Where To Report Waste

Fraud, Abuse, Or Retaliation

CDC's Internal Control Weaknesses Led to Its Initial COVID-19 Test Kit Failure, but CDC Ultimately Created a Working Test Kit

Submitting OIG:

Department of Health & Human Services OIG

Date Issued:

Tuesday, October 24, 2023

Agency Reviewed / Investigated:

Department of Health & Human Services

Submitting OIG-Specific Report Number:

A-04-20-02027

Component, if applicable:

Centers for Disease Control and Prevention

Centers for Disease Control and Prevention

Location(s):

GA,

United States

Type of Report:

Audit

Special Projects:

Questioned Costs:

$0

Funds for Better Use:

$0

Number of Recommendations:

6

Report updated under NDAA 5274:

No

View Document:

Attachment	Size
42002027.pdf	2.99 MB

Related Open Recommendations

Recommendation Number	Recommendation Status	Significant Recommendation	Additional Details
24-A-04-007.01	Open	No
We recommend that the Centers for Disease Control and Prevention create policies and procedures for developing test kits that include roles, responsibilities, and oversight.
24-A-04-007.02	Open	No
We recommend that the Centers for Disease Control and Prevention ensure that the recently finalized GRF addresses the findings we identified in this report.
24-A-04-007.03	Open	No
We recommend that the Centers for Disease Control and Prevention develop and implement documented processes to ensure that adequate staffing and laboratory space can be obtained for future responses and provide for separation of duties and supervisor controls.
24-A-04-007.04	Open	No
We recommend that CDC re-evaluate the IMS structure at all levels of CDC's response framework and integrate positions or roles and responsibilities that provide effective oversight of a response effort, including a laboratory-based response effort.
24-A-04-007.05	Open	No
We recommend CDC implement a CDC-wide laboratory document control system.
24-A-04-007.06	Open	No
We recommend that CDC ensure that all infectious disease laboratories implement and periodically evaluate a QMS.