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Really, is that what has been the experience of some labs? - I speak 4 languages, including English. I think key phrase in standard is:

"verified as performing satisfactorily before being used in conjunction with patient samples"

Unless UKAS are operating from a secret language interpretation guide, a process that verifies new lot is acceptable when it is brought out from store, prior to being used for patient samples meets that standard. You could do that on arrival, but I think it would need all reagents to go through process rather than a "sample"

I think we are all aware of "subjectivity" issues with accreditation processes, and hopefully common sense will prevail and labs will be assessed against the published standards

DJ





-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of SUBSCRIBE ACB-CLIN-CHEM-GEN Stephen Gibbons
Sent: 27 January 2016 13:04
To: [log in to unmask]
Subject: UKAS - Acceptance testing

Hello

We are currently developing a strategy to confirm to the UKAS acceptance testing standard.

‘5.3.2.3
Reagents and consumables - Acceptance testing: New lots/batches of reagents shall be verified as performing satisfactorily before being used in conjunction with patient samples. If the formulation changes then the performance should again be verified’

Would anyone, particularly those who have gone through the UKAS inspection, like to share how they went about this?

My understanding is that every batch, i.e. delivery will require testing before being ‘accepted’ and hence usable.  This must be done on arrival, and not as the reagents are loaded as essentially the process ensures the reagents have been stored correctly etc. by the manufacturer/ during shipment.

We plan to quarantine all reagents on arrival, test a selection of assays with pre-prepared pooled serum, before moving the reagents to the ‘usable’ cold room.  We are hoping testing a selection e.g 4 or 5 assays would be sufficient.  To test all reagents from each delivery would be difficult to manage in practice.

Any advice would be appreciated

Thanks

Stephen

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Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content.
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