At my new hospital, we transfuse mainly apheresis platelets but have a few hematologists who prefer pooled platelets. I recently found out that if we don't have any pooled platelets in house and there is a request for pooled platelets, we prepare our own pooled platelet by taking "one unit equivalent" from 6 apheresis units and pooling those 6 "one unit equivalents" together to make a pooled platelet.

 

I have never heard of doing this before. I can't find anything in the technical manual that talks about this. The new pooled unit is not bacterial tested. The reasoning I was given was that the apheresis units were tested so the pooled unit is fine. Does anyone else do this? This practice concerns me and I would prefer we don't do this but I need evidence or support to show that we shouldn't be doing this. Thanks.

My kneejerk reaction is that this is absurd, but I've been wrong before and I'm looking forward to further discussion on the topic.

That was mine as well but I am newer to this field and maybe I am missing something.

I am with goodchild on this one.  One place to start is the "why" some physicians insist upon pooled vs. apheresis products.  It seems to me there is approximately 6 times the risk of exposure utilizing pooled vs apheresis products in terms of exposure to something causing current or future issues since the recipient is exposed to multiple donor products.  You do not indicate if the sampling from the pheresis units is a closed system process or open.  This changes the time of expiration potentially for all of the pheresis units entered to create the pool.  These are the issues I see immediately.

What do you do then with the apheresis units you "stole" from? I would certainly be questioning this practice! Some Dr.s are just unaware that there is such a thing as an apheresis! We have a policy that we ONLY provide apheresis platelets!

http://www.ncbi.nlm.nih.gov/pubmed/11604581

 

 

There's also FDA/AABB standards related to pooled platelets, but since this situation is so unique I'd have to read around to see if they apply in your circumstances:

 

21CFR640.25(b )

 

AABB 5.7.5.18/5.7.5.19

 

Talks about validation/quality control that the platelet product demonstrates >=5.5x10^11 platelets at least 75% of the time.

Edited August 5, 201312 yr by goodchild

I am trying to get to the bottom of why some prefer pooled platelets and why we don't just go to 100% apheresis platelets as I know our supplier would like us to do. One thing I have learned is that there has been a thinking/theory here that if someone is refractory to platelet transfusions and we can't get HLA matched or HLA matched has not worked, you should give pooled platelets. The idea is that maybe there will be some bump in plt count.

 

As far as the pooling from the apheresis units, I have no idea how that got started. I believe the sampling is in a closed system so the apheresis units are still good for the remainder of their shelf life but I need to confirm. The apheresis units are given as a regular unit and I was told it is because an apheresis unit is equivalent to 5-6 WBD plt units. So taking 1 unit off still qualifies it as equivalent to 5 units of WBD plts. 

 

From a QA standpoint, I have to investigate what is or is not being done. But I can't find this situation anywhere to figure out what needs to be done in way of plt count or bacterial testing.  From the responses so far, it appears no one else does this. Thank you for all your responses!

I believe you are manufacturing a new product . . . as intimated above you had better have some QA on the product you make and the product you are taking from. I also think the FDA would look askance at this practice. Maybe you could contact them and ask their opinion (but don't quote them).

I agree with Dave. You are augmenting a received product from your supplier and there needs to be a new product code, expiration, and ultimately a complete explanation of what this new product is and it's intended use, as well as some documentation of the rest of the medical staff having been made aware of this new product.

This is one more example of when I think I've "seen it all", some one comes along and shows me how wrong I was.  Frankly I'm surprised that a blood bank medical director would go along with this but then I've run across a few with the philosophy give the docs anything they asked for.

 

I just had another thought, what about the 6 patients who get those single donor units.  You are short changing them.  Kinda like watering down the whiskey in your bar to make more money!

 

Edited August 6, 201312 yr by John C. Staley

Is there an ISBT product code for a pool of apheresis platelets made up of parts of other apheresis platelets?

A platletpheresis unit must contain a minimum of 3.0 x 10^11, so I think you would need to be concerned about the residual platelet yield after you removed a portion. At the very least it seems like there should be some QC of the remaining product to be sure that it still meets the criteria. True, many units would contain considerably more than the minimum and might pass, but some may be close to that minimum and would fail after removing a portion. At our facility, we do ocassionally remove small aliquots from apheresis platelets for neonatal transfusions. We do not use the remainder for adult transfusions. For this reason and the reasons listed above I would not recommend this practice.

Edited August 7, 201312 yr by Sandy L

A platletpheresis unit must contain a minimum of 3.0 x 10^11, so I think you would need to be concerned about the residual platelet yield after you removed a portion. At the very least it seems like there should be some QC of the remaining product to be sure that it still meets the criteria. True, many units would contain considerably more than the minimum and might pass, but some may be close to that minimum and would fail after removing a portion. At our facility, we do ocassionally remove small aliquots from apheresis platelets for neonatal transfusions. We do not use the remainder for adult transfusions. For this reason and the reasons listed above I would not recommend this practice.

