To be implemented 1 September 2008.

 In accordance with ANZSBT/NPAAC requirements, blood products must be stored in an appropriate temperature controlled (and monitored) environment to conform with AS 3864 – 1997 Medical refrigeration equipment – For the storage of blood and blood products.  The maintenance and monitoring provisions are outlined in Appendices A and G.

NATA recognises that there is a large variation in age, design and construction of blood bank refrigerators in use and that it is not always possible to access the temperature probes (for older equipment) preventing adherence to Appendix A, AS 3864 .

However, it is now possible to retrofit stand alone recording devices to such equipment which will allow compliance with Appendix A.

Accordingly, a resolution has been passed by the Medical Testing Accreditation Advisory Committee, at its May 2008 meeting, that the maintenance and monitoring of all blood bank refrigerators must now adhere to AS3864, Appendices A & G.

Compliance with the intent of other sections of AS 3864 is seen as good laboratory practice.

i) The minimum requirements for monitoring of blood bank refrigerators are:

• a continuously monitored alarm with an audible signal, the alarm function to be checked weekly;
• a temperature recording device which is checked frequently – at least daily;
• an annual check of the temperature recorder against a certified reference thermometer; and
• a check of the alarm points (2.5°C and 5.5°C) to be conducted on a weekly basis. The temperature at which the alarm is activated must be recorded.

(ii) Where a laboratory is using off-site or external refrigerators to store blood intended for transfusion purposes, it should ensure that the blood units are stored and handled appropriately. A procedure must be in place to confirm and monitor the suitability of the off-site storage locations to ensure that the refrigerators used for storing blood and blood products for transfusion are being maintained in accordance with AS 3864. These records must be available for review at assessment.

Laboratories should be aware that AS3864 is currently undergoing review at Standards Australia.

If you have any questions please do not hesitate to contact NATA in Sydney on (02) 9736 8222 or in Melbourne on (03) 9329 1633.