The National Cold Chain Audit by sor88113

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									                                        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                                                         Helen Christie
Scientist                                                             National Quality Coordinator
Institute of Environmental Science and Research                       Immunisation Advisory Centre
Porirua                                                               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
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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 variable1, 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 tetanus-
diphtheria) 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.




The National Cold Chain Audit
December 2002 June 2003
                                                    i                                                 31/07/03
SUMMARY continued

Figure 2: Types of cold chain events Dec 02-Jun 03
                                      Number recorded
Monitor Monitor                       (% of valid completed cards)
type       Status/Index               N = 985
Freeze     Clear                      824 (84)
           Violet                     158 (16)
Heat       Index 0
           (No colour/partial colour  614 (62)
           in window 1)
           Index 1
           Window 1 completely red 340 (35)
           Index 2
           Window 2 completely red 22 (2)
           Index 3
           Window 3 completely red 9 (1)

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 interpretation5 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.




The National Cold Chain Audit
December 2002 June 2003
                                                   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.




The National Cold Chain Audit
December 2002 June 2003
                                                   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 standards2. 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.




The National Cold Chain Audit
December 2002 June 2003
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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      Warm        Cold                     Location                       Date     Warm           Cold Mark
       in       Mark        Mark                                                    out      Mark            Status
                Index      Status                                                            Index




      WarmMark™ Monitor

       If no colour or partial colour in
       Window 1, record index as 0


      ColdMark™ Monitor                                               If window 1    If window 2   If window 3    If window
                                                                            is             is            is           4 is
                                                                      completely     completely    completely    completely
                                                                      red, record    red, record   red, record   red, record
        If the bulb is clear in colour, record status as C.            index as 1     index as 2    index as 3   index as 4
        If the bulb is violet in colour, record the status as V


         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




The National Cold Chain Audit
December 2002 June 2003
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        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)
                        Zuellig Pharma
                        Auckland          766 (33)
                        Zuellig Pharma
                        Hamilton          483 (21)
                        Zuellig Pharma
                        Wellington        518 (22)
                        Zuellig Pharma
                        Christchurch      332 (14)
                        Zuellig Pharma
                        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.




The National Cold Chain Audit
December 2002 June 2003
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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     Monitors returned Valid monitors returned
                       from each RVS (% of total)             (% 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 failures1
                                  No. of monitors with heat          % of        No. of monitors            % of
                                  exposures. Index of:               monitors with freeze                   monitors
Location                          1        1,2     1,2,3    1,2,3,4 returned exposure                       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.




The National Cold Chain Audit
December 2002 June 2003
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         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.




The National Cold Chain Audit
December 2002 June 2003
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Table 3: Location of the heat exposure of the heat-sensitive monitors by health district.
                                                                                         Number of monitors with any heat exposure
Location                                                                                                                                                                                                                                                                                                   All Health




                                                                        Count-Manak




                                                                                                                                         Lakes District




                                                                                                                                                                                                                                 Nelson-Marlb
                                                                                                                                                                                                          Capital Coast
                                                                                                Bay of Plenty
                                                                                                                                                                                                                                                                                                           Districts




                                                                                                                            Hawkes Bay




                                                                                                                                                                                 MidCentral




                                                                                                                                                                                                                                                Canterbury
                                                                                                                                                                     Whanganui




                                                                                                                                                                                                                                                             West Coast


                                                                                                                                                                                                                                                                          South Cant
                                                                                                                                                                                              Wairarapa
                                             Waitemata
                                 Northland




                                                                                                                                                                                                                                                                                               Southland
                                                                                                                Tarawhiti
                                                                                                                                                                                                                                                                                                           (% of



                                                         Auckland




                                                                                                                                                          Taranaki
                                                                                      Waikato
                                                                                                                                                                                                                                                                                                           monitors




