I was very interested to read Peter Furness' excellent commentary on the
MHRA meeting he attended to discuss POCT. As many of you will know we
recently produced our 3rd Wales version of a Guidance document ( the 1st
produced circa 1984)and all have had the very helpful support of the
Government in Wales. However, we met the same problem that Peter alludes to
in that the documents were only guidance and could n't be enforced in
"legal" terms. With the excellent advisory mechanism we have in Wales the
document went to all the committees - Medical, Nursing, General Practice,
Pharmacy as well as Scientific and received their unanimous support. This
meant that it was published as a Wales Assembly Government document,
supported by the Chief Medical Officer and the advice in it is taken
extremely seriously. For example, the Welsh Ambulance Service are in the
process of producing protocols to comply with the advice. All of this makes
our lives easier in the labs.
Finally, I would just like to add (and this is n't the purpose of this
e-mail) that the Wales ACB and the All Wales Clinical Biochemistry Audit
group are organising a meeting on the 7th April "POCT - the Wales
Perspective" in Newport to discuss such issues. We have high level input
from the WAG, Primary Care, Ambulance service, Lloyds Pharmacy and WEQAS.
The aim is to evolve a strategy to manage POCT from the broadest point of
view which will include funding support, EQA, Accreditation, IT etc. We
would be delighted to see colleagues from outside Wales although places are
limited to 100. Anyone interested in attending should contact Catherine
Davies at: [log in to unmask]
Best wishes
Keith Griffiths
Chairman WACB and All Wales Clinical Biochemistry Audit Group
-----Original Message-----
From: Royle Chris [mailto:[log in to unmask]]
Sent: 17 February 2005 07:25 AM
To: [log in to unmask]
Subject: FW: POCT / NPT
Dear all,
Information below from Peter Furness.
-----Original Message-----
From: Furness Peter - Professor of Renal Pathology
[mailto:[log in to unmask]]
Sent: 16 February 2005 12:45
To: Royle Chris
Subject: RE: POCT / NPT
Please do!
Peter
-----Original Message-----
From: Royle Chris [mailto:[log in to unmask]]
Sent: 16 February 2005 10:54
To: Furness Peter - Professor of Renal Pathology
Subject: RE: POCT / NPT
Peter,
Thank you.
May I broadcast this via the ACB mailbase (unless you have done so already?)
Chris
-----Original Message-----
From: Furness Peter - Professor of Renal Pathology
[mailto:[log in to unmask]]
Sent: 16 February 2005 10:44
To: Royle Chris
Subject: RE: POCT / NPT
Dear Chris
Please find below the message I tried to send to everyone yesterday. NHSnet
apparently has a gremlin... Peter
-----Original Message-----
From: Peter Furness [mailto:[log in to unmask]]
Sent: 15 February 2005 10:36
To: [log in to unmask]
Subject: RE: Point of Care Testing
I thought I should provide some brief feedback from the meeting last Friday,
with my thanks to everyone who contributed comments and evidence. I am
promised minutes of the meeting in due course and I will circulate them when
I receive them. I should clarify that the meeting was called by the MHRA,
not the Department of Health. Twenty-three people attended, including
representatives from RCPath (Graham Beastall), UKNEQAS, CPA and various
pharmaceutical interests. Susan Ludgate chaired the meeting. The opening
MRHA presentations seemed to emphasise regulation of the quality of the
devices, but those present repeatedly emphasised that mistakes made by the
users were more commonly a problem, that users had a naïve faith in the
reliability of POCT results, and that merely having a user's manual with a
CE mark was not a solution to operator error. The importance of education
and training was discussed, but there was agreement that this would not
resolve problems alone. The need for some form of accreditation and for
external quality assessment schemes seemed to be accepted without challenge.
It was agreed that the existing MHRA advice on POCT was intended to apply
broadly, not just to NHS establishments, though over the counter test kits
(where the test is actually performed by the user/patient) probably
represent a separate category, where all that can be regulated is the device
itself (and its instructions). So everyone offering results to the public
ought to follow the MRHA guidance - which of course includes collaboration
with an NHS pathology laboratory and could thereby mean involvement in an
accreditation system.
But it is clear that in many locations external oversight is not is not
happening at present. CPA would have difficulty expanding its accreditation
schemes to cover this even if NHS clinical chemistry laboratories could
cope, which seems unlikely. But the underlying problem is that the MHRA
guidelines are guidelines, not laws; there is no method of enforcement.
Suggestions for how to introduce enforcement were somewhat lacking. It was
pointed out that introducing a system of enforcement would be contrary to
the general trend of current DoH policy. I suggested that tests which are
performed outside a proper system of accreditation should at least be
clearly labelled as such, to avoid confusing the public and clinical staff;
but even this seemed to receive little support. So despite remarkably
unanimous agreement on the nature of the problem, I was disappointed by the
lack of a clear way to resolve it. Perhaps post-meeting discussions will
come up with some progress, but I've not been involved in any yet. Not
related to this meeting, you may be interested that there is a Parliamentary
Select Committee about to start considering 'the introduction of new
technology into the NHS'. The RCPath has submitted evidence to this Select
Committee, and I ensured that our evidence includes a discussion of the
problem of unregulated POCT use. Whether anything comes of it remains to be
seen. With best wishes Peter Furness
-----Original Message-----
From: Royle Chris [mailto:[log in to unmask]]
Sent: 16 February 2005 10:38
To: Furness Peter - Professor of Renal Pathology
Subject: POCT / NPT
Peter,
How did your meeting re. the above go last week?
Chris
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