MeganPLT

We have had our two Visions for about 6 weeks now and love them!  We routinely run Panel A on them.  Each shift has two panels.  We take the panels out of the fridge and let them come to room temp.  The Visions are configured to reflex the panel when an antibody screen is positive.  (Note: if you have to manually review a positive screen, it will not reflex) When the instrument reflexes a panel, it will beep and the bubble will turn red if the panel is not on board.  That is our cue to load the panel.  We will put Panel B on if we want to run it, but it is not routinely taken out of the fridge until needed.  If we don't get clear-cut results with Panel A, we will use Panel B, or maybe selected cells to help confirm an antibody.
As for the second question, I have never heard of extending the incubation for weak to 1+ reactions on antibody screens and panels in gel.  I don't think this is necessary at all. Gel is very sensitive already and the instructions are for a 15 minute incubation.  I seem to remember reading that gel cards should not go past a 30-minute incubation due to dissociation of antigen-antibody complexes if formed. 

We didn't.  We now have 2 Erytras.  Had the first for about 1 1/2 years, the second we just got.
 

I will have to go back to my validation binder to get the specifics for you.....plus am a little hesitant in that I do not want to make a definitive negative statement concerning Grifols testing (as I myself have not come to a negative conclusion).  For the most part, it is working as expected.  But I can answer some of the other issues you raised.  So when the Erytra is questioning whether or not a Screen is Positive (calls it an NRD), then you have to make a decision. You can look at the card (or picture....but as stated previously, I tend to shy away from those giant pictures); and perhaps you decide to change the NRD to Negative....or you can do further work.  At least at this moment, we choose to do further work based on both our validation results and on our admitted need to become more used to how we interpret the Grifols Cards , but also just the fact that it is new and I want to kind of continue correlation studies a little longer.  So we would not interpret that questionable reaction just based on looking at the card.  We would perform a panel (Grifols; or Immucor) and/or PeG testing. 
As far as other screens we have pursued further....if we run a patient on the Erytra who has known antibodies (and was reactive when last tested) and it is Negative, we will either perform a PeG Screen, or run some Immucor cells in Ortho IgG (which is better as far as comparison studies than using PeG).  So I guess we are still just "learning" about the Erytra (and I am feeling better about it the more we use it...AND, the more I do these comparison studies).  Another thing to keep in mind is that when we did our initial comparison studies, a lot of those were frozen known antibody specimens, so perhaps those just didn't run as well on the Erytra as other techniques....because as I stated, it is getting better.
Hope that helps a little....sorry for not being more specific on antibodies but don't know how much could be due to being new users and/or using older, frozen specimens....so would not want to make too many associations with the Erytra at this point in time. But will keep you guys posted should I become more concerned....just wanted to throw it out initially so you would all also do due diligence when doing your comparison studies.
Thanks
Brenda

Great answer @AMcCord! I would just add - if you are just getting used to the echo or NEO - everyone has forgotten once and then they are really careful not to do it again; so don't beat yourselves up! I know I still check by ringing the vial like a bell at the beginning of my shift just to make sure! - Because - if the vial doesn't have the stirball and the person before you loaded it; it is stills works for the first couple hours or so until the red cells start to settle to the bottom of the vial!  

Great answer @AMcCord! I would just add - if you are just getting used to the echo or NEO - everyone has forgotten once and then they are really careful not to do it again; so don't beat yourselves up! I know I still check by ringing the vial like a bell at the beginning of my shift just to make sure! - Because - if the vial doesn't have the stirball and the person before you loaded it; it is stills works for the first couple hours or so until the red cells start to settle to the bottom of the vial!  

Yes. Without the stir ball the Echo is sampling a reduced number of indicator red cells/more diluent. The longer the vial is on the instrument without the stir ball, the more settled the red cells become and fewer and fewer of them are sampled/added to the test well. In the package insert for the indicator cells under Limitations: "Addition of too few indicator cells, as might occur with improper mixing of the reagent or through hemolysis of red cells, will cause weak falsely positive results." The vial should be discarded and a new vial with a stir ball loaded on the instrument before performing any additional testing. You'll see funky results with A and B cells missing the stir ball, too. Those vials should also be discarded and replaced with new vials/stir ball added.

