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    Blood Bank Supervisor

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  1. Logan51

    FDA Question

    Hello everyone, Thank you all for your insightful replies, your input is very helpful. We do use a Blood Bank LIS for all of our operations and it is validated to identify typing errors. It’s relieving to know that this is taken into consideration when determining compliance with this regulation. Since we do all testing manually and since it’s not impossible for us to release some products before a second type is collected, it would be ideal if we could have a second tech confirm our first-types. However, with only one tech on-duty during certain shifts that would be impossible. The suggestion regarding our FDA registration is also very interesting, I hadn’t previously considered our registration status up to this point. I know that in the past we had pooled some products but no longer do so. I will be certain to look into this further tomorrow morning. Thank you all again for all of your help.
  2. Logan51

    FDA Question

    Hello, thanks for your inquiry. This was not actually in reference to QC, this observation was specifically referring to ABO/Rh testing, crossmatches, etc. We do perform a history check prior to all compatibility testing and will perform a second ABO/Rh type on all patients without history.
  3. Logan51

    FDA Question

    Hello, I'm a new Blood Bank Supervisor and have a question regarding an observation from a recent FDA inspection. The inspector filed an observation that we were not following CFR 606.100(c) "All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product". The inspector asserts that testing review must be performed prior to releasing products and since supervisory review is typically performed each morning, any products that were released throughout the day (or night) would not have had their associated testing reviewed prior to release. My question to the group is how would you address this observation? Having been a night-shift tech most of my life, I can say that products being released prior to a supervisor's review is fairly standard. That being said I am open to improvements wherever needed, I would just like to be sure I'm not overdoing it with my response. For informational purposes, we are a small transfusion service that operates as part of a larger clinical lab. We don't modify products other than thawing FFP. We perform 4-8 T+S per day and average about 1.5 products transfused per day. We use manual tubes for immediate spin phase and gel cards for antiglobulin testing. Our techs are all generalists and we are staffed with a single technologist on third shift. Thank you for any help

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