Matching Items (2)
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Description

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

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.

ContributorsJenkins, Landon James (Co-author) / Espinoza, Hale Anna (Co-author) / Filipek, Marina (Co-author) / Ross, Nathaniel (Co-author) / Salvatierra, Madeline (Co-author) / Compton, Carolyn (Thesis director) / Rigoni, Adam (Committee member) / Stanford, Michael (Committee member) / School of Life Sciences (Contributor) / School of Politics and Global Studies (Contributor) / Barrett, The Honors College (Contributor)
Created2021-05
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Description

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

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.

ContributorsCompton, Carolyn C. (Project director) / Christianson, Serena L. (Project director) / Floyd, Christopher (Project director) / Schneller, Eugene S (Research team head) / Rigoni, Adam (Research team head) / Stanford, Michael (Research team head) / Cheong, Pauline (Research team head) / McCarville, Daniel R. (Research team head) / Dudley, Sean (Research team head) / Blum, Nita (Research team head) / Magee, Mitch (Research team head) / Agee, Claire (Research team member) / Cosgrove, Samuel (Research team member) / English, Corinne (Research team member) / Mattson, Kyle (Research team member) / Qian, Michael (Research team member) / Espinoza, Hale Anna (Research team member) / Filipek, Marina (Research team member) / Jenkins, Landon James (Research team member) / Ross, Nathaniel (Research team member) / Salvatierra, Madeline (Research team member) / Serrano, Osvin (Research team member) / Wakefield, Alex (Research team member) / Calo, Van Dexter (Research team member) / Nofi, Matthew (Research team member) / Raymond, Courtney (Research team member) / Barwey, Ishna (Research team member) / Bruner, Ashley (Research team member) / Hymer, William (Research team member) / Krell, Abby Elizabeth (Research team member) / Lewis, Gabriel (Research team member) / Myers, Jack (Research team member) / Ramesh, Frankincense (Research team member) / Reagan, Sage (Research team member) / Kandan, Mani (Research team member) / Knox, Garrett (Research team member) / Leung, Michael (Research team member) / Schmit, Jacob (Research team member) / Woo, Sabrina (Research team member) / Anderson, Laura (Research team member) / Breshears, Scott (Research team member) / Majhail, Kajol (Research team member) / Ruan, Ellen (Research team member) / Smetanick, Jennifer (Research team member) / Bardfeld, Sierra (Research team member) / Cura, Joriel (Research team member) / Dholaria, Nikhil (Research team member) / Foote, Hannah (Research team member) / Liu, Tara (Research team member) / Raymond, Julia (Research team member) / Varghese, Mahima (Research team member)
Created2021