Karrieb61

Thanks tbostock, I did read that here previously so I am trying to be very cautious in how we do this. At the moment, I am telling the techs that if the cold is very strong, (4+) in tube, then they can pre-warm the plasma up to 30 minutes before running it on the Echo. I am mindful that warming has its issues. And yes Goodchild, we have a fair number of known colds that we will continue to use to validate this before I make it official. Lots of fun, especially for the techs who think that pre-warming for 60 + minutes (like they used to do) is the answer to all problematic antibody IDs. The flack I am getting back from that small group is ridiculous. The lack of immediate transfusion reactions is their comeback of course, no worries on their part about a potential delayed reaction or a full blown antibody discovered later. .....

I did just find an excerpt froma 2012 article in the American Journal of Clin Path that said that "CLIA allows clin labs to modify FDA-approved tests (so called off label use) to develop their own tests as long as they follow the requirements to validate the performance characteristics of the lab developed test. There were no references cited from what I could see but it does sound like as long as we validate that putting warmed plasma on the Echo doesn't negatively affect expected results (loss of significant antibodies for example) then we might be OK.

Wow, since we are on Memory Lane, I remember back a good 40 years or so working at a prestigious hosp in Boston and needing fresh blood for newborns. We had donors come in from a paid donor service and they frequently arrived filthy dirty, drunk, and desparate for the $25.00 or so that they got for the donation. After cleaning the arms multiple times to get rid of the dirt, I would draw them. If I missed, I would hear 'stick it again, stick it again"!!! OMG, not the kind of memories I am happy to have. Then there was the sweet early 20's hemophiliac guy who came in to infuse his own Factor VIII from our Blood Bank in the late70s-early 80s. Died of AIDS somewhere in the 90s I heard.

Hi all, this goes along with my BBTalk post on running pre-warmed plasma on the Echo. Immucor does not say this is OK to do. I know that many of us run cold screens and panels using reagents that have not been 'sanctioned" to use at 5 or 15 degrees so we are using products off-label at least for this. I am wondering if anyone can quote an FDA-CFR or other agency standard that tells us we can't run a test that we have validated on our own (method comparison kind of validation) but which the manufacturer has not sanctioned, blessed, validated themselves, whatever? This might apply for pre-warmed plasma run by tube also, I haven't checked that yet. Hope this makes sense, thanks

Hello again all Echo users, today's topic is pre-warmed plasma use on the Echo. We have had a couple of known patients with HX of cold, non-specific antibodies where we have used pre-warmed plasma (heat block 30-60 min) and run the usual pre-warmed manual screens, panels, and crossmatches. For the heck of it, our lead tech confirmed the colds again on both patients, prewarmed the plasma and ran panels and crossmatches on each by popping the warmed plasma into the Echo and running the tests individually (no other test of any kind on any patient loaded at the same time). In all cases, we got negative screens, panels, and/or crossmatches, just like we did doing the usual manual pre-warm technique with tubes. Yes, I know this is not approved by Immucor but I am wondering if you run pre-warmed plasma anyway on the Echo. In order to make this legitimate, I want to validate this by doing a method comparison as we get more samples into the Blood Bank. One of my continual concerns is that many labs run cold screens and panels routinely even though the vendors do not approve this using their liquid reagents (with the exception of the Ortho panel which permits a 15 degree cold). I would like to eliminate these all together since we aren't supposed to be concerned with IgM antibodies usually but if a patient has a strong cold, AND we can warm it up enough to run it on the Echo AND then get negative panels, or compatible crossmatches, then it seems like we have also ruled out misc. warm allo antibodies that may have been masked by the cold. What do you think?

Without consulting my current antigrams, you are finding enough homozygous cells epfeiffer to do all these rule outs with select cells? How did you happen to pick up the Kidds- incompatible, Kidd pos unit crosmatches? We did switch to the Echo back in September and things are OK with some significant exceptions that I continue to address, mostly non-specific allos (or are they false pos cells?) and equivocal results, most of which go with the non-specifid allos. . I am about to put up a new post on using pre-warmed plasma on the Echo for your reading pleasure everyone.

