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- Creators: Bach, Johann Sebastian, 1685-1750
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)
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.
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.