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Just wanted to comment that starting 6/27/2016 I will become the interim Blood Bank Manager for the Cottage Hospital system in Santa Barbara, California. Looking forward to the challenges and opportunities this will bring my way.

So I got some buffered gel cards to run anti-C3b C3d for complement testing in a DAT. How many samples do I have to do to validate this method? I ran the last DAT survey from CAP and it worked out perfectly. For those of you who use this method, do you run controls with each sample, since you have to remember to add the antibody? Or do you run a patient control with each sample? I'm trying to get rid of my poly reagent and complement check cells. Appreciate any help!

A little behind the times but I hope everything is going well for you David.

I see this as a current dilemma in our lab since our "seniors" are too fond of the "Nonspecific Reaction" dump. And, if you have read my previous post tilted: "Missing Plasma Protocol", we have faced a patient who had a transfusion reaction which apparently had Anti-Jka but was misdiagnosed as a Nonspecific reaction. I would want to ask for ideas so I could ,at least, evade this problem. Thanks Smiller.

Rant totally justified Anna - and gagpinks, I should have suggested to you well before now to challenge your UKAS Inspector to show where (anywhere) NIBCS reagents are mentioned in ISO15189. I presume that you are aware that the weak anti-D reagent produced by NHSBT has a specific concentration of anti-D (although I am at home at the moment, and cannot, for the life of me, remember what is this concentration, but I know that it is very low, as it was lowered a few years back, to reflect the fact that everyone was getting "too good" at detecting the the slightly higher concentration of anti-D, as a result of using more sensitive techniques, such as column agglutination technology, and, not to be forgotten, a general increase in the ability of Biomedical Scientists to actually detect antibodies!). As I said above, we do NOT routinely use NIBSC reagents in RCI in NHSBT, except for quantification, where we are looking at a concentration of antibody, and all of our eight RCI laboratories have just been inspected by UKAS. We did not get an NC for this. I would suggest that your particular UKAS inspector was, shall we say, a little over-enthusiastic! Were they actually a Blood Transfusion person themselves (either now or retired)?

The nice part about changing from Echo is that the Vision uses the same technology on the manual bench as on the analyzer. The Griffols Erytrya and Griffols bench procedures use the same technology too. I am a proponent of the bench and analyzer to use the same technology. I am a fan of automation in the BB, regardless of the vendor or the size of your BB. Fewer chances for errors and it frees up your techs to do "other things". The nice part about staying with an Echo is that you are "staying the same". I am sure $$ will factor into this decision at some point. I currently do lab IT and we have interfaced Biorad Tangos, soon to interface an Infinity. Our organization was required to purchase a third party piece of software to get this analyzer to interface to Mediware HCLL. This added an extra layer of "work" and most likely cost. Good luck, this is a big decision, hope all goes well for you.

Amy, we recently switched to rotating QC through all shifts this year, after re-interpreting CAP/CMS regulations. I think the staff were || (this close) to a mutiny but it's improved our operations overall because now everyone is more comfortable with performing and documenting QC.

We do!

We do not separate plasma from the red cells. I think that just opens up another opportunity for error and adds a step to the workload. Once testing is complete we toss it into a plastic shoe box in the fridge. Our testing is mostly done on the Echo - if we need to add an automated test, the specimen is brought to room temp and respun for 6 minutes at 3500 RPM. If the tube happens to land upright in the storage box and the plasma/cell separation is good, we would not respin for an immediate spin (tube) crossmatch.

No to separating plasma from red cells because most of our testing is automated. For manual testing - very little "jostling" of the red cell layer occurs during patient testing so specimen re-spinning is usually not required if the tech is careful. We are electronic crossmatch so the majority of additional red cell requests do not require serological crossmatches. Also, for additional requests for blood that requires serological crossmatch we do not include a repeat patient front type.

Lab week has come and gone but this is worth watching. Enjoy! https://youtu.be/1Aq8nrxqYpY

Just finished writing these- Not sure if it is enough- we rarely have a positive so External QC will have to suffice TRM 299 Parallel Testing.doc TRM 299A Lot-to-Lot Verification.doc

Welcome to the West!

Congratulations!

Is your patient male or female - not that it matters that much, to be honest???!!!!!!! IgM antibodies, which include ABO and H isoagglutinins, react optimally at 4oC, and so, if you are storing the patient's sample for 15 minutes in a refrigerator, you will be bringing down the temperature of the plasma in the sample, perhaps not to 4oC, but certainly closer to 4oC. In addition, IgG ABO and H isoagglutinins also react at 4oC, with no need for any potentiators, such as enzyme-treatment of the red cells, and cause direct agglutination (just see an EDTA sample of a cord blood from a baby suffering from even mild HDFN due to ABO, that has been left in a fridge over night. The baby cannot have made an IgM auto-antibody at this stage, the maternal IgM antibodies cannot have passed through the placenta, and so the agglutination seen in the sample must be down to the maternal IgG ABO and H isoantibodies). So, to cut a long story short, The patient's condition can account for the reverse group at initial testing, but the temperature can certainly account for the "appearance" of the reaction after time in the fridge.

They're still applying an incorrect interpretation of CLIA as it pertains to Transfusion Services (immunohematology). All blood bank activities are high complexity. High complexity testing doesn't have a 'technical consultant' designation. They have technical supervisors and (without re-reading) only MD, DO, and maybe doctor of podiatry(?) qualify. Technologists who Lead/Supervise/Manage/Senior Tech (however your organization calls it doesn't change the CLIA interpretation of personnel) have to be qualified as general supervisors. General supervisors may perform competency assessments. If you qualify as testing personnel and have two years of experience in high complexity testing (which it sounds like you do), you are qualified to be a general supervisor.

We are performing direct observation audits routinely so we are "QC'ing the user" to determine if the staff are performing the test correctly. We perform correlation studies 2 x year in which we correlate automated vs manual methods. I have searched the regulations and can't find any requirement addressing the initial post.