Scope: Guidelines - Strive For Five (2005) Regulations
Scope: Guidelines - Strive For Five (2005) Regulations
Scope: Guidelines - Strive For Five (2005) Regulations
Scope
This document contains policies and guidelines that apply to all Western Australian (WA)
Public and Community Health Services providing immunisation services in WA.
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.
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.
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.
Table 1: Role of the Regional Immunisation Coordinator following a Cold Chain Breach
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.
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)
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
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.
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
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.
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.
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).
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
Type of Incident: fridge failure power outage transport issue vaccine expiry other
Description of Incident:
Name of Practice/Clinic:
Name of contact person: