Dar Posted July 15, 2009 Share Posted July 15, 2009 My CAP inspector nailed me for no panel QC. The last thread on this was a year ago, so I thought I'd start it again. I thought Id run one heterozygous little c cell (negative for D) with my diluted ortho confidence antibody each day of use to prove specificity and reactivity. What is everyone doing out there? Is anyone running a negative cell? Thanks! Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 15, 2009 Share Posted July 15, 2009 Hi Dar,There is a thread on just this topic under "All other topics" started by PHYLLIS on 22.12.08, named "Quality Control of Panel Cells" that has some more up-to-date posts than you suggest.Yes, we run a negative as well as a positive. Link to comment Share on other sites More sharing options...
John C. Staley Posted July 15, 2009 Share Posted July 15, 2009 Nonsense!!! Challenge the CAP inspector. They are off base on this issue. So what if you run anti-c? That tells you nothing about the rest of the antigens. This is one more example of QC gioing off the deep end. Waste of time and money!Just what CAP question did the inspector refer to when "nailing you"? Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 15, 2009 Share Posted July 15, 2009 Nonsense!!! Challenge the CAP inspector. They are off base on this issue. So what if you run anti-c? That tells you nothing about the rest of the antigens. This is one more example of QC gioing off the deep end. Waste of time and money!Just what CAP question did the inspector refer to when "nailing you"? I couldn't agree more with you John.If they are going to insist on other antigens being tested, they should at least choose those that are known to be labile upon storage (or maybe not labile, but at least are known to weaken during storage) like the Duffy antigens.It is utter nonsense. Link to comment Share on other sites More sharing options...
Dar Posted July 15, 2009 Author Share Posted July 15, 2009 Well, funny you mentioned Duffy. Actually, my inspector was hit for the same item, so she dilutes Duffy a and runs it only when she receives the panel. I asked her why she chose Duffy, thinking along for your reasoning. She said: "that's just the one I picked". I'm sorry, but antisera costs too much for this stuff. Personally, I think running it only upon receipt is kind of silly. Remember, the CAP 31400 says follow manufacturer's directions.....which say to check "periodically with weak antibodies" and "may be checked periodically by testing the antigens likely to deteriorate, like Lea, with a weakly reacting antibody of the same specificity". Link to comment Share on other sites More sharing options...
PaulSunV Posted July 15, 2009 Share Posted July 15, 2009 In addition to the posts by others Immucor's Panoscreen cells does not require any QC to be performed other than a visual inspection. It does indicate that the cells MAY be checked periodically for antigens likely to deteriorate. The key word being may and not shall and therefor no requirement to do so."Quality Control: In addition to visual inspection for evidence of deterioration, the reactivity of the red blood cells maybe checked periodically by testing antigens likely to deteriorate, such as Lea, with a weakly reactive antibody of the same specificity. If such red blood cells are found nonreactive, the product should not be used." Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 15, 2009 Share Posted July 15, 2009 Well, funny you mentioned Duffy. Actually, my inspector was hit for the same item, so she dilutes Duffy a and runs it only when she receives the panel. I asked her why she chose Duffy, thinking along for your reasoning. She said: "that's just the one I picked". I'm sorry, but antisera costs too much for this stuff. Personally, I think running it only upon receipt is kind of silly. Remember, the CAP 31400 says follow manufacturer's directions.....which say to check "periodically with weak antibodies" and "may be checked periodically by testing the antigens likely to deteriorate, like Lea, with a weakly reacting antibody of the same specificity".Dar, I agree wholeheartedly with you. What on Earth is the point of testing for the antigens that weaken during storage before you've stored them?I think she's lost the plot and needs retraining before she comments on others' shortcomings (an incredibly common problem amongst inspectors throughout the world it would seem). Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 15, 2009 Share Posted July 15, 2009 In addition to the posts by others Immucor's Panoscreen cells does not require any QC to be performed other than a visual inspection. It does indicate that the cells MAY be checked periodically for antigens likely to deteriorate. The key word being may and not shall and therefor no requirement to do so."Quality Control: In addition to visual inspection for evidence of deterioration, the reactivity of the red blood cells maybe checked periodically by testing antigens likely to deteriorate, such as Lea, with a weakly reactive antibody of the same specificity. If such red blood cells are found nonreactive, the product should not be used."I think that they are being optimistic or wildly over-confident about their product. Link to comment Share on other sites More sharing options...
