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Logan51

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    Blood Bank Supervisor

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  1. Hello, I am preparing for an upcoming CAP inspection and I am wondering how other people interpret the "Special Transfusion Requirements (if warranted)" section of TRM.41300? My thinking is that requirements-checks for transfusionists should be limited to items that would be listed in an order to transfuse, such as "infuse over 2 hours" but would not include lab-specific items such as E-Negative. If that's the case, are there people who train their transfusionists to read product labels and confirm irradiation or washed requirements? Thank you in advance for any insight
  2. Hello, I recently received notification of a false-positive IgG DAT result on a survey. The notification stated that this was caused by IgG contamination in the survey sample, and that because of this, we weren't graded on our response. In reviewing the other participant responses, most gel users reported the same result as us; compared to almost none for users of other methods. Our QC protocols for the IgG DAT call for using A1 cells as a negative control, which has always resulted as expected. So I had hoped to prove for certain that this is an issue with the survey sample, and not with our assay, by running our own Complement Control Cells as a negative control in an IgG Card. To my surprise however, the Complement Control Cells that we use for our IgG/C3 cards also yield a positive result in our IgG cards. The manufacturer of the Complement Control Cells has simply stated that their cells are designed to be run as a control for poly-specific or complement-specific assays, and are not meant to be used as QC for an IgG-specific assay. My first thought is that our Proficiency Testing Program purchased their cells from the same manufacturer as our Complement Control Cells; and that the written statement from the PT Program, along with statements from our gel manufacturer should sufficiently prove that our assay is working as it should. That being said, it is a little unsettling that at this moment, I am unable to prove that our IgG DAT assay truly won't react against Complement Coated Cells (if those cells aren't also coated in IgG). I am tempted to purchase a vial of Anti-C3, which we don't currently use in-house, so that I may manufacture my own C3-Coated Cells and demonstrate a negative result in an IgG Specific DAT. I realize now though that I have never tried doing this before, and before placing the order I was wondering if anyone can confirm that adding Anti-C3 to an RBC sample would successfully create cells that could be used for this purpose? Thanks for any help
  3. 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.
  4. 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.
  5. 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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