The National Cold Chain Audit

The National 

Cold Chain Audit 

Biannual Report 

December 2002 to June 2003 

Prepared as part of a Ministry of Health 

contract for scientific services 

by 

Pamela Raynel 

Scientist 

Institute of Environmental Science and Research 

Porirua 

Helen Christie 

National Quality Coordinator 

Immunisation Advisory Centre 

Auckland 

July 2003 

Client Report 

FW 0352

DISCLAIMER 

This report or document ("the Report") is given by the Institute of Environmental Science and Research 

Limited ("ESR") and the Immunisation Advisory Centre (“IMAC”) solely for the benefit of the Ministry of 

Health, Public Health Services Providers and other Third Party Beneficiaries as defined in the Contract 

between ESR and the Ministry of Health, and is strictly subject to the conditions laid out in that Contract. 

Neither ESR nor IMAC or any of their employees makes any warranty, express or implied, or assumes any 

legal liability or responsibility for use of the Report or its contents by any other person or organisation.

ACKNOWLEDGMENTS 

Thanks to Nathaniel Bacchus, Surveillance Information Management Systems, ESR, for setting up the data 

base to enable the data analysis; Peter Dallinger, ESR vaccine store, for inclusion of the monitors in issues 

from the national vaccine store; and to immunisation coordinators; staff in regional stores and vaccinators 

who have participated in the audit.

TABLE OF CONTENTS 

SUMMARY.......................................................................................................................................................I 

SUMMARY CONTINUED ............................................................................................................................ II 

RECOMMENDATIONS ..............................................................................................................................III 

INTRODUCTION ........................................................................................................................................... 4 

METHOD......................................................................................................................................................... 5 

RESULTS......................................................................................................................................................... 7 

DISTRIBUTION AND RETURN OF MONITORS..................................................................................... 7 

COLD CHAIN FAILURES ............................................................................................................................ 7 

HEAT FAILURE............................................................................................................................................. 7 

FREEZE FAILURE ........................................................................................................................................ 8 

COMBINATION OF HEAT AND FREEZE ................................................................................................ 8 

DISTRIBUTION TIME ................................................................................................................................ 11 

VACCINE DISTRIBUTION AND POTENTIAL COST OF VACCINE WASTAGE ........................... 11 

DISCUSSION................................................................................................................................................. 12 

REFERENCES .............................................................................................................................................. 13 

APPENDICES................................................................................................................................................ 14 

APPENDIX 1: TEMPERATURE-SENSITIVE MONITOR RECORD CARD................................................................ 14 

APPENDIX 2: COLD CHAIN SURVEY PACK NOTICE......................................................................................... 15 

APPENDIX 3: INFORMATIONAL MATERIAL SENT TO REGIONAL VACCINE STORES.......................................... 16 

APPENDIX 4: INFORMATIONAL MATERIAL SENT TO GENERAL PRACTICE VACCINATORS ............................... 20 

APPENDIX 5: INFORMATION PROVIDED TO VACCINATORS AS A LAMINATED POSTER FOR THEIR FRIDGES..... 25 

APPENDIX 6: INFORMATION PUBLISHED IN THE IMMUNISATION ADVISORY CENTRE’S NEWSLETTER........... 26 

APPENDIX 7: UPDATE INFORMATION PUBLISHED IN THE IMMUNISATION ADVISORY CENTRE’S NEWSLETTER 

..................................................................................................................................................................... 27 

APPENDIX 8: UPDATE OF INSTRUCTIONS FOR COMPLETING THE MONITOR RECORD CARDS .......................... 28 

APPENDIX 9: FACT SHEET FOR COORDINATORS............................................................................................ 29 

APPENDIX 10: FEEDBACK RECEIVED FROM COORDINATORS DEC 02 – JUN 03 ............................................. 31 

REGION ........................................................................................................................................................ 35 

APPENDIX 11: REPORT DISTRIBUTION....................................................................................................... 36 

The National Cold Chain Audit 

December 2002 June 2003 

i 31/07/03

SUMMARY 

The system of maintaining vaccines at the correct temperature during transport and storage is referred to as 

the vaccine cold chain. All vaccines currently used in the national immunisation programme in New Zealand 

have a recommended transport and storage temperature of 2-8 °C 

Vaccines need to be stored and transported at their recommended storage temperature to ensure their 

effectiveness and safety. The effects of exposure to vaccines to temperatures outside their recommended 

storage temperatures are variable 1, 6 . Vaccines such as the aluminium-adsorbed vaccines can degrade if 

frozen. Freezing promotes flocculation of the vaccine and increases the sedimentation rate. In contrast live 

vaccines such as measles-mumps-rubella vaccine (MMR) are extremely stable when frozen. However the 

potency of MMR is particularly affected by extended exposure to heat. 

Previous cold chain surveys have been carried out in New Zealand 3, 4 . The last survey 4 showed a slight 

improvement in protecting vaccines from excessive heat exposure but this improvement may have been at the 

expense of an increase in exposure of vaccines to freezing, indicating vaccines are more often being stored 

‘too cold’ than ‘too hot’. A key recommendation from the 1999-2000 survey was to implement routine 

ongoing monitoring of the cold chain. 

Routine ongoing monitoring of the cold chain from the national vaccine store at ESR to administration of the 

vaccine was implemented during December 2002. A heat sensitive monitor and a freeze sensitive monitor 

are included in a proportion of childhood immunisation schedule vaccine packs issued from ESR’s national 

vaccine store. The monitors are attached to a record card to record the temperature exposures for each 

monitor at each transport and storage steps. 

This is the first biannual report which covers the first seven months of the national cold chain audit and 

provides the results of an analysis that was carried out on a total of 985 validly completed cold chain monitor 

cards returned to ESR. The return of monitors is outlined in figure 1. 

Figure 1: Return of monitors Dec02-Jun03 

No. of monitor cards sent by ESR to regional stores 

2,332 

No. of monitor cards on-sent from regional stores to vaccinator sites (% of total) 

2,009 (86%) 

1,229 (61%) of monitor cards returned to ESR 

985 (80%) of cards 247 (20%) of cards 

returned valid 

returned invalid 

The cold chain monitors had been attached to DTaP-IPV (diphtheria tetanus acellular pertussis-Inactivated 

polio), DTaP/Hib (diphtheria tetanus acellular pertussis/Haemophilus influenza b), MMR (Measles mumps 

rubella), HibHepB (Haemophilus b Hepatitis B), IPV (Inactivated Polio vaccine), Td (adult tetanusdiphtheria) 

and HepB (Hepatitis B 5mcg) vaccine packs. The colour change was read and recorded for each 

monitor at each step from the National Vaccine Store at ESR to when the last dose was used at the 

vaccinator’s practice. The cold chain events for the reporting period are summarised in Figure 2. 



i 31/07/03

SUMMARY continued 

Figure 2: Types of cold chain events Dec 02-Jun 03 

Monitor 

type 

Monitor 

Status/Index 

Freeze Clear 824 (84) 

Violet 158 (16) 

Heat Index 0 

(No colour/partial colour 

in window 1) 

Number recorded 

(% of valid completed cards) 

N = 985 

614 (62) 

Index 1 

Window 1 completely red 340 (35) 

Index 2 


Index 3 


None of the WarmMark monitors had turned red in window 4 indicating that the vaccine had not been 

exposed to temperatures ≥ 34 °C for 2 hours. 

Most of the recorded heat exposure occurred in the two transport steps between the national vaccine store 

(NVS) and the regional vaccine stores (RVS) and between the RVS and the vaccinator sites. This is most 

likely due to recording the heat exposure incorrectly when the vaccine arrives at the regional store or 

vaccinator site. The World Health Organisation’s interpretation 5 of the heat-sensitive monitor indicates that 

it takes three days at 12°C for the indicator in window one to turn completely coloured. The mean time any 

vaccine was in transit was one day. Although all of the heat exposure having a likely affect 31/371 (8 %) 

occurred during storage at the vaccinator site. Of the ColdMark monitors 158 (16 %) had turned purple 

indicating exposure of vaccines to temperatures at or below 0°C and thereby reducing or even destroying 

vaccine potency. Most of the freezing occurred during storage at the vaccinator site followed by transport 

between RVS and vaccinator sites. 



ii 31/07/03

RECOMMENDATIONS 

1. The national cold chain audit remains in place in its present form until further data can be gathered 

to allow a comprehensive evaluation of the benefits or otherwise of the national cold chain audit. 

2. The four-hour threshold for vaccine deliveries between regional stores and vaccinator sites within 

the same city should be reviewed as this guideline is resulting in unnecessary vaccine wastage. 

Most vaccines on the current immunisation schedule have a high sensitivity to freezing but good 

thermostability. 

3. Provide funding to contract a scientific company to perform independent annual spatial distributions 

on vaccinator’s fridges that are used to store vaccines. Most practices store vaccines in a domestic 

refrigerator where there is strong evidence that shows significant temperature variation at different 

locations within the domestic fridge. A spatial distribution would provide a temperature map of the 

fridge identifying where vaccines can be safely stored in the refrigerator. Coordinators would 

monitor the adherence to safe vaccine storage during routine visits to practices. 

4. Provide funding to assist implementation of electronic monitoring in all fridges used to store 

vaccines. Evaluating a cold chain event is aided by having both time and temperature information 

available. Being able to make an informed decision after a temperature excursion and remove 

guesswork would save unnecessary wastage of vaccine and also reduce the risk of administering 

compromised vaccines. 

5. Consider providing incentives to encourage practices to purchase or lease a designated vaccine 

specific fridge. However the fridge chosen must be electronically monitored with audible alarm. 



iii 31/07/03

INTRODUCTION 

This report provides analysis on the national cold chain audit implemented for vaccines on the National 

Childhood Immunisation Schedule. It covers the period from the start of the audit in December 2002 to 

30 June 2003. The implementation of this audit was contracted jointly to ESR and the Immunisation 

Advisory Centre (IMAC). 

Routine ongoing monitoring of the cold chain from the National Vaccine Store at ESR to 

administration of the vaccine was implemented during December 2002. A heat-sensitive monitor 

(WarmMark ) and a freeze-sensitive monitor (ColdMark ) were included in a proportion of Childhood 

Immunisation Schedule vaccine packs issued from ESR’s National Vaccine Store (NVS). The 

monitors were attached to a record card to record the temperature exposures for each monitor at each 

transport and storage step. 

This audit has been implemented as a result of a recommendation of the survey carried out in 

1999-2000 4 . This report recommended routine ongoing monitoring and audit of the entire cold chain, 

from manufacturer to administration of the vaccine. However the audit being reported on at this time is 

restricted to the cold chain between the National Vaccine Store (NVS) and the vaccinator’s site due to 

the logistical difficulties associated with commencing the survey at the point of vaccine manufacturer. 

All national immunisation programme vaccines are manufactured overseas and airfreighted to New 

Zealand. They are accepted and stored at the NVS at ESR’s Kenepuru site in Porirua as described in 

the Vaccine storage and distribution national standards 2 . The vaccine is then distributed to a network 

of regional vaccine stores (RVS), who in turn supply the vaccine to vaccinator sites. All of the 

vaccines included in this analysis went through two storage steps and two transport steps each. 

During this reporting period cold chain failures (CCF’s) were reported from each health district. The 

locations of reported CCF’s are as follows: 

 

 

 

 

During transport between national store and regional store 

Storage at regional store 

During transport between regional store and vaccinator site 

Storage at the vaccinator site 

Of the 529 CCF’s recorded 249 (47 %) occurred at vaccinator sites and 32 (6 %) at the regional vaccine 

store either due to vaccine stored in their refrigerator or vaccine left out after a delivery and 248 (47 %) 

occurred during transport stages. 



4 31/07/03

METHOD 

Two temperature sensitive cold chain monitors were used, a heat sensitive monitor and a freeze 

sensitive monitor. One of each of these monitors was attached to record cards (Appendix 1) to record 

the status of the monitors when they arrived and left each point in the distribution chain (Figure 2). 

A record card with monitors was assigned to between 0.2-1 % of vaccine doses in each shipment 

received at the national vaccine store for the immunisation programme. The precise number was based 

on the number of doses in the shipment and the number of doses of that vaccine issued each year. The 

packs of vaccines containing monitors are marked with a prominent notice to indicate the pack contains 

a cold chain monitor (Appendix 2). 

Heat-sensitive monitor 

The heat-sensitive monitor, WarmMark provides a visual history of time and temperature exposure. 

A dual temperature indicator was used, as well as having progressive multiple windows referred to as 

index 1,2 &3, it also includes an additional disc indicator activated at a higher temperature of 34°C, 

referred to as index 4. When the monitor is exposed to temperatures above 10°C a red indicator 

appears in the left-most index (index 1). The indicator is irreversible but movement of the indicator is 

halted after the temperature returns to below 10°C. When the monitor is exposed to temperatures over 

34°C for two hours, the disc changes colour to red. 

Freeze-sensitive monitor 

The freeze-sensitive monitor, ColdMark provides a visual indicator of temperature exposures below 

0°C. When the temperature drops to 0°C the clear colourless indicator bulb irreversibly changes to a 

violet colour 

Figure 2: Temperature-sensitive monitor record card with monitors attached 

Temperature-Sensitive Monitor Record Card 

Date 

in 

Warm 

Mark 

Index 

Cold 

Mark 

Status 

Location 

Date 

out 

Warm 

Mark 

Index 

Cold Mark 

Status 

WarmMark Monitor 

If no colour or partial colour in 

Window 1, record index as 0 

ColdMark Monitor If window 1 

is 

completely 

red, record 

If the bulb is clear in colour, record status as C. 

index as 1 

If the bulb is violet in colour, record the status as V 

If window 2 

is 

completely 

red, record 

index as 2 

If window 3 

is 

completely 

red, record 

index as 3 

If window 

4 is 

completely 

red, record 

index as 4 

Monitors issued 

A total of 2,332 monitor record cards with monitors were issued from the national vaccine store to 

regional stores. During the reporting period 2,009 had further been issued from the regional stores to 

vaccinator sites. The packs with monitors were marked with a prominent notice to indicate that the 

pack contained a cold chain monitor. This notice was also placed on the outside of the cartons being 

used to send vaccines to regional stores. Regional stores also used this notice on the outside of the 

container used to transport vaccines to vaccinator sites. 

The total number of monitors issued to each regional store is shown in Figure 3 



5 31/07/03

Figure 3: Number of monitors issued from ESR according to the regional store that they 

were sent to 

Regional store Number of monitors issued 

(% of total) 

Zuellig Pharma 

Whangarei 105 (5) 


Auckland 766 (33) 


Hamilton 483 (21) 


Wellington 518 (22) 


Christchurch 332 (14) 


Dunedin 128 (5) 

Total 2332 

Instructions to regional vaccine stores, vaccinators and immunisation coordinators 

In mid November, information about the national cold chain audit along with samples of the 

temperature-sensitive record cards with monitors was given to David Lewis, General Manager, Zuellig 

Pharma wholesale division for distribution to regional stores (Appendix 3). Similar information was 

also mailed to general practice surgeries using a mailing list provided by Zuellig Pharma healthcare 

logistics (Appendix 4). 

The information included instructions on how to: 

• identify when a monitor was included in a pack of vaccine 

• interpret the monitors 

• record the status of the monitors 

• send the monitors on (in the case of regional stores) or return the monitors to ESR (in the case 

of vaccinators) 

• who to contact when a monitor was received or cold chain failure recorded 

Concise instructions were also provided in the form of a laminated fridge magnet for vaccinators 

(Appendix 5). 

Notices about the cold chain audit were included in the Immunisation Advisory Centre’s newsletter in 

November 2002 (Appendix 6). A further notice was included in the May 2003 newsletter (Appendix 

7). Supplementary instruction notices similar to the fridge magnet were distributed in each vaccine 

order sent from regional stores to vaccinator sites during June (Appendix 8). 

