Avoximeter 1000E control frequency

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Our H&V department currently runs the Avoximeter QC filters every 8 hours and then they run all 3 levels of liquid QC once every 7 days.  I'm thinking this may be overdoing it.  This is the way it has been prior to my taking this position and I'm just thinking that this may be more QC than is required for this instrument.  The only result that is used from the Avox is the O2Hb%.  I don't believe this instrument would fall under one of the categories that require QC every 8 hours (coagulation or blood gas testing) unless I am misinterpreting the requirements.  What is your QC frequency if you all use the Avoximeter 1000E?  We are CAP accredited.  I supposed if we changed the frequency of QC from what we are currently doing,  iQCP would need to be re-evaluated as well...thoughts?

Thank you!
aholland@catawbavalleymc.org  

15 Replies

We use the AVOX 1000e model and only perform the O2Hb% as well. We are CAP accredited and do use an IQCP for this test. We moved to daily filter QC and only perform liquid QC once per week as applied in our IQCP.

Good luck!
Erika

The Operators Manual lists Daily Optical controls and weekly testing of one level of liquid controls.  We run the Optical filters once an 8 hour shift and 2 levels of liquid controls once a week.

Manual states Quality control testing of the AVOXimeter 1000E consists of the following operations:
● Daily optical quality control.
● Weekly testing of one level of liquid controls.

We do as Erika - both optical 1 every 24 hours, 2 levels of AQC every 7 days

An IQCP is required to get away from Daily QC required in CAP POC.07300 and the IQCP can be stated to match the manufacture minimum which is published in the Avox manual. 

Attachment.
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We run Daily Optical QC and wet controls weekly.  An IQCP is also required.

We run the optical filters every 8 hrs of testing and 2 levels of liquid weekly.  We do have an IQCP.  

Same here - Daily: both levels of Optical QC and Weekly: 2 levels of liquid QC with IQCP 

If everyone above is performing QC based on manufacturer recommendation or even exceeding their recommendation by performing 2 levels of liquid QC once weekly.....then why does everyone have an IQCP? 
Also how does everyone establish their control ranges with each new lot? Manufactuer provides a control range but package insert says it is only a guide and the control range should be established at each facility.

1.     If everyone above is performing QC based on manufacturer recommendation or even exceeding their recommendation by performing 2 levels of liquid QC once weekly.....then why does everyone have an IQCP?

CAP POC.07300 states Daily QC is a minumum requirement for non-waived testing β€œThe laboratory performs controls for quantitative and qualitative tests each day of testing or more frequently if specified in manufacturer's instructions, laboratory procedure, or the CAP Checklist, and when changes occur that may impact patient results.” An IQCP is needed to reduce the daily QC requirement.  

CAP gets the Daily QC requirement from CLIA Title 42 Chapter 4 Subchaprter G Part 493.1256 (3)  - https://www.ecfr.gov/current/title-42/section-493.1256 (3) Same as CAP an IQCP is required to deviate from the daily QC requirement. 

IQCP instructions and requirements come from Appendix C of the State Operations Manual (CMS Pub. 7) - SOM- Appendix C (cms.gov)
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 2. Also how does everyone establish their control ranges with each new lot? Manufactuer provides a control range but package insert says it is only a guide and the control range should be established at each facility.

The Avox manual says to use the acceptable values on the insert sheet or value chart which comes with the LQC.
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1. I understand the CAP and CLIA requirements but according to manufacturer the daily optical filter is a QC so can't you argue that it meets the daily QC requirement?...just a thought. This instrument was in place before I took over and we don't have an IQCP and haven't got cited....yet. Just debating if I need to put one in place. 
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2. Package insert for controls from IL states "The stated reference range on the insert serves as a guide for the user. IL recommends that was laboratory establish its own mean value, which should fall within the reference range specified for their model instrument." Previous POCC was running 20 samples of each level then establishing a range for the QC. Just wondering if other sites are doing something similar.

Under CAP POC.07300 in the Point of Care Testing checklist it states the following:
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According to this I think the QC filters classify as in "internal QC" meaning that an IQCP would be required in order to not run liquid QC daily.  Hope this helps!

The daily filters do not measure "the accuracy and precision of the complete analytic process" because they don't check the cuvettes or assess the operator's technique.  An IQCP is needed to justify the use of the daily filters in place of daily liquid QC.

Thank you for everyone's input. Does anyone have an AVOX IQCP they are willing to share? Apparently I need to start working on one. hahaha
breana.birmingham@dignityhealth.org

What about AMR Verification for the Avoximeter 1000E? Is this required per CAP checklist requirements? 

Mary,

The Avox is non-waived analyzer, so yes, per CAP you would need to validate the AMR every 6 months.  This is done with your 6 month Cal/Ver that you should also be performing, just make sure that your defined AMR is covered by in the range your Cal/Ver. 

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