COLD CHAIN

REMOTE HEALTH ATLAS Section 16: PHARMACY

REMOTE HEALTH ATLAS

COLD CHAIN
1.

General Information

The cold chain is the system of transporting and storing vaccines, medicines and Point of
Care (POC) Pathology consumables within the safe temperature range of 2oC to 8oC from
the place of manufacture to the point of administration ensuring people receive an effective
vaccine / medicine / POC consumable that have retained their viability and have not had
exposure to temperature excursions (ie affected by heat or cold).
The cold chain system requires that processes be in place to ensure that potent vaccines
and viable medicines / POC consumables reach the recipients. Maintenance of a satisfactory
temperature range will not only assure this occurs but will prevent potential costly wastage.
This dual rationale warrants commitment of staff to the relevant processes.
Information in this document includes:
Vaccines
Medicines
Point of Care Pathology Consumables
Transportation
Purpose Built Temperature Controlled Refrigerators
Cold Chain Monitoring
Managing Cold Chain Monitor Changes / Breach in Cold Chain
Quality Assurance (QA)
Also see Vaccine Storage Quality Returns which describes relevant Quality Assurance (QA)
activities.

2.

Definitions

Cold Chain: a system of transporting and storing vaccines / medicines / POC consumables
within the safe temperature range of +2oC to +8oC from the place of manufacture to the point
of administration.
Freezing: a situation where vaccines / medicines / POC consumables experience
temperatures at, or below, 0C. Importantly vaccines may not appear frozen, but may have
been damaged at these temperatures.
Freeze Monitor (FreezeAlert): a re-usable electronic device that has been factory-set to
detect exposure to < +2 C to meet Northern Territory requirements. An alarm is triggered if
the temperature goes below the threshold setting.
Vaccine Time Temperature Monitor: a device that indicates exposure to temperatures >
12C for differing periods (A, B, C indexes) or > 34C (index D).
Medicines: for the purpose of this document this only includes medicines requiring cold
chain monitoring.
Point of Care Pathology Consumables: for the purpose of this document this only includes
POC consumables requiring cold chain monitoring.

Developed by: Quality & Safety Team

Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

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Reviewed: Nov 08, Oct 12,

Next Review: October 2015

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REMOTE HEALTH ATLAS Section 16: PHARMACY

3.

Responsibilities

3.1

Clinical Staff

Be familiar with, and apply, the principles of the cold chain and monitoring system
Complete relevant training, such as the About Giving Vaccines (AGV) course and POC
training
Understand storage procedures and the operation of the Purpose Built Temperature
Controlled Refrigerator and other refrigerators in the health centre
Effectively participate in cold chain quality assurance activities. See Section 4.4
Be familiar with packing, unpacking and handling procedures of vaccines / medicines /
POC consumables to be transported

Note: RNs and AHPs who have not participated in any recognised vaccine training course / certificate
should not administer vaccinations without Medical Practitioner supervision. For staff who have
completed a recognised vaccine training course see About Giving Vaccines Section 4.1 for details.

3.2

Ensure standard cold chain maintenance and monitoring practices are observed by all
staff, and assign staff to cold chain quality assurance activities
Support relevant professional development activities (AGV and POC training)
Ensure monthly submission of cold chain monitoring quality assurance returns
Maintain necessary equipment to ensure vaccines / medicines / POC consumables can
be stored and maintained according to cold chain standards
Investigate any breach of the cold chain occurring at health centre level and liaise with
relevant personnel:
- for vaccines contact the Centre for Disease Control (CDC) for assistance in
interpreting findings
- for medicines contact the supplying pharmacy
- for POC consumables contact the relevant Professional Practice Nurse
Liaise with relevant staff to facilitate refrigerator repairs / replacement:
- CA Infrastructure Coordinator
- TE Medical Equipment Coordinator

3.3

Area Service Manager (ASM)

