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.

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.

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.

In 1972, the United States District Court for the Eastern District of Pennsylvania decided the case of Pennsylvania Association for Retarded Citizens (PARC) v. Commonwealth of Pennsylvania, hereafter PARC v. Pennsylvania. The court ruled that the state could not deny an individual's right to equal access to education based on an intellectual or developmental disability status. PARC brought the case against the state of Pennsylvania on behalf of fourteen families with intellectually disabled children who were unable to access to public schools based on their child’s disability. PARC challenged state laws that permitted schools to deny education to children who do not reach the mental age of five, or the average intelligence of people aged five, by the time they begin first grade. Both sides settled following the testimony of expert witnesses on PARC's behalf, and the US District Court approved the consent decree. PARC v. Pennsylvania was one of the first cases to establish that people born with an intellectual disability should have the same access to education as the rest of the population.

In Mills v. Board of Education of District of Columbia (1972), the United States District Court for the District of Columbia held that students with disabilities are entitled to an education, and that education cannot be denied based on the accommodations’ additional cost to the school. Mills was a class action lawsuit brought to the court on behalf of seven children denied public education by the District of Columbia School District because of their disabilities and the cost of accommodations the school would incur to educate them. US District Court Judge Joseph Cornelius Waddy presided over the case and ruled in favor of the students, finding that they were not given due process prior to expulsion from the school. Mills was one of the first cases in the US that guaranteed the right of students with any disability to a public education, regardless of the cost to the school system, and led to comprehensive federal legislation protecting disabled children's right to free public education.

On March 28, 1978, in Stump v. Sparkman, hereafter Stump, the United States Supreme Court held, in a five-to-three decision, that judges have absolute immunity from lawsuits involving any harm their judicial decisions cause. Linda Sparkman, who was unknowingly sterilized when she was fifteen years old in 1971, sued Harold Stump, the county circuit court judge who signed the petition to allow Sparkman’s mother to have her sterilized. Sparkman’s mother stated to Stump that she wanted her daughter sterilized because of Sparkman’s alleged mental deficiencies and sexual promiscuity. Sparkman argued that Stump violated her Fourteenth Amendment rights to due process because nobody informed her about the nature of the procedure and because Stump did not perform typical court proceedings. Stump argued that, because he was acting within his role as a judge, the doctrine of judicial immunity prevented his liability from lawsuit. Stump strengthened the impunity with which judges can act, including acts found to be unconstitutional, regardless of any rights upon which such actions may infringe.

In 1990, the United States Congress passed the Americans with Disabilities Act, or the ADA, which prohibits discrimination against people with disabilities by employers, governments, or public accommodations. Following gains made during the civil rights movements of the 1900s, people with disabilities sought similar anti-discrimination legislation. The ADA was the culmination of decades of protest and advocacy from the disability rights movement. After the ADA, federal law protected people with an impairment that limited major life functions like sight or mobility from discrimination. The ADA changed the lives of millions of Americans with disabilities by expanding the opportunities they had to work, travel, and participate in their communities legally protected from discrimination.