CDC’s internal control weaknesses led to its initial COVID-19 test kit failure, but CDC ultimately created a working test kit Centers for Disease Control and Prevention (U.S.) COVID-19 Testing -- instrumentation Equipment Failure Analysis Government Regulation Why OIG Did This Audit. HHS is the U.S. Government’s principal agency for protecting the health of all Americans. Included in this role is the responsibility to respond to pandemics. The first cases of COVID-19 were identified in China and reported to the Centers for Disease Control and Prevention (CDC) in December 2019, and the first case in the United States was officially diagnosed on January 20, 2020. In mid-January 2020, CDC began developing a diagnostic test kit to detect COVID-19. Our objective was to review CDC’s process for developing the COVID-19 test kits and determine factors that contributed to the initial COVID-19 test kit failure. How OIG Did This Audit. Using Federal internal control standards, we assessed the effectiveness of CDC’s controls throughout the test kit development process. We interviewed HHS personnel who participated in the development of the COVID-19 test kits, focusing mainly on the CDC laboratories that developed the test kits. We requested and reviewed available documentation such as white papers, final and draft policies and procedures, strategies, and emails that were produced between January and March 2020. We also reviewed the results of CDC’s Root Cause Analysis, in addition to HHS’s Office of the General Counsel’s report of its investigation into the initial test kit failure. [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, October 2023 United States. Department of Health and Human Services. Office of Inspector General. Office of Audit Services, issuing body. Technical Report Text Illustrations 1 online resource (1 PDF file (31 pages)) nlm:nlmuid-9918750684306676-pdf 9918750684306676 http://resource.nlm.nih.gov/9918750684306676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0