apheresis splitting guidelines

[kim]

Hi,

Could anybody give me information where to find guidelines for the criteria for splitting apheresis platelets based on platelet ct and volume? I love this site and I know I'll have a answer befor morning you guys are the best!

[pdavenport]

Pediatric Transfusion Therapy from AABB Press gives a dose of 5 mL /kg.

[Cliff]

Hi Kim,

Welcome to BloodBankTalk.

Not too sure you'll find specific rules related to split pheresis platelets.

AABB Standards

5.7.5.19

APHERESIS PLATELETS (Platelets Pheresis)

Validation and quality control of Apheresis Platelets shall demonstrate that at least 90% of units sampled contain ≥3.0 × 1011 platelets and have a pH ≥6.2 at the end of allowable storage. FDA criteria apply.*

*21 CFR 640.24(d).

FDA Guidance

This is an older guidance document that talks of collecting multiple products, keep in mind it's a draft. There is a much older guidance document, some of which is still relevant, most of which is outdated. I found it fairly vague when it was more "current".

Manufacturer

The pheresis equipment manufacturer will likely have some guidance for you as well. Considerations such as plasma volume, and platelet concentration were submitted by the manufacturer to FDA for device approval and need to be followed in component manufacturing.

[kim]

Thanks for replying,

This is driving me a little crazy only for the fact that I know that plt vol and plt count should be taken in account when deciding if they should be put in one bag or left in two until issue. Recently our compliance person told us it would be fine to put the platelets into one bag because it is a closed system, so we don't have outdate them in 24 hrs. I know there is other factors influencing this than just putting them in one bag. I am just trying to get my facts straight befor I say anything. Thanks for the manufacturer suggestions I'm going to take a peek at them ASAP!

[Eagle Eye]

As far as I know you can have up to certain amount (~250 mL?) in one bag. If volume is more then --need to divide in two bags. If we keep in one bag it affects platelet viability.

I believe American Red Cross used to have tag with two bag plateletpheresis---stating that once you pool expiration date is 24 hrs from the time of pooling.

[OPUS104]

Hey Kim, at our donor center we split anything 6.4 or above (as long as they meet minimum volume requirements). We used to do 6.2 but ran into several monthly QC "at issue" failures when the pre- was 3.1 and the at issue was 2.9. We were told by the manufacturer that any single with a plt count above 4.7 had to be in two bags due to gas exchange............we said OK. (we use same tag as mentioned) Our double QC must meet 100% for the "at issue" count on our double plts.......don't know if this is our rules or following FDA,AABB etc. try to find out more and post for you.

[Colleen]

You also need to look at the manufacturer's volume/concentration limits on the bags.

Amicus (Baxter/Fenwal) Product Specifications: No more than 4.7 x 1011 platelets with a

minimum plasma volume of 193 mL/bag can be stored in a single PL2410 bag, in order to

maintain a pH above 6.2 for the life of the component.

COBE or Trima(Gambro) Product Specifications: No more than 1.0-2.1 x 106/µL platelets

concentration and a platelet yield of 5.1 x 1011 platelets in a product volume of 100-400 mL per bag in order to maintain a pH above 6.2 for the life of the component.

If you exceed these, then you have a 24 hr outdate because there isn't sufficient plasma to maintain the required pH.

Colleen