Follow up on cold chain issues with PHCMs as appropriate
Ensure staff have undertaken relevant training to provide vaccines and POC Testing
Approve requests for refrigerator repairs
In consultation with Best Practice Group consider and approve the purchase of new
Purpose Built Temperature Controlled Refrigerators as appropriate

3.4

CA Infrastructure Coordinator / TE Medical Equipment Coordinator

Liaise with health centre staff to expedite repairs / replacement refrigerators as
appropriate
Arrange transportation of the refrigerator to and from the service provider as necessary

3.5

Professional Practice Nurse (PPN)

Ensure the yearly distribution of the Quality Assurance package
Maintain cold chain Quality Assurance database and master records
Forward Vaccine Cold Chain Graph to CDC Immunisation Program in the region
Identify deficits in health centre processes and advise of best practice to PHCMs
Report QA issues as required to the relevant person, eg ASM, Infrastructure Coordinator
Provide reports on QA activities as required, to Management Team

3.6

Primary Health Care Manager (PHCM)

Centre for Disease Control (CDC): Immunisation Officer

Process and monitor Vaccine Cold Chain Graph returns from health centres
Provide advice regarding vaccine cold chain management
Respond to and advise action if there are breaches in the cold chain

Developed by: Quality & Safety Team

Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

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Reviewed: Nov 08, Oct 12,

Next Review: October 2015

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REMOTE HEALTH ATLAS Section 16: PHARMACY

3.7

Supplying Pharmacy
Distribute vaccines / medicines from pharmacies in accordance with cold chain
requirements

3.

Procedure

4.1

Vaccines

Vaccines are delicate biological substances that can become less effective or destroyed if
they are frozen, allowed to get too hot, exposed to direct sunlight or fluorescent light. Health
practitioners have a professional responsibility for administering effective (potent) vaccines.
This responsibility is primarily assured by the correct transport and storage of vaccines
inherent in the cold chain process.
4.1.1

About Giving Vaccines

About Giving Vaccines is a comprehensive course of study providing information on the cold
chain, including management, handling, storage and transporting vaccines. Completion of
this course is a requirement for remote clinical practice.
4.2

Medicines

Some medicines require refrigeration to ensure their viability. These should be managed
according to the cold chain protocols for transport, packaging, storage, monitoring as
described in this document.
Different arrangements exist for the provision of medicines that are not room temperature
stable, where clients receives medicines in a DAA. For local arrangements contact your
S100 pharmacy provider.
When the vaccine refrigerator has the capacity to store medicines as well as vaccines, in
accordance with guidelines provided in the National Vaccine Storage Guidelines - Strive for
5 1st Ed. (page 19) and the Pharmacy Guild of Australia, Standard 9 - Receiving, Unpacking,
Pricing and Storing Stock, medicines are to be stored in the vaccine refrigerator.
When the capacity of the vaccine refrigerator does not allow this to occur, a dedicated
refrigerator must be used to store temperature sensitive items. The temperature of the
refrigerator must be monitored per the guidelines provided in Section 4.4 Cold chain
Monitoring.
4.3

Point of Care Consumables

POC consumables for i-STAT Analyser, DCA and HemoCue Quality Controls (QCs) are
used for POC testing in a number of remote health centres. POC Cartridges and QC are to
be kept refrigerated at +2 +8 C until product expiry date.
Troponin I Cardiac Marker QC Level 2 is the exception, which must be stored frozen.
i-STAT and DCA cartridges and QCs can be stored in the vaccine refrigerator in accordance
with the guidelines provided in the National Vaccine Storage Guidelines - Strive for 5 1st Ed.
(page 19). When the capacity of the vaccine refrigerator does not allow this to occur, a
dedicated refrigerator must be used to store temperature sensitive items. The temperature
of the refrigerator must be monitored per the guidelines provided in Section 4.4 Cold chain
Monitoring
4.4

Transportation

Cold chain monitors must be used in the transportation and storage of vaccines / medicines /
POC consumables.
4.4.1