Immunisation coordinators were provided with copies of all of the above information as well a fact 

sheet put together based on their questions (Appendix 9). 

Audit management reporting 

Local and regional immunisation coordinators were required to report monthly to the national 

immunisation coordinator on any feedback or incidences occurring within the area covered by each 

coordinator. This report summarises the incidences and feedback collated (Appendix 10). 

Results analysis 

The data recorded on the returned monitor record card was analysed using Access database. 



6 31/07/03

RESULTS 

Distribution and return of monitors 

By the end of June 2003, 2332 monitors had been issued to regional vaccine stores, of these 2009 had 

been on sent to vaccinator sites by the regional stores. Of the monitors received by vaccinator’s 

1,229 (61%) had been returned to ESR. Two hundred forty four (19%) of the returned monitors were 

invalid as the monitor record card was either incompletely or inaccurately filled in. There was no 

regional distinction in how vaccinators completed the record cards when compared between regional 

stores and the vaccinators they service. The number of monitors issued from each regional vaccine 

store (RVS) and the rate of return of monitors and valid monitors from the vaccinators they service are 

shown in table 1. 

Table 1: Distribution and return of monitors by regional vaccine store Dec 02 – Jun 03 

Regional Vaccine 

Temperature sensitive monitor record cards 

Store (RVS) Number issued 

from each RVS 

Monitors returned 

(% of total) 

Valid monitors returned 

(% of monitors returned) 

Zuellig Whangarei 87 55 (63) 39 (71) 

Zuellig Auckland 606 386 (64) 311 (80) 

Zuellig Hamilton 444 261 (59) 215 (82) 

Zuellig Wellington 473 291 (61) 238 (82) 

Zuellig Christchurch 281 174 (62) 132 (76) 

Zuellig Dunedin 118 62 (52) 50 (81) 

Total 2009 1229 (61) 985 (80) 

The 244 invalid monitors are not included in the analysis used for the data reported in the following 

tables. 

Cold Chain Failures 

The cumulative heat exposure of the WarmMark and the freeze exposure of the ColdMark monitors 

at the various steps in the chain are shown in table 2. 

Table 2: Location of the heat and freeze exposure of the temperature sensitive monitors 

Dec 02 – Jun 03 

Types of reported cold chain failures 1 

No. of monitors with heat 

exposures. Index of: 

Location 1 1,2 1,2,3 1,2,3,4 

% of 

monitors 

returned 

No. of monitors 

with freeze 

exposure 

% of 

monitors 

returned 

Storage at national store 0 0 0 0 0 0 0 

Transport between the national 

store and regional stores 117 0 0 0 12 8 1 

Storage at regional store 32 0 0 0 3 0 0 

Transport between regional store 

and vaccinator site 94 0 0 0 9 29 3 

Storage at vaccinator site 97 22 9 0 13 121 12 

Total 340 22 9 0 38 158 16 

Note 1: Excludes invalid monitors 

Heat Failure 

The results of the cumulative exposure of the heat-sensitive monitors indicate that 3 % (heat exposure 

index of 1,2 and 1,2,3) of the vaccines issued and valid monitors returned were exposed to 

temperatures above 10°C for sufficient time to reduce the vaccine’s potency. 



7 31/07/03

Freeze Failure 

Just over one sixth of the freeze sensitive monitors were subjected to temperatures at or below 0°C. 

Seven of the eight freeze failures during transport between the NVS and the RVS occurred in the same 

shipment yet these vaccines were not packed in the layer closest to the ice. The other failure was 

recorded by the RVS but they did not unpack their delivery until 2 days after it was received. In the 

second month of the survey there was evidence that one regional store had a high rate of freezing 

during transport between their store and the vaccinators’ site. 

This store was contacted, the local IMAC coordinator was also asked to assist in reviewing their 

packing procedures, in particular the separation of the icepacks from the vaccines and the quantity of 

vaccine being packed per container. 

Combination of Heat and Freeze 

Twenty (2%) of the returned completed monitor record cards indicated both heat and freeze exposure 

episodes. Nineteen during storage in the refrigerator at the provider site and one during transport 

between regional vaccine store and provider site. 

The heat exposure of the monitors by health district is shown in table 3. The freeze exposure of the 

monitors by health district is shown in table 4. 



8 31/07/03

Table 3: Location of the heat exposure of the heat-sensitive monitors by health district. 

Number of monitors with any heat exposure 

Location 

Northland 

Waitemata 

Auckland 

Count-Manak 

Waikato 

Bay of Plenty 

Tarawhiti 

Hawkes Bay 

Lakes District 

Taranaki 

Whanganui 

MidCentral 

Wairarapa 

Capital Coast 

Hutt 

Nelson-Marlb 

Canterbury 

West Coast 

South Cant 

Otago 

Southland 

All Health 

Districts 

(% of 

monitors 

returned) 

Storage at national store 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 


store and regional stores 65 8 16 28 117 (12) 

Storage at regional store 2 11 2 7 6 4 32 (3) 

Transport between regional 

store and vaccinator site 12 1 3 6 5 6 7 1 3 7 1 2 1 13 14 7 1 2 2 94 (10) 

Storage at vaccinator site 5 6 13 10 5 12 4 3 4 8 1 4 3 16 5 8 15 2 3 1 128 (13) 

Total 

(% of monitors returned) 

19 

(2) 

7 

(1) 

92 

(9) 

16 

(2) 

20 

(2) 

18 

(2) 

11 

(1) 

4 

(

Table 4: Location of the freeze exposure of the freeze-sensitive monitors by health district 

Location 

Northland 

Waitemata 

Auckland 

Count-Manak 

Waikato 

Bay of Plenty 

Tarawhiti 

Hawkes Bay 

Lakes District 

Number of monitors with any freeze exposure 

Taranaki 

Whanganui 

MidCentral 

Wairarapa 

Capital Coast 

Hutt 

Nelson-Marlb 

Canterbury 

West Coast 

South Cant 

Otago 

Southland 

All Health 

Districts (% of monitors 

returned) 

Storage at national store 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

Transport between the national store and 

regional stores 7 1 8 (

Distribution time 

The length of time the monitors were in the cold chain is shown in table 5. 

Table 5: Minimum, maximum and median distribution times 

Time in days 

Location Minimum Maximum Median 


store and regional stores

DISCUSSION 

Most of the accumulated heat exposure occurred at the vaccinator site. This is expected, as cumulative 

heat exposure should be greatest at the end of the chain. Significant freeze exposure occurred during 

transport between regional stores and vaccinator sites. Vaccine damage depends on the ambient 

temperature and the duration of exposure to adverse temperatures, therefore any assessment of the 

vaccine cold chain needs to record both variables. Unlike the heat-sensitive monitor, cold sensitive 

monitors cannot provide the accumulative time of exposure of vaccine to cold, only electronic 

temperature monitoring can achieve this. 

The length of time the vaccines remained in the chain was acceptable. The median transport time from 

the national vaccine store was one day and the median transport time from the regional stores to the 

vaccinator site was less than one day. The median storage time in regional stores was 16 days however 

these stores normally aim to keep 4-6 weeks stock. This may be attributed to the vaccines being issued 

for the school-based programmes during the reporting period. Public health units in the north island 

usually advise regional stores of their quantities just prior to the date required, the regional store then 

orders from the national store, this means that these vaccines are generally in the chain for shorter than 

usual lengths of time. The median storage time at vaccinator sites was 47 days. This is within the 

recommendations as described in the Vaccine storage and distribution national standards 2 

The return rate of 61 % is satisfactory however 20 % of these were invalid due to incomplete or 

inaccurate information being recorded therefore the data presented in this report is not all-inclusive. 

