Implementing cold chain accreditation processes: How to prepare for your CCA

Implementing cold chain
accreditation processes:
How to prepare for your CCA
Georgina Gymer
Northern Regional Immunisation Advisor
IMAC National Workshop September 2013
Session objectives
• Understand the importance of maintain
the Cold Chain
• Understand the MoH requirements for
Cold Chain Accreditation (CCA)
• Prepare for your Cold Chain Accreditation –
assessment criteria
2
What is the cold chain?
• The cold chain is the process which
ensures that vaccines are continuously
stored in temperatures between +2- to
+8°C from the time of manufacture to
the point of administration
Why is maintaining the cold chain
important
• Vaccines are delicate biological substances. If
exposed to temperatures above or below
those recommended, vaccines may be
irreversibly damaged and cannot be relied
upon to provide the expected level of
protection against the disease/s for which
they were designed. This may put people’s
lives and wellbeing at risk, and also has the
potential to result in a loss of confidence in
the National Immunisation Programme.
Cold Chain Accreditation (CCA)
• A tool which enables immunisation
providers to demonstrate their cold chain
management
• A self assessment followed by a review
with an immunisation coordinator/
accredited assessor
• All immunisation providers require a
current CCA which may be valid for up to 3
years.
• For providers to achieve CCA they must
meet all the criteria areas
Preparing for your CCA
• Contact your local Immunisation Coordinator
• Complete CCA Provider self assessment
forms
• Complete and send back with a copy of your
Cold Chain Policy
• Make appt for your CCA review
Assessment criteria
1.
2.
3.
4.
5.
Cold Chain Policy
Vaccine reference information
Vaccine stock management
Temperature monitoring and performance
Refrigerator details
Cold Chain Policy
• Designated cold chain person(s)
• Vaccine requirement estimates
• Vaccine ordering process, frequency & stock
management
• Cold Chain equipment – operation and maintenance
plan
• Documented monitoring of refrigerator
temperature
• Procedures in place in event of equipment power
failure
• Orientation of all staff dealing with vaccines
Vaccine reference information
• Copy of 2011 Immunisation Handbook
• Copy of The National Guidelines for Vaccine
Storage and Distribution 2012
• Annual Cold Chain Management Guide
10
Vaccine stock management
• System to record vaccine stock levels – vaccine
register or log book
• Appropriate stock level are maintained
• Describe process for receipt of vaccines
• Ensure stock rotation
• Adequate ventilation between vaccines in
refrigerator
• Vaccines stored in original packaging in appropriate
location in fridge
• Aware of coldest & warmest places in refrigerator
Temperature monitoring and
performance
• Aware of recommended storage
temperatures
• Three months worth of daily min/max
temperature recordings
• Document any action taken if refrigerator
falls outside of recommend temperatures
• Correct demonstrate correct action to take
when receiving a national Cold Chain Audit
card
• Retains documentation for 10 years
Temperature monitoring:
daily, monthly, annual
• Shows the minimum and
maximum temperatures
since memory last cleared
• No indication of duration
of these temperatures
Daily temperature recording
14
Temperature monitoring and
performance ctd....
• Access to alternative storage in event of
power failure
• Provider has electronic recording device –
data logger
22/9 /2010
23/9/2011
25/9/2011
22/9 /2011
OK
OK
OK
OK
Infanrix hexa
ProPharma Auckland
Happy Days GP Surgery,
Happyville
24152
25/9/2011
25/11/2011
OK
OK
AM
OK
OK
Refrigerator details
• Make/model of pharmaceutical fridge –
maintenance schedule
• Only medical material is stored in refrigerator
• Placed in suitable position – adequate
ventilation
• Top is kept clear
• Connected to independent power point with
surge protector
What happens next?
• Independent data loggers will be placed on
three shelves in refrigerator
• Assessor will complete provider review
• Any recommendations made – further
appointment made if necessary
• Once data has been reviewed paperwork will
be sent to provider with CCA certificate