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26 February 2021

COVID-19 vaccine rollout and meeting the 5th edition

As Australia’s COVID-19 vaccinations rollout across Australia, be it the Pfizer/BioNTech or Oxford University/AstraZeneca types, general practices and pharmacies are preparing to administer.

Initially, priority groups will be administered the vaccine in hospital sites and aged care and disability facilities across Australia. When the rollout occurs to non-priority groups, accredited general practices and registered pharmacists will administer the vaccine to the general public.

The success of establishing immunity for better public health requires adequate vaccine potency. It is essential they are stored at a safe temperature between 2°C to 8°C for quality assurance. Due to their sensitivity, if they fall outside of this temperature range, it is highly likely to become less effective or even inactive.

It’s important to maintain the potency to safeguard the quality of care delivered to Australians through the effective administration. The systems and processes used to ensure appropriate temperatures at all times is referred to as the ‘cold chain management’.

The current COVID-19 Vaccination Administration Advice for General practice has a number of items outlined for practices to adhere to. These include:

5.1 Have adequate number and capacity of refrigerators to store vaccines (in addition to usual stock), with refrigerators to be maintained and monitored at 2 – 8 degrees Celsius.
5.2 Have appropriate refrigerators and opaque containers to store syringes. That has been prepared for administration under appropriate temperature conditions. That is protected from light from the time they are prepared till the time they are administered.
5.3 Have specific procedures associated with receipt of doses including packaging acceptance, temperature checks.
5.4 Sites must be able to adhere to the Strive for 5 guidelines and will need to have or be able to develop policies for cold chain management including:
- 5.4.1 Able to monitor the temperatures of the refrigerator(s) where stored
- 5.4.2 Have an appropriate policy and protocol in place to respond to temperature breaches, including relocating vials to another refrigerator (or freezer, where relevant) and responding at times where clinic may not have any staff present.

Take a look at our COVID-19 vaccination advice for general practice page

Meeting the 5th edition for accreditation

The Royal Australian College of General Practitioners (RACGP) Standards for general practices (5th edition) is aligned with Australian Government Department of Health National Vaccine Storage Guidelines: Strive for 5.

Criterion GP6.1 – Maintaining vaccine potency requires practices to maintain the potency of vaccines. While this information is specific to general practices, this information can also be used by chemists and pharmacists who are administering to the public against Coronavirus.

Practices must demonstrate that they meet this Criterion by meeting the following mandatory Indicators:

GP6.1 > A Our practice has at least one team member who has primary responsibility for cold chain management in the practice.
GP6.1 > B The team member who has primary responsibility for cold chain management ensures that the process used complies with the current edition of the National vaccine storage guidelines: Strive for 5.
GP6.1 > C The team member who has primary responsibility for cold chain management reviews the following processes to ensure potency of our stock:
- Ordering and stock rotation protocols
- Maintenance of equipment
- Annual audit of our vaccine storage procedures
- Continuity of the cold chain, including the handover process between designated members of the practice team
- Accuracy of our digital vaccine refrigerator thermometer
GP6.1 > D Our practice has a written, practice-specific policy that outlines our cold chain processes.

Checklist for safe vaccine handling and storage

Is there the following in place for vaccine management?
- Nominated person responsible
- Nominated back-up person
Have all staff received the following for vaccine management?
- Orientation
- Annual update
Has the following occurred in the last 12 months for vaccine management?
- Policies reviewed to ensure procedures are up to date
- Vaccine storage audit
Are the following readily available?
- Graph/logbook/chart for temperature
- Contact numbers to report a cold chain breach
- Written procedure for what to do during a power failure
Is the temperature of the vaccine refrigerator recorded twice daily when the facility is open?
Were the following for all deviations outside the +2°C to +8°C completed?
- Reported to the appropriate state or territory health department
- Responses documented and recommended actions taken

Your refrigerator:
- Has it shown evidence of malfunction (e.g. poor seals, rusting, door issues)?
- Is there an appropriate gap between the vaccines and the walls?
- Continues to store the required volume of vaccines safely according to these guidelines?
  If ‘No’, what action is being taken?
- Is there a map or guide vaccine locations on the outside of the door, if not see-through?
- Does the power source indicate ‘Do not turn off or disconnect’?
- Are there temperature probe(s) placed correctly?

If your refrigerator fails (due to breakdown or power failure etc.)
- Do you have another monitored refrigerator?
  - Do you have a generator if there is a power outage for refrigerators
- Do you have alternative storage such as an ice cooler with ice or gel packs?
  - Do coolers each have minimum/maximum thermometers
  - Is there enough insulating material for each cooler
  - Are ice packs/gel packs at the correct temperature available