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.

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.

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.

The ASU COVID-19 testing lab process was developed to operate as the primary testing site for all ASU staff, students, and specified external individuals. Tests are collected at various collection sites, including a walk-in site at the SDFC and various drive-up sites on campus; analysis is conducted on ASU campus and results are distributed virtually to all patients via the Health Services patient portal. The following is a literature review on past implementations of various process improvement techniques and how they can be applied to the ABCTL testing process to achieve laboratory goals. (abstract)

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.

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.