Does anyone use an actual value for determining annual RBC loss? I've seen everything from 1300 ml to 1450 and 1451. We perform whole blood and apheresis plts only- no double red cells- is it sufficient to have policies in place to defer donors for 56 days after whole blood donation or apheresis donation in which RBCs can not be returned? Or is it necessary to calculate the number- if so, what is the number? Thanks for your input!

Hello ncehall,

I presume you are referring to AABB BBTS Standard 5.5.3.4 when you ask about tracking RBC loss.

I have written a small program in Microsoft Access that tracks all of our platelet donors RBC loss. It calculates the RBC loss based on the procedure, donors Hgb and volume of samples collected. The program then prints a report of their loss for the last 365 days and in a table prints their RBC loss for the last 56 and 365 days, their current plasma loss and their 365 day plasma loss.

But, back to your question. What defines "...do not exceed the loss of red cells permitted for whole blood collections"? I dunno!:cool: AABB references the FDA Revised Guideline for the Collection of Platelets, Pheresis document. (Link)

OK, so enough of being a wise guy, when I first tried to tackle this I found the same issue. I honestly don't think you'll find a regulatory publication addressing the allowed RBC loss for a 365 day period. What I did at our institution is took an average of our donors Hgb's, and average of the mass of WB collected (we collect 450) and calculated what the average loss is. Then I divided 365 by 56 and determined there are 6.5 donations allowed and multiplied this times the figure we got (purposefully not included - each center needs to work this out on their own).

Anyhow, that's what we did.

As an interesting aside, this is how BloodBankTalk came to be. I had originally started this site as DonorLimits.com with the intent of developing a commercial product for centers to track RBC loss. It got to be more work than I wanted manage on a part-time basis, and this is much more fun.

Cliff - this has been an issue that our donor centers have been struggling with on a continuing basis. Can you share a little bit more about what you developed for your facility, please. Thanks!

I agree, this is a tough one. We did not want to go to a paper record for tracking the RBC loss, so I wrote an Access Database tool for it. It's very easy to use, and has a bunch of warning messages built in. I attached a screen shot and a mock report.

Wow...that is impressive looking! Are you able to share the tool?

Yes and no.

I'll be happy to work with an individual, but as a general download, no. It's a highly customized database that I designed for our needs and will need to be reprogrammed for a different user. There aren't an user definable options.

If interested, you know where to contact me.

Wow...that is impressive looking! Are you able to share the tool?

Cliff -

Just my $0.02 - if you are using a computer program to "make decisions" about donor eligibility, it needs to be Part 11 compliant AND validated. From what I have learned from several IT folks is that off the shelf Microsoft programs are difficult, if not impossible, to validate.

Judi

Thanks Judi, I am aware of that. I don't know so much that I consider it a tool to determine eligibility. We use it to ensure the RBC loss is safe for the donor - so it's more of an after the fact kinda thing. They still have a prequalifying Hgb and a post of pre platelet count.

We do perform an extensive validation on it, it is NOT Part 11 compliant.

FDA has seen it several times, and has asked for a couple of modifications, other than that anyone who has inspected us has liked it.

Cliff,

This is a nice tool. I plan to show this to my apheresis manager. We have just recently modified a very outdated tracking report and want to make some final adjustments. Your report is very helpful!

Thanks,

Bkinard

Glad you found it helpful, let me know if I can assist in any way.

Thank GOD. You decided to go from Donorlimits.com to Bloodbanktalk.com.:):)

Thank GOD. You decided to go from Donorlimits.com to Bloodbanktalk.com.:):)

Why is that? I still toy with the idea of developing this as a web based commercial product.