Dar Posted July 15, 2009 Author Share Posted July 15, 2009 Well, I don't believe my c option is the best; however, it's not wasting big money on antisera. And really, do we care if we are not seeing the labile antigens, since our screening cells aren't checked for them. Evidently, we don't care if we can detect them. We only care that we can ID once we detect:) Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 15, 2009 Share Posted July 15, 2009 Well, I don't believe my c option is the best; however, it's not wasting big money on antisera. And really, do we care if we are not seeing the labile antigens, since our screening cells aren't checked for them. Evidently, we don't care if we can detect them. We only care that we can ID once we detect:)No Dar, I think you've got the wrong end of the stick about what I was saying.You could miss an anti-Fya (for example) because your Fy(a) antigens on your panel have deteriorated.It is important to know that your panel's labile (ish) antigens have not deteriorated to such an extent that you miss a clinically significant antibody. It is not that the antibody is labile (although, of course, some are, such as anti-Jka). Link to comment Share on other sites More sharing options...
Dar Posted July 15, 2009 Author Share Posted July 15, 2009 No, we are on the same path. I'm just not making myself clear. What I am saying is that we are not required to check for the labile antigens on our antibody screening cells. Why should the panels be any different? Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 15, 2009 Share Posted July 15, 2009 (edited) No, we are on the same path. I'm just not making myself clear. What I am saying is that we are not required to check for the labile antigens on our antibody screening cells. Why should the panels be any different?The answer is, logically, that you should be required so to do. Otherwise there is a danger that clinically significant antibodies will be missed.I am not, by the way, disputing that you are not required so to do. You just should be! Edited July 15, 2009 by Malcolm Needs AS always, terrible spelling! Link to comment Share on other sites More sharing options...
clmergen Posted July 15, 2009 Share Posted July 15, 2009 The manufacturer's outdate should be such that the labile (ish) antigens are still detectable at time of expiration. IWe concern ourselves about those antigens only if we are using an expired panel. We ran an internal study to determine which antibodies could be ruled out using an expired panel and have that stated in our procedure. We do not run any QC on panels. Link to comment Share on other sites More sharing options...
L106 Posted July 15, 2009 Share Posted July 15, 2009 I see eye-to-eye with John Staley. We do not do any routine QC on our Antibody Identification panels. Never have, and have never been questioned by an inspector from FDA, CAP, AABB, or JCAHO (Joint Commission for the Accreditation of Healthcare Organizations. (Now watch.....one will walk in tomorrow and nail me for it!!)Although it is not checking the stability of the antigens on the panel cells, I do always check that my panel identification matches the pattern observed in the Antibody Screening Test. Also, we type the patient's red cells for the corresponding antigen the first time we identify an antibody (and the lack of the antigen supports the antibody ID.) I know these couple things are not the traditional, confirmatory type of QC, but if it walks like a duck and looks like a duck and sounds like a duck......... Link to comment Share on other sites More sharing options...
SMW Posted July 15, 2009 Share Posted July 15, 2009 CHALLENGE THE CITATION!!!!! Periodically (just like weak) is not defined and one could argue that "weak" reactivity with a patient sample tested anytime during the period of using the panel meets the intent of "....periodically with weak antibodies". May also does not mean MUST. Please don't perpetuate the viscious cycle of implementing a change just because an inspector/assesor "said so" or because they were cited so now they're citing you. If the next inspector/assessor says it's not necessary, will you then discontinue at their whim? :cries:[and not to muddy up your original question, but I disagree with the "you should" comments. If "you should" test those cells then "you should" test every sample (not just those with an initial positive antibody screen) with every possible known technique so you don't possibly miss an antibody that might possibly..........] Link to comment Share on other sites More sharing options...
Dar Posted July 15, 2009 Author Share Posted July 15, 2009 I just got off the phone from CAP. The panel QC is not required! Link to comment Share on other sites More sharing options...
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