Everything posted by lehooke1
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Preop Specimen
We extend our samples to 10 days.
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Bacterial Testing - Apheresis Platelets
Same here!
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Secondary Bacterial Testing for Platelets
As I understand it, you would only need to perform secondary bacterial testing if you plan to extend the life of your platelets. In that case, you would also need to register with the FDA, if you have not already done so.
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Ortho Panel Cells -Quality Assurance
Yes, we currently perform all of our antigen typing in tube. Thanks for the clarification!
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Ortho Panel Cells -Quality Assurance
This covers 3% panel cells, but what about any 0.8% panels? We currently have 7 indated 0.8% panels and three 3% indated panels. We had to add additional panels to our standing order since we can no longer use out-dated panel cells!
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Automated Cord Blood Testing
We remove an aliquot from the primary container and rim the sample for clots prior to centrifugation. We use the Ortho Vision analyzers. Prior to that we used the ProVue.
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childbearing age
50 and younger
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Secondary Bacterial Testing for Platelets
We will not be using the Verax point of issue testing. Our blood supplier will be going to the FDA approved pathogen reduction system, INTERCEPT, by CERUS.
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Continuing Issues with Ortho Gel Reagents and or Equipment
We also have two Ortho Vision analyzers. We have been having issues with the IgG cards for a few months now. This is a nation-wide problem according to our Ortho Technician. and Account Manager. We've tried several lot numbers of cards, some with better results than others... Thankfully, we recently upgraded the Vision software to version 4.8.0 (Mod 16) and we are now able to edit reaction grades on the QC results after reviewing the cards. Before that, the QC would fail automatically and we would be forced to repeat the QC, sometimes 3-4 times. I'm surprised by some of the comments of Ortho representatives denying that there is a problem. While they don't currently have a solution to the problem, our account manager and service technician have been very forthcoming that this is a known issue with the IgG cards.
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Changing Venue
Welcome to the "Left" coast!
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Terumo sterile connecting device validation
We are considering purchasing the Terumo TSCD II Sterile Tubing Welder for our Transfusion Service. We are not currently registered with the FDA. Would we have to register with the FDA if we used this device to split units and make neonatal aliquots? I'm thinking we wouldn't since we're not actually making a new product.