                                                                                                                                                                                                                                                                                       Otago
                                                                                                                                                                                                                          Hutt
                                                                                                                                                                                                                                                                                                           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                                  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                             19           7          92              16           20         18             11           4             7              15          2           6            3           24              5      21            57            7            3          37        3         371 (38)
(% of monitors returned)          (2)         (1)         (9)             (2)          (2)        (2)            (1)        (<1)           (1)             (1)       (<1)         (1)         (<1)          (2)           (<1)     (2)           (6)          (1)         (<1)         (4)     (<1)




The National Cold Chain Audit
December 2002 June 2003
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Table 4: Location of the freeze exposure of the freeze-sensitive monitors by health district
                                                                                                                                                                Number of monitors with any freeze exposure
Location                                                                                                                                                                                                                                                                                                          All Health




                                                                              Count-Manak




                                                                                                                                               Lakes District




                                                                                                                                                                                                                                        Nelson-Marlb
                                                                                                                                                                                                                 Capital Coast
                                                                                                      Bay of Plenty
                                                                                                                                                                                                                                                                                                                  Districts (% of monitors




                                                                                                                                  Hawkes Bay




                                                                                                                                                                                        MidCentral




                                                                                                                                                                                                                                                       Canterbury
                                                                                                                                                                            Whanganui




                                                                                                                                                                                                                                                                    West Coast


                                                                                                                                                                                                                                                                                 South Cant
                                                                                                                                                                                                     Wairarapa
                                                       Waitemata
                                           Northland




                                                                                                                                                                                                                                                                                                      Southland
                                                                                                                      Tarawhiti
                                                                                                                                                                                                                                                                                                                  returned)




                                                                   Auckland




                                                                                                                                                                 Taranaki
                                                                                            Waikato




                                                                                                                                                                                                                                                                                              Otago
                                                                                                                                                                                                                                 Hutt
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 (<1)

Storage at regional 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 regional store and
vaccinator site                            3           1           2          7             4         3                                                          1          1                                    1                                     3                                      1       2           29 (3)

Storage at vaccinator site                 1           11          12         14            5         12              3           7            5                 8          1           1            1           14              7      2              8            1            1            6       1           121 (12)

Total                                      4           12          14         21            9         15              3           7            5                 9          2           1            1           22              7      2              11           1            1            8       3           158 (16)
(% of monitors returned)                   (<1)        (1)         (1)        (2)           (1)       (1)             (<1)        (1)          (<1)              (1)        (<1)        (<1)         (<1)        (2)             (1)    (<1)           (1)          (<1)         (<1)         (1)     (<1)




The National Cold Chain Audit
December 2002 June 2003
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         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
Transport between the national
store and regional stores          <1           2           1

Storage at regional store               <1               109              16
Transport between regional
store and vaccinator site               <1               12               <1

Storage at vaccinator site              <1               173              30

Total                                   <1               296              47

          Vaccine distribution and potential cost of vaccine wastage
During the reporting period 476,862 doses of childhood immunisation schedule vaccine valued at
NZD 6,316,861 were distributed. The minimum number of vaccine doses potentially wasted due to
cold chain failure was 12,300 doses (9,860 (80%) due to freeze failures) being 2.6 % of all
immunisation schedule vaccine doses distributed during the reporting period. The estimated minimum
cost of vaccines wasted by recorded cold chain failure was NZD 249,660. The audit does not provide
good information on the proportion of wastage for two reasons. Firstly what happens to the vaccine
after a cold chain failure has occurred is not recorded on the monitor card, it is assumed the vaccine is
wasted if that particular vaccine is likely to be compromised as a result of the CCF. Secondly
additional doses of vaccine not monitored but delivered in the same shipment may also have been
discarded. This also applies to cold chain failures during storage in the provider’s fridge.

Not all CCF’s result in vaccine wastage. During the period at least 342 (65%) events did not result in
vaccine wastage. When a CCF is reported to ESR the nature of the event is discussed with the person
notifying ESR. Recommendations are made and the local immunisation coordinator (LIC) is contacted
who can offer support by visiting the vaccinators’ site. Vaccine replacement is advised where
necessary according to temperature exposure that could affect vaccine efficacy. Vaccine efficacy was
determined by referring to the Immunisation Handbook1 and World Health Organisations5
interpretation of the monitors and the likely effects of the temperature exposure7.




