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Sysmex XT2000i open vs closed comparison


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I've been performing open vs closed comparisons on our Sysmex for a couple years but had the expected limits  wrong.  I was using instrument vs instrument numbers but actually found the correct data accidently searching for something else.  My question is:  Does each individual sample comparison have to meet Sysmex claims or is it on average.  I couldn't get a straight answer from sysmex at all in fact they claimed that no one was doing that and that if we were testing controls on both modes then it was all we needed to do.  I finally talked to someone that told me that the average was ok and that I should always use a normal sample for this but they could not provide any documentation on this other than what I already had ( one paragraph and a table of limits).  I also spoke to JCAHO and they told me that it should meet claims on average but that there should also be some individual limits as well.  When I asked him where do I get these limits he said the typical JCAHO response "you lab director must determine this".  I spoke to our director as well as our pathologist and neither had a clue on where to look for this.   On average we are fine both % difference and/or less than some expected actual number and the regressions all look good (even Basophils) but individually there are failures on everything platelets being the worst.  What was suggested several years ago by a JCAHO inspector was to do this testing every Monday and crunch the number every 6 months.  I quizzed a friend at another hospital but they use a Colter and that information is provided by Colter in their documentation which consists of running ten samples each in triplicate (averaging the triplicate results) and using that average results to crunch the numbers.  What is everyone else doing along these lines.  We just finished our JCAHO inspection in May and had a state health validation inspection last week but neither looked at this information this time. 

Thanks

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  • 3 weeks later...


A simple standard to go by would be to use the same acceptable limits for correlation that you use for QC.  You cannot expect precision to be better for patient correlations than  you get for QC, and it should be at least as good.

Scott

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4 hours ago, SMILLER said:

A simple standard to go by would be to use the same acceptable limits for correlation that you use for QC.  You cannot expect precision to be better for patient correlations than  you get for QC, and it should be at least as good.

Scott

Thanks Scott I'll take a look at comparing my data with QC ranges to see if that will help me.  I talked to a guy at JCAHO and basically they can't tell you anything or maybe won't would be a better term.  He did tell me though that there should be some individual limits and that our director has to decide what they are... He doesn't have a clue nor does our pathologist.  The problem with sysmex is that they make claims about the correlation between the modes but they don't elaborate.  On average we are aok but individually we are out on different parameters.  Sysmex went as far as to tell me if I'm running controls in both modes then we don't have to do it... JCAHO said controls aren't really patient samples and we have to do the correlations with patient samples.  So we just got inspected so it will be 2 years before we have to worry about it but I sure would like to know something lol thanks again..

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