EPOC Validation to determine running QC each lot and shipment
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Did anyone who uses the EPOC or Istat run all levels of QC for a length of time to determine the accepability of only running QC once per month? I am reviewing my IQCP and realize I did not address this issue. We did not run QC daily during the validation period.
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Kathleen,
do you know what checklist that requirement comes from? I'd like to look at it. I do have my devices set up to run an electronic QC every 8 hours or as soon as they are turned on. Our Medical Director has in the past been ok with only 20 days of liquid QC. I'm really surprised that you were sited on that. As far as I know and I took the inspection training yesterday so this was a question on the inspector training for CAP. It is not up to the inspector to make a judgement if a risk assessment is sufficient or not. As long as the work has been done and the Medical Director approves its sufficient.
Don,
Glad you laughed! They do though and refuse to make any type of eye contact! It's great! Regardless, I really do have some AMAZING Nurses.
Mary,
Thanks for the information. EPOC's manufacturer recommendation is running it in duplicate for every lot/shipment. So it's kind of a free for all.
When we had our CAP inspection they tried to cite us on the every 30 days QC requirement, we didn't do lot-to-lot, and tried to say QC was never reviewed. We were able to defend it because I had my IQCP, the EVAS in the DM it showed that the QC passed, we had the letter from Abbott saying that as long as cartridges passed EVAS and were kept at maintained temps they were valid, I evaluated the QC runs and put comments in the results, printed them off and gave them to the lab manager to review. CAP removed the deficiency. Even though I didn't need to do lot-to-lot one of the awesome folks from list serv shared a lot-to-lot for ISTAT. I now use the crap out of it...even though I didn't received the citation I never wanted to be questioned regarding it again.
To be honest the EPOC liquid QC is a pain...there are some days that it takes me an hour to get it done. I don't know how a nurse wouldn't struggle to get it to pass. We currently run 5 levels.
Kammy
This is in the notes for COM.05300 Risk Assessment (IQCP)
The QC study to assess the performance and stability of the tests must support the QC frequency and elements defined in the laboratory's quality control plan. At a minimum, the study must include laboratory data representing the maximum interval between runs of external quality control. Consecutive days of date collection are not specifically required if testing is done sporadically, or is not performed seven days a week.Laboratories may use historical data for tests already in place, and may supplement with data from published literature. For new tests, devices, and instruments introduced into the laboratory, the laboratory must collect in-house data and may need to define a more frequent QC interval until sufficient data is available to support a longer time interval between runs of external QC.
We were cited because we had done the 20 days of consecutive QC, as we've done for many years. We were told that if we wanted to do QC monthly, our risk assessment (LQC vs. EQC) needed to span that length of time.
Kathleen,
Yeah it looks like you had a punk for an inspector! You really should have challenged that. 20 consecutive days of QC in more QC ran than once a month. That is more QC than the maximum time between intervals. You ran the QC daily for 20 days. The manufacturer only requires QC every lot or shipment. What was that inspector thinking?
The point they made (and this was cited by a CMS inspector as well, at another site) is that, for the risk assessment part of the IQCP, you need to do as many days of liquid QC so that you cover the time interval you want to go to. So, if you want to do QC monthly, you need to prove that you have done at least 30 days of LQC to show that it's ok to go to monthly only. 20 days doesn't cover the time interval of monthly. We were allowed to do it in phases, so we did 7 days of consecutive QC to prove that we were good for a week, then we did it weekly until we got to a month. We're now doing QC for our IQCP-qualified devices monthly, and it's written that way in the QC plan. I don't know if inspectors are all looking at this, but we had both CAP and CLIA looking at it.
I know I've asked this before but when you do monthly QC (which is what I'm going), do you do 2 levels on all meters? Has anyone gone to just doing a subset or even just QCing your current lots on a couple meters?
Right now we run 2 levels on all meters on the CG4 and Chem8 since that covers all analytes. We do run monthly QC on the other cartridge types but just on the spare lab analyzers.
Danyel,
Depending on your QC Plan in your IQCP. CLIA requires 2 levels of QC every 24 hours on every reagent and instrument. Instead of going by this requirement, you did your risk assessment and came up with QC monthly instead. Because of that, I would say that you need to QC all meters.
If you prefer not to QC all meters, then you need to do another Risk Assessment and QC Plan to stretch your QC interval.
We did QC daily, all levels, and defined the same IQCP as Kathy did. We do not have a large fleet of epocs. We run all four levels on each epoc every 28 days.