Scope: Guidelines - Strive For Five (2005) Regulations

Download as pdf or txt
Download as pdf or txt
You are on page 1of 12

1.

Scope

This document contains policies and guidelines that apply to all Western Australian (WA)
Public and Community Health Services providing immunisation services in WA.

2. The cold chain

The “cold chain” is a system of transporting and storing vaccines within a recommended
temperature range of +2 to +8 degrees Celsius (°C). This temperature range has been
selected by the World Health Organization (WHO), and adopted by the Australian Technical
Advisory Group on Immunisation (ATAGI) for the National Immunisation Program (NIP), as a
guide to protect vaccines against loss of vaccine potency due to excessive cold or heat1.

The Communicable Disease Control Directorate (CDCD), Department of Health, Western


Australia, is committed to best practice standards in the shipment, storage and administration
of vaccines. The recommended standards outlined in this policy document are drawn from the
current edition of the Australian Immunisation Handbook2, the National Vaccine Storage
Guidelines – Strive for Five (2005)3 and the current Western Australian Drugs and Poisons
Regulations4. For further information on maintaining the cold chain process, consult these
publications.

Every immunisation service provider (ISP) should have access to a copy of the current edition
of the Australian Immunisation Handbook2, along with the National Vaccine Storage Guidelines
- Strive for Five3, the Cold Chain Action Plan and the Daily Vaccine Fridge Temperature
Recordings Calendar (all on-line at:
http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm). These documents
should be referred to for best practice guidelines.

The Australian Government provides Western Australia with over $30 million of vaccines under
the NIP. It is the responsibility of CDCD, Child and Adolescent Community Health (CACH), the
public health units (PHU) and all ISPs to monitor, review and implement the processes in place
to maintain the efficacy of these vaccines and minimise wastage.

3. Recommendations for monitoring and maintaining the cold chain process

WA ISPs are required to adopt and adhere to the recommendations set out below for
monitoring and maintaining the cold chain process.
3.1. Vaccines during transport
• The WA Department of Health contracts a commercial logistics company to distribute
vaccines around the State from a central distribution warehouse based in Perth. In
the metropolitan area vaccine shipments are made directly from the State Distribution
Centre to ISPs. In regional areas, the State Distribution Centre ships vaccines to the
regional pharmacies who act as Regional Distribution Centres by on-forwarding
vaccines to ISPs within their region.
• Vaccines should be transported in refrigerated, temperature-monitored vehicles or in
portable insulated containers (eskies) in order to maintain vaccine immunogenicity as
described in the National Vaccine Storage Guidelines – Strive for Five3.
• When using eskies to transport vaccines, eskies must be packed and ice bricks
sweated according to National Vaccine Storage Guidelines – Strive for Five3.