Continued efforts are required to emphasise to vaccinators the importance of completing the record 

cards correctly to provide good national data. Modifications to the record card will be made when they 

are next printed. Changes include making reference on the front of the card to the instructions on the 

reverse and changing the format of the yellow notice, using dot points to make the instructions stand 

out more. Of greater concern is the risk that some vaccinators are using vaccine after the freeze 

sensitive monitor has been activated. All adsorbed vaccines on the national immunisation schedule are 

susceptible to damage if frozen and should not be used. We will add information on not to use the 

vaccine if the ColdMark is activated and we will discontinue placing freeze-sensitive monitors on the 

record card attached to MMR vaccine. 

Some wastage has occurred unnecessarily as a result of the four-hour delivery time required for 

transport between regional stores and vaccination sites. On each occasion notified to ESR neither 

temperature-sensitive monitors showed a temperature excursion however the vaccine was returned to 

the regional store and replacement vaccine was sent. There is good evidence 7 that most of the 

immunisation schedule vaccines are stable at temperatures above 8°C therefore it is time to review the 

4-hour time limit for deliveries within the same city. 

The fridges at some provider sites are below standard demonstrating significant temperature variation 

within the unit. It is widely known that refrigerators have cyclical temperature fluctuations, however 

some refrigerators perform better than others. Studies have shown that the domestic refrigerator 

performs poorly 6 demonstrating high temperature gradients when compared to pharmacy type 

refrigerators. The refrigerator storing vaccines needs to be carefully monitored and adjusted to always 

remain above 0°C. Some vaccinators are overfilling their fridge which not only impairs the 

performance of the fridge but causes the vaccine to be stored inappropriately near the icebox or 

condenser resulting in vaccines being potentially frozen leaving them ineffective. The length of time 

vaccines are being stored at some vaccinator sites (up to 5 months) demonstrates substandard ordering 

processes. More detailed consideration of the vaccinator sites’ compliance to the guidelines described 

in the Vaccine storage and distribution national standards 2 is required. Vaccine storage standards 

should be a key component of an audit for general practices. 



12 31/07/03

REFERENCES 

1 Immunisation handbook 2002. Wellington Ministry of Health; 2002. 

2 Vaccine storage and distribution national standards. 2 nd ed. Auckland: Immunisation advisory 

Centre University of Auckland; 2002. 

3 Heffernan H. Vaccine cold chain survey 1999-2000. Porirua: Institute of Environmental and 

Scientific Research; 2000. 

4 Matheson D, Bolotovsky A. Review of the storage and distribution of vaccine used in the New 

Zealand childhood immunisation programme. Porirua: New Zealand Communicable Disease 

Centre, Institute of Environmental Health and Forensic Sciences Ltd; 1993, EHFS publication 

series no. 6. 

5 Temperature monitors for vaccines and the cold chain. Geneva: Department of vaccines and 

other biologicals, World Health Organisation: 1999. Document No: WHO/V&B/99.15 

6 Grassby P.F. Safe storage of vaccines: problems and solutions. The Pharmaceutical Journal 

1993; 251:323-7 

7 Galazka A, Milstien J, Zaffran M. Thermostability of vaccines. Geneva: Global Programme 

for Vaccines and Immunisation, World Health organisation; 1998. Document No: 

WHO/GPV/98.07. 



13 31/07/03

APPENDICES 

Appendix 1: Temperature-sensitive monitor record card 


Dat 

e in 

WarmM 

ark 

Index 


Mark 

Status 

Location Date out WarmM 

ark 

Index 


Mark 

Status 




ColdMark Monitor 

If window 

1 is 

completely 

red, 

record 

index as 1 

If window 

2 

completely 

red, 

record 

index as 2 

If window 

3 

completely 

red, 

record 

index as 3 

If window 

4 

completely 

red, 

record 

index as 4 

If the bulb is clear in colour, record status as C 

Ifthebulbispurpleincolour, record the status as V 

Keep the monitor with the vaccine that it arrives with. 

When the monitor arrives, complete the top part of the card: 

• fill in the ‘Date in’ 

• fill in the Monitor Mark ‘Index’ (0, 1, 2, 3 and/or 4) 

• fill in the Cold Mark ‘Status’ (C or V) 

• fill in the ‘Location’ with your organisation’s name and town 

When the monitor leaves your store or the last vaccine in the pack is used, complete the top part of the card: 

• fill in the ‘Date out’ 


• fill in the Freeze Watch ‘Status’ (C or V) 

Return the completed card to: 

Please direct any enquiries to: 

National Vaccine Store 

Pamela Raynel 

ESR 

National Vaccine Store, ESR 

PO Box 50-348 phone: (04) 914 0727 

PORIRUA fax: (04) 914 0770 

email: pamela.raynel@esr.cri.nz 

Extra envelopes used for the return of monitors are available from ESR 



14 31/07/03

Appendix 2: Cold chain survey pack notice 

Cold chain monitor enclosed 

Please read and record the monitors when you receive this pack 

and again when you either dispatch the pack or use the last dose 

of vaccine in the pack. 



15 31/07/03

Appendix 3: Informational material sent to regional vaccine stores 

[prepared on ESR/IMAC letterhead] 

November 2002 

To regional vaccine stores 

Vaccine cold chain audit 

Ongoing national monitoring and audit of the vaccine cold chain will be conducted from November 

this year with 6 monthly reviews. The Ministry of Health has contracted ESR and the Immunisation 

Advisory Centre (IMAC) to conduct the audit. 

The vaccine cold chain is the system of transporting and storing vaccines at their recommended storage 

temperature from the time they are manufactured to the time they are used. Exposure to temperatures 

outside the recommended storage range may reduce or even destroy the potency, and therefore 

effectiveness, of vaccines. 

A survey in 1992 of the distribution of vaccines for the childhood immunisation programme found that 

at least 8% of the freeze-sensitive vaccines and 12% of the most heat-sensitive vaccines were 

potentially damaged by inadequate maintenance of the cold chain. A further survey in 1999/2000 

found that at least 20% of the freeze-sensitive vaccines and 8% of the heat-sensitive vaccines were 

potentially damaged by inadequate maintenance of the cold chain. Comparison of the 1992 and 

1999/2000 survey results suggests that there has been improvement in protecting vaccines from 

excessive heat exposure, however the improvement appears to have been at the expense of an increase 

in exposure of vaccines to freezing. The results from both cold chain surveys have highlighted the need 

for continual monitoring and audit of the cold chain. 

Despite the attention given to improving the vaccine cold chain in recent years, the results of these two 

surveys indicate that the effectiveness of vaccines continues to be compromised by incorrect 

temperature handling. It is now time to introduce a continuous cold chain audit for the childhood 

immunisation programme vaccines in the hope of making further improvements to the vaccine cold 

chain. The scope of this audit covers the transport of vaccines from ESR’s National Vaccine Store 

(NVS) to the immunisation provider. 

Commencing November 2002, cold chain monitors, which indicate cumulative exposure to 

temperatures over 10°C, and monitors that indicate exposure to temperatures below 0°C will be 

included in some packs of the childhood immunisation vaccine issued from the NVS. At each stage in 

the transport and storage of the vaccine, the condition of the monitors must be noted and recorded on 

the monitor record card to which the monitors are attached. 

Attached are instructions on how to identify when a monitor is included with a vaccine delivery, and 

how to read and record the monitors. Brief instructions are also included on the reverse side of the 

monitor record cards. 

I will ring you in the next week about this survey. At that time we can discuss any issues you may 

have with the survey and clarify any queries you may have about reading and recording the monitors. 

Pamela Raynel 

Scientist 



16 31/07/03

Vaccine cold chain audit instructions for regional vaccine stores 

Heat-sensitive monitors and freeze-sensitive monitors are included with some packs of childhood 

immunisation programme vaccines. The temperature exposure of both monitors at each stage in the 

transport and storage of the vaccine needs to be recorded on the monitor record card to which they are 

attached. 

