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