David Saikin

How can you prove anyone did anything?  Unless you watch.  Inspectors cannot impune your work is bogus based on your process, unless something seems amiss.  I would immediately contact their regulatory agency and ask for the official stance on such and/or a replacement inspector. 

We do this to cover all of the bases in the event of a transfusion reaction. We keep an unopened segment and the segment that was used in the crossmatch. We keep everything related to the crossmatch for a period of ten days.

My audits are on line and remain available indefinitely.  I'm assuming you are auditing your transfusions.

Erroneous post. Many apologies, thank you. 

Agree with donellda, with the addition that a “foray into manufacturing” is not to be taken lightly and will be resource heavy in time, training, paperwork, inspections etc. and so may not be justifiable for your facility. 

We give Rh positive to  males and females >45 for traumas and MTP's. The medical director still wants to be made aware of the switches though.

My Medical Director still has to approve this switch.

My Medical Director still has to approve this switch.

My Medical Director still has to approve this switch.

Get a disclaimer from your administration that you are not responsible for cell saver operations.  Your Medical Director should offer advice on what is acceptable practice even if you get the disclaimer.  You don't want to be responsible if you are not the responsible party operating the device(s).

We are using a small hang tag (purchased from Amazon, cheap - intended to tag clothing) with a sticker I print on a fluorescent label. See below (actual size).

Erythrocytes cannot be either homozygous or heterozygous (or hemizygous for that matter).  The terms homozygous, heterozygous and hemizygous should only be used when referring to genes, and, while antigens are (ultimately) derived from genes, many, such as A, B, H, I, i, Lea and Leb are not proteins, and cannot, therefore, be direct gene products (although even the "protein" antigens go through post-translational modification and so also cannot, strictly speaking, be direct gene products).  On top of this, of course, the mature erythrocyte has exuded all nuclear material.
Antigens, therefore, should only be referred to a single or double "dose".

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've never had a problem w BB reagents not working (except when I set them up to fail).  I have seen problems with reactivity not on par with usual results.  Contacting vendor discovered a change in the formula at production. 

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

We've never been cited by CAP, the FDA or TJC. TJC does come into Blood Bank because we handle the frozen/refrigerated tissue grafts and never a word said. Our saline in use is quite visible to anyone who walks into the department. That request is overboard and made by people that have never worked in the lab.
Agree with the comments about safely handling the plastic blob, utilizing the reagent w/o waste, proper labeling w/ lot, etc.  and the fact that it would look just like formalin and some of the reagents hemo uses.

We got the same song and dance from our infection department some years ago. Our manager told them the instruments would not work correctly if the saline/reagents were not in the manufacturer's container, the interior plastic bag would droop and possibly break without the cardboard support to contain it. The solution/compromise was to make a notebook of "acceptable" cardboard containers, e.g. saline/reagent cubes. If an inspector questioned, we would show them the book with pictures of what had to be in cardboard to maintain lot numbers or integrity of the reagent.  
I agree, the rule is to reduce incoming exterior dirt and insect infestation for patient areas but the lab is not a patient care area. Some committees make a mountain out of a molehill and go too far.

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.

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'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.  

I've never had a problem w BB reagents not working (except when I set them up to fail).  I have seen problems with reactivity not on par with usual results.  Contacting vendor discovered a change in the formula at production. 

When temp increases to the threshold set point (usually 0.5’C off limit), everything gets moved to a different freezer or shipping containers with dry ice. If you get dry ice from your blood supplier your set point may need to be lower to give a transport buffer. If using containers the temp is monitored every four hours. In other words everything is moved before it goes out of temp so nothing is thrown out. 

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.

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