HemoCue users and failed QC documentation

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Hi everyone! I am currently in the middle of our CAP inspection and I am probably going to be cited for POC.07124 - QC Corrective Action - Waived Tests, in regard to our HemoCue. For those of you that have a HemoCue, how are you meeting this standard? The inspector feels that the user should be documenting what the corrective action was - further mixing, new control bottle, etc., whatever was done to get the QC in range. In the Nova Glucose meter, we have canned comments that the user can select, operator error, wrong control ran, etc. Can canned comments be added to the HemoCue; does it have that functionality? When there's time, I'll check the manual and/or call but just wondering what others are doing. If there is nothing electronic that can be documented at the meter level, I'll have to have them document on a log, ugh! The instrument has QC lockout and I guess I didn't think of this standard in regard to HemoCue; my mind went straight to Glucose since it is so much more prevalent. Thank you!

7 Replies

Vicky McArdle

Thu Jul 27, 2023 at 2:08PM

The Hemocue 201 DM has the ability to display canned comments for the user to select when the QC fails.

Danyel Olson

Thu Jul 27, 2023 at 2:10PM

That's a real stretch. I personally would argue that those meters have lockout - a patient test cannot be run until QC has passed. The operator has no choice but to troubleshoot in some way (usually mixing the vial) and repeat to get passed QC.
You can add any comments you want to the Hemocues so you have that options if you choose. It's in the software under Comment Lists.

Raymond Li

Thu Jul 27, 2023 at 2:22PM

Hi Anita,
Just want to hijack your discussion for a quick question. I am a POCT technologist from Vancouver Coastal Health authority, BC, Canada.

Are you using the WiFi capable version of the Nova StatStrip glucose meters? We have them deployed basically across our entire province, and we are dealing with a WiFi issue where random meters will disconnect from the wireless network and couldn't reconnect.

Nova is investigating this, but mentions we (entire province) are their only clients with this issue. Just want to see if you (or anyone else) have experienced something similar.

Raymond

James Beck

Thu Jul 27, 2023 at 2:23PM

100% agree with both of the above responses. Also, if you are using AQURE to configure your Hemocue devices, you can do it there as well.

As an aside and to Danyel's point, I wish the CAP standards would catch up with the QC lockout feature that has been part of most POC devices for 20 years or more :).

Anita Belanger

Thu Jul 27, 2023 at 4:04PM

Thank you everyone! We found where the comments live in the meter. Staff are repeating QC, but not "recording corrective action". Oh well, that was the only citation.

Terry Hawkins

Fri Jul 28, 2023 at 8:55AM

We were recently cited on POC.07124 for our glucose and UA devices. (The inspectors didn't ask about HemoCue.) Reviewing corrective action for devices with QC lockout is a huge waste of time...
Do any of you use the Joint Commission for inspections? Are they any more reasonable than CAP?

James Beck

Fri Jul 28, 2023 at 2:42PM

Terry - the JC WT 1.40 Elements of Performance states only that "Written policies and procedures address the following items:" - one of which is "Quality Control (including frequency and type) and remedial action." But not expressly documenting what type of remedial action [by an operator]. My JC resource is a bit dated however and I don't have a more current one at the moment. Hopefully they haven't added more to it.

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HemoCue users and failed QC documentation