Cap Trm-31241

[johna]

"Are all new lots of reagents and critical materials (e.g. blood collection sets) inspected and tested, as applicable, before use, with documentation of acceptance?"

Is anyone interpreting this CAP checklist item to mean that all new lot numbers must be parallel tested against the same patient specimens with the current lot in use? Shouldn't daily reagent QC of a new lot number before use be adequate?

[rcurrie]

I don't interpret it that way. We just use our day of use QC when we put a new lot into use.

BC

[Lcsmrz]

You have to define your own acceptance criteria for each critical material/supplies, then compare each lot or shipment against these before use. If you say you will parallel test, then you should and document accordingly.

We don't parallel test anything, espcially since the usual daily QC doesn't do alot for me as it is.

[John C. Staley]

We do the same as Bob, day of use when it's first opened. We used to do "on receipt" testing but our QA gurus decided it was no longer required. I certainly didn't argue that one with them and I usually argue with everything they come up with.

[Shari]

We perform daily QC on each new lot, and it has satisfied the AABB and CAP assessors.

[bevydawn]

We do the same as the others and have never had any probelms with inspectors.