Hemocue DM

Anyone care to share how often they require external QC on the hemocue DM testing platform? 

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At my facility I have them perform liquid QC every day of patient testing (technically every 8 hours) and we have lockout implemented.

Since it is a waived test, start with your accrediting agency or state requirements if applicable.  For instrument based waived testing (hemoglobin or glucose) 2 levels of external controls daily are typically required on each instrument used for patient testing.

We follow Joint Commission requirements of two levels of control each day of patient testing on each instrument for which patient testing was performed.

As Greg said, JC requires two levels of QC on instrument-based waived tests, so you pretty much have to go with 2 external, since the internal/electronic QC is only 1 point.  Unless of course your facility does not use JC.  Remember, they always have the option to peek in on your waived tests, even if you have another lab accreditor for everything else.

Guys, JC stopped requiring two levels of liquid QC on waived methods a few years ago. The waived testing AMP says to follow manufacturer instructions now - you may want to get an updated copy from your hospital admins.

We were doing QC daily before I came to work at this facility, I will be moving to no external QC required soon, just like the Coaguchek XS.

 

You are correct, Silka - I stand corrected!   We stopped using Hemocue a few years ago, so I didn't have occasion to keep up with what JC was currently requiring.  Looks like hat got changed in 2012.  Thank you!

 

https://www.jointcommission.org/assets/1/6/Revised_req_waived_testing.pdf

 

 

Totally! It was great cause for celebration for POCC's across the land Laughing

Indeed!

 

(Now, to just work on a few of the other things! Smile)

Silka,

under the Waived Chapter WT.04.01.01 EP #5 it still states: 

5 For instrument-based waived testing, quality control checks require two levels of control, if commercially available. (See also WT.01.01.01, EP 6)

Only for non-instrument based testing is QC performed at the frequency recommended by the manufacturer or the end-user.

Nope! Check out the link James posted above - it applies to instruments too Laughing

Word of caution.  The Joint Commission Perspective's edition cited is from 2012.

The current Elements of Performance as of January 2018 (under debate) are: (not including EPs # 1-3)

4 For instrument-based waived testing, quality control checks are performed on each instrument used for patient testing per manufacturers' instructions. (See also WT.01.01.01, EP 6)  (This matches what James posted, however it doesn't end there)

5 For instrument-based waived testing, quality control checks require two levels of control, if commercially available. (See also WT.01.01.01, EP 6)

These EP's need to be used to guide the end user in conjunction with manufacturer's recommendations to determine the frequency needed. 

Yes, those are the ones we use as well. It says "per manufacturers' instructions. Line item 5 means that IF the manufacturer does in fact require liquid QC, that you are using 2 levels. in the case of the HemoCue, the manufacturer states that the device performs internal QC and calibration with every test, and they also supply OPTIONAL liquid QC.

...and the debate rages! HAHA! Gotta love TJC WT Chapter Standards 'redefining' back to pre 2012 (thanks Silka for mentioning the year).

Post 2012ish, at the time we saw the change, we went back to MIFU and decided to hedge our bets (just like a good State University!). For sites performing low volumes of testing where manufacturer did not say 'day of testing liquid QC required/recommended' we kept the 'day of testing'. For sites ordering A1c kits as if they were almost free of charge, as long as their liquid QC had been stable, they went to new shipment/new lot# frequency.

Ditto Hemocue but we do not have data management for either Hemocue or Vantage. And we do not have State add-on QC rules here in the freedom we call Texas.

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