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Texas Lynn

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  1. Like
    Texas Lynn reacted to swede in ORTHO VISION SALINE   
    We are using the NERL saline on our Vision.  We've been running for about 18 months with no problems.
  2. Like
    Texas Lynn got a reaction from jalomahe in FDA Registration   
    this is what I found from AABB "ask the FDA'
    estion 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities.
    thaw plasma and split RBCs receive washed red cells from the blood supplier and then add plasma for an exchange transfusion divide red cell or platelet products for pediatric use re-label thawed fresh frozen plasma to thawed plasma MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation.
  3. Like
    Texas Lynn reacted to Malcolm Needs in Gold Medal.   
    I am enormously honoured to announce that I am going to be awarded the Gold Medal of the British Blood Transfusion Society at their Annual Scientific Meeting in Brighton this year.  It is awarded to an individual for their exceptional and long standing services to the Society and to the practice of blood transfusion in the UK.  Sorry if this sounds egocentric, but I am very excited.
  4. Like
    Texas Lynn reacted to David Saikin in Giving Rhogam to weakly D mothers?   
    Yep!  There are some weak D's that predispose towards making anti-D if exposed to D+ rbcs (missing mosaic pieces, e.g.).  Only way to really know is with molecular testing - which right now is not really feasible at the community hospital level (or even tertiary care, as I have tried to bring it on board and offer it to the 15 - 500+ bed hospitals around me - not enough demand to make it work).
    I used the Du nomenclature 'cuz that's what we called it when the policy was to not give RhIg to Du+ individuals.  Now the term is Weak D.
     
  5. Like
    Texas Lynn reacted to SMILLER in Confused about dosage   
    From the My Two Cents Dept...
    I would just point out that it is important that people doing testing understand what and why they are doing what they are doing.  I guess this goes without saying.  I am not a fan of throwing computer AI at problems when staff have trouble understanding what it is they are doing.  I get it that with staff shortages and what not, that generalists have a lot of hats to wear, but a computer algorithm should never be a substitute for appropriate education and regular, effective performance evaluation.
    Scott
  6. Like
    Texas Lynn reacted to MaryPDX in Confused about dosage   
    RC-Aid is another program. 
    http://www.rcaid.net/
     
  7. Like
    Texas Lynn reacted to R1R2 in Confused about dosage   
    I have used and liked this one-
    http://www.antibodycheck.com/
     
  8. Like
    Texas Lynn reacted to David Saikin in Cleaning the Helmer Plasma Thawer   
    i believe the instructions specifically say not to use deionized/distilled water.
  9. Like
    Texas Lynn reacted to Likewine99 in Blood Bank Manager   
    Still doing IgG crossmatches but they are on an analyzer so that helps.
  10. Like
    Texas Lynn reacted to Dansket in Return and Reissue of components   
    see attached
    Blood returned unused.pdf
  11. Like
    Texas Lynn reacted to LIMPER55 in Alarm Activation   
    Our units have the peltier probes already
    test activated and performed by touching the screen
    validate annually with slurry of ice and thermometer 
  12. Like
    Texas Lynn reacted to tms8313 in Sorvall CW2 plus Cellwasher problems?   
    Is anyone else able to produce a dry cell button? I can't get a dry button, there is always about 2 drops of saline in the tubes after the wash cycles are complete. What is "normal" for this equipment?
  13. Like
    Texas Lynn reacted to gagpinks in Malcolm Needs Blog   
    I enjoyed reading it.  Thank you Blut! !
    UK is lucky to have him with his wealth of knowledge and he is always on board to reply any time.
  14. Like
    Texas Lynn reacted to Cliff in Lookback Policy   
    We did a lot of work developing the attached charts.  It does not include ZIKA, we are modifying it now for that.  This is a small excerpt from a long SOP.
    696.docx
     
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