Vaccine Cold Chain Guidelines 2


• The State Distribution Centres must use cold chain monitors or data loggers when
transporting vaccines, as recommended in the National Vaccine Storage Guidelines –
Strive for Five.3
• Regional Distribution Centres should use cold chain monitors, minimum/maximum
thermometers or data loggers when sending vaccines to ISPs in their regions, as
recommended in the National Vaccine Storage Guidelines – Strive for Five3.
• Out-reach clinics should use minimum/maximum thermometers, data loggers or cold
chain monitors when transporting vaccines in eskies.
• On receipt of vaccine shipments, ISPs should check the cold chain monitor to ensure
the vaccines are within the +2° to +8°C range. In the metropolitan area, if the cold
chain monitor indicates the vaccines fall outside this range, the delivery should be
refused and the State Distribution Centre should be informed immediately. In regional
areas, if vaccines fall outside the +2° to +8°C range during forward transportation
from the Regional Distribution Centre, the Regional Distribution Centre must be
informed of the breach and the regional immunisation coordinator (RIC) should be
contacted for advice on the efficacy of the vaccines.
3.2. Vaccines in the refrigerator
• Where possible, vaccines should be stored in a vaccine-specific refrigerator. Bar
fridges are unsuitable for storing vaccines and cyclic defrost fridges are not
recommended.
• The refrigerator temperature should be checked and recorded twice daily on the Daily
Vaccine Fridge Temperature Recordings Calendar (available from the Public health
website http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm).
Notable changes in temperature ranges should be discussed with your RIC.
• Accurate determination of the refrigerator temperature is important as deviations
outside the recommended +2° to +8°C range can affect the efficacy of vaccines. ISPs
are strongly encouraged to have a data logger installed in their vaccine refrigerator.
Data from the data logger should be downloaded and reviewed weekly.
• A back-up minimum/maximum thermometer or data logger in the refrigerator is
recommended. This will enable the refrigerator temperature to be assessed in the
event of a power outage that may result in reduced vaccine wastage. In addition, a
back-up thermometer or data logger provides an alternate reading in case of battery
or technical failure of your primary thermometer.
• In unusual circumstances where vaccines are stored in refrigerators in buildings which
are not accessed daily, data loggers must be installed and they need to be read
weekly. Minimal vaccine stocks should be stored in refrigerators that are not regularly
accessed.
3.3. Vaccine management
• Vaccine management is the responsibility of all staff. It is important that more than
one staff member is educated on how to appropriately store vaccines, read and record
daily refrigerator temperatures and reset data loggers and vaccine refrigerator
monitors.
• Management of a new vaccine refrigerator – All newly installed vaccine refrigerators
need to be monitored continuously with a data logger for at least 48 hours prior to use
to ensure the refrigerator has a stable reading within the recommended range of
+2° to +8°C.

Vaccine Cold Chain Guidelines 3


• Ongoing management of a vaccine refrigerator – To ensure optimal functionality, the
vaccine refrigerator should be continuously monitored for 48 hours with a data logger
at least once annually. If the refrigerator cannot maintain a temperature range of +2 to
+8°C it should be serviced or decommissioned.
• Vaccine refrigerators should be serviced as per the manufacturer’s guidelines.
Documentation of the service should be retained by the provider.
• Vaccine management is considered a key performance indicator for GP accreditation.
Records of daily temperature readouts, weekly data logger readouts and annual
refrigerator audits should be kept for accreditation purposes.
3.4. Ordering vaccines
• Government-procured vaccines can be ordered from CDCD via the on-line ordering
website (http://colors.csldirect.com.au/). Those without internet access may order by
fax on 9388 4877. A vaccine order form can be obtained from the Public Health
website at:
http://www.public.health.wa.gov.au/3/473/2/provider_information__immunisation.pm.
• When placing a vaccine order, ‘stock on hand’ (i.e. the vaccines currently in the ISPs
refrigerator) must be recorded in the appropriate column of the ordering sheet. This is
a compulsory field and without this information the order cannot be processed.
• On receiving new stock, ensure vaccines closest to expiration are stored at the front of
the refrigerator. Vaccines that have passed the ‘expiry date’ need to be disposed of
and the wastage reported to the RIC using the Vaccine Wastage Report Form
(Appendix C, and on-line at:
http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm).
• Order and maintain appropriate levels of stock to meet the needs of clinic/practice
while ensuring the refrigerator is not overcrowded. Stockpiling large quantities of
vaccines is strongly discouraged as this poses a greater risk of substantial loss in the
event of a refrigerator failure or power outage.
• A vaccine storage self-audit should be undertaken by the clinic/practice every six
months, as recommended in the National Vaccine Storage Guidelines – Strive for
Five3. An audit template is included in Appendix 1 of the Strive for Five document
which can be downloaded from:
http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/provider-store

4. Cold chain breach


The cold chain is a shared responsibility that begins from the time the vaccine is manufactured,
and ends when the vaccine is administered to the recipient. A cold chain breach (CCB) occurs
when the temperature falls outside of the recommended +2° to +8°C temperature range at any
point during the cold chain process. Common breaks in the cold chain occur through
refrigeration failure, power outage, overheating of vaccines during transportation, and freezing
of vaccines.
Temperature variations outside the +2° to +8°C temperature range can result in loss of efficacy
to the vaccine. It is therefore imperative that all CCBs be reported to the RIC using the
reporting process for a CCB, as outlined in section 4.1.

