i-STAT and CAP POC.07540
0 followers
0 Likes
CAP POC 0.7540 states that controls are reviewed for acceptability before reporting results--
How do you take care of this in your istat policy? Here is an example:
We run liquid QC once per month and is performed by unit staff. QC might be run on Friday at 8pm, fails and they do not repeat (even though they have been told to repeat failures). We do not see QC failure until Tuesday, and patient testing has been continuing since QC failure.
Just wondering how creative everyone might be 
15 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| iSTAT in NICU -chem 8, CG4 | 4 | 0 | 131 | ||
| Rotem Sigma Validation Help | 1 | 0 | 85 | ||
| Hemochron Sig Elite use outside of manufacturer temperature range | 1 | 0 | 137 |
We use EVAS on our iSTATs so they see PASS or FAIL on the iSTAT. We also can lock out the iSTAT if the QC Fails, until they repeat it and it Passes.
We use eurotrol QC which I believe does not allow eVAS. We however only let the lab tech's run quality control as needed and they will rerun if QC fails.
I am thinking of switching to iSTAT QC so that I can use eVAS for all QC.
We've written an IQCP for our i-STAT. The only time we run QC is when we have a new shipment of cartridges or there is a question of cartridge integrity. I'm new to POC at our facility so I had been running all QC runs. I've now started sending them to the floor for nursing staff to run. I give them 2 QC vials and 2 cartridges then give them a due date so I can monitor the new shipment before it's put into use. If there is a failure I rerun the failure.
This process seems to work well and prevents results without a valid QC run.
Kammy if your cartridges go past 30 days you will need to QC the same lot again. Welcome to POCT world.
Shannon,
What requirement is this?
Brian Wittkop
Sent via Groupsite Mobile.
As of Aug 2017 CAP changed that requirement for Non-waived testing. We are no longer required to run aqueous controls every 31 days. I need to look into that requirement for the CHEM8+ because it is a waived test. Unless any one else already know the answer to that question.
Hi Silka,
We use eVAS also but it doesn't lock out the iSTAT if they fail. How do you get the iSTAT to lock them out until they pass QC? Thanks.
Please let us know how the lock out is setup
There is a bulletin from abbott called Liquid Quality Control Schedule and lockout customization on the istat 1 handheld. It has instruction on how to set up the QC lock out and set up frequencies for when you want it performed. Just google it. It's 21 pages.
https://www.pointofcare.abbott/download?docUri=/technical-library/static-assets/technical-documentation/730077-00D.pdf
From: Thiruppathy Sabapathy via POCT Listserv (Groupsite) [mailto:users+1160319@poct.groupsite.com]
Sent: Friday, January 04, 2019 12:32 PM
To: Hollis, Cynthia M
Subject: [EXTERNAL] [POCT Listserv] Re: i-STAT and CAP POC.07540
WARNING:
This email came from outside of CHS’s email system.
DO NOT CLICK LINKS
or
ATTACHMENTS
in this email unless you recognize the sender.
Disclaimer: This electronic message may contain information that is Proprietary, Confidential, or legally privileged or protected. It is intended only for the use of the individual(s) and entity named in the message. If you are not an intended recipient of this message, please notify the sender immediately and delete the material from your computer. Do not deliver, distribute or copy this message and do not disclose its contents or take any action in reliance on the information it contains.
We also use EVAS so the user can see if the result passes or fails. We do not use the scheduler.
If you read page 2 of tech bulletin 730077-00D -Liquid Quality Control schedule and lockout customization on the I-stat handheld
C. QC Lockout---
....A QC test profile is satisfied when at least one of each required QC cycle is run and is determined to have "passed".
4. A failed QC cycle in itself will not cause a cartridge set to be locked out. Lockout occurs only when a QC test profile is past the set grace period and has not been satisfied.
So if an analyzer is required to run level 1 and 3 on a G3 cartridge, and QC is run on schedule, but one level fails and one passes, the analyzer DOES NOT lock out patient testing.
If someone has found this not to be the case, please let me know. Abbott tech support also states the same as above.
Hi,
That is what we have experienced too. If one level passes and the other level fails the iSTAT will allow patient testing. We've complained to Abbott to no avail.
"As of Aug 2017 CAP changed that requirement for Non-waived testing. We are no longer required to run aqueous controls every 31 days. I need to look into that requirement for the CHEM8+ because it is a waived test. Unless any one else already know the answer to that question."
If you use chem 8 as waived than FDA says you need to QC every month to verify storage conditions. But if you are using it nonwaivwd than you can specify whatever frequency in your IQCP.
Brian
Sent via Groupsite Mobile.
I suppose I didn't think of it that way, but we only send them one set of QC and we do use the scheduler. So, if it fails they cannot repeat it until we send them another vial, unless they repeat it right away and it passes. Therefore, if they go past the due date then it is locked out for that cartridge type. They always run it on the date that displays on the iSTAT as the Next QC Due date. I suppose they could get away with running a test that same day, but we are monitoring them pretty closely, since we set the due date, we know what day they are going to be running it. I will add that in my organization we are one big hospital, and 6 ancillary ED/Urgent Cares. At the big hospital the POC team runs all of the liquid QC for lot/shipment. Only the ED/Urgent Cares run iSTAT QC on the shipments of cartridges we courier over to them. So this works for us on a small scale. We control the "shipment" because all cartridges arrive at our main facility, then we are packaging up what is needed at the ED/Urgent Care site and sending it over along with two vials of QC.
Thanks Cynthia