An Eleven-Step Checklist to Safely Store and Handle Vaccines

According to the Centers for Disease Control and Prevention, vaccine manufacturers distributed nearly 3.5 billion vaccines in the United States from 2006 to 2017. On average, this figure breaks down to 287 million doses annually. Vaccines protect people from many preventable diseases; however, their effectiveness relies on their potency. They must be at full strength to trigger the body’s immune response.

Unfortunately, every year, providers endure financial losses because of vaccine storage and handling errors. This failure can result in wasted, unused vaccine doses, and inadequate immune responses in people. Patients may also lose confidence in providers that inadvertently administer compromised vaccines.

Maintaining an effective temperature-controlled cold chain is the only effective way to protect vaccine potency. How can you safely handle and store vaccines to protect your supply? We’ve developed a comprehensive storage and handling checklist, based on CDC recommendations, to protect your vaccine supply.

1. Create Standard Operating Procedures for Vaccine Storage and Handling

Your organization should develop a clear, detailed, up-to-date standard operating procedure as a reference and training tool for staff. This comprehensive plan will ensure that your facility is organized and that your employees will follow proper procedures when identifying, reporting, and correcting problems. They must provide emergency plans for power outages, equipment failures, and natural disasters.

SOPs should contain information about the following three areas:

General information – Facilities should maintain up-to-date contact information for vaccine manufacturers, equipment service providers, and essential staff and their job descriptions. Additionally, every SOP should contain regularly used forms and staff training requirements to handle vaccines.
Routine storage and handling SOPs – The CDC says organizations must provide information for all aspects of vaccine inventory management, including ordering and monitoring storage conditions.
Emergency SOPs for vaccine storage, handling, and transport – Your organization must outline steps your employees should take when there are power failures, equipment malfunctions, natural disasters, and other emergencies that can impact stored vaccines.

To learn more, review the CDC’s Vaccine Storage and Handling Toolkit worksheets to develop your organization’s general and emergency SOPs. Make sure you keep all SOPs next to vaccine storage units and tell your staff where to find them.

2. Train Your Staff to Handle Vaccine Deliveries

Vaccine storage and handling practices are only effective if you have a trained staff member that can implement the CDC’s general storage and handling recommendations. Assigned employees must know your facility’s SOP. This training will protect your vaccine supply and patients.

The CDC recommends that your organization document all completed training sessions with dates and participant names. The federal agency recommends that employees should undergo training during:

New employee orientation
Annual refresher training for all staff that handle immunizations and vaccine storage and handling activities
Whenever a facility adds new vaccines to its inventory
Whenever a manufacturer or federal agency updates vaccine storage and handling recommendations

3. Designate Your Primary Vaccine Coordinator

Next, you should appoint a primary vaccine coordinator to oversee the storage and handling of your vaccine stock. Additionally, name an alternate coordinator who will manage inventory when the lead one is absent. Both persons must know how to execute your routine and emergency SOPs. Here are the following responsibilities of coordinators. They should:

Order vaccines
Oversee the delivery and storage of doses
Record inventory information
Organize vaccines within storage units
Calibrate temperature monitoring devices
Check and record the minimum/maximum temperatures at the start of the workday
Review and analyze shifts in temperature data trends every week
Review stock once a week, so vaccines to ensure your facility uses vaccines with the earliest expiration dates first
Respond to temperature excursions (out-of-range temperatures)
Maintain all documentation, including inventory and temperature logs
Organize vaccine-related training and completion of staff training
Monitor the operation of vaccine storage equipment and systems
Manage proper vaccine transport, when necessary, according to your facility’s SOPs
Handle emergency preparation according to the SOPs. These include tracking inclement weather conditions and ensuring that facilities handle vaccines appropriately during disasters or power outages.

The coordinator can handle these responsibilities or delegate them to appointed staff members. They should ensure each designated member has finished training, with the required documentation for each assigned task.

