CDC's Vaccines for Children Program Recipients Did Not Conduct Site Visits at Some Providers as Required

Why OIG Did This Audit

The Vaccines for Children (VFC) program provides vaccines at no cost to children whose parents or guardians may not be able to afford them, which helps ensure that all children have a better chance of receiving recommended vaccinations on schedule. The Centers for Disease Control and Prevention (CDC) requires that program recipients conduct three types of provider site visits (enrollment, compliance, and storage and handling), which allow recipients to determine whether vaccines are stored, handled, and administered in accordance with the laws and policies governing the VFC program. However, multiple State auditors' reports identified overdue site visits, site visits that were not conducted, and overdue followup actions for compliance issues.

Our objective was to determine whether CDC's VFC program recipients conducted site visits at enrolled and active VFC providers according to program requirements.

How OIG Did This Audit

We identified 39,120 providers and 2 CDC-approved depot providers that were enrolled and active at any point from July 1, 2020, through June 30, 2021. We reviewed 3 years' worth of data for all enrollment, compliance, and storage and handling site visits and reviewed the data for more than 127,000 followup actions associated with these site visits.

What OIG Found

CDC's VFC program recipients conducted enrollment site visits for all newly enrolled and reenrolling VFC providers as required. However, recipients did not meet all program requirements for conducting compliance site visits and storage and handling site visits. Specifically, recipients did not: (1) conduct compliance site visits in a timely manner at 11,499 of 39,120 enrolled and active providers (29 percent), (2) conduct storage and handling site visits at either of the 2 CDC-approved depot providers, (3) conduct storage and handling site visits for at least 5 percent of their providers, and (4) verify that providers completed followup actions by the deadlines for 33,316 of 127,594 issues (26 percent) identified during compliance and storage and handling site visits.

CDC officials stated that staffing constraints and the COVID-19 pandemic were reasons that program recipients did not conduct site visits at some providers as required. CDC officials also stated that, during the COVID-19 pandemic, CDC and recipients were focused on the priority of COVID-19 vaccination program development and vaccine distribution, some providers were temporarily closed, and travel was restricted. In addition, we found that CDC did not have internal written policies and procedures for CDC's monitoring and oversight activities, including oversight of recipients' site visits at providers. Finally, CDC's Provider Education, Assessment, and Reporting (PEAR) online system did not have interactive reminders or alerts related to overdue site visits and followup actions. Because recipients did not conduct site visits as required or verify that providers completed followup actions to address identified compliance issues, CDC and recipients could not ensure that providers were complying with VFC program requirements.

What OIG Recommends and CDC Comments

We recommend that CDC: (1) work with program recipients to implement a plan and timeline to conduct the required site visits that are overdue and verify the completion of followup actions that had not been completed by the deadlines; (2) develop an action plan to enforce site visit requirements by CDC's planned date of July 1, 2023; (3) complete the development and implementation of internal written policies and procedures for VFC program oversight activities, including oversight of program recipients' site visits to ensure that requirements are met; and (4) update its PEAR online system to include interactive reminders or alerts related to overdue site visits and followup actions.

CDC concurred with our recommendations and described actions that it had taken or planned to take to address our recommendations, including working with recipients that have overdue site visits to develop an implementation plan and timeline for conducting those site visits and developing an action plan to provide guidance to recipients for site visits.