plateletpheresis...

[lyla_n]

we have started with double platelet collections recently.

What is the best time to split the product?? immediately after preparing it or at the time of issue? hw to know which split should have how much volume and platelet count and what should be the ideal procedure for decing how to split the product?

[Liz]

Splitting is good immediately after collection for viability and "breathing" of the platelets, more space.

They should be equally split. You make sure they are gently, homogenously mixed in the first bag then by weight tranfer half to the Satelitte bag. Secure the clamp between them but keep them attached in case you need to give different volume aliquotes. You can also use a transfer bag and sterile connectiong device for transfer of small aliquotes.. oups have to go, more later.

[velliott]

You need to reference your manufactures recommendations. Usually your vendor is very good in helping you get the process started because they have done a lot of validation and they have many clients that they can help you network with.

Our policy is to count / split before the platelet is 24 hours old. We let the platelets rock over night to allow all the clumping to dissapate. We have a sample tube we collect the plasma / platelet in and then perform the count. This is also the sample we perform our WBC count on. At this time we also get a rough volume and estimate whether the product will be a single, double or triple. We do bacterial detection by BacTech Alert and then wsample off the 10 mls after the unit has been collected for 24 hours. Then we start to we divide up our units or dock on an additional bag if the collection qualifited for a triple. Our products are FDA licensed and I was told that the bags have to agree within 10 mls of each other.

[heathervaught]

Here is our process at a large blood center. It is similar to velliott's protocol.

Products are collected on Day 0. They are divided into two bags, but remain connected. If the volume is over 600 mL, then we add a 3rd bag for the breathability issue that Liz mentioned. They are stored, agitating, overnight.

On Day 1, when the product reaches 24 hours old, it is removed from the agitator. A 10-mL sample is collected. 8 mL is placed into an aerobic BacT/ALERT bottle, and 2 mL into an EDTA tube. The product is weighed, and our Testing laboratory is provided with the weight of the entire collection. At this point, our Component Lab also makes a judgement call based on product volume (since volume collected correlates to single, double, or triple targeted). If it potentially qualifies for a double or a triple, we equilibrate it within the 2 or 3 bags, then weigh each individual bag. While the BacT sample is incubating, the Testing laboratory does a platelet count using the EDTA tube, then multiplies the count times all of the weights provided. The product yields are reported to our Labeling department, and the Labeling associate will separate the bags if the product qualifies for a double or a triple.

[Liz]

Here is our process at a large blood center. It is similar to velliott's protocol.

Products are collected on Day 0. They are divided into two bags, but remain connected. If the volume is over 600 mL, then we add a 3rd bag for the breathability issue that Liz mentioned. They are stored, agitating, overnight.

On Day 1, when the product reaches 24 hours old, it is removed from the agitator. A 10-mL sample is collected. 8 mL is placed into an aerobic BacT/ALERT bottle, and 2 mL into an EDTA tube. The product is weighed, and our Testing laboratory is provided with the weight of the entire collection. At this point, our Component Lab also makes a judgement call based on product volume (since volume collected correlates to single, double, or triple targeted). If it potentially qualifies for a double or a triple, we equilibrate it within the 2 or 3 bags, then weigh each individual bag. While the BacT sample is incubating, the Testing laboratory does a platelet count using the EDTA tube, then multiplies the count times all of the weights provided. The product yields are reported to our Labeling department, and the Labeling associate will separate the bags if the product qualifies for a double or a triple.

How do you draw the sample for the Bact Alert? do you have or attach a sampling device?

I was advised Charter Medical (as the kits with sampling devices are much more expensive) anyhow Charter doesn’t export to the ME. Do you know any other brands? And does the bottle head actually fit into the sampling device Thank you very much; I want to totally eliminate needle use.

[heathervaught]

We collect platelets using the Trima device, and the sampling set is pre-attached to the platelet bag. They also sell them individually and can be sterile-docked onto a component. I do know if they are available where you are, but I have found and attached the Instructions for Use for the sampling set.

[ATTACH]443[/ATTACH]

Sampling Set IFU.pdf

[Liz]

Thank you, yes we use TRIMA so they must surely sell the sampling set individually. I appreciate it, thank you very much.

Liz

[lyla_n]

wat bag to use to transfer half of the contents to? there is only a plasma collection bag with the kit that we are using.so do we transfer half the product into plasma collection bag and half is stored in the platelet collection bag?

is it then necessary to use kits meant for double platelet collection?

[Liz]

You must order kits that are for double platelet collection. You cannot store platelets in a bag meant for plasma it will effect their viability.

[lyla_n]

another thing i need to clear is how soon after apheresis can we issue the product i.e SDP?

is it necessary to place it on the plat agitator for an hour after preparing it and den issue it

[Liz]

You will need to have an SOP established before starting, so it is good that you are gathering info.

The proper way is to take a sample for bacterial detection after 24 - 36 hours so do not release before you draw the sample.

You need to let the bag rest at room temperature after collection for at least an hour out of the agitator-environmental chamber. Then place it in the chamber for the next 24-36 hours prior to bacterial culture sampling. Then keep it there until release. Max 5 days. There are several techniques for Bacterial detection, it is up to your center.

I refer you to the AABB Tech Manual and Standards for your SOP.