Though no longer in the field, I largely agree with both Elizabeth
Mac Namara and Michael Ryan. My lab's primary past role in providing
routine analytical services was as an 'expert' Supraregional hormone
assay laboratory, one of half a dozen or so established in the UK
before the age of kits and analysers. We  certainly did not see
ourselves as an ivory tower, but simply as a specialised group with
the experience and equipment necessary to measure the hormones in
which we and other departments had a research interest, and for which
we had therefore developed the relevant assays.

Samples were sent to us from across the UK, often accompanied by
almost undecipherable request forms with little or no useful
information  regarding the patient.  We regarded our central
responsibility as being the provision to the requesting clinician of
a reliable result as quickly and efficiently as possible, having used
every internal quality control procedure of which we were aware to
ensure that results were "accurate" or (if this concept was
inapplicable) "consistent". We made no attempt to interpret results,
but the Supraregional Assay Service Laboratory Directors - realising
that requesting clinicians might have insufficient experience either
to know when a particular test was  appropriate or to interpret the
result -  published a manual largely written by experienced
endocrinologists providing the information required to do both. This
was very popular and went to 3-4 editions. If a clinician requesting
a test from my lab still had difficulty in regard to a particular
patient, he /she was encouraged to call the lab, when he/she would be
referred to a clinical endocrinologist with specialised knowledge of
the particular field to which the assay related.

Times and technologies have changed, and clinical chemists (and the
routine functions of labs such as my own) have been effectively
replaced by automated machines.  I sympathise with many of the points
made by Mike Addison. but perhaps I am naive and out of touch in
believing that many of the problems he highlights could be addressed
(in the age of the Internet) by the development of sophisticated
information and data analysis systems that minimise the risk of
unnecessary tests being requested, and of the results of tests being
incorrectly interpreted.

Given the prospect of the introduction of miniaturised
microarray-based diagnostic testing  in the near future (possibly in
every GP's surgery)*, my personal feeling  is that such a development
is both vital and inevitable.

Roger Ekins

Molecular Endocrinology
University College London

*Note: For example, since every major pharmaceutical company in the
world is now developing "personalised" drugs using  microarray based
"genomic" and (ultimately) "proteomic" assay technologies to classify
patients, it is likely that the prescribing  of drugs will generally
be preceded by such a test.




>I hate to add yet another stick to a well burning fire but as a physician
>practicing on the wards and in the laboratory I have to be honest and say
>that I  think interpretative comments are close to useless and stem from the
>days when the laboratory tests were influenced by everything including the
>temperature in the laboratory. After accuracy and precision TAT is the next
>most important component vis-à-vis patient care. Most of the automated
>results from my laboratory are automatically released, i.e. are never seen
>by a laboratory technologist or Biochemist. This occurs if there is no error
>messages sent across the interface and they are not in the panic value
>range. I would want some serious data, not just ideologies, to change this
>practice. The sooner a good result is back to a physician the better it is
>for the patient. Hard as it may be for me to say it I agree with Mike Ryan
>
>Elizabeth Mac Namara
>JGH Montreal, Quebec, Canada
>
>-----Original Message-----
>From: This list is an open discussion list for the academic community
>workingin [mailto:[log in to unmask]]On Behalf Of
>[log in to unmask]
>Sent: November 30, 2001 6:31 AM
>To: [log in to unmask]
>Subject: Re: Out of hours validation - responses
>
>
>This 'validation debate' is fascinating. This 'add-on' type of activity
>must surely be ripe for review. When a result is analytically correct,
>additional validation and interpretative commenting is more often than not
>merely a form of occupational therapy for senior laboratory staff rather
>than a useful contribution to patient care. The information available to
>the laboratory is simply insufficient to merit any definitive contribution
>in many cases.
>
>We have just received our CPA report. Our accreditation status has been
>'reduced' to conditional unless our laboratroy computer system is replaced
>within a year. The reason given is that interpretative reporting facilities
>are limited.
>
>Naturally, we are disappointed as we feel that the level of clinical detail
>given on request forms is often insufficient to  provide an intelligent
>interpretive comment. Indeed, with limited knowledge of the global state of
>the patient, so-called interpretive comments based on biochemistry alone
>are often unhelpful and may be downright dangerous. Indeed, this is
>recognized in recent college guidelines (SAC , Chemical Pathology).The
>personal interaction with clinicians is far more useful. 'Ivory tower'
>interpretive comments based on little more than a 'biochemical snapshot'
>undermines the credibility of clinical biochemistry and risks the dismissal
>of the laboratory's contribution to patient management as mere
>'interference'. Holding results for such 'validation procedures' increases
>TAT, insults the intelligence of our users more often than we would like to
>admit, and has little evidence base to back it up.
>
>Has anyone ever tested the utility of interpretative comments in terms of
>contribution to patient mangement rather than in terms of an internal
>feelgood factor ? Has CPA overstepped the mark here? It seems the oucome of
>the debate has been anticipated to the point where interpretive comments
>have become an end in themselves, without due regard to their
>appropriateness. Surely evidence based practice should apply to the
>accreditation process as well. In the absence of evidence of any shortfall
>in service to patients, should the limitations of 'interpretative comments'
>facilities threaten the Accreditation of the entire service ?
>
>Michael Ryan

--
Regards

Roger

Molecular Endocrinology
University College London Medical School
London W1N 8AA

Fax +44 20 7580 2737
Phone +44 20 7679 9410

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