Cold Chain Requirements

According to the Ministry of Health, cold chain includes all of the materials, equipment and procedures used to maintain vaccines in the required temperature range of +2.0°C to +8.0°C from the time of manufacture until the vaccines are administered to individuals.

These requirements and instructions are for facilities storing publicly funded vaccine:

  • New set-ups needing an orientation to store publicly funded vaccines
  • Cold chain education for new staff at facilities already storing publicly funded vaccines
  • Individuals looking for answers to their cold chain questions or preparing for an upcoming cold chain inspection

How to:

  • Position your vaccine fridge

    Location

    The fridge must be located in a well-ventilated area away from direct sunlight and external walls. This reduces the likelihood for extreme external heat / cold temperatures to affect the fridge. Vaccine fridges should be placed in a secure area or kept locked. This minimizes the risk of unnecessary door openings, power being switched off and tampering with vaccine.

    Security

    Fridge doors should be locked after each use if the fridge is located in an area where it can be accessed by patients, for example, if the fridge is in a clinic room or a waiting area.

    If the fridge is located in an area where patients cannot access it, lock the fridge or room where the fridge is located at the end of each day, for example, if the fridge is behind a reception desk or in a storage area.

    Electrical outlet

    If the electrical outlet is easily accessible, cover it with a metal cage or label it with a "DO NOT UNPLUG" sticker. It is not recommended to plug the fridge into a power bar as there is a risk it may be turned off without knowing.

  • Store vaccine in a fridge

    Store vaccines in the middle of the fridge away from fridge walls, floors and cold air vents. Store the products on the internal shelves and not in the drawers or fridge door. Fill empty spaces on the door or fridge shelves with full water bottles (not for consumption). This will help keep the fridge at the appropriate temperature. No specimens, food or drinks should be stored in the fridge.

    Vaccine fridge organization

    The vaccines should be kept in their original packaging and organized by product with space between them to allow for air circulation. Store products with the shortest expiry date in the front and use them first. Never store more than a one-month supply of vaccine in your fridge at any given time. Remember to remove vaccines from the fridge only for immediate use and to mark multi-dose vials with the date they are opened. Vaccines should not be pre-drawn ahead of time. This is due to the unknown stability of vaccine in plastic syringes, the risk of contamination and the increased potential for vaccine administration errors and wastage.

  • Monitor the vaccine fridge temperatures

    To keep your fridge between +2.0°C to +8.0°C:

    • Minimize door openings / fridge access
    • Position water bottles (not for consumption) in the fridge spaces to help keep it at the appropriate temperature
    • Make incremental adjustments to the fridge thermostat, as needed
    • Record maximum, minimum and current temperatures twice daily during all days the office / facility is open

    If your office will be closed due to vacation, arrange for a staff member to record fridge temperatures. If you aren't able to do so, contact Public Health to discuss alternate storage options.

  • Use thermometers, data loggers and probes

    Digital thermometer

    There are several different types of digital maximum-minimum thermometers. Your digital thermometer must be able to show maximum, minimum or current temperatures within a tenth of a degree (0.1°C).

    It is recommended to change the thermometer batteries at least every four to six months. This ensures your thermometer is working properly. You can buy replacement digital thermometers through Niagara Region Public Health.

    Data logger

    Consider buying a data logger as a back up to your digital thermometer in case of a thermometer malfunction or power outage. Data loggers do not replace digital thermometers or the need for twice daily monitoring and temperature log recordings. They accurately record the length of time that temperatures are out of range. Therefore, data loggers can decrease the amount of vaccine wastage when used as a back up.

    Data loggers should be set at intervals of every five to 10 minutes. Download the data logger weekly / more often, as needed, to prevent overwriting earlier readings.

    Probe

    Place the digital thermometer probe in an empty vaccine box and position it in the center of the middle shelf. This will help ensure that the measured temperature is similar to a vaccine vial in its original packaging.

  • Use the temperature log book

    You must document temperatures twice daily. Include the date, time and initials for each entry. Reset / clear the maximum and minimum thermometer display each time when recording temperatures. If there is an out-of-range temperature, the length of exposure will be calculated based on the last within-range recording.

    You will need a copy of your current four week fridge temperature log (up to present day) with each vaccine order.

    Health care providers and medical offices

    Record temperatures before opening your office and just before closing.

    Long-term care and retirement homes and hospitals

    You should record temperatures every 12 hours, typically at shift change. Submit a monthly temperature log to Public Health for review at the end of every month along with any temperature logs that go with a vaccine order.

