GEM 5000 CAP 6 Month Cal/Ver, Linearity, AMR, and Reference Range Verification

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I am working on the CAP 6 month Cal/Ver, AMR, Reference Range and Linearity study on my GEM 5000’s. We usually use PVP to complete this in addition to patient samples to correlate to the lab. I have 3 devices in use where two are in OR and one in the Cath Lab. One of the Gem 5000’s in the OR is measuring lower than the TAE from the mean on tHb for PVP 1. When the last 6-month study was completed the instrument was in range of the tHb TAE. I have used 3 cartridge lots and run two different lots of PVP 1 (total of19 samples) and it will not pass TAE tHb on the low PVP 1.

CAP has made the TAE much narrower as well. It fails both the 7% and the new TAE of 4% on the low end. The other devices are fine. The field technician has changed the tension on the tubing and run diagnostic tests in house and he has taken it out for further extensive testing. He states is passes all diagnostic tests. It has failed PVP all along. Currently the instrument is out of service because of this. Werfen states it is ok to use based on their TAE listed in the GEM 5000 manual of +/- 0.7 for tHb < 18 g/dL. This is not compatible with CAP. Werfen has stated that no further service is needed. I am wondering if anyone has encountered any issues with your GEM similar to this situation.

Thank you!

5 Replies

Charles Yaple

Wed Jun 04, 2025 at 3:34PM

I don't think CAP publishes a TAE for tHb. I believe you are thinking of CLIA proficiency standards for tHb. https://www.ecfr.gov/current/title-42/section-493.941 Those requirements have recently been adjusted from 7% to 4% for proficiency testing purposes.

Laboratory Medical Directors choose to use CLIA proficiency testing acceptability requirements for other purposes including device comparison TAE, acceptably requirements for QC, and acceptably requirements for linearity when the manufacturer does not state an acceptable range.

For our GEM5000's, we do not use CLIA's proficiency standards for acceptability on the manufacturer's linearity kit (PVP). Our Laboratory medical director has not adjusted the acceptability requirements from 7%. Another resource to use is the total allowable error table from Data Innovations Total Allowable Error Table - Data Innovations. In the data innovations table for Hemoglobin 7% is acceptable according to AAB (American Association of Bioanalysts).

In CAP POC and All Common Checklists I could not find requirement to use CLIA’s proficiency standards for AMR studies, Linearity, or LQC acceptability requirements. I did find the requirements to follow Manufacturer process and when the manufacturer does not define a process to follow the Laboratory Medical Directors acceptability requirements.

I look forward to seeing other folks thoughts on this question.

Kellie Graham

Thu Jun 05, 2025 at 9:47AM

I understand that CAP does not post TAE or has checklist items regarding this. My lab follows the CLIA and TAE. CAP uses this for proficiency on the AQH survey.

Miranda Cotter

Mon Jun 09, 2025 at 10:35AM

We are currently looking at the TAE due to CLIA's proficiency testing update. Since it does not mean this has to be used for validation nor biannual studies, the medical director can set what criteria is used. In the past we have used CLIA's suggested TAE, but some of the "new' values may be difficult to meet like you have questioned. Not sure yet if we will adopt those values.

Jeremy MacDonald

Tue Jun 10, 2025 at 4:22PM

Kelly, I want to thank you for bring this up.

I believe that this issue for the lab is going to become more prevalent as more facilities run into this. I've already come across this with Nova and had a discussion about it with Werfen as well. Both Nova and Werfen take similar positions.

Issue:
The Platforms (Gem, Prime+, Radiometer) were approved by the FDA with the system defined TAE. These manufacturers are NOT going to change the TAE now: it was approved.

CLIA / CAP now says they need to be more accurate... lower TAE.... This issue doesn't become immediately apparent until:
Example:

Your analyzer is running 7 points high (TAE is ±10 points) for an analyte. By the defined of the analyzer, it is good, it is within the defined acceptable range... but wait! CAP says the new TAE is ±5 and your submitted point is 7 points high, you're OUT!. Reaching out to the Manufacturer and their responses is: the result is good enough; it's within acceptable parameters.

"Been there, done that" already.

I've been having our acceptable QC ranges tightened beyond the manufacturer's defined AMR to address this.

We are being caught between regulatory agencies and the manufacturers. I understand the desire to tighten the ranges; I also understand the manufacturers position as well.

Tianna Stein

Tue Jul 08, 2025 at 12:17PM

Hey, just an FYI - because the GEM 5000s perform 5 levels of calibration every 30 minutes, you do not need to perform linearity. This has been confirmed by CAP and CLIA (and NYS DOH).

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GEM 5000 CAP 6 Month Cal/Ver, Linearity, AMR, and Reference Range Verification