We are inspected by the Joint Commission and DNV.  We are not CAP or AABB inspected/certified.  We use the Echo as our automated system and the gel card/tube type as a back-up and/or clarification method.  Does anyone know of an AABB standard and/or Joint Commission standard stating the blood bank must perform parallel studies between methods? Such as Echo compared to Gel compared to tube?

The CLIA requirement is in 42CFR493.1281:

 

If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. 

Yes. We were cited for such by the JC. She said to do just the antibody screen, which didn't make much sense to me, so any test that I do in multiple methods, I do the correlation for.

So for example I do blood types in tube and on the Tango. The antibody screens I do in tube, gel, and Tango. When they don't correlate (which weak antibodies sometimes do), I explain it in the comment section. I have my Medical Director review and sign.

I run pretty much the same as Terri. We use an absc positive CAP survey specimen. Our screening cells are R1R1, R2R2, rr from a 3% panel. Since we already know the antibody we can select cells which will give both positive and negative rxs. We run a tube ABORh (if present we will run one that presents with an anti-A1). For the screen we use gel and tubes with both PeG and LISS. Our disclaimers are: 1) the ABORh rxs should be comparable; for the screen we state that gel reactivity will be greater than both the PeG and LISS testing. Never a problem so far.

Thank you all for your input

We were doing comparisons between gel and tube for antibody ID, but didn't have an actual policy written up.  TJC dinged us for not having the policy.

 

We had some weak antibodies that didn't correlate and we had just made a simple notation on the spreadsheet, like Terri mentioned.  TJC inspector mentioned it and was happy with our explaination/documentation. 

It seems like our daily reagent QC using the same QC kit antibody should suffice as the comparison testing, no?  Maybe we just need to look at it and document that we have evaluated the comparison?

We perform antibody screens/ panels primarily in gel , but use tube occasionally.  I have my techs run CAP survey samples (antibody screens, panels, auto control, crossmatches) in both gel and tube once per year.  Thus, the method correlation actually gets done three times a year because we get three surveys a year, but this also serves as a competency for both methods for each tech.  We report the gel results for the CAP survey because that is our primary method.  I have been doing this for about 5 years now and CAP inspectors have been OK with it.  I have a form that the techs use to record both sets of results.  I review the results to make sure they correlate as expected (tube is typically 1-2 grades weaker than gel), that the same antibodies are found, etc. Both I and the Medical Director sign off.

It seems like our daily reagent QC using the same QC kit antibody should suffice as the comparison testing, no?  Maybe we just need to look at it and document that we have evaluated the comparison?

Mabel,

When we were cited I was told that you have to specifically test samples as comparison samples.  Routine testing by both methods doesn't count.  We perform our routine testing by gel and our ABO RH retypes by tube, and periodically perform ABS by both methods, so I said I was compliant, but they said that didn't count.

Mabel,

CAP will not accept using QC material. At my previous hospital, that is what I set up and CAP/AABB were happy with it. This year that hospital was cited, and told that QC material cannot be used.

Dalene

We are TJC and AABB but not CAP inspected.  Does anyone know how JC surveyors might react to using the QC antibody for comparison?

Even CAP sample might not count!

I passed my last 2 CAPs using their survey samples. I would fight a citation based on their usage. If my accreditation is dependent on the results obtained on those specimens I should be able to use them to validate any other required testing.

During our last inspection, CAP was ok with our using QC materials to test between tube and gel IAT.  We used patient samples for correlations with DAT and XM.  I think it's a personal preference with CAP inspectors.

 

With respect to correlation studies, what are the acceptable limits? For example, if you get a 2+ on a positive antibody screen on one sample, would you have to get the same reaction using a different method in order for the methods to be considered correlated?

Also, with regards to non-blood bank testing, i.e. ABG's does the CLIA standard or Joint Commission standard define acceptable limits of correlation studies?

 

We are TJC and AABB but not CAP inspected.  Does anyone know how JC surveyors might react to using the QC antibody for comparison?

 

We are TJC inspected only. 

 

Last year we were cited for using QC material for correlation between gel and tube.  The inspector said QC material was not acceptable because it has strongly positive or negative reactions.  Using patient or proficiency samples is better because there is more variation in the reaction strengths.

 

Now we use proficiency samples for correlation, as others have stated.  We do the proficiency testing in gel since that is our "main" method and submit our results.  After we have submitted our results, I assign the same proficiency samples to different techs to repeat in tube testing.  So we do the correlation 3 times a year, since we have 3 proficiency events a year, and the techs can get signed off on competency.

 

The inspector was happy with this solution and approved of the policy I wrote.

 

Catherine