initial Validation - 30 day requirement?

Originally, that was the case. However, from recent CAP and CMS inspections, we have been told that we need to do external QC for as many days as we will not be doing daily QC. So, if you want to do QC monthly per your IQCP, you need to have 30 days (we do 35 to be safe). That is a huge expense, so we now do 7 consecutive days, then get that signed off by the medical director. Then we do QC weekly at 14, 21, 28, and 35 days. We get that signed off by the medical director and then are able to do QC monthly. We also have some areas of the lab that have moved to lot/shipment QC of 6 months, after proving that the monthly QC is stable. This has been through numerous inspections and has been approved.

I just came here to say the same thing! I'm going to reword it differently too: Kathleen says "you need to do external QC for as many days as you will not be doing QC".  That is exactly right, but I would also say "you need to do external QC for as long as the manufacturer says you can go between doing external QC".  For instance, iSTAT doesn't have an external QC requirement.  So...you can go as long as you did your external study for (hint, you can use historical data!).  But Rom+ stills says in their IFU that 30 day QC is required.  Therefore, the longest you can go between QC is 30 for Rom+.  Just make sure this is all nicely laid out in your IQCP! Mary

I guess I have an issue with backtracking; if that was not the requirement when implemented, then should not be cited for it.  Moving forward with a new system, if required, then make that plain so can be achieved.  

Oh, were you cited?? From what I can remember, AFTER the initial IQCP regs were put in place, the 30 day requirement was only that first year of CAP checklists.  After that first go round with IQCP, the 30 day requirement was dropped from the CAP checklist and replaced with "as per manufacturer's guidance" or something like that.   I guess I would have to see the exact citation but that does seem strange. Mary

What is the CLSI doc number that states this?
Is it CLSI EP23 ED2:2023 ?

That is what I would like to know, where is the standard that specifies this?