And he is right but that includes QA and EQA. Lab standard and good
enough require QA. Without QA it is not good enough.
Bet he would not buy a car from a manufacturer that didn't QA its
brakes.
Beware the search for imprecision perfection when biological variation
is high.
Paul Collinson
Consultant Chemical Pathologist
St George's Hospital, London
0208 725 5934
-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]] On Behalf Of Janice Still
Sent: 14 August 2007 11:48
To: [log in to unmask]
Subject: Re: Is "POCT" all that it now seems accepted to be.
Rhodri Morgan, First Minister for Wales, speaking two years ago
regarding POCT said "POCT does not have to be to laboratory standard; it
needs to be good enough."
Mrs. J. Still,
POCT Manager,
Biochemistry Dept,
Watford General Hospital. 01923-217998.
The views expressed in this message are personal and do not reflect West
Herts NHS Hospitals Trust policy.
----- Original Message ----
From: Jonathan G. Middle <[log in to unmask]>
To: [log in to unmask]
Sent: Tuesday, 14 August, 2007 10:53:46 AM
Subject: Re: Is "POCT" all that it now seems accepted to be.
I think that anything that encourages providers of POCT services to
embrace quality management and accreditation is a good thing, but there
is still the fundamental question of whether these systems are
analytically valid and the results are comparable with main laboratory
systems. This can't assume that the results from the latter are
analytically valid, as we know that many are not. We still have huge
problems with methods giving different results and, as a consequence,
labs needing completely different reference ranges and clinical decision
points. We have further problems with variable interpretation of
results and the lack of high quality evidence that tests are clinically
useful in the first place.
It seems to be a hopeless task now to get these problems across to those
who wish to re-configure laboratory medicine and use POCT in the front
line to send patients them down different clinical pathways. No
politician or commissioner wants to know about 'problems' (all your
results are the same wherever they come from aren't they?), and there
are even members of our profession who want to warmly embrace this new
service delivery infrastructure before establishing that tests results
are correct and useful. (The pragmatists vs the purists debate again.) I
used to be told by colleagues that all this didn't really matter because
POCT had a 'different purpose', and it could always be backed up and
checked by 'proper' tests at the local laboratory. This may not be the
case in the future.
Those of you who watched Richard Dawkins (Enemies of Reason - Ch 4) last
night might be tempted to speculate that like large swathes of our
society who prefer to believe something because of how it makes them
feel rather than what is supported by scientific evidence, laboratory
medicine has now become infected by the POCT 'meme' and there is no
going back!
I have proposed at least twice before in this forum that we need an
independent body that has the clear two-pronged mandate to examine the
evidence for the clinical utility of laboratory investigations, and to
enforce strict quality specifications (trueness, traceability,
uncertainty, robustness to interference, linearity, recovery etc - all
the things that used to be our bread and butter as scientists) on
manufacturers of instruments, reagents and calibrators. I believe that
such a body is needed now more than ever.
Jonathan
(I am on holiday!)
Dr Jonathan Middle
Deputy Director, UK NEQAS Birmingham
0121 414 7300, fax 0121 414 1179
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Birmingham NHS Foundation Trust or University of Birmingham.
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-----Original Message-----
From: Clinical biochemistry discussion list on behalf of Annette Thomas
Sent: Mon 13/08/2007 20:07
To: [log in to unmask]
Subject: Re: Is "POCT" all that it now seems accepted to be.
My experience with the large high street Pharmacist chains is that
things
are rapidly changing and they are now very much concerned with Quality.
As
of this month Boots will be rolling out a fairly comprehensive EQA
programme
for all stores carrying out Cholesterol, HDL and glucose. All stores
carry
out daily QC and there are quality protocols in place including Training
guides, SOPs, troubleshooting guides and procedures to recall clients
should
anything go wrong. So far I have been quite impressed.
To comment on Jan's last statement - they did ask for my advice and
hopefully would have been influenced accordingly (re Richard's comment
on
NEQAS influence).
Re: previous comments on accreditation. I don't think they fit into the
typical CPA accreditation or even ISO 22870 model, however it wouldn't
be
too difficult to come up with a certification system for pharmacy (or
any
other) POCT activity.
Initial thoughts for a model for certification:
Partnership with accredited laboratory (otherwise organisation have to
comply with ISO 9001:2000)
Accredited trainers - to undertake training, certification and review
(ideally laboratory POCT co-ordinators)
Accredited Training courses for end users to include Knowledge and
skills
assessment
Mandatory annual review to include audit, EQA performance assessment.
Am I being too simplistic.
Annette
Annette Thomas
Consultant Clinical Biochemist
Cardiff and Vale NHS Trust
Quality Laboratory
Quadrant Centre
Cardiff Business park
Llanishen
Cardiff
CF14 5WF
Tel 02920 748332
Fax 02920 748336
www.weqas.com
_____
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]] On Behalf Of Williams David G
(RLN) City Hospitals Sunderland - Clinical Scientist
Sent: 13 August 2007 16:25
To: [log in to unmask]
Subject: Re: Is "POCT" all that it now seems accepted to be.