Sandy, I have practiced reserving a unit of packed cells for exclusive use by one neonatal patient once that unit is deemed compatible and an aliquot is taken. This practice ensures limited exposure for this neonatal patient and others. Do you do the same with the single donor platelet?

Sandy, I have practiced reserving a unit of packed cells for exclusive use by one neonatal patient once that unit is deemed compatible and an aliquot is taken. This practice ensures limited exposure for this neonatal patient and others. Do you do the same with the single donor platelet?

 

We do the same thing with RBCs. Platelets are somewhat of a different animal since they usually only have 2-3 days of shelf life at most, but we do try to limit their donor exposure as much as possible.

rravkin,

We do the same as you for RBC's, dedicating one unit of RBC's for one infant and use for its shelf life. For platelets we do not dedicate for one infant. We do stock one AB plateletpheresis at all times for infant use. Our supplier collects only apheresis platelets, so basically our AB platelet which we get as fresh as possible from our supplier is dedicated for infant only use. We sterile dock satellite bags whenever we get an infant platelet order. The remainder is available for infant use only for any neonate that needs platelets in the next few days until the unit outdates. So if the same infant needs another platelet transfusion before unit outdates, they will automatically receive an aliquot from the same unit. On the day that the platelet outdates, if it has not been used for infants, it goes into adult stock. We have a large NICU and we frequently have multiple babies that require platelets or one baby needing more than one platelet transfusion during the dating period on one platelet unit.

Wow, I'm with John on this one.  This is probably something that you should look at as an "opportunity for improvement".  IMHO it's a huge waste of time for your staff.

 

Think about asking your medical director to intervene here.  Docs will only listen to docs and basically don't give them the option to get a pool of plts.  One pheresis fills their order, no muss, no fuss.

 

Sandy L. is absolutely correct in her statement.  And I agree with her, I don't recommend this practice either.

I would guess that this request originally came from hem/onc. Pooling apheresis platelets seems to be inviting a whole boat load of trouble for all the reasons mentioned above.

 

We too have access only to apheresis platelets, but one of our past oncologists requested that we give some of her patients only pooled random platelets. She explained to me at great length that when she had a suspected refractory patient she wanted to give a pool of platelets to see if the patient would respond. If the patient did respond, she wanted us to obtain an apheresis unit from each of the donor's in turn to see which donor her patient liked. THEN............she wanted the donor(s) her patient liked to be drawn for apheresis units and reserved for her patient   . After which she started to explain refractory response - at which point I called for a time out and told her that I 'got' all that...about 10 minutes before  ! Then I explained (very nicely) that only apheresis platelets were available to us and that had been true for a number of years and no, we could not special order random donors.

 

THEN.............she wanted to give apheresis units and when the patient liked one, we were supposed to call up the donor center and request that they reserve that donor for the exclusive use of her patient, even have them put that donor on a schedule that meshed with her patients scheduled appointments    . I explained (very nicely) to her that it didn't really work that way. . . Why don't we check out your patient for platelet antibodies or try HLA matched??? We checked for platelet antibodies. And the patient didn't have any. I wasn't sorry when that physician decided to move on down the road.

Currently we have random donor platelets that we may pool into a single product. These random platelets are bacterial tested by our current blood supplier. We use 6 random donor platelets to equal a single apheresis product, but I've seen 4 randoms used at times to match an apheresis product. This pooled product is used when apheresis product inventory is low, or when there is a suspicion of platelet refractoriness. We usually see patients who do not display a "bump" with an apheresis product. We will switch to a pooled product to see if we see a "bump". If yes, we send specimen for platelet antibody screen testing. If positive, we request a crossmatch compatible platelet product for patient.

rravkin,

We do the same as you for RBC's, dedicating one unit of RBC's for one infant and use for its shelf life. For platelets we do not dedicate for one infant. We do stock one AB plateletpheresis at all times for infant use. Our supplier collects only apheresis platelets, so basically our AB platelet which we get as fresh as possible from our supplier is dedicated for infant only use. We sterile dock satellite bags whenever we get an infant platelet order. The remainder is available for infant use only for any neonate that needs platelets in the next few days until the unit outdates. So if the same infant needs another platelet transfusion before unit outdates, they will automatically receive an aliquot from the same unit. On the day that the platelet outdates, if it has not been used for infants, it goes into adult stock. We have a large NICU and we frequently have multiple babies that require platelets or one baby needing more than one platelet transfusion during the dating period on one platelet unit.

Sandy, how, and with what frequency do you test these SDP aliquots for bacterial contamination??

Is there a requirement/guideline to test SDP aliquots for bacterial contamination?

Because our supplier has tested the apheresis platelets already and the platelet aliquot has a 4 hour expiration once prepared, we do not test the aliquot. I do not know of any requirement to do so.

Hellow to all

I've a question about single random donor platelets, we know that the required concentration of platelets minimum 5x10¹⁰ /unit or more, but some times we found the concentration less than this range, in this case can we use this units which not meet the required concentration, or we have to discard them ?.

 

thank you