So we went LIVE with our Erytra this week.  We had a couple of hardware issues along the way (though nothing major).  One change I made (and this was just a personal decision) to prophylactically prevent 1 type of issue, is that we changed the double-layer racks to single layer (so when we take them out of the box....we have saved empty racks after use so we place the top layer in a 2nd rack).  We do that because in training, they emphasize how you have to make sure the cards are patted down; that a corner doesn't pull back up, like maybe from your glove sticking; that the drawers must be closed very carefully or it could jar the cards.  Well,  you can "teach" your staff all of those things, but you KNOW it is going to happen (some heavy-handed tech. is going to come along and just slam the door shut.....then you are in trouble  ).  So by making single-layer racks, we hope to decrease gripper vs. card issues.  Our workload is not so high that we needed the 2nd layer....even filling the Erytra with single-layer card racks in every space, is more than we would use in 24 hours. One thing to be careful with if you do that though is that when you are handling the cards, do it gently so as not to cause splashing within the wells; otherwise, you create another problem.  Another change we made is that it was initially connected to a drain.  After training (and learning to do decontamination), we decided to have it switched to reagent waste bottles.  Again, our workload is such that we would not even fill 1 of those bottles in 24 hours much less 2; so we cut down on the tedious decontamination process.
You also learn some things the hard way.....like if you remove a solution bottle to add more solution, don't close the drawer!  If you do and the analyzer is priming (or wants it for something else), it will disable the probes.  So leave the drawer open during the process.  There were several things like that we learned by making the mistake.  The more we use it, the more we learn (there is a lot to learn with the touchscreen).
But we still really like it.  There are some software changes we would like so they are adding them to a new version coming out next year.  Also, they definitely need to "beef up" their panels (and they know that).
All in all.....a good purchase.  My only outstanding concern is some missed weak antibodies (which we will continue to watch for.....for now, every questionable antibody screen will be repeated by Tube PeG).
Brenda Hutson, MT(ASCP)SBB

Do you have a big L&D service?  We do a T&S on all L&D admissions.  This saves us time (and anxiety) when it comes to a delivery going bad.  It also makes our RhIg evaluations faster.  I'm all for eliminating unnecessary work, but I can't imagine not doing a T&S on our OB patients.

We use the 16 panocell from Immucor and it has 3-4 cells bracketed for the use of a "mini-panel" similar to the @ for ortho.  However - if you look at the note at the bottom of the immucor panel it says this about the bracketed cells:
"In those instances where a patient's serum is known to contain anti D, it may be desirable to perform antibody screening tests with D negative red cells. The panel cells whose vial numbers are set off by brackets [()] can be used together to form a three or four vial D negative antibody screening reagent. All bracketed cells must be used to construct a complete screening reagent"
.
The intent of the bracketed panel is not to perform antibody ID but to be used as an additional extended screen (especially if you use a 3 cell screen where cell 3 will be positive in cases of RhIg administraion). So we perform this "mini panel" as a screen - not as antibody identification.  Remember - Screening cells are not required to have homozygous expression for antigens.  Big distinction so I think people may be trying to use this for more than what it's intent is really for....like tbostock described above.

To add onto what Malcolm stated as well - if we get unexpected reactivity in one method - we do use another method just to be sure - and if there is nothing there we usually monitor the patient with AHG XMs until the screen goes back to negative. We don't try to "chase something down" that isn't there or isn't "clinically significant."  For example, we know we see more Jka's on echo that don't show up in other methods, but I am happy to identify them - the old philosophy "pay me now or pay me later," but we do see nonspecific reactivity. We've used manual gel, PeG, LISS, solid phase (echos) - and gel and echo seem to both have their issues with nonspecific reactivity but I do love when they "find the antibody first." I will also say that we treat our echos as AUTOMATION (not as a tech) everything goes on them; they are the first TOOL to do our workups, so we set our expectations to still do complex workups by bench.  I couldn't imagine life without them. (we are a big hospital with lots of prenatals) However, when a complex antibody comes up or a screen is pos but the panel is unexplained or panagglutinin - we refer back to another method, and move on with life. I also don't believe in a "gold standard" in blood banking - everything is a tool to help aide in patient care (and safety).
I think whatever method you choose to do primarily it is nice to have a flow chart or two - but of course they are not going to catch every scenario and there will always be exceptions. I'll try to get an attachment on here if I can! Nice thread!