    Pharmacies

    Record temperatures daily before opening your pharmacy and just before closing. Submit a monthly temperature log to Public Health for review on the first Wednesday of every month. Failure to submit a temperature log may result in your pharmacy being placed on hold from ordering and receiving vaccines. Niagara Region Public Health is responsible for placing pharmacies on / off hold with the distributors for temperature log issues.

  • Pack a transport cooler

    Keep vaccines in a monitored transport cooler between +2.0°C to +8.0°C. Place them in the hard-sided cooler with ice packs and fridge temperature gel blankets using the digital transport thermometer. Do not use your fridge thermometer to monitor transport cooler temperatures. Instead, use your designated transport thermometer.

    You must keep the digital thermometer display outside the cooler and the probe within the cooler. Ensure that the vaccines and thermometer probe are not directly touching any frozen ice packs.

    Record the time and temperatures (maximum, minimum and current) on a temperature log. All temperatures must at least be recorded hourly when vaccines are stored in a transport cooler.

    Follow the images in the "New office set-up for publicly funded vaccine" document from Public Health. Contact Public Health if you do not have a copy.

    Learn about recommended practices for COVID-19 vaccine.

  • Develop an emergency plan

    All facilities storing publicly funded vaccine must develop an emergency plan in the event of a cold chain excursion, for example, vaccine refrigerator malfunction, power failure or other emergencies.

    Learn about cold chain procedures to follow during a power failure.

    Important notice for long-term care homes. As per the Ontario Reg. 246 / 22, a generator must be available at all times to maintain and store drugs (including vaccines) at safe temperatures.

  • Pass your cold chain inspection

    First inspection

    If this is your first inspection, use the information on this page to prepare along with the "New office set-up for publicly funded vaccine" document you received from Public Health. Contact Public Health if you do not have a copy.

    The Ministry's Vaccine Cold Chain Maintenance Inspection Report will be sent to your office when complete via fax following your site visit.

    Ensure you review the entire report for cold chain management standards, recommendations and strategies to put in place, if any.

    This report will be completed with every annual and / or new vaccine fridge inspection. All new vaccine fridges must be inspected before use. The date of your vaccine fridge inspection will be reported to the Ministry.

    Annual inspection

    Address any issues at the time of your inspection.

    Review your previous year's Vaccine Cold Chain Maintenance Inspection Report as you prepare for your annual cold chain maintenance inspection.

Handling a cold chain excursion

Vaccines may lose potency if the maximum, minimum or current temperature readings are below +2.0°C and / or above +8.0°C.

Prompt action minimizes vaccine wastage and helps to ensure client safety.

  • What to do
  • During a power failure

    Refer to cold chain procedures to follow during a power failure.

  • Reporting an excursion

    Step 1. Contact Public Health immediately to report out-of-range temperatures and receive further instructions: 905-688-8248 or 1-888-505-6074 ext. 7396.

    Step 2. Stop the use of the vaccine until given further instructions from Public Health.

    Step 3. Bag and label the vaccine as "DO NOT USE." Keep the labelled bag in your monitored vaccine fridge.

    Step 4. Record extra maximum, minimum and current temperatures, accompanied with the time. Clear the maximum and minimum temperatures after recording.

    Step 5.If advised by Public Health, complete and fax the Vaccine Inventory and Return Form with the current four week temperature log to 905-688-4667.

    Step 6. Public Health will determine vaccine stability and then notify your facility on which vaccine can continue to be used and which vaccine must be returned.

    Do not assume that vaccines are no longer stable and can't be used, but, do not determine vaccine stability yourselves.

  • How to return vaccine

    Vaccines need to be returned when:

    • The vaccine has expired
    • There has been a cold chain excursion and the vaccine is no longer stable to use as determined by Public Health

    All unused seasonal influenza vaccines needs to be returned to Public Health by the end of each flu season.

    If you have stable vaccines that haven't expired that you no longer want, keep it in your inventory until the expiry date. Public Health cannot take it back for use or redistribute to other facilities.

    Steps for returning vaccine to Public Health:

    • Step 1. Complete the appropriate boxes on the Vaccine Inventory and Return Form
    • Step 2. Place vaccine in an empty bag
    • Step 3. Attach the completed form to the bag (or place inside) and close securely
    • Step 4. Write "Vaccine Return" and the facilities name on the outside of the bag
    • Step 5. Return the vaccine to Public Health via the delivery service or drop off at a Public Health office

More information

Contact

Call the Vaccine Preventable Disease program at 905-688-8248 or 1-888-505-6074 ext. 7396, Monday to Friday, 8:30 a.m. - 4:30 p.m.

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