Managing iSTAT QC

To give myself a fighting chance, I deliver the QC to each department and ask a RN that feels comfortable to perform it. I also express that if it fails, the meter can not be used for patient use until a passing result is obtained. My POC refrigerator is clearly labeled for staff members to obtain more, if needed. I also send out an email to the department UBE notifying them that it has been delivered along with troubleshooting tips.

Most departments of ours have a designated person who is trained and comfortable with running the monthly QC. We're pretty hands off unless they have a problem. And most keep their own QC materials in a designated refrigerator in or near their department. They do their own ordering, but if you do the ordering maybe they would come get it from you? Our most common problem is when that designated person is off when QC is due and doesn't pass it someone else! But that's rare.

For regulatory purposes, we pull and review the EQC monthly into a report that shows the name of the testing operator. That is the end user QC - and for that matter, the end user is also performing a calibration with every cartridge technically. Therefore, I have no concerns about the POC team doing all of the LQC on the new lot/shipments at the main hospital. Out at our free standing ED's the end users do it - and we send them a little care package with QC and cartridges for each new lot and shipment, we also have EVAS turned on so we can see that it passed, and try to have them complete those while we are still around for the day in case we need to STAT Courier a replacement QC vial or anything. We have 6 of those ED's that we send QC to.

Also, LQC on each iSTAT? That is way too much.

I sent out QC to each department Monthly (every 30 days) so every cartridge type is QC'd. QC Report is pulled from QML.  I use APOC also.

Sylvia

We have QC in our fridge and the units come get it as they need it.  They have been doing the QC for a few years and since each operator has to do it for their competency they are pretty good at it.  Each unit is responsible for doing QC on the Istats on their unit. POCT only does the new lot QC and the Istats we keep as spares. Our CICU has "Istat Monday" where they line all their Istats up and QC them. 

On occasion we do have a unit that has a new operator performing QC that has an issue with L1 pO2 and they have to repeat it a couple of times to get it in.  I have them set up with a 5 day grace period so they can start the QC before the last day to keep them from being locked out.

Some of our units use blunt tips or needles on their 1cc syringes and they work pretty well for them. To start off with we had them open 1 vial for each Istat they QC'd so education about room air contamination is key.

Good luck :)

Silka - that opens up another discussion...We run LQC on each iSTAT, using CG4 and Chem8 so we cover all analytes. I know some of us are doing more and some doing less! CAP told us long ago, no matter how much we argued that it's the cartridges that need QC and not the meter, that we need to run LQC per meter.

I don't know how to argue the point any more and my medical director would not agree anyway.

Yes, that was CAP's argument before the invention of the glorious IQCP.  

Baseline Manufacturer Recommendation: LQC is not required AT ALL, the cartridges QC and Calibrate themselves with each run.

CAP Baseline: Lot/Shipment QC is required

CLIA Baseline: LQC is due each day UNLESS you have an IQCP showing there is no value-add, in which case you can drop to manufacturer recommendations.

At the end of the day, we have 65 iSTAT's at our main hospital, the only LQC we do is lot/shipment using the two spare iSTAT's we keep in the lab. Plus our network sites that each have 2 iSTAT's in their ED's and we have them do monthly LQC - we taught them that it is faster to use 2 iSTATs, but they don't have to.

I explain it like this: a traditional chemistry analyzer has on-board reagents that get mixed with the patient specimen at very precise volumes of diluent and catalyst, to create a reaction within a small reaction vessel or test tube, and then the measurement of the reaction is taken either via a lamp or color change. There are many variables there - from the probe being calibrated, to the reaction vessel being clean, to the lamp being out, etc.

The iSTAT has NONE of that! There are NO variables to account for, there is no such thing as "drift" with the iSTAT. Running all of that LQC is a giant waste of lots and lots of $$$. Abbott knows this, and yet they aren't really going to stop you from throwing money down the drain. It is all articulated quite clearly in the iSTAT Operators Manual.

So what you can do for your IQCP is take all of that LQC you have been doing and show how often it was out. In our case, back when we were doing all iSTAT's for all analytes every 30 days, it was literally never out - not even once over the course of the entire year. Then we looked at the EQC, and that too was rarely out, and the outliers locked down the handheld for patient testing, so that meant it was working as expected. The EQC is the real QC for the iSTAT - if that fails, then the iSTAT won't run a patient test. LQC has almost no value other than to ensure the cartridges were not compromised during shipping.

To all. 

We do it kind of like Silka and outline it in procedure and IQCP.  The sites (lab techs) run New lot/ new shipment QC on whatever ISTAT is handy. We live in a very hot area and this proves cartridges have not been baked on a loading dock.

Every 6 months all ISTAT at CLEW update time have every cartridge type they perform done on each handheld. This satisfies the CAP “ compare all instruments to each other.” End users do this only.

I currently have 92 in production soon to be 107 across 6 hospitals. 

Now as an aside, literally, my IQCP have NEVER been looked at in the two times I have been inspected with them. My last inspector handed the book back to me saying” I don’t want to see them....I am not a fan.” 

Since you are running CG4 and CHEM8, I would call CAP. See if their standards have changed as per the time you last spoke with them. (You said “long ago” in your post.) There is a lot of angst from CAP about the ISTAT presently especially for new ones and their validation. 

Deanna Bogner

Just a little heads up with having the POCC or lab staff run the new lot/shipment of QC.  I had some inspectors try to site our facility because I ran the majority of the QC when we received a new shipment.  POC.07512 States that QC is run by the same personnel performing patient testing.  I was able to fight it because I had taken QC to the floors and had nursing staff run it.  So if you have and IQCP and do not do the monthly QC then you must assign the new lot/shipment QC to your staff running the tests. 

I put together a packet with instructions on how to run it with new cartridges and sometimes a back up cartridge.  Then take the packet to the floor and hand it to nursing staff.  They scatter like cockroaches when a light is turned on when they see me coming.  When I corner one I tell the staff member to call if they have any other issues, cross my fingers and hope then can figure it out.  The only time I have a failure is when they overfill the cartridge. 

Silka-

You are literally blowing my mind right now! I started in POC only this past September and have been swamped trying to wrap my head around everything. I started at the same time as another coworker because two people retired the same month, so we inherited many, many "old, traditional" policies and procedures. I sure don't need another project, but would love to kick the monthly QC to the curb!!! I'll need to explore this with my manager and lab medical director for sure! Thanks!

I am also a newbie (March 2018) and have heard so many times, "well, that's the way we've always done it"! So many things I just end up starting from scratch to meet regulatory standards, but most of the time I feel like I am just winging it because I can't find all of the resources I need. This is especially true when it comes to good written policies and forms for documenting testing. It can get very overwhelming. That being said, I am really enjoying working with the nurses and giving them a better insight into the Lab.

I hate "reinventing the wheel"! Remember that this listserv is an excellent resource, and people are very willing to share their procedures, documentation, ideas, processes, etc. I do highly recommend a publication called "The Poor Lab's Guide to the Regulations" that is extremely helpful for many POCT issues, from regulatory to QC, IQCP, quality management, much more! Also, if you haven't gotten to pointofcare.net, try that as well. There is a link there to webinars that you can watch on your own, as well as new webinars. These are great as well. 

Welcome to the POCT Universe!