Christy Spence Posted October 6, 2016 Share Posted October 6, 2016 I just finished listening to an ARC webinar that included accred reps from CAP, AABB, and CLIA. A question regarding use of expired panel cells was brought up and answered by the reps with, what sounded to me like, some hesitation. CLIA added that we are required to add a disclaimer with each test report in which expired panel cells was used. Something along the lines of it not being an FDA approved reagent, yada yada yada...AND that this will be considered an LDT. Yes, the dreaded laboratory developed test. Have any of you ditched the use of expired panel cells altogether? Are you currently validating as an LDT, including using the disclaimer on each test result? I guess this CLIA person threw me for a loop. Christy Link to comment Share on other sites More sharing options...
mld123 Posted October 7, 2016 Share Posted October 7, 2016 When I came to my current hospital they were using expired panel cells. I got rid of the practice because of the QC issue and having to maintain a policy for when to use and not use expired panel cells. I am glad that I did because this issue looks like it is turning into a problem. So as of about 6 months ago, we do not use expired panel cells for any reason. I would rather give antigen negative blood for an antibody I cannot rule out or send the specimen out to the reference lab if we have multiple antibodies that cannot be ruled out. How did the CAP and AABB reps answer this question? frenchie 1 Link to comment Share on other sites More sharing options...
qualitygal Posted October 7, 2016 Share Posted October 7, 2016 What about using some rare expired antisera? Would that be considered in the same way? Link to comment Share on other sites More sharing options...
Marianne Posted October 7, 2016 Share Posted October 7, 2016 I was listening to that same webinar. They stated that anything past expiration, is off manufacturers approved FDA usage and therefore requires the disclaimer and would be considered an LTD. Link to comment Share on other sites More sharing options...
Gkloc Posted October 10, 2016 Share Posted October 10, 2016 Does anyone who attended this webinar remember the name of it? I would like to check this out and I am hoping that it is/will be posted on the ARC Success site. Thanks Link to comment Share on other sites More sharing options...
Marianne Posted October 11, 2016 Share Posted October 11, 2016 They presented 4 webinars on10-7-16. They did say they would eventually get posted to Success. The one that had this topic was "Ask The Expers: Quesiton and Answer with Blood Bank Inspector"s. They had resp from CLIA, CAP and AABB. The CLIA person stated this and cited CLIA interpretive guideline 42 CFR 494.1271(a)(1), saying that using expired reagents is not following manufacturer's instructions and thus an LDT. Link to comment Share on other sites More sharing options...
Dansket Posted October 11, 2016 Share Posted October 11, 2016 2 hours ago, Marianne said: They presented 4 webinars on10-7-16. They did say they would eventually get posted to Success. The one that had this topic was "Ask The Expers: Quesiton and Answer with Blood Bank Inspector"s. They had resp from CLIA, CAP and AABB. The CLIA person stated this and cited CLIA interpretive guideline 42 CFR 494.1271(a)(1), saying that using expired reagents is not following manufacturer's instructions and thus an LDT. So, it that just one single CLIA person's opinion? Individual inspectors vary as to their personal interpretations within CLIA, CAP and AABB! Link to comment Share on other sites More sharing options...
Marianne Posted October 12, 2016 Share Posted October 12, 2016 So true, but now that they put that out there for the world to hear, you know it will be on some inspectors "radar". Doesn't mean you can't contest it though. Never a dull moment in our field! Link to comment Share on other sites More sharing options...
macarton Posted October 12, 2016 Share Posted October 12, 2016 We use expired panels for ruling out multiple antibodies after testing with an in date panel and also for student training. We have a box back in the walk in out of BB and have the box labeling for student training. Link to comment Share on other sites More sharing options...
Christy Spence Posted October 12, 2016 Author Share Posted October 12, 2016 AABB and CAP didn't respond to the CLIA rep's comments. We use expired panel cells for rule outs only and run controls with each cell (anti-sera and diluent for gel). Since we are a smaller facility, we rely on this practice as we do not stock more than 1 in date panel. If they decide to go down this road, I'm afraid we will be sending workups to the reference lab more often. I have no interest in LDTs! And as far as I know, reference labs have been trying to get some sort of exception for their use of expired reagents. Link to comment Share on other sites More sharing options...