I agree with Dansket. I would call any "process" that produces a result with steps that are different from another "process" to be a different method

Thanks Terri, the Note to Tech sounds awesome!

OK thanks for the info!

Hi all, there is an outside chance that our little blood bank will have Soft SCC software installed as a stand alone program. First of all, I didn't think that was possible, I thought it was part of a larger LIS. Our current, very antiquated "LIS" (Star) allows us to enter BB results manually, no interface with our Echo, all other procedures are strictly manual anyway. If we get Soft SCC, is it set up so that we could manually transcribe all the patient histories into it from Star, then going forward we have our patient histories in Soft such that a new manual entry into Soft will be flagged if, for example, the ABO/Rh does not match the historical type on record? Hope this makes sense. I did a validation once years ago for a hospital going from manual Blood Bank record keeping to Meditech but it was a module as part of a lab-wide Meditech. So I don't know if this single Blood Bank system is even possible. Are my lab administrators misinformed?

We use clear plastic. In a former job, the BB was using lunch bags till the day when a transporter went to the Caf first, left the bag on the table and it was scooped up and tossed in the trash somewhere. That was the end of the lunch bags.

Funny that another Echo user just emailed me about this belt thing. Overall, it appears to be an issue with the cells getting older in their little bottles, as it only seems to happen when we've been using the bottles for many days. We are too small for a ProVue but I have to say that where I was before, they had constant mechanical breakdowns. So nothing is perfect. Both are better than tube for sure for a variety of reasons so despite occasional problems, I would hate to give up the Echo.

Thanks RaeRae, I heard from a couple of other Echo users that they see this often when the bottle is "old" but its still a pain in the neck.

Hey all Echo users, we seem to be experiencing an increase in the number of patients who are backtyping very weakly, 99% of the time on the B which drives us to double check the type manually. These are not elderly (although our new young 23 ish tech though that the current patient at 52 was elderly..... ) or immunocompromised patients to the best of our knowledge. Daily QC is fine. Anyone else seeing this?

Oh boy, I am so confused. For what's it worth, we get some units already screened by our Blood Center for Kell, C, E, c, e and we don't charge the patients if they need one of these. Kind of like they already were screened for the ABO and D antigens when we got them and we don't charge the patient for retyping the units from the Blood Center. We charge only the first patient we antigen typed the unit for, then tag it, and if not used, its a freebie for the next patient. We charge for each and every antigen on a single unit that we screen and that is the part that now worries me. If audited, do we get slapped? We were billing for some misc charges using a defunct CPT code (gone since 2010 I found out) and our billing people never said a word which amazes me because these were screens that they had to look at each time. I only found out when I investigated an error a tech made while billing a patient recently. Now I have a headache

We dispense it but we don't call the medical staff to tell them that they need it. Its up to them to read the report sent with fetal Hgb results or Mon's bl od type, whatever which they can read from their monitors.

OK, thanks, I will let this ride until I am on site. I am still not clear on what the word "label" implies- little sticker on bag? Separate label with all kinds of official sounding words and references to standards??? I'm probably worrying too much about it anyway plus I am 9 plus hours away from a short vacation so my brain is shutting down LOL

For the expired patients, I decided to keep the paper workcards indefinitely if they had an ABX or other sig history and I am tossing the rest of them whenever the file gets full which should take a couple of years. All of the patient info is kept in other files including the medical records so hopefully I will never be challenged on keeping "dead" patient workcards available in the lab itself

RaeRae251 and anyone else reading this for Echo -interest. We finally got a few weeks of equivocal results "corrected" with a new lot of Indicator cells and Immucor is telling me that they think the equiv. results had something to do with the donor mix in some lots. Whatever, all I know is that now things are much, much better. I didn't have a choice of new technologies here for political reasons but would probably have not chosen manual gel as it would still constrict our second and third shift techs from working in other parts of the lab due to the clock watching. We are way toosmall for a Provue and my experiences with the Provue is that there is frequent downtime due to mechanical issues. So for our volume and convenience of crosstrained 2nd and 3rd shift people, Echo was a good choice. We are certainly struggling with the What to Do When xxxx Happens but nothing is perfect. Now its a matter of slowly convincing a few older techs to trust it and stop running to the tube every time the Echo presents them with a challenge. I am at least insisting that even if we have a nonspecific antibody on the Echo that crossmatches be done on it so we have the same level of sensitivity for the donor units/patients.

