validating new shipments of ACTk cartridges
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Hi,
Does anyone compare new lots/shipments of i-stat ACTk cartridges to in-use lots and if so, what is your process? Is patient blood used or some other material? How many cartridges are tested? What is the acceptable variance between lots?
Thanks,
Nancy
Nancy A. Toscano MT (ASCP)
Point of Care Coordinator
Laboratory Administration
Office: 617-732-7410
Pager: #37918
ntoscano@bwh.harvard.edu
brighamandwomens.org
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Years ago we did do that but now we only QC the new cartridges. If they Pass, we can use the cartridges. Our Monthly QC has been done on the current lot in house and we have the QC on this new lot.
Gina, when you have a new cartridge, do you QC the cartridge on every i-STAT that does cartridge? Or do you switch the i-STAT for every QC done for the new lot of cartridge?
Weonly QC new cartridges. We document and use them.
We do not QC on every iSTAT. It is not neessary to do so. Our cath lab operators do use different iSTATs for new lot numbers. It is the cartridge that is being verified not the iSTAT itself.
On the ACT-K I make sure that my EVAS is updated and have staff run the QC. I had inspectors last year try to cite me on not performing monthly QC. We have our IQCP set up so the iSTAT is the reader and the cartridge is the actual testing device and as long as the cartridges are stored at the correct temps they are stable enough to perform the same thru that lot. The testing is done on new shipments. As long as they pass the EVAS they can be used.
I felt annoyed at the almost citation so I chose to do a lot to lot evaluation on each cartridge to see if there could be any fluctuations is results. Someone on here already had a spread sheet they shared for their ISTAT. Total life saver. Anyway I built on that idea and created my own evaluation sheet for ACTK.
I know it may be overkill but it's nice to know when you may see a fluctuation in results with a new cartridge lot.
Kammy,
Would you mind sharing a copy of the evaluation sheet you built? I'd be interested in looking at something like that. Thanks in advance!
Lindsay
lmmartin2@cmh.edu
Yes! Please share this sheet.
crystal.capili@va.gov
I had a similar idea about revising my IQCP concerning monthly liquid controls, but have not followed through just yet.
Could you share your evaluation sheet and other helpful info about this topic?
Kammy would you mind to share with me as well. Kaylaisaacs@sjhlex.org
Thanks!
Would I be able to see this sheet as well?
Thank you kindly,
Karla.Clayton@rwjbh.org
Hamilton, NJ
Would you be able to share with me as well! Thanks so much...
sstamps@stdom.com
Here is a copy of my template. The original template that calculates the lot-lot for the other istat cartridges is from someone else on here. I did build the ACT template from their idea. Both are on the same spreadsheet you will just need to toggle using the tabs on the bottom.
I hope you can understand what I did.
Kammy
I am interested in the ACT validation sheet also.
I've attached it to my previous comments. Let me know if you cannot get it and I will email it to you.
When I get a new lot of ACT-k cartridges, I run QC on the new lot and patient correlation on new vs. existing lot. I also run monthly QC on existing lots on rotating I-stats around the hospital. Might be overkill, but rather err on that side.
How about new lot of ACT-k controls? What do you all do upon receiving new lot of controls?