Cold chain management

Report all vaccine incidents to WA Health when government-funded vaccines are exposed:

• to temperatures outside the recommended range of +2°C to +8°C (exclude fluctuations up to 12°C for less than 15 minutes that may occur during routine tasks)
• to light (such as removal from packaging; light penetrates through a glass fridge door)

Cold chain breach protocol

Follow the steps below, when government-funded vaccines are exposed to temperatures below +2°C or above +8°C at your premises:

1. DO NOT DISCARD. Immediately isolate the vaccines, and label ‘DO NOT USE’. 
2. Keep vaccines refrigerated between +2°C and +8°C or transfer affected stock into temporary monitored vaccine storage. 
3. Complete the cold chain breach form (PDF 127KB) and send by email to the Regional Immunisation Coordinator (RIC) at your local public health unit (HealthyWA) (PHU). 
4. For non-government vaccines, contact the manufacturer directly. 
5. Your RIC will advise whether affected vaccines are safe to retain or should be discarded, and will send you a signed copy of their advice within the finalised form. 
6. If advised to discard vaccines, do not enter vaccines involved in a breach on the online expiry wastage form, even if the vaccines are due to expire soon. Your RIC will notify the Department of Health Communicable Disease Control Directorate (CDCD) separately of any wastage. 
7. Your RIC may advise you of improvements or steps to prevent recurrences. 

Cold chain information required

Your completed form should contain specific information to assist the RIC on how best to advise you of vaccine stability, including: 

• date and time of the breach 
• reason for the cold chain breach, if known, and whether it has been rectified 
• the breach period from your data logger: 
  • minimum and maximum temperature readings before, during and after the cold chain breach 
  • length of time outside +2°C to +8°C range 
  • a copy of the data logger printout saved as a PDF. 
• whether the vaccines have previously been exposed to temperatures outside the +2°C to +8°C range, if so: 
  • minimum and maximum temperature readings during the previous cold chain breach 
  • length of time outside +2°C to +8°C range during the previous breach 
  • type and number of vaccines affected by the cold chain breach. 
• whether all vaccines are in their original packaging, and if there was any visible damage to the vaccines, or if the vaccines were pushed up against the cooling plate or a cold air outlet 
• whether anybody has been vaccinated with the potentially affected vaccines. 
• Your RIC may contact you to seek further information about: 
• the brand and size of refrigerator in which the vaccines are stored 
• the date the refrigerator was last serviced 
• whether the vaccine refrigerator has had any maintenance issues recently 
• the length of time that these issues have been occurring (if relevant) 
• the expiry date of the vaccines, and 
• whether there is any visible damage to vaccines such as wet or soggy packaging. 

For vaccine orders that arrive from Onelink, each delivery has a Sensitech TagAlert® cold chain monitor to electronically record the vaccine temperature during transport. The TagAlert® has four temperature and time-out-of-range alarm limits. An alarm is triggered if a heat or freeze breach occurs during transport from the Onelink warehouse to your premises.

TagAlert® is an accurate validation of cold chain management for the delivery of vaccines:

• the TagAlert® is subjected to a one-point accuracy test before it is shipped to the customer
• the TagAlert® is validated for 12 months and has a certificate of validation
• Sensitech (manufacturer of TagAlert®) is a world-leading provider of cold chain solutions.

When orders arrive, follow the steps outlined on the Vaccine ordering webpage under the heading ‘Receiving vaccines (cold chain monitoring)’.