4. Select the Correct Vaccine Storage and Monitoring Equipment

Your organization should select a purpose-built, pharmaceutical-grade refrigerator and freezer. Manufacturers design these laboratory-grade units to specifically house biologics and vaccines. These machines have microprocessor-based temperature controls with a digital temperature sensor. They also rely on powerful, fan-forced circulation and fast recovery for out-of-range temperatures. Here are some things to remember:

The CDC prohibits the use of dormitory-style and combination-style refrigerators and freezers for vaccine storage. These units cannot adequately maintain consistent temperatures to ensure vaccine potency.
The federal agency recommends the use of dedicated, stand-alone medical freezers and refrigerators for vaccines.
Providers should conduct routine maintenance for all vaccine storage units and related equipment, so your medical refrigerator or freezer operates efficiently.

American Biotech Supply has a great selection of medical-grade refrigerators and freezers that can protect the potency of your vaccines. Check out our selection on our website.

5. Choose the Right Location for Your Medical Refrigerator or Freezer

Good air circulation is essential for your laboratory-grade unit. Here are some things your facility should follow when selecting a spot for your medical refrigerator or freezer. Check your owner’s manual for additional information on spacing and placement.

Find a well-ventilated room with standard room temperatures between 20°C and 25°C (68°F and 77°F).
There should be enough room between the unit, ceiling, and walls.
No items or debris should cover or block the motor’s compartment.
Your unit should be level and firm with its bottom off the floor.
The doors should close smoothly and fit squarely over the unit. If it’s not secured properly, it will be unable to maintain the proper internal temperatures.

6. Stabilize your Unit’s Temperature Ranges

The correct temperatures will ensure your vaccine maintains its potency. Your facility needs to stabilize the medical-grade unit’s temperatures before storing vaccines. This process will take:

Two to seven days for medical refrigerators to stabilize
Two to three days for freezers.

Check the minimum/maximum temperatures every workday for two to seven days before using your vaccine unit. If it can’t digitally record temperatures, manually record these values for a minimum of two times each workday. Once you have two consecutive days of recorded temperatures within the recommended range, your unit is stable and ready to use.

The CDC recommends the following temperature ranges for medical-grade units.

Refrigerators must maintain temperatures between 2°C and 8°C (36°F and 46°F).
Freezers should maintain temperatures between -50°C and -15°C (-58°F and +5°F).

Your facility should set your medical refrigerators or freezer thermostats at the factory-set or midpoint temperature to decrease the likelihood of excursion events.

7. Get a Temperature Monitoring Device (TMD)

Your facility’s vaccine storage unit must have a TMD that records an accurate temperature history that reflects the actual vaccine temperatures. These devices are essential to protect your vaccine supply. It is less expensive to invest in a reliable TMD than to replace lost vaccines due to out-of-range excursion events.

The CDC recommends the use of a TMD called a digital data logger (DDL). This device provides the most accurate storage unit temperature information, including information about how long the unit has been operating outside of recommended temperatures. Standard thermometers only measure the air temperatures, and the coldest and warmest values a medical refrigerator has reached.

Buffered probes match vaccine temperatures more closely. The data from a DDL can be downloaded to computers using special third-party applications. You can also retrieve this information from a website. The manufacturer’s software may allow you to set the frequency of temperature readings. You must review DDL data regularly to ensure your vaccine supply remains safe.

DDLs should have the following features:

A detachable probe that best reflects the vaccine temperature
Alarm for out-of-range temperatures
Low-battery indicator
Current, minimum, and maximum temperature display
Recommended uncertainty of +/-0.5°C (+/-1°F)
Logging interval (or reading rate) that can be programmed by the user to measure and record at temperatures at least every 30 minutes
A current and valid Certification of Calibration Testing

The CDC recommends that you keep DDL data for three years so your facility can analyze it for long-term trends and recurring problems.

Use a DDL or other appropriate TMD for each vaccine storage unit. Also, make sure your facility has DDLs for each transport unit (emergency and non-emergency).

