Replacing reagent on Sysmex XE analyzer

[mrdth5]

At our laboratory, we have a policy to run 2 levels of QC after each reagent change, even if it’s same lot number. I can see if it’s a new lot and Sysmex has provided documentation on that, but with every, same lot # change seems excessive to me. Does anyone else do this? Is this required by any accrediting agency?

I’m a newbie Hematology supervisor so I’m looking at things with a fresh set of eyes, albeit a little rusty in Hem so I need the community help. Thanks for your response.

[Auntie-D]

It is good practice to run QC after each reagent change, regardless of a change of lot number. Your initial batch validation ensures that no deterioration happened in transit, and the pre use QC ensures that reaction strength is still as expected, with passing time.

 

ETA - I have seen a case where a weak anti-E was missed as the reagents were 'going off' and the QC barely gave a 2+ reaction but had been accepted as OK. Fortunately the patient was known and it was used as a learning tool for a new student. It was used to demonstrate that the titre of anti-E can fall to undetectable levels. When the sample was run on the other analyser it was weakly positive. It was then used to demonstrate the importance of running QC and ensuring correct reaction strengths.

Edited June 26, 2015 by Auntie-D

[Alan Neal]

I would suggest read information about preacceptance testing.

I would be VERY careful about the use of QC with every reagent change.

My approach, if accreditated supplier with good history and performance, then I wouldn't amend QC frequency (Use internal tools xM & xB), unless reagent manufactured or criticial compenent i.e. Risk assessment.

 

Suggest review:

A review of current intervention guidelines, best practice guidelines and other relevant publications was performed, these included:

• JACHO – Quality system assessment for non-waived testing 20132
• CLIA – Brochure #4 2003, Facts 16E, 19
• CAP Standards: HEM 65850, 24575, 30070
• RCP(UK) 2005 – Code of practice haematology departments

[SMILLER]

We currently are using Beckman-Coulter LHs, and we do run two levels after reagent changes, with the exception of diluent.  I guess you have to at least follow manufacturer recomendations.

 

Scott

[Auntie-D]

I'd be very careful about NOT doing it...

 

It isn't about how good the supplier is - it is about validating the reagent works currently. That reagents haven't deteriorated over time.

 

We run our QCs twice a day, so each time they are run we change any reagents that need changing - then there is no requirement for additional QC.

 

 

I would be VERY careful about the use of QC with every reagent change.

My approach, if accreditated supplier with good history and performance, then I wouldn't amend QC frequency 

[mrdth5]

There seems to be a lot of variation among local users and those on this forum regarding this issue. Some run the QC after each rgt change (same lot#), whereas others will use various versions of patient control or XbarM.  I think I’ll keep our current practice until I have time to dig deeper into IQCP, which could change everything.   We’ll see.