How are thos eof you who are iSTAT users meet CAP POCT.07456?
Folks,
We are wondering how those of you who use the iSTAT meet the CAP standard that I have detailed below? we are curious as to how some of you have decided meet this requirement.
It is standard POC.07456 (REVISED on 9/17/2019)
Control Range Establishment or Verification
An acceptable control range is established for each lot of control material.
NOTE: For unassayed control materials, an acceptable control range mush be established by repetitive analysis in runs that include previously tested control material. For assayed control materials, control ranges supplied by the manufacturer must be verified.
Evidence of Compliance
Written procedure to establish or (in our case) verify control ranges AND
Records for control range establishment or verification of each lot.
Your thoughts on this are much appreciated.
Thanks!
Diana
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We run our QC as usual, but document the first run on a new lot of controls by making a separate copy and state that the results are within the VAS ranges.
I just called CAP about this last week and was told just what Max said. Just run the new lot of QC and if it is within manufacturer range it is "verified".
I was told the same thing. If it is within the expected range, then it has been verified.
Thank you.
Thank you.
Thanks!
We run the QC when we get it in. We have a spreadsheet that we record the lot number, date it arrived and if QC was ok. We don't print it out as we can get the results from QML if we need to.
Thank you!
We run the new controls on a lot of cartridges that has already been QC'd Thus, verifying the new lot does not produce significant differences to the old.
On a side note. Would anyone have a communication from CAP available saying "just running QC is enough". That might save my staff some work :)
-Dean Derhaag MS, MLS
For iSTAT QC we do a 5 day study to verify consistently within the manufacturer's range on each cartridge type.