seraph44 Posted October 12, 2016 Share Posted October 12, 2016 I just got inspected by JC and got hit on my Ortho panels. They recommended I do QC with a diluted anti-D on each panel to ensure the panel is working according to manufacturer recommendations. I've been looking into this for a bit now and I plan on making the the following change to my process. This process is the same for both my in date panel cells and expired cells. Ultimately, the reason for all of this is to prove red cell viability. We all perform quality control on our screen cells; I use a QC kit. We then test a patient that happens to demonstrate one or multiple reactions on the detection phase. This patient sample is now used to QC our panel cells. We basically validated our patient with cells that were QC'd. When running the patient (QC sample) against the panel cells, we will detect positive reactions, proving the viability of the cells. When doing additional rule outs, I will also select a cell that is positive for the suspected antibody, to ensure I also get a positive reaction there. Basically, every panel I use will have at least one positive reaction to prove red cell viability. If no reactions are noted, I will have a troubleshoot guide (repeat testing, try a different panel, repeat AB screen, antigen type panel, etc...). I plan on using this same process to prove red cell viability in expired red cells. I think this is safer than doing random QC for a limited number of antibodies, you are ensuring the reactions on the QC'd screen cells are reacting on the panel each time you have a positive antibodies vs. "Should periodically perform quality control on panel cells" as stated by the manufacturer. As far as the disclaimer goes, I think I will wait for something more concrete for these inspectors. I am currently working on responding to JC with this process and see if they are in agreement. AMcCord, mollyredone, AuntiS and 2 others 5 Link to comment Share on other sites More sharing options...
DebbieL Posted October 12, 2016 Share Posted October 12, 2016 We also do something similar to Seraph44. If we start with ECHO and then move to Gel or tube, we choose a positive panel cell to prove that the antibody could be detected using a different method. I called CAP a year or so back about doing QC on panel cells in general but expired panel cells in particular. As far as doing QC on indate panels, each time we use panel cells as controls for antigen typing, you are performing QC on the panel. The control cells should react as expected. However this has to be documented. So.... I redid my antigen typing form and included the panel lot # used to perform the controls. If it is not documented, you didn't do it. So in the life of a panel, it should have QC performed several times without much effort. As far as expired panels, we do not have to do QC to prove the antigen worked. It must be written in our procedure that indate panel cells are used first and expired cells are only used to confirm or ruleout. The expired panel cells would be considered rare or difficult to obtain since we couldn't find exactly what we needed in the indate ones. Also you must follow manufacturers package insert so if it says you must do QC, you must do QC. I certainly hope they don't change this to where it is a LDT to use expired panel cells. Who thinks up these things? Do they try to make our lives miserable? AuntiS, seraph44 and SMILLER 3 Link to comment Share on other sites More sharing options...
macarton Posted October 13, 2016 Share Posted October 13, 2016 We use a patient we did a workup up on a current panel on the new panel before placing the new panel in use. Link to comment Share on other sites More sharing options...
ANORRIS Posted October 19, 2016 Share Posted October 19, 2016 My AABB/CAP inspection is in 2 weeks...I'll let y'all know. LOL Malcolm Needs, AuntiS, Christy Spence and 2 others 5 Link to comment Share on other sites More sharing options...
SMILLER Posted October 19, 2016 Share Posted October 19, 2016 I wonder about using a patient known to have atypical antibodies qualifying as an adequate positive control. Antigen-antibody reactions vary drastically, dependent on the type and quantity of both the antibodies and antigens in question. The point being that a panel that produces a positive for a known anti-K (that particular vial has RBCs that are "viable" for the K antigen), is not necessarily going to detect any other antibody. It would be like saying that if your QC for a potassium checks that everything else on a Basic Metabolic Panel must be OK. Having said all that, it is obviously impractical to QC every cell we use for every antigen that appears on it--we certainly do not even come close to that using commercial QC antisera with our screening cells every day. But when we consider using expired cells--even for "just rule-outs"--I can kinda see the regulator's point about whatever QC we justify using would be considered a lab-developed technique. Scott seraph44, goodchild and Malcolm Needs 3 Link to comment Share on other sites More sharing options...
ANORRIS Posted November 7, 2016 Share Posted November 7, 2016 Well I had my AABB/CAP inspection last week...did great, thank you, but she never once brought up the subject of expired panel cells....and neither did I. LOL Christy Spence, mollyredone, seraph44 and 1 other 4 Link to comment Share on other sites More sharing options...
p1nkr05e5 Posted November 7, 2016 Share Posted November 7, 2016 Excuse my ignorance...Can someone explain to me what the initials LTD stand for? Thanks, Christina Link to comment Share on other sites More sharing options...
