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Showing content with the highest reputation on 04/15/2019 in all areas

  1. 4 points
    Bb_in_the_rain

    Mock-up cases

    For those of who works in transfusion service laboratory and would like to learn more reference cases, I can post some mock-up cases here. If you would like me to do it, please hit the "heart" button on this post. If enough folks want to practice case studies on reference lab cases, I can post mock-up cases here weekly or so..
  2. 2 points
    SMILLER

    Repeat antibody investigations

    If the patient has been transfused or pregnant in the last 3 mos, one has to r/i r/o significant atypical antibodies every three days. This going to involve more than a screen. Scott
  3. 1 point
    Mabel Adams

    Elution Studies

    We have found that not adding enough buffer will cause false positives, especially in gel testing. I say to add an extra drop or two after they already think it is blue enough to be sure.
  4. 1 point
    I just answered this question. My Score PASS  
  5. 1 point
    I just answered this question. My Score PASS  
  6. 1 point
    I just answered this question. My Score PASS  
  7. 1 point
    In general, here the anesthesiologist is responsible for transfusions during major surgeries. A tech or nurse would do the documentation in OR. When all areas used transfusion forms that were attached to the units, regardless of where they were transfused, copies of those tags were sent back to the BB. We reviewed them for completeness and anythin g else that may have been missed, such as a raise in temp, and then sent the reports back to the managers in charge of those associates for comments and corrections. I believe the deficiency statistics were reported to the transfusion committee. Now the transfusion vitals, etc. are put right on the electronic chart. Deficiencies are almost non-existent as the system alerts the person entering data when something is amiss. Scott
  8. 1 point
    Just out of curiosity, what prompted this question? In my experience most facilities have a Risk Management Department which is usually headed and staffed with nurses. They would be most interested in any noncompliance in the facility.
  9. 1 point
    Without a doubt, we would follow your method srichar3, otherwise, what is the point of performing a reverse group on ANY sample?
  10. 1 point
    SMILLER

    Just for fun

    LOL! We would send it to our reference lab! We have other things to do here... Scott
  11. 1 point
    applejw

    Secondary Blood Bags

    Update: This was not cited by TJC but inspector really wanted to. We prevailed when we asked to read the requirement.
  12. 1 point
    TreeMoss

    FDA Question

    I had the same thought. If you don't modify products, you don't need to have the FDA registration -- and you don't need the privilege of having them come to inspect.
  13. 0 points
    AMcCord

    FDA Question

    I had an FDA inspector hit us with the same thing. I asked what her expectation would be for the night shift with one tech on duty. Her response was...well you don't transfuse anyone at night, so that would solve the problem. I guess she thought that a 180 bed hospital in rural American didn't practice medicine or something. I told her that we certainly do transfuse patients at night. Her response was that we should decline to transfuse patients at night. I asked her what we were supposed to do about the trauma patient in the ER or the OB who goes bad or the active GI bleeder admitted with the 5 Hgb. Well, we would have to review the unit prior to distribution. I asked...so you are saying that we have to call someone in to perform that task? Response...isn't there someone that could do that? I asked her (with sarcasm in mind, but not in voice) what she though about a phlebotomist or an RN doing that. She said she didn't think that they would be qualified. I asked her again if she was expecting us to call someone in every time a transfusion was needed on the night shift, possibly multiple times per night. At this point she called someone back at the office and nothing more was said. We now have two techs on the night shift and no FDA registration, so this whole thing no longer applies. Your inspector may have been a little overly zealous or misinterpreting something. Many of the inspectors I saw had no medical background and did not understand the distinction between transfusion service and blood center (though technically that doesn't really matter as far as the regs are concerned). My advice would be to contact the FDA directly - email or phone - and discuss the situation with them. I have found them to be helpful. They may have a useful suggestion. My strongest piece of advice would be to drop your registration - if you are not irradiating product and doing nothing fancier than thawing plasma or pooling cryo, you don't need it. No registration, no inspection. Meet CLIA regs and whatever standards are required for whoever else inspects your facility and you should be fine.
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