Rapidpoint Calibration Verification

Anyone out there with multiple Rapidpoint devices within the same facility? Are you performing six month calibration verification on every device, or just one device and considering that the "test system"?

I have 7 devices, each performs 8 analytes, and in order to put that data into EP Evaluator it will take me forever. This seems like major overkill for a device that self-calibrates and self-Qc's all day long. Also, is there a trick to getting the Linearity data graphed in Rapidcomm? I can enter the CVM ranges and yet when I go to Linearity reports its just a list of the results??!! How is that helpful? Shouldn't it graph the data for me so I know if it passed or not?

Please tell me there is an easier way!

Replies to this Topic

Hi Silka,

Yes, we validate all of our RP500s every 6 months. We also compare the “primary” instrument to the lab for Chemistries. The CVM is graphed in RC but I think you must perform the samples with “CVM” as part of the sample identifier i.e. CVM350602. Then it will need to be assigned level 1-5 in the linearity report to plot it. Tech support can walk you through it the first time.

I hope this helps,

Sara

Ooh! Thanks Sara! I can't see a graph of any kind in Rapidcomm, I will call tech support for sure!

 

I asked my technical rep for Siemens that question and was told they don’t require it but our regulatory agency might.  So I think this may be more a question for CAP or JC, etc., to answer.  I agree with your interpretation and would love to hear that a subset would be fine, similar to the i-Stat, another cartridge based analyzer.

 

To make the process a bit easier I spread my 10 analyzers out throughout the year.  I do 1-2 each month so it doesn’t take up so much of any one month.

 

Lara



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Hello Silka.

We perform CVM every 6 months for all RP-500 analyzers.

We do NOT use RapidComm! This is a by hand kind of thing.

It was insane at first but I have a cool Excel form that has helped me.

It was given to me by a Siemens Rep. Maybe it would be helpful to you too.

Email me and I will send it to you.

We also do every 6-month comparisons with the primary analyzers (Cobas) for chemistries and Sysmex for the H&H.

 

Jackie Lee Hartman

Point of Care Coordinator

Alaska Native Medical Center Laboratory

jjhartman@anthc.org

(907)729-1276 (office)

(907)947-8427(cell)

 

 

 

Lara - question for you - where did you get the information that a subset of analyzers in use was acceptable for cal ver for iSTAT?  I've never seen specifics that actually say this is OK for particular test systems.  Thanks for anything you can share!

James, Look at CAP standard POC.08500.

The notes under POC.08500 on the CAP checklist (see below). 



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Right, exactly what I am wondering...why would we treat the Rapidpoints different than the iSTATs - it didn't matter if I had two iSTATs or 200, we still only ran Cal Ver on one or two handhelds and even reduced our replicates to just one run per level. Typically our iSTAT Cal Ver took about 10 minutes to perform - grab 5 iSTATs and run one level per handheld - done and done Foot in mouth  The Rapidpoints, similar to ABL90's or GEM's, have an onboard cartridge that contains its own QC and Calibrators, it self-calibrates, disables its own analytes if they fail, and so forth. 

With that said, I wanted to share with you all that previously the Cal Ver was being done on a spreadsheet that really was simply checking to see that each level of the CVM's were within the package insert stated range. As long as they were all "in" they called it good. That might even be the same spreadsheet from Siemens mentioned above.

However, once I plugged the data into EP using the experiment that evaluates Accuracy, Linearity and Reportable Range - the Rapidpoints failed on nearly every analyte if using CAP standards for AMR (50% of the low and 10% of the high), and the Total Allowable Error defined by CAP for PT.  That information would have never come to light if I hadn't taken the time to enter the CVM data into EP for each device.

The difference is that the istat is a “voltmeter” and the actual instrument is the cartridge which is disposed of after each test. With the rapidpoint, the “cartridge” still contains the sensors but there are many other components in the system that are not disposed of that will affect the results i.e. optics. They are really apples to oranges.

Yes, but Sara I can't find in the operators manual where Siemens requires we perform the CVM's at all, much less at any specific interval. And as far as CAP is concerned the language used is that we must establish criteria for when to do it which "typically" includes "as recommended by the manufacturer" and "at least every six months" - however it does not state on every device, it states each "instrument/test system" - one might argue that their fleet of Rapidpoints is one "test system". Furthermore, the following questions on AMR say that we can use a subset of devices for cartridge based/strip based analyzers. The Rapidpoints are cartridge based even if the cartridge does run more than one test, but I do see your point about them not being like iSTAT. 

I suppose I had better get back to crunching data - I just find it an alarming waste of time whenever I have to sit down and spend hours crunching data for any reason in POC, haha 

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