Validating new shipments of EPOC cards

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What does everyone do with regard to validating a new shipment of EPOC cards?

I was reviewing our EPOC procedure today (written by my predecessor) and discovered that what's in the procedure differs from what they've had me doing for the past 5 years!

The procedure (directly from the operator's manual) says: "From each lot in each shipment of cards, analyze at least two (2) levels of aqueous controls using one reader."
I have been running all 6 levels of QC (3 gas/metabolites, 3 HCT) in duplicate on every new shipment of cards! If I followed what's in the procedure, I'd probably choose to run gas levels 1& 3, and HCT A& C-- 4 cards, as opposed to 12! I also spoke with Siemens technical support, and they verified that what I've been doing is overkill...

How do you do your new card shipment validations?
Thanks!

8 Replies

Cristina Gonzalez

Tue Jun 14, 2022 at 3:13PM

For new lots, I run 4 cards. L1 and L3 and HCT-A and HCT-B. This is what our implementation specialist requested for us to order. For 30 day QC, we run the same 4 levels on each device. We have 7 devices. (I think this is overkill because we are QCing the cards, not the reader, but I have not asked CAP about this to confirm).

Shea Woodward

Wed Jun 15, 2022 at 5:50AM

We try to order once a month, we run L1, L3, HCT-A, HCT-B and one patient sample on old and new lot. We have 120+ devices so we run one device from each CLIA/CAP location.

Chelsey Pleiss

Thu Jun 16, 2022 at 8:45AM

We run the 4 levels (L1, L3, HCT-a and HCT-b) on new shipments in duplicate on only one device. First of the month we run the four levels on all lots we have in the system, so some months its one lot (4 cards) and some months we have 2 lots (8 cards).

We only run QC on one of the EPOCS, like Cristina said, we are QCing the reagent (cards) not the readers. This has met Joint standards thus far.

Leslie Barber

Thu Jun 16, 2022 at 11:55AM

From the manufacturer:

We perform 4 levels of QC (GAS L1, GAS L3, HCT A, HCT B) twice on the new lot of cards and once on the current lot. We also run 2 patient samples (once on current card lot and once on new card lot).

Thomas Miller

Fri Jun 17, 2022 at 11:04AM

We do all the LQC and correlate 5 patient samples against our backup method. This comes from noticing a shift in lactate between lots about 8 years ago. Since then we have noted one creatinine shift and an additional lactate shift. The QC was in but the WB results defiantly demonstrated small bias shifts and I like to be aware of things like that. Used to get 5 to 6 months worth of cards at a time though. Now that seimens barley gives a 3 month outdate we are rethinking things.

Terry Hawkins

Wed Jun 22, 2022 at 12:58PM

Thank you to everyone who replied to this topic. I was writing our procedure for the epoc, and your comments were a big help.
Now I have a question... We built a log sheet to document information about new Test Card shipments. Does anyone make note of the specific Reader used to validate new cards? Looking for this information in POCCelerator is not easy.
And one more thing... Yesterday we received a shipment of cards where the low temperature sensor registered out of range. Kudos to Lori at Technical Support. She arranged for a new batch of cards to be shipped out immediately, and they arrived in less than 24 hours!

Gloria MacLean

Wed Jun 22, 2022 at 1:33PM

Hi Terry-- No, we don't do any paper documentation of the card validation or which meter was used because it's all easily retrieved from RALS. We have 3 'loaner' meters, so it's always one of them, anyway. We do use a review note indicating that the results were from either a new card lot or QC validation, though.
Glad to hear you got great customer service from Siemens. We're still waiting on gas CalVer that we ordered a month ago...

Jeremy MacDonald

Thu Jun 23, 2022 at 11:28AM

Question to group:
What is your acceptance criteria when comparing LOT to LOT on the Siemens Epic cartridges. Originally, I set them up with the 1 SD of the Siemens QC acceptable range and have had to widen it.

We are new to this system and I'm finding more variation between cartridge lots than what I was expecting.
- Case in point: pO2 on a LOT that we just received is running 15 points higher than the current lot. This has been repeated 4 times using different meters. Results are consistent on both LOTS.
- I've had to widen the acceptable criteria range on the analytes and really don't want to widen it further.
  - | Acceptability Criteria
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Validating new shipments of EPOC cards