A June 5 report(oig.hhs.gov) by the HHS Office of the Inspector General (OIG) indicates inappropriate storage of vaccines and faulty documentation is all too common among participants in the CDC's Vaccines for Children(www.cdc.gov) (VFC) program. The CDC has acknowledged the report's findings and pledged to work with the program's vaccine providers to tighten up their logistical and administrative practices.
According to one family physician who participates in the VFC program, adhering to the program's requirements is no mean feat. His recommendation: Physicians who wish to administer the free vaccines this program provides for uninsured and underinsured children and adolescents should be prepared to make a firm commitment to complying with the program's dictates.
The report, which is based on a routine two-week assessment of 45 different vaccine providers from the five largest city and state VFC grantees, said that although the majority of storage temperature measurements taken during the assessment period were "within the required ranges," vaccines stored by 76 percent of the selected providers "were exposed to inappropriate temperatures for at least five cumulative hours during that period." Moreover, the report stated, none of the providers reviewed met requirements in all 10 vaccine management categories on which they were assessed, and 40 of the 45 providers did not meet requirements in "at least half" of the categories.
- A June 5 report by the HHS Office of the Inspector General (OIG) indicates inadequate storage and handling of vaccines is all too common among participants in the CDC's Vaccines for Children (VFC) program.
- In response, the CDC has pledged to work with its VFC grantees and providers to tighten up their processes.
- Ninety percent of U.S. children are vaccinated by a provider that participates in the VFC program.
The 10 management categories in which VFC providers perform required activities are
- vaccine storage equipment,
- vaccine storage practices,
- temperature monitoring,
- vaccine storage and handling plans,
- vaccine personnel,
- vaccine waste,
- vaccine security and equipment maintenance,
- vaccine ordering and inventory management,
- receiving vaccine shipments, and
- vaccine preparation.
For example, the report stated that 13 VFC providers were found to be storing expired vaccines together with nonexpired vaccines, thereby increasing the risk of mistakenly administering expired product. The OIG also said vaccine providers generally did not maintain required documentation and recommended that the CDC work with its grantees and providers to ensure such errors are rectified.
"CDC is in the process of implementing substantial improvements in vaccine ordering and inventory management systems, which will support improvements in vaccine management at the provider office," CDC Director Thomas Frieden, M.D., M.P.H. wrote in a letter(oig.hhs.gov) (see pages 46-47) responding to the OIG report.
"Because VFC providers generally manage their public and private stock vaccines in a similar manner, and 90 percent of U.S. children are vaccinated by a provider that participates in the VFC program, CDC believes that efforts to strengthen storage and handling practices will help improve vaccination services nationally and benefit children vaccinated with both publicly and privately purchased vaccines."
Jamie Loehr, M.D., of Ithaca, N.Y, a VFC provider and the AAFP liaison to the CDC's Advisory Committee on Immunization Practices, told AAFP News Now that providers must practice good business management to ensure vaccines are stored safely.
"Once a week, we go through and check our inventory to look for two things: Are any vials getting close to expiring, and do we need to order any more vaccine?" he said. "We are a small practice, so we order small amounts more frequently so that we don't have to have such a large burden in our refrigerator/freezer."
Loehr said he and his staff have had their share of headaches managing the vaccines, but the office is committed to safe handling.
"It is my job to manage these vaccines, and I take that seriously," he said. "We recently bought a new refrigerator/freezer and found out that the freezer was not performing to expectations, so we pulled the old freezer back into service until we either replace the new one or find a better way to store the frozen vaccine."
Loehr stressed the importance of having temperature alarms on both the refrigerator and freezer, adding that the alarm tipped him off the freezer was getting too warm. Now, with the vaccines stored safely in the old unit, he is experimenting with the new freezer to see if he can get it in line.
"The new fridge is keeping the temperature range fairly narrow, but the new freezer has to go up to 25 degrees farenheit four times a day in order to stay frost free, which is out-of-range for frozen vaccines," Loehr said. "So I have been looking at CDC suggestions on how to better manage the temperature by putting cold packs in there to maintain the range. If we can't make it work, we'll just have to return it and find another option."
CDC Recommendations and Guidelines: Vaccine Storage and Handling(www.cdc.gov)