Ordering of vaccines

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					Vaccine Cold-Chain Audit Form
Teaching Primary Care Trust

General Information
Inspection Date Premises Name Auditor Address

Known As Site contact Time spent on site

Postcode Phone Number Email

Details of storage unit(s)
Type of Fridge 1 Thermometer type Type of Fridge 2 Thermometer type Location & security Annual maintenance Location & security Annual maintenance


Procedures for receipt, storage and temperature recording
Trained Individual Trained Deputy 2 Trained Deputy 1 Trained Deputy 3

Yes/No Score if No (1-4) Are the procedures for the receipt, checking and immediate refrigeration of vaccines being followed? Are vaccines in their original packaging and being stored inline with the vaccine fridge loading instructions? Are vaccines packages examined in-date? Is there evidence of daily temperature recording; actual, max-min temps+ reset & monthly record sheet sign off?
Is there evidence of stock rotation and is the “receipt of vaccines file” & “refrigerator file” being kept up-to-date?


Are vaccines transported to outlying clinics / schools in validated cool boxes with a max-min temperature indicator? Check specimens are not being stored in the vaccine refrigerators (Y = not being stored) Comments:

Officers signature


Description A non-compliance which has a potentially major effect A non-compliance which has a potentially significant effect A non-compliance which has a potentially minor effect A non-compliance which has a potentially no effect

Score 1 2 3 4

HPV Vaccine Order, Receipt and Storage Procedure

Ordering The person ordering vaccines for clinics (name) should inform clinic reception staff and the sites HPV team regarding what has been ordered (vaccine type, manufacturer, quantity ordered and expected delivery date). The person ordering vaccines should fax or email this information to the parties concerned, seek confirmation of receipt of this information (in particular clinic reception personnel) and ensure the information is placed in the “receipt of vaccines file”. The person ordering vaccines should ensure the vaccine supplier is aware of the clinics opening times (including lunch breaks as many clinics are closed for lunch). Receipt of vaccines Clinic reception staff should have a “receipt of vaccines file” which contains details of what has been ordered. This file should be kept at the clinic reception desk and contain this procedure and contact details for person ordering vaccines. Each clinic should have one trained individual, with at least one trained deputy, responsible for the receipt and storage of vaccines and the recording of refrigerator temperatures. HPV nurses are regarded as trained individuals as they will have attended immunisation and vaccination courses and updates. However, as these nurses may not be available at vaccine delivery and temperature logging times, HPV nurses should ensure a selection of permanently based clinic administrative staff are trained to check deliveries against orders, un-pack, store vaccines in appropriate vaccine fridges and monitor vaccine fridge temperatures when the nurses are unavailable to do this. HPV nurses are responsible for providing training for clinic based staff. On receipt of vaccines, trained individuals (preferably the HPV nurses) must check deliveries against the order for discrepancies and leakage or damage before signing for them. If vaccines arrive that do not appear to have been ordered (e.g. details are not in the receipt of vaccines file), staff should refuse to take delivery of them, similarly if more vaccine is delivered than has been ordered, staff should only accept the quantity that has been delivered. Delivered vaccines must be refrigerated immediately on receipt and must not be left at room temperature, consequently a key for the vaccine fridge(s) should be kept in the clinic reception key cabinet. Access to this key must be recorded in the “receipt of vaccines file”, consequently if commissioning or provider services staff need access to the refrigerator for audit purposes. Storage & Housekeeping Vaccine types, brands, quantities, batch numbers and expiry dates should be recorded with the date and time at which the vaccines were received. This information should be kept by the HPV nurses in the “refrigerator file” used to archive refrigerator temperature logs. Vaccine refrigerators should not be over-filled. The space adjacent the fan on the top shelf should be kept clear to allow adequate air circulation, in addition, their should be gaps between vaccines and the front, back and sides of the refrigerator and a gap between the top of the vaccines on each shelf of the fridge and bottom of the next shelf. Vaccine fridges and power supplies should be labelled to prevent them being accidentally switched off. “HPV Returns Forms” should be returned on a monthly basis to (a named individual). Temperature recording (actual, max-min and max-min reset) should be recorded every working day and records kept in the refrigerators file. Monthly checks of vaccine fridge temperature monitoring sheets should be undertaken by the HPV nurses to check storage temperatures have not deviated beyond the 2 – 8 degree Celsius range (it is acceptable for this to occur for short periods during stock-checks or during receipt of deliveries). Monthly temperature record sheets should be signed off at the end of each month by the HPV team based at the site and kept in the “refrigerator file”. Regular vaccine fridge / cold-chain audit (at least annually) should be undertaken by HPV nurses from a different teams using the attached audit form. HPV nurses should retain any refrigerator annual maintenance check reports in the “refrigerator file”. Ray Wright, Infection Control Technical Manager 14/11/08