Pharmacy Supplied Vaccines / Medicines

Distribution of vaccines / medicines from pharmacies occurs in an esky, with adequate

insulation and cold packs for routine transport timelines. Each vaccine type / medicine will be
accompanied by a freeze monitor and vaccine time temperature monitor.
Developed by: Quality & Safety Team
Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

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Reviewed: Nov 08, Oct 12,

Next Review: October 2015

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REMOTE HEALTH ATLAS Section 16: PHARMACY

4.4.2

Remote Health Supplied Point of Care Consumables

Distribution of POC consumables is completed using an esky with adequate insulation and
cold packs for routine transport timelines. Each POC consumable order will be accompanied
by a freeze monitor and vaccine time temperature monitor.
4.4.3

Vaccines / Medicines / POC consumables used outside the health centre

Vaccines / medicines / POC consumables transported for use outside the health centre are
to be packed according to guidelines in Strive for 5 pp 28-33, as referenced in The Australian
Immunisation Handbook 10th Ed. pp 24-25.
The same freeze monitor and vaccine time temperature monitor are to remain with this stock
at all times ie during transportation and storage in the fridge. On return to the health centre
these cold chain items are to be returned to the refrigerator as appropriate. Staff are to use
this stock first. Where cold chain monitors indicate a breach in the cold chain this must be
discussed with the relevant personnel (see Section 4.5).
The use of a digital minimum-maximum thermometer to monitor the temperature inside the
esky (see page 29 & 31) is to be considered when items may be out of the refrigerator for
extended periods.
4.5

Purpose Built Temperature Controlled (Vaccine) Refrigerators

Purpose Built Temperature Controlled Refrigerators are manufactured for the purpose of
storing cold chain items under optimum conditions and provide:
a stable, uniform, controlled temperature unaffected by ambient temperature
defrost cycle without raising the cabinet temperature
standard alarm and safety features for fluctuations in cabinet temperature
Each Remote Health Centre will have a Purpose Built Temperature Controlled Refrigerator/s
and these are to be connected to a 24 hour power supply whenever possible.
Storage of other temperature sensitive medical products, eg pharmaceuticals and POC
consumables stored between 2 C to 8 C, is acceptable in a vaccine storage refrigerator1.
Note: A licensed Refrigeration Mechanic should service Purpose Built Temperature Controlled
Refrigerator annually. Under product warranty (<12 months old), a Refrigeration Mechanic accredited
by the manufacturer must provide maintenance. Companies recommend contacting them to obtain
advice on authorised service organisations for maintenance.

4.5.1

Repairs / Replacement Refrigerators

When a refrigerator requires repair, the PHCM is to report this to the CA Infrastructure
Coordinator / TE Medical Equipment Coordinator via the Urgent Minor Repairs (UMR)
process. The relevant staff member will liaise with health centre staff to expedite repairs.
The CA Infrastructure Coordinator / TE Medical Equipment Coordinator will liaise with the
service provider (with a qualified refrigeration mechanic) who may:
- discuss the issues and provide advice via the telephone to the PHCM
- in the event a qualified refrigeration mechanic is visiting the community (eg
providing routine air conditioner maintenance), the service provider may request
the mechanic to investigate the fault. To facilitate payment to the service provider
this request must be arranged with the CA Infrastructure Coordinator / TE Medical
Equipment Coordinator prior to commencing the work
When a refrigerator needs to be transported to a regional centre for repair, the PHCM should
liaise with CA Infrastructure Coordinator / TE Medical Equipment Coordinator. A replacement
refrigerator may be available and should be arranged in:
- Central Australia with the Infrastructure Coordinator
- Top End with the service provider repairing the Temperature Controlled Refrigerators.
1

Reference: National Vaccine Storage Guidelines - Strive for 5 1st Ed. 2005 Page 19
Developed by: Quality & Safety Team
Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

