CHEM8 and CG4 Blue cartridge

WE have a small sister hospital that use G3+  ( no alternate method  within the hospital) and Chem8+ ( back up for Chemistry analyzer)  cartridges. 

We are seriously looking at EPOC  to use for ABG and the same cartridge has BMP in it. I think this will solve our problem.  If it all work out, we will not look back.  Abbott betrayed our  trust.

Hi Elham,

I emailed what I have as an ABL90 SOP.

quick question here, does anyone know if we have to do 20 days of qc to validate the CG8 cartridge before use?

Hi Liz,

Back in 2008 when my predecessor implemented all the iSTAT cartridges including the CG8+, that is exactly what she did, 20 days of QC.

That was the "old days". Now you need to do a risk assessment, and it needs to cover the full length of time that you will be doing QC--so if you do monthly liquid QC, you need to do 31-35 days of QC. We had gotten a plan from our CLIA which was approved by CAP that we could do 7 days of LQC, then days 14, 21, 28, and 35. Then we can go to monthly LQC, as long as you've written a QC plan and gotten it approved by the medical director. The alternative is to do 2 levels of QC daily, or Q 8 hours for blood gas.

Does anyone use the ABL 820 Series for blood gas testing?  We are considering using as a backup should delays occur with getting more CG3+ before May.  Currently we're performing a comparison correlation with our ISTATs.  If anyone is using for blood gas, were any comparison studies done with other instrumentation prior to use, and if so, how close or how much deviation occurred?

Kathleen can you share your IQCP plan?

Kathleen, thanks for sharing this updated information. We are thinking in implementing the Epoc so you IQCP plan will be helpful to have. Please share it with me too, if you can.

Thanks!

Kathleen - I'd also love a copy of that QC plan if you don't mind. This is my first time transitioning from waived to mod complexity.

Thank you!

I too would love a copy of your IQCP plan as well!

I'm not sure what QC plan everyone is asking for--we have multiple IQCP for all the different sites, devices, and cartridges. Are you  talking about the risk assessment plan to allow for monthly liquid QC? Once we have the risk assessment completed, then we do LQC monthly on each cartridge, on one or a subset of i-STATs depending on how many we have at each site. I have 6 hospitals that run i-STAT, as well as 2 ED UC sites, and each one has their own IQCP.

If you are talking about the plan for the risk assessment, then we run LQC for 7 days, then weekly for the next 3 weeks, then after that we run monthly. We had to write an amendment to our IQCP for this, as when we started with i-STAT we were doing the 20 day LQC that CAP originally was requiring.

Did anyone see that the CAP checklist now states (under Note#4) on the performance verification that you must have a performance verification and written summary for each instrument used for testing. I don't think we can argue that the cartridge is the "test system" any longer.

This means if I want to implement a new cartridge I need to do a full validation on each i-STAT device. I know some of you possibly do this already, but for those of you who don't, how can you accomplish this given the financial and reagent volume requirements?

My head is spinning.

What reg in cap are you looking at?

Sent via Groupsite Mobile.

So our facility did meter validations on exchanged meters using the CG4 and CHEM8 cartridges.  Would this mean that since they were not FDA approved that I would need to revalidate every analyzer?  I haven't asked CAP yet but my gut says yes.

Laboratories are required to perform analytical validation or verification of each nonwaived test, method, or instrument system before use in patient testing, regardless of when it was first introduced by the laboratory, including instruments of the same make and model and temporary replacement (loaner) instruments. There is no exception for analytical validation or verification of tests introduced prior to a specific date. The laboratory must have data for the validation or verification of the applicable method performance specifications and retain the records as long as the method is in use and for at least two years after discontinuation.

**REVISED** 09/17/2019

COM.40300 Verification of Test Performance Specifications - FDA-cleared/approved

Tests

Phase II

Prior to clinical use of each unmodified FDA-cleared or approved test, the laboratory has

performed a verification study and prepared a written assessment of each of the following

test method performance specifications, as applicable, using a sufficient number of

characterized samples:

1. Analytical accuracy

2. Analytical precision

3. Reportable range

NOTE 1: Accuracy is verified by comparing results to a definitive or reference method, or

an established comparative method. Use of matrix-appropriate reference materials, patient

specimens (altered or unaltered), or other commutable materials with known concentrations

or activities may be used to verify accuracy. The use of routine quality control materials or

calibrators used to calibrate the method is not appropriate.

NOTE 2: Precision is verified by repeat measurement of samples at varying concentrations or

activities within run and between run over a period of time.

NOTE 3: The reportable range of an assay is the range of values that the laboratory reports for

that assay.

NOTE 4: If multiple identical instruments or devices are in use, there must be records (data and

written assessment) showing that the method performance specifications have been separately

verified for each test and instrument or device.