Technically Speaking: What to Do If There’s a Vaccine Storage & Handling Error
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In the July 2023 issue of Vaccine Update for Healthcare Professionals, we focused on the prevention of vaccine storage and handling (S&H) errors. This month, we focus on what to do if you are in the unfortunate situation in which a vaccine S&H error has been made at your office. We interviewed Laurel Wood, MPA, the Director for Public Health at Immunize.org, to get her insights and recommendations for helpful resources should you find yourself in this predicament.
After an error has been identified, the ‘mantra’ is “Notify. Document. Contact. Correct.”
A good source of information for this process is the Centers for Disease Control and Prevention’s (CDC’s) "Vaccine Storage and Handling Toolkit." The information can be found on page 15.
The vaccine shipping packages should be opened and inspected immediately. The person unpacking the shipment should consider the following questions: Do the vaccines seem too warm or too cold to the touch? If a temperature indicator (i.e., usually a temperature-sensitive strip that changes colors) is included, does it indicate a problem? Do the vaccine quantities, lot numbers, and expiration dates match the packing slip? If any problems are found, start the process defined above, specifically the ‘notify’ and ‘document’ steps. To be sure no one inadvertently uses vaccine that may not be viable, put it in a specially marked, segregated area of a properly functioning refrigerator or freezer (as indicated for the specific vaccine) and contact the source of your shipment for advice about next steps. This is detailed in Immunize.org’s resource, "Vaccinating Adults: A Step-by-Step Guide" (see Step 3: Vaccine Storage and Handling).
Your first impulse may be to throw out the vaccine, but don’t follow that impulse! Several factors should go into determining whether the vaccine is still viable, such as the magnitude of the temperature excursion, the total amount of time that the vaccines were outside the recommended temperature range, and which vaccine(s) is in question.
The response to a temperature excursion in your own storage unit is essentially the same as a temperature excursion during shipping. The person who discovers the excursion should immediately notify their supervisor and the vaccine coordinator and ensure that staff will be aware by labeling exposed vaccines "DO NOT USE" and keeping them in a properly functioning unit segregated from other vaccines. Follow your office’s standard operating procedure to determine if the temperature setting in the original storage unit should be adjusted. Documentation should also begin. One easy way to maintain appropriate documentation is to use Immunize.org’s "Vaccine Storage Troubleshooting Record." The form can be filled out electronically or printed to complete manually. Contact your state, local or territorial immunization program and/or vaccine manufacturers for further guidance. If any patients received the vaccine in question, you also need to get guidance regarding whether they should be revaccinated. Once you’ve determined what to do, be sure that the corrective action plan is followed. Final documentation should include the details of what was done to correct the temperature excursion. Details for this process can be found on page 15 of the CDC’s "Vaccine Storage and Handling Toolkit."
Important protocols to prevent use of expired vaccines were outlined in last month’s Technically Speaking, but sometimes clinicians find determining the exact expiration date to be confusing. Simply put, the vaccine may be used through the last date shown. If the expiration date on the vial is just a month and a year (e.g., “08/23”), then the vaccine should not be used after the last day of August 2023. If the expiration date is a specific day (e.g., “08/15/2023”), then the vaccine should not be used after that date, but it can be used on that date.
Another consideration is that some vaccines expire within a certain time after they are opened or reconstituted. Check the vaccine’s package insert for guidance. Immunize.org also has a useful resource related to this called "Vaccines with Diluents: How to Use Them."
Finally, the expiration date for some COVID-19 vaccines may have been extended beyond the date printed on the packaging. While this is atypical, it was warranted in the case of COVID-19 vaccines because stability data were still being, and continue to be, collected after vaccines were released due to the pandemic. To stay abreast of this developing information, check Immunize.org’s quick links to COVID-19 vaccine expiration date tools in its "Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools."
If an expired or nonviable vaccine is administered, the dose generally should not be counted as valid and should be repeated. Here’s the guidance for administering a repeat dose:
This topic is covered in Immunize.org’s "Ask the Experts: Storage and Handling" website section.
Providers often ask for advice about purchasing an appropriate vaccine storage unit. One way to have confidence in your choice is to look for a unit labeled as meeting the “NSF/ANSI 456” standard for vaccine storage. This voluntary certification indicates that the model has been tested and certified to maintain proper vaccine storage conditions under a range of normal clinic conditions.
I am always proud to emphasize Immunize.org resources. Here are my top picks:
Other key resources include:
Contributed by: Sharon G. Humiston, MD, MPH, FAAP
Categories: Vaccine Update August 2023, Technically Speaking
Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.
You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. You should not use it to replace any relationship with a physician or other qualified healthcare professional. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult your physician or, in serious cases, seek immediate assistance from emergency personnel.