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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-----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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