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Quality Control
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Performing QC for Leukoreduced Products Locked Topic 1 C. Forum Our CBBS ENetwork Forum Moderator with donor center expertise responds:   We are not able to share our procedure currently as we are waiting for our Biologics License Application approval. In general, we follow the recommendations in the FDA guidance document, specifically the pre-LR on Whole Blood released by FDA on September 2012, but we also refer to the Platelet Guidance in 2007. Here are links to the FDA guidance documents:   http://tinyurl.com/mmyryzk   http://tinyurl.com/kaepfgb   The blood bag package inserts also would have some recommendations. We use both Flow Cytometer and Adams in detecting residual WBC though some centers are still using the Nageotte chambers.   Product QC methods or requirements can also be reviewed using the old purple Quality Control manual published by AABB which may need some updating  but most information are still applicable today. We copied two formulas from manual and pasted below:   Each filter type will need a separate data set, and FDA recommends using the binomial or hypergeometric sampling contained in the 2012 Pre-LR guidance document.
by C. Forum
Monday, March 20, 2017
Monitoring the Temperature in OR Blood Coolers Locked Topic 0 C. Forum From a CBBS member: If coolers used to issue blood to operating rooms have been validated for X number of hours (for example 8 hours), do transfusion services also have to measure the temperature of inside the cooler continuously?
by C. Forum
Thursday, April 7, 2016
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