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srichar3

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srichar3 last won the day on January 15

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  1. But what temp do you consider acceptable for return? what evidence did you use to validate this? If you state it must still be at 1oC to 6oC, you may be throwing units away that are still fit for use. As CAP are asking for a validation then it needs to be evidence based, opting for 1oC to 6oC would be the easy option but I dont want to be throwing away units that we can still use. Are there any standards from AABB regarding this? I have a copy in the post but not sure it will come before our CAP inspection next month. Thanks Steve
  2. But what is the acceptable temperature limit for a 30 minute excursion? If it was in a validated transport box with a logger inside that remained between 1oC and 6oC then it wont be considered to have left cold storage hence the 30 minute rule wouldn't apply. We have transport boxes validated for 8 hours that we send to OR. So that fact that a limit to "30 minutes rule" exists suggests that the unit does not need to be kept at cold storage temperatures, but what would be acceptable? temperature for the unit to reach for 30 minutes? For example UK guidelines state that a unit of PRBC can be used with temperature excursion of up to 10oC for up to 5 hours. Some interesting info in this document for the UKBTS reviewing the evidence of various studies, https://www.transfusionguidelines.org/document-library/documents/change-notifcation-no-33-2016/download-file/Change Notification No 33 2016 - Removal of red cells from a controlled temp.pdf Ramirez-Arcos and colleagues from the Canadian Blood Service reported on two studies using red cells in SAGM. In the first study, a single five hour exposure to room temperature showed no immediately significant effects on the in vitro quality of the red cells, although six days after the exposure ATP and K+ levels were significantly lower than in unexposed controls[22]. In the second study, units were exposed to room temperature for 30 minutes on each of five separate days, and no significant effects on in vitro red cell quality markers were reported[23]. Steve
  3. I have always used total number of outgoing RBC's for that month, used + wasted. The issue with using the number received is that some months you may receive a large quantity for that month but due to expiry they wont expire till the following month where your received stock may be less than the month before hence this will skew the figures giving a higher % waste for this month. Using total outgoing RBC's gives a better indication of the waste against use for each particular month. My previous lab had a stats program built in that was based on MHRA and UK BSMS requirements and this always reported waste as a % of total outgoing RBC's. Steve
  4. Just found this from the BBTS; https://www.bbts.org.uk/downloads/bbts2016/presentations/15.00_wed_qs_3_kate_aplin_bbts_2016.pdf/
  5. This was my point exactly, without a full on viability study, the likes of which would be far out of the realms of possibilities for a hospital lab, I cannot see what validation can be done. Just proving temperature does not mean that one that exceeded say 10oC for 10 or 15 minutes is still not a viable unit. Studies have been done on this matter, what is the point of individual labs trying to validate it, should we validate expiry dates too? of cause not we have to go with what the suppliers have validated them for and trust the information we are given.