Vaccine Cold Chain Guidelines 4


4.1. Process for reporting a cold chain beach (CCB)
• See Appendix A for a flow chart of the reporting process.
• Following a CCB, ISPs should isolate the affected vaccines by moving them to an
alternate +2 to +8°C location and marking the vaccines clearly with ‘Do Not Use’. The
ISP should complete the check list on page 2 of the Cold Chain Incident Report Form
(Appendix B, also on-line at
http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm) and fax
the form to the RIC. The ISP should then telephone the RIC for follow-up advice. The
RIC will provide advice around the use or disposal of vaccines affected by the breach.
ISPs should not discard any vaccines until authorised to do so by the RIC.
• On receipt of the Cold Chain Incident Report Form, the RIC will take the steps outlined
in Table 1 in order to maintain efficacy of the vaccines, reduce, where possible,
unnecessary wastage of vaccines, and support the education and ongoing
involvement of the ISP in safe, effective immunisation delivery.

Table 1: Role of the Regional Immunisation Coordinator following a Cold Chain Breach

RIC Action following a Cold Chain Breach (CCB)

1. Ask the ISP to safely store the affected vaccines in an alternate +2° to +8°C environment and clearly
labelled them ‘Do Not Use.’

2. Obtain full details of the temperatures reached and the duration for which the vaccines were outside
the +2° to +8°C range.

3. Request the ISP completes a Cold Chain Incident Report Form (Appendix B, and on-line at
http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm )

Consult the Temperature Sensitivity of Vaccines Table* for advice on the efficacy of the affected
4. vaccines. Contact CDCD or the relevant vaccine manufacturer for vaccines or circumstances not
listed in the temperature sensitivity table.

5. Provide written advice to the ISP on the recommended course of action for each vaccine affected by
the CCB.

6. If appropriate, request the affected refrigerator and temperature monitors are replaced or serviced
prior to the ISP placing an order to re-stock their vaccines.

Alert the vaccine orders team at CDCD of any CCB resulting in significant wastage of vaccines
7. ([email protected]). This will facilitate the approval process of replacement orders for
ISPs who have lost their stock.

Request the ISP provide a full record of vaccine wastage resulting from the CCB using the Vaccine
8. Wastage Report Form (Appendix C). Note that this may occur several times over the next few
months as stock with shortened shelf life expires.

9. Review the processes undertaken by the ISP in this cold chain event and, if needed, provide
education to minimise vaccine loss associated with future CCBs.

Consider if a subsequent review of the ISP practice is needed to ensure that the cold chain storage
10. complies with the recommended guidelines. If needed, this review may be referred to a Division
Immunisation Project Officer (DIPO), CACH or RIC for follow-up.
*Note: the Temperature Sensitivity of Vaccines Table* is for RIC use only. The table has been developed by
the WA Department of Health and is predominantly based on the WHO Temperature Sensitivity of Vaccines’
2006 guidelines1 and a number of other published sources. The National Immunisation Committee has a
Working Group tasked with compiling national guidelines around the temperature sensitivity of vaccines used on
the National Immunisation Program. When the Working Group’s guidelines become available they will replace
the WA Department of Health temperature sensitivity of vaccines table.

Vaccine Cold Chain Guidelines 5


4.2. Role of CDCD following a cold chain breach
• Following a CCB, CDCD can assist the RIC and ISP in a number of ways, as detailed
in Table 2 below.
Table 2: Role of the Communicable Disease Control Directorate in supporting RICs and
ISPs following a Cold chain breach

CDCD Action following a Cold Chain breach (CCB)

1. If adequate information on vaccine efficacy is not available from the Temperature Sensitivity of
Vaccines Table, CDCD will seek information from vaccine supply companies and/or relevant
vaccine experts on a case by case basis. Findings will be reported back to the RIC to guide their
feedback to the ISP

2. Where needed, CDCD will provide advice on revaccination to RICs and public health physicians
through consultation with immunisation experts (see section 4.3)

