donellda

I could NOT agree more, particularly as most of the antibodies available are exceedingly strong monoclonal antibodies, which will QC NOTHING, and as the equilibrium constant of a truly weak antibody is quite different from that of a diluted strong antibody, particularly a strong monoclonal antibody, so just what do these inspectors think we are "QCing" using such antibodies.  It is utter nonsense.

I agree with David and his comments above.  We transfuse neonates very rarely as well.  Considering you are a small rural health center and will not be doing this routinely, you just have to do the best you can in an emergent situation.  We do keep neonatal syringe sets and most of them outdate.

We don't do special antigen typing of our units unless we do it specifically for a patient who has the corresponding antibody. Do they do this because the Kell antigen is very antigenic? It would seem to me, that it would be costly to type units for Kell to avoid using Kell positive units, unless of course the units are for a patient with anti-Kell.

There are several layers to this question. First, you will need a fresh O negative, CMV-, irradiated prbc available rather quickly. We are not small but we only transfuse neonates about 3-4 times/year yet we receive a fresh unit every Monday to use for emergency transfusions. If it is non emergent (say for iatrogenic anemia), then we order from our supplier a fresh unit with satellite bags sterile docked so we can continue to use that unit for future transfusions on that baby. The goal here is to limit donor exposure. You may not need to worry about that if you do not have a high level NICU.
Are you aliquoting the unit into syringes? You will need a procedure and supplies for that. You need to meet with your Neonatologist and work out your logistics.
Those are just a few things to think about. I assume you already have policies and procedures in place for this.

The three months was chosen following a paper written by Laine EP, Leger RM, Arndt PA, Calhoun L, Garratty G, Petz LD. (In vitro studies of the impact of transfusion on the detection of alloantibodies after autoadsorption.  Transfusion 2000; 40 1384-1387.  DOI: 10.1046/j.1537-2995.2000.40111384.x.) that showed that red cells that had been transfused (or entered the circulation  via a feto-maternal haemorrhage could adsorb out weak alloantibodies for up to three months in a patient with AIHA.  This in vivo adsorption would, of course, also apply to individuals who did not have AIHA, but could lead to a secondary stimulation, leading to a stronger antibody (higher titre and higher concentration per mL of plasma), if the alloantibody was "missed" in the antibody screen and/or cross-match, particularly as it is unlikely that the full phenotype of the transfused (or foetal) red cells would be known.

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.

3-Inventory, Edit, Create product, Pool.  Select units and volume.  We haven't pooled anything in awhile since we get cryo already pooled.

I've experienced remote alarms that were monitored by facilities crew.  Even though the lab was 24/7.  Facilities even did the alarm checks.  Seemed to work pretty well though I had to tweak that system while I was their temp manager.  Alarm probe in freezer in the air - they wanted it to be sensitive, well it was.  The chart looked like a supernova explosion.  I told the medical director if I was inspecting they would be tossing everything out.  Once we put the probe in 50% glycerol the system worked pretty well.  I still did weekly checks on the documented temps for both refriges and freezer.  Otherwise, I agree, if you are 24/7 there is no need for a remote alarm.

Welcome!

In this paper from 1985, "The Lui elution technique A simple and efficient method for eluting ABO antibodies c. s. FENG, K. c. KIRKLEY, c. A. EICHER, AND D. s. DE JONGH, TRANSFUSION 1985; 25:433-434.", the authors thank A. Lui. MT(ASCP)SBB, who introduced this technique to them. Therefore, I believe Lui is the name of the MT who invented this elution method. 

In the blood banks that I have worked at, all used the screen cells to test the last wash except for the ARC IRL which had a very different method of testing the last wash.

In the blood banks that I have worked at, all used the screen cells to test the last wash except for the ARC IRL which had a very different method of testing the last wash.

If you have enough of the unit left, you could use blood culture vials along with an initial gram stain.

In the blood banks that I have worked at, all used the screen cells to test the last wash except for the ARC IRL which had a very different method of testing the last wash.

