Accruacy and Precision

Abbott put out a suggestion on a workup plan for new/replacement analyzers a couple of years ago. In a nutshell:

• Reportable range-low, medium and high. We run blood gases on our meters so I throw in a hyperbaric vial also


• Accuracy-use reportable range study plus run 1-2 samples to comparable  method or previously verified handheld. I use the SDs that CAP uses for their surveys as standard of pass for each parameter


• Precision-2 levels of controls in duplicate for 2 days for each analyte that will be tested by that handheld

Hope this helps. I tried to attach the actual document that I was given but this system kept fighting me.

Debra,

Could you please send a copy of the actual document (or the reference number for the document) to pointofcare@libertyhospital.org?

Thanks,

Vicki Shanks

We do pretty much what Debra stated except we run hypoxic controls from Eurotrol as well.

What standards were you cited for?

In the Abbott I-STAT technical bulletin the i-STAT technical bulletin 715209-00F, Calibration Verification and the i-STAT System under the section Verifying that results have not been affected by maintenance or repair procedures it states:

Repaired and newly purchased analyzers are received with factory calibration. Again, the Electronic Simulator can better assure that the analyzer's most important function is within factor specifications than calibration or control solutions.

Testing calibration verification samples or comparing patient sample results on new or repaired analyzer with an older analyzer will assess cartridge performance only. Any variations in analyzer performance will not be statistically discernible above the performance of the cartridges. when multiple analyzers are to be used a facility, Abbott Point of Care Inc. recommends at least two analyzers in any performance verification studies so that statistics reflect the system.

I am curious which standard they cited you under? It sounds as if there is confusion between initial validation and new/replacement handhelds. Did you question the citation and if so what did CAP say?

I sent that actual item to CAP on the challenge. What came back was this  

"COM 30350 COM 40310  Provide your validation for the new ISTAT  A full validation is required for all new instruments and the CAP requirements are in the All Common Checklist."

 When I called the CAP to ask what I was supposed to do with this standard, the person told me "I think your inspector was over reaching. I have nothing in my notes about doing this on the ISTAT."

The person that inspected me said that she has been doing a full validation for 10 years. when I asked her how many of them had "flunked" she said "None. We do it only because CAP says we have to." CAP has always been behind in how they deal with the ISTAT. Anyone remember when they did not accept the electronic simulator for QC in the early 2000's?

TJC uses IQCP for validations. (That is what I was doing by following the manufacturers' instructions.) I have had several e-mails on this posts from people who have switched for this reason. They did not have as many handhelds as I do either.

For us, it may cost us $20,000 more per year for absolutely no benefit. Just $20,000 worth of busy work; added tech time and used cartridges. I am going to have 20 more ISTAT in the next few months with techs that do bench work as their primary duties.