The 30 minute rule has been a subject of much discussion since the introduction of the Blood Quality and Saftey Regulations and the following clarification was given on www.transfusionguidelines.org.uk Clarification on the "30 minute rule" and reports to SABRE There has been some uncertainty regarding the requirement for SAE reports which involve units out of cold chain storage. The "30 minute rule" is the customary limit accepted in the UK as the time allowed out of controlled storage, which if not exceeded, can allow the unit to be replaced back into controlled storage for re-use. See Joint UKBTS/NIBSC Professional Advisory Committee- Deviations from. 4C temperature storage for red cells: effect on viability and bacterial growth, February 2005 Scenario 1: Unit taken to ward, decision made not to transfuse and unit returned to the issue fridge. The unit has been out of controlled storage for 45 minutes and is replaced into the issue fridge for re-use. As the time out of controlled storage is greater than 30 minutes, the pack should not be returned to the fridge and this should be reported as an SAE. Scenario 2: Unit of red blood cells taken from controlled storage but transfusion not started within 30 minutes. However, clinical decision taken to proceed and unit subsequently transfused within 4 hours of removal from controlled storage. Handbook of Transfusion Medicine (4th edition) states: Administration Use blood administration set; complete the infusion within four hours of removal from controlled temperature storage (see Table 2) This is not reportable as an SAE Scenario 3: Unit taken from controlled storage, transfusion started within 30 minutes but not completed until more than 4hours after removal from controlled storage This is not reportable to MHRA as an SAE, as it is a 'clinical' error outwith the remit of the BSQR A hospital may raise a local incident report due to breach of a local guideline (e.g. where a limit is specified between removal of blood from controlled storage and time of commencing transfusion). This is acceptable, however national guidance (BCSH Handbook) is that transfusion must be 'started as soon as possible and completed within 4 hours of removal from storage'.