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Everything posted by SbbPerson

  1. May I ask what type of audits are they? Are they blood bank patient results audits? Or are they general laboratory procedure audits?
  2. There are 3 key pieces of the validation process you must inspect and "validate": 1) Your hardware : printers, code readers, etc.. 2) software: (your bloodbank and/or laboratory information systems) 3) User performance: mechanism to test the user's ability to understand and correctly operate your electronic crossmatch process. I attached an old copy of the FDA guidance for computer crossmatch. Good luck. FDA-Guidance-Computer-Crossmatch.pdf
  3. I thought it was straight forward. RBC surfaces is negatively charged. LISS is positive (though a "low" positive). You increase the positive charge (the sodium ions) it dissipates the negative charges of the RBC surfaces, thus lowering the zeta potential between the cells. And more sodium ions, the bigger the ionic cloud.
  4. I apologize, I have never used Softbank, but I am familiar with reconstituted RBCs. I assume when you say Reconstituted RBCS, you are talking about adding plasma to red cells to get a desired hematocrit. The attachments is from the ICCBBA website. It tells you how to get an FDA compliant product label for reconstituted red blood cells. https://www.iccbba.org/uploads/b3/03/b303897194221c1b11b7637c5b3812f0/Reconstituted-Red-Blood-Cells.pdf Also, there are simple math formulas to figure out how much plasma you need to add to RBCs in order to get a desired hematocrit. But your software should be able to handle the math, all you need are the numbers for your product label. Reconstituted-Red-Blood-Cells.pdf
  5. This link lists some "high level" changes to the 2021 AABB Quality Systems Framework. https://www.aabb.org/standards-accreditation/standards/about-aabb-standards/quality-systems-framework
  6. Yeah, joint commission actually checks for that. It's because cardboard boxes or shipping containers can carry dirt and other contaminants and introduce them to new environments. Is there a room where you can store the saline boxes where the plebs don't go in and out of? Maybe put a sign outside your blood bank storeroom, "No phlebotomist allowed". We have used saline in cardboard boxes for many years, but phlebotomists usually have no business to go in our blood bank storeroom. The safety committee's job is to be familiar with joint commission and OSHA standards and regulations, and patient and employee safety is their first priority. There is probably a "technicality" somewhere you can find that might help you, good luck.
  7. You can use a simple FFP dosage formula or online calculator. There are many of them on google. Of course, this is not a solve-all , and other clinical indications must be taken into consideration when administering FFP or any blood product. Good luck.
  8. I just answered this question. My Score PASS  
  9. The mom is probably a subgroup of Group A, perhaps she is A2 type. If so, she probably has Anti-A1. Subgroup A cells will react with Anti-A reagents. From first read of your post, I was thinking maybe the Anti-A1 was passed through the breast milk. But if I am not mistaken, Anti-A1 is an IgM antibody, and those don't usually get passed through breastmilk. Let me dig further into this and see what I can find. Good luck.
  10. It has always been an unspoken rule for me to gently mix it once before every centrifugation. For the Jka/b, you mixed it once then incubate and then centrifuge. For the CEce you mixed it once for the IS before centrifuge. Then for the RT incubation part, you mixed it once before centrifuge. The gentle mixing before centrifugation allows cells to resuspend and bind to any possible "unbound" antibodies and then latticed together in the centrifuge. I attached the Ortho Instructions for Use for Anti-CEce. Good luck. Ortho_CcEe_.pdf
  11. I believe the product code doesn't need to change if it's directed donation. But of course if it was autologous, it needs to be changed. https://www.iccbba.org/isbt-128-basics/frequently-asked-questions/national
  12. I have never used the Vision, but I googled it and looks like the FDA did a carryover study on it. I attached it. It is from 2019, sorry. Maybe you can find something more current. Good luck. BK190399-Summary.pdf
  13. We only use Hematrax just in the event that our LIS is down and unavailable. You have no LIS for your lab? So your lab results are handwritten? I can give you instructions on how to use it but I would need time to dig them up. I will if you still need help. Good luck.
  14. Have people ever had to rule in or rule out cold antibodies based on reactions you get from a gel card panel/screen? For example in a case where you get a discrepant ABO result because a cold antibody is messing up the reverse typing. Anyone with any knowledge on this? Thank you.
  15. Hi Malcom, I attended your presentation on ABO discrepancy. Thank you, it was a very informational presentation! Thumbs up!
  16. Same here. It wasn't that long ago when Electronic XM's weren't a thing. I find it so amazing how far technology has "improved" blood banking in a relatively short time.
  17. I just answered this question. My Score PASS  
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