This is a bit of a hobby horse of mine. The profile of (and demand for) POCT
is likely to rise for at least 3 reasons: GPs now see that this could be
regarded as providing an 'enhanced service' for which they could be
renumerated under the new GP contract. Secondly, the DoH perceive POCT
(rightly or wrongly) as a means of hitting the forthcoming 18 week referral
to treatment target. Lastly, NPfIT allows the opportunity that results from
POCT instrumentation can be indelibly recorded into an patient's electronic
record so that near patient result would no longer have to be automatically
checked by a central laboratory.
With regard to the way forward, there could be 2 guiding principles which
would help in mandating that results from community POCT were of adequate
quality.
The first principle is to exclude non-'accredited' organisations from being
able to place results onto the NHS NPfIT spine:
It is currently mandatory in England that NHS laboratories pursue CPA
accreditation. It would therefore seem consistent with DoH policy- not
against it as suggested at the meeting below- that if an organisation
(pharmacy, TC etc) wished to provide results for the NHS via the NPfIT spine
then they too should meet minimum quality standards. Otherwise how is a
clinician going to be able to distinguish between a ropey NPfIT result and
one that can be used diagnostically?
The second guiding principle relates to defining a minimum quality standard:
This is not to say that every pharmacy will need to be accredited to current
lab CPA standards, but that they will either have to be responsible to a lab
that is, or itself be accredited through a subset of our standards. The
point is made that NHS clinical chemistry labs would have difficulty in
coping accrediting such a number of sites, but I am not currently aware of
hospital pharmacists having to spend time accrediting their commercial
counterparts. This is through an independent system funded by the
organisations which wish to be included.
Furthering this analogy, I just wonder if the MHRA would tolerate smaller
pharmaceutical companies adhering to less stringent quality control
standards than the larger ones? It would certainly get round the national
diamorphine shortage I hear about!
Kindest regards
Eric
Dr. Eric S. Kilpatrick
Consultant in Chemical Pathology
Department of Clinical Biochemistry
Hull Royal Infirmary
Anlaby Road
Hull HU3 2JZ
Tel 01482-607708
Fax 01482-607752
>From: Royle Chris <[log in to unmask]>
>Reply-To: Royle Chris <[log in to unmask]>
>To: [log in to unmask]
>Subject: FW: POCT / NPT
>Date: Thu, 17 Feb 2005 07:25:13 -0000
>
>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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