Sonya Martinez

Attached is the validation plan for the last freezer we bought in 2020 but it was not a Helmer.  Also, if you ask Helmer (it might even be on their website) you can get their temperature mapping they already completed.  Normally it's included on the technical data sheet.  We validate the temp holds for 24 hours empty then 24 hours full of normal stock.  However, we are staffed 24/7 and we use Isensix continuous temperature monitoring (which pages me and the other lab leaders if the temp is out longer than 5 minutes, again at 15 minutes and a third one at 20 minutes) so if it alarms staff know to move the stock back to our second freezer.
Validation Plan NEW Plasma Freezer 05.22.2020.doc Freezer Temperature Mapping.pdf Helmer Refrigerator and Platelet Incubator Temperature Mapping.pdf

Attached is my procedures for creating labels (we only use it for computer downtime) using Digi-Trax's HemaTrax Unity Client (111119 version) and the older version we used to have.  We used to have to hand create our labels prior to moving from a very old version of Meditech to Mediware (now WellSky) in 2013, so I attached our Preparation of Aliquots from 2008 because page 10 has our log for creating aliquots, pooling and sterile docking use and page 11 has the expiration date/time grid (24 hour clock).  Hopefully some or all of this helps.  
BBI0014 Labeling Blood Products_111119.doc BBI0014 Labeling Blood Products.doc BBC015.6 Preparation of Aliquots.doc

We've had staffing issues (CLS/MT less so with MLT) not just in the blood bank but the entire laboratory.  With COVID on top of retirements, we lost a lot to the COVID testing in our MDL and they haven't come back.  Plus we are increasing in acuity and volume of patients to the point we're now trying to increase staffing on all shifts.  We have 3 travelers right now, with one working for us for many years (night shift is the hardest to fill) and 2 newer travelers that have just renewed their contracts.  The younger people don't want to stay in the same place, they like being able to take as much time off as they want when they want, and they like the money.  I know COVID hasn't helped but I think the problem is more the fact there just aren't enough CLS/MT's out there and there's no schools anymore that you can get a BSMT vs science BS (like biology) + post grad training.  Most of us in the lab aren't vocal enough at the state and national levels like the nurses and RTs (glamor jobs of the hospital) to get the word out that lab is necessary/required and we don't have support.  There is a CLS program in our area but we're so short staffed we can't bring in the CLS trainees because we can't even staff without supervisors and technical specialists on the bench as it is.  

Are you looking for reconstituted RBC from AS3 or AS1 when adding FFP? Or are you switching to using actual whole blood?  Here's a list with CPDA-1, AS3 and AS1 final product codes when you reconstitute with thawed FFP, FP24 or RT<24hr Frozen <24hr.
Starting RBC Product Code
Reconstituted RBC Product Code
 
Starting RBC Product Code
Reconstituted RBC Product Code
E0224
E5797
 
E4532
E7651
E0226
E6453
 
E4533
E7652
E0332
E6128
 
E4538
E6147
E0336
E6786
 
E4539
E6791
E0379
E6148
 
E4540
E6792
E0382
E6785
 
E4543
E6788
E0420
E6149
 
E4544
E6789
E0424
E6787
 
E4545
E6790
E0661
E6796
 
 
 
E0668
E6797
 
 
 
E0678
E6793
 
 
 
E0685
E6794
 
 
 
E0686
E6795
 
 
 

Most certainly it can.
There have been published papers on newborn babies being typed as D Negative, and K Negative, not because they have received an IUT, but because their mother's antibody has such a high titre that they sensitise virtually every antigen site on the cord red cells, thus causing a sort of prozone effect.

The same can happen with a "blocking antibody" and AHG.

It is also not uncommon for newborn babies with ABO HDFN to have a negative DAT, and be released from hospital, only to be brought in again when they become "floppy", and for the DAT to then be positive.

This phenomenon is also described with the monoclonal antibody therapy anti-CD47 (Hu5F9-G4) where red cells are so heavily loaded with IgG that it creates steric hindrance. Basically, antibodies bound to the red cells hinder the binding sites of the anti-human globulin leading from very weak to negative DAT. Anti-CD47 can be eluted off the red cells and it gives very strong reaction in IAT. Of note: it is not the same mechanism involved with the anti-CD38 (another monoclonal antibody therapy often called DARA) where here the DAT can be negative too because of down-regulation of CD38 expression onto the red cell membrane.         

We did not. Units were kept refrigerated until they were ready to into the irradiator. We documented the time that the unit went into the irradiator and the time it came out. Electronic component prep was done immediately. If this was not possible, the units were placed back in the fridge until it could be done. I don't know what is the current checklist because I retire a year and a half ago.

If you're looking for a procedure see attached.  
BBI0023 Exchange Transfusion 031522.docx

We usually pay Helmer to provide us a validation certificate. I believe this includes temperature mapping. We then validate the alarms, charts, temp stability etc. as described above. We never freeze anything from room temp but only store plasma that arrives frozen.

