Cliff

Welcome

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:
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 1-6○C 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.
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 1-6○C and has an expiration date of 5 days from the end of the Whole Blood dating period. 
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.
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
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
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
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
Table of dating periods. Product
Storage temperature
Dating period
Liquid Plasma
Between 1-6○C
5 days from end of Whole Blood dating period.
We hope this information is helpful.  Let us know if you have further questions.

I attached it below as a pdf.
The P1PK Blood Group System.pdf

I attached it below as a pdf.
The P1PK Blood Group System.pdf

I attached it below as a pdf.
The P1PK Blood Group System.pdf

Antibody / Antigen Reaction
Antibody/Antigen Reaction

This question was submitted by forum member, Malcolm Needs. Any errors are those of the site admin, not Malcolm.
Antibody Antigen Reactions - Clifford Reeves.pptx
Submitter Cliff Category BloodBankTalk Submitted 11/27/2020  

I do know of one case in the UK that involved an IUT given by Professor Kypros Nicolaides (a world renowned foetologist) at Kings College Hospital involving anti-Kpa in pregnancy, but I never saw it written up, and there was certainly no clinical sequalae, and so it could be that the anti-Kpa (the titre was not all that high) may well have been coincidental to some other pathological condition (KCH was one of "our" hospitals in terms of Red Cell Immunohaematology).

In all my years in blood transfusion/blood group serology, I never saw an unequivocal case of anti-Kpa that caused clinically significant HDFN, and it was a fairly common antibody at our laboratory.

That probably doesn't help that much, but that is my experience on the subject.

I would recommend getting the LIS.
It will provide a level of patient safety that you can't get with paper.
It improves workflow, especially if you are using automation.
Decreases documentation errors and omissions.
It will simplify billing.
It will vastly reduce the piles of paper documentation that you would otherwise be storing for years - patient, donor and potentially QC (depending on the software).
It simplifies inventory management, especially when you get look-backs and recalls from your blood supplier years down the road.
We are a smaller hospital that went to an LIS just a few years ago. I can't imagine ever going back to paper (gives me nightmares actually!). It has definitely reduced my workload in terms of all the record keeping, reporting, etc. that is required. I am filling out fewer error reports and deviations from SOP. With staffing issues a 'normal' thing now, I need all the time I can find to do all the other things I need to get done, including working on the bench.
Are you going to do the reaction workups or refer those?
 
 

I think you should invite members of that committee to remove a bag from its cube, try to label it sufficiently (substance, lot #, expiration, etc.), attach that label in such a way that it will stay attached when the bag 'collapses' as it's emptied, hoist the bag up to the level of a cell washer without the aid of the box (especially this part), and suggest ways to keep the collapsed bag at an angle that will ensure all the contents are used. 
I'm willing to bet they'll come around. 

I'm going to be blunt.  This is ridiculous!!  You have the potential of causing far more problems by removing the cubes from their protective container.  

Here is where we landed.
 

Make just one post this week.
Think of the difference you could make to the site if you make just one post a week.
Not sure where to start?  
There are many unanswered topics.  Some are new, some are more than 10 years old.
Why respond to these?  While not all visitors to the site participate, many don't even register, thousands of people visit the site each month to use it as a reference.  Keeping the unanswered topics to a minimum helps the whole Pathology Community!
Try to answer just one topic this week, you never know who you may help.
These topics can be found in the main menu under Unanswered Topics, or here.
Thank you!
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Hi @Emmanuel Akomanin Asiamah,
You can create a new post about histotechnology or cytotechnology.  Maybe a new efficiency you come up with in testing, equipment issues, trouble finding qualified staff...

There are FDA requirements for labels that are directly adhered to a blood product.  If you are applying a label on top of an approved label, those rules do not apply.
I always had good luck with Shamrock labels.  https://www.shamrocklabels.com/

Has the baby had any infusions / transfusion?  Plasma, platelets, IVIG?

One option to help attract people to a post is to "mention? them by typing the @ symbol followed immediately by their username.  You can then select them from the list that displays, and it will look like this: @PammyDQ
If that users' notifications are set to alert them, they will get either a notice when they come to the site, and / or an email.  Again, this is based on an individuals settings, and there is no way to see what their settings are.

