Why this matters for your practice
Vaccines lose potency when they are stored outside +2°C to +8°C, and the damage is cumulative and irreversible. Strive for 5 puts it plainly: "Repeated exposure to temperatures outside the +2°C to +8°C range may diminish vaccine potency. This effect is cumulative and cannot be reversed." A cold chain breach is also a reportable event you cannot resolve yourself. You must not discard affected vaccines until your state or territory health department advises you to. And under the RACGP Standards 6th edition, criterion CG12 names the temperature record and the written, practice-specific policy as requirements in their own right. The two things an assessor will look for first are your twice-daily temperature record and your cold chain policy based on the current edition of Strive for 5.
What is cold chain management?
Cold chain management is the system of transporting and storing vaccines within the recommended temperature range of +2°C to +8°C. The National Vaccine Storage Guidelines "Strive for 5" (4th edition) define the cold chain as "the system of transporting and storing vaccines within the recommended temperature range", and state that "the optimal storage temperature for vaccines is +5°C".
The chain is long. In the guidelines' words, it "begins from the time the vaccine is manufactured, continues through vaccine distribution centres, and ends when the vaccine is administered". For a general practice, the part you control runs from the moment a delivery arrives at your door to the moment the vaccine goes into a patient's arm.
Vaccines are sensitive to heat and to freezing. They can become less potent or be destroyed if exposed to temperatures below +2°C (unless that is the intended storage condition, which applies to current mRNA COVID-19 vaccines and mpox vaccines) or above the recommended storage range of +2°C to +8°C. Because potency loss is cumulative and cannot be reversed, every excursion matters, not just the dramatic ones.
The abbreviation the guidelines use for a purpose-built vaccine refrigerator is PBVR, and the guidelines require vaccines to be stored in one.
What counts as a cold chain breach?
A cold chain breach occurs when vaccine storage temperatures deviate outside the recommended range of +2°C to +8°C. That is the definition in section 2.3 of Strive for 5, 4th edition.
There is one carve-out. Single temperature excursions up to +12°C for 15 minutes or less, such as when restocking the PBVR, do not constitute a cold chain breach. The guidelines are explicit that this does not include excursions below +2°C. Freezing is never covered by the carve-out, no matter how brief.
UV light exposure also counts as a reportable incident. All instances, including suspected incidents, in which vaccine is exposed to UV light during storage must be reported to your state or territory health department for advice on vaccine viability or disposal. COVID-19 vaccine incidents must be reported to the Commonwealth via the Vaccine Operations Centre until further advised.
| Reading or event | Is it a cold chain breach? | What to do |
|---|---|---|
| Temperature between +2°C and +8°C | No. Within the recommended range. | Record it twice daily as usual. |
| A single excursion up to +12°C for 15 minutes or less, for example when restocking the PBVR | No. The guidelines say this does not constitute a breach. | Correct the cause and keep recording. |
| Any excursion below +2°C | Yes. The 15-minute carve-out does not apply to excursions below +2°C. | Follow the breach protocol. |
| Temperature above +8°C beyond the carve-out | Yes. | Follow the breach protocol and report to your state or territory health department. |
| Suspected or actual UV light exposure during storage | Report it. | All instances, including suspected incidents, must be reported for advice on vaccine viability or disposal. |
What to do when you have a cold chain breach
Appendix 3 of Strive for 5, 4th edition sets out five steps.
1. Quarantine the vaccines. Keep vaccines in the PBVR and ensure the temperature is between +2°C and +8°C. Label the vaccine or vaccines with "Do not use / Do not discard". Vaccines may need to be transferred to an alternative PBVR or cooler using your back-up plan.
2. Contact your state or territory health department. Do this as soon as possible, during business hours. They will require affected vaccine details, data logs and twice-daily temperature readings to assess the breach.
3. Do not discard any vaccine until advised. The health department decides whether the vaccines are still viable.
4. Fix the cause. Take steps to correct the problem and to prevent it from recurring.
5. Contact the manufacturer for privately purchased vaccines. For privately purchased vaccines, the manufacturer is the source of advice.
When you report, the health department will ask for a specific set of information, listed in Appendix 3: the date, time and duration of the breach; the reason for it, if known, and whether it has been rectified; the brand and size of the PBVR; the data logger download covering the full breach period; the minimum and maximum temperature readings while the vaccines were exposed; the length of time the storage temperature was outside range; the date the PBVR was last serviced and any recent maintenance issues; the type and number of vaccines in stock; the expiry date and batch number of the vaccines; whether any vaccines were pushed up against the cooling plate or a cold air outlet; whether all vaccines are in their original packaging; and whether patients have been vaccinated with potentially affected vaccines. Having your temperature records and data logger reports in order before you call makes this conversation much shorter.
The daily routine Strive for 5 requires
Section 2.5 of the guidelines sets out the operating requirements for immunisation service providers.
The core discipline is temperature recording. You must monitor and record the minimum, maximum and current temperature of the PBVR twice daily, or more if required, and reset the PBVR temperature display, the data logger display or the thermometer after each reading. Manual recording is still required even with digital monitoring: current, minimum and maximum temperatures must also be manually recorded twice daily.
Beyond the twice-daily readings:
- All PBVRs must have continuous data logging set at 5-minute read intervals.
- Download and review the data logger report at a minimum weekly.
- Perform vaccine storage self-audits every 6 to 12 months.
- On receipt of a vaccine delivery, immediately place vaccines into a PBVR, to maintain the cold chain and avoid the risk of temperature fluctuations.
- Nominate a staff member to be responsible for vaccine management, and a back-up staff member to take responsibility in their absence.
