Our anti-D antiserum package insert requires a positive and negative control. My previous employer (who we've borrowed procedures from) runs a positive using Immucor's core QC kit, and their negative is alternating reverse A1 and B cells, but they then take the negative through Coombs. If my facility does not test patients for weak D through Coombs, is it necessary for our negative control to be taken through Coombs?

Please be gentle, I'm just starting to dip my toes in this whole new world of procedure writing/interpretation; I've always just done what the procedure says, now I have to actually know why...

What is the IFU method for the anti-D you are controlling?  If it says you should use it in IAT then you need to control the IAT.  If it is for immediate spin, or 5 mins at RT then that is how you have to control it.....

13 hours ago, kblewett said:

Our anti-D antiserum package insert requires a positive and negative control. My previous employer (who we've borrowed procedures from) runs a positive using Immucor's core QC kit, and their negative is alternating reverse A1 and B cells, but they then take the negative through Coombs. If my facility does not test patients for weak D through Coombs, is it necessary for our negative control to be taken through Coombs?

Please be gentle, I'm just starting to dip my toes in this whole new world of procedure writing/interpretation; I've always just done what the procedure says, now I have to actually know why...

I don't think you would need to take it to coombs.   Do you not perform cord blood testing? 

We do occasionally perform cord blood testing, and on those days we do the negative control through Coombs.

Galvania- I don't know what IFU means, but the package insert gives test methods for both immediate spin and IAT ("if the test result is negative or doubtful and a test for weak D is required").

IFU means package insert.  So, in your case, both methods are stated, provided they mean by '("if the test result is negative or doubtful and a test for weak D is required") that you then go on to perform an IAT using THIS reagent.  If that is the case, and you actually DO that test, then you need to control both methods

anna

Controls are required every day of testing, not every day, if you are CAP inspected. Under that condition, you could get away with running the weak D QC only when weak D testing is performed, but you must spell that out in your procedure for QC and weak D testing.

The regulatory risk for you would come if somebody forgot to run the QC for weak D when patient testing was performed. So your decision will be based on the frequency that the test is performed and the likelihood that the QC will be forgotten by your staff. If the test is performed incorrectly and the error is not detected because the QC wasn't done, what is the risk to the patient?