4.3. Re-vaccination following a cold chain breach


• The need to recall patients for revaccination following a CCB is rare. If re-vaccination
is necessary, it will be undertaken by the ISP in consultation with the RIC and an
immunisation expert. Where needed, CDCD will provide advice through consultation
with immunologists and vaccine experts. To facilitate timely advice, a detailed list
including patient name, date of birth, and vaccination history should be prepared by
the ISP and forwarded to the RIC. CDCD should be notified of all complex or large
scale revaccinations.
• National guidelines for re-vaccination have been developed by a Working Party of the
National Immunisation Committee and ratified by the Australian Technical Advisory
Group on Immunisation Compromised Vaccine Guidelines 2011. These guidelines
are intended for use by jurisdictional immunisation coordinators to facilitate the
provision of best practice advice to ISPs. These guidelines have been distributed by
CDCD to RICs throughout the State.
5. Vaccine efficacy following a cold chain breach
Vaccines are delicate biological substances that can become less effective or destroyed if they
are frozen, allowed to get too hot and/or exposed to direct sunlight or fluorescent light.
5.1. Freezing
• Freezing of vaccine is the most common reason for vaccine damage and loss in
Australia. For vaccines that are cold or freeze-sensitive, the loss of potency following
freezing is immediate and these vaccines must not be administered. There are some
exceptions to this rule, such as those vaccines in their dried form that are stable below
0°C and are not damaged by freezing2.
• In all instances where vaccines are exposed to temperatures outside the
recommended +2° to +8°C temperature range, ISPs are required to contact the RIC
for advice on vaccine efficacy.
5.2. Heat
• Freezing is a greater danger to vaccine efficacy than mild heat exposure2. Heat
impact on vaccines is cumulative, therefore, vaccines exposed to temperature ranges
over +8°C will, in some instances, still be able to be administered but may have a
shortened shelf life as a result of the heat exposure. When vaccines are exposed to

Vaccine Cold Chain Guidelines 6


repeated episodes of heat, the loss of vaccine potency is cumulative and cannot be
reversed.
• In all instances where vaccines are exposed to temperatures outside the
recommended +2°to +8°C temperature range, ISPs are required to contact the RIC for
advice on vaccine efficacy.
5.3. Accuracy of temperature measurement
• An accurate reading of temperature is essential in order to determine a vaccines
efficacy following an excursion outside the recommended +2° to +8° C temperature
range. All immunisation service provides (ISPs) need to know the accuracy of the
equipment they are using to measure temperature in their refrigerator. A standard
min/max thermometer (with a single digit display) usually has an error margin of ±
1°C. In contrast, data loggers can have an error margin of ±0.5°C or less. Most
vaccines are irreversibly damaged when they freeze, therefore, the ability to
accurately and confidently measure 0°C within your refrigerator will determine whether
the vaccines can be kept following a cold chain breach (CCB) between the range of
0° to +2°C.
• ISPs are strongly encouraged to have data loggers within their refrigerator which will
enable a detailed picture of the temperature excursions during a CCB to be examined
and potentially hundreds of dollars worth of vaccines to be saved. In addition, ISPs
are encouraged to know the accuracy of the equipment within their refrigerator and to
check the calibration annually. For advice on calibration of data loggers, refer to the
manufacturers’ directions. For advice on calibration of min/max thermometers, follow
the steps described in the National vaccine Storage Guidelines – Strive for Five3
(http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/provider-
store).

