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 +2C to +8C 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 +2C or +8C 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