Cold Chain Protocol - Vaccines and Biologics



8.  Managing Cold Chain Problems

Relevant Reference Materials:

Cold Chain Failures Happen…Regardless of How…Take Action!

 

8.1.  What to do when the temperature is below +2°C or above +8°C

A temperature reading of below +2°C or above +8°C means that the vaccines and biologics have been exposed to temperatures outside of the manufacturer’s storage recommendation and may have lost potency. This is referred to as a “cold chain failure.”

If a cold chain failure occurs, the Vaccine Coordinator or back-up should be informed as soon as possible.

Required Actions by the Vaccine Coordinator or back-up for a Cold Chain Failure
Action 1
  • Conduct a quick assessment of the situation to determine if the issue can immediately be identified (i.e. power disconnected, fridge door ajar or opened too frequently, temperature probe misplacement, etc.)
  • Put affected product into a separate container (ex. paper bag) marked “DO NOT USE.”
  • Place product in a functioning and monitored refrigerator or cooler until clear instructions have been received about next steps.
  • The vaccines and biologics may still be viable. Don’t assume the vaccines cannot be salvaged.
Action 2
Action 3
  • Calculate the maximum length of time the stock was possibly exposed to temperatures outside the manufacturer recommended 2°C to 8°C range. If the specific time and temperature details are not available, use the time of the last temperature check as when the refrigerator malfunctioned.
Action 4
  • Review the most current product monographs for stability information outside of 2-8°C.
  • If required, contact the manufacturers and provide details on the exposure and request direction regarding viability of the product. Indicate the results on the Cold Chain Failure Response Form.
Action 5
  • If deemed useable, clearly identify on the product (e.g., with a sticker) the date of the cold chain failure and the number of hours exposed. Use at the first opportunity.
Action 6
  • Fax completed Cold Chain Failure Response Form to Communicable Disease Control, Manitoba Health, Seniors and Active Living at 204-948-2040.
Action 7
  • Vaccines deemed NOT useable can be removed from the refrigerator and returned to the Provincial Vaccine Warehouse for potential cost recovery and/or destruction.
  • Consult Manitoba Health, Seniors and Active Living prior to ordering replacement product or returning product to the Provincial Vaccine Warehouse.
  • After approval for return is given by Manitoba Health, Seniors and Active Living contact the Provincial Vaccine Warehouse for return instructions at 204-948-1333 or Toll Free: 855-683-3306.

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8.2.  Inventory Management of Cold Chain Failures

In most circumstances, replacement of stock can occur once the cause of the cold chain failure has been rectified and the Cold Chain Failure Response Form has been completed and faxed to Communicable Disease Control, Manitoba Health, Seniors and Active Living.

Actions for product exposed to a cold chain failure but deemed useable:
  1. Clearly mark on the product (e.g., with a sticker) the date of the cold chain failure and the number of hours exposed. Two or more exposures may require special consideration by the manufacturer if the product can still be used.
  2. Use up product exposed to a cold chain failure before using other stock.
Actions when product deemed unusable is inadvertently used:
  1. Contact the applicable product manufacturer(s) about appropriate actions/next steps and provide them with the following information to help with assessing the situation:
    •     name of the product,
    •     duration and temperature of exposure,
    •     whether multi-dose vials were open at the time of exposure,
    •     the number of doses, and
    •     the date the dose(s) were administered.
    •     any other information requested by the manufacturer.

  2. People immunized with a vaccine or biologic with questionable potency may need to be tested for serologic evidence of immunity (presence of protective antibody levels) or be re-immunized. The local Medical Officer of Health within the Regional Health or First Nations Authority can be consulted on these matters.

Note: On occasion, vaccines or biologics may be required for an immediate situation. If the current supply has potentially been compromised by a cold chain failure, special arrangements can be made by contacting the Provincial Vaccine Warehouse at 204-948-1333 or Toll-Free 855-683-3306 during regular working hours to obtain a temporary/one week supply of replacement stock.

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8.3.  Refrigerator Malfunctions

When the refrigerator containing vaccines and biologics is not working it is important to determine if the malfunction can be corrected quickly. Please refer to Appendix 3: Malfunctioning Refrigerator Trouble Shooting Checklist and Appendix 4: Algorithm to Assess Problems in Temperature Readings for required actions during a refrigerator malfunction.

Note: If the malfunction cannot be corrected quickly (< 3 hours) alternative storage for the stock is required as products cannot remain in a non-functioning refrigerator for an extended period of time.

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Communicable Disease Control (CDC)
Public Health
Manitoba Health, Seniors and Active Living

4th Floor - 300 Carlton St.
Winnipeg MB  R3B 3M9  CANADA
Phone: 204-788-6737
Fax: 204-948-2040