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HPLC QC dilemma


Auntie-D

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We are using the Menarini something-or-other for our routine antenatal haemoglobinopathy screening and diagnostic tests and have a bit of a situation at the mo...

 

Both normal and High control are running within acceptable ranges (right at midpoint) but we are getting approximately 50% of samples running with a low A2. l have been out of the section for a month and have found out that all the reports have just been issued out with comments stating 'Low HbA2 - of no clinical significance'. Now of course periodically you do get some like this, but in my experience it has only been about  1 in 100 samples.

 

l raised my concerns with my line manager pointing out that l thought that there was a problem with both the analyser and the control and that we should take the persistently low A2 as a an indicator that there is something wrong with the analysis. l explained that l was concerned that a patient with low MCH and normal A2, could as a result actually have a raised A2 indicating thalassaemia and be reported off as 'no partner follow up needed' when in fact they are at high risk of having an affected child (possibly hydrops).

 

My line manager didn't seem to get the point and kept labouring the point that 50% of cases are not going to be thal. l wasn't trying to claim that 50% may be thal but the occasional may be and it is risking missing it. She stated that if the MCH is normal and the A2 is normal it isn't high risk - l'm worried about the low MCH and 'normal' A2 ones signed of as no follow up needed.

 

How the heck do l convince her to spend some time sorting out the analyser - she just keeps quoting that the QCs are in normal range. But l don't trust the results :(

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Had one today :( FOQ with HbA2 of 3.4 - technically not high risk (and potentially 3.7/3.8), but if we are trending .3-.4 below what we should then the followup would be totally different :(

 

Can anyone give me advice on how to shake my boss?!?!

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Well after complaining about this for about 3 months and nothing being done (other me being told l was overreacting) we have just failed out HPLC EQA - what a surprise… QC manager has got involved and now all negative antenatal screens for the past god knows how long may have to be recalled for repeat testing :( The have vetoed all results reporting until the issue is resolved - thank goodness for that!

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  • 2 weeks later...

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