8. Implement the CDC’s Vaccine Storage and Organization Checklist

The CDC has several recommendations to help providers store vaccines correctly and minimize administration errors. Your facility should implement the following practices

Store vaccines or diluents in their original packaging and within separate containers.
Place vaccines and diluents two to three inches away from the unit’s walls, ceiling, floor, and door
When using a household-grade refrigerator, avoid storing vaccines and diluents in any part of the unit that doesn’t provide stable temperatures or sufficient airflow, such as under cooling vents, in deli, fruit, or vegetable drawers or door shelves. These areas have unstable temperatures and airflow and will expose vaccines to inappropriate temperatures.
Clearly label your shelves and containers to identify where to store each type of vaccine and diluent.
Your facility should place vaccines and diluents with similar packaging, names, and formulations (adult and pediatric) on different shelves.
Whenever possible, store diluent with its corresponding refrigerated vaccine. Never store diluent in a freezer.
Avoid placing or storing items other than vaccines, diluents, and water bottles inside your medical-grade refrigerator.
Mark and store medications or biological products in separate containers and bins if your organization stores them in the same unit as vaccines.
Potentially contaminated biological products (blood, urine, stool) must be contained and stored below vaccines due to the risk of contamination from leaks and drips.
The freezer of a household-grade may be used for non-vaccine, medical storage, as long as it doesn’t compromise the temperature range within the refrigerator area where the vaccines are stored.
Arrange your vaccines and diluents in rows. Allow enough space between these rows to promote better air circulation.
Put vaccines and diluents with the earliest expiration dates in front of those with later ones.
Place water bottles on the top shelf and floor and in the door racks. Putting water bottles in the unit can help maintain stable temperatures caused by frequent opening and closing unit doors or power failures.
Certain pharmaceutical-grade units do not recommend the use of water bottles. Follow the manufacturer’s guidance for more information.
Never allow vaccines to remain in a malfunctioning unit for an extended period. If you believe your medical freezer or refrigerator has ailed, execute your emergency SOP.

9. Properly Manage Vaccine Deliveries

Scheduling and Receiving Deliveries

Organizations should maintain the cold chain when they receive vaccines in their facility. Protecting the cold chain is the first step in vaccine inventory management. Your facility must train staff who may accept vaccine deliveries. They should notify the vaccine coordinator or the alternate coordinator when vaccine deliveries arrive. Don’t place an unopened or unpacked shipping box in a vaccine storage unit. The cool packs (used during shipping) may make the packaged vaccine too cold.

Here is a small checklist for examining your newly arrived deliveries.

Carefully unpack vaccine and diluent.
Examine shipments for signs of damage.
Check the contents against the packing list to make sure they match. (Frozen vaccines will show the maximum time vaccines can be in transit based on its shipment date.)
Make sure that freeze-dried vaccines came with the correct type and quantity of diluents.
Examine both vaccine and diluent expiration dates to make sure you haven’t received any soon-to-expire vaccines.
Check the cold chain monitor (CCM) which tracks vaccine temperatures during transport, if one was included, to learn if any temperature excursion events occurred during transit.

10. Manage your Vaccine Inventory

The CDC recommends using stock records to determine the quantity and types of vaccines your facility needs. Here are a few tips that providers should follow.

Every month, count all vaccine and diluent doses. The number of doses within the unit should match the recorded storage documentation.
Providers should check expiration dates while counting stock. Please remove any expired doses.
When the number of stored doses don’t match the stock record, enter the correct value based on your count. Place the amount on a separate line below the old balance. Write a note about the new entry, indicating you confirmed the new balance. Sign and date the notation.
Document the number of diluents in a separate stock record. There should be equal quantities of corresponding vaccines.
Your facility should rotate its vaccine stock regularly to check for expired doses. Providers should remove any expired doses to avoid inadvertently administering them.
When ordering vaccines, you should only order enough stock to meet your patients’ needs.

11. Oversee the Disposal of Vaccines

The CDC has three recommendations for vaccine disposal.

What should I do with experienced or compromised vaccines? Your healthcare facility can sometimes receive credit for unused doses or diluents. They allow providers to send back some unopened, expired, and potentially compromised vaccines. Contact the manufacturer or your state’s immunization program for information about specific vaccines.
What should I do with open/broken vials, activated manufacturer-filled syringes, or pre-drawn vaccines? These vials, including syringes, can’t be returned. Your facility should discard them according to your state’s requirements.
What should I do with empty vaccine vials? Check with your state’s requirements regarding the disposal of empty vials. Most don’t require disposal in a biomedical waste container, because they don’t consider them as hazardous, pharmaceutical waste.

Your facility needs the best equipment to protect the potency of your vaccine supply. American Biotech Supply has a variety of outstanding models that can keep your stock safe. Contact us for details.