• Cold Chain includes all the materials, equipment and procedures needed to maintain vaccines in the required temperature range of +2.0°C to +8.0°C. Cold chain must be maintained from the time of manufacture until the vaccines are administered to individuals.
• Vaccines may lose their potency and effectiveness if they are exposed to adverse storage conditions such as light and/or temperatures outside of +2.0°C to +8.0°C. This can lead to a lack of protection against vaccine preventable diseases.

• If your premises is interested in storing publicly funded vaccines, please contact Halton Region Public Health by calling 311.
• Halton Region Public Health will provide you with a list of steps to follow to help you prepare for your inspection.

• Your premises must have a thermometer or data logger for each refrigerator and cooler used for vaccine storage or transport.
• The two types of temperature monitoring devices are:
  1. digital maximum-minimum thermometers
  2. data loggers
• A thermometer with a glycol temperature probeis recommended for the following reasons:
  • Matches actual temperatures of vaccines allowing for accurate readings (Centers for Disease Control and Prevention (CDC), 2022).
  • Acts as a buffer to prevent false temperature readings caused by temporary fluctuations in air temperature (for example, opening the refrigerator door) (CDC, 2022).
• A temperature monitoring device can be purchased from Halton Region Public Health, or from any supplier.

Troubleshooting Thermometers

• Begin troubleshooting your temperature monitoring device if refrigerator temperatures reach +3.0 ºC or +7.0 ºC.
• Ensure that you change the batteries every 6 months.
• Always keep the manufacturer instructions available for information on troubleshooting.
• Refer to How to Use a Maximum-Minimum Thermometer (PDF file)  for information on troubleshooting digital maximum-minimum thermometers.
• Additionally, verify that the:
  • thermometer is displaying Celsius (not Fahrenheit).
  • cord connecting the probe to the thermometer is plugged in and intact. (LL appearing on the display indicates that the probe is disconnected or damaged).

Refrigerators used for vaccine storage must be inspected and approved by Halton Region Public Health prior to use.

• Assign one staff member as the lead, and another staff member as the backup, to monitor vaccine storage and handling practices at your premises.
• All staff must read and be knowledgeable on the content in the Ontario Ministry of Health’s Vaccine Storage and Handling Guidelines (2021)  . Your premises’ designated lead must train all staff on how to read your facility’s vaccine temperature monitoring device and how to monitor and document vaccine storage temperatures.

• The purpose of a cold chain inspection is to:
  • provide education and support for vaccine storage and handling practices; and
  • promote vaccine safety and effectiveness.
• Halton Region Public Health will conduct the following cold chain inspections at premises that store publicly funded vaccines:
  • Annual routine inspections
  • New refrigerator inspections
  • Relocation of existing refrigerator inspections
  • New premises inspections
  • Follow-up inspections, as required
  • Cold chain incident inspections, as required
• Cold Chain Inspectors will attempt to book an inspection during a timeframe that will work best with your premise’s schedule. There may be instances when an unscheduled, drop-in inspection is warranted.
• Please allow 1.5 hours for scheduled inspections.
• The lead staff member or designate responsible for vaccine storage and handling at the premises must be present for the inspection.

• The Temperature Log Book is a record that allows your staff to monitor temperatures and recognize when temperatures go outside of +2.0°C to +8.0°C.
• Ensuring accurate, complete, and up to date documentation of refrigerator temperatures is necessary to protect vaccines.
• Incomplete documentation in your Temperature Log Book may result in a delay in processing your online vaccine orders.
• How to document in your Temperature Log Book:
  • Document the current, maximum, and minimum temperatures twice daily, at the beginning and end of each day, when your premises is open.
  • Ensure that the current, maximum, and minimum temperatures are documented in the correct places as indicated on the log book.
  • Ensure that you resetthe maximum and minimum temperatures on the thermometer after each time that the temperature readings are recorded.
    • Variation amongst the ‘Max Temp’ and ‘Min Temp’ recordings on the Temperature Log Book indicates that the maximum and minimum temperatures are being reset.
    • For more information, refer to Troubleshooting Thermometers.
  • Document temperatures to the tenth decimal place (for example, 5.1°C).
  • Include the date, time, initials, and name of your premise.
  • Mark days off as “closed”.
  • Ensure writing is clear and legible.

• When handling vaccines, please ensure that you:
  • only take vaccines out of the refrigerator when ready to administer; and
  • protect vaccines from light.
• Please note that there are specific practices required when using multi-dose format vaccines.
• For COVID-19 Vaccines, please refer to:
  • COVID-19 Vaccine-Relevant Information and Planning Resources, Ministry of Health for the most up-to-date information and the vaccine-specific product monographs.
  • the Halton-generated vial label to:
    • determine the “use-by date and time”; and
    • document the date and time of first puncture or reconstitution (depending on the vaccine).

• Refer to the Vaccine Information for Physicians page for the vaccine delivery schedule and information on online vaccine ordering.
  • Note: A minimum of 30 days of temperatures recorded in your Temperature Log Book must be submitted with online vaccine orders. Failure to do so may result in a delay in processing your order due to the required educational follow-up from Halton Region Public Health staff.
• Once you receive your order, immediately place vaccines in the refrigerator.

