jayinsat

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.

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

We did this 3 years ago. We did a minimal validation. The reagents were all the same so you're only really validating the mechanical components of the new analyzer. Therefore, we did just enough to show that the new machines got the same results as the old in regards to blood types, antibody screens (no identifications), DAT, and crossmatches. I think we did 10 specimens of each representing each blood type.

No here as well. Curious though, is there a standard or regulation that forbids autoverification in Blood Bank? I have always heard that it is not allowed in blood bank but why? Can someone point me to the standard? This question has come up where I work several times and I have always just said it is not allowed but can't say why.

Cold-stored platelets are being used in limited situations in the US. To my knowledge, they can only be used for active bleeding, which FDA has loosely defined. Most hospitals are not yet using them because of this loose definition of "active bleeding" and reimbursement. Here are some articles: https://www.fda.gov/media/132379/download https://mrdc.amedd.army.mil/index.cfm/media/articles/2015/FDA_approves_cold-stored_platelets_for_resuscitation#:~:text=The agreement by the FDA,33.8 to 42.8 degrees Fahrenheit.

I would report the crossmatch as compatible and recommend use of a blood warmer for transfusion. No further workup necessary.

We use Immucor ECHO Lumena and, as of right now, it does not do the IS XM. If it did, I would absolutely validate and run them on the automated platform. The reason I say that is because of the staffing and competency issues we are currently experiencing and is forecasted to only get worse. I cannot keep consistent blood bank techs in the blood bank and the generalists, who are often new and weak, do not remember to do the IS portion. I am constantly having to remind them and perform the retroactively. Sure, I can write them up each time but then I would have no one to work the blood bank. Having that on automation eliminates the problem. I did the same with antigen typing, cord bloods, unit retypes, and anything else I could move to automation, simply to make it easier for the generalists. It also provides peace of mind and a level of safety, where I can go back and clearly see what was done. No more wondering whether they added plasma to the tube or not. Just my two cents.

Finding and retaining competent blood bank techs post-Covid has become a real challenge. We have lost so many techs to retirement or travel agencies that it has created a logistical nightmare staffing the blood bank 24/7. There just aren't enough techs to go around. Those still working are all close to retirement (myself included) and are all burnt out. Is anyone else experiencing the same issues? The looming lab staffing crisis is now upon us. Help!

Does the patient have ITP? Is it possible that she is receiving WinRHO (same as RHIG) for ITP? Does she have a low platelet count. I haven't seen this situation in several years but there was a time when patients with ITP who were rh pos would be treated with WinRHO (as long as they had their spleen). It would present as this very scenario you are describing. Another possibility is anti-Lw?

My experience is a little different. We actually had a CAP inspector cite us for not performing qc (1 pos, 1 neg control) on our in lot, unexpired panel cells (Immucor Panel 16) with each run about 7 years ago. We have been doing it since. We only use the liquid panels when we need to rule out additional antigens that the ECHO (solid phase) panel did not exclude. Since we are going from solid phase to ECHO, it does make sense to be sure that the antibody does react in the additional matrix via controls. However, I still disagreed with the need to run a positive and negative control on an in date panel.

Well...I just noticed this post is more than a year old. Not sure why it was revived.

@DARREN, can you order partial sleeves from Ortho? Will they sell them in smaller packages? Another thought is, if you are part of a system, perhaps you can get your supply of cards from your sister facilities that use more volume. That would alleviate the wastage. Just a few thoughts.

@Sonya Martinez, I also would like to know who it is telling you this. My guess is it is some infection control nurse during an inspection that has no idea about immunology, just following a checklist. I experienced that years ago and simply pointed them to similar information that @Malcolm Needs stated. I have always been taught that plastic tubes were not acceptable in blood bank for that reason.

Hi Malcolm, What terminology is recommended in these situations? We have always used "least incompatible" in the states. I think, probably, the majority of our databases have that option listed besides "compatible" and "incompatible." What terminology should replace "least incompatible?"

My initial thought is check for ABO compatibility, which is what exlimey is suggesting. How was the Jka antigen testing performed? Were controls run and did they work? Also, perform a DAT on the units. If they are DAT positive, your crossmatches are invalid. I doubt that would be the issue though. 4 donors all having positive DAT's? If you had a clear anti-Jka identified, and all other antigen groups ruled out homozygously, there is no reason the units should be XM incompatible if they are ABO matched.