Teristella Posted November 7, 2016 Share Posted November 7, 2016 LDT (I think someone typoed above and used LTD) stands for laboratory developed test. Link to comment Share on other sites More sharing options...
mollyredone Posted November 17, 2016 Share Posted November 17, 2016 I wonder about using a patient known to have atypical antibodies qualifying as an adequate positive control. Antigen-antibody reactions vary drastically, dependent on the type and quantity of both the antibodies and antigens in question. The point being that a panel that produces a positive for a known anti-K (that particular vial has RBCs that are "viable" for the K antigen), is not necessarily going to detect any other antibody. It would be like saying that if your QC for a potassium checks that everything else on a Basic Metabolic Panel must be OK. Scott, So probably what should be done is to run antisera (expired or not!) on a cell positive for the one you are trying to rule out and if it's positive and your patient is negative, you could rule that antibody out. If you are trying to rule in an antibody and the cell you selected is positive then that would be adequate without a control. Do you agree? Link to comment Share on other sites More sharing options...
SMILLER Posted November 17, 2016 Share Posted November 17, 2016 Yes, that always seemed reasonable to me too. From comments above, it appears that at least some inspectors would agree that that is a good way to justify using expired reagents, at least for rule-in/rule outs. However, I believe there are still a number of places that do bother doing ANY QC on panels, much less on individual vials for specific antigens, expired or not. Scott Link to comment Share on other sites More sharing options...
tbostock Posted November 27, 2016 Share Posted November 27, 2016 In NY State, their updated regulations ban the use of any expired reagent, validated or not. Link to comment Share on other sites More sharing options...
mrmic Posted December 14, 2016 Share Posted December 14, 2016 God is Great, Beer is Good, Some Regulations are Crazy... Why not use outdated sera and cells for screening and then use the 1 in-date bottle to retest and use as test of record? What about rare red cells and sera from commercial or patients that may be frozen in liquid nitrogen and used to help with antigen and antibody problems? Of course you would run controls. Where have all the blood bankers gone? Who is writing these regs.? Have they been out of the lab too long? There are patients waiting for us and our results..... I will step off my soapbox now. Good Luck to all and to all Good Luck. BankerGirl, mollyredone, exlimey and 3 others 6 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted December 14, 2016 Share Posted December 14, 2016 (edited) 27 minutes ago, mrmic said: Why not use outdated sera and cells for screening and then use the 1 in-date bottle to retest and use as test of record? What about rare red cells and sera from commercial or patients that may be frozen in liquid nitrogen and used to help with antigen and antibody problems? Of course you would run controls. Where have all the blood bankers gone? Who is writing these regs.? Have they been out of the lab too long? There are patients waiting for us and our results..... Could NOT agree more! Edited December 14, 2016 by Malcolm Needs Carrie Easley 1 Link to comment Share on other sites More sharing options...
exlimey Posted December 14, 2016 Share Posted December 14, 2016 1 hour ago, mrmic said: Why not use outdated sera and cells for screening and then use the 1 in-date bottle to retest and use as test of record? What about rare red cells and sera from commercial or patients that may be frozen in liquid nitrogen and used to help with antigen and antibody problems? Of course you would run controls. Where have all the blood bankers gone? Who is writing these regs.? Have they been out of the lab too long? There are patients waiting for us and our results..... Sometimes I think that the "regulators" feel obliged to fix problems that don't exist. Does anyone recall a rash of patient morbidity/mortality due to the use of expired reagents in the blood bank arena? That being said, the use of such material should be restricted to those with the appropriate knowledge and expertise. seraph44, Carrie Easley, Malcolm Needs and 3 others 6 Link to comment Share on other sites More sharing options...
SMILLER Posted December 15, 2016 Share Posted December 15, 2016 I just have to observe here (being a mere generalist) that when an inspector finds us using ANY expired reagent or control anywhere else in the Lab, we would certianly be cited---regardless of any evidence of a "rash of patient morbidity/mortality due" to its use. It seems odd that we expect less oversight for an area within the lab where the potential outcome of even one mis-interpretation of a test outcome could mean life or death for our patients. Just sayin'... Scott seraph44 and exlimey 2 Link to comment Share on other sites More sharing options...
Recommended Posts
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now