To add onto what Malcolm stated as well - if we get unexpected reactivity in one method - we do use another method just to be sure - and if there is nothing there we usually monitor the patient with AHG XMs until the screen goes back to negative. We don't try to "chase something down" that isn't there or isn't "clinically significant."  For example, we know we see more Jka's on echo that don't show up in other methods, but I am happy to identify them - the old philosophy "pay me now or pay me later," but we do see nonspecific reactivity. We've used manual gel, PeG, LISS, solid phase (echos) - and gel and echo seem to both have their issues with nonspecific reactivity but I do love when they "find the antibody first." I will also say that we treat our echos as AUTOMATION (not as a tech) everything goes on them; they are the first TOOL to do our workups, so we set our expectations to still do complex workups by bench.  I couldn't imagine life without them. (we are a big hospital with lots of prenatals) However, when a complex antibody comes up or a screen is pos but the panel is unexplained or panagglutinin - we refer back to another method, and move on with life. I also don't believe in a "gold standard" in blood banking - everything is a tool to help aide in patient care (and safety).
I think whatever method you choose to do primarily it is nice to have a flow chart or two - but of course they are not going to catch every scenario and there will always be exceptions. I'll try to get an attachment on here if I can! Nice thread!

Over the years, tube testing antibody screen has changed significantly: eliminating room temperature incubation (just immediate-spin), then doing away with immediate-spin, eliminating the saline tube and doing 37C Albumin, switching from Antihuman Globulin to Anti-IgG antiserum, then dropping albumin in favor or LISS, reducing incubation time from 30 minutes in albumin to 15 minutes in LISS. 
 
So when I hear about tube testing being the "Gold Standard", I ask, "Which flavor of antibody screen is it?".  4-tubes, 2-tubes, two-cell screen, 3-cell screen, 4-cell screen,  immediate-spin and room temperature/both or neither, Saline and Albumin, Saline only, Albumin only, 37C-to-Antiglobulin only, LISS-suspended cells, LISS-additive, PEG?  How many varieties did I miss?  Tube Testing was a journey, not a Gold Standard.

To add onto what Malcolm stated as well - if we get unexpected reactivity in one method - we do use another method just to be sure - and if there is nothing there we usually monitor the patient with AHG XMs until the screen goes back to negative. We don't try to "chase something down" that isn't there or isn't "clinically significant."  For example, we know we see more Jka's on echo that don't show up in other methods, but I am happy to identify them - the old philosophy "pay me now or pay me later," but we do see nonspecific reactivity. We've used manual gel, PeG, LISS, solid phase (echos) - and gel and echo seem to both have their issues with nonspecific reactivity but I do love when they "find the antibody first." I will also say that we treat our echos as AUTOMATION (not as a tech) everything goes on them; they are the first TOOL to do our workups, so we set our expectations to still do complex workups by bench.  I couldn't imagine life without them. (we are a big hospital with lots of prenatals) However, when a complex antibody comes up or a screen is pos but the panel is unexplained or panagglutinin - we refer back to another method, and move on with life. I also don't believe in a "gold standard" in blood banking - everything is a tool to help aide in patient care (and safety).
I think whatever method you choose to do primarily it is nice to have a flow chart or two - but of course they are not going to catch every scenario and there will always be exceptions. I'll try to get an attachment on here if I can! Nice thread!

To add onto what Malcolm stated as well - if we get unexpected reactivity in one method - we do use another method just to be sure - and if there is nothing there we usually monitor the patient with AHG XMs until the screen goes back to negative. We don't try to "chase something down" that isn't there or isn't "clinically significant."  For example, we know we see more Jka's on echo that don't show up in other methods, but I am happy to identify them - the old philosophy "pay me now or pay me later," but we do see nonspecific reactivity. We've used manual gel, PeG, LISS, solid phase (echos) - and gel and echo seem to both have their issues with nonspecific reactivity but I do love when they "find the antibody first." I will also say that we treat our echos as AUTOMATION (not as a tech) everything goes on them; they are the first TOOL to do our workups, so we set our expectations to still do complex workups by bench.  I couldn't imagine life without them. (we are a big hospital with lots of prenatals) However, when a complex antibody comes up or a screen is pos but the panel is unexplained or panagglutinin - we refer back to another method, and move on with life. I also don't believe in a "gold standard" in blood banking - everything is a tool to help aide in patient care (and safety).
I think whatever method you choose to do primarily it is nice to have a flow chart or two - but of course they are not going to catch every scenario and there will always be exceptions. I'll try to get an attachment on here if I can! Nice thread!

