- Copyright © 2012, The American Academy of Pediatrics
The Centers for Disease Control and Prevention (CDC) has released interim guidance for vaccine storage that includes changes to record-keeping, refrigerator/freezer requirements, thermometer requirements and certification of devices (www.cdc.gov/vaccines/recs/storage/interim.htm).
The changes were prompted by a recent government study that showed significant problems with storage and handling of vaccines used in the Vaccines for Children (VFC) program. CDC state grantees are expected to implement the new recommendations with the approximately 44,000 individual practice and clinic sites across the country that are contracted to receive vaccines through the VFC program.
The changes cover:
increased documentation, including recording temperature twice a day and recording each morning the minimum and maximum temperature over the prior 24 hours;
replacement of glass thermometers with data-logging temperature monitors designed with a thermal buffer and 24/7 recording capability;
elimination of combination refrigerator/freezer units; and
certification of temperature-monitoring probes/devices.
The guidance recognizes that exposing refrigerated vaccines (i.e., all except measles-mumps-rubella and Varivax) to freezing temperatures for a few minutes poses greater safety issues than storing them for hours in a refrigerator that is too warm. Freezing will destroy vaccine, making it unsuitable for use in patients and requiring practices to spend large amounts of money replacing it. Many vaccines can tolerate temperatures that are warmer than recommended for a significant length of time, although practices should call their state immunization program for guidance when temperatures exceed recommendations.
To ensure that temperatures remain within range, the CDC now recommends use of continuous data-logging temperature monitors in a glycol or similar temperature buffer. The CDC recommends simple data loggers, which cost about $100-$150 and will inform offices retrospectively if a temperature deviation occurred and for how long.
Some practice experts recommend a more sophisticated phone-enabled monitor that calls a physician or practice administrator to report a “temperature excursion.” That added safety measure could prevent tens of thousands of dollars in vaccine replacement costs, as well as the revaccination of hundreds of children if vaccine is found to have lost potency after a temperature excursion.
Domestic refrigerator-only units are still acceptable under the new guidelines but have risks. Generally, they do not have continuously running fans to circulate air and avoid cold spots. In addition, glass shelves block air flow, compressor cycles lead to wide temperature swings and unexpected failure can occur.
If offices choose to keep their domestic refrigerator, the CDC offers best practices for loading the refrigerator. Vaccines should never be stored in the door, and the bins and bottom of the refrigerator should be avoided. In addition, the vaccine should be placed 2-3 inches from refrigerator walls. The CDC also recommends putting a large number of chilled water bottles in the refrigerator to mitigate temperature swings.
If practices have combination refrigerator/freezer units and are not ready to purchase new equipment, the CDC recommends against using the freezer portion. The combination units are cooled by allowing very cold air to flow out of the freezer compartment above the top shelf of the refrigerator. If vaccine is in the path of the air flow, it will freeze even if the overall refrigerator temperature is in range. It is best to avoid the top shelf and to adjust the freezer to a warmer setting as long as the refrigerator remains in compliance at 2 to 8 degrees Celsius (35.6 to 46.4 degrees Fahrenheit).
Although the new recommendations are appropriate, they will add a significant cost to vaccine delivery. The CDC is working with the Academy to address these costs. In addition, the Academy is revising the Business Case for Pricing Vaccines and Immunization Administration to include the new storage costs.
In developing the guidance, the CDC asked the Academy to provide feedback on how proposed changes will affect busy primary care practices. Graham Barden, M.D., FAAP, a member of the AAP Committee on Practice and Ambulatory Medicine, and Christoph Diasio, M.D., FAAP, a member of the AAP Section on Administration and Practice Management, reviewed the guidance and requested changes that should help practices comply without breaking the bank or driving practices out of VFC participation.
“We have an obligation to our patients to provide the safest and most potent vaccine available,” Dr. Barden said. “We need to do a great job with temperature monitoring because we put ourselves at significant financial risk if vaccines are not stored properly.
Our office crunched the end-of-month inventory numbers for public and private vaccine at our three sites and found our daily average inventory would cost $390,000 to replace. Although VFC vaccine is ‘free’ to receive, we are financially responsible for losses.”
Dr. Diasio agreed. “Although it is painful to spend more money in the current fiscal environment on changes required by the government, our children deserve fully potent vaccines. We need to demand that private and public payers recognize the increased costs of upgrading the vaccine storage infrastructure by paying additional money linked to the administration code.”
While administration fees for publically purchased vaccine will increase in 2013 and 2014 under the Affordable Care Act, the Academy continues to discuss with the CDC ways to ensure payments do not drop below cost after 2014. The Academy also is preparing information on how to implement the guidance and safeguard vaccine stock for practices that are ready to invest in new equipment and for those that are not.