UKAS - Uncertainty of measurement in BT

[BethBMS]

Hi!

Was wondering if anyone had any advice and guidance on how to tackle uncertainty of measurement for testing using Diamed gelstation/IH system.

We have been inspected by UKAS (last year) and one of our connected hospitals/labs have had their surveillance recently only to bring up UoM for transfusion testing. I don't know if I am just being a bit niave but I was under the assumption that UoM should be used for quantitative assays, and obviously we are using qualitative assays. Does anyone know how we would go about calculating UoM from this? We've again not been given any guidance from UKAS themselves (surprise?) and I am struggling to find a sensible way to work this out!

Any help is much appreciated

Beth

[Malcolm Needs ★]

1 hour ago, BethBMS said:

Hi!

Was wondering if anyone had any advice and guidance on how to tackle uncertainty of measurement for testing using Diamed gelstation/IH system.

We have been inspected by UKAS (last year) and one of our connected hospitals/labs have had their surveillance recently only to bring up UoM for transfusion testing. I don't know if I am just being a bit niave but I was under the assumption that UoM should be used for quantitative assays, and obviously we are using qualitative assays. Does anyone know how we would go about calculating UoM from this? We've again not been given any guidance from UKAS themselves (surprise?) and I am struggling to find a sensible way to work this out!

Any help is much appreciated

Beth

I would thoroughly agree with you Beth.  UoM was only supposed to be used on quantitative assays, as I understood it.  Certainly, when the NHSBT RCI Laboratories were inspected the first time, UoM only reared its ugly head with quantification of anti-D and anti-c, measurement of FMH by flow, and a bit of a nod to the "art" of titrations.  They have recently been inspected for a second time, and passed with flying colours.  I would love to know where your particular inspector(s) got the idea about UoM  testing for DiaMed Gelstation/IH system.  I would suspect that he/she/they did not do blood transfusion as a primary discipline and, although UKAS seem to have taken over the mantle of "most arrogant organisation in UK Pathology" from the MHRA (and they were bad enough), I would still put the question formally to UKAS, if necessary via your Regional Transfusion Committee (so that they would be forced to answer).

[BethBMS]

Thanks Malcolm! I thought we were just missing something!

Will put it to UKAS and see what they come up with

Beth

[A little lab lost]

We were inspected recently and did not have any UoM for Diamed systems, which they had no issue with.  We do however have a table in the SOP listing mitergation of uncertainty for the analysers but no actual calculations and they were happy that we had considered it.  I think in the standards it says to 'consider' uncertainty so we listed things like IQC, EQA, competency assesment of users, 3rd party controls, standard reagents that have a BAT etc. 

[BethBMS]

Thanks! This is quite helpful and lots of things to consider

Beth

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