To add onto what Malcolm stated as well - if we get unexpected reactivity in one method - we do use another method just to be sure - and if there is nothing there we usually monitor the patient with AHG XMs until the screen goes back to negative. We don't try to "chase something down" that isn't there or isn't "clinically significant."  For example, we know we see more Jka's on echo that don't show up in other methods, but I am happy to identify them - the old philosophy "pay me now or pay me later," but we do see nonspecific reactivity. We've used manual gel, PeG, LISS, solid phase (echos) - and gel and echo seem to both have their issues with nonspecific reactivity but I do love when they "find the antibody first." I will also say that we treat our echos as AUTOMATION (not as a tech) everything goes on them; they are the first TOOL to do our workups, so we set our expectations to still do complex workups by bench.  I couldn't imagine life without them. (we are a big hospital with lots of prenatals) However, when a complex antibody comes up or a screen is pos but the panel is unexplained or panagglutinin - we refer back to another method, and move on with life. I also don't believe in a "gold standard" in blood banking - everything is a tool to help aide in patient care (and safety).
I think whatever method you choose to do primarily it is nice to have a flow chart or two - but of course they are not going to catch every scenario and there will always be exceptions. I'll try to get an attachment on here if I can! Nice thread!

I've had some inspectors that get really subjective on the standards and I always ask to call CAP "as a referee" or to get clarification of the standard - most of the time they are able to sort it out over the phone! When in doubt challenge the very same day they are questioning you. Sounds to me like your inspector is trying to understand the intent of the standard but may not be a practicing blood banker or they would know comparing IS XM to IgG crossmatch is not method correlation - I'd show them the technical manual in which explains the definitions of the two types of crossmatches and what they are used for - then hopefully the inspector would understand it's like comparing apples to oranges versus gala apples to golden crisp apples (for example gel AHG XM vs tube AHG XM for which the standard is intended).
 
Just to cover ourselves as far as QC review goes - we wrote in our policy that QC is reviewed and passed and marked down on the daily maintenance record sheet and the medical director signs off on that sheet on a monthly basis - so the Medical Director is essentially reviewing that QC passes on a daily basis. If there was ever a QC failure, we have a seperate procedure for corrective action to document what we did to troubleshoot and when QC ultimately passed and the medical director signs off on all corrective actions documents as well. So maybe that might help for the future. It's absurd that the MD would have to look at every QC reaction on a daily basis!
Good luck!

We use the 16 panocell from Immucor and it has 3-4 cells bracketed for the use of a "mini-panel" similar to the @ for ortho.  However - if you look at the note at the bottom of the immucor panel it says this about the bracketed cells:
"In those instances where a patient's serum is known to contain anti D, it may be desirable to perform antibody screening tests with D negative red cells. The panel cells whose vial numbers are set off by brackets [()] can be used together to form a three or four vial D negative antibody screening reagent. All bracketed cells must be used to construct a complete screening reagent"
.
The intent of the bracketed panel is not to perform antibody ID but to be used as an additional extended screen (especially if you use a 3 cell screen where cell 3 will be positive in cases of RhIg administraion). So we perform this "mini panel" as a screen - not as antibody identification.  Remember - Screening cells are not required to have homozygous expression for antigens.  Big distinction so I think people may be trying to use this for more than what it's intent is really for....like tbostock described above.

I've had some inspectors that get really subjective on the standards and I always ask to call CAP "as a referee" or to get clarification of the standard - most of the time they are able to sort it out over the phone! When in doubt challenge the very same day they are questioning you. Sounds to me like your inspector is trying to understand the intent of the standard but may not be a practicing blood banker or they would know comparing IS XM to IgG crossmatch is not method correlation - I'd show them the technical manual in which explains the definitions of the two types of crossmatches and what they are used for - then hopefully the inspector would understand it's like comparing apples to oranges versus gala apples to golden crisp apples (for example gel AHG XM vs tube AHG XM for which the standard is intended).
 
