COM.04250 Comparability of Instruments and Methods

Do you have 100+ different devices or 100+ of the same device?  We compare methodologies such as RapidPoint vs. iSTAT vs. Architect, but not every single iSTAT, etc.  We do rotate instruments/devices so that we are using different ones for each method comparison we do...  

We have 130 epoc's used for gases/electrolytes and 50 iSTAT's that are used for Creatinine and ACT testing. Our inspector said that we should be testing "all" 130 epoc's against each other twice per year.  

I do not interpret COM.04250 that way.  "The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites."  You may want to call CAP directly and ask the question and document the call.  We have never had an inspector tell us to do it differently throughout the 5 major facilities that we oversee.  Whenever interpretation is in question - I just call them directly and ask them to explain and provide documentation of anything the Rep references in our conversation.

Kayla,  Thank so much for your responses!  I did not interpret that way either and will definitely be reaching out to CAP for clarification.  

COM.04250 Comparability of Instruments and Methods - Nonwaived Testing Phase II
If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments and methods are checked against each other at least twice a year for comparability of results.

NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods, even if there are different reference intervals or levels of sensitivity. It includes primary and back up methods used for patient testing. The purpose of the requirement is to evaluate the relationship between test results using different methodologies,instruments, or testing sites.

How we address this:

 All same type analyzers must be compared against each other:

Example: If you have 100 Epocs they must all be compared against each other.  We use QC for this which isn’t ideal but it’s very difficult to use patient specimens for ABG testing. 

·         Pick one Epoc and compare all other Epoc's against it.

All test methods performing the same test must be compared against each other.

Example:

If you have Epocs that do electrolytes and a main chemistry analyzer that also does electrolytes you must compare them against each other.  You do not have to compare all 100 Epocs to all lab chemistry analyzers.

Summary: This effectively means that you have confirmed that all your test systems are reporting the same results: different analyzer types and all analyzers.

Jeremy,
Could you please elaborate on how you compare 100 meters twice per year in addition to method comparisons?  I cannot seem to wrap my head around what that would look like.  Is that all in one facility or multiple facilities?  

Shea,
Could you please share what you learn from CAP?

Thank you.

We use a system similar to Jeremy's.  We compare at least one i-Stat with our core lab analyzer and then compare the rest to each other using QC or CAP Quality Cross-Check surveys.  In the case of using QC, we make sure they all were tested with the same lot number of QC and then apply our established allowable difference to the results to confirm that they correlate.

Kalya,
 
 You only have to compare analyzers to each other that all fall under the same CLIA licensure, for most situations this limits you to the analyzers at each facility.  

What we do for the Epocs:

Epoc vs Epoc:

We run the same LOT of QC for all tests on every Epoc using the same LOT of reagent cartridge. Take this QC data and enter it into a spreadsheet and compare all against the “Primary” Epoc…. Just pick one.  You will have to define what your acceptance criteria will be.
Example:
·        Epoc serial number 12345 vs Epoc 56789

·        Epoc serial number 12345 vs Epoc 34567

·        Epoc serial number 12345 vs Epoc 98766 

· Do this for all Epocs you have.

After completing this you have now proven that all Epocs are reporting the same results.

Comparing different testing methods; Epoc vs Lab
·       Our Lab does not do ABG testing so we are only looking at Chem and H&H.

In the ED they draw samples to send to the lab for testing. We collect 1ml of this same blood sample draw and run the whole blood on the Epoc. The sample gets sent to the lab to be ran there. We then get the lab results on this same sample and enter it into a spreadsheet to compare Epoc vs Lab. We do this for with 10 samples.  Develop what your acceptance criteria will be.

·        Develop good relations with the ED team, it helps significantly. It also helps to explain why you are doing it. 

 

Per CAP regulations: You have now proven that all Epoc analyzers are comparable to the lab results as well. This is done on a semi-annual basis.  NOTE: semi-annual does not mean it must be done exactly every 6 months but that is best laboratory practice.  This is not to be confused with the Cal/Ver of these systems which does need to be every 6 months.

Jeremy,

Thank you for taking the time to share this information.  I appreciate your efforts.

Thanks for everyone's feedback, this group is amazing!
I contacted CAP for further clarification, and this was the response.

Thank you for contacting the CAP. We have reached out to CMS regarding this issue; unfortunately, because the Epoc performs nonwaived tests, you must compare all of your instruments. This would not apply if the instruments are in locations that have separate CLIA and CAP numbers, or if the testing was classified as strictly waived. 
 
 Jeremy, would you share your correlation spreadsheet?  My email is woodwars@musc.edu