assay verification
I know this has been discussed many times on this list and others. No one wants end users to be a part of their V&V of a new test, but the following is from this month’s CAP Today. Since it is in the Common checklist I think it applies to everything, right?
July 2020—If a manufacturer assists a laboratory in setting up a new FDA-approved or -cleared test, the lab must make sure that the personnel who will perform the test participate in the verification or validation study. If the personnel don’t participate, there must be some way to confirm that performance is consistent with in-house studies performed by lab personnel.
That is a new condition of an existing requirement that is in the 2020 edition of the all common accreditation program checklist, released in June. It can be found in the introduction to the test method validation and verification section and in COM.40300 “Verification of Test Performance Specifications—FDA-Cleared/Approved Tests.”
Marcia
Marcia L. Zucker, Ph.D., FAACC
ph: 732-603-1194
fax:732-603-1608
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Hi Marcia,
To play devil's advocate here, perhaps if one is running under TJC and not CAP accreditation, one may not think the checklist item includes them.
But well made point. I thought the article in CAP Today was interesting because it opens with how CAP came to change the checklist item. A sort of "woah, guess what CMS reviews of CAP-inspections showed? Lab are asking/letting vendors run the instrument validations without having end users participate...pull the reins on that run away horse, Betsy!"
Many years ago we allowed a vendor to run the validations studies for a new POCT device. The results looked good, so we purchased two meters.
Six months later we used specimens from our general laboratory to check the calibration and AMR. One sample did not correlate well, which led to further investigation. We ended up repeated all of the validation studies. Our results were
so far off from what the vendor had produced that we suspected monkey business.
We discontinued using those meters; they are collecting dust in a cabinet to this day. We learned an expensive lesson. That vendor is on our black list.
Thanks for sharing, Terry. If we all combined our lessons learned, we'd had quite a large volume.