Validation of new Avoximeter cuvette lots

Tracey,

I do a lot to lot validation on the Avoximeter cuvettes.  I actually just performed it last week.  When I do it I run Level 1 and Level 3 controls on the old lot and new lot.  I don't know which value exactly you are looking at for the 5% but I have a document that shows me the range for all tests and here is how my requirements are:

tHb: +/- 7%

O2Hb: +/- 3

COHb: +/- 3

MetHb: +/- 2

I didn't have any trouble using this method.  Hope this helps.

Cassie

Thanks Cassie, it's very helpful. I was validating COHb. 

I'll troubleshoot precision and be able to perform the validation.

Tracey    

Vulnerability through learning from one another: AVOX 1000E

We do not do lot to lot on AVOX cuvettes.

We are CAP accredited and I will refer to CAP Standard: COM.30450 New Reagent Lot/Shipment of Acceptability. Using the manufacturer's recommendations, we run optical QC daily and liquid QC (one level) weekly. The manufacturer does not state anywhere that the cuvette is a reagent. It does not contain anything but is more like a vessel for testing. When I spoke to the manufacturer (because after this post I was really digging deeper!) they said the same. The cuvette could be likened to a heparinized syringe used for blood gas testing. The wavelength change is updated for the AVOX but has no tie to a "reagent" therein but tied to the plastic of the cuvette.

I am having the manufacturer send me their SDS for the cuvettes.

Considerations?  

I asked CAP if the requirement specifically applies to AXOX cuvettes, below is the response that I got.

Dear Mrs. Melissa Perez,

It does not appear that the cuvette used for this instrument is a reagent. The CAP's definition of a reagent is ‘Any substance in a test system other than a solvent or support material that is required for the target analyte to be detected and its value measured in a sample'. COM.30450 (New Reagent Lot Confirmation of Acceptability) would not apply. The laboratory must follow manufacturer's instructions for the introduction of new lots or shipments of cuvettes.

Margaret Dahlgren MS, MT(ASCP)

---- Original Message ----
Name: MRS. Melissa Perez Email: mel.perez@dhr-rgv.com Lab CAP Number: 7183767 Phone: 956-362-7648 Country: US The customer sent us the following question or comment: In regards to COM.30450 New Reagent Lot Confirmation of Acceptability - I am questioning if this requirement specifically applies to whole blood oximeters (AVOX 1000E) where there are no 'reagents' used by the test system. Analysis is accomplished by injecting the sample into a disposable cuvette an inserting the cuvette into the instrument. The analyzer illuminates the sample with multiple wavelengths, records the optical density of the sample at each of the wavelengths, and computes the results. Would this requirement be applicable to this test system? Please advise.

Erika,

Thank you!  That is exactly what our facility does.  I saw those post just before heading home for the day and panicked all night as to compliance.  I planned on coming in and reviewing my IQCP to make sure I was covered.  Then in the case of not being compliant worrying about how to get my Cathlab staff on board with yet another process. 

Thank you for removing that mess from my things to do list!

Thank you so much, everyone, for your input!

Thanks Erica! We also do not do lot to lots but I had been thinking about it. Your response makes complete sense!