ABQ bloodbanker

I have been trying to reduce the amount of QC we do on reagents, so I've been investigating the requirements that the regulatory agencies have for performing reagent QC. Currently we run QC daily, and repeat it when we switch out reagents or run out of a vial and open a new one, even if it is the same lot number. On our ProVues, we switch out cells and diluents every 12 hours. All of the responses I have received so far have been to just do what the manufacturers recommendations are, which is do only perform on day of use and when switching to a new lot #s. I have just discovered that JACHO, which inspects the hospital we are located in, has a standard QC.5.220 C stating "each opened vial of antisera, reactive cells, and reagents is tested for reactivity on each day of use and when a new lot of reagents is first used.":cries: How is it that most labs are getting by with only performing QC once a day? This is what I would like to go to, but do not want to get "dinged" if the hospital inspectors look in the lab at our QC.

Does anyone have a sample variance letter to the FDA requesting to extend the expiration date of thawed plasma from 24 hours to 5 days? Thanks

I have been in Albuquerque for 9 months and can't figure out why we do so much QC on our reagents. It is a "supposed" CLIA regulation that everytime you switch out reagents, even when they are the same lot number, you have to QC them. I cannot find anywhere in the CMS/CLIA regs that state this. All I can find is to do what the manufacturer recommends, which is once daily. We used to have an Immucor ABS2000 and now we have 2 Ortho ProVues, and we switch out all reagents every 12 hours (the diluent is good for only 16 hours at RT) and we rerun all of our QC. Or if on our manual rack, we run out of a vial (of Anti-A for example) we redo QC even if it is the same lot. I personnally think we are going overboard with our QC, wasting QC material and gel cards and wanting to stop duplicating our efforts. All the labs in the area only perform QC once a day, so if you could please offer some insight for me, I would greatly appreciate it! Thanks, QC'd to death!

Yes, I know. We do use the Anti-IgG/Anti-C3d, but cannot get the C3d/Control cards yet. But unfortunately, they are not available in the US yet. Thanks for your reply.

Hi Dave, I see how you would add your 0.8% patient cells and your Anti-C3d to the buffered gel card, but how do you do your check cells? I guess I'm confused about that part. Denise Campbell/Dufault PS Are you still at Littleton Regional?

Hello All! We currently do DAT's in tubes, Polyspecific first, and then if it is Positive, we will do IgG and C3d separately. I would like to switch to doing DAT's in gel, because of the increased sensitivity (and we just got 3 ProVues). This presents a problem, however, because Ortho does not have a C3d gel card. How many people out there are just doing IgG and Polyspecific only and letting the physician figure that if Poly is Positive and IgG is negative, it's probably due to Complement??? This is what I want to do, so we don't have to keep d oing the C3d portion in tubes, but I can't find any documentation in the Tech Manual to support this. Any recommendations??? Thanks Denise

I have seen a few significant Anti-M's in my day, but I don't want to go overboard and treat every Anti-M that we see in gel as significant and have to antigen type units. Currently, we just do crossmatch compatible units, however, this doesn't work if the patient has a current negative antibody screen, or if its very weak. Any suggestions? We really don't want to go back to tube testing and test all 3 phases..... Denise

I actually preferred the Tango over the ECHO and the ProVue, because of its ease of use, refrigerated reagents, and the ability to do 140 specimens at once. We went with the ProVue however, due to the FDA licensure of the panels and antigen typing, which is what we were mainly looking for and the Tango is yet to be licenced (should be by this summer though)

We currently do a forward retype on all patients with no prior history, regardless of transfusion status. It is preferable that a second tech perform the retype on the same tube (if a second tube is unavailable), however, the retype must be done before units are issued, so if it's on an off-shift or weekend, the same tech may do their own retype, using fresh aliquots. We are thinking of requiring a second tube for our cardiac surgery patients with no prior history so we can utilize the electronic xmatch on them, getting that second draw when the IV is started before their procedure.

We do test all cords from Rh Neg mothers as well as type O mothers. The physicians do not want to give this up, try as we might.

I do plan on it, but we haven't actually implemented it yet.

We had our AABB/CAP inspection in August and all of our facilities got dinged on this one. What we proposed to CAP and they agreed is that when we do our history check to see if a patient needs to be drawn, we will document if they have a prior history with us, and if not, we send 2 individuals if possible to identify the patient and both sign the requisiton and tube. If only one person is available, they grab a nurse to double identify patient. I stated in our policy that two "individuals" identify the patient, not necessarily licensed personnel. ABQ bloodbanker

We get our platelets from United Blood Services and they have the 7 day expiration. We definitely have a decrease in our outdating! ABQ bloodbanker

Franklyn, Would you consider it mislabeling if the original product was 24hr plasma and not "FFP"? That is typically what we get here.

I have been researching 5 day plasma because we outdate so many with the 24 hour rule. I plan on relabeling units as thawed plasma with a 5 day outdate from the get-go for use on all patients except neonates, pediatrics and liver transplant patients.