Open expiration of QC

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Good morning,

I have a question and was curious how others do their monthly QC and if it is a written rule somewhere. Currently I have 9 units that use the Hemochron Signature Elite and they run QC on a lot of cuvettes for patient testing. Lets say for example they run QC on Lot A2DLA014 on Jan 1, 2024. They have another lot they QC on Feb 1, 2024, lets say B3DLA011 for their 30 day QC. Should A2DLA014 also be re-QC'd on Feb 1, 2024 or is that lot still good under QC guidelines as being ok? The manufacturer just says the instrument is QC'd every 30 days and I can't find specifics in the CAP checklists for the re-testing of already QC'd lot numbers. I guess what I am getting at is we have always asked that a cuvette lot be re-certified every 30 days but is that a hard written rule somewhere to back that up or is it above and beyond the minimum guidelines as good lab practice.

9 Replies

Hello Jason,

It was my understanding that QC ( levels 1 and 2) was required to be performed on each analyzer every 30 days, regardless of purpose. If the QC was run on an analyzer for new lot/ new shipment verification purposes, it would still satisfy the 30-day QC requirement. My only concern would be running QC outside of your QC-Lock-out schedule, which may get a little hairy if you have a strict schedule for when all departments are required to perform QC on the Hemochron.

When you run QC every 30 days, you are verifying the instrument is working properly, therefore it doesn't matter which lot of cuvette you are using.  We QC each new lot or new shipment of cuvettes to verify the integrity of the cuvettes.  We do not have a rule to re-certify a particular cuvette lot every 30 days.  

Tierra, you are correct. We do have levels one and two run every 30 days. That is their lock out schedule.  I agree with your concern and that is what Jay is saying about re-certifying outside the QC schedule. The practice of re-certifying was in place before I got to the department and I am questioning why they have to re-certify a previously verified lot just because it was done 30+ days ago on that particular cuvette lot. If everyone is saying that it needs re-verified every 30 days of patient testing for the cuvette lot (not the instrument) where is that written or is that a practice that got started and just continued.

I perform ACT-LR on our Hemochron Sig Elite and the package insert for the cuvettes say after validating the new lot it should be QC'd every 30 calendar days thereafter. I would recommend checking the package insert of the cuvettes for QC intervals.

Hi. I am also new to POC. We have three signature elites, but only QC one instrument every 30 days. Do we need to be performing QC on each instrument? Thank you! 

Hiya, Falynn Florane, each instrument 

Where is the Hemochrom documentation does it say each instrument. I’m only asking because if I bring this to my LD he will want to see the source. Thank you! 

All- I just read the manual and don't see where it requires 30 day QC on the instrument.  There is a requirement for 30 day QC of the bag of cuvettes.  Am I missing something?
Mary Hammel

Do you utilize the QC lock-out feature? I believe that is configured by instrument, not cuvette lots.

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Jason Ferrell
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