OIG announces audit plan for COVID-19 test kits
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced plans to audit the U.S. Centers for Disease Control and Prevention (CDC) widely criticized rollout of novel coronavirus (COVID-19) test kits, in a statement released earlier this week. However, results are not expected to be issued until next year.
When a new viral disease emerges, the CDC develops and distribute tests to state public health laboratories. The CDC uses confirmed viral samples from initial patients to develop these tests. To ensure that it has a functioning test, the CDC also conducts quality assurance reviews. After validating that it has a functioning test, the CDC sends the tests to state public health labs for their use, the OIG statement said.
Over the last few months as COVID-19 cases began to rise, the CDC developed testing kits, called the CDC 2019-Novel Coronavirus Real-Time Reverse Transcriptase-PCR Diagnostic Panel, and sent the kits to qualified laboratories to identify COVID-19 cases.
The OIG plans to review the controls that the HHS has in place to produce and distribute the COVID-19 test kits and whether the CDC has designed and implemented controls to mitigate any potential risks. The objective of the audit is to review the CDC's process of producing and distributing the COVID-19 test kits.
Healthcare experts have widely criticized accessibility, efficiency, and accuracy of COVID-19 testing. The results of the audit will be posted in 2021, according to the OIG.