Hemocue 201+

Hi,

We perform QC on Hemocue 201 everyday of patient testing.

Thank you

We don't run QC. Our rep says that the FDA doesn't require it, and we are not CAP or TJC or COLA or anything, so we go by product insert.

We recommend running each day of patient testing as part of Good Lab Practices. If no patients, then at least once a week to make sure device is working

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We started out requiring every day of patient testing QC (external).

Since there internal/electronic controls, and it’s WT, we reduced to new lot/new shipment plus 30 days for in use cassettes.

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I wrote in their procedure that a High and Low QC must be run on the day they have glucose test to do. They don't have to run it everyday, only when there is  a patient tested that day.

Even though the procedure is waived,  by definition "waived test have insignificant risk of an erroneous result", as a lab  scientist and for good practice,  we should check to make sure the instrument is giving out good and accurate result.

Jill Dwyer,

Who inspects you if  TJC,CAP, COLA do not?   Do you have a CLIA certificate to do lab test?  Do you charge for the test? You should ask for documentation from your vendor that FDA does not require QC if you are not required to do them. Does CLIA/CMS inspect you? You could be the lucky one in their lottery to be inspected.

We are inspected by the state DOH (WA state is exempt from CLIA - I think NY is the only other state that works this way). Depending on site, we are either at Cert of Compl or Cert of Waiver. Our group was recently purchased by a larger national group so I'm sure some changes are coming down the road, and the POC department (me - part time) was only created 7 months ago (while POC testing has been happening for years). We are only running Hgb, no glucose on that inst (is it just the 201D that has glucose?) and we also have some 801s. We are looking at replacing all the 201+ with 801 going forward as well. Since we are in compliance with MFR insert, DOH says we are ok. I agree that it would be better lab practice to do external QC, but right now I'm trying to get everyone UTD with skills competencies and making sure they are running the QC they do have for other tests. I'm kind of picking my battles.  Not ideal for sure.

https://www.cliawaived.com/web/items/pdf/Hb-201-microcuvettespackage-insert~752file1.pdf

We run 2 levels monthly and when a new box of cuvettes are opened. 

We require QC every day of (prior to) patient testing for good lab practice and also to QC our staff's testing skills (filling microcuvettes incorrectly can change the result be a full hemoglobin point or more). 

Additionally we require QC at least every 30 days because many of our clinics have Rural Health Status meaning they are required to be able to test hemoglobin.  The fear is that clinics who don't run patients very often may not be aware that their instrument is not working or that their QC is expired (especially the sites that still use R&D which is only stable for the specific 3 month period, although we've changed most clinics over to Hemotrol which has a MUCH longer unopened outdate).

Since this is a waived test with (as you mentioned) very little company input, I doubt you can go wrong as far as being inspected is concerned as long as you stick to your procedure.  Most of our decision was based on staffing concerns, not HemoCue concerns.

We perform with each new lot of cuvettes.