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I don't see why notices should suffice. Most G.P.'s
post a notice on the day, in their surgery, when they
have a medical student present. In hospitals ,patients
are surrounded daily by medical students before the
consultant announces them.







 --- "Steven C. Martin" <[log in to unmask]>
wrote: > >We have tackled the problem of using
patients
> samples for QC and method
> development. No formal consent is required. The
> RCPath guidelines for
> dealing with surplus tissue samples (anything
> containing human DNA) state
> that at present consent is implied and that we
> should work towards specific
> consent (as a distant goal). We are only required to
> inform patients of the
> current situation and allow them to 'opt-out' of
> further testing should
> they so wish. We are putting up notices in
> Phlebotomy, Out-Patients and on
> the ward phlebotomy trolleys. There is a summary
> printed on the back of our
> request forms, too. In practical terms the phrase,
> "No Other Consent" (NOC)
> has been adopted to indicate that the tissue should
> be disposed of after
> testing and blood tubes are to be marked with a
> thick black felt pen (the
> Black spot!). Any QC or development work can then
> proceed as before without
> reference to the ethics committee as long as the
> samples are anonymised
> beforehand.
>
> Steven C. Martin
> West Suffolk Hospital
>
>
> Indeed Jonathan.
> >I think this problem extends far beyond the issue
> of EQA.
> >We need to bring this up as a clinical governance
> issue -
> >"can we really continue to provide a service for
> analyte X unless these
> >problems are addressed?"
> >
> >Here is a letter I wrote to John Underwood in
> August in response to their
> >"consultation" document. Did anyone else write, and
> how were these views
> >addressed in the final document?
> >
> >Dear Professor Underwood
> >
> >We were invited to comment on the human tissues
> consultation document
> >available at:
> >www.doh.gov.uk/tissue
> >
> >The main issue I would raise is that the approach
> to the issue of the use
> of
> >samples for quality control and related issues is
> naive to say the least.
> >The use of samples to manage methodological change
> in routine clinical NHS
> >practice is not addressed at all. Thus all we read
> is:
> >
> >"(i) quality assurance and audit
> >With some clinical procedures or tests (e.g.
> cervical screening) some
> >separate examination or testing of tissue is
> essential to ensure a high
> >quality of service and hence the reliability of
> such procedures. The
> >Department believes that tissue samples may be used
> for quality assurance
> >and audit purposes without requiring specific
> patient consent. However,
> >there need to be active local arrangements for
> informing patients of such
> >use. Wherever possible, such samples should be
> anonymised or
> pseudonymised."
> >
> >This doesn't really address the practical issue at
> all. This is in part
> >because quality control is not defined, and in the
> absence of such
> >definition, ethics committees have to treat all
> things passed before them
> >with a common brush.  The absence of clear and
> appropriate guidance in
> this
> >area is leading to real problems with quality
> service provision.
> >
> >To give a real-world example:  I am involved in the
> development and
> clinical
> >application of biochemistry measurements in bone
> disease (working 300
> yards
> >from you in the Clinical Sciences Centre as it
> happens). Method A might be
> >in routine clinical use at the moment. However
> methods evolve, often in
> ways
> >which are not fundamental (for example method A
> might be upgraded from a
> >manual method, to an automated method using a
> similar but slightly
> different
> >antibody). There is no guarantee that the new
> variant of Method A will
> >provide the same information as Method A version 1.
> Furthermore, reference
> >ranges and clinical decision thresholds are likely
> to alter.
> >
> >In order to allow this change to happen, it is
> mandatory that there should
> >be direct comparison of the two methods in real
> samples from patients in
> >whom the measurement matters. Since appropriate
> samples take time to
> >collect, use of stored material collected during
> routine use of the assay
> is
> >necessary. Obtaining consent is usually impractical
> because this implies
> >that one knows in advance 1) exactly how a
> methodology is likely to
> >transmute, 2) that a patient is likely to require
> consent, before the
> sample
> >is actually collected,  3) where the number of
> patients required for a
> >method evaluation is large as in clinical
> chemistry, arranging for
> patients
> >to return specifically for another sample and
> carries a huge clinical
> cost,
> >and also projects this activity firmly into the
> area of research (which it
> >is not). This is activity which falls very much at
> the border-zone between
> >quality control, and rather simple (often
> unpublishable) research. Writing
> >an ethics proposal every time I want to change the
> parameters of a
> >particular assay is unfeasible.
> >
> >What happens in practice is that laboratories
> simply fail to provide an
> >adequate service, because to do so is too daunting
> a task. I note with
> >amazement that many clinical chemistry laboratories
> are abandoning the use
> >of in-house reference ranges for many analytes
> (even those which are
> >in-house assays!) and are also abandoning method
> comparisons based on
> >RELEVANT patients, simply because this data is too
> hard to obtain. This
> can
> >(and I know already has) led to NHS laboratories
> generating much data
> which
> >is of poor quality, and which is often entirely
> meaningless.
> >
> >You will note that I have not attempted to make any
> positive suggestions!
> >However, creative ways have to be found to address
> this problem e.g.. easy
> >provision for retrospective telephonic consent to
> use and store blood
> >samples for QC purposes,  good guidance and
> definitions for use by ethics
> >committees in relation to analytical service
> provision and so on.
> >
> >Regards
> >
> >Aubrey Blumsohn
> >
> >----- Original Message -----
> >From: "Jonathan Middle" <[log in to unmask]>
> >To: <[log in to unmask]>
> >Sent: Thursday, December 19, 2002 1:23 PM
> >Subject: Re: Request for help re: Consent Issues
> >
> >
> >> This issue affects the EQA community greatly and
> has been a
> >> cause of considerable concern and even 'drying
> up' of some
> >> sources of material without which some schemes
> will cease to
> >> exist or have to get by on inadequate material.
> >>
> >> As stated, the guidance is that for QA, education
> and research
>
=== message truncated ===

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