It's got to be more than 10k cost. Hard to quantify as we are accredited as an entire directorate so there is a large "central" quality section, but I have one clinical scientist on permanent secondment there and a large number of staff hours devoted to looking after directorate wide documents as well as departmental quality leads etc.
The quality "overhead" is crippling in some respects. Heading towards our second surveillance visit and potentially flexible scope of things go well, which should help enormously with extension to scope issues.
Our historical assays were fine, largely due to luck - (thanks Bill Bartlett for having the original validation data for our cats assays on 3.5 inch floppies and in lotus 123 format I think!!! ) and due to how we set assays up in the first place, almost ukas standard.
Cheers
Craig
Sent from my iPhone
On 18 Jul 2016, at 11:09, Myers Martin (LTHTR) <[log in to unmask]<mailto:[log in to unmask]>> wrote:
Don’t talk to me about UKAS! We have it and have passed the year one surveillance as well, so I am not bitter; just £10k a year worse off (just for biochem) and questioning the whole approach, especially the extension to scope issues.
Martin
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of OConnor John (ROYAL DEVON AND EXETER NHS FOUNDATION TRUST)
Sent: 18 July 2016 09:45
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: UKAS
Dear Collective
How have labs found the UKAS inspections in the context of validation/verification of historical methods that may have been in use for many years. Is a reference to the original work acceptable with on-going evidence of good performance using EQA and IQC?.
BW John
Dr John O’Connor
Consultant Clinical Scientist
Lead Scientist RDE
<image001.jpg>
Website: www.exeterlaboratory.com<http://www.exeterlaboratory.com>
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