ACT LR Testing on Werfen Signature Elite

21 followers
0 Likes

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:
  • 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

7 Replies

We have the GH100s, but use the ACT-LR cartridges as well.  The departments are responsible for ordering and maintaining their own supplies.  We have the instruments set up to only allow valid entered lot numbers for both QC and cartridges.  This ensures that they must send me the lot information prior to being able to use the supplies.  I do keep a manual log for myself in my office that has the lot information, received date, date QC run and that it was acceptable.  Again, they must send me the new lot information when they receive them in order for the instrument to allow them to be used.  This helps to ensure that they run QC after being entered.  I try to continue to remind them if I notice that QC hasn't been run once I let them know the lot is available to use.  We also have the instruments set up to require the liquid QC every 30 days or it will lock.  It's not a perfect system by any means and there are always occasions where someone gets a hold of a new lot before it has been QC'd and is ready, although infrequently, it does still occur.  

Hi Karen and Happy Friday!

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

Our Cath Lab uses the Hemochron Sig Elites and they take care of ordering their own supplies. I have a great group there, in that they are very cognizant of the requirements for running QC. Also, they do not have a lot of storage space, so they always use up a lot within 30 days of receipt, so I never worry that they will not run QC at 30 days! If they ever get more storage space, that may be something I have to watch for.
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

Hi Karen
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.  

We are using the ACT + on the Signature Elite.  I place the order.  Arrives at the lab, lab performs QC on the incoming lot number.  This covers the new lot and each new shipment.  Then depts present at the lab when stock is low or depleted to pick up cartridges.  The meter is set to alert user for the 30 Liquid QC lock out.  Each dept is in charge of performing the 30 day QC.  Pt testing can not be performed until they pass the QC.  I track the new lot and new shipment on paper. with the QC lot number/exp, cartridge lot number/exp, number of boxes in the lot,  and result and tech who performed test, range for QC so it proves if it passed or failed.
 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.

Hi Karen
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.

Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Karen Jenkins
7 months ago
7
Replies
0
Likes
21
Followers
668
Views
Liked By:
Suggested Posts
TopicRepliesLikesViewsParticipantsLast Reply
POC ammonia test
Jake Fray
3 days ago
00169
Jake Fray
3 days ago
Glucose Meter Strip Validations
Adelina Wright
3 days ago
40326
Jeremy MacDonald
3 days ago
FOB - moving away from POC
Brian Castle
4 days ago
100494
Jeremy MacDonald
3 days ago