NOVA: New Lot Validation

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Does your facility validate StatStrip new lots? According to NOVA information, this is not required.
I haven't found anything in Federal Guidelines - basically follow mfg. recommendations.

16 Replies

Alma Knudson

Thu Jan 30, 2025 at 12:28PM

I do not believe there is a requirement for the TEST STRIP itself but there are regulatory requirements that you need to do for the instrument to prove you have done due diligence prior to putting the instrument to use for patient testing.

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
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[cid:image002.png@01DB72F9.49C4F7B0]1531 Esplanade Chico CA 95926
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• alma.calzadoknudson@enloe.org
“Together you and I will Each Accomplish More as we WORK towards achieving a common goal – Patient Safety and Satisfaction”

Alma Knudson

Thu Jan 30, 2025 at 12:30PM

* What is the use of GEM SYTEM EVALUATOR
* Do you run GEM SYSTEM EVALUATOR all the time? If not when do you run the GEM SYSTEM EVALUATOR?

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
[cid:image001.png@01DB72F9.5DE5DC50]
[cid:image002.png@01DB72F9.5DE5DC50]1531 Esplanade Chico CA 95926
•530-332-7360 (Main Lab) l 530-332-7362 (Direct) l 254-722-5388 (Mobile) / [cid:image003.png@01DB72F9.5DE5DC50] 530-893-6809
• alma.calzadoknudson@enloe.org
“Together you and I will Each Accomplish More as we WORK towards achieving a common goal – Patient Safety and Satisfaction”

Liz Reed

Thu Jan 30, 2025 at 12:31PM

If anyone can direct me to the specific CAP or CLIA reg that addresses this, I would be most appreciative!

Jeremy MacDonald

Thu Jan 30, 2025 at 12:39PM

I don't think there is a specific CAP reg that requires a LOT to LOT study or Cal/Ver a new LOT to be performed on the waived glucometer strips. However, given that it only takes a few minutes to run a Cal/Ver on them and we only get a New LOT ~once a year, we do this anyway. We chalk this up as good lab practice.

Its just one more thing we can say do when a floor complains it doesn't match the lab analyzer perfectly.

Liz Reed

Thu Jan 30, 2025 at 12:43PM

Thanks Jeremy. We were performing 10 QC tests per level, Linearity (duplicate), and 5 patient samples comparing them to the old lot and our main lab analyzer.
Would you share what you do?

Amanda Casavant

Thu Jan 30, 2025 at 12:49PM

Hello
If we are discussing the glucometer strips then as a waiver test under CAP & CLIA no validation is required. Not sure about TJC rules regarding waived testing. This is all I do before placing a new lot of strips or QC into service - more to see what the variability is between lots. Only had one lot number that just squeaked by (years ago)...the acceptability is significantly tighter than manufacturer's range.
~ A simple precision assessment (minimum of 10 data points) will be performed on new strip lots and new QC lot numbers with current QC and strip lots respectively, prior to being placed into service. Acceptability limits: 12.5% or 12 mg/dL mean whichever is greatest.

All meters have a linearity and 2 levels of QC performed before placing into service.

Jeremy MacDonald

Thu Jan 30, 2025 at 1:01PM

Liz,
for new LOT of Strips: run both levels of QC 5 times and enter this into a spreadsheet that includes the previous LOT number's QC x̄.

I'll email you our spreadsheet that automatically grades it once the data is entered.

We also perform a Cal/Ver on the new LOT, it also will get Cal/Ver'ed often with meters continually being replaced as well.

We also do new QC LOT studies as well.

Danyel Olson

Thu Jan 30, 2025 at 1:02PM

CAP does not have a requirement to do anything and neither does TJC that I'm aware of. Unless the manufacturers instructions advise something, it's not required. That being said, we generally follow the generic "best laboratory practice" for our waived testing. We run 10 reps of 2 levels of QC and 5 patient comparisons.

Glen McDaniel

Thu Jan 30, 2025 at 1:05PM

We don't. I agree with others here that as a waived system new lot verification, or lot-to-lot comparability is not required by CLIA or CAP. We do the full validation of course when bringing on a new fleet of meters. We do linearity and QC when adding meters to our current fleet, but for current meters we just do QC. If QC fails or we notice a shift with a new lot (results just barely coming in, we inform users over the region and we will even swap out that lot from clinical sites, and use it for training)

Liz Reed

Thu Jan 30, 2025 at 1:34PM

I have a follow-up question. Who determines "best laboratory practice?" Is this specific to your facility or is it per lit review?

Danyel Olson

Thu Jan 30, 2025 at 1:38PM

There's probably a CLSI document out there somewhere that may address "best practice". Best answer? It's up to the medical director to decide what they feel is appropriate.

Karin Gehringer

Thu Jan 30, 2025 at 1:46PM

You have to do a "Performance Verification" study not a "Validation" study. There's a difference between these two. Performance Verification is for waived tests. Nova StatStrip is waived, so when a new lot of reagents is put into use, you must first verify that it is performing as expected. Run QC on new lot of strips or run new QC with current lot of strips, compare to Value Assignment Sheet (or Target Values), review and write up, approve for use for patient testing.

Glen McDaniel

Thu Jan 30, 2025 at 1:49PM

Best practices are from industry experts basically, so I always start with regulatory standards, then CLSI. But for some things it can be CDC or professional standards. E.g. for blood culture contamination we have used 3% for a long time, now Infectious Disease and Microbiology organizations are recommending a benchmark of 2%. CLSI has strict guidance for specimen labeling, much more than we usually do. So in that context, that could be considered a best practice.

Erika Deaton-Mohney BS, MT(ASCP), CPP

Fri Jan 31, 2025 at 8:47AM

Not getting far in the weeds on waived testing, our new lots of test strips are not given a verification prior to sending out into use as in a true Lot to Lot study.
Disclaimer!!
We do not have our waived testing under a CLIA for accreditation. We do monitor quality control performance by lot of test strips and by lot of qc using our middleware. We look at use in real time, daily and monthly for acceptability with SD and CV, trends for bias and reasons for outliers.

Melva Anderson

Wed Feb 05, 2025 at 6:57AM

Jeremy would you share your spreadsheet with me. Currently, I do a linearity check on all new strips, and run QC x 5. For new QC, I run it x 10 on the current strips. I would love to have something that I can show any difference between the prior and the current. My email is meand@colquittregional.com. Thank you.

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NOVA: New Lot Validation