Waived Urine drug screening

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We have a couple of sites that perform the urine one step multi-drug screen test cup.
They send out all specimens for confirmation.
They don't run external QC as they feel that sending all out for confirmation doesn't require it.
The package insert does recommend external pos and neg QC.
Is anyone doing this same process and not running the external QC?
Thanks!
Debbie Martuch, MT(ASCP), CPP
POCT Manager

2 Replies

Who is "they"?  the staff on the floor performing the test?
In my experience, Manufacturer "recommendations"  essentially equals a regulatory requirement.

I would not be comfortable excluding the external QC from being performed on every LOT/Shipment.

Jeremy

For CAP, recommendations do not equal regulatory requirements.

We do kind of the same thing you do with UDS testing.  Most kits are collected and mailed without making a "quick read".  We have one kit that our staff do a quick read and mail out.  On that kit we perform and record external positive and negative QC.

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