GEM 5000 pH AMR

The AMR on your non-waived tests must be validated every 6 months at minimum per CAP or JC standards.

If the product you are using to validate the test ranges do not go wide enough:

OR

We also use the GEM5000 and the PVP material for pH typically (depending on lot number) doesn't reach the lower end of the measuring range (6.80). We've  adjusted the lower limit of our reportable range to 7.00 and only occasionally get a complaint on that lower end. In that case I will tell them to run a blood gas on the EPOC, which has a lower reportable range, as verified by the Eurotrol Linearity standards used for the EPOC.  If CAP makes a linearity material for pH that does cover that the low/high end of your range, I would think you are covered. 

We only use the PVP material.  The range we get from the PVP study is entered into the GEM Web under configuration/reportable ranges.  That becomes our established AMR.  The range of the PVP we just used was 6.94-7.74 which pretty much covers that manufacturers AMR range (Our operator manual states AMR of 6.8-7.92).    Any pH below 6.9 or above 7.8 is generally considered incompatible with life anyway.  Your policy should include the materials you use and be approved by the CLIA Director.

Thanks, appreciate the feedback. Our Dir of Resp does not want to adjust reporting range to <7 and CAPs linearity product doesn't cover all analytes so he will just have to continue using both products. Wish the PVP would go down a bit lower. 

We also use the GEMS 5000 for ABG/Lactates and Chemistries.  Werfen does not require PVP and this is the response I received from the Joint Commission regarding 6 month AMR verification.  So this would also apply to any non waived test that is calibrated by the manufacturer, like i-STATs.

The Joint Commission response:

 

GEM Premier blood gas analyzers cannot be modified for testing purposes by the lab therefore they meet the exception found in the note in QSA.02.03.01 and calibration verification is not required. 
 
 QSA.01.05.01 requires labs to evaluate the accuracy and reliability of results obtained for both nonregulated analytes that are not included in a formal proficiency testing program and regulated analytes for which compatible proficiency testing samples are not available. 
 Check your organization policy since the use of proficiency testing is one way to meet this requirement. There are other ways as well addressed in the note found in QSA.01.05.01. 
 
 Regulated analytes are required to have proficiency testing as addressed in QSA.01.0.01.

 

I hope you will find this information helpful.  

 

If you have additional questions, please visit the Standards Interpretation page on our website to view the FAQs or to complete the online 

Thanks Penny. We are also CAP accredited, which supersedes the Joint standards whenever they are more stringent :(

WHOA! This is crazy! The GEM5000 is not the only instrument I cannot calibrate. I have never heard about this exception and now I'm thinking about other analyzers it might apply to.
QSA 02.03.01.... 
Note 3: Calibration verification is not required on instruments that are manufacturer-calibrated and/or tests that are considered non-quantitative. This exception only applies to those instruments that cannot be calibrated after implementation.

I'll also be sharing note 1 with our Chem Section Coordinator because it will eliminate semi-annual calibration for several therapeutic drug assays:
Note 1: Semiannual calibration verification is not required when the laboratory performs calibration at least once every six months using three or more levels of calibration materials that include a low, mid, and high value.

Based on some responses here, I decided to reach out to the CAP. Not only is an IQCP not required, but neither is biannual instrument calibration / verification. Attaching the email as a PDF for everyone.

GEM 5000 Blood Gas Email From CAP.pdf

Thank you, Tianna! One part of that email gave me pause when re-reading:
"However, AMR verification is a separate concept (POC.08600) and must be the AMR must be verified if calibrators or QC do not meet the criteria in POC.08500 "

We are JCAHO certified, so I looked up the CAP standard referenced and it has the same exception as note 1 in QSA 02.03.01; if  If there are enough calibration points to cover the AMR (more often than q6 month), then AMR verification is not necessary. Slowly learning all the ins and outs of all of these regs...