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Logan51

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    Male
  • Occupation
    Blood Bank Supervisor

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  1. Thank you all for the feedback. As always this is very helpful.
  2. Hello, I have a question for the group regarding a practice that I've been familiar with throughout my career. Due to an unexpected departure, my facility has had to name an acting Blood Bank Medical Director who has previously not had any experience in Transfusion Medicine. The plan has been to find a replacement but I've been informed that a hiring freeze will prevent that for some more time. In the meantime I've been asked to "probe" our current practices and determine if there is anything that should be urgently evaluated. In doing so, I've come across a question for which I don't
  3. Hello, My facility has recently initiated a purchase order for Ortho's Panel B cells and I'm wondering if it is common-place to perform a validation for a new reagent before being put into use? We won't be using them past their expiration date and we currently use Panel A cells. I have no idea if we performed any validation when we started using Panel A but if we did then we didn't save any record of it. Thanks for any insight
  4. Hello, I would like to ask for any advice about the minimal QC requirements for cell-salvage devices. Both myself and my Medical Director are fairly new to our roles here and Intraoperative Cell Salvage is not something that either of us has much experience with. Our facility utilizes Cell-Savers and historically we have received about 4 QC samples/year which we have performed and reported a Hct on. I have recently noted that we have not received any QC samples in more than six months and reached out to the head of our Anesthesia, whom is ultimately responsible for the devices.
  5. Thank you all for your replies, this has been very helpful. I hope you all have a nice day.
  6. Hello, I am wondering if any of your facilities allow the issuance of two separate units of apheresis platelets to a single patient at the same time? My understanding has been that platelets should be agitated right up to the moment that they are issued/transfused and our current procedures forbid issuing multiple products at once. Our Operating Room has recently asked that we change this practice and allow multiple units to be issued at the same time so that they do not have send their courier back in the middle of a procedure. I'd simply like to gain a sense as to whether this is com
  7. 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
  8. 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
  9. 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.
  10. 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.
  11. 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
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