I can't give you info anything as great as Malcolm can but I will say that I am finding recently that the methodology can create some problems- we are now Echo users and the Echo is super sensitive. Frequently our tube backup will be negative but we think there is something going on and we can find no compatible units. But our Reference lab always starts with tube and only goes to GEL (no Echo) if the tube results from the specimen we send are positive. So now we don't send much because if they start with tube and get negative results, that's the end of it unless we insist on an eluate (pos DAT under 3 months since last transfusion etc) or full phenotyping of the patient at least. Basically, we now call and "negotiate" what we want done based on our current problem. Tons of fun

OK, so I think I asked something around this recently. I am clearing out a ton of very old records (mostly putting into Storage) and I really wonder what "Indefinitely" means- if a patient has expired, can we dispose of the panel records also after a time? I can imagine that the possibility of someone wanting to review records in a death investigation but , for example, I have records dating back to the 80s on patients who would now be 110 if they are alive. I have old patient workcards of officially expired patients that have sat there for years. If the information/history of the patient and the units they received and their antibody history is retrievable elsewhere, there's no reason to keep the cards of the expired patients right?

My first concern here is- who's overseeing your training? This sounds pretty scary to me if you are being left on your own to figure out old SOPs. Is there no Blood Bank Supervisor? Did they ever put together a flowchart about what to do when you get what looks like a cold auto or allo from your screening? Do you have a Lab Director to talk to and ask who should have answers for these questions. I do understand that many blood banks are not overseen by blood bank experts but that's no excuse for leaving a tech helpless. Are you accredited by CAP or AABB? Why are only screens done on the Echo? That sounds weird too. Bottom line is that someone needs to be held accountable for the validity of your SOPS but if people are saying they don't understand them, then I would get the heck out of there unless you find someone to help you. I was out of BB for many years when I landed back in one and have re-learned A LOT right on this site. So my first suggestion is to look at the tons of previous posts here on how people handle colds and whether or not they do prewarming. You will see many opinions but they pretty much fall into a pattern. Overall, the consensus is to avoid prewarming since a traditional screen will use 37 degrees incubation which should take care of most colds. Otherwise, you risk warming-away a significant antibody. Colds I have a problem with myself. Unless they are Anti M's which may carry through to IgG/Coombs testing at the end of a screen or xmatch, colds are generally harmless. Your unique patients may be those who require a blood warmer but those are few and far between. One problem with colds we have here (which I am trying to address around other stuff) is that we do cold screens and panels in the 4 degree frig which the reagent manufacturers don't approve of. So what happens if there is an adverse event with the patient and the FDA says show me how you were able to validate a procedure not approved by the vendor? Hopefully lots of the GREAT folks here will respond to you also but my experience as a consultant working with 19th century labs is that I've seen these situations before and you are smart to be worried!!

HI David, just saw your post. I read somewhere that they have these units but I'll be finding out soon when I go there.

Thanks SMW, its a CAP inspection . I was looking for some official language to use but 5.6.7.1 is way too vague. I am wondering what the label should look like or is a sticker on the bag OK? How detailed should the label be? Maybe the guidance says all this which I will check now.

HI, I am about to inspect a Blood Bank that draws some of its own blood. Just wondering about labeling for those hemocromatosis units drawn as therapeutic phlebotomies but which can be used as an allogeneic unit. I can't seem to find any guidelines or standards on how, if at all, the unit has to be labeled to alert someone (?) that the donor has hemochromatosis. Any suggestions?