Cold chain management policy template for immunisation providers

advertisement
Cold chain management policy template for
immunisation providers and clinics Appendix two
This template provides the information required to assist immunisation providers to develop their own cold
chain management policy. Each provider, clinic or department storing vaccines must have an individualised
policy. Contact your local immunisation coordinator if you have any questions or need advice about your cold
chain management.
Name of provider/clinic/department:
Date:
Name of our local immunisation coordinator:
Contact number(s):
Name of our IMAC Regional Advisor:
Contact number(s):
Designated staff with overall responsibility for cold chain management
First person:
Second person:
All staff are responsible for ensuring the vaccines they administer are stored correctly.
Vaccine documents
Ensure you have copies of:

Immunisation Handbook 2014 – hard copies can be ordered from Wickliffe on (04) 496 2277 or available
on the Ministry of Health website at www.health.govt.nz/immunisation

National Guidelines for Vaccine Storage and Distribution 2012 – available on the Ministry of Health
website at www.health.govt.nz/national-guidelines-vaccine-storage

Annual Cold Chain Management Guide and Record available on the Ministry of Health website at
www.health.govt.nz/cold-chain-management-guide and can also be ordered as a hard copy from this
address.
These documents should be located with your cold chain policy document and/or attached as an appendix to
the policy.
The vaccine documents provide detailed information to support your cold chain management and the
development of your cold chain policy.
Cold chain accreditation
All immunisation providers, clinics and departments storing vaccines must achieve cold chain accreditation
(CCA). Document when your next CCA review is due or your CCA expires and what actions you had to take
to achieve CCA if any. For more information on CCA refer to the vaccine documents above and discuss with
your local immunisation coordinator.
Cold Chain Management Policy Template – February 2013
1
Vaccine requirements
Staff should know how much vaccine stock they require at any one time, according to the size of the
population they serve. To avoid overstocking and to ensure stock rotation a minimum National Immunisation
Schedule vaccine stock of two weeks is recommended, but no more than six weeks of stock should be held
at any given time.
Refer to the dose requirements tables in the National Guidelines for Vaccine Storage and Distribution 2012
(pages 16-17) to calculate your vaccine stock levels.
Our stock requirements
(Complete the tables below with the information relevant for your clinic/department.)
The number of:
Children aged under five years (including casuals)
Children aged 11 years and 12 years* (including casuals)
Adults aged 45 and 65 years
*
Depending on whether there is a school based programme delivered in your region.
Our minimum and maximum vaccine stock levels are:
DTaP-IPVHepB/Hib
PCV10
Hib
MMR
DTaP-IPV
Tdap
HPV
Td
RV
Minimum
Maximum
Also consider:

seasonal variations (for example influenza), special programmes and disease outbreaks when ordering
vaccines

the amount of Tdap and HPV vaccines will depend on the number of children vaccinated in a Year 7 or 8
school-based immunisation programme

the type and capacity of your vaccine refrigerator

the impact of the addition of new vaccines or changes in vaccine combinations as part of the National
Immunisation Schedule changes

non-funded vaccine requirements, eg, travel vaccines.
Vaccine ordering and stock keeping
We undertake a stock count
times per month on
and order vaccines as appropriate.
(eg, 2nd and 4th Wednesday of the month)
All vaccines are logged in a vaccine register, or similar record, including their arrival date, name, batch
number and expiry dates. An example of a vaccine register can be found on the IMAC website at
www.immune.org.nz.
Cold Chain Management Policy Template – February 2013
2
Receiving and storing vaccines
All staff should know what to do when a vaccine order arrives from the distributor or hospital pharmacy.
Refer to the Annual Cold Chain Management Guide and Record (page 2).
Vaccines must be left in their original packaging, as this acts as insulation and protects vaccines sensitive to
light. Refer to the National Guidelines for Vaccine Storage and Distribution 2012 (page 18) and the Annual
Cold Chain Management Guide and Record (page 3) for more information on storing vaccines.
What to do if you receive a National Cold Chain Audit TagAlert monitor and record
card with your vaccine order
All staff should know what to do when a National Cold Chain Audit TagAlert monitor and record card arrive
with your vaccine order. Refer to the National Guidelines for Vaccine Storage and Distribution 2012 (pages
7-8 and Appendix 1) and the Annual Cold Chain Management Guide and Record (page 5).
Cold chain equipment – operation and maintenance
All immunisation providers/clinics and departments must use a pharmaceutical refrigerator to store vaccines.
The use of a domestic fridge to store vaccines is now only possible for the short term and all providers are
expected to make the change to a pharmaceutical refrigerator either by their next CCA review or within an
agreed timeframe with their local immunisation coordinator.
In the short term, if you are using a domestic refrigerator to store vaccines refer to the National Guidelines for
Vaccine Storage and Distribution 2012 and the Annual Cold Chain Management Guide and Record for more
information.
All vaccinators are responsible for ensuring that their vaccine refrigerator:

is not used to store non-medical materials (eg, food)

is positioned in a well-ventilated room

away from direct sunlight or heat source

at least 10 cm away from surrounding surfaces to allow air to circulate around the condenser

has an independent power point and a plug in surge protection unit. The plug should be taped over, with
a notice ‘Do not disconnect this plug’.
Contact your local immunisation coordinator when purchasing new equipment or if you have any questions
about your cold chain equipment.
Maintenance plan and schedule
This covers all cold chain equipment including: (location and model numbers of all refrigerators and data
loggers need to be noted)
Equipment
Location in clinic
Maintenance plan
Refrigerator:
As per Immunisation Handbook 2014 (page
600).
Date
purchased:
Annual service according to manufacturer’s
recommendations.
Model:
Annual check of refrigerator performance and
temperature ranges by your local immunisation
coordinator or refrigerator manufacturer.
Cold Chain Management Policy Template – February 2013
3
Equipment
Location in clinic
Maintenance plan
Electronic temperature recording
device, eg, data logger or
thermocron
Annual calibration of the recording device as per
manufacture’s recommendations.
Chilly bin for:
Have a plan in place to store vaccines when
transporting vaccines, defrosting refrigerators
and in the event of a power or equipment failure.