The National Cold Chain Audit
December 2002 June 2003
                                                   11                                                  31/07/03
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.




The National Cold Chain Audit
December 2002 June 2003
                                                    12                                                   31/07/03
REFERENCES
1    Immunisation handbook 2002. Wellington Ministry of Health; 2002.
2    Vaccine storage and distribution national standards. 2nd 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.




The National Cold Chain Audit
December 2002 June 2003
                                               13                                             31/07/03
APPENDICES



Appendix 1: Temperature-sensitive monitor record card
                                             Temperature-Sensitive Monitor Record Card
   Dat     WarmM             Cold                             Location                       Date out     WarmM         Cold
   e in      ark            Mark                                                                            ark        Mark
            Index           Status                                                                         Index       Status




  WarmMark™ Monitor
  If no colour or partial colour in
  Window 1, record index as 0
  ColdMark™ Monitor                                                       If window      If window      If window    If window
                                                                               1 is            2              3            4
                                                                          completely     completely     completely   completely
                                                                              red,           red,           red,         red,
                                                                             record         record         record       record
                                                                          index as 1     index as 2     index as 3   index as 4

    If the bulb is clear in colour, record status as C
    If the bulb is purple in colour, 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 Monitor Mark ‘Index’ (0, 1, 2, 3 and/or 4)
    • 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




The National Cold Chain Audit
December 2002 June 2003
                                                                    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.




The National Cold Chain Audit
December 2002 June 2003
                                                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




The National Cold Chain Audit
December 2002 June 2003
                                                   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.


                               Temperature-Sensitive Monitor Record Card
    Date      Warm         Cold                        Location                     Date         Warm           Cold
     in       Mark         Mark                                                     out          Mark           Mark
              Index       Status                                                                 Index         Status




   WarmMark™ Monitor in
    If no colour or partial colour
     Window 1, record index as 0


   ColdMark™ Monitor                                              If window 1 is   If window 2   If window 3    If window
                                                                    completely           is            is           4 is
                                                                        red,       completely    completely    completely
                                                                   record index        red,          red,           red,
                                                                       as 1           record        record        record
                                                                                    index as 2    index as 3   index as 4
       If the bulb is clear in colour, record status as C.
       If the bulb is violet in colour, record the status as V




The National Cold Chain Audit
December 2002 June 2003
                                                            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.




The National Cold Chain Audit
December 2002 June 2003
                                                     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

    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

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


The National Cold Chain Audit
December 2002 June 2003
                                                       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.

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 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




The National Cold Chain Audit
December 2002 June 2003
                                                     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 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.


                                   Temperature-Sensitive Monitor Record Card
     Date      Warm          Cold                       Location                       Date          War          Cold
      in       Mark         Mark                                                       out            m          Mark
               Index        Status                                                                  Mark         Status
                                                                                                    Index




                     Monitor
    WarmMark™ partial colour in
     If no colour or
      Window 1, record index as 0


    ColdMark™ Monitor                                                 If window 1     If window 2   If window    If window 4
                                                                            is              is          3 is           is
                                                                    completely red,    completely   completely    completely
                                                                    record index as       red,         red,          red,
                                                                            1            record       record        record
     If the bulb is clear in colour, record status as C.                               index as 2   index as 3    index as 4
     If the bulb is violet in colour, record the status as V




The National Cold Chain Audit
December 2002 June 2003
                                                               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.




The National Cold Chain Audit
December 2002 June 2003
                                                     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

    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 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.




The National Cold Chain Audit
December 2002 June 2003
                                                     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
         National Vaccine Store
         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.




The National Cold Chain Audit
December 2002 June 2003
                                                    24                                              31/07/03
        Appendix 5: Information provided to vaccinators as a laminated poster
        for their fridges

                                      Cold-Chain Monitor Enclosed
    1      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.