Having discussed the matter with our local pharmacists, the following
may be
of interest:-
1. The majority of small pharmacies (and their pharmacist owners) are
not
over keen on the concept of POCT, due to the cost of the equipment, plus
the
additional cost of staff time and training for what may prove to be the
occasional customer.
2. The concept of External Quality Assurance is a new (and rather
frightening) concept for them, (let alone CPA) and again there are cost
implications.
3. The "High Street" Chemists (mainly Boots) are being (or possibly were
being, following their takeover) courted by the government with a view
to
providing "drop in" centres, along with supermarkets.
4. In amongst all of this, there seems to be no discussion of the
quality of
results.
I suspect that commercial POCT providers may well escape the need for
EQAS
etc, until, that is, the first few cases of litigation.
-----Original Message-----
From: Janice Still [mailto:[log in to unmask]]
Sent: 10 August 2007 17:27
To: [log in to unmask]
Subject: Re: Is "POCT" all that it now seems accepted to be.
I agree Richard. As one working in POCT full time, (I was wicked in a
previous life) you have to have someone keeping their eye on what is out
there all the time. I have a strong multi-disciplinary committee to vet
all
POCT applications and the first question is one of clinical need, and
why
cannot the laboratory provide this service.However, someone has failed
to
point out the pitfalls to the government , who seem to have been sold
the
idea that POCT is the new wonder drug for the ailing NHS.
Having stood in my own local pharmacy and watched someone take the most
useless sample for blood glucose, I have grave concerns about the
quality of
the service. I know that the big companies like Lloyds and Boots are
keen on
EQA and quality matters, but as far as I am aware there is no laboratory
overview of this.The attitude seems to be that these are private
companies
and the rules are different. Perhaps the first litigation will sharpen
the
issue.
Dare I suggest that perhaps we are all at fault for not having seen this
coming, and got in on the ground floor to advise and influence, and be a
part of the initiative.The old adage about which side of the tent you
are on
springs to mind.
Jan
Mrs. J. Still,
POCT Manager,
Biochemistry Dept,
Watford General Hospital. 01923-217998.
The views expressed in this message are personal and do not reflect West
Herts NHS Hospitals Trust policy.
----- Original Message ----
From: Mainwaring-Burton Richard (RGZ)
<[log in to unmask]>
To: [log in to unmask]
Sent: Friday, 10 August, 2007 4:53:15 PM
Subject: Re: Is "POCT" all that it now seems accepted to be.
In a similar vein - our local PCT is determined to remove laboratory
services nearer the patient, a trend which I agree to be socially
beneficial
to such as anticoagulant and diabetes patients. However, when asked
about
accreditation of the service, there seems to be an assumption that the
equipment is totally reliable, and external QC is not necessary, and of
course all operators are infallible. This also applies to high street
operators, be they cowboys, pharmacists or both.
Is it in order or possible for the NEQAS team, ACB etc to exercise some
influence ? It seems somewhat unfair inconsistent that the real
laboratories have very tight CPA hoops to traverse, but if we set up in
the
community, no rules apply. The document drawn up by the MDA in 2002 has
little weight now as the PCTs seem to be declaring UDI from their local
laboratories - indeed they may be setting the laboratories against each
other.
I understand that the CLSI in the US is looking at the issues. Anybody
know
how it progresses?
with best wishes
Richard
Richard Mainwaring-Burton
Consultant Biochemist
Queen Mary's Hospital
Sidcup, Kent
020-8308-3084
-----Original Message-----
From: Grimes, Helen, UCHG [mailto:[log in to unmask]]
Sent: 10 August 2007 16:03
To: [log in to unmask]
Subject: Is "POCT" all that it now seems accepted to be.
Am I being "non-modern" in querying POCT?
The most comprehensive review of POCT to date, published by the US
National
Academy of Clinical Biochemistry in 2007 states "There is a need for
establishing an evidence based practice for POCT. POCT is an
increasingly
popular means of delivering laboratory testing. When used appropriately,
POCT can improve patient outcome by providing a faster result and a
shorter
timeframe to therapeutic intervention. However, when over utilised or
incorrectly performed, POCT presents a patient risk. POCT may seem
deceptively simple, but the test is not freely interchangeable with
traditional core lab instrumentation in all patient care situations.
POCT
may seem inexpensive, but over utilization leads to significant
increases in
cost of care. The value of POCT really needs to be demonstrated through
well
designed randomised control trials"
How then has "POCT" managed to be suggested as the replacement for
laboratories. POCT used to mean blood gas, expanded to critical care
analysers and glucometers, and when used in units such as ICU, PBU etc
we
are all aware how useful that is, but that is obtained with major
laboratory
input. For those of you who have "modernised", how have you changed
medical
staff from being used to 10 tests/patient 24 hours a day, to a few
limited
analyses? How many staff do you have supporting the instruments? Is it
really as wonderful as claimed? Are there some crazy results being
recorded
for patients, or are they being recorded at all?
Helen
------------------------------------------------------------------------
----
--------------
Dr Helen Grimes, Dept Clinical Biochemistry, University College
Hospital,
Galway, Ireland
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