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Splitting Whole Blood into products


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This may be old hat, but I couldn't find anything searching around here so here goes:

We currently stock O pos LTOWB for trauma MTPs only. These are CPD 500ml units, with anticoagulant already added of course. When they are getting close to expiration (maybe about 5 days before), I would like to split the units into a red cell (with E code E0181) and a liquid plasma (E2457). I have been able to find that making the red cell is well documented, but I can't find anything about being able to keep the expressed plasma and label it as a liquid plasma and transfuse it! I have sent an inquiry to the FDA, but no response yet. The regulations I have come across make it sound like the liquid plasma is possible, but 21 CFR 640.34 (c) says the LP has to be separated from cells "within 4 hours of filling the final container", which makes me think I can't transfuse the LP when split from the whole blood unit so long after collection. 

Is anyone out there doing this, or have any insight as to what is possible? I am a transfusion service, so this would be a foray into manufacturing. I'm just looking to save as much of this product as possible, since most of our traumas are type O anyway. Thanks!

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I just looked at the Red Cross Circular of Information and under liquid plasma it states "liquid plasma is separated and infused no later than 5 days after the expiration date of the Whole Blood and is stored at 1 to 6C".  It's only use would be for massive transfusion. I would wait for the FDAs response.

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You will need to develop a validation and QC plan to ensure that the hematocrit on the RBC product meets pre-defined criteria and regulatory standards.  You will need to have proficiency testing program as well.  We transfuse LTOWB as well but consider the wastage as part of the provision of products meeting the Trauma programs needs - I do not want the headache of manufacturing regulation (I might have skipped over the FDA inspections as well- don't forget that....)

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Guess I should have mentioned that I am already inspected by the FDA. :) 

@applejw - you mention proficiency testing - of what? The hematocrit QC on the units, or do you mean something regarding the making of the red cell and possible plasma? I'm not aware of PT for expressing off plasma. We do not have the space for a refrigerated centrifuge, so our plan is to allow the unit to settle (this is expressly allowed in FDA regs), so there is no QC/QA on that equipment either. 

I agree that the circular makes it sound as though you could split the plasma off at any time, and that the plasma would expire 5 days after the whole blood, though I think there may be poor English at work there making me read it that way. 

Intended process would be to let the unit settle, express off the plasma, leaving about an inch of plasma on the red cell unit (since we will not be adding anything to the red cell), run a hct on each red cell we make, and relabel. If anyone sees a flaw or issue, please let me know! Still waiting on the FDA.... 

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The FDA responded! See below if you're interested. It sounds as though this IS allowed, provided I follow the regs mentioned, which I had planned on doing of course!

Dear Janine,

Thank you for your inquiry.

Please see our responses below:

  1. I would like to start splitting donor whole blood (originally collected by the ARC) into a packed red cell and a liquid plasma unit. I am unclear on if the creation of a liquid plasma unit is allowed?

Response: Yes, it is allowed to separate Liquid Plasma from the Red Blood Cells, provided it is performed in a closed system using a bag attached to the original blood collection set or using a bag attached by a sterile connecting device. Per 21 CFR 640.35(c), Liquid Plasma shall be separated from the Red Blood Cells and stored at a temperature of 1-6C within 4 hours of filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system.

  1. I would like to split the WB 5 days before it expires, creating a red cell with the same expiration, and a liquid plasma with essentially a 10 day expiration. It seems as if this CAN be done by the regulations I’ve been able to find, but I also cannot find anyone who is ALREADY doing this, which makes me concerned that it’s not allowed. CFR 640.34 dictates that the liquid plasma must be separated from the red cells “within 4 hours after filling the final container”, and I wonder if this is why it seems that liquid plasma unit cannot be made from WB that has been anticoagulated and stored at 1-6C?

Response: Please note in 21 CFR 610.53(b), Liquid Plasma must be stored at 1-6C and has an expiration date of 5 days from the end of the Whole Blood dating period. 

  1. I understand that I can make a red cell from a WB unit, but I would like to be able to attempt to use both portions of the units if possible, hence my questions about the validity of making a liquid plasma.

Response: As stated above, this is allowed.

  1. Also, I am already registered with the FDA, but I believe doing this splitting of WB will also require me to change my registration to “prepare” both RBC and liquid plasma. Can you confirm that?

Response: You are correct. Transfusion Services who routinely perform component preparation (e.g., separate whole blood into RBCs, Liquid Plasma) must be registered and the blood establishment registration will need to be updated to reflect that information.

In addition, please note the following Regulations:

Subpart B - Red Blood Cells.

Per 21 CFR 640.11 General requirements

  1. Storage.  Immediately after processing, the Red Blood Cells shall be placed in storage and maintained at a temperature between 1 and 6 °C.

Per 21 CFR 640.16 Processing

  1. Separation.  Within the timeframe specified in the directions for use for the blood collecting, processing, and storage system used, Red Blood Cells may be prepared either by centrifugation…

Subpart D - Plasma.

Per 21 CFR 640.32 Collection of source material

  1. Whole Blood must be collected, transported, and stored as prescribed in § 640.4. When whole blood is intended for… Liquid Plasma, until the plasma is removed, the whole blood must be maintained at a temperature between 1 and 6 °C or as specified in the directions for use for the blood collecting, processing, and storage system…The red blood cells must be placed in storage at a temperature between 1 and 6 °C immediately after the plasma is separated.

Per 21 CFR 640.34 Processing

      ( c) Liquid Plasma.  Liquid Plasma shall be separated from the red blood cells and shall be stored at a temperature of 1 to 6 °C within 4 hours after filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system.

Subpart F – Dating Period Limitations

Per 21 CFR 610.53 Dating periods for Whole Blood and blood components

  1. Table of dating periods.

Product

Storage temperature

Dating period

Liquid Plasma

Between 1-6C

5 days from end of Whole Blood dating period.

We hope this information is helpful.  Let us know if you have further questions.

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I might be dating myself - years ago I worked for a transfusion service that manufactured packed red cells. CAP had required proficiency testing for the manufacturing process - if I remember, it was measuring the hematocrit. Just looked on the test menu and it seems that is no longer 'a thing'. So use the word 'competency' instead.

Our trauma program uses a lot of blood and liquid plasma before we know the patient's blood type - I don't think I would choose Group O liquid plasma even though it is low-titer.  As I write this, I realize that I'm looking at the problem with a distinct bias against more work for my team so please forgive.  When we implemented whole blood, I was definitely averse to splitting the product to create components because of the work - both physical and intellectual - and I  am still thinking that way.  If it is feasible for you and you embrace the process, go forth!

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