                                              Temperature-Sensitive Monitor Record Card                                   124
2
           Date in        Warm            Cold                     Location                    Date out       Warm           Cold
                          Mark           Mark                                                                 Mark          Mark
                          Index          Status                                                               Index         Status




          WarmMark™ Monitor
3
          If no colour or partial colour in
         Window 1, record index as 0
         ColdMark™ Monitor                                                    If window     If window       If window     If window
                                                                                   1 is           2               3             4
                                                                              completely    completely      completely    completely
4                                                                                 red,          red,            red,          red,
                                                                                 record        record          record        record
          If the bulb is clear in colour, record status as C                  index as 1    index as 2      index as 3    index as 4
          If the bulb is purple in colour, record the status as V
                                                                                           DTaP-IPV 30 Nov 2002




         Keep the monitor with the vaccine that it arrives with.

5        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:
6           • fill in the ‘Date out’
            • fill in the Monitor Mark ‘Index’ (0, 1, 2, 3 and/or 4)
            • fill in the Freeze Watch ‘Status’ (C or V)

         Return the completed card to:                Please direct any enquiries to:
             National Vaccine Store                      Pamela Raynel
7            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


              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.


        The National Cold Chain Audit
        December 2002 June 2003
                                                                       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
The vaccine cold chain is the system of transporting and storing vaccines at their recommended storage
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 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 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




The National Cold Chain Audit
December 2002 June 2003
                                                   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.




The National Cold Chain Audit
December 2002 June 2003
                                                    27                                                  31/07/03
    Appendix 8: Update of instructions for completing the monitor record
    cards
                                     Cold-Chain Monitor Enclosed
1     Please read and record the monitors when you receive this pack and again when you either
             1
      dispatch the pack or use the last dose of vaccine in the pack.

                                       Temperature-Sensitive Monitor Record Card                                      124
2      Date in       Warm           Cold                Location                 Date out                Warm            Cold
                     Mark          Mark                                                                  Mark            Mark
                     Index         Status                                                                Index          Status
                                            ESR                                Date leaves               Record         Record
                                                                                   ESR                    Index          Index
       Date          Record        Record   Zuellig Branch                     Date leaves               Record         Record
      Rec’d at        Index        Status                                         Zuellig                 Index         Status
      Zuellig
       Date          Record        Record        Record Name of Your Practice          Date Last         Record           Record
      Rec’d at        Index        Status                                              Dose Used          Index           Status
      Practice


     WarmMark™ Monitor
3
     If no colour or partial colour in
     Window 1, record index as 0
     ColdMark™ Monitor                                                  If window      If window       If window      If window
                                                                             1 is            2               3              4
                                                                        completely     completely      completely     completely
4                                                                           red,           red,            red,           red,
                                                                           record         record          record         record
      If the bulb is clear in colour, record status as C                index as 1     index as 2      index as 3     index as 4
      If the bulb is purple in colour, record the status as V
                                                                                              DTaP-IPV         Feb 2003



     Keep the monitor with the vaccine that it arrives with.

5    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:
6       • fill in the ‘Date out’
        • fill in the Monitor Mark ‘Index’ (0, 1, 2, 3 and/or 4)
        • fill in the Freeze Watch ‘Status’ (C or V)

     Return the completed card to:                Please direct any enquiries to:
         National Vaccine Store                      Pamela Raynel
7        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


         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.

    The National Cold Chain Audit
    December 2002 June 2003
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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:               Helen Christie, IMAC National Cold Chain / Quality Coordinator
                      Pamela Raynel, Scientist, ESR

  Subject:            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.
The National Cold Chain Audit
December 2002 June 2003
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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
2                   8 days                    6 days
3                   14 days                   11 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.



Helen Christie
IMAC National Cold Chain & Quality Coordinator

The National Cold Chain Audit
December 2002 June 2003
                                                   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:




The National Cold Chain Audit
December 2002 June 2003
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Northern region feedback Dec 02 – Jun 03

Region                          Issue                               Outcome

Northern                        Facilitators not contacted by the   Redistribution of the
                                provider when a monitor card        information sheet by Zuellig.
                                arrived with vaccines.              Face to face education by
                                                                    facilitator.