Description of the heat-sensitive monitors 

The heat-sensitive monitor, Warm Mark , has two separate indicators: (1) a strip indicator consisting 

of three rectangular windows, referred to as index 1, 2 and 3, and (2) a disc indicator with a small 

circular window, referred to as index 4 (see diagram below). The strip indicator is sensitive to 

temperatures over 10°C. When the monitor is exposed to temperatures over 10°C, a red colour appears 

in the left-most index (index 1) and moves gradually across the strip with time. Movement of the 

colour is halted if the temperature falls below 10°C, and resumes again when the temperature rises 

above 10°C. After a cumulative total of 14 days at 10°C, the whole strip will be completely coloured. 

At higher temperatures, the red colour moves more quickly. For example, at 21°C the whole strip will 

be completely coloured after 11 days. 

The disc indicator is sensitive to temperatures over 34°C. When the monitor is exposed to 

temperatures over 34°C for more than 1 hour, a red colour appears in the window. 


Date 

in 

Warm 

Mark 

Index 


Mark 

Status 

Location 

Date 

out 

Warm 

Mark 

Index 


Mark 

Status 







If window 1 is 

completely 

red, 

record index 

as 1 

If window 2 

is 

completely 

red, 

record 

index as 2 

If window 3 

is 

completely 

red, 

record 

index as 3 

If window 

4 is 

completely 

red, 

record 

index as 4 



17 31/07/03

Description of the freeze-sensitive monitors 

The freeze-sensitive monitor Cold Mark , consists of a glass tube containing coloured liquids with a 

bulb on one end containing clear liquid. The tube with the bulb visible to the user is encased in a 

plastic cover (see previous diagram). When the Cold Mark is exposed to temperatures below 0°C, the 

clear liquid in the bulb contracts, drawing the coloured liquids into the bulb. The bulb changes from 

clear and colourless to cloudy with streaks of violet. When the Cold Mark warms the bulb changes 

irreversibly to a uniform violet colour. 

If the liquid in the bulb is clear and colourless, record the status of the Cold Mark as C (clear). 

If the liquid in the bulb is coloured, record the status of the Cold Mark as V (violet). 

How to recognise when a monitor is included with a vaccine delivery 

The monitors are attached to monitor record cards, which are then folded up inside the packs of 

vaccine. Any packs of vaccine that contain a monitor will have a prominent yellow-coloured 

notice attached to them that states that a cold chain monitor is enclosed. 



18 31/07/03

Interpreting the monitors and recording their temperature exposure on 

the monitor record card when vaccine with monitors is received 

When you receive vaccine that has monitors with it, record the following information on the next 

available line on the monitor record card (see previous diagram). The first line will have already been 

completed at ESR’s National Vaccine Store. 

 

 

 

Record the date you receive the vaccine in the ‘Date in’ field 

Record the temperature exposure of the heat-sensitive monitor in the adjacent ‘Index’ field 

Record the temperature exposure of the freeze-sensitive monitor in the adjacent ‘Status’ field 

Heat-sensitive monitors: If index 1 on the strip is completely white or partially red, record the index 

as ‘0’. If index 1 is completely red, record the index as ‘1’. If index 2 is completely red, record the 

index as ‘2’, but if it is only partially red, record the index as ‘1’. If index 3 is completely red, record 

the index as ‘3’, but if it is only partially red record the index as ‘2’. If the disc indicator is red, record 

the index as ‘4’. If index 4 is recorded, the state of the strip indicator must also be recorded (as 0, 1, 2 

or 3). 

Freeze-sensitive monitors: If there is no colour of the liquid in the bulb, record the status as ‘C’ (for 

clear). If there is colour of the liquid in the bulb, record the status as ‘V’ (for violet). 

 

Record the name of your organisation and your city in the ‘Location’ field. 

Read and record the monitors as soon as possible after receiving the vaccine. After reading, return the 

monitors and card to the vaccine pack that it was received with. Store and handle the vaccine in your 

usual way. 

Recording the temperature exposure of the monitors when the vaccine 

is issued 

When you issue vaccine with monitors: 

 

 

 

Record the date of issue in the ‘Date out’ field 



If you do not notice a monitor when you receive vaccine, and only become aware of it when you issue 

the vaccine, leave the ‘Date in’ and the adjacent ‘Index’ and ‘Status’ fields blank. Complete the 

‘Location’, ‘Date out’ and the adjacent ‘Index’ and ‘Status’ fields only. 

Contact Details 

Please direct any enquiries about this survey to: 

Pamela Raynel 

Scientist 

ESR 

Box 50-348 

Porirua 

Ph: 04 914 0727 

Fax: 04 914 0770 

Email: pamela.raynel@esr.cri.nz 



19 31/07/03

Appendix 4: Informational material sent to general practice vaccinators 

[prepared on joint ESR-IMAC letterhead] 

November 2002 

To the practice nurse responsible for vaccines 

Vaccine cold chain audit 

Ongoing national monitoring and audit of the vaccine cold chain will be conducted from November 

this year with 6 monthly reviews. ESR, who purchase and distribute the vaccines for the national 

childhood immunisation programme and the Immunisation Advisory Centre (IMAC) will conduct this 

audit for the Ministry of Health. 


temperature from the time they are manufactured to the time they are used. Exposure to temperatures 

outside the recommended storage range may reduce or even destroy the potency, and therefore 

effectiveness, of vaccines. 

A survey in 1992 of the distribution of vaccines for the childhood immunisation programme found that 

at least 8% of the freeze-sensitive vaccines and 12% of the most heat-sensitive vaccines were 

potentially damaged by inadequate maintenance of the cold chain. A further survey in 1999/2000 

found that at least 20% of the freeze-sensitive vaccines and 8% of the heat-sensitive vaccines were 

potentially damaged by inadequate maintenance of the cold chain. Comparison of the 1992 and 

1999/2000 survey results suggests that there has been improvement in protecting vaccines from 

excessive heat exposure, however the improvement appears to have been at the expense of the an 

increase in exposure of vaccines to freezing. The results from both cold chain surveys have highlighted 

the need for continual monitoring and audit of the cold chain. 

Despite the attention given to improving the vaccine cold chain in recent years, the results of these two 

surveys indicate that the effectiveness of vaccines continues to be compromised by incorrect 

temperature handling. It is now time to introduce a continuous cold chain audit for the childhood 

immunisation programme vaccines in the hope of making further improvements to the vaccine cold 

chain. The scope of this audit covers the transport of vaccines from ESR’s National Vaccine Store 

(NVS) to the immunisation provider. 

Commencing November 2002, cold chain monitors which indicate cumulative exposure to 

temperatures over 10°C, and monitors which indicate exposure to temperatures below 0°C will be 

included with some packs of childhood immunisation programme vaccine issued from the NVS. At 

each stage in the transport and storage of the vaccine, the condition of the monitors must be noted and 

recorded on the monitor record card to which the monitors are attached. Many practices may only 

receive one monitor in each delivery and some may not receive any. 

Attached are instructions on how to identify when a monitor is included with a vaccine delivery, how to 

read and record the monitors, and how to return them to ESR. Brief instructions are also included on 

the reverse side of the monitor record cards. 

Pamela Raynel 

Scientist 



20 31/07/03

Vaccine cold chain survey instructions for general practices 

Heat-sensitive monitors and freeze-sensitive monitors are included with some packs of childhood 

immunisation programme vaccines. The temperature exposure of both monitors at each stage in the 

transport and storage of the vaccine needs to be recorded on the monitor record card to which they are 

attached. 

Description of the heat-sensitive monitors 

The heat-sensitive monitor Warm Mark , has two separate indicators: (1) a strip indicator consisting of 

three rectangular windows, referred to as index 1, 2 and 3, and (2) a disc indicator with a small circular 

window, referred to as index 4 (see diagram below). The strip indicator is sensitive to temperatures 

over 10°C. When the monitor is exposed to temperatures over 10°C, a red colour appears in the leftmost 

index (index 1) and moves gradually across the strip with time. Movement of the colour is halted 

if the temperature falls below 10°C, and resumes again when the temperature rises above 10°C. After a 

cumulative total of 14 days at 10°C, the whole strip will be completely coloured. At higher 

temperatures, the red colour moves more quickly. For example, at 21°C the whole strip will be 

completely coloured after 11 days. 

