rockrock

How many identifiers do you use for blood donor samples infectious disease testing? How about for pre-platelet counts for donor qualification?

We submitted pooled cryo license supplement to change number of units in the pool. We submitted our labels also and when the reviewer saw E3588 "open" system we were told the FDA does not allow the process of spiking or opening the unit when you are manufacturing it. Check the Ask the FDA and CLIA 2011 transcript. The FDA stated that all steps in the manufacturing of pre-storage pooled cryo should be either closed or what they consider functionally closed which is Sterile Connecting.

Thank you for all this helpful information.

AABB is our deemed CLIA provider. Yes we do testing on human specimens and for our IRL most of the samples are patient samples. I was hoping other blood centers in this forum who are also AABB accredited can comment on this.

Regarding the Technical Supervisor , which for BB has to be an MD - has anyone read the AABB Accreditation Information Manual - Process for Evaluating Exceptions to IRL Technical Supervisor Qualifications. Under Background - "AABB IRL Standards require the technical supervisor to be 1) a licensed physician certified in blood banking/transfusion medicine, OR 2) have SBB or equivalent certification OR 3) possess a doctorate degree in an immunohematology field. When these criteria are not met........ So from the above qualifications the Technical Supervisor per AABB standards can be any of the above. So an MT with an SBB or equivalent certification can be a Technical Supervisor in an IRL, correct?