Just to cover ourselves as far as QC review goes - we wrote in our policy that QC is reviewed and passed and marked down on the daily maintenance record sheet and the medical director signs off on that sheet on a monthly basis - so the Medical Director is essentially reviewing that QC passes on a daily basis. If there was ever a QC failure, we have a seperate procedure for corrective action to document what we did to troubleshoot and when QC ultimately passed and the medical director signs off on all corrective actions documents as well. So maybe that might help for the future. It's absurd that the MD would have to look at every QC reaction on a daily basis!
Good luck!

We use the Ortho panel with the @ symbols with no problems.  Here's why I don't care so much that it doesn't rule out everything with a double dose/homozygous expression:
 
Passive Anti-D isn't really an "antibody" as far as our rule out "rules" go.  We have information that the patient received the RhIg, which confirms the reactions in the screen.
 
If we detect an antibody, we are mostly concerned with identifying it.  If they have a history of antibodies, we are mostly concerned with looking for new ones.  With an "interference", like a RhIg or non-clinically significant cold agglutinin, we are just trying to get it to go away.
 
If you look at your screening cells, we are ruling out with single dose cells every single day.  So I look at the @ cells as a screen of D negative cells.  I'm not really considering them rule outs in the true sense.

Megan - Since CAP does not offer an automated DAT survey (as far as I know), my suggestion would be a variation of the #2 option in your list:
 
1.  Perform your regular manual proficiency testing on the CAP-DAT Survey samples (and report your results to CAP.)
 
2.  Then perform the DAT testing on the CAP-DAT Survey samples on your Echo instrument.
 
3.  Don't submit your Echo results to CAP.  Rather, keep the results in a file.  When you get the results report from CAP, compare the report with your Echo results, document whether your Echo results were satisfactory, and have your Pathologist Medical Director sign and date this (and return it to your file.)
 
Donna

HI Michaele, without going to much into the LIS world/language - I am wondering which LIS you use and how you set your system up to NOT do the IS XM. Logically like everyone else is saying the computer is validated to not let an ABO incompatibilty slip pass but our rules are set up as such we can't move on without entering IS grid results....? Any suggestions?
 
Also, we are not electronically crossmatching yet but even if we were to go there I have heard the the rules are set in the truth tables to not allow electronic crossmatch if AHG crossmatch is required due to positive screen....any body have any suggestions for how to set up rules to just let the computer be the ABO crossmatch but not miss doing the IgG portion of the crossmatch? 
 
Good Topic no matter what type of AHG crossmatch you're doing ...

We have had our ECHO for 4yrs now and we love it.  Yes, there are some reactions that the instrument calls "?".  If it appears to be negative visually, we check the reading for the strength of the reaction (Highlight the specimen<Right click<Result file<then scroll down to REACTIONS)  The Assay cutoffs are on page D-6 of the ECHO manual.  It helps us decide how strong the instrument feels the reaction is.  Then if we question, we go to PeG as our backup.  If we get positive screen, then negative or inconclusive panel, we repeat screen in PeG.  If negative, then we crossmatch on the ECHO and if compatible, consider our reactions due to capture technology.  Otherwise we address whatever specificity is determined.  You must keep in mind that some antibodies react stronger on the ECHO while others react better in PeG.  That is why it is good to have two different methodologies available.

Given the extreme sensitivity of the ECHO screens - we call them negative if the instrument calls them negative.  Only very rarely now do we see one the instrument calls negative that visually looks "somewhat positive", especially since Immucor has their Solid Phase problems fixed again.  Any samples that we have any questions on, we also take to PEG in tubes - not much other choice.  If you are used to Solid Phase manual testing, you will think the ECHO looks a little "hazy" around the dots, but that just seems to be the nature of the test on this platform.  We have been using an ECHO for 5 years now and are doing very well with it.  Antibody panels on the ECHO are the only way to even replicate some of these weak positives if you want to have some idea of what the instrument is trying to detect.  Tube testing and manual solid phase testing just don't show them.  Most of the time they are just some non-specific "junk" and the only thing you can do is coombs crossmatch units for the pt.  That may sound like too little work, but understand, the ECHO is probably the most sensitive platform out there and it will find stuff at the very edge of detectability.  Good luck.