transporting vaccines

defrosting your vaccine
refrigerator, and

in the event of a power or
equipment failure.
Ice pointing of temperature recording device as
per manufacturers’ recommendations.
Your plan should include the number of chilly
bins that will be required for transporting your
vaccine stocks.
Packing material available, eg, approved
insulation material Immunisation Handbook 2014
(page 608) and National Guidelines for Vaccine
Storage and Distribution 2012 (pages 27–28).
Ice packs for use when:
Ice packs are kept frozen, not refrigerated.

transporting vaccines

defrosting your vaccine
refrigerator, and

in the event of a power or
equipment failure.
Document the number of ice packs you will need
to store your vaccine supply when transporting
vaccines, defrosting refrigerators and in the
event of a power or equipment failure.
Battery changed according to manufacturer’s
recommendations or removed when not in use.
Independent digital thermometer
Calibration and ice pointing undertaken as per
manufactures recommendations.
Refrigerator temperature monitoring
The vaccine refrigerator temperature is monitored with an inbuilt digital thermometer or specify alternative if
used:
. The minimum and maximum temperature is recorded at the same time of each working day.
The temperature records are kept close to the refrigerator and archived as with other medical records for at
least 10 years. The Annual Cold Chain Management Guide and Record can be used to document your daily
readings.
All vaccine refrigerators must have a digital temperature monitoring device (eg, data logger) to record and
download data from the previous month and in response to temperatures outside of the +2C to +8C
temperature range. Review your monthly readings with your local immunisation coordinator. Keep your
monthly downloads from your electronic temperature monitoring device either electronically or both.
Document any additional information as appropriate including:

reasons and actions taken when the refrigerator temperature is outside the recommended range

information on the refrigerator maintenance

annual temperature validation

Cold Chain Accreditation review and expiry date

information on new equipment purchased.
Cold Chain Management Policy Template – February 2013
4
What to do if you have a cold chain failure, ie, the temperature is outside of the +2C
or +8C range

Refer to temperature control chart in the Annual Cold Chain Management Guide and Record and the
Immunisation Handbook 2014 (page 604).

Label the vaccines ‘not for use’ and leave in the refrigerator.

Download the data logger and check for inconsistencies or temperature fluctuations.

Contact your local immunisation coordinator for advice.

If you cannot contact your local immunisation coordinator, contact the IMAC regional advisor for
advice.

Document the steps and actions you have taken in your cold chain record.

If you are recalling or re-immunising children or adults as a result of a cold chain failure please inform
the Ministry of Health’s National Immunisation Programme by emailing immunisation@moh.govt.nz or
by contacting the National Immunisation Programme Manager directly.
Emergency plan for dealing with equipment and power failures
In the event of a power failure and/or equipment failure, the refrigerator should be monitored using an
independent digital thermometer or logger and the door closed. If the power failure extends beyond four
hours, seek alternative refrigeration.
Our emergency vaccine storage plan is: (amend and complete the table below with the information relevant
for your provider/clinic/department)
Action
Refrigerator failure for
0–4 hours
Keep refrigerator door closed and monitor refrigerator
temperature.
Who responsible
Complete
If the refrigerator temperature is above or below +2°C
to +8°C degrees – complete
Refrigerator failure for
4 hours or more
Or refrigerator temperatures
are above or below
+2°C to + 8°C degrees
Pack vaccines for transport in accordance with the
National Guidelines for Vaccine Storage and
Distribution 2012 and take to – complete
Complete
Location for alternate refrigeration – complete –
Contact details for alternate refrigeration – complete –
Before transporting vaccines check the alternative facility has storage capacity for the vaccines.
Inform the local immunisation coordinator of the failure and for further advice.
Refer to the Immunisation Handbook 2014 (page 604) and the National Guidelines for Vaccine Storage and
Distribution 2012 (pages 19, 21-22 and Appendix 2) for more information.
Vaccine disposal
Contact your local immunisation coordinator before disposing of vaccines. Refer to National Guidelines for
Vaccine Storage and Distribution 2012 (page 21) and the Annual Cold Chain Management Guide and
Record (page 10) for more information on vaccine disposal and returning vaccines for destruction.
Cold Chain Management Policy Template – February 2013
5
Policy review
All new staff should be orientated to this cold chain management policy.
Your cold chain policy should be reviewed and updated annually and when changes are made to designated
cold chain staff or the vaccine documents.
Contact your immunisation coordinator:

when there is a significant change in staff responsible for cold chain management

before purchasing a new vaccine refrigerator or cold chain equipment

in the event of a cold chain failure

before disposing of vaccines

for cold chain management advice.
The undersigned accept this document as the provider’s/clinic’s or department’s cold chain management
policy.
Signature of 1st designated staff member:
Signature of 2nd designated staff member:
Position:
Position:
Name:
Name:
Date policy approved:
Date of next cold chain policy review:
Cold Chain Management Policy Template – February 2013
6
Download