In the blood banks that I have worked at, all used the screen cells to test the last wash except for the ARC IRL which had a very different method of testing the last wash.

It is with huge regret that I have to report the fact that I have heard that Dr Larry Petz died on 2nd June following a short illness.

One of the all time greats of the world of blood transfusion.
May he rest in peace and I send my condolences to his family, friends and colleagues. 

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 had a melanoma patient on Nivolumab = Opdivo who apparently has hemolytic anemia but his IgG was only microscopically positive and his complement was negative.  Hgb 5.5. Retic % slightly elevated, absolute retic normal, immature fraction retic very high. Bili and LDH normal. Hpt <14 and responded to steroids.  They blamed this drug so I hunted up this article.  This was new to me so I wanted to share it.
Clinical Trial Am J Hematol  2019 May;94(5):563-574. doi: 10.1002/ajh.25448. Epub 2019 Mar 13.
Clinical and laboratory features of autoimmune hemolytic anemia associated with immune checkpoint inhibitors
Rebecca Karp Leaf 1, Christopher Ferreri 2, Deepa Rangachari 3, James Mier 3, Wesley Witteles 4, George Ansstas 5, Theodora Anagnostou 6, Leyre Zubiri 1, Zofia Piotrowska 1, Thein H Oo 7, David Iberri 8, Mark Yarchoan 9, April K S Salama 10, Douglas B Johnson 11, Andrew D Leavitt 12, Osama E Rahma 13, Kerry L Reynolds 1, David E Leaf 14
PMID: 30790338 DOI: 10.1002/ajh.25448
Free article
Abstract
Immune checkpoint inhibitors (ICPis) are a novel class of immunotherapeutic agents that have revolutionized the treatment of cancer; however, these drugs can also cause a unique spectrum of autoimmune toxicity. Autoimmune hemolytic anemia (AIHA) is a rare, but often severe, complication of ICPis. We identified 14 patients from nine institutions across the United States who developed ICPi-AIHA. The median interval from ICPi initiation to development of AIHA was 55 days (interquartile range [IQR], 22-110 days). Results from the direct antiglobulin test (DAT) were available for 13 of 14 patients: 8 patients (62%) had a positive DAT and 5 (38%) had a negative DAT. The median pretreatment and nadir hemoglobin concentrations were 11.8 g/dL (IQR, 10.2-12.9 g/dL) and 6.3 g/dL (IQR, 6.1-8.0 g/dL), respectively. Four patients (29%) had a preexisting lymphoproliferative disorder, and two (14%) had a positive DAT prior to initiation of ICPi therapy. All patients were treated with glucocorticoids, with three requiring additional immunosuppressive therapy. Complete and partial recoveries of hemoglobin were achieved in 12 (86%) and 2 (14%) patients, respectively. Seven patients (50%) were re-challenged with ICPis, and one (14%) developed recurrent AIHA. Clinical and laboratory features of ICPi-AIHA were similar in DAT positive and negative patients. ICPi-AIHA shares many clinical features with primary AIHA; however, a unique aspect of ICPi-AIHA is a high incidence of DAT negativity. Glucocorticoids are an effective first-line treatment in the majority of patients with ICPi-AIHA, and most patients who are re-challenged with an ICPi do not appear to develop recurrence of AIHA.
 
 
 

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   

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 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. 

Wow. Never heard this one. I agree with SbbPerson that it's a JC thing due to the dirt that could be on the box, but if you are keeping the boxes in an area where you are not doing testing (aka the storeroom) I don't see how they can enforce this. We keep our saline in the boxes as well, and they are just on a wire rack in the room next door. No one has batted an eye at this, between CAP, JC and the FDA. Can you make a case that when the saline bag is out of the cardboard it is less safe? Like, once the level of the saline gets too low in the bag, its too difficult to get the saline out, and therefore it's wasteful? Try to find a way to make them see the bad sides of having it out of the box. Good luck! 

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.

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 actually injured myself resulting in surgery trying to save a cube of saline that was in a damaged box. They weigh 50 pounds and without the support of the box, they are a hazard.