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Logan51

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    Blood Bank Supervisor

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  1. 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. He has reported to me that they only periodically use the Cell Savers and doesn't feel that QC is worth-while any longer. My initial response is that as a CAP Laboratory we need to ensure the safety and efficacy of the recovered blood components (TRM.41550); and recommended that they should at least perform QC on the day of use. However, I am wondering what, if any, other regulations we are subject to? I see that AABB has Standards for Perioperative Collection and Administration which states that a QC program should be in place but we are not accredited in any way by AABB. I'm sure the manufacturer publishes an Instructions for Use, do these typically include requirements for QC? (for which I'm sure FDA and JCAHO would require us to follow). I wasn't involved in the implementation of these devices and I don't even know how we decided upon the plan for the quarterly Hct so any insight will be very much appreciated. Thanks
  2. Thank you all for your replies, this has been very helpful. I hope you all have a nice day.
  3. 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 common practice or not. Thank you all in advance for any insight.
  4. 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
  5. 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
  6. 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.
  7. 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.
  8. 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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