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Everything posted by SMILLER

  1. You are not overreacting. You are being responsible, which is what all healthcare workers need to be. Other than discussing all of this with your department administrative director (your manager's manager -- maybe you have done this already -- at our hospital, this is at the department director level), I am not sure there is much else you can do within your department. You mentioned talking to the FDA and your risk management department. Your hospital should also have a corporate compliance fallback for things like this (that cannot be resolved through management -- you can report anonymously if you desire) For corporate compliance issues, the business must respond to your concerns and report back to you within a limited amount of time. Good luck. Scott
  2. How nice it must be to live in a country where people do not have to borrow another's ID to receive health care! Scott
  3. Welcome Vivek. You may note, from some of the old posts above from 2017, that many labs do not use grading. In my lab, for instance, we have a chart of all appropriate morphology that we report here. The chart lists the proper name for each, causes, and what a significant level would be when reviewing a slide. If a particular morph is not present in significant numbers, it is not reported. When it is reported, we do not grade it. Scott
  4. Also, I am pretty sure that our inspectors over here would also have a problem with D+ platelets being given to a child-bearing-age female who was actually D-! Scott
  5. We went through this a few years ago. The problem with any kind of written worksheet is that it becomes your primary record -- the computer entry is secondary. -- resulting in both sets of records must be retained. When results are directly entered into the computer, almost all written testing records are not needed. Scott
  6. Except, as been noted here on various threads over the years, it can happen that a patient becomes admitted under someone else's identity. Scott
  7. Agree with Ward's points, above. Any change in policy will involve discussion with ER, Surgery, etc. that includes education once a decision is made. When we became a level 2 truma center a few years ago, we had a rather elaborate MTP process that included things like Coag and CBC results. We have two different orders for emergent situations: An "Initial Resusitation Cooler" order (2 RBCs, 2FFP), and an "MTP Protocol" order (5 RBCs, 5 FFPs, 1 5-pk platelets). We repeat the MTP order until it is called off. In addition, individual orders for uncross matched products can also be made. Scott
  8. Here we have to positively ID a patient for each admission. This involves arm banding and at least an ABO/Rh for plasma or platelets. Scott
  9. I would think that the rephrasing was to emphasize that is is the reagent in the vials (not just the vials themselves!) that expires after 7 days. I think it is clear that they are saying they claim the reagent is stable for 7 days after opening. If I were an inspector, I would interpret the new phrase as indicating that the "performance characteristics" end after being "maintained" for 7 days, which would mean that you cannot use a vial after that time. Scott
  10. A policy that concerns massive transfusion situations (where a patient with an unknown ABO may have to be switched from AB to A plasma) would fit here I think. For the other, our blood supplier does not send out plasma from donors with atypical antibodies---I think that is common practice. Scott
  11. We have been doing open heart surgeries for decades and do not miss having a TEG or Rotem. (From what I understand, they are more sought after for trauma surgeries.) For BB products to be held available, you may have to have platelets on hand. Here, many OH patients end up having 2 units of RBCs on hold (or sent to OR in a cooler). Cell savers are maintained by Surgery here. Almost all of these issues should be determined by your cardiac surgery department--it is unlikely that you will have to make a decision one way or another for deciding on these types of services. I would think that rather your job will be the Lab side implementation once decisions are made. Scott Scott
  12. This may not be exactly what you are looking for, but it is instructive for basic step-by-step procedures for antibody ID. https://camlt.org/wp-content/uploads/2017/09/Advanced-ABID-Case-Studies-CAMLT.pdf
  13. All 'it is written's should be the property of each individual facility, approved by your medical director or pathologist. Here is one discussion regarding drawing blood specimens and transfusions: https://www.phlebotomy.com/pt-stat/stat0513.html There are also old threads here in Pathlabtalk on this topic. Scott
  14. Ya. If I recall correctly, this patient had a strong 1+ reaction with all C pos cells, except for that one screening cell. That one screening cell otherwise reacted normally with anti-C from both reagent and another patient. So just have to forget about this one. Scott
  15. Some important stuff here, too... https://www.youtube.com/watch?v=1VKt2LysGxA
  16. Not being familiar with HFAP, I would wonder why they do not inspect Blood Bank along with the rest of the Lab? Scott
  17. Yes. At least we got a reaction with anti-C reagent. Likewise, that particular cell reacted with another patient who was producing ant-C. Scott
  18. The patient is long gone. But the same method -- manual gel -- was used for both the screening cells and the panel cells. As I mentioned, the reagent cells were both all R1R1 (but from different donors)--yet only the cells from the one screening set was negative. Had to be something wrong with that particular cell and that particular patient. Scott
  19. It seems like you are suggesting that CAP inspect your lab for all departments except BB, which you would have done by AABB? Is this even possible? Can you be selective about what CAP looks at? Under CLIA, regulations for all areas in the Lab are pretty stringent, whether AABB, CAP, JCAHO or FDA. If you want the extras ('prestige'?) that come with paying the AABB for another inspection, then I guess it's worth it. Scott
  20. Agree with the comment above. While the patient is in your chopper with your blood, it's your patient. Somehow you must be be charging for the ride and any other care in flight. And like any unit transferred with a patient to another facility, you will have to follow up to finish the transfusion record. Scott
  21. You almost got it. But I think the original question here was about using gel diluent with QC materials to create positive and negative control cells. Scott
  22. I am not explaining myself well. Perhaps it may be hard to understand unless you have used such a system. In a transfusion service, like a hospital, the BB armband number (regardless of the name or other information on the label) is placed on the specimen when it is drawn. That number goes into the BB computer system when the type and screen and other testing is done. If a product is ordered, that BB number is on the tag on the unit. When it is issued from the blood bank, that number must be on the request form brought to the BB--otherwise no issue no matter what information matches up. (Of course, name, birthdate, etc. must match also.) When the unit reaches the patient, the BB number on the unit tag must match the BB number on the BB armband which is on the patient. Its a full-circle kinda thing. The unit is very unlikely going to go to the wrong patient--no matter how they are otherwise ID'd--if a strict BB number and armband system is used. With such a system, which is relatively common I think, the patient can come in and be under a false ID, and still get appropriately matched blood products. One cannot say this for a system that only depends on two separate draws for assurance that an electronic XM is appropriate. If the wrong patient is drawn once for some reason resulting in WBIT (like in the wrong bed in a room)--the same circumstances can cause the second draw to be WBIT. Then if the unit goes to another patient---well, that's when the God Help us comes in! Scott
  23. Right, but I am sure that you do not antigen type all patients and give them antigen negative units as appropriate for those antigens! Scott
  24. Except that the QC manufacturer's diluent used to make a control antibody solutions is not used in any phase of patient testing--it does not need the be QC'd--it is QC. I would think the point is that the gel diluent is being controlled (which it should be), by showing it does not produce a positive reaction as a negative control. When patient or unit cells are being tested in gel, you use that gel diluent to create an 0.8% suspension--so for a positive gel control, if you are creating your own 0.8% suspension, again you want to use the manufacturer's diluent. Scott
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