6. Vaccine wastage
Vaccine wastage occurs as a result of many factors including refrigerator failure, power
outages, CCBs during transportation, breakage, vaccine expiry, or administering the wrong
dose or incorrect vaccine to an individual.
Reporting of vaccine wastage is a requirement of the vaccine procurement contract with the
Australian Government and is done on a quarterly basis. This data is used to inform the
National Immunisation Program of vaccine wastage under the current National Partnership
Agreement for Essential Vaccines (NPAEV). Vaccines wasted through natural disasters,
power outages and refrigeration failure (i.e. events beyond human control) are taken into
account by the Commonwealth when calculating the wastage incurred by each State and
Territory. Reduction of vaccine wastage is a performance indicator under the NPAEV and is
tied to additional payments which are used to run State-funded vaccination programs. To
provide accountability and maximise WA’s opportunity to meet the performance benchmark, it
is important to document all vaccine wastage and the circumstances in which the wastage
came about.
ISPs are required to document vaccine wastage as it occurs and report it to their RIC using the
Vaccine Wastage Report Form (Appendix C, also available on-line at
http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm). This form can be
used to report all wastage, regardless of whether or not the wastage resulted from a CCB. The
report should be faxed or emailed to the RIC using contact details on the bottom of the form.
RICs are required to collate the vaccine wastage reports received from ISPs within their area
on a quarterly basis at the end of March, June, September and December of each year using
the Quarterly Wastage Report Form. RICs can download the report form from

Vaccine Cold Chain Guidelines 7


the Public Health website:
(http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm). Reports should
be faxed or emailed to CDCD within five working days of the end of each quarter.

6.1. Vaccine disposal


• Vaccines that need to be destroyed should be disposed of according to the medical
waste disposal procedures operating within the practice/clinic.

7. Conclusion
All vaccine service providers play a vital role in maintenance of the cold chain to ensure the
efficacy and safety of vaccines administered. Maintaining cold chain standards is vital given
the large number of vaccines now stored within each practice/clinic and the cost attached to
these vaccines.
CDCD is working closely with the RICs, Child and Adolescent Community Health, the local
government authorities and General Practice to ensure all ISPs are consistently working within
the recommended standards of practice.
ISPs are required to use the cold chain protocols provided by CDCD, the National Guidelines
for Vaccine Storage - Strive for 53 and the current edition of the Australian Immunisation
Handbook2 in order to provide correct and consistent cold chain monitoring.
When a cold chain breach results in vaccine loss, accurate wastage reporting is essential as it
is a requirement of the NPAEV and is crucial for WA to meet the nationally set performance
benchmarks.

Vaccine Cold Chain Guidelines 8


References
1. World Health Organization (2006). Temperature sensitivity of vaccines. View this
reference at http://www.who.int/vaccines-documents/DocsPDF06/847.pdf
2. National Health and Medical Research Council (2008). The Australian Immunisation
Handbook 9th Ed. Commonwealth of Australia. View this reference at
http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook-home
3. Australian Government Department of Health and Ageing (2005). National Storage
Guidelines. Strive for Five. Commonwealth of Australia. View this reference at
http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/provider-store
4. Poisons Act – Regulations 1965 (WA) and the Poisons Amendment Regulations 2010
(WA). View this reference at
http://www.public.health.wa.gov.au/1/872/2/pharmaceutical_services.pm

Appendices - for use by immunisation service providers

Appendix A: Cold Chain Breach (CCB) protocol flow chart


Appendix B: Cold Chain Incident Report Form
(http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm)
Appendix C: Vaccine Wastage Report Form for Immunisation Service Providers
(http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm)

Abbreviations

°C Degrees celsius
ATAGI Australian Technical Advisory Group on Immunisation
CACH Child and Adolescent Community Health
CCB Cold chain breach
CDCD Communicable Disease Control Directorate
DIPO Division immunisation project officer (General Practice)
DoH Department of Health
GP General practice
ISP Immunisation service provider
NIP National Immunisation Program
NPAEV National Partnership Agreement on Essential Vaccines
OP Operational Procedure
PHU Public health unit
Regional immunisation coordinator – designated Public Health Unit professional who
RIC promotes immunisation and responds to vaccine issues in their Area Health Service
WA Western Australia
WHO World Health Organization

Vaccine Cold Chain Guidelines 9


Appendix A

Cold Chain Breach (CCB) Protocol Flow Chart

Immunisation Service Providers Regional Immunisation Coordinator

1. Isolate all vaccines involved in the 1. Ask ISP to move all vaccines involved
Child
CCB inand
anAdolescent Health
alternate +2˚ Services
to +8˚C in the CCB to an alternate +2˚ to +8˚C
location. Clearly mark the vaccine with location and clearly mark the vaccines
‘do not use’. with ‘do not use’.