I have never used plasma to validate a freezer. I have validated that alarms work, temp is accurate, plugged into proper receptacle, chart works, door seals properly, unit maintains temp etc.

We had an over zealous infection control team (made up of 100% nurses) come to our lab last year making the same demand. We told them, in essence, we will not comply because the risk of injury from handling those containers were greater than the risk they were trying to alleviate. Furthermore, the risk of accidently confusing saline with formalin, whose containers look exactly alike, was to high when removing from the cardboard containers. In addition to that, we told them the man hours required to keep up with that would require additional FTE's, which would not be approved. 
They conceded and we continued on, business as usual. TJC does not really inspect labs that are CAP, AABB, or CLIA certified. Those organizations understand the logistics of the cubes and do not have a problem with it. Most infection control officers are nurses and think from the nursing perspective only.

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.  

All may not be lost. One of our seminar speakers last week did a talk on FFP which included some data on stability of FFP stored for various times/temps out of range. I'll see if I can get the references from her.

You would only need to file a BPD with the FDA if you distribute any of these products for transfusion or transfer.  Just because you had that event is not cause to report.

I QC reagents before I put them into use; usually not upon receipt.

We have a handout we created (fact sheet) and one the state of CA says that the MD gives to patient's, family, etc. prior to obtaining consent to transfuse.  This might be what you are looking for.
TRANSFUSION FACT SHEET ENGLISH 07 2018-no track changes.doc Blood Transfusion Brochure (1)_CA_June 2018.pdf

Attached is my procedures for creating labels (we only use it for computer downtime) using Digi-Trax's HemaTrax Unity Client (111119 version) and the older version we used to have.  We used to have to hand create our labels prior to moving from a very old version of Meditech to Mediware (now WellSky) in 2013, so I attached our Preparation of Aliquots from 2008 because page 10 has our log for creating aliquots, pooling and sterile docking use and page 11 has the expiration date/time grid (24 hour clock).  Hopefully some or all of this helps.  
BBI0014 Labeling Blood Products_111119.doc BBI0014 Labeling Blood Products.doc BBC015.6 Preparation of Aliquots.doc

Our computer system (WellSky Transfusion v. 2020R3) build utilizes the ISBT formulas to modify products.  So we only had to build in the codes going from the original RBC unit to the final reconstituted one.  It only requires the starting RBC and the ending RBC component information to make it work using a pooling process and it works with all our thawed plasma.  You may have to to validate that all your thawed plasma product codes can be used if it's a different process/computer build.  For example: Start with RBC E0224 who's component code is 002 and ISBT equation is @08C2 D4 then pool it in an open system, using process code PLS-A (add plasma) to E5797 with component code 002 and ISBT equation @08B2 C2 D4 E4.  The B2 makes it an open system and the E4 gives it the 'plasma added' on the label.  I hope this helps.
 

You can store reagents and patient specimens in the same fridge as blood but you need to make sure that the range is set to accommodate both.  Our fridges are set with 2.5-5.5 C which meet both blood product guidelines and those of our reagents and specimens.  

You can store reagents and patient specimens in the same fridge as blood but you need to make sure that the range is set to accommodate both.  Our fridges are set with 2.5-5.5 C which meet both blood product guidelines and those of our reagents and specimens.  

Agree with Sonya, our fridges store reagent and blood products, so our range is 2.5-5.5 as well. I recall that autologous units that were "biohazard" because the donor was Hep C pos or something like that should be sequestered to their own area, and besides the BB knowledge of segregating certain things, I don't believe there is any rule about what can and cannot be in the same fridge. 
If you're talking about utilizing a fridge in or near the OR to store blood products for these transplants, then you just need to be sure the fridge is rated for storing blood products. Any old Frigidaire may not hold temps accurately throughout the whole fridge, which is what our OR attempted to get! We bought them an actual BB fridge (Helmer undercounter), and kept it specifically for blood only. 

You can store reagents and patient specimens in the same fridge as blood but you need to make sure that the range is set to accommodate both.  Our fridges are set with 2.5-5.5 C which meet both blood product guidelines and those of our reagents and specimens.  

You can store reagents and patient specimens in the same fridge as blood but you need to make sure that the range is set to accommodate both.  Our fridges are set with 2.5-5.5 C which meet both blood product guidelines and those of our reagents and specimens.  

I contacted AABB directly about  the added standard 5.7.2.1.3 because it requires the vendors to provide expiration dates of the transfer bags even if the weld is complete which for us is a huge issue.  I'm glad they are reversing this.  That all being said, as long as the weld is complete we keep the expiration date/time of the product placed in the transfer bag.   We only keep platelets in the mother bag and take aliquots from it for transfusion.  We do change the expiration time to 4 hours when we place them in a syringe.

We use Isensix continuous monitoring system in our hospital which I verify against the chart recorder on the unit but it's probably overkill.  Attached is the last plan I wrote and used.
Validation Plan NEW Plasma Freezer 05.22.2020.doc