This site uses cookies to store information on your computer. I'm fine with this Cookie information
Cookie Control

Cold Chain Audit

Cold Chain Audit
It is important that all medicines are stored appropriately. Thermolabile medicines such as vaccines and insulin should be maintained in the cold chain which means their storage must be maintained at a temperature between 2C and 8C.
NHS Scotland and Greater Glasgow and Clyde Health Board (GG&C) have recently launched cold chain guidelines, the GG&C guidelines give in depth guidance on storage and temperature monitoring and are available as Section 4 of the Immunisation Resource Manual.
  
Maintenance of the cold chain is a significant risk on the Community Pharmacy Risk Register which is managed by the Community Pharmacy Development Team (CPDT) for the Pharmacy and Prescribing Support Unit (PPSU).
 
The Community Pharmacy Clinical Governance Audit (CPCGA) team has conducted a cold chain audit in community pharmacies over the last few years and re-audit has demonstrated encouraging improvements.
However, after a recent National Patient Safety Agency (NPSA) Alert2, this work is still considered to be a priority. So it is important that audit of this particular area of pharmacy practice is maintained. 
 
In previous years the CPCGA team has administered a cold chain audit questionnaire to community pharmacies.
This year to ensure as full an inclusion of GG&C community pharmacies as possible, they are asking some community pharmacies to complete their own audit.
 
The attached self audit sheet is self explanatory. It has space for comments and actions identified. Please use the comments section but the ‘target date’ and completed sections for are for your own use. Do not wait until any identified actions have been completed before you return the audit. Please be assured the details of the audit are absolutely confidential to the CPDT at PPSU.
 
References
1.      Greater Glasgow and Clyde Immunisation Resource Pack
2.      National Patient Safety Alert, ‘Vaccine cold storage’
3.      Immunisation against infectious disease ‘The Green Book’  
 
Please complete the attached audit and return it by Thursday September 30th at the latest preferably by secure fax to;
Bridie McCallum, PPSU, Queens Park House, Langside Road, Glasgow, G42 9TY. Fax 0141 201 5637

 
Criteria
Audit Result
Comments/ action to be taken
Target date
completed
Equipment and Facilities
Yes
No
n/a
 
 
 
Fridge is a pharmaceutical fridge (domestic fridges are not suitable for storage of vaccines or insulin)
 
 
 
 
 
 
The fridge is situated away from direct heat source.
 
 
 
 
 
 
Fridge plug is protected e.g. encased to prevent tampering,  security marked “Do Not Switch Off” or is hardwired (‘spurred’).
 
 
 
 
 
 
Fridge is cleaned and defrosted if necessary regularly (at least every 6 months).
 
 
 
 
 
 
Only pharmaceutical items are stored in the fridge e.g. no food, drink or medical samples are stored in the fridge.
 
 
 
 
 
 
Thermometer is able to give Max/Min/Current readings
 
 
 
 
 
 
 
Criteria
Audit Result
Comments/ action to be taken
Target date
completed
Storage and Stock Control
Yes
No
n/a
 
 
 
Vaccines/Insulin are stored in the body of the fridge not in the fridge door.
 
 
 
 
 
 
Items are stored away from the back and sides of the fridge and the freezer compartment if it has one.
 
 
 
 
 
 
No more than 66% of the internal volume of fridge is filled.
 
 
 
 
 
 
 Vaccines are not being stored in the bottom drawer of the floor of fridge. Unless it is a pharmaceutical fridge with custom made wire baskets. The ‘salad’ boxes of domestic fridges must not be used.
 
 
 
 
 
 
Expiry dates are checked regularly at least once a month and records are kept of this activity.
 
 
 
 
 
 
Stock rotation is carried out to ensure shortest expiry dates are used first.
 
 
 
 
 
 
Cold chain deliveries are refrigerated immediately on receipt.
 
 
 
 
 
 
Named person and deputy responsible for receipt of the cold chain lines.
 
 
 
Names....
 
 
 
Criteria
Audit Result
Comments/ action to be taken
Target date
completed
Temperature Monitoring
Yes
No
n/a
 
 
 
Named person and deputy responsible for monitoring the fridge.
 
 
 
Names....
 
 
Procedures in place for at least daily recording of temperatures.
 
 
 
 
 
 
All staff involved in temperature monitoring are aware of responsibilities
 
 
 
 
 
 
Recording form or equivalent is used.
 
 
 
 
 
 
Minimum, Maximum and Actual temperature is checked and recorded.
 
 
 
 
 
 
Reset button is used for every documented measurement.
 
 
 
 
 
 
Procedures in place for action to be taken in the event of abnormal temperatures.
 
 
 
 
 
 
 
Criteria
Audit Result
Comments/ action to be taken
Target date
completed
Contingency Arrangements
Yes
No
n/a
 
 
 
Procedures in place for suitable monitored alternative storage to maintain cold chain when required.