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Posts posted by pinktoptube
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On 9/27/2020 at 9:50 AM, Malcolm Needs said:
I know I'm in the UK, but I can't see how that works. Surely, a thorough revision of a form could make it end up being, in effect, a new form? Would your Medical Director have to approve that?
I suppose if it was a major revision then the procedure would have been revised which would trigger a medical director sign-off.
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It looks like we have the Medical Director sign-off on new forms but not revised.
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On 12/15/2019 at 5:53 PM, Kmur4kits said:
Do you have a chart on your ultra low freezer? Changing the chamber temp to the alarm range may not be enough to make the chart pen move. Are you using isopropyl alcohol that has been prechilled for your plasma freezer?
The ultra-low chart is electronic, we download it monthly.
Yes, it is prechilled for the freezer.
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We make a 0.8% suspension of donor Rhpos red blood cell unit with the diluent and then test it with manufactured control antiserum (as positive control) and saline (as negative control).
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9 hours ago, cswickard said:
. At what temp do you call it a Febrile reaction? we use temp increase - unless the pt is already hot and they had to transfuse anyway - then we would still look for temp rise beyond start point
2. Do you also use temp increase from the baseline? If so what is? start temp with 2F/ 1C temp rise
3. Do you use other criteria with Temp increase for culture? If so what are they? any symptoms that indicated bacterial contamination - shock, hypotension (significant drop from start point), high fever (from start point), chills, vomiting, diarrhea - are what we list for RN
4. If you do have one, what is your definition for tachycardia (eg =>100 bpm?) - no definition
5. Same with Hypotension, any numerical definition? - no - significant/noticeable drop from start point
Same as cswickard, except for temp increase, we use an increase greater than 38C
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Special Transfusion Requirements, such as Irradiate and antigen negative w/ antibody, are listed on our unit tag and record. Transfusionists are trained to review what is on the label/record with what is on the unit.
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Thank you Noelrbrown.
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On 6/24/2013 at 1:00 PM, Brenda Hutson said:
Just wanted to bring this issue up again (as we continue to experience problems). Here is the dilemna:
1. Reactions of Eluates in GEL that have a hazy, grainy look throughout GEL, sometimes mixed-field appearance also.
2. Often also "appears" to be hemolysis in top of GEL well (above the GEL itself)
3. Does not occur in every patient
4. Most of the time, these are repeat Negative by Tube Eluate Testing
What I have tried so far:
1. Having them make up new Wash Solution
2. Doing the last spin (where it is just the eluate in the tube and you are getting rid of any exraneous cells) of the eluate in a centrifuge with a higher speed and longer time
3. We have already been checking the pH of the eluate; not just relying on the blue color
Any other thoughts/ideas/suggestions?
Thanks,
Brenda
Reviving this. We are trying to validate the Hemobioscience EluClear in gel method and we are seeing 1, 2, 4, however our last wash is clean (no hazy/grainy look, no appearance of hemolysis on the top of the gel). Any suggestions?
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1. At what temp do you call it a Febrile reaction? >/= 38C
2. Do you also use temp increase from the baseline? If so what is? No
3. Do you use other criteria with Temp increase for culture? If so what are they? Have symptoms related to sepsis (CDC defin); however it is our MD call to culture.
4. If you do have one, what is your definition for tachycardia (eg =>100 bpm?) do not define
5. Same with Hypotension, any numerical definition? do not define
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For units tested to find the antigen negative unit.
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Does anyone know if there is a requirement that Transfusion Service/Blood Bank personnel cannot work more than 12 hours in a row? I've never heard of this but was told our policy came about because of this unknown requirement.
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Does anyone have an eluate blind sample recipe for unknowns that will yield enough sample for an ID?
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We strive for 100% completion but have a threshold of at least 85%. Nursing has to part-take in corrective action planning when they fall below the threshold, this way they have ownership of documentation.
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On 2/13/2017 at 1:22 PM, KLCarter said:
Can anyone offer information as to the 30-day expiration date rule applied to saline cubes? Does this only apply to routine patient testing? We use saline to make reagents and I need to determine how to out-date these reagents. For example - saline expires in 30 days but is used to make PBS (we give a 6-month out-date to refrigerated PBS); which in turn is used to make enzymes (another 6-month out-date). How can I document an expiration date 1 year longer than the raw materials used to make the reagents? Any help or clarity would be most appreciated!
Bringing this back...
When a manufacturers states a product is accept for 1 month once opened. How do you calculate the expiration date?
- Would it always be 30 days from the day opened?
- Would you alternate between 30 and 31?
- Would you could 4 weeks?
- Do you count the date opened as day 1?
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We are looking at sending the transfusions outside of threshold to the chiefs of each specialty to review. However we do not know yet how we can confirm they are reviewing it. Currently we send them quarterly CT ratios.
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3 hours ago, Texas Lynn said:
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.
We only thaw plasma/cryo and rarely split RBCs and the FDA stated registration is not needed. When in doubt just ask them, they are always helpful.
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On 7/27/2018 at 11:12 AM, mld123 said:
I use a Poly reagent by Immucor that states you must perform QC using the IgG coated as well as complement coated check cells. We QC the poly reagent with both cells once per day of use and then when we perform patient testing we only us the IgG coated cells to QC the negative results.
We do the same with the BioRad Poly. I also include a negative cell with QC (A1 cell), just to say it reacts with IgG coated cells and Complement coated cells but not with non-coated cells.
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We take the temp and only will return to inventory if between 20-24C. We do not take the temp when they are received from the blood supplier since they validate their boxes for transport.
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I would say that depends on your manufacturer's instructions for QC.
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I'm at a 220 bed hospital, we have dedicated Transfusion Medicine technologists on all shifts. We have hired new grads, they are able to work successfully alone with proper training and the willingness to learn on their part.
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We have always kept the packing slip for 10 years as part of the traceability of unit, granted the information is entered in our LIS.
ABO Confirmation, 2nd Draw
in Transfusion Services
Posted
Experienced this. We backup the backup on an encrypted flash drive. If it happens again we would have IT give us a laptop (not connected to internet or network) to use just to pull the files.