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 COVID-19 pandemic has led to high demand for testing. It also has affected minorities at disproportionate rates, and the impact is made worse due to the underlying mistrust minorities hold against medical institutions. A similar theme is observed against physicians, especially Asian American healthcare providers experiencing firsthand discrimination. Therefore, there is this reciprocal relationship between the patient and provider rooted in mistrust and discriminatory biases. This thesis aims to analyze how ASU Biodesign COVID-19 Testing Lab (ABCTL) functions to implicitly modify potential effects of a patient-provider relationship based on the concepts of health equity and cultural humility. The analysis then suggests that ABCTL accomplished the concept of health equity through community partnerships and by recruiting community healthcare workers for long-term stability, it successfully achieved cultural humility.

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.