Dear colleagues anyone knows, how many times we shall check residual leucocytes in RBCs' & Platelets' units? and how many units of PRBC and Platelets shall I check?

There is a CBER Guidance document that provides the number of units to test based on a statistical method.

Pre-Storage Leukocyte Reduction of Whole Blood and Blood

Components Intended for Transfusion September 2012

There is a CBER Guidance document that provides the number of units to test based on a statistical method.

Pre-Storage Leukocyte Reduction of Whole Blood and Blood

Components Intended for Transfusion September 2012

Thanks Iph but could you launch that document here or post link here.

Here is the link to the guidance document

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm

Thanks my dear lph

Is this just for the donor processing facilities or are hospital transfusion services supposed to perform a check of the blood product units received from those facilities such as ARC, etc?

The guidance is for donor centers that manufacture leukocyte reduced blood products.

 

msdesoki your welcome