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Reviewed: Nov 08, Oct 12,

Next Review: October 2015

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REMOTE HEALTH ATLAS Section 16: PHARMACY

When a refrigerator cannot be repaired, a replacement refrigerator is to be requested

utilising the Internal Requisitions process.
Requests for Temperature Controlled Refrigerators must be discussed with the PPN in order
to maintain standardisation in the type of Temperature Controlled Refrigerator in health
centres.
4.6

Cold Chain Monitoring

4.6.1

Vaccine Cold Chain Graph

Monitoring and maintaining a safe temperature for vaccine / medicine / POC consumables
storage from the time of manufacture to their final administration to clients is crucial to the
cold chain process.
Temperature Controlled Refrigerators are fitted with electronic temperature monitoring
equipment, which records the minimum and maximum temperatures within the refrigerator. A
Vaccine Cold Chain Graph is used to record the temperatures within the refrigerator, and
minimum and maximum temperatures should be checked and recorded daily. Temperature
settings are reset following each reading.
It is advisable to use an additional digital minimum-maximum thermometer in the vaccine
storage refrigerator as a cross checking measure, and will be of value in the event of an
electronic malfunction. Electronic thermometers are recommended in this instance. Mercury
thermometers are not authorised due to the potential Workplace Health and Safety risk of
mercury spills.
When medicines and POC consumables are stored in an alternative refrigerator, a digital
minimum-maximum thermometer must be kept in the refrigerator and the minimum and
maximum temperatures within the refrigerator must be recorded on a cold chain graph daily.
Vaccine Cold Chain Graphs are to be returned monthly to the PPN who will forward to the
relevant regional CDC Immunisation Program.
In order to accurately read the cold chain monitors, staff need to have adequate training and
knowledge. This should be provided at orientation and by staff completing the About Giving
Vaccines course. However, where this has not occurred clinical staff should none the less
be familiar with cold chain management to enable them to effectively participate in this
quality assurance activity.
4.6.2

Vaccine Time Temperature Monitor

Record the date and time on the vaccine time temperature monitor when:

the vaccines / medicines / POC consumables arrive at the health centre

the vaccines / medicines / POC consumables are taken from the health centre (eg
outstation visits) and are returned
any of the monitor index becomes totally blue
the batch of vaccines / medicines / POC consumables accompanying that monitor
is all used

When the associated batch of vaccines is completely used (or no longer required) return
monitors to the CDC Immunisation Program in the region, ie Darwin or Alice Springs for
quality assurance purposes.
4.6.3

Freeze Monitor (FreezeAlert)

Record date and time on the Freeze Monitor when:

the vaccines / medicines / POC consumables arrive at the health centre

the vaccines / medicines / POC consumables are taken from the health centre (eg
outstation visits) and are returned
the batch of vaccines / medicines / POC consumables accompanying that monitor
are all used

Developed by: Quality & Safety Team

Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

Page 5

Reviewed: Nov 08, Oct 12,

Next Review: October 2015

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REMOTE HEALTH ATLAS Section 16: PHARMACY

the monitor alert has been activated, indicating vaccines / medicines / POC
consumables have been frozen

FreezeAlert monitors have a 36 month battery life and will be activated for use by the
Pharmacy prior to dispatch with vaccines. If the start button on the FreezeAlert monitor is
accidentally pressed after it has been activated, this will not affect nor change the function of
the monitor.
The new FreezeAlert monitor uses a simple or X to indicate if the accompanying
vaccines / medicines / POC consumables have been frozen.
When the batch of vaccines / medicines accompanying the FreezeAlert monitor are all
used, the monitor can be returned at room temperature to the Pharmacy for re-cycling if the
alert has not been activated on the monitor. Similarly, FreezeAlert monitors which
accompany POC consumables are to be returned to the relevant PPN.
4.7