When managing your vaccine inventory, please ensure that:

• your office can order vaccines from Halton Region Public Health on a regular basis. Refer to Vaccine Information for Physicians for the current vaccine ordering and delivery schedule and the online vaccine order form.
• you store no more than one month’s supply of vaccine at a time. This reduces vaccine loss in the event that refrigerator temperatures go outside of +2.0°C to +8.0°C. Your office can order vaccines from Halton Region Public Health every 2 weeks.
• you rotate your stock and check expiry dates. Use vaccine with closest expiry, first.

• Expired or non-useable vaccines that are in whole, un-punctured vials are to be returned to Halton Region Public Health.
• Partial, multi-dose vials and COVID-19 vaccines (full or partial vials) cannot be returned to Halton Region Public Health.
• Vaccines that cannot be returned to Halton Region Public Health must be disposed of in your premises’ biomedical waste container. Contact Halton Region Public Health by calling 311 if you do not have a process for biomedical waste disposal at your facility.
• COVID-19 vial labels must be destroyed by removing, tearing or marking the label before disposal.
• Any COVID-19 vaccines that are not used before the “use –by date and time” printed on the Halton-generated vial label, must be reported as waste in COVax.

Steps for vaccine returns:

1. Place non-reusable vaccines in a secure bag marked as “WASTE”. Label bag with your premise’s name and Holding Point Code (HAL_OK_#####). Non-reusable vaccines that are being returned do not have to be stored in cold chain.
2. Complete a Non-Reusable Vaccine Return Record (PDF file)  and include in bag. Document punctured vials that are disposed of onsite as biomedical waste as wastage on the record.
3. Return vaccines with your bi-weekly delivery courier.

Note: Any vaccine that is returned to Halton Region Public Health is considered wasted and will not be re-used.

• If vaccines are exposed to temperatures outside of +2.0°C to +8.0°C for any period of time, it is considered a cold chain incident.
• Vaccines that are exposed to temperatures outside of +2.0°C and +8.0°C can lose their potency, which makes them less effective. This can result in a lack of protection against vaccine preventable diseases. Halton Region Public Health will assess if vaccine potency has been affected.
• All cold chain incidents must reported to Halton Region Public Health.
• Public Health will assess each affected vaccine to determine if the vaccine is safe to administer. Do not administer any vaccines until this assessment is complete.
• If vaccines involved in a cold chain incident are administered to individuals, re-vaccination will be required if vaccine potency was affected.

What to do if Temperatures are Below +2.0°C or Above +8.0°C

• If temperature are outside of +2.0°C to +8.0°C, Immediately report the cold chain incident Halton Region Public Health by calling 311.
• Troubleshoot thermometer. Refer to ‘Troubleshooting Thermometers’ above.
• Ensure refrigerator is plugged into the outlet.
• Record the date, time, and current/max/min temperature in your Temperature Log Book.
• Minimize the length of the cold chain incident by ensuring that the vaccine is stored in proper cold chain as soon as possible. Refer to your contingency plan.
• Do not administer or discard exposed vaccine until Halton Region Public Health has been notified and has determined vaccine viability.

• The Vaccine Storage and Handling Protocol (2018) (external link)  identifies that all premises are required to develop a contingency plan for refrigerator malfunctions and power outages.
• A contingency plan is a back-up plan that outlines where vaccines will be stored in the event of a refrigerator malfunction/electrical disruption to ensure that cold chain is maintained.
• If vaccines need to be moved into another refrigerator, the refrigerator must be inspected and approved for vaccine storage by Halton Region Public Health.
• Having a contingency plan helps to reduce vaccine loss by minimizing the time that vaccines are exposed to temperatures outside of +2.0°C to +8.0°C.
• Your contingency plan must include the following:
  • Lead contact name and phone number
  • Backup contact name and phone number
  • Contingency plan and location
  • Location of contingency tools and equipment
• Please ensure that all:
  • processes and equipment involved in your contingency plan are available at all times; and
  • premises staff members are aware of the plan so that prompt action can be taken in the event of an emergency.
• Refer to the Contingency Planning Resource (PDF file)  for more information.
• Please share a copy of your contingency plan with Halton Region Public Health. You can reach out to Halton Region Public Health for support with developing your contingency plan, if required.

What to do in the Event of an Electrical Disruption

• Immediately document the time and temperature and then reset the thermometer.
• Keep the refrigerator doors closed (opening the doors will let cool air out).
• Begin to prepare an insulated container. Refer to ‘Packing a Hard-Sided Insulated Container’ below.
• Immediately report electrical disruption to Halton Region Public Health by calling 311.
• Determine the length of the power outage by calling your municipal hydro supplier.
• Monitor temperature monitoring device closely.
• If temperatures are reaching +8.0°C, activate your contingency plan.

• Hard-sided insulated containers may be used for short-term storage of vaccines.
• The temperature inside the container must be between +2.0○C and +8.0○C before placing vaccines inside.
• Most insulated containers can maintain the required temperatures for a maximum of 3-4 hours depending several factors.
• If vaccines will be stored for more than 3-4 hours in the insulated container, the icepack(s) and/or gel pack(s) should be removed and replaced.
• A maximum-minimum thermometer must be used to monitor and document the temperature of the insulated container on an hourly basis.
• Specific steps must be followed when preparing and packing a hard-sided insulated container.

Note: In the Ministry of Health’s steps for preparing and packing an insulated container, it states that ‘pre-conditioned ice blankets’ must be used, in addition to the icepacks. Halton Region requires that you use refrigerated water blankets instead of 'pre-conditioned ice blankets."