The disc indicator is sensitive to temperatures over 34°C. When the monitor is exposed to 

temperatures over 34°C for more than 1 hour, a red colour appears in the window. 


Date 

in 

Warm 

Mark 

Index 


Mark 

Status 

Location 

Date 

out 

War 

m 

Mark 

Index 


Mark 

Status 







If window 1 

is 

completely red, 

record index as 

1 

If window 2 

is 

completely 

red, 

record 

index as 2 

If window 

3 is 

completely 

red, 

record 

index as 3 

If window 4 

is 

completely 

red, 

record 

index as 4 



21 31/07/03

Description of the freeze-sensitive monitors 

The freeze-sensitive monitor Cold Mark , consists of a glass tube containing coloured liquids with a 

bulb on one end containing clear liquid. The tube with the bulb visible to the user is encased in a 

plastic cover (see previous diagram). When the Cold Mark is exposed to temperatures below 0°C, the 

clear liquid in the bulb contracts, drawing the coloured liquids into the bulb. The bulb changes from 

clear and colourless to cloudy with streaks of violet. When the Cold Mark warms the liquid in the bulb 

changes irreversibly to a uniform violet colour. 

If the liquid in the bulb is clear and colourless, record the status of the Cold Mark as C (clear). 

If the liquid in the bulb is coloured, record the status of the Cold Mark as V (Violet). 

How to recognise when a monitor is included with a vaccine delivery 

The monitors are attached to monitor record cards, which are then folded up inside the packs of 

vaccine. Any packs that contain a monitor will have a prominent yellow-coloured notice attached 

to them that states that a cold chain monitor is enclosed. 



22 31/07/03

Interpreting the monitors and recording their temperature exposure on 

the monitor record card when vaccine with monitors is received 

When you receive vaccine that has monitors with it, record the following information on the next 

available line on the monitor record card (see previous diagram). Usually, the first two or three lines 

on the card will have already been completed at ESR’s National Vaccine Store and the regional vaccine 

store - Zuellig Pharma. 

 

 

 

Record the date you receive the vaccine in the ‘Date in’ field on the next available line 



Heat-sensitive monitors: If index 1 on the strip is completely or partially white, record the index 

as ‘0’. If index 1 is completely red, record the index as ‘1’. If index 2 is completely red, record 

the index as ‘2’, but if it is only partially red, record the index as ‘1’. If index 3 is completely red, 

record the index as ‘3’, but if it is only partially red record the index as ‘2’. If the disc indicator is 

red, record the index as ‘4’. If index 4 is recorded, the state of the strip indicator must also be 

recorded (as 0, 1, 2 or 3). 

Freeze-sensitive monitors: If there is no colour of the liquid in the bulb, record the status as ‘C’ 

(for clear). If there is colour of the liquid in the bulb, record the status as ‘V’ (for violet). 

 

Record the name of your practice and your city or town in the ‘Location’ field. 

Read and record the monitors as soon as possible after receiving the vaccine. After reading, return the 

monitor and card to the vaccine pack that it was received with. 

Store and handle the vaccine in your usual way. 



23 31/07/03

Recording the temperature exposure of the monitors when the vaccine 

is used 

When you use the last syringe or vial of vaccine in the pack with monitors: 

 

 

Record the date the last syringe or vial of vaccine was used in the ‘Date out’ field 

Record the temperature exposure of the monitors in the adjacent ‘Index’ and ‘Status fields. 

If you do not notice a monitor when you receive vaccine, and only become aware of it when you open 

the pack to start using the vaccine, leave the ‘Date in’ and the adjacent ‘Index’ and ‘Status’ fields 

blank. Complete the ‘Location’, ‘Date out’ and the adjacent ‘Index’ and ‘Status’ fields only. 

Returning the monitors 

Return the completed monitors using the pre-addressed postage-paid envelope provided with the 

vaccine or vaccinators cold chain training pack to: 

ESR 


Box 50-348 

Porirua 

Extra envelopes used for the return of monitors to ESR can be obtained by contacting ESR. 

Contact details 

Please direct any enquiries about this survey to: 

Pamela Raynel 

Scientist 

ESR 

Box 50-348 

Porirua 

Ph: 04 914 0727 

Fax: 04 914 0770 

Email: pamela.raynel@esr.cri.nz. 



24 31/07/03

Appendix 5: Information provided to vaccinators as a laminated poster 

for their fridges 

1 

Cold-Chain Monitor Enclosed 

Please read and record the monitors when you receive this pack and again when you either 

dispatch the pack or use the last dose of vaccine in the pack. 

2 

Date in 

Warm 

Mark 

Index 


Mark 

Status 

Temperature-Sensitive Monitor Record Card 124 

Location Date out Warm 

Mark 

Index 


Mark 

Status 

3 





4 


If the bulb is purple in colour, record the status as V 

If window 

1 is 

completely 

red, 

record 

index as 1 

If window 

2 

completely 

red, 

record 

index as 2 

If window 

3 

completely 

red, 

record 

index as 3 

DTaP-IPV 30 Nov 2002 

If window 

4 

completely 

red, 

record 

index as 4 


5 

6 

7 













Pamela Raynel 

ESR 


PO Box 50-348 phone: (04) 914 0727 

PORIRUA fax: (04) 914 0770 



1. Label on vaccine packs indicates monitors are included and must be read. 

2. A record card that regional and local providers fill in to show when vaccines are received and despatched. The status 

of the monitors is also recorded. 

3. An indicator that is a heat-sensitive strip, WarmMark with four windows, marked 1,2,3,and 4. 

4. An indicator that is freeze-sensitive at 0°C indicator, ColdMark, a colour change occurs from clear to violet 

5. Instructions on use when vaccine is received. 

6. Instructions on use when vaccine is despatched or the last dose are used. 

7. Instructions on where to send the completed monitor card. 



25 31/07/03

Appendix 6: Information published in the Immunisation Advisory 

Centre’s newsletter 

Vaccine Cold Chain Audit Starting 

Key Points 

• Monitoring of the vaccine cold chain will start late November 2002 

• Monitors with record cards will arrive attached to some vaccine supplies 

• Practices will need to read the condition of the monitors, record results and return cards, as 

per the instructions on the cards 

• Further details and support is available from your local coordinator 


temperature from the time of manufacture to the time of use. Ongoing national monitoring of the cold 

chain will be conducted from late November 2002. The Ministry of Health has contracted ESR’s 

National Vaccine Store and the Immunisation Advisory Centre (IMAC) to conduct the audit. 

ESR undertook national cold chain surveys in 1992 and 2000. The 1992 survey found that at least 8% 

of the freeze-sensitive vaccines and 12% of the most heat-sensitive vaccines were potentially damaged 

by inadequate maintenance of the cold chain. The 2000 survey found that at least 20% of the freezesensitive 

vaccines and 8% of the heat-sensitive vaccines were potentially damaged by inadequate 

maintenance of the cold chain. 

Comparison of the 1992 and 2000 cold chain survey results suggests that there has been improvement 

in protecting vaccines from excessive heat exposure, but this improvement has been at the expense of 

an increase in exposure of vaccines to freezing. 

Despite the attention given to improving the vaccine cold chain, the effectiveness of vaccines continues 

to be compromised by incorrect temperature storage and transportation. Therefore it is now time to 

continuously audit the cold chain for the childhood immunisation programme vaccines to ensure an 

increased focus on the cold chain at regional and local levels. 

Starting from late November, cold chain monitors that indicate cumulative exposure to temperatures 

over 10°C and monitors that indicate exposure to temperatures below 0°C will be included with some 

packs of the childhood immunisation programme vaccines. The audit is monitoring both the transport 

and storage of vaccines from National Vaccine Store up until the time the last vaccine in the pack is 

used. At each stage in the transport and storage of the vaccine, the condition of both monitors with the 

vaccine must be noted and recorded on a card attached to the monitors. Many practices may only 

receive one monitor per delivery and some may not receive any. 