  6. With regards to cap standard TRM.42470 What levels of validation are people performing? I can see this from 2 angles, 1 is the risk of bacterial growth should anything already be in the bag, the second is the risk of reduced blood viability from 30 minutes extra of been out of storage. The latter I would imagine would be extremely difficult to validate, in the UK the 30 minute rule is an accepted standard on which we have never been required to validate this. Is a simple temperature check ok? should quarantine of the unit be performed with microbial culture? as has been suggested by one of my staff, however this would remove the unit from use for 3 days and possibly result in waste of the unit anyway. TRM.42470 Acceptance Back Into Inventory Phase II There is a written procedure, validated by the laboratory, for accepting blood/blood components back into inventory after they have been issued. NOTE: The procedure must include steps to verify the integrity and appearance of the blood/ blood component and maintenance at appropriate temperatures. The steps and criteria defined in the procedure for acceptance of units back into inventory, such as the use of transport containers Thanks Steve
  7. Hi Does anyone use the bartender bar-code software from seagull to print ISBT128 format blood bag labels? Thanks
  8. Do you know how the treatment would differ say for DAT due to anti-D compared to ABO incompatibility? I can see the benefit of knowing prior to delivery as they can asses the risk based on what antibody is present and at what titre but post delivery surly monitoring Bilirubin and HGB will give them far more information about what the neonate needs than what antibody is bound to the cells. That seemed to be the response from out pediatricians when I asked them. Steve
  9. Recently I started working at a lab in the UAE and here the process for all positive DAT's on neonates is to do an Elution and antibody ID, from my experience in the UK this practice is unheard of and I have not come across any site I've worked at before doing this. However I appreciate different parts of the world have different standards that they follow. As here we follow CAP I wondered what other sites in the US are doing with DAT positive babies? As a side note I asked the lead pediatrician if the antibody ID is useful to them and was informed they treat all positive DAT's the same regardless of what antibody it is. Thanks Steve
  10. Hi Kaytee Thank you very much for you help with this, that description seems to match what we need and I will look into getting the request made. Regards Steven Richards
  11. I have also reached out to our blood supplier who gave this responce; "Hi Steven I checked in the ISBT 128 table and didn’t find the RBC in SAGM with plasma added, the additive solutions are AS1/AS2.. It’s not only a problem of volume but also the additive solution. These are the only codes for RBC SAGM 450ml" So it would appear currently there is no code that is suitable for the products we have available? Product Description Codes PRODDESCRIPCODE Class Identifier Modifier Identifier PRODDESCRIP0 E0429 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg E0430 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|For mnf:injectable E0431 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|For mnf:noninjectable E0432 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Not for tx or mnf E0433 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Open E0434 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Open|Irradiated E0435 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Open|Irradiated|ResLeu:<5E6 E0436 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Open|ResLeu:<5E6 E0437 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Irradiated E0438 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|Irradiated|ResLeu:<5E6 E0439 C0002 M0000 RED BLOOD CELLS|SAGM/450mL/refg|ResLeu:<5E6
  12. Hi Kaytee Thank you for the information and the offer to help identify the correct code and description. After further reading, the closest description I have come up with is as shown below, however donations here are only 450ml not 500ml. Can the same code be used but the description altered to account for this? Or is the description attached to the code fixed? (I presume it is) E8989 RED BLOOD CELLS|CPD>AS1/500mL/refg|RBC irradiated|ResLeu:NS|Supernat rem/Plasma added. The original code I posted above (E5529) would not be allowed as we do not have irradiated plasma out here, and we have no irradiator to irradiate the final prepared unit on site so we are limited to irradiated PRBC only. The units we use here are irradiated PRBC's from a 450ml donation in CPD-SAGM (E0438), we then centrifuge the unit and remove as much additive and residual plasma as possible to give an Hct of >.9. The requisite volume of AB plasma (E0701) is then added to the unit to give a final target Hct of .55. Also the plasma is not leukocyte reduced but the PRBC's are. Regards Steve
  13. Following the ICCBBA document it would appear this is the correct label;
  14. And this is before getting into additions such as irradiated and leucodepleted.
  15. Thanks for that but after reading it and googling the descriptions for a better understanding of the product, this has muddied the water further. I found the below document which has various different descriptions but not sure which would be most appropriate between supernatant removed plasma added and plasma reduced plasma added? IF The product is made by first removing additive from the Red Blood Cells and then adding blood group-compatible plasma Product is encoded as Red Blood Cells with the Attribute “Supernatant removed/Plasma added” IF The product is made by removing some of the plasma from Red Blood Cells and then adding blood group-compatible plasma Product is encoded as Red Blood Cells with the Attribute “Plasma reduced/Plasma added Would the latter be referring to whole blood and the former to PRBC? https://www.iccbba.org/uploads/bc/26/bc268d3ab8e8533579768db2e3c9e40e/Reconstituted-Red-Blood-Cells.pdf As in PRBC its mainly additive but still some residual plasma so before are relevant. Thanks
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