cryoprecipitate quality control

[climent]

We recently had three out of four cryo FVIII levels out of control in one month, all prepared the same day. We discarded the cryo and reviewed the SOP with the supervisor and MTs, since the SOP states that the samples must be representative of the entire month, review temperature, procedure timing etc. and performed FVIII levels in two cryo representaive of each day cryo was prepared in that month. My question is: is it adequate to perform mathematical average of FVIII content for quality control, since FDA states that the average of FVIII concentrate must be 80IU or over in each unit tested. For example, if you have eight cryos, seven with over 90 IU of FVIII and one with 76 IU, is it acceptable to calculate the average and, if the average is over 80IU, accept the QC? Thanks .

[heathervaught]

We send our Cryo QC out for testing. We send four units, the facility pools them and tests the pool, then divides the Factor VIII and fibrinogen over the 4 products. We also send pre-pooled products to them (we pool 5 at a time), and they test the pool and report the average over the 5 units. Both of these products are FDA licensed.

[harbi1420]

we are in a big transfusion medicine department and we are doing every three month cryoprecipitate quality control . our procedure is : thaw 12 units at room temperature then inject 10 ml pre-warmed saline and place 2 ml in plastic tube then send to hematology to measure factor 8 and fibrinogen level .

do you have an alternative method .

thanks \

AHMED

saudia arabia

Edited May 19, 2010 by harbi1420