EPOC Validation to determine running QC each lot and shipment

We finished up our 30-day run today. Only ran TriControl Levels 1 and 3. The plan is to go new shipment/new lot/new user prior to first patient test/every 30 days. This is my first time setting up a moderate complexity test, so hopefully it's adequate.

Our medical director decided he wanted them done weekly.

We did all for 30 days. But that was before IQCP. I'm not sure what the manufacturer is recommending nowadays. I suppose it's still a good idea to verify the eqc claims.

We are in the process of validating the EPOC right now. I have the understanding that we no longer are required to do the 20-30 days in a row of QC since we are required to have an IQCP. We are also Joint Commission certified and the inspector told me in November that we didn't need to do cal ver any longer for cartridge based systems. Now, the question is, do we still have to do AMR?? JC standards are harder to find then CAP (in my opinion), but what are others' experiences ? Also, no one seems to do instrument comparisons with multiple I-STAT analyzers, but I still think I need to compare all my I-STATs each 6 months with chem 8 and EPOC being nonwaived

We do AMRs and we use the AQQ survey from CAP to satisfy the instrument comparison.

Hi Carolyn,

How did you end up handling this?  I am validating epoc devices currently and ran into this as well.  I am getting confusing information from CAP, so any advice/information that anyone can give me would be very helpful.  

Thanks!

When we implemented the use of EPOCs we did a 30 day QC study.

We validate new readers with linearity and precision.

In patient test areas QC is done monthly, except in the ED, where it is done every 2 weeks.

We validate new shipments in duplicate, as described in the operator's manual. Same for NSSLs.

We use the AQQs for meter to meter correlations, and random patients on both the EPOCs and the ABL90s (our lab blood gas analyzers) for lab to meter correlations, 2X/year.

Linearities are done every 6 months, including a Thermal QA check, usually after the biannual software updates.

Thank you for the information - that is basically what we have done in the past on the istats and how we will approach the epocs. My main concern right now is the 30 day QC study - I'm relatively new to POC, and haven't had experience with the 30 day QC study before.  I'm curious - was this done before you went live with patient testing.  What about Blood Gas QC - during the 30 day study, is it run every 8 hours?  I'm trying to figure out how to navigate all of this and make sure it is done correctly, but I'm a little confused, especially after reaching out to CAP, so I appreciate any guidance!  

Hi everyone,

I, am currently doing my 20 QC study for my EPOC.  My facility is switching from ISTAT to EPOC.  I've been looking for anything about manufacturers recommendation for frequency  of QC.  All I have been able to find is run it in duplicated when it arrives at facility.  In the past we chose not to do every 30 QC on the ISTATs.  I'm hoping to be able to do the same thing with the EPOC.  I already struggle with Nursing scattering like cockroaches when a light comes on when I need to drop off proficiency testing it's going to be much worse when I have to drop off QC.  I feel this QC will be difficult for nurses and it's very time consuming.  Because of COVID my nursing staff is already worn out I'm trying not to tax them any more than they already have been.  When I asked a Seimens Rep about it they said they are leaving the decision up to the individual facilities.

Currently the QC looks fabulous with little to no fluctuations in values even when using a new lot of cards/QC.  It seems very stable.  I know there will be CAP requirement and I will have to answer to the 30 day QC questions. 

From what I've read the cards are stable as long as card packages remain closed and stay in require temps (already monitor temps in departments).  Readers internal QC already occurs every 8 hours. (Proves reader is working).  I do lot to lot comparisons when a new shipment comes and have a current EVAS in my DM.  As long as I am meeting those requirements I should not have to run 30 QC. 

What do you think?

Kammy,

I think 20 QC is fine.  I just reviewed CAP's IQCP Checklists.  CAP does NOT have a specific requirement as long as you follow your lab's QC plan.

LOL to your cockroach analogy.   

If you are talking about 20 QC for a risk assessment for IQCP, that will not be sufficient. It is required that liquid QC be run along with alternative (electronic) QC for the entire period of time you want to not have to run QC. We've already been cited for this. We too ran 20 days of LQC for IQCP, but that is no longer acceptable. We have developed a protocol where we run 7 consecutive days, (get signed by MD), then days 14, 21, 28, 35. At the end of that we can run monthly QC. That is for i-STAT and other devices. For Epoc (just starting that) we would like to investigate running QC every 3 months or so, with new lots, since Siemens only recommends QC with lot/shipment. But we'll have to do QC monthly until we show that is ok.

Just to clarify this a bit more: I emailed CAP on what to do if a manufacturer doesn't specify liquid QC requirements beyond New Lot/Shipment (for example, it doesn't state 30 day liquid QC is required--ROM plus, iSTAT, for example).  She said the length of time to run liquid QC would then be up to your medical director.  I don't know what the manufacturer's requirements for liquid QC is on the EPOC, but I thought I would through that out there.

Mary