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No validation studies required? -
My facility is keen to convert FFP thawed after 24 hrs to 5 days. However, may I know if any validation studies (eg checking Factor 8 levels etc) are required before we do this? We are outside of USA, but AABB accredited facility.
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Would also appreciate if anyone can share their lookback policy with me. I am unable to open the ones attached here. Thanks!
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Would also appreciate if anyone can share their lookback policy with me. I am unable to open the ones attached here. Thanks!
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Great thanks! Now my director is thinking of asking x-ray department to do it for us? Anyone in USA using x-ray machine?
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Our facility wants to share the use of irradiator with research group that need to irradiate their products. Is that allowed if we follow all the necessary requirements under AABB, CAP with the 25GY at the center, dose mapping, maintenance etc? Any regulations with FDA, AABB or CAP? We are AABB and CAP accreditated but our facility is not in the USA.
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Does anyone have any latest statistics of transfusion trasmitted diseases associated with transfusion of albumin/IVIG/immunoglobulins (if any at all)? Recently we had a case of a child who has HCV infection after having been transfused with red cells, FFP and Albumin. We called back the donors of the red cells and FFP but they were Negative for HCV. Somehow we could not track the lot # of albumin. And one of the doctors ask for statistics of the transmission of HCV via transfusion of albumin and I am not sure how to obtain this...so if anyone could help me please, appreciate it!!