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.
We will delve into specific types of vaccine breeches, but first, do you have any overarching guidance on how to handle errors in vaccine S&H?
After an error has been identified, the ‘mantra’ is “Notify. Document. Contact. Correct.”
- Notify: Whoever discovers the error needs to notify their supervisor and the person in charge of vaccine S&H. While the circumstances are being investigated, everyone in the office should be notified NOT to use the vaccine in question. This usually is accomplished by labeling the vaccine “DO NOT USE” and segregating it, meaning putting it in a specially marked, separate area of a properly functioning refrigerator or freezer (whichever is indicated for the specific vaccine).
- Document: The details of the problem, such as how long the vaccine was out of the recommended temperature range, who discovered it, etc., should be well-documented.
- Contact: Because most vaccine S&H errors need to be handled on a case-by-case basis, the vaccine-specific authority (e.g., manufacturer, distributor, or health department) needs to be contacted for guidance.
- Correct: Subsequent guidance needs to be enacted, so no one receives vaccine that has become non-viable (i.e., less effective or ineffective).
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.
Let’s start at the beginning, when the vaccine arrives in the office. What should we do to assess if our vaccine shipment may already be damaged upon arrival?
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).
Once the vaccine is in our facility’s storage unit, we follow CDC guidelines to be sure there is never a temperature reading outside the recommended vaccine storage range (typically called an excursion). What should we do if we discover a questionable vaccine storage temperature?
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."
I think most of us are aware that we should never use an expired vaccine, not even expired by a day. Do you have any important notes for us on this issue?
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."
Despite our best efforts, vaccines that are expired or nonviable due to a temperature excursion are sometimes inadvertently given to a patient. What should we do when this is discovered?
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:
- If the error is detected on the day the vaccine is given, the dose can be repeated that day.
- If the error is detected one day or more after the vaccine was given and the vaccine is:
- A live vaccine (e.g., MMR, MMRV, varicella [chickenpox]) — You must wait at least 28 days after receipt of the expired dose to give the repeat dose.
- A non-live vaccine (e.g., hepatitis A, hepatitis B, Tdap) — The dose should be repeated as soon as possible. One exception to this rule is the recombinant zoster vaccine, Shingrix®. If a dose of Shingrix must be repeated, at least four weeks must pass after receipt of the expired dose before the repeat dose is administered.
- For some vaccines, serologic testing to check for disease immunity (e.g., measles, rubella, hepatitis A, diphtheria, varicella, and tetanus) can be considered. However, insurance may not cover the test, and if the test shows the person is not protected, they will need an additional visit and another ‘poke,’ increasing the chance that the patient might not return and could remain unprotected.
This topic is covered in Immunize.org’s "Ask the Experts: Storage and Handling" website section.
Although we discussed prevention of S&H problems last month, is there any other news that you’d like to share?
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.
You already mentioned the value of the CDC’s “Vaccine Storage and Handling Toolkit.” Are there other S&H resources we should check out?
I am always proud to emphasize Immunize.org resources. Here are my top picks:
- Free, downloadable materials are available on the "Handouts: Vaccine Storage and Handling webpage"
- Immunize.org’s "Ask the Experts: Q&A on Vaccine Storage and Handling"
- "Vaccinating Adults: A Step-by-Step Guide" (see Step 3: Vaccine Storage and Handling).
Other key resources include:
- State, local or territorial health department immunization program personnel are extremely knowledgeable and eager to help when you have questions about vaccine S&H. Links to state websites are available on the Immunize.org "State Health Departments" webpage.
- CDC’s "You Call the Shots program" is a web-based training that includes a module specifically devoted to vaccine S&H. All modules in this excellent program include self-test questions, resource materials, glossary, and CE credits.
- CDC’s General Best Practice Guidelines for Immunization has a section on "Storage and Handling of Immunobiologics."
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.
We will delve into specific types of vaccine breeches, but first, do you have any overarching guidance on how to handle errors in vaccine S&H?
After an error has been identified, the ‘mantra’ is “Notify. Document. Contact. Correct.”
- Notify: Whoever discovers the error needs to notify their supervisor and the person in charge of vaccine S&H. While the circumstances are being investigated, everyone in the office should be notified NOT to use the vaccine in question. This usually is accomplished by labeling the vaccine “DO NOT USE” and segregating it, meaning putting it in a specially marked, separate area of a properly functioning refrigerator or freezer (whichever is indicated for the specific vaccine).
- Document: The details of the problem, such as how long the vaccine was out of the recommended temperature range, who discovered it, etc., should be well-documented.
- Contact: Because most vaccine S&H errors need to be handled on a case-by-case basis, the vaccine-specific authority (e.g., manufacturer, distributor, or health department) needs to be contacted for guidance.
- Correct: Subsequent guidance needs to be enacted, so no one receives vaccine that has become non-viable (i.e., less effective or ineffective).
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.
Let’s start at the beginning, when the vaccine arrives in the office. What should we do to assess if our vaccine shipment may already be damaged upon arrival?
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).
Once the vaccine is in our facility’s storage unit, we follow CDC guidelines to be sure there is never a temperature reading outside the recommended vaccine storage range (typically called an excursion). What should we do if we discover a questionable vaccine storage temperature?
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."
I think most of us are aware that we should never use an expired vaccine, not even expired by a day. Do you have any important notes for us on this issue?
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."
Despite our best efforts, vaccines that are expired or nonviable due to a temperature excursion are sometimes inadvertently given to a patient. What should we do when this is discovered?
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:
- If the error is detected on the day the vaccine is given, the dose can be repeated that day.
- If the error is detected one day or more after the vaccine was given and the vaccine is:
- A live vaccine (e.g., MMR, MMRV, varicella [chickenpox]) — You must wait at least 28 days after receipt of the expired dose to give the repeat dose.
- A non-live vaccine (e.g., hepatitis A, hepatitis B, Tdap) — The dose should be repeated as soon as possible. One exception to this rule is the recombinant zoster vaccine, Shingrix®. If a dose of Shingrix must be repeated, at least four weeks must pass after receipt of the expired dose before the repeat dose is administered.
- For some vaccines, serologic testing to check for disease immunity (e.g., measles, rubella, hepatitis A, diphtheria, varicella, and tetanus) can be considered. However, insurance may not cover the test, and if the test shows the person is not protected, they will need an additional visit and another ‘poke,’ increasing the chance that the patient might not return and could remain unprotected.
This topic is covered in Immunize.org’s "Ask the Experts: Storage and Handling" website section.
Although we discussed prevention of S&H problems last month, is there any other news that you’d like to share?
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.
You already mentioned the value of the CDC’s “Vaccine Storage and Handling Toolkit.” Are there other S&H resources we should check out?
I am always proud to emphasize Immunize.org resources. Here are my top picks:
- Free, downloadable materials are available on the "Handouts: Vaccine Storage and Handling webpage"
- Immunize.org’s "Ask the Experts: Q&A on Vaccine Storage and Handling"
- "Vaccinating Adults: A Step-by-Step Guide" (see Step 3: Vaccine Storage and Handling).
Other key resources include:
- State, local or territorial health department immunization program personnel are extremely knowledgeable and eager to help when you have questions about vaccine S&H. Links to state websites are available on the Immunize.org "State Health Departments" webpage.
- CDC’s "You Call the Shots program" is a web-based training that includes a module specifically devoted to vaccine S&H. All modules in this excellent program include self-test questions, resource materials, glossary, and CE credits.
- CDC’s General Best Practice Guidelines for Immunization has a section on "Storage and Handling of Immunobiologics."