This is an old topic, but in case anyone else could use them, here are some resources for planning/sponsoring a fundraising walk or run.
Planning:
https://www.thebalancesmb.com/plan-successful-fundraising-walk-event-1223691
https://donorbox.org/nonprofit-blog/organize-a-charity-run
https://www.peoplepoweredmovement.org/site/images/uploads/How_to_Organize_a_Walk-a-thon.pdf
Sponsorship:
https://www.qgiv.com/blog/sponsorship-letter-samples/
https://thefundraisingauthority.com/fundraising-events/securing-sponsors-for-your-event/
https://donorbox.org/nonprofit-blog/how-to-get-sponsorship-for-fundraising-events

Clinical Aspects of Transfusion Reactions
Clinical Aspects of Transfusion Reactions

This question was submitted by forum member, Malcolm Needs. Any errors are those of the site admin, not Malcolm.
Clinical Aspects of Transfusion Reactions.pptx
Submitter Cliff Category BloodBankTalk Submitted 08/30/2021  

What are RTTIs?
This information in this question / answer was generously provided by AABB. Any errors are those of the site admin, not AABB.
Mention of specific products or equipment in this AABB publication does not represent an endorsement of such products by the AABB nor does it necessarily indicate a preference for those products over similar competitive products.
Efforts are made to have publications of the AABB consistent in regard to acceptable practices. However, they may not be. As new developments in the field of relationship testing occur, changes may be recommended to the AABB Standards for Blood Banks and Transfusion Services. It is not possible, however, to revise each publication at the time such a change is adopted. Thus, it is essential that the most recent edition of the Standards be consulted as a reference in regard to current acceptable practices.
Copyright © 2018 by AABB.  Permission to republish on PathLabTalk has been granted by AABB.
If you would like to purchase the source material this was quoted from, please visit here.
Submitter Cliff Category BloodBankTalk Submitted 05/02/2022  

Once it's in place, I suggest taking the internal temp with an independent device for 24 hours.  If it held temp, I'd be satisfied.
Are you using the on-device data recorder?  We used a Rees system, so we never validated the temp display, nor the recorder.  That would be a whole separate validation.

Once it's in place, I suggest taking the internal temp with an independent device for 24 hours.  If it held temp, I'd be satisfied.
Are you using the on-device data recorder?  We used a Rees system, so we never validated the temp display, nor the recorder.  That would be a whole separate validation.

Lies, damned lies, and statistics.
You've asked the question that has plagued my small brain for almost three decades.  How many is enough - the question cannot be answered to everyone's satisfaction.  Some will tell you to do more, others will tell you your plan is overkill.
Everything is a risk; you need to use sound judgment and work with your CLIA director to make sure they are satisfied with your plan.
When we moved to a new computer system, we had millions of records.  I chose to use statistics.  We fully validated 384 randomly selected records - lots of sites to determine this number.  This took a tremendous effort to complete.  As the years went on and we "simply" upgraded to a newer version, we had a solid history of working with, and validating, the software so we eased up a bit on our plan.
These are brand new instruments, albeit with the same methodology.  You need to perform a validation that will ensure each new device performs as expected.
I always started with the vendor; they almost always offer a suggested plan.

Lies, damned lies, and statistics.
You've asked the question that has plagued my small brain for almost three decades.  How many is enough - the question cannot be answered to everyone's satisfaction.  Some will tell you to do more, others will tell you your plan is overkill.
Everything is a risk; you need to use sound judgment and work with your CLIA director to make sure they are satisfied with your plan.
When we moved to a new computer system, we had millions of records.  I chose to use statistics.  We fully validated 384 randomly selected records - lots of sites to determine this number.  This took a tremendous effort to complete.  As the years went on and we "simply" upgraded to a newer version, we had a solid history of working with, and validating, the software so we eased up a bit on our plan.
These are brand new instruments, albeit with the same methodology.  You need to perform a validation that will ensure each new device performs as expected.
I always started with the vendor; they almost always offer a suggested plan.

Lies, damned lies, and statistics.
You've asked the question that has plagued my small brain for almost three decades.  How many is enough - the question cannot be answered to everyone's satisfaction.  Some will tell you to do more, others will tell you your plan is overkill.
Everything is a risk; you need to use sound judgment and work with your CLIA director to make sure they are satisfied with your plan.
When we moved to a new computer system, we had millions of records.  I chose to use statistics.  We fully validated 384 randomly selected records - lots of sites to determine this number.  This took a tremendous effort to complete.  As the years went on and we "simply" upgraded to a newer version, we had a solid history of working with, and validating, the software so we eased up a bit on our plan.
These are brand new instruments, albeit with the same methodology.  You need to perform a validation that will ensure each new device performs as expected.
I always started with the vendor; they almost always offer a suggested plan.

That's a tough one.  As a patient I like to see my results in a graph over time.  If I've been coming to you for my cancer treatment for the past two years and there is a two-month gap, that would be disappointing.
As a black and white person living in a grey world, the OCD person in me would want the results entered.  Maybe hire temps to enter and verify by a tech?