                                Two incidents where the             Discussion with ESR vaccine
                                monitor card showed that the        scientist.
                                cold mark was activated during      Coordinator visited the Zuellig
                                transport between Zuellig and       Pharma branch.
                                the provider, vaccines used.



                                School based immunisation           Discussion with ESR re using
                                programme cold chain failure.       vaccines.
                                Cold mark on monitor card
                                showed violet. Vaccines             Fridge temperature monitored
                                incorrectly packed by Zuellig,      using multiple data loggers, two
                                monitor card in contact with ice    shelves in fridge showed
                                packs in chilly bins.               temperatures below °C
                                                                    Public Health Unit purchased
                                                                    vaccine specific fridge.



                                GP practices need more              Face to face education by
                                instructions on completing the      facilitator.
                                monitor record card.




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Midland region feedback Dec 02 – Jun 03

Region                          Issue                               Outcome

Midland                         Overnight courier cold chain        Practice completed card and
                                failure.                            returned vaccines to Zuellig.



                                One monitor card left behind for    Card completed and returned,
                                several months after the vaccine    explanation provided.
                                was given.



                                Reporting of monitors arriving      Practices reminded of the need
                                has dropped off in recent           to contact facilitator when card
                                months.                             arrives. Vaccinator training
                                                                    updates used to remind
                                                                    providers.



                                Monitors being pushed against       Advice given by facilitators on
                                the ice plate or back of ‘fridge.   process for completion and
                                                                    return of monitors.



                                Monitor card showing cold           ESR contacted and only IPOL
                                mark activated, ‘fridge min/max     returned to Zuellig.
                                showing all o.k. Temprecord
                                logger supported min/max.



                                One practice reported a yellow
                                notification sticker alerted to a
                                monitor enclosed. No monitor
                                found.




The National Cold Chain Audit
December 2002 June 2003
                                                33                                                  31/07/03
Central region feedback Dec 02 – Jun 03

Region                          Issue                                Outcome

Central                         Not being notified when              Sent out updated information
                                monitors arrived.                    sheet via Zuellig



                                Public Health Unit cold chain        ESR notified and discussion
                                failure, facilitator not notified    clarified that vaccines had been
                                that several monitors had been       used within 24hrs of arrival and
                                received. 7/20 monitors showing      not left with monitors.
                                cold mark activated. Cards
                                placed against the icebox.



                                Monitor card removed from            Education provided using
                                vaccine and left on top of fridge.   vaccinator update material.



                                Internal provider                    Immunisation coordinators must
                                communication methods                be diligent in addressing any
                                inadequate to inform all staff on    cold chain management issues.
                                how to identify and complete
                                monitor record cards.




The National Cold Chain Audit
December 2002 June 2003
                                               34                                                   31/07/03
Southern region feedback Dec 02 – Jun 03

Region                          Issue                              Outcome

Southern                        Instructions on laminated fridge   Local immunisation
                                magnet not easy to follow.         coordinators reiterate
                                Some have not understood the       instructions and provide
                                purpose or function of the         support.
                                monitors.



                                Instructions are not clear as to   Immunisation coordinators
                                what they do with the vaccine      reinforce usual practices when a
                                when the cold sensitive monitor    cold chain failure is reported.
                                is activated



                                Yellow alert labels not bold or    ESR reviewing labels
                                big enough.



                                Rural practices are reporting      Referred to ESR for advice.
                                that monitors are arriving with    Reinforce the national cold
                                the heat sensitive monitor         chain standards with local
                                showing movement                   Zuellig branch.



                                Nurses overstretched in general
                                practices, becoming less focused
                                on correct vaccine storage



                                Providers not notifying            Immunisation coordinators
                                immunisation coordinators          provided explanation.
                                when they receive vaccine with
                                monitors. Questioning the need
                                to notify




Helen Christie
National Quality Coordinator
Immunisation Advisory Centre
Auckland University

July 2003




The National Cold Chain Audit
December 2002 June 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




The National Cold Chain Audit
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