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    AMcCord

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    Cliff

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Showing content with the highest reputation on 04/11/2018 in all areas

  1. Yes. Our OR nurses document every four hours. If the cooler temp reaches 6 degrees C, they call and request a new cooler with fresh blocks. We have quite a few cases that easily exceed four hours. We also put temp indicator stickers on each unit to make sure they weren’t left out of the cooler. We validated at RT, Trauma Bay (warm extreme), and CV surgery suite (cold extreme). We did those for both maximum (6 units) and minimum (1 unit). Message me if you need more specifics!
    2 points
  2. Cliff

    COOLER FOR THE OR

    FDA and AABB had gone back and forth over the years on storage vs transport. In the past few "Ask the FDA" sessions I've been at during the AABB Annual meetings both FDA and AABB have said coolers are transport. People even brought up newer cooler technology reminding them that coolers can be out of the blood bank for an extended time. We validate our coolers to hold temp at 1 - 6. We do not take temps every 4 hours.
    1 point
  3. AMcCord- Thank you so much for your response. That helps a lot!
    1 point
  4. We have order sets available to providers, but will go into action with a phone call for MTP and emergency release. The order does need to be placed for that to happen. The patient comes first. CAP specifically says that blood products the patient needs should not be delayed so as to endanger that patient by sticking to paperwork rules. The orders do need to be placed as soon as it is feasible, but sometimes some of those orders are placed by lab. Our procedures spell that out. TRM.40770 Life-Threatening Situations Phase II Adequate policies and procedures have been established for the investigation and handling of life-threatening situations (such as the use of uncrossmatched blood or abbreviation of testing) that include the written authorization of a qualified physician. NOTE: Written policies and procedures must be available to expedite testing for transfusion in a life-threatening situation. If an institution's procedure allows abbreviated testing in massive transfusion situations, records should indicate that the procedure was followed. Records must include the authorization by a qualified physician. (If approved by the institution and recorded in the laboratory's procedures, the physician responsible for the transfusion service laboratory may accept this responsibility.) If an incompatibility is discovered on completion of an incomplete crossmatch, the responsible physician must be notified in a timely manner and this notification recorded. 29 of 85 Transfusion Medicine Checklist 08.21.2017 Red blood cells released before testing has been completed must be conspicuously labeled as uncrossmatched on the tag or label. Records of completion of compatibility testing for units released uncrossmatched must be maintained. Evidence of Compliance: ✓ Records of emergency release authorization by a qualified physician REFERENCES 1) Food and Drug Administration. Current good manufacturing practice for blood and blood components. Laboratory controls. Compatibility testing. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.151] 2) ibid. Records and reports. Records. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.160]
    1 point
  5. Performing a manual antibody screen, in addition to the temp, RPM and timer checks, would be checking your system (centrifuge/incubator/pipette) as well as reagents (strips). You could use 'serum' from the QC material you run on the ProVue for your positive control and inert patient plasma (previously tested & negative on the ProVue) for a negative control. As far as QC for the ID panel, that's a whole nother discussion. For tube testing, we run a weak antibody against an antigen positive and an antigen negative cell. That is not something we did when we were running gel, but that was more than 8 years ago and regulatory issues have changed since then.
    1 point
  6. Thanks, Cliff, for the Velcro idea! It took a few hours to get all the old labels off without alarming the poor fridge but I relabeled our shelves this week.
    1 point
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