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FDA reportable? Failure to follow XM procedure

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Hello everyone,


I recently discovered that the techs are not following the SOP for crossmatching for patients with antibodies.  The SOP states the following in the scope section of the SOP: A full serological crossmatch is done on all patients with currently demonstrating clinically significant antibodies or who have a history of clinically significant antibodies. 


The SOP states later:  Perform Immediate Spin Phase when the patient has antibodies as the first phase of a complete serologic crossmatch.


There is also a flow chart that clearly indicates that an IS reading is required when performing a serological crossmatch.


I discovered that blood had been transfused that did not have the IS reading done.  I suspect that this practice spans several years.



My question to you all is this:  is this reportable to the FDA as a BPD? 







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Under 21 CFR 606.171 you must report any event associated with manufacturing/storage/distribution, if


a] it represents a deviation from cGMPs, applicable regulations, applicable standards or established specifications, that may affect the safety, purity or potency of the product,

b] occurs in your facility, and

c] involves a distributed blood product.


manufacturing includes testing (including compatibility testing)


From a strict interpretation of the FDA guidance, I would say that it's reportable. The crux here is your own procedure that indicates it must be done, so if it's not done and there's a blood product distributed then it's reportable because you've identified that as a step which must be done and the process should have prevented it from being issued.


Some follow up questions I would have: Why aren't the techs following the procedure as written? Personal diversion/Training-related? Why wasn't it caught sooner? e.g. competency assessment, review process. Is there an opportunity to have another look at your procedure?


edits due to the infernal sunglasses smiley face emoticon.

Edited by goodchild
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Thank you goodchild you confirmed what I suspected.


I am new to this facility and to this position--only been here 1 month.  I asked why the IS reading was omitted and was told that the previous supervisor indicated that since the ABSC did not include a reading at IS the XM did not require it.  WHAT???????????  to say that I got red in the face is an understatement. 


My question is then how much digging do I need to do to report this?  How far back do I need to go? 

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I think their is a failure in understanding the principles in both thee techs and the prior supervisor.


That IS can save 40 minutes wasted time if the tech has selected ABO incompatible blood in error. Yes, it would be come apparent via computer checks when the crossmatch is being reported, but at that point you then have to start again. All for the sake of a test that takes 2 minutes... It isn't there to detect IgM incompatibilty, not IgG like the asc/panel does.

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It's reportable. The Lab Director should be involved, as they eventually will have to sign off on corrective action plans that are submitted to the FDA and whatever other regulatory agencies that are over your Lab.


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Agree with Scott and Goodchild. Another wrinkle on this is that CAP and AABB both want you to do what your own P&P states. Whatever the issue is, it may not be required as a specific standard or checklist item, but you still need to stay true to yourself. 

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  • 4 weeks later...

To play the devil's advocate here: The infraction itself doesn't violate the CFR, it is not in compliance with your policy and procedure, which to me, would be of more interest to CAP/AABB or Joint Commission. The question is, does the omission of the immediate spin crossmatch adversely affect the safety, purity, or potency of the transfused products. What method of Coombs crossmatching is being performed?


We have both a computer truth table that prevents the selection of ABO incompatible units and we did a validation study to show that gel technology does detect ABO incompatibility; therefore, we have deleted the immediate spin crossmatch when a Coombs/gel crossmatch is performed. BUT, this is NOT in violation of our policy and procedure.

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As a former blood banker now turned LIS analyst I see a few areas of concern:

1. Are you using a computer system?  If so, I would be concerned with how your truth tables have been set up.  Most (well the 3 I have set up) require an ISXM so either techs are falsifying a reaction to get by the computer, or the tables were not setup to correctly and perhaps should also be revisited.

2.What system are you using when crossmatching?  Some require an ISXM for the ABO reasons stated above, If that were the case then I would challenge that the "safety" was compromised and would be reportable.


Just a humble opinion.

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I, too, have an IS background (former Mediware consultant and former EHR analyst) and the system we use is a national system with nationally established truth tables.  I find this very frustrating.  Our truth table is not set up to force an entry for the IS phase.  You can bet I am bringing this issue to light--I just started here in my position and was not part of the initial blood bank info system implementation.

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