2. Assess the temperature the fridge 2. Obtain full details of the temperature
reached and the length of time the reached and the duration for which the
temperature was out of the +2˚ to +8˚C vaccines were outside the +2˚ to +8˚C
range. If a data logger was present an range.
immediate read out should be
undertaken.

3. Record the type and number of 3. Request the ISP completes and
vaccines involved in the CCB using the forwards to you a Cold Chain Incident
Cold Chain Incident report form for report form for Government-funded
Government-funded vaccines. vaccines.

4. Contact the RIC to report the CCB and 4. Provide the ISP with written advice on
seek advice on vaccine efficacy. Do the efficacy of the affected vaccines
NOT discard any vaccines prior to and coordinate the follow up action,
contacting the RIC. including revaccination if necessary.
Advice can be sought from CDCD as
required.

5. Shorten the shelf life or destroy 5. If appropriate, request the affected


affected vaccines, as advised by the fridge and temperature monitors are
RIC. Destroyed vaccines should be replaced or serviced prior to the ISP
disposed of using your standard restocking their fridge.
medical waste procedures.

6. Report all vaccine wastage to the RIC. 6. Request full details of all vaccines
This may occur more than once destroyed by the ISP as a result of
following a CCB, depending on the the CCB. Include this wastage in
advice given by the RIC for shortening your next quarterly wastage report to
the shelf life of affected vaccines. CDCD.

7. Conduct a patient recall if 7. Review the processes undertaken by


revaccination is deemed necessary the ISP in this CCB. If you have
after consultation with the RIC. concerns about the vaccine storage
equipment or cold chain knowledge of
the ISP, refer the ISP to a DIPO /
CACHS / RIC for subsequent follow
up.

Vaccine Cold Chain Guidelines 10


Appendix B
Cold Chain Incident Report Form
Government-funded vaccines
(available on-line at http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm)

Complete the Cold Chain Breach Incident Checklist on the following page prior to contacting your Regional
Immunisation Coordinator (RIC) for advice.
FAX both pages of this form to the RIC in your area (see RIC contact details on next page).

RIC Name: Public health unit:


RIC Fax No: RIC Telephone No:

Report the number of government-funded vaccines involved in the cold chain incident in the table below.
Do not discard any of these vaccines before discussing the incident with your RIC.

Adacel Gardasil HBVax-II HBVax-II Hiberix Infanrix Ipol Neisvac Pneumovax Prevenar
(dTpa) (HPV) (Adult) (Paed) (Hib) Hexa (IPV) (MenCCV) (23vPPV) (13vPCV)

Priorix Quadracel Rotateq Twinrix Vaqta Varilrix Fluvax Influvac Vaxigrip Vaxigrip
(MMR) (DTPa-IPV) (ORV) (HepA/B) (HepA) (VZV) Jnr

Other vaccine (not listed above):

Date of Incident: Name of Notifier:

Location/Address of Cold Chain Incident:

Phone: Fax: Email:

Type of Incident: fridge failure power outage transport issue vaccine expiry other

Description of Incident:

Actions undertaken by practice/clinic reporting incident:

Further recommended actions from the RIC:

Signed (notifier): Date:


Signed (RIC): Date:

Vaccine Cold Chain Guidelines 11


Appendix B
Cold Chain Incident Report Form (continued)
Government-funded vaccines
(available on-line at http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm)

