ACT LR Testing on Werfen Signature Elite
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Hey Everyone!
It's Friday when I'm writing this so Happy Friday! Here's my question:
We are using ACT LR Testing on Werfen Signature Elite. How are others using this (or any other instrument) meeting the IFU under QUALITY CONTROL (QC) stating: "Each lot of Hemochron Jr. ACT-LR cuvettes should be validated for performance at two liquid quality control levels:
It's Friday when I'm writing this so Happy Friday! Here's my question:
We are using ACT LR Testing on Werfen Signature Elite. How are others using this (or any other instrument) meeting the IFU under QUALITY CONTROL (QC) stating: "Each lot of Hemochron Jr. ACT-LR cuvettes should be validated for performance at two liquid quality control levels:
- When a new shipment is received, AND
- Once per 30 calendar days thereafter
Are you keeping paper logs for shipment receipts?
Do all reagents come into POC (and QC'd) and distributed from there?
I'm trying to get some ideas because what we are doing isn't working well!
Thanks
Karen Jenkins
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We have changed things up since I started in POC in 2019. We used to have a standing order go to our 5 locations within our hospital (no involvement from us other than to set up the order) which was very hands-off, however, we had issues with sites not rotating stock and not performing new lot checks.
About 2 years ago, we started ordering and storing cuvettes and upon receipt, we perform QC on the incoming lot. This leaves the sites that perform testing to do 30 day QC on their analyzers in the area only. We edited our IQCP to reflect this as well.
This has made a huge difference in not having more than 5 lots to program for the sites since our bulk order lasts around 2 months.
Hope you find a solution!
Stacy
Although I like the "control" aspect of knowing what supplies are here and when they come, I'm glad to relinquish this one to a group I can trust to do it right!
Hello Karen… I can FAX a worksheet for you to follow
Works good for me and it passed two CAP inspections
Send me your FAX #
Betty Ritzer, MT(ASCP)
PennHighlands Mon Valley
Laboratory Supervisor
1163 Country Club Road
Monongahela, Pa. 15063
britzer@monvalleyhospital.com
724-258-1588 P
724-258-1780 F
Our Cath lab orders their own supplies; however, they are delivered to me in the lab. Once I receive shipment, I put on a sticker, "DO NOT USE" . They come to me to grab supplies, and they know they must perform QC. I document the lot to lot on paper, (both for QC and cuvettes) Once this is complete, I then put on the Green Stickers, "This lot is ready to use." It was suggested from an inspection that I put in the allowable limit, as I didn't have that one the paper document. I can send to you. I also make them do QC each day of patient testing.
Its not a perfect process but it works for our hospital. 300 beds, 2 cath labs, 1 ep lab, and perform 1 to 2 open hearts a day. I order 30-35 boxes of ACT cartridges at a time last about 4-5 months.
We try to use QC for each month also as the direct observation for proficiency. I will get a call from the floor to come up and observe running of QC. Encourgaes them to share the duty and to stay proficient. Especially in smaller depts.
What has worked for us is that we order the reagent (they are shipped to our office), and we enter the lot numbers and ranges in RALS since our Hemochrons are interfaced. Once the new lot numbers have been updated, reviewed, and locations have been assigned, we then proceed to download the hemochrons (PRINT/SCAN 6) to get the new lot information. If your instruments are interfaced through a middleware or directly to the LIS, you can track QC electronically and have operator lockouts.
Hope this helps.