A government report released this week claims that many Vaccines for Children program providers and grantees are not storing and managing vaccines properly, potentially putting children at risk.
The Department of Health and Human Services’ Office of the Inspector General (OIG) reported that most storage temperatures independently measured by OIG staff during a 2-week period in April and May 2011 were within the required ranges need to maintain vaccine efficacy and potency. However, the assessment did reveal that Vaccines for Children (VFC) vaccines stored by 34 of the 45 selected providers were exposed to inappropriate temperatures and 17 had expired vaccines in their stockpile.
Using CDC data, the OIG staff selected a sample of 45 VFC providers from the five grantees with the highest volume of vaccines ordered in 2010 (California, Florida, Georgia, New York City and Texas). The staff conducted site visits at these providers’ medical practice locations, interviewed their vaccine coordinators, and observed their vaccine management practices. They also independently measured these providers’ vaccine storage unit temperatures for 2 weeks and interviewed the five grantees’ VFC program staff to discuss program oversight, according to the OIG report.
Some of the major findings of the report include:
- VFC vaccines stored by 76% of 45 providers reviewed were exposed to inappropriate temperatures.
- All 45 providers recorded temperatures that differed from the OIG independently measured temperatures.
- Sixteen of 45 providers reviewed had expired VFC vaccines.
- None of the 45 providers reviewed met the vaccine management requirements in all 10 categories; Forty of the 45 selected providers did not meet all requirements in at least half of the vaccine management categories.
- Thirty-eight of 45 selected providers did not have all documents required under VFC regulations.
- None of the five VFC grantees reviewed met all oversight requirements, and grantee site visits were not effective in ensuring that providers met VFC requirements over time.
The authors of the OIG report calculated that if the 34 providers’ freezer and refrigerator temperatures followed this same pattern for a year, the storage units could expose vaccines to inappropriate temperatures for at least 130 hours, which could result in an estimated wastage of 9,173 VFC vaccine doses, worth approximately $368,820.
The OIG recommended that CDC work with grantees and providers to ensure that: 1) VFC vaccines are stored according to requirements; 2) expired vaccines are identified and separated from non-expired vaccines; 3) grantees better manage providers’ vaccine inventories; and 4) grantees meet oversight requirements.
CDC response to findings
CDC released an official statement regarding the report and said that the agency and its partners are working with a sense of urgency to address these issues. CDC is incorporating the report findings and recommendations in its plan to strengthen the VFC program.
“CDC is not recommending that parents revaccinate their children. The main concern with improper storage temperatures is that they can make vaccines less effective rather than less safe. The OIG report did not assess vaccine potency or effectiveness. While it is possible that some children have received less potent vaccines due to exposure to improper temperatures, our data do not suggest that this is a common or widespread problem,” the official CDC statement read. “While the safety and health of our nation’s children has not been compromised by the issues identified by the OIG, the findings are important and underscore that we must do better at ensuring that all vaccines are stored properly at all times, including removing expired vaccine from units where viable vaccines are stored.”
The VFC program provides free vaccines to eligible children through a national network that includes all states and US territories and is composed of more than 44,000 participating provider sites, according to CDC. In 2010, approximately 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion. VFC providers must meet certain requirements for vaccine management, such as storing vaccines within required temperature ranges and monitoring expiration dates, to ensure that these vaccines provide children with maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse, according to the report.
Go to oig.hhs.gov/oei/reports/oei-04-10-00430.asp to view the full OIG report. Go to www.cdc.gov/vaccines/programs/vfc/default.htm for more information on the VFC program and its requirements.
The Vaccines for Children program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. VFC was created by the Omnibus Budget Reconciliation Act of 1993 as a new entitlement program to be a required part of each state’s Medicaid plan. The program was officially implemented in October 1994.
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and allocated through the CMS to the CDC. The CDC buys vaccines at a discount and distributes them to grantees, which in turn distribute them at no charge to those private physicians’ offices and public health clinics registered as VFC providers.
Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the Advisory Committee on Immunization Practices.
In 2010, the program cost $3.6 billion, and approximately 44,000 providers participated. These providers ordered approximately 82 million VFC vaccines.
According to the report from the Office of the Inspector General, CDC manages 61 VFC grantees that implement the program at the state and local levels. Grantees include all 50 state health departments, public health agencies in six metropolitan areas and five US territories and protectorates. VFC provider types include private providers, public health departments, federally qualified health centers or rural health clinics, other public health clinics and private hospitals. Approximately 70% of VFC providers are private providers.
VFC providers are required to follow the vaccine management module of CDC’s VFC Operations Guide, which include the following categories, among others, related to vaccine storage practices and equipment maintenance; vaccine security; temperature monitoring; vaccine ordering, shipments and inventory management; vaccine waste; vaccine personnel and preparation.
VFC providers must perform required activities in 10 categories established in the Vaccine Management Module of CDC’s VFC Operations Guide. In addition, the VFC Operations Guide establishes documentation requirements for VFC providers. Each provider must maintain seven different types of documents related to vaccine management.
Go to www.cdc.gov/vaccines/programs/vfc/default.htm for more information on the VFC program and its requirements.