- Educate and train all people involved in vaccine transport, storage and administration, including receptionists and store persons. The guidelines' FAQ is explicit that all people who handle vaccines are responsible for maintaining the cold chain.
- Have an established mechanism for reporting temperature excursions within the practice, and plans in place for responses to cold chain breaches and power failures.
- Ensure policies, procedures and protocols for vaccine management are in place and easily accessible.
The PBVR itself should be designed specifically for vaccine storage at temperatures between +2°C and +8°C, have an alarm with preset parameters set outside +2°C to +8°C, and include a "door left open" alarm.
What the assessor expects under RACGP criterion CG12
Criterion CG12, "Maintaining vaccine potency", sits in the clinical governance standard of the RACGP Standards 6th edition. Its consumer expectation reads: "I expect that this practice stores and delivers vaccines safely and effectively in line with current guidelines." The RACGP's framing of why it matters is direct: "The success of any vaccination program depends on the potency of vaccines when they are administered to patients."
| Criterion | What the practice must have |
|---|---|
| CG12.A | A written, practice-specific policy that outlines its cold chain processes. The policy must be based on the current edition of the National vaccine storage guidelines: Strive for 5, communicated to patients and members of the practice team, and implemented by all members of the practice team. The practice must also have a record of all monitoring of vaccine refrigerators, including the temperature. |
| CG12.B | At least one member of the practice team with primary responsibility for cold chain management. That person must have had appropriate training and understand their role. The rest of the team must be informed of who is responsible, and there must be a process to delegate cold chain management when that person is unavailable. |
The policy review interval is set by the RACGP: "The practice's cold chain management policy is an operational document and needs to be reviewed for currency every two years."
On communicating to patients, the RACGP notes that while the policy is a documented operational procedure, communication with patients about vaccine storage and handling needs to be transparent and reassuring, rather than procedural or technical. The practice could display a short statement, for example in the waiting room, in treatment rooms, or on the practice website, that it adheres to national guidelines relating to cold chain management; inform patients, if they ask, that vaccines are stored and managed according to best practice cold chain procedures; and include a brief explanation in patient information materials that vaccines are stored under strict temperature-controlled conditions.
For the responsible person, the RACGP suggests a set of practical actions: discuss the cold chain management policy in team meetings; create a template to make monitoring and recording of refrigerator temperatures easier; create a roster for monitoring cold chain compliance; include education about cold chain management in induction and ongoing training; and conduct an audit of vaccine storage to determine whether it complies with Strive for 5. To keep the policy current, the practice could subscribe to updates from federal and state or territory health departments about cold chain requirements and public health alerts, and conduct regular continuous quality improvement activities related to cold chain management. If you are new to the 6th edition, see what changed in the 6th edition or the 6th edition migration guide.
Common mistakes
Relying on the data logger alone. Digital monitoring does not replace the manual record. Current, minimum and maximum temperatures must also be manually recorded twice daily, even with continuous logging in place.
Not resetting the display after a reading. The guidelines require you to reset the PBVR temperature display, the data logger display or the thermometer after each reading. Without the reset, the next reading's minimum and maximum values still reflect the previous period.
Discarding vaccines before the health department advises. Step 3 of the breach protocol is unambiguous: do not discard any vaccine until advised to do so by your state or territory health department.
Treating an excursion below +2°C as covered by the carve-out. The 15-minute, up-to-+12°C allowance applies to warm excursions only. The guidelines state it "does not include temperature excursions <2°C". Any reading below +2°C is a breach.
Having no back-up person. CG12.B and Strive for 5 both require a nominated person plus a delegation process. If the routine stops every time the responsible team member takes leave, the twice-daily record develops gaps.
Letting the policy go past its two-year review. The RACGP sets the review interval at every two years, and the policy must reference the current edition of Strive for 5. A policy citing an old edition is a finding waiting to happen.
Frequently asked questions
What is cold chain management?
Cold chain management is the system of transporting and storing vaccines within the recommended temperature range of +2°C to +8°C, from the time the vaccine is manufactured through distribution centres until it is administered. For a practice, it covers delivery, storage in a purpose-built vaccine refrigerator, temperature monitoring, breach response and the written policy that ties it together.
What temperature should vaccines be stored at?
Vaccines should be stored between +2°C and +8°C, with +5°C the optimal storage temperature. This is the range used by the National Vaccine Storage Guidelines "Strive for 5". Some vaccines, including current mRNA COVID-19 vaccines and mpox vaccines, are stored below +2°C as their intended condition, but this page does not cover individual product ranges.
What is a cold chain breach?
A cold chain breach occurs when vaccine storage temperatures deviate outside the recommended range of +2°C to +8°C. One exception exists: single excursions up to +12°C for 15 minutes or less, such as when restocking the vaccine refrigerator, do not constitute a breach. That exception never applies to excursions below +2°C.
How often do vaccine fridge temperatures need to be recorded?
Twice daily, at minimum. You must record the minimum, maximum and current temperature of the vaccine refrigerator twice daily, or more if required, and reset the display after each reading. You must also download and review the data logger report at least weekly, with continuous logging set at 5-minute read intervals.
Can I throw out vaccines after a cold chain breach?
No. Do not discard any vaccine until advised to do so by your state or territory health department. Label the affected stock "Do not use / Do not discard", keep it between +2°C and +8°C, and report the breach with your data logs and twice-daily temperature readings so the department can assess vaccine viability.
What does the RACGP require for cold chain management?
Criterion CG12 requires a written, practice-specific cold chain policy based on the current edition of Strive for 5, a record of all monitoring of vaccine refrigerators including temperature, and at least one trained team member with primary responsibility for cold chain management plus a delegation process. The policy must be reviewed for currency every two years.
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