Clinic waived testing and procedure/IFU

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If (big if) the clinic lab is following the waived IFU exactly and there are no facility specific changes needed, what is the best way to have the medical director signature on the procedure ie IFU? For nonwaived it's pretty easy to obtain an editable version of the IFU from the manufacturer. I'm having a hard time finding that with the waived test kits. Instead of manually re-writing the IFU and adding signature, can a policy be created stating that for test XYZ the manufacturer IFU is to be followed and have med director signature that?



 

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That's actually a very good question and I'd be interested to see what responses you get.  We do procedures for our waived tests but it would be good to hear what other options people are doing.

I help to oversee clinic labs for a physician group.  For all of our procedures we have as the very first page a simple sign off sheet for the clinic's Lab director to sign to accept the procedure intially then space for them to sign for subsquent reviews.  If there is a change I update the entire procedure and they have to sign the new form again.

Heather,
If they are using the IFU as written, are you still putting the IFU into a Word/pdf document? Or do you have a statement on the sign off page stating the IFU is being used as written and include the actual IFU in the procedure pages?

I inherited them in a Word/PDF document, however for our non-waived tests we had used the operator's manual in the past and had the lab directors sign that off using the sign off sheet as the first page seen.  We use COLA and didn't have an issue during our surveys, so I would think for us using the IFU in a similar fashion would be accepted as well.

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