Managing Cold Chain Monitor Changes / Breaches in Cold Chain

4.7.2

Vaccines

Instances where changes occur in the Cold Chain Monitor will affect vaccine efficacy and the
shelf life of the vaccine.
When any change occurs to the A, B, C indexes and the D index is clear a use by date is to
be recorded on the affected vaccine. The date may be calculated using the guidelines on
the monitors yellow card.
Contact CDC in your region, when the A, B, C and D indexes are all blue, for advice on the
management of these vaccines.
Please refer to CDC if there is any uncertainty on how to manage a vaccine where changes
have occurred on Vaccine Time Temperature Monitors or Freeze Monitors. Do not discard
any vaccine prior to talking with CDC.
Any disruption to the cold chain is to be investigated to prevent a reoccurrence. Should you
have concerns about a breach in cold chain, the following protocol should be followed:

immediately isolate the vaccines within the refrigerator and label do not use
contact CDC as soon as possible for advice
the disruption to the cold chain should be investigated to correct the problem and
prevent reoccurrence

4.7.2

Medicines

Where monitors indicate a breach in cold chain (either below +2 C or above +8 C), the
supplying pharmacy must be contacted to advise on viability of the medicine.
4.7.3

Point of Care Consumables

Where monitors indicate a breach in cold chain, the relevant PPN should be contacted to
advise on the viability of the POC consumables. See I-STAT Analysers section 4.8 Storage
of Cartridges and Quality Controls for additional information.
4.8 Quality Assurance
RHB Vaccine Quality Assurance mechanisms comprise:
Vaccine Storage Quality Return
Vaccine Cold Chain Graph
(label which refrigerator when
completing more than one graph)
Vaccine Usage & Wastage Report
Vaccine Time Temp Monitor

Complete monthly and return to the PPN

Complete monthly for all dedicated vaccine / medicines / POC
refrigerators and return to the PPN.
The Vaccine Refrigerator Cold Chain Graph will be forwarded to the
regional CDC Immunisation Officer
Complete twice per year and return to CDC Immunisation Project
Officer Darwin
Record the date and time as indicated in 4.4.2 and return to the
regional CDC Immunisation Unit (Darwin / Alice Springs)

Developed by: Quality & Safety Team

Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

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Reviewed: Nov 08, Oct 12,

Next Review: October 2015

COLD CHAIN

REMOTE HEALTH ATLAS Section 16: PHARMACY

5.

Forms

Vaccine Cold Chain Graph (HM 144 - c), provided annually with Quality Assurance Folder
Inserts and also available from Stores
Vaccine Storage Quality Return, also provided annually with Quality Assurance Folder
Inserts
Vaccine Freeze Monitor
supplied with vaccines / medicines by Pharmacy
Vaccine Time Temp Monitor
and POC consumables by the PPN
Vaccine Usage & Wastage Report, also distributed by CDC

6.

References and Supporting Documents

Related Atlas Items:

About Giving Vaccines
Diabetes Control Analyser (DCA)
Immunisation Program
Internal Requisitions
i-Stat 1 Analysers

Staff Immunisation
Urgent Minor Repairs
Vaccine Storage Quality Returns
Vaccine Usage & Wastage Reports
Vaccines

Centre for Disease Control: Immunisation Project Officer, ph 89228564

About Giving Vaccines (AGV) Course Manual and Readings. 2006. Centre for Disease
Control. DHCS NT. pp 75-99
Immunise Australia Program
The Australian Immunisation Handbook 10th Ed.
National Vaccine Storage Guidelines - Strive for 5 1st Ed.
FreezeAlert Sensitech website
Pharmacy Guild of Australia, Standard 9 - Receiving, Unpacking, Pricing and Storing Stock
Purpose Built Temperature Controlled (Vaccine) Refrigerators websites:
Arcus
Thermoline Scientific
Quirks Australia

Developed by: Quality & Safety Team

Endorsed by: Remote Executive Leadership Group
Release Date: May 2007

Page 7

Reviewed: Nov 08, Oct 12,

Next Review: October 2015