COLD CHAIN BREACH (CCB) INCIDENT CHECK LIST


Follow steps 1-6 and complete the table below prior to contacting your Regional Immunisation
Coordinator (RIC). See RIC contact list at the bottom of this page for details of your nearest RIC.
1. Isolate the vaccines in a +2˚C to +8˚C environment and clearly label ‘do not use.’
2. Record the type and number of vaccines involved in the CCB, using the table on the previous page.
3. Contact your RIC as soon as possible, see contact details below.
4. Do not discard any vaccines until advice has been sought from your RIC.
5. Take active steps to correct and prevent the problem recurring.
Date of the breach
What were the minimum and maximum temperature readings?
What was the reading when the breach was noticed?
How long was the temperature outside +2°C to +8°C?
When was the thermometer last reset?
When was the battery in the thermometer last changed?
When was the accuracy of the thermometer last checked?
How long do you think these problems have been occurring?
Where is the temperature probe situated?
Where are the vaccines stored in the refrigerator?
Have any vaccines been pushed up against the cooling plate
or a cold air outlet?
What is the expiry date of the vaccines?
Are the vaccines in their original packaging?
Are the vaccines kept in a domestic refrigerator?
If using a domestic refrigerator, are there water bottles in the
doors, unused shelves and drawers?
Does the refrigerator have a designated power source?
Does the refrigerator have an alarm fitted?
What do you think was the cause of the CCB?
Has the cause of the CCB been rectified?
Has anybody been vaccinated with potentially affected
vaccines?

REGIONAL IMMUNISATION COORDINATOR (RIC) CONTACT LIST


Lower North Upper North
South Metro Wheatbelt Goldfields Great Southern
Metro Metro
Tel: 9380 7746 Tel: 9380 7745 Tel: 9431 0217 Tel: 9622 4320 Tel: 9080 8200 Tel: 9842 7500
Fax: 9380 7751 Fax: 9380 7736 Fax: 9431 0223 Fax: 9622 5752 Fax: 9080 8202 Fax: 9842 7534

Kimberley Midwest Carnarvon Pilbara South West


Tel: 9194 1643 Tel: 9956 1964 Tel: 9941 0519 Tel: 9158 9207 Tel: 9781 2355
Fax: 9194 1631 Fax: 9956 1991 Fax: 9941 0520 Fax: 9158 9220 Fax: 9781 2382

Vaccine Cold Chain Guidelines 12


Appendix C
Vaccine Wastage Report Form for Immunisation Service Providers
Government-funded vaccines
(available on-line at http://www.public.health.wa.gov.au/3/471/2/cold_chain__immunisation.pm)
Immunisation Service Providers must report all wastage of government-funded vaccines as it occurs within
their practice/clinic. Please enter the number of government-funded vaccines wasted and destroyed in the
chart and fax the form to your RIC, using the contact details below.
Date of disposal: Date of Cold Chain Event (if applicable):
Fridge Power Vaccine
VACCINE Other (specify)
failure outage expiry
Adacel (dTpa)
Gardasil (HPV)
HBVax-II Adult (Hep B)
HBVax-II Paediatric (Hep B)
Hiberix (Hib)
Infanrix Hexa (DTPa-hepB-IPV-Hib)
Ipol (IPV)
Neisvac-C (MenCCV)
Pneumovax 23 (23vPPV)
Prevenar 13 (13vPCV)
Priorix (MMR)
Quadracel (DTPa-IPV)
RotaTeq (ORV1)
Twinrix (HepA-HepB)
Vaqta (Hep A)
Varilrix (VZV)
Fluvax (Influenza)
Influvac (Influenza)
Vaxigrip (Influenza)
Vaxigrip Junior (Influenza)
Other: __________________
Other: __________________
Total

Name of Practice/Clinic:
Name of contact person:

Phone: Fax: Email:

REGIONAL IMMUNISATION COORDINATOR (RIC) CONTACT LIST


Lower North Upper North
South Metro Wheatbelt Goldfields Great Southern
Metro Metro
Tel: 9380 7746 Tel: 9380 7745 Tel: 9431 0217 Tel: 9622 4320 Tel: 9080 8200 Tel: 9842 7500
Fax: 9380 7751 Fax: 9380 7736 Fax: 9431 0223 Fax: 9622 5752 Fax: 9080 8202 Fax: 9842 7534
Kimberley Midwest Carnarvon Pilbara South West
Tel: 9194 1643 Tel: 9956 1964 Tel: 9941 0519 Tel: 9158 9207 Tel: 9781 2355
Fax: 9194 1631 Fax: 9956 1991 Fax: 9941 0520 Fax: 9158 9220 Fax: 9781 2382

Vaccine Cold Chain Guidelines 13

You might also like