnessing domestic water insecurity in events such as Hurricane Katrina, the instability in Flint, Michigan, and most recently the winter storms affecting millions across Texas, we decided to take action. The period between a water supply’s disruption and restoration is filled with anxiety, uncertainty, and distress -- particularly since there is no clear indication of when, exactly, restoration comes. It is for this reason that Water Works now exists. As a team of students from diverse backgrounds, what started as an honors project with the Founders Lab at Arizona State University became the seed that will continue to mature into an economically sustainable business model supporting the optimistic visions and tenants of humanitarianism. By having conversations with community members, conducting market research, competing for funding and fostering progress amid the COVID-19 pandemic, our team’s problem-solving traverses the disciplines. The purpose of this paper is to educate our readers about a unique solution to emerging issues of water insecurity that are nested across and within systems who could benefit from the introduction of a personal water reclamation system, showcase our team’s entrepreneurial journey, and propose future directions that will this once pedagogical exercise to continue fulfilling its mission: To heal, to hydrate, and to help bring safe water to everyone.

Consider Steven Cryos’ words, “When disaster strikes, the time to prepare has passed.” Witnessing domestic water insecurity in events such as Hurricane Katrina, the instability in Flint, Michigan, and most recently the winter storms affecting millions across Texas, we decided to take action. The period between a water supply’s disruption and restoration is filled with anxiety, uncertainty, and distress -- particularly since there is no clear indication of when, exactly, restoration comes. It is for this reason that Water Works now exists. As a team of students from diverse backgrounds, what started as an honors project with the Founders Lab at Arizona State University became the seed that will continue to mature into an economically sustainable business model supporting the optimistic visions and tenants of humanitarianism. By having conversations with community members, conducting market research, competing for funding and fostering progress amid the COVID-19 pandemic, our team’s problem-solving traverses the disciplines. The purpose of this paper is to educate our readers about a unique solution to emerging issues of water insecurity that are nested across and within systems who could benefit from the introduction of a personal water reclamation system, showcase our team’s entrepreneurial journey, and propose future directions that will this once pedagogical exercise to continue fulfilling its mission: To heal, to hydrate and to help bring safe water to everyone.

For our project, we explored the growth of the ASU BioDesign Clinical Testing Laboratory (ABCTL) from a standard university research lab to a COVID-19 testing facility through a business lens. The lab has pioneered the saliva-test in the Western United States. This thesis analyzes the laboratory from various business concepts and aspects. The business agility of the lab and it’s quickness to innovation has allowed the lab to enjoy great success. Looking into the future, the laboratory has a promising future and will need to answer many questions to remain the premier COVID-19 testing institution in Arizona.

For our project, we explored the growth of the ASU BioDesign Clinical Testing Laboratory (ABCTL) from a standard university research lab to a COVID-19 testing facility through a business lens. The lab has pioneered the saliva-test in the Western United States. This thesis analyzes the laboratory from various business concepts and aspects. The business agility of the lab and it’s quickness to innovation has allowed the lab to enjoy great success. Looking into the future, the laboratory has a promising future and will need to answer many questions to remain the premier COVID-19 testing institution in Arizona.

For our project, we explored the growth of the ASU BioDesign Clinical Testing Laboratory (ABCTL) from a standard university research lab to a COVID-19 testing facility through a business lens. The lab has pioneered the saliva-test in the Western United States. This thesis analyzes the laboratory from various business concepts and aspects. The business agility of the lab and it’s quickness to innovation has allowed the lab to enjoy great success. Looking into the future, the laboratory has a promising future and will need to answer many questions to remain the premier COVID-19 testing institution in Arizona.

For our project, we explored the growth of the ASU BioDesign Clinical Testing Laboratory (ABCTL) from a standard university research lab to a COVID-19 testing facility through a business lens. The lab has pioneered the saliva-test in the Western United States. This thesis analyzes the laboratory from various business concepts and aspects. The business agility of the lab and it’s quickness to innovation has allowed the lab to enjoy great success. Looking into the future, the laboratory has a promising future and will need to answer many questions to remain the premier COVID-19 testing institution in Arizona.

Early on in the pandemic, ASU leadership recognized an opportunity to involve the Biodesign Institute in an effort to keep local communities safe. Equipped with capital investments (and expertise) in diagnostic testing, university president Michael Crow tasked Dr. Joshua LaBaer - the executive director of Biodesign - to begin mapping out the lab’s logistic capabilities and operational plan. While initially testing through nasopharyngeal swabs, the Arizona Biodesign Clinical Testing Laboratory (ABCTL) eventually developed a saliva-based COVID-19 test that demonstrated higher efficacy and resource-efficiency. By maintaining rapid turnaround times for test results, the ABCTL has helped both the university population and local community operate safely. Lauded as a highly innovative testing site, the lab proved to be an essential asset as ASU, and the world, look to return to normalcy. The purpose of this thesis is to analyze the ABCTL’s inception and development using multi-faceted approaches from the business realm. There will be five topics discussed which are: • Volume I- Stakeholder Theory and Analysis Regarding the COVID-19 Bio-design Institute at Arizona State University (Claire Agee), • Volume II- The Lab as a Business Within a University Environment (Samuel Cosgrove) • Volume III- A Managerial Economic Perspective (Michael Qian) • Volume IV- An Analysis of its Upstream Supply Chain ( Kyle Mattson) • Volume V- An Operations Management Perspective (Corinne English) After these volumes, there will be a discussion about the growth and sustainability of the laboratory looking into the future. Although the ABCTL is young,the ever-changing market dynamics leave the organization with critical decisions going forward.

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.