Peter:
My own (personal) "twopennorth" to add to others' contributions (in
haste - I'm away elsewhere tomorrow, and the meeting is on Friday)
1. Though I understand that MHRA have invited major stakeholders
to Friday's meeting, there is no guarantee that this will have much
wider attendance than the 2003 meeting arranged by Pathology
Alliance (almost exclusively from laboratory medicine, ie no end
users, no alternative providers)
2. There appears to have been little by way of positive response to
date to cries of "foul" or "give us a level playing field" from
laboratory medicine. For example, NHS labs must be at least
registered with CPA whereas pharmacies and others have a
completely free hand with regard to service quality, and are
encouraged to 'compete' for funding etc
3. Though I have seen a statement along the lines of "pharmacies
don't know what EQA is", I have indications that some
organisations DO know what it is but have rejected it as
"unnecessary" (see 2. above)
4. Previous professional guidelines from organisations outwith
laboratory medicine included mention of the importance of quality
(QA, IQC and EQA), but the current equivalents do not
5. Though many ethical IVD suppliers fully support the quality
agenda, I understand that (in some areas at least) there are also
'grey imports', ie IVDs obtained not from the authorised UK
distributor but from other organisations within or outwith the EU -
these carry potential risks to the purchaser with regard to liability,
risk assessment, etc . . .
Best wishes - and best of luck!
David
Dr David Bullock
Director, Wolfson EQA Laboratory
P O Box 3909, Birmingham B15 2UE, U K
FAX: 0121 414 1179 [+44 121 414 1179]
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