Full instructions on how to identify when a monitor is included with a vaccine delivery, how to read 

and record the monitors, and how to return them to ESR, will be given to the practice nurse responsible 

for vaccines at each surgery. Briefer instructions about how to complete the monitor cards are given on 

the back of the cards. When you receive a monitor card, please contact your local immunisation 

coordinator or Pamela Raynel, ESR, phone (04) 914 0727, fax (04) 914 0770, email 

pamela.raynel@esr.cri.nz 



26 31/07/03

Appendix 7: Update information published in the Immunisation Advisory 

Centre’s newsletter 

Vaccine Cold Chain Audit News 

• Be alert for yellow notices-these vaccines contain monitors 

• Monitors must accompany vaccine until the LAST dose is used 

• Please take care completing cards to ensure solid national data. 

Monitoring of the vaccine cold chain started in December 2002. Thanks to all who have returned 

monitors. 

Unfortunately, only 36% of the returned record cards have been filled in correctly. Some key points to 

aid this process: 

The audit is monitoring both the transport and storage of vaccine right up until the last vaccine is used. 

Therefore the monitors must stay with the vaccine they were received with until the last dose is used. 

The audit is monitoring both the transport and storage of vaccine right up until the last vaccine is used 

therefore the monitors must stay with the vaccine they were received with until the last dose is used. 

There are two instances at the surgery that the monitors should be read and their temperature exposures 

recorded: 

1. When the vaccine is received in the surgery: 

2. When you use the last dose of vaccine in the pack: 

Only record the index for a window if the window is completely red for example if window 1 is red 

and window 2 is partly red record index as 1. 

Brief instructions about how to complete the monitor record cards are given on the back of the cards. If 

you have any queries about the audit, please contact your Local Coordinator or ESR, 

phone (04) 914 0727, email pamela.raynel@esr.cri.nz. 



27 31/07/03

Appendix 8: Update of instructions for completing the monitor record 

cards 

1 

Cold-Chain Monitor Enclosed 

Please read 1 and record the monitors when you receive this pack and again when you either 

dispatch the pack or use the last dose of vaccine in the pack. 

2 

Date in 

Date 

Rec’d at 

Zuellig 

Date 

Rec’d at 

Practice 

Warm 

Mark 

Index 

Record 

Index 

Record 

Index 


Mark 

Status 

Record 

Status 

Record 

Status 

Temperature-Sensitive Monitor Record Card 124 

Location Date out Warm 

Mark 

Index 

ESR 

Zuellig Branch 

Record Name of Your Practice 

Date leaves 

ESR 

Date leaves 

Zuellig 

Date Last 

Dose Used 

Record 

Index 

Record 

Index 

Record 

Index 


Mark 

Status 

Record 

Index 

Record 

Status 

Record 

Status 

3 

4 






If the bulb is purple in colour, record the status as V 

If window 

1 is 

completely 

red, 

record 

index as 1 

If window 

2 

completely 

red, 

record 

index as 2 

If window 

3 

completely 

red, 

record 

index as 3 

DTaP-IPV Feb 2003 

If window 

4 

completely 

red, 

record 

index as 4 


5 

6 

7 













Pamela Raynel 

ESR 


PO Box 50-348 phone: (04) 914 0727 

PORIRUA fax: (04) 914 0770 



1. Yellow label on vaccine packs indicates monitors are included and must be read. Monitors must be stored with the 

vaccine they arrive with. 

2. A record card that regional and local providers fill in to show when vaccines are received and despatched/used. Both 

monitors are read and recorded when vaccines are received and when the last dose is used. Use the diagram as a 

guide when filling in the record card. 

3. A heat-sensitive strip indicator, WarmMark with four windows, marked 1,2,3,and 4. The vaccine should not be 

used if the strip shows an index greater than 2. Consult your local immunisation coordinator, as replacement vaccine 

may be needed. 

4. A freeze-sensitive indicator, ColdMark. At 0°C a colour change occurs from clear to violet. If you notice the bulb 

is violet do NOT use the vaccine. Consult your local immunisation coordinator, as replacement vaccine may be 

needed. 

5. On the back of the card are: Instructions on how to record the monitors when vaccine is received. 

6. Instructions on how to record the monitors when the last dose of vaccine is used. 

7. Instructions on where to send the completed monitor card. 



28 31/07/03

Appendix 9: Fact sheet for coordinators 

[Prepared on IMAC/ESR joint letterhead] 

Memo 

Date: 21 November 2002 

To: 

Regional and Local Coordinators, 0800 Immune Staff 

Cc: 

Dr Nikki Turner, Tania Pomapllier 

From: 

Subject: 

Helen Christie, IMAC National Cold Chain / Quality Coordinator 

Pamela Raynel, Scientist, ESR 

National Cold Chain Audit 

This information is in response to the questions raised by the Auckland and South Island regions 

Immunisation Coordinators 

1: Reporting Requirements 

Reporting on Requests received 

Please provide a monthly breakdown of the types of requests you have received. This information 

should go to your Regional Immunisation Coordinator with a copy to Helen Christie, National Cold 

Chain Coordinator 

Information provided by Local Immunisation Coordinators will form part of the 6 monthly reporting on 

the national cold chain audit. 

Please provide information using the following format: 

Provider description: e.g. GP Practice, Occupational Health Nurse, Vaccine Store, Pharmacy, Public 

Health Unit, Maori or Pacific Island Provider. 

Issue: What the concern was e.g. completing information on card, WarmMark changed colour, how to 

return completed card to ESR, cold chain failure. 

Where: Which district or area e.g. if all concerns, issues or requests are coming from one area it is 

beneficial to identify if that is a local problem or is it happening around the country. This will enable 

early identification of trends, and corrective action can be planned and implemented. 

Reporting on Cold Chain Failures 

Please include information on cold chain failures in the monthly report to the Regional and National 

Coordinator. There is no need for a separate report. 

Please provide information on: 

Where in the cold chain process did it happen? 

What situation contributed to the failure? 

When did the event happen? 

What action was taken, this may mean involving Pamela Raynel to make decisions about large vaccine 

wastage. 

2: Cold Chain Failure-Who does what 

Cold chain failures should be approached as usual. 

Some practices will be familiar with the cold chain and conversant with the handbook 

recommendations. In this case little or no intervention by the local coordinator (LC) will be required or 

requested. 

However the recommendations in the handbook pertain mainly to temperature excursions during 

storage of the vaccine and not specifically during transportation. 

Some practices may require advice when they receive a delivery and there has been a change in status 

of either or both monitors. In this case they should first consult their LC. If deemed necessary the 

query can be escalated to regional coordinator, national coordinator or ESR. This applies to all queries. 

Most deliveries to practices contain a mixture of vaccines with varying heat or freeze sensitivities, 

hence a decision is not always straightforward and extra expertise should be sought. 



29 31/07/03

3: The WarmMark 

The following table gives information on the time and temperature characteristics of the WarmMark 

indicator. 

If the windows 1,2 and 3 are completely red but the disc 4 is still white this means the vaccine has been 

exposed to temperatures above 10°C but below 34°C for the following number of days. 

Index At 12°C At 21°C 

1 3 days 2 days 



NB: The higher the temperature the faster the red colour spreads 

Below is a guide to interpretation of the colour changes on the monitors in relation to the 

vaccines with which the monitor card is attached. 

• Windows 1,2,3, and 4 all white i.e. no red showing and no colour showing in ColdMark: 

Vaccines may be used as usual 

• Window 1 all red, the colour in all other windows white and no colour showing in ColdMark: 

Vaccines may be used as usual 

• Windows 1 and 2 all red, the colour in all other windows white and no colour showing in 

ColdMark: 

MMR should be used within three months all other vaccines may be used as usual. 

• Windows 1,2 and 3 all red, the colour in 4 white and no colour showing in ColdMark: 

MMR should not be used; all other vaccines should be used within 3 months. 

• Windows 1,2 3 and 4 all red, no colour or colour showing in ColdMark: 

Do NOT use the vaccine 

• Colour in the ColdMark and no colour or colour in window 1 in the WarmMark: 

MMR may be used as usual. Do NOT use other vaccines 

4: Choice of heat-sensitive monitor 

One of the objectives of this audit is to identify the stages of the cold chain where cold chain failure 

occurs. The monitors are not intended to monitor fridges and should not replace the daily recording of 

the fridge temperature. 

WarmMarks are available with a range of temperature activation points. The 10°C activation point 

WarmMark was chosen, because it is closest to the recommended maximum temperature for storing 

and transporting vaccine. 

5: Which vaccines are being monitored? 

Temperature sensitive monitors are being attached to childhood schedule vaccines only. Other state 

funded vaccines and related products are NOT included in this audit. 

Monitor cards must stay with the vaccine they were received with until the vaccine or last vial in the 

pack is used unless the vaccine has expired or needs to be discarded. In this case record the statuses of 

the monitors and return the completed card to ESR 

6: Envelopes for the return of monitors 

LC’s have a supply of prepaid preaddressed envelopes to be used for the return of monitors when 

appropriate. In addition to this envelopes will be with the monitor card attached to the vaccine when 

practical e.g. DTaP-IPV and DTaP/Hib. Zuellig branches also have a supply of envelopes, which they 

will be adding to a delivery if cold chain monitors are enclosed. Extra envelopes are also available 

from ESR as indicated on the back of the monitor card. 

On behalf of Pam Raynel from ESR, and myself I would like to take this opportunity to thank all 

Immunisation Coordinators who have raised these issues, please continue to seek clarification on any 

aspect of the national cold chain audit. 


IMAC National Cold Chain & Quality Coordinator 



30 31/07/03

Appendix 10: Feedback received from coordinators Dec 02 – Jun 03 

National Cold Chain Audit: 6 Monthly feedback from Northern, Midland, Central and Southern 

Regions. 

Provider Description 

• G.P. Practices 

• Occupational Health Nurses 

• Zuellig Pharma distributors 

• Public Health Units 

• Maori Health Providers 

• Pacific Health Providers 

Issues reported 

• Completing information on the card 

• Cold Chain Failure 

• Warm Mark changed colour 

• Cold Mark changed colour 

• Returning completed cards process 

There is a general feeling within the Immunisation Facilitator/Coordinator group that a high number of 

providers understand the rationale for the audit. 

Nearly all coordinators reported in the early months, that providers were not always notifying them, 

when a monitor card arrived with their vaccines. 

Some commentary reported includes: 

• Providers had initial difficulty in completing the card and some could not find their 

information pack. 

• Facilitators/Coordinators identified internal practice communication processes as being a 

barrier to compliance with the instructions of the audit. 

• Cold chain failures linked to domestic style refrigerators were reported from each region. 

• The second mail out of the instruction sheet with amendments was well received by new staff 

members at the provider sites. 

• On the occasions when a provider notified the Facilitator/ Coordinator of cold mark activation, 

corrective action and advice was given around ongoing cold chain management. 

• Most GP practices are finding the process straightforward and are prepared to continue to 

identify, complete and return the monitor card as appropriate. 

• Each region reported incidents of cold chain failures associated with domestic style 

refrigerators. 

Individual incidences reported from each region are recorded in the following table: 



31 31/07/03

Northern region feedback Dec 02 – Jun 03 

Region Issue Outcome 

Northern 

Facilitators not contacted by the 

provider when a monitor card 

arrived with vaccines. 

Redistribution of the 

information sheet by Zuellig. 

Face to face education by 

facilitator. 

Two incidents where the 

monitor card showed that the 

cold mark was activated during 

transport between Zuellig and 

the provider, vaccines used. 

Discussion with ESR vaccine 

scientist. 

Coordinator visited the Zuellig 

Pharma branch. 

School based immunisation 

programme cold chain failure. 

Cold mark on monitor card 

showed violet. Vaccines 

incorrectly packed by Zuellig, 

monitor card in contact with ice 

packs in chilly bins. 

Discussion with ESR re using 

vaccines. 

Fridge temperature monitored 

using multiple data loggers, two 

shelves in fridge showed 

temperatures below °C 

Public Health Unit purchased 

vaccine specific fridge. 

GP practices need more 

instructions on completing the 

monitor record card. 

Face to face education by 

facilitator. 



32 31/07/03

Midland region feedback Dec 02 – Jun 03 


Midland 

Overnight courier cold chain 

failure. 

Practice completed card and 

returned vaccines to Zuellig. 

One monitor card left behind for 

several months after the vaccine 

was given. 

Card completed and returned, 

explanation provided. 

Reporting of monitors arriving 

has dropped off in recent 

months. 

Practices reminded of the need 

to contact facilitator when card 

arrives. Vaccinator training 

updates used to remind 

providers. 

Monitors being pushed against 

the ice plate or back of ‘fridge. 

Advice given by facilitators on 

process for completion and 

return of monitors. 

Monitor card showing cold 

mark activated, ‘fridge min/max 

showing all o.k. Temprecord 

logger supported min/max. 

ESR contacted and only IPOL 

returned to Zuellig. 

One practice reported a yellow 

notification sticker alerted to a 

monitor enclosed. No monitor 

found. 



33 31/07/03

Central region feedback Dec 02 – Jun 03 


Central 

Not being notified when 

monitors arrived. 

Sent out updated information 

sheet via Zuellig 

Public Health Unit cold chain 

failure, facilitator not notified 

that several monitors had been 

received. 7/20 monitors showing 

cold mark activated. Cards 

placed against the icebox. 

ESR notified and discussion 

clarified that vaccines had been 

used within 24hrs of arrival and 

not left with monitors. 

Monitor card removed from 

vaccine and left on top of fridge. 

Education provided using 

vaccinator update material. 

Internal provider 

communication methods 

inadequate to inform all staff on 

how to identify and complete 

monitor record cards. 

Immunisation coordinators must 

be diligent in addressing any 

cold chain management issues. 



34 31/07/03

Southern region feedback Dec 02 – Jun 03 


Southern 

Instructions on laminated fridge 

magnet not easy to follow. 

Some have not understood the 

purpose or function of the 

monitors. 

Local immunisation 

coordinators reiterate 

instructions and provide 

support. 

Instructions are not clear as to 

what they do with the vaccine 

when the cold sensitive monitor 

is activated 

Immunisation coordinators 

reinforce usual practices when a 

cold chain failure is reported. 

Yellow alert labels not bold or 

big enough. 

ESR reviewing labels 

Rural practices are reporting 

that monitors are arriving with 

the heat sensitive monitor 

showing movement 

Referred to ESR for advice. 

Reinforce the national cold 

chain standards with local 

Zuellig branch. 

Nurses overstretched in general 

practices, becoming less focused 

on correct vaccine storage 

Providers not notifying 

immunisation coordinators 

when they receive vaccine with 

monitors. Questioning the need 

to notify 

Immunisation coordinators 

provided explanation. 


National Quality Coordinator 

Immunisation Advisory Centre 

Auckland University 

July 2003 



35 31/07/03

APPENDIX 11: Report distribution 

Copies have been made and distributed to: 

Derek Thompson, Portfolio Manager, Wellington Locality, Ministry of Health 

Nikki Turner, Director, Immunisation Advisory Centre, Auckland 

Electronic copies have been distributed to: 

Zuellig Pharma principle branches 

Independent Practitioners Associations (IPA’s) 

Primary Healthcare Organisations (PHO’s) 

Regional and Local Immunisation Coordinators 

Further copies of this report may be obtained from: 

Information Research Services 

Kenepuru Science Centre 

P O Box 50 348 

Porirua 



36 31/07/03

The National Cold Chain Audit - Environmental Science & Research

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The National Cold Chain Audit - Environmental Science & Research

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