Ensis01

Certainly this is what is recommended in the UK's BCSH (BSH) Guidelines (i.e. that they are referred to a foetal medicine unit for ultrasound monitoring) for any Kell-related antibody in pregnancy.  I know this for a fact, as I was one of the co-authors!

All potentially clinically significant antibodies like this can be managed pretty well by non-invasive fetal monitoring for anemia by ultrasound (doppler velocity), so the management should be the same for all such antibodies. Clinical variation is great, as you all know, so the drill is to monitor the fetus.  No anemia, no worries. Anemia leads to intervention.  Serology is largely irrelevant (e.g., titers) but habit is to measure them by most clinicians.

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'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. 

The sand doesn't react to temp changes as quickly, like a door open too long, which causes a false alarm, especially on an ultra low freezer. It provides a bit of a buffer, better than ethylene glycol or glycerol. 

Request new safety committee to audit the trail the saline boxes take from the manufacturer to the blood bank to ascertain where this "dirt" is coming from. Or to put it another way show the manufacturer for this product is required to maintain a level of cleanliness to prevent roaches etc., the couriers the same. As mentioned above this is ridiculous   

Visual inspection, review package insert for changes, log-in and QC when opened

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. 

Finer the sand the better. Cat sand should be ok as long as not used

Finer the sand the better. Cat sand should be ok as long as not used

My guess is the reason your process is "a little over the top" is because, like us, we were cited for non-compliance with COM.30450 New Reagent Lot and Shipment Confirmation of Acceptability - Nonwaived Tests Phase II New reagent lots and shipments are checked against previous reagent lots or with suitable reference material before or concurrently with being placed in service CAP checklist item. According to this checklist you must do one of the following:
Examples of suitable reference materials for qualitative tests include:
Positive and negative patient specimens tested on a previous lot;  Previously tested proficiency testing materials;  External QC materials tested on the previous lot (eg, antigen testing kit controls, immunohematology antisera and reagent red cells)  Control strains of organisms or previously identified organisms for microbiology reagents used to detect or evaluate cultured microorganisms;  If none of the above options is available, control material provided by the assay manufacturer with the new test kit. For our regular antisera (anti-A, B, D), reagent red cells (A1 cells, B cells), we can prove that the new lot is tested using pos/neg controls used on previous lot in accordance with the first option. This is easily verifiable on both the analyzers and our manual recording of daily reagent rack QC.
For Fetal Screen kits, we started testing the new lot against the controls from the old lot upon receipt of the new kit. This is in accordance with the first option, or using a previously tested specimen in accordance with the 2nd option. This is documented on a manual log. It seems to me that, primarily, the fetal screen test kit is where inspectors have caught us on this checklist item.
Hope this helps

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. 

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.

Visual inspection, review package insert for changes, log-in and QC when opened

Request new safety committee to audit the trail the saline boxes take from the manufacturer to the blood bank to ascertain where this "dirt" is coming from. Or to put it another way show the manufacturer for this product is required to maintain a level of cleanliness to prevent roaches etc., the couriers the same. As mentioned above this is ridiculous   

Request new safety committee to audit the trail the saline boxes take from the manufacturer to the blood bank to ascertain where this "dirt" is coming from. Or to put it another way show the manufacturer for this product is required to maintain a level of cleanliness to prevent roaches etc., the couriers the same. As mentioned above this is ridiculous   

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.  

Interesting discussion. Yes, cardboard can carry dirt and/or insects, but to imply that the presence of such on supplies like saline cubes creates a risk to patients and staff is an extreme stretch. We don't live in a  vacuum and most of us spend time outdoors with the dirt and bugs every day (potentially bringing them inside with us). A wipe with a damp paper towel should be sufficient to clean an obviously soiled outer container.
If you talk to the manufacturer of the saline, I'm sure they would argue that the outer box is not merely a convenient shipping container, but also an integral part of the product itself, designed to support the flexible primary container and get the best performance from the product. After all, they've designed in a nice little tear-out section that creates a perfect hole for the spigot/tap.

Here is a follow up. The baby had tested with anti-A on 27, April  and transfused with O washed cells the same day, but on 10, May she had no anti-A and received A type packed red cells with no transfusion reaction. She has stoped feeding on her mother's milk for 14 days.
I tried to persuade her mother to do some tests. The results came out and she has no anemia, with normal reticulocyte count and percentage. Her bilirubin and LDH are normal too. But she has not tested her haptoglobin.
She has not received any blood transfusion and IVIG.  She just diagnosed with slight anemia during pregnancy and after birth.  She had taken iron supplements during pregnancy,.
This is her eventh pregnancies and the third baby, she had several miscarriages. She told me her case seems like a mystery both to her and the doctors she know. She just want to know if she is ok and the baby will be healthy in the future.
 

We do not do the testing in tube to confirm. We will send the sample to American Red Cross for Genotyping for RHD variants if the reaction is 1-2+. The majority come back as weak D type 1 and are not considered to be at risk for production of allo-anti-D. It is generally accepted that females of child-bearing potential with weak D type 1 can be considered D positive for transfusion and are not candidates for Rh immune globulin. Their type will be updated with that comment. If the patient comes back as one of the other weak D types and there is a chance for production of the allo-anti-D, we will leave it as Rh negative and put the comment that testing was done in the patient history.

What you say has made me doubt it is anti-FORS1, as the FORS1 antigen is relatively rare in a human, so being positive with all five cases of group A would be highly unusual.  I just wondered, but I think I am wrong.
I doubt that it is Tn.  It may be, but you can test this by using Dolichos biflorus, which would be positive with Tn activated red cells, while human-derived anti-A1 would be negative.
Come what may, it is a VERY interesting case.  THANK YOU for sharing it.

Here is an interesting paper showing that antibodies to red cell/platelet... may be transmitted via breast milk indeed, causing prolonged HDFN. Milk contains mostly IgA but IgM and IgG may be present of course and IgGs can cross the different barriers up to blood circulation (not on the same model - not actively -  as the placenta though). The surprizing part here is the mother and baby are group A, A antigen is ubiquitous so the anti-A titer in breast milk should high enough to interfer with reverse group despite the adsorption of anti-A on various tissues.     
https://pubmed.ncbi.nlm.nih.gov/30720868/

While I am not an auditor; I would assume that from an auditor's perspective a hospital not being able to show the tracking of how, where, when and why a unit of blood disappeared from the BB inventory would be a bigger problem than verbally taking registration for a patient in transit to a different hospital